Royal Decree 118/2003 of 31 January approving the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food and are regulated test conditions, has been modified on three occasions, the last time being by Order SCO/3508/2006 of 10 November, amending the Annexes to Royal Decree 118/2003 of 31 January, approving the list of substances permitted for the manufacture of plastic materials and articles intended to come into contact with the food and certain test conditions are regulated.

This royal decree incorporates the Community provisions contained in Council Directive 78 /142/EEC of 30 January 1978 on the approximation of the laws of the Member States relating to materials and articles containing vinyl chloride monomer, intended to come into contact with foodstuffs, Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for the verification of the migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, Council Directive 85 /572/EEC of 19 December 1985 determining the list of simulants to be used to monitor the migration of components of materials and articles of material plastic intended to come into contact with foodstuffs and Commission Directive 2002/72/EC of 6 August 2002 on plastic materials and articles intended to come into contact with foodstuffs.

Commission Directive 2007 /19/EC of 2 April 2007 amending Directive 2002/72/EC on plastic materials and articles intended to come into contact with foodstuffs and the Directive Council Regulation (EEC) No 525/88 of the Council of 15 December 1985 laying down the list of simulants to be used for the control of the migration of components of plastic materials and articles intended to come into contact with foodstuffs, introduces important changes in Community legislation on plastic materials in food contact, by substantially amending the provisions of Directive 2002/72/EC and updating the annexes to both directives.

This royal decree incorporates Directive 2007 /19/EC into our legal order, but, in the interests of greater simplification and clarity, it has been recast in a new text together with Royal Decree 118/2003 and its amendments later.

On the other hand, Royal Decree 1425/1988 of 25 November 1988 on the approval of the Technical Health Regulations for the circulation and trade of plastic materials intended to be in contact with Food and food products, which has been mentioned several times in Royal Decree 118/2003. Given that this Royal Decree is repealed by the application of Community regulations and Royal Decree 118/2003 itself, it is necessary to replace these terms with those currently in force. For greater legal clarity and simplification of legislation, the repeal of this royal decree is appropriate.

In its treatment, the autonomous communities, the sectors affected, the consumer associations have been heard and the Interministerial Commission for Food Management has issued a mandatory report.

In its virtue, on the proposal of the Ministers for Health and Consumer Affairs and the Environment, and the Rural and Marine Environment, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 23 May. 2008,

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, their permitted maximum migrations in migration tests, either globally or for a specific constituent, and to determine the test conditions for them.

Article 2. Definitions.

1. For the purposes of this royal decree, it is understood by:

(a) Plastic matter: 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 may be added to that macromolecular compound, considered additives.

(b) Additive: any substance incorporated in polymers during the processes of synthesis, processing or processing in order to facilitate such processes and/or to conveniently modify the final properties of the finished product. These additives, with the exception of colours, must appear on the corresponding positive lists.

(c) Plastic materials or articles of several layers: a material or a plastic object composed of two or more layers of material, each of which is composed exclusively of plastic materials, which are joined together with each other by means of adhesives or by any other means.

(d) Plastic functional barrier: a barrier consisting of one or more layers of plastic material which ensures that the material or final object complies with Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and the Council and in this royal decree.

e) Non-fatty food: the food for which different simulant D simulants are set out in Annex VIII of this royal to carry out the migration tests.

f) Supports for the production of polymerisation: additives used in the process of polymerisation, either for direct intervention in the reaction (polymerisation aids, such as catalysts and initiators) or to create a suitable medium (auxiliary for the production of polymers, such as suspension agents and pH regulators). These supports are not intended to remain in the finished object or have a technological effect on it.

2. 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, although each one of them must comply separately with the general or specific conditions that correspond to it.

3. However, no plastic materials shall 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 plastic material.

d) Surface coatings obtained from:

1. Parafine Ceras, including synthetic paraffin waxes and/or microcrystalline waxes.

2. ° 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 applies to the following materials and articles which, in the state of finished products, are intended to come into contact with or contact foodstuffs, and are intended for this purpose:

(a) materials and articles, and parts thereof, consisting exclusively of plastic materials

b) multilayer plastic materials and objects

(c) plastic layers or plastic coatings forming obturators in lids that together are composed of two or more layers of different types of materials

2. Without prejudice to point (c) of the preceding paragraph, 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, including if the intended purpose of direct contact with the food products is made exclusively by plastic material.

Article 4. Global migration limit.

1. Plastic materials and articles must not give up their components to foodstuffs in quantities exceeding 60 milligrams of constituents released per kilogram of food product or food simulant (mg/kg) (limit of global migration).

However, this limit will be 10 milligrams per square tenths of material or object surface (mg/dm²) in the following cases:

(a) objects which are packaging or which are comparable to packaging or which can be filled in, of a capacity of less than 500 millilitres (ml) or more than 10 litres (l);

(b) sheets, films or other materials or articles which cannot be filled or for which it is not possible to calculate the ratio between their surface area and the quantity of food in contact with them.

2. As regards plastic materials and articles intended to come into contact with food intended for infants and young children, or who are already in contact with them, as defined in Royal Decree 490/1998 of 27 March 1998, The Specific Technical-Health Regulations of the Food and Infant Foods Base for Infants and Children of Short Age and the Royal Decree 72/1998 of 23 January, for which the Regulations are approved, are approved. (a) specific health-technical requirements for infant formulae and follow-on formulae, the limit of Global migration will always be 60 mg/kg.

Article 5. Specific migration limits (SML).

1. The specific migration limits indicated in Annexes II and III 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 in, of 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 not possible 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 Annexes II and III, expressed in mg/kg, shall be divided by six, as the conventional conversion factor, to be expressed in mg/dm².

3. As regards plastic materials and articles intended to come into contact with food intended for infants and young children, or who are already in contact with them, as defined in Royal Decree 490/1998 of 27 March and the Royal Decree of 27 March 1998. Decree 72/1998 of 23 January, the specific migration limits shall be applied as mg/kg.

Article 6. Conditions of the migration tests.

1. The migration tests may be performed either in food products 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 VIII 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.

To demonstrate the non-compliance of a material or 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 paragraph 2 shall not be mandatory if one of the following cases can be demonstrated:

a) That the value of the overall migration determination implies that the specific migration limits referred to in that paragraph 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 food products 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.

5. By way of derogation from paragraph 2, as regards phthalates (reference numbers 74640, 74880, 74560, 75100 and 75105) referred to in Section A of Annex III, the verification of the SML shall only be carried out in the simulants food. However, the verification of the SML may be carried out in food when the food has not yet been in contact with the material or object, and a pre-test of phthalates is performed and the level is not statistically significant. significant, or greater than or equal to the limit of quantification.

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

1. Only monomers and other starting substances listed in Annex II may be used for the manufacture of plastic materials and articles, with the restrictions specified therein.

2. For the purposes of this royal decree, the list set out in Annex II does not include monomers and other starting substances used only 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 triggers.

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 restrictions and, where appropriate, specified specifications, are those set out in Annex III, as well as those contained in the Resolution of the Deputy Secretary for Health, 4 November 1982, as amended by the Order of 3 July 1985, which are not provided for in this royal decree.

The use of supports for the production of polymerisation, as defined in Article 2 (1) (f), which is legally authorised in other Member States of the European Union, is authorised, as defined in Article 2 (1) of the Treaty. the same restrictions and restrictions as there are, for the same purpose, in accordance with the principle of mutual recognition established by the Treaty establishing the European Community.

2. For the substances in Section B of Annex III, verification of compliance with the specific migration limits shall apply from 1 May 2008 when it is carried out in simulants D or in the test means of replacement analysis, in accordance with the provisions set out in Annex IX.

3. The lists set out in Sections A and B of Annex III do not include the following additives:

a) Additives used only to manufacture:

1. ° Coatings of surfaces obtained from resinous or polymerized products in liquid form, powder or dispersion, such as varnishes, lacquers, paints.

2. Epoxy Resin.

3. Adhesive and adhesion activators.

4. Tintas printing.

b) Colorants.

c) solvents.

4. For the values admitted for the specific migrations of the additives in which the functional duality of monomer or substance of heading and additive may be presented, the criteria laid down in this royal decree shall apply.

Article 9. Products obtained by bacterial fermentation.

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

Article 10. Food additives and flavourings.

1. The additives referred to in Article 8 which are also authorised as food additives by the legislation of food additives, that is, Royal Decree 3177/1983 of 16 November, approving the regulation (a) technical-health food additives, or as flavourings in accordance with Royal Decree 1477/1990 of 2 November 1990 on the technical and health regulation of flavourings used in foodstuffs and materials of the base for your production, you should not migrate:

a) To food products in quantities that have a technological effect on the final food product.

(b) to foodstuffs in which their use is authorised as additives or flavourings in quantities exceeding the restrictions laid down in the legislation on food additives by Royal Decree 142/2002 of 1 January 2002. February, which approved the positive list of additives other than colours and sweeteners for use in the manufacture of foodstuffs, as well as their conditions of use, by Royal Decree 2001/1995 of 7 December 1995. approving the positive list of colours authorised for use in the manufacture of products food, as well as its conditions of use, and by Royal Decree 2002/1995 of 7 December, approving the positive list of additives authorised for use in the manufacture of foodstuffs, as well as their conditions of use; or of flavourings as provided for in Royal Decree 1477/1990 of 2 November; or in Article 8 of this royal decree, taking into account the one which establishes the greatest restriction.

(c) Food products in which their use as food additives or flavourings is not authorised in quantities exceeding the restrictions laid down in Article 8.

2. In the marketing stages other than the retail stages, plastic materials and articles intended to be brought into contact with foodstuffs and containing additives referred to in paragraph 1 shall be accompanied by a a written declaration containing the information referred to in Article 13.

Article 11. Functional barriers.

1. In a multi-layer plastic material or object, the composition of each plastic layer must conform to the requirements of this royal decree.

2. By way of derogation from paragraph 1, a layer which is not in direct contact with a food and is separated from it by a functional plastic barrier may, provided that the material or finished object complies with the migration limits specific and global established in this royal decree:

a) do not comply with the restrictions and specifications set forth in this royal decree

(b) being manufactured with substances other than those included in this royal decree or in the Resolution of 4 November 1982, of the Health Secretariat.

3. The migration of the substances referred to in point (b) of paragraph 2 to a food or simulant shall not exceed 0,01 mg/kg, measured with statistical certainty by a method of analysis in accordance with Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council. This limit shall always be expressed as a concentration in food or simulant and shall be applied to a group of compounds, if they are structurally and toxicologically related, particularly isomers or compounds with the same relevant functional group, and include possible unwanted transfers.

4. The substances referred to in point (b) of paragraph 2 shall not belong to the following categories:

(a) substances classified as substances which are or are suspected to be "carcinogenic", "mutagenic" or "toxic for reproduction" in Annex I to Royal Decree 363/1995 of 10 March 1995 approving the the regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances or

(b) substances classified according to the criteria of self-responsibility as "carcinogens", "mutagens" or "toxic for reproduction" in accordance with the rules of Article 6 of Royal Decree 363/1995 of 10 March.

Article 12. Specifications.

Part A of Annex V contains the general specifications for plastic materials and articles. Other specifications concerning certain substances listed in Annexes II, III and IV are set out in Annex V, Part B.

Article 13. Declaration for marketing.

1. In the marketing stages other than the retail stages, plastic materials and articles, as well as substances intended for the manufacture of such materials and articles, must be accompanied by a written declaration of in accordance with Article 16 of Regulation (EC) No 1935/2004.

2. The operator of the undertaking shall issue the declaration referred to in paragraph 1, which shall contain the information set out in Annex VII. The operator of the undertaking shall make available to the competent authorities, if they so request, the appropriate documentation showing that the materials and articles, as well as the substances intended for the manufacture of the materials and articles thereof, materials and objects, meet the requirements of this royal decree. Such documentation shall include the conditions and results of the tests, the calculations, other analyses, and the safety tests, or a reasoning demonstrating compliance.

Article 14. Sanctioning regime.

1. Without prejudice to other provisions which may be applicable, failure to comply with the provisions of this royal decree may be the subject of an administrative penalty, subject to the instruction of the appropriate administrative file, in accordance with Article 1 (2) of Regulation (EU) No as provided for in Chapter VI of Title I of Law 14/1986 of 25 April, General of Health.

