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To Change The Code. About Regulation. Requirements For Products In Contact With Foodstuffs

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

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271/2008 Sb.



The DECREE



of 28 June. July 2008,



amending the Decree of the Ministry of health no. 38/2001 Coll., on the

hygiene requirements for the products intended to come into contact with foodstuffs and

dishes, as amended



The Ministry of health provides under section 108, paragraph. 1 of law No.

258/2000 Coll., on the protection of public health and amendment to certain

related laws, as amended by Act No. 254/2001 Coll., Act No.

274/2001 Coll., the Act No. 76/2002 Coll., Act No. 320/2002 Coll., Act No.

274/2003 Coll., Act No. 392/2005 Coll., Act No. 59/2006 Coll., Act No.

222/2006 Coll. and Act No. 110/2007 Coll. (hereinafter the "Act") to implement section

26 paragraph. 1 (a). (b)), and (d)) of the Act:



Article. (I)



Decree No. 38/2001 Coll. on hygienic requirements for products intended for

to come into contact with foodstuffs and dishes, as amended by Decree No. 186/2003 Coll.

Decree No 207/2006 Coll. and Decree No. 551/2006 Coll., is hereby amended as follows:



1. Footnote 1a is added:



"1a) Council Directive 78/142/EEC of 30. January 1978, which relates to the

approximation to the law of the Member States relating to materials that

contain vinyl chloride monomer and are intended to come into contact with foodstuffs.



Commission Directive 80/766/EEC of 18. in July 1980, which establishes the

the analytical method for the purposes of official checks on the quantity of monomerního

vinyl chloride in materials and articles intended to come into contact with

food.



Commission Directive 81/432/EEC of 29. April 1981, which establishes the

the analytical method for the purposes of official control of vinyl chloride released from

materials and articles to foodstuffs.



Council Directive 82/711/EEC of 18. October 1982, which establishes the basic

rules for testing migration of constituents of plastic materials and articles of them

manufactured and intended for contact with food.



Council Directive 84/500/EEC of 15. October 1984, which concerns the approximation of

the legislation of the Member States relating to ceramic

articles intended for contact with food.



Council Directive 85/572/EEC of 19. in December 1985, which establishes a list of

food simulants to be used in the migration tests the components of plastics and

the subjects of them produced and intended to come into contact with foodstuffs.



Commission Directive 93/11/EEC of 15. in March 1993, concerning the determination of the

N-nitrosamines and N-nitrosatable substances released from the teats and sosáků

made from eleastomerů or rubber.



Commission Directive 97/48/EC of 29 April 2004. in July 1997, for the second time

amending Council Directive 82/711/EEC laying down the basic rules

necessary for testing migration of constituents of plastic materials and articles

intended to come into contact with foodstuffs.



Commission Directive 2002/72/EC of 6 May 2003. August 2002 on materials and

articles of plastics intended to come into contact with foodstuffs.



Commission Directive 2004/1/EC of 6 May 2003. January 2004 amending Directive

2002/72/EC, concerning the suspension of the use of azodikarbonamidu as a

blowing agent for plastics.



Commission Directive 2004/19/EC of 1 July 1999. March 2004, amending and

the following directive 2002/72/EC relating to plastic materials and articles

intended to come into contact with foodstuffs.



Commission Directive 2005/41/EC of 29 April 2004. April 2005 amending the

Council Directive 84/500/EEC as regards a declaration of compliance and criteria

the implementation of the methods of analysis for ceramic articles intended to come into contact with

food.



Commission Directive 2005/79/EC of 18 June 2003. November 2005 amending the

Directive 2002/72/EC relating to plastic materials and articles intended for

come into contact with foodstuffs.



Commission Directive 2007/19/EC of 2 December 1996. April 2007 amending

Directive 2002/72/EC relating to plastic materials and articles intended for

come into contact with food and Council Directive 85/572/EEC laying down the list of

simulants to be used for testing migration of constituents of the materials and articles

of plastics intended to come into contact with foodstuffs.



Commission Directive 2007/42/EC of 29 April 2004. June 2007 on materials and

articles made of regenerated cellulose film intended to come into contact with foodstuffs. ".



2. In article 2, point 7 shall be deleted.



The former items 8 to 31 shall be renumbered 7 to 30.



3. In section 2, at the end of paragraph 30 of the dot is replaced by a comma and the following points

31 to 33, as follows:



"31. the layered materials or to be the subject of plastic material or

product made of plastic, which is composed of two or more layers of materials, from

Each consists entirely of plastic and together

adhesives or otherwise,



32. a functional barrier plastic barrier, which is made up of one or

multiple layers of plastic and ensures that the final product was in accordance with the

Article 3 of the regulation of the European Parliament and the Council No. 1935/2004 and with this

the Decree,



33. beztukovými food foods for which annex No 4 to this

the Decree provides for testing migration other than simulant (s) (D). ".



4. In section 10, paragraph 2:



"(2) the requirements referred to in section 11 to 14 shall apply to products intended for

contact with food and on their part and components consisting exclusively

of plastics, or composed of two or more layers, each of which is

made up exclusively of plastics, the layer of plastic or surfaces, forming a seal

rings of the eyelids, which together are composed of two or more layers

different types of materials. Do not apply to products composed of two or

more layers, one or more of which does not consist exclusively of plastics, and

even in cases where the layer is designed for direct contact with foodstuffs is

made of plastic. Such products are evaluated according to the section 4, paragraph 4. 2. ".



5. In section 10, the following paragraphs 3 to 5 shall be added:



"(3) by way of derogation from paragraph 2, in the case of a layer that is not in direct

contact with foodstuffs and which separates the barrier from the functional food of

plastic, can make the case that the final material or object is in the

accordance with the specifications and with the migration limits laid down in this

Decree:



and) was not in accordance with the restrictions and specifications set out in this

the Decree,



(b)) was made for the use of substances other than those referred to in

Annex No. 3 to this notice.



(4) migration of the substances referred to in paragraph 3 (b). (b)) to the food or

the food simulant shall not exceed 0.01 mg/kg, measured analysis

method in accordance with article 11 of the regulation of the European Parliament and of the Council

(EC) No 882/2004. This limit must always be expressed as a concentration in the

foods or simulants. It shall apply to a group of compounds that

they are structurally and toxicologically related, in particular isomers or

compounds with the same functional group, and includes any undesirable

the transfer of the imprint.



(5) the substances referred to in paragraph 3 (b). (b) may not even belong to) one of the

the following categories:



a) substances classified as substances for which it is established or has a

they are substances carcinogenic, mutagenic or toxic for

reproduction according to annex I to Council Directive 67/548/EEC, or



b) substances classified according to the criteria of its responsibility as

carcinogenic, mutagenic or toxic for reproduction in accordance with the

the rules of annex I to Council Directive 67/548/EEC. '.



6. In section 11 is at the end of paragraph 2 the following sentence "the particulars of the written

the Declaration, which is attached to plastic materials and articles, are

regulated in annex No. 3 to this Ordinance. ".



7. In section 12 (1):



"(1) Plastics and plastic products, must not transfer their constituents to food

in quantities in excess of 60 milligrams of the constituents released per kilogram of

food or food simulant (hereinafter, the limit of the total

Migration ").".



8. In section 12 paragraph 2 is added:



"(2) in the following cases can be used to limit the overall migration 10

milligrams per square foot of surface material or product:



containers or products), which are similar to the vessels and which can be filled,

with a capacity of less than 500 millilitres or more than 10 litres,



b) sheet, film or other articles which cannot be filled or for which cannot be

estimate the ratio between the surface area of the product and the quantity of food,

that is in contact with him. ".



9. In section 12, the following paragraph 3 is added:



"(3) in the case of products of plastics, which have come into contact with

foods intended for infants and young children, according to a special legal

code ^ 4) or are already in contact with these foodstuffs, the limit

overall migration always 60 milligrams per kilogram of food or

the food simulant. ".



4) Decree No 54/2004 Coll. on foodstuffs intended for particular nutritional uses

and how to use them, as amended.



10. under section 11a is added to the new section 11b is inserted:



"section 11b



(1) additives referred to in annex 3 to this Decree, which shall apply

in the production of layers and surfaces of plastics in the eyelids, must comply with the restrictions

and the specifications for their use in accordance with this annex.



(2) For the use of ingredients which act solely as auxiliary substances

for polymerisation and which do not remain in the final product (hereinafter referred to as

"PPA"), for the manufacture of plastic layers and surfaces mentioned in annex No. 3 to

This Decree shall apply to restrictions and specifications listed in this

Annex. ".



11. Appendix 3:



"The annex No. 3 to Decree No. 38/2001 Sb.



The requirements on plastics and plastic products



LIST OF MONOMERS, ADDITIVES AND OTHER STARTING SUBSTANCES, WHICH MAY BE

USED FOR MANUFACTURE OF PRODUCTS FROM PLASTIC



1. This annex contains the list of monomers, additives and other default
substances, which may be used for the production of plastics and plastic products,

intended to come into contact with foodstuffs. In the list are included



1.1 substances, which are subject to polymerization, which includes

polykondenzaci, polyadici, or any other similar process creation

macromolecules;



1.2 natural or synthetic macromolecular substances used for

manufacture of modified macromolecules, if the monomers or the other

the default substances necessary for their manufacture are not included in the list;



1.3 substances used to modify existing natural or

synthetic macromolecular compounds;



1.4 substances added to plastics to achieve a technical

effect in the final product, including polymer additives. These substances are

intended to be included in the final product, and

polymer additives for the purposes of this annex, shall mean all

polymers and prepolymers, oligomers, which may be added to plastics

in order to achieve a technical effect but which cannot be used without

other polymers as the main structural component of finished materials and

the products;



1.5 the substances that are used to create the environment in which

polymerization occurs (e.g. emulsifiers, surfactants,

buffer solutions).



For the purposes of this annex, the substances referred to in paragraphs 1.4 and 1.5 on

referred to as the ingredients.



2. the following are not included in the list of substances, even though they are used

intentionally and are allowed:



and aluminum salts, calcium), iron, magnesium, potassium and sodium and salt

ammonium (including double salts and acid salts) of authorised acids,

phenols or alcohols. The name "salt" appears in the list only if

the corresponding free acid (acid free) is not in the list

(not listed).



b) zinc salts (including double salts and acid salts) of allowed

acids, phenols or alcohols. For these salts are applied, the Group

SML = specific migration limit of 25 mg/kg (expressed as zinc). The same thing

restrictions for the zinc is applied to:



I) substances whose names include the term "salts" are listed

only if the corresponding free acid is not in the list,



(ii)) of the substance referred to in Note 38 of Appendix III.



3. the following are not included in the list of substances, although they may be

present:



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



-impurities in the substances used;



-reaction intermediates;



-decomposition products;



b) oligomers and natural or synthetic macromolecular substances and their

mixtures, if the monomers or starting substances required for their synthesis

included in the list;



(c) mixtures of substances);



(d)) the substances which directly influence the formation of polymer (e.g. catalytic

systems);



e) dyes;



(f)) of the solvent.



Products which contain substances listed in points (a) to (c))) must

comply with the requirements provided in § 3 (3). 1.



4. substances shall be of good technical quality as regards the criteria

purity.



5. For contact with foodstuffs can be used only to products obtained from bacterial

the fermentation process in accordance with Appendix I to this annex.



6. the list contains the following information:



-column 1 (PM/REF. No.): the EEC packaging material reference number for the

the substance in the list;



-column 2 (CAS): CAS registration 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 product

(QM),



-maximum permitted quantity of the substance in the finished material or product

expressed in mg per 6 dm2 of the area in contact with foodstuffs (QMA),



-any other restriction specifically mentioned,



-all specifications related to the substance or polymer.



7. If a substance that is listed in the list individually, is also

in the General Group, for this group, the restrictions referred to in

individually listed substances.



8. If the CAS number does not match the chemical name, chemical name

precedence over the CAS number. If the CAS number, the EINECS, according to registry

does not match the number of CAS in accordance with the CAS registry, the CAS number, according to the registry

CAS.



9. In the tables in column 4 are used abbreviations and expressions that have

the following meanings:



DL = limit of quantification of the analytical methods;



FP = final material or product;



NCO = isocyanates;



ND = not to be detected. For the purposes of this order means that the substance

may not be detected by certified analytical method is specified by the

limit of determination (DL). If such a method is currently

does not exist, proceed to the elaboration of a certified procedure method

under section 4 (1) of the Ordinance.



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

the product.



For the purposes of this Ordinance, the amount of the substance in the material or product

provides validated method of analysis. If such a method in the current

time does not exist, proceed to the elaboration of a certified procedure method

under section 4 (1).



QM (T) = maximum permitted quantity of the residual substance in the material or

the product, expressed as the total contents of the listed substances or groups of substances.

For the purposes of this Ordinance, the amount of the substance in the material or the product should

be made for a certified analytical method. If such a method in the

the present time does not exist, proceed to the elaboration of the proven methods

procedure referred to in article 4, paragraph 1.



QMA = maximum permitted quantity of the residual substance in the material or

the product, expressed in mg per 6 dm2 of the area in contact with foodstuffs.



