Royal Decree 1425/1988 of 25 November 1998 approving the Technical Health Regulations for the production, circulation and trade of plastic materials intended to come into contact with foodstuffs and food, incorporated into national law the Community Directives on materials and packaging intended to come into contact with food.

Subsequently, Royal Decree 2207/1994 of 16 November, approving the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food and are regulated certain test conditions, as amended by the Royal Decrees 510/1996 of 15 March; 1042/1997 of 27 June, and 1752/1998 of 31 July 1998, also included the incorporation into our national law of Directives 85 /572/EEC; 82 /711/EEC, amended by 97 /48/EC and Directive 90 /128/EEC, as amended in turn by the Directives 95 /3/EC and 96 /11/EC.

In Article 5 (2) of that Royal Decree 2207/1994, the list of monomers and other starting substances authorised for the manufacture of plastic materials and articles (Section A) was envisaged. Annex II) may be amended as a result of the provision of new scientific data or a revision of existing scientific data.

By making use of this possibility and on the basis of the new technical data provided, as well as the full evaluation of certain substances, the review of the Community lists of monomers and additives has been permitted. plastic materials, included in Directive 90 /128/EEC, carrying out an amendment of that Directive, as embodied in Commission Directive 1999 /91/EC of 23 November 1999.

This Royal Decree incorporates, as a consequence, our national legislation Directive 1999 /91/EC of the Commission of 23 November 1999 amending Directive 90 /128/EEC, adapting the provisions of Directive 90 /128/EEC. in force on the new information available on the subject, with the addition of certain substances to Section A of Annex II to Royal Decree 2207/1994, and the deletion of other substances from Section B of that Annex.

Substances are also added to the list of additives that may be used in the manufacture of plastic materials and articles, included in Annex V to Royal Decree 2207/1994 of 16 November 1994.

This list of additives, which will be extended in successive stages until a full list is obtained, replaces in part the one contained in the Resolution of 4 November 1982 by the Health Undersecretary for the positive list of substances intended for the manufacture of macromolecular compounds, the list of maximum migrations in tests for the disposal of certain substances, the purity conditions for colouring matters used in the same products and the list of polymeric materials suitable for the manufacture of packaging and other utensils; may be in contact with foodstuffs and foodstuffs, as amended by Order of the Ministry of Health and Consumer Affairs of 3 July 1985, and may therefore be used only in the manufacture of plastic materials and articles additives included in Annex V to this Royal Decree, as well as those contained in the said Resolution and their amendment, which are not referred to in that Annex.

Furthermore, specifications and purity criteria are set for certain substances only.

This Royal Decree is dictated by the provisions of Article 149.1.16.a of the Constitution and in accordance with the provisions of article 40.2 and 4 of Law 14/1986 of 25 April, General of Health.

In its preparation the sectors affected have been heard, having issued its precept report the Inter-Ministerial Commission for Food Management.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs; of Agriculture, Fisheries and Food; of Science and Technology, and of the Economy, according to the Council of State and after deliberation of the Council of Ministers in its Meeting of the 27th April 2001,

D I S P O N G O:

Single item. Amendment of Royal Decree 2207/1994 of 16 November 1994 approving the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food and regulated test conditions.

Royal Decree 2207/1994 is amended as follows:

1. Article 5 (3) (d) shall be deleted.

2. Article 6, 'Positive list of additives', is replaced by the following:

" Article 6. Positive list of additives.

1. The additives which may be used in the manufacture of plastic materials and articles together with the specified restrictions are those set out in Annex V, as well as those contained in the Resolution of 4 November 1982, of the Subsecretariat of Health and its modification by the Order of the Ministry of Health and Consumer Affairs of 3 July 1985, which are not covered by this Royal Decree.

2. The criteria laid down in this Royal Decree shall apply to the values admitted for specific migrations of additives in which the functional duality of monomer or substance of departure and additive may be presented.

3. All the colouring matters used for the manufacture or manufacture of plastic materials and articles which comply with the provisions of Article 7 (7.5) of the Technical-Health Regulations approved by the Royal Decree 1425/1988 of 25 November 1988.

Such materials shall not be included in the positive list of permitted substances for the manufacture of plastic materials and articles. "

3. The following Articles 7 and 8 are

:

" Article 7. Products obtained by bacterial fermentation.

Only products obtained by bacterial fermentation, listed in Annex VI, may be used in contact with foodstuffs.

Article 8. Specifications.

The specifications for certain substances listed in Annexes II, V and VI are included in Annex VII. "

4. Article 7, 'Declaration for the marketing', shall be as Article 9.

5. Annex II is replaced, which shall be drawn up in the terms specified:

" ANNEX II

List of monomers and other starting substances authorised for use in the manufacture of plastic materials and articles

General Introduction

1. This Annex sets out the list of monomers and other starting substances. That list contains:

a) Substances intended to be subjected to polymerization, including polycondensation, polyaddition or any other similar process, to produce macromolecules.

(b) macromolecular substances, natural or synthetic, used in the manufacture of modified macromolecules, provided that the monomers or other starting substances necessary for the synthesis of those substances are not included in the list.

(c) Substances used to modify existing natural or synthetic macromolecular substances.

2. The list does not include salts (are considered double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of acids, phenols or alcohols, which are also authorised; however, they appear in the list names containing the word ... acid (s), salt (s), in case the corresponding free acid (s) is not mentioned (n). In such cases, the meaning of the term 'salts' is 'aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc salts'.

3. The list also does not include the following substances that could be found in the finished product:

a) Substances that might be found in the finished product, such as:

1. St Impurities of the substances used.

2. The intermediate reaction products.

3. Decomposition Products.

(b) Oligomers and macromolecular substances, natural or synthetic, as well as mixtures thereof, if the monomers or starting substances necessary to synthesise them are already included in the list.

(c) Mixtures of the authorised substances.

The materials and articles containing the substances referred to in paragraphs (a), (b) and (c) shall comply with the requirements laid down in Royal Decree 1425/1988 of 25 November 1988 on the Technical-Health for the elaboration, circulation and trade of plastic materials destined to come into contact with the food.

4. The authorised substances must be of good technical quality as regards the purity criteria.

5. The list contains the following data:

Column 1 (PM/REF number): The EEC reference number of the packaging material substance, from the list.

Column 2 (CAS number): The CAS ("Chemical Abstracts Service") record number.

Column 3 (name): The chemical name.

Column 4 (Restrictions and/or Specifications).

These can include:

a) The specific migration limit (LME).

b) Maximum amount of substance allowed in the finished material or object (CM).

(c) The maximum permitted quantity of the substance per unit of surface in contact with the food products (CMA), for example: mg (of substance) per 6 dm2 (of contact surface with the food products).

d) Any other specifically mentioned restrictions.

e) Any other type of specifications linked to the substance or polymer.

6. If a substance appearing in the list as an isolated compound is also included in a generic name, the restrictions applicable to this substance shall be those for the isolated compound.

7. In case of disagreement between the CAS number and the chemical name, the chemical name shall prevail against the first. If there is disagreement between the CAS number collected in the EINECS and the CAS record, the CAS number shall apply.

8. A series of abbreviations are used in column 4 of the table, meaning the following:

LD: Analysis method detection limit.

PT: Material or finished object.

SA: Food simulator.

NCO: isocyanate functional group.

ND: Not detectable.

For the purposes of this Royal Decree, the expression "not detectable" means that the substance should not be detected by a validated analytical method, which has a detection limit according to the requirements of its restriction. specific. If there is no such method at the time of the analysis, a reliable and reproducible analytical method may be used which has the limit of detection required by its specific restriction, pending the development of a validated method.

CM: Maximum amount allowed of "residual" substance in the material or object.

CM (T): Maximum allowed amount of "residual" substance in the material or object, expressed as a total of the indicated groups or substances. 'CM (T)' means that the maximum permitted amount of 'residual' substance in the material or object shall be determined by an analytical method validated at the specified limit. If such a method does not exist for the time being, an analytical method may be used which has the necessary sensitivity to reliably determine the specified limit, pending the preparation of a validated method.

LME: Food-specific migration limit or food simulants, unless otherwise stated. For the purposes of this Royal Decree, 'SML' means that the specific migration of the substance will be determined by a validated analytical method that has a detection limit in accordance with the requirements of its LME. If there is no such method at the time of the analysis, a reliable and reproducible analytical method may be used which possesses the sensitivity required by its LME, pending the development of a validated method.

SML (T): Specific migration limit in food or in food simulants, expressed as a total of the indicated groups or substances.

"SML (T)" means that the specific migration limit of the substances will be determined by an analytical method validated at the specified limit. If there is no such method at present, an analytical method may be used which has the necessary sensitivity to reliably determine the specified limit, pending the preparation of a validated method.

