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Royal Decree 118/2003, Of 31 January, By Which The List Of Allowed For The Manufacture Of Plastic Materials And Articles Intended To Come Into Contact With Food And Certain Test Conditions Are Regulated Substances Is Approved.

Original Language Title: Real Decreto 118/2003, de 31 de enero, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo.

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TEXT

Royal Decree 1425/1988 of 25 November 1988 approving the Technical and Health Regulations for the elaboration, 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, the approval of the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food and the regulation of certain test conditions was carried out This is the case with the Royal Decree 2207/1994 of 16 November 1994, which incorporated into our national law Directives 93 /8/EEC and 93 /9/EEC. The aforementioned Royal Decree 2207/1994 was, in turn, amended by Royal Decree 510/1996 of 15 March, which transposed Directive 95 /3/EC, by Royal Decree 1042/1997 of 27 June 1997, which transposed Directive 96 /11/EC and the Royal Decree of 27 June 1996. Decrees 1752/1998 of 31 July 1998 and 442/2001 of 27 April 2001 transposing Directives 97 /48/EC and 1999 /91/EC respectively.

The existence of new scientific data and a review of existing data, based on the evaluations carried out by the Scientific Committee for Food (SCF), led to the successive amendments of the directives and therefore of the respective Royal Decrees, allowing the review of the community lists of monomers and additives of the plastic materials.

On the other hand, in the interests of greater simplification and clarity, this provision has resulted in a single text merging the Royal Decrees 2207/1994, 1752/1998 and 442/2001.

It is also appropriate to incorporate Commission Directive 2001 /62/EC of 9 August 2001 amending Directive 90 /128/EEC, adapting the existing provisions to the new information available on materials and plastic objects: in addition to Section A of Annex II to this Royal Decree, certain substances and other substances are deleted from Section B of that Annex. Substances are also added to the list of fully harmonised additives at Community level, which may be used in the manufacture of plastic materials and articles, included in Annex V, other substances are deleted and the content of the column of restrictions and/or specifications as well as a section B of additives, the specific migration limits of which shall apply from January 2004.

Since the list of authorised additives in the manufacture of plastic materials is not currently harmonised, the additives which can be used in the manufacture of plastic materials and articles are only those of included in Annex V to this Royal Decree, and on a provisional basis, until the Community list is completed and provided that they are not mentioned in Annex V, those set out in the Resolution of 4 November 1982, of the Proposal for a Directive of the European Community and of the European Community on the protection of the environment macromolecular, the list of maximum migrations in tests for the disposal of certain of them, the purity conditions for the colouring matters used in the same products and the list of the polymeric materials suitable for the manufacture of packaging and other utensils which may be in contact with foodstuffs and foodstuffs, as amended by the Order of the Ministry of Health and Consumer Affairs of 3 July 1985.

Further specifications and purity criteria are also set for certain substances.

On the other hand, silicones are excluded from the definition of plastic materials because they are elastomeric materials, which are not within the scope of this Royal Decree.

New scientific knowledge indicates that for certain types of plastics it is possible to have commonly recognized diffusion models, based on experimental data, allowing to estimate the level of migration of a substance under certain conditions, thus avoiding complex, costly and lengthy analyses. It is also easier to determine the amount of a substance in a finished plastic material or object than to determine its specific level of migration, thus establishing the possibility of verification of compliance with migration in plastic materials and articles, under certain conditions, by measuring the amount of substance in the finished plastic material or object.

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, Agriculture, Fisheries and Food, of Economics and of Science and Technology, in agreement with the Council of State and after deliberation of the Council of Ministers in its Meeting of the day 31 January 2003,

D I S P O N G O:

Article 1. Object.

This Royal Decree aims to approve the positive list of monomers and starting substances authorized for the manufacture of plastic materials and articles intended to come into contact with foodstuffs and food, its maximum permitted migrations given in migration tests, either globally or for a specific constituent and to determine the test conditions for them.

Article 2. Definition.

1. For the purposes of this Royal Decree, plastic material is understood to be the organic macromolecular compound obtained by polymerisation, polycondensation, polyaddition or other similar process from lower molecular weight molecules or by chemical modification of natural macromolecules. Other substances or substances, considered additives, may be added to the macromolecular compound.

2. For the purposes of this Royal Decree, an additive is understood as a substance incorporated in polymers during the processes of synthesis, processing or processing, in order to facilitate such processes and/or to modify the final properties of the finished product. These additives, with the exception of colours, must appear on the corresponding positive lists.

3. The so-called complexes formed by layers of different plastic materials will be considered, for specific purposes of this Royal Decree, as a unique set and not only the one that is in contact with the food, but each one of them must to comply separately with the general or specific conditions that correspond to it.

4. However, "plastic materials" shall not be considered:

(a) The regenerated, varnished and unvarnished cellulose films regulated by Royal Decree 1413/1994 of 25 June.

b) Natural and synthetic elastomers and rubbers.

(c) Paper and paperboard, modified or not added to the plastic material.

d) Surface coatings obtained from:

parafine Ceras, including synthetic paraffin waxes and/or microcrystalline waxes.

2.o Mixtures of waxes mentioned in the first indent, with each other and/or with plastic materials.

e) The ion exchange resins.

f) The silicones.

Article 3. Scope of application.

1. This Royal Decree shall apply to plastic materials and articles and to their parts, included in Articles 1 and 2 of the Technical-Health Regulations for the elaboration, circulation and trade of plastic materials intended to come into contact with food and food products, approved by Royal Decree 1425/1988 of 25 November 1988, which are:

(a) Constituted exclusively of plastic materials.

(b) Compositions of two or more layers, each of which consists exclusively of plastic materials and which are joined together by welding, adhesives or by any other means, and which, in the state of finished products are intended to come into contact with or contact food or food products.

2. The provisions of this Royal Decree shall not apply to materials and articles composed of two or more layers, where at least one of them is not exclusively made up of plastic materials, even if it is intended for direct contact The invention relates to a food product consisting exclusively of plastic material.

Article 4. Global migration limit.

Plastic materials and articles must not give up their components to foodstuffs in quantities exceeding 10 milligrams per square tenths of the surface of the material or object (mg/dm2) (migration limit ). However, that limit shall be 60 milligrams of constituents released per kilogram of food product (mg/kg) in the following cases:

(a) Objects which are packaging or which are comparable to packaging or which can be filled with a capacity of not less than 500 millilitres (ml) and not more than 10 litres.

(b) Objects which may be refilled and whose surface in contact with foodstuffs is impossible to calculate.

c) Clocaps, shutters, plugs, or other similar closure devices.

Article 5. Specific migration limits.

1. The specific migration limits set out in Annex II to this Royal Decree are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases:

(a) Objects which are packaging or which are comparable to packaging or which can be filled with a capacity of less than 500 millilitres (ml) or more than 10 litres.

(b) Lamines, films or other materials which cannot be filled or for which it is impossible to calculate the ratio between the surface of such materials and the quantity of food product in contact with them.

2. In the cases referred to in paragraph 1, the limits set out in Annex II, expressed in mg/kg, shall be divided by 6, as the conventional conversion factor, to be expressed in mg/dm2.

Article 6. Conditions of the migration tests.

1. The migration tests may be carried out either in foodstuffs or in simulants.

2. The verification of compliance with the migration limits shall be carried out in accordance with the provisions of Annexes I and IV to this Royal Decree. It may also be carried out by determining the quantity of a substance in the material or the finished object, provided that a relationship has been defined between that quantity and the value of the specific migration of the substance through of appropriate experimentation or through the application of commonly recognised models of dissemination, based on scientific evidence. In order to demonstrate the non-compliance of a material or an object it will be mandatory to confirm by experimental analysis the estimated migration value.

3. Verification of compliance with the specific migration limits provided for in Article 5 shall not be mandatory, where one of the following scenarios can be demonstrated:

a) That compliance with the global migration limit set out in Article 4 implies that the specific migration limits are not exceeded.

b) That the amount of residual substance in the material or object, even considering the complete migration of the substance or object, does not exceed the specific migration limit.

4. The tests to check whether the migration to the foodstuffs is in accordance with the maximum permitted limits shall be carried out under the most extreme conditions of foreseeable duration and temperature of actual use.

Article 7. Positive list of monomers and other starting substances.

1. The monomers and other starting substances listed in Sections A and B of Annex II to this Royal Decree may only be used for the manufacture of plastic materials and articles, with the restrictions specified therein.

However, the monomers and other starting substances included in Section B of Annex II may continue to be used until 31 December 2004 at the latest, pending the Scientific Committee for Food. Human conduct your assessment.

2. The extension of the list in Section A of Annex II, including the substances listed in Section B of Annex II, may be carried out in accordance with the criteria set out in Annex III or substances not listed in Annex II.

3. For the purposes of this Royal Decree, the positive lists of monomers and other starting substances listed in Sections A and B of Annex II cannot be considered until the approval of their specific legislation, as positive lists of such products. substances, used in the manufacture of:

(a) Surface coatings obtained from resinous or polymerized products in liquid form, powder or dispersion, such as varnishes, lacquers, paints, etc.

b) epoxy resin.

c) Adhesives and adhesion activators.

d) Printing Tintas.

Article 8. Positive list of additives.

1. Additives which may be used in the manufacture of plastic materials and articles together with the specified restrictions are those set out in Sections A and B of Annex V, as well as those contained in the Resolution of 4 November 1982, by the Health Department, and its amendment by the Order of 3 July 1985, which are not covered by this Royal Decree.

For the substances of Section B of Annex V, the specific migration limits shall apply from 1 January 2004 when the verification of compliance is carried out in simulants D or in test means In accordance with the provisions set out in Annex IV to 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.

Article 9. Products obtained by bacterial fermentation.

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

Article 10. Specifications.

In Section A of Annex VII, the general specifications for plastic materials and articles are set out in Annex VII. Other specifications concerning certain substances listed in Annexes II, V and VI are set out in Section B of Annex VII.

Article 11. Declaration for marketing.

Plastic materials and articles, when they are intended to come into contact with foodstuffs or foodstuffs, must be accompanied, in the marketing stages other than those for retail sale, of a a written declaration certifying that they are in conformity with the relevant legal provisions in force.

The above provisions will not apply to plastic materials and articles which, by their nature, are obvious their use in contact with food or food products.