QMA (T) = maximum permitted quantity of the residual substance in the material or

the product, expressed as the total content of substances or groups of substances listed in

mg per 6 dm2 of the area in contact with foodstuffs. For the purposes of this order would

the quantity of the substance in the material or product should be provided for certified

the method of analysis. If such a method does not currently exist,

proceed to the elaboration of the proven methods the procedure in section 4

1.



SML = specific migration limit in food or in the food

the simulant, unless stated otherwise. For the purposes of this Decree should

be the value of the specific migration of the substance of the material or product set

a verified method of analysis. If such a method is currently

does not exist, proceed to the elaboration of a certified procedure method

under section 4 (1).



SML(t) = specific migration limit in food or in the food

simulant expressed as total content of listed substances or groups of

substances. For the purposes of this order would be the value of the specific migration of the substance or

a group of substances of a material or product, established a certified analysis

method. If such a method does not currently exist, the

until the drawing up of proven methods procedure laid down in article 4, paragraph 1.



LIST OF AUTHORISED MONOMERS AND OTHER STARTING SUBSTANCES



SECTION AND

--------------------------- ----------------------------------------------------------------------

PM/REF No. CAS number Name restrictions and/or specifications

--------------------------- ----------------------------------------------------------------------

(1) (2) (3) (4)

--------------------------- ----------------------------------------------------------------------

10030 000514-10-3 abietová 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), (T) QMA = 0.05 mg/6 dm2 (27)

dimers, distilled

10599/91 061788-89-4 fatty acids, unsaturated (C18), (T) QMA = 0.05 mg/6 dm2 (27)

dimers, non-distilled

10599/92A 068783-41-5 fatty acids, unsaturated (C18), (T) QMA = 0.05 mg/6 dm2 (27)

dimers, hydrogenated, distilled

10599/93 068783-41-5 fatty acids, unsaturated (C18), (T) QMA = 0.05 mg/6 dm2 (27)

dimers, hydrogenated, non-distilled

10630 000079-06-1 acrylamide SML = ND (DL = 0,01 mg/kg)

10660 015214-89-8, 2-akrylamido-2-methylpropanesulfonic acid SML = 0.05 mg/kg

acid

10690 000079-10-7 acrylic acid SML(t) = 6 mg/kg (36)

10750 002495-35-4-benzyl-ester 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 ester SML(t) = 6 mg/kg (36)

11005 012542-30-2, dicyklopentenyl-QMA = 0.05 acrylic mg/6 dm2

11245 002156-97-0-dodecyl ester SML = 0.05 mg/kg (1)

11470 000140-88-5-ethyl-ester 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. acrylic acid, monoester

with ethylene glycol

11530 000999-61-1, 2-hydroxy-acrylic QMA = 0.05 mg/6 dm2 for the sum of 2-hydroxy-

acrylate and 2-hydroxyisopropyl-acrylate

and in accordance with the specifications laid down

in Appendix II to this annex.

11590 00106-63-8-isobutyl acrylate SML(t) = 6 mg/kg (36)
11680 000689-12-3-isopropyl ester SML(t) = 6 mg/kg (36)

11710 000096-33-3 methyl-ester SML(t) = 6 mg/kg (36)

11830 000818-61-1 acrylic acid monoester SML(t) = 6 mg/kg (36)

with ethylene glycol

11890 002499-59-4, n-Octyl-ester SML(t) = 6 mg/kg (36)

11980-000925 60-0-propyl ester 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-adipová acid

12265 004074-90-2, divinyl-adipát QM = 5 mg/kg in FP. For use only as a

komonomer.

12280 002035-75-8 adipanhydrid

12310-albumin

12340-albumin formaldehyde koagulovaný

12375 — alcohols, aliphatic, with one

a group of OH, saturated, linear,

primary (C4-C22)

12670 002855-13-2, 1-amino-3aminomethyl-3, 5.5-SML = 6 mg/kg

trimethylcyklohexan

12761 000693-57-2 12-aminododecanoic acid acid SML = 0.05 mg/kg

12763 00141-43-5, 2-aminoethanol SML = 0.05 mg/kg. The substance must not be used

in polymers in contact with foodstuffs for which

to be in accordance with annex 4 to this notice

simulant D is used, the substance may only be used

only for indirect food contact

separate layer PET

12765 84434-12-8 N-(2-aminoethyl)-alpha-alanine, SML = 0.05 mg/kg

sodium salt

12786 000919-30-2, 3-aminopropyltriethoxysilan Residual extractable content of 3-

aminopropyltriethoxysilanu must be less

than 3 mg/kg filler. When you use just for

reactive surface treatment of inorganic

fillers and SML = 0.05 mg/kg when used for

surface treatment of materials and products.

12788 002432-99-7 11-aminoundekanová acid SML = 5 mg/kg

12789 007664-41-7 ammonia

12820 000123-99-9 azelaic acid

nonandiová acid

12970 004196-95-6 azelanhydrid

nonandiové acid anhydrite

13000 001477-55-0 1.3-benzendimethanamin SML = 0.05 mg/kg

1.3-bis (aminomethyl) benzene

13060 004422-95-1, trichlorid 1, 3, 5-benzentrikarboxylové QMA = 0.05 mg/6 dm2 (measured as 1, 3, 5

acid benzentrikarboxylová acid)

benzene-1,3,5-tri (Carbonyl chloride)

13075 000091-76-9 benzoguanamine see 2,4-diamino-6-phenyl-1,3,5-triazin

13090 000065-85-0 benzoic acid

13150 000100-51-6 benzyl alcohol

13180 000498-66-8-bicyklo [2.2.1] hept-2en, SML = 0.05 mg/kg

(= norbornen)

13210 001761-71-3 bis (4-aminocyklohexyl) methane SML = 0.05 mg/kg

13317 132459-54-2, N, N '-bis [4-(ethoxykarbonyl) phenyl]-SML = 0.05 mg/kg. Purity higher than 98.1%

1, 4, 5, 8-naftalenetetrakarboxy-diimid (w/w). Only for use as a komonomer

(max. 4%) for polyesters (PET, PBT)

13323 000102-40-9 1.3-bis (2-hydroxyethoxy) benzene SML = 0.05 mg/kg

13326 000111-46-6 bis (2-hydroxyethyl) ether diethylene glycol, see

13380 000077-99-6 2.2-bis (hydroxymethyl)-butan-1-ol; see 1, 1, 1-trimethylolpropan

2-ethyl-2-(hydroxymethyl)-1.3-

diol

13390 000105-08-8 1.4-bis (hydroxymethyl) cyclohexane

13395 04767-03-7 2.2-bis (hydroxymethyl) also named propionic QMA = 0.05 mg/6 dm2

acid

13480 000080-05-7 2.2-bis (4-hydroxyphenyl) propane SML (T) = 0, 6mg/kg (28)

4,4 '-(propane-2.2-diyl) difenol

Bisphenol A

13510 001675-54-3-2.2-bis (4-hydroxyphenyl) propane bis (2,3-according to the requirements of Commission Regulation No 1895/2005

epoxypropyl ether) dated 18 November 2005 on the restriction of the use of

(= BADGE); certain epoxy derivatives in materials

2.2-bis [4-(2,3-and articles intended to come into contact with foodstuffs

epoxypropoxy) phenyl] propane

13530 038103-06-9-2.2-bis (4-hydroxyphenyl) propane-SML = 0.05 mg/kg

bis (phthalic anhydride)

13550 000110-98-5 bis (hydroxy) ether see dipropylene glycol will

13560 005124-30-1, bis (4-isokyanatocyklohexyl) methane see dicyklohexylmethan-4, 4 '-diisocyanate

13600 047465-97-4-3.3-bis (3-methyl-4-hydroxyphenyl-SML = 1.8 mg/kg

indolin-2-on

13607 000080-05-7 phenol, and see 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) see 13530

13617 00080-09-1 of Bisphenol a with 4,4 '-see dihydroxydifenylsulfon

13620 010043-35-3, boric acid SML(t) = 6 mg/kg (11) (expressed as boron)

without prejudice to the provisions relating to the

indicators of the quality of drinking water in accordance with

special 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, 05mg/kg (24)

13780 002425-79-8 1.4-Butanediol-bis QM = 1 mg/kg in FP (expressed as epoxy

(2.3-epoxypropyl) ether; Group, molecular weight = 43)

1.4-bis (2,3-epoxypropoxy) butane

13810 00505-65-7 butane-1.4-diolformal; QMA = 0.05 mg/6 dm2

1.3-dioxepan

13840 000071-36-3 butan-1-ol

13870 000106-98-9-1-en

13900 000107-01-7-2-en

13932 00598-32-3-3-en-2-ol QMA = ND (DL = 0, 02mg/6dm2). When used as a

Copolymer of propřípravu curing ingredients

14020 000098-54-4 4-tert-butylfenol SML = 0.05 mg/kg

14110 000123-72-8 butyraldehyde;

butanaldehyd

14140 000107-92-6 butyric acid;

butanová acid

14170 000106-31-0 butyric acid anhydride;

butananhydrid

14200 000105-60-2, caprolactam; SML(t) = 15 mg/kg (5)

hexano-6 a lactam antibiotic

14230 002123-24-2, caprolactam, sodium salt; SML(t) = 15 mg/kg (5)

hexano-6-a lactam, sodium salt (expressed as caprolactam)

14260 000502-44-3 kaprolakton SML = 0.05 mg/kg

(expressed as the sum of the kaprolaktonu and

6-hydroxyhexanové acid)

14320 000124-07-2 Caprylic acid;

octanoic acid

14350 000630-08-0 carbon monoxide

14380 000075-44-5-Carbonyl chloride QM = 1 mg/kg in FP

14411 008001-79-4 castor oil

14500 009004-34-6 cellulose

14530 007782-50-5 chlorine

14570 000106-89-8, 1-chloro-2.3-is 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 krotonová acid; QMA (T) = 0.05 mg/6 dm2 (33)

(E)-2-enová acid

14841-000599-64-4 4-(1-phenyl-1-methylethyl) phenol SML = 0.05 mg/kg

4-cumylphenol

14880 000105-08-8 1.4-cyklohexandimethanol see 1.4-bis (hydroxymethyl)

cyclohexane

14950 003173-53-3, cyklohexyl-isocyanate QM (T) = 1 mg/kg in FP (expressed as NCO)

(26)

15030 00931-88-4 cyklookten SML = 0, 05mg/kg. The substance may be used

in polymers in contact with foodstuffs,

that is according to annex No 4 to this notice

determined using the simulant and the

15070-001647 16-1 blanket-1.9-dien SML = 0.05 mg/kg

15095 000334-48-5-dekanová acid

15100 000112-30-1, Dean-1-ol

15130 000872-05-9 dec-1-en SML = 0.05 mg/kg

15250 000110-60-1 1.4-diaminobutan

15267 000080-08-0 bis (4-aminophenyl) sulfone SML = 5 mg/kg

15272 000107-15-3 1.2-ethylenediamine diaminoethan see

15274 000124-09-1.6-diaminohexan 4 see hexamethylendiamin

15310 000091-76-9 2.4-diamino-6-phenyl-1,3,5-triazin; QMA = 5 mg/6 dm2

6-phenyl-1,3,5-triazin-2.4-diamine

15565 000106-46-7 1.4-dichlorbenzen SML = 12 mg/kg

15610 00080-07-9 '-dichlordifenylsulfon SML = 0.05 mg/kg

15700 005124-30-1, dicyklohexylmethan-4, 4 '-diisocyanate; QM (T) = 1 mg/kg in FP

bis (4-isokyanatocyklohexyl) methane; (expressed as NCO) (26)

4,4 '-methylendicyklohexyldiisokyanát

15760 000111-46-6 bis (2-hydroxyethyl) ether; SML(t) = 30 mg/kg (3)

diethylene glycol

15790 000111-40-0 diethylenetriamine SML = 5 mg/kg

15820 000345-92-6 '-difluorbenzofenon SML = 0.05 mg/kg

15880 000120-80-9 1.2-dihydroxybenzen; SML = 6 mg/kg

benzene-1.2-diol

15910 000108-46-3 1.3-dihydroxybenzen; SML = 2.4 mg/kg

benzene-1.3-diol
15940 000123-31-9 1.4-dihydroxybenzen; SML = 0.6 mg/kg

benzene-1.4-diol

15970 000611-99-4, 4 '-dihydroxybenzofenon SML(t) = 6 mg/kg (15)

16000 000092-88-6 '-dihydroxydifenyl SML = 6 mg/kg

16090 00080-09-1, 4 '-dihydroxydifenylsulfon; SML = 0.05 mg/kg

4,4 '-sulfonyldifenol

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)

diaminodicyklohexylmethan; For use only in polyamidech

4,4 '-methylenebis (2-methylcyklohexan-1-

Amin)

16240 000091-97-4, 3,3-dimethyl-4, 4 '-QM (T) = 1 mg/kg in FP (expressed as NCO)

diisokyanatodifenyl; (26)

4.4 ' methylenebis (2-

methylfenyl diisocyanate);

bis (4-isokyanato-3-methylfenyl) methane

16360 000576-26-1, 2.6-dimethylphenol SML = 0.05 mg/kg

16390 00126-30-7 2.2-e.g. dimethylpropane-1.3-diol; SML = 0.05 mg/kg

neopentylglykol

16450 000646-06-0 1.3-dioxolan SML = 5 mg/kg

16480 000126-58-9 dipentaerythritol

16540 000102-09-0-diphenyl carbonate SML = 0.05 mg/kg

16570 004128-73-8 diphenyl ethers-4, 4 '-diisocyanate QM (T) = 1 mg/kg in FP (expressed as NCO)

(26)

16600 005873-54-1, difenylmethan-2, 4 '-diisocyanate QM (T) = 1 mg/kg in FP (expressed as NCO)

(26)

16630 000101-68-8 difenylmethan-4, 4 '-diisocyanate QM (T) = 1 mg/kg in FP (expressed as NCO)

(26)

16650 000127-63-9 difenylsulfon SML (T) = 3 mg/kg (25)

16660 000110-98-5 dipropylene glycol will

16690 001321-74-0 divinylbenzen QMA = 0.01 mg/6 dm2 or SML = ND (DL = 0.02

mg/kg, including measurement uncertainty) for the sum of

divinylbenzene and ethylvinylbenzenu

and in accordance with the specifications laid down

in Appendix II to this annex.