(SEE IMAGES, PAGE 15461 TO 15477)

SECTION A

Authorized list of monomers and other starting substances

TABLES (View images pages 15461 to 15477)

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

10030 000514-10-3 Abiotic acid.

10060 000075-07-0 Acetaldehyde. SML (T) =6mg/Kg (2).

10090 000064-19-7 acetic acid.

10120 000108-05-4 Vinyl Acetate. LME=12 mg/Kg.

10150 000108-24-7 Anhydride acetic.

10210 000074-86-2 Acethylene.

10630 000079-06-1 Acrilamide. LME=ND (LD=0.01 mg/Kg).

10660 015214-89-8 2-acrylamide-2-methylpropanesulfonic acid. LME=0.05 mg/Kg.

10690 000079-10-7 acrylic acid.

10750 002495-35-4 Benzyl acrylate.

10780 000141-32-2 N-butyl acrylate.

10810 002998-08-5 sec-butyl acrylate.

10840 001663-39-4 Ter-butyl acrylate.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

11000 050976-02-8 acrylate dicyclopentadienyl. CMA= 0.05 mg /6 dm2.

11245 002156-97-0 acrylate dodecyl. LME=0.05 mg/Kg (1).

11470 000140-88-5 ethyl acrylate.

11510 000818-61-1 hydroxyethyl acrylate. See "Diethylene glycol monoacrylate".

11590 00106-63-8 Isobutyl acrylate.

11680 000689-12-3 Isopropyl acrylate.

11710 000096-33-3 methyl acrylate.

11830 000818-61-1 ethylene glycol monoacrylate.

11890 002499-59-4 N-octyl acrylate.

11980 000925-60-0 Propyl acrylate.

12100 000107-13-1 Acrilonitrile. SML = Not detectable (LD= 0.020 mg/kg, analytical tolerance included).

12130 000124-04-9 Adipeak acid.

12265 004074-90-2 Divinyl Adiduck. CM= 5 mg/Kg in PT For use only as a comonomer.

12280 002035-75-8 Anhydride adipic.

12310 Albumin.

12340 Albums coagulated by formaldehyde.

12375 Primary linear saturated aliphatic Monoalcohols (C4-C22).

12670 002855-13-2 1-Amino-3-aminomethyl-3,5, 5-trimethylcyclohexane.

LME= 6 mg/Kg.

12761 000693-57-2 12-aminododecanoic acid. LME= 0.05 mg/Kg.

12788 002432-99-7 11-aminoundecanoic acid. LME= 5 mg/Kg.

12789 007664-41-7 Ammonia.

12820 000123-99-9 Azelaic Acid.

12970 004196-95-6 Azelaic Anhydride.

13000 001477-55-0 1,3-benzenedimethanamine. LME= 0.05 mg/Kg.

13060 004422-95-1 Chloride 1,3,5-benzene-tricarboxylic acid.

CMA= 0.05 mg/6 dm2 (determined as 1,3,5 benzenetricarboxylic acid).

13090 000065-85-0 benzoic acid.

13150 000100-51-6 Benzyl alcohol.

13180 000498-66-8 Bicyclo [2,2, 1] hept-2-ene (= norbornene). LME= 0.05 mg/Kg.

13210 001761-71-3 Bis (4-aminocyclohexyl) methane. LME=0.05 mg/Kg.

13326 000111-46-6 Ether bis (2-hydroxyethyl). See "Diethylene glycol".

13380 000077-99-6 2.2-Bis (hydroxymethyl) 1-butanol. See 1,1,1-Trimethylolpropane.

13390 000105-08-8 1,4-Bis (hydroxymethyl) cyclohexane.

13480 000080-05-7 2,2-Bis (4-hydroxyphenyl) propane. LME= 3 mg/Kg.

13510 001675-54-3 Ether bis (2,3-epoxypropyl) of 2, 2-bis-(4-hydroxyphenyl) propane (= BADGE).

LME (T) = 1 mg/Kg (9) authorized up to 01-01-2005.

13530 038103-06-9 Bis (phthalic anhydride) of 2,2-bis (4-hydroxyphenyl) propane.

LME=0.05 mg/Kg.

13550 000110-98-5 Ether bis (hydroxypropyl). See Dipropylene glycol.

13560 005124-30-1 Bis (4-isocyanatocyclohexyl) methane. See 4,4-Diisocyanate of dicyclohexylmethane.

13600 047465-97-4 3,3-Bis (3-methyl-4-hydroxyphenyl) -2-indolinone. LME=1.8 mg/Kg.

13607 000080-05-7 Bisphenol A. See 2,2-bis (4-hydroxy-phenyl) propane.

13610 001675-54-3 Ether bis (2,3-epoxypropyl) of Bisphenol A. See Ether bis (2,3 epoxy-propyl) of 2, 2-bis (4-hydroxyphenyl) propane.

13614 038103-06-9 Bis (phthalic anhydride) of bisphenol A. See 13530.

13630 000106-99-0 Butadiene. CM= 1 mg/Kg in PT or LME= not detectable (LD=0.02 mg/Kg, analytical tolerance included).

13690 000107-88-0 1,3-Butanediol.

13780 002425-79-8 Ether bis (2,3-epoxypropyl) of 1,4-butanediol. CM= 1 mg/Kg in PT (expressed as epoxy group, molecule weight = 43).

13840 000071-36-3 1-Butanol.

13870 000106-98-9 1-Butene.

13900 000107-01-7 2-Butene.

14020 000098-54-4 4-tert-Butylphenol. LME= 0.05 mg/Kg.

14110 000123-72-8 Butiraldehyde.

14140 000107-92-6 butyric acid.

14170 000106-31-0 butyric anhydride.

14200 000105-60-2 Caprolactama. SML (T) =15 mg/Kg (5).

14230 002123-24-2 Caprolactama, sodium salt. SML (T) =15 mg/Kg (5) (expressed as Capro-lactam).

14320 000124-07-2 Caprylic acid.

14350 000630-08-0 Carbon Monoxide.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

14380 000075-44-5 carbonyl chloride. CM= 1 mg/Kg in PT.

14411 008001-79-4 castor oil.

14500 009004-34-6 Cellulose.

14530 007782-50-5 Cloro.

14570 000106-89-8 1-Chloro-2,3-epoxypropane. See "Epiclorhydrin".

14650 000079-38-9 Chlorotrifluoroethylene. CMA= 0,05 mg/6 dm2.

14680 000077-92-9 Citric acid.

14710 000108-39-4 m-Cresol.

14740 000095-48-7 o-Cresol.

14770 000106-44-5 p-Cresol.

14841 000599-64-4 4-Cumilphenol. LME= 0.05 mg/Kg.

14880 000105-08-8 1,4-Cyclohexanedimethanol. See "1,4-Bis (hydroxymethyl) cyclohexane".

14950 003173-53-3 Cyclohexyl isocyanate. CM (T) = 1 mg/Kg in PT (expressed as NCO).

15070 001647-16-1 1.9 Decadiene. LME=0.05 mg/Kg.

15095 000334-48-5 Decanoic acid.

15100 000112-30-1 1-Decanol.

15130 000872-05-9 1-Decene. LME= 0.05 mg/Kg.

15250 000110-60-1 1,4-Diaminobutane.

15272 000107-15 -3 1,2-Diaminoethane. See "Ethylenediamine".

15274 000124-09-4 1,6-Diaminohexane. See "Hexamethylenediamine".

15565 000106-46-7 1,4-Dichlorobenzene. LME=12 mg/Kg.

15700 005124-30-1 4,4-decyl-hexylmethane. CM (T) = 1 mg/Kg in PT (expressed as NCO).

15760 000111-46-6 Diethylene glycol. SML (T) =30 mg/Kg (3).

15790 000111-40-0 Diethylentriamine. SML = 5 mg/kg.

15820 000345-92-6 4,4 ' -Difluorbenzophenone. SML = 0,05 mg/kg.

15880 000120-80-9 1,2-Dihydroxybenzene. SML = 6 mg/kg.

15910 000108-46-3 1,3-Dihydroxybenzene. SML = 2.4 mg/kg.

15940 000123-31-9 1,4-Dihydroxybenzene. SML = 0.6 mg/kg.

15970 000611-99-4 4.4 ' -Dihydroxybenzophenone. SML = 6 mg/kg.

16000 000092-88-6 4,4 ' -Dihydroxybiphenyl. SML = 6 mg/kg.

16150 000108-01-0 Dimethylaminoethanol. SML = 18 mg/kg.

16240 000091-97-4 4,4 '-Diisocyanate of 3,3' dimethyl phenyl. CM (T) = 1 mg/kg in PT (expressed as NCO).

