Change Decree. Hygien.požadavcích Of Products In Contact With Food

Original Language Title: změna vyhl. o hygien.požadavcích na výrobky ve styku s potravinami

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386/2008 Coll.
DECREE


Dated 8 October 2008

Amending Decree of the Ministry of Health no. 38/2001 Coll., On
hygiene requirements for products intended for contact with food and
dishes, as amended

Ministry of Health, pursuant to § 108 paragraph. 1 of Law no.
258/2000 Coll., On protection of public health and amending some
related laws, as amended, to implement § 26 paragraph
. 1 point. b) and d) of the Act:

Art. I

Decree no. 38/2001 Coll., On hygienic requirements on products intended
contact with food and meals, as amended by Decree no. 186/2003 Coll.
Decree no. 207/2006 Coll. , Decree no. 551/2006 Coll. and Decree no.
271/2008 Coll., is amended as follows:

First Annex no. 3 reads:

"Annex no. 3 to Decree no. 38/2001 Coll.

Requirements for plastics and plastic products

LIST monomers INGREDIENTS AND OTHER STARTING SUBSTANCES WHICH MAY BE || | use for the manufacture of objects or materials from plastic

first This appendix contains a list of monomers and other starting ingredients
substances that may be used for the manufacture of plastics and articles and materials
plastic intended food contact. 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 macromolecular
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 below
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 (free acid) is not listed
(not listed).

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,

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

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

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

- Impurities in the substances;

- Reaction intermediates;

- Decomposition products;

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

C) mixtures of the authorized substances;

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

E) colorants;

F) 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
.

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

6th 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.

7th If a substance is listed individually, are also
a generic term, is subject to the restrictions mentioned this at
individually listed substances.

8th If a CAS number does not match the chemical name, the chemical name
precedence over the CAS number. If a CAS number EINECS
by the registry does not match the CAS Registry, the CAS number is valid according to the register
CAS.

9th 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 substance in the material or product
provides validated analytical method. If such a method
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 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
.

LIST OF ALLOWED MONOMERS AND OTHER STARTING SUBSTANCES
SECTION
A

----------------------------------------------- ------------------------ -------------------------- --------------
PM / REF No. CAS No Name Restrictions and / or specifications
---------------------------------- ------------------------------------- ------------- ---------------------------
(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-methylpropanesulfonic SML = 0.05 mg / kg
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 acrylic
acid with 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
and 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
measurement uncertainty)
12130 000124-04-9 Adipic acid
12265 004074-90-2 divinyl adipate QM = 5 mg / kg in FP. To use
pouzejako comonomer.

Adipanhydrid 002035-75-8 12280 12310 - 12340 albumin
-
albumin coagulated by formaldehyde 12375 - 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. Substance not
be used in polymers
stykus foods for which has
be in accordance with Annex 4 to this
Decree simulant D
látkasmí be used only for
indirect food contact,

separate PET layer 12765 84434-12-8 N- (2-aminoethyl) -N-alanine, sodium salt SML = 0.05 mg / kg
12786 000919-30-2 3-aminopropyltriethoxysilane Residual extractable content of 3 -
aminopropyltriethoxysilane must
be less than 3 mg / kg filler.
using only reactive
surface treatment of inorganic
fillers 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 trichloride, 1,3,5-benzenetricarboxylic QMA = 0.05 mg / 6 dm2 (measured as
1,3,5-benzenetricarboxylic acid | || 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-en (= norbornene) SML = 0,05 mg / kg 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. Cleanliness higher
1,4,5,8-naftalenetetrakarboxy-carbodiimide than 98.1% (w / w). Only for
use as a co-monomer (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) see diethylene ether
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 (28)
4,4 '- (propane-2,2-diyl) diphenol
bisphenol A
13510 001675-54-3 2,2-bis (4-hydroxyphenyl) propane bis (2,3-Podlepožadavků Commission Regulation
epoxypropyl) ether č.1895 / 2005 dated November 18 || | (= BADGE); 2005 on the restriction of use
2,2-bis [4- (2,3- certain epoxy derivatives
epoxypropoxy) phenyl] propane in materials and articles
intended for food contact
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-epoxypropyl) ether, see.
13510 (= BADGE) 2 , 2-bis (4-hydroxyphenyl) propane
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
the provisions concerning
drinking water quality indicators

podlezvláštního legal regulation
13630 000106-99-0 butadiene QM = 1 mg / kg in FP or SML = ND

( DL = 0.02 mg / kg, including
measurement uncertainty)
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
epoxypropyl) ether; such as epoxy group, molecular
1,4-bis (2,3-epoxypropoxy) butane weight = 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
for use as copolymer
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-

hydroxyhexanoic acid)
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 in FP (expressed as NCO
) (26)
15030 00931-88-4 cyclooctene SML = 0,05 mg / kg. The substance may be
used in polymers contacting
food for which
podlepřílohy no. 4 of this
Decree determined using
simulant A
15070 001647-16-1 deca-1,9-diene SML = 0.05 mg / kg 15095 000334-48-5

