About Hygiene. Requirements For Products Intended For Contact With Food

Original Language Title: o hygien. požadavcích na výrobky určené pro styk s potravinami

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=50826&nr=38~2F2001~20Sb.&ft=txt

38/2001 Coll.
DECREE

Ministry of Health


Dated 19 January 2001

On hygienic requirements for products intended for contact with food and dishes


Change: 186/2003 Coll.

Change: 207/2006 Coll.

Change: 551/2006 Coll.

Change: 271/2008 Coll.

Change: 386/2008 Coll.

Change: 127/2009 Coll.

Change: 111/2011 Coll.

Ministry of Health, pursuant to § 108 paragraph. 1 of Law no.
258/2000 Coll., On protection of public health and amending some
related laws, (hereinafter the "Act") to implement § 26. 1 point.
B) and d) and paragraph. 2 and 3 of the Act:
PART ONE


General hygiene requirements for products intended for contact with food and

DISHES
§ 1
Heading left


This Decree implements the relevant regulations of the European Communities ^ 1)
and adjusted in relation to the directly applicable regulations of the European Communities
^ 1) hygienic requirements for materials and articles intended
contact with food (hereinafter " products intended for contact with food
").

§ 2

Interpretation of certain terms

For the purposes of this Decree

First overall migration total weight of components of plastic or
plastic product, which is released during the leaching test and
precisely defined conditions to a food or food simulant,
per unit area of ​​the plastic or plastic product, or
mass quantities of food or food simulant;

Second specific migration transition of a substance from a product into food or
on food or in food simulant, unless specified otherwise
;

Third food simulant test solution precisely defined composition and
exactly defined properties, replacing a food or group of foods
in verifying overall and specific migration;

Fourth specific migration limit of the maximum allowable value
specific migration of substances from the product into food or food or
food simulant, unless otherwise specified;

Fifth short intercourse intercourse exceeding four hours for drinks and food
liquid consistency and for 48 hours for solid food or
pasty;

6th fats besides fats and of oil, water-in fats and oils and
food to which spontaneously separates the fat phase;

7th Acidic foods food with a pH lower than 4.5;

8th highly acidic foods Foods with a pH of less than 3.7;

9th food dry food that its appearance and features
responds to this indication and in which the water content is such that it does not contribute to
accelerate its deterioration or decrease in biological value;

10th using a "low temperature" contact materials and food
temperature lower than +5 st. C;

11th using a "high temperature" contact materials and foods
temperature above 45 st. C;

12th completing hot food contact material at 45 Wed.
100 st. C, the system no longer heated;

13th cooking material products used to prepare food or edit
food at temperatures above 90 st. C;

14th contact by boiling and food contact material with a temperature higher than 90
st. C;

15th functional flat surface portion of the product which in normal use
product comes into direct contact with foodstuffs;

16th edge for drinking 20 mm wide strip along the top edge on the outer side
refillable products that could result from drinking from these products
come into contact with the mouth;

17th harmful influence effect which is caused by the substantial reduction
edibility food (for example chemical, pathogenic or other undesirable
microorganism toxin pests, domestic animals and other contaminants
);

18th sensory analysis for organoleptic product
sense organs;

19th elastomers entire spectrum of elastic polymers or polymers with rubbery
behavior unsystematically known as: rubber, synthetic rubbers or elastomers
;

20th rubber polymer which can be converted to rubber vulcanization;

21st natural rubber latex obtained from rubber kaučukodárných
plants (such as Hevea brasiliensis). The essence is cis-1,4-polyisoprene with
nekaučukovitých small amount of impurities;

22nd synthetic rubber rubber produced growth polymerization, especially
polymerization and copolymerization;

23rd rubber vulcanised rubber mixture or rubber;


24th pottery objects made of a mixture of inorganic
materials with a generally high argillaceous or silicate, to which may be added
small amount of organic substances.
These articles are first shaped and the shape thus obtained is permanently fixed by firing.
Products can be glazed, enamelled or decorated;

25th inorganic glass material produced by fully melting the raw materials at high temperatures
homogeneous liquid which is then cooled to a liquid state
without substantial crystallization;

26th inorganic glass ceramic material produced by fully melting
raw materials at high temperatures to a homogeneous liquid which is subsequently
cooled to a solid state to form a specific proportion of the crystals;

27th vitreous enamel, inorganic coating which is fused onto the metal at a temperature above 500
Wed. C.

28th plastics, organic macromolecular compounds obtained by polymerization,
polyaddition or other similar processes from molecules with a lower molecular weight
or chemical alteration of natural macromolecules
. These macromolecular compounds can be added
other substances or materials listed in Annex no. 3 hereto and
under the terms of this decree,

29th polymer additive material which is physically in the polymers
dispersed without significantly affecting the structure of the polymer, and is added
due to influence of processing properties or for the purpose of modifying useful properties
polymer

30th GMP implemented and maintains a set of measures
guarantees the production process control and reproducible product quality with
desired properties.

31st multi-layer material or article made of plastic material or
plastic product, which is composed of two or more layers of materials, each consisting
entirely from plastic and which are joined together
adhesives or otherwise

32nd plastic functional barrier, a barrier consisting of one or more
layers of plastics which ensures that the finished product complies with the requirements of this Decree
and directly applicable European Community
^ 1b)

33rd fatty foods foods for which Annex no. 4 to this
Decree provides for migration testing simulants other than simulant D

§ 3

Requirements on the composition of products intended for contact with food

(1) Products intended for contact with food must meet
directly applicable European Community ^ 1b)
hygiene requirements and limitations set out in this notice and the kind of product requirements to protect human health
against risks that might arise through oral contact with
products according to the requirements set out in § 15 point. ) and
Annex no. 9.

(2) Hygiene requirements and limits for products intended for contact with food
must be verified under the conditions and rules laid down by this Decree and
directly applicable European Communities ^
1c).

(3) In the manufacture of products intended for contact with food
may be used only natural materials such as cork or wood
non-toxic trees, without defects, bark and resin release with
smooth nepopraskaným surface. These materials may not show signs
by pests or microorganisms, especially microscopic filamentous fungi
.

(4) Materials and articles of plastics, paints, coatings and products
covered by surface coatings, and adhesives that contain, or are
made from one or more of the following

) 2,2-bis [4- (2,3-epoxypropoxy) phenyl] propane, and some of its derivatives,

B) bis (2,3-epoxypropyl) ether, bis (hydroxyphenyl) methane, and some of their derivatives
,

C) novolac ethers and some of their derivatives must meet the requirements
directly applicable European Community ^ 1d).

(5) The requirements set out in paragraph 4 shall not apply to containers and
storage tanks having a capacity greater than 10,000 liters, as well as their
pipe and connected with them, which is regulated by heavy-duty || | coating.

§ 4

Verification of compliance with hygiene requirements

(1) to verify the hygienic requirements laid down by this decree
using validated analytical methods meeting the requirements
directly applicable regulation of the European Communities ^ 1c) or

Rules and conditions laid down in Annexes Nos. 1 to 14 to this Decree.
If the method is to be modified, you can use the method with reasonable
characteristics with respect to the relevant hygiene limit laid down
this decree.

(2) Products intended for contact with food made by combining multiple types of materials
is evaluated as a whole, with the main emphasis on
material that comes into direct contact with food.

§ 5

Construction products intended for contact with food

(1) Products intended for contact with food must be in relation to their use
designed to allow proper cleaning, sterilization, disinfection
possibly before any food contact, and that throughout
his lifetime withstand cleaning, disinfecting and sterilizing
resources and procedures. Must have a functional and mechanical properties
corresponding to the intended use.

(2) surfaces, coatings or decorations products must be free of violations,
resistant to cracking, chipping, flaking and abrasion.
Must withstand exposure of food, food ingredients and substances.

(3) Products intended for contact with food intended for repeated use
must also repeated use
conform to the hygiene requirements laid down by this Decree. These products may be neither
temporarily used for non-food goods.

(4) Products intended for contact with food, not intended for repeated use
, not in food production and placing on the market of foods
reused either the original or another purpose
food.

§ 6

Dyeing, printing and decoration products intended for contact with food

(1) For dyeing, printing and decoration products intended for contact with food
may only be used dyes and pigments which are the products
embedded and meet the purity requirements
provided for in Annex . 1st

(2) Products intended for contact with food can be printed just for
surfaces that come in contact with food.
For products consisting of several layers may be printed in the interlayer.
Printing can not penetrate or be imprinted on surfaces that come into contact with food
. Solvents paint must be completely draining.

(3) For the dyeing and printing products intended for contact with food
not use coloring agents based on compounds of antimony
arsenic, hexavalent chromium, cadmium, lead, mercury and selenium.

(4) For the dyeing and printing products intended for contact with food can be used
azo dyes and disazo (eg diarylpigmenty)
only under the condition that during all stages of the technological process of production and processing of products and
at their next proper and predictable
use will not exceed the temperature at which the decomposition of dye
to form carcinogenic aromatic amines.

(5) Carbon black is used as an ingredient in products for food contact
must conform to the purity requirements in accordance with Annex No.1.

(6) Paragraphs 1 to 3 do not apply to baked decors
silicate products, which must meet the hygiene requirements of
§ 19th

§ 7

Fillers for products intended for contact with food

(1) As the filler products intended for contact with food must
use substances based on compounds of antimony, arsenic, hexavalent
chromium, cadmium, lead, mercury and selenium.

(2) Fillers products intended for contact with food may be used only
substances that meet the purity requirements set out in Annex
no. 1st

§ 8


Canceled
§ 9


Canceled PART TWO


HYGIENE REQUIREMENTS individual materials they are made of
products intended for contact with food
TITLE
I

REQUIREMENTS FOR PRODUCTS OF PLASTIC

§ 10

(1) The plastics are not

A) varnished or unvarnished regenerated cellulose film,

B) elastomers and materials based on natural and / or synthetic rubber
,

C) paper and paperboard, modified and unmodified addition of plastics,

D) finishes obtained

First paraffin waxes, including synthetic paraffin waxes or microcrystalline
,

Second mixtures of the above-mentioned waxes or with plastics,

E) ion exchange resin,

F) silicones.

(2) The requirements of § 11 to 14 shall apply to products intended for

Contact with food, and parts thereof, consisting solely
plastic, or consist of two or more layers, each of which is composed exclusively
plastics layers or surfaces of plastics, forming a sealing | || rings lids that together are composed of two or more layers
different materials. Apply to products composed of two or more
layers of which one or more is not composed solely of plastics and
even in cases where the layer intended for direct contact with food is
plastic. Such products are evaluated according to § 4 para. 2nd

(3) Notwithstanding paragraph 2, in the case of a layer that is not in direct
contact with food and is separated from the food functional barrier
plastic, can make the case that the final material or article
in accordance with the specifications and migration limits specified in this decree
:

A) not comply with the restrictions and specifications set by the
decree

B) be manufactured with substances other than those listed in Annex
no. 3 hereto.

(4) The migration of the substances pursuant to paragraph 3. b) into food or food simulant
provided a method of analysis complying with the requirements
directly applicable European Community ^ 2)
not exceed 0.01 mg / kg. This limit shall always be expressed as
concentration in foods or simulants. Shall apply to
group of compounds which are structurally and toxicologically related, in particular
isomers or compounds with the same functional group, and includes possible
off transfer.

(5) The substance listed in paragraph 3. b) shall not belong to either one of these categories
:

) Substances classified as substances for which evidence is or is deemed
that the substances are carcinogenic, mutagenic or toxic for reproduction
by special legislation 2a) or

B) substances classified under the self-responsibility criteria as
carcinogenic, mutagenic or toxic for reproduction
under a special legal regulation 2a).

§ 11

(1) For the manufacture of plastics and plastic products intended for contact with food
can only be used monomers, starting substances and additives listed
list of substances in Annex no. 3, while respecting the limitations established || | and specifications.

(2) General specifications related to plastic products and materials
are set out in Appendix II of Annex no. 3. More specifications
relating to certain substances included in the positive list of Annex
no. 3 are set out in Appendix II to Part B of this Annex. Particulars
declaration of conformity 2b), which connects to materials and articles
plastics, are set forth in Annex no. 3 hereto.

(3) The lists of substances under Annex no. 3 hereto exclude

A) monomers and other starting materials and additives used in the manufacture

First surface coatings obtained from resinous or polymerised products in liquid, powder
or dispersion form, such as varnishes and paints,

Second epoxy resins,

Third adhesives and adhesion promoters,

Fourth inks, or

B) colorants

C) solvents.

§ 11a

(1) If the production of plastic products intended for contact with food
used additives which are authorized as food
additives or flavorings food
by special legislation, 3) not these substances are released into
food

A) in quantities having a technological function in the finished
food

B) which is authorized as food additives or substances
flavorings, in quantities exceeding the restrictions set
according to special regulations or restrictions provided for in § 11;
Compliance with this provision is assessed by restriction, which is
stricter

C) which are not permitted as food additives or flavorings substances
in quantities exceeding the restrictions provided for in § 11th

§ 11b

(1) additives listed in Annex no. 3 hereto, which are used in the production
layers and surfaces of plastics lids must meet
restrictions and specifications on their use under this Annex.

(2) the use of additives which exclusively act as adjuvants
for polymerization and which do not remain in the final product (hereinafter

"PPA"), to produce films and surfaces of plastics listed in Annex no. 3 to
this Decree shall apply to the restrictions and specifications listed in this Annex.

§ 12

(1) Plastics and plastic products must not transfer their constituents to foodstuffs
in quantities exceeding 60 milligrams of the constituents released per kilogram
food or food simulant (hereinafter the "overall limit
migration"). | ||
(2) the following may be used overall migration limit of 10 milligrams per decimeter
square surface of a material or product:

a) containers or products that resemble containers and other fillable ,
capacity of less than 500 milliliters or more than 10 liters

b) sheet, film or other products which can not be filled or for which it is impracticable to estimate
relationship between the surface of the product and the quantity of food ,
which is in contact with it.

(3) in the case of plastic products that have come into contact with
food intended for infants and young children under a special legal regulation
^ 4) or already in contact with these foodstuffs, the limit on overall migration always
60 milligrams per kilogram of foodstuff or food simulant
.

§ 13

(1) The migration of the individual components of materials and plastic products
not exceed specific migration limits or other restrictions specified in the list of substances
.

(2) The specific migration limits of substances listed in Annex no. 3
are expressed in mg.kg-1, based on the weight of food or food simulant
.

(3) In these cases, the limits of specific migration
expressed in mg.dm-2:

A) containers or products that are similar to containers or which can be
filled, with a capacity of less than 500 milliliters or more than 10 liters

B) sheet, film or other products that can not be filled and which can not be
determine the relationship between the surface of the product and the quantity of food
which is in contact therewith.

(4) In cases where the limits specified in Annex no. 3 are expressed in
mg.kg-1 can be divided by the conventional conversion factor of 6 to convert
mg.dm-2.

(5) Verification of compliance with the migration limits shall be carried out according to the rules
laid down in Annex 4.

(6) Verification of compliance with specific migration limits are not mandatory,
if it can be established that compliance with the overall migration limit is not exceeded
specific migration limits.

(7) The verification of compliance with the specific migration limits provided for in paragraph 5
not mandatory unless it can be demonstrated that, by assuming complete migration
residual substance in the product is not exceeded
specific migration limits.

(8) Verification of compliance with specific migration limits can be done by setting
amount of substance in the finished material or article assuming
relationship between this amount and the value of the specific migration of the substance was determined by sufficient
experiments or
using generally recognized diffusion models based on scientific evidence. To demonstrate disagreement
material or product must confirm the set value migration
experimental testing.

(9) The substances listed in Annex no. 3 hereto in
incomplete list of additives which may be used for the production of plastics, the section B at
attesting the conformity of their migration with the specific migration limits
simulant D or in test media of substitute
migration test described in Annex no. 4 hereto.

§ 14

(1) The content of vinyl chloride monomer in products of polyvinyl chloride and its copolymers
not be higher than one milligram per kilogram
final product (1 mg vinyl chloride monomer per 1 kg of product).

(2) Method for determining the content of vinyl chloride monomer in products from
polyvinyl chloride and its copolymers is given in Annex 5.

(3) products made from polyvinyl chloride and its copolymers
not pass into food or food
vinyl chloride monomer in an amount that would be detectable by the analytical method mentioned in Annex
no. 6. || |
(4), vinyl chloride monomer released from food products to be determined in the food
method described in Annex no. 6. If this determination can not be
due to technical reasons, the determination can be made in food simulants
.
TITLE II


REQUIREMENTS FOR elastomer products AND MATERIALS ON THE BASIS OF NATURAL AND
synthetic rubber

§ 15

Depending on the application, the products of the elastomers and materials based on

Natural and synthetic rubber ranks in categories I to V:

A) I category to which it belongs products for applications from a health perspective
particularly challenging (such as child teat, teats and other
products that children put into the mouth or presumed contact with
baby food)

B) Category II, to which, the products for which the contact time
food assumes more than 24 hours (for example
storage tanks, large gaskets, seals for containers, jars)

C) category III, which belongs to the products in which the contact time
food assumes more than 10 minutes but not more than 24 hours
(such as hoses for food transport)

D) Category IV, which belongs to the products in which the contact time
food assumes a maximum of 10 minutes (for example, components
milking equipment, dairy packing machines, roller coverings and conveyor belts for food
with fat on the surface, gloves used in the processing of foodstuffs
)

E) In the category to which they belong products, which are expected
short time or minimum surface contact with foodstuffs, and which can not be included
in categories II to IV (eg, roller coverings and conveyor belts, seals | || pumps, seals and coats konzervových day packages).

§ 16

(1) For products in categories I and II are permitted to use only substances
listed in Part A of the Annex no. 7. For products in categories III and V can be used
substances listed in Parts A and B of Annex. 7th

(2) elastomer products and materials based on natural and synthetic rubber
must meet hygiene requirements
point 9 of Annex no. 7.

(3) Children's teat and teat that children put into the mouth or where
assumes contact with baby food must not contain inorganic and organic
pigments, dyes and fillers.
TITLE III


Requirements for products from metal materials

§ 17

(1) For the manufacture of products from metal materials may be used metals, alloys and solders
listed in Annex no. 8

(2) Finish products from metallic materials
must meet the hygiene requirements of § 20.

(3) External and internal surfaces of metal products must be clean and smooth, without
macroscopically visible cracks, stains, and obvious scratches, signs of corrosion
otřepků, embedded objects, dents,, burrs or | || sharp lateral flow. It is only permitted a degree of deformation of metal
products which do not adversely affect their function.

(4) on the inner surface of metal products, including the inner layers of varnish,
must be free of droplets of solder or other residues of metals and their alloys
or drops sealants, except for some melting solder in cans
produced by overlapping.
TITLE IV


REQUIREMENTS FOR PRODUCTS silicate materials

§ 18

(1) For the production of glass tableware and glass containers are allowed to use
glass of water resistance class I to IV in
provided that under normal and foreseeable usage
product will guarantee compliance with § 3 Sec. 1. For the manufacture of baby bottles
intake is allowed to use only clear glass class resistance to water
I

(2) In the manufacture of glass products, including baby bottles intake, may be
outer surface treatment used the following substances:

A) compounds of tin (in the treatment of so-called glass. Hot end)

B) titanium (titanium plating)

C) mineral oil, liquid

D) methyl esters of fatty acids C12-C18 of natural oils and fats, polypropylene
approved types of oil, polyethylenes and polyethylene waxes
, oleic acid (in the treatment of so-called.
Cold end of the manufacturing line).

§ 19

(1) limits the migration of lead and cadmium in extracts from glassware,
ceramic, pottery, porcelain and enamel products with surface
listed in section 1, no. 9.

(2) Verifying migration of lead and cadmium is carried out under conditions and using
analytical methods listed in Section 2 of Annex no. 9 or by
standardized methods. Furthermore, Annex no. 9 regulates matters
written statement which shall be provided with ceramics.

(3) silicate products for verification purposes limit the migration of lead and cadmium
divided according to application into the following categories:

A) Category 1, which includes products that can not be met,

Or products, which can be filled, but the internal depth
measured from the lowest point to the horizontal plane that passes through the upper edge
does not exceed 25 mm

B) Category 2, which includes products that can be filled,

C) Category 3, which includes products that are intended for heating during
preparing meals and beverages, and packaging and storage tanks, the inner
volume is larger than 3 liters.

(4) silicate product which comprises a container provided with a lid of
same material above the limit of the migration of lead and cadmium
relating to the container itself, the container and lid inner surface
They must be tested separately and under the same test conditions.
The sum of these two values ​​specified migration of lead and cadmium shall be referred to
surface area of ​​the container or on its volume.
TITLE V


REQUIREMENTS FOR SURFACE TREATMENT products intended for contact with food

§ 20

(1) Surface treatment (especially painting, tinning, coated
plastic glazing, enamelling) must be continuous, evenly applied
, with a minimal amount of microscopic pores, well adhering to
product. After a period of use of a product intended for contact with food
the prescribed usage conditions finish may not exfoliate,
have obvious scratches, cracks, blisters or other violations. If the surface of the seas
products may not occur untreated sites.

(2) A list of acceptable materials and surface technology
products intended for contact with food is given in Annex # 10.

(3) Finish coating products must be manufactured from substances listed in Annex
No. 11.

(4) non-silicate and metal surface treatment products intended for contact with food
must meet hygiene requirements set out in paragraph 7 of Annex
No. 11.

(5) The production of metal products intended for contact with food is acceptable
sided oiling sheets dioktylsebakátem,
butyl stearate, vaseline oil, fatty acid methyl esters
C12-C18 from natural oils and fats and polypropylene oil .
Amount of grease on the one hand can be up to 0.25 g.dm-second

(6) The production of metal products intended for contact with food is acceptable
passivation tinned sheets in a bath containing chromate and dichromate
. Passivation bath residues must be removed from the sheet
proper washing.
TITLE VI


REQUIREMENTS paper products, cardboard and paperboard

§ 21

(1) For the production of paper products, cardboard and paperboard including
processed forms are only allowed to use materials made from raw material
additives, processing aids and other substances, a list and tolerances are
listed in Appendix 12.

(2) Paper packaging materials may reach the highest moisture content of 8%.

(3) Re-use of paper packaging for direct food packaging
permitted.

§ 22

(1) Paper, cardboard and paperboard hardened plastics, where they come
food into direct contact with a polymer substance that creates
perfect barrier against migration of contaminants from paper, cardboard and cardboard products
the food surface, to be judged according to the conditions specified in § 4
paragraph. second

(2) The production of papers intended to be used for reflux and filtered hot
(tea bags, tea bags, filter papers, hot filtration) and
use as filter layers intended for the hot extraction may | || only use the substances listed in section 2 of Annex 12.

(3) In the manufacture of paper intended for use in the filter layer for filtering
cold can be used only substances listed in section 3 of Annex
no. 12th

(4) Paper, paperboard including compensating
forms must comply with the hygiene requirements set out in Section 4
Annex 12.
TITLE VII


Requirements for products cellophane

§ 23

(1) For the purposes of this decree means cellophane-thin sheet material obtained from
regenerated cellulose made from virgin wood or cotton.
To meet technical requirements may be the mass or on the surface of the added
additives and other auxiliaries. Cellophane can be on one or both
sides. The substances used shall be of good technical quality
.

(2) The provisions of this Decree shall apply to the cellophane that

A) itself constitutes a finished product, or


B) form part of a finished product containing other materials and is designed
for contact with foodstuffs or with them comes into contact due to their
purpose.

(3) For the production of cellophane can be used substances or groups of substances listed in Annex
no. 13, and only under specified conditions.

(4) Regenerated cellulose film may be used dyes, pigments and adhesives for
conditions that will lead to their migration into food or
food and meet the requirements specified in § 6

(5) Paragraphs 2-4 shall not apply to cellophane intestine.

(6) To cellophane under paragraph 2 include films of regenerated cellulose

A) uncoated,

B) a coating derived from cellulose

C) coated with plastic.

§ 23a

(1) During the production of films from regenerated cellulose according to § 23 para. 6 point.
) And b) can be used only substances or groups of substances covered in Annex.
13 hereto, their Parts I and II, under the conditions laid down in this Annex
. The production of films from regenerated cellulose according to § 23 paragraph
. 6 point c) only substances or groups of substances covered in
Annex no. 3 hereto.

(2) Products intended for contact with food made from sheets of regenerated cellulose
according to § 23 para. 6 point. c) must be in accordance with
requirements stipulated in § 12 to 14
TITLE VIII


REQUIREMENTS FOR cork products

§ 24

For natural cork processing for the manufacture of products
coming into contact with food should only be used substances
the list, tolerances and requirements so modified cork
are listed in Annex no. 14.
PART THREE

FINAL PROVISIONS


§ 25

Repealed:

First the directive of the Ministry of Health of Czechoslovakia on hygienic requirements
plastics and articles of plastics that come into contact with foodstuffs,
published under Ser. no. 49/1978 in the collection of Hygiene Regulations and notified
totaling 13/1978 Coll .;

Second Decree of the Ministry of Health and Social Affairs, which
amending Directives no. 49/1978 Coll. Sanitary regulations, a
hygienic requirements on plastic and articles of plastic
coming into contact with foodstuffs, published under Ser. no. 73/1989 collection
hygiene regulations and announced in Volume 8/1989 Coll .;

Third the directive of the Ministry of Health of Czechoslovakia on hygienic requirements for metal packaging
, published under the Ser. no. 68/1985 Coll.
Hygiene regulations and announced in the amount of 34/1985 Coll.

§ 26

This Decree shall take effect on the date of publication.
Minister
:

Prof. MD. Fiser, MD. vr
Appendix 1


Requirements for purity of dyes, pigments and fillers

1

Requirements for purity of dyes and pigments
1.1
dyes and pigments may contain most of the following substances
percentage by weight:

1.1.1 elements soluble in 0.1 M HCl:

1.1.1.1 0.01% barium

1.1.1.2 0.1% chromium

1.1.1.3 0.01% cadmium

1.1.1.4 0.01% selenium

1.1.1.5 0.005% mercury

1.1.1.6 0.05% antimony

1.1.1.7 0.01% arsenic

1.1.1.8 0,01% lead
leachate is prepared by treatment with 150 ml 0.1 M-1 acid HCl
10 g of pigment at a temperature of 23 +/- 3 st. C for 15
minutes under constant shaking mixtures.

1.1.2 .05% of primary aromatic amines soluble in a solution of 1
mol.l-1 HCl and expressed as aniline, wherein the content of benzidine,
beta-naphthylamine and 4-aminobiphenyl not exceed 0.001% .

1.1.3 0.005% extractable polychlorinated biphenyls, expressed as
dekachlorbifenyl.

1.2 absorbance of the filtrate from the suspension of 1.0 g of carbon black in 100 ml of distilled cyclohexane
after 24 hours of leaching at temperature of 23 +/- 3
Wed. C, measured at a path length of 5 cm at a wavelength of 385 nm
not be higher than 0.1.

1.3 toluene extract prepared an 8-hour extraction 10 g of carbon black in
Soxhlet apparatus must not be higher than 0.15%.
2


Requirements for purity fillers

2.1 builders can contain most of these risk elements
soluble in a solution of 0.1 M-1 HCl:
2.1.1
0.01% lead
2.1.2
0.01% arsenic

2.1.3 0.0005% mercury
2.1.4
0.01% cadmium

2.1.5 0.005% antimony

2.2 purity barium sulfate according to the Czech Pharmacopoeia 1997
Appendix 2



Canceled Appendix 3


Requirements for plastics and plastic products


LIST monomers INGREDIENTS AND OTHER STARTING SUBSTANCES WHICH MAY BE USED FOR
manufacture of plastics

First This appendix contains a list of monomers and other starting ingredients
substances that may be used in the manufacture of plastics and plastic products,
intended for contact with food. The list includes:

1.1 substances undergoing polymerisation, which includes
polyaddition or any other similar process
macromolecules;

1.2 natural or synthetic macromolecular substances used
manufacture of modified macromolecules, if the monomers or other starting substances
necessary for their production not included in the list;

1.3 substances used to modify existing natural or synthetic substances
;

1.4 substances that are added to plastics to achieve a technical effect
in the final product, including the polymer additives. These substances are
intended to be contained in the final products, while
polymeric additives for the purposes of this Annex shall mean all
polymers, prepolymers and oligomers, that can be added to plastics in order
achieve a technical effect which can not be used without
other polymers as the main structural component of finished materials and products
;

1.5 substances that are used to create an environment in which
polymerization occurs (for example, emulsifiers, surfactants, buffers
). For the purposes of this Annex, the substances referred to in paragraphs 1.4 and 1.5
hereinafter referred to as additives.

Second The list does not include the following substances although they are used
intentionally and are authorized:

A) the salts of aluminum, calcium, iron, magnesium, potassium and sodium and ammonium salts
(including double salts and acid salts) authorized acids, phenols or alcohols
. The name "salt" is listed only if
the corresponding free acid is not listed (not shown in the list
).

B) a zinc salt (including double salts and acid salts)
authorized acids, phenols or alcohols. For these salts a group
SML SML = 25 mg / kg (expressed as Zn).
The same restriction for Zn applies to:

I) substances whose name contains 'salts' are listed
only if the corresponding free acid is not listed
(not listed).

Ii) substances referred to in note 38 of Appendix III
.

Third The list does not include the following substances although they may be present
:

B) substances that may be present in the final product:

- Impurities in the substances;

- Reaction intermediates;

- Decomposition products;

C) oligomers and natural or synthetic macromolecular substances and their
mixtures, if the monomers or starting substances required to synthesise
included in the list;

D) mixtures of the authorized substances;

E) substances which directly influence the formation of polymers (eg.
Catalytic systems);

F) dyes;

G) solvent.

Products that contain the substances referred to in subparagraphs a) to c)
must meet the requirements provided for in § 3. 1st

Fourth Substance shall have a good technical quality as regards the purity criteria
.

First Food contact can only use products obtained by bacterial fermentation
in Appendix I to this Annex.

Second The list contains the following information:

- Column 1 (PM / REF no.) Reference number of the EEC packaging material
substances on the list;

- Column 2 (CAS) CAS Registry Number (Chemical Abstracts Service
);

- Column 3 (Name): the chemical name;

- Column 4 (Restrictions and / or specifications): May contain

- Specific migration limit (SML)

- Maximum permitted quantity of the substance in the finished material or article
(QM)

- Maximum permitted quantity of the substance in the finished material or article
expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA)

- Any other restriction specifically mentioned,

- Any type of specifications related to the substance or polymer.

Third If a substance is listed individually, are also
a generic term, is subject to the restrictions mentioned this at
individually listed substances.

Fourth If a CAS number does not match the chemical name, the chemical name
precedence over the CAS number. If a CAS number, according to the register EINECS

Does not match the CAS Registry, the CAS number is valid according to the register
CAS.

Fifth In the tables, in the column 4 are used abbreviations and terms having the following meanings
:

DL = detection limit of the analytical method;

FP = Finished material or article;

NCO = isocyanates;

ND = not be detected. For the purposes of this decree means that the substance can not be detected
validated analytical method specified
limit of quantification (DL). If such a method does not currently exist
, proceed to the development of validated methods
procedure under § 4 paragraph 1 of the Decree.

QM = maximum permitted quantity of the residual substance in the material or product
.

For the purposes of this Decree, the amount of the substance in the material or product
provides validated analytical method. If such a method does
currently exist, it proceeds to the development of validated methods
procedure under § 4 paragraph 1.

QM (T) = maximum permitted quantity of the residual substance in the material or product
expressed as total of moiety or substance.
For the purposes of this Order, the amount of substance in the material or article should be determined
validated analytical method. If such a method
currently exist, it proceeds to the development of validated methods
procedure under § 4 paragraph 1.

QMA = Maximum permitted quantity of the residual substance in the material or
article expressed as mg per 6 dm2 of the surface in contact with foodstuffs.

QMA (T) = maximum permitted quantity of the residual substance in the material or product
expressed as total of moiety or substance in
mg per 6 dm2 of the surface in contact with foodstuffs. For the purposes of this decree would
quantity of the substance in the material or article should be determined
validated analytical method. If such a method does not currently exist
proceed to the development of validated methods of procedure in accordance with § 4, paragraph 1
.

SML = specific migration limit in food or in food simulant
, unless otherwise stated. For the purposes of this decree should be
value of the specific migration of substances from the material or product set
validated analytical method. If such a method does not currently exist
, proceed to the development of validated methods
procedure under § 4 paragraph 1.

SML (T) = specific migration limit in food or in food simulant
expressed as total of substances or groups of substances
. For the purposes of this Decree, the value of the specific migration of the substance or group of substances
material or product, determined by validated analytical method
. If such a method does not currently exist
progresses until the development of validated methods of procedure in accordance with § 4 paragraph 1.

LIST OF ALLOWED MONOMERS AND OTHER STARTING SUBSTANCES


SECTION A
------------------------- -------------------- ------------- ----------------------------------
PM / REF CAS No Name Restrictions and / or specifications
no.
------------------------- ---------------------- ---------------------------------- -----------
(1) (2) (3) (4)
------------------------- ---------- ----------------------- --------------------------- -------
10030 000514-10-3 abietic acid
10060 000075-07-0 acetaldehyde SML (T) = 6 mg / kg (2)
10090 000064-19-7 acetic acid
10120 000108-05-4 vinyl acetate SML = 12 mg / kg 10150 000108-24-7 acetic anhydride

10210 000074-86-2 acetylene
10599 / 90A 061788-89-4 fatty acids, unsaturated (C18) QMA (T) = 0.05 mg / 6 dm2 (27)
dimers, distilled 10599/91 061788-89-4
fatty acids, unsaturated (C18) QMA (T) = 0.05 mg / 6 dm2 (27)
dimers, undistilled
10599 / 92A 068783-41-5 fatty acids, unsaturated (C18) QMA (T) = 0.05 mg / 6 dm2 (27)
dimers, hydrogenated, distilled 10599/93 068783-41-5
fatty acids, unsaturated (C18) QMA (T) = 0.05 mg / 6 dm2 (27)
dimers, hydrogenated,
undistilled
10630 000079-06-1 acrylamide SML = ND (DL = 0,01 mg / kg)
10660 015214-89-8 2-acrylamido-2- SML = 0.05 mg / kg
methylpropanesulphonic acid
10690 000079-10-7 acrylic acid SML (T) = 6 mg / kg (36)
10750 002495-35-4 benzyl acrylate SML (T) = 6 mg / kg (36) | || 10780 000141-32-2 n-butyl acrylate SML (T) = 6 mg / kg (36)
10810 002998-08-5 sec-butyl acrylate SML (T) = 6 mg / kg (36 )

10840 001663-39-4 tert-butyl acrylate SML (T) = 6 mg / kg (36)
11005 012542-30-2 dicyklopentenyl acrylate QMA = 0.05 mg / dm2 6
11245 002156-97-0 dodecyl acrylate SML = 0.05 mg / kg (1)
11470 000140-88-5 ethyl acrylate SML (T) = 6 mg / kg (36)
11500 000103- 11-7 2-ethylhexyl acrylate SML = 0.05 mg / kg 11510 000818-61-1
hydroxyethyl acrylate see. monoester of acrylic acid
ethylene glycol
11530 000999-61-1 2-hydroxypropyl acrylate QMA = 0.05 mg / dm2 for the sum of 6 2-
hydroxypropyl acrylate and 2-
hydroxyisopropyl acrylate
in accordance with the specifications
set out in Appendix II to this
Annex.
11590 00106-63-8 isobutyl acrylate SML (T) = 6 mg / kg (36)
11680 000689-12-3 isopropyl acrylate SML (T) = 6 mg / kg (36) || | 11710 000096-33-3 methyl acrylate SML (T) = 6 mg / kg (36)
11830 000818-61-1 monoester of acrylic acid SML (T) = 6 mg / kg (36)
ethylene glycol
11890 002499-59-4 n-octyl acrylate SML (T) = 6 mg / kg (36)
11980 000925-60-0 propyl acrylate SML (T) = 6 mg / kg ( 36)
12100 000107-13-1 acrylonitrile SML = ND
(DL = 0.020 mg / kg, including the uncertainty of measurement
)
12130 000124-04-9 Adipic acid
12265 004074-90-2 divinyl adipate QM = 5 mg / kg in FP. To use
only as a comonomer.