16694 013811-50-2, N, N '-divinylimidazolidin-2-on the QM = 5 mg/kg in FP

16697 000693-23-2 dodecanedioic acid

16704 000112-41-4 dodec-1-en 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;

ethylene

16955 000096-49-1 ethylene carbonate residual content = 5 mg/kg of hydrogel

in the maximálnímpoměru 10 g of Hydrogel to 1 kg

food. The hydrolysate contains ethylene glycol

and SML = 30 mg/kg

16960 000107-15-3 ethylenediamine SML = 12 mg/kg

16990 000107-21-1 ethane-1.2-diol; SML(t) = 30 mg/kg (3)

ethylene glycol

17005 000151-56-4 parent SML = ND (DL = 0.01 mg/kg)

17020 000075-21-8 EO QM = 1 mg/kg in FP

17050 000104-76-7 2-ethylhexan-1-ol SML = 30 mg/kg

17110 016219-75-3, 5-ethylidenbicyklo [2, 2, 1] hept-2-en-QMA = 0.05 mg/6 dm2

The ratio between the size of the areas and quantities

food must be less than 2 dm2/kg

17160 000097-53-0 eugenol; SML = ND (DL = 0.02 mg/kg, including uncertainty

2-methoxy-4-(propen-2-yl) phenol) measurement)

17170 061788-47-4 fatty acids, coconut

17200 068308-53-2 fatty acids, soya

17230-12 061790-3 fatty acids, tálový 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 glucaric acid

18070 000108-55-4 glutaranhydrid

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)

ftalová acid;

1, 4, 5, 6, 7, 7,-

hexachlorbicyklo [2.2.1] hept-5-en-2.3-

dikarboxylová acid

18280 000115-27-5 hexachlorendomethylentetrahydro-SML = ND (DL = 0.01 mg/kg)

phthalic anhydride;

anhydride of 1, 4, 5, 6, 7, 7,-

hexachlorbicyklo [2.2.1] hept-5-en-2.3-

dicarboxylic acids

18310 036653-82-4, hexadekan-1-ol

18430 000116-15-4 hexafluorpropylen SML = ND (DL = 0.01 mg/kg)

18460 000124-09-4 hexamethylendiamin SML = 2.4 mg/kg

18640 000822-06-0 hexamethylendiisokyanát; QM (T) = 1 mg/kg in FP (expressed as NCO)

hexane-1.6-diyldiisokyanát; (26)

1.6-diisokyanatohexan

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-en SML = 3 mg/kg

18867 000123-31-9 hydroquinone; see 1, 4dihydroxybenzen

benzene-1.4-diol

18880 000099-96-7 of p-hydroxybenzoic acid acid;

4-Hydroxybenzoic acid acid

18896 001679-51-2, 4-(hydroxymethyl) cyclohex-1-en 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 (vinyl) isobutyl ether QM = 5 mg/kg in FP

19110 04098-71-9-[3-(isokyanatomethyl) -3,5, 5-QM (T) = 1 mg/kg in FP (expressed as NCO)

trimethylcyklohexyl] isocyanate (26)

19150 000121-91-5 1.3-Benzenedicarboxylic acid; SML = 5 mg/kg

isoftalová acid

19210 001459-93-4 dimethyl-isoftalát SML = 0.05 mg/kg

19243 00078-79-5 isoprene see 2-methylbuta-1.3-dien

19270 000097-65-4-itakonová acid;

prop-2-en-1.2-dikarboxylová acid

19460 000050-21-5 the lactic acid

19470 000143-07-7 lauric acid;

dodekanová acid

19480 002146-71-6 vinyl-the Irgun;

Vinyl-dodekanoát

19490 00947-04-6 laurolaktam; SML = 5 mg/kg

dodekano-12-a lactam

19510 011132-73-3, lignocellulose

19540 000110-16-7-maleinová acid; SML(t) = 30 mg/kg (4)

(Z)-butenedioic acid

19960 000108-31-6 maleic anhydride SML(t) = 30 mg/kg (4) (expressed as

maleinová acid)

19975 000108-78-1, Melamine; see the 2, 4, and 6-triamino-1,3,5-triazin

1, 3, 5-triazin-2, 4,6-triamine

19990 000079-39-0 methakrylamid 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)

20170-07-09 000585 tert-butyl methacrylate SML(t) = 6 mg/kg (37)

20260 00101-43-9 cyklohexyl-methacrylate SML = 0.05 mg/kg

20410 02082-81-7 methacrylic acid diester with butane-SML = 0.05 mg/kg

1.4-diol

20440 000097-90-5, methacrylic acid diester SML = 0.05 mg/kg

with 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 methacrylic acid monoester SML(t) = 6 mg/kg (37)

with 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/6 dm2

21460 000760-93-0 methakrylanhydrid SML(t) = 6 mg/kg (37)

21490 000126-98-7 methakrylnitril 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-methylbuta-1.3-dien QM = 1 mg/kg, vFP or SML = ND

(DL = 0,02 mg/kg, including measurement uncertainty)

21730 000563-45-1, 3-methylbut-1-en-QMA = 0.006 mg/6 dm2. Only for use

in polypropylene.

21765 106246-33-7, 4 '-methylenebis (3-chloro-2.6-QMA = 0.05 mg/6 dm2

diethylanilin)

21821 00505-65-7 1.4-(methylendioxy) butane see butane-1.4-diolformal

21940 000924-42-5 N-methylolakrylamid SML = ND (DL = 0.01 mg/kg)

21970 000923-02-4, N-(hydroxymethyl) methakrylamid SML = 0.05 mg/kg

22150 000691-37-2-(methyl) pent-1-en SML = 0.05 mg/kg

22210 000098-83-9 alpha-methylstyren SML = 0.05 mg/kg

22331 025513-64-8 mixture (35-45% w/w) 1.6-diamino-QMA = 5 mg/6 dm2

2.2, 4trimethylhexanu and (55-65%)
1.6-diamino-2, 4,4-trimethylhexanu

22332 028679-16-5 a mixture of (40% w/w 2, 2, 4-QM (T) = 1 mg/kg in FP (expressed as NCO)

trimethylhexanu and 1.6-(26)

diyldiisokyanátu (60%), 2, 4, 4,-

trimethylhexan-1.6-diyldiisokyanátu

22350 000544-63-8-myristová acid;

tetradekanová acid

22360 01141-38-4, naphthalene-2.6-dikarboxylová acid, SML = 5 mg/kg

22390 000840-65-3 dimethyl-2.6-naftalendikarboxylát 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 neopentylglykol see 2.2-e.g. dimethylpropane-1.3-diol

22450 009004-70-0 nitrocellulose

22480 000143-08-8 nonan-1-ol

22550 000498-66-8 norbornen see bicyklo [2.2.1] hept-2-en

22570 000112-96-9 oktadecylisokyanát; QM (T) = 1 mg/kg in FP (expressed as NCO)

1-isokyanatooktadekan (26)

22600 000111-87-5 octane-1-ol

22660 000111-66-0 Oct-1-en SML = 15 mg/kg

22763 000112-80-1 oleic acid

22775 000144-62-7 oxalic acid SML(t) = 6 mg/kg (29)

22778 07456-68-0 '-oxybis (benzensulfonylazid) QMA = 0.05 mg/6 dm2

22780 000057-Palmitic acid, 10-3;

hexadekanová acid

22840 000115-77-5 of pentaerythritol

22870 000071-41-0, pentan-1-ol

22900 00109-67-1, pent-1-en SML = 5 mg/kg

22932 001187-93-5 perfluormethylperfluorvinylether SML = 0.05 mg/kg. To be used only for the

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 uncertainty

measurement)

23070 000102-39-6 (1.3-fenylendioxy) dioctová acid QMA = 0.05 mg/6 dm2

23155 000075-45-5, see phosgene Carbonyl chloride

23170 007664-38-2 phosphoric acid

23175 000122-52-1, triethyl-fosfit QM = ND (DL = 1 mg/kg in FP)

23187 — see Terephthalic acid, ftalová acid

23200 000088-99-3-ftalová acid

23230 000131-17-9-diallyl-phthalate SML = ND (DL = 0.01 mg/kg)

23380 000085-44-9 phthalic anhydride

23470 000080-56-8 alpha-pinene

23500 000127-91-3 beta-pinene

23547 009016-00-6 polydimethylsiloxane (molecular design specifications referred to in

063148-62-9 weight higher than 6 800) in Appendix II of this annex

23590 025322-68-3 polyethylene glycol

23650 025322-69-4 polypropylene glycol (molecular

weight greater than 400)

23651 025322-69-4 polypropylene glycol

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

23830 000067-63-0 propan-2-ol

23860 000123-38-6 propionaldehyde;

propanaldehyd

23890 000079-09-4-propionic acid

23920 000105-38-4-vinyl-propanoát SML(t) = 6 mg/kg (2) (expressed as

acetaldehyde)

23950 000123-62-6 propionanhydrid

23980 000115-07-1 propylene;

condensation reactions

24010 000075-56-9 propylene oxide QM = 1 mg/kg in FP

24051 000120-80-9 catechol; see 1.2-dihydroxybenzen

benzene-1.2-diol

24057 000089-32-7 pyromellitanhydrid SML = 0.05 mg/kg (expressed as

pyromellitovákyselina)

24070 073138-82-6 resin acids and rosin

acid

24072 000108-46-3, see 1, 3dihydroxybenzen resorcinol

24073 000101-90-6 (diglycidyl) resorcinol ether QMA = 0.005 mg/6 dm2. The substance must not be

used in polymers in contact with foodstuffs,

for that is referred to in annex No 4 to this

the Decree provided for the use of the simulant D

the substance may only be used for indirect contact

with food, separated by a layer of PET

24100 008050-09-7 Rosin

24130 008050-09-7 kalafunová resin see Rosin

24160 008052-10-6 kalafunový talový oil

24190 009014-63-5 wood Rosin

24250 009006-04-6 rubber, natural

24270 000069-72-7 salicylic acid;

2-hydroxybenzoic acid acid

24280 000111-20-6 sebacic acid;

dodecanedioic acid

24430 002561-88-8 sebakanhydrid;

dekandiové acid anhydride

24475 001313-82-2 sodium sulfide

24490 000050-70-4, sorbitol

24520 008001-22-7 soybean oil

24540 009005-25-8 starch, food

24550 000057-11-4 stearic acid;

oktadekanová acid

24610 000100-42-5 styrene

24760 026914-43-2, styrensulfonová acid SML = 0.05 mg/kg

24820 000110-15-6 amber acid

24850 000108-30-5, amber acid anhydride

24880 000057-50-1 sucrose

24886 046728-75-0 monolithium-5-sulfoisoftalát SML = 5 mg/kg, and for lithium SML(t) = 0.6

mg/kg (8) expressed as lithium

24887 006362-79-4, 5-sulfoisoftalová acid, monosodium SML = 5 mg/kg

Salt

24888 003965-55-7 dimethyl ester 5-sulphoisoftalové SML = 0.05 mg/kg

acid, monosodium salt

24903 068425-17-2, syrups, hydrolysed starch, in compliance with the specifications laid down

hydrogenated in Appendix II of this annex

24910 000100-21-0 Terephthalic acid SML = 7.5 mg/kg

24940 000100-20-9 dichlorid Terephthalic acid SML(t) = 7.5 mg/kg (expressed as

Terephthalic acid)

24970 000120-61-6-dimethyl terephthalate

001120 25080-36-1, tetradec-1-en SML = 0.05 mg/kg

25090 000112-60-7 tetraethylenglykol

25120 000116-14-3 tetrafluorethylen 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 toluene-2.4-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) acetates (= QMA = 0, 05mg/6 dm2

Vinyl-versatáty)

25385 000102-70-5 triallylamin in compliance with the specifications laid down

in Appendix II to this annex.