decanoic acid 15100 000112-30-1 Dean-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
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'-diisocyanate; QM (T) = 1 mg / kg in FP (expressed
bis (4-isocyanatocyclohexyl) methane; as NCO) (26)
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
16210 006864-37-5 3,3'-dimethyl-4,4' SML = 0.05 mg / kg (32)
diaminodicyclohexylmethane; Pouzepro use in polyamides
4,4'-methylenebis (2-methylcyclohexane-1-amine
)
16240 000091-97-4 3,3'-dimethyl-4,4'-QM (T) = 1 mg / kg in FP (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-dimethyl-propan-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 in FP (expressed as NCO
) (26) 16600 005873-54-1 diphenylmethane
-2,4'-diisocyanate QM (T) = 1 mg / kg in FP (expressed as NCO
) (26)
16630 000101-68-8 diphenylmethane-4,4'-diisocyanate QM (T) = 1 mg / kg in FP (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
measurement uncertainty) for the sum
divinylbenzene
and ethylvinylbenzene and in accordance
the specifications laid down
Appendix II to 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
hydrogel at a maximum rate
10 g of hydrogel per 1 kg
food. The hydrolyzate contains
ethylene 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
17110 016219-75-3 5-ethylidenbicyklo [2.2.1] hept-2-ene QMA = 0.05 mg / dm2 6
Poměrmezi area size
and the quantity of food must be
LessThan 2 dm2 / kg 17160 000097-53-0
eugenol; SML = ND (DL = 0.02 mg / kg,
2-methoxy-4- (propen-2-yl) phenol) including 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 hexamethylene SML = 2.4 mg / kg 18640 000822-06-0
hexamethylene diisocyanate; QM (T) = 1 mg / kg in FP (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)
18700 000629-11-8 hexane-1,6-diol SML = 0.05 mg / kg 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
trimethylcyclohexyl] isocyanate as NCO )) (26)
19150 000121-91-5 1,3-benzenedicarboxylic acid; SML = 5 mg / kg
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
19460 000050-21-5 lactic acid
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
1,3,5-triazine-2,4,6-triazine zine
19990 000079-39-0 methacrylamide SML = ND
(DL = 0.02 mg / kg, including
measurement uncertainty)
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 of methacrylic acid with butane-SML = 0.05 mg / kg
1,4-diol
20440 000097-90-5 diester of methacrylic acid SML = 0.05 mg / kg
ethylene glycol
20530 002867-47-2 2- (dimethylamino) ethyl methacrylate SML = ND
(DL = 0.02 mg / kg, including
measurement uncertainty)
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)
21370 010595-80-9 2-sulfoethyl methacrylate QMA = ND
(DL = 0,02mg / 6 dm2)
21400 054276-35-6 sulfopropyl methacrylate QMA = 0.05 mg / dm2 6
21460 000760-93-0 methakrylanhydrid SML (T) = 6 mg / kg (37)
21490 000126-98-7 methacrylonitrile SML = ND
(DL = 0.02 mg / kg, including
measurement uncertainty)
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
measurement uncertainty)
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 / 6 dm2
2,2,4trimethylhexanu and (55-65% wt)
1,6-diamino-2,4,4-trimethylhexanu
22332 028679-16-5 mix (40% wt.) 2,2,4- QM (T) = 1 mg / kg in FP (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 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 in FP (expressed as NCO
) (26)
22437 00126-30-7 neopentylglycol see. 2,2-dimethylpropane-1,3-
diol

nitrocellulose 009004-70-0 22450 22480 000143-08-8 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 in FP (expressed
1-isokyanatooktadekan as NCO) (26)
22600 000111-87-5 octan-1-ol
22660 000111-66-0 oct 1-ene 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. For use
for 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 acid QMA = 0.05 mg / 6 dm2
23155 000075-44- 5 see phosgene 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 || | 23470 000080-56-8 alpha-pinene
23500 000127-91-3 beta-pinene
23547 009016-00-6 polydimethylsiloxane (molecular In accordance with specifications
063148-62-9 weight higher than 6 800) listed 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 polypropylene

23740 000057-55-6 propane-1,2-diol
23770 000504-63-2 propane-1,3-diol SML = 0.05 mg / kg 23800 000071-23-8
propan-1-ol 23 830 000 067
-63-0 propan-2-ol
23860 000123-38-6 propionaldehyde;
propanaldehyd
23890 000079-09-4 propionic acid
23920 000105-38-4 vinyl propionate 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
nesmíbýt used in polymers
in contact with food for
window stacking according to Annex 4
this decree provided

using simulant D substance may
be used only for indirect
contact with food, separated
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 lithium
24887 006362-79-4 5-sulfoisophthalic acid monosodium SML = 5 mg / kg
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 in FP (expressed as NCO
) (26)
25240 000091-08-7 2 6-toluene diisocyanate QM (T) = 1 mg / kg in FP (expressed as NCO
) (26)
25270 026747-90-0 2,4-toluene diisocyanate, dimer QM (T) = 1 mg / kg in FP (expressed as NCO
) (26)
25360 - 2,3-epoxypropyl-trialkyl (C5-C15) QM = 1 mg / kg in FP (expressed as epoxy acetate
group, molecular weight = 43
)
25380 - vinyl-trialkyl (C7-C17) acetate (= 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 26320 002768-02-7
vinyltrimethoxysilane QM = 5 mg / kg in FP 26360 007732-18-5
water V according to a special legal
regulation, which provides
requirements for drinking water.
----------------------------------------------- ------------------------ -------------------------- --------------
SECTION B


LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY BE USED TO
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
15730 00077-73-6 dicyclopentadiene
18370 000592-45-0 hexa-1,4-diene
26230 000088-12-0 vinylpyrrolidone

INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED FOR THE PRODUCTION OF PLASTIC


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 as copper)
30140 000141-78-6 ethyl acetate
30280 000108-24- 7 acetic anhydride
30295 000067-64-1 acetone
30340 330198-91-9 2,3-bis (acetone) propyl 12-
(Acetone) stearic
30370 - acetyloctová acid salts
30401 - acetylated mono- and diglycerides of fatty

acids 30 610 - C2-C24 aliphatic linear
monocarboxylic acids of natural
oils and fats, and their mono-, di-
and triglycerides (including branched
fatty acids as they naturally occur in nature
)
30612 - synthetic C2-C24, aliphatic, linear,
monocarboxylic acids and their mono-
di- and triglycerides
30960 - esters of aliphatic, monocarboxylic
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-SML = 5 mg / kg
pentyl-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 of 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 up to 0.1% (wt.)
but not in LDPE, which is intended to come into contact
Food, for which according to Annex no. 4

this decree provides that the reduction factor
než3 smaller;
b) PETv amount to 0.25% (wt.), which is
intended for contact with foodstuffs, except those
for which, according to Annex no. 4 hereto
stanovenopoužití simulant D.
34895 000088-68-6 2-aminobenzamide SML = 0.05 mg / kg
The substance can only be used for PET, which is
prostyk designed with drinking water 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. Not to be used
in polymers contacting foods for which
pursuant to Annex no. 4 to this Decree provided
using simulant D substance may be used only
for 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. Not to be used
in polymers contacting foods for which
pursuant to Annex no. 4 to this Decree provided
using simulant D substance may be used only
for indirect contact with food, separated from
Food 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
36000 000050-81-7 ascorbic acid
36080 000137-66-6 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
prejudice to special legislation laying
establishing 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) in Appendix III to this
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- SML = 5 mg / kg (sum of phosphite and phosphate)
methylphenoxy) -2,4,8,10-tetraoxa-3,9-
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 substance itself, its oxidised form
diphosphite bis (2,4-dicumylphenyl)
pentaerythritolfosfátu and the product of its hydrolysis
2,4-dikumylfenol)
38879 135861-56-2 bis (3,4- dimethylbenzylidene) sorbitol
38885 002725-22-6 2,4-bis (2,4-dimethylphenyl) -6- [2-hydroxy-SML = 0.05 mg / kg. Only for aqueous foods.
4- (octyloxy) phenyl] -1,3,5-triazine
38950 079072-96-1 bis (4-ethylbenzyliden) sorbitol
39200 006200-40-4 bis (2-hydroxyethyl) -2-hydroxypropyl -3- SML = 1,8mg / 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 QMA = 0.05 mg / dm2 6
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 Bis (polyethylene glycol) hydroxymethyl SML = 0,6mg / kg
phosphonate;
[(Hydroxymethyl) phosphoryl] bis [poly (oxyethylene
ylene)]
40320 010043-35-3 boric acid SML (T) = 6 mg / kg (23)
(Expressed as Boron) without prejudice
provisions of special legislation, which
establishing 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) in Appendix III to this
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 laid down 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, salts || | 42640 009000-11-7 008015-86-9 42,720 carboxymethylcellulose

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

ceresin 008001-75-0 43440 43480 064365-11-3 charcoal operation in accordance with specifications laid down in Appendix
II of this Annex.
43515 - choline chloride fatty acids QMA = 0.9 mg / 6 dm2
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) = 1 mg / 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 / 6 dm2 (33)
(E) -but-2-enoic acid
45640 005232-99-5 ethyl-3,3-diphenyl-2-cyanoacrylate; SML = 0.05 mg / kg
ethyl 2-cyano-3,3-diphenyl-
acrylic
45705 166412-78-8 diisononyl cyclohexane-1,2-dicarboxylate

cyclohexylamine 000108-91-8 45760 45920 45940 009000-16-2 dammar
n-000334-48-5 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 to
20 wt.%)
46720 004130- 42-1 2,6-di-tert-butyl-4-ethylphenol QMA = 4,8mg / 6 dm2
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; Operation in accordance with specifications in Appendix II to this
thiobis (butyltin sulfide) polymer attachments.
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 = 0,6mg / kg
48720 00611-99-4 4,4'- dihydroxybenzophenone SML (T) = 6 mg / kg (15)
49485 134701-20-5 2,4-dimethyl-6- (1-methylpentadecyl) phenol SML = 1 mg / kg 49 540
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 SML (T) = 5 mg / kg (7) (expressed as copper)
copper salt
53650 000107-21-1 ethane-1,2-diol (ethylene glycol) SML (T) = 30 mg / kg (3)
54005 005136-44-7 ethylene-N-N'-palmitamide stearamide
54260 009004-58-4 ethylhydroxyethylcellulose
54270 - ethylhydroxymethylcelulóza
54280 - ethylhydroxypropylcelulóza
54300 118337-09-0 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 food sources,
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 55440 009000-70-8 gelatin
55,520 - 55,600
glass fibers - glass microspheres
55680 000110-94-1 glutaric acid 55920 000056-81-5 glycerol