12280 002035-75-8 adipanhydrid 12310 1st - 2nd albumin
12340 - albumin coagulated by formaldehyde 12375
3rd - alcohols, aliphatic, with one
OH, saturated, linear,
primary (C4-C22)
12670 002855-13-2 1-amino-3,5,5-3aminomethyl SML = 6 mg / kg
trimethylcyclohexane
12761 000693-57-2 12-aminododecanoic acid SML = 0.05 mg / kg
12763 00141-43-5 2-aminoethanol SML = 0.05 mg / kg.Látka not be
used in polymers contacting
food for which to be
Annex No. 4 to this Decree is used
simulant D látkasmí be used
only nepřímýstyk
Food, separate layer
PET
12765 84434-12-8 N- (2-aminoethyl) -N-alanine, sodium SML = 0.05 mg / kg
Salt
12786 000919-30-2 3-aminopropyltriethoxysilane Residual extractable content of 3-
aminopropyltriethoxysilane be
lower than 3 mg / kgplniva.
using only reactive
Surface úpravuanorganických
fillers and SML = 0,05 mg / kg when
used for the surface treatment
materials and products.
12788 002432-99-7 11-aminoundecanoic acid SML = 5 mg / kg 12789 007664-41-7 ammonia

12820 000123-99-9 azelaic acid
nonanedioic acid 12970 004196-95-6 azelanhydrid

anhydrite nonanedioic acid
13000 001477-55-0 1,3-benzenedimethanamine SML = 0.05 mg / kg
1,3-bis (aminomethyl) benzene
13060 004422-95-1 1,3,5- trichloride QMA = 0.05 mg / 6 dm2 (measured as
benzenetricarboxylic acid, 1,3,5-benzenetricarboxylic | || benzene 1,3,5-tri (carbonyl) acid)
13075 000091-76-9 benzoguanamine viz.2,4-diamino-6-phenyl-1,3,5
triazine
13090 000065-85-0 Benzoic acid
13150 000100-51-6 000498-66-8 13180
benzyl bicyclo [2.2.1] hept-2-ene (= SML = 0,05 mg / kg
norbornene)
13210 001761-71-3 bis (4-aminocyclohexyl) methane SML = 0.05 mg / kg
13317 132459-54-2 N, N'-bis [4- (ethoxycarbonyl) phenyl] - SML = 0,05 mg / kg.Čistota higher than
1,4,5,8-naftalenetetrakarboxy- 98.1% (w / w). For use as
diimide comonomer (max 4%) for polyesters
(PET, PBT)
13323 000102-40-9 1,3-bis (2-hydroxyethoxy) benzene SML = 0.05 mg / kg 13326 000111-46-6
bis (2-hydroxyethyl) ether, see diethylene
13380 000077-99-6 2,2-bis (hydroxymethyl) butan-1-ol; refer to 1,1,1-trimethylolpropane
2-ethyl-2- (hydroxymethyl) propane
1,3-diol

13390 000105-08-8 1,4-bis (hydroxymethyl) cyclohexane
13395 04767-03-7 2,2-bis (hydroxymethyl) propanoic QMA = 0.05 mg / dm2 6
acid

13480 000080-05-7 2,2-bis (4-hydroxyphenyl) propane SML (T) = 0.6 mg / kg
4,4 '- (propane-2,2-diyl) diphenol is not intended for use in the manufacture
bisphenol A polykarbonátovýchkojeneckých *
bottles.

* § 4 paragraph 1 point. a) Decree no. 54/2004 Coll.
on foodstuffs intended for
special nutrition and the way
their use, as
amended
13510 001675-54-3 2,2-bis (4-hydroxyphenyl) propane According to the requirements of the directly applicable
bis (2,3-epoxypropyl) ether rule předpisuEvropských
(= BADGE); Community 1b)
2,2-bis [4- (2,3
epoxypropoxy) phenyl] propane
13530 038103-06-9 2,2-bis (4-hydroxyphenyl) propane SML = 0.05 mg / kg
bis (phthalic anhydride)
13550 000110-98-5 bis (hydroxypropyl) ether, dipropylene see
13560 005124-30-1 bis (4-isocyanatocyclohexyl) -methane see. dicyclohexylmethane-4,4'
diisocyanate
13600 047465-97-4 3,3-bis (3-methyl-4-hydroxyfenyl- SML = 1.8 mg / kg
indoline-2-13607 000080-05-7 bisphenol
A viz.13480
2,2-bis (4-hydroxyphenyl) propane

13610 001675-54-3 bisphenol A bis (2,3 see. 13510
epoxypropyl) ether of 2,2-bis (4-hydroxyphenyl) propane
(= BADGE) bis (2,3-epoxypropyl) ether
13614 038103-06-9 bisphenol A bis (phthalic anhydride) viz.13530
13617 00080-09-1 bisphenol S see. 4,4'-dihydroxydiphenyl
13620 010043-35-3 boric acid SML (T) = 6 mg / kg (23) (
expressed as boron) without prejudice to the provisions
,
indicators regarding the quality of drinking water in accordance with a special legislative

13630 000106-99-0 butadiene QM = 1 mg / kg in FP or SML =
ND (DL = 0.02 mg / kg including uncertainty
measurement)
13690 000107-88-0 butane-1,3-diol
13720 000110-63-4 butane-1,4-diol SML (T) = 0.05 mg / kg (24)
13780 002425-79-8 1,4-butanediol bis (2,3-QM = 1 mg / kg in FP (expressed as
epoxypropyl) ether; epoxy group, molecular weight || | 1,4-bis (2,3-epoxypropoxy) butane = 43)
13810 00505-65-7 butane-1,4-diolformal; QMA = 0.05 mg / dm2 6
1,3-dioxepane
13840 000071-36-3 butan-1-ol
13870 000106-98-9 1-butene
13900 000107-01-7 but-2-ene
13932 00598-32-3 but-3-en-2-ol QMA = ND (DL = 0,02mg / 6dm2).
When used as a copolymer for
preparing a polymerization ingredients
14020 000098-54-4 4-tert-butylphenol SML = 0.05 mg / kg 14110 000123-72-8
butyraldehyde;
butanoaldehyde
14140 000107-92-6 butyric acid;
butanoic acid
14170 000106-31-0 anhydride butyric acid;
butananhydrid
14200 000105-60-2 caprolactam; SML (T) = 15 mg / kg (5)
hexane-6-lactam
14230 002123-24-2 caprolactam, sodium salt; SML (T) = 15 mg / kg (5)
hexane-6-lactam, sodium salt (expressed as caprolactam)
14260 000502-44-3 caprolactone SML = 0.05 mg / kg
(Expressed as the sum of caprolactone and 6-hydroxyhexanovékyseliny
)
14320 000124-07-2 caprylic acid;
octanoic acid 14350 000630-08-0

CO 14380 000075-44-5 carbonyl QM = 1 mg / kg in FP 14411 008001-79-4

14500 castor oil 009004-34- 6 cellulose
14530 007782-50-5 000106-89-8 chloro
14570 1-chloro-2,3-epoxypropane see epichlorohydrin
14650 000079-38-9 chlortrifluorethen QMA = 0.05 mg / kg
14680 000077-92-9 citric acid
14710 000108-39-4 m-cresol
14740 000095-48-7 o-cresol
14770 00106-44-5 p-cresol
14800 003724-65-0 crotonic acid; QMA (T) = 0.05 mg / 6 dm2 (33)
(E) -but-2-enoic acid
14841 000599-64-4 4- (1-phenyl-1-methylethyl) phenol SML = 0.05 mg / kg
4-cumylphenol

14880 000105-08-8 1,4-cyclohexanedimethanol, see 1,4-bis (hydroxymethyl)
cyclohexane
14950 003173-53-3 cyclohexyl isocyanate QM (T) = 1 mg / kg (VFP
expressed as NCO) (26)
15030 00931-88-4 cyclooctene SML = 0.05 mg /kg.Látka may be
used in polymers contacting
Food, for which, according
Annex no. 4 hereto
A determined použitísimulantu
15070 001647-16-1 deca-1,9-diene SML = 0.05 mg / kg 15095 000334-48-5

decanoic acid 15100 000112-30-1 decan-1 ol
15130 000872-05-9 dec-1-ene SML = 0.05 mg / kg
15250 000110-60-1 1,4-diaminobutane
15267 000080-08-0 bis (4 aminophenyl) sulfone SML = 5 mg / kg
15272 000107-15-3 1,2-diaminoethane see ethylenediamine
15274 000124-09-4 1,6-diaminohexane see hexamethylenediamine
15310 000091-76- 9 2,4-diamino-6-phenyl-1,3,5-triazine; QMA = 5 mg / dm2 6
6-phenyl-1,3,5-triazine-2,4-diamine
15404 000652-67-5 1,4: 3,6-dianhydro-D-glucitol SML = 5 mg / kg. Only for use as
monomer in poly (ethylene terephthalate-co
-isosorbid-
terephthalate).
15565 000106-46-7 1,4-dichlorobenzene SML = 12 mg / kg
15610 00080-07-9 4,4-dichlordifenylsulfon SML = 0.05 mg / kg
15700 005124-30 -1 dicyclohexylmethane-4,4'-QM (T) = 1 mg / kg (VFP expressed
diisocyanate; as NCO) (26)
bis (4-isocyanatocyclohexyl) methane;
4,4'
metiylendiciklohexyil
15760 000111-46-6 bis (2-hydroxyethyl) ether; SML (T) = 30 mg / kg (3)
diethylene
15790 000111-40-0 diethylene SML = 5 mg / kg
15820 000345-92-6 4,4-difluoro SML = 0.05 mg / kg 15880 000120-80-9 1
, 2-dihydroxybenzene; SML = 6 mg / kg
benzene-1,2-diol
15910 000108-46-3 1,3-dihydroxybenzene; SML = 2.4 mg / kg
benzene-1,3-diol
15940 000123-31-9 1,4-dihydroxybenzene; SML = 0.6 mg / kg
benzene-1,4-diol
15970 000611-99-4 4,4'-dihydroxybenzophenone SML (T) = 6 mg / kg (15)
16000 000092-88-6 4,4'-dihydroxydiphenyl SML = 6 mg / kg
16090 00080-09-1 4,4'-dihydroxydiphenyl; SML = 0.05 mg / kg
4,4'-sulfonyl
16150 000108-01-0 2- (dimethylamino) ethanol SML = 18 mg / kg
Fourth 006864- 3,3'-dimethyl-4,4'-SML = 0.05 mg / kg (32)
16210 37-5 diaminodicyclohexylmethane; Only for použitív polyamides
4,4'-methylenebis (2-
methylcyclohexane-1-amine)
16240 000091-97-4 3,3'-dimethyl-4,4'-QM (T) = 1 mg / kg (VFP expressed
-diisocyanato; as NCO) (26)
4,4'methylenbis (2-
phenyl) diisocyanate;
bis (4-isocyanato-3-
methylphenyl) methane
16360 000576-26-1 2,6-dimethylphenol SML = 0.05 mg / kg
16390 00126-30-7 2,2-dimethylpropane -1,3-diol; SML = 0.05 mg / kg
neopentyl
16450 000646-06-0 1,3-dioxolane SML = 5 mg / kg 16480 000126-58-9 dipentaerythritol

16540 000102-09-0 diphenyl carbonate SML = 0,05 mg /
kg 16570 004128-73-8 diphenylether-4,4'-diisocyanate QM (T) = 1 mg / kg (VFP
expressed as NCO) (26) 16600 005873-54-1 diphenylmethane
2,4'-diisocyanate QM (T) = 1 mg / kg (VFP
expressed as NCO) (26)
16630 000101-68-8 diphenylmethane-4,4'-diisocyanate QM (T) = 1 mg / kg (VFP
expressed as NCO) (26)
16650 000127-63-9 diphenylsulfone SML (T) = 3 mg / kg (25)
16660 000110-98-5 dipropylene
16690 001321-74-0 divinylbenzene QMA = 0.01 mg / 6 dm2 or SML = ND
(DL = 0.02 mg / kg, including uncertainty
measurements) for the sum of divinylbenzene and
ethylvinylbenzenua in accordance with
specifications set out in Appendix
II of this Annex.
16694 013811-50-2 N, N'-divinylimidazolidin-2-one QM = 5 mg / kg in FP 16697 000693-23-2
dodecanedioic acid
16704 000112-41-4 dodec-1 ene SML = 0.05 mg / kg 16750 000106-89-8
epichlorohydrin QM = 1 mg / kg in FP 16780 000064-17-5 ethanol

16950 000074-85-1 ethylene;
ethene

16955 000096-49-1 ethylene carbonate Residual content = 5 mg / kg of hydrogel
at a maximum ratio of 10 g of hydrogel
1 kg potravin.Hydrolyzát
It contains ethylene glycol and SML = 30
mg / kg
16960 000107-15-3 Ethylenediamine SML = 12 mg / kg 16990 000107-21-1
ethane-1,2-diol; SML (T) = 30 mg / kg (3)
ethylene
17005 000151-56-4 ethylenimine SML = ND (DL = 0.01 mg / kg)
17020 000075-21-8 ethylene QM = 1 mg / kg in FP 17050
000104-76- 7 2-ethylhexane-1-ol SML = 30 mg / kg
016219-75-3 5-ethylidenbicyklo [2.2.1] hept-2-ene QMA = 0.05 mg / dm2
6 17 110 The ratio between the surface area and
the quantity of food must be less
2 dm2 / kg
17160 000097-53-0 eugenol; SML = ND (DL = 0.02 mg / kg, including
2-methoxy-4- (propen-2-yl) phenol) measurement uncertainty)
17170 061788-47-4 fatty acids, coconut || | 17200 068308-53-2 fatty acids, soya
17230 061790-12-3 fatty acids, tall oil
17260 000050-00-0 formaldehyde SML (T) = 15 mg / kg (22)
17290 000110-17-8 fumaric acid 17530 000050-99-7 glucose

18010 000110-94-1 glutaric acid 18070 000108-55-4 glutaric anhydride

18100 000056-81-5 glycerol | || 18220 068564-88-5 N-heptylaminoundekanová acid SML = 0.05 mg / kg (1) 18250 000115-28-6
hexachlorendomethylentetrahydro- SML = ND (DL = 0.01 mg / kg)
phthalic acid;
1,4,5,6,7,7-
hexachlorbicyklo [2.2.1] hept-5-ene
2,3-dicarboxylic acid
18280 000115-27-5 hexachlorendomethylentetrahydro- SML = ND (DL = 0.01 mg / kg)
phthalic anhydride;
anhydride 1,4,5,6,7,7-
hexachlorbicyklo [2.2.1] hept-5-ene
2,3-dicarboxylic acid
18310 036653-82-4 hexadecane-1-ol
18430 000116-15-4 hexafluoropropylene SML = ND (DL = 0.01 mg / kg)
18460 000124-09 -4 hexamethylenediamine SML = 2.4 mg / kg 18640 000822-06-0
hexamethylene diisocyanate; QM (T) = 1 mg / kg (VFP expressed
hexane-1,6-diyldiisokyanát; as NCO) (26)
1,6-diisocyanatohexane
18670 000100-97-0 hexamethylenetetramine SML (T) = 15 mg / kg (22)
(Expressed as formaldehyde)
000629-11-8 hexane-1,6-diol SML = 0.05 mg / kg

18700 18820 000592-41-6 hex-1-ene SML = 3 mg / kg
18867 000123- 31-9 hydroquinone; see 1,4dihydroxybenzen
benzene-1,4-diol 000099-96-7
18880, p-hydroxybenzoic acid;
4-hydroxybenzoic acid
18896 001679-51-2 4- (hydroxymethyl) cyclohex-1-ene SML = 0.05 mg / kg
18897 016712-64-4 6-hydroxynaphthalene-2-carboxylic SML = 0 , 05 mg / kg
acid
18898 000103-90-2 N- (4-hydroxyphenyl) acetamide SML = 0.05 mg / kg 19000 000115-11-7 isobutene

19060 000109-53-5 isobutyl (vinyl) ether QM = 5 mg / kg in FP
19110 04098-71-9 [3- (isocyanatomethyl) -3,5,5- QM (T) = 1 mg / kg in FP (expressed as
trimethylcyclohexyl] isocyanate NCO )) (26)
19150 000121-91-5 benzene-1,3-dicarboxylic acid; SML (T) = 5 mg / kg (43)
isophthalic acid
19180 000099-63-8 isoftaloyldochlorid SML (T) = 5 mg / kg (43) (expressed
as isophthalic acid).
19210 001459-93-4 dimethyl isophthalate SML = 0.05 mg / kg
19243 00078-79-5 isoprene see. 2-methylbut-1,3-diene
19270 000097-65-4 itaconic acid;
prop-2-ene-1,2-dicarboxylic

acid, lactic acid 19460 000050-21-5
19470 000143-07-7 lauric acid;
dodecanoic acid
19480 002146-71-6 vinyl laurate;
vinyl dodecanoate
19490 00947-04-6 laurolactam; SML = 5 mg / kg
dodecane-12-lactam
19510 011132-73-3 000110-16-7 19540 lignocellulose
maleic acid; SML (T) = 30 mg / kg (4)
(Z) -butenedioic acid
19960 000108-31-6 maleic SML (T) = 30 mg / kg (4) (expressed
as maleic acid)
19975 000108-78-1 melamine; see. 2,4,6-triamino-1,3,5-triazine
1,3,5-triazine-2,4,6-triamine
19990 000079-39-0 methacrylamide SML = ND
(DL = 0.02 mg / kg, including the uncertainty of measurement
)
20020 000079-41-4 methacrylic acid SML (T) = 6 mg / kg (37)

20050 000096-05-9 allyl methacrylate SML = 0.05 mg / kg 20080 002495-37-6
benzyl methacrylate SML (T) = 6 mg / kg (37)
20110 000097- 88-1 butyl methacrylate SML (T) = 6 mg / kg (37)
20140 002998-18-7 sec-butyl methacrylate SML (T) = 6 mg / kg (37)
20170 000585- 07-9 tert-butyl methacrylate SML (T) = 6 mg / kg (37)
20260 00101-43-9 cyclohexyl methacrylate SML = 0.05 mg / kg
20410 02082-81-7 diester methacrylic acid SML = 0.05 mg / kg
with butane-1,4-diol
20440 000097-90-5 diester of methacrylic acid with SML = 0.05 mg / kg
ethylene glycol
20530 002867-47-2 2- (dimethylamino) ethyl methacrylate SML = ND
(DL = 0.02 mg / kg, including the uncertainty of measurement
)
20590 00106-91-2 2,3-epoxypropyl methacrylate QMA = 0,02mg / 6 dm2 20890 000097-63-2
ethyl methacrylate SML (T) = 6 mg / kg (37)
21010 000097-86-9 isobutyl methacrylate SML (T) = 6 mg / kg (37)
21100 004655-34-9 isopropyl- methacrylate SML (T) = 6 mg / kg (37)
21130 000080-62-6 methyl methacrylate SML (T) = 6 mg / kg (37)
21190 000868-77-9 monoester of methacrylic acid SML (T) = 6 mg / kg (37)
ethylene glycol
21280 002177-70-0 phenyl methacrylate SML (T) = 6 mg / kg (37)
21340 002210-28-8 propyl methacrylate SML (T) = 6 mg / kg (37)
010595-80-9 2-sulfoethyl methacrylate QMA =
ND 21370 (DL = 0,02mg / 6 dm2)
054276-35-6 sulfopropyl methacrylate QMA = 0.05 mg / dm2 6

21400 21460 000760-93-0 methakrylanhydrid SML (T) = 6 mg / kg (37)
21490 000126-98 -7 methacrylonitrile SML = ND
(DL = 0.02 mg / kg, including uncertainty of measurement
)
21520 01561-92-8 sodium methallylsulfonát SML = 5 mg / kg 21550 000067-56-1 methanol

21640 00078 -79-5 2-methylbut-1,3-diene QM = 1mg / kg in FP or SML = ND
(DL = 0.02 mg / kg, including the uncertainty of measurement
)
21730 000563-45-1 3-methylbut-1-ene QMA = 0,006 mg / 6 dm2. Only for
use in polypropylene.
21765 106246-33-7 4,4'-methylenebis (3-chloro-2,6 QMA = 0.05 mg / dm2 6
diethylaniline)
21821 00505-65-7 1,4- (methylenedioxy ) butane-1,4-viz.butan diolformal
000924-42-5 21940 N-methylolacrylamide SML = ND (DL = 0.01 mg / kg)
21970 000923-02-4 N- (hydroxymethyl) methacrylamide SML = 0.05 mg / kg
22150 000691-37-2 4- (methylthio) pent-1-ene SML = 0.05 mg / kg 22210 000098-83-9
alpha-methylstyrene SML = 0.05 mg / kg 22331 025513-64-8
mixture (35-45% wt.) 1,6-diamino QMA = 5 mg / dm2 6
2,2,4trimethylhexanu and (55-65%
weight) of 1,6-diamino-2,4,4-
trimethyl
22332 028679-16-5 mixture (40 wt.%) 2,2,4- QM (T) = 1 mg / kg (VFP expressed
trimethylhexane and 1,6 as NCO) (26)
diyldiisokyanátu (60%) 2,4,4-
trimethyl-1,6
diyldiisokyanátu
22350 000544-63-8 myristic acid;
tetradecanoic acid
22360 01141-38-4 naphthalene-2,6-dicarboxylic acid SML = 5 mg / kg
acid
22390 000840-65-3 dimethyl-2,6-naphthalenedicarboxylate SML = 0.05 mg / kg
22420 003173-72-6 1,5-naphthalene diisocyanate QM (T) = 1 mg / kg (VFP
expressed as NCO) (26)
22437 00126-30-7 neopentylglycol see. 2,2-dimethyl-propane-1,3-diol
22450 009004-70-0 000143-08-8 nitrocellulose
22480 nonane-1-ol
22550 000498-66-8 norbornene See. bicyclo [2.2.1] hept-2-ene
22570 000112-96-9 oktadecylisokyanát; QM (T) = 1 mg / kg (VFP expressed
1-isokyanatooktadekan as NCO) (26)
22600 000111-87-5 octan-1-ol
22660 000111-66-0 oct-1 -en SML = 15 mg / kg 22763 000112-80-1
oleic acid
22775 000144-62-7 oxalic acid SML (T) = 6 mg / kg (29)
22778 07456-68- 0 4,4'-oxybis (benzensulfonylazid) QMA = 0.05 mg / dm2 6
22780 000057-10-3 palmitic acid;
hexadecanoic acid
22840 000115-77-5 Pentaerythritol
22870 000071-41-0 pentan-1-ol 00109-67-1
22900 pent-1-ene SML = 5 mg / kg
22932 001187-93-5 perfluormethylperfluorvinylether SML = 0.05 mg / kg K use only
non-stick surfaces.
22937 001623-05-8 perfluorpropyl (perfluorvinyl) ether SML = 0.05 mg / kg 22960 000108-95-2 phenol

23050 000108-45-2 1,3-phenylenediamine SML = ND ( DL = 0,02mg / kg

including measurement uncertainty)
23070 000102-39-6 (1.3-phenylenedioxy) diacetic QMA = 0.05 mg / 6 dm2
acid
23155 000075-44-5 phosgene see carbonyl
23170 007664-38-2 phosphoric acid
23175 000122-52-1 triethyl phosphite QM = ND (DL = 1 mg / kg in PBS) | || 23187 - phthalic acid, terephthalic acid see
23200 000088-99-3 o-phthalic acid
23230 000131-17-9 diallyl phthalate SML = ND (DL = 0.01 mg / kg)
23380 000085-44-9 phthalic anhydride
23470 000080-56-8 alpha-pinene
23500 000127-91-3 beta-pinene
23547 009016-00-6 polydimethylsiloxane (molecular to the specifications
063148-62-9 weight greater than 6800) set out in Appendix II to this Annex

23590 025322-68-3 polyethylene glycol 23650 025322-69-4 polypropylene (molecular weight greater than
400)
23651 025322-69-4 000057-55-6 polypropylene
23740 propane-1,2-diol
23770 000504-63-2 propane-1,3-diol SML = 0.05 mg / kg
23800 000071-23-8 propan-1-ol
23830 000067-63-0 propan-2-ol
23860 000123-38-6 propionaldehyde;
propanaldehyd
23890 000079-09-4 propionic acid
23920 000105-38-4 vinyl propanoate SML (T) = 6 mg / kg (2)
(Expressed as acetaldehyde) 23950 000123-62-6 propionic

23980 000115-07-1 propylene;

24010 000075-56-9 propylene, propylene oxide QM = 1 mg / kg in FP 24051 000120-80-9
pyrocatechol; see 1.2 dihydroxybenzen
benzene-1,2-diol
24057 000089-32-7 pyromellitanhydrid SML = 0,05 mg / kg (expressed as
pyromellitic acid)
24070 073138-82-6 resin acids and rosin
acid
24072 000108-46-3 resorcinol see 1,3dihydroxybenzen
24073 000101-90-6 resorcinol (diglycidyl) ether QMA = 0,005 mg / 6 dm2. Substance not
be used in polymers contacting
Food, for which, according
Annex No. 4 to this Decree
provided použitísimulantu D
the substance can only be used for
indirect food contact,
separate PET layer 24100 008050-09-7 Rosin

24130 008050-09-7 rosin see.
24160 008052-10-6 Rosin tall oil rosin
24190 009014-63-5 wood rosin
24250 009006-04-6 rubber, natural
24270 000069-72-7 salicylic acid;
2-hydroxybenzoic acid
24280 000111-20-6 sebacic acid;
dodecanedioic acid
24430 002561-88-8 sebakanhydrid;
decanedioic acid anhydride
24475 001313-82-2 Sodium sulfide

sorbitol 000050-70-4 24490 24520 008001-22-7 soybean oil
24540 009005-25-8 starch, food
24550 000057-11-4 stearic acid;
octadecanoic acid 24610 000100-42-5 styrene

24760 026914-43-2 styrene sulfonic acid SML = 0.05 mg / kg 24820 000110-15-6

succinic acid 24850 000108-30- 5 succinic anhydride
24880 000057-50-1 046728-75-0 24886 sucrose
monolithium-5-sulfoisophthalate SML = 5 mg / kg and for lithium SML (T)
= 0.6 mg / kg (8) expressed as

24887 006362-79-4 lithium 5-sulfoisophthalic acid SML = 5 mg / kg
monosodium salt
24888 003965-55-7 dimethyl 5-sulphoisoftalové SML = 0.05 mg / kg
acid, monosodium salt
24903 068425-17-2 Syrups, hydrolysed starch, in accordance with the specifications
hydrogenated set out in Appendix II to this
Annex
24910 000100-21-0 Terephthalic acid SML = 7.5 mg / kg 24940 000100-20-9
dichloride of terephthalic acid SML (T) = 7.5 mg / kg (expressed as terephthalic
acid)
24970 000120-61-6 dimethyl terephthalate
25080 001120-36-1 tetradec-1-ene SML = 0.05 mg / kg 25090 000112-60-7 tetraethyleneglycol

25120 000116-14-3 tetrafluoroethylene SML = 0.05 mg / kg 25150 000109-99-9
tetrahydrofuran SML = 0.6 mg / kg
25180 000102-60-3 N, N, N ', N' tetrakis (2-hydroxypropyl
)
ethylenediamine
25210 000584-84-9 2,4-toluene diisocyanate QM (T) = 1 mg / kg (VFP
expressed as NCO) (26)

25240 000091-08-7 2,6-toluene diisocyanate QM (T) = 1 mg / kg (VFP
expressed as NCO) (26)
25270 026747-90-0 2,4- toluene diisocyanate, dimer QM (T) = 1 mg / kg (VFP
expressed as NCO) (26)
25360 - 2,3-epoxypropyl-trialkyl (C5-C15) QM = 1 mg / kg FP (expressed as
acetate epoxy group, molecular weight = 43
)
25380 - vinyl-trialkyl (C7-C17) acetates QMA = 0.05 mg / dm2 6
(= Vinyl versatate)
25385 000102-70-5 triallylamine In accordance with the specifications
set out in Appendix II to this
Annex.
25420 000108-78-1 2,4,6-triamino-1,3,5-triazine SML = 30 mg / kg
25450 26896-48-0 tricyklodekandimethanol SML = 0.05 mg / kg || | 25510 000112-27-6 000528-44-9 triethylene
25540 trimellitic acid SML (T) = 5 mg / kg (35)
25550 000552-30-7 trimelitanhydrid SML (T) = 5 mg / kg (35) (expressed as trimellitic acid
)
25600 000077-99-6 1,1,1-trimethylolpropane; SML = 6 mg / kg
2-ethyl-2 (hydroxymethyl) propane-1,3-
diol
25840 003290-92-4 2,2-bis (methakryloxymethyl) -but-yl- SML = 0.05 mg / kg
methacrylate
25900 00110-88-3 trioxane SML = 5 mg / kg 25910 024800-44-0 tripropylene

25927 027955-94-8 1,1,1-tris (4-hydroxyphenyl) ethane QM = 0.5 mg / kg in FP. Only for
use in polycarbonates.

25960 000057-13-6 urea vinyl chloride 26050 000075-01-4 see.
requirements of this Decree 26110 000075-35-4 vinylidene QM = 5 mg / kg in FP or
SML = ND
(DL = 0.05 mg / kg)
26140 000075-38-7 vinylidene fluoride SML = 5 mg / kg
26155 001072-63-5 1-vinylimidazole QM = 5 mg / kg in FP || | 26170 003195-78-6 N-vinyl-N-methylacetamide QM = 2 mg / kg in FP 26305 000078-08-0
triethoxy (vinyl) silane SML = 0.05 mg / kg.K use only
as a surface treating agent.
26320 002768-02-7 vinyltrimethoxysilane QM = 5 mg / kg in FP 26360 007732-18-5 Water
In accordance with a special legal
regulations establishing requirements
for drinking water.
------------------------- ---------------------- ---------------------------------- -----------

SECTION B
LIST OF MONOMERS AND OTHER STARTING SUBSTANCES
Which can be used
Pending a decision on inclusion in Section A
------------------------- -------------- ------------------- ------------------------------- ---
PM / REF CAS No name Restrictions and / or specifications
no.
------------------------- ---------------------- ---------------------------------- -----------
(1) (2) (3) (4)
------------------------- ---------- ----------------------- --------------------------- -------
13050 00528-44-9 1,2,4-benzenetricarboxylic acid see trimellitic acid

dicyclopentadiene 00077-73-6 15730 18370 000592-45-0 hexa-1, 4-diene

26230 000088-12-0 vinylpyrrolidone ------------------------- --------- ------------------------ -------------------------- --------


INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED
For plastics

SECTION A
------------------------- -------------------- ------------- ----------------------------------
PM / REF CAS No name Restrictions and / or specifications
no.
------------------------- -------------------- ------------- ----------------------------------
(1) (2) (3) (4)
------------------------- ---------- ----------------------- --------------------------- -------
30000 000064-19-7 acetic acid
30045 000123-86-4 butyl acetate
30080 004180-12-5 acetic cuprous salt SML (T) = 5 mg / kg (7)
(Expressed jakoměď)
30140 000141-78-6 ethyl acetate, acetic anhydride 000108-24-7 30,280


acetone 000067-64-1 30,295 30,370 - acetyloctová acid salt
30401 - acetylated mono- and diglycerides of fatty

acids 30 610 - C2-C24 aliphatic linear monocarboxylic
acids of natural oils and fats and
mono-, di- and triglycerides (including
branched fatty acids as
naturally occur in nature)

30612 - synthetic C2-C24, aliphatic, linear,
monocarboxylic acids and their mono-, di-

30960 and triglycerides - fatty esters, mono-
acids (C6-C22) polyglycerol
31328 - fatty acids from animal or
vegetable fats and oils
31530 123968-25-2 2,4-di-tert-pentyl-6- [1- (3,5-di-tert-pentyl-SML = 5 mg / kg 2-hydroxyphenyl
) ethyl] phenyl acrylate
31542 174254-23-0 methyl acrylate, telomer with 1- QM = 0.5% (w / w) in FP
dodekaneethiolem, C16-C18 alkyl
31730 000124-04-9 Adipic acid
33120 - alcohols, aliphatic, with one group
OH, saturated, linear, primary (C4-C24)
33350 009005-32-7 alginic acid
33801 - n-alkyl (C10-C13) benzenesulfonic acid SML = 30 mg / kg
34240 - esters alkyl (C10-C20) sulfonic acid SML = 6 mg / kg
phenols
34281 - alkyl sulfate acids (C8-C22) linear,
primary with an even number of carbon atoms
34475 - phosphite hydroxide, aluminum-calcium

hydrate 34480 - Aluminium fibers, flakes and powders
34560 021645-51-2 aluminum hydroxide
34690 011097-59-9 hydroxide-magnesium carbonate, aluminum
34720 001344-28-1 alumina | || 34850 143925-92-2 oxidised QM = dialkylminy technically use only:
hydrogenated and) in polyolefins
in an amount do0,1% (wt.)
but not VLDPE which is
intended for contact
foods for which
by přílohyč. 4 of this
Decree provides that the
reduction factor less than 3;
b) in PET in a quantity of 0.25 to
% (Wt.), Which is designed
food contact
except for that
According to Annex no. 4 to this
Decree determined using
simulant D.
34895 000088-68-6 2-aminobenzamide SML = 0.05 mg / kg
The substance can only be used
PET, which is designed for
Relations pitnouvodou and
beverages.
35120 013560-49-1 thiobis (2-hydroxyethyl) diester
3-aminocrotonate
35160 06642-31-5 6-amino-1,3-dimethyluracil SML = 5 mg / kg
35170 00141-43-5 2-aminoethanol SML = 0.05 mg / kg. Substance not
vpolymerech be used in
contact with foods for which
According to Annex no. 4 to this
Decree determined using
simulant D; the substance can be
pouzepro used indirect
contact with food, separated
from food
PET layer 35284 00111-41-1 N- (2-hydroxyethyl) ethane-1,2-diamine SML = 0.05 mg / kg. Substance not
vpolymerech be used in
contact with foods for which
According to Annex no. 4 to this
Decree determined using
simulant D; the substance can be
pouzepro used indirect
contact with food, separated
Food from PET layer 35320 007664-41-7 ammonia

35440 012124-97-9 ammonium bromide
35600 001336-21-6 ammonium hydroxide
35840 000506-30-9 arachidonic acid
35845 007771-44-0
arachidonic acid, ascorbic acid 36000 000050-81-7 000137-66-6 36,080
ascorbyl palmitate;
ascorbyl hexadecanoate
36160 010605-09-1 ascorbyl stearate
36840 012007-55-5 Barium tetraborate SML (T) = 1 mg / kg (12)
(Expressed as barium) and
SML (T) = 6 mg / kg (23)
(Expressed as Boron) without
the separate legal
regulation laying down

requirements for drinking water.
36880 008012-89-3 beeswax

behenamide 003061-75-4 36960 37040 000112-85-6 behenic acid 37280 001302-78-9 bentonite

37360 000100-52- 7 benzaldehyde In accordance with footnote (9)
Appendix IIItéto Annex. 37600 000065-85-0

benzoic acid 37680 000136-60-7 butyl benzoate
37840 000093-89-0 ethyl-benzoate
38080 000093-58-3 methyl benzoate
38160 002315-68-6 propyl benzoate
38510 136504-96-6 1,2-bis (3-aminopropyl) ethylenediamine, SML = 5 mg / kg
polymer with N-butyl-2,2,6,6-tetramethyl-4-
piperidinamine and 2,4,6-trichloro-1,3,5
triazine
38515 001533-45-5 4,4'-bis (2-benzoxazolyl) stilbene SML = 0.05 mg / kg (1)
38810 080693-00-1 3,9-bis (2, 6-di-tert-butyl-4-methylphenoxy) - SML = 5 mg / kg (amount of phosphites
2,4,8,10-tetroxa-3,9- and phosphate)
diphosphaspiro [5.5] undecane
(Bis (2,6-di-tert-butyl-4-
methylphenyl) diphosphite pentaerythhhritol)
38840 154862-43-8 Bis (2,4-dicumylphenyl) SML = 5 mg / kg (as the sum
pentaerythritol substance itself, its oxidised form
bis (2,4-dicumylphenyl)

pentaerythritolfosfátu and product jejíhydrolýzy 2,4
dikumylfenol)
38875 002162-74-5 bis (2,6-diisopropylphenyl) carbodiimide SML = 0.05 mg / kg. The substance may
be used if
PET layer separated.
38879 135861-56-2 Bis (3,4-dimethylbenzylidene) sorbitol
38885 002725-22-6 2,4-bis (2,4-dimethylphenyl) -6- [2-hydroxy-4- SML = 0.05 mg / kg. Only for
(Octyloxy) phenyl] -1,3,5-triazine aqueous foods.
38950 079072-96-1 bis (4-ethylbenzyliden) sorbitol
39200 006200-40-4 bis (2-hydroxyethyl) -2-hydroxypropyl-3- SML = 1.8 mg / kg
(Dodecyloxy) methylammonium chloride
39680 000080-05-7 2,2-bis (4-hydroxyphenyl) propane SML (T) = 0.6 mg / kg (28)
39815 182121-12-6 9 , 9-bis (methoxymethyl) fluorene SML = 0.05 mg / kg 39890 087826-41-3
bis (methylbenzylidene) sorbitol
069158-41-4
054686-97-4
081541-12-0
39925 129228-21-3 3,3-bis (methoxymethyl) -2,5-dimethylhexane SML = 0.05 mg / kg 40120 068951-50-8
fifth bis (polyethylene glycol ) hydroxymethyl SML = 0.6 mg / kg
phosphonate;
[(Hydroxymethyl) phosphoryl] bis [poly (oxyethylene)]
40320 010043-35-3 boric acid SML (T) = 6 mg / kg (23)
(Expressed as Boron) without
prejudice
special legal
regulation laying down
requirements for drinking water.
40400 010043-11-5 boron nitride
40570 000106-97-8 000110-63-4 40580
butane butane-1,4-diol SML (T) = 5 mg / kg (24) | || 41040 005743-36-2 calcium butyrate
41120 10043-52-4 calcium chloride 41280 001305-62-0

calcium hydroxide, calcium oxide 41520 001305-78-8
41600 012004- 14-7 Sulpho calcium