Single transient arrangement. Extension of marketing.

The requirements set out in this Royal Decree shall not apply to materials and articles containing the substances covered by Directive 2001 /62/EC which are subject to transposition, which are in turn regulated by the Directive. This provision, which are marked with the symbol i in the column 'Number PM/REF', provided that they have been put into circulation before 1 December 2002.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed, they are contrary to the provisions of this Royal Decree, and in particular the Royal Decrees 2207/1994 of 16 November, 1752/1998 of 31 July, and 442/2001 of 27 of April.

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 (4) of Law 14/1986 of 25 April, General of Health.

Final disposition second. Powers of development.

The Ministers for Health and Consumer Affairs, Agriculture, Fisheries and Food, the Economy and Science and Technology are hereby authorised to make the necessary arrangements for the development of the This Royal Decree, as well as for the updating of its Annexes where necessary to adapt them to the provisions of the European Union.

Final disposition third. 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, 31 January 2003.

JOHN CARLOS R.

First Deputy Prime Minister and Minister of the Presidency, MARIANO RAJOY BREY

ANNEX I

Additional provisions applicable to the control of compliance with migration limits

I. General provisions

1. Where the results of the migration tests specified in Annex IV are compared, it shall be accepted in a conventional manner that the specific weight of all simulants is 1 g/cm3. Therefore, the milligrams of substance or substances migrated per litre of simulant (mg/l), shall correspond numerically to milligrams of substance or substances released per kilogram of simulant and, in accordance with the conditions laid down in the Annex IV, to milligrams of substance or substances released per kilogram of food.

2. Where the migration tests are carried out on samples taken from the material or object or on purpose-made samples and the quantities in food or simulant products brought into contact with the sample are different from those which are use in the actual conditions in which the material or object is used, the results obtained shall be corrected by applying the following formula:

(VIEW IMAGES PAGES 5313 TO 5343)

M = m a2 1000a1 q

Where:

M = will be the migration in mg/Kg.

m = shall be the mass expressed in mg of substance released by the sample and determined in the migration test.

A1 = shall be the surface expressed in dm2 of the sample in contact with the food or simulants in the migration test.

a2 = shall be the area expressed in dm2 of the material or object under the actual conditions of use.

q = shall be the quantity expressed in grams of food product in contact with the material or object under the actual conditions of use.

3. The determination of migration shall be carried out on the material or object or, if this is not possible, using samples taken from the material or object or, where appropriate, representative samples of that material or object.

The sample shall be contacted with the food product or the simulant in a manner equivalent to the actual contact conditions. For this purpose, the test shall be carried out in such a way that only the parts of the samples intended to come into contact with the foodstuffs in actual use are brought into contact with the food product or the simulant. This condition is particularly important in the case of materials or objects that are composed of different layers, for closures, etc.

Migration tests performed on caps, shutters, plugs or similar devices used with closure shall be carried out by putting these objects in contact with the packages to which they are intended for such purposes. form corresponding to normal or foreseeable conditions of use.

In all these cases it will be lawful to demonstrate compliance with the migration limits through more severe tests.

4. In accordance with the provisions of Article 6 of this Royal Decree, the sample of the material or object shall be placed in contact with the appropriate food product or simulant for a period of time and at a temperature chosen in relation to with the conditions of contact in the actual use, in accordance with the rules laid down in Annex IV. At the end of the prescribed time, the analytical determination of the total amount of substance (global migration) and/or the specific quantity of one or more substances (specific migration) shall be carried out on the food product or simulant. released by the sample.

5. Where a material or object is intended to come into contact with foodstuffs, the migration test or tests shall be carried out three times on the same sample in accordance with the conditions laid down in the Annex. Annex IV using another food sample or simulant in each test. The conformity of such material or object with the limits shall be monitored on the basis of the level of migration found in the third test. However, if there is a conclusive proof that the migration level does not increase in the second and third tests and if the migration limit or limits are not exceeded in the first test the following are not required.

II. Special provisions related to global migration

1. If the aqueous simulants specified in Annex IV are used, the determination of the total quantity of substance released by the sample may be carried out by evaporation of the simulant and determination of the weight of the residue.

If rectified olive oil or any of the replacement products is used, the following procedure may be followed: the sample or object shall be weighed before and after contact with the simulant. The amount of this absorbed by the sample will be extracted and determined quantitatively. The amount of simulant found will be subtracted from the weight of the sample measured after contact with the simulant. The difference between the initial and final weights corrected will represent the overall migration of the sample examined.

When a material or object is intended to come into repeated contact with foodstuffs and it is technically impossible to carry out the test described in paragraph I. 5, modifications of this test may be accepted with This will allow you to determine the level of migration that takes place during the third test. The following describes one of these possible modifications: the test will be carried out in three identical samples of the material or object. One of these will be submitted to the appropriate tests and the overall migration (M1) will be determined; the second and third samples will be subjected to the same temperature conditions, but the contact periods will be respectively two and three times. higher than specified and the overall migration in each case (M2 and M3, respectively).

The material or object shall be deemed to be as long as M1 or M3-M2 or exceed the overall migration limit.

2. A material or object exceeding the overall migration limit in quantities not exceeding the analytical tolerance referred to below shall be considered in accordance with this Royal Decree.

The following analytical tolerances are supported:

a) 20 mg/kg or 3 mg/dm2 in the migration tests using rectified olive oil or substitute products.

b) 12 mg/kg or 2 mg/dm2 in the migration tests used by the other simulants referred to in Annex IV.

3. Migration tests using olive oil or substitute products shall not be carried out to verify compliance with the overall migration limit in cases where it has been conclusively demonstrated that the analytical method specified is from the technical point of view.

In such cases, for substances that do not have specific migration limits or other restrictions in the list set out in Annex II, a specific migration limit of 60 mg/kg or 10 mg/dm2 is applied as the case may be. The sum of all specified specific migrations shall not, however, exceed the overall migration limit.

ANNEX II

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

I. 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) natural or synthetic macromolecular substances 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 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), aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the 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.o Impurities of the substances used.

2.o Intermediate reaction products.

3.o Decomposition products.

(b) Oligomers and natural or synthetic macromolecular substances as well as their mixtures, 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 Health-technology for the manufacture, circulation and trade of plastic materials intended to come into contact with food.

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

5. The list contains the following data:

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

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

3.o Column 3 (name): the chemical name.

4.o 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. Column 4 of the table uses a series of abbreviations whose meaning is as follows:

LD = detection limit of the analysis method.

PT = material or finished object.

SA = food simulant.

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 allowed amount 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 = specific migration limit in food or in 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.

SECTION A:

Authorized list of monomers and other starting substances

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.

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".

11530 i 00999-61-1 2-hydroxypropyl acrylate. CMA= 0,05 mg/6 dm2.

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 single-grouse.

12280 002035-75-8 Anhydride adipic.

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

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.

12763 i 00141-43-5 2-Aminoethanol. SML = 0.05 mg/Kg. Substance not for use in food contact polymers for which the simulant D in Annex IV is established and only for indirect contact with food behind the PET layer.

12765 i 84434-12-8 N- (2-Aminoethyl) -beta-alaninate sodium. SML = 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.

13395 i 04767-03-7 propionic 2,2-bis (hydroxymethyl) acid. CMA= 0,05 mg/6 dm2.

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

13510 i 001675-54-3 E te r b is (2, 3-e p o x ip r o p ilic o) d e 2,2-bis-(4-hydroxyphenyl) propane (= BADGE).

According to the Royal Decree on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs.

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

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

13617 i 00080-09-1 Bisphenol S. See 4.4-Dihydroxy-diphenylsulfone.

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) 1, 4-butanediol.

CM= 1 mg/Kg in PT (expressed as epoxy group, molecule weight = 43).

13810 i 00505-65-7 1,4-Butanediolformal. CMA = 0,05 mg/6 dm2.

13840 000071-36-3 1-Butanol.

13870 000106-98-9 1-Butene.

13900 000107-01-7 2-Butene.

13932 i 00598-32-3 3-Buten-2-ol. CMA = ND (LD = 0.02 mg/6 dm2) Only for use as a comonomer for the preparation of polymeric additives.

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

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

14230 i 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.

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).

15030 i 00931-88-4 Ciclocteno. LME= 0.05 mg/Kg. For use only in polymers in contact with food for which simulant A is set out in Annex IV.

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".

15370 i 03236-53-1 1,6-Diamino-2,2,4-trimethylhexane. CMA = 5 mg/6 dm2.

15400 i 03236-54-2 1,6-Diamino-2,2,4-trimethylhexane. CMA = 5 mg/6 dm2.

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

15610 i 00080-07-9 4,4-LME = 0.05 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. LME= 5 mg/Kg.

15820 000345-92-6 4,4-LME=0.05 mg/Kg.

15880 000120-80-9 1,2-Dihydroxybenzene. LME= 6 mg/Kg.

15910 000108-46-3 1,3-Dihydroxybenzene. LME=2.4 mg/Kg.

15940 000123-31-9 1,4-Dihydroxybenzene. LME=0.6 mg/Kg.

15970 i 000611-99-4 4,4 ' -Dihydroxybenzophenone. LME= 6 mg/Kg (15).

16000 000092-88-6 4,4-LME=6 mg/Kg.

16090 i 00080-09-1 4,4-LME = 0.05 mg/Kg.

16150 000108-01-0 Dimethylaminoethanol. LME=18 mg/Kg.

16240 000091-97-4 4,4-3,3 dimethyl biphenyl. CM (T) = 1 mg/Kg in PT (expressed as NCO).

16360 000576-26-1 2,6-Dimethylphenol. LME= 0.05 mg/Kg.

16390 i 00126-30-7 2,2-Dimethyl-1,3-propanediol. LME= 0.05 mg/Kg.

16450 000646-06-0 1,3-Dioxolane. LME= 0.05 mg/Kg.

16480 000126-58-9 Dipentaerythritol.

16570 004128-73-8 4,4-diphenyl ether. CM (T) = 1 mg/Kg in PT (expressed as NCO).

16600 005873-54-1 2,4-diphenyl-methane. CM (T) = 1 mg/Kg in PT (expressed as NCO).

16630 000101-68-8 4,4-diphenyl-methane. 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. LME= 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. LME=12 mg/Kg.