25420 000108-78-1, 2, 4, and 6-triamino-1,3,5-triazin SML = 30 mg/kg

25450 26896-48-0 tricyklodekandimethanol SML = 0.05 mg/kg

25510 000112-27-6 triethylene glycol

25540 000528-44-9 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-trimethylolpropan; SML = 6 mg/kg

2-ethyl-2-(hydroxymethyl)-1.3-

diol

25840 003290-92-4 2.2-bis (methakryloxymethyl)-yl-SML = 0.05 mg/kg

methacrylate

25900 00110-88-3 trioxan SML = 5 mg/kg

25910-024800 44-0 tripropylenglykol

25927 027955-94-8, 1, 1, 1 '-tris (4-hydroxyphenyl) ethan QM = 0.5 mg/kg in FP. For use only

in the polykarbonátech.

25960 000057-13-6 urea

26050 000075-01-4 vinyl chloride see. the requirements of this Ordinance

26110 000075-35-4 vinylidene chloride QM = 5 mg/kg in FP or

SML = ND

(DL = 0.05 mg/kg)

26140 000075-38-7 vinyliden-fluoride SML = 5 mg/kg

26155 001072-63-5 1-vinylimidazol QM = 5 mg/kg in FP

26170 003195-78-6 N-vinyl-N-methylacetamid QM = 2 mg/kg, vFP

26320 002768-02-7 vinyltrimethoxysilan QM = 5 mg/kg in FP

26360-18 007732-5 the water in accordance with a special law,

that stanovípožadavky to the drinking water.



SECTION B



LIST OF MONOMERS AND OTHER STARTING SUBSTANCES, WHICH MAY BE USED TO

THE DECISION ON INCLUSION IN SECTION A

----------------------------------------------------------------------------

PM/REF CAS number Name restrictions and/or

no specifications

----------------------------------------------------------------------------

(1) (2) (3) (4)

----------------------------------------------------------------------------

13050 00528-44-9-1, 2, 4-benzentrikarboxylová, see trimellitová

acid acid

15730 00077-73-6 of dicyclopentadiene

18370 000592-45-0, hexa-1.4-dien

26230 000088-12-0 vinylpyrrolidone

----------------------------------------------------------------------------



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



SECTION AND

---------------------------------------------------------- ------------------------------

PM/REF CAS number 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 acid, měďná 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 (acetony) propylester

12-acid (acetony), stearic

30370 — acetyloctová acid, salts

30401-ACETYLATED mono-and diglycerides

fatty acids

30610-C2-C24 aliphatic, linear

monocarboxylic acids

from natural oils and fats

and their mono-, di-

and triglycerides (including

branched-chain fatty acids, how

they occur naturally

in nature)

30612 — synthetic C2-C24, aliphatic,

linear, monocarboxylic

acids and their mono-, di-

and triglycerides

— esters of aliphatic, 30960

monocarboxylic acids (C6-

C22) with polyglycerolem

31328-fatty acids from animal

or vegetable edible fats

and oils

31530 123968-25-2 2.4-diterc-pentyl-6-[1-(3,5-di-SML = 5 mg/kg

tert-pentyl-2-

hydroxyphenyl phenyl) ethyl]-

Acrylic

31542 174254-23-0-methyl acrylate, Telomere with 1-QM = 0.5% (w/w) in FP

dodekaneethiolem, C16-C18

alkyl esters

31730 000124-04-9-adipová acid

33120-alcohols, aliphatic, with one

a group of OH, saturated,

linear, primary (C4-C24)

33350 009005-32-7-alginová acid

33801-n-alkyl (C10-C13)/benzene sulphonic SML = 30 mg/kg

acid

34240-esters of alkyl (C10-C20) sulphonic SML = 6 mg/kg

with phenols acid

34281 — alkylsírové acid (C8-C22)

linear, primary, with an even

the number of carbon atoms

34475 — fosforitan calcium-hydroxide

aluminium hydrate

34480 — aluminium fibers, flakes

and pills

34560 021645-51-2 aluminum hydroxide

34690 011097-59-9-magnesium carbonate hydroxide-

aluminium

34720-001344 28-1 aluminium oxide

34850 143925-92-2 oxidized dialkylminy technically QM = for use only:

hydrogenated and) in polyolefinech

in the amount of 0.1% in the

(w), but not

in LDPE, which is designed for

contact with food, for

that is according to annex No 4

This decree established

the specified reduction factor

less than 3;

(b)) in the PET to 0.25

% (w/w), which is designed

to come into contact with foodstuffs

with the exception of those for which

According to annex No 4

This Decree provided for

application of simulant D.

34895 000088-68-2-6 aminobenzamid SML = 0.05 mg/kg

The substance may be used only

for the PET, which is designed for

contact with drinking water

and drinks.

35120 013560-49-1 thiobis (2-hydroxyethyl) diester

3-aminokrotonové acid

35160 06642-31-5 to 6-amino-1.3-dimethyluracil SML = 5 mg/kg

35170 00141-43-5, 2-aminoethanol SML = 0.05 mg/kg. The substance

may not be used

in polymers in contact

with the food for which it is

According to annex No 4 this

the Decree provided for the use of

simulant D substance may be

used only for indirect

come into contact with foodstuffs,

separate from the food

layer PET

35284 00111-41-1, N-(2-hydroxyethyl) ethane-1.2-SML = 0.05 mg/kg. The substance

diamine must not be used

in polymers in contact

with the food for which it is

According to annex No 4 this

the Decree provided for the use of

simulant D substance may be

used only for indirect

come into contact with foodstuffs,

separate from the food

layer PET

35320 007664-41-7 ammonia

35440 012124-97-9 ammonium bromide

35600 001336-21-6 ammonium hydroxide

35840 000506-30-9-arachidová acid

007771-35845 44-0 arachidonic acid

36000 000050-81-7 of Ascorbic acid

36080 000137-66-askorbyl 6-palmitate;

askorbyl-hexadekanoát

36160 010605-09-1 askorbyl-stearate

36840 012007-55-5 tetraboritan barium SML(t) = 1 mg/kg (12)

(expressed as barium) and

SML(t) = 6 mg/kg (23)

(expressed as boron) without

prejudice to the specific legal

the regulation laying down

the requirements for potable water.

36880 008012-89-3 beeswax

36960 003061-75-4 behenamid

37040 000112-85-6 behenová acid

37280 001302-78-9 bentonite

37360 000100-52-7 benzaldehyd in accordance with note (9)

in Appendix III to this annex.

37600 000065-85-0 benzoic acid

37680 000136-60-7 butyl benzoate

37840 000093-89-0 of ethyl-benzoate

38080 000093-58-3 methyl-benzoate

002315-38160-68 6-propyl benzoate

38510 136504-96-6 1.2-bis (3-SML = 5 mg/kg

Aminopropyl) ethylenediamine,

polymer with N-butyl-2, 2-6, 6-

tetramethyl-4-piperidinaminem

and 2, 4, 6-trichloro-1, 3.5-

Triazine

38515 001533-45-5, 4 '-bis (2-4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene) stilben 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 fosfitů

methylfenoxy) -2,4, 8.10-tetraoxa-and phosphate)

3.9-difosfaspiro [5.5] undekan

(bis (2,6-di-tert-butyl-4-

pentaerythhhritol-methylfenyl)

difosfit)

38840 154862-43-8 bis (2,4-dikumylfenyl) SML = 5 mg/kg (as the sum

pentaerythritoldifosfit of the substance itself, its

the oxidised form bis (2.4-

dikumylfenyl)

pentaerythritolfosfátu

and its hydrolysis product

2.4-dikumylfenol)

38879 135861-56-2 bis (3,4-

dimethylbenzyliden) sorbitol

38885 002725-22-6 2.4-bis (2,4-dimethylfenyl)-6-[2-SML = 0.05 mg/kg. Only for the

hydroxy-4-(oktyloxy) phenyl]-aqueous foods.

1, 3, 5-triazin

38950 079072-96-1, bis (4-ethylbenzyliden) sorbitol

39200 006200-40-4, bis (2-hydroxyethyl)-2-SML = 1.8 mg/kg

3-Hydroxy-

(dodecyloxy)-n-

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/6 dm2

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-SML = 0.05 mg/kg

dimethylhexan

40120 068951-50-8 bis (polyethylene glycol) hydroxymetSML = 0.6 mg/kg

hyl fosfonát;

[(hydroxymethyl) fosforyl] bis [poly

(ethers)]

40320 010043-35-3, boric acid SML(t) = 6 mg/kg (23)

(expressed as boron) without

prejudice to the provisions of the

a specific legal

the regulation laying down

the requirements for potable water.

40400 010043-11-5 Boron Nitride

40570 000106-97-8 butane

40580 000110-63-4 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

41520 001305-78-8 calcium oxide

41600 012004-14-7 sulfohlinitan calcium

037293-22-4

41680 000076-22-2, camphor in accordance with note (9)

in Appendix III to this annex.

41760 008006-44-8 wax kandelilla

41840 00105-60-2, caprolactam SML(t) = 15 mg/kg (5)

41960 000124-07-2 Caprylic acid;

octanoic acid

42080 001333-86-4 carbon black in accordance with specifications

laid down in Appendix II of this

Annex.

42160 000124-38-9 carbon dioxide

42320 007492-68-4 copper carbonate SML (T) = 5 mg/kg (7)

(expressed as copper)

42500-carbonic acid, salts

42640 009000-11-7 carboxymethylcellulose
42720 008015-86-9 carnauba wax

42800 009000-71-9 of the casein

42880 008001-79-4 castor oil

42960 064147-40-6 castor oil, anhydrous

43200 — castor oil, mono-

and diglycerides

43280 009004-34-6 cellulose

43300 009004-36-8-cellulose acetate butyrate

43360 068442-85-3 cellulose, regenerated

43440 008001-75-0 ceresin

43480 064365-11-3 active coal in accordance with specifications

laid down in Appendix II

of this annex.

43515 — cholinesterů, chlorides fatty QMA = 0.9 mg/6 dm2

acids of coconut oil

44160 000077-92-9 citric acid

44640 000077-93-0-methyl citrate

45195 007787-70-4 copper bromide SML (T) = 5 mg/kg (7)

(expressed as copper)

45200 001335-23-5 copper iodide SML (T) = 5 mg/kg (7)

(expressed as copper)

SML(t) = 1 mg/kg (11)

(expressed as iodine)

45280 — cotton fibres

45450 068610-51-5 reaction product of p-cresol, SML = 5 mg/kg

with dicyklopentadienem

and isobutylene;

p-cresol-dicyklopentadie-

isobutylene, copolymer

45560 014464-46-1 kristobalit

45600 003724-65-0 krotonová acid; QMA (T) = 0.05 mg/6dm2 (33)

(E)-2-enová acid

45640 005232-99-5-ethyl 3.3-diphenyl-2-Cyanoacrylate; SML = 0.05 mg/kg

acid, 2-ethyl ester kyano-3.3-

diphenyl-acrylic

45705 166412-78-8, diisononyl-cyclohexane-1.2-

dikarboxylát

45760 000108-91-8 cyklohexylamin

45920 009000-16-2, dammar

45940 000334-48-5, n-dekanová acid

46070 010016-20-3 Alpha-dextrin

46080 007585-39-9 beta-dextrin

46375 061790-53-2 diatomaceous earth

46380 068855-54-9, diatomaceous earth, anhydrous carbonate

sodium, calcined from melt

46480 032647-67-9 dibenzyliden-sorbitol

46700-5.7-di-tert-butyl-3-(3,4-and 2.3-SML = 5 mg/kg

dimethylfenyl) benzofuran-2 (3 h)-

He, containing:

and) 5.7-di-tert-butyl-3-(3,4-

dimethylfenyl) benzofuran-2 (3 h)-

He (80 to 100%), and materials.

(b)) 5.7-di-tert-butyl-3-(2,3-

dimethylfenyl) benzofuran-2 (3 h)-

He (0 to 20%), the plastic.