41680 037293-22-4 000076-22-2 camphor in accordance with footnote (9)
Appendix IIItéto Annex.
41760 008006-44-8 candelilla wax
41840 00105-60-2 caprolactam SML (T) = 15 mg / kg (5)
41960 000124-07-2 caprylic acid;
octanoic acid
42080 001333-86-4 soot in accordance with the specifications
set out in Appendix II.této
Annex.
42160 000124-38-9 carbon dioxide
42320 007492-68-4 cupric carbonate SML (T) = 5 mg / kg (7)
(Expressed as copper)
42500 - carbonic acid, salt
42640 009000-11-7 008015-86-9 42,720 carboxymethylcellulose

carnauba wax 42800 009000-71-9 casein
42880 008001 -79-4 castor oil
42960 064147-40-6 castor oil, anhydrous
43200 - castor oil, mono- and diglycerides
43280 009004-34-6 009004-36-8 43300 cellulose
cellulose acetate butyrate
43360 068442-85-3 cellulose, regenerated 43440 008001-75-0 ceresin

43480 064365-11-3 charcoal In accordance with the specifications
set vdodatku II of this
Annex.
43515 - choline chlorides of fatty acids QMA = 0,9 mg / dm2 6
coconut oil
44160 000077-92-9 citric acid

44640 000077-93-0 methyl citrate
45195 007787-70-4 CuBr SML (T) = 5 mg / kg (7)
(Expressed as copper)
45200 001335-23-5 iodide SML (T) = 5 mg / kg (7)
(Expressed as copper) SML (T) =
1mg / kg (11) (expressed as iodine
)
45280 - cotton fibers
45450 068610-51-5 reaction product of p-cresol SML = 5 mg / kg
with dicyclopentadiene and isobutylene;
p-cresol-dicyklopentadie-isobutylene,
copolymer

cristobalite 014464-46-1 45560 45600 003724-65-0 crotonic acid; QMA (T) = 0.05 mg / dm2 6
(E) -but-2-enoic acid (33)
45640 005232-99-5 ethyl-3,3-diphenyl-2-cyanoacrylate; SML = 0.05 mg / kg
ethyl 2-cyano-3,3-diphenyl-
acrylic
45703 491589-22-1 calcium-cis-cyclohexane-1,2-dicarboxylate SML = 5 mg / kg.
45705 166412-78-8 diisononyl cyclohexane-1,2-dicarboxylate
45760 000108-91-8 009000-16-2 cyclohexylamine
45920 dammar
45940 000334-48-5 n-decanoic acid
46070 010016-20-3 alpha-dextrin
46080 007585-39-9 beta-dextrin
46375 061790-53-2 068855-54-9 46380
diatomaceous silica, anhydrous sodium carbonate,
calcined melt
46480 032647-67-9 dibenzylidene sorbitol
46700 - 5,7-di-tert-butyl-3- (3,4- and 2,3- SML = 5 mg / kg || | dimethylphenyl) benzofuran-2 (3H) -one
comprising:
a) 5,7-di-tert-butyl-3- (3,4-dimethylphenyl
) benzofuran-2 (3H) -one (80
100 wt.%), and
b) 5,7-di-tert-butyl-3- (2,3-dimethylphenyl
) benzofuran-2 (3H) -one (0-20
wt.%)
46720 004130- 42-1 2,6-di-tert-butyl-4-ethylphenol QMA = 4,8 mg / dm2 6
46790 004221-80-1 2,4-di-tert-butylphenyl 3,5-di-tert -
butyl-4-hydroxybenzoic acid
46800 067845-93-6 hexadecyl 3,5-di-tert-butyl-4-
hydroxybenzoic acid
46870 003135-18-0 dioctadecyl 3,5-di-tert-butyl-4-
hydroxybenzylphosphonate
46880 065140-91-2 monoethyl- (3,5-di-tert-butyl-4- SML = 6 mg / kg
hydroxybenzyl) phosphonate, calcium salt
47210 26427-07-6 dibutyl thiocíničitan polymer; In accordance with the specifications
thiobis (butyltin sulfide) polymer in Appendix II to this Annex.
47440 000461-58-5 dicyandiamide
47540 27458-90-8 di-tert-dodecyl disulfide SML = 0.05 mg / kg 47680 000111-46-6
bis (2-hydroxyethyl) ether ; SML (T) = 30 mg / kg (3)
diethylene
48460 000075-37-6 1,1-difluoroethane
48620 00123-31-9 1,4-dihydroxybenzene SML = 0.6 mg / kg
48720 00611-99-4 4,4 ' -dihydroxybenzofenon SML (T) = 6 mg / kg (15)
48960 _ 9,10-dihydroxystearic acid and SML = 5 mg / kg
oligomers
49485 134701-20-5 2,4-dimethyl-6- (1-methylpentadecyl) phenol SML = 1 mg / kg 49540 000067-68-5 dimethylsulfoxide

51200 000126-58-9 dipentaerythritol
51700 147315-50-2 2- (4,6-diphenyl-1,3,5-triazin-2-yl) -5- SML = 0.05 mg / kg
(Hexyloxy) phenol
51760 025265-71-8 dipropylene
000110-98-5 016389-88-1 dolomite

52640 52645 10436-08-5 cis-11-eikosenamid

erucamide 000112-84-5 52720 52730 000112-86-7 erucic acid
52800 000064-17-5 ethanol
53270 037205-99-5 009004-57-3 ethylkarboxymethylcelulóza
53280 ethylcellulose
53360 000110-31-6 N, N'-ethylenebis (oleamide) || | 53440 005518-18-3 N, N'-ethylenebis (palmitamide)
53520 000110-30-5 N, N'-ethylenebis (stearamide)
53600 000060-00-4 ethylenediaminetetraacetic acid
53 610 054 453 -03-1 ethylenediaminetetraacetic acid, copper SML (T) = 5 mg / kg (7)
salt (expressed as copper)
53650 000107-21-1 ethane-1,2-diol SML (T) = 30 mg / kg (3)
(Ethylene glycol)
54005 005136-44-7 ethylene-N-N'-palmitamide stearamide
54260 009004-58-4 ethylhydroxyethylcellulose
54270 - ethylhydroxymethylcelulóza
54280 - 54300 118337- ethylhydroxypropylcelulóza
09-0 2,2'-ethylidene-bis (4,6-di-tert-butyl SML = 6 mg / kg
phenyl) fluorfosfonit
54450 - fats and oils of animal or

vegetable food sources 54480 - Fats and oils of animal or
plant sources of food, hydrogenated
54930 025359-91-5 formaldehyde-1-naphthol, copolymer; poly (1- SML = 0.05 mg / kg
hydroxynaftylmethan)]
55040 000064-18-6 formic acid
55120 000110-17-8 fumaric acid

55190 029204-02-2 gadoleic acid

gelatin 009000-70-8 55,440 55,520 - 55,600
glass fibers - glass microspheres
55680 000110-94-1 glutaric acid
55910 736150-63-3 hydrogenated, acetates monoglycerides
castor oil
55920 000056-81-5 099880-64-5 56020
glycerol glycerol dibehenate;
glycerol didokosonoát
56360 - esters of glycerol with acetic
56486 - glycerol esters with acids
aliphatic, saturated, linear, with
an even number of carbon atoms (C14-C18) and
with acids, aliphatic, unsaturated,
linear, with an even number of carbon
atoms (C16-C18)
56487 - glycerol esters with butyric acid
56490 - glycerol esters of erucic acid
56495 - glycerol esters with acid 12-
hydroxystearic
- Glycerol esters with lauric acid

56500 56510 - esters of glycerol with linoleic acid
56520 - glycerol esters with myristic
56535 - glycerol esters with nonanoic acid
56540 - esters of glycerol with oleic acid
56550 - esters of glycerol with palmitic acid
56570 - glycerol esters with propionic acid
56580 - glycerol esters of ricinoleic acid
56585 - glycerol esters with stearic
56610 030233-64-8 monobehenate
glycerol 56720 026402-23-3 monohexanoát
56800 030899-62-8 glycerol monolaurate diacetate glycerol 56880 026402-26-6

glycerol monocaprylate 57040 - glycerol ester monooleate
with ascorbic acid
- Ester of glycerol monooleate
57120 with citric acid
- Glycerol monopalmitate ester with ascorbic acid 57200

57280 - glycerol ester palmitate acid
lemon
57600 - ester glycerol monostearate
with ascorbic acid
57680 - ester glycerol monostearate
citric acid
57800 018641-57-1 glycerol tri (dokosanoát)
57920 000620-67-7 triheptanoát glycerol
58300 - glycine, salts
58320 007782-42-5 graphite
58400 009000-30-0 58,480
guar gum, gum arabic 009000-01-5 000111-14-8 58,720

heptanoic acid 59280 000100-97-0 hexamethyletetraamin; SML (T) = 15 mg / kg (22)
1,3,5,7-tetraazaadamantan (expressed as formaldehyde)
59360 000142-62-1 hexanoic acid
59760 019569-21-2 007647-01-0 59990 huntite
hydrochloric acid
60025 _ hydrogenated homopolymers or copolymers in accordance with the specifications
dec-1-ene, dodec-1-ene or oct-1-ene. set out in Annex V.
Not to be used for articles in
contact with fatty foods.
60030 012072-90-1 012304-65-3 hydromagnesite
60080 hydrotalcite
60160 000120-47-8 ethyl 4-hydroxybenzoate
60180 004191-73-5 isopropyl 4-hydroxybenzoate || | 60200 000099-76-3 methyl 4-hydroxybenzoate
60240 000094-13-3 propyl 4-hydroxybenzoate
60480 003864-99-1 2- (2-hydroxy-3,5-di-tert- butyl-phenyl) -5- SML (T) = 30 mg / kg (19)
chlorobenzotriazole²

hydroxyethyl 009004-62-0 60560 60880 61120 009032-42-2 009005-27-0 hydroxyethyl methylcellulose

hydroxyethyl starch 61390 037353-59-6 hydroxymethyl
61680 009004-64- 2 hydroxypropylcellulose
61800 009049-76-7 hydroxypropyl starch
61840 000106-14-9 12-hydroxystearic acid
62020 007620-77-1 lithium 12-hydroxystearate SML (T) = 0.6 mg / kg (8)
expressed as lithium
62140 006303-21-5 hypophosphorous acid
62240 001332-37-2 iron oxide
62245 012751-22-3 Iron phosphide For polymers and
PET copolymers
62280 009044-17-1 copolymer of isobutylene (2-methylpropene) and
butene

isopentane 000078-78-4 62450 62640 008001-39-6 Japan wax 62720 001332-58-7 kaolin

62800 - kaolin, calcined
62960 000050-21-5 milk
acid 63040 000138-22-7 butyl lactate
63280 000143-07-7 lauric acid 63760 008002-43-5 lecithin

63840 000123-76-2 levulinic acid
63920 000557 -59-5 lignoceric
64015 000060-33-3 acid, linoleic acid 64150 028290-79-1

64500 linolenic acid - lysine salt
64640 001309-42-8 magnesium hydroxide
64720 001309-48-4 magnesium oxide

64800 00110-16-7 maleic acid SML (T) = 30 mg / kg (4)
64990 02573661-2 maleic anhydride-styrene copolymer, sodium in accordance with the specifications
salt set vdodatku II of this
Annex.
65020 006915-15-7 malic acid
65040 000141-82-2 malic acid 65520 000087-78-5 mannitol

65920 66822-60-4 sodium [N-methakryloyloxyethyl- || | N, Ndimethyl-N-carboxymethyl-amonium-
chloride-octadecyl-methakrylát-
ethyl methacrylate-cyclohexyl methacrylate-N-
vinyl-2-pyrrolidone, copolymers
66200 037206-01-2 009004-67-5 66240 methylkarboxymethylcelulóza

methylcellulose 66560 004066-02-8 2,2'-methylene-bis (4-methyl-6 - SML (T) = 3 mg / kg (6)
cyclohexylphenol)
66580 000077-62-3 2,2'-methylene-bis [4-methyl-6- (1- SML (T) = 3 mg / kg (6)
methylcyclohexyl) phenol]
66640 009004-59-5 methyl ethyl
66695 - 66700 009004-65-3 methylhydroxymethylcelulóza

methylhydroxypropylcellulose 66755 002682-20-4 2 methyl-2,3-dihydroisohiazol-3-one SML = 0.5 mg / kg. To use
only in aqueous dispersions
polymer emulsions and
at concentrations that do not
to the polymer surface or
food itself
antimicrobial effect.
66905 000872-50-4 N-methyl
66930 068554-70-1 methylsilseskvioxan residual monomer in
methylsilseskvioxanu; <1mg
methyltrimethoxysilane / kg
methylsilseskvioxanu

67120 012001-26-2 mica
67155 - A mixture of 4- (2-benzoxazolyl) -4 '- (5-methyl-2- most 0.05%
benzoxazolyl) stilbene, 4,4 bis (2- (amount used
benzoxazolyl) stilbene and 4,4'-bis (5-methyl- substance / composition) .In
2-benzoxazolyl) stilbene accordance with specifications
set vdodatku II of this
Annex.
67180 - mixture of decyl octylftalátu (50 wt.%) SML = 5 mg / kg (1)
didecyl phthalate (25% wt.) and
dioctylphthalate (25 wt.)
67200 001317-33-5 molybdenum disulfide
67840 - montanic acid and / or esters thereof
with ethylene glycol and / or butane-1,3-diol
and / or glycerol
67850 008002-53-7 Montan waxes
67891 000544-63-8 myristic acid
68040 003333-62-8 7- [2H-naphtho (1,2-d) triazole -2-yl] -3-
phenylcoumarin
68078 027253-31-2 neodecanoic acid, cobalt salt; SML (T) = 0,05mg / kg
7,7-dimethyloctanoic acid, cobalt salt (expressed as neodecanoic acid
) and
SML (T) = 0,05mg / kg (14)
(Expressed as cobalt)
Not to be used
in polymers intended for
contact with foods for which
According to Annex no. 4 to this
Decree established simulant
D.
68125 037244-96-5 nefelinsyenit
68145 080410-33-9 2,2 ', 2 "- nitrilo [triethyl-tris (3,3', 5,5' SML = 5 mg / kg (sum of phosphite and
tetra-tert-butyl-1,1'-biphenyl-2,2'-phosphate)
diyl) phosphite]
68960 000301-02-0 oleamide
69 040 000 112 -80-1 oleic acid oleyl
69760 000143-28-2 000144-62-7
69920 oxalic acid SML (T) = 6 mg / kg (29)
70000 070331-94-1 2 2'-oxamidobis [ethyl-3- (3,5-di-tert-butyl
4-hydroxyphenyl) propionate]
70240 012198-93-5 000057-10-3 ozokerite
70400 palmitic
acid 70480 000111-06-8 butyl palmitate
71020 000373-49-9 palmitoleic acid 71440 009000-69-5 pectin


71600 000115-77-5 pentaerythritol 71635 025151- 96-6 2,2-bis (hydroxymethyl) propane-1,3-diol- SML = 0.05 mg / kg. Should not be
di (octadec-9-enoate) used in polymers contacting
(Pentaerythritol dioleate) with food for which
Annex no. 4k hereto
established
simulant D 71670 178671-58-4 Pentaerythritol tetrakis (2-cyano-3,3-di- SML = 0.05 mg / kg
phenyl acrylate)
71680 006683-19-8 Pentaerythritol tetrakis [3- (3,5-di-tert
butyl-4-hydroxyphenyl) propionate]


71720 000109-66-0 Pentane 71960 003825-26-1 aminium-ammonium salt Only to be used in subjects
for opakovanépoužití
sintered přivysokých
temperatures.
72640 007664-38-2 phosphoric acid
73160 - mono- and di-n-alkyl (C16 and C18) esters SML = 0.05 mg / kg

phosphoric acid 73720 000155-96-8 (trichloroethyl) phosphate SML = ND (DL
= 0,02mg / kg, including
measurement uncertainty)
74010 145650-60-8 Bis (2 , 4-di-tert-butyl-6-methylphenyl) ethyl SML = 5 mg / kg (amount phosphites
phosphite and phosphate)
74240 031570-04-4 tris (2,4-di-tert- butylphenyl) phosphite
74480 000088-99-3 o-phthalic acid
74560 000085-68-7 benzyl butyl phthalate be used only as:
a) plasticizer in materials
and products for repeatedly
use
b) plasticizer in materials
and disposable articles
coming into use
contacting non-fatty
foods except for initial
and pokračovacíkojenecké
Nutrition by special
legal regulation 4).
c) technical support
in concentrations up
0.1% in the final product
SML = 30 mg / kg simulant
Food
74640 000117-81-7 Bis (2-ethylhexyl) phthalate be used only as:
a) plasticizer in materials
and products for repeatedly
coming into use
contacting non-fatty
food
b) technical support
in concentrations up
0.1% in the final product
SML = 1,5 mg / kg food simulant
Food
74880 000084-74-2 dibutyl phthalate be used only as:
a) plasticizer in materials
and products for repeatedly
coming into use
contacting non-fatty
food
b) technical support
in concentrations up
0.05% in the final product
SML = 0,3 mg / kg food simulant
Food
75100 068515-48-0 di-saturated branched phthalates be used only as:
028553-12-0 primary alkyl C8-C10 and containing more) plasticizer in materials
than 60% C9 and products for repeated
use
b) plasticiser in
Disposable
coming into contact
with beztukovýmipotravinami
apart from the initial and
infant formula
under a special legal
regulation4).
c) technical support
in concentrations up
0.1% in the final product
SML (T) = 9 mg / kg simulant
Food (42)
75105 068515-49-1 dialkyl phthalates with primary, saturated Only for use as:
026761-40-0 C9-C11 containing more than 90% a) plasticizer in materials
C10 and products for repeatedly
use
b) plasticiser in
Disposable
coming into contact
with beztukovýmipotravinami

apart from the initial and
infant formula
under a special legal
regulation4)
c) technical support
in concentrations up
0.1% in the final product
SML (T) = 9 mg / kg simulant
foods (42)
76320 000085-44-9 019455-79-9 phthalic
76415 pimelic acid calcium salt
76463 _ salts of poly (acrylic acid) SML (T) = 6 mg / kg (36 ) (for
polyakrylovoukyselinu)
76721 009016-00-6 polydimethylsiloxane (Mw> 6800) In compliance with the specifications
063148-62-9 set vdodatku II of this
Annex.
76723 167883-16-1 copolymers of poly (dimethyl siloxane) In accordance with the specifications
with end 3-aminopropyl groups and set vdodatku II of this
bis (4-isocyanatocyclohexyl) methane Annex
76725 661476-41-1 Polydimethylsiloxane (dimethyl siloxane) In accordance with the specifications
with end 3-aminopropyl groups and set vdodatku II of this
5-isocyanato-1- (isocyanatomethyl) -1,3,3- Annex
trimethylcyclohexane
76730 - polydimethylsiloxane, A-hydroxypropylated SML = 6 mg / kg
76815 - Polyester of adipic acid with glycerol in accordance with the specifications
or pentaerythritol, esters with even laid vdodatku In this
carbon number fatty acids Annex.
C12-C22, linear
76845 031831-53-5 Polyester of 1,4-butanediol with caprolactone In compliance with the specifications
set vdodatku II of this
Annex.
76866 - polyesters propane-1,2-diol and / or butane SML = 30 mg / kg
1,3-diol and / or butane-1,4-diol and / or
polypropylene glycol with adipic acid,
which may be terminated groups
derived from acetic or
fatty acids C12-C18 or n-1-ol
and / or decan-1-ol
76960 025322-68-3 070142-34-6 77,370
polyethylene poly (ethylene glycol-30)
dipolyhydroxystearate
77600 061788-85-0 polyethylene glycol esters with hydrogenated
castor oil
77702 - polyethylene glycol esters with aliphatic
monocarboxylic acids (C6-C22) and
their ammonium and sodium sulphates
77732 - poly (ethylene glycol) having 1 to 30 oxyethylene SML = 0.05 mg / kg. To use
units (typically 5) ether of butyl-3- (4-only PET.
hydroxy-3-methoxyphenyl) -2-cyanoacrylate
77733 - poly (ethylene glycol) having 1 to 30 oxyethylene SML = 0, 05 mg / kg. To use
units (typically 5) ether of butyl-3- (4-only PET.
hydroxyphenyl) -2-cyanoacrylate
77895 068439-49-6 ether of polyethylene glycol (EO = 2-6) and SML = 0 , 05 mg / kg and in accordance
monoalkyl (C16-C18) with the specifications in Appendix II
this Annex
77897 - poly (ethylene glycol) monoalkylethersulfát SML = 5 mg / kg
salt (1 to 50 oxyethylene units, typically 5
; alkyl C8-C20 linear and branched
)
79040 009005-64-5 sorbitan monolaurate polyethylene
79120 009005-65-6 sorbitan monooleate
79200 009005-66-7 polyethylene glycol sorbitan monopalmitate
79280 009005-67-8 polyethylene glycol sorbitan monostearate polyethylene
79360 009005-70-3 sorbitan trioleate, polyethylene glycol sorbitan 009005-71-4 79,440
-tristearát polyethylene
79600 009046-01-9 poly (ethylene glycol) tridecylether, phosphate SML = 5 mg / kg. For materials
and articles intended for
contact with aqueous foods. In
compliance with specifications
set vdodatku II of this
Annex.
79920 009003-11-6 poly (ethylene glycol-co-propylene glycol)
106392-12-5 009002-88-4 80000

polyethylene wax 80240 029894-35-7 polyglycerol ricinoleate
80640 - polyoxyalkylene (C2-C4) dimethylpolysiloxane
80720 008017-16-1 polyphosphoric acid
80800 025322-69-4 polypropylene
81060 009003-07-0 Polypropylene wax
81220 192268-64-7, poly [[6- [N- (2,2,6,6-tetramethylpiperidin-4 -SML = 5 mg / kg

yl) -n-butylamino] -1,3,5-triazine-2,4-
diyl] [N- (2,2,6,6-tetramethylpiperidin-4- yl
) imino] hexane-1,6-diyl, [N- (2,2,6,6-tetramethylpiperidin-4
yl) imino]] - a-
[N, N, N ', N'-tetrabutyl-N' - (2,2,6,6-tetramethylpiperidin-4-

ylamino) hexyl] [1,3,5-triazine -2,4,6
triamino] -U-N, N, N ', N'-tetrabutyl-1,3,5
triazine-2,4-diamine
81500 9003-39-8 poly (vinylpyrrolidone) In accordance with the specifications
set vdodatku II of this
Annex
81515 087189-25-1 polyglycerol zinc SML (T) = 25 mg / kg (38)
(Expressed as Zn)
81520 007758-02-3 potassium bromide
81600 001310-58-3 potassium hydroxide
81760 - powders, flakes and fibers of brass, bronze, SML (T) = 5 mg / kg (7)
copper, stainless steel, tin and alloys (expressed as copper) SML =
copper, tin and iron 48mg / kg (expressed as
iron)
81840 000057-55-6 propane-1,2-diol 000067-63-0
81882 propan-2-ol
82000 000079-09-4 propionic acid
82080 009005-37-2 1,2-propyleneglycol alginate
82240 022788-19-8 1,2-propyleneglycol dilaurate
82400 000105-62-4 dioleate 1.2
033587-20-1 82,560-propylene 1,2-glycol dipalmitate
82720 006182-11-2 1,2-glycol distearate
82800 027194-74-7 1,2-propylene glycol monolaurate
82960 001330-80-9 1,2-glycol monooleate
83120 029013-28-3 1,2-glycol monopalmitate
83300 001323-39-3 1,2-glycol monostearate
83320 - propylhydroxyethylcelulóza || | 83325 - 83330 propylhydroxymethylcelulóza
-
propylhydroxypropylcelulóza 83440 002466-09-3 pyrophosphoric acid 83455 013445-56-2

diphosphonic acid 83460 012269-78-2 pyrophyllite
83,470 014808-60- 7 quartz
83599 68442-12-6 reaction products of 2-sulfonylethyl oleate SML (T) = 0,18mg / kg (16)
with dichloro-dimethylcínem, sodium sulphide and (expressed as tin)
trichlormethylcínem
83610 073138-82-6 resin acids and rosin acids
83840 008050-09-7 008050-31-5 84000
colophony rosin, glycerol ester of rosin
84080 008050-26-8, pentaerythritol ester of rosin 065997-06-0
84210, 84240 065997-13-9
hydrogenated rosin, hydrogenated,

ester and glycerol 84320 008050-15-5 Rosin, hydrogenated,
ester with methanol
84400 064365-17-9 Rosin, hydrogenated,
pentaerythritol ester with
84560 009006-04-6 rubber, natural 000069-72-7 84,640

salicylic acid 85360 000109-43-3 dibutyl decanedioate
85601 - natural silicates (excluding asbestos) | || 85610 - silicates, natural, silanated (except
asbestos)
85680 01343-98-2 silicic acid
85840 053320-86-8 lithium silicate, sodium-magnesium SML (T) = 0.6 mg / kg (8)
(Expressed as lithium)
86000 - silicic acid, silylated
86160 000409-21-2 silicon carbide
86240 007631-86-9 86,285
silica - silica, silanized
86560 007647 -15-6 sodium bromide
86720 001310-73-2 sodium hydroxide
87040 001330-43-4 sodium tetraborate SML (T) = 6 mg / kg (23)
(Expressed as Boron) without
prejudice
special legal
regulation laying down
the drinking water requirements
87200 000110-44-1 sorbic acid
87280 029116-98-1 sorbitan dioleate
87520 062568-11-0 sorbitan monobehenate
87600 001338-39-2 sorbitan
87680 001338-43-8 monolaurate sorbitan monooleate
87760 026266-57-9 sorbitan monopalmitate
87840 001338-41-6 sorbitan monostearate
87920 061752-68-9 sorbitan tetrastearate | || 88080 026266-58-0 sorbitan trioleate
88160 054140-20-4 sorbitan tripalmitate
88240 026658-19-5 sorbitan tristearate

sorbitol 000050-70-4 88,320 88,600 026,836 -47-5 sorbitan monostearate
88640 008013-07-8 soybean oil, epoxidised SML = 60 mg / kg. However
in the case of PVC gaskets
to seal glass jars
with initial apokračovací
baby food by
special legislation,

adapting the requirements
foods for
special nutrition and the way
their use, or
with the cereal and other
foods for infants and young
Children under this Decree
SML is lowered to 30 mg / kg.
In accordance with the specifications
Appendix II to this Annex.
88800 009005-25-8 starch, food
88880 068412-29-3 Starch, Hydrolyzed

stearamide 88960 89040 000124-26-5 000057-11-4 stearic acid
89120 000123 -95-5 butyl stearate
89200 007617-31-4 cuprous stearate SML (T) = 5 mg / kg (7)
expressed as copper
89440 - esters of stearic acid with ethylenklykolem SML (T) = 30 mg / kg (3)
90720 058446-52-9 005793-94-2 stearoylbenzoylmethane
90800 stearoyl-2-lactic acid , calcium sixth
90960 000110-15-6 succinic acid
91200 000126-13-6 sucrose acetate isobutyrate
91360 000126-14-7 sucrose octaacetate
91840 007704-34-9 sulfur
91920 007664-93-9 sulfuric acid
92030 010124-44-4 copper sulfate SML (T) = 5 mg / kg (7)
expressed as copper

talc 014807-96-6 92080 92150 01401-55-4 acid, tannin, in accordance with the specifications
JECFA
92160 000087-69-4 tartaric acid
92195 - taurine, salts seventh
92205 057569-40-1 2,2'-methylenebis (4-methyl-6-tert-eighth || | butylphenol) diester of terephthalic acid
92350 000112-60-7 tetraethylene ninth
92640 000102-60-3 N, N, N ', N'-tetrakis (2- 10th
hydroxypropyl) ethylenediamine | || 92700 078301-43-6 2,2,4,4-tetramethyl-20 (2,3-epoxypropyl) -7- 11th SML = 5 mg / kg
oxa-3,20-diazadispiro [5.1.11.2] -heneikosan-
21-one, polymer
92930 120218-34-0 thiodiethylenbis (5-methoxycarbonyl-2,6- 12th SML = 6 mg / kg
dimethyl-1,4-dihydropyridine-3-carboxylate
93440 013463-67-7 titanium dioxide
93520 000059-02-9 alpha-tocopherol

93680 010191-41-0 009000-65-1 gum tragacanth
93720 00108-78-1 2.4 , 6-triamino-1,3,5-triazine SML = 30 mg / kg
93760 000077-90-7 Tri-O-acetyl citrate
93970 - Tricyclodecanedimethanol SML = 0.05 mg / kg
bis (hexahydrophthalate)
94320 000112-27-6 000077-99-6 triethylene
94960 2-ethyl-2- (hydroxymethyl) propane-1,3-diol SML = 6 mg / kg 95 000 028 931
-67-1 poly [2,2-bis (hydroxymethyl) butan-1-ol trimethacrylate
] -co-methyl methacrylate
95020 6846-50-0 2,2,4-trimethylpentane-1, 3-diyl- SML = 5 mg / kg. When using
diisobutyrát necessary disposable gloves use

95200 001709-70-2 1,3,5-trimethyl-2,4,6-tris (3,5-di-tert
butyl-4-hydroxybenzyl) benzene
95270 161717-32-4 2,4,6-tris (tert-butyl) phenyl-2-butyl-2- SML = 2 mg / kg (as the sum
ethylpropane-1,3-diol phosphate, phosphite, phosphate and the product
hydrolysis = TTBP)
95420 745070-61-5 1,3,5-tris (2,2-dimethylpropanamide) benzene SML = 0,05 mg / kg food
95725 110638-71-6 vermiculite reaction product with lithium SML (T) = 0.6 mg / kg (8)
expressed as lithium citrate
95855 007732-18-5 Water In compliance with the special
legislation laying
establishing requirements for drinking
water
95858 - paraffins, refined, derived from petroleum or SML = 0,05 mg / kg and in accordance
synthetic hydrocarbon with the specifications
Appendix II to this Annex.
Not to be used
in subjects that come
into contact with fatty
food.
95859 - waxes, refined, derived from petroleum or in accordance with the specifications
synthetic hydrocarbons contained in Appendix II to this
Annex
95883 - white mineral oils, paraffinic, derived in accordance with specifications
Petroleum hydrocarbons contained in Appendix II to this
Annex
95905 013983-17-0 wollastonite

95920 - wood flour and fibers, untreated
95935 011138-66-2 xanthan gum
96190 020427-58-1 zinc hydroxide SML = 25 mg / kg (38)
(Expressed as Zn)
96240 001314-13-2 zinc oxide SML = 25 mg / kg (38)
(Expressed as Zn)
96320 001314-98-3 zinc sulfide SML = 25 mg / kg (38)
(Expressed as Zn)
------------------------- ----------------- ---------------- ----------------------------------

SECTION B
------------------------- -------------------- ------------- ------------------------------------- -----------------------
PM / REF. no. CAS No Name Restrictions and / or specifications
------------------------- ------------ --------------------- ----------------------------- -------------------------------
30180 02180-18-9 manganese acetate SML (T) = 0.6 mg / kg (10) (expressed as manganese
)
31500 025134-51-4 acrylic acid-2-ethylhexyl acrylate copolymer SML (T) = 6 mg / kg (36) (expressed
such as acrylic acid) and SML = 0.05
mg / kg (expressed as 2-ethylhexyl acrylate
)
31520 61167-58-6 2-tert-butyl-6- (3-tert-butyl-2-hydroxy-5- SML = 6 mg / kg
methylbenzyl) -4-methylphenyl acrylate
31920 00103-23-1 bis (2-ethylhexyl) -hexandioát SML = 18 mg / kg (1)
bis (2-ethylhexyl) adipate
34130 - alkyldimethylamine (linear alkylyC12-C20 with even SML = 30 mg / kg
carbon number)
34230 - alkyl (C8-C22) sulfonic acid SML = 6 mg / kg
34650 151841-65-5 hydroxide bis [2,2'methylbis (4,6-di-tert-SML = 5 mg / kg
butylphenyl) phosphate], aluminum
35760 01309-64-4 antimony trioxide SML = 0.02 mg / kg (expressed as
antimony and including measurement uncertainty)
36720 17194-00-2 barium hydroxide SML (T) = 1 mg / kg (12) (expressed as barium
)
36800 10022-31-8 barium nitrate SML (T) = 1 mg / kg (12) (expressed as barium
)
38240 00119-61-9 benzophenone SML = 0.6 mg / kg | || 38560 07128-64-5 2,5-bis (5-tert-butyl-2-benzoxazolyl) thiophene SML = 0.6 mg / kg
38700 63397-60-4 bis (2-karbobutoxyethyl) activity SML = 18 mg / kg
bis (isooktylsulfanylacetát)
38000 000553-54-8 lithium benzoate SML (T) = 0.6 mg / kg (8) (expressed as lithium
)
38505 351870-33-2 cis-endo bicyclo [2.2.1] heptane-2,3-dicarboxylic acid SML = 5 mg / kg. Do not use
acid di-sodium salt with polyethylene in contact with acidic
food. Purity> = 96%.
38800 32637-78-8 N, N'-bis (3- (3,5-di-tert-butyl-4- SML = 15 mg / kg
hydroxyphenyl) propionyl) hydrazide
38820 26741 -53-7 bis (2,4-di-tert-butylphenyl) pentaerythritol diphosphite SML = 0.6 mg / kg
38940 110675-26-8 2,4-bis (dodecylthiomethyl) -6-methylphenol SML (T) = 5 mg / kg (40)
39060 35958-30-6 1,1-bis (2-hydroxy-3,5-di-tert-butylphenyl) ethane SML = 5 mg / kg
39090 - N , N-bis (2-hydroxyethyl) alkyl (C8-C18) amine SML (T) = 1.2 mg / kg (13)
39120 - N, N-bis (2-hydroxyethyl) alkyl (C8-C18 ) amine SML (T) = 1,2mg / kg (13) (expressed
hydrochlorides such as N, N-bis (2-hydroxyethyl)
alkyl (C8 -C18) amine)
40000 00991-84 -4 2,4-bis (oktylsulfanyl) -6- (4-hydroxy-3,5-di-tert-SML = 30 mg / kg
aniline) -1,3,5-triazine
40020 110553 -27-0 2,4-bis [(octylthiomethyl) -6-methyl] phenol SML (T) = 5 mg / kg (40)
40160 61269-61-2 N, N'-bis (2,2 , 6,6-tetramethylpiperidine-4- SML = 2.4 mg / kg
yl) hexamethylene-1,2-dibromoethane, copolymer
40720 025013-16-5 2-tert-butyl-4-methoxyphenol; SML = 30 mg / kg
tert-butyl-4-hydroxyanisole (BHA =)
40800 13003-12-8 4,4'-butylidenbis (6-tert-butyl-3- SML = 6 mg / kg
methylfenylditridecylfosfit)
40980 19664-95-0 butyric acid manganese salt SML (T) = 0.6 mg / kg (10) (expressed as manganese
)
42000 63438-80-2 (2-karbobutoxyethyl) tin-tris ( isooktylsulfanylacetát) SML = 30 mg / kg
42400 10377-37-4 lithium carbonate SML (T) = 0.6 mg / kg (8)
(Expressed as lithium)
42480 00584-09-8 rubidium carbonate SML = 12 mg / kg
43600 04080-31-3 1- (3-chloroallyl) -3,5,7-triaza-1-azoniaadamantane SML = 0.3 mg / kg
chloride
43680 00075-45-6 chlorodifluoromethane SML = 6 mg / kg in accordance with
specifications laid down
Appendix II to this Annex.
44960 11104-61-3 cobalt oxide SML (T) = 0.05 mg / kg (14)
(Expressed as cobalt)
45440 - stryenované butylated cresols SML = 12 mg / kg
46640 000128-37-0 2,6-di-tert-butyl-4-methylphenol; SML = 3 mg / kg
(= BHT)

47500 153250-52-3 N, N'-dicyklohexylnaftalen-2,6-dicarboxamide SML = 5 mg / kg
47600 084030-61-5 di-dodecyltin bis (isooctyl-methylthioacetate) SML (T) = 0 , 05 mg / kg (41) (as sum dodecyltriisooktylcín-

sulfanylacetátu, didodecyliisooktylcín-

sulfanylacetátu, dodecylcín-
trichloride and dodecyltin
dichloride) expressed as the sum || | mono- and didodecylcínchloridů.
48640 00131-56-6 2,4-dihydroxybenzophenone SML (T) = 6 mg / kg (15)
48800 00097-23-4 2,2'-dihydroxy-5,5'-dichlorodiphenylmethane SML = 12 mg / kg
48880 00131-53-3 2,2'-dihydroxy-4-methoxybenzophenone SML (T) = 6 mg / kg (15)
49595 057583-35-4 dimethylcínbis (ethylhexyl mercaptoacetate) SML (T) = 0.18 mg / kg (16)
(Expressed as tin)
49600 26636-01-1 dimethylcínbis (isooktylsulfanylacetát) SML (T) = 0.18 mg / kg (16)
(Expressed as tin)
49840 02500-88-1 dioctadecyl disulfide SML = 3 mg / kg
50160 - di-n-oktylcínbis (n-alkyl (C10-C16) methylthioacetate) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50240 10039-33-5 di-n-oktylcínbis (2-ethylhexylmaleinát) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50320 15571-58-1 di-n-oktylcínbis (2-ethylhexyl-methylthioacetate) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50360 - di-n-oktylcínbis (ethylmaleinát) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50400 33568-99-9 di-n-oktylcínbis (isooctyl maleate) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50480 26401-97-8 di-n-oktylcínbis (isooktylsulfanylacetát) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50560 - di-n-oktylcínbutan1,4-diol bis SML (T) = 0.006 mg / kg (17)
(Methylthioacetate) (expressed as tin)
50640 03648-18-8 di-n-oktylcíndidodekanoát SML (T) = 0.006 mg / kg (17)
di-n-octyltin dilaurate (expressed as tin)
50720 15571-60-5 di-n-oktylcíndimaleinát SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50800 - di-n-oktylcíndimaleinát esterified SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50880 - di-n-oktylcíndimaleinát polymers (n = 2-4) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
50960 69226-44-4 di-n-oktylcínethylenglykolbis (methylthioacetate) SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
51040 15535-79-2 di-n-oktylcínsulfanylacetát SML (T) = 0.006 mg / kg (17)
(Expressed as tin)
51120 - di-n-oktylcínthiobenzoát [(2-ethylhexyl) SML (T) = 0.006 mg / kg (17)
methylthioacetate] (expressed as tin)
51570 00127-63-9 diphenylsulfone SML = 3 mg / kg (25)
51680 00102-08-9 N, N'-diphenylthiourea SML = 3 mg / kg
52000 27176-87-0 dodecylbenzenesulfonic acid SML = 30 mg / kg
52320 52047-59-3 2- (4-dodecylphenyl) indole SML = 0.06 mg / kg
52880 23676-09-7 ethyl 4- ethoxybenzoate SML = 3.6 mg / kg
53200 23949-66-8 2-ethoxy-2'-ethyloxanilide SML = 30 mg / kg 53670 032509-66-3
ethyleneglycol-bis [3,3-bis (3-tert-butyl4- SML = 6 mg / kg
hydroxyphenyl) butanoate]
54880 000050-00-0 formaldehyde SML (T) = 15 mg / kg (22)
55200 001166-52- 5-dodecyl-3,4,5-trihydroxybenzoate; SML (T) = 30 mg / kg (34)
dodechl gallate
55280 001034-01-1 octyl-3,4,5-trihydroxybenzoate; SML (T) = 30 mg / kg (34)
octyl gallate
55360 000121-79-9 propyl 3,4,5-trihydroxybenzoate; SML (T) = 30 mg / kg (34)
propyl gallate
58960 00057-09-0 hexadecyl SML = 6 mg / kg
59120 23128-74-7 1,6-bis [3- (3,5-di-tert-butyl-4- SML = 45 mg / kg
hydroxyphenyl) propanamide] cyclohexane
59200 35074-77-2 1,6-bis [3- (3,5-di-tert-butyl-4- SML = 6 mg / kg | || hydroxyphenyl) propanoate] cyclohexane
60320 70321-86-7 2- (2-hydroxy-3,5-bis (1,1-SML = 1.5 mg / kg
dimethylbenzyl) phenyl) benzotriazole | || 60400 03896-11-5 2- (2'-hydroxy-3'-tert-butyl-5'-methylphenyl) -5- SML (T) = 30 mg / kg (19)
chlorobenzotriazole
60800 65447-77-0 dimethyl [1- (2-hydroxyethyl) -4-hydroxy-2,2,6,6 SML = 30 mg / kg
tetramethylpiperidine] succinate copolymer
61280 03293-97-8 2-hydroxy-4-n-hexyloxybenzofenon SML (T) = 6 mg / kg (15)
61360 00131-57-7 2-hydroxy-4 -methoxybenzofenon SML (T) = 6 mg / kg (15)
61440 02440-22-4 2- (2-hydroxy-5-methylphenyl) benzotriazole SML (T) = 30 mg / kg (19)
61600 01843-05-6 2-hydroxy-4-n-oktyloxybenzofenon SML (T) = 6 mg / kg (19)
63200 51877-53-3 manganese salt, lactic acid SML (T) = 0.6 mg / kg (10)
Manganui-dilaktát (expressed as manganese)
63940 008062-15-5 lignosulfonic acid SML = 0.24 mg / kg and for use as
dispersant for plastics dispersions.