2. In particular, failure to comply with the provisions relating to the global and specific migration limits and the declaration of conformity referred to in Articles 4, 5 and 13 shall be considered to be a serious infringement, in accordance with the provisions of the Article 35 (B), 1. of Law 14/1986, General of Health.

3. In addition, failure to comply with the provisions relating to the use of monomers, additives and other starting substances and products obtained by means of bacterial fermentation specified in Articles 7, 8 and 9 shall be taken into account a very serious infringement, in accordance with Article 35 (C), 1. of Law 14/1986, General of Health.

Single transient arrangement. Marketing extension.

Plastic materials and articles intended to come into contact with foodstuffs manufactured before 1 July 2008 in respect of the products referred to in paragraphs 1 and 2 of the Final Disposition First, and before 1 May 2009, in respect of all other materials, and which comply with the provisions of the regulations in force prior to the entry into force of this royal decree, may continue to be placed on the market until the end of the of their stocks.

Single repeal provision. Regulatory repeal.

Royal Decree 118/2003 of 31 January 2003, which approves the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with food, is hereby repealed. (a) the conditions for testing, and the Royal Decree 1425/1988 of 25 November 1988 on the Health Technical Regulations for the production and trade of plastic materials intended for use in the contact with food and food products.

Final disposition first. Prohibition of manufacture and import.

1. From 1 July 2008, the manufacture and import of lids containing a shutter which does not comply with the restrictions and specifications for substances with references n. 30340, 30401, 56800, 76815, 76866 shall be prohibited. 88640 and 93760 as provided for in Section A of Annex III.

2. From 1 July 2008, the manufacture and import of plastic materials and articles intended to come into contact with foodstuffs which do not comply with the restrictions and specifications relating to phthalates shall be prohibited. reference 74560, 74640, 74880, 75100 and 75105) provided for in Section A of Annex III.

3. By way of derogation from paragraphs 1 and 2, the manufacture and import of plastic materials and articles intended to come into contact with food not complying with the provisions of paragraphs 1 and 2 shall be prohibited from 1 May 2009. royal decree.

Final disposition second. Competence title.

This royal decree is issued in accordance with the provisions of Article 149.1.16 of the Constitution, which attributes to the State the competence in the field of bases and general coordination of health, and in accordance with the provisions of the Article 40 (2) and (4) of Law 14/1986 of 25 April, General of Health.

Final disposition third. Powers of development.

The Ministers for Health and Consumer Affairs and the Environment, and the Rural and Marine Environment are hereby authorised to make, in the field of their powers, the necessary provisions for updating and amending the Annexes to this Directive. a decree on the progress of scientific and technical foundations and to adapt them to the provisions and amendments introduced by the European Union legislation.

Final disposition fourth. Incorporation of European Union law.

This royal decree incorporates into Spanish law Commission Directive 2007 /19/EC of 2 April 2007 and updates the transposition of Directives 2002/72/EC on plastic materials and articles intended to come into contact with foodstuffs, and Council Directive 85 /572/EEC of 19 December laying down the list of simulants to be used to monitor the migration of components of materials and articles of plastic material intended to come into contact with foodstuffs, modified by that.

Final disposition fifth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 23 May 2008.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ

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 IX 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 IX, to milligrams of substance or substances released per kilogram of food product.

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:

M =

m • a2	• 1000
arq

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.

to₁ = will be the surface expressed in dm² of the sample in contact with the food or simulants in the migration test.

to₂ = will be the surface 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. Correction of specific migration in foods containing more than 20% fat by the fat reduction coefficient (FRF):

The "fat reduction coefficient" (FRF) is a coefficient between 1 and 5 for which the measured migration of lipophilic substances into a fatty food or a simulant D and its substitutes must be divided before a comparison with specific migration limits.

General rules

The substances considered "lipophilic" for the application of FRF are listed in Annex VI. The specific migration of lipophilic substances in mg/kg (M) will be corrected by the FRF variable between 1 and 5 (M_FRF). The following equations will be applied before the comparison is made with the legal limit:

M_FRF = M/FRF

FRF = (g fat in food/kg of food) /200 = (fat% × 5 )/100

This correction with the FRF will not apply in the following cases:

(a) when the material or the object is in contact with food containing less than 20% fat, or is intended to be fat;

(b) where the material or the object is in contact with food intended for infants and young children as defined in Royal Decree 72/1998 of 23 January 1998 and Royal Decree 490/1998 of 27 March 1998. 1998, or intended to be;

(c) in the case of substances in the lists in Annexes II and III for which a restriction is given in column 4 LME = ND, or substances not included in the lists used behind a functional plastic barrier with a migration limit of 0,01 mg/kg;

(d) in the case of materials and articles for which it is not possible to estimate the relationship between their surface and the quantity of food in contact with them, due, for example, to their shape or use, and where the migration is calculated using the conventional surface/volume conversion factor of 6 dm²/kg.

This correction by the FRF shall be applicable if a number of conditions are met in the following case: For packaging or other articles which may be refilled and which have a capacity of less than 500 millilitres or more than 10 litres, and film and film which is in contact with food containing more than 20% fat, the migration shall be calculated as a concentration in the food or food simulant (mg/kg) corrected by the FRF, or recalculate as mg/dm² without applying the FRF. If one of the two values is lower than the LME, the material or the object shall be deemed to meet the requirements.

The application of the FRF will not lead to a specific migration that exceeds the overall migration limit.

4. Correction of specific migration in food simulant D:

The specific migration of lipophilic substances to simulant D and its substitutes will be corrected by the following factors:

(a) the reduction coefficient referred to in point 3 of Annex VIII, hereinafter referred to as the 'Simulator D Reduction Factor-DRF' coefficient of reduction.

The DRF may not be applicable when the specific migration to the D simulant is greater than 80% of the substance of the substance in the finished material or object (e.g. fine films). Scientific or experimental tests (e.g., testing with the most critical foods) are required to determine whether the DRF is applicable. It is also not applicable to substances in the Community lists for which a restriction is given in column 4 LME = ND or to substances not included in the lists used behind a functional plastic barrier with a migration limit of 0,01 mg/kg;

(b) the FRF is applicable to the migration to simulants, provided that the fat content of the food to be packaged is known and the requirements referred to in point 3 are met;

c) the total reduction coefficient (Total Reduction Factor-TRF) is the coefficient, with a maximum value of 5, by which a specific migration measured to the simulant D or a substitute will be divided before the comparison with the limit legal. This coefficient is obtained by multiplying the DRF by the FRF when both coefficients are applicable.

5. 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 migration limits through more severe testing.

6. 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 IX. 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.

7. 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 IX 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.

8. Caps, caps, shutters, stoppers and similar closure devices:

(a) If the intended use is known, these objects shall be tested by applying them to the packaging to which they are intended under conditions of closure corresponding to normal or foreseeable use. It is assumed that these objects are in contact with a certain amount of food contained in the container. The results shall be expressed in mg/kg, or in mg/dm², in accordance with the rules of Articles 4 and 5, taking into account the entire contact surface of the closure device and the packaging.

(b) If the intended use of these objects is unknown, they shall be tested in a separate test and the result shall be expressed in mg/object. Where appropriate, the value obtained shall be added to the quantity migrated from the packaging to which they are intended.

II. Special provisions related to global migration

1. If the aqueous simulants specified in Annex VIII 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 corrected start and end weights 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. 7, 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 greater than specified and global migration will be determined in each case (M₂ and M₃, respectively).

The material or object will be considered to be as long as M₁ or M₃-M₂ does not exceed the global 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 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 VIII.

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 inappropriate from a 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 generic migration limit of 60 mg/kg or 10 mg/dm² is applied as the case. 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

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 following substances are not included but are intended to be used intentionally and are authorised:

(a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols; however, names containing the word appear in the list 'acid (s) [...], salt (s)' in case the free acid (s) is not mentioned (n)

(b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. A group SML is applied to these salts = 25 mg/kg (expressed as Zn). The restriction applicable to the Zn applies also to:

i) substances whose name contains "acid (s) [...], salt (s)" appearing on the lists, if the free acid (s) is not mentioned (n),

(ii) the substances mentioned in note 38 of Annex III.

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:

i) impurities of the substances used.

ii) Intermediate reaction products.

iii) 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 Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004, on materials and articles intended to come into contact with food and on which Directives 80 /590/EEC and 89 /109/EEC are repealed.

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

5. The list contains the following data:

(a) Column 1 (Ref. number): the EEC reference number of the substance of the packaging material, in the list.

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

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

d) 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 per unit of surface in contact with the food products (CMA), for example: mg (of substance) by 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 listed as an isolated compound is also included in a generic name, the restrictions applicable to this substance shall be those for the isolated compound.

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

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 that will detect it with the indicated limit of detection (LD). If there is no such method at the time of the analysis, an analytical method with due characteristics may be used for the detection limit, pending the development of a validated method.

CM = Maximum amount allowed of "residual" substance in the material or object. For the purposes of this royal decree, the quantity of substance in the material or object shall be determined by a validated method of analysis. In the absence of such a method, an analytical method possessing the appropriate sensitivity to reliably determine the specified limit could be used while a validated method is developed.

CM (T) = maximum allowed amount of "residual" substance in the material or object, expressed as a total of the indicated groups or substances; for the purposes of this royal decree, the quantity of the substance in the material or object is determine by a validated analytical method; 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 method validated.

CMA = Maximum allowed quantity of the substance in the finished material or object, expressed in mg per 6 dm² of the surface in contact with the food products; for the purposes of this royal decree, the quantity of the substance on the surface of the material or object shall be determined by a validated analytical method; if such a method does not exist for the time being, an analytical method may be used which possesses the sensitivity necessary to determine the limit fiably. specified, waiting for a validated method to be developed.

CMA (T) = Maximum allowed amount of "residual" substance in the material or object, expressed as a total of the groups or substances indicated by 6 dm² of the surface in contact with the food products; for purposes of this royal decree, the quantity of the substance in the material or object shall be determined by a validated analytical method; if such method does not exist for the time being, an analytical method may be used which possesses the necessary sensitivity to reliably determine the specified limit, waiting for a validated method to be developed.

LME = Specific migration limit in food or food simulants, unless otherwise stated; for the purposes of this royal decree, the specific migration of the substance shall be determined by an analytical method. validated; if such 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.

SML (T) = Specific migration limit in food or in food simulants, expressed as a total of the indicated groups or substances; for the purposes of this royal decree, the specific migration of the substances shall be determined by a validated analytical method; 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.

SECTION A

Authorized list of monomers and other starting substances

10120

12310

13600

6 mg/kg ⁽²³⁾ (expressed as boron) without prejudice to the provisions of Royal Decree 140/2003 of 7 February, establishing the health criteria for human consumption water

14710

14740

14770

15 mg/kg ⁽²²⁾ (ex-pre-sated as formaldehyde)