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

17005 000151-56-4 ethylenimine. LME=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. LME=30 mg/Kg.

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

17160 000097-53-0 Eugenol. LME=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 i 000050-00-0 formaldehyde. LME=15 mg/Kg (22).

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).

18250 000115 -28-6 Hexachloroendomethylene-tetrahydrophthalic acid.

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

18460 000124-09-4 Hexamethylenediamine. LME=2.4 mg/Kg.

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

18670 i 000100-97-0 Hexamethylenetramine. SML (T) =15 mg/Kg (22) (expressed as formaldehyde).

18820 000592-41-6 1-Hexene. LME= 3 mg/Kg.

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

18880 000099-96-7 P-hydroxybenzoic acid.

19000 000115 -11-7 Isobuteno.

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

19110 i 04098-71-9 1-Isocianato-3-isocyanatomethyl-3,5,5, -trimethylcyclohexane.

CM (T) = 1 mg/Kg in PT (expressed as NCO).

19150 000121-91-5 Isoftalic acid. LME= 5 mg/Kg.

19210 001459-93-4 dimethyl isophthalate. LME=0.05 mg/Kg.

19243 i 00078-79-5 Isorene. See 2-Methyl-1,3-butadiene.

19270 000097-65-4 Itaconic acid.

19460 000050-21-5 Lactic acid.

19470 000143-07-7 Lauric acid.

19480 002146-71-6 vinyl Laurate.

19490 i 00947-04-6 Laurolactama. SML = 5 mg/Kg.

19510 011132-73-3 Lignocellulose.

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

19960 i 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. LME=ND (LD=0.02 mg/Kg, analytical tolerance included).

20020 000079-41-4 Methacrylic acid.

20050 000096-05-9 Alyl methacrylate. LME= 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.

20260 i 00101-43-9 cyclohexyl methacrylate. LME= 0.05 mg/Kg.

20410 i 02082-81-7 Dimethacrylate of 1,4-butanediol. LME= 0.05 mg/Kg.

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

20590 i 00106-91-2 Methacrylate 2,3-epoxypropyl. CMA=0.02 mg/6 dm2.

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.

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

21490 000126-98-7 Metacrylonitrile. LME= Undetectable (LD= 0.020 mg/Kg analytical tolerance included).

21520 i 01561-92-8 Sodium Metallylsulfonate. LME= 5 mg/Kg.

21550 000067-56-1 Methanol.

21640 i 00078-79-5 2-Methyl-1,3-butadiene. CM = 1 mg/Kg in PT or LME = ND (LD = 0.02 mg/Kg, analytical tolerance included).

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

21765 i 106246-33-7 4.4 Methylenbis (3-chloro-2,6-diethylaniline). CMA=0.05 mg/6 dm2.

21821 i 00505-65-7 1,4-(Methylenedioxy) butane. See 1.4-Butanediol-formal.

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

22150 000691-37-2 4-Methyl-1-pentene. LME=0.02 mg/Kg.

22331 025513-64-8 Mix of 1,6-diamino-2,2, 4-trimethylhexane (40 per 100 w/w) and 1, 6-diamino-2,4,4-trimethyl-hexane (60 per 100 w/w).

CMA= 5mg/6 dm2.

22350 000544-63-8 Myristic Acid.

22360 i 01141-38-4 2,6-naphthalenedicarboxylic acid. SML = 5 mg/Kg.

22390 000840-65-3 2,6-Naphthalenodicarboxylate dimethyl. LME=0.05 mg/Kg.

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

22437 i 00126-30-7 Neopentylglycol. See 2,2-Dimethyl-1,3-propanediol.

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. LME=15 mg/Kg.

22763 000112-80-1 oleic acid.

22778 i 07456-68-0 4.4 Oxibis (benzenesulfonyl azide). CMA = 0,05 mg/6 dm2.

22780 000057-10-3 Palmitic acid.

22840 000115 -77-5 Pentaerythritol.

22870 000071-41-0 1-Pentanol.

22900 i 00109-67-1 1-Pentene. LME= 5 mg/Kg.

22937 001623-05-8 Eter perfluoropropylperfluoro-vinyl. LME= 0.05 mg/Kg.

22960 000108-95-2 Fenol.

23050 i 000108-45-2 1,3-Phenylenediamine. LME= ND (LD = 0.02 mg/Kg, analytical tolerance included).

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 (PM6800).

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 acetaldehyde).

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".

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

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

24070 073138-82-6 Resync and rosin acids.

24072 000108-46-3. See "1,3-Dihydroxybenzene".

24073 i 000101-90-6 Eter diglyceride from resorcinol. CMA = 0.005 mg/dm2. Substance not for use in food contact polymers for which the simulant D in Annex IV is established and only for indirect contact with food behind the PET layer.

24100 008050-09-7 Colofonia.

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

24160 008052-10-6 Tall oil colophony.

24190 009014-63-5 Wood Colophony.

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 Single-sodium salt of acio5-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.

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

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

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

25360 Trialkyl (C5-C15) acetate of 2, 3-epoxypropyl.

CM= 1 mg/Kg in PT (expressed as epoxy group, weight molecule = 43).

25380 i Trialkyl (C7-C17) vinyl acetate (= vinyl versatate).

CMA = 0.05 mg/6 dm2.

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.

25450 i 26896-48-0 Tricyclodecanedimethanol. LME= 0.05 mg/Kg.

25510 000112-27-6 Triethylene glycol.

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

25900 i 00110-88-3 Trioxane. LME= 0.05 mg/Kg.

25910 024800-44-0 Tripropylene glycol.

25927 027955-94-8 1,1,1-Tris (4-hydroxyphenol) 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).

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

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

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

26170 003195-78-6 N-Vinyl-N-methylacetamide. CM= 2 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 numbers PM/REF.:

10060 and 23920, must not exceed the indicated constraint.

(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), in this case means that the sum of the migration of the following substances, marked with the numbers PM/REF.: 19540, 19960 and 64800 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, 14230 and 41840 must not exceed the indicated restriction.

(15) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.:

15970, 48640, 48720, 48880, 61280, 61360, and 61600, must not exceed the indicated restriction.

(22) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 17260 and 18670, must not exceed the indicated restriction.

SECTION B: (View image page 5321)

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)

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.

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

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

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

14260 000502-44-3 Caprolactone.

14800 003724-65-0 Crotonic Acid.

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

15730 000077-73-6 Dichlorpentadiene.

16210 006864-37-5 3.3-4-16690 i 001321-74-0 Divinylbenzene. CMA=0.01 mg/6 dm2 or LME=ND.

. (LD=0.02mg/Kg analytical tolerance included) *.

16697 000693-23-2 Dodecanedioic acid.

17110 016219-75-3 5-Ethylidenbicyclo (2.2.1) hept-2-ene.

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

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

21370 010595-80-9 Methacrylate 2-sulfoethyl.

21400 054276-35-6 Sulfopropyl methacrylate.

21970 000923-02-4 n-Methylolmetacrylamide.

22210 000098-83-9 alpha-Methylstyrene.

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).

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

26230 000088-12-0 Vinylpyrrolidone.

* According to the evaluation of the Scientific Committee for Food (SCF) 69-70 Meeting, 1997.

ANNEX III

Health criteria to be applied for inclusion of new products in positive lists

1. It shall be determined whether a substance or matter can be entered on a positive list taking into account both the quantity of substance or matter which may be transmitted to the foodstuff and the toxicity of the substance or matter.

2. Only a substance or material shall be included in a positive list if, under normal or foreseeable conditions of use, of any material or object of which the substance or matter is part, it cannot be transmitted to foodstuffs in a amount that may present a danger to human health.

3. All substances or substances shall be subject to continuous monitoring and examination when new scientific information or a new assessment of existing scientific data so warrant.

4. Where an acceptable daily dose or a tolerable daily dose is established for a substance or matter in particular, it is appropriate to determine a specific migration limit in order to prevent the dose from being exceeded. Where the specific migration limit for a substance or matter is determined, account shall be taken of the remaining sources of possible exposures of the substance or matter.

5. The establishment of a specific migration limit for a substance or matter may not be the most valid means of protecting human health. In such cases, the need to protect human health shall prevail before any other consideration when determining the appropriate actions to be provided.

ANNEX IV

SECTION A

List of simulants and food products

1. In the list, not exhaustive, of foodstuffs, which is included below, the simulants to be used in the migration tests with regard to a food product or a group of food products are laid down. indicate the following abbreviations:

Simulant A: distilled water or water of equivalent quality.

Simulant B: acetic acid at 3 per 100 (P/V), in aqueous solution.

Simulant C: ethanol 10 per 100 (V/V), in aqueous solution.

Simulation D: rectified olive oil (paragraph 7.1); where for technical reasons linked to the method of analysis other simulants must be used, the olive oil must be replaced by a mixture of triglycerides synthetic (paragraph 7.2) or sunflower oil (paragraph 7.3). If all the simulants cited as simulant D are inappropriate, other simulants and other conditions of time and temperature may be used.

However, simulant A should only be used in the cases specifically mentioned in the table of test conditions.

2. For each food product or for each group of foodstuffs only the simulants indicated by the X sign shall be used, using for each simulant a new sample of the material or object concerned. The absence of the X sign means that no test shall be required for that item or subheading.

3. Where the X sign is followed by a figure of which the mark is separated by an oblique stripe, the result of the migration tests shall be divided by that figure. This, called "reduction coefficient", will take into account, in a conventional way, the greatest power of extraction of the fatty food simulant in relation to certain types of food products.

4. If the X sign is accompanied by parenthesis to the letter a, only one of the two simulants indicated must be used:

(a) If the pH of the food product is greater than 4,5, the simulant A shall be used.

(b) If the pH of the food product is less than or equal to 4,5, the simulant B shall be used.

5. If a foodstuff is listed under a specific heading as under a general heading, only the intended simulant (s) under the specific heading must be used.

6. Where the food product or group of foodstuffs is not included in the list of foodstuffs included below, the tests shall be carried out using the food simulants referred to in paragraph 1. those that most closely resemble the actual behavior of the food.