16360 000576-26-1 2,6-Dimethylphenol. SML = 0,05 mg/kg.

16450 000646-06-0 1,3-Dioxolane. SML = 0,05 mg/kg.

16480 000126-58-9 Dipentaerythritol.

16570 004128-73-8 4,4 ' -Diphenyl ether diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO).

16600 005873-54-1 2,4 ' -Diphenyl-methane diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO).

16630 000101-68-8 4,4 ' -Diphenyl-methane Diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO).

16660 000110-98-5 Dipropylene glycol.

16694 013811-50-2 N, N ' -Divinyl-2-imidazolidinone. CM = 5 mg/kg in PT.

16704 000112-41-4 1-Dodecene. SML = 0,05 mg/kg.

16750 000106-89-8 Epiclorhydrin. CM = 1 mg/kg in PT.

16780 000064-17-5 Ethanol.

16950 000074-85-1 Ethylene.

16960 000107-15 -3 Ethylenediamine. SML = 12 mg/kg.

16990 000107-21-1 Ethylene Glycol. SML (T) = 30 mg/kg (3).

17005 000151-56-4 ethylenimine. SML = ND (LD = 0.01 mg/kg).

17020 000075-21-8 ethylene oxide. CM = 1 mg/kg in PT.

17050 000104-76-7 2-Etil-1-hexanol. SML = 30 mg/kg.

17160 000097-53-0 Eugenol. SML = ND (LD = 0.02 mg/kg, analytical tolerance included).

17170 061788-47-4 Coconut oil fatty acids.

17200 068308-53-2 Soy oil fatty acids.

17230 061790-12-3 Fatty acids of the tall oil.

17260 000050-00-0 Formaldehyde. SML = 15 mg/kg.

17290 000110-17-8 fumaric acid.

17530 000050-99-7 Glue.

18010 000110-94-1 Glutaric Acid.

18070 000108-55-4 Glutaric Anhydride.

18100 000056-81-5 Glycerol.

18220 068564-88-5 N-heptylaminoundeca-noic acid. LM = 0,05 mg/kg (1).

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

18250 000115 -28-6 Hexachloroendomethylene-tetrahydrophthalic acid. SML = ND (LD = 0.01 mg/kg).

18280 000115 -27-5 Anhydride hexachloroendome-tilentetrahydrophthalic.

LME = ND (LD = 0.01 mg/kg).

18310 036653-82-4 1-Hexadecanol.

18430 000116-15 -4 Hexafluorpropylene. SML = ND (LD = 0.01 mg/kg).

18460 000124-09-4 Hexamethylenediamine. SML = 2.4 mg/kg.

18640 000822-06-0 Hexamethylene Diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO).

18670 000100-97-0 Hexamethylenetramine. SML (T) = 15 mg/kg (expressed as formaldehyde).

18820 000592-41-6 1-Hexene. SML = 3 mg/kg.

18867 000123-31-9 Hydroquinone. See "1,4-Dihydroxyben-cene".

18880 000099-96-7 P-hydroxybenzoic acid.

19000 000115 -11-7 Isobuteno.

19060 000109-53-5 Eter isobutylvinyl. CM = 5 mg/kg in PT.

19150 000121-91-5 Isoftalic Acid. SML = 5 mg/kg.

19210 001459-93-4 dimethyl isophthalate. SML = 0,05 mg/kg.

19270 000097-65-4 Itaconic acid.

19460 000050-21-5 Lactic acid.

19470 000143-07-7 Lauric acid.

19480 002146-71-6 vinyl Laurate.

19510 011132-73-3 Lignocellulose.

19540 000110-16-7 Maleic acid. SML (T) = 30 mg/kg (4).

19960 000108-31-6 Maleic Anhydride. SML (T) = 30 mg/kg (4) (expressed as maleic acid).

19975 000108-78-1 Melamine. See "2,4,6-Triamino-1,3,5-triazine".

19990 000079-39-0 Metacrylamide. SML = ND (LD = 0.02 mg/kg, analytical tolerance included).

20020 000079-41-4 Methacrylic acid.

20050 000096-05-9 Alyl methacrylate. SML = 0,05 mg/kg.

20080 002495-37-6 Benzyl methacrylate.

20110 000097-88-1 butyl methacrylate.

20140 002998-18-7 sec-butyl methacrylate.

20170 000585-07-9 Tert-butyl methacrylate.

20530 002867-47-2 Methacrylate 2-(dimethyl-amino) ethyl. SML = ND (LD = 0.02 mg/kg, analytical tolerance included).

20890 000097-63-2 ethyl methacrylate.

21010 000097-86-9 isobutyl methacrylate.

21100 004655-34-9 Isopropyl methacrylate.

21130 000080-62-6 methyl Methacrylate.

21190 000868-77-9 ethylene-glycol Monomethacrylate.

21280 002177-70-0 phenyl methacrylate.

21340 002210-28-8 propyl methacrylate.

21460 000760-93-0 Methacrylic Anhydride.

21490 000126-98-7 Metacrylonitrile. SML = Not detectable (LD = 0.020 mg/kg analytical tolerance included).

21550 000067-56-1 Methanol.

21730 000563-45-1 3-Methyl-1-butene. CMA = 0.006 mg/6 dm2. For use only in polypropylene.

21940 000924-42-5 N-Methylolacrylamide. SML = ND (LD = 0.01 mg/kg).

22150 000691-37-2 4-Methyl-1-pentene. SML = 0,02 mg/kg.

22331 025513-64-8 Mix of 1,6-diamino-2,2,4-trimethylhexane (40% w/w) and 1,6-diamino-2,4, 4-trimethyl-hexane (60% w/w).

CMA = 5mg/6 dm2.

22350 000544-63-8 Myristic Acid.

22390 000840-65-3 2,6-Naphthalenodicarboxylate dimethyl. SML = 0,05 mg/kg.

22420 003173-72-6 1,5-naphthalene diisocyanate. CM (T) = 1 mg/kg in PT (expressed as NCO).

22450 009004-70-0 Nitrocellulose.

22480 000143-08-8 1-Nonanol.

22550 000498-66-8 Norbornene. See "Bicyclo (2,2, 1) hept-2-ene".

22570 000112-96-9 Octadecyl Isocyanate. CM (T) = 1 mg/kg in PT (expressed in NCO).

22600 000111-87-5 1-Octanol.

22660 000111-66-0 1-Octeno. SML = 15 mg/kg.

22763 000112-80-1 oleic acid.

22780 000057-10-3 Palmitic acid.

22840 000115 -77-5 Pentaerythritol.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

22870 000071-41-0 1-Pentanol.

22937 001623-05-8 Eter perfluoropropylperfluoro-vinyl. SML = 0,05 mg/kg.

22870 000071-41-0 1-Pentanol.

22960 000108-95-2 Fenol.

23050 000108-45-2 1,3-Phenylenediamine. CM = 1 mg/kg in PT.

23155 000075-44-5 Fosgeno. See "carbonyl chloride."

23170 007664-38-2 phosphoric acid.

23175 000122-52-1 Triethyl phosphite. CM=ND (LD= 1 mg/Kg in PT).

23187 phthalic acid. See "terephthalic acid".

23200 000088-99-3 Acid or phthalic.

23230 000131-17-9 Diallyl Ftalate. LME=ND (LD=0.01 mg/Kg).

23380 00085-44-9 Phthalic Anhydride.

23470 000080-56-8 alpha-Pinene.

23500 000127-91-3 beta-Pinene.

23547 009016-00-6 Polidimethylsiloxane. In accordance with the specifications in Annex VII.

063148-62-9 (PMT6800).

23590 025322-68-3. Polyethylene glycol.

23651 025322-69-4 Polypropylene glycol.

23740 000057-55-6 1,2-Propanodiol.

23770 000504-63-2 1,3-Propanodiol. LME=0.05 mg/Kg.

23800 000071-23-8 1-Propanol.

23830 000067-63-0 2-Propanol.

23860 000123-38-6 Propionaldehyde.

23890 000079-09-4 propionic acid.

23920 000105-38-4 Vinyl propionate. SML (T) = 6 mg/Kg (2) (expressed as acetal-dehido).

23950 000123-62-6 propionic Anhydride.

23980 000115 -07-1 Propylene.

24010 000075-56-9 propylene oxide. CM= 1 mg/Kg in PT.

24051 000120-80-9 Pirocatecol. See "1,2-Dihydroxybenzene".

24057 000089-32-7 Anhydride pyromelitic. LME=0.05 mg/Kg (expressed as pyromelytic acid).

24070 073138-82-6 Resync Aids.

24072 000108-46-3. See "1,3-Dihydroxyben-cene".

24100 008050-09-7 Colofonia.