21130

21640

000109-67-1

008052-10-6

24270

24280

24490

24520

24540

25120

26050

N. Ref. (1)	CAS (2)	Name (3)	Restrictions and/or Specifications (4)
10030	000514-10-3	Abiotic acid
10060	000075-07-0	Acetaldehyde	LME (T) = 6 mg/kg (2)
10090	000064-19-7	acetic acid
000108-05-4	vinyl acetate	LME = 12 mg/kg
10150	000108-24-7	acetic Anhydride
10210	000074-86-2	Acethylene
10599 /90A	061788-89-4	unsaturated fatty acids (C18)	CMA (T) = 0.05 mg/6 dm2 (27)
10599/91	061788-89-4	Undistilled Dimers of the fatty acids unsaturated (C18)	CMA (T) = 0.05 mg/6 dm2 (27)
10599 /92A	068783-41-5	Hydrogenated distillates of unsaturated fatty acids (C18)	CMA (T) = 0.05 mg/6 dm2 (27)
10599/93	068783-41-5	Undistilled hydrogenated Dimers of unsaturated fatty acids (C18)	CMA (T) = 0.05 mg/6 dm2 (27)
10630	000079-06-1	Acrilamide
10660	015214-89-8	2-acrylamide-2-methylpropanosulfo-only	LME = 0.05 mg/kg
10690	000079-10-7	acrylic acid	LME (T) = 6 mg/kg (36)
10750	002495-35-4	Benzyl acrylate	LME (T) = 6 mg/kg (36)
10780	000141-32-2	n-butyl acrylate	LME (T) = 6 mg/kg (36)
10810	002998-08-5	sec-butyl	LME (T) = 6 mg/kg (36)
10840	001663-39-4		LME (T) = 6 mg/kg (36)
	11005	012542-30-2	dicyclopentenyl acrylate	CMA = 0.05 mg/6 dm2
11245	002156-97-0	dodecyl	LME = 0.05 mg/kg (1)
11470	000140-88-5	T) = 6 mg/kg (T)	6 mg/kg (36)
11500	000103-11-7	2-ethylhexyl acrylate	SML = 0.05 mg/kg
11510	000818-61-1	hydroxyethyl acrylate	View "ethylengli-col" Monoacrylate "
11530	00999-61-1	2-hydroxypropyl acrylate	CMA = 0.05 mg/6 dm2 for the addition of 2-hydro-xypropyl acrylate and 2-hydro-xiisopropyl acrylate and according to the standard specifications in Annex V
11590	000106-63-8	isobutyl acrylate	LME (T) = 6 mg/kg (36)
11680	000689-12-3	11710
11710	11710	11710	11710		000096-33-3	methyl acrylate	LME (T) = 6 mg/kg (36)
11830	000818-61-1	ethylene glycol monoacrylate	(36)
11890	002499-59-4	acrylate n-octyl	LME (T) = 6 mg/kg (36)
11980	000925-60-0	Propyl acrylate	LME (T) = 6 mg/kg (36)
12100	000107-13-1	Acrilonitrile	LME = ND (LD = 0.020 mg/kg, analytical tolerance included)
12130	000124-04-9	adipic acid
12265	004074-90-2	Divinyl Adiduck	CM = 5 mg/kg in PT. For use only as a comonomer
12280	002035-75-8	adipic anhydride
	Albumin
	12340		Formaldehyde Coagulated Albumin
12375		Saturated, Linear, Primary Aliphatic Monoalcohols (C4-C22)
12670	002855-13-2	1-Amino-3-aminomethyl-3,5,5-trimethylcycle-hexane	LME = 6 mg/kg
12761	000693-57-2	12-aminodecanoic acid	LME= 0.05 mg/kg
12763	000141-43-5	2-Aminoethanol	LME = 0.05 mg/kg. Substance not for use in polymers in contact with food for which the simulant D in Annex VIII is established and only for indirect contact with food, behind the PET
12765	084434-12-8	N- (2-Aminoethyl) -sodium beta-alaninate	LME= 0.05 mg/kg
12786	000919-30-2	3-aminopropyltriethoxysilane	The extractable residual content of 3-aminopropyltriethoxysilane should be less than 3 mg/kg of filler material when Use to increase reactivity of the surface of inorganic filler materials and SML = 0,05 mg/kg when used for surface treatment of materials and objects
12788	002432-99-7	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-Bencenodimethanamine	LME= 0.05 mg/kg
13060	004422-95-1	1,3,5-benzenotricar-boxylic acid chloride	CMA = 0.05 mg/6 dm2 (determined as acid 1,3,5-ben-cenotriboxylic)
13075	000091-76-9	Benzoguanamine	View "2,4-Diamino-6-phenyl-1,3,5-triazine"
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
13317	132459-54-2	N, N ' -Bis [4-(ethoxycarbonyl) phenyl] -1,4,5,8-naphthalenotetracarboxidiimide	LME = 0,05 mg/kg. Purity > 98.1% (w/w). Should only be used as a comonomer (max. 4%) for polyesters (PET, PBT)
13323	000102-40-9	13326
13326	13326	13326	13326 Table_table_izq"> 000111-46-6	Ether bis (2-hydroxyethyl)	View "Diethylene glycol"
13380	000077-99-6	2,2-Bis (hydroxymethyl) -1-butanol	View "1,1,1-Trimethylolpropane"
13390	000105-08-8
13395	004767-03-7	propionic 2.2-bis (hydroxymethyl) Acid	CMA = 0.05 mg/6 dm2
13480	000080-05-7	2,2-bis (4-hydroxyphenyl) propane	(28)
13510	001675-54-3	2,2-Bis (4-hydroxyphenyl) propane bis (2,3-epoxypropyl) ether (= BADGE)	In accordance with Royal Decree 293/2003 of 7 March, concerning the use of certain epoxy derivatives in materials and articles intended to come into contact with food
13530	038103-06-9		LME = 0.05 mg/kg
13550	000110-98-5	Ether Bis (hydroxypropyl)	View "Dipropylengicol"
13560	0005124-30-1	Bis (4-isocyanatocyclohexyl) methane	View " 4,4 ' -Deci-clohexylmethane
047465-97-4	3.3-Bis (3-methyl-4-hydroxyphenyl)-2-indo-linona	LME = 1.8 mg/kg
13607	000080-05-7	View " 2.2-Bis (4-hydroxyphenyl) pro-cloth
	13610		001675-54-3	Ether bis (2,3-epoxypropyl) bisphenol A	View "Ether bis (2,3-epoxypropyl) 2,2-bis (4-hydroxyphenyl) propane"
13614	038103-06-9	Bis (phthalic anhydride) of bisphenol A	See "Bis (phthalic anhydride) of 2,2-bis (4-hydroxyphenyl) propane"
13617	000080-09-1	Bisphenol S	View "4.4 ' -Dihydroxyphenylsulfone"
13620	010043-35-3	LME (T)
13630	000106-99-0	Butadiene	CM = 1 mg/kg in PT or LME = ND (LD = 0.020 mg/kg, analytical tolerance included)
13690	000107-88-0	1.3-Butanediol
	13720	000110-63-4	1.4-Butanediol	LME (T) = 5 mg/kg (24)
13780	002425-79-8	1.4-Butanediol bis (2,3-epoxypropyl) ether	CM = 1 mg/kg in PT (expressed as epoxy group, PM=43)
13810	000505-65-7	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	000598-32-3	3-Buten-2-ol	CMA = ND (LD = 0.02 mg/6 dm2) Only to use as a comonomer for the preparation of polymeric
14020	000098-54-4	LME = 0.05 mg/kg
LME = 0.05 mg/kg			14110	000123-72-8	Butiraldehyde
14140	000107-92-6	butyric acid
14170	000106-31-0	butyric anhydride
14200	000105-60-2	14230
	14230	14230	14230	14230	Table_table_izq"> 002123-24-2	Caprolactama, sodium salt	LME (T) = 15 mg/kg (5) (ex-pre-sated as caprolactam)
14260	000502-44-3	Caprolactone	LME = 0.05 mg/kg (expressed as the sum of caprolactone and 6-hydroxyhexanoic acid)
14320	000124-07-2	Caprylic acid
14350	000630-08-0	Monoxide carbon
14380	000075-44-5	Chloride Carbonyl	CM = 1 mg/kg in PT
14411	008001-79-4
	14500	009004-34-6	Cellulose
14530	007782-50-5	Cloro
14570	000106-89-8	1-Chloro-2,3-epoxypropane	View " Epiclorhydrin
14650	000079-38-9	Clorotrifluoroethylene	CMA = 0.5 mg/6 dm2
14680	000077-92-9	citric acid
000108-39-4	m-Cresol
000095-48-7	o-Cresol
000106-44-5	p-Cresol
14800	003724-65-0	Crotonic Acid	CMA (T) = 0.05 mg/6 dm2 (33)
14841	000599-64-4	4-Cumilphenol	LME = 0.05 mg/kg
14880	000105-08-8	1,4-Ciclohexanedimethanol	See "1,4-Bis (hydroxymethyl) cyclohexane"
14950	003173-53-3	Cyclohexyl isocyanate	CM (T) = 1 mg/kg in PT (expressed as NCO) (26)
15030	000931-88-4	Ciclooctene	LME = 0.05 mg/kg. For use only in food contact polymers for which simulant A is set in Annex VIII
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-Diaminobutan
15267	000080-08-0	4.4-Diaminodiphenylsulfone	LME = 5 mg/kg
15272	000107-15 -3	1,2-Diaminoethane	View " Ethylenediamine
15274	000124-09-4	1.6-Diaminohexane	See "Hexamethylenediamine"
15310	000091-76-9	2,4-Diamino-6-phenyl-1,3,5-triazine	CMA = 5 mg/6 dm2
15565	000106-46-7	1,4-Diclorobenzene	LME = 12 mg/kg
15610	000080--07-9	4.4 ' -Dichlorodiphenylsulfone	LME = 0.05 mg/kg
15700	005124-30-1	4.4 ' -Deciclohexylmethane Diisocyanate	CM (T) = 1 mg/kg (expressed as NCO) (26)
15760	000111-46-6	Diethylene glycol	LME (T) = 30 mg/kg (3)
15790	000111-40-0	Diethylentriamine	LME = 5 mg/kg
15820	000345-92-6	4.4 ' -Difluorobenzophenone	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	000611-99-4	4.4 ' -Dihydroxybenzophenone	LME (T) = 6 mg/kg (15)
16000	000092-88-6	4.4 ' -Dihydroxydiphenyl	LME = 6 mg/kg
16090	000080-09-1	4.4 ' -Dihydroxyphenylsulfone	LME = 0.05 mg/kg
16150	000108-01-0	Dimethylaminoethanol	LME = 18 mg/kg
16210	006864-37-5	3,3 '-dimethyl-4,4' -diaminodicyclohexilme-tano	LME = 0.05 mg/kg (32). To use only polyamides
16240	000091-97-4	4.4 ' -Diisocyanate 3.3 '-dimethylbiphenyl	CM (T) = 1 mg/kg (expressed as NCO) (26)
16360	000576-26-1	2.6-Dimittilphenol	LME = 0.05 mg/kg
16390	000126-30-7	2.2 ' -Dimethyl-1,3-Propanodiol	SML = 0.05 mg/kg
16450	000646-06-0	1.3-Dioxolane	LME = 5 mg/kg
16480	000126-58-9	Dipentaeritritol
16540	000102-09-0	Diffenyl carbonate	LME = 0.05 mg/kg
16570	004128-73-8	4,4 ' -Diphenyl ether Diisocyanate	CM (T) = 1 mg/kg (expressed as NCO) (26)
	16600	005873-54-1	2.4 ' -Diphenylmethane Diisocyanate	CM (T) = 1 mg/kg (expressed as NCO) (26)
16630	000101-68-8	4.4 ' -Diphenylmethane Diisocyanate	CM (T) = 1 mg/kg (expressed as NCO) (26)
16650	000127-63-9	Diphenylsulfone	LME (T) = 3 mg/kg (25)
16660	000110-98-5	Dipropylene glycol
16690	001321-74-0	Divinylbenzene	CMA = 0.01 mg/6 dm2 or LME = ND (LD = 0.02 mg/kg, analytical tolerance included) for the sum of divinylben-cene and ethylvinylbenzene and according to the specifications set out in Annex V
16694	013811-50-2	N, N ' -Divinyl-2-imidazolidinone	CM = 5 mg/kg in PT
16697	000693-23-2	n-dodecanedioic acid
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
16955	000096-49-1	ethylene carbonate	Residual content = 5 mg/kg hydrogel at a maximum ratio of 10 g of hydrogel per 1 kg of hydrogel Feed product. The hydrolysate contains ethylene glycol with an LME = 30 mg/kg
16960	000107-15 -3	LME = 12 mg/kg
16990	000107-21-1	Ethylene Glycol	LME (T) = 30 mg/kg (3)
17005	000151-56-4	Ethylene	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
17110	016219-75-3	5-etilidenicycle [2.2.1] hept-2-ene	CMA = 0.05 mg/6 dm2. The quotient surface/quantity of food shall be infe-rior at 2 dm2/kg
17160	000097-53-0	Eugenol	LME = ND (LD = 0.02 mg/kg, analytic tolerance included)
17170	061788-47-4	Coconut Oil fatty acids
	17200	068308-53-2	Soy Oil Fatty Acids
17230	061790-12-3	Oil fatty acids
17260	000050-00-0	formaldehyde	LME (T) = 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-heptillaminoundecanoic acid	LME = 0.05 mg/kg (1)
18250	000115 -28-6	hexachloroendomethylentetrahydrof-talic acid	LME = ND (LD = 0.01 mg/kg)
18280	000115 -27-5	Anhidde hexachloroendomethylentetil-drophthalic	LME = ND (LD = 0.01 mg/kg)
18310	036653-82-4	1-Hexadecanol
18430	000116-15 -4	Hexafluoropropylene	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 (expressed as NCO) (26)
18670	000100-97-0	(T)
	18700	000629-11-8	1,6-hexanediol	LME = 0.05 mg/kg
18820	000592-41-6	1-Hexene	LME = 3 mg/kg
18867	000123-31-9	View " 1,4-Dihydroxybenzene
	18880	000099-96-7	p-hydroxybenzoic acid
18896	001679-51-2	4-(hydroxymethyl) -1-cyclohexene	LME = 0.05 mg/kg
18897	016712-64-4	6-hydroxy-2-naphthalenocarboxylic acid	LME = 0.05 mg/kg
18898	000103-90-2	N-(4-hydroxyphenyl) acetamide	LME = 0.05 mg/kg
19000	000115 -11-7	Isobuteno
19060	000109-53-5	Eter isobutylvinyl	CM = 5 mg/kg in PT
19110	004098-71-9	1-isocyanate-3-isocyanatomethyl-3,5,5-tri-methylcyclohexane	CM (T) = 1 mg/kg (expressed as NCO) (26)
19150	000121-91-5	Acid isophthalic	LME = 5 mg/kg
19210	001459-93-4	19243
19243	000078-79-5	Isorene	View "2-Methyl-1,3-butadiene"
19270	000097-65-4	Iaconic acid
19460	000050-21-5	lactic acid
19470	000143-07-7
19480	002146-71-6
	19490	000947-04-6	Laurolactama	LME = 5 mg/kg
19510	011132-73-3	Lignothulose
19540	000110-16-7	Maleic acid	LME (T) = 30 mg/kg (4)
19960	000108-31-6	Maleic Anhydride	LME (T) = 30 mg/kg (4) (expressed as maleic acid)
19975	000108-78-1	Melamine	View "2,4,6-Triamino-1,3,5-triazine"
19990	000079-39-0	Metallylamide	LME = ND (LD = 0.02 mg/kg, analytics tolerance included)
20020	000079-41-4	methacrylic acid	LME (T) = 6 mg/kg (37)
20050	000096-05-9	allyl methacrylate	LME = 0.05 mg/kg
20080	002495-37-6	Benzyl methacrylate	LME (T) = 6 mg/kg (37)
20110	000097-88-1	butyl methacrylate	LME (T) = 6 mg/kg (37)
20140	002998-18-7	Sec-butyl methacrylate	LME (T) = 6 mg/kg (37)
20170	000585-07-9	Methacrylate tert-butyl	LME (T) = 6 mg/kg (37)
20260	000101-43-9		LME = 0.05 mg/kg
20410	002082-81-7	1,4-butanediol Dimethacrylate	20440
	000097-90-5
Dimethacrylate ethylene glycol	LME = 0.05 mg/kg
20530	002867-47-2		LME = ND (LD = 0.02 mg/kg, tolerance included analytics
20590	000106-91-2	2,3-epoxypropyl methacrylate	CMA = 0.02 mg/6 dm2
20890	000097-63-2	Methacrylate ethyl	LME (T) = 6 mg/kg (37)
21010	000097-86-9	isobutyl methacrylate	LME (T) = 6 mg/kg (37)
21100	004655-34-9	isopropyl methacrylate	(37)
000080-62-6	methyl methacrylate	LME (T) = 6 mg/kg (37)
21190	000868-77-9	ethylene glycol Mononometacrylate	LME (T) = 6 mg/kg (37)
21280	002177-70-0	phenyl Methacrylate	LME (T) = 6 mg/kg (37)
21340	002210-28-8	Propyl methacrylate	LME (T) = 6 mg/kg (37)
21370	010595-80-9	2-sulfoethyl methacrylate
21400	054276-35-6	sulfopropyl methacrylate	CMA = 0.05 mg/6 dm2
21460	000760-93-0	methacrylic anhydride	LME (T) = 6 mg/kg (37)
21490	000126-98-7	Metacrylonitrile	LME = ND (LD = 0.020 mg/kg, analytical tolerance included)
21520	001561-92-8	Sodium Metallulfonate	SML = 5 mg/kg
21550	000067-56-1	methanol
000078-79-5	2-Metil-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-Metil-1-buteno	CMA = 0.006 mg/6 dm2. For polypropylene only
21765	106246-33-7	4.4 ' -Metilenbis (3-chloro-2,6-diethylaniline)	CMA = 0.05 mg/6 dm2
21821	000505-65-7	1.4-(Methylenedioxy) butane	View "1,4-Butanediolformal"
21940	000924-42-5	N-Methylolacrylamide	LME = ND (LD = 0.01 mg/kg)
21970	000923-02-4	LME = 0.05 mg/kg
22150	000691-37-2	4-methyl-1-pentene	LME = 0.05 mg/kg
22210	000098-83-9	Alfa-methylstyrene	LME = 0.05 mg/kg
22331	025513-64-8	Mix of (35-45% w/w) 1,6-diamino-2,2,4-Trimethylhexane and (55-65% w/w) 1,6-diamino-2,4,4-Trimethylhexane	CMA = 5 mg/6 dm2
22332		Mixing (40% w/w) 1,6-diisocyanate 2,2,4-trimethylhexane and (60% w/w) 1,6-dii socianate of 2,4,4-trimethylhexane	CM (T) = 1 mg/kg (expressed as NCO) (26)
22350	000544-63-8
22360	001141-38-4	LME = 5 mg/kg
LME = 5 mg/kg
22390	000840-65-3	2,6-Naftalenodicarboxylate dimethyl	LME = 0.05 mg/kg
22420	003173-72-6	1.5-naphthalene diisocyanate	CM (T) = 1 mg/kg (expressed as NCO) (26)
22437	000126-30-7	Neopentylglycol	View "2.2-dimethyl-1,3-propane-diol"
22450	009004-70-0	Nitrocellulose
22480	000143-08-8	1-Nonanol
22550	000498-66-8	Norbornene	View "Bicyclo [2.2.1] hept-2-ene"
22570	000112-96-9	isocyanate octadeco	CM (T) = 1 mg/kg (expressed as NCO) (26)
22600	000111-87-5	1-Octanol
22660	000111-66-0	1-Octeno	LME = 15 mg/kg
22763	000112-80-1	oleic acid
22775	000144-62-7	Oxalic acid	LME (T) = 6 mg/kg (29)
22778	007456-68-0	4.4 '-oxybis (benzenesulfonilazide)	CMA = 0.05 mg/6 dm2
22780	000057-10-3	Palmitic acid
22840	000115 -77-5
22870	000071-41-0			22900
1-Pentene	LME = 5 mg/kg
22932	001187-93-5	Eter perfluoromethyl perfluorovinyl	LME = 0.05 mg/kg. Should only be used for non-stick
22937	001623-05-8	Eter perfluoropropylperfluorovinyl	LME = 0.05 mg/kg
22960	000108-95-2
23050	000108-45-2	1,3-Fenylenediamine	LME = ND (LD = 0.02 mg/kg, tolerance included analytics
23070	000102-39-6	Acid (1,3-phenylenedioxy) diacetic	CMA = 0.05 mg/6 dm2
23155	000075-44-5	Fosgeno	View " 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	View " terephthalic acid
23200	000088-99-3	Phthalic or-phthalic
	23230	000131-17-9	diallyl Ftalate	LME = ND (LD = 0.01 mg/kg)
23380	000085-44-9	Anhydride Phthalic
	23470	000080-56-8	alpha-Pineno
23500	000127-91-3	beta-Pineno
23547	009016-00-6 063148-62-9	Polidimethylsiloxane (PM > 6 800)	According to the specifications in Annex V
23590	025322-68-3	Polyethylene glycol
23651	025322-69-4
	23740
000057-55-6	1,2-Propanediol
23770	000504-63-2	1,3-Propanediol	LME = 0.05 mg/kg
23800	000071-23-8	1-Propanol
23830	000067-63-0	2-Propanol
23860	000123-38-6
23890	000079-09-4
23920	000105-38-4		23920		23920 Vinyl table_table_izq"> vinyl propionate	LME (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	View "1,2-Dihydroxybenzene"
24057	000089-32-7	= 0,05 mg/kg (expressed as pyrolelitic acid)
24070	073138-82-6	Resync and colophony acids
24072	000108-46-3	View " 1,3-Dihydroxybenzene
	24073	000101-90-6	resorcinol Eter diglycidyl	CMA = 0.005 mg/6 dm2. Substance not for use in polymers in contact with food for which the simulant D in Annex VIII is established and only for indirect contact with food, behind the PET
24100	008050-09-7	Colofonia
24130	008050-09-7	24160
24160	008052-10-6
Tall oil colophony
24190	008050-09-7	Wood Colophony	See "Colofonia" (No. of ref. 24100)
24250	009006-04-6	Natural Rubber
000069-72-7	Salicylic acid
000111-20-6	sebacic acid
24430	002561-88-8	Sebacic Anhydride
24475	001313-82-2	Sodium Sulfide
000050-70-4	Sorbitol
008001-22-7	Soy Oil
009005-25-8	Starch, Food Quality
24550	000057-11-4	stearic acid
24610	000100-42-5	styrene
24760	026914-43-2	Styrenesulfonic acid	LME = 0.05 mg/kg
24820	000110-15 -6	Acid succinic
24850	000108-30-5	Succinic Anhydride
24880	000057-50-1	sucrose
24886	046728-75-0	Acid 5-Sulfoisophthalic acid, monolithic salt	LME = 5 mg/kg and for lithium LME (T) = 0.6 mg/kg (8)(expressed as lithium)
24887	006362-79-4	5-Sulfoisophthalic acid, monosodium salt	LME = 5 mg/kg
24888	003965-55-7	5-Dimethyl Sulfoisophthalate, mono-sodium salt	LME = 0.05 mg/kg
24903	068425-17-2	Jarabes, hydrolyzed starch, hydrogenated	According to the specifications set out in Annex V
24910	000100-21-0	terephthalic acid	LME = 7.5 mg/kg
24940	000100-20-9	terephthalic acid dichloride	LME (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
000116-14-3	Tetrafluorethylene	LME = 0.05 mg/kg
25150	000109-99-9	Tetrahydrofuran	LME = 0.6 mg/kg
25180	000102-60-3	N, N, N ', N', -Tetrakis (2-hydroxypropyl) ethylenediamine
25210	000584-84-9	2.4-Toluene Diisocyanate	CM (T) = 1 mg/kg (expressed as NCO) (26)
25240	000091-08-7	2.6-Toluene Diisocyanate	CM (T) = 1 mg/kg (expressed as NCO) (26)
25270	026747-90-0	2.4-Toluene diisocyanate, dimerized	CM (T) = 1 mg/kg (expressed as NCO) (26)
25360		Trialkyl (C5-C15) 2,3-epo-xipropyl acetate	CM = 1 mg/kg in PT (expressed as epoxy group, molecular weight = 43)
25380		Trialkyl (C7-C17) vinyl acetate (=vinyl versatate)	CMA = 0.05 mg/6 dm2
25385	000102-70-5	Trialline	According to the specifications in Annex V
25420	000108-78-1	2,4,6-Triamino-1,3,5-triazine	LME = 30 mg/kg
25450	026896-48-0	Tricyclodecanedimethanol	LME = 0.05 mg/kg
25510	000112-27-6	Triethylene glycol
25540	000528-44-9	Trimelitic acid	LME (T) = 5 mg/kg (35)
25550	000552-30-7	Trimelitic Anhydride	LME (T) = 5 mg/kg (35) (expressed as trimelitic acid)
25600	000077-99-6	1,1,1-Trimethylolpropane	LME = 6 mg/kg
25840	003290-92-4	1,1,1-trimethylolpropane trimethacrylate	LME = 0.05 mg/kg
25900	000110-88-3	Trioxane	LME = 5 mg/kg
25910	024800-44-0
	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
000075-01-4	vinyl chloride	CM = 1 mg/Kg in PT. LME=0.01 mg/Kg.
26110	000075-35-4	vinylidene chloride	CM = 5 mg/kg in PT or LME = ND (LD = 0.05 mg/kg)
26140	000075-38-7	LME = 5 mg/kg
26155	001072-63-5	1-Vinilimidazole	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	According to Royal Decree 140/2003, of 7 February, establishing the health criteria for the quality of water for human