7. Characteristics to be collected by the products covered under the simulant D.

1.a Characteristics of rectified olive oil:

Iodine index (Wijs) = 80-88 Index of refraction at 25 oC = 1,4665-1,4679 Acidity (expressed as percentage of oleic acid) = = 0,5 per 100 maximum Peroxides index (expressed in milliequivalents of oxygen per Kg of oil) = 10 maximum

2.a Composition of the synthetic triglyceride mixture:

Distribution of fatty acids Number of C atoms in fatty acid residues:

6, 8, 10, 12, 14, 16, 18, others

GLC Area (percent):

1, 6-9, 8-11, 45-52, 12-15, 8-10, 8-12, " 1

Purity:

Content in monoglycerides (determined by enzymatic route: " 0,2 per 100 Content of diglycerides (determined by enzymatic route): ' 2.0 per 100 Non-saponifiable materials: " 0.2 per 100 Iodine Index (Wijs): " 0,1 per 100 Index of acidity: ' 0,1 per 100 Water content (K. Fischer): " 0.1 per 100 Merge point: 28 > 2 oC

Typical absorption spectrum (layer thickness: d= 1 cm; reference: water at 35 oC) wavelength (nm): 290 310 330 350 370 390 430 470 510 Transmission (percent): 2 15 37 64 80 88 95 97 98 At least 10 per 100 of transmittance light at 310 nm (1 cm bucket; reference: water at 35 oC)

3.a Sunflower Oil Characteristics:

Iodine index (Wijs): 120-145 Index of refraction at 20 oC: 1,474-1,476 Saponification index: 188-193 Density relative to 20 oC: 0.918-0.925 Non-saponifiable materials: 0.5 per 100-1.5 per 100.

Simulants to be used Reference number Denomination of the food products C D

01 Drinks.

01.01 Non-alcoholic beverages or alcoholic beverages of an alcoholic strength by volume of less than 5 per 100:

Water, ciders, fruit juices or vegetables, simple or concentrated, musts, fruit nectars, lemonades, sodas, syrups, bitters, infusions, coffee, tea, liquid chocolate, beers and others. X (a) X (a) 01.02 Alcoholic beverages of an alcoholic strength of 5 per 100 vol or more:

Beverages classified under heading No 01.01 but whose alcoholic strength is 5 per 100 vol or more: Wines, spirits, liqueurs.

X* X* *

01.03 Miscellaneous: Undenatured ethyl alcohol. X* X* *

02 Cerals, derived from cereals, products of biscuits, bakery and pastry products.

02.01 Almidones and Fecules.

02.02 Cereals in natural state, in flakes, in sheets (including swollen corn and corn petals and others).

02.03 Grain and semi-grain flour.

02.04 Food Pastas 02.05 Dry bakery products, gallerteria and dry pastry products:

A. They present fatty substances on their surface.

B. Others.

X/5

Fresh bakery and pastry products:

A. They present fatty substances on their surface.

02.06 B. Other X X/5

03 Chocolates, sugars and their derivatives, confectionery products.

03.01 Chocolates, chocolate-coated products, substitutes and products covered by substitutes.

X/5

Confectionery products:

03.02 A. In solid form:

I. They present fatty substances on their surface.

II. Others. X/5

B. In the form of paste:

I. They present fatty substances on their surface. X/3 II. Wet. X

Sugars and confectionery:

03.03 A. In solid form.

B. Honey and the like. X C. Melaces or sugar syrups. X

04 Fruit, vegetables and their derivatives.

04.01 Whole, fresh or chilled Fruit.

04.02 Transformed paths:

A. Dried or dehydrated fruit, whole or in the form of flour or powder.

B. Fruit in pieces, or in the form of puree or pasta.

C. Preserved fruit (jams and similar products, whole fruit or in pieces, in the form of flour or powder, preserved in a liquid medium):

X (a) X (a)

I. In an aqueous medium.

II In an oily medium III. In an alcoholic medium (" 5 per 100 vol)

X (a) X (a)

Simulants to be used Reference number Denomination of the food products C D

Nuts (peanuts, chestnuts, almonds, hazelnuts, common nuts, pine nuts and others):

X (a) X (a) X

A. Uncorked, dried. X* X B. Descorded and roasted.

04.03 C. In the form of paste or cream.

Whole vegetables, fresh or chilled.

Transformed Vegetables: X/5 * **

A. Dried or dehydrated vegetables, whole, in the form of flour or powder.

X X/3 * **

04/04 B. Horches in pieces, in the form of puree.

C. Vegetables in preserved:

04.05 I. In an aqueous medium.

II. In an oily medium.

III. In an alcoholic medium (" 5 per 100 vol).

X (a) X (a) X (a) X (a) X (a) X X* X

05 Grasses and Oils.

05.01 Animal and vegetable oils and oils, natural or processed (including cocoa butter, butter, melted butter).

X

05.02 Margarine, butter and other fats composed of water emulsions in oil.

X/2

06 Animal products and eggs.

06.01 Fish:

A. Fresh, chilled, salted, smoked. X X/3 * ** B. In the form of paste. X X/3 * **

06.02 Crustaceans and molluscs (including oysters, mussels and snails) that are not naturally protected by their shell or shell.

Meat of all zoological species (including poultry and hunting): X

06.03 A. Fresh, chilled, salted, smoked. X/4 B. In the form of pasta, cream.

Processed meat products (ham, ichalon, bacon and others).

X X

06.04 Conservas or semi-servings of meat or fish.

A. In an aqueous medium. X X/4

B. In an oily medium.

06.05 Eggs without shell:

A. Powder or dried. X (a) X (a) B. Other. X (a) X

06.06 Egg Yolk.

A. Liquid B. In powder or frozen X

06.07 Clear of dried egg. X 06.08

07 Dairy products.

07.01 Milk:

A. Whole. X B. Partly dehydrated. X C. Partial or low-fat. X D. Totally dehydrated.

Simulants to be used Reference number Denomination of the food products C D

07.02 fermented milk, such as yogurt, whipped milk and its associations with fruit or fruit derivatives. X

07.03 Nata and acidic cream. X (a) X (a)

Cheeses:

07.04 A. Enters with bark.

B. Melted.

C. All the others. X (a) X (a) X (a) X (a) X/3***

Cover:

07.05 A. Liquid or pasty.

B. Powder or drying X (a) X (a)

08 Miscellaneous Products.

08.01 Vinagre. X 08.02 fried or roasted food:

A. Crisps, bunuelos and others. X/5 B. Of animal origin. X/4

08.03 Preparation of prepared soups, potages or bales (extracts, concentrates), homogenised heterogeneous food preparations, prepared dishes:

A. In powder or dried:

I. They present fatty substances on their surface. X/5 II. Other

B. Liquids or pasty:

I. They present fatty substances on their surface. X (a) X (a) X/3 II. Others. X (a) X (a)

08.04 Levatures or fermenting substances.

A. In pasta. X (a) X (a) B. Secas.

08.05 Cooking Salt.

08.06 Salsas:

A. Do not present fatty substances on their surface. X (a) X (a) B. Mayonnaise, sauces derived from mayonnaise, salad cream and other emulsified sauces (oil-in-water type emulsion).

X (a) X (a) X/3

C. Sauce containing oil and water that form two distinct layers. X (a) X (a) X

08.07 Mostasses (with the exception of dust musts of heading No 08.17).

X (a) X (a) X/3***

8.08 Slices of bread, sandwichs, toast, and others that contain any kind of food:

A. They present fatty substances on their surface.

B. Others.

Ice Cream. X/5

Dry food:

08.09 A. That they present fatty substances on their surface. X 08.10 B. Other.

08.11 Frozen or superfrozen foods. X/5 08.12 Concentrated extracts with an alcoholic strength of 5 per 100 vol of alcohol or more.

X* X

Cocoa:

08.13 A. Cocoa powder. X/5 * ** B. Cacao in paste. X/3 * **

Simulants to be used Reference number Denomination of the food products C D

08.15 Coffee, whether or not roasted or decaffeinated or soluble, granulated or powdered coffee substitutes.

08.15 Extracts of liquid coffee.

08.16 aromatic plants and other plants: chamomile, malva, mint, tea, tila and others.

X

08.17 Species and aromas in their normal state: cinnamon, cloves, mustard powder, pepper, vanilla, saffron and others.

Notes:

* This test shall be carried out only in the case where the pH is less than or equal to 4,5.

** This test may be carried out, in the case of liquids or beverages of more than 10 per 100 alcohol volume, with ethanol in aqueous solution of an analogous concentration.

*** If with an appropriate test, it is possible to demonstrate that no "fatty contact" will be established with the plastic material, the test may be omitted with the D simulant.

SECTION B

Basic rules for global and specific migration verification

1. 'Migration tests' for the determination of specific and global migration shall be carried out using 'food simulants', as referred to in Chapter I, and in the 'conventional migration test conditions' set out in Chapter II.

2. 'Substitute tests' using 'test means' according to the 'conventional conditions of replacement testing', as set out in Chapter III, shall be carried out if the migration test used by the simulants of the test Fatty foods (see Chapter I) is not feasible for technical reasons related to the method of analysis.

3. Where the conditions specified in Chapter IV are met, the 'alternative tests' referred to in Chapter IV may be permitted instead of the migration tests with fatty food simulants.

4. In all three cases it can be allowed:

a) Reduce the number of tests to be performed on those or those who, in the particular case object

of examination, are commonly accepted as the most stringent on the basis of scientific evidence.

b) omitting migration tests, or substitutes or alternatives, where there is conclusive evidence that the limits of migration cannot be exceeded in any of the foreseeable conditions of use of the material or object.

CHAPTER I

Food Simulants

I. Introduction

It is not always possible to use food to examine materials in contact with food products, so food simulants are used.

By convention they are classified as having the characteristics of one or more types of food. The types of food and the food simulants to be used are given in Table 1. In practice, several mixtures of types of food, such as fatty foods and aqueous foods, are possible. Its description is given in Table 2, accompanied by the indication of the food simulant or simulant to be selected when carrying out the migration tests.

TABLE 1:

Food types and food simulants

Food Type Conventional Classification of Abbreviation Food

aqueous food (i.e. aqueous foods having a pH 4.5).

Food products whose test is only prescribed with the A simulant.

Distilled water or water of equivalent quality.

A Simulator

Acidic foods (i.e., aqueous foods that have a pH) 4, 5).