24130 008050-09-7 Colophony Goma. See "Colofonia".

24160 008052-10-6 Tall oil resin.

24190 009014-63-5 Wood resin.

24250 009006-04-6 Natural Rubber.

24270 000069-72-7 Salicylic acid.

24280 000111-20-6 Sebacic acid.

24430 002561-88-8 Sebacic Anhydride.

24475 001313-82-2 Sodium sulphide.

24490 000050-70-4 Sorbitol.

24520 008001-22-7 Soy Oil.

24540 009005-25-8 Starch, food quality.

24550 000057-11-4 stearic acid.

24610 000100-42-5 Styrene.

24760 026914-43-2 Styrenesulfonic acid. SML = 0.05 mg/Kg.

24820 000110-15 -6 Succinic acid.

24850 000108-30-5 Anhydride succinic.

24880 000057-50-1 Sucrose.

24887 006362-79-4 1 monosodium salt of 5-sulfoisophthalic acid. LME= 5 mg/Kg.

24888 003965-55-7 5-sulfoiso dimethyl monosodium salt.

LME=0.05 mg/Kg.

24910 000100-21-0 terephthalic acid. LME=7.5 mg/Kg.

24940 000100-20-9 terephthalic acid dichloride. SML (T) =7.5 mg/Kg (expressed as terephthalic acid).

24970 000120-61-6 dimethyl terephthalate.

25080 001120-36-1 1-Tetradecene. LME=0.05 mg/Kg.

25090 000112-60-7 Tetraethylene glycol.

25120 000116-14-3 Tetrafluoroethylene. LME=0.05 mg/Kg.

25150 000109-99-9 Tetrahydrofuran. LME=0.6 mg/Kg.

25180 000102-60-3 N, N, N, ethylenediamine.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

25210 000584-84-9 2,4-Toluylene diisocyanate. CM (T) = 1 mg/Kg in PT (expressed as NCO).

25240 000091-08-7 2,6-Toluylene diisocyanate. CM (T) = 1 mg/Kg in PT (expressed as NCO).

25270 026747-90-0 2,4-Dimerized toluylene diisocyanate. CM (T) = 1 mg/Kg in PT (expressed as NCO).

25360 Trialkyl (C5-C15) 2,3-epoxypropyl acetate. CM= 1 mg/Kg in PT (expressed as epoxy group, molecule weight = 43).

25385 000102-70-5 Triallylamine. In accordance with the specifications in Annex VII.

25420 000108-78-1 2,4,6-Triamino-1,3,5-Triazine. LME=30 mg/Kg.

25510 000112-27-6 Triethylene glycol.

25600 000077-99-6 1,1,1-Trimethylolpropane. LME= 6 mg/Kg.

25910 024800-44-0 Tripropylene glycol.

25927 027955-94-8 1,1,1-Tris (4-hydroxyphenyl) ethane. CM=0.5 mg/Kg in PT. For use only in polycarbonates.

25960 000057-13-6 Urea.

26050 000075-01-4 vinyl chloride. CM= 1 mg/Kg in PT.

LME=0.01 mg/Kg 26110 000075-35-4 Vinylidene chloride. CM= 5 mg/Kg in PT or LME=ND (LD=0.05 mg/Kg).

26140 000075-38-7 Vinylidene Fluoride. LME= 5 mg/Kg.

26170 003195-78-6 N-Vinyl-N-methylacetamide. CM= 2 mg/Kg in PT.

26155 001072-63-5 1-Vinylimidazole. CM= 5 mg/Kg in PT.

26320 002768-02-7 Vinyltrimethoxysilane. CM= 5 mg/Kg in PT.

26360 007732-18-5 Water. In accordance with the regulations governing the waters of human consumption.

Notes on the "Restrictions and/or Specifications" column:

(1) Warning: There is a risk of exceeding the SML in fatty food simulants.

(2) SML (T) means in this case that the sum of the migration of the following substances, marked with the N. or PM/REF.: 10060 and 23920, must not exceed the indicated restriction.

(3) SML (T) means in this case that the sum of the migration of the following substances, identified with the N. or PM/REF.: 15760, 16990, 47680,53650 and 89440, must not exceed the indicated restriction.

(4) SML (T) means in this case that the sum of the migration of the following substances, identified with the N. or PM/REF.: 19450 and 19960 must not exceed the indicated restriction.

(5) SML (T) means in this case that the sum of the migration of the following substances, indicated with the N. or PM/REF.: 14200 and 14230 must not exceed the indicated restriction.

(9) LME (T), means in this case that the sum of the migration of the following substances:

a) Badge (= 2,2-bis (-4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether.

b) Badge. H2O.

d) Badge. HCl.

e) Badge. 2HCl.

f) Badge. H2OHCl.

However, in aqueous food simulants, the SML (T) should also include BADGE 2H2 (c), unless the material or object is labelled for use in contact only with those foods and beverages for which it has been shown that the sum of migrations of the five substances referred to in paragraph (a), (b), (d), (e) and (f) cannot exceed 1 mg/kg.

SECTION B

The list of monomers and other starting substances that may continue to be used until their inclusion in Section A is decided.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

10155 000542-02-9 Acetoguanamine. See "2,4-Diamino-6-me-til-1,3,5-triazine".

10599 /90A 061788-89-4 Distillates of unsaturated fatty acids (C18).

10599/91 061788-89-4 Non-distillates of unsaturated fatty acids (C18).

10599 /92A 068783-41-5 hydrogenated dimers de-labelled unsaturated fatty acids (C18).

10599/93 068783-41-5 Non-distilled hydrogenated dimers of unsaturated fatty acids (C18).

11500 000103-11-7 acrylate 2-ethylhexyl.

11530 000999-61-1 acrylate 2-hydroxypropyl.

12910 001732-10-1 dimethyl Azelate.

13050 000528-44-9 Acid 1,2,4-benzenetricarb-xilic. See "Trimellitic acid".

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

13075 000091-76-9 Benzoguanamine. See "2,4-Diamina-6-phenyl-1,3,5-triazine".

13617 000080-09-1 Bisphenol S. See "4.4 dihydroxyphenyl-sulfone".

13720 000110-63-4 1,4-Butanediol.

13810 000505-65-7 1,4-Butanediolformal.

13932 000598-32-3 3-Buten-2-ol.

14260 000502-44-3 Caprolactone.

14800 003724-65-0 Crotonic Acid.

15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazine.

15370 003236-53-1 1,6-Diamino-2,2,4-trimethyl-hexane.

15400 003236-54-2 1,6-Diamino-2,4,4-trim-thylhexane.

15610 000080-07-9 4,4-15730 000077-73-6 Dichlorpentadiene.

16090 000080-09-1 4,4-Dihydroxyphenylsulfone.

16210 006864-37-5 3,3-16390 000126-30-7 2,2-Dimethyl-1,3-propanediol.

16540 000102-09-0 Diphenyl carbonate.

16690 001321-74-0 Divinylbenzene. CM= 1 mg/kg in PT or LME=ND (LD= 0.02 mg/kg, analytical tolerance included).

16697 000693-23-2 Dodecanedioic acid.

17110 016219-75-3 Ethylidenbicyclo (2.2.1) hept-2-ene.

18370 000592-45-0 1,4-Hexadiene.

18441 000085-42-7 Hexahydrophthalic Anhydride.

18700 000629-11-8 1,6-Hexanediol.

19180 000099-63-8 isophthalic acid dichloride.

19243 000078-79-5 Isorene. See "2-Methyl-1,3-but-diene".

19490 000947-04-6 Laurolactama.

19570 000999-21-3 Diallyl Maleate.

19600 000105-76-0 Drawing Maleate.

20260 000101-43-9 cyclohexyl methacrylate.

20380 001189-08-8 Dimethacrylate of 1,3-butane-diol.

20410 002082-81-7 Dimethacrylate of 1,4-butane-diol.

20440 000097-90-5 ethylene glycol Dimethacrylate.

20590 000106-91-2 2,3-epoxy-propyl methacrylate. CM (T) = 5 mg/kg in PT. (expressed as epoxy group, molecular weight = 43).

21370 010595-80-9 Methacrylate 2-sulfoethyl.

21400 054276-35-6 Sulfopropyl methacrylate.

21520 001561-92-8 Sodium Metallylsulfonate. CM= 5 mg/kg in PT.

21640 000078-79-5 2-Methyl-1,3-butadiene.

21821 000505-65-7 1,4-(Methylenedioxy) butane. See "1,4-butane diol-bad".

21970 000923-02-4 n-Methylolmetacrylamide.

22210 000098-83-9 alpha-Methylstyrene.

22360 001141-38-4 2,6-naphthalenedicarboxylic acid.