46720 004130-42-1, 2.6-di-tert-butyl-4-ethylfenol QMA = 4.8 mg/6 dm2

46790 004221-80-1, 2.4-di-tert-butylfenylester-3.5

di-tert-butyl-4-Hydroxybenzoic acid

acid

46800 067845-93-6 hexadecylester 3.5-di-tert-

Butyl-4-Hydroxybenzoic acid

acid

46870 003135-18-0 dioktadecylester 3.5-di-tert-

Butyl-4-hydroxybenzylfosfonové

acid

46880 065140-91-2-3,5-monoethyl (di-tert-butyl-4-SML = 6 mg/kg

hydroxybenzyl) fosfonát,

calcium salt

47210 26427-07-6 of the dibutyl-thiocíničitan, polymer; In accordance with the specifications

thiobis (butylcín sulfide), in Appendix II to this annex.

polymer

47440 000461-58-5 dikyanodiamid

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 glycol

48460 000075-37-6-1.1 difluorethan

48620 00123-31-9 1.4-dihydroxybenzen SML = 0.6 mg/kg

48720 00611-99-4, 4 '-dihydroxybenzofenon SML(t) = 6 mg/kg (15)

49485 134701-20-5 2.4-dimethyl-6-(1-SML = 1 mg/kg

methylpentadecyl) phenol

49540 000067-68-5 dimethylsulfoxide

51200 000126-58-9 dipentaerythritol

51700 147315-2-50-2 (4.6-diphenyl-1,3,5-triazin-2-SML = 0.05 mg/kg)

YL)-5-(hexyloxy) phenol

51760 025265-71-8 dipropylene glycol will

000110-98-5

52640 016389-88-1 of the Dolomites

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

000112 52720-84-5 erukamid

52730 000112-86-7-eruková acid

52800 000064-17-5 ethanol

53270 037205-99-5 ethylkarboxymethylcelulóza

53280 009004-57-3 ethyl cellulose

53360 000110-31-6 N, N '-ethylenbis (oleamid)

53440 005518-18-3 N, N '-ethylenbis (palmitamid)

53520 000110-30-5, N, N '-ethylenbis (stearamid)

53600 000060-00-4 edetic

acid

53610 054453-03-1 ethylenediaminetetraacetic SML (T) = 5 mg/kg (7)

acid, copper salt (expressed as copper)

53650 000107-21-1 ethane-1.2-diol (ethylene glycol) SML(t) = 30 mg/kg (3)

54005 005136-44-7-N-palmitamid-N '-

stearamid

54260 009004-58-4 ethylhydroxyethylcelulóza

54270 — ethylhydroxymethylcelulóza

54280 — ethylhydroxypropylcelulóza

54300 118337-09-0, 2 '-bis (ethyliden-4,6-di-tert-SML = 6 mg/kg

Butyl-phenyl) fluorfosfonit

54450 — fats and oils of animal or

plant sources of food

54480 — fats and oils of animal or

plant sources of food,

hydrogenated

54930 025359-91-5-1-naphthol, SML = 0.05 mg/kg

copolymer; Poly (1-

hydroxynaftylmethan)]

55040 000064-18-6 Ant acid

55120 000110-17-8 fumaric acid

55190 029204-02-2-gadoleová acid

55440 009000-70-8 gelatine

55520 — glass fibers

55600-glass microspheres

55680 000110-94-1 glucaric acid

55920 000056-81-5, glycerol

56020 099880-64-5-dibehenát;

glycerol-didokosonoát

— esters of glycerol with 56360 acid

acetic

— esters of glycerol with 56486 acids,

aliphatic, saturated,

linear, with an even number of

carbon atoms (C14-C18)

and with acids, aliphatic,

unsaturated, linear,

an even number of carbon atoms

(C16-C18)

— esters of glycerol with 56487 acid

upon

— esters of glycerol with 56490 acid

erucic

— esters of glycerol with 56495 acid 12-

hydroxystearovou

— esters of glycerol with 56500 acid

(a)

— esters of glycerol with 56510 acid

Linoleic

— esters of glycerol with 56520 acid

myristovou

— esters of glycerol with 56535 acid

nonanovou

— esters of glycerol with 56540 acid

oil

— esters of glycerol with 56550 acid

Palmitic acids

— esters of glycerol with 56570 acid

propionic

— esters of glycerol with 56580 acid

ricinolejovou

— esters of glycerol with 56585 acid

stearic acids

56610 030233-64-8 monobehenát glycerol

56720 026402-23-3 monohexanoát glycerol

56800 030899-62-8 monolaurát-glycerol diacetate

56880 026402-26-6 monooktanoát glycerol

57040-monooleátu ester of glycerol

acid Ascorbic acid

57120 — ester monooleátu glycerol

with citric acid

57200-monopalmitátu ester of glycerol

acid Ascorbic acid

57280 — ester monopalmitátu glycerol

with citric acid

57600 — ester monostearátu glycerol

acid Ascorbic acid

57680-monostearátu ester of glycerol

with citric acid

57800 018641-57-1 glyceryl-tri (dokosanoát)

57920 000620-67-7 triheptanoát glycerol

58300-glycine, salts

58320 007782-42-5 graphite

58400 009000-30-0 guar resin

58480 009000-01-5 Gum Arabic

58720 000111-14-8 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, hexanová acid

59760 019569-21-2 huntit

59990 007647-01-0 hydrochloric acid

60030-90 012072-1 hydromagnesit

60080 012304-65-3 hydrotalkit

60160 000120-47-8-ethyl-4-hydroxybenzoát

60180 004191-73 5-isopropyl-4-hydroxybenzoát

60200 000099-76-3-methyl-4-hydroxybenzoát

60240 000094-13-3 propyl-4-hydroxybenzoát

60480 003864-99-1 of 2-(2-hydroxy-3.5-di-tert-butyl-SML (T) = 30 mg/kg (19)

phenyl)-5-chlorbenzotriazol

60560 009004-62-0 hydroxyethylcelulóza

60880 009032-42-2 hydroxyethylmethylcelulóza

61120 009005-27-0 hydroxyethylový starch

61390 037353-59-6 hydroxymethylcelulóza

61680 009004-64-2 hydroxypropylcelulóza

61800 009049-76-7 hydroxypropylový starch

61840 000106-14-9-12-hydroxystearic acid acid

62020 007620-77-1 lithium 12-hydroxystearát SML(t) = 0.6 mg/kg (8)

expressed as lithium

62140 006303-21-5-fosforná acid

62240 001332-37-2, iron oxide

62245 012751-22-3 iron phosphide Only for polymers

and PET copolymers

62450 000078-78-4 isopentan

008001 62640-39-6 Japan wax

62720 001332-58-7 kaolin

62800 — kaolin, calcined

62960 000050-21-5 the lactic acid

63040 000138-22-7 butyl lactate

63280 000143-07-7 lauric acid

63760 008002-43-5, lecithin

63840 000123-77-2, levulová acid

63920 000557-59-5-lignocerová acid

64015 000060-33-3 linoleic acid

64150 028290-79-1, linolenic acid

64500-lysine, salts

64640 001309-42-8 magnesium hydroxide

64720 001309-48-4 magnesium oxide
64800 00110-16-7-maleinová acid SML(t) = 30 mg/kg (4)

64990 025736-61-2-styrene maleic anhydride, in accordance with the specifications

copolymer, sodium salt laid down in Appendix II

of this annex.

65020 006915-15-7 Apple acid

65040 000141-82-2, malonová acid

65520 000087-78-5 mannitol

65920 66822-60-4 1-[N-methakryloyloxyethyl-

N, N-dimethyl-N-carboxymethyl-

ammonium chloride-oktadecyl-

methacrylate-ethylmethakrylát-

cyklohexyl methacrylate-N-vinyl-

2-pyrrolidon, copolymers

66200 037206-01-2 methylkarboxymethylcelulóza

66240 009004-67-5 methyl cellulose

66560 004066-02-8 '-methylene-bis (4-methyl-6-SML (T) = 3 mg/kg (6)

cyklohexylfenol)

66580 000077-62-3, 2 '-methylene-bis [4-methyl-6-(1-SML (T) = 3 mg/kg (6)

methylcyklohexyl) phenol]

66640 009004-59-5 methylethylcelulóza

66695 — methylhydroxymethylcelulóza

66700 009004-65-3 methylhydroxypropylcelulóza

66755 002682-20-4, 2-methyl-4-isothiazolin-3-on SML = ND (DL = 0,02

mg/kg, including uncertainty

measurement)

66905 000872-50-4, N-methylpyrrolidon

66930 068554-70-1 methylsilseskvioxan Residual monomer

in methylsilseskvioxanu;

> 1 mg

methyltrimethoxysilanu/kg

methylsilseskvioxanu



67120 012001-26-2 MICA

67155 — a mixture of 4-(2-4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene)-4 '-(5-Most 0.05% by weight

methyl-2-4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene), (the amount used

4,4 '-bis (2-substances/quantity

4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene) stilbene and 4,4 '-product). In accordance with the

bis (5-methyl-2-specifications laid down

4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene) stilbene in Appendix II to this annex.

67180 — a mixture of decyl-octylftalátu (50% of SML = 5 mg/kg (1)

materials) didecyl phthalate (25%

materials.) and dioktylftalátu (25%

materials.)

67200 001317-33-5 molybdeničitý sulfide

67840 — montanové acid and/or

their esters with ethyleneglycol

and/or butane-1.3-propanediol and/or

1,2,3-propanetriol

67850 008002-53-7 montanový wax

67891 000544-63-8-myristová acid

68040 003333-62-8 7-[2 h-nafto-(1,2-D)-triazol-2

YL]-3-fenylkumarin

68078 027253-31-2, neodekanová acid, salt SML(t) = 0.05 mg/kg

cobalt; (expressed as neodekanová

7.7-dimethyloktanová acid, acid) and

salt of cobalt SML(t) = 0.05 mg/kg (14)

(expressed as cobalt)

The substance must not be used

in polymers intended for

contact with food, for which

According to annex No 4

This decree established

simulant D.

68125 037244-96-5 Nefelinsyenit

68145 080410-33-9-2, 2 ', 2 ''-nitrilo [triethyl-SML = 5 mg/kg (sumafosfitů

Tri (3,3 ', 5,5 '-tetra-tert-butyl-and phosphate)

1,1 '-biphenyl-2, 2 '-diyl) fosfit]

68960 000301-02-0 Okeanid

69040 000112-80-1 oleic acid

69760 000143-28-2 Oleylalkohol

69920 000144-62-7 oxalic acid SML(t) = 6 mg/kg (29)

70000 070331-94-1, 2 '-oxamidobis [ethyl-3-(3,5-di-

tert-butyl-4-hydroxyphenyl)-

propionate]

70240 012198-93-5 Ozokerit

70400 000057-Palmitic acid, 10-3

71020 000373-49-9-palmitolejová acid

71440 009000-69-5 Pectin

000115 71600-77-5 of Pentaerythritol

71635 025151-96-6 2.2-bis (hydroxymethyl)-SML = 0.05 mg/kg. Must not be

1.3-diol-di ((z)-9-butenoate) used in polymers in

(pentaerythritol-dioleát) in contact with food, for

which is the annex No 4 to this

the decree established the simulant

(D).

71670 178671-58-4 pentaerythritol tetrakis (2-SML = 0.05 mg/kg

kyano-3.3-di-fenylakrylát)

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 perfluoroktanoát to use only

in articles for repeated

the use of sintered at

high temperatures.

72640 007664-38-2 phosphoric acid

73160 — mono-and di-n-alkyl (C16 SML = 0.05 mg/kg

and C18) esters of phosphoric acid

73720 000155-96-8 (trichlorethyl)-phosphate SML = ND (DL = 0, 02mg/kg,

including measurement uncertainty)

74010 145650-60-8 bis (2,4-di-tert-butyl-6-SML = 5 mg/kg (sumafosfitů

methylfenyl) ethyl fosfit and phosphate)

74240 031570-04-4 of the tris (2,4-di-tert-butylfenyl)-

fosfit

74480 000088-99-3-ftalová acid

74560 000085-68-7 butyl benzyl phthalate for use as:

a) plasticizer

in the materials and products

for repeated use

b) plasticizer

in the materials and products

single use

coming into contact

with food-beztukovými

In addition to the initial

and follow-on formulae

Nutrition under the Special

legal předpisu4).

(c)) the technical assistant

material in concentrations in the

0.1% in the final product

SML = 30 mg/kg of simulant

food

74640 000117-81-7 bis (2-ethylhexyl) phthalate for use as:

a) plasticizer

in the materials and products

for repeated use

coming into contact

with food-beztukovými

(b)) Technical Assistant

material in concentrations in the

0.1% in the final product

SML = 1.5 mg/kg simulant

food

74880 000084-74-2 Dibutylphthalate for use as:

a) plasticizer

in the materials and products

for repeated use

coming into contact

with food-beztukovými

(b)) Technical Assistant

material in concentrations in the

0.05% in the final product

SML = 0.3 mg/kg simulant

food

75100-068515 48-0 1,2-Benzenedicarboxylic with saturated to be used only as:

028553-12-0 paraffin primary Alkyls) emollient

C8-C10, containing more than 60% of the materials and products

alkylů C9 for reuse

b) plasticizer in products

single use

coming into contact

with food-beztukovými

In addition to the initial

and follow-on formulae

Nutrition under the Special

legal předpisu4).

(c)) the technical assistant

material in concentrations in the

0.1% in the final product

SML (T) = 9 mg/kg simulant

food (42)

75105 068515-49-1 1,2-Benzenedicarboxylic with saturated to be used only as:

026761-40-0 primary Alkyls C9-C11), emollient

containing more than 90% of the alkylů in materials and products

C10 for reuse

b) plasticizer in products

single use

coming into contact

with food-beztukovými

In addition to the initial

and follow-on formulae

Nutrition under the Special

legal předpisu4)

(c)) the technical assistant

material in concentrations in the

0.1% in the final product

SML (T) = 9 mg/kg simulant

food (42)

76320 000085-44-9 phthalic anhydride

76415 019455-79-9 pimelic acid, calcium salt

76721-00-6 009016 Polydimethylsiloxane (Mw > 6 800) in accordance with the specifications

063148-62-9 set out in Appendix II

of this annex.