Food products whose test is only prescribed with simulant B.

acetic acid at 3 per 100 (w/v). Simulant B.

Alcoholic foods. Food products for which the test is only prescribed with the C simulant.

Ethanol at 10 per 100 (v/v). This concentration shall be adjusted to the actual alcoholic strength of the food if it exceeds 10 per 100 (v/v).

C.

Fatty foods. Foodstuffs for which the test is only prescribed by the simulant D.

Rectified olive oil or other fatty food simulants.

D. Simulator

Dry food. None. None.

II. Selection of food simulants

1. Materials and articles intended to come into contact with all types of food:

The tests shall be carried out using the food simulants indicated below, which are considered to be the most stringent, in the test conditions specified in Chapter II, taking a new sample of the material or plastic object for each simulant.

a) acetic acid at 3 per 100 (w/v) in aqueous solution.

b) Ethanol 10 per 100 (v/v) in aqueous solution.

(c) rectified olive oil ("reference simulant D").

However, this reference simulant D may be replaced by a synthetic mixture of triglycerides or sunflower oil or maize oil with standardised specifications ('other fatty food simulants '), 'simulants D'). If, when using any of these other fatty food simulants, the limits of migration are exceeded, a confirmation of the result using olive oil, when technically possible, is mandatory to determine the non-compliance. If this confirmation is not technically possible and the material or object exceeds the limits of the migration, it shall be deemed not to meet the requirements of this Royal Decree.

2. Materials and articles intended to come into contact with specific types of food:

This case refers only to the following situations:

a) When the material or object is already in contact with a known food product.

(b) When the material or object is accompanied, in accordance with the rules of Article 9 of Royal Decree 1425/1988, of a specific indication indicating which types of food described in Table 1 may or may not be used, example "for aqueous food only".

(c) When the material or object is accompanied, in accordance with the rules of Article 9 of Royal Decree 1425/1988, of a specific mention indicating which foodstuffs or groups of foodstuffs mentioned above in the list of names of food and simulants may or may not be used. This indication shall be expressed:

1. In the marketing stages other than the retail stage, using the reference number or the "name of the foodstuffs" in the list of designations of foodstuffs and Previously cited simulants.

2.o In the retail stage, using an indication that refers only to a few foods or food groups, preferably with easily understandable examples.

In these situations, the tests shall be carried out using in case (b) the simulant or food simulants indicated as examples in Table 2, and in cases (a) and (c) the simulant or simulants mentioned in the list of Names of foodstuffs and simulants. If the foodstuffs or groups of foodstuffs are not included in the list referred to, the element in Table 2 which is more closely related to the food product or group of foodstuffs under examination shall be selected.

If the material or object is intended to come into contact with more than one food product or group of food products with different reduction coefficients, the coefficients of the food shall be applied to each foodstuff. appropriate reduction to the test result. If one or more results of the calculation exceed the limits, then the material is not suitable for that particular food product or group of food products.

The tests shall be carried out in the test conditions specified in Chapter II, taking a new sample for each simulant.

TABLE 2:

Food simulants to be selected to examine, in special cases, materials intended to come into contact with food

Simulator contact food

Only aqueous foods. Simulant A.

Only acidic foods. Simulant B.

Only alcoholic foods. Simulant C.

Only fatty foods. Simulant D.

All aqueous and acidic foods.

Simulator B.

All aqueous and alcoholic foods.

C.

All acidic and alcoholic foods.

Simulants B and C.

All aqueous and fatty foods.

Simulants A and D.

All acidic and fatty foods. Simulants B and D.

All aqueous, alcoholic and fatty foods.

Simulations C and D.

All acidic, alcoholic and fatty foods.

Simulants B, C, and D.

CHAPTER II

I. Migration test conditions (times and temperatures)

The migration tests shall be carried out by choosing, between the time and temperature indicated in Table 3, those corresponding to the worst foreseeable conditions of the contact of the plastic materials and articles in study and to any labelling information on the maximum working temperature. Therefore, if the plastic material or object is intended for a food contact application covered by a combination of two or more selected times and temperatures of the table, the migration test shall be carried out by submitting the sample. successively to all the worst applicable foreseeable conditions suitable to the sample, using the same food simulant portion.

II. More stringent commonly recognized contact conditions

In application of the general criteria according to which the determination of migration will be circumscribed to the test conditions which, in the specific case examined, are recognized as the most stringent according to the The following are some concrete examples of contact conditions during the trials:

1. Plastic materials and articles intended to come into contact with foodstuffs in any condition of time and temperature:

If there is no label or instructions indicating the foreseeable temperature and contact time under the actual conditions of use, the tests shall be carried out using, depending on the type of food, the simulants A and/or B and/or C for four hours at 100 oC or for four hours at the reflux temperature, and/or the simulant D for two hours only at 175 oC.

These weather and temperature conditions are by convention considered the most stringent.

2. Plastic materials and articles intended to come into contact with foodstuffs at room temperature or at a lower temperature for an unspecified period of time:

If the label indicates that the materials or articles are intended for use at room temperature or at a lower temperature, or if by its nature it is evident that they are intended for use at room temperature or at a lower temperature, the test shall be carried out at 40 oC for 10 days. These conditions of time and temperature are by convention considered the most stringent.

3. Volatile migrant substances:

For the specific migration of volatile substances, the simulant tests shall be carried out in such a way as to show the loss of volatile migrant substances which may occur in the worst conditions of use foreseeable.

4. Special cases:

1.o In the migration tests of plastic materials and articles for use in microwave ovens, a conventional oven or microwave oven shall be used in the relevant time and temperature conditions. selected from Table 3.

2.o If, as a result of the tests under the contact conditions specified in Table 3, physical or other changes occur in the sample that do not occur in the worst foreseeable conditions of use of the material or The purpose of the test shall be to ensure that the migration tests are carried out in the worst foreseeable conditions of use in which these physical or other changes do not take place.

3.o Notwithstanding the conditions set out in Table 3 and paragraph 2, if a material or object of plastic material can be used in practice for periods of less than 15 minutes at temperatures between 70 oC and 100 oC (for example, 'hot fill') and this is indicated appropriately on the label or the instructions, only the two-hour test shall be carried out at 70 oC. However, if the material or object is also intended for storage at room temperature, the test shall be replaced by a test at 40 oC for 10 days, by convention considered to be the most stringent.

4.o In cases where the conventional conditions of the migration test are not adequately covered by the contact conditions of the test in Table 3 (e.g. contact temperatures above 175 oC or contact times less than five minutes), other contact conditions may be used which are more appropriate to the case under consideration, provided that the conditions selected may be the worst foreseeable conditions of contact for the materials or objects of plastic material examined.

TABLE 3:

Conventional conditions for food simulant migration testing

Conditions of Contact in the Worst Conditions of Foreseeable Use Conditions

Contact Duration: Test Duration:

t " 5 min. See the conditions of point 4.4 5 min. t " 0.5 hours 0.5 hours 0.5 h t " 1 hour 1 hour 1 h t ' 2 hours 2 hours 2 h t " 4 hours 4 hours 4 h t " 24 hours 24 hours t 24 hours 10 days

Contact Temperature: Test Temperature:

T " 5 oC 5 oC 5 oC 20 oC 20 oC 20 oC 40 oC 40 oC 40 oC T ' 70 oC 70 oC 70 oC ' 100 oC 100 oC or 100 oC T reflux temperature " 121 oC 121 oC (*) 121 oC T ' 130 oC 130 oC (*) 130 oC T " 150 oC 150 oC (*) T 150 oC 175 oC (*)

(*) This temperature shall be used only for simulant D. For simulants A, B or C, the test may be replaced by a test at 100 oC or at reflux temperature for four times the time selected according to the test. General rules of paragraph 1.

CHAPTER III

Fatty-matter replacement trials for global and specific migration

1. If no fatty food simulants can be used for technical reasons related to the method of analysis, all the test means prescribed in Table 4 shall be used instead in the test conditions corresponding to the test method. test conditions relating to the simulant D.

This table provides some examples of the most important conventional migration test conditions and their corresponding conventional replacement test conditions. For the other test conditions not listed in Table 4, these examples shall be taken into account as well as the experience of the type of polymer being examined.

A new sample should be used for each test.

Apply in each test medium the same standards as prescribed in Chapters I and II for simulant D.

Where appropriate, the reduction coefficients set out in the list of food and simulant products should be used. To ensure that all migration limits are met, the highest value obtained using all test means shall be selected.

However, if it is found that the performance of the tests results in physical or other modifications, which do not occur in the worst foreseeable conditions of use of the material or object under examination, it shall be discarded. the result of these test means and the largest of the remaining values shall be selected.

2. By way of derogation from paragraph 1, one or two of the replacement tests referred to in Table 4 may be omitted if such tests are generally considered inappropriate for the sample under examination on the basis of scientific data.

TABLE 4:

Conventional Conditions for Substitute Trials

Test conditionswith the simulant D Conditiontest conditioningConditionof the test conetanolal95% Conditionessoftest conMPPO (*)

10 d-5 oC 0.5 d-5 oC 10 d-5 oC -10 d-20 oC 1 d-20 oC 10 d-20 oC -10 d-40 oC 2 d-20 oC 10 d-40 oC -2 h-70 oC 0.5 h-40 oC 2.0 h-60 oC -0.5 h-100 oC 0.5 h-60 oC (**) 2.5 h-60 oC 0.5 h-100 oC 1 h-100 oC 1.0 h-60 oC (**) 3.0 h-60 oC (**) 1 h-100 oC 2 h-100 oC 1.5 h-60 oC (**) 3.5 h-60 oC (**) 2 h-100 oC 0.5 h-121 oC 1.5 h-60 oC (**) 3.5 h-60 oC (**) 0.5 h-121 oC 1 h-121 oC 2 h-60 oC (**) 4 h-60 oC (**) 1 h-121 oC 2 h-121 oC 2.5 h-60 oC (**) 2 h-121 oC 0.5 h-130 oC 2.0 h-60 oC (**) 4.0 h-60 oC (**) 0.5 h-130 oC 1 h-130 oC 2.5 h-60 oC (**) 4.5 h-60 oC (**) 1 h-130 oC 2 h-150 oC 3.0 h-60 oC (**) 5.0 h-60 oC (**) 2 h-150 oC 2 h-175 oC 4.0 h-60 oC (**) 6.0 h-60 oC (**) 2 h-175 oC

(*) MPPO = modified polyphenylene oxide.