22437 000126-30-7 Neopentylglycol. See "2,2-Dimethyl-1,3-propanediol".

22550 000498-66-8 Norbornene. See "Bicyclo (2,2, 1) hept-2-ene".

22720 000140-66-9 4-ter-Octylphenol. See "4-(1,1,3,3-Tetrame-tilbutyl) phenol".

22900 000109-67-1 1-Pentene.

23185 Phthalic Acids.

24370 000106-79-6 dimethyl Sebacate.

25185 000140-66-9 4-(1,1,3,3-tetramethylbutyl) phenol (=4-tert-Octylphenol).

LME=ND (LD= 0 ,01mg/kg analytical tolerance included).

25380 T r ai l q u i l (C5-C15) a c e t at o d e v in il o (= vinyl versatate).

25390 000101-37-1 Triallyl Cianurate.

25450 026896-48-0 Tricyclodecanedimethanol.

25540 000528-44-9 Trimelitic acid. CM (T) = 5 mg/kg in PT.

25550 000552-30-7 Trimelitic Anhydride. CM (T) = 5 mg/kg in PT (expressed as trimelitic acid).

25810 015625-89-5 Triacrylate 1,1,1-trimo-tilolpropane.

25840 003290-92-4 Trimethacrylate 1,1,1-trimethylolpropane.

25900 000110-88-3 Trioxane.

25922 000102-71-6 Tris (2-hydroxyethyl) amine. See "Triethanolamine".

26230 000088-12-0 Vinylpyrrolidone.

26292 000622-97-9 p-Viniltoluene. See "p-Methylstyrene".

26375 000105-67-9 m-Xilenol. See "2,4-Dimethylphenol".

26377 000526-75-0 o-Xilenol. See "2,3-Dimethylphenol".

26379 000095-87-4 p-Xilenol. See "2.5-Dimethylphenol".

6. Annex V, the wording of which is the text

is replaced by:

" ANNEX V

List of additives that can be used in the manufacture of plastic materials and articles

General Introduction 1) This Annex contains the list of:

a) Substances that are incorporated into plastics to produce a technical effect on the finished product, with the intention that they remain present in the finished objects.

b) Substances used to provide a suitable medium for polymerization, such as emulsifiers, surfactants and pH dampers.

The list does not include substances that directly influence the formation of polymers, such as catalysts.

2) The list does not include salts (are considered double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of acids, phenols or alcohols, which are also authorised, however names that contain the word appear in the list ... acid (s), salt (s) ' in case the corresponding free acid (s) is not mentioned (n).

In such cases, the meaning of the term "salts" is "aluminum, ammonium, calcium, iron, magnesium, potassium, sodium, and zinc salts."

3) The list does not include the following substances, although they may be present:

(a) Substances which may be present in the finished product, such as: impurities of the substances, intermediate reaction products and decomposition products.

(b) Mixtures of the authorised substances.

The materials and articles containing the substances referred to in (a) and (b) must comply with the requirements laid down in Article 6 (6.2), (6.3) and (6.4) of the Technical-Health Regulation for the development, circulation and trade in plastic materials intended to come into contact with food, approved by Royal Decree 1425/1988 of 25 November.

4) Substances should be of good technical quality in terms of purity criteria.

5) The list contains the following information:

Column 1 (PM/REF number): the EEC reference number of the packaging materials of the substance mentioned in the list.

Column 2 (CAS number): the Chemical Abstracts Service (CAS) record number.

Column 3 (Name): the chemical name.

Column 4 (Restrictions and/or Specifications):

these can include:

a) The specific migration limit (LME).

b) Maximum amount of substance allowed in the finished material or object (CM).

c) The maximum permitted quantity of the substance in the finished material or object, expressed per unit of surface in contact with the food products (CMA), e.g. mg (of substance) /6 dm2 (surface in contacus with the food products).

d) Any other specifically mentioned restrictions.

e) Any other type of specifications linked to the substance or polymer.

6) If a substance listed as an isolated compound is also included in a generic name, the restrictions applicable to this substance shall be those for the isolated compound.

7) In case of disagreement between the CAS number and the chemical name, the chemical name shall prevail against the first. If there is disagreement between the CAS number collected in the EINECS and the CAS record, the CAS number of the CAS record shall be applied.

List of Additives

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

30000 000064-19-7 acetic acid.

30045 000123-86-4 Butyl Acetate.

30080 004180-12-5 Copper Acetate. SML (T) = 30 mg/Kg (7) (expressed as copper).

30140 000141-78-6 Ethyl Acetate.

30280 000108-24-7 Anhydride acetic.

30295 000067-64-1 Acetone.

30370-Acetylacetic acid, salts.

30400-Acetylated Glycerides.

30610-Aides, C2-C24, aliphatic, linear, monocarboxylic, obtained from natural fats and oils and their esters with mono-, di and triglycerol (including branched fatty acids at the levels that are presented ).

30612-Cooked, C2-C24, aliphatic, linear, monocarboxylic, synthetic and its esters with mono-, di-and triglycerol.

30960-esters of monocarboxylic aliphatic acids (C6-C22) with polyglycerol.

31328-fatty acids obtained from animal or vegetable fats and oils.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

31530 123968-25-2 A c r i l a t o d e 2, 4-d i-t e r c-p e n t i l-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl) ethyl] phenyl.

LME= 5 mg/Kg.

31730 000124-04-9 Adipeak acid.

33120-Saturated, Linear, Primary Aliphatic Monoalcohols (C4-C24).

33350 009005-32-7 Alginic acid.

33801-n-alkyl (C10-C13) bence-nosulfonic acid. LME= 30 mg/Kg.

34240-alkyl (C10-C20) sulfonic acid esters with phenols.

LME= 6 mg/Kg. Authorised until 1 January 2002.

34281-Alkyl Acids (C8-C22) primary linear sulphurics with an even number of carbon atoms.

34475-Aluminium and calcium hydroxyphosphite, hydrate.

34480-Aluminium (fibres, flakes, powders).

34560 021645-51-2 Aluminum Hydroxide.

34690 011097-59-9 Aluminium and magnesium hydroxycarbonate.

34720 001344-28-1 Aluminium oxide.

35120 013560-49-1 3-aminocrotonic acid diester with thiobis (2-hydroxyethyl) ether.

35320 007664-41-7 Ammonia.

35440 012124-97-9 ammonium bromide.

35600 001336-21-6 Ammonium Hydroxide.

35840 000506-30-9 Arachidic acid.

35845 007771-44-0 Arachidonic acid.

36000 000050-81-7 Ascorbic acid.

36080 000137-66-6 Ascorbilo Palmitate.

36160 010605-09-1 Ascorbilo stearate.

36640 000123-77-3 Azodicarbonamide. For use only as a foaming agent.

36880 008012-89-3 Bee Cera.

36960 003061-75-4 Behenamide.

37040 000112-85-6 Behenic acid.

37280 001302-78-9 Bentonite.

37360 000100-52-7 Benzaldehyde. According to note 10.

37600 000065-85-0 benzoic acid.

37680 000136-60-7 butyl Benzoate.

37840 000093-89-0 ethyl Benzoate.

38080 000093-58-3 methyl Benzoate.

38160 002315 -68-6 propyl Benzoate.

38320 005242-49-9 4-(2-Benzoxazolyl) -4 '-(5-methyl-2-benzoxazolyl) stilbene.

According to the specifications in Annex VII.

38510 136504-96-6 1,2-Bis (3-aminopropyl) ethylenediamine, polymer with N-butyl-2.2,6, 6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine.

LME= 5 mg/Kg.

38515 001533-45-5 4.4 ' Bis (2-benzoxazolyl) stilbene. LME= 0.05 mg/Kg (1).

38810 080693-00-1 bis (2,6-di-tert-butyl-4-methylphenyl) pentaerythritol diphosphite.

LME= 5 mg/Kg (sum of phosphite and phosphate).

38879 135861-56-2 Bis (3,4-dimethylbenzylidene) sorbitol.

38950 079072-96-1 Bis (4-ethylbenzylidene) sorbitol.

39200 006200-40-4 bis (2-hydroxyethyl) -2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride.

LME= 1.8 mg/Kg.

39815 182121-12-6 9,9-Bis (methoxymethyl) fluorene. CMA= 0.05 mg/6 dm2 39890 087826-41-3 069158-41-4 054686-97-4 081541-12-0

bis (methylbenzylidene) sorbitol.

40120-hydroxymethylphosphonate bis (polyethylene glycol). LME= 0.06 mg/Kg. Authorised until 1 January 2002.

40400 010043-11-5 Boron Nitride.

40570 000106-97-8 Butane.

41040 005743-36-2 Calcium Butitime.

41280 001305-62-0 Calcium Hydroxide.