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

⁽²⁾ LME (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 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 ref's. 15760, 16990, 47680, 53650, and 89440, must not exceed the indicated constraint.

⁽⁴⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 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 ref's. 14200, 14230, and 41840, must not exceed the indicated constraint.

⁽⁸⁾ SML (T) means in this case that the sum of the migration of the following substances, noted with reference nos 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, should not exceed the indicated constraint.

⁽¹⁵⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 15970, 48640, 48720, 48880, 61280, 61360, and 61600, must not exceed the indicated constraint.

⁽²²⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 17260, 18670, 54880, and 59280, must not exceed the indicated constraint.

⁽²³⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 13620, 36840, 40320, and 87040, must not exceed the indicated constraint.

⁽²⁴⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 13720 and 40580, must not exceed the indicated constraint.

⁽²⁵⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 16650 and 51570, must not exceed the indicated constraint.

⁽²⁶⁾ CM (T) means in this case that the sum of the residual amounts of the following substances, marked with the ref's. 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240, and 25270, must not exceed the indicated restriction.

⁽²⁷⁾ CMA (T) means in this case that the sum of the residual amounts of the following substances, marked with the ref's. 10599 /90A, 10599/91, 10599 /92A and 10599/93, must not exceed the indicated restriction.

⁽²⁸⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 13480 and 39680, must not exceed the indicated constraint.

⁽²⁹⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 22775 and 69920, must not exceed the indicated constraint.

⁽³²⁾ When there is a fatty contact, compliance will be evaluated using isoctane as a replacement for the (unstable) D simulant.

⁽³³⁾ CMA (T) means in this case that the sum of the residual amounts of the following substances, marked with the ref's. 14800 and 45600, must not exceed the indicated constraint.

⁽³⁵⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 25540 and 25550, must not exceed the indicated constraint.

⁽³⁶⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 10690, 10750, 10780, 10810.10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980, and 31500, must not exceed the indicated restriction.

⁽³⁷⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 20020, 20080, 20110, 20140, 20170, 20890, 21010, 21100, 21130, 21190, 21280, 21340 and 21460, must not exceed the indicated restriction.

SECTION B

List of monomers or other starting substances that may continue to be used until their inclusion in section A is decided upon

N. Ref. (1)	CAS (2)	Name (3)	Restrictions and/or specifications (4)
13050	000528-44-9	1,2,4-benzenecarboxylic acid	View "Trimelitic Acid"
15730	000077-73-6	Diciclopentadiene
18370	000592-45-0	1.4-Hexadiene
26230	000088-12-0	Vinylpyrrolidone

ANNEX III

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 which are incorporated into plastics to produce a technical effect on the finished product, including "polymeric additives"; they are designed to be present in the finished objects;

(b) substances used to provide a suitable medium for polymerization.

For the purposes of this Annex, the substances referred to in (a) and (b) shall be hereinafter referred to as 'additives'.

For the purposes of this Annex, "polymeric additive" means any polymer, prepolymer or oligomer which may be added to the plastic in order to achieve a technical effect but which cannot be used in the absence of other polymers as the main structural component of finished materials and objects. It also includes substances that can be added to the medium in which the polymerization develops.

The list does not include:

(a) substances that directly influence the formation of polymers;

b) colorants;

c) solvents.

2. The following substances are not included but are intended to be used intentionally and are authorised:

(a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols; however, names containing the word appear in the list 'acid (s) [...], salt (s)' in case the free acid (s) is not mentioned (n)

(b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. A group SML is applied to these salts = 25 mg/kg (expressed as Zn). The restriction applicable to the Zn applies also to:

i) substances whose name contains "acid (s) [...], salt (s)" appearing on the lists, if the free acid (s) is not mentioned (n),

(ii) the substances mentioned in note 38

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

(a) Substances that 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) shall comply with the requirements laid down in Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004, on materials and articles intended to come into contact with food and on which Directives 80 /590/EEC and 89 /109/EEC are repealed.

4. The substances should be of good technical quality in terms of purity criteria.

5. The list contains the following information:

(a) Column 1 (Ref. number): the EEC reference number of the packaging materials of the substance mentioned in the list.

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

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

d) Column 4 (restrictions and/or specifications):

These can include:

i) The specific migration limit (LME).

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

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

iv) Any other specifically mentioned restrictions.