(**) Volatile test means are used up to a maximum temperature of 60 oC. A prior condition of use of the replacement tests is that the material or object supports the test conditions which would otherwise be used with a simulant D. Submergir a sample in olive oil under the appropriate conditions. If the physical properties are modified (e.g., melt or deformation), then the material is considered unfit for use at that temperature. If the physical properties are not modified, continue the replacement tests using new samples.

CHAPTER IV

Alternative Fats for Global and Specific Migration

1. The use of the result of alternative tests, as specified in this chapter, may be permitted provided the following two conditions are met:

(a) The results obtained in a "comparison test" show that the values are equal to or greater than those obtained in the test with the dummy D.

b) Migration in alternative trials does not exceed the migration limits, once the appropriate reduction coefficients have been applied, as set out in the table of food and simulants found in Section A of this Annex.

If any of these conditions are not met, the migration tests must be carried out.

2. Notwithstanding the condition referred to in paragraph 1 (a) above, it is possible to discontinue the comparison test if there is another conclusive proof, based on experimental scientific results, that the values obtained in the Alternative test is equal to or greater than those obtained in the migration test.

3. Alternative testing:

1.o Alternative tests with volatile means: these tests use volatile means such as isooctane or ethanol at 95 per 100 or other volatile solvents or mixture of solvents. They shall be carried out in contact conditions such that the condition laid down in subparagraph (a) of paragraph 1 is met.

2.o Extraction tests: other tests may be used using means with very strong extraction power under very strict test conditions, if generally recognised on the basis of scientific data which is results obtained using these tests ("extraction tests") are equal to or greater than those obtained in the test with the simulant D.

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 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 "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 paragraphs (a) and (b) must comply with the requirements laid down in Article 6 (6.2), (6.3) and (6.4) of the Technical-Health Regulations 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. The substances should be of good technical quality in terms of purity criteria.

5. The list contains the following information:

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

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

3.o Column 3 (name): the chemical name.

4.o 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) 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 (substance) /6 dm2 (surface in contact 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 name

generic, the restrictions applicable to this substance shall be those corresponding to 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.

SECTION A:

List of fully harmonised additives at Community level

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 Acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their 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.

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 -til-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) benzenesulfonic acid. SML = 30 mg/Kg.

34281 Primary linear sulphuric alkyl (C8-C22) alkyl (C8-C22) 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.

35160 i 06642-31-5 6-Amino-1,3-dimethyluracil. SML = 5 mg/Kg.

35170 i 00141-43-5 2-Aminoethanol. SML = 0.05 mg/Kg. Substance not for use in polymers in contact with food for which the simulant D in Annex IV is established and only for indirect contact with food, behind the PET layer.

35284 i 00111-41-1 N-2 (aminoethyl) ethanolamine. SML = 0.05 mg/Kg. Substance not for use in polymers in contact with food for which the simulant D in Annex IV is established and only for indirect contact with food, behind the PET layer.

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

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 9.

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. SML = 0.05 mg/Kg (1).

38810 080693-00-1 Diphosphite bis (2, 6-di-tert-butyl-4-methylphenyl) pentaerytri-tol.

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

38840 i 154862-43-8 Diphosphite bis (2, 4-dicumylphenyl) pentaerythritol.

LME = 5 mg/Kg (as the sum of the substance itself, its oxidized form [bis (2,4-dicumylphenyl) pentaerythritol phosphate] and its hydrolysis product [2, 4-dicumilphenol].

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.

39925 i 129228-21-3 3,3-Bis (methoxymethyl) -2,5-dimethylhexane. SML = 0.05 mg/Kg.

40020 i 110553-27-0 2,4-Bis (octylthiomethyl)-6-methyl-phenol. SML = 6 mg/Kg.

40120 i hydroxymethylphosphonate bis (polyethylene glycol).

LME = 0.6 mg/Kg. Authorised until 1 January 2004.

40400 010043-11-5 Boron Nitride.

40570 000106-97-8 Butane.

41040 005743-36-2 Calcium Butitime.

41120 i 10043-52-4 Calcium chloride.

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 9.

41760 008006-44-8 Candelilla Cera.

41840 i 00105-60-2 Caprolactama. SML (T) = 15 mg/Kg (5).

41960 000124-07-2 Caprylic acid.

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 from castor oil.

43280 009004-34-6 Cellulose.

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

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 i 001335-23-5 Copper iodide. SML (T) = 30 mg/Kg (7) (expressed as copper) and LME = 1 mg/Kg (11) (expressed as iodine).

45280 Cotton fibers.

45450 068610-51-5 Copolymer p-cresol-dicyclo-pentadienoisobutylene.

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.

47210 i 26427-07-6 Ddrawn acid, polymer [= Tiobis (butyltin sulfide) polymer].

According to the specifications in Annex VII.

47440 000461-58-5 Diciandiamide.

47540 i 27458-90-8 di-tert-dodecyl disulfide. SML = 0.05 mg/Kg.

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

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

48620 i 00123-31-9 1,4-Dihydroxybenzene. SML = 0.6 mg/Kg.

48720 i 00611-99-4 4,4 ' -Dihydroxybenzophenone. SML (T) = 6 mg/Kg (15).

49485 134701-20-5 2,4-Dimethyl-6-(1-methylpenta-decyl) phenol. SML = 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 025265-71-8 000110-98-5 Dipropylene glycol.

52640 016389-88-1 Dolomite.

52645 i 10436-08-5 Cis-11 -Eicosenamide.

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 '-ethylene-bis-oleamide.

53440 005518-18-3 N, N '-ethylene-bis-palmitamide.

53520 000110-30-5 N, N '-Ethylene-bis-stearamide.

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 '-stearamide.

54260 009004-58-4 Ethylhydroxyethylcellulose.

54270 Ethylhydroxymethylcellulose.

54280 Ethylhydroxypropylcellulose.

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

LME = 6 mg/Kg.

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

54450 Fat and oils of animal or plant food origin.

54480 Fat and hydrogenated oils 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.

60160 000120-47-8 4-ethyl hydroxybenzoate.

60180 004191-73-5 4-Isopro-pito Hydroxibenzoate.

60200 000099-76-3 4-methyl hydroxybenzoate.

60240 000094-13-3 4-propyl hydroxybenzoate.

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

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

LME (T) = 30 mg/Kg (19).

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.

64800 i 00110-16-7 Maleic acid. SML (T) = 30 mg/Kg (4).

65020 006915 -15 -7 Malic acid.

65040 000141-82-2 Malonic acid.

65520 000087-78-5 Mannitol.

65920 i 66822-60-4 copolymers of N-methacrylyloxyethyl-N, N-dimethyl-N-carboxymethylammonium chloride, sodium-methacrylate salt-methacrylate salt-methacrylate of cyclohexyl methacrylate-N-vinyl-2-pyrrolidone.

66200 037206-01-2 Methylcarboxymethylcellulose.

66240 009004-67-5 Metilcellulose.

66560 004066-02-8 2,2 ' Methylenbis (4-methyl-6-cycle-hexylphenol). SML (T) = 3 mg/Kg (6).

66580 000077-62-3 2, 2 ' Methylenbis [4-methyl-6-(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. SML = 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) triazol2-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.

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

70000 070331-94-1 2,2 ' -Oxamidobis [ethyl-3-(3, 5-di-tert-butyl-4-hydroxyphenyl) propionate].

70240 012198-93-5 Ozocerite.

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. SML = 0.05 mg/Kg. Substance not for use in polymers in contact with food for which the simulant D in Annex IV is established.

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.

73160 i mono-and dialkyl phosphates (C16 and C18). SML = 0.05 mg/Kg.

73720 000115 -96-8 Trichloroethyl phosphate. SML = 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 Eye acid.

76320 000085-44-9 Ophthalmic Anhydride.

76721 009016-00-6 063148-62-9 Polidimethylsiloxane (PM 6800). In accordance with the specifications in Annex VII.

76730 i Polodimethylsiloxane, gamma-hydroxypropyl.

LME = 6 mg/Kg.

76865 Polyesters of 1,2-propanediol and/or 1,3-and 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 (C16-C18) 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) dimethylpo-lisiloxane.

80720 008017-16-1 Polyphosphoric acids.

80800 025322-69-4 Polypropylene glycol.

81220 i 192268-64-7 Poli-[[6-N-(2,2,6, 6-tetramethyl-4piperidinyl)-n-butylamino] 1, 3, 5-triazine-2, 4-diyl] [2, 2, 6, 6,-tetra methyl-4-piperidinyl) imino] -1, 6-hexanediyl [(2, 2, 6, 6, -tetramethyl-4-piperidinyl) imino]-alpha- [N, N, N', N'-tetrabutil-N ''-(2, 2, 6, 6-tetramethyl-4 piperidinyl) -N "-[6-(2, 2, 6, 6-tetramethyl-4-piperidinylamino)-hexyl] [1, 3, 5, -triazine-2-4, 6-triamine]-omega-N, N, N', N'-tetrabutil-1, 3, 5-triazine-2, 4-diamine].

LME = 5 mg/Kg.

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

81520 007758-02-3 Potassium bromide.

81600 001310-58-3 Potassium Hydroxide.

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

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

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

83455 013445-56-2 Pirophosphorous acid.

83460 012269-78-2 Pirofilita.

83470 014808-60-7 Quartz.

83599 i 68442-12-6 2-mercaptoethyl oleate reaction products with dichlorodimethyltin, sodium sulfide, and trichloromethyltin.

LME (T) = 0.18 mg/Kg (16) (expressed as tin).

83610 073138-82-6 Resync acids and rosin acids.

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).

85680 i 01343-98-2 silicic acid.

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

86000 Silicic acid silylated.

86160 000409-212-2 Silicon carbide.

86240 007631-86-9 Silicon dioxide.

86285 Silanised 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.

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

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.

92150 i 01401-55-4 Tanic acid, food quality.

92160 000087-69-4 Tartaric acid.

92195 Taurina, salts.

92205 057569-40-1 terephthalic acid diester with 2, 2 '-methylenebis (4-methyl-6-tert-butylphenol).