64320 10377-51-2 lithium iodide SML (T) = 1 mg / kg (11) (expressed as iodine
) and SML (T) = 0.6 mg / kg (8)
(Expressed as lithium)
65120 07773-01-5 manganese chloride SML (T) = 0.6 mg / kg (10) (expressed as manganese
)
65200 12626-88-9 manganese hydroxide SML (T) = 0.6 mg / kg (10) (expressed as manganese
)
65280 10043-84-2 manganese hypophosphite SML (T) = 0.6 mg / kg (10) (expressed || | as manganese)
65360 11129-60-5 manganese oxide SML (T) = 0.6 mg / kg (10) (expressed as manganese
)
65440 - manganese pyrophosphate SML (T) = 0 6 mg / kg (10) (expressed as manganese
)
66350 085209-93-4 2,2'-methylenebis (4,6-di-tert-BUTYLPHENYL) SML = 5 mg / kg and SML (T) = 0.6 mg / kg
lithiumfosfát (8) (expressed as lithium)
66360 85209-91-2 2,2'-methylenebis (4,6-di-tert-butylphenyl) sodium phosphate SML = 5 mg / kg
66400 00088-24- 4 2,2'-methylenebis (4-ethyl-6-tert-butylphenol) SML (T) = 1.5 mg / kg (20)
66480 00119-47-1 2,2'-methylenebis (4- methyl-6-tert-butylphenol) SML (T) = 1.5 mg / kg (20)
67360 067649-65-4 dodecyltriisooktylcín-methylthioacetate SML (T) = 0.05 mg / kg (41) (as

sum dodecyltriisooktylcín- sulfanylacetátu, didodecyliisooktylcín-

sulfanylacetátu, dodecylcín-

trichloride and dodecyltin dichloride) expressed as the sum
mono- and didodecylcínchloridů.
67515 057583-34-3 monomethylcíntris (ethylhexylmerkaptoacetát) SML (T) = 0.18 mg / kg (16)
(Expressed as tin)
67520 54849-38-6 monomethylcíntris (isooctyl-methylthioacetate) SML (T) = 0.18 mg / kg (16)
(Expressed as tin)
67600 - mono-n-oktylcíntris (alkyl (C10-C16) -sulfanylacetát) SML (T) = 1.2 mg / kg (18)
(Expressed as tin)
67680 27107-89-7 mono n-oktylcíntris (2-ethylhexylsulfanylacetát) SML (T) = 1.2 mg / kg (18) (expressed as tin
)
67760 26401-86-5 mono n-oktylcíntris (isooctyl-methylthioacetate) SML (T) = 1.2 mg / kg (18) (expressed as tin
)
67896 020336-96-3 lithium-tetradecanoate; SML (T) = 0.6 mg / kg (8) (expressed
lithium as lithium myristate)
68320 02082-79-3 oktadecyl3- (3,5-di-tert-butyl-4- SML = 6 mg / kg
hydroxyphenyl) propanoate
68400 10094-45-8 octadecyl (Z) -dokos-9-enamide SML = 5 mg / kg
oktadecylerukamid
68860 004724-48-5 n oktylfosfoniová acid SML = 0.05 mg / kg 69160 014666-94-5
oleic acid, cobalt salt SML (T) = 0.05 mg / kg (14)
(Expressed as cobalt)
69840 16260-09-6 N- (Z) -octadec-9-en-1-ylhexadekanamid SML = 5 mg / kg
oleylpalmitamid
71935 007601-89-0 sodium perchlorate monohydrate SML = 0.05 mg / kg (31)
72081/10 - hydrogenated Petroleum hydrocarbon resins in accordance with the specifications
set out in Appendix II to this
Annex.
72160 00948-65-2 2-phenylindole SML = 15 mg / kg
72800 01241-94-7 diphenyl-2-ethylhexyl SML = 2.4 mg / kg
73040 13763-32-1 acid phosphoric acid, lithium salt SML (T) = 0.6 mg / kg (8) (expressed as lithium
)
73120 10124-54-6 phosphoric acid, manganese salt SML (T) = 0.6 mg / kg (10) (expressed as manganese
)
74400 - tris (nonylphenyl) ester of phosphorous acid SML = 30 mg / kg
or
tris (dinonylphenyl) ester of phosphorous acid
tris (nonyl and / or dinonylphenyl) phosphite
77440 - polyethylene glycol di (12hydroxyoktadec9enoát) SML = 42 mg / kg
polyethylenglykoldiricinoleát
77520 61791-12-6 polyethylene glycol ester of castor oil SML = 42 mg / kg
78320 09004-97-1 polyethylenglykol12hydroxyoktadec9enoát SML = 42 mg / kg
polyethylene glycol monoricinoleate
81200 71878-19-8 poly (6 - [(1,1,3,3-tetramethylbutyl) amino] -1,3,5- SML = 3 mg / kg
triazine-2, 4-diyl] - [(2,2,6,6-tetramethylpiperidine-4-
yl) imino] hexamethylene [(2,2,6,6-tetramethylpiperidine-4-
yl) imino] || | 81680 07681-11-0 potassium iodide SML (T) = 1 mg / kg (11) (expressed as iodine
)
82020 19019-51-3 propanoic acid, cobalt salt SML (T) = 0, 05 mg / kg (14)
(expressed as cobalt)
83595 119345-01-6 reaction product of di-tert-butylfosfonitu with biphenyl SML = 18 mg / kg in accordance with
obtained by condensation of 2,4 di-tert-butyl phenol products with specifications set out in Appendix II
Friedel-Craft reaction chloride fosforitéhoa this Annex.

biphenyl 83700 00141-22-0 (Z) -12-hydroxyoktadec-9-enoic acid SML = 42 mg / kg of ricinoleic acid

84800 00087-18-3 4-tert-butylphenyl salicylate SML = 1.2 mg / kg
84880 00119-36-8 methyl salicylate SML = 30 mg / kg

85760 12068-40-5 lithium aluminum silicate SML (T) = 0.6 mg / kg (8) (expressed as lithium
)
85920 12627-14-4 lithium silicate SML (T) = 0 6 mg / kg (8) (expressed as lithium
)
85950 037296-97-2 silicic acid, a salt with a sodium fluoride-magnesium SML = 0.15 mg / kg (expressed as fluoride
) . Only for use in
layers of multilayer materials
which come into contact
with food.
86480 007631-90-5 sodium bisulfite SML (T) = 10 mg / kg (30)
(Expressed as SO2)
86800 07681-82-5 sodium iodide SML (T) = 1 mg / kg (11) (expressed as iodine
)
86880 - natriummonoalkyl-dialkylfenoxybenzendisulfonát SML = 9 mg / kg
86920 007632-00-0 sodium nitrite SML = 0.6 mg / kg
86960 007757-83-7 sodium sulfite SML (T) = 10 mg / kg (30)
(Expressed as SO2)
87120 007772-98-7 sodium thiosulfate SML (T) = 10 mg / kg (30)
(Expressed as SO2)
89170 13586-84-0 octadecanoic acid, cobalt salt SML (T) = 0.05 mg / kg (14)
stearic acid, cobalt salt (expressed as cobalt)
92000 07727-43-7 barium sulfate SML (T) = 1 mg / kg (12) (expressed as barium
)
92320 - tetradecylpolyethylenglykol (EO = 3-8) ether SML = 15 mg / kg
glycolic acid
92560 38613-77-3 tetrakis (2,4-di-tert-butylphenyl) biphenyl-4,4'-ylene SML = 18 mg / kg
diifosfonit
92800 00096-69-5 4,4'-thiobis (6-tert-butyl-3-methylphenol) SML = 0.48 mg / kg
92880 41484-35-9 thiodiethanolbis (3- (3 , 5-di-tert-butyl-4- SML = 2.4 mg / kg
hydroxyphenyl) propanoate)
93120 00123-28-4 didodecylthiodipropanoát SML (T) = 5 mg / kg (21) || | 93280 00693-36-7 dioctadecyl thiodipropanoát SML (T) = 5 mg / kg (21)
94400 036443-68-2 triethylene glycol bis [3- (3-tert-butyl-4-hydroxy-5- SML = 9 mg / kg
methylphenyl) propanoate]
94560 00122-20-3 triisopropanolamine SML = 5 mg / kg
95265 227099-60-7 1,3,5-tri (4-benzoylphenyl) benzene SML = 0.05 mg / kg
95280 40601-76-1 1,3,5-tris (4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl) -SML = 6 mg / kg
1,3,5-triazine-2,4,6 (1H, 3H, 5H) -trione
95360 27676-62-6 1,3,5-tris (3,5-di-tert-butyl-4 hydroxybenzyl) -1,1,3,5-SML = 5 mg / kg
triazine-2,4,6 (1H, 3H, 5H) -trione
95600 01843-03-4 1,1,3-tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane SML = 5 mg / kg
------------------------- ----------------- ---------------- ---------------------------------- --------------------------

APPENDIX I

PRODUCTS OBTAINED bacterial fermentation -------------------------------------------
----------------- -------------------------------- | || PM / Ref. CAS No Name Restrictions and / or specifications
NO.
--------------------------------------------- --------------- --------------------------------
(1) (2) (3) (4)
----------------------------------- ------------------------- ------------------------- -------
18888 080181-31-3 3-hydroxybutyric acid and 3- In accordance with the specifications
hydroxypentanoic acid copolymer, set out in Appendix II to this
Annex
---------------------------------------------- -------------------------------- --------------
APPENDIX II

SPECIFICATIONS

Part A: General specifications

Materials and articles made of plastic
shall not release primary aromatic amines in a determinable quantity (DL =
0.01 mg / kg food or food simulant).
Values ​​migration of primary aromatic amines listed in the Annex to this
restrictions apply.

Part B: Other specifications
--------------------------------------- ---------------------------------------------
PM / Ref. Other specifications
no.
----------------------------------------------- -------------------------------------
11530 (2-hydroxypropane-1-yl) acrylate
It may contain up to 25% (wt.), 2-hydroxyisopropyl acrylate (CAS No. 002918-23-2
)
16690 divinylbenzene
It may contain up to 45% of ethyl (vinyl) benzene.
18888 3-Hydroxybutanoic acid 3-hydroxypentanoic acid copolymer
Definition The copolymers are produced by the controlled fermentation
Alcaligenes eutrophus eluting
glucose and propanoic acid as carbon sources.
The organism used may be obtained by genetic
modifications and must come from a naturally
occurring Alcaligenes eutrophus strain
H16 NCIMB 10,442th stock culture of the organism is kept

in freeze-dried ampoules. Sub / working
is prepared from the stock culture, store
in liquid nitrogen and used to prepare the inoculum for
fermentation. Samples from the fermenter are viewed daily
under a microscope for any changes in morphology
colonies on a variety of agars at different
temperatures. The copolymers are isolated from heat-treated
bacteria by controlled digestion of the other cellular components,
washing and drying. These copolymers are usually
offered as shaped or reshaped melting
granules containing additives such as nucleating agents,
plasticizers, fillers, stabilizers and pigments which
satisfy the general and individual specifications.

- Chemical name Poly (3Dhydroxybutanoátco3Dhydroxypentanoát)
- CAS 80181-31-3
- Structural

formula CH3 - Structural formula |
CH 3 CH 2 O O
| | | |
(-O-CH-CH3-C-) m (O-CH-CH2-C-) n

wherein n / (m + n) is greater than 0 and less than or equal to 0.25
- Average of at least 150,000 (determined by gel permeation chromatography molecular
).
weight
- Content of less than 98% poly (3Dhydroxybutanoátco3D
hydroxypentaneoate) analyzed after hydrolysis as a mixture
3Dhydroxybutanové acid and kyseliny3D
pentanoic.
Description After isolation, white to off-white powder.
properties
- Identification
test:
- Solubility Soluble in chlorinated hydrocarbons such as
chloroform or dichloromethane but practically
insoluble in ethanol, aliphatic alkanes ave
water.
- Restriction QMA for but2enovou acid (crotonic acid) must
exceed 0.05 mg / 6dm2.
- Purity Prior to granulation the starting material (powder copolymer)
include:
- Nitrogen Not more than 2500 mg / kg of plastic
- Zinc Not more than 100 mg / kg of plastic
- Copper Not more than 5 mg / kg of plastic
- Lead more than 2 mg / kg of plastic
- Arsenic Not more than 1 mg / kg of plastic
- Chromium Not more than 1 mg / kg of plastic

23547 Polydimethylsiloxane (Mw> 6800)
The minimum viscosity of 100 × x 10-6 m2 s-1 * (= 100 centistokes) at 25 ° C
24903 Syrups, hydrolysed starch, hadrogenované
In compliance with the purity criteria for maltitol syrup E 965 (ii) set
Decree No. 54/2002 Coll.
25385 triallylamine
40 mg / kg of hydrogel at a ratio of 1 kg food to a maximum of 1.5 g
hydrogel. Use only in hydrogels intended for non-contact
with food.
38 320 4 (2-benzoxazolyl) -4 '(5metylbenzoxazolyl) stilbene
At most 0.05% (m / m) (amount of substance / composition)
42080 Soot
specifications
- Toluene extract: max. 0.1% determined by the ISO 6209
- UV absorption of cyclohexane extract at a wavelength of 386 nm: <0.02
to 1 cm cuvette or <0.1 to 5 cm cell, determined by generally accepted
analytical method
- Benzo [a] pyrene: max. 0.25 mg / kg of soot
- Maximum content of carbon black in the polymer: 2.5%.
43480 Active carbon
For use in PET material and the amount max.10mg / kg of polymer.
Same purity requirements as for Vegetable Carbon (black plant) (E
153) established by Decree No. 54/2002 Coll.
43680 chlorodifluorométhane
Chlorodifluoromethane content less than 1 mg per kg of substance
47210 dibutylthiocíničitá acid polymer
- Molecular unit = (C8H18S3Sn2) and (n = 1.5 - 2)
60025 Specifications:
- The minimum viscosity (at 100ST. C)> 3.8 cSt
- Average molecular weight> 450
64990 Maleianhydrid-styrene copolymer, sodium
MW fraction <1000 comprises less than 0.05% (by weight)
67155 A mixture of 4- (2-benzoxazolyl) -4 '- (methyl-2-benzoxazolyl) stilbene, 4,4'-bis (2-
benzoxazolyl) stilbene and 4,4'-bis (5-methyl-2 -benzoxazolyl) stilbene
Mixture obtained from the manufacturing process in the typical ratio:
(58-62%) (23-27%) (13-17)
72081/10 resins, hydrogenated petroleum products
Specifications:
Hydrogenated Petroleum hydrocarbon resins are produced by the catalytic or
thermal polymerisation of aliphatic, alicyclic or arylalkene

dienes and olefins, from distillates of cracked materials with a boiling point at a higher
than 220st. C.Rovněž as the pure polymers from these sources
followed by distillation, hydrogenation and additional processing
Features:
Viscosity:> 3 Pa.s at 120 st. C.
Softening point::> 95 st. C as determined by ASTM Method E 28-67.
Bromine number: <40 (ASTM D 1159)
The color of a 50% solution in toluene <11 on the Gardner scale.
Residual aromatic polymer of <50 ppm.
76721 polydimethylsiloxane (Mw> 6800)
The minimum viscosity of 100x10-6 m2 * s-1 (= 100 centistokes) at 25 ° C
76723 Copolymers of poly (dimethylsiloxane) with terminal 3-aminpropylovými
groups and bis (3-isocyanatocyclohexyl) methane
Specifications:
The fractions having molecular weight <1000 should not exceed 1.5%
(Weight)
76725 Copolymers of poly (dimethylsiloxane) with terminal 3-aminopropyl
groups and 5-isocyanato-1- (isocyanatomethyl) -1,3,3-
trimethylcyclohexane
Specifications:
The fractions having molecular weight <1000 should not exceed 1%
(Weight)
76845 Polyester of 1,4-butanediol with caprolactone
MW fraction <1000 comprises less than 0.5% (by weight)
76815 Polyester of adipic acid with glycerol or pentaerythritol esters
with an even number of carbon atoms, fatty acids C12 -C22 linear
MW fraction <1000 comprises less than 0.05% (by weight)
77,895 alkyl (C16 - C18) ethers, poly (ethylene glycol) (n = 2-6)
Composition of the mixture:
The first alkyl (C16 - C18) ethers, poly (ethylene glycol) (n = 2-6) (
about 28 wt.%)
Second fatty alcohols (C16 - C18) (about 48 wt.%)
3rd alkyl (C16 - C18) ethers of ethylene glycol) (about 24 wt.%) "
79600 Poly (ethylene glycol) tridecylether, phosphate
Poly (ethylene glycol) (EO = <11) tridecylether, phosphate (including mono- and dialkyl ester
) with max. 10% content of poly (ethyleneglycol) (EO = <11)
tridecyletheru.
81500 Poly (vinylpyrrolidone)
Substance meets the purity criteria established in Commission Directive
96/77 / EC
83595 Reaction products of di-tert-butylfosfonitu with biphenyl obtained by condensing
2,4-di-tert-butylphenol with products of Friedel-Crafts chloride
Phosphorous biphenyl

composition
- 4,4'-bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]
(CAS 38613-77-3) (36-46 wt% *)
- 4,3'-bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]
(CAS 118421-00-4) (17 to 23 wt.%)
- 3,3'-bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]
(CAS 118421-01-5) (1-5 wt.%)
- 4 -bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]
(CAS 91362-37-7) (17 to 19 wt.%)
- Tris (2,4-di-tert-butylphenyl) phosphonite
(CAS 31570-04-4) (9-18 wt.%)
- 4,4'-bifenylenbis {[0,0-bis (2,4-di-tert-butylphenyl) phosphonite] [0,0-
bis (2,4-di-tert-butylphenyl) phosphonite]}
(CAS 112949-97-0) (<5 wt.%)
Other specifications:
- A phosphorus content of at least 5.4 to 5.9%
- Acid number of at most 10 mg KOH per gram
- Melting range: 85-110 st. C
88640 Soybean oil, epoxidized
Oxirane <8%, iodine number <6
95858 Specifications:
- Content of hydrocarbons with carbon number less than 25, not more than 40%
(M / m)
- Viscosity of at least 2.5 cSt at 100 ° C.
- Average molecular weight of at least 350.
95859 Waxes, refined, derived from petroleum based or synthetic hydrocarbon
The product should meet the following specifications:
- Content of mineral hydrocarbons with carbon number less than 25, exceeding
5% (m / m)
- Viscosity of at least 11x10-6 m2 * s-1 (= 11 centistokes) at 100 ° C.
- Average molecular weight not less than 500.
95883 White mineral oils, paraffinic, derived from petroleum or synthetic
hydrocarbons
The product should meet the following specifications:
- Content of mineral hydrocarbons with carbon number less than 25, exceeding
5% (m / m)
- Viscosity of at least 8.5 x * x 10-6 m2 s-1 (= 8,5 centistokes) at 100 ° C.
- Average molecular weight of at least 480
---------------------------------------- --------------------------------------------
*) Used the amount of the substance / mixture amount
------------------------------------------ ------------------------------------------

APPENDIX III


NOTES RELATING TO THE COLUMN "RESTRICTIONS AND / OR SPECIFICATIONS"

(1) Warning: there is a risk SML could be exceeded in fatty food simulants


(2) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 10060 and 23920.


(3) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
15760, 16990, 47680, 53650, 89,440th

(4) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
19540, 19960 and 64800.

(5) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
14200, 14230 and 41,840th

(6) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 66560 and 66580.


(7) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
30080, 42320, 45195, 45200, 53610, 81760, 89200 , the 92,030th

(8) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
24886, 38000, 42400, 62020, 64320, 66350, 67896 , 73040, 85760, 85760,
85840, 85920 and 95,725th

(9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food
with which it is in contact, and consequently
final product does not comply with Article 2, second indent of Directive 89/109 / EEC.

(10) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
30180, 40980, 63200, 65120, 65200, 65280, 65360 , 65440 and 73,120th

(11) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
45200, 64320, 81680 and 86,800th

(12) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
36720, 36800, 36840 and 92,000th

(13) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 39090 and 39,120th


(14) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
44960, 68078, 69160, 82020 and 89,170th

(15) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
15970, 48640, 48720, 48880, 61280, 61360 and 61600 .

(16) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
49595, 49600, 67515, 67520 and 83,599th

(17) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
50160, 50240, 50320, 50360, 50400, 50480, 50560 , 50640, 50720, 50800,
50880, 50960, 51040 and 51,120th

(18) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
67600, 67680 and 67,760th

(19) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
60400, 60480 and 61,440th

(20) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 66400 and 66,480th


(21) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 93120 and 93,280th


(22) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
17260, 18670, 54880 and 59,280th

(23) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
13620, 36840, 40320 and 87,040th

(24) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 13720 and 40,580th


(25) SML (T) in this specific case means that the restriction shall not be

Exceeded by the sum of specific migration of the substances listed under numbers PM / REF 16650 and 51,570th


(26) QMA (T) in this specific case means that the restriction shall not be exceeded by the sum
residual quantities of the substances listed under numbers PM / REF
14950, 15700, 16240, 16570, 16600, 16630, 18640 , 19110, 22332, 22420,
22570, 25210, 25240 and 25,270th

(27) QMA (T) in this specific case means that the restriction shall not be exceeded by the sum
residual quantities of the substances listed under numbers PM / REF
10599 / 90A, 10599/91, 10599 / 92A and 10599 / 93rd

(28) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 13480 and 39680.


(29) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 22775 and 69920.


(30) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
86480, 86960 and 87,120th

(31) The rules on migration testing, where it is assumed contact with
fats must always be the verification of compliance with the requirements simulant D
as food simulant saturated fats.

(32) The rules on migration testing, where it is assumed contact with
fats must always be the verification of compliance with the requirements
used as a replacement food simulant D iso-octane.

(33) QMA (T) in this specific case means that the restriction shall not be exceeded by the sum
residual quantities of the substances listed under numbers PM / REF 14800 and 45,600th


(34) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
55200, 55280 and 55,360th

(35) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 25540 and 25550.


(36) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
10690, 10750, 10780, 10810, 10840, 11470, 11590 , 11680, 11710, 11830,
11890, 11980, 31500 and 76,463th

(37) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
20020, 20080, 20110, 20140, 20170, 20890, 21010 , 21100, 21130, 21190,
21280, 21340 and 21,460th

(38) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF
81515, 96190, 96240 and 96320, as well as salts (including
double salts and acid salts) of zinc of authorized acids, phenols or alcohols.
Same restriction for Zn applies to the names containing
-acid (s), salts which are present in the list, if the
corresponding free acid are not listed.

(39) at very high temperature could be a migration limit is exceeded.

(40) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 38940 and 40020.


(41) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 47600 and 67360


(42) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
specific migration of the substances listed under numbers PM / REF 75100 and 75,105th


(43) SML (T) in this specific case means that the restriction shall not be exceeded by the sum
migration of substances listed below Ref.č .: 19150 and 19,180th ".
APPENDIX IV


Lipophilic substances for which the application of the FRF
------------------------ ----------- -------------------------------------------------- -
Ref. No. CAS Name
no.
--------------------- ------------------------ ------------------------------------------
31520 061167-58- 6 2-tert-butyl-6- (3-tert-butyl-2-hydroxy-5-methylbenzyl) -4-
methylphenyl acrylate
31530 123968-25-2 2,4-di-tert-pentyl-6- [1- (2-hydroxy-3,5-di-tert
pentylphenyl) ethyl] acrylate | || 31920 000103-23-1 bis (2-ethylhexyl) adipate
34130 _ alkyldimethylamine (linear C12-C20 alkyl groups with even number of carbon atoms
)
38240 000119-61-9 benzophenone
38515 001533-45-5 4,4-di (benzoxazol-2-yl) stilbene

38560 007128-64-5 2,5-bis (5-tert-butylbenzooxazol-2-yl) thiophene
38700 063397-60-4 bis [2- (butoxycarbonyl) ethyl] tin bis (isooctyl- methylthioacetate)
38800 032687-78-8 N, N'-bis [3- (3,5-di-tert-butyl-4-
hydroxyphenyl) propanoyl] hydrazine
38810 080693-00-1 bis (2,6-di-tert-butyl-4-methylphenyl) pentaerythritol biphosphite
38820 026741-53-7 bis (2,4-di-tert-butylphenyl) pentaerythritol biphosphite
38840 154862 -43-8 bis [2,4-bis (alpha, alpha-dimethylbenzyl) phenyl] -pentaerythritol-
biphosphite
39060 035958-30-6 2,2-ethane-1,1-diylbis (4,6-di-tert-butylphenol)
39815 182121-12-6 9,9-bis (methoxymethyl) fluorene
39925 129228-21-3 3,3-bis (methoxymethyl) -2,5-dimethylhexane
40000 000991-84-4 2- (3,5-di-tert-butyl-4-hydroxyanilino) -4,6-bis (oktylsulfanyl) -
1,3,5-triazine
40020 110553-27-0 2-methyl-4,6-bis [(oktylsulfanyl) methyl] phenol
40800 013003-12-8 [4,4-butane-1 1-diylbis (6-tert-butyl-3-methylphenyl)] -
bis (ditridecyl phosphite)
42000 063438-80-2 [2- (butoxycarbonyl) ethyl] tris (isooctyl-methylthioacetate)
45450 068610-51-5 copolymer of p-cresol, dicyclopentadiene and isobutylene
45705 166412-78-8 diisononyl cyclohexane-1,2-dicarboxylate
46720 004130-42-1 2,6-di-tert-butyl-4-ethylphenol
47540 027458-90-8 di-tert- dodecyldisulfid
47600 084030-61-5 di-dodecyltin bis (isooctyl-methylthioacetate)
48800 000097-23-4 4,4'-dichloro-2,2'-methylendifenol
48880 000131-53-3 ( 2-hydroxyphenyl) (2-hydroxy-4-methoxyphenyl) -methanone
49485 134701-20-5 2,4-dimethyl-6- (1-methylpentadecyl) phenol
49840 002500-88-1 dioctadecyl
51680 000102-08-9 N, N'-diphenylthiourea
52320 052047-59-3 2- (4-dodecylphenyl) indole
53200 023949-66-8 N- (2-ethoxyphenyl) -N '- ( 2-ethylphenyl) oxalamide
53670 032509-66-3 Ethylene glycol-bis [3,3-bis (3-tert-butyl-4-
hydroxyphenyl) butanoate]
54300 118337-09-0 2 2'-ethane-1,1-diylbis (4,6-di-tert-butyl phenyl) -fluorfosfonit
59120 023128-74-7 N, N'-hexane-1,6-diylbis [3- (3 , 5-di-tert-butyl-4-
hydroxyphenyl) propanamide]
59200 035074-77-2 hexane-1,6-diyl-bis [3- (3,5-di-tert-butyl-4-
hydroxyphenyl) propanoate]
60320 070321 -86-7 2- [3,5-bis (a, a-dimethylbenzyl) -2-hydroxyphenyl] benzotriazole
60400 003896-11-5 2- (3-tert-butyl-2-hydroxy-5-methylphenyl ) -5-chlorobenzotriazole
60480 003864-99-1 2- (3,5-di-tert-butyl-2-hydroxyphenyl) -5-chlorobenzotriazole
61280 003293-97-8 phenyl [4- (hexyloxy ) -2-hydroxyphenyl] methanone
61360 000131-57-7 phenyl (2-hydroxy-4-methoxyphenyl) -methanone
61600 001843-05-6 phenyl [2-hydroxy-4- (octyloxy) phenyl] methanone
66360 085209-91-2 sodium [2,2'-methylenebis (4,6-di-tert-butylphenyl)] - phosphate
66400 000088-24-4 2,2'-methylenebis (6- tert-butyl-4-ethylphenol)
66480 000119-47-1 2,2'-methylenebis (6-tert-butyl-4-methylphenol)
66560 004066-02-8 2,2'-methylenebis ( 6-cyclohexyl-4-methylphenol)
66580 000077-62-3 2,2'-methylenebis [4-methyl-6- (1-methylcyclohexyl) phenol]
68145 080410-33-9 nitrilotriethylentris (3, 3 ', 5,5'-tetra-tert-butylbifenyl
2,2'- diyl) -trisfosfit]
68320 002082-79-3 octadecyl-3- (3,5-di-tert-butyl -4-hydroxyphenyl) propanoate
010094-45-8 68400 N-oktadecyldokos-13-enamide
016260-09-6 69840 N-octadec-9-en-1-ylpalmitamid
71670 178671-58- 4 pentaerythritol tetrakis (3,3-diphenyl-2-cyanoacrylate)
72081/10 - hydrogenated petroleum hydrocarbon resins
72160 000948-65-2 2-phenylindole
72800 001241-94-7 2- ethylhexyl diphenyl phosphate
73160 - mono- and di (n-C16 and n-C18) phosphate
74010 145650-60-8 bis (2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite
74400 - tris (nonylphenyl) phosphite and tris (dinonylphenyl) phosphite
76866 - polyesters propane-1,2-diol or butane-1,3-diol or butane
1,4-diol or poly (propylene glycol) with adipic acid,
also end groups derived from acetic acid or
fatty acids C12-C18 or n-1-ol or decan-1-ol
77440 - poly (ethylene glycol) -diricinoleát
78320 009004-97-1 poly (ethylene glycol) -monoricinoleát
81200 071878-19 -8 poly ({6 - [(1,1,3,3-tetramethylbutyl) amino] -1,3,5-triazine-2,4- diyl}
[(2,2,6,6-tetramethylpiperidine -4-yl) imino] hexane-1,6-diyl
[(2,2,6,6-tetramethylpiperidin-4-yl) imino])
83599 068442-12-6 reaction products of 2-sulfanylethyl -oleátu
with dichlordimethylstannanem, sodium sulphide and
trichlormethylstannanem
83700 000141-22-0 ricinoleic acid
84800 000087-18-3 4-tert-butylphenyl salicylate
92320 - A- (carboxymethyl) -U-tetradecylpoly (ethylene glycol), n = 3 8
92560 038613-77-3 tetrakis (2,4-di-tert-butylphenyl) 4,4'-biphenyl-diylbisfosfonit

92700 078301-43-6, poly [20- (2,3-epoxypropyl) -2,2,4,4-tetramethyl-7-oxa-3,20
diazadispiro [5.1.11.2] henikosan-21-one]
92800 000096-69-5 4,4 sulfanylbis (6-tert-butyl-3-methylphenol)
92880 041484-35-9 sulfandiyldiethylen bis [3- (3,5-di-tert-butyl-4-
hydroxyphenyl) propanoate]
93120 000123-28-4 didodecyl-3,3'-sulfandiyldipropanoát
93280 000693-36-7 dioctadecyl -3,3'-sulfandiyldipropanoát
95270 161717-32-4 (2-butyl-2-ethylpropane-1,3-diyl) - (2,4,6-tri-tert-butylphenyl) -
phosphite
95280 040601-76-1 1,3,5-tris (4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl) -1,3,5-
triazine-2,4,6 (1H, 3H, 5H) -trione
95360 027676-62-6 1,3,5-tris (3,5-di-tert-butyl-4-hydroxybenzyl) -1 3,5-triazine
2,4,6 (1H, 3H, 5H) -trione
95600 001843-03-4 1,1,3-tris (5-tert-butyl-4-hydroxy-2-methylphenyl) butane
- ----------------------- --------------------------- ------------------------------------
APPENDIX V


Particulars of declaration of conformity

Written declaration attached to materials and articles of plastics
must contain the following information:

A) the name and registered office or place of business operator which manufactures or imports
plastic items or substances intended for the manufacturing of those materials and articles
;

B) identification of the materials, articles or substances for the manufacture of these
materials or articles;

C) the date of the declaration;

D) certifying that the materials and articles of plastics meet the requirements of this ordinance and
directly applicable legal rule of the European Communities
^ 1b);

E) relevant information concerning the use of substances for which
by this decree imposed restrictions or specifications that
downstream business operators to ensure compliance with those restrictions;

F) the relevant information concerning the substances subject to restrictions
in food, obtained by experimental data or theoretical calculations
, specific information about the level of their specific migration and possibly
purity criteria in accordance with specific legal
regulations5), the user of these materials and articles to comply
relevant legislation;

G) specifications on the use of materials and articles, for example:

I) type or types of food with which it has come into contact

Ii) time and temperature of treatment and storage in contact with
food

Iii) the relationship between the surface that is in contact with food and
volume used to determine the compliance of the material or article;

H) using a plastic functional barrier multi-layer material or object
confirmation that the material or article complies with the requirements of §
10 of this Decree.
Appendix 4


Testing of overall and specific migration of plastics and plastic products

Basic rules for testing overall and specific migration

First

"Migration tests" for overall and specific migration
carried out using the "food simulants" laid down in Chapter I of this
Annex and under "conventional migration test conditions" specified in Chapter II
this Annex .

Second

If for technical reasons associated with the analytical method
You can not perform a "migration test" using the fatty food simulants
(under Chapter I) can be made "substitute test" in which
use test media under conventional conditions
alternative tests that are given in Chapter III of this Annex.