56020 099880-64-5 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
56500 - glycerol esters with lauric acid
56510 - esters of glycerol with linoleic acid
56520 - glycerol esters with myristic
56535 - glycerol esters with nonanoic acid
56540 - glycerol esters with acid oil
56550 - esters of glycerol with palmitic acid
56570 - glycerol esters with propionic acid
56580 - glycerol esters with acid
ricinoleic
56585 - glycerol esters with stearic acid 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
57120 - glycerol monooleate ester
Citric acid
57200 - glycerol ester palmitate

with ascorbic acid 57280 - Glycerol ester palmitate
Citric acid
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
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 Only prepolymer and PET copolymers
62450 000078 -78-4 isopentane
62640 008001-39-6 Japan wax 62720 001332-58-7 kaolin

62800 - kaolin, calcined
62960 000050-21-5 lactic 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 acid
64015 000060-33-3 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 025736-61-2 maleic anhydride-styrene copolymer, sodium operation in accordance with specifications laid down in Appendix
SALT II of this Annex.
65020 006915-15-7
malic acid, malonic acid 65040 000141-82-2 000087-78-5
65520 mannitol
65920 66822-60-4 sodium [N-methacryloyloxyethyl-N, N
dimethyl-N-carboxymethyl ammonium chlorid-
octadecyl methacrylate-ethylmethakrylát-
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-4 -isothiazolin-3-one SML = ND (DL = 0.02 mg / kg, including measurement uncertainty)
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% by weight (amount used
benzoxazolyl) stilbene; 4,4'-bis (2- substance / composition) .In accordance with
benzoxazolyl) stilbene and 4,4'-bis (5- specifications set out in Appendix II to this
methyl-2-benzoxazolyl) stilbene Annex.
67180 - mixture of decyl octylftalátu (50 wt.%) SML = 5 mg / kg (1)
didecyl phthalate (25% by wt.)
and dioctyl phthalate (25% by wt.)
67200 001317-33-5 molybdenum disulfide
67840 - montanic acid and / or esters thereof
with ethylene glycol and / or butane-1,3-
butanediol 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) triazol-2-yl] -3-
phenylcoumarin
68078 027253-31-2 neodecanoic acid, cobalt salt; SML (T) = 0.05 mg / kg
7,7-dimethyloctanoic acid salt (expressed as neodecanoic acid) and
cobalt SML (T) = 0.05 mg / kg (14)
(Expressed as cobalt)
Not to be used in polymers intended
for contact with food, for which according to Annex

no. 4 hereto set simulant D

Nefelinsyenit 037244-96-5 68125 68145 080410-33-9 2,2 ', 2' - nitrilo [triethyl-tris (3,3 ', 5, 5'- SML = 5 mg / kg (sum of phosphite and phosphate)
tetra-tert-butyl-1,1'-biphenyl-2,2'
diyl) phosphite]
68960 000301-02 -0 Okeanid
69040 000112-80-1 oleic acid 69760 000143-28-2 Oleyl alcohol

69920 000144-62-7 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 Ozokerite || | 70400 000057-10-3
palmitic acid and palmitoleic acid 71020 000373-49-9 009000-69-5 Pectin 71440


71600 000115-77-5 Pentaerythritol 71635 025151-96-6 2 , 2-bis (hydroxymethyl) propane-1,3-diol- SML = 0.05 mg / kg. They may not be used in polymers
di (-octadec-9-enoate) (pentaerythritol in contact with foodstuffs for which the Annex no. 4
dioleae) hereto set 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 repeated
use sintered at high 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 (sum of phosphite and phosphate)

74240 031570-04-4 phosphite tris (2,4-di-tert-butylphenyl) phosphite
74480 000088-99-3 o-phthalic acid
74560 000085-68-7 benzyl butyl The phthalate použitípouze as:
a) plasticizer in materials and products for
opakovanépoužití
b) plasticizer in materials and products for
disposable in contact
with fatty foods except the initial
infant formula under a special
legal regulation 4).
c) technical support agent in concentrations up
0.1% in the final product
SML = 30 mg / kg food simulant
74640 000117-81-7 bis (2-ethylhexyl) phthalate The použitípouze as:
a) plasticizer in materials and products for
opakovanépoužití coming into contact
with fatty foods
b) technical support agent in concentrations up
0.1% in the final product
SML = 1.5mg / kg food simulant
74880 000084-74-2 dibutyl phthalate K použitípouze as:
a) plasticizer in materials and products for
opakovanépoužití coming into contact
with fatty foods
b) technical support agent in concentrations up
0.05% in the final product
SML = 0.3 mg / kg food simulant
75100 068515-48-0 dialkyl phthalates with saturated K použitípouze as:
028553-12-0 branched primary alkyl C8-C10) plasticizer in materials and products for
containing more than 60% C9 opakovanépoužití
b) a plasticiser in disposable
coming into contact with fatty foods
except for infant nutrition
under a special legal regulation 4).
c) technical support agent in concentrations up
0.1% in the final product
SML (T) = 9 mg / kg food simulant (42)