92350 000112-60-7 Tetraethylene glycol.

92640 000102-60-3 N, N, N ', N'-tetrakis (2-hydroxy-propyl) ethylenediamine.

92700 078301-43-6 Polymer of 2,2,4,4-tetra-methyl-20-(2, 3epoxypropyl) -7-ox-3, 20-diazadispiro [5.1.11.2]-henecosan-21-one.

LME = 5 mg/Kg.

92930 120218-34-0 Tiodiethanolbis (5-methoxycarbo-nil-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.

93720 i 00108-78-1 2,4,6-Triamino-1,3,5-triazine. SML = 30 mg/kg.

94320 000112-27-6 Triethylene glycol.

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

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

95270 i 161717-32-4 Fosphyto of 2,4,6-tris (tert-butyl) phenyl 2-butyl-2-ethyl-1,3-propanediol.

LME = 2 mg/Kg (as sum of phosphite, phosphate and hydrolysis product = TTBP).

95725 i 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.

SECTION B

List of additives whose specific migration limits will apply from 1 January 2004, in accordance with the provisions of Article 6.1 of this Royal Decree

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

30180 i 02180-18-9 manganese acetate. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

31520 i 61167-58-6 acrylate 2-tert-butyl-6-(3 tert-butyl-2-hydroxy-5-methylbenzyl) -4-methylphenyl.

LME = 6 mg/kg.

31920 i 00103-23-1 Adduck of bis (2-ethylhexyl). SML = 18 mg/kg (1).

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

34230 i alkyl (C8-C22) sulfonic acid. SML = 6 mg/kg.

35760 i 01309-64-4 Antimony Trioxide. SML = 0,02 mg/kg (expressed as antimo-y, analytical tolerance included).

36720 i 17194-00-2 Barium hydroxide. SML (T) = 1 mg/kg (12) (expressed as barium).

36800 i 10022-31-8 Barium Nitrate. SML (T) = 1 mg/kg (12) (expressed as barium).

38240 i 00119-61-9 Benzophenone. SML = 0.6 mg/kg.

38560 i 07128-64-5 2,5-Bis (5-tert-butyl-2-benzoxazolyl) thiophene. SML = 0.6 mg/kg.

38700 i 63397-60-4 Bis (isooctyl thioglycolate) bis (2-carbobutoxyethyl) tin.

LME = 18 mg/kg.

38800 i 32687-78-8 N, N ' -Bis [3-(3, 5-di-tert-butyl-4-hydroxyphenyl) propionyl] hydrazide.

LME = 15 mg/kg.

38820 i 26741-53-7 Diphosphite of bis (2,4-di-tert-butylphenyl) pentaerythritol.

LME = 0.6 mg/kg.

39060 i 35958-30-6 1,1-Bis (2-hydroxy-3, 5-di-tert-butylphenyl) ethane.

LME = 5 mg/kg.

39090 i N, N-Bis (2-hydroxyethyl) alkyl (C8-C18) amine.

LME (T) = 1,2 mg/kg (13).

39120 i N, N-bis (2-hydroxyethyl) alkyl (C8-C18) amine hydrochloride.

SML (T) = 1,2 mg/kg (13) (expressed as N, N-bis (2-hydroxyethyl) alkyl (C8-C18) amine).

40000 i 00991-84-4 2, 4-B i s (o c t i l t i o) -6-(4-h i d r o x i-3, 5-di-tert-butylanilino)-1, 3, 5-triazine.

LME = 30 mg/kg.

40020 i 110553-27-0 2,4-Bis (octylthiomethyl) -6-methylphenol. SML = 6 mg/kg.

40160 i 61269-61-2 Copolymer N, N '-bis (2,2,6, 6-tetramethyl-4-piperidyl) hexamethylenediamine 1,2 -dibromoethane.

LME = 2.4 mg/kg.

40800 i 13003-12-8 4, 4 '-Butylenbis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite).

LME = 6 mg/kg.

40980 i 19664-95-0 manganese Butitime. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

42000 i 63438-80-2 Tris (isooctyl thioglycolate) of (2-carbobutoxyethyl) tin.

LME = 30 mg/kg.

42400 i 10377-37-4 Lithium carbonate. SML (T) = 0,6 mg/kg (8) (expressed as lithium).

42480 i 00584-09-8 Rubidium carbonate. SML = 12 mg/kg.

43600 i 04080-31-3 Chloride of 1-(3-chloroalyl) -3,5, 7-triaza-1-azoniaadamantane.

LME = 0.3 mg/kg.

43680 i 00075-45-6 Chlorodifluoromethane. SML = 6 mg/kg In accordance with the specifications in Annex VII.

44960 i 11104-61-3 cobalt oxide. SML (T) = 0,05 mg/kg (14) (expressed as cobalt).

45440 i Cresoles, butylated, styrenated. SML = 12 mg/kg.

46720 i 04130-42-1 2,6-Di-tert-butyl-4-ethylphenol. CMA = 4.8 mg/6 dm2.

47600 i 84030-61-5 Bis (isooctyl tioglycolate) di-n-dodecyltin.

LME = 12 mg/kg.

48640 i 00131-56-6 2,4-Dihydroxybenzophenone. SML (T) = 6 mg/kg (15).

48800 i 00097-23-4 2,2 '-Dihydroxy-5,5'-dichlorodiphenylmethane. SML = 12 mg/kg.

48880 i 00131-53-3 2,2 ' -Dihydroxy-4-methoxybenzophenone. SML (T) = 6 mg/kg (15).

49600 i 26636-01-1 Bis (isooctyl thioglycolate) of dimethyltin. SML (T) = 0.18 mg/kg (16) (expressed as tin).

49840 i 02500-88-1 Dioctadecyl disulfide. SML = 3 mg/kg.

50160 i Bis [n-alkyl (C10-C16) thioglycolate] di-n-octyltin.

LME (T) = 0.04 mg/kg (17) (expressed as tin).

50240 i 10039-33-5 Bis (2-ethylhexyl maleate) di-n-octyltin.

LME (T) = 0.04 mg/kg (17) (expressed as tin).

50320 i 15571-58-1 Bis (2-ethylhexyl thioglycolate) di-n-octyltin.

LME (T) = 0.04 mg/kg (17) (expressed as tin).

50360 i Bis (ethyl maleate) di-n-octyltin. SML (T) = 0,04 mg/kg (17) (expressed as tin).

50400 i 33568-99-9 Bis (isooctyl maleate) di-n-octyltin. SML (T) = 0,04 mg/kg (17) (expressed as tin).

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

50480 i 26401-97-8 Bis (isooctyl thioglycolate) di-n-octyltin.

LME (T) = 0.04 mg/kg (17) (expressed as tin).

50560 i 1,4-Butanediol bis (thioglycolate) di-n-octyltin.

LME (T) = 0.04 mg/kg (17) (expressed as tin).

50640 i 03648-18-8 di-n-octyltin dilaurate. SML (T) = 0,04 mg/kg (17) (expressed as tin).

50720 i 15571-60-5 Dimaleate di-n-octyltin. SML (T) = 0,04 mg/kg (17) (expressed as tin).

50800 i Dimaleate of esterified di-n-octyltin. SML (T) = 0,04 mg/kg (17) (expressed as tin).

50880 i Dimaleate di-n-octyltin, polymers (n = 2-4).

LME (T) = 0.04 mg/kg (17) (expressed as tin).

50960 i 69226-44-4 Etlienglycol bis (thioglycolate) di-n-octyltin.

LME (T) = 0.04 mg/kg (17) (expressed as tin).

51040 i 15535-79-2 di-n-octyltin tioglycolate. SML (T) = 0,04 mg/kg (17) (expressed as tin).

51120 i (Tiobenzoate) (2-ethylhexyl thioglycolate) di-n-octyltin.

LME (T) = 0.04 mg/kg (17) (expressed as tin).

51570 i 00127-63-9 Diphenylsulfone. SML = 3 mg/kg.

51680 i 00102-08-9 N, N ' -Diphenylthiourea. SML = 3 mg/kg.

52000 i 27176-87-0 Dodecylbenzenesulfonic acid. SML = 30 mg/kg.

52320 i 52047-59-3 2-(4-Dodecylphenyl) indole. SML = 0.06 mg/kg.

52880 i 23676-09-7 4-Ethoxybenzoate. SML = 3.6 mg/kg.

53200 i 23949-66-8 2-Ethoxy-2 '-etiloxanilide. SML = 30 mg/kg.

58960 i 00057-09-0 Hexadecyltrimethylammonium bromide. SML = 6 mg/kg.

59120 i 23128-74-7 1,6-Hexamethylene-bis [3-(3, 5-ditercbutyl-4-hydroxyphenyl) propionamide].

LME = 45 mg/kg.

59200 i 35074-77-2 1,6-Hexamethylene-bis [3-(3, 5-ditercbutyl-4-hydroxyphenyl) propionate].

LME = 6 mg/kg.

60320 i 70321-86-7 2-[2-Hydroxy-3,5-bis (1, 1-dimethylbenzyl) phenyl] benzotriazole.

LME = 1.5 mg/kg.

60400 i 03896-11-5 2-(2 '-Hydroxy-3'-tert-butyl-5 '-methylphenyl) -5-chlorobenzotriazole.

LME (T) = 30 mg/kg (19).

60800 i 65447-77-0 Copolymer 1-(2-hydroxyethyl) -4-hydroxy-2,2,6,6-tetramethylpiperidine succinate dimethyl.

LME = 30 mg/kg.

61280 i 03293-97-8 2-Hydroxy-4-n-hexyloxybenzophenone. SML (T) = 6 mg/kg (15).

61360 i 00131-57-7 2-Hydroxy-4-methoxybenzophenone. SML (T) = 6 mg/kg (15).

61440 i 02440-22-4 2-(2 '-Hydroxy-5'-methylphenyl) benzotriazole. SML (T) = 30 mg/kg (19).

61600 i 01843-05-6 2-Hydroxy-4-n-octiloxibenzophenone. SML (T) = 6 mg/kg (15).

63200 i 51877-53-3 manganese lactate. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

64320 i 10377-51-2 Lithium iodide. SML (T) = 1 mg/kg (11) (expressed as iodine) and LME (T) = 0,6 mg/kg (8) (expressed as lithium).