Third

"Alternative tests" indicated in Chapter IV is permissible to use
instead of migration tests with fatty food simulants if they are satisfied
conditions specified in Chapter IV of this Annex.

Fourth

In all three cases it is permissible:

4.1 to reduce the number of tests to be performed on those
in the specific case under examination on the basis of scientific evidence
generally considered the more severe,

4.2 omit the migration or the substitute or the alternative tests
if there is conclusive proof that the migration limits can not be
any foreseeable conditions of use of the material or product
exceeded.
Chapter
I
Food simulants


First

Introduction

1.1 Given that the testing of materials or products intended
food contact is not always possible to use directly the food introduced

Food simulants. Food simulants are conventionally classified
according to the characteristics of one or more kinds of food. Food types and food simulants
appropriate to be used are indicated in Table 1.


1.2 In practice there are also various kinds of food mixtures, e.g.
fatty and aqueous foods. These mixtures foods accompanied enumeration
food simulants to be selected and used to perform
migration tests are described in Table 2. TABLE 1


Food types and the food simulants

----------------------------------------------- ----------------------------------------
Type of food Conventional classification food simulant Abbreviation
----------------------------------------------- ----------------------------------------
aqueous foods foods are tested Distilled water water and simulant A
(ie. water using a simulant A corresponding quality
having food under Chapter II
pH> 4.5 --------------
-------------------------------------------------- -----------------------
Acidic foods food is tested acetic acid 3% simulant B
(ie. water using a simulant B (weight / volume)
having food under Chapter II
pH <4.5 ---------------------------
-------------------------------------------------- ----------
Alcoholic food is tested ethanol 10% (V / V) simulant C
food simulant using C. This concentration should be
under Chapter II adjusted according to actual || |
alcohol concentration in food, if
exceeds 10% (V / V)
--------------------------------------- ------------------------------------------------ || | Fatty foods foods are tested Rectified olive oil simulant D
using simulant D or other fat food
under Chapter II simulant -------------------------------------------
--------------------------------------------
Dry foods None no
---------------------------------------------- -----------------------------------------

Second
Selection of food simulants


02.01 Products coming into contact with all kinds of food

Migration tests are carried out using the simulants mentioned below
food while selecting those which are considered the most stringent
at the test conditions specified in Chapter II. For each simulant
food must always take a new sample material or plastic product:

2.1.1 3% (w / v) aqueous acetic acid solution

2.1.2 10% (V / V) aqueous ethanol solution

2.1.3 rectified olive oil ( "reference simulant D")

Reference simulant D, referred to in paragraph 2.1.3 may be replaced by "other
fat food simulants", called "simulants D", namely:

2.1.3.1 synthetic mixture of triglycerides

2.1.3.2 sunflower oil

2.1.3.3 corn oil

These simulants D must have the appropriate specification and purity.
Characteristics of these 'other fatty food simulants "
listed in paragraph 2.1.4.

If using any of these other food simulants
found to exceed the migration limit is to assess
non compliance mandatory if it is technically possible to confirm
result of the test using the reference simulant D i.e.
rectified olive oil. If this determination is not
control is technically feasible and the determined value migration
material or article exceeds the migration limit, the product is considered unsatisfactory
requirements of § 10 of the Decree.

Specification 2.1.4 and the requirements for purity "fat simulants D"

2.1.4.1 Characteristics of rectified olive oil: Iodine value
(according to the Wijs) of 80-88, refractive index at 25 ° C. C = 1.4665 to 1.4679,
acidity (expressed as% oleic acid) = more than 0.5%,
Peroxide number (expressed in milliequivalents of oxygen per kg of oil) = maximum 10th

2.1.4.2 Composition Distribution synthetic triglycerides fatty acids

The number of C atoms fatty acid residues 6 8 10 12 1416 18 Other
GLC peak area in the chromatogram [%] přibl.1 6-9 8-11 45-52 12-15 8-10 8-12 = <1
Cleanliness
Content of monoglycerides (enzymatically) = <0.2%
Content of diglycerides (enzymatically) = <2.0%
Unsaponifiables = <0.2%
The iodine value (according to Wijs) = <0.1%

Acid number = <0.1%
Water content (Karl Fischer) = <0.1%
Melting point of 28 +/- 2 st. C
The absorption spectrum (
thickness of layer: d = 1 cm, reference: water at 35
Wed C)
Wavelength (nm) 290 310 330 350 370390 430 470 510
Transmittance (%) přibl.2 přibl.15 přibl.37 přibl.64 přibl.80 přibl.88 přibl.95 přibl.97 přibl.98
At least 10% transmittance at 310 nm (1 cm cuvette,
reference substance: water at 35 Wed C)

2.1.4.3 Characteristics of sunflower oil
The iodine value (according to Wijs) 120-145
The refractive index at 20 st. C 1.474 to 1.476
Saponification number 188-193
Relative density at 20 st. C 0.918 to 0.925
Unsaponifiables 0.5% to 1.5%

02.02 Products coming into contact with certain types of food
This case refers only to the following situations:

2.2.1 product is already in contact with a known foodstuff

2.2.2 product is accompanied in accordance with the requirements specified in § 8
paragraph (1) point. b) Decree-specific data with which
kinds of foods listed in Table 1 may or may not come into contact, for example.
"only for aqueous foods".

2.2.3 product is accompanied with specific information in accordance with § 8, paragraph
(1) point. b) hereof stating for which food or group of foods
, as shown in Table 3, may or may not be used in this application
can be expressed in the following ways:

2.2.3.1 on the level of business activity, with the exception of sales to consumers -
using the "reference number" or "description of foodstuffs", listed in Table 3


2.2.3.2 at the retail level - using information that will
refer to several foods or food groups. Preference is given
examples which consumers can readily understand.

In the case of the situations described in paragraphs 2.2.1 to 2.2.3 migration
test performed as follows:

- In the situation described in paragraph 2.2.2 products are tested using food simulants
mentioned as examples in Table 2

- For the situation referred to in paragraphs 2.2.1 and 2.2.3 shall apply to food simulants
according to Table 3

In cases where food or food groups are not included in
list set out in Table 3, to select an item from Table 2 which corresponds most closely
food, food or food group, with whom
test product and to be in contact.

If the material or product has come into contact with more than one
foodstuff or more than one group of food and these have different
reduction factors listed for individual foods or food groups
in Table. 3 it is necessary to determine the final test result
apply for each foodstuff corresponding reduction factor.
If one or more of the results obtained in this manner exceeds migration
limit, then this product is for food or group of foods
unsatisfactory. TABLE 2




Food simulants
----------------------------------------------- -------------------
food coming into contact with simulant
-------------------- ----------------------------------------------
Only aqueous food simulant A -------------------------------------------
-----------------------
Only acidic food simulant B
---------------- --------------------------------------------------
Only alcoholic food simulant C
--------------------------------------- ---------------------------
Only fatty food simulant D
------------ -------------------------------------------------- ----
All aqueous and acidic food simulant B
--------------------------------- ---------------------------------
All alcoholic and aqueous foods simulant C
---- -------------------------------------------------- ------------
All alcoholic and acidic food simulants B and C
----------------------- -------------------------------------------
All fat and water food simulants a and D
------------------------------------------
------------------------ All fatty and acidic food simulant D and B -----------
-------------------------------------------------- All -----

fat and alcohol and aqueous food simulants D and C
------------------------- -----------------------------------------
All fat and alcoholic || | and acidic food simulants D, C and B

----------------------------------------------- -------------------
TABLE 3


Definition simulants used to determine the size of the migration
components of plastics and plastic products for individual foods or groups of foods


----------------------------------------------- -------------------------------------
Reference Description Used food simulants
number - ------------------------------
ABCD
---------------------------------------------- -------------------------------------- 01 Drinks
----
-------------------------------------------------- ------------------------------
01.01 Non-alcoholic beverages or alcoholic
beverages with alcohol content of less than
5% V / V:
Water, ciders, fruit
vegetable juices, natural or
concentrated, musts, fruit nectars,
soft drinks and mineral waters, syrups,
hořčinové beverages, extracts, coffee,
tea, chocolate drinks, beer and others. X (a) X (a) ------------------------------
-------------------------------------------------- ----
01.02 alcoholic beverages containing alcohol
equal to or higher than 5% V / V:
Drinks referred to in item 1.1, but
on alcohol content equal to or higher
than 5% V / V:
Wines, spirits and liqueurs X (*) X (**)
--------------------------------- -------------------------------------------------- -
01.03 Miscellaneous: undenatured ethyl alcohol X (*) X (**)
----------------------------- -------------------------------------------------- -----

----------------------------------------------- -------------------------------------
02 Cereals, cereal products, pastry, biscuits, pastries and other bakery

products ---------------------------------------------- -------------------------------------- 02.01 Starches
----
-------------------------------------------------- ------------------------------
02.02 Cereals, unprocessed, expanded
(Puffed), in flakes (including
roasted corn, corn flakes and similar products
.)
----------------------- -------------------------------------------------- -----------
02.03 Cereal flour and semolina
---------------------------- -------------------------------------------------- ------
02.04 Macaroni, spaghetti and similar products
------------------------------- -------------------------------------------------- ---
02.05 biscuits, cookies, cakes
and other long-life bakery products:
A. With fatty substances on the surface X / 5
B. Other
-------------------------------------------- ----------------------------------------
02.06 Fresh bread, pastries and other fresh
bakery products:
A. With fatty substances on the surface X / 5
B. Other X -------------------------------------------
-----------------------------------------

----------------------------------------------- -------------------------------------
03 Chocolate, sugar and products thereof || | Cakes, confectionery -------------------------------------------
-----------------------------------------
03.01 Chocolate, chocolate coated products ,
substitutes chocolate coated products
substitutes X / 5 -------------------------------------------
-----------------------------------------
03.02 confectionery products, sweets:
A. In solid form:
I. With fatty substances on the surface X / 5
II. Other
B. In paste form:
I. With fatty substances on the surface X / 3
II. With higher moisture content X ------------------------------------------
------------------------------------------
03.03 Sugar and products sugar:
A. In solid form
B. Honey and the like X
C. Molasses and sugar syrups X ----------------------------------------
--------------------------------------------

----------------------------------------------- -------------------------------------
04 Fruit, vegetables and their products || | ------------------------------------------------- -----------------------------------
04.01 Whole fruit, fresh or chilled
--------------------------------------- ---------------------------------------------
04.02 Processed fruit:
A. Dried or dehydrated fruits, whole
or in the form of flour or powder
B. Fruit in the form of pieces of fruit

fruit puree, puree or paste
C. Fruit preserves (jams and similar X (a) X (a)
products - whole fruit or fruit pieces
, or in the form of flour or
powder, preserved in a liquid brine)
I. In an aqueous liquid medium X (a) X (a)
II. The oil medium X (a) X (a) X
III. The alcoholic infusion
(> = 5% V / V) X (*) X
--------------------------------- -------------------------------------------------- -
04.03 nuts (peanuts, chestnuts, almonds,
hazelnuts, walnuts, pine kernels and other
):
A. Shelled, dried
B. Shelled and roasted X / 5 (**)
C. In paste or cream form XX / 3 (**)
--------------------------------- -------------------------------------------------- -
04.04 whole vegetables, fresh or chilled
------------------------------------ ------------------------------------------------ || | 04.05 Processed vegetables:
A. Dried or dehydrated vegetables, whole
or in the form of flour or powder
B. Vegetables cut in the form of puree X (a) X (a)
C. Vegetables:
I. In an aqueous liquid medium X (a) X (a)
II. The oil medium X (a) X (a) X
III. The alcoholic infusion
(> = 5% V / V) X (*) X
--------------------------------- -------------------------------------------------- -

----------------------------------------------- -------------------------------------
05 Fats and oils ---
-------------------------------------------------- -------------------------------
05.01 Animal and vegetable fats and oils
natural or processed (including
cocoa butter, lard, butter
přepouštěného)
X -------------------------- -------------------------------------------------- --------
05.02 Margarine, butter and other fats and oils
produced from aqueous emulsions in oil X / 2
-------------------------------------- ----------------------------------------------

----------------------------------------------- -------------------------------------
06 Animal products and eggs
- -------------------------------------------------- --------------------------------
06.01 Fish
A. Fresh, chilled, salted, smoked XX / 3 (*)
B. In the form of paste XX / 3 (*)
------------------------------------ ------------------------------------------------ || | 06.02 Crustaceans and molluscs (including oysters, mussels
edible, snails), without natural
protection of their shells, shell or
X --------------------------------------------- boxes
---------------------------------------
06.03 Meat of all zoological species (including
poultry and game):
A. Fresh, chilled, salted, smoked XX / 4
B. In the form of pastes or creams XX / 4
------------------------------------- -----------------------------------------------
06.04 Processed meat products (ham, salami, bacon and other
products) XX / 4
--------------------------- -------------------------------------------------- -------
06.05 Meat and fish cans and semi-:
I. In an aqueous liquid medium X (a) X (a)
II. The oil medium X (a) X (a) X
----------------------------------- ------------------------------------------------- | || 06.06 poached eggs
A. Powdered or dried
B. Other X -------------------------------------------
-----------------------------------------
06.07 Egg yolks: || | A. Liquid X
B. Powdered or frozen
----------------------------------------- -------------------------------------------
06.08 Dry egg white
----------------------------------------------- -------------------------------------

----------------------------------------------- ------------------------------------- 07
----
Dairy products -------------------------------------------------- ------------------------------
07.01 Milk:
A. Whole X (b)
B. Concentrated X (b)
C. Skimmed X (b)
D. Dried
-------------------------------------------- ----------------------------------------
07.02 Fermented milk such as yoghurt buttermilk XX (b)
and similar products

----------------------------------------------- -------------------------------------
07.03 cream and sour cream X (a) X (b)
-------------------------------------------- ----------------------------------------
07.04 Cheeses:
A. blocks, with non-edible rind
B. All other X (a) X (a) X / 3 * -------------------------------
-------------------------------------------------- ---
07.05 rennet:
A. In liquid or viscous form X (a) X (a)
B. Powdered or dried.
----------------------------------------------- -------------------------------------

----------------------------------------------- -------------------------------------
08 Miscellaneous manufactured articles
---- -------------------------------------------------- ------------------------------ 08.01 Vinegar X

----------- -------------------------------------------------- -----------------------
08.02 Fried and baked edibles:
A. Fried potatoes, donuts, pastry
with meat or fruit filling
and the like X / 5
B. Products of animal origin X / 4
--------------------------------------- ---------------------------------------------
08.03 Preparations soups, broths, in liquid,
solid or powder form (extracts, concentrates
); homogenised mixture
food preparations, prepared dishes:
A. Powdered or dried:
I. With fatty substances on the surface X / 5
II. Other
B. Liquid or paste:
I. With fatty substances on the surface X (a) X (a) X / 3
II. Other X (a) X (a)
-------------------------------------- ----------------------------------------------
08.04 yeast, baking agents:
A. Pasty X (a) X (a)
B. Dried
-------------------------------------------- ----------------------------------------

08.05 Edible salt - -------------------------------------------------- --------------------------------- 08.06 Sauces

A. Without fatty substances on the surface X (a) X (a)
B. Mayonnaise, mayonnaise sauces,
salad dressings and other emulsion oil
in water X (a) X (a) X / 3
C. Non-emulsified sauces containing
oil and water X (a) X (a) X
----------------------------------- ------------------------------------------------- | || 7.8 mustard (except mustard powder
defined in item 8.17) X (a) X (a) X / 3 (*)
---------------- -------------------------------------------------- ------------------
08.08 Sandwiches, toasted bread and similar
products containing any kind
Food:
A. With fatty substances on the surface X / 5
B. Other
-------------------------------------------- ----------------------------------------
08.09 Ice X
- -------------------------------------------------- ---------------------------------
08.10 Dried foods:
A. With fatty substances on the surface X / 5
B. Other
-------------------------------------------- ----------------------------------------
08.11 frozen or deep-frozen foods | || ------------------------------------------------ ------------------------------------
08.12 Concentrated extracts containing
alcohol equal to or exceeding
5% V / VX (**) X
------------------------------------- -----------------------------------------------
08.13 Cocoa:
A. Cocoa powder X / 5 (*)
B. Cocoa paste X / 3 (*)
------------------------------------- -----------------------------------------------
08.14 Coffee, roasted or unroasted, without
decaffeinated or soluble, coffee substitutes,
granulated or powdered -------------------------------------------
-----------------------------------------
08.15 Liquid coffee extracts X | || ------------------------------------------------ ------------------------------------
08.16 Aromatic herbs and other herbs:
camomile, mallow, mint, tea, lime blossom
and other
--------------------------------------------- ---------------------------------------
08.17 Spices and condiments throughout || | or powder in the natural state:
cinnamon, cloves, mustard powder,
pepper, vanilla, saffron and other
---------------------------------------- --------------------------------------------

Note:


(*) If it can be an appropriate test to prove that there is no contact
between fat and plastic, test may be waived simulant D.
(**) This test is performed only if the pH is 4.5
or less.

2.3 Rules for application to Table 3 for the implementation of migration tests

2.3.1 For each substance or group of substances used only the simulant
(or stimulants), which is marked "X". For each simulant used
always a new product sample. If "X" above, is not required for
the group or subgroup of food migration test.
Following
2.3.2 If the letter "X" slash and numbers, divided by the result of the migration tests
figure indicated. In the case of certain types of fatty
food, this conventional figure, known. "Simulant D Reduction Factor"
(DRF), is used to take account of the greater extractive capacity of the simulant compared to the food
.

2.3.3 If a "X" indicated in parentheses the letter "a" is used only
one of these simulants according to the following rules:

2.3.3.1 - if the pH value of the food is greater than 4.5, simulant used
A

2.3.3.2 - if the pH value of 4.5 or less food is used simulant B.


2.3.4 If the letter "X" in brackets after the letter (b)
executes the specified test with ethanol 50% (V / V).

2.3.5 If the food is placed under a specific and common name,
uses only the simulant (s) indicated (s) with a specific name.

-------------------------------- *) Note. ASPI: Changing Chapters and implementing decree of the Ministry health no. 386/2008 Coll.
Has been through an amendment 271/2008 Coll., And therefore are not included.

Chapter II


Migration test conditions: temperature and time

1
Basic rules


Migration testing shall be performed under these test conditions
to the times and duration of the test temperatures specified in Table 4 were selected
those which correspond to the worst foreseeable conditions under which
product being tested is or will be in fact used, for example.
data on the maximum temperature of use of the product listed on its label.
2


Rules for the selection of the test conditions
migration tests are generally carried out under the test
conditions i.e. temperature and time, which in the specific case considered worst
. Some specific examples
application of these rules are given in the following paragraphs 2.1 and 2.2.

2.1 Products intended for contact with food without any temperature and time
Contact with Food For products which do not appear on the label, instructions or instructions for use
given temperature food contact and no time
own use, must be chosen depending on the type of food or food
following test conditions, which are based on scientific investigation
considered worst: food simulant a
and / or B and / or C for 4 hours at 100 st. C or 4 hours at reflux temperature
and / or fat simulant D for 2 hours at a temperature of 175
Wed. C. These values ​​are the time and temperature for this case
generally considered, however.

2.2 products coming into contact with food or at a lower room temperature
undetermined period Products which are the directions for use
designed for use at room temperature or a lower temperature than
room, or, where the product by its nature is clearly possible
used only at such temperatures and contact time to be determined, must be
migration test performed at 40 Wed. C for 10 days.
These conditions are in this case considered the worst.
3


Determination of volatile substances migrating

When testing for the specific migration of volatile substances from product samples to test
food simulants made in such manner that takes into account losses
volatile migrants which may occur in the worst foreseeable conditions of use
product.
4

Special cases


4.1 migration tests of products intended for use in microwave ovens
can be used both conventional and microwave ovens for
provided that they are properly selected test conditions (time and temperature
) Table 4. || |
4.2 If during migration tests found that testing for
contact conditions listed in Table 4 causes physical or other
changes in the test sample, which occur under the worst

Foreseeable conditions of use of the product, the migration test
under the worst foreseeable conditions of use in which these
physical or other changes do not occur. Terms of use of the product must be
then be modified in the manuals or instructions for use of the product, according
facts found during the migration testing.

4.3 Edit test conditions migration tests listed in Table 4
case testing of products actually to be used in
periods shorter than 15 minutes at temperatures between 70 Wed.
C and 100 st. C (for example, hot filling definitions see Annex no. 1) and
this information is found also on the product label or instructions for its use
to be done so that it is applied only in the 2-hour test || | at 70 st. C. However, when such products are intended also for
storing food at room temperature, test conditions, test
replaced by more appropriate, which are considered for the worst case
use and migration test was conducted at 40 st . C for 10
days.

4.4 In those cases where the conventional conditions for migration testing
not covered by the test conditions specified in Table 4 (example:
use temperatures are higher than 175 Wed C or time of contact of the product with food is
less than 5 minutes), can use other test
conditions which correspond to more effective use of the tested product.
These selected test conditions must not pose
worst foreseeable conditions during actual use of the product. TABLE 4


Test conditions for migration tests with food simulants

----------------------------------------------- ----------------------------
conditions most adverse foreseeable conditions of migration tests
how to use the product tested
--- -------------------------------------------------- ----------------------
longest foreseeable use time migration tests

product ----------- -------------------------------------------------- --------------
T = <5 min See. conditions in Chapter II,
4.4 ---------------------------------------------
------------------------------
5 min <t = <0.5 h 0.5 h
-------------------------------------------------- -------------------------
0.5 h <t = <1 h 1 h
------- -------------------------------------------------- ------------------
1 h <t = <2 h 2 h
------------------------------------- --------------------------------------
2 h <t = <4 h 4 h
------------------------------------- --------------------------------------
4 h <t = <24 h 24 h
------------------------------------- --------------------------------------
t> 24 h 10 days
----------------------------------------- ----------------------------------

----------------------------------------------- ----------------------------
highest temperature foreseeable use temperature migration test product

----- -------------------------------------------------- --------------------
T = <5 st. C 5 st. C
---------------------------------------------- -----------------------------
5 st. C <= T <20 st. C 20 st. C
---------------------------------------------- -----------------------------
20 st. C <= T <40 st. C 40 st. C
---------------------------------------------- -----------------------------
40 st. C <= T <70 st. C 70 st. C
---------------------------------------------- -----------------------------
70 st. C <= T <100 st. C 100 st. C or temperature

reflux ---------------------------------------------- -----------------------------
100 st. C <= T <121 st. C 121 st. C (*)
------------------------------------------- --------------------------------
121 st. C <= T <130 st. C 130 st. C (*)
------------------------------------------- --------------------------------
130 st. C <= T <150 st. C 150 st. C (*)
------------------------------------------- --------------------------------
T> 150 st. C 175 st. C (*)
-------------------------------------------
-------------------------------- (*) This temperature can be used only for simulant D. for | || using food simulants A, B or C must migration
tests conducted at 100 st. C or reflux
temperature four times the time selected according to the basic

the rules set out in Chapter II, paragraph 1
Chapter III


Substitute tests for overall and specific migration using fatty simulants


First

If you can not, for technical reasons related to the method of analysis
monitored migrants use fatty food simulants can be replaced
test media, which are shown in Table 5 and under test conditions
that match test conditions for fat simulant D.
table 5 gives some examples of the most important conditions
migration tests and their associated conventional conditions that
be used in the implementation of alternative tests.
For different test conditions, which are not listed in Table 5, it is necessary to take into account
following examples, as well as the existing experience with the test polymer type
:

1.1 For each test must always use a new product sample.

1.2 must be applied for each test medium the same rules
prescribed in Chapters I and II. For fat simulants D. Where it
appropriate, apply the provisions of Table 3
reduction factors for fatty food simulants.

1.3 To evaluate the test sample for comparing the result of migration
to set a migration limit selects the highest migration
value obtained using all the test media.

1.4 However, if it finds that the implementation of the migration tests with these
test medium is causing some of these media
physical or other changes in the test sample, and these changes under the worst foreseeable conditions of use of the product
not occur, the result of this test
medium is discarded and the highest value will be selected from the remaining
migration tests.

Second

It is permissible to omit one or two spare migration tests
specified in Table 5, provided that these tests are not
test sample based on the scientific evidence appropriate. TABLE 5


Conventional conditions for migration testing alternative

----------------------------------------------- ------------------------------------------------- | || Test conditions Test conditions Test conditions the test conditions are
simulant D with isooctane with 95% ethanol with MPPO (*)
-------------------- -------------------------------------------------- --------------------------
10 days at 5 st. C 0.5 days at 5 st. C for 10 days at 5 Wed. C -
--------------------------------------------- -------------------------------------------------- -
10 days at 20 st. C 1 day at 20 st. C 10 days at 20 Wed. C -
--------------------------------------------- -------------------------------------------------- -
10 days at 40 st. C 2 days at 20 Wed. C 10 days at 40 Wed. C -
--------------------------------------------- -------------------------------------------------- -
2 h at 70 Wed. C for 0.5 h at 40 Wed. C for 2 h at 60 Wed. C -
--------------------------------------------- -------------------------------------------------- -
0.5 h at 100 st. C for 0.5 h at 60 Wed. C (**) 2.5 h at 60 Wed. C for 0.5 h at 100 st. C
---------------------------------------------- --------------------------------------------------
1 h at 100 st. C for 1 h at 60 Wed. C (**) 3 h at 60 Wed. C (**) for 1 h at 100 st. C
---------------------------------------------- --------------------------------------------------
2 h at 100 st. C for 1.5 h at 60 Wed. C (**) 3.5 h at 60 Wed. C (**) for 2 h at 100 st. C
---------------------------------------------- --------------------------------------------------
0.5 h at 121 st. C for 1.5 h at 60 Wed. C (**) 3.5 h at 60 Wed. C (**) 0.5 h at 121 st. C
---------------------------------------------- --------------------------------------------------
1 h at 121 st. C for 2 h at 60 Wed. C (**) 4 h at 60 Wed. C (**) for 1 h at 121 st. C
---------------------------------------------- --------------------------------------------------
2 h at 121 st. C for 2.5 h at 60 Wed. C (**) 4.5 h at 60 Wed. C (**) 2 h at 121 st. C
---------------------------------------------- --------------------------------------------------
0.5 h at 130 st. C for 2 h at 60 Wed. C (**) 4 h at 60 Wed. C (**) 0.5 h at 130 st. C
---------------------------------------------- --------------------------------------------------
1 h at 130 st. C for 2.5 h at 60 Wed. C (**) 4.5 h at 60 Wed. C (**) for 1 h at 130 st. C
---------------------------------------------- --------------------------------------------------
2 h at 150 st. C for 3 h at 60 Wed. C (**) 5 h at 60 Wed. C (**) 2 h at 150 st. C

----------------------------------------------- ------------------------------------------------- | || 2 h at 175 st. C 4 h at 60 Wed. C (**) 6 h at 60 Wed. C (**) 2 h at 175 st. C
---------------------------------------------- --------------------------------------------------

(*) = MPPO modified polyphenylene
(**) The volatile test media are used up to a maximum temperature
60 st. C
Chapter IV


Alternative tests with fatty food simulants for determining
overall and specific migration

First

It is permissible to use alternative migration test results as
specified in this Chapter, unless the following conditions are met:

1.1 results obtained in a "comparison test" is greater than or equal to
values ​​obtained in the test with simulant D

1.2 migration value determined by alternative tests must
after application of appropriate reduction factors listed in Table 3
exceed the migration limits, if one of the conditions set out in paragraphs
1.1 and 1.2 of this chapter is not satisfied, it must take Migration
tests with fatty food simulant D.

Second

It is possible to omit the "comparative tests" indicated in paragraph 1.1, if
there is another conclusive proof that the values ​​obtained in the alternative
tests are equal to or greater than the value obtained by migratory
tests.

Third
Alternative tests


3.1 Alternative tests with volatile media tests using
volatile media such as isooctane or 95% ethanol or other volatile solvents
or solvent mixture is carried out under such test conditions that
the condition in point 1.1 of this chapter .

3.2 "Extraction tests" Other tests, which can be done
verification set migration limits are tests that use
media with a very strong extraction capabilities under very strict test
conditions. These tests can be applied provided that
on the basis of scientific knowledge is verified that the results of these "extraction
tests" are equal to or higher than the results obtained during
migration tests with food simulants.
Chapter V


Rules for monitoring the migration limits

First


General Provisions
1.1 When comparing the results of the migration tests specified in this Annex
should be specific gravity of all the simulants conventionally equal
first The number of milligrams of substance (s) released () released per liter
simulant (mg / l) will thus correspond numerically to milligrams of substance
(s) release (s) released per kilogram of simulant and having regard to the provisions of Chapter I
. of this annex, the number of milligrams of substance (s)
loose (loose) for a kilogram of food.

1.2 If the migration tests carried out on samples taken from
products or samples produced for this purpose and the amount of food simulant
or which is brought into contact with the sample differs from the amount used for
actual use of a product must be corrected
results obtained using the following formula:


m. a2
M = ------. 1000
a1. q

Where
:

M is the migration in mg / kg

M is the mass of a substance released from the sample in mg provided a test migration

A1 size of the sample surface in dm2, which is in contact with the foodstuff or
simulant during the migration test,

A2 is the surface area in dm2 of the product under actual conditions of use

Q amount of food in grams, which is in contact with the product
under actual conditions of use.

Determination of migration is carried out with the product, or if this is not possible,
sample taken from a product, or optionally its
representative sample.

1.3 sample must be brought into contact with food or food simulant
way that conditions in actual use.
For this purpose, the test must be carried out so that in contact with food or food simulant
only those parts of the sample intended
contact with foodstuffs in actual use.
These conditions are especially important in the case of products consisting of several layers, such
. closures, foils, etc. Testing migration for caps, gaskets, stoppers and similar
closures must be done using with
containers for which they are intended in a manner corresponding
conditions of closing in normal or foreseeable use .


In any case, it is permissible to demonstrate compliance with migration limits
one or several stringent tests.

1.4 In accordance with the provisions of Chapter II of this Annex, a sample of the product
brought into contact with food or food simulant corresponding
time and temperature, which are selected according to conditions of contact in actual use and according
the rules set out therein. At the end of the prescribed period, the
foodstuff or simulant carry out the analytical determination of the total
quantity of substances (overall migration) and / or the specific quantity
one or more substances (specific migration) released by the sample.

1.5 If the product is intended for repeated contact with food
migration test (test migration) three times on a single sample
under the conditions laid down in this Annex, each time using another sample of the food or
simulant (s) of food.
Respecting the limits shall be assessed by the migration found in the third test.
If there is conclusive proof that the migration during the second and third tests
match, and if the first test is not a migration limit exceeded
(migration limits are not exceeded), no further test is necessary.

Second

Special provisions relating to overall migration

2.1 If the aqueous simulants specified in Chapter I of this Annex
may be analytical determination of the total quantity of substances released by the sample
done by evaporation of the simulant and weighing
nonvolatile residue.

2.2 If rectified olive oil or any of its
compensation can follow the steps below.

Product sample is weighed before contact with the simulant and beyond.
Simulant absorbed by the sample is extracted and determined quantitatively.
Identified simulant amounts deducted from the weight of the sample measured after contact with the simulant
. The difference between the initial and corrected final weights
represents the overall migration of the sample examined.

2.3 If the product is intended for repeated contact with food and
test described in paragraph 1.5 of this chapter is technically impossible to carry out,
permissible modifications to that test, provided that they allow
the level of migration in third test. One of these possible modifications is described below
.

The test is carried out on three identical samples of the product. One of them
subjected to the appropriate test and the overall migration determined (M1).
Second and third samples are at the same temperatures are brought into contact at a time that is twice
respectively. three times that specified and overall migration
(M1), and in both cases, the total migration (M2
resp. M3). The product is deemed satisfactory, either M1 or
M3 - m2 exceed the overall migration limit.

2.4 material or article that exceeds the overall migration limit
maximum value of deviation analysis should be considered as complying
hereto. The following analytical tolerances:

- 20 mg / kg or 3 mg / dm2 in migration tests using rectified
olive oil or fat substitutes,

- 6 mg / kg or 1 mg / dm2 in migration tests using the other simulants
specified in Chapter I.

2.5 migration tests to check compliance with the overall migration limit
using rectified olive oil or substitutes shall not be performed
if there is conclusive proof that the analytic method from a technical viewpoint
inappropriate.

2.6 In all these cases, the substance for which there
specific migration limits or other restrictions apply general
specific migration limit of 60 mg / kg or 10 mg / dm 2.
But the sum of all specific migrations determined shall not exceed the overall migration limit
.

Third

Special rules for provisions relating to specific migration substances


3.1 Correction of specific migration in foods containing more than 20%
fat by the Fat Reduction Factor (FRF):

"Fat Reduction Factor" (FRF) is a factor between 1 and 5, which divides
measured migration of lipophilic substances into a fatty food or
simulant D and its substitutes before comparison with the specific migration
limits.
General rules


Substances considered 'lipophilic' for which the application of the FRF
are listed in Appendix IV of Appendix 3 to this decree.
Specific migration of lipophilic substances in mg / kg (M) shall be corrected by the FRF

Which ranges between 1 and 5 (MFRF). Before comparison with the legal limit
, the following equation:
MFRF = M / FRF (1)

And

FRF = (g fat in food / kg of food) / 200 =
(% Fat x 5) / 100 (2)


This correction by the FRF is not applicable in the following cases:

3.1.1 If the material or article in contact with food
containing less than 20% fat these foods has come into contact
;

3.1.2 If the material or article in contact with food intended
for infants and young children under a special legal regulation 4) or
these foods has come into contact;

3.1.3 In the case of substances listed in Annex no. 3, which are in
column (4) SML = ND restrictions or substances in lists are not listed
used behind a plastic functional barrier
with a migration limit of 0.01 mg / kg;

3.1.4 In the case of materials and articles for which it is impracticable to estimate
ratio between the surface and the amount of food that is in contact therewith, for example
. due to their shape or use, migration is calculated using the conventional conversion factor
surface / volume 6 dm2 / kg.

This correction by the FRF is applicable under certain conditions in this case
:

For containers or other objects that can be filled, with a capacity of less
than 500 milliliters or more than 10 liters and for sheets and films
in contact with foods containing more than 20% fat with
either the migration is calculated as concentration in the food or food simulant
(mg / kg) and corrected by the FRF, or it is re-calculated
as mg / dm2 without applying the FRF. If one of the two values ​​is below the SML
, it is assumed that the material or object is consistent. "

Application of the FRF shall not lead to a specific migration exceeding the overall migration limit
. "

03.02 Correction of specific migration in food simulant D:

Specific migration of lipophilic substances into simulant D and its substitutes shall
corrected by the following factors:

3.2.1 reduction factor according to section 2.3.2 of this Annex, hereafter referred to as
simulant D Reduction Factor (DRF). The DRF may not be applicable
when the specific migration into simulant D is higher than 80%
substance content in the finished material or article (eg. A thin film). To determine whether
DRF is applicable, are required or
scientific experimental evidence (e.g. testing most critical foods).
Is also not applicable for substances in the Community lists
which are in column (4) SML = ND restrictions or substances in non-listed
used behind a plastic functional barrier with || | migration limit of 0.01 mg / kg;

3.2.2 FRF is applicable to migration into simulants, provided
known fat content of the food to be packed and
fulfilled the requirements set out in Section 3.1;

3.2.3 Total Reduction Factor (TRF) is the factor, with
maximum value of 5, which is divided by a measured specific migration into simulant D
or refund before comparison with the legal limit.
Overall reduction factor is obtained by multiplying the DRF by the FRF,
if applicable both factors. "

03.03 Caps, lids, gaskets, stoppers and similar sealing

3.3.1 If it is known their intended use shall be tested for these items
use the containers for which they are intended under conditions of closure corresponding
normal or foreseeable use. It is assumed that these articles are in
contact with a quantity of food container is filled with
. Results are expressed in mg / kg or mg / dm2 in accordance with
rules set out in § 12, paragraphs 1 and 2, taking into account the whole contact surface of sealing
and containers.

3.3.2 Unless known their intended use shall be tested in these subjects
separate test and the result be expressed in mg / article.
value obtained is optionally added to the quantity, migrated from the container for which it has
be used in this subject.
------------------------------- -
*) Note. ASPI: Change Chapter V Implementation Ministry of health Decree no. 386/2008 Coll.
Has been through an amendment 271/2008 Coll., And therefore are not included.

Appendix 5


Determination of vinyl chloride monomer in products of polyvinyl chloride and its copolymers


1

Purpose and use

This method determines the amount of vinyl chloride monomer in articles.
2


Principle


Content of vinyl chloride monomer (VCM) in materials or articles is
determined by gas chromatography using the "headspace"
after dissolution or suspension of the sample in N, N-dimethylacetamide.
3

The chemicals


3.1 Vinyl chloride (VC), of purity higher than 99.5% V / V

3.2 N, N-dimethylacetamide (DMA), free from all impurities with the same retention time
under the test conditions as VC or
internal standard (3.3).

3.3 diethyl ether or cis-but-2-ene in DMA (3.2) as a solution
internal standard. These internal standards must not contain any impurity with
same retention time as VC, under the test conditions.
4

Apparatus

Note:
It is reported only devices or components for special equipment.
Assumed that the usual apparatus and equipment are available.