75105 068515-49-1 dialkyl phthalates with primary, saturated K použitípouze as:
026761-40-0 C9-C11 containing more than 90% a) plasticizer in materials and products for
C10 opakovanépoužití
b) a plasticiser in disposable
coming into contact with fatty foods
except for infant nutrition
under a special legal regulation 4)
c) technical support agent in concentrations up
0.1% in the final product
SML (T) = 9 mg / kg food simulant (42)
76320 000085-44-9 019455-79-9 Phthalic anhydride
76415 pimelic acid calcium salt
063148- 76721 009016-00-6 Polydimethylsiloxane (Mw> 6800) operation in accordance with specifications laid down in Appendix
62-9 II of this Annex.
76730 - polydimethylsiloxane A- SML = 6 mg / kg
hydroxypropyl
76815 - Polyester of adipic acid with glycerol operation in accordance with specifications laid down in Appendix
or pentaerythritol, esters with even in this Annex.
carbon number fatty acids
C12-C22, linear
76845 031831-53-5 Polyester of 1,4-butanediol operation in accordance with specifications laid down in Appendix
with caprolactone 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 an acid
adipic acid, which may be terminated
groups derived from acetic acid
or fatty acids C12-C18 or octane
1-ol and / or decan-1-ol

76960 025322-68-3 Polyethyleneglycol 77370 070142-34-6 poly (ethylene glycol-30)
dipolyhydroxystearate
77600 061788-85-0 polyethylene glycol ester
hydrogenated castor oil
77702 - polyethylene glycol esters with aliphatic
monocarboxylic acids (C6-C22)
and their ammonium and sodium sulphates
77895 068439-49-6 ether of polyethylene glycol (EO = 2-6) SML = 0,05 mg / kg and in accordance with the specifications
and monoalkyl (C16-C18) in this Annex dodatkuII
79040 009005-64-5 sorbitan monolaurate polyethylene
79120 009005-65-6 sorbitan monooleate, polyethylene glycol
79200 009005-66-7 polyethyleneglycol sorbitan monopalmitate
79280 009005-67-8 sorbitan monostearate polyethyleneglycol
79360 009005-70-3 sorbitan trioleate, polyethylene glycol
79440 009005-71-4 sorbitan tristearate PEG
79600 009046-01-9 poly ( ethyleneglycol) tridecylether, phosphate SML = 5 mg / kg. For materials and articles intended
for contact with aqueous foods. In accordance
the specifications set out in Appendix II to 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-SML = 5 mg / kg
4-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] omega-N, N, N ', N'-tetrabutylammonium
1,3,5-triazine-2,4-diamine
81500 9003-39-8 poly (vinylpyrrolidone) operation in accordance with specifications laid down in Appendix
Annex II to this
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) (expressed as copper)
copper, stainless steel, tin and alloys SML = 48mg / kg (expressed as iron)

copper, tin and 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 1,2-propyleneglycol dioleate
82560 033587-20-1 dipalmitate, 1,2-propylene glycol distearate
82720 006182-11-2 1,2-propylene glycol monolaurate
82800 027194-74-7 1,2-glycol monooleate
82960 001330-80-9 1,2-
propylene glycol monopalmitate 83120 029013-28-3 1,2-glycol
83300 001323-39-3 1,2-glycol monostearate
83320 - 83325 propylhydroxyethylcelulóza
-
propylhydroxymethylcelulóza 83330 - propylhydroxypropylcelulóza | || 83440 002466-09-3 pyrophosphoric acid 83455 013445-56-2

diphosphonic acid 83460 012269-78-2 014808-60-7 83,470 pyrophyllite

83599 Quartz 68442-12-6 reaction products of 2-sulfonylethyl oleate SML (T) = 0,18mg / kg (16) (expressed as tin)
with dichloro-dimethylcínem, sodium sulfide
and trichlormethylcínem
83610 073138-82-6 resin acids and rosin
acid
83840 008050-09-7 Rosin
84000 008050-31-5 rosin, glycerol ester
84080 008050-26-8 rosin ester, pentaerythritol rosin
84210 065997-06-0,
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
(Other than 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 to the provisions of special legislation
regulations establishing requirements for drinking
Water
87200 000110-44-1 sorbic acid
87280 029116-98-1 sorbitan dioleate
87520 062568-11-0 sorbitan monobehenate
87600 001338-39-2 sorbitan monolaurate || | 87680 001338-43-8 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 88320 88600 026836-47- 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 containing infant and follow
baby food under a special legal
regulation adapting the requirements
potravinyurčené for particular nutritional uses and the way
their use, or with cereal and other
foods for infants and young children under the
Decree SML is lowered to 30 mg / kg.
Operation in accordance with specifications in 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
89200 007617 -31-4 cuprous stearate SML (T) = 5 mg / kg (7) expressed as copper
89440 - esters of stearic acid SML (T) = 30 mg / kg (3)
with ethylenklykolem
90720 058446-52-9 005793-94-2 stearoylbenzoylmethane
90800 stearoyl-2-lactic acid, the calcium salt
90960 000110-15-6 succinic acid

91200 000126-13-6 sucrose acetate isobutyrate
91360 000126-14-7 sucrose octaacetate

Sulfur 007704-34-9 91840 91920 007664-93-9 sulfuric acid
92030 010124 -44-4 copper sulphate SML (T) = 5 mg / kg (7), expressed as copper