65120 i 07773-01-5 manganese chloride. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

65200 i 12626-88-9 manganese hydroxide. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

65280 i 10043-84-2 manganese hypophosphite. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

65360 i 11129-60-5 manganese oxide. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

65440 i manganese pyrophosphite. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

66360 i 85209-91-2 Fosphate of 2,2 '-methylenbis (4, 6-di-tert-butylphenyl) sodium.

LME = 5 mg/kg.

66400 i 00088-24-4 2,2 '-Methylenbis (4-ethyl-6-tert-butylphenol). SML (T) = 1,5 mg/kg (20).

66480 i 00119-47-1 2,2 '-Methylenbis (4-methyl-6-tert-butylphenol). SML (T) = 1,5 mg/kg (20).

67360 i 67649-65-4 Tris (isooctyl thioglycolate) of mono-n-dodecyltin.

LME = 24 mg/kg.

67520 i 54849-38-6 Tris (isooctyl thioglycolate) of monomethyltin.

LME (T) = 0.18 mg/kg (16) (expressed as tin).

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

67600 i Tris [alkyl (C10-C16) thioglycolate] of mono-n-octyltin.

LME (T) = 1,2 mg/kg (18) (expressed as tin).

67680 i 27107-89-7 Tris (2-ethylhexyl thioglycolate) mono-n-octyltin.

LME (T) = 1,2 mg/kg (18) (expressed as tin).

67760 i 26401-86-5 Tris (isooctyl thioglycolate) of mono-n-octyltin.

LME (T) = 1,2 mg/kg (18) (expressed as tin).

68078 i 27253-31-2 cobalt Neodecanoate. SML (T) = 0,05 mg/kg (expressed as neodecanoic acid) and SML (T) = 0,05 mg/kg (14) (expressed as cobalt).

Substance not for use in food contact polymers for which the simulant D in Annex IV is established.

68320 i 02082-79-3 3-(3, 5-Di-tert-butyl-4-hydroxyphenyl) octadecyl propionate.

LME = 6 mg/kg.

68400 i 10094-45-8 Octadecerucamide. SML = 5 mg/kg.

69840 i 16260-09-6 Oleylpalmitamide. SML = 5 mg/kg.

72160 i 00948-65-2 2-Fenilindol. SML = 15 mg/kg.

72800 i 01241-94-7 Diphenyl 2-ethylhexyl phosphate. SML = 2.4 mg/kg.

73040 i 13763-32-1 Lithium phosphate. SML (T) = 0,6 mg/kg (8) (expressed as lithium).

73120 i 10124-54-6 manganese phosphate. SML (T) = 0,6 mg/kg (10) (expressed as manga-neso).

74400 i Fosphyto de tris (nonyl-and/or dinonylphenyl). SML = 30 mg/kg.

77440 i polyethylene glycol diricinoleate. SML = 42 mg/kg.

77520 i 61791-12-6 polyethylene glycol ester with castor oil.

LME = 42 mg/kg.

78320 i 09004-97-1 polyethylene glycol monorinoleate. SML = 42 mg/kg.

81200 i 71878-19-8 Poli [6-[(1,1,3,3-tetramethylbutyl) amino] -1,3,5-triazine-2, 4-diyl-[(2,2,6,6, -tetramethyl-4-piperidyl) imino-hexamethylene-[(2,2,6,6-tetramethyl-4-piperidyl) imino.

LME = 3 mg/kg.

81680 i 07681-11-0 Potassium iodide. SML (T) = 1 mg/kg (11) (expressed as iodine).

82020 i 19019-51-3 cobalt propionate. SML (T) = 0,05 mg/kg (14) (expressed as cobalt).

83595 i 119345-01-6 Product of di-tert-butyl phosphonite reaction with diphenyl, obtained by m e d i o d e c o n d e n s a c i o n d e 2,4-di-tert-butylphenol with the product of the reaction Friedel Craft of phosphorus trichloride with diphenyl.

LME = 18 mg/kg. In accordance with the specifications in Annex VII.

83700 i 00141-22-0 ricinoleic acid. SML = 42 mg/kg.

84800 i 00087-18-3 4-tert-butylphenyl Salicilate. SML = 12 mg/kg.

84880 i 00119-36-8 methyl Salicylate. SML = 30 mg/kg.

85760 i 12068-40-5 Aluminium lithium silicate (2:1: 1). SML (T) = 0,6 mg/kg (8) (expressed as lithium).

85920 i 12627-14-4 Lithium silicate. SML (T) = 0,6 mg/kg (8) (expressed as lithium).

86800 i 07681-82-5 Sodium iodide. SML (T) = 1 mg/kg (11) (expressed as iodine).

86880 i monoalkyl dialkylphenoxybenzenesulfonate, sodium salt.

LME = 9 mg/kg.

89170 i 13586-84-0 cobalt stearate. SML (T) = 0,05 mg/kg (14) (expressed as cobalt).

92000 i 07727-43-7 Barium Sulphate. SML (T) = 1 mg/kg (12) (expressed as barium).

92320 i Eter of tetradecyl-polyoxyethylene (OE=3-8) of glycolic acid.

LME = 15 mg/kg.

92560 i 38613-77-3 tetrakis diphosphonite (2, 4-di-tert-butylphenyl)-4,4 '-biphenylene.

LME = 18 mg/kg.

92800 i 00096-69-5 4,4 '-Tiobis (6-tert-butyl-3-methylphenol). SML = 0.48 mg/kg.

92880 i 41484-35-9 Bis [3-(3, 5-di-tert-butyl-4-hydroxyphenyl) propionate] of thiodiethanol.

LME = 2.4 mg/kg.

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

93120 i 00123-28-4 Didodecyl Tiodipropionate. SML (T) = 5 mg/kg (21).

93280 i 00693-36-7 Dioctadecyl Tiodipropionate. SML (T) = 5 mg/kg (21).

94560 i 00122-20-3 Triisopropanolamine. SML = 5 mg/kg.

95280 i 40601-76-1 1,3,5-Tris (4-tert-butyl-3-hydroxy-2, 6-dimethylbenzyl) -1,3,5-triazine-2,4,6 (1H, 3H, 5H)-trione.

LME = 6 mg/kg.

95360 i 27676-62-6 1,3,5-Tris (3, 5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2, 4,6 (1H, 3H, 5H)-trione.

LME = 5 mg/kg.

95600 i 01843-03-4 1, 1, 3-T r i s (2-m e t i l-4-h i-droxy-5-tert-butylphenyl) butane.

LME = 5 mg/kg.

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.: 19540, 19960 and 64800, 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, 14230 and 41840, must not exceed the indicated restriction.

(6) SML (T) means in this case that the sum of the migration of the following substances, marked 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.: 42400, 64320, 73040, 85760, 85840, 85920 and 95725, must not exceed the indicated restriction.

(9) Warning: there is a risk that the migration of the substance will impair the organoleptic characteristics of the food with which it is in contact and, in that case, the finished product could cause a change of the organoleptic characteristics or an unacceptable modification of the composition of the foodstuffs.

(10) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120, must not exceed the indicated restriction.

(11) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 45200, 64320, 81680 and 86800, must not exceed the indicated restriction.

(12) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 36720, 36800 and 92000, must not exceed the indicated restriction.

(13) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 39090 and 39120, should not exceed the indicated restriction.

(14) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 44960, 68078, 82020 and 89170, must not exceed the indicated restriction.

(15) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 15970, 48640, 48720, 48880, 61280, 61360 and 61600, must not exceed the indicated restriction.

(16) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 49600, 67520 and 83599, must not exceed the indicated restriction.

(17) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120, should not exceed the indicated restriction.

(18) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 67600, 67680 and 67760, must not exceed the indicated restriction.

(19) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 60400, 60480 and 61440, must not exceed the indicated restriction.

(20) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 66400 and 66480, must not exceed the indicated restriction.

(21) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 93120 and 93280, must not exceed the indicated restriction.

(22) SML (T) means in this case that the sum of the migration of the following substances, marked with the numbers PM/REF.: 17260 and 18670, must not exceed the indicated restriction.

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

Materials and objects manufactured using aromatic isocyanates or dyes prepared by diazo bonds must not release primary aromatic amines (expressed as anilines) in detectable quantity (DL= 0,02 mg/kg food or food simulant, analytical tolerance included). However, the migration value of the primary aromatic amines included in this Royal Decree is excluded from this restriction.

Part B: Other Specifications

PM/REF Number Other Specifications

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

Definition: These copolymers are produced by controlled fermentation of Alcalgenes eutrophus which uses 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 comply with the general and specific specifications.

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

CAS Number: 80181-31-3.

Structural Formula:

CH3 | 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: not less than 150,000 daltons (measured by gel penetration chromatography).

Assay: not less than 98% of poly (3-D-hydroxybutanoate-co-3-D-hydroxyphenanoate) 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: not 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).

43680 i Chlorodifluoromethane.

Chlorofluoromethane content less than 1 mg/kg of the substance.

47210 i dibutylthiostannoic acid polymer.

Molecular Unit = (C8H18S3Sn2) n (n=1.5-2).

PM/REF Number Other Specifications

76721 Polidimethylsiloxane (pm Minimum viscosity: 100 ^ 10-6 m2/s (=100 centistokes) at 25 oC.

83595 i Di-tert-butylphosphonite reaction product with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with the product of a Friedel Craft reaction of phosphorus trichloride and biphenyl.

Composition:

4,4 ' Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]. (CAS number 38613-77-3) [36-46% w/w (1)].

4,3 ' Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]. (CAS number 118421-00-4) (17-23% w/w (1).

3,3 '-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]. (CAS number 118421-01-5) (1-5% w/w) (1).

4-Biphenylene-0,0-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite]. (CAS number 91362-37-7) (11-19% w/w) (1).

Tris (2,4-di-tert-butylphenyl) phosphite. (CAS number 31570-04-4) (9-18% w/w) (1).

4,4-Biphenylene-0,0-bis [2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite. (CAS number 112949-97-0) (5% w/w) (1).

Other specifications:

Phosphorus content: min. 5.4%, max. 5.9%.

Acidity index: max. 10 mg KOH/g.

Merge interval: 85-110 oC.

88640 Epoxidado soybean oil.

Oxirane 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.

(1) Amount of substance used/amount of formulation.