41520 001305-78-8 Calcium Oxide.

41600 012004-14-7 037293-22-4 Calcium Sulfoaluminate.

41680 000076-22-2 Alcanfor. According to note 10.

41760 008006-44-8 Candelilla Cera.

41960 000124-07-2 Caprylic acid.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

42160 000124-38-9 Carbon dioxide.

42320 007492-68-4 Copper carbonate. SML (T) = 30 mg/Kg (7) (expressed as copper).

42500-Carbon acid, salts.

42640 009000-11-7 Carboximethylcellulose.

42720 008015 -86-9 Carnauba Cera.

42800 009000-71-9 Casein.

42960 064147-40-6 dehydrated castor oil.

43200-Mono and diglycerides of castor oil.

43280 009004-34-6 Cellulose.

43300 009004-36-8 Cellulose Acetobutyrate.

43360 068442-85-3 Regenerated cellulose.

43440 008001-75-0 Ceresina.

43515 Coconut oil fatty acid esters with choline chloride.

CMA= 0.9 mg/6 dm2.

44160 000077-92-9 Citric acid.

44640 000077-93-0 Triethyl citrate.

45195 007787-70-4 Copper bromide. SML (T) = 30 mg/Kg (7) (expressed as copper).

45200 001335-23-5 Copper iodide. SML (T) = 30 mg/Kg (7) (expressed as copper) and LME= 1 mg/Kg (expressed as iodine).

45280 Cotton fibers.

45450 068610-51-5 Copolymer p-cresol-dicyclo-pentadiene-isobutylene.

LME= 0.05 mg/Kg.

45560 014464-46-1 Cristobalite.

45760 000108-91-8 Cyclohexylamine.

45920 009000-16-2 Dammar.

45940 000334-48-5 N-decanoic acid.

46070 010016-20-3 alpha-Dextrin.

46080 007585-39-9 beta-Dextrin.

46375 061790-53-2 diatom Earth.

46380 068855-54-9 Land of calcined diatoms with sodium carbonate flux.

46480 032647-67-9 Dibenzylidensorbitol.

46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxy-benzoate of 2,4-di-tert-butylphenyl.

46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxy-benzoate.

46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxy-benzylphosphonate diocta-decyl.

46880 065140-91-2 3.5, Di-tert-butyl-4-hydroxy-benzylphosphonate monoethyl, calcium salt.

LME= 6 mg/Kg.

47440 000461-58-5 Diciandiamide.

47680 000111-46-6 Diethylene glycol. SML (T) = 30 mg/Kg (3).

48460 000075-37-6 1,1-Difluoroethane.

49485 134701-20-5 2,4-Dimethyl-6-(1-methylpenta-decyl) phenol. LME= 1 mg/Kg.

49540 000067-68-5 Dimethyl sulfoxide.

51200 000126-58-9 Dipentaerythritol.

51700 147315 -50-2 2-(4,6-Diphenyl-1,3, 5-triazin-2-yl) -5-(hexyloxy) phenol.

LME= 0.05 mg/Kg.

51760 0025265-71-8 Dipropylene glycol.

000110-98-5 52640 016389-88-1 Dolomite.

52720 000112-84-5 Erucamida.

52730 000112-86-7 Erucic acid.

52800 000064-17-5 Ethanol.

53270 037205-99-5 Ethylcarboxymethylcellulose.

53280 009004-57-3 Etilcellulose.

53360 000110-31-6 N, N-53440 005518-18-3 N, N-53520 000110-30-5 N, N-53600 000060-00-4 Ethylenediaminetra-acetic acid.

53610 054453-03-1 Copper Etilenediaminotetraacetate. SML (T) = 30 mg/Kg (7) (expressed as copper).

53650 000107-21-1 Ethylene Glycol. SML (T) = 30 mg/Kg (3) 54005 005136-44-7 Ethylene-N-palmitamide-N-

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

54260 009004-58-4 Ethylhydroxyethylcellulose.

54270 Ethylhydroxymethylcellulose.

54280 Ethylhydroxypropylcellulose.

54300 118337-09-0 2,2Etylidenbis (4, 6-di-tert-butylphenyl) fluorophosphonite.

LME= 6 mg/Kg.

54450 Fat and oils of animal or plant food origin.

54480 Fat and hydrogenated oils-two of animal or plant food origin.

54930 025359-91-5 Copolymer formaldehyde-1-naphthol [=Poli (1-hydroxinaf-tilmethane)].

LME= 0.05 mg/Kg.

55040 000064-18-6 formic acid.

55120 000110-17-8 fumaric acid.

55190 029204-02-2 Gadoleic acid.

55440 009000-70-8 Gelatin.

55520 Fibers of glass.

55600 Microparticles of glass.

55680 000110-94-1 Glutaric Acid.

55920 000056-81-5 Glycerol.

56020 099880-64-5 glycerol Dibehenate.

56360 glycerol esters with acetic acid.

56486 glycerol esters with linear saturated aliphatic acids with an even number of carbon atoms (C14-C18) and with linear unsaturated aliphatic acids with an even number of carbon atoms (C16-C18).

56487 glycerol esters with butyric acid.

56490 glycerol esters with erucic acid.

56495 glycerol esters with 12-hydroxystearic acid.

56500 glycerol esters with lauric acid.

56510 glycerol esters with linoleic acid.

56520 glycerol esters with myristic acid.

56540 glycerol esters with oleic acid.

56550 glycerol esters with palmitic acid.

56565 glycerol esters with nonanoic acid.

56570 glycerol esters with propionic acid.

56580 glycerol esters with ricinoleic acid.

56585 glycerol esters with stearic acid.

56610 030233-64-8 Glycerol Monobehenate.

56720 026402-23-3 Glycerol Monohexanoate.

56800 030899-62-8 Glycerol Diacetate Monolaurate.

56880 026402-26-6 glycerol Monooctanoate.

57040 glycerol monooleate, ester with ascorbic acid.

57120 glycerol monooleate, ester with citric acid.

57200 glycerol Monopalmitate, ester with ascorbic acid.

57280 glycerol Monopalmitate, ester with citric acid.

57600 glycerol monostearate, ester with ascorbic acid.

57680 glycerol, ester with citric acid.

57800 018641-57-1 glycerol tribehenate.

57920 000620-67-7 glycerol Triheptanoate.

58300-Glycine, salts.

58320 007782-42-5 Graphite.

58400 009000-30-0 Goma guar.

58480 009000-01-5 Goma arabica.

58720 000111-14-8 Heptanoic acid.

59360 000142-62-1 Hexanoic acid.

59760 019569-21-2 Huntite.

59990 007647-01-0 Hydrochloric acid.

60030 012072-90-1 Hidromagnesite.

60080 012304-65-3 Hydrotalcite.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

60160 000120-47-8 4-ethyl hydroxybenzoate.

60180 004191-73-5 isopropyl hydroxybenzoate.

60200 000099-76-3 4-methyl hydroxybenzoate.

60240 000094-13-3 4-propyl hydroxybenzoate.

60480 003864-99-1 2-(2-Hydroxy-3, 5-di-tert-butylphenyl)-5-chlorobenzotriazole.

LME=30 mg/Kg.

60560 009004-62-0 Hydroxyethylcellulose.

60880 009032-42-2 Hydroxyethylmethylcellulose.

61120 009005-27-0 Hydroxyethylstarch.

61390 037353-59-6 Hydroxymethylcellulose.

61680 009004-64-2 Hydroxypropylcellulose.

61800 009049-76-7 Hydroxypropyl starch.

61840 000106-14-9 12-hydroxystearic acid.

62140 006303-21-5 Hypophosphorous acid.

62240 001332-37-2 Iron oxide.

62450 000078-78-4 Isopentane.

62640 008001-39-6 Japanese Cera.

62720 001332-58-7 Caolin.

62800 calcined Caolin.

62960 000050-21-5 Lactic acid.

63040 000138-22-7 butyl lactate.

63280 000143-07-7 Lauric acid.

63760 008002-43-5 Lecithin.

63840 000123-76-2 Levulinic acid.

63920 000557-59-5 Lligneric acid.

64015 000060-33-3 Linoleic acid.

64150 028290-79-1 Linolenic acid.

64500 Lisina, salts.

64640 001309-42-8 Magnesium hydroxide.

64720 001309-48-4 Magnesium oxide.

65020 006915 -15 -7 Malic acid.

65040 000141-82-2 Malonic acid.

65520 000087-78-5 Mannitol.

66200 037206-01-2 Methylcarboxymethylcellulose.

66240 009004-67-5 Metilcellulose.

66560 004066-02-8 2,2Metilenbis (4-methyl-6-cycle-hexylphenol). SML (T) = 3 mg/Kg (6).