92080 92150 014807-96-6 Talc 01401-55-4 acid, tannin operation in accordance with specifications JECFA
92160 000087-69-4 tartaric acid
92195 - taurine, salts
92205 057569-40-1 2,2'-methylenebis (4-methyl-6-tert-butylphenol
) diester of terephthalic acid
92350 000112-60-7 Tetraethylene glycol
92640 000102-60-3 N, N, N ', N'-tetrakis (2-
hydroxypropyl) ethylenediamine
92700 078301-43-6 2,2,4 , 4-tetramethyl-20 (2,3-epoxypropyl) - SML = 5 mg / kg
7-oxa-3,20-diazadispiro [5.1.11.2] -
heneicosan-21-one, polymer
92930 120218-34-0 thiodiethylenbis (5-methoxycarbonyl-2,6- 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 || | 95000 028931-67-1, 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 food. to be used
diisobutyrát disposable gloves
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 sum of phosphite, phosphate
ethylpropane-1,3-diol phosphate and the hydrolysis product = TTBP)
95420 745070-61-5 1,3,5-tris (2,2-dimethylpropanamide) - SML = 0,05mg / kg food
benzene
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 special legislation, which
stanovípožadavky the drinking water
95859 - waxes, refined, derived from petroleum or operation in accordance with specifications set out in Appendix II
synthetic hydrocarbons of this Annex
95883 - white mineral oils, paraffinic, operation in accordance with specifications set out in Appendix II
derived from petroleum hydrocarbons of 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 Mn)
31500 025134-51- acrylic acid-2-ethylhexyl acrylate copolymer SML ( T) = 6 mg / kg (36) (expressed as acrylic acid)
4 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-methylbenzyl ) -4- SML = 6 mg / kg
methylphenyl acrylate
31920 00103-23-1 bis (2-ethylhexyl) -hexandioát SML = 18 mg / kg (1)
bis (2-ethylhexyl) adipate
34230 - alkyl (C8-C22) sulfonic acid SML = 6 mg / kg
34650 151841-65- hydroxide bis [2,2'methylbis (4,6-di-tert-SML = 5 mg / kg 5
butylphenyl) phosphate], aluminum
35760 01309-64-4 antimony trioxide SML = 0.04 mg / kg (39) (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) tin bis (isooktylsulfanylacetát ) SML = 18 mg / kg
38000 000553-54- lithium benzoate SML (T) = 0.6 mg / kg (8)
8 (expressed as lithium)
38505 351870-33- cis-endo-bicyclo [2.2.1] heptane-2,3-dicarboxylic acid SML = 5 mg / kg. Not to be used with polyethylene in contact
2 di-sodium salt with acidic foods. 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- 2,4-bis (dodecylthiomethyl) -6-methylphenol SML (T) = 5 mg / kg (40)
8
39060 35958-30-6 1,1-bis (2-hydroxy-3,5-di-tert-butylphenyl) ethane SML = 5 mg / kg
39 090 - 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 hydrochloride SML (T) = 1,2mg / kg (13) (expressed 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
110553-27- 40020 2,4-bis [(octylthiomethyl ) -6-methyl] phenol SML (T) = 5 mg / kg (40)
0
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- 2-tert-butyl-4-methoxyphenol; SML = 30 mg / kg
5-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 Mn)
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-azoniaadamantanchlorid SML = 0.3 mg / kg
43680 00075-45-6 chlorodifluoromethane SML = 6 mg / kg in accordance with specifications set
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- 2,6-di-tert-butyl-4-methylphenol; SML = 3 mg / kg
0 (= BHT)
47500 153250-52- N, N'-dicyklohexylnaftalen-2,6-dicarboxamide SML = 5 mg / kg
3
47600 084030-61- di-dodecyltin bis (isooctyl-methylthioacetate) SML (T) = 0.05 mg / kg (41) (summing
5 dodecyltriisooktylcín-sulfanylacetátu,
didodecyliisooktylcín-sulfanylacetátu, dodecylcín -
trichloride and di-dichloride) expressed as
the sum of 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) 49 595
057583-35- dimethylcínbis (ethylhexyl mercaptoacetate) SML (T) = 0.18 mg / kg (16) (expressed as tin)
4
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 /
50160 kg - 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) (expressed as tin)
(Methylthioacetate)
50640 03648-18-8 di-n-oktylcíndidodekanoát SML (T) = 0.006 mg / kg (17) (expressed as tin)
di-n-octyltin dilaurate
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) methylthioacetate] SML (T) = 0.006 mg / kg (17) (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
54880 000050-00- formaldehyde SML (T) = 15 mg / kg (22)
0
55200 001166-52- dodecyl-3,4,5-trihydroxybenzoate; SML (T) = 30 mg / kg (34)
5 dodechl gallate
55280 001034-01- octyl-3,4,5-trihydroxybenzoate; SML (T) = 30 mg / kg (34)
1 octyl gallate
55360 000121-79- propyl 3,4,5-trihydroxybenzoate; SML (T) = 30 mg / kg (34)
9 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-dimethylbenzyl) phenyl) benzotriazole SML = 1.5 mg / kg
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) (expressed as Mn)
Manganui-dilaktát
63940 008062-15- lignosulfonic acid SML = 0.24 mg / kg and for use as a dispersant for
5 plastic dispersion.
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 Mn) 65200 12626
-88-9 manganese hydroxide SML (T) = 0.6 mg / kg (10) (expressed as Mn)
65280 10043-84-2 manganese hypophosphite SML (T) = 0.6 mg / kg (10) (expressed as Mn)
65360 11129-60-5 manganese oxide SML (T) = 0.6 mg / kg (10) (expressed as Mn)
65440 - manganese pyrophosphate SML (T) = 0.6 mg / kg (10) (expressed as Mn)
66350 085209-93- 2,2'-methylenebis (4,6-di-tert-BUTYLPHENYL) lithiumfosfát SML = 5 mg / kg and SML (T) = 0 6 mg / kg (8) (expressed as lithium
4)
66360 85209-91-2 2,2'-methylenebis (4,6-di-tert-butylphenyl) natriumfosfátSML = 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- dodecyltriisooktylcín-methylthioacetate SML (T) = 0.05 mg / kg food (41) (4
summing dodecyltriisooktylcín-sulfanylacetátu,
didodecyliisooktylcín-sulfanylacetátu, dodecylcín-
trichloride and di-dichloride) expressed as
the sum of mono- and didodecylcínchloridů.
67515 057583-34- monomethylcíntris (ethylhexylmerkaptoacetát) SML (T) = 0.18 mg / kg (16) (expressed as tin)
3
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)
67,896 020336-96- lithium-tetradecanoate; SML (T) = 0.6 mg / kg (8) (expressed as lithium)
3 lithium myristate
68320 02082-79-3 oktadecyl3- (3,5-di-tert-butyl-4-hydroxyphenyl) propanoate SML = 6 mg / kg
68400 10094-45-8 octadecyl (Z ) -dokos-9-enamide SML = 5 mg / kg
oktadecylerukamid
68860 004724-48- n-oktylfosfoniová acid SML = 0.05 mg / kg
5
69160 014666-94- oleic acid, cobalt salt SML (T) = 0.05 mg / kg (14) (expressed as cobalt)
5
69840 16260-09-6 N- (Z) -octadec-9-en-1-ylhexadekanamid SML = 5 mg / kg
oleylpalmitamid