76730-polydimethylsiloxane, Alpha-SML = 6 mg/kg

hydroxypropylovaný
76815-polyester of adipic acid in accordance with specifications

with glycerol or set out in the Appendix

pentaerythritol, esters with in this annex.

an even number of carbon atoms,

fatty acids, C12-C22,

linear

76845 031831-53-5 1.4-Butanediol polyester in accordance with specifications

with the kaprolaktonem laid down in Appendix II

of this annex.

76866-polyester propane-1.2-diol SML = 30 mg/kg

and/or butane-1.3-diol, and/or

butane-1.4-diol and/or

polypropylenglykolu acid

adipovou, which can be

completed groups derived from the

from acetic acid or

fatty acids, C12-C18 or

octane-1-OL and/or Dean-1-OL

76960 025322-68-3 polyethylene glycol

77370 070142-34-6 poly (ethylene glycol-30)

dipolyhydroxystearát

77600 061788-85-0, polyethylene glycol ester

with hydrogenated ricínovým

oil

77702 — polyethylene glycol esters

with aliphatic

monokarboxylovými acids

(C6-C22) and their ammonium

and sodium sulphates

77895 068439-49-6 ether polyethylene glycol (EO = SML = 0.05 mg/kg and in accordance

2-6) and monoalkylu (C16-C18) with the specifications in the Appendix

II of this annex

79040 009005-64-5 sorbitan-monolaurát

polyethylene glycol

009005 79120-65-6 sorbitan monooleate

polyethylene glycol

79200 009005-66-7, sorbitan-monopalmitát

polyethylenglycolu

79280 009005-67-8 sorbitan-monostearát

polyethylene glycol

79360 009005-70-3 sorbitan trioleate-

polyethylene glycol

79440 009005-71-4 sorbitan-tristearát

polyethylene glycol

79600 009046-01-9 poly (ethylene glycol) SML = 5 mg/kg. For

tridecylether phosphate, materials and articles intended

only for contact with aqueous

food. In accordance with the

specifications laid down

in Appendix II to this annex.

79920 009003-11-6 poly (ethylene-co-

106392-12-5, propylene glycol)

80000 009002-88-4 of the polyethylene wax

80240 029894-35-7 ricinoleát homopolymer

80640 — polyoxyalkyl (C2-

C4) dimethylpolysiloxan

80720 008017-16-1, polyfosforečné acid

80800 025322-69-4 polypropylene glycol

81060 009003-07-0 polypropylene wax

81220 192268-64-7 poly [[6-[N-(2, 2, 6, and 6-SML = 5 mg/kg

tetramethylpiperidin-4-yl)-n-

butylamino]-1,3, 5-triazin-2.4-

4] [N-(2, 2, 6, 6

tetramethylpiperidin-4-

YL) Abdurrahman] hexane-1.6-4 [N-

(2, 2, 6, and 6-tetramethylpiperidin-4-

YL) Abdurrahman]]--[N, N, N ', N '-

tetrabutyl-N '' '-(2, 2, 6, 6

tetramethylpiperidin-4-

Benzoic ylamino)] [1, 3, 5-triazin-

2, 4, 6]-triamino-s-N, N, N ', N '-

tetrabutyl-1, 3,5-triazin-2.4-

diamine

81500 9003-39-8 poly (vinylpyrrolidone) in accordance with the specifications

laid down in Appendix II

of this annex

81515 087189-25-1 zinc polyglycerolát SML(t) = 25 mg/kg (38)

(expressed as zinc)

81520 007758-02-3 potassium bromide

81600 001310-58-3 potassium hydroxide

81760 — powders, flakes and fibres of brass, SML (T) = 5 mg/kg (7)

bronze, copper, stainless (expressed as copper)

steel, Tin and alloys of copper, Tin, SML = 48 mg/kg (expressed as

iron and iron)

81840 000057-55-6 propane-1.2-diol

81882 000067-63-0 propan-2-ol

82000 000079-09-4-propionic acid

82080 009005-37-2 1.2-propylene glycol alginate

82240 022788-19-8 dilaurát 1.2-propylene glycol

82400 000105-62-4 dioleát 1.2-propylene glycol

82560 033587-20-1 dipalmitát 1.2-propylene glycol

82720 006182-11-2 distearát 1.2-propylene glycol

82800 027194-74-7 monolaurát 1.2-propylene glycol

82960 001330-80-9 1.2-propylene glycol monooleát

029013-83120 28-3 1.2-monopalmitát

propylene glycol

83300-001323 39-3 monostearát 1.2-propylene glycol

83320 — propylhydroxyethylcelulóza

83325 — propylhydroxymethylcelulóza

83330 — propylhydroxypropylcelulóza

83440 002466-09-3 difosforečná acid

83455 013445-56-2-difosforitá acid

83460 012269-78-2 Pyrophyllit

83470 014808-60-7 Quartz

83599 68442-12-6 reaction products of 2-SML (T) = 0, 18 mg/kg (16)

sulfonylethyl-oleátu with Dichloro-(expressed as Tin)

dimethylcínem, sulfidem sodium

and trichlormethylcínem

073138 83610-82-6 resin acids

and rosin acids

83840 008050-09-7 Rosin

84000 008050-31-5, Rosin, ester with 1,2,3-propanetriol

84080 008050-26-8 Rosin, ester

with pentaerythritol

84210 065997-06-0 Rosin, hydrotreated

84240 065997-13-9 Rosin, hydrotreated;

ester with 1,2,3-propanetriol

84320 008050-15-5 Rosin, hydrotreated;

ester with methanol

84400 064365-17-9 Rosin, hydrotreated;

ester with pentaerythritol

84560 009006-04-6 rubber, natural

84640 000069-72-7 salicylic acid

85360 000109-43-3, dibutyl dekandioát

85601 — natural silicates (in addition to the

asbestos)

85610-silicates, natural,

silanized (except asbestos)

85680 01343-98-2 silicic acid

85840 053320-86-8 lithium-sodium-silicate SML(t) = 0,6 mg/kg (8)

magnesium (expressed as lithium)

silicic acid, 86000 — silylovaná

86160 000409-21-2 silicon carbide

86240 007631-86-9 silica

86285 — silica, silanizovaný

86560 007647-15-6 sodium bromide

86720 001310-73-2 sodium hydroxide

87040 001330-43-4 disodium tetraborate SML(t) = 6 mg/kg (23)

(expressed as boron) without

prejudice to the provisions of the

a specific legal

Regulation establishing a

pitnouvodu requirements

87200 000110-44-1, acid sorbic acid

87280 029116-98-1-sorbitan dioleát

87520 062568-11-0 sorbitan-monobehenát

87600 001338-39-2 sorbitan-monolaurát

87680 001338-43-8 sorbitan monooleate

87760 026266-57-9 sorbitan-monopalmitát

87840 001338-41-6 sorbitan-monostearát

87920 061752-68-9 sorbitan-tetrastearát

88080 026266-58-0 sorbitan trioleate-

88160 054140-20-4 sorbitan-tripalmitát

88240 026658-19-5 sorbitan-tristearát

88320 000050-70-4, Sorbitol

88600 026836-47-5 monostearát sorbitol

88640 008013-07-8 oil from soybeans, SML = 60 mg/kg. However,

oxidised in the case of seal zPVC

the jars

with the initial and follow-on

infant nutrition according to the

a specific legal

the regulation, which

requirements

foods intended for

special diets and method

their use, or

grain and other

foods for small kojencea

children under this Ordinance,

SML is reduced to 30 mg/kg.

In accordance with the specifications

in Appendix II to this annex.

88800 009005-25-8 starch, food

88880 068412-29-3, starch, hydrolyzed

88960 000124-26-5 Stearamid

89040 000057-11-4 stearic acid

89200 007617-31-4 copper stearate SML (T) = 5 mg/kg (7)

expressed as copper

— esters of stearic acid 89440 SML(t) = 30 mg/kg (3)

with ethylenklykolem

90720 058446-52-9 stearoylbenzoylmethan

90800 005793-94-2-stearoyl 2-lactic acid,

calcium salt

90960 000110-15-6 amber acid

91200 000126-13-6-acetate isobutyrát sucrose

91360 000126-14-7 oktaacetát sucrose

91840 007704-34-9 Sulfur

91920 007664-93-9 sulfuric acid

92030 010124-44-4 copper sulfate SML (T) = 5 mg/kg (7)

expressed as copper

92080 014807-96-6 of Talc

92150 01401-55-4 of tannin acid in accordance with specifications

JECFA

92160 000087-69-4 wine acid

92195 — TAURINE, salts

92205 057569-40-1, 2 '-methylenebis (4-methyl-6-

tert-diester butylfenol)

Terephthalic acid

92350 000112-60-7 Tetraethylenglykol

92640 000102-60-3, N, N, N ', N '-tetrakis (2-

hydroxypropyl) ethylenediamine

92700 078301-43-6, 2, 2, 4, and 4-tetramethyl-20 (2.3-SML = 5 mg/kg

epoxypropyl)-7-oxa-3.20-

diazadispiro [5.1.11.2]-

heneikosan-21-on polymer

120218 92930-34-0 thiodiethylenbis (5-SML = 6 mg/kg

methoxykarbonyl-2.6-dimethyl-

1.4-dihydropyridine-3-
cell

93440 013463-67-7 Titanium dioxide

93520 000059-02-9, alpha-tocopherol

010191-41-0

93680 009000-65-1 rubber tragant

93720 00108-78-1, 2, 4, and 6-triamino-1,3,5-triazin SML = 30 mg/kg

93760 000077-90-7 tributyl-about-acetylcitrát

93970-tricyklodekandimethanol-SML = 0.05 mg/kg

bis (hexahydroftalát)

94320 000112-27-6 triethylene glycol

94960 000077-99-6, 2-ethyl-2-(hydroxymethyl)-SML = 6 mg/kg

1.3-diol

95000-028931 67-1 poly [2.2-

bis (hydroxymethyl) butan-1-ol-

trimethakrylát]-co-methyl-

methacrylate

95020 6846-50-0 of 2, 2, 4-point-1.3-diyl-SML = 5 mg/kg food. When

diisobutyrát the use of gloves are required

single use

95200 001709-70-2 1, 3, 5-trimethyl-2-tris (3,5-

di-tert-butyl-4-

hydroxybenzyl) benzene

95270 161717-32-4-2, 4-6, tris (tert-butyl) phenyl-2-SML = 2 mg/kg (as the sum

butyl-2-ethylpropan-1.3-diol-fosfitu, phosphate and product

phosphate hydrolysis = TTBP)

95420 745070-61-5 1, 3, 5-tris (2,2-SML = 0.05 mg/kg food

dimethylpropanamido)-benzene

95725 110638-71-6, vermiculite, reaction product SML(t) = 0,6 mg/kg (8)

with lithium citrate expressed as lithium

95855 007732-18-5 the water in accordance with a special

the law, which

sets out the requirements for potable

water

95859-waxes, refined, obtained in accordance with the specifications

of oil or synthetic referred to in dodatkuII this

the hydrocarbons of the annex

95883 — White mineral oils, in accordance with the specifications

paraffin, obtained from petroleum referred to in dodatkuII this

the hydrocarbons of the annex

013983-17-95905 0 wollastonit

95920 — wood flour and fibers

the unmodified

011138 95935-66-2 xanthanová gum

96190 020427-58-1 zinc hydroxide SML = 25 mg/kg (38)

(expressed as zinc)

96240 001314-13-2 zinc oxide SML = 25 mg/kg (38)

(expressed as zinc)

96320 001314-98-3 zinc sulphide SML = 25 mg/kg (38)

(expressed as zinc)

---------------------------------------------------------- ------------------------------



SECTION B

---------------------------------------------------------- ------------------------------

PM/REF no CAS number Name restrictions and/or

specifications

---------------------------------------------------------- ------------------------------

30180 02180-18-9 acetate manganese SML(t) = 0,6 mg/kg (10)

(expressed as

manganese)

31500 025134-51-4 acrylic acid-2-ethylhexyl-SML(t) = 6 mg/kg (36)

acrylic, copolymer (expressed as

acrylic acid)

and SML = 0.05 mg/kg

(expressed as 2-

ethylhexyl-acrylate)

31520 61167-58-6, 2-tert-butyl-6-(3-tert-butyl-2-SML = 6 mg/kg

hydroxy-5-4-methylbenzyl)-

methylfenyl-acrylic

31920 00103-23-1, bis (2-ethylhexyl)-hexandioát SML = 18 mg/kg (1)

bis (2-ethylhexyl)-adipát

34230-alkyl (C8-C22) sulphonic acids SML = 6 mg/kg

34650 151841-65-5 bis-hydroxide [2, 2 ' methylbis (4,6-di-SML = 5 mg/kg

tert-butylfenyl) phosphate] aluminium

35760 01309-64-4 carbon antimonitý SML = 0.04 mg/kg (39)

(expressed as

antimony and including

uncertainty of measurement)

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 is refluxed with SML = 0.6 mg/kg

38560 07128-64-5 of 2.5-bis (5-tert-butyl-2-SML = 0.6 mg/kg

4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene) Thiophene

38700 63397-60-4, bis (2-karbobutoxyethyl) Tin-SML = 18 mg/kg

bis (isooktylsulfanylacetát)

38000 000553-54-8 lithium benzoate SML(t) = 0.6 mg/kg

(8)

(expressed as

Lithium)

38505 351870-33-2, cis-endo-bicyklo [2.2.1] heptane-2.3-SML = 5 mg/kg.

dikarboxylová acid di-sodium Bypass

salt with polyethylene in

contact with acids

food. Purity > =

96%.