66580 000077-62-3 2, 2Methylenbis [4-methyl6-(1-methylcyclohexyl) phenol].

LME (T) = 3 mg/Kg (6).

66640 009004-59-5 Metiletilcellulose.

66695 Methylhydroxymethylcellulose.

66700 009004-65-3 Methylhydroxypropylcellulose.

66755 002682-20-4 2-Methyl-4-isothiazolin-3-one. LME=ND (LD=0.02 mg/Kg, analytical tolerance included).

67120 012001-26-2 Mica.

67170 5,7-di-tert-butyl-butyl-3 (3, 4-dimethylphenyl) -2 (3H) ben-zofuranone (80-100% w/w) and 5,7-di-tert-butyl-3-(2,3-dime-tylphenyl)-2 (3H) benzofuranone (0-20% w/w).

LME= 5 mg/Kg.

67180 N-decyl n-octyl phthalate (50% w/w) phthalate, di-n-decyl phthalate (25% w/w) and di-n-octyl phthalate (25% w/w).

LME= 5 mg/Kg (1).

67200 001317-33-5 molybdenum disulfide.

67840 Montanic acids and/or their esters with ethylene glycol and/or 1,3-butanediol and/or glycerol.

67850 008002-53-7 Mountain Cera.

67891 000544-63-8 Myristic Acid.

68040 003333-62-8 7-[2-H-Nafto-(1, 2-d) triazol-2-yl] -3-phenylcoumarin.

68125 037244-96-5 Nefelina sienite.

68145 080410-33-9 2,2,2 " -Nitrile [triethyl tris (3,3, 5, 5-tetra-tert-butyl-1.1-bife-nil-2,2-diyl)phosphite].

LME= 5 mg/Kg (as sum of phosphite and phosphate).

68960 000301-02-0 Oleamide.

69040 000112-80-1 oleic acid.

69760 000143-28-2 oleic alcohol.

70000 070331-94-1 2,2-5-di-tert-butyl4-hydroxyphenyl) propionate].

70240 012198-93-5 Ozocerite.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

70400 000057-10-3 Palmitic acid.

71020 000373-49-9 Palmitoleic acid.

71440 009000-69-5 Pectin.

71600 000115 -77-5 Pentaerythritol.

71635 025151-96-6 pentaerythritol dioleate. LME= 0.05 mg/Kg. Substance not for use in polymers in contact with food for which simulant D is established in Royal Decree 1752/98.

71680 006683-19-8 Tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate] of pentaerythritol.

71720 000109-66-0 Pentano.

72640 007664-38-2 phosphoric acid.

73720 000115 -96-8 Trichloroethyl phosphate. LME=ND (LD= 0.02 mg/Kg, analytical tolerance included).

74010 145650-60-8 bis (2,4-di-tert-butyl-6-methylphenyl) ethyl

LME= 5 mg/Kg (as sum of phosphite and phosphate).

74240 031570-04-4 Tris (2,4-di-tert-butylphenyl) Fosphyto.

74480 000088-99-3 Acid or phthalic.

76320 000085-44-9 Phthalic Anhydride.

76721 009016-00-6 063148-62-9 Polidimethylsiloxane.

(PM According to the specifications of Annex VII.

76865 Polyesters of 1,2-propanediol and/or 1.3y 1,4-butanediol and/or polypropylene glycol with adipic acid, in addition to the end encapsulated with acetic acid or C10-C18 or n-octanol and/or n-decanol fatty acids.

LME= 30 mg/Kg.

76960 025322-68-3 Polyethylene Glycol.

77600 061788-85-0 polyethylene glycol ester with hydrogenated castor oil.

77702 polyethylene glycol esters with monocarbo-xylic aliphatic acids (C6-C22) and their ammonium and sodium sulfates.

77895 068439-49-6 Monoalkyl Ether (C16C18) polyethylene glycol [ethylene oxide (OE) = 2-6].

LME= 0.05 mg/Kg.

79040 009005-64-5 Polyethyleneglycol sorbitan Monolaurate.

79120 009005-65-6 Polyethyleneglycol sorbitan Monooleate.

79200 009005-66-7 polyethylene glycol-sorbitan Monopalmitate.

79280 009005-67-8 polyethylene glycol-sorbitan monostearate.

79360 009005-70-3 Polyethylene glycol sorbitan trioleate.

79440 009005-71-4 polyethylene glycol sorbitan tristearate.

80240 029894-35-7 Polyglycerol Ricinoleate.

80640 Polyoxyalkyl (C2-C4) dimethylpolysiloxane.

80720 008017-16-1 Polyphosphoric acids.

80800 025322-69-4 Polypropylene glycol.

81515 087189-25-1 Poli (zinc glycerolate).

81520 007758-02-3 Potassium bromide.

81600 001310-58-3 Potassium Hydroxide.

81760 Polvos, brass, brass, brass, copper, stainless steel, tin and alloy copper, tin and iron.

LME (T) = 30 mg/Kg (7) (expressed as copper); LME= 48 mg/Kg (expressed as iron).

81840 000057-55-6 1,2-Propanodiol.

81882 000067-63-0 2-Propanol.

82000 000079-09-4 propionic acid.

82080 009005-37-2 Alginate of 1,2-propylene glycol.

82240 022788-19-8 1,2-propylene glycol Dilaurate.

82400 000105-62-4 1,2-propylene glycol dioleate.

82560 033587-20-1 Dipalmitate of 1,2-propylene-glycol.

82720 006182-11-2 Distearate of 1,2-propylene-glycol.

82800 027194-74-7 Monolaurate of 1,2-propylene-glycol.

82960 001330-80-9 Monooleate of 1,2-propylene-glycol.

83120 029013-28-3 Monopalmitate of 1,2-propi-lenglycol.

83300 001323-39-3 Monostearate of 1,2-propyl-englycol.

83320 Propilhydroxyethylcellulose.

83325 Propilhydroxymethylcellulose.

83330 Propilhydroxypropylcellulose.

83440 002466-09-3 Pyrophosphoric acid.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

83455 013445-56-2 Pirophosphorous acid.

83460 012269-78-2 Pirofilita.

83470 014808-60-7 Quartz.

83610 073138-82-6 Resync Aids.

83840 008050-09-7 Colofonia.

84000 008050-31-5 Colophony ester with glycerol.

84080 008050-26-8 Rosin Ester with pentaerythritol.

84210 065997-06-0 hydrogenated Colofonia.

84240 065997-13-9 Glycerol Hydrogenated Rosin Ester.

84320 008050-15 -5 Ester hydrogenated colophony with methanol.

84400 064365-17-9 Ster of hydrogenated rosin with pentaerythritol.

84560 009006-04-6 Natural Rubber.

84640 000069-72-7 Salicylic acid.

85360 000109-43-3 Drawing Sebacate.

85600 Natural Silicates.

85610 Natural silicates silicates (except asbestos).

85840 053320-86-8 Sodium magnesium lithium silicate. SML (T) = 0.6 mg/Kg (8) (expressed as lithium).

85980 silicic acid, salts.

86000 Silicic acid silylated.

86160 000409-212-2 Silicon carbide.

86240 007631-86-9 Silicon dioxide.

86285 Silylated silicon dioxide.

8660 007647-15 -6 Sodium bromide.

86720 001310-73-2 Sodium Hydroxide.

87200 000110-44-1 Sorbic acid.

87280 029116-98-1 Sorbitan dioleate.

87520 062568-11-0 Sorbitan Monobehenate.

87600 001338-39-2 Sorbitan Monolaurate.

87680 001338-43-8 Sorbitan Monooleate.

87760 026266-57-9 Sorbitan Monopalmitate.

87840 001338-41-6 Sorbitan Monostearate.

87920 061752-68-9 Sorbitan tetrastearate.

88080 026266-58-0 Sorbitan trioleate.

88160 054140-20-4 Sorbitan Tripalmitate.

88240 026658-19-5 Sorbitan Tristearate.

88320 000050-70-4 Sorbitol.

88600 026836-47-5 Sorbitol Monostearate.

88640 008013-07-8 Epoxidado soybean oil. In accordance with the specifications in Annex VII.

88800 009005-25-8 Starch, food quality.

88880 068412-29-3 Hydrolyzed Starch.

88960 000124-26-5 Estearamide.

89040 000057-11-4 stearic acid.

89200 007617-31-4 Copper stearate. SML (T) = 30 mg/Kg (7) (expressed as copper) 89440 stearic acid esters with ethylene glycol. SML (T) = 30 mg/Kg (3).

90720 058446-52-9 stearoylbenzoylmethane.

90800 005793-94-2 Calcium stearoyl-2-lactylate.

90960 000110-15 -6 Succinic acid.