71935 007601-89- sodium perchlorate monohydrate SML = 0.05 mg / kg (31)
0
72081/10 - hydrogenated Petroleum hydrocarbon resins SML = 5 mg / kg (1) and 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 Mn)
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-triazine-2,4- SML = 3 mg / kg | || 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- reaction product of di-tert-butylfosfonitu with biphenyl obtained SML = 18 mg / kg in accordance with the specifications
6 condensation of 2,4-di-tert -butylfenolu products Friedelovy- in Appendix II to this Annex.
Craft reaction of phosphorous trichloride and biphenyl
83700 00141-22-0 (Z) -12-hydroxyoktadec-9-enoic acid SML = 42 mg / kg || | 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- silicic acid, a salt with a sodium fluoride-magnesium SML = 0.15 mg / kg (expressed as fluoride). only
2 to be used in layers of multi-layer materials which
come into contact with food.
86480 007631-90- sodium bisulfite SML (T) = 10 mg / kg (30)
5 (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- sodium nitrite SML = 0.6 mg / kg
0
86960 007757-83- sodium sulfite SML (T) = 10 mg / kg (30)
7 (expressed as SO2)
87120 007772-98- sodium thiosulfate SML (T) = 10 mg / kg (30)
7 (expressed as SO2)
89170 13586-84-0 octadecanoic acid, cobalt salt SML (T) = 0.05 mg / kg (14) (expressed as cobalt)
stearic acid, cobalt salt
92000 07727-43-7 barium sulfate SML (T) = 1 mg / kg (12) (expressed as barium)
92320 - tetradecylpolyethylenglykol (EO = 3-8) ether glycol SML = 15 mg / kg
acid
92560 38613-77-3 tetrakis (2,4-di-tert-butylphenyl) 4,4'-biphenyl SML = 18 mg / kg
ylendiifosfonit
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)
93970 _ tricyklodekandimethanol bis (hexahydrophthalate) SML = 0.05 mg / kg
94400 036443-68- triethylene glycol bis [3- (3-tert-butyl-4-hydroxy-5- SML = 9 mg / kg
2-methylphenyl) propanoate]
94560 00122-20-3 triisopropanolamine SML = 5 mg / kg
95265 227099- 60- 1,3,5-tri (4-benzoylphenyl) benzene SML = 0.05 mg / kg
7
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. No. Name Restrictions and / or specifications

NO. CAS
---------------------------------------------- -----------------------------------------------
(1) (2) (3) (4)
----------------------------------- -------------------------------------------------- --------
18888 080181- 3-hydroxybutyric acid and 3 In accordance with specifikacemistanovenými
Hydroxypentanoic acid 31-3 in Appendix II to this Annex

copolymer ---------------------------------------------- -----------------------------------------------
APPENDIX II


SPECIFICATIONS

Part A: General specifications

Materials and articles made of plastic
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 limitation may not apply.