38800 32637-78-8, N, N '-bis (3-(3,5-di-tert-butyl-4-SML = 15 mg/kg

hydroxyphenyl) propionyl) hydrazid

38820 26741-53-7 bis (2,4-di-tert-butylfenyl) SML = 0.6 mg/kg

pentaerythritoldifosfit

38940 110675-26-8 2.4-bis (dodecylthiomethyl)-6-SML (T) = 5 mg/kg (40)

methylfenol

39060 35958-30-6-1.1-bis (2-hydroxy-3.5-di-tert-SML = 5 mg/kg

butylfenyl) ethane

39090-N, N-bis (2-hydroxyethyl) alkyl (C8-SML(t) = 1,2 mg/kg (13)

C18) amin

39120 — N, N-bis (2-hydroxyethyl) alkyl (C8-SML (T) = 1, 2 mg/kg (13)

C18) aminhydrochloridy (expressed in N-jakoN,

bis (2-hydroxyethyl)

alkyl (C8-C18) amine)

40000 00991-84-4-2.4-bis (oktylsulfanyl)-6-(4-hydroxy-the SML = 30 mg/kg

3.5-di-tert-butylanilino)-1,3, 5-

triazin

40020 110553-27-0 2.4-bis [(oktylthiomethyl)-6-SML (T) = 5 mg/kg (40)

methyl] phenol

40160 61269-61-2, N, N '-bis (2, 2, 6, and 6-tetramethylpiperid-SML = 2.4 mg/kg

4-yl)-1.2-hexamethylendiamin

dibromoethane, copolymer

40720 025013-16-5, 2-tert-butyl-4-methoxyphenol; SML = 30 mg/kg

tert-butyl-4-hydroxyanisole (BHA =)

40800 13003-12-8, 4 '-butylidenbis (6-tert-butyl-3-SML = 6 mg/kg

methylfenylditridecylfosfit)

40980 19664-95-0, butanová acid, manganese salt SML T = 0.6 mg/kg

(10) (expressed as

manganese)

42000 63438-80-2 (2-karbobutoxyethyl) Tin-SML = 30 mg/kg

TRIS (isooktylsulfanylacetát)

42400 10377-37-4 Lithium Carbonate SML(t) = 0.6 mg/kg (8)

(expressed as

Lithium)

42480 00584-09-8 rubidný carbonate SML = 12 mg/kg

43600 04080-31-3, 1-(3-chlorallyl) -3,5, 7-triaza-1-SML = 0.3 mg/kg

azoniaadamantanchlorid

43680 00075-45-6 chlordifluormethan SML = 6 mg/kg

In accordance with the

specifications

laid down

in Appendix II to this

Annex.

44960 11104-61-3 carbon kobaltitý SML(t) = 0.05 mg/kg

(14) (expressed as

Cobalt)

45440 — stryenované butylované cresols SML = 12 mg/kg

46640 000128-37-0, 2.6-di-tert-butyl-4-; SML = 3 mg/kg

(= BHT)

47500 153250-52-3 N, N '-dicyklohexylnaftalen-2.6-SML = 5 mg/kg

dikarboxamid

47600 084030-61-5 (didodecylcín-bis-isooktyl SML(t) = 0.05 mg/kg

sulfanylacetát) (41) (as the sum of

dodecyltriisooktylcín-

sulfanylacetátu,

didodecyliisooktylcín-

sulfanylacetátu,

dodecylcín-

trichloride

and didodecylcín-

dichloridu)

as the sum of mono-

and didodecylcínchloridů.

48640 00131-56-6 2.4-dihydroxybenzofenon SML(t) = 6 mg/kg (15)

48800 00097-23-4 2, 2 '-dihydroxy-5, 5 '-SML = 12 mg/kg

dichlordifenylmethan

48880 00131-53-3, 2 '-dihydroxy-4-methoxybenzophenone SML(t) = 6 mg/kg (15)

49595 057583-35-4 (ethylhexyl-dimethylcínbis SML(t) = 0.18 mg/kg

merkaptoacetát) (16) (expressed as

Tin)

49600 26636-01-1 dimethylcínbis (isooktyl SML(t) = 0.18 mg/kg

sulfanylacetát) (16) (expressed as

Tin)

49840 02500-88-1 dioktadecyl-disulfide SML = 3 mg/kg

50160 — di-n-oktylcínbis (n-alkyl (C10-C16) SML (T) = 0, 006mg/kg

sulfanylacetát) (17) (expressed as

Tin)

50240 10039-33-5 di-n-oktylcínbis (2-SML (T) = 0, 006mg/kg

ethylhexylmaleinát) (17) (vyjádřenojako

Tin)

50320 15571-58-1 di-n-oktylcínbis (2-ethylhexyl-SML (T) = 0, 006mg/kg

sulfanylacetát) (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 (isooktyl-maleinát) SML (T) = 0, 006mg/kg

(17) (expressed as

Tin)

50480 26401-97-8 di-n-SML (T) = 0, 006mg/kg

oktylcínbis (isooktylsulfanylacetát) (17) (expressed as

Tin)

50560 — di-n-oktylcínbutan1, 4-diol-bis SML(t) = 0.006 mg/kg

(sulfanylacetát) (17) (expressed as

Tin)

50640 03648-18-8 di-n-oktylcíndidodekanoát SML(t) = 0, 006mg/kg

di-n-oktylcíndilaurát (17) (expressed as

Tin)

50720 15571-60-5 di-n-oktylcíndimaleinát SML(t) = 0, 006mg/kg

(17) (expressed as

Tin)

50800 — di-n-oktylcíndimaleinát, SML (T) = 0, 006mg/kg

esterified (17) (expressed as

Tin)

50880-di-n-oktylcíndimaleinát, polymers of SML (T) = 0, 006mg/kg

(n = 2-4) (17) (expressed as

Tin)

50960 69226-44-4 di-n-SML (T) = 0, 006mg/kg

oktylcínethylenglykolbis (17) (expressed as

(sulfanylacetát) Tin)

51040 15535-79-2 di-n-oktylcínsulfanylacetát SML(t) = 0, 006mg/kg

(17) (expressed as

Tin)

51120-di-n-oktylcínthiobenzoát [(2-SML (T) = 0, 006mg/kg

ethylhexyl) sulfanylacetát] (17) (vyjádřenojako

Tin)

51570 00127-63-9 difenylsulfon SML = 3 mg/kg (25)

51680 00102-08-9 N, N '-difenylthiomočovina SML = 3 mg/kg

52000 27176-87-0 dodecylbenzensulfonová acid SML = 30 mg/kg

52320 52047-59-3, 2-(4-dodecylfenyl) indole SML = 0.06 mg/kg

52880 23676-09-7-ethyl 4-ethoxybenzoát SML = 3.6 mg/kg

53200 23949-66-8 2-ethoxy-2 '-ethyloxanilid SML = 30 mg/kg

54880 000050-00-0 formaldehyde SML(t) = 15 mg/kg (22)

001166 55200-52-5 dodecyl-3, 4,5-trihydroxybenzoát; SML(t) = 30 mg/kg (34)

dodechl-gallate

55280 001034-01-1 of Octyl-3, 4,5-trihydroxybenzoát; SML(t) = 30 mg/kg (34)

Octyl gallate-

55360 000121-79-9, propyl-3, 4,5-trihydroxybenzoát; SML(t) = 30 mg/kg (34)

Propyl gallate-

58960 00057-09-0 hexadecyltrimethylamoniumbromid SML = 6 mg/kg

59120 23128-74-7 of 1.6-bis [3-(3,5-di-tert-butyl-4-SML = 45 mg/kg

hydroxyphenyl) propanamid] cyclohexane

59200 35074-77-2 1.6-bis [3-(3,5-di-tert-butyl-4-SML = 6 mg/kg

hydroxyphenyl) propanoát] cyclohexane

60320 70321-86-7, 2-(2-hydroxy-3.5-bis (1,1-SML = 1.5 mg/kg

dimethylbenzyl) phenyl) benzotriazol

60400 03896-11-5, 2-(2 '-hydroxy-3-tert-butyl-5 '-SML (T) = 30 mg/kg (19)

methylfenyl)-5-chlorbenzotriazol

60800 65447-dimethyl ester [77-0 1-(2-hydroxyethyl)-4-SML = 30 mg/kg

hydroxy-2, 2-6, 6-

tetramethylpiperidin]-sukcinátu,

copolymer

61280 03293-97-8 2-hydroxy-4-n-hexyloxybenzofenon SML(t) = 6 mg/kg (15)

61360 00131-57-7, 2-hydroxy-4-methoxybenzophenone SML(t) = 6 mg/kg (15)

61440 02440-22-4, 2-(2-hydroxy-5-SML (T) = 30 mg/kg (19)

methylfenyl) benzotriazol

61600 01843-05-6, 2-hydroxy-4-n-oktyloxybenzofenon SML(t) = 6 mg/kg (19)

63200 51877-53-3 lactic acid salt SML T = 0.6 mg/kg

manganum-dilaktát (10) (expressed as

manganese)

63940 008062-15-5 lignosulphonic acid SML = 0.24 mg/kg

and for use as

nebulizer for

dispersion of plastics.

64320 10377-51-2 lithium iodide SML(t) = 1 mg/kg (11)

(expressed as iodine)

and SML(t) = 0.6 mg/kg

(8) (vyjádřenojako

Lithium)

65120 07773-01-5 manganese chloride SML(t) = 0.6 mg/kg

(10) (expressed as

manganese)

65200 12626-88-9 manganese hydroxide SML(t) = 0.6 mg/kg

(10) (expressed as

manganese)

65280 10043-84-2 manganese hypofosfit SML(t) = 0.6 mg/kg

(10) (expressed as

manganese)

65360 11129-60-5 carbon manganese SML(t) = 0.6 mg/kg

(10) (expressed as

manganese)

65440 — dicalcium phosphate manganese SML(t) = 0,6 mg/kg (10)

(expressed as

manganese)

66350 085209-93-4, 2,2 '-methylenebis (4,6-di-tert-SML = 5 mg/kg and SML (T)

butylphenyl) lithiumfosfát = 0.6 mg/kg (8)

(expressed as

Lithium)

66360 85209-91-2, 2 '-methylenebis (4,6-di-tert-SML = 5 mg/kg

butylfenyl) natriumfosfát

66400 00088-24-4, 2,2 '-methylenebis (4-ethyl-6-tert-SML (T) = 1.5 mg/kg (20)

butylfenol)

66480 00119-47-1, 2 '-methylenebis (4-methyl-6-tert-SML (T) = 1.5 mg/kg (20)

butylfenol)

67360 067649-65-4-dodecyltriisooktylcín SML(t) = 0.05 mg/kg

sulfanylacetát foods (41) (as

the sum of the

dodecyltriisooktylcín-

sulfanylacetátu,

didodecyliisooktylcín-

sulfanylacetátu,

dodecylcín-

trichloride

and didodecylcín-

dichloridu)

as the sum of mono-

and didodecylcínchloridů.

67515 057583-34-3 monomethylcíntrist SML(t) = 0.18 mg/kg

(ethylhexylmerkapoacetát) 16) (expressed as

Tin)

67520 54849-38-6 (isooktyl-monomethylcíntris SML(t) = 0,18 mg/kg (16)

sulfanylacetát) (expressed as Tin)

67600 — mono-n-oktylcíntris (alkyl (C10-C16) SML(t) = 1,2 mg/kg (18)

sulfanylacetát) (expressed as Tin)

67680 27107-89-7 mono-n-(2-oktylcíntris SML(t) = 1,2 mg/kg (18)

ethylhexylsulfanylacetát) (expressed jakocín)

67760 26401-86-5 mono-n-oktylcíntris (isooktyl-SML (T) = 1,2 mg/kg (18)

sulfanylacetát) (expressed as Tin)

67896 020336-96-3 lithium-tetradekanoát; SML(t) = 0,6 mg/kg (8)

Lithium-oleate (expressed as

Lithium)

68320 02082-79-3 (oktadecyl3-3,5-di-tert-butyl-4-SML = 6 mg/kg

hydroxylfenyl) propanoát

68400 10094-45-8 oktadecyl-(Z)-9-enamid dokos-SML = 5 mg/kg

oktadecylerukamid

68860 004724-48-5, n-oktylfosfoniová acid SML = 0.05 mg/kg

69160 014666-94-5, oleic acid, cobalt salt SML(t) = 0.05 mg/kg

(14) (expressed as

Cobalt)

69840 16260-09-6 N-(Z)-(z)-9-en-1-SML = 5 mg/kg

ylhexadekanamid

oleylpalmitamid

71935 007601-89-0, sodium perchlorate monohydrate SML = 0.05 mg/kg (31)

72081/10 — the pitch from the oil, hydrogenated SML = 5 mg/kg (1)

hydrocarbons and in accordance with the

specifications

set out in the Appendix

(II) of this annex.