4.1 Gas chromatograph equipped with autosampler
"head-space" or equipment for manual sample injection.

4.2 Flame ionization detector or detectors mentioned in point 7

4.3 column for gas chromatography

The column must permit the separation of the peaks of air, of VC and internal standard, if used
. It must also combined 4.2 and 4.3 enable the signal
solution containing 0.02 mg VC / liter DMA or 0.02 mg VC / kg DMA
was at least five times higher than background noise.

4.4 Sampling ampoules or vials with septa
silicone elastomer or butyl rubber.

When using manual techniques dosage may sampling syringe
syringe from the space above the liquid causing a partial vacuum inside
ampoules or vials. Therefore, when the manual sampling techniques
sample unless ampoule pressurized prior to collection, it is recommended to use large
ampoule.

A micro injection 4.5

4.6 Gas-tight syringes for manual sampling of liquid
(headspace)

4.7 Analytical balance capable of weighing 0.1 mg.
5



Workflow CAUTION: VC is at room temperature dangerous gaseous substance, and
therefore it is necessary to prepare a solution in a well ventilated hood.

Note:
Make all necessary measures to prevent the escape
VC or DMA. When manually dispensing sample should be used
internal standard (3.3).
When using an internal standard should be used during the entire analysis
used the same solution.

5.1 Preparation of concentrated standard VC solution
approximately 2000 mg / kg

Suitable glass vessel weighed with an accuracy of 0.1 mg is introduced
certain amount (eg. 50 ml) of DMA (3.2). The container with the DMA reweigh.
The DMA was slowly added via cannula a certain amount (e.g. 0.1 g) of VC (3.1)
liquid or gaseous form. In case of using a device which prevents leakage
DMA VC can also be added by bubbling it into the DMA. The vessel is again
weighed to 0.1 mg. For the equilibration solution in a vessel
allowed to stand for two hours. Keep the standard solution in a refrigerator.

5.2 Preparation of dilute standard VC solution

Take a weighed amount of concentrated standard solution of VC
(5.1) and dilute DMA (3.2) or internal standard solution (3.3)
known volume or a known weight.
Concentration of the resultant dilute standard solution is expressed in mg / l or mg / kg.

5.3 calibration curve

Calibration curve must be constructed at least seven duplicate
determination. The accuracy of the response must be greater than 0.02 mg VC per liter or kilo
DMA. The calibration curve is calculated from these points by the least squares
ie. the regression line must be calculated using the following equation
:

y = a1. x A0 +



Where
:

Y height or peak area of ​​each individual determination, x
concentrations corresponding to points on the regression curve
n number of performed determinations (n ​​greater than or equal to 14).

Dependence must be linear, i.e. standard deviation (s)
differences between measured values ​​(yi) and the corresponding values ​​calculated from
regression line (zi) divided by the average value of all measured values ​​
(s) must not exceed 0.07.
It is calculated by:


Where
:

Yi individual measured response zi
values ​​corresponding response (yi) on the calculated regression
line, n> = 14


Prepare two series of at least seven ampules or vials (4.4).
Into each vial or vials is added the volume of the diluted standard solution
VC (5.2) and DMA (3.2) or internal standard solution in DMA
(3.3) to a final concentration of VC duplicate solutions were approximately || | equal values ​​of 0, 0.050, 0.075, 0.100, 0.150, 0.200 etc. mg / l or DMA
mg / kg of DMA and that all ampoules or vials contained the same amount
DMA that is to be used under point 5.5. Ampoules or vials tightly sealed
and proceed as described in Section 5.6
Construct a graph in which the ordinate shows the areas (or heights) of the VC peaks of the duplicate solutions
, or the ratio of these areas (or heights)
peaks to the areas (or heights) peaks of the internal
standard and the horizontal axis are plotted VC concentrations of the duplicate solutions.

5.4 Validation of preparation of standard solutions obtained in points 5.1 and 5.2


When preparing the second dilute standard solution with a concentration equal
0.1 mg VC / l or 0.1 mg VC / kg of DMA or internal standard solution
proceed as described in points 5.1 and 5.2. Average of two
chromatographic assay, for this solution must not differ by more than
5% from the corresponding point of the calibration curve. If the difference is greater than 5%
, discard all the solutions obtained in points 5.1, 5.2, 5.3 and 5.4 and
repeat the procedure from the beginning.

5.5 Preparation of samples of materials or products

Prepare two ampoules or vials (4.4). To each of them with
0,1 mg weigh at least 200 mg of sample obtained from one
tested material or product, the comminuted into small pieces.
It is necessary to ensure that in each bottle or vial were weighed the same
amount. Ampoule / vial was immediately sealed. To each vial / vials
added for each gram of sample of 10 ml or 10 g of DMA (3.2) or 10 ml or 10 g
internal standard solution (3.3). Ampoules / vials are sealed and
proceed under point 5.6.

5.6 Determination by gas chromatography

5.6.1 The ampoules / vials are shaken so as to avoid
liquid contact with a septum (4.4) and creates the most homogeneous possible
solutions or suspensions of material samples from (5.5).

5.6.2 All sealed ampoules / vials (5.3, 5.4 and 5.5) are placed on two
hours in a water bath at 60 +/- 1 st. C to achieve
balance. If necessary, again by shaking.

5.6.3 from the space above the liquid in the ampoule / vial sample.
When manual sampling is necessary to see to it that were taken
reproducible sample (see section 4.4), in particular the syringe must
be preheated to a temperature of the sample. Measure the area (or height) of the peaks
to the VC and, if used, the internal standard.

5.6.4 soon appear on the chromatogram peaks of DMA is removed from the column
(4.3) excess DMA suitable method.
6

Calculation results


6.1 interpolation of the chart deducted unknown concentration of sample pairs.
If used internal standard, it must be taken into account. The VC
in each pair of samples of test product is calculated using the following equation
:

c. In
x = ----- 1000
m
Where
:

X is the concentration of VC in the sample of the product, expressed in mg / kg
c concentration of VC in the phial containing the sample of the product (see section 5.5
), expressed in mg / l or mg / kg
the volume or mass of DMA in the phial containing the sample of product
(See section 5.5) expressed in liters or kilograms,
m sample weight of the product, expressed in grams.

6.2 The concentration of VC in the tested product, expressed in mg / kg
is defined as the average of the two concentrations of VC according to paragraph 6.1
provided that the criteria are satisfied precision referred to in Chapter 8
7


Checking VC

In cases where the content of VC in products calculated under 6.2
exceeds the maximum permissible amount, the values ​​must be obtained
analyzing individual sample pairs (5.6 and 6.1) must be confirmed by one of the three following
ways:

- Using at least one other column (4.3) having a stationary phase different
polarity. This process should be repeated until
chromatogram obtained to be no signs of overlapping peaks VC and / or internal standard with the components
product sample or food or food


- By using other detectors, eg. A detector based on mikroelektrolytické conductivity


- Using mass spectrometry; in this case, with high probability
deduce the presence of VC, if they have been found ions
molecules of the starting mass (m / e) of 62 and 64 in the ratio 3: 1. In case of doubt
be checked full mass spectrum.
8


Accuracy of the method

The difference between the results of two determinations (6.1) carried out simultaneously or in
rapid succession on the same sample by the same operator under the same conditions
not exceed 0.2 mg VC / kg of product.
Annex 6


Determination of vinyl chloride released products of polyvinyl chloride and copolymers
food

1

Purpose and use

The method determines the content of vinyl chloride in foodstuffs.
2


Principle of

Level of vinyl chloride (VC) in foodstuffs is determined by gas chromatography
using the "headspace" (method of sampling
headspace).
3

The chemicals


3.1 Vinyl chloride (VC) with a purity greater than 99.5% V / V.

3.2 N, N-dimethylacetamide (DMA), free from any impurity with the same retention time
under the test conditions as VC or as internal
standard (3.3).

3.3 Diethyl ether or cis-but-2-ene in DMA (3.2) as a solution
internal standard. These internal standards must not contain any impurity with
same retention time as VC, under the test conditions.

3.4 Distilled water or demineralized water of equivalent purity.
4

Apparatus

Note:
It is reported only devices or components for special equipment.
Assumed that the usual apparatus and equipment are available.

4.1 Gas chromatograph equipped with an automatic dispensing
sample from the headspace ( "headspace") or with facilities for manual sample injection
.

4.2 Flame ionization detector or other detectors mentioned in point 7

4.3 column for gas chromatography

The column must permit the separation of the peaks of air, of VC and internal standard, if used
. Furthermore, the combined 4.2 and 4.3 system must allow the signal
solution containing 0.005 mg VC / liter DMA or 0.005 mg VC / kg DMA
was at least equal to five times the background noise.

4.4 ampoules or vials for samples must be equipped with septa
silicone or butyl rubber.

When using manual sampling can sample at
filled syringe from the space above the liquid created a vacuum inside the vial or vials
. Therefore, when the manual sampling techniques,
unless ampoule pressurized prior to collection, it is recommended to use large
ampoule.

A micro injection 4.5

4.6 Gastight syringes for manual dispensing of the sample from the space above the liquid
(headspace).

4.7 Analytical balance capable of weighing 0.1 mg.
5



Workflow CAUTION: VC is a hazardous substance and at room temperature is
gaseous state. Therefore, the preparation should be done in a well ventilated fume hood
.

Note:
Make all necessary measures to prevent the escape
VC or DMA.
When manual sampling techniques should be used
internal standard (3.3).
When using an internal standard to be used during the whole procedure
same solution.

5.1 Preparation of standard VC solution (solution A)

5.1.1 Concentrated standard VC solution at approximately 2,000
mg / kg

Suitable glass vessel weighed with an accuracy of 0.1 mg poured
certain amount (eg. 50 ml) of DMA (3.2). The container with the DMA reweigh.
The DMA was added slowly injecting a certain amount (e.g. 0.1 g)
VC (3.1) in liquid or gaseous form. VC may also be added by bubbling it into the DMA
assuming that a device preventing
loss of DMA. The vessel was re-weighed to 0.1 mg.
To achieve balance, the solution in the vessel was allowed to stand for two hours. When used
internal standard, was added the internal standard in an amount
to its concentration in the concentrated standard VC solution was
same as the concentration of the internal standard solution prepared by
point (3.3) . Keep the standard solution in a refrigerator.

5.1.2 Preparation of dilute standard VC solution

Weighed amount of concentrated standard solution of VC (5.1.1)

Diluted to a known volume or a known weight using DMA (3.2) or
internal standard solution (3.3).
Concentration of the resultant dilute standard solution (solution A) is expressed in mg / l or mg / kg.

5.1.3 Construction of the curve with solution A

Calibration curve must be constructed using at least seven points
duplicates. Repeatability responses must be less than 0.002 mg VC
per liter or kg of DMA. The calibration curve is calculated from these points
least squares method, ie. that
regression line is calculated using the following equation:
y1 = a. and x0 +



Where
:

Y is the peak height or area of ​​an individual determination, x
corresponding concentration on the regression line, n
number of performed determinations (n ​​greater than or equal to 14).

Curve must be linear, i.e. standard deviation (s)
differences between measured responses (yi) and the corresponding values ​​calculated
responses from the regression line (zi) divided by the mean value (s) of all measured
responses can not exceed 0.07.

Calculated using the expression:

Where
:

Yi individual measured response zi
values ​​corresponding response (yi) on the calculated regression
line, n> = 14th

Prepare two series of at least seven phials (4.4). To each vial
add a volume of dilute standard VC solution (5.1.2) and DMA
(3.2) or internal standard solution in DMA (3.3) to a final concentration of VC
duplicate solutions was approximately equal values 0
0.005, 0.010, 0.020, 0.030, 0.040, 0.050, etc. mg / l or DMA mg / kg of DMA
and each ampoule containing the same total volume of solution.
Amount of dilute standard VC solution (5.1.2) must be such that
ratio between the total volume (microliters) of added VC solution and quantity
DMA (g or ml) or internal standard solution (3.3) does not
greater than 5. the ampoule was sealed and treated in the same procedure as described in paragraphs 5.4.2, 5.4.3 and 5.4.5
. Plot a graph where the y-axis are plotted
areas (or heights) of the VC peaks duplicate solutions, or the ratio of these areas
(or heights) of the areas (or heights) of the corresponding peaks
internal standard, and x-axis are plotted VC concentrations duplicate
solutions.

5.2 Validation of preparation of standard solutions obtained in point 5.1


5.2.1 Preparation of a second standard VC solution (solution B)

The procedure described in paragraphs 5.1.1 and 5.1.2 to obtain
second standard solution, in this case with a concentration approximately equal to 0.02
mg VC / l or 0.02 mg VC / kg of DMA or internal solution
standard. This solution was placed in two ampoules (4.4).
Ampoule is sealed and loaded them with the procedure set out in paragraphs 5.4.2, 5.4.3 and 5.4.5
.

5.2.2 Validation of solution A

If the diameter of two chromatographic determination regarding
solution B (5.2.1) does not differ by more than 5% from the corresponding point of the curve
responses obtained in 5.1.3, the accuracy of the solution and proven.
If the difference is greater than 5%, discard all the solutions obtained in points 5.1 and 5.2
and repeat the procedure from the beginning.

5.3 calibration curve "standard addition"

NOTE: The curve must comprise at least seven pairs of points.

The curve must be calculated from these points by the least squares
(5.1.3, third paragraph). Dependence must be linear, i.e. standard deviation
(s) of the differences between the measured responses (yi) and the corresponding values ​​
responses calculated from the regression line (zi) divided by the average
value (s) of all measured responses can not exceed 0.07 (5.1.3
fourth paragraph).
5.3.1 Sample Preparation


Sample analyzed food must be representative
foodstuffs submitted for analysis. Therefore it must be before the sample is mixed
foodstuff or broken up into small pieces and mixed.
5.3.2 Procedure


Prepare two series of at least seven ampules (4.4). To each vial was charged
least 5 g of the sample obtained from the test food (5.3.1).
Ensure that in each vial was added the same amount.
Ampoules were immediately closed. To each vial was added for each gram of sample 1 ml
preferably distilled water or demineralized water at least equal
quality, or, if necessary, an appropriate solvent (Note:
homogeneous foods addition of distilled or demineralised waters

Not necessary). To each phial a volume
dilute standard VC solution (5.1.2) containing internal standard (3.3)
if it is considered useful to the concentration of VC added to the phials
values ​​were equal to 0, 0.005, 0.010, 0.020, 0.030, 0.040, 0.050 etc.
mg / kg food. Ensure that the total volume of DMA or DMA containing
internal standard (3.3) were the same in each vial.
Amount of diluted standard solution of VC (5.1.2) and additional DMA if used,
must be such that the ratio between the total volume (microliters) of these solutions and the quantity
(g) of food contained in the vial It was possible
least, but not more than 5, and the same in all vials.
Ampoule is sealed and loaded them with the procedure referred to in paragraph 4.5

5.4 Determination by gas chromatography

5.4.1 vial is shaken in such a way to avoid contact with liquid contained
septum (4.4) and to obtain as homogeneous as possible
solutions or suspensions of food samples.

5.4.2 All sealed vial (5.2 and 5.3) it is possible for two hours
water bath at 60 +/- 1 st. C in order to achieve equilibrium. In
if necessary again shaken.

5.4.3 from the space above the liquid in the vial with the sample. In manual
dosage must ensure that reproducible
collected samples (4.4), in particular the syringe must be preheated to a temperature
sample. Measure the area (or height) of the peaks relating to the VC and, if it was
used internal standard.

5.4.4 Construct a graph where the y-axis plotted values ​​
areas (or heights) of the VC peaks or the ratio of the areas (or heights) of the VC peaks to
areas (or heights) of the internal peaks standard and the abscissa is plotted
amount (mg) VC, based on the amount of sample eatables
weighed into individual vials (kg). The chart is subtracted segment on the x axis.
The value corresponds to the concentration of VC in the sample edibles.

5.4.5 soon appear on the chromatogram peak DMA remove excess
DMA from the column (4.3), using any suitable method.
6

Results


VC released product into the test food expressed as mg / kg is
defined as the mean of two determinations (5.4), provided that the criteria are satisfied
reproducibility mentioned in point 8.
7


Checking VC

In cases where the VC released from the product into food and
calculated under point 6 exceeds the criterion specified in § 13 para. 3
ordinance, the values ​​must be obtained in each of the two determinations (5.4) || | confirmed in one of three ways:

- Using at least one other column (4.3) having a stationary phase different
polarity. This process should be repeated until
chromatogram obtained to be no signs of overlapping peaks VC and / or internal standard with the components
food sample

- By using other detectors, eg. A detector based on mikroelektrolytické conductivity


- In case of using mass spectrometry; can with high probability
deduce the presence of VC, if they have been found ions
molecules of the starting mass (m / e) of 62 and 64 in the ratio 3: 1. In case of doubt
is necessary to check the entire mass spectrum .
8


Accuracy of the method

The difference between the results of two determinations (5.4) carried out simultaneously or in
rapid succession on the same sample by the same operator under the same conditions
not exceed 0,003 mg VC / kg of foodstuff.
Annex 7


List of ingredients for products made of elastomers and materials based on natural and synthetic rubber
and their conditions of use

1

Elastomers based on these compounds:
1.1 Part
A
1.1.1 ethylene

1.1.2 propylene


1.1.3 1-butene
1.1.4 isobutene


1.1.5 1,3-butadiene
1.1.6 isoprene

1.1.7 styrene


1.1.8 alpha-methylstyrene
1.1.9 divinylbenzene


1 January 10 dicyclopentadiene; (Tricyclo [5,2,1,0E2,6] deca-3,8-diene)

1 January 11 5-methylene-2-norbornene; (5-methylene-bicyclo [2.2.1] hept-2-ene)

1 January 12 5-vinyl-2-norbornene; (5-vinyl-bicyclo [2.2.1] hept-2-ene)

1 January 13 silanes and siloxanes for silicone elastomers having at least one OH
group and one or more CH 3 groups on each Si atom

1.2 Part B

1.2.1 1,4-hexadiene

1.2.2 chloroprene; (2-chloro-1,3-butadiene)

1.2.3 2,3-dichloro-1,3-butadiene

1.2.4 1,2,3-trichloro-1,3-butadiene
1.2.5 acrylonitrile


1.2.6 methacrylic acid

1.2.7 methacrylate

1.2.8 ethylene glycol

1.2.9 vinyl


1 February 10 methyl

1 February 11 ethyl

1 February 12 acrylate


1 February 13 tert-butyl acrylate

Vinyl alkyl 1 February 14 *) in the list for some substances are in parentheses after the commonly used names, the names
systematic IUPAC nomenclature or
other common names.
2

Curing agents

Crosslinking agents

2.1 of Part A
2.1.1 Sulfur


2.2 Part B

2.2.1 bis (2,4-dichlorobenzoyl) peroxide 1 /

2.2.2 dibenzoyl 1 /

2.2.3 dicumyl 1 /

2.2.4 di-tert-butyl 1 /
3

Accelerators

3.1 Part
A

3.1.1 tetramethylthiurammonosulfid 2 /

3.1.2 tetramethylthiuram 2 /

3.1.3 tetraethylthiuraumdisulfid 2 /

3.1.4 tetrabutylthiurammonosulfid 2 /

3.1.5 sym-dimethyldifenylthiuramdisulfid 2 /

3.1.6 di-N-pentamethylenthiuramtetrasulfid 2 /

3.1.7 di-thio-bis (2-benzothiazole) 2 /
3.1.8
N, N-dimethyldithiocarbamate, zinc 3 /
3.1.9
N, N-diethyldithiocarbamate, zinc 3 /

January 3 10 N, N-zinc dibutyldithiocarbamate 3 /

January 3 11 N, N-dibenzyldithiocarbamate zinc 3 /

Pentamethylendithiokarbamát zinc January 3 12 3 /

Ethylfenyldithiokarbamát zinc January 3 13 3 /

3.2 Part B

3.2.1 1,3-diphenyl - more than 0.3%

3.2.2 1- (2-tolyl) biguanide; (O-tolylbiguanid) - not more than 1.0%

3.2.3 2-mercapto-benzothiazole (and / or Zn salt) - not more than 0,05% 3 /
4

Activators

4.1 Part
A

4.1.1 fatty acids, C6-C18 4 /

4.1.2 zinc salts of fatty acids, C6-C18 3/4 /

4.1.3 Zinc Oxide 3 /

4.1.4 zinc carbonate 3 /

4.2 Part B

4.2.1 amides of fatty acids C14-C22 4 /

4.2.2 magnesium carbonate

4.2.3 magnesium oxide

4.2.4 dibutylamine 5 /

4.2.5 dibutylamoniumoleát 5 /
5

Barriers

5.1 Part
A

5.1.1 benzoic acid - more than 1.0% 6 /

5.1.2 salicylic acid - more than 1.0% 6 /

5.1.3 stearic acid - not more than 1.5% 6 /

5.1.4 phthalic anhydride - more than 0.5% 6 /
6



Antidegradants 6.1 Part
A

6.1.1 2,6-di-tert-butyl-4-methylphenol 7 /

6.1.2 pentaerythritol tetrakis [3- (3st.5st.-di-tert-butyl-
4st.-hydroxyphenyl)] propionate 7 /

6.1.3 1,3,5-trimethyl-2,4,6-tris (3,5-di-tert.butyl-4-hydroxybenzyl) benzene 7
/

6.1.4 2,4-bis (octylthiomethyl) -6-methylphenol - not more than 0.3% 7 /

6.2 Part B

6.2.1 reaction product of styrene to diphenylamine 8/9 /

6.2.2 reaction product of: styrene and / or alpha-methyl-styrene and / or alkenes
(C3-C12) with phenol and / or 9 methylphenol /

6.2.3 2,6-di-tert-butyl-4-methylphenol 9 /

6.2.4 2,2'-methylene-bis (4-methyl-6-tert-butylphenol) 9 /

6.2.5 2,2'-methylene-bis (4-methyl-6-cyclohexylphenol) 9 /

6.2.6 2,2'-methylene-bis [4-methyl-6- (1-methylcyclohexyl) phenol] 9 /

6.2.7 2,2'-methylene-bis (4-methyl-6-terc.oktylfenol) 9 /

6.2.8 2,2'-methylene-bis (4-methyl-6-nonylphenol) 9 /

6.2.9 2,2'-isobutylidene-bis (4,6-dimethylphenol) 9 /

6 February 10 4,4'-butylidene-bis (3-methyl-6-tert-butylphenol) 9 /

6 February 11 octadecyl-3- (3 ', 5'-di-tert-butyl-4'-hydroxyphenyl) propionate -
more than 0.5% 9 /

February 6 12 tris (mono- and dinonylphenyl) phosphite 8/9/10 /
6 February 13
mixture of alkylated arylfosfitů (Antioxidant 6) 8/9/10 /
7



Processing Additives 7.1 Part
A
7.1.1 diisooctyl adipate


7.1.2 di-n-oktylsebakát

7.1.3 refined mineral oil 11 /

7.1.4 microcrystalline wax 12 /

7.1.5 zinc and sodium salts of fatty acids, C6-C18 4 /

7.1.6 lecithin 13 /
7.1.7 polydimethylsiloxane


14 7.1.8 polyethylene /

7.1.9 polyethylene glycol (polyoxyethylene) molecular weight greater than 4000
(containing ethylene glycol and / or bis (2-hydroxyethyl) ether
less than 0.3%)

7 January 10 disproportionated rosin and / or its potassium or sodium salt

7.2 Part B
7.2.1 dibutyl

7.2.2 acetyl


Calcium stearate 7.2.3

7.2.4 paraffin 15 /

7.2.5 epoxidized soybean oil 16 /

7.2.6 butyl soybean oil 16 /

7.2.7 sulfate sodium (alkyl C8-C18)

7.2.8 urea - more than 3.0%

7.2.9 xylenolformaldehydová resin 17/18 /

7 February 10 melaminresorcinformaldehydová resin 17/18 /

7 February 11 sodium salt of a condensation product of naphthalenesulfonic acid and formaldehyde 18
/


Azodicarbonamide 7 February 12 - more than 3.0%

February 7, 13 polyethylene glycol (molecular weight greater than 200;
containing ethylene glycol and / or bis (2-hydroxyethyl) ether less than 0.3%) and its
ethers with alcohols (monohydric, primary, linear, saturated
C4-C18 and oleyl 19/7 February 14



coumarone resin factice February 7 15 20/8



Fillers

8.1 Part A 8.1.1



calcium carbonate, magnesium carbonate 8.1.2 8.1.3



zinc carbonate 8.1 4 alumina 8.1.5



magnesium oxide, silicon dioxide 8.1.6 8.1.7



titanium dioxide, calcium silicate 8.1.8
8.1.9


magnesium silicate, aluminum silicate January 8 10 8.2



Part B 8.2.1 Carbon Black - a maximum of 10.0%, 21 /
| 9 ||

requirements for finished products made of elastomers and materials
based on natural and synthetic rubber

9.1 In assessing product category I and II will perform the following tests
aqueous extract, prepared by leaching 8 g of product
distilled water, ^ 1) at 100 st. C for 0.5 hours.
Product must meet the following health requirements:
a) Reducing substances not more than 15 ml of 0.002 mol / l KMnO4
b) The residue of not more than 20.0 mg.dm-2
c) Opalescence and turbidity negative ^ 1)
d) Primary aromatic amines negative ^ 1)
e) Proof of ammonium negative ^ 1)
f) Detection of sulfides and acidic sulfides negative ^ 1)
g) Proof of thiosulphate negative ^ 1)
h) Evidence of barium negative ^ 1)
i) secondary aliphatic amines 22 / more than 5.0 mg.dm-2

9.2 In assessing product categories III and IV tests are carried out
aqueous extract prepared by leaching 8 g of the product at 40
st. C for 24 hours in category III and for 0.5 hours at
category IV. Rubber must meet the following requirements:

a) Reducing substances of 30 ml of 0.002 mol / l KMnO4
b) The residue of not more than 10.0 mg.dm-2
c) Primary aromatic amines negative ^ 1)
d) Proof of ammonium negative ^ 1)
e) Evidence of sulphides and acidic sulfides negative ^ 1)
f) Proof of thiosulphate negative ^ 1)
g) Proof of barium negative ^ 1)
h) secondary aliphatic amines negative ^ 1)

9.3 In assessing product category in the tests are carried out
aqueous liquor, prepared by leaching the product at 40 st.
C for 0.5 hours. The product must meet the following requirements:

The residue exceeding 10.0 mg.dm-2

9.4 U of silicone elastomers in categories I to V is performed following tests
aqueous extract prepared by digesting 1 dm 2 of the product in 100 ml of distilled water
at 20 Wed. C for 24 hours:

a) oxidizable substances exceeding 0.5 mg KMnO4 / 100ml
b) The residue of not more than 10.0 mg.dm-2

9.5 For products of category I, determining the content of released N-nitrosamines and N-nitrosatable
substances by leaching of 10 g
elastomer into 50 ml of a modeling saliva prepared in accordance with paragraph 9.6 of this Annex at
40 +/- 2 st. C for 24 hours and after
subsequently extracted with dichloromethane simple nitrosamines
by gas chromatography. Total amount of released N-nitrosamines
not exceed 0.01 mg per 1 kg of the elastomer and the amount of N-nitrosatable substances
not exceed 0.1 mg per 1 kg of the elastomer.

9.6 test solution modeling saliva is a solution of pH 9 containing 4.2 g
sodium bicarbonate (NaHCO3), 0.5 g of sodium chloride (NaCl), 0.2
g of potassium carbonate (K2CO3) , and 0.03 g of sodium nitrite (NaNO2) in
1000 ml of distilled water or water of equivalent quality.

Notes:

1 / Remnants of peroxides in the finished product of a silicone elastomer
must be demonstrable.

2 / Sulfur compounds in the extract of the finished product must be proven
.

3 / total content of zinc compounds in the cured product may not
exceed 2.0% (relative to the zinc).

4 / Saturated and unsaturated aliphatic unbranched monocarboxylic acid
containing the unsaponifiable fraction of not more than 1.0%.

5 / These substances, or their residues in extract of the finished product must be demonstrable
.

6 / Total maximum of 2.5%.

7 / Just as a part of basic elastomer.


8 / elastomer products, produced from these compounds must not be used
contact with fats and foods containing more than 5% fat.

9 / total no more than 1.0%.

10 / Requirements for purity of phosphite antioxidants:
contents of unreacted nonylphenol (nonylphenol and dinonyl) may not exceed 6.0%.
Contents free of unsubstituted phenol may be more than 0.05%. Contents
tris (nonyl-phenyl) phosphate and bis (nonylphenyl) phosphite may together
exceed 1.0%. As a means for preventing the hydrolysis may be
tris (nonylphenyl) phosphite is added more than 1.0% of tri-2-propanol amine.
This substance must not be detectable in the finished products.

11 / Czech Pharmacopoeia 1997 Volume 2.

12 / Using various types of food contact approved
public health authorities.

13 / Peroxide number not exceeding 10.0.

14 / Polyethylene meets hygiene requirements of § 10 of the Decree.

15 / Paraffin approved by public health authorities.

16 / Iodine value not exceeding 8.0.

17 / A total of more than 5.0%.

18 / formaldehyde content in the extract of the finished product to food simulants
and leaching conditions pursuant to Annex no. 4, and a 1 cm2:
1 ml exceeding 0.1 mg.dm-2.

19 / more than 1.0%.

20 / as raw materials for factice can only be used with natural or
hydrogenated fats and oils of vegetable or animal origin, but not
oxidized.

21 / for the selected application, where a small area of ​​elastomer comes into contact with a larger volume
food over a period not exceeding 10 minutes at room temperature
or lower (e.g. rubber components for milking apparatus, for sealing
machines for processing milk, seals for pumps and pipes
valves for drinking water, pump stators, conveyor belts,
suction and pressure lines for filling and emptying containers.

22 / performed only category II products.



8 Appendix List of metals, alloys and solders for the production of materials and products

1

metals and alloys
|| | 1.1 stainless steel (ie. stainless steel containing not more than 21%
chromium, 14% nickel and 10.5% manganese, 1.2

cast iron, different kinds of steel and iron alloys, which are susceptible to rust
must be against it provided an appropriate finish
specified or decree shall be used only for contact with dry food
, under conditions where there would be no corrosion product
.

1.3 aluminum: metal with a minimal weight fraction of 99.0%.
Weight proportion of each other element not exceed the following limits:
1.0% (iron + silicon), 0.1% of copper, when the content of chromium and / or manganese
is greater than 0.05% and / or if the chromium content is less than
0.05% manganese and more than 0.05%, 0.20% copper, provided that neither
chromium or manganese does not exceed the weight proportion of 0.05% elements (boron,
chromium, magnesium, manganese, nickel, zinc) individually 0.10%, other elements
less than 0.05% individually. 1 /

1.4 Aluminium alloys containing a maximum weight fraction
following elements: 13.5% silicon, 2.0% iron, 0.5% copper, 4.0% manganese, 11.0%
magnesium, 0 , 35% chromium, 3.0% nickel, 0.25% zinc, 0.2% antimony, 0.10
% tin, 0.2% strontium, 0.3% zirconium, 0.3% titanium and other elements
total of 0.15% of the maximum of 0.05% individually. 1 /

1.5 Non-ferrous alloys of various elements if they contain no more than this amount
elements: 0.01% arsenic, 5% chromium, 0.01% of cadmium, 2.5% copper, 2% nickel
0.5 % lead, 5% aluminum, other elements individually to 0.1%, in aggregate
however, to 0.8%, with the exception of the alloys used by britanium
Decree no. 141/1997 Coll., on technical requirements for manufacturing ,
processing and storage of alcohol ^ 6). These alloys may contain tin
magnesium, calcium, silicon, manganese, titanium, and silver quantities without limitation.

1.6 Tin containing not more than 0.1% lead, 0.3% arsenic, 0.1% bismuth and
0.05% antimony.

1.7 Silver, gold, platinum, iridium, rhodium and their alloys.

1.8 Titan.

1.9 Copper and its alloys with zinc, tin, or aluminum (brass, bronze and aluminum bronze
), if not more than 0.5% lead, 0.01% arsenic and 0.1%
antimony, but only for the following purposes:

1.9.1 To produce scales and their parts (eg. Cups), weights, including mortars
drumsticks;

1.9.2 The kettles, pots, confectioning drums, cooking and similar containers
in confectionery production and confectionary industry;


1.9.3 To produce cooking kits, cooling Stoke, settling vats and
trickle coolers wort in the brewing industry;

1.9.4 To produce valves or other valves, tubes and pipes in various food establishments
provided where only short
contact with food, but not liquids that contain free or bound sulfur
dioxide (e.g. in cuvettes for soda water, lemonades, near
dispensing equipment for beer, etc.).

1.10 abolished

1.11 alloys of tin, lead, bismuth and antimony for the manufacture of fuses
maximum diameter up to 10 mm for pressure cookers.
2

Solder


2.1 Tin solder with lead with the highest content of 10% lead and 0.15%
antimony, 0.1% bismuth, 0.05% arsenic and 0.1% cadmium.

2.2 Tin solder zinc with the highest content of 30% zinc, 0.5% lead and 0.1%
cadmium.

2.3 Pure silver, alloys of silver with copper, tin, zinc and phosphorus
highest content of 35% zinc, 6% phosphorus and 0.5% lead. 2 /

2.4 Solder alloy of silver, copper, manganese, nickel and zinc containing
not more than 6.5% manganese, 4% nickel, 23% zinc and 5% lead. 2 /

2.5 Solder alloy of copper and phosphorus, with the highest content of 10% phosphorus,
0.5% antimony and 0.1% lead. 2 /

2.6 Solder alloy of copper, nickel and zinc with the highest content of 10% nickel,
40% zinc and 0.05% lead. 2 /

2.7 Solder alloy of aluminum, silicon and manganese, for which the content of impurities and additives
other elements does not exceed the values ​​specified in paragraph 1.4
Part 1 of this Annex.

Notes:

1 / Aluminium and its alloys (in accordance with paragraphs 1.3 and 1.4) can be used only
where they come into contact with food, excluding
strongly acidic foods (i.e., pH <3.7), after a period not exceeding four hours.
This restriction does not apply to dry foods. In other cases they must be covered
finishes specified by decree.

2 / These solders can only be used for brazing copper and copper alloys
according to section 1.9 of Part 1 of this Annex.
Appendix 9

Section 1


Hygiene requirements for products made of glass, ceramic, pottery, porcelain and objects
enamelled finish

First Migration limits for lead and cadmium in extracts from glassware,
ceramic, pottery, porcelain and objects with enamel surface
prepared under Chapter II of this Annex or by a standardized norm
:

----------------------------------------------- --------------------------------
Lead (Pb), cadmium (Cd)
--------------------------------------- ----------------------------------------
1.1 category 1 0.8 mg .dm-2 0.07 mg.dm-2
category 2 1.2 4.0 0.3 mg.l-1 mg.l-1
category 3 1.3 1.5 mg.l-1 0 1 mg.l-1
1.4 margin for drinking 2.0 mg / 0.20 mg object / subject
---------------------- -------------------------------------------------- -------

Second Migration limits for lead and cadmium in extracts from children's intake bottles

lead [mg .l-1], cadmium [mg.l-1]

2.1.vnitřní surface
0.25 0.03 2.00 0.15 2.2.vnější surface

Third If the migration levels of lead, cadmium from silicate product
migration exceed the limit by more than 50%, the product is considered as
satisfy the requirements of this ordinance if at least three other products
same shape, dimensions, the same decor
and glaze are subjected to the conditions set out in section 2 of this Annex
average quantities of lead, cadmium released from these products do not exceed the limits set
migration, none of these products shall not exceed the following limits
about more than 50%.
Section 2


Basic rules for verifying the migration of lead and cadmium

01.01 Test liquid ( "simulant")

4% (v / v) freshly prepared aqueous solution of acetic acid.

1.2 Test conditions

test is performed at 22 + / - 2 ° C for 24 +/- 0.5 hours.

to be determined amount of migration of lead, the sample was covered with a suitable
material and subjected to the usual lighting conditions in a laboratory. || |
to be determined quantity migration of cadmium or lead and cadmium,
cover the sample so as to ensure that the test surface is
kept in total darkness.

1.3 method of filling samples of test fluid

1.3.1. samples which can be filled

product is charged with 4% (v / v) acetic acid solution to a level no more than 1
mm below the point where the overflow, the distance is measured from the top

Edge of the sample. Samples with a flat or slightly sloping rim should be
filled so that the distance between the surface of the liquid and the point where
overflow no more than 6 mm measured along the oblique edges.

1.3.2. Samples which can not be filled

Surface of the sample, which is not intended for contact with foodstuffs is first covered with a protective layer
able to resist the action of the 4% (v / v) acetic acid solution
. The sample is then immersed in a vessel containing a known volume
acetic acid solution so that the surface intended for contact with food
completely covered by the test liquid.

04.01 Determination of the surface area

The surface area of ​​products of category 1 is equal to the surface area of ​​the meniscus formed
free liquid surface while complying with the filling
products specified above under point 1.3.

Second Analytical method for building the migration of lead and cadmium

02.01 Subject matter and use

Method allows the specific migration of lead, cadmium.

02.02 Principle

Determination of the specific migration of lead, cadmium is carried
instrumental analytical method that meets the criteria specified in section 4.