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

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

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

SECTION A

List of fully harmonised additives at Community level

36960

37360

42320

43440

52720

52800

53360

56800

58720

60030

61840

63280

66200

002682-20-4

68078

69760

69920

70240

70400

77702

77895

79280

80640

82960

84400

85360

85601

85840

95020

N. Ref (1)	CAS (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	LME (T) = 5 mg/kg (7) (expressed as copper)
30140	000141-78-6	Etil acetate
30280	000108-24-7	acetic anhydride
30295	000067-64-1	Acetone
30340	330198-91-9	12-(Acetoxi) 2,3-bis stearate (acetoxy) propyl
30370	-	Acid acetylacetic, salts
-		Monoglycerides and diglycerides of fatty acids, acetylates
30610	-	Alike, C2-C24, aliphatic, linear, monocarboxylic, obtained from natural fats and oils, and their esters with mono-, di and triglycerol (including acids Branched fatty to the naturally occurring levels)
30612	-	Alike, C2-C24, aliphatic, linear, monocarboxylic, synthetic, and their esters with mono-, di-, and triglycerol
30960	-	Alif acid esters. monocarb. (C6-C22) with polyglycerol
31328	-	Fatty acids obtained from animal or vegetable fats and oils
31530	123968-25-2	acrylate 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxy-phenyl) ethyl) phenyl	LME = 5 mg/kg
31542	174254-23-0	methyl acrylate, telomere with 1-dode-ca-notiol, alkyl esters C16-C18	CM = 0.5% (w/w) on PT
31730	000124-04-9	adipic acid
33120		Alif Monoalcohols. sat. linear, premium rivers (C4-C24)
33350	009005-32-7	Alginic acid
33801	-	10-C13) benzenespho-nic	SML = 30 mg/kg
34281	-	Alked Aides (C8-C22) Primary linear sulphuric, with a pair of carbon atoms
34475		Aluminium and Calcium Hydroxyphospite, hydrate
	34480	-	Aluminium (fibers, flakes, powders)
34560	021645-51-2	Aluminum hydroxide
34690	011097-59-9	Aluminium and Magnesium Hydroxicarbonate
34720	001344-28-1	Aluminum Oxide
34850	143925-92-2	Mines, bis (alkyl of hydrogenated sebum) oxidized	CM = Only for use in: (a) 0,1% (w/w) polyolefins, except in low-density polyethylene when in contact with food for which Annex VIII establishes a "simulant reduction factor D" below 3; b) 0,25% (w/w) PET in contact with different foods for which Annex VIII sets the simulant D
34895	000088-68-6	2-aminobenzamide	LME = 0.05 mg/kg. For use in PET for water and beverages
35120	013560-49-1	Acid Diester 3-aminocrotononic ether tiobis (2-hydroxyethyl)
35160	006642-31-5	6-amino-1,3-dimethyluracil	LME = 5 mg/kg
35170	000141-43-5	2-aminoethanol	LME = 0,05 mg/kg. Substance not for use in polymers in contact with food for which the simulant D in Annex VIII is established and only for indirect contact with food, behind the PET
35284	000111-41-1	N-(2-aminoethyl) ethanolamine	LME = 0.05 mg/kg. Substance not for use in polymers in contact with food for which the simulant D in Annex VIII is established and only for indirect contact with food, behind the PET
35320	007664-41-7	Ammonia
35440	001214-97-9
	35600	001336-21-6
	35840	000506-30-9	Arachidic acid
35845	007771-44-0	Arachidonic acid
36000	000050-81-7	ascorbic acid
36080	000137-66-6
36160	010605-09-1	ascorbilo stearate
36840	012007-55-5	Barium tetraborate	LME (T) = 1 mg/kg expressed as barium (12) and LME (T) = 6 mg/kg (23) (expressed as boron), without prejudice to the provisions of Royal Decree 140/2003 of 7 February establishing the health criteria for the quality of drinking water human
36880	008012-89-3	Bee Cera
003061-75-4	Behenamide
37040	000112-85-6	behenic acid
	37280	001302-78-9	Bentonite
000100-52-7	Benzaldehyde	37600
	000065-85-0	Acid benzoic
37680	000136-60-7	butyl Benzoate
37840	000093-89-0	ethyl Benzoate
38080	000093-58-3
	38160	002315 -68-6	propyl Benzoate
38510	136504-96-6	1,2-Bis (3-aminopropyl) ethylenediamine, polymer with N-butyl-2.2,6,6-tetramethyl 4-piperidinamine and 2,4,6-trichloro-1,3,5 triazine	LME = 5 mg/kg
38515	001533-45-5	4.4 ' Bis (2-benzoxazolyl) stilbene	LME = 0.05 mg/kg (1)
38810	080693-00-1	bis Diphosphite (2,6-di-tert-butyl-4-methylphenyl) pentaerythritol	LME = 5 mg/kg (as sum of phosphite and phosphate)
38840	154862-43-8	bis (2,4-dicumilphenyl) pentaerythritol	LME = 5 mg/kg (as the sum of the substance itself, its oxidized form [bis (2,4-dicumylphenyl) pentaeri tritol phosphate] and its hydrolysis product [2,4-dicumilphenol]
38879	135861-56-2	Bis (3,4-dimethylbenzylidene) sorbitol
38885	002725-22-6	2,4-Bis (2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine	LME = 0.05 mg/kg. For aqueous food
38950	079072-96-1	Bis (4-ethylbenzylidene) sorbitol
39200	006200-40-4	Chloride bis (2-hydroxyethyl)-2-hydroxy-propyl-3-(dodecyloxy) methylammonium	LME = 1,8 mg/kg
39680	000080-05-7	2,2-bis (4-hydroxyphenyl) propane	LME (T) = 0.6 mg/kg (28)
39815	182121-12-6	9.9-Bis (metoxymethyl) fluorene	CMA = 0.05 mg/6 dm2
39890	087826-41-3 069158-41-4 054686-97-4 081541-12-0	Bis (methylbenzylidene) sorbitol
39925	129228-21-3	3,3-Bis (methoxymethyl) -2,5-dimethylhexane	LME = 0.05 mg/kg
40120	068951-50-8		LME = 0.6 mg/kg
40320	010043-35-3	Boric acid	LME (T) = 6 mg/kg (23) (expressed as boron) without prejudice to the Royal Decree 140/2003 of 7 February establishing health criteria for the quality of water for human consumption
40400	010043-11-5	Boron Nitride
40570	000106-97-8	Butano
40580	000110-63-4	1,4-Butanediol	LME (T) = 5 mg/kg (24)
41040	005743-36-2	Calcium Butitime
41120	010043-52-4	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	Candelette Cera
41840	000105-60-2	Caprolactama	LME (T) = 15 mg/kg (5)
41960	000124-07-2	Acid caprylic
42080	001333-86-4	Coal Black	According to the specifications set in Annex V
42160	000124-38-9	Carbon dioxide
007492-68-4	Copper carbonate	LME (T) = 5 mg/kg (7) (expressed as copper)
-	carbonic acid, sales
42640	009000-11-7
	42720	008015 -86-9	Carnauba Wax
42800	009000-71-9	Casein
42880	008001-79-4	castor oil
42960	06147-40-6	dehydrated castor oil
43200	-
43280		43280		43280		43280	009004-34-6	Cellulose
43300	009004-36-8	cellulose Acetobutyrate
43360	068442-85-3	Regenerated cellulose
008001-75-0	Ceresina
	43480	064365-11-3	Carbon activated	According to the specifications set out in the Annex
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	LME (T) = 5 mg/kg (7) (expressed as copper)
45200	001335-23-5	Copper iodide	LME (T) = 5 mg/kg (7) (expressed as copper) yLME = 1 mg/kg (11) (expressed as iodine)
45280	~	Cotton Fibers
45450	068610-51-5	Copolymer p-cresol-dicyclopentadie-noisobutylene	LME = 5 mg/kg
45560	014464-46-1	Cristobalite
45600	003724-65-0	Crotonic Acid	CMA (T) = 0.05 mg/6 dm2 (33)
45640	005232-99-5	2-cyano-3,3-diphenylacrylate	LME = 0.05 mg/kg
455705	166412-78-8	1,2-cyclohexanedicarboxylic acid, diisononil ester
45760	000108-91-8	Ciclohexylamine
45920	009000-16-2
	45940	000334-48-5
	46070	010016-20-3		010016-20-3	010016-20-3	010016-20-3	alpha-Dextrin
46080	007585-39-9	beta-Dextrin
46375	061790-53-2	Diatomeas Earth
46380	068855-54-9	Land of Calcined Diatoms with Sodium Carbonate Flux
46480	032647-67-9	Dibenzylidensorbitol
46700		5,7-di-tert-butyl-3-(3,4-and 2,3-dimethyl-phenyl)- 3H-benzofuran-2-one with: a) 5,7-di-tercbutyl-3-(3,4-dimethylphenyl)-3H benzofuran-2-one (80 to 100% w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20% w/w)	LME = 5 mg/kg
46720	004130-42-1	2.6-di-terc-butyl-4-ethylphenol	CMA = 4.8 mg/6 dm2
46790	004221-80-1
46800	067845-93-6	3.5-Di-terc-butyl-4-hydroxybenzoate
46870	003135-18-0
	46880		46880		46880	46880	46880 Table_table_izq"> 065140-91-2	3.5-Di-terc-butyl-4-hydroxybenzylphosphona-to monoethyl, calcium salt	LME = 6 mg/kg
47210	026427-07-6	Dibutyltiostannoic acid, polymer [= Tiobis (butyltin sulfide) polymer]	According to the specifications in Annex V
47440	000461-58-5	Dicianamide
47540	027458-90-8	di-tert-dodecyl disulfide	LME = 0.05 mg/kg
47680	000111-46-6	Diethylene glycol	LME (T) = 30 mg/kg (3)
48460	000075-37-6	1.1-Difluoroethane
	48620	000123-31-9	1,4-Dihydroxybenzene	LME = 0.6 mg/kg
48720	000611-99-4	4.4 ' -Dihydroxybenzophenone	LME (T) = 6 mg/kg (15)
49485	134701-20-5	2,4-Dimethyl-6-(1-methylpentadecyl) phenol	LME = 1 mg/kg
49540	000067-68-5	Dimethyl sulfoxide
51200	000126-58-9	Dipentaeritritol
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	010436-08-5	cis-11-Eicosenamide
000112-84-5	Erucamide
	52730	000112-86-7	erucic acid
000064-17-5	Ethanol
	53270	037205-99-5	Etilcarboxymethylcellulose
53280	009004-57-3	Etilcellulose
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	ethylenediaminetraacetic acid
53610	054453-03-1	Copper Etilenediaminetetraacetate	LME (T) = 5 mg/kg (7) (expressed as copper)
53650	000107-21-1	Ethylene glycol	LME (T) = 30 mg/kg (3)
54005	005136-44-7	ethylene-N-palmitamide-N '-stearamide
54260	009004-58-4	Etilhydroxyethylcellulose
	-	-
	54280	-
54300	118337-09-0	54300	54300	2,2 ' Etylidenbis (4,6-di-tert-butylphenyl) fluorophosphonite	54450
		Food source oils and oils animal or vegetable
54480	-	Grasses and Animal or plant food source hydrogenated oils
54930	025359-91-5	formaldehido-1-naphtol Copolymer [=Poli (1-hydroxinaftilmethane)]	SML = 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	-	Glass Fibers
	55600	-	Glass Microparticles
	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 alif acids. sat.linear with an even number of carbon atoms (C14-C18) and with alif acids. insat. linear with a pair of carbon atoms (C16-C18)
56487	-	Glycerol esters with butyric acid
56490	-	glycerol esters with erucic acid
56495	-	glycerol esters with 12-hi droxestearic acid
56535	-	glycerol esters with nonanoic acid
56500
			56510	56510		-	glycerol esters with linoleic acid
56520	-	glycerol esters with myristic acid
56540	-	You are glycerol with oleic acid
56550	-
		-
	-
56580	-	glycerol esters with ricinoleic acid
56585	-	Glycerol esters with stearic acid
56610	030233-64-8	glycerol Monobehenate
56720	026402-23-3	glycerol Monohexanoate
030899-62-8	glycerol diacetate Monolaurate
56880	026402-26-6	Monooctanoate glycerol
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	-	Glycina, sales
58320	007782-42-5	Graphite
58400	009000-30-0	Guar Goma
58480	009000-01-5	Arabic Goma
000111-14-8	heptanoic acid
	59280	000100-97-0	Hexamethylentetramine	LME (T) = 15 mg/kg (22) (expressed as formal dehido)
59360	000142-62-1	hexanoic acid
59760	019569-21-2	Huntite
59990	007647-01-0
012072-90-1
60080	012304-65-3
60160	000120-47-8	4-ethyl hydroxybenzoate
60180	004191-73-5	4-isopropyl hydroxybenzoate
60200	0099-76-3	4-methyl hydroxybenzoate
60240	000094-13-3	4-propyl hydroxybenzoate
60480	003864-99-1	2-(2 '-Hydroxy-3,5'-di-tert-butyl-phenyl)-5-chlorobenzotriazole	LME (T) = 30 mg/kg (19)
60560	009004-62-0	Hydroxyethylcellulose
60880	009032-42-2
61120	009005-27-0
009005-27-0	61120	Hydroxyethylstarch
61390	037353-59-6	Hydroxymethylcellulose
61680	009004-64-2	Hidroxypropyl cellulose
61800	009049-76-7	hydroxypropyl starch
000106-14-9	12-hydroxystearic acid
62020	007620-77-1	12-hydroxystearic acid, lithium salt	LME (T) = 0.6 mg/kg (8) (expressed as lithium)
62140	006303-21-5	Hypophosphorous acid
62240	001332-37-2	Iron Oxide
62245	012751-22-3	Iron Fosfuro	Only PET polymers and
62450	000078-78-4
	62640	008001-39-6	Cera
62720	001332-58-7	Caolin
	calcined Caolin
62960	000050-21-5
63040	000138-22-7		63040	63040
000143-07-7		63280		63280
Table_table_izq"> 63760	008002-43-5	Lecithin
63840	000123-76-2	Levulinic acid
63920	000557-59-5
64015	000060-33-3
64150	028290-79-1
64500	-	Lisina, sales
64640	001309-42-8	Magnesium hydroxide
64720	001309-48-4	Magnesium Oxide
64800	00110-16-7	64990
(T) = 30 mg/kg (4)	64990	64990	64990	64990	Table_table_izq"> 025736-61-2	styrene copolymer sodium salt and maleic anhydride	According to the specifications set out in Annex V
65020	006915 -15 -7	Malic acid
65040	000141-82-2
		Table_table_izq"> 65520	000087-78-5	Mannitol
65920	066822-60-4	N-metacriloyl chloride copolymers xyethyl-N, N-dimethyl-N-carboxymethylammonium, sodium salt-methacrylate Octadecyl-methyl-methacrylate of cyclohexyl-N-vinyl-2-pyrrolidone
037206-01-2	Methylcarboxymethylcellulose
66240	009004-67-5	Methylcellulose
66560	004066-02-8	2.2 ' Metilenbis (4-methyl-6-cyclohexilfe-nol)	LME (T) = 3 mg/kg (6)
66580	000077-62-3	2.2 ' Methylenbis [4-methyl-6-(1-methylcycle-hexyl) phenol]	LME (T) = 3 mg/kg (6)
66640	009004-59-5	Metiletilcellulose
66695	-	Metilhydroxymethylcellulose
66700	009004-65-3
66755	002682-20-4	66755
2-Methyl-4-isothiazolin-3-one	LME = ND (LD = 0.02 mg/kg, analytical tolerance included)
66905	000872-50-4
	66930	068554-70-1	Methylsilsesquioxane	Residual monomer in methyl-silsesquioxane: < 1 mg methyltrimethoxysilane/kg methylsilsesquioxane