91200 000126-13-6 Sucrose isobutyrate.

91360 000126-14-7 Octaacetate of sucrose.

91840 007704-34-9 Sulphur.

91920 007664-93-9 sulphuric acid.

92030 010124-44-4 Copper Sulphate. SML (T) =30 mg/Kg (7) (expressed as copper) 92080 014807-96-6 Talc.

92160 000087-69-4 Tartaric acid.

92195 Taurina, salts.

92205 057569-40-1 terephthalic acid diester with 2, 2-92350 000112-60-7 tetraethylene glycol.

92640 000102-60-3 N, N, N,

92700 078301-43-6 Polymer 2,2,4,4-tetramethyl-20-(2,3-epoxypropyl) -7-oxa-3,20-diazadispiro [5.1.

11.2]-henecosan-21-one.

LME= 5 mg/Kg.

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

92930 120218-34-0 Tiodiethanolbis (5-methoxycarbonyl-2, 6-dimethyl-1,4-dihydropyri-dina-3-carboxylate).

LME= 6 mg/Kg.

93440 013463-67-7 Titanium dioxide.

93520 000059-02-9 010191-41-0 Alfa-Tocoferol.

93680 009000-65-1 Goma tragacanto.

94320 000112-27-6 Triethylene glycol.

94960 000077-99-6 1,1,1-Trimethylolpropane. LME= 6 mg/Kg.

95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris (3, 5-di-ter-cbutyl-4-hydroxybenzyl) benzene.

95725 110638-71-6 Vermiculita, lithium citrate reaction product.

LME (T) = 0.6 mg/Kg (8) (expressed as lithium).

95855 007732-18-5 Water. In accordance with the regulations governing the waters of human consumption.

95859 Ceras, of high purity, derived from petroleum based on synthetic hydrocarbon raw materials.

According to the specifications in Annex VII.

95883 White mineral oils, paraffinic, petroleum derivatives, based on hydrocarbon raw materials.

According to the specifications in Annex VII.

95905 013983-17-0 Wollastonita.

95920 Harine and wood fibres, not treated.

95935 011138-66-2 Goma Xantana.

96190 020427-58-1 Zinc Hydroxide.

96240 001314-13-2 zinc oxide.

96320 001314-98-3 zinc sulphide.

Notes on the "Restrictions and/or Specifications" column

(1) Warning: There is a risk of exceeding the SML in fatty food simulants.

(2) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 10060 and 23920, must not exceed the indicated restriction.

(3) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 15760.16990, 47680, 53650 and 89440, must not exceed the indicated restriction.

(4) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 19450 and 19960 must not exceed the indicated restriction.

(5) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 14200 and 14230 must not exceed the indicated restriction.

(6) SML (T) means in this case that the sum of the migration of the following substances, indicated with the numbers PM/REF.: 66560 and 66580 must not exceed the indicated restriction.

(7) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030, should not exceed the indicated restriction.

(8) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 85840 and 95725 must not exceed the indicated restriction.

(9) LME (T), means in this case that the sum of the migration of the following substances:

a) Badge (= 2,2-bis (-4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether b) Badge. H2O.

d) Badge. HCl.

e) Badge. 2HCl.

f) Badge. H2O.HCl.

However, in aqueous food simulants, the SML (T) should also include BADGE 2H2 (c), unless the material or object is labelled for use in contact only with those foods and beverages for which it has been shown that the sum of migrations of the five substances referred to in paragraph (a), (b), (d), (e) and (f) cannot exceed 1 mg/kg.

(10) Warning: There is a risk that the migration of the substance will impair the organoleptic characteristics of the food in contact and, in that case, the finished product could cause an alteration of the characters organoleptics or an unacceptable modification of the composition of the food products.

7. Annexes VI and VII are added:

" ANNEX VI

Products obtained by bacterial fermentation

PM/REF Number (1) CAS Number (2) Name (3) Restrictions and/or Specifications (4)

18888 80181-31-3 Copolymer of 3-hydroxyphenanoic and 3-hydroxybutanoic acids.

LME= 0,05 mg/Kg for crotonic acid (as impurity) and in accordance with the specifications mentioned in Annex VII '

ANNEX VII

Specifications

Part A: General specifications (will be set later).

Part B: Other specifications.

N. or PM/REF Other specifications

18888 Copolymer of 3-hydroxyphenanoic and 3-hydroxybutanoic acids.

Definition: These copolymers are produced by controlled fermentation of Alcalgenes eutrophus using mixtures of glucose and propanoic acid as sources of carbon. The organism used has not been genetically engineered and comes from a single natural organism, Alcalgenes eutrophus strain H16 NCIMB 10442. Mother strains of this organism are stored in lyophilized ampoules. From the mother strain a secondary strain of work is prepared which is preserved in liquid nitrogen and is used to prepare inoculum for the fermenter. The fermenter samples are examined daily both under a microscope and to detect any changes in the colonial morphology in a series of agares at different temperatures. The copolymers are isolated from the heat treated bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally presented as formulated and melt-prepared granules containing additives such as nucleating agents, plasticizers, filler material, stabilizers and pigments, all of which are in accordance with the invention. general and specific specifications.

Chemical name: Poli (3-D-hydroxybutanoate-co-3-D-hydroxyentanoate).

CAS Number: 80181-31-3.

Structural Formula:

(-O-)-mm (CH3 (-O-) m-(| CH3 OR CH2 O | | | | | | (-O-CH-CH2-C-) m-(O-CH-CH2-C-) n where n/(m + n) to 0 and " to 0.25

Average molecular weight: No less than 150,000 dalton (measured by gel penetration chromatography).

N. or PM/REF Other specifications

Assay: No less than 98 per 100 of poly (3-D-hydroxybutanoate-co-3-D-hydroxypen-tanoate) analyzed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxyentanoic acids.

Description: White or off-white powder after isolation.

Features.

Identification tests:

Solubility: Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane, but practically insoluble in ethanol, aliphatic alkanes, and water.

Migration: The migration of crotonic acid must not exceed 0.05 mg/kg of food.

Purity: Before granulation, the raw copolymer powder must contain:

Nitrogen: Not more than 2,500 mg/kg.

Cinc: No more than 100 mg/kg plastic material.

Copper: Not more than 5 mg/kg plastic material.

Lead: Not more than 2 mg/kg plastic material.

Arsenic: Not more than 1 mg/kg plastic material.

Chromium: Not more than 1 mg/kg plastic material.

23547 Polidimethylsiloxane (pm Minimum viscosity: 100 ^ 10-6 m2/s (= 100 centistokes) at 25 oC.

25385 Triallylamine.

40 mg/kg hydrogel in the ratio of 1 kg of food product to a maximum of 1.5 g of hydrogel. It should only be used in hydrogel not intended for direct contact with food.

38320 4-(2-Benzoxazolyl) -4 '-(5-methyl-2-benzoxazolyl) stilbene.

Not more than 0.05% w/w (amount of substance used/amount of formulation).

76721 Polydimethylsiloxane (Pm Minimum Viscosity: 100 ^ 10-6 m2/s (= 100 centistokes) at 25 oC.

N. or PM/REF Other specifications

88640 Oxirane epoxy soybean oil 8%, iodine number 6

95859 refined crude oil or synthetic hydrocarbon raw materials derived from raw materials.

The product must have the following specifications:

Quantity of mineral hydrocarbons having carbon numbers less than 25: not more than 5% (w/w).

Viscosity not less than 11 ^ 10-6 m2/s (= 11 centistokes) at 100 oC.

Average molecular weight not less than 500.

95883 Oil-based hydrocarbon-derived white paraffinic mineral oils.

The product must have the following specifications:

Quantity of mineral hydrocarbons having carbon numbers less than 25: not more than 5% (w/w).

Viscosity not less than 8.5 ^ 10-6 m2/s (= 8,5 centistokes) at 100 oC.

Average molecular weight not less than 480.

First transient disposition. Extension of marketing.

Those plastic materials and articles intended to come into contact with food that do not conform to the provisions of this Royal Decree, but which comply with the regulations in force at the date of its entry into force, may be placed on the market until 1 January 2003.

Second transient disposition. Marketing conditions.

As of 1 January 2003, the import and manufacture of plastic materials and articles intended to come into contact with food that does not comply with the provisions of this Royal Decree is prohibited.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed, they oppose the provisions of this Royal Decree.

Final disposition first. Competence title.

This Royal Decree is dictated by the provisions of Article 149.1.16.a of the Constitution and in accordance with the provisions of Article 40.2 and 40.4 of Law 14/1986 of 25 April, General of Health.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid on April 27, 2001.

JOHN CARLOS R.

The Minister of the Presidency,

JUAN JOSE LUCAS GIMENEZ