03.02 Reagents

All reagents must be of analytical grade unless otherwise specified.

When said water, this always means distilled water or water of equivalent purity
.

2.3.1. 4% (V / V) aqueous solution of acetic acid

Into distilled water, add 40 ml of glacial acetic acid and make up
1000 ml with distilled water.

2.3.2. Stock solutions

Stock solution is prepared containing lead 1000 mg.1-1
stock solution with a cadmium content of at least 500 mg.l-1 čtyřprocentním acid solution
acetate (2.3.1).

2.4.Kritéria implementation of instrumental analytical methods

2.4.1. The limit of detection devices for lead and cadmium must be equal to or less than
0.1 mg.l-1 for lead, 0.01 mg.l-1 for cadmium.

The detection limit is defined as the concentration of the four per m
acetic acid solution (2.3.1) which gives a signal equal to twice the background noise
device.

2.4.2. The limit of quantification for lead and cadmium must be equal to or less than
0.2 mg.l-1 for lead, 0.02 mg.l-1 for cadmium

2.4.3. Yield.

Extraction of lead and cadmium added to a four percent solution of acetic acid
referred to in paragraph 2.3.1 should be between 80-120% of the added amount
.

2.4.4. Specificity.

Instrumental analytical method used must be free from all
matrix and spectral interferences.

05.02 Method A procedure 2.5.1. Sample Preparation

Sample must be clean and free from grease or other substances that could affect
test.

Wash the sample at a temperature of about 40 ° C in a solution containing normal
liquid detergent. The sample was rinsed first in tap water and then
distilled water or water of equivalent purity. The sample was allowed
drain and dry so as to avoid its contamination. The surface to be tested
, then not touch.
2.5.2. Determination of lead, cadmium

Sample thus prepared is tested under the conditions set out in paragraph 1 of this section
.

Before removing the test solution for the determination of lead, cadmium content
sample homogenized by a suitable method, in which there are no losses
solution or abrasion of the test surface.

Carry out a blank experiment with the chemicals used for each series
determination. Determination of lead, cadmium under appropriate conditions.
Section 3


Particulars written statement

First A written statement, which must equip ceramics
include the following:

01.01 the name and registered office or place of business of the person who produced
final ceramic product or name and registered office or place of business
person who brought it to the Member State of the European Communities,

02.01 identifying ceramic article

03.01 date of the declaration,

1.4.potvrzení that the ceramic product meets the requirements of this ordinance and
Regulation of the European Parliament and Council Regulation (EC) no. 1935/2004 of 27
October 2004 on materials and articles intended for contact with food
repealing Directives 80/590 / EEC and 89/109 / EEC. "

second written statement issued recently, when substantial changes
in the production bring about changes in the migration of lead and cadmium.



10 Appendix List of acceptable materials and surface technology products

first


materials

To modify the surfaces intended for contact with foodstuffs within the meaning of this decree allowed to use
:

1.1 Metallization physically harmless metal or alloy under Annex
no. 8, with any limitations.

1.2 Tinning surfaces that come only with food in short
contact. Used tin may contain more than 1% lead, 0.05%
arsenic, 0.1% bismuth and 0.05% antimony.

1.3 titanium nitride coatings for surfaces.

1.4 surface coverage zirconia.

1.5 Chrome and nickel, but only for short-term contact with
food (including beverages) or for contact with dry food (s
more than 20% humidity).

01.06 Plastic meets hygiene requirements of § 10 of the Decree.

1.7 Elastomers complying with the hygiene requirements of § 15 and § 16 of the Decree.

1.8 Silica and Titanium paints meeting the requirements of § 19
decree.

1.9 compliant paints § 20 of the Ordinance.

1.10 waxes, microwaxes, paraffin, ceresin, and other petroleum products. 1 /

Second
Technological procedures


Technological procedures, after which it shall be of material surfaces
remove residual resources they use, solutions and spas:
2.1 Sandblasting

Tumbling 2.2

2.3 Grinding

2.4 Polishing

Brushing 2.5


2.6 Degreasing or organic alkaline agents (e.g.
gasoline, kerosene, trichlorethylene, sodium hydroxide or potassium
sodium phosphate, solutions of various surfactants, detergents and their mixtures
and inorganic and organic materials) with
subsequent removal (e.g. by washing) from the surface degreasing

2.7 Pickling (e.g. in dilute sulfuric acid, dilute hydrochloric acid
etc.).

2.8 Oxide (ie. Burnishing)

2.9 anodic passivation


2.10 Phosphatization
2.11 Passivation bath with an alkaline chromate or dichromate. 2 /
Notes


1 / Approved public health authorities.

2 / Z of the coated surface may be in the extract from 1 dm2
into distilled water for 24 h at 20 to 22 st. C detected chromium
when sensitivity of 0.001 mg.l -1.
Annex 11


List of substances for the manufacture of varnishes

First
Binders


1.1 Natural products and modified natural products: 1 /
1.1.1 shellac


1.1.2 and copal copal esterified polyhydric alcohols, C3-C6

1.1.3 dammar resin

1.1.4 hydrogenated rosin esters of polyhydric alcohols and 3- C3-C6

1.1.5 rosin esters of polyhydric alcohols and 3- C3 -C6 modified
acrylic acid and / or maleic acid

1.1.6 rosin-modified phenol formaldehyde resin
xylolformaldehydovou resin, acrylic acid and / or maleic acid


1.1.7 unsaturated drying oils (linseed oil), as well as their heating
resulting concentrated oil

1.1.8 acetate and cellulose propionate

1.1.9 cellulose nitrate 2 /

1 January 10 ethoxyl ethyl cellulose containing from 46.5 to 50.0% 3 /

1 January 11 cyklokaučuk 4 /

1.2 Products polycondensation, polymerisation and polyaddition:

1.2.1 alkyd resins (polyesters of polyhydric alcohols and acids
phthalic), if necessary. modified fatty acids of chain length C 6 and more


1.2.2 condensates and etherified condensation products of
purified mono- and polybasic, optionally alkylated phenols with formaldehyde
; xylene-formaldehyde resins and their condensation products with
phenol and alkylated phenols

1.2.3 ketone resins, ketone-formaldehyde resins and
furfurol formaldehyde resins

1.2.4 phenol-formaldehyde resin modified with a fatty acid of chain length
C6 and more

1.2.5 mono- or polyhydric alcohols etherified with C3-C6
condensation products from urea and melamine (or mixtures thereof) with formaldehyde
and resin from carbamic acid esters

1.2.6 epoxy compounds, crosslinked etherified urea
or phenolic resins, or esterified with fatty acids with
chain length of more than 6, or crosslinked polyaminoamides and / or
polyaminoimidazoliny of dimerization and trimerization products || | unsaturated fatty acids and / or aliphatic polyamines and / or isocyanates


1.2.7 polyamides 5 /

1.2.8 polycondensates isocyanates with alkyd resins, polyesters and
polyethers containing hydroxyl groups


1.2.9 phenol-formaldehyde resin and xylene-formaldehyde resin
, optionally in combination with cellulose acetobutyrate 6 /

Polycarbonates February 1 10 5 /

1 February 11 polyesters of acrylic acid and / or methacrylic acid with monohydric alcohols
saturated aliphatic C1-C18 5 /

1 February 12 polyvinyl chloride and its copolymers 5 /

1 February 13 polymers and copolymers of styrene, butadiene, isoprene and acrylonitrile 5
/

1 February 14 polychlorobutadiene (polychloroprene), polyvinyl
saturated aliphatic alcohols C1-C12 5 /

1 February 15 polyvinylacetals aliphatic saturated aldehydes C1-C6
molecular weight over 10,000 5 /

1 February 16 polyvinyl esters of aliphatic saturated fatty acids of C2-C18
5 /

1 February 17 cyclic polymers of butadiene and isoprene

Second
Plasticizers
:

Painted surfaces in a 1 dm 2 may contain up to 25 mg
following plasticizers:

2.1 dibutyl

Dioctyl 2.2

2.3 acetyl
2.4 acetyltrietylhexylcitrát


2.5 dibutyl

Dioctyl 2.6
2.7 dihexylazelát


Dioctyl 2.8

Butyl stearate 2.9


2.10 dioktylstearát
2.11 epoxidized soybean oil 7 /

2.12 Butyl soybean oil 7 /

2.13 dialkyl (C6 -C12) phthalates 8 /

2.14 dicyclohexyl 8 /

15/02 polyester of adipic acid with 1,3-butanediol and 1,6-hexanediol

02/16 polyester of adipic acid with 1,3-butanediol and 1,4-butanediol
whose free hydroxyl groups are acetylated

Third

Ingredients / Excipients:

3.1 Drying:

In the dry paint film may be more than 0.5% following desiccants
(based on cation) and more than 0.2% cobalt:

3.1.1 oxides and salts of cobalt, manganese, iron, calcium, zirconium and cerium
naphthenic acids, especially of saturated tertiary
monokarbonovými acids of C9-C11 and 2-ethylhexanoic acid

03.02 Catalysts - a total of more than 1.0%:

3.2.1 formic acid

3.2.2 acetic acid

3.2.3 lactic acid

3.2.4 malic acid

Tartaric acid 3.2.5

3.2.6 citric acid

Salicylic acid 3.2.7

3.2.8 Hydrochloric acid

Sulfuric acid 3.2.9

3 February 10 phosphoric acid

3 February 11 ammonia

3 February 12 sodium hydroxide
February 3 13

potassium hydroxide
3 February 14 calcium hydroxide

3 February 15 magnesium hydroxide and salts thereof

3 February 16 acidic phosphoric acid esters of monohydric saturated
aliphatic alcohols of chain length C2-C4

3 February 17 saturated aliphatic dicarboxylic acid, C4-C8

3 February 18 toluenesulfonic acid or toluenesulfonic acid chloride

3 February 19 polyesters of aliphatic alcohols with C3-C6 titanic acid

3 February 20 aluminum or magnesium alcoholates C2 -C8

Fourth
Stabilizers
:

4.1 allowed for polymers 5 /

4.2 zinc oxide - more than 11,0% 9 /

Fifth

Emulsifiers and protective colloids:

Just as if remnants of emulsifiers and protective colloids used in the manufacture of individual
binders and additives.

6th

Services:

6.1 carnauba wax 10 /
6.2
refined paraffin 10 /, 11 /

6.3 glycerol esters of natural fatty acids, C6-C20 10 /

6.4 esters of aliphatic alcohols with C4 -C20 unbranched saturated aliphatic acids
C6-C22 10 /

6.5 silicone oil - more than 2 mg.dm-2 10/12 /

6.6 pigments, dyes and fillers 13 /

7th

Hygiene requirements for the final varnish layer:

7.1 lacquer layer must, with respect to their composition, dried by
to them not go into any food volatiles, especially
solvents and must not affect the organoleptic properties of foods
.

7.2.1 phenolic compounds 0.05mg fenolu.dm-2

7.2.2 Compounds -NH2 group 0.05mg NH2.dm-2

7.2.3 primary aromatic amines 0,005 mg anilinhydrochloridu.dm-2

7.2.4 Formaldehyde 0.10 mg CH2O.dm-2

7.2.5 organic aromatic compounds 0.10 mg styrenu.dm-2

7.2.6 phthalic esters in total 0.20 mg.dm-2

7.2.7 2,2-bis (hydroxyphenyl) propane bis (2,3-epoxypropyl) ether (BADGE) ND 14
/

7.2.8 bisphenol A 0.5 mg.dm-2

7.2 The amount of chemicals specified in extracts from nesilikátových
and metallic finishes to food simulants for testing
accordance with Annex no. 4 of this Decree shall not exceed the following limits
:


7.2.1 phenolic compounds 0.05mg fenolu.dm-2

7.2.2 Compounds -NH2 group 0.05mg NH2.dm-2

7.2.3 primary aromatic amines 0,005 mg anilinu.dm-2

7.2.4 Formaldehyde 0.10 mg CH2O.dm-2

7.2.5 organic aromatic compounds 0.10 mg styrenu.dm-2

7.2.6 phthalic esters in total 0.20 mg.dm-2

7.2.7 2,2-bis (hydroxyphenyl) propane bis (2,3-epoxypropyl) ether (BADGE) ND 14
/

7.2.8 bisphenol A 0.5 mg.dm-2

Notes:

1 / arsenic content of these substances exceeding 3 mg.kg-1, lead 10 mg.kg-1
zinc 25 mg.kg-1, zinc and copper, a total of 50 mg.kg-1, the mercury 2 , 0 mg.kg-1 and 2.0 mg.kg
cadmium-1, wherein said impurities aggregated maximum 50
mg.kg -1.

2 / viscosity 2% solution in acetone at 25 ° C. C for at least 6 cP.

3 / The 6% solution in a mixture of 80 parts by weight toluene and 20 parts by weight of ethanol
must have at 20 Wed. C
viscosity of at least 6 cP.

4 / Viscosity of 20% solution cyklokaučuku in petrol (boiling range 140-200
Wed C) must be at 20 st. C be at least 20 cP.

5 / meets hygiene requirements pursuant to § 10 of the Decree.

6 / acetic acid content 20%, content of butyric acid of 30 - 45%,
polymerization degree of 100 - 180.

7 / iodine number of not more than 8, and the oxygen content in the epoxy-bonds less than 8%.

8 / Specific migration limit for phthalate plasticizers in aggregate 0.20
mg.dm-second

9 / as stabilizer against discoloration
inorganic and organic sulfur compounds. Lacquers stabilized in this way can not be used for
strongly acidic contents.

10 / mg.dm aggregate maximum 5-second

11 / Types approved by the public health authorities.

12 / Using various types authorized by the protection of public health
.

13 / Composition and purity according to § 6 and § 7 of the Decree.

14 / May not be detected at the detection limit 0.020 mg.kg-1
food simulant or mg.dm 0.004-second
Annex 12


List of substances for the manufacture of paper and paperboard
Section 1


A.

Raw materials for paper production

As raw materials for paper production may be used:

First
Fibrous materials


1.1 natural fibers and synthetic fibers based on cellulose, unbleached or bleached


1.2 fibers of synthetic polymer and copolymer compounds
if you meet the requirements for plastics intended for food contact

1.3 Wood bleached or unbleached

1.4 regenerated fibers from the manufacture and processing of paper and paperboard
and out of recovered paper, paperboard or cardboard classes C11, C14, C15, C16, C17
, C18, C19 and D6 according to EN 643, if products made of them meet the hygiene requirements


Second
Mineral additives


2.1 anthraquinone as an accelerator for separating lignin and cellulose from wood
a maximum of 0.15%, based on the finished paper.
Major proportion antrachininu must be washed out in the production.
Residual content of anthraquinone not be higher than 30 mg.kg-1 dry paper

Third
Fillers


As fillers may be used following a natural or synthetically produced
water-insoluble substance:

3.1 precipitated calcium carbonate, plain BaE2 +

3.2 calcium carbonate, very finely ground, plain BaE2 +

3.3 silica

3.4 magnesium carbonate

3.5 titanium dioxide (titanium white)

3.6 calcium silicate

3.7 magnesium silicate (talc)

3.8 precipitated and mixed silicates of sodium, potassium, magnesium, calcium, aluminum and iron


3.9 calcium sulphate (plain BaE2 +)

3.10 barium sulphate, plain-soluble barium salts - purity according to the Czech Pharmacopoeia 1997


3.11 kaolin

3.12 bentonite

3.13 synthetically precipitated sulphate complex and calcium aluminate (Satin white
)

3.14 aluminum sulphate

3.15 oxides and hydroxides of aluminum and magnesium

B.

Auxiliary production materials

As processing aid agents may be used:

First

Binder / sizing /

1.1 kolofónium, addition products of maleic acid and fumaric
and / or formaldehyde and rosin

1.2 and casein glue, preservative-free, boron-containing

Starches 1.3 1 / native starches, such as listed below physically,
enzymatically and chemically modified starches as an emulsifying agent for the sizing agent may be used
2-stearosalicylát sodium in an amount exceeding 0.02%

1.3.1 food starches ^ 1)


0.6% based on dry fiber, wherein the ethyleneimine and
epichlorohydrin may not be detectable at the sensitivity of the method 100 ppb

1.19 anionic water-soluble polyurethanes 2 /

1.19.1 produced from glycerol monostearate, diozokyanátu toluene
dimethylolpropionic acid and N-methyldiethanolamine (
mean molecular weight 10,000), not more than 0.15% based on dry fiber


20.1 copolymer of maleic acid and dicyclopentadiene (ammonium salt)
most 2.0 mg.dm-2

1.21 3-hexadecenyl-dihydrofuran-2,5-dione, at most 1.0%

Second

Precipitating, fixing and pergamenační means

2.1 aluminum sulphate

Aluminum acetate 2.2

2.3 sodium aluminate and calcium

2.4 aluminum formate

2.5 aluminum oxychloride

2.6 sulfuric acid

2.7 tannin

2.8 potassium aluminum sulfate (alum)

2.9 ammonia

2.10 sodium carbonate

2.11 sodium bicarbonate

2.12 sodium phosphate

02.13 condensation products of urea, dicyandiamide, melamine with formaldehyde


02.14 condensation products of aromatic thioacids with formaldehyde, not more than 1.0%


2.15 sodium salt of ethylenediamine tetraacetic acid
diethylene triamine pentaacetic and acid
n-oxoethyl-ethylene diamino-triacetic

2.16 gluconic

2.17 vinylformamide vinylamine copolymer, more than 0.4%

2.18 polycondensate of dicyandiamide and diethylenetriamine than 0.45%

Third
Retention means


3.1 polyacrylamide and copolymers of acrylamide with dimethylaminoethyl methacrylate
unless they contain more than 0.1%
acrylamide monomer, not more than 0.1%

3.2 polyethyleneimine than 0.5%

3.3 crosslinked cationic polyalkyleneamines, namely:

3.3.1 polyamine-epichlorohydrin resin manufactured from epichlorohydrin and
diaminopropylmethylamine 3 /

3.3.2 polyamide-epichlorohydrin resins, made of
epichlorohydrin, adipic acid, caprolactam, diethylenetriamine
and / or ethylenediamine 3 /

3.3.3 polyamide-epichlorohydrin resin manufactured from adipic acid
, diethylenetriamine and epichlorohydrin or a mixture of epichlorohydrin and ammonia 3
/

3.3.4 polyamide-polyamine-epichlorohydrin resin manufactured from epichlorohydrin
, methyl adipic acid and diethylenetriamine, 3 /

3.3.5 polyamide-polyamine-dichloroethane resin, produced from
dichloroethane amide of adipic acid, caprolactam and diethylenetriamine 3
/

3.3.6 polyamide-epichlorohydrin resins, made of
epichlorohydrin, diethylenetriamine, adipic acid and ethyleneimine,
not more than 0.5% 3 /

3.3.7 polyamide-epichlorohydrin resin manufactured from adipic acid
, diethylenetriamine and a mixture of epichlorohydrin and dimethylamine
exceeding 0,2% 3 /

3.3.8 polyamide-epichlorohydrin resins, made of
polyepichlorohydrins, diethylenetriamine and a mixture of epichlorohydrin and dimethylamine
maximum 0.2% 3 /

3.3.9 polyamide-epichlorohydrin resins, made of
epichlorohydrin, diethylenetriamine, adipic acid, ethylene imine and polyethylene glycol
not more than 0.2% 3 /
3 March 10
polyamide-polyamine-epichlorohydrin resin manufactured from epichlorohydrin
, dimethyl adipic acid, dimethyl glutaric
acids and diethylenetriamine, not more than 2.0% 3 /
3 March 11
polyamide-polyamine-dichloroethane resin, produced from
adipic acid, diethylenetriamine and 1,2-dichloroethane of not more than 0.2%
3 March 12
polyamide-polyamine-dichloroethane resin, produced from
adipic acid, diethylenetriamine and a mixture of ethylene diamine, pentaethylene hexamine
, aminoethylpiperazine and 1,2-dichloroethane of not more than 0.2%


3 March 13 polyamine-dichloroethane resin, produced from
bis- (3-aminopropyl) -methylamine and 1,2-dichloroethane of not more than 0.2%

3 March 14 polyetheramine polyamideamine-epichlorohydrin resin,
made from diethylenetriamine, caprolactam, adipic acid, polyethylene glycol, and epichlorohydrin
not more than 0.2%

3.4 high molecular weight cationic polyamideamine, produced from
triethylenetetramine and adipic acid containing 15%
diethyleneglycol (as diluent), or a mixture of 70 parts
polyamidaminového this solution 30 parts of sulfated spermaceti
(spermaceti ), for a total of more than 0.2% (calculated as polyamideamine
dry pulp)

3.5 mixture of: polyamide-epichlorohydrin resins, made of acid

Adipic acid, diethylenetriamine and a mixture of epichlorohydrin and dimethylamine
exceeding 0,05%, a linear high molecular weight polyethylene oxide
not more than 0.015% and the condensation product of acid xylolsulfonové,
dihydroxydiphenyl and formaldehyde (sodium and ammonium salts) not more than 0.1% 4
/

3.6 mixture of: polyamide-epichlorohydrin resin manufactured from adipic acid
, diethylenetriamine and a mixture of epichlorohydrin dimethylamine
exceeding 0,05%, a linear high molecular weight polyethylene oxide
not more than 0.015% and the condensation product of beta acids -naftolsulfonové,
phenol and formaldehyde such as sodium salts, up to 0.06% 4 /

3.7 reaction product of polyacrylamide with formaldehyde and dimethylamine,
not more than 0.06% based on dry weight of paper, cardboard or paperboard
wherein dimethylamine may be detectable in the aqueous extract at
sensitivity of 0.002mg .dm-2

3.8 copolymer of N, N, N-trimethylamoniumpropyl-acrylamide and acrylamide
more than 0.05%, wherein the residual acrylamide content of not more than 50 mg.kg-1

3.9 dimethylamine-epichlorohydrin copolymer, a maximum of 0.25%, while
dimethylamine may not be detectable in water extract with the sensitivity method
0,002 mg.dm-2

3.10 dimethylamine-ethylenediamine-epichlorohydrin copolymers,
exceeding 0.2%, with dimethylamine may not be detectable in an aqueous liquor at
sensitivity of 0.002 mg.dm-2

3.11 vinylaminový-vinylformamide homopolymer or copolymer, more than 0.2%


Fourth
Accelerators drainage


4.1 polyethyleneimine, not more than 0.5%

4.2 alkyl aryl sulfonates and their sodium salts, at most 1.0%

4.3 paraffin dispersion containing silicones, as well as silicones and paraffins
meets hygiene requirements for food contact
more than 0.5%, based on dry dispersion

4.4 lignosulfonic acid and its calcium, magnesium, sodium and ammonium salts
, totaling a maximum of 1%

Fifth

Dispersing and flotation devices

5.1 polyvinylpyrrolidone (molecular weight of at most 11,000,
viscosity of a 5% aqueous solution at 20 degrees of Celsius, at least 34 mPa.s) 5 /

5.2 alkyl (C10 -C20) sulfonates 5 /

5.3 alkyl-arylsulphonates more than 1.0% 5 /

5.4 alkali salts predominantly linear condensed phosphoric acids
(polyphosphates), the content of cyclic condensed phosphates
(meta) must not be higher than 8.0% 5 /

5.5 alkyl polyglycol ethers and / or alkylphenol with 6 - 12 ethylene oxide groups 5
/

5.6 sulfonated castor oil 5 /

5.7 condensation products of aromatic thioacids with formaldehyde 5 /

5.8 lignosulfonic acid and its calcium, magnesium, sodium and ammonium salts of 5
/

09.05 sodium lauryl sulfate 5 /

5.10 polyethylenimine is not more than 0.5%

5.11 sodium salt of polyacrylic acid, not more than 0.5%
5.12
alkyl (C13) alcohol polyglycol ether with 5 to 7 ethylene oxide groups and 1
- two end groups of propylene oxide, not more than 0.014%

5.13 citric acid

5.14 polyvinyl alcohol (ie. Dried type), a maximum of 5%

6th
Defoamers


6.1 organopolysiloxanes with methyl and / or phenyl groups
(silicone oils), the viscosity at 20 Wed. C of at least 97.3 mPa.s. 6 /

6.2 tributyl and / or triizobutylfosfát 6 /

6.3 higher aliphatic alcohols (C8-C26) 6 /

6.4 fatty acid esters of mono- and polyhydric alcohols of C1-C18 and
fatty acid esters of polyethylene glycol and polypropylene glycol 6 /

6.5 alkylsulfonamides (C10-C20) 6 /

6.6 liquid paraffins, whose purity must meet hygiene requirements
contact with food, not more than 0.1%

6.7 copolymer of glycerol with ethylene oxide and propylene oxide
esterified coconut fatty acid or oleic acid, not more than 0.075%


7th

Slimicide means

7.1 Means, enzymatically active:

7.1.1 fructose polysaccharide (Levan) - hydrolase, 12.5 mg per kg of dry matter
paper, and may not be detectable more than 1 unit of activity levanazy


7.2-acting antimicrobial agents

7.2.1 sodium hypochlorite, hydrogen peroxide, sodium peroxide, sodium hydrosulfite,
peroxioctová acid, not more than 0.1%, on a dry fiber
wherein the aqueous extract of the finished products must have positive || | reaction to chlorides, sulphides and peroxides

7.2.2 1,4-bis (bromoacetoxy) butene, wherein the extract of the finished products
may be a maximum of 0.01 mg bromu.dm-2


7.2.3 1-bromoacetoxy-2-nitrobutane, wherein the extract of the finished products
may be a maximum of 0.01 mg bromu.dm-2

7.2.4 bis-1,2-bromacetoxyethen, wherein the extract of the finished products
may be a maximum of 0.01 mg bromu.dm-2

7.2.5 tetramethyl-thriuram disulfide, wherein in the finished extract
products may not be this excipient provable

7.2.6 3,5-dimethyl-tetrahydro-1,3,5-thiadiazin-2-thione, wherein in
finished products must be this excipient provable

7.2.7 bromhydroxyacetonfenon, while the extract of the finished products should not be
this excipient provable

7.2.8 disodium cyano-dithioimidokarbonát and / or
N-methyl-dithiocarbonate potassium, in which both aids
not be detectable in the extract of the finished product

7.2.9 N- (2-p-chlorbenzoylethyl) -hexaminiumchlorid, wherein the cleavage product
2- (p-chlorobenzene) -ethylamine must not be detectable in methanol extract


February 7, 10 methylene-bis-thiocyanate, in which the extract of finished products must be
this substance provable

February 7 11 N-hydroxymethyl-N'-methyl-dithiocarbamate and potassium
2-mercaptobenzothiazole sodium, both substances including their products
decomposition (especially methylthiourea, N, N'-dimethylthiourea and
dithiocarbamates) must be detectable extract finished products

February 7 12 2-Oxo-2- (4-hydroxyphenyl) acid chloride acethydroximové, wherein
extract final products may not be the substance provable

February 7 13 2-bromo-2-nitropropaddiol (1.3), not more than 0.003% based on dry fiber
, whereby this substance may be in the extract of the finished products provable


7 February 14 mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (approximately 3 parts) and
2-methyl-4-isothiazolin-3-one (about 1 part), to a maximum 0.0004%
based on the weight of dry fiber

Mixture February 7 15 N, N'-dihydroxymethylenmočoviny, not more than 0.0125%,
1,6-dihydroxy-2,5-dioxahexen, not more than 0.029%,
5-chloro-2-methyl -4-isothiazolin-3-one, and not more than 0.00045%
2-methyl-4-isothiazolin-3-one, not more than 0.00015% the above percentages
restrictions are always based on the weight of dry pulp | ||
February 7 16 2,2-dibromo-3-nitrile-propionamide, not more than 0.0045%, based on dry fiber
, wherein the extract of finished products may not be the substance provable


Mixture February 7 17: Phenyl- (2-chloro-2-cyano-vinyl) sulfone (80%)
phenyl- (1,2-dichloro-2-cyano-vinyl) sulfone (10% ) and
2-phenyl-sulfonylpropionitril (about 10%), a total of not more than 0.001%,
based on the weight of dry fiber, these substances and their degradation products
phenylsulfonyl-acetonitrile may be in the extract
finished products provable

February 7 18 1,2-benzothiazoline-3-one, more than 0.15 mg.dm-2, where
extract the finished products must be provable when this substance between
detection method: 5 microg. dm-2

February 7 19 1,2-dibromo-2,4-dicyanobutane, not more than 0.005%, on a dry fiber
, wherein the extract may not be the substance provable when the
detection method: 0.6 mikrog.dm-2

February 7 20 4,5-dichloro- (3H) -1,2-dithiol-3-one, a maximum of 0.004% based on dry fiber
, while in the extract should not be this excipient
provable in an amount greater than 2.0 mg.kg-1, based on the dry fiber


February 7 21 3-bromo-3-nitrostyrene, not more than 0.045% based on dry fiber
, wherein the extract of finished products may not be the substance
provable when the non-repudiation 0.06 mg.kg-1 paper

7 February 22 glutaraldehyde, not more than 2.5%, on a dry fiber
wherein in 1 kg of finished product shall be shown more than 2 mg glutaraldehyde


February 7 23 1-bromo-3-chloro-5,5-dimethylhydantoin, at most 0.04%, based on dry fiber
, wherein the extract of finished products must be demonstrable
hypochlorite and hypobromit || |
7 February 24 didecyl dimethyl ammonium chloride, not more than 0.05% based on dry fiber


February 7 25 2-methyl-4,5-trimethylene-4-isothiazolin-3-one, at most 0.034%,
based on the dry fiber

7 February 26 2- (thiokyanatomethylthio) -benzothiazolin, not more than 0.00045%
based on the dry fiber

8th
Preservatives


8.1 sorbic acid and its salts 7 /

8.2 propyl and / or ethyl p-hydroxybenzoic acid 7 /

8.3 formic acid 7 /

8.4 benzoic acid and its calcium, potassium and sodium salts 7 /

Adduct 8.5 70% benzyl alcohol and 30% formaldehyde 7 /


8.6 mixture of: 5-chloro-2-methyl isothiazolin-3-one, at most 0.001%, 8 /
2-methyl-4-isothiazolin-3-one, at most 0.0004%, 8 / formaldehyde not more than 0.022%
8 / ethylene glycol, 0,03% 8 /

9th
Lubricants


Can be used in the total quantity of at most 0.25% thereof:

Calcium stearate 9.1

Sodium stearate 9.2

Ammonium Stearate 9.3

Aluminum stearate 9.4

C.

Special agents for converting paper

The refinement of paper can be used the following substances:

First

Means for wet strength

1.1 glyoxal, while the extract of the finished products may be detectable
amount of not more than 1.5 mg glyoxal in dm2

1.2 urea-formaldehyde resins

01/03 melamine-formaldehyde resin

1.4 crosslinked cationic polyalkyleneamines namely:

1.4.1 polyamine-epichlorohydrin resin manufactured from epichlorohydrin and
diaminopropylmethylamine 3 /

1.4.2 polyamide-epichlorohydrin resins, made of
epichlorohydrin, adipic acid, caprolactam, diethylenetriamine and / or ethylenediamine
3 /

1.4.3 polyamide-epichlorohydrin resin manufactured from adipic acid
, diethylenetriamine and epichlorohydrin or a mixture of epichlorohydrin with ammonia 3
/

1.4.4 polyamide-polyamine-epichlorohydrin resin manufactured from epichlorohydrin
, dimethyl adipic acid and diethylenetriamine, 3 /

1.4.5 polyamide-polyamine-epichlorohydrin resin manufactured from epichlorohydrin
amide of adipic acid and 3 diaminopropylmethylamine /

1.4.6 polyamide-epichlorohydrin resin manufactured from epichlorohydrin
, dimethylentriaminu, adipic acid, ethylene imine and polyethylene glycol
not more than 0.2% 3 /

1.4.7 vinylformamide copolymer of vinyl amine, more than 1.0% 3 /

Second
Hydrophobic means


2.1 Glycerin 9 /

2.2 monoethylene glycol, polyethylene glycols containing more than 0.2% 9 /

2.3 urea 9 /

2.4 sorbitol 9 /

2.5 sucrose, glucose, glucose syrup 9 /

2.6 sodium chloride, calcium chloride and magnesium chloride 9 /

2.7 sodium nitrate but only to urea 9 /

2.8 polyethylene oxide, molecular weight 200 9 /

2.9 polypropylene oxide, molecular weight 400 9 /

2.10 1,2-propanediol 9 /

Third

Dyes and optical brighteners
dyes and optical brighteners are not the products
move onto or into the food.

3.1 Colouring agents for dyeing and printing paper, paperboard and cardboard
must meet hygiene requirements § 6 of the Decree

3.2 optical brightening agents

May be used following sulfonated derivatives of stilbene, not more
aggregate amount of 0.3%:

3.2.1 4,4-bis / (4- (bis (2-hydroxyethyl) amino) -6-m oa
p-sulfoanilino) -s-triazin-2-yl amino / -2, 2-stilbenedisulfonic acid, sodium salt


3.2.2 4,4-bis- 4-diethylamino-6- (2,5-disulfoaminilino) -s-triazine-2-yl
amino-2,2-stilbenedisulfonic acid, sodium salt

3.2.3 4,4-bis 4-methoxy-6-anilino-s-triazin-2-yl amino-2,2
stilbendiusulfonová acid, sodium

3.2.4 4,4-bis- 4-mono-ene bis (hydroxyethylene)
amino-6-anilino-s-triazin-2-yl amino-2,2-stilbenedisulfonic acid, sodium salt


3.2.5 1- (4,6-dimethoxy-s-triazine-2-yl) pyrene

Fourth

Means for surface treatment and painting

4.1 macromolecular compounds (sheet melts, solutions, varnishes, dispersion
) if they correspond to hygienic requirements pursuant to § 10 of the Decree
and / or approved for these purposes, public health authorities

4.2 paraffin and microcrystalline waxes, low molecular weight polyolefins and polyterpenes
if you meet the hygiene requirements for contact with
food and / or approved by the authorities for such purposes to protect public health


4.3 polyvinyl alcohol, if the viscosity of its 4% aqueous solution at 20
Wed. C is at least 5 cP

4.4 silicone oils with special additives and / or
silicone resin, respectively. silicone elastomers that meet the hygiene requirements
ordinance for contact with food and / or approved for such purposes
public health authorities

4.5 ammonium bis (N-ethyl-2perfluoralkyl-sulfonamidoethyl) phosphate, with more than 15%

ammonium mono (N-ethyl-2-perfluoroalkyl-sulfoamidometyl) phosphate, however
the following conditions:

4.5.1 content C8 alkyl groups of the two compounds must be based on the

Total content of alkyl groups amount to more than 95%, the fluorine content in
these compounds may not be less than 50% and greater than 55%
4.5.2
paper, cardboard and paperboard treated by impregnating agent
not come into contact with food containing alcohol

4.5.3 for paper, cardboard and paperboard products that come into contact with
soft foods at temperatures lower than 66 st. C
can be used in amounts not exceeding 8.3 mg.dm-2 (equivalent to 4.4 mg fluoru.dm-2
)

4.5.4 for paper, cardboard and paperboard products that come into contact with
soft foods at temperatures higher than 66 st. C
can be used in amounts not exceeding 4.3 mg.dm-2 (equivalent to 2.2 mg fluoru.dm-2
)

4.6 complexes of chromium chloride (třímocného) with saturated fatty
straight-chain acids of chain length C14 and more, more than 0.4
mg.dm-2, based on chromium, while in a cold water extract | || finished products must be proven třímocného 0,004 mg chromium per 1 dm2, while
may be no evidence of hexavalent chromium

4.7 aluminum, sodium, calcium, potassium and ammonium salts of aliphatic carboxylic acids
straight chain of chain length C12-C20

4.8 casein and vegetable protein 10 /

4.9 binder under Chapter B "Auxiliary production substances", paragraph 1.3 of this Annex


4.10 bean gum ethers galaktomanů accordance with paragraph 1.14 of Chapter B
"Auxiliary production materials", 11 /

4.11 carboxymethylcellulose and its sodium salt (pure) 12 /

4.12 methylcellulose, ethylcellulose 13 /

4.13 hydroxyethyl cellulose 13 /

4.14 natural or synthetically produced, water-insoluble substances as fillers
under Chapter A, paragraph 3 of this Annex

4.15 alginates 14 /

4.16 xanthan ^ 1)

4.17 zirconic carbonate-ammonium, most 10 mg.dm-2 (calculated as oxide
zirconia) 13 /

18.4 ammonium salt of perfluoroalkyl-substituted phosphoric esters
formed as product of 2,2 bis - / (alpha
omega-perfluoro-C4-C20-alkylthio) methyl / -1,3-propanediol , polyphosphoric acid
and ammonium hydroxide, a maximum of 0.44%, while paper, cardboard and paperboard
processed by the accelerator must not come into contact with
foods that contain alcohol

4.19 perfluoralkylakrylátu copolymer produced by polymerizing
trimethyl-2 - / (2-methyl-1-oxo-2-propenyl) oxy / ethyl ammonium chloride with
2 - / (heptadekafluoroctyl-sulfonyl) - methylamino / ethyl-2-propenoate and
glycidyl methacrylate, a fluorine content of 35-40%, not more than 0.5%

4.20 diethanolamine salt 4,4-Bis / (gamma
omega-perfluoro-C8-C20-alkyl) thio / pentanoic acid, not more than 0.38%

21/04 copolymer of vinyl alcohol-izopropenylalkoholu wherein
viscosity of 4% aqueous solution must be at 20 Wed. C at least 5 cP

22/04 copolymer of perfluoralkylethylakrylátu, vinyl acetate and
N, N'-dimethylaminoethyl methacrylate, not more than 0.87%

4.23 alkaline potassium zirkoniumkarbonát, a maximum of 1.25 mg.dm-2, calculated as ZrO2


24/04 mixture of bis-
(diethanolammonium) -mono- (1H-1H, 2H 2H-perfluoroalkyl) orthophosphate and
diethylammonium-bis (1H-1H, 2H 2H-perfluoroalkyl) orthophosphate no more than 8.3
mg.dm-2, paper, cardboard and paperboard laminated by means
not come into contact with foods containing alcohol
Section 2


List of substances for the production of paper for use at the boil, the hot filtration
and as filter layers 22 /

A.