67120	012001-26-2	Mica
67155	-	Mix of 4-(2-benzoxazolyl) -4 '-(5-methyl-2-benzoxazolyl) stilbene, 4,4 'bis (2-ben-zoxa-zolyl) stilbene and 4,4 '-bis (5-methyl-2-benzoxa-zolyl) stilbene	Not more than 0,05% w/w (amount of substance used/amount of formulation). According to the specifications set out in Annex V
67180	-	Phthalate Mixture n-decyl n-octyl (50% w/w), di-n-decyl phthalate (25% w/w) and phthalate di-n-octyl (25% w/w)	LME = 5 mg/kg (1)
67200	001317-33-5	Disulfide Molybdenum
67840	-	Montanics and/or its ethylene glycol and/or 1,3-butanediol and/or glycerol esters
67850	008002-53-7	Montana Cera
67891	000544-63-8	Myristic acid
68040	003333-62-8	7-[2-H-Nafto-(1,2-D) triazol-2-yl]-3-phenylcoumarin
027253-31-2	cobalt Neodecanoate	LME (T) = 0.05 mg/kg (expressed as neo-decanoic acid) and LME (T) = 0.05 mg/kg (14) (expressed as cobalt). It should not be used in food contact polymers for which Annex VIII sets the simulant D
68125	037244-96-5	Nefelina sienita
68145	080410-33-9	2.2 ', 2' '-Nitrile [triethyl tris (3,3 ', 5,5'-tetra-tert-butyl-1,1 '-biphenyl-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
000143-28-2	oleic Alcohol
000144-62-7	oxalic acid	(29)
70000	070331-94-1	2.2 '-Oxamidobis [ethyl-3-(3,5-di-terc-butyl 4-hydroxyphenyl) propionate]
012198-93-5	Ozocerite
000057-10-3	palmitic acid
71020	000373-49-9	Palmitoleic acid
71440	009000-69-5	Pectin
	71600	000115 -77-5	Pentaeritritol
	71635	025151-96-6	pentaerythritol Dioleate	LME = 0.05 mg/kg. Substance not for use in food contact polymers for which simulant D in Annex VIII is
71670	178671-58-4	Tetrakis (2-cyano-3,3-diphenylacrylate) of pentaerythritol	LME = 0.05 mg/kg
71680	006683-19-8	Tetrakis [3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate] of pentaerythritol
71720	000109-66-0	Pentano
71960	003825-26-1	Perfluorooctanoic acid, salt of amo-nio	Only used for repeated use, sintered at high
	72640	007664-38-2	Phosphoric acid
73160		mono-and di-n-alkyl phosphates (C16 and C18	LME = 0.05 mg/kg
73720	000115 -96-8		LME = ND (LD = 0.02 mg/kg, analytical tolerance included
	74010	145650-60-8	bis (2,4-di-tert-butyl-6-methylfe-nyl) ethyl	LME = 5 mg/kg (as sum of phosphite and phosphate)
74240	031570-04-4	Tris (2,4-di-terc-butylphenyl)
74480	000088-99-3	Phthalic or Acid
74560	000085-68-7	Ftalate benzylbutyl	It will be used only: (a) as a plasticizer in materials and articles of repeated use; b) as a plasticiser in materials and articles of a single use which are in contact with non-fatty foods except for infant formulae and follow-on formulae as follows: define in Royal Decree 72/1998 of 23 January, and products in accordance with Royal Decree 490/1998 of 27 March; c) as a technical support agent in concentrations up to 0,1% in the final product. LME = 30 mg/kg food simulant
74640	000117-81-7	bis (2-ethylhexyl) Ftalate	It will be used only: a) as a plasticizer in materials and objects of repeated use that are in contact with non-fatty foods; b) as a technical support agent in concentrations up to 0.1% in the final product. SML = 1.5 mg/kg food simulant
74880	000084-74-2	Drawing Ftalate	It will be used only: (a) as a plasticizer in materials and objects of repeated use which are in contact with non-fatty foods; (b) as a technical support agent in polyolefins in concentrations up to 0,05% in the final product. SML = 0,3 mg/kg of simulant food
75100	068515 -48-0 028553-12-0	phthalic acid diesters with primary branched alcohols, saturated C8-C10, more than 60% C9	shall only use: (a) as a plasticizer in materials and articles of repeated use; b) as a plasticizer in materials and articles of a single use which are in contact with non-fatty foods except for infant formulae and follow-on formulae such as define in Royal Decree 72/1998 of 23 January, and products in accordance with Royal Decree 490/1998 of 27 March; c) as a technical support agent in concentrations up to 0,1% in the final product. SML (T) = 9 mg/kg food simulant (42)
75105	068515 -49-1 026761-40-0	phthalic acid diesters with primary alcohols, saturated C9-C11, more than 90% C10	Used only: (a) as a plasticizer in materials and articles of repeated use; b) as a plasticizer in materials and articles of a single use which are in contact with non-fatty foods except for infant formulae and follow-on formulae such as define in Royal Decree 72/1998 of 23 January, and products in accordance with Royal Decree 490/1998 of 27 March; c) as a technical support agent in concentrations up to 0,1% in the final product. SML (T) = 9 mg/kg food-shelf (42)
76320	000085-44-9	Anhydride Phthalic
76415	019455-79-9	Pimelato of calcium
76721	009016-00-6 063148-62-9	Polidimethylsiloxane (PM > 6800)	According to the specifications in Annex V
76730	-	Polidimethylsiloxane, gamma-hydroxypro-pip	LME = 6 mg/kg
76815	-	Polyester Esters of adipic acid with glycerol or pentaerythritol, with C12-C22 non-branched fatty acids with number of carbon atoms	to the specifications set out in Annex V
76845	031831-53-5	Polyester 1,4-butanediol with capro-lactone	The restriction for reference number 14260 and reference number 13720. According to the specifications set out in Annex V
76866	-	Polyesters of 1,2-propanediol or 1,3-o1,4-butanediol or polypropylene glycol with adipic acid, which may have the end encapsulated in acetic acid fatty acids C12-C18 or n-octanol or n decanol	SML = 30 mg/kg
76960	025322-68-3	Polyethylene glycol
77370	070142-34-6	Polyethylenglycol-30 dipolyhydroxystee time
77600	061788-85-0
77702		77702	77702	-	polyethylene glycol esters with monocarboxylic aliphatic acids (C6-C22) and their ammonium and sodium sulfates
068439-49-6	monoalkyl (C16-C18) polyethylene glycol (OE = 2-6)	LME = 0.05 mg/kg and according to the specifications set out in Annex V
79040	009005-64-5	Monolaurate of polyethyleneglycol sorbi-tano
79120	009005-65-6	Sorbi-tano polyethylene glycol Monooleate
79200	009005-66-7	Polyethylene Glycol-Bitane Monopalmitate
009005-67-8	Polyethylene Glycol-Sister-bitan Monostearate
79360	009005-70-3	Sorbitan Polyethylene Glycol Trioleate
79440	009005-71-4
79600		79600				79600	Table_table_izq"> 009046-01-9	Polyethylene Glycol Ether tridecyl phosphate	LME = 5 mg/kg. Only for materials and articles intended to come into contact with aqueous food. According to the specifications set out in Annex V
79920	009003-11-6 106392-12-5	Poli (ethylene propylene) glycol
80000	009002-88-4	polyethylene Cera
80240	029894-35-7	Polyglycerol Riciinoleate
-	Polyoxyalkyl (C2-C4) dimethylpolysiloxane
80720	008017-16-1
80800	025322-69-4	Polypropylenoglycol
81060	009003-07-0	polypropylene Cera
81220	192268-64-7	Poli-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl) -N-butylamino] 1,3,5-triazine-2,4-diyl] [2,2,6,6-tetramethyl-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, 5triazine-2,4,6-triamine]-omega N, N, N', N '-tetrabutil-1,3,5-triazine-2,4-day mine	LME = 5 mg/kg
81500	9003-39-8	Polivinylpyrrolidone	According to the specifications set out in Annex V
81515	087189-25-1	Poli (zinc glycerolate)	LME (T) = 25 mg/kg (38) (expressed as zinc)
81520	007758-02-3	Potassium bromide
81600	001310-58-3	Potassium hydroxide
81760	-	Polves, scales, and fibers brass, bronze, copper, stainless steel, tin and copper, tin and iron alloys	LME (T) = 5 mg/kg (7) (expressed as copper). LME = 48 mg/kg (expressed as iron)
81840	000057-55-6	1,2-Propanediol
81882	000067-63-0	2-Propanol
82000	000079-09-4	propionic acid
82080	009005-37-2	1,2-propylene glycol Alginate
82240	022788-19-8	Dilaurate 1,2-propylene glycol
82400	000105-62-4
	82560	033587-20-1	82560	1,2-propylene glycol dipalmitate
82720	006182-11-2	1,2-propylene glycol distearate
82800	027194-74-7	1,2-propylene glycol Monolaurate
001330-80-9	1,2-propylene glycol Monooleate
83120	029013-28-3	1,2-propylene glycol Monopalmitate
83300	001323-39-3
	83320	-	Propilhydroxyethylcellulose
83325	-	Propilhydroxymethylcellulose
83330	-	Propilhydroxypropylcellulose
83440	002466-09-3	pyrophosphoric acid
83455	013445-56-2	pyrophosphorous acid
83460	012269-78-2	Pirofilita
83470	014808-60-7	Quartz
83599		068442-12-6	oleate reaction products 2-mercaptoethyl with dichlorodimethyltin, sodium sulfide and trichloromethyltin	LME (T) = 0.18 mg/kg (16) (expressed as tin)
83610	073138-82-6
83840		83840	83840	83840	Table_table_izq"> 008050-09-7	Colofonia
84000	008050-31-5	Colophony with glycerol
	84080	008050-26-8	Colofonia Ester with pentaeritritol
84210	065997-06-0	Colofonia hydrogenated
84240	065997-13-9	hydrogenated colophony with gli cerol
84320	008050-15 -5	hydrogenated colophony with me tanol
064365-17-9	hydrogenated colophony with pentaerythritol
84560	009006-04-6	Natural Rubber
84640	000069-72-7
000109-43-3		85360
-		-	-	- Table_table_izq"> Natural Silicatos (except the ts)
85610	-	Natural silicates (except asbestos)
	85680	001343-98-2	silicic acid
053320-86-8	Sodium magnesium Silicate	LME (T) = 0.6 mg/kg (8) (expressed as lithium)
86000	-	Silicic acid silylated
86160	000409-21-2
86240
007631-86-9		86240	86240	Silicon Dioxide
86285	-
866560	007647-15 -6	Sodium bromide
86720	001310-73-2	Sodium hydroxide
87040	001330-43-4	Sodium tetraborate	LME (T) = 6 mg/kg (23) (expressed as boron), subject to the provisions of Royal Decree 140/2003 of 7 February, establishing Human consumption water quality health
87200	000110-44-1	Acid sorbic
87280	029116-98-1	Sorbitan Dioleate
87520	062568-11-0	Sorbitan Monoehenate
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
88640	008013-07-8	epoxidado soybean oil	LME = 60 mg/kg. However, in the case of PVC packers used to seal glass jars containing infant formulae and follow-on formulae, as defined in Royal Decree 72/1998 of 23 January 1998, or prepared foods based on of cereals and infant foods for infants and young children, as defined in Royal Decree 490/1998 of 27 March, the SML is reduced to 30 mg/kg According to the specifications set out in Annex V
88800	009005-25-8	Starch, food quality
88880	068412-29-3
Table_table_izq"> 88960	000124-26-5	stearamide
89040	000057-11-4	stearic acid
89200	007617-31-4	Copper stearate	LME (T) = 5 mg/kg (7) (expressed as copper)
89440	-	stearic acid with ethylene glycol	LME (T) = 30 mg/kg (3)
90720	058446-52-9
	90800	005793-94-2	90800		90800	Calcium stearoyl-2-lactylate
90960	000110-15 -6	Succinic acid
91200	000126-13-6	sucrose isobutyrate
	91360	000126-14-7	sucrose Octaacetate
91840	sulphur
91920	007664-93-9	sulfuric acid
92030	010124-44-4	Copper Sulphate	LME (T) = 5 mg/kg (7) (expressed as copper)
92080	014807-96-6
92150
001401-55-4	According to JECFA specifications	According to JECFA specifications
92160	000087-69-4	Tartaric acid
92195	-	Taurin, sales
92205	057569-40-1	terephthalic acid with 2,2 '-me-tilenebis (4-methyl-6-tert-butylphenol)
92350	000112-60-7	Tetraethylene glycol
92640	000102-60-3	N, N, N ', N' -Tetrakis (2-hydroxypropyl) ethylenediamine
92700	078301-43-6	Polymer of 2 ,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadies-piro [5.1.11.2]-henecosan-21-one	LME = 5 mg/kg
92930	120218-34-0	Tiodietanolbis (5-methoxycarbonyl-2,6-di-methyl-1,4-dihydropyridine-3-carboxylate)	LME = 6 mg/kg
93440	013463-67-7	Titanium dioxide
93520	000059-02-9 010191-41-0	alpha-Tocoferol
93680	009000-65-1	tragacto Goma
93720	000108-78-1	2,4,6-Triamino-1,3,5-triazine	LME = 30 mg/kg
93760	000077-90-7	tri-n-butyl citrate acetyl
94320	000112-27-6
94960	000077-99-6	1,1,1-Trimethylolpropane	LME = 6 mg/kg
95000	028931-67-1	Trimethyll propane and methyl methacrylate trimethacrylate copolymer
6846-50-0	2,2,4-trimethyl-1,3-pen-tanediol Diisobutyrate	LME = 5 mg/kg food. Will only be used in single-use
95200	001709-70-2	1,3,5-Trimethyl-2,4,6-tris (3,5-di-tert-butyl 4-hydroxybenzyl) benzene
95270	161717-32-4	2,4,6-tris (tert-butyl) phenyl 2-butyl-2-ethyl-1,3-propanediol	LME = 2 mg/kg (as sum of phosphite, phosphate and hydrolysis product = TTBP)
95420	745070-61-5	1,3,5-tris (2,2-dimethylpropanamide)-benzene	LME = 0.05 mg/kg food
95725	110638-71-6	Vermiculita, Lithium citrate reaction product	LME (T) = 0.6 mg/kg (8) (expressed as lithium)
95855	007732-18-5	Water	According to Royal Decree 140/2003
95859	-	Ceras, high purity, derived of petroleum based on synthetic hydrocarbon raw materials	According to the specifications of Annex V
95883	-	Oil derivatives, white, paraffinic, petroleum derivatives, based on hydrocarbon raw materials	According to Annex V
95905	013983-17-0	Wollastonita
95920	-	Harine and wood fibers, not treated
95935	011138-66-2	xanthan Goma
96190	020427-58-1	zinc hydroxide	LME (T) = 25 mg/kg (38) (ex-pre-sated as zinc)
96240	001314-13-2	Zinc Oxide	LME (T) = 25 mg/kg (38)
96320	001314-98-3	zinc Sulfide	(38) (expresated as zinc)