72160 00948-65-2, 2-fenylindol SML = 15 mg/kg

72800 01241-94-7-diphenyl-2-ethylhexylfosfát SML = 2.4 mg/kg

73040 13763-32-1 phosphoric acid, lithium salt SML T = 0,6 mg/kg (8)

(expressed as

Lithium)

73120 10124-54-6 phosphoric acid, manganese salt SML T = 0,6 mg/kg (10)

(expressed as

manganese)

74400-tris (nonylfenyl) acid ester SML = 30 mg/kg

fosforité

or

TRIS (dinonylfenyl) acid ester

fosforité

TRIS (nonyl-and/or

dinonylfenyl) fosforitan

77440 — polyethylenglykoldi (12hydroxyokt SML = 42 mg/kg

adec9enoát)

polyethylenglykoldiricinoleát

77520 61791-12-6 polyethylenglykolester Castor SML = 42 mg/kg

oil

78320 09004-97-1 polyethylenglykol12hydroxyoktadec SML = 42 mg/kg

9enoát

polyethylene glycol-monoricinoleát

81200 71878-19-8 poly (6-[(1, 1, 3, and 3-SML = 3 mg/kg

tetramethylbutyl) amino]-1,3, 5-

triazin-2.4-diyl]-[(2, 2, 6, 6

tetramethylpiperid-4-

Abdurrahman hexamethylen YL)] [(2, 2, 6, 6

tetramethylpiperid-4-yl) Abdurrahman]

81680 07681 – 11-0 potassium iodide SML(t) = 1 mg/kg (11)

(expressed as iodine)

82020 19019-51-3, also named propionic acid, cobalt salt SML(t) = 0,05 mg/kg (14)
(expressed as

Cobalt)

83595 119345-01-6 reaction product of di-tert-SML = 18 mg/kg

butylfosfonitu with the bifenylem obtained in accordance with

condensation of 2.4-di-tert-butylfenolu specifications

products Friedelovy-Craftovy listed in Appendix II

the reaction of chloride fosforitého of this annex.

and bifenylu

83700 00141-22-0 (Z)-12-hydroxyoktadec-9-enová SML = 42 mg/kg

acid

ricinolejová acid

84800 00087-6-3 4-tert-butylfenyl-salicylate SML = 1.2 mg/kg

84880 00119-36-8-methyl-salicylate SML = 30 mg/kg

85760 12068-40-5 lithnohlinitý silicate SML(t) = 0,6 mg/kg (8)

(expressed as

Lithium)

85920 12627-14-4 lithium silicate SML(t) = 0,6 mg/kg (8)

(expressed as

Lithium)

85950 037296-97-2 silicic acid, fluoride salt SML = 0.15 mg/kg

sodium-magnesium (expressed as

fluoride). Only

to be used in layers

multilayer

materials that

do not come into contact

with food.

86480 007631-90-5 sodium bisulphite SML (T) = 10 mg/kg (30)

(expressed as SO2)

86800 07681-82-5 sodium iodide SML(t) = 1 mg/kg (11)

(expressed as iodine)

86880-natriummonoalkyl-SML = 9 mg/kg

dialkylfenoxybenzendisulfonát

86920 007632-00-0 sodium nitrite SML = 0.6 mg/kg

86960 007757-83-7 sodium sulfite SML (T) = 10 mg/kg (30)

(expressed as SO2)

87120 007772-98-7 sodium thiosulfate SML (T) = 10 mg/kg (30)

(expressed as SO2)

89170 13586-84-0, oktadekanová acid, kobaltnatá SML(t) = 0,05 mg/kg (14)

salt (expressed as

stearic acid, kobaltnatá salt of cobalt)

92000 07727-43-7 barium sulfate SML(t) = 1 mg/kg (12)

(expressed as

barium)

92320 — tetradecylpolyethylenglykol (EO = 3-SML = 15 mg/kg

8) ether glycollic acid acid

92560 38613-77-3, tetrakis (2,4-di-tert-SML = 18 mg/kg

butylfenyl) biphenyl-4, 4 '-

ylendiifosfonit

92800 00096-69-5 '-thiobis (6-tert-butyl-3-SML = 0.48 mg/kg

methylfenol)

41484 92880-35-9 thiodiethanolbis (3-(3,5-di-tert-SML = 2.4 mg/kg

Butyl-4-hydroxyphenyl) propanoát)

93120 00123-28-4 didodecylthiodipropanoát SML(t) = 5 mg/kg (21)

93280 00693-36-7 dioktadecyl-thiodipropanoát SML(t) = 5 mg/kg (21)

93970 _ tricyklodekandimethanol SML = 0.05 mg/kg

bis (hexahydroftalát)

94400 036443-68-2 triethylene glycol bis [3-(3-tert-SML = 9 mg/kg

Butyl-4hydroxy-5-

methylfenyl) propanoát]

94560 00122-20-3 triisopropanolamin SML = 5 mg/kg

95265 227099-60-7 1, 3, 5-tri (4-benzoylfenyl) benzene SML = 0.05 mg/kg

95280 40601-76-1 1, 3, 5-tris (4-tert-butyl-3-hydroxy-the SML = 6 mg/kg

2.6-dimethylbenzyl)-1,3, 5-triazin-

2, 4, 6 (1 h, 3 h, 5 h)-trion

95360 27676-62-6 1, 3, 5-tris (3,5-di-tert-butyl-4-SML = 5 mg/kg

hydroxybenzyl) -1,1, 3.5-triazin-

2, 4, 6 (1 h, 3 h, 5 h)-trion

95600 01843-03-4-1, 3-1, tris (2-methyl-4-hydroxy-5-SML = 5 mg/kg

tert-butylfenyl) butane

---------------------------------------------------------- ------------------------------



APPENDIX I



PRODUCTS OBTAINED BY THE FERMENTATION OF BACTERIAL

P

--------------------------------------------------- -------------------------------------

M/Ref. CAS number Name restrictions and/or specifications

No.

--------------------------------------------------- -------------------------------------

(1) (2) (3) (4)

--------------------------------------------------- -------------------------------------

18888 080181-31-3, 3-hydroxybutanová acid in accordance with specifications

and 3-hydroxypentanová set out in Appendix II to this

acid, copolymer annex

--------------------------------------------------- -------------------------------------



APPENDIX II



SPECIFICATIONS



Part a: general specifications



Materials and articles made of plastics may release the primary

aromatic amines in stanovitelném quantity (DL = 0.01 mg/kg food

or food simulant). The value of the migration of the primary aromatic amines

referred to in this annex, this limit shall not apply.



Part b: other specifications

------------------------- ------------------------------------------------------

PM/Ref. No. Other specifications

------------------------- ------------------------------------------------------

11530 (2-hydroxypropan-1-yl)-Acrylic

Can contain up to 25% (w/w) 2-hydroxyisopropyl-acrylate

(CAS No 002918-23-2)



16690 divinylbenzen

Can contain up to 45% ethyl benzene (vinyl).



18888 3hydroxybutanová acid and 3hydroxypentanová acid,

copolymer

The definition of These copolymers are produced by the controlled

fermentation of Alcaligenes eutrophus for bacteria

the use of mixtures of glucose and propanoic acid

as carbon sources. Used body may not

be obtained through genetic modification and must

come from a naturally occurring

Alcaligenes eutrophus strain H16 NCIMB 10442.

The stock culture of the organism is kept

in the lyophelised State in ampoules.

Partial/working culture is prepared from stock

culture, kept in liquid nitrogen

and used for the preparation of the inoculum for the

fermentation. Samples from the fermenter are daily

viewed under a microscope, track

any changes in the morphology of colonies at different

an agar soils at different temperatures.

Copolymers are isolated from heat-treated

the bacteria by controlled decomposition of other cell

folders, by washing and drying. These copolymers

they are usually offered as shaped or

melting přetvarované granules containing

additives such as nucleating agents,

emollients, fillers, stabilizers

and pigments, which comply with the General

and individual specifications.

— Chemical Poly (3Dhydroxybutanoátco3Dhydroxypentanoát)

the name of the

— CAS number 80181-31-3

— Structural

formula

Ch3

|

Ch2 CH2 Of A

| || | ||

(-O-CH-CH2-C) m-(O-CH-CH2-C) n



where n/(m + n) is greater than 0 and less than or

equal to 0.25

— The average of at least 150 000 (set gel permeation

Molecular chromatographic method).

the weight of the

At least 98% of the content

Poly (3Dhydroxybutanoátco3Dhydroxypentano

át), analysed after hydrolysis as a mixture of

3Dhydroxybutanové acid and acid

3Dhydroxypentanové.

Description After the isolation of the white to creamy white powder.

The properties of the

— Identification

tests:

— Solubility Soluble in chlorinated hydrocarbons such as

chloroform or dichloromethane but practically

insoluble in ethanol, aliphatic alkanes

and in the water.

— Limitations for QMA (krotonovou acid but2enovou

acid) may not exceed the value of the

0.05 mg/6dm2.

— Purity before it must default the substance (powder

copolymer) include:

— Nitrogen not more than 2 500 mg/kg of plastic

— Zinc not more than 100 mg/kg of plastic

— Copper not more than 5 mg/kg of plastic

— Lead of not 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 > 6 800)

The minimum viscosity of 100x106 m2 * s1 (= 100 centistokesů) when

25 ° c



24903 syrups, hydrolysed starch, hadrogenované

In accordance with the criteria of purity for maltitolový syrup E 965 (ii)

laid down by Decree No 54/2002 Sb.



25385 triallylamin

40 mg/kg Hydrogel at a ratio of 1 kg of food at the

a maximum of 1.5 grams of Hydrogel. Use only in hydrogels

intended for indirect contact with food.



38320 4 (2benzoxazolyl) 4 ' (5metylbenzoxazolyl) stilben

Not more than 0.05% (m/m) (quantity/quantity of the product)



42080 Soot

Specifications

-Extract Toluenový: max. 0.1%, determined according to ISO method 6209

-UV absorbance at a wavelength of cyklohexanového extract of 386

NM: 0.02 for 1 cm Cuvette or 0.1 to 5 cm cell,

a generally accepted method of analysis

-Benzoapyrenu Content: max. 0.25 mg/kg of carbon black

-Maximum content of carbon black in the polymer: 2.5%.



43480 Active coal

Only for use in the PET and in the amount of 10 mg/kg max.

the polymer. Same purity requirements as for medicinal charcoal

(vegetable black) (153) as laid down by Decree No 54/2002 Sb.



43680 Chlordifluormethan
CHLORODIFLUOROMETHANE content of less than 1 mg/kg of the substance



47210 dibutylthiocíničitá acid, a polymer



— Molecular unit = (C8H18S3Sn2) (n = 1.5-2)



64990 Maleianhydrid-styrene, copolymer, sodium salt

MW fraction < 1000 less than 0.05% (by weight)



67155 mixture of 4-(2-4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene)-4 '-(methyl-2-4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene),

4,4 '-bis (2-4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene) stilbene and 4 '-bis (5-methyl-2-

4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene) stilbene

The mixture obtained from the production process in the typical ratio of:

(58-62%): (23-27%): (13-17)



72081/10 Hydrogenated pitch from petroleum products

Specifications:

Hydrogenated pitch from petroleum hydrocarbons are produced

catalytic or thermal polymerization of aliphatic,

alicyclic or alkenylbenzenových dienů and olefins

from the spirits of the raw materials with cracked boiling point higher than

220oC. Also are made from pure polymers from these sources

with the subsequent distillation, hydrogenation and other processing

Properties:

Viscosity: 3. with 120 ° C.

Softening point: 95th (C), as determined by the ASTM E 28-

67.

Bromine number: 40 (ASTM D 1159)

The color of the 50% solution in toluene 11 in Gardnerově scale.

Residual aromatic polymer 50 ppm.



76721 polydimethylsiloxane (Mw > 6 800)

Minimum viscosity 100 × 10-6 m2 s-1 (= 100 centistokesů) when

25 ° c



1.4-Butanediol 76845 Polyester with kaprolaktonem

MW fraction < 1000 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

MW fraction < 1000 less than 0.05% (by weight)



77895 alkyl (C16-C18) ethers, poly (ethylene glycol) (n = 2-6)

The composition of the mixture:

1. alkyl (C16-C18) ethers, poly (ethylene glycol) (n = 2-6)

(approximately 28%.)

2. fatty alcohols (C16-C18) (approximately 48%),

3. alkyl (C16-C18) ethers of ethylene glycol) (approximately 24%

materials.) “



Poly (ethylene glycol) 79600 tridecylether phosphate,

Poly (ethylene glycol) (EO < 11) tridecylether phosphate (mono-,

and dialkyl ester) with max. 10% content of poly (ethylene glycol) (EO

= 11. tridecyletheru