Raw materials for paper production:

First
Fibrous materials


1.1 natural and synthetic fibers based on cellulose and cellulose derivatives

1.2 synthetic fibers based on:

1.2.1 vinyl chloride-vinyl acetate copolymer, without the use of plasticizers 15 /

1.2.2 polyethylene 15 /

15 1.2.3 polypropylene /

15 1.2.4 polyester /

Second
Fillers


2.1 Silica 16 /

2.2 silicates, if necessary. mixed silicates of aluminum, calcium and magnesium, including kaolin and talc
(free from asbestos fibers) 16 /

2.3 calcium sulphate 16 /

2.4 titanium oxide 16 /

2.5 calcium carbonate and magnesium 16 /

2.6 alumina 16 /

2.7 activated carbon 16/17 /

B.

Auxiliary production materials

First

Slimicide means

May be used the following substances unless they are found in the hot water extract
conducted according to the recommended analytical methods:

1.1 means acting enzymatically:


1.1.1 fructose polysaccharide (levan) - hydrolase, 12.5 mg of dry matter per kg
paper, and may not be detectable for more than 1 unit of activity
levanazy in 1 g of paper

1.2 antimicrobially active agents
1.2.1 Oxidation

1.2.2 natriumchlorit


Hydrogen peroxide 1.2.3

Sodium peroxide 1.2.4
1.2.5 natriumdithionit


1.2.6 1,2-benzisothiazolin-3-one, wherein the substance must not be detectable in the extract
hot distilled water, the finished products (yield 5
evidential mikrog.dm-2)

Second

Special paper refining agents

2.1 polyacrylamide, if it contains no more than 0,1% of monomeric
acrylamide; no more than 0.015%

2.2 cationic crosslinked polyallylamines namely:

2.2.1 polyamine-epichlorohydrin resin manufactured from epichlorohydrin and
diaminopropylmethylamine 18 /

2.2.2 polyamide-epichlorohydrin resins, made of
epichlorohydrin, adipic acid, caprolactam, diethylenetriamine
and / or ethylenediamine 18 /

2.2.3 polyamide-epichlorohydrin resin manufactured from adipic acid
, diethylenetriamine and epichlorhydrin, or a mixture of epichlorohydrin and ammonia
18 /

2.2.4 polyamide-polyamine-epichlorohydrin resin manufactured from epichlorohydrin
, dimethyl adipic acid and diethylenetriamine, 18
/

2.2.5 polyamide-polyamine-epichlorohydrin resin manufactured from epichlorohydrin
amide of adipic acid and diaminopropylmethylamine 18 /

2.2.6 polyamide-epichlorohydrin resins, made of
epichlorohydrin, diethylenetriamine, adipic acid and ethylenniminu,
most 0.3% 18 /

2.2.7 polyamide-epichlorohydrin resin manufactured from adipic acid
, diethyltriaminu and mixtures of epichlorohydrin and dimethylamine
maximum 0,1% 18 /

2.2.8 vinylformamide-vinylamine copolymer, a maximum of 1.0%

Third
Preservatives


3.1 sorbic acid 19 /

Fourth

Dewatering accelerators, dispersing agents and the flotation

4.1 lignosulfonic acid

D.

Special materials and manufacturing aids

First

For cooking bags

1.1 Pergamentační means:

Sulfuric acid 1.1.1

1.2 Neutralization and precipitation means:

Ammonia 1.2.1

1.2.2 Sodium carbonate
1.2.3 Sodium bicarbonate


Aluminum sulphate 1.2.4

Sodium aluminate 1.2.5
1.3 Binders


1.3.1 dispersion of copolymer of vinylidene chloride and methyl acrylate
, at most 15.0% 20 /

Second

For teabags

2.1 Means for surface processing and layering

2.1.1 sodium carboxymethylcellulose ^ 1)

2.1.2 methyl-1)

2.1.3 hydroxymethyl-1)

2.1.4 xanthanl ^ 1)

Third

For papers to hot filtration and the filter layer for filtering hot 21 /

3.1 Special fibers

3.1.1 inorganic fibers based on aluminum oxide
3.2 precipitants


Aluminum sulphate 3.2.1

Sodium aluminate 3.2.2
Section 3


List of substances for the production of paper for use in a filter layer for filtering
cold 21 /

First

Special fiber

1.1 fibers based on alumina

1.2 carbon fiber

1.3 fibers made of simple and mixed silicates (e.g. glass fibers
)

1.4 polyoximethylenová fiber

Second


Precipitants
2.1 aluminum sulphate

2.2 sodium aluminate

Third

Binders and means for increasing the wet strength

01/03 melamine-formaldehyde resin

3.2 dispersion polyethyleneimine, not more than 4.0%

3.3 neutral resins based on abietic acid (rosin) acid
maleic / fumaric acid, not more than 4.0%

3.4 anionic polyacrylamide, more than 0.3%

3.5 crosslinked polyalkyleneamines: 22 /

3.5.1 polyamine-epichlorohydrin resin manufactured from epichlorohydrin and diaminopropylmethylamine


3.5.2 polyamide-epichlorohydrin resins, made of
epichlorohydrin, adipic acid, caprolactam, diethylenetriamine
and / or ethylenediamine

3.5.3 polyamide-epichlorohydrin resin manufactured from adipic acid
, diethylenetriamine and epichlorhydrin, or a mixture of epichlorohydrin and ammonia


3.5.4 polyamide-polyamine-epichlorohydrin resin manufactured from epichlorohydrin
, dimethyl adipic acid and diethylenetriamine

3.5.5 polyamide-polyamine-epichlorohydrin resin, produced from

Epichlorohydrin amide of adipic acid and diaminopropylmethylamine

3.5.6 polyamide-epichlorohydrin resins, made of
epichlorohydrin, diethylenetriamine, adipic acid and ethyleneimine,
most 0.3% by

3.5.7 polyamide-epichlorohydrin resin manufactured from adipic acid
, diethyltriaminu and mixtures of epichlorohydrin and dimethylamine
maximum 0,1%

3.6 polyethyleneimine, not more than 0.5%, on a dry fiber

3.7 formamide - vinylaminový copolymer, a maximum of 1.0%

3.8 galactomannan, more than 0.5%

03/09 copolymer of styrene, butyl acrylate and methyl methacrylate, not more than 5.0%


Fourth

Special aids

4.1 polyvinyl
Section 4


Hygiene requirements for finished products

First

For paper and paper products can not contain substances of the weight of the final product solids
exceed these limits hygiene

1.1 polyhalogenated biphenylene cumulatively more than 2.0 mg.kg-1

1.2 polychlorinated phenols (such as pentachlorophenol) 0.05 mg.kg-1

1.3 polycyclic aromatic hydrocarbons (such as benzo (a) pyrene) 0.05 mg.kg-1

Second

Amount of chemical substances specified in the leachate from the 20 DME-2 paper
1000 ml of distilled water at 20 st. C for 24 hours must not exceed the following limits
:

2.1 Aldehydes 0.1 mg formaldehydu.dm-2

2.2 total nitrogen 0.2 mg N.dm-2

2.3 dialkyl esters of phthalic cumulatively more than 0.2 mg.dm-2

2.4 primary aromatic amines 0,002 mg anilinhydrochloridu.dm-2

2.5 phenolic compound 0.05mg fenolu.dm-2

2.6 brighteners type stilbensulfonové acid
undetectable (leachate may fluoresce in UV 254/365 nm)

Third

The content of the elements laid out in the leachate from the paper referred to in paragraph 2 of this
provision shall not be greater than the following hygienic limits, based on the dry weight of the paper
:

3.1 mercury 0.3 mg.kg-1

3.2 cadmium 0.5 mg.kg-1

3.3 hexavalent chromium 0.1 mg.kg-1

3.4 Lead 3.0 mg.kg-1

3.5 arsenic 3.0 mg.kg-1

Fourth

Paper intended for the manufacture of products for use as reflux to filtration
heat and as a filter layer for hot applications must besides
limits specified in paragraphs 1-3 meet after extraction with hot distilled water following
hygienic limits:
total residue extract 10 mg.dm-2
total residue extract filter layers 10 mg.g-1 filter layers
total nitrogen extract 0.1 mg N.dm-24 2 / | || total nitrogen extract filter layers Ng 1 mg-1 of the filter layer 23 /

Fifth

Paper for the production of filter layers for the cold filtration must
except the limits specified in paragraphs 1-3 meet after extraction
cold distilled water hygiene following limits:
total residue extract 5 mg.g-1 filter layers
inorganic proportion of the total residue of the extract 3 mg.g-1 filter layers
total nitrogen content of 3 mg of extract Ng-1 of the extract

Notes:

1/1 kg of starch should not be included more than 3 mg of arsenic, 2 mg of lead,
25 mg zinc, 50 mg of copper and zinc, in total, 2 mg of mercury and 2 mg of cadmium, whereby the total
the amount of these heavy metals must not be higher than 50
mg.kg -1.

2 / For the manufacture of said polyurethanes may be used whenever 0,03%
dibutyldiacetátu tin, based on the sizing agent, the 1 dm2
sized paper shall not contain more than 0.3 microg dibutyldiacetátu
tin.

3 / Total substance referred to in paragraphs 3.3.1 to March 3, 10, not more than 4.0%.
Content of free epichlorohydrin condensation products in paragraphs 3.3.1
until March 3, 10, a maximum of 1 mg.kg -1.

4 / content of free epichlorohydrin in said condensation products
maximum of 1 ppm. Higher percentages border
amount of individual components of the two mixtures under point 3.5 and 3.6 chapters
B refer to the dry weight of paper and paperboard.

5 / aids listed under points can be used individually to
1.0%, collectively, not more than 3.0%.

6 / auxiliaries indicated in those points may not add
more than 0.1%.

7 / These preservatives may be used in amounts necessary to
enable raw materials (Section A), production aids (Chapter
B) and the paper processing means to be protected from deterioration
. Packaging must not adding these substances act
preservative for foods that are in contact with it.


8 / percentage limits of the individual mixture components always relate
to the dry weight of fiber. The extract of the finished products may be
dokazatelných no more than 0,005 mg izothiazolinů.dm-second

9 / Z substances referred to in these paragraphs may be used a maximum total
7.0%.

10/1 kg of these substances may not contain more than 3 mg of arsenic and 10 mg
lead, 2 mg of mercury, cadmium and 2 mg of chlorinated biphenyls, the sum
listed ingredients not exceed 50 mg.kg- first

11/1 kg of these substances may not contain more than 3 mg of arsenic and 10 mg
lead, 25 mg of zinc, 50 mg of copper and zinc, in total, 2 mg of mercury, cadmium 2 mg, 5 g
glycolate sodium chlorinated biphenyls, the sum of said
impurities should not exceed 50 mg.kg -1.

12/1 kg of these substances may not contain more than 3 mg of arsenic and 10 mg
lead, 25 mg of zinc, 50 mg of copper and zinc, in total, 2 mg of mercury, cadmium
2 mg and 5 g glycolate solution, the sum of said impurities should not exceed
50 mg.kg -1.

13/1 kg of these substances may not contain more than 3 mg of arsenic and 10 mg
lead, 25 mg of zinc, 50 mg of copper and zinc, in total, 2 mg of mercury and 2 mg
cadmium, the sum of said impurities must not exceed 50 mg.kg -1.

14/1 kg of these substances may not contain more than 3 mg of arsenic and 10 mg
lead, 25 mg of zinc, 50 mg of copper and zinc, in total, 2 mg of mercury, cadmium
2 mg and 10 mg of polychlorinated biphenyls (of which more than 5 mg of PCB 60)
the sum of said impurities should not exceed 50 mg.kg -1.

15 / These polymers and copolymers must meet hygiene requirements
plastics in contact with food in accordance with § 10 of the Decree. To produce polyethylene
possible to use polyvinyl alcohol as a protective colloid, wherein, the viscosity
4% aqueous solution of polyvinyl alcohol must be at 20 Wed. C
least 5 mPa.s.

16 / Substance listed must conform to the purity requirements
fillers mentioned in § 7 of the Decree.

17 / Purity requirements according to the Czech Pharmacopoeia 1997 Volume 2.

18 / Z means of wet strength, indicated under 2.1 to 2.7
may be used together no more than 4% based on the dry fiber
finished product.

19 / The preservative may only be ingested in quantities
needed to ensure that the raw materials and production aids are protected against deterioration
. Papers for cooking and hot filtration and filter layers
shall in no case affect on food preservative.

20 / These copolymer dispersions must meet hygiene requirements
plastics in contact with food in accordance with § 10 of the Decree.

21 / filter layers means products weighing from 500
mg.m-2 and above.

22 / Z binders and the means for increasing the wet strength referred to in paragraph 3.5
may be used together not more than 4.0% based on dry fiber
finished product.

23 / Determination of the total nitrogen content should follow
immediately after manufacture of the paper, but only after about 8 days after manufacture
or before placing the paper in circulation, whereas the wet strength through
cationic polalkylaminů is reached only after 8 days.
Annex 13


List of authorized substances for the manufacture of cellophane 1 /

Mass percentages referred to in Part I and II are based on the amount of anhydrous
uncoated film.


Part I.
Films uncoated

A.

Regenerated cellulose at least 72% (m / m)

B.
Ingredients


First

Plasticizers in aggregate more than 27% (m / m)

1.1 Bis (2-hydroxyethyl) ether (= diethyleneglycol) 2 /

1.2 ethanediol (monoethylene glycol =) 2 /

1.3 butane-1,3-diol

Glycerol 1.4

1.5 propane-1,2-diol (= propylene glycol)

1.6 polyethylene oxide (= polyethylene glycol) 3 /

1.7 1,2-polypropylene oxide (= polypropylene) 4 /

Sorbitol 1.8

Triethylene 1.9


1.10 tetraethyleneglycol
1.11 urea

Second

Other ingredients in aggregate more than 1% (m / m)


2.1 Group I.
The aggregate amounts of substances of this group of substances shall not exceed 2 mg.dm-2
uncoated sheet:

2.1.1 acetic acid and its ammonium, calcium, magnesium, potassium and sodium salts


2.1.2 ascorbic acid and its ammonium, calcium, magnesium, potassium and sodium salts


2.1.3 benzoic acid and sodium benzoate

2.1.4 formic acid and its ammonium, calcium, magnesium, potassium and sodium salts


2.1.5 linear fatty acids, saturated or unsaturated, with an even number

8-20 C atoms inclusive, and behenic acid and ricinoleic acid and their
ammonium, calcium, magnesium, potassium, sodium, aluminum and zinc salts

2.1.6 citric acid, D- and L-lactic, maleic, L-tartaric acids and their
sodium and potassium salts

2.1.7 sorbic acid and its ammonium, calcium, magnesium, potassium and sodium salts


2.1.8 amides of linear saturated and unsaturated fatty acids
C8-20, with an even number of C atoms and also the amides of behenic acid and ricinoleic


2.1.9 Natural edible starches and flours

2 January 10 edible starches and flours modified by chemical treatment
2 January 11

amylose 2 Jan. 12
carbonates and chlorides of calcium and magnesium

2.1.13 glycerol esters of linear saturated and unsaturated fatty acids
C8-20, an even number of C atoms and / or with adipic acid, citric
, 12-hydroxystearic (oxystearin), ricinoleic

2.1.14 polyoxyethylene (8 to 14 oxyethylene groups) with
linear saturated and unsaturated C8-20 fatty acids, with
even number of C atoms

2 January 15 sorbitan esters of linear saturated and unsaturated fatty acids, C8-20
with an even number of C atoms

2 January 16 mono- and / or di-esters of stearic acid with ethanediol and / or
bis (2-hydroxyethyl) ether and / or triethylene glycol

2 January 17 oxides and hydroxides of calcium, magnesium, silica and aluminum
2 Jan. 18
silicates and hydrated silicates of calcium, magnesium, aluminum and potassium


2 January 19 polyethylene glycol having an average molecular weight between 1200
- 4000

2 January 20, sodium propionate

2.2 Group II

Aggregate amount of substances of this group of substances must not exceed 1 mg.dm-2
uncoated film, wherein the amounts of the individual substances or groups of substances
not exceed 0.2 mg.dm-2 surface
untreated foil or lower limit unless specified:

2.2.1 alkyl (C8-C18) benzene sulfonate
2.2.2 Sodium isopropyl naphthalene


2.2.3 alkyl (C8-C18) sulfate

2.2.4 alkyl (C8-C18) sulfonate
2.2.5 dioctyl sodium


2.2.6 distearate-dihydroxyethyl diethylene triamine monoacetate, maximum
0.05 mg.dm-2 surface-modified film

2.2.7 ammonium lauryl sulfate, magnesium and potassium
2.2.8
N, N'-distearoyldiaminoetan
2.2.9
N, N'-dipalmitoyldiaminoethan

February 2, 10 N, N'-dioleoyldiaminoethan

2 February 11 2-heptadecyl-4,4-bis (methylenstearát) oxazoline

2 February 12 polyethylene aminostearamid-ethyl sulfate, a maximum of 0.1 mg.dm-2
uncoated film

2.3 Group III

The aggregate amount of compounds from this group of substances may not exceed 1
mg.dm-2 surface-modified film or a lower limit unless specified.

2.3.1 Anchoring agents

2.3.1.1 condensation product of melamine and formaldehyde
unmodified or modified by one or more of the following substances: 5/6 /
2.3.1.1.1 butanol

2.3.1.1.2 ethanol

2.3.1.1.3 diethylene

2.3.1.1.4 triethylenetetramine

2.3.1.1.5 tetraethylenepentamine


2.3.1.1.6 tri- (2-hydroxyethyl) amine

2.3.1.1.7 3,3'-diaminodipropylamin

2.3.1.1.8 4,4'-diaminodibutylamin

2.3.1.2 condensation product of melamine, urea and formaldehyde
modified with tris- (2-hydroxyethyl) amine 5/6 /

2.3.1.3 condensation product of urea and formaldehyde,
unmodified or modified by one or more of the following substances: 5/6 /

2.3.1.3.1 acid aminomethylsulfonovou

2.3.1.3.2 sulfanilic acid
2.3.1.3.3 butanol

2.3.1.3.4 ethanol

2.3.1.3.5 methanol

2.3.1.3.6 diaminobutane

2.3.1.3.7 diaminodiethylaminem

2.3.1.3.8 diaminodipropylaminem

2.3.1.3.9 diaminopropane

2.3.1.3.10 diethylenetriamine

2.3.1.3.11 guanidine

2.3.1.3.12 tetraethylenepentamine

2.3.1.3.13 triethylenteraminem


2.3.1.3.14 sodium sulfite

2.3.1.4 mesh cationic polyalkyleneamines:

2.3.1.4.1 polyamide-epichlorohydrin resin based on epichlorohydrin and diaminopropylmethylamine


2.3.1.4.2 polyamide-epichlorhydrin resin based
epichlorohydrin, adipic acid, caprolactam, diethylenetriamine
and / or ethylenediamine

2.3.1.4.3 polyamide-epichlorhydrin resin based
acid, adipic acid, diethylenetriamine and epichlorohydrin or a mixture of epichlorohydrin and ammonia


2.3.1.4.4 polyamide-polyamine-epichlorohydrin resin based on epichlorohydrin
, dimethyl adipate and diethylenetriamine


2.3.1.4.5 polyamide-polyamine-epichlorohydrin resin based on epichlorohydrin
adipamide and diaminopropylmethylamine

2.3.1.5 Polyethyleneamines and polyethyleneimines, more than 0.75 mg.dm-2
uncoated film
2.4 Group IV


Aggregate quantity of substances may not exceed 0.01 mg.dm-2 surface-modified film
:

2.4.1-products of the reaction of amines of food oils with polyethylene oxide


2.4.2 monoethanolaminlauryl sulfate

Part II.
Surface-modified cellophane


A.
Regenerated cellulose


See Part I

B.
Ingredients


See Part I

C.

Coatings and processing layers:

The coating layer may not exceed 50 mg.dm-2 film on the side in contact with food 7
/

First
Polymers


1.1 ethyl, hydroxyethyl, hydroxypropyl, and methyl cellulose ethers

01.02 cellulose nitrate, a maximum of 20 mg.dm-2 coating on the side
coming into contact with food, wherein the content of nitrogen in the nitrate
cellulose should be between 10.8 to 12.2% (m / m)

Second
Resin


The total quantity of substances may not exceed 12,5 mg.dm-2 sedimentary layers
film on the side in contact with foodstuffs and solely for the preparation of regenerated cellulose films coated
based on cellulose nitrate:

2.1 rosin and / or its products of polymerization, hydrogenation, or
disproportionation and their esters with methyl, ethyl or (C2-C6)
polyvalent alcohols or mixtures thereof

2.2 rosin and / or its products of polymerization, hydrogenation, or
disproportionation condensed with acrylic acid, maleic
citric acid, fumaric acid and / or phthalic acid and / or 2,2
bis (4-hydroxyphenyl ) -propan-formaldehyde and esteryfikované methyl-, ethyl-
or (C2-C6) polyvalent alcohols or mixtures of these alcohols


03.02 esters derived from bis- (2-hydroxyethyl) ether with addition products
beta-pinene and / or dipentene and / or diterpene and maleic anhydride

Edible gelatine 2.4

Casein 2.5

2.6 castor oil and its products of dehydration or hydrogenation and its
condensation products with polyglycerol, adipic, citric,
maleic, phthalic and sebacic

2.7 rosin (damar)

2.8 poly-beta-pinene (terpene resin)

2.9 urea-formaldehyde resin 5/6 /

Third
Plasticizers


The total amount of these substances exceeding 6 mg.dm-2 surface layer film
on the contact side of food:

3.1 acetyl

3.2 acetyl-tri- (2-ethylhexyl) citrate

3.3 di-isobutyladipát

3.4 di-n-butyl adipate

3.5 di-n-hexylazelát

3.6 2-ethylhexyl diphenyl phosphate (synonym: 2-ethyl hexyl diphenyl-fostátu
), not more than 2.4 mg.kg-1 of a food that is in contact with
this type of film, or 0.4 mg.dm-2 of the coating on the side
, which is intended for contact with food.
3.7 glycerolmonoacetát

3.8 glyceroldiacetát


Glycerol 3.9

3.10 dibutyl

3.11 abolished

3.12 di-n-butylvinan

3.13 di-isobutylvinan

Fourth
Other ingredients


Total amount of these substances should not exceed 6.0 mg.dm-2 cellophane i.e.
uncoated film including shingled layers on the side in contact with
food.

4.1 Ingredients - see list of ingredients. Part I of this Annex, including restrictions
herein. These restrictions apply to the quantities cellophane i.e.
base film including shingled layers on the side in contact with the food.

4.2 Specific převrstvovací ingredients

The amounts of substances or groups of substances exceeding 2 mg.dm-2
sedimentary layers on the side in contact with food, or a lower limit unless specified
:

4.2.1 1-hexadecanol and 1-octadecanol

4.2.2 esters of linear fatty acids, saturated or unsaturated
with an even number of carbon atoms from 8 to 20, inclusive, and ricinoleic
acid with ethyl, butyl, amyl and oleyl linear alcohols || |
4.2.3 montan waxes, including net montane acids (C26-C32)
and / or esters thereof with ethanediol and / or 1,3-butanediol and / or their
calcium and potassium salts

4.2.4 carnauba wax

4.2.5 beeswax

4.2.6 espartograss wax
4.2.7 candelilla wax


4.2.8 dimethyl polysiloxane, a maximum of 1 mg.dm-2 deposition on the side in contact with food


4.2.9 epoxidized soybean oil (oxirane content 6 to 8%)

4 February 10 purified paraffin and microcrystalline waxes

4 February 11 pentaerythritol tetrastearate


4 February 12 mono- and bis (oktadecyldiethylenoxid) phosphates, more than 0.2
mg.dm-2

4 February 13 aliphatic acids (C8-C20) mono- or esterified
di- (2-hydroxyethyl) amine

4.2.14 2- and 3-tert-butyl-4-hydroxyanisole / BHA /, not more than 0.06 mg.dm-2
sedimentary layers on the side in contact with food

February 4 15 2,6-di-tert-butyl-4-methylphenol / BHT /, not more than 0.06 mg .dm-2
sedimentary layers on the side in contact with food

4 February 16 di-n-octyl tin-bis (2-ethylhexyl) -maleinát, not more than 0.06 mg.dm-2
sedimentary layers on the side in contact with food

Fifth
Solvents


May be used these substances, but the lacquered foil
must be completely draining.

Total amount of these substances should not exceed 0.6 mg.dm-2
surface layer which is in contact with food.

Acetate 5.1

Butyl acetate 5.2

5.3 isobutyl

5.4 propyl

5.5 isopropyl

Acetone 5.6

Ethanol 5.7

5.8 1-butanol

5.9 2-butanol

5.10 1-propanol

5.11 2-propanol


5.12 cyclohexane
5.13 ethylene glycol monobutyl

5.14 ethylene glycol monobutyl ether acetate

5.15 methyl (ethyl) ketone

5.16 methyl (isobutyl) ketone


5.17 tetrahydrofuran
5.18 toluene, exceeding 0,06 mg / dm2 of the coating on the side
in contact with food


5.19 methyl ethyl ketone
5.20 methyl


5.21 tetrahydrofuran
5.22 toluene

-------------------------------- *) Note. ASPI: Change Chapter V Implementation Ministry of health Decree no. 386/2008 Coll.
Has been through an amendment 271/2008 Coll., And therefore are not included.


Notes:

1 / The percentages are by weight percent (m / m) and are based on
quantity of anhydrous uncoated regenerated cellulose film. Common synonyms
compounds are given in parentheses.

2 / Only for films intended to be coated and then used for packing
foodstuffs which are not moist, ie. Do not on the surface of open water.
The total amount of these substances in food that are in contact with this type of film
in aggregate more than 30 mg.kg -1.

3 / Average molecular weight between 250 - 1200.

4 / average molecular weight greater than 400 and the content of free 1,3-propanediol
more than 1% (w / w) in substance.

5 / formaldehyde was determined in extracts in distilled water and 3% acetic acid
prepared under the conditions: 24 hours, 20 st. C 1 cm2:
1 ml.

6 / free formaldehyde content of more than 0.3 mg.dm-2 film, the content of free melamine
more than 0.3 mg.dm-2 film.

7 / At higher coating weight, the material is considered laminate.

8 / Used polymers, copolymers, and mixtures thereof, must conform
hygiene requirements of § 10 of the Decree.
Annex 14


List of substances for the treatment of cork and cork and requirements for these products


1

The treatment of cork may be used the following materials:

1.1 sulfur dioxide

Hydrogen peroxide 1.2

1.3 benzoic acid and its calcium, potassium and sodium salts,
exceeding 0.2% (m / m) 1 /

1.4 p-hydroxybenzoic acid and its ethyl or propyl ester 1 /

1.5 formic acid 1 /

1.6 sorbic acid and its sodium and / or potassium salt of 1 /

1.7 boric acid and / or its sodium salt 1 /

1.8 formaldehyde
1.9 hexamethylenetetramine


1.10 paraffin

1.11 beeswax

1.12 glycerin

1.13 paraffin oil

1.14 waxes

1.15 polyethyleneoxide of molecular weight greater than 200

1.16 triethylene

1.17 carnauba wax
2

Binders


As binders for cork agglomerates may be used crushed cork treated
substances referred to in paragraph 1 of this annex and the following substances:

2.1 cured phenol-, melamine-, urea- and dicyandiamide-formaldehyde resin


2.2 methyl, carboxymethyl, ethyl, hydroxyethyl, hydroxypropyl cellulose


2.3 polyester resin
2.4 polyurethanes


2.5 unplasticized polyvinyl acetate, in accordance with § 10 of the Decree

2.6 neoprene rubber

2.7 epoxy resins


2.8 dextrin 2.9 percha



2.10 kolofonium
2.11 rosin: damar, kicking

2.12 insoluble pigments that meet the requirements of § 6 of the Decree
3


Hygiene requirements for treated cork and cork (agglomerated)
products:

3.1 In leach into food simulants for 24 hours at room

Temperature and the ratio of the wetted surface area to leaching fluid by
actual use of the product may not be exceeded leaching limits
following substances or groups of substances:

3.1.1 Compounds -NH2 group 0.05mg -NH2.dm-2

3.1.2 phthalic esters in aggregate 0.2 mg.dm-2

3.1.3 phenols 0.05 fenolu.dm-2

3.1.4 Formaldehyde 0.1 mg CH2O.dm-2

3.1.5 sulfur dioxide 0.05 mg SO2.dm-2
Notes


1 / aggregate more than 0.2% (by weight of cork).
Annex 15



Canceled Selected provisions of amendments


Article II Decree no. 551/2006 Coll.
Transitional provisions


First Seals made of polyvinyl chloride containing epoxidised oil
soybean with reference number 88640 in Section A Incomplete
list of additives which may be used for the production of plastics Annex. 3 to
hereto, which are used for seal glass jars with initial and follow-on formulas
, with cereal or other foods for infants and young
children ^ 1), filled before 19 November 2006, fulfilling
limitations, or specifications provided for in Section a Incomplete
list of ingredients that can be used to produce plastics Annex no. 3 to
this decree may continue to be marketed under the assumption that the
labeling it is the date of filling or other information that will allow
determine this date.

Second Ceramic products intended for contact with food, which is not in accordance with Article
. I paragraphs 2 and 4 in the marketing of assessed
19 May 2007, under the existing legislation.

Third Products from plastic intended for contact with food, which is not in accordance with Article
. I point 3, with the exception of those listed under point 1, the
in the marketing judged to November 18, 2007 according to existing
legislation.

Art. II Act no. 271/2008 Coll.


Transitional provisions
Plastic products intended for contact with food which do not comply
with the provisions of this decree, without prejudice to paragraphs 1 and 2, Art. II
this decree, with the exception of plastic products in contact with | || foodstuffs which do not comply with restrictions and specifications for phthalates
(ref. no. 74560, 74640, 74880, 75100, 75105) referred to in this
decree and lids containing gaskets made of plastics, which are not
in accordance with the restrictions and specifications as ref. Nos. 30340, 30401, 36640,
56800, 76815, 76866, 88640 and 93760, to be marketed until 1 may 2009.


Art. II Act no. 386/2008 Coll.


Transitional provisions
Materials and articles of plastics intended for food contact
which are not in accordance with the provisions of this Order, except
materials and plastic articles intended for contact with food, which is not in accordance with
restrictions and specifications for phthalates (ref. Nos. 74560, 74640,
74880, 75100, 75105) referred to in this decree and lids containing
sealing rings made of plastics, which do not comply with restrictions and specifications under
ref. Nos. 30340, 30401, 36640, 56800, 76815, 76866, 88640 and 93760
can produce and import until 1 May 2009.

Art. II Act no. 127/2009 Coll.
Transitional provisions


Products intended for contact with food and dishes that do not comply
with the provisions of this Decree, may produce and market the longest until 7 March 2010.


Art. II Decree no. 111/2011 Coll.


Transitional provisions
Polycarbonate baby bottles containing bisphenol A may be marketed or imported
until 1 June 2011.

1) Council Directive 78/142 / EEC of 30 January 1978, which concerns the approximation
law of the Member States relating to materials that contain
vinyl chloride monomer and are intended for contact with food.

Commission Directive 80/766 / EEC of 18 July 1980, which establishes
method of analysis for the official control of the amount of vinyl chloride monomer
in materials and articles intended to come into contact with foodstuffs
.

Commission Directive 81/432 / EEC of 29 April 1981, which establishes
analytical method for the official control of vinyl chloride released
materials and articles into food.

Council Directive 82/711 / EEC of 18 October 1982, which establishes the basic
rules for migration testing components, plastics and articles thereof
manufactured and intended for contact with food.

Council Directive 84/500 / EEC of 15 October 1984 concerning the approximation
laws of the Member States relating to ceramic

Articles intended for contact with food.

Council Directive 85/572 / EEC of 19 December 1985, which establishes a list
food simulants used for migration testing components
plastics and articles made therefrom and intended for contact with food.

Commission Directive 93/11 / EEC of 15 March 1993, which concerns the determination
N-nitrosamines and N-nitrosatable substances released from teats and teats
made of elastomer or rubber.

Commission Directive 97/48 / EC of 29 July 1997 amending for the second
Council Directive 82/711 / EEC laying down the basic rules
necessary for testing migration of the constituents of the materials and articles
plastics intended for food contact.

Commission Directive 2002/72 / EC of 6 August 2002 on materials and articles
plastics intended for food contact.

Commission Directive 2004/1 / EC of 6 January 2004 amending Directive
2002/72 / EC, to suspend the use of azodicarbonamide as blowing
plastics.

Commission Directive 2004/19 / EC of 1 March 2004, amending and supplementing
Directive 2002/72 / EC relating to materials and articles of plastics
intended for contact with food.

Commission Directive 2005/31 / EC of 29 April 2005 amending
Council Directive 84/500 / EEC as regards the declaration of compliance and implementation criteria
analytical method for ceramic articles intended to
contact with food.

Commission Directive 2005/79 / EC of 18 November 2005 amending
Directive 2002/72 / EC on materials and articles of plastics intended for food contact
.

Commission Directive 2007/19 / EC of 2 April 2007 amending
Directive 2002/72 / EC on materials and articles intended for plastic
contact with food and Council Directive 85/572 / EEC laying down the list
simulants to be used for testing migration of constituents of the materials and articles
plastic intended for contact with food.

Commission Directive 2007/42 / EC of 29 June 2007 on
materials and articles made of regenerated cellulose film intended for contact with food.

Commission Directive 2008/39 / EC of 6 March 2008 amending
Directive 2002/62 / EC on plastic materials intended for contact with food
.

Commission Directive 2011/8 / EU of 28 January 2011 amending
Directive 2002/72 / EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles
.

1) Regulation of the European Parliament and Council Regulation (EC) no. 178/2002 of 28
January 2002 laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down
procedures relating to food safety.

Regulation of the European Parliament and Council Regulation (EC) no. 1935/2004 of 27
October 2004 on materials and articles intended to come into contact with food and
repealing Directive 80/590 / EEC and 89/109 / EEC.

Commission Regulation (EC) no. 1895/2005 of 18 November 2005 on the restriction
use of certain epoxy derivatives in materials and articles intended for contact with food
.

Commission Regulation (EC) no. 2023/2006 of 22 December 2006 on good
manufacturing practice for materials and articles intended for contact with food.

Commission Regulation (EC) no. 282/2008 of 27 March 2008 on materials and articles
recycled plastics intended for food contact and
amending Regulation (EC) no. 2023/2006.

Regulation of the European Parliament and Council Regulation (EC) no. 882/2004 of 29 April
2004 on official controls to ensure verification of compliance with laws and regulations
with feed and food law, animal health and || | animal welfare.

1b) Article 3 of the European Parliament and Council Regulation (EC) no. 1935/2004.

1c) of the European Parliament and Council Regulation (EC) no. 882/2004.

1d) Commission Regulation (EC) no. 1895/2005 of 18 November 2005
restriction of use of certain epoxy derivatives in materials and articles
intended for contact with food.

2) Article 11 of the European Parliament and Council Regulation (EC) no. 882/2004.

2a) Act no. 356/2003 Coll., On chemical substances and
preparations and amending certain laws, as amended.

2b) Article 16 of the European Parliament and Council Regulation (EC) no. 1935/2004.

3) Act no. 110/1997 Coll., On foodstuffs and tobacco products and
amending and supplementing some related laws, as amended
regulations.

Decree no. 4/2008 Coll., Laying down the types and conditions of additives

Materials and extraction solvents in food production.

Decree no. 447/2004 Coll., On requirements for the amount and types of substances
food flavorings, conditions for their use, requirements for
their safety and conditions for the use of quinine and caffeine.

4) Decree no. 54/2004 Coll., On foodstuffs intended for particular nutritional uses
and how we use, as amended.

1) Methods for verifying hygiene requirements according to CSN 62 1156.

1) Decree of the Ministry of Health no. 298/1997 Coll., Laying down
chemical requirements for health safety of different types of foods and food ingredients
, conditions for their use, their labeling on packaging requirements
purity and identity of additives and dietary supplements and
microbiological requirements for food supplements and additives.

1) Decree no. 54/2004 Coll., On foodstuffs intended for particular nutritional uses
and how we use, as amended by Decree no. 402/2006 Coll.