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

⁽³⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 15760, 16990, 47680, 53650, and 89440, must not exceed the indicated constraint.

⁽⁴⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 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 ref's. 14200, 14230, and 41840, must not exceed the indicated constraint.

⁽⁶⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 66560 and 66580, must not exceed the indicated constraint.

⁽⁷⁾ LME (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 30080, 42320, 45195, 45200, 53610, 81760, 89200, and 92030, must not exceed the indicated restriction.

⁽⁸⁾ SML (T) means in this case that the sum of the migration of the following substances, noted with reference nos 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, should not exceed the indicated constraint.

⁽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 therefore the finished product does not respect the provided for in Article 3 (1) (b) and (c) of Regulation 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and on which the Directives 80 /590/EEC and 89 /109/EEC.

⁽¹¹⁾ SML (T) means in this case that the sum of the migration (expressed as iodine) of the following substances, marked with the ref's. 45200, 64320, 81680, and 86800, must not exceed the indicated constraint.

⁽¹²⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 36720, 36800, 36840, and 92000, must not exceed the indicated constraint.

⁽¹⁴⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 44960, 68078, 69160, 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 ref's. 15970, 48640, 48720, 48880, 61280, 61360, and 61600, must not exceed the indicated constraint.

⁽¹⁶⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 49595, 49600, 67520, 67515, and 83599, must not exceed the indicated constraint.

⁽¹⁹⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 60400, 60480, and 61440, must not exceed the indicated constraint.

⁽²²⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 17260, 18670, 54880, and 59280, must not exceed the indicated constraint.

⁽²³⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 13620, 36840, 40320, and 87040, must not exceed the indicated constraint.