Part B: Other specifications
-------------------------- ------------- --------------------------------------------------
PM / Ref. no. Other specifications
-------------------------- ----------------- ----------------------------------------------
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 These copolymers are produced by the controlled fermentation sbakterií
Alcaligenes eutrophus using mixtures of glucose akyseliny
propanoic acid as carbon sources. The organism used must be
produced by genetic modification, and must come from one
naturally occurring Alcaligenes eutrophus strain
H16 NCIMB 10,442th stock culture of the organism seuchovává
in freeze-dried ampoules. Submaster / working with
prepared from a stock culture stored in liquid nitrogen
and used for preparation of inoculum for fermentation. samples
from the fermenter they are viewed under a microscope every day, watching
with any changes in colonial morphology on a variety of agar
soils at various 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 by melting granules
containing additives such as nucleating agents, plasticizers,
fillers, stabilizers and pigments that satisfy the general
and individual specifications.
- Chemical Poly (3Dhydroxybutanoátco3Dhydroxypentanoát)
name
- CAS 80181-31-3
- Structural
formula

CH3
-Strukturní 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
method).
weight
- The content of less than 98%
poly (3Dhydroxybutanoátco3Dhydroxypentanoát) analyzed
after hydrolysis as a mixture of 3Dhydroxybutanové
acid 3Dhydroxypentanové.
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 and 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)

Minimum viscosity 100x106 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 of hydrogel.
For use only in hydrogels intended for direct food contact.
--------------------- -------------------------- ------------------------------------------
38 320 4 (2-benzoxazolyl) -4 '(5metylbenzoxazolyl) stilbene
More than 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
by
- Contents benzoapyrenu: 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. The same
purity requirements as for Vegetable Carbon (black plant) (E 153)
with 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)
-------------------------- ---- -------------------------------------------------- ---------
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 greater than
220st. C.Rovněž as the pure polymers from these sources followed
distillation, hydrogenation and additional processing
Features:
Viscosity: 3 poise 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 50 ppm.
--------------------- -------------------------- ------------------------------------------
76721 polydimethylsiloxane (Mw> 6800) Minimum viscosity 100x106 m2 * s-1
(= 100 centistokes) at 25 ° C
-------------------------- ------------ -------------------------------------------------- -
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) (approximately 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 (ethylene glycol) (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 products Friedel-Crafts reaction of phosphorous trichloride
and biphenyl

composition
- 4,4'-bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (čísloCAS
38613-77-3) (36 - 46% by weight *)
- 4,3'-bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (čísloCAS
118421-00-4) (17-23% wt.)
- 3,3'-bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (čísloCAS
118421-01-5) (1-5 wt.%)
- 4 -bifenylenbis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (CAS 91362- 37-7
) (17-19% 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
-------------------------- ------------ -------------------------------------------------- -
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: not more than 5%
(M / m)
- Viscosity least 11x106 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: not more than 5%
(M / m)
- Viscosity least 8,5x106 m2 * s-1 (= 8,5 centistokes) at 100 ° C.
- Average molecular weight of at least 480
-------------- -------------------------- ------------------------------------------------- | || *) 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 of 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
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 and 31,500th

(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 (acid) salts, which appear 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 75105 '.
APPENDIX IV


Lipophilic substances for which the application of the FRF

------------------------------ ----------------- -------------------------------------------------- -------
Ref. No. CAS Name ------------------------------ ----------
-------------------------------------------------- --------------
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
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)
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 -sulfanylacetát)
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
54300 118337-09-0 2,2-ethane-1,1-diylbis ( 4,6-di-tert-BUTYLPHENYL) -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 (alpha, alpha-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
69840 016260-09-6 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-diolunebo butane-1,4-diol or
poly (propylene glycol) with adipic acid and heavier 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
tetramethylpiperidin-4-yl) imino] hexane-1 , 6-diyl [(2,2,6,6
tetramethylpiperidin-4-yl) imino])
83599 068442-12-6 reaction products of 2-sulfanylethyl oleate with dichlordimethylstannanem sulfide
sodium trichlormethylstannanem
83700 000141-22-0 ricinoleic acid
84800 000087-18-3 4-tert-butylphenyl salicylate
92320 - a- (carboxymethyl) -omega-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

Declaration of conformity attached to materials and articles made of plastics must contain
:

) Name and place of business or place of service

^ 1 the company which manufactures or imports articles of plastics or substances intended
for the manufacture of those materials and articles

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

C) the date of the declaration,

D) certifying that the materials and articles of plastics meet the requirements of this ordinance
and directly applicable regulation on materials and articles intended
contact with food ^ 1

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

Where appropriate, purity criteria in accordance with special legislation and
where appropriate, purity criteria in accordance with Directives 95/11 / EC
95/45 / EC and 96/77 / EC, the user of these materials and articles
complied with relevant legislation

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

H)

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 ratio between the surface area that is in contact with food, and
volume used to establish the compliance of the material or article

I) 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. ".
-----


1 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 Directives 80/590 / EEC and 89/109 / EEC

Second Annex no. 4 in Chapter I, section 2.3.2 reads:
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
.

Third Annex no. 4 in Chapter I of section 2.3.3, a new point 2.3.4
added:
2.3.4 If the letter "X" in brackets after the letter (b)
executes the said test with ethanol 50% (V / V).

Fourth Annex no. 4 in Table 3, Section 07 Dairy reads:
--------------------------------- -------------------------------------------------- - Dairy products

07 ---------------------------------------- --------------------------------------------
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 Cheese: | || 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.
----------------------------------------------- -------------------------------------

Fifth Annex no. 4 at the end of Chapter V complements Section 3, which reads:

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. ".

6th In Annex no. 13 is inserted at the end of Chapters V Solvents new
points from 5.15 to 5.18, which added:

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

Art. II


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. III
Efficiency


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

MD. Julínek, MBA vr

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