⁽²⁴⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 13720 and 40580, must not exceed the indicated constraint.

⁽²⁸⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 13480 and 39680, must not exceed the indicated constraint.

⁽²⁹⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 22775 and 69920, must not exceed the indicated constraint.

⁽³³⁾ CMA (T) means in this case that the sum of the residual amounts of the following substances, marked with the ref's. 14800 and 45600, must not exceed the indicated constraint.

⁽³⁸⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 81515, 96190, 96240 and 96320, as well as salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols, must not exceed the prescribed restriction. The restriction provided for the Zn shall also apply to substances whose name contains '... acid (s), salt (s)' appearing on the lists, if the free acid (s) is not mentioned (n).

⁽⁴²⁾ LME (T) means in this case that the sum of the migration of the following substances, marked with reference nos 75100 and 75105, must not exceed the indicated restriction.

SECTION B

List of additives whose specific migration limits will apply from 1 May 2008, in accordance with the provisions of Article 8.2 of this royal decree.

51680

mono-n-octyltin (T) = 1,2 mg/kg (

) (expressed as tin)

77440

5 mg/kg ⁽²¹⁾

N. Ref. (1)	CAS (2)	Name (3)	Restrictions and/or specifications (4)
30180	002180-18-9	manganese acetate	LME (T) = 0.6 mg/kg (10) (expressed as man)
31500	025134-51-4	Acrylic acid and 2-ethylhexyl acrylate copolymer	LME (T) = 6 mg/kg (36) (expressed as acrylic acid) and LME = 0.05 mg/kg (expressed as 2-ethyl acrylate) hexyl)
31520	061167-58-6	2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl acrylate	LME = 6 mg/kg
31920	000103-23-1	bis (2-ethylhexyl)	LME = 18 mg/kg (1)
34230		LME 6 mg/kg	LME = 6 mg/kg
34650	151841-65-5	Aluminium (4,6-di-tert.-butylphenyl)] aluminum phosphate	SML = 5 mg/kg
35760	001309-64-4	Antimony Trioxide	LME = 0.04 mg/kg (39) (expressed as antimo)
36720	017194-00-2	Barium hydroxide	LME (T) = 1 mg/kg (12) (expressed as barium)
36800	010022-31-8	Barium Nitrate	LME (T) = 1 mg/kg (12) (expressed as barium)
38000	000553-54-8	Lithium Benzoate	LME (T) = 0.6 mg/kg (8) (expressed as Lithium)
38240	000119-61-9	Benzophenone	LME = 0.6 mg/kg
38505	351870-33-2	Ci-endo-bicyclo[2.2.1] heptane-2,3-dicarboxy-lic acid disodium salt	LME = 5 mg/kg. It should not be used with polyethylene in touch with acid-food products. Purity ≥96%
38560	007128-64-5	2.5-Bis (5-tert-butyl-2-benzoxazolil) tiofe-no	LME = 0.6 mg/kg
38700	063397-60-4	Bis (isooctile tioglycolate) of bis (2-carbo-bu-toxyethyl) tin	LME = 18 mg/kg
38800	032687-78-8	N, N '-Bis [3-(3,5-di-terc-butyl-4-hydroxyphenyl) propionyl] hydrazide	LME = 15 mg/kg
38820	026741-53-7	bis (2,4-di-tert-butylphenyl) pentaerythritol	LME = 0,6 mg/kg
38940	110675-26-8	2,4-Bis (dodecylthiomethyl) -6-methylphenol	LME (T) = 5 mg/kg (40)
39060	035958-30-6	1.1-Bis (2-hydroxy-3,5-di-tert -butylphenyl) ethane	LME = 5 mg/kg
	-	N, N-Bis (2-hydroxyethyl) alkyl (C8-C18) amine	(13)
	39120	-	N, N-Bis (2-hydroxyethyl) alkyl (C8-C18) amine	LME (T) = 1,2 mg/kg (13) expressed as tertiary amine (excluding HCl)
40000	000991-84-4	2,4-Bis (octyltio)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine	LME = 30 mg/kg
40020	110553-27-0	2,4-Bis (octyltiomethyl) -6-methylphenol	LME (T) = 5 mg/kg (40)
40160	061269-61-2	Copolymer N, N ' -Bis (2,2,6,6-tetramethyl-4-piperidyl) hexamethylenediamine-1,2-dibromoethane	LME = 2,4 mg/kg
40720	025013-16-5	Terc-butyl-4-hydroxyanisole (= BHA)	LME = 30 mg/kg
40800	013003-12-8	4,4 '-butylidenbis (6-tert-butyl-3-methylphenylditridecyl phosphite)	LME = 6 mg/kg
40980	019664-95-0	manganese Butitime	LME (T) = 0.6 mg/kg (10) (expressed as manga-neso)
42000	063438-80-2	Tris (isooctyl tioglycolate) of (2-carbobutoxyethyl) tin	LME = 30 mg/kg
42400	010377-37-4	Lithium carbonate	LME (T) = 0.6 mg/kg (8) (ex-pre-sated as lithium)
42480	000584-09-8	Rubidium carbonate	LME = 12 mg/kg
43600	004080-31-3	Chloride 1-(3-chloroalil) -3,5,7-triaza-1-azoniaadamantane	LME = 0.3 mg/kg
43680	000075-45-6	Chlorodifluoromethane	LME = 6 mg/kg; according to the specifications of Annex V
44960	011104-61-3	Oxide cobalt	LME (T) = 0.05 mg/kg (14) (expressed as cobalt)
45440	-	Cresoles, butylates, styrenates	LME = 12 mg/kg
45650	006197-30-4	Ester 2-ethylhexyl acid 2-cyano-3,3-diphenylacrylic	LME = 0.05 mg/kg
46640	000128-37-0	2.6-di-terc-butyl-p-cresol (= BHT)	LME = 3.0 mg/kg
47500	153250-52-3	N, N ' -Diciclohexyl-2,6-naphthalendicarboxamide	SML = 5 mg/kg.
47600	084030-61-5	Bis (isooctyl tioglycolate) di-n-dode-cyltin	SML (T) = 0,05 mg/kg in food (41) (as sum of tris (isooctyl mercaptoacetate) of mono-dodecyltin, bis (isooctyl mercaptoacetate) di-n-dodecyltin, trichloride mono-dodecyltin and di-dodecyltin dichloride) expressed as the sum of chloride mono-and di-dodecyltin
48640	000131-56-6	2.4-Dihydroxybenzophenone	LME (T) = 6 mg/kg (15)
48800	000097-23-4	2,2 '-Dihydroxy-5,5'-dichlorodiphenylmethane	LME = 12 mg/kg
48880	000131-53-3	2.2 ' -Dihydroxy-4-methoxybenzophenone	LME (T) = 6 mg/kg (15)
49595	057583-35-4	Bis (ethylhexyl tioglycolate) of dimethyles-tano	LME (T) = 0.18 mg/kg (16) (exceeded as tin)
49600	026636-01-1	Bis (isooctyl tioglycolate) of dimethyles-tano	LME (T) = 0.18 mg/kg (16) (ex-sated as tin)
49840	002500-88-1	Dioctadecyl Disulfide	LME = 3 mg/kg
50160	-	Bis [n-alkyl (C10-C16) tioglycolate] di-n-octyltin	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50240	010039-33-5	bis (2-ethylhexyl maleate) di-n-octiles-tano	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50320	015571-58-1		LME (T) = 0.006 mg/kg (17) (expressed as tin)
50360	-	Bis (ethyl di-n-octyltin maleate	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50400	033568-99-9	Bis (isooctyl maleate) di-n-octyltin	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50480	026401-97-8	Bis (isooctyl tioglycolate) di-n-octiles-tano	LME (T) = 0.006 mg/kg (17) (expressed as tin)
		1.4-Butanediol bis (tioglycolate) di-n-octyltin	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50640	003648-18-8	di-n-octyltin Dilaurate	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50720	015571-60-5	di-n-octyltin Dimaleate	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50800	-	esterified di-n-octyltin Dimaleate	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50880	-	di-n-octyltin Dimaleate, poly-ros (N = 2-4)	LME (T) = 0.006 mg/kg (17) (expressed as tin)
50960	069226-44-4	Etlienglycol bis (tioglycolate) di-n-oc-tiltin	LME (T) = 0.006 mg/kg (17) (expressed as tin)
51040	015535-79-2		LME (T) = 0.006 mg/kg (17) (expressed as tin)
51120	-		LME (T) = 0.006 mg/kg (17) (expressed as tin)
51570	000127-63-9	(T) = 3 mg/kg (25)
	000102-08-9	N, N ' -Diphenylthiourea	LME = 3 mg/kg
52000	027176-87-0	Dodecylenesulfonic acid	LME = 30 mg/kg
52320	052047-59-3	2-(4-Dodecylphenyl) indol	LME = 0.06 mg/kg
52880	023676-09-7	4-Ethoxybenzoate	LME = 3,6 mg/kg
53200	023949-66-8	2-Etoxi-2 '-etiloxanilide	LME = 30 mg/kg
54880	000050-00-0	formaldehyde	LME (T) = 15 mg/kg (22)
55200	001166-52-5	Dodecyl Galate	LME (T) = 30 mg/kg (34)
55280	001034-01-1	octyl Galate	LME (T) = 30 mg/kg (34)
55360	000121-79-9	(T) = 30 mg/kg (34)
58960	000057-09-0	hexadecimal hexadecimal	LME = 6 mg/kg
59120	023128-74-7	1,6-Hexamethylbis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionamide]	LME = 45 mg/kg
59200	035074-77-2	1.6-Hexamethylenis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]	LME = 6 mg/kg
60320	070321-86-7	2-[2-Hydroxy-3,5-bis (1,1-dimethylbenzyl) phenyl] benzotriazole	LME = 1.5 mg/kg
60400	003896-11-5	2-(2 '-Hydroxy-3'-tert-butyl-5 '-methylphenyl) -5-chlorobenzotriazole	(19)
60800	065447-77-0	Copolymer 1-(2-hydroxyethyl) -4-hydroxy-2,2,6,6-tetramethylpiperidine-dimethyl succinate	LME = 30 mg/kg
61280	003293-97-8	2-Hydroxy-4-n-hexyloxybenzophenone	LME (T) = 6 mg/kg (15)
61360	000131-57-7	2-Hydroxy-4-methoxybenzophenone	LME (T) = 6 mg/kg (15)
61440	002440-22-4	2-(2 '-Hydroxy-5'-methylphenyl) benzotriazole	LME (T) = 30 mg/kg (19)
61600	001843-05-6	2-Hydroxy-4-n-octiloxibenzophenone	LME (T) = 6 mg/kg (15)
63200	051877-53-3	manganese lactate	(10) (expressed as manga-notho)
63940	008062-15 -5	lignosulfonic acid	LME = 0.24 mg/kg. It should only be used as a dispersant for plastic dispersions
64320	010377-51-2	Iohard Lithium	LME (T) = 1 mg/kg (11) (expressed as iodine) and LME (T) = 0.6 mg/kg (8) (expressed as lithium)
65120	007773-01-5	Chloride manganese	LME (T) = 0.6 mg/kg (10) (ex-pre-sated as manganese)
65200	012626-88-9	manganese hydroxide	LME (T) = 0.6 mg/kg (10) (ex-pre-sated as manganese)
65280	010043-84-2	Manganese Hypophosphite	LME (T) = 0.6 mg/kg (10) (ex-pre-sated as manganese)
65360	011129-60-5	manganese Oxide	LME (T) = 0.6 mg/kg (10) (ex-presated as manganese)
65440	-	Manganese-Pirophosphite	LME (T) = 0.6 mg/kg (10) (ex-pre-sated as manganese)
66350	085209-93-4	2,2 '-methylenbis (4,6-di-tert-butylphenyl) lithium	LME = 5 mg/kg and LME (T) = 0,6 mg/kg (8) (expressed as lithium)
66360	085209-91-2	2,2 '-methylenbis (4,6-di-terc-butylphenyl) sodium phosphate	LME = 5 mg/kg
66400	000088-24-4	2.2 '-methylenbis (4-ethyl-6-terc-butylphenol)	LME (T) = 1.5 mg/kg (20)
66480	000119-47-1	2.2 '-methylenbis (4-methyl-6-terc-butylfe-nol)	LME (T) = 1.5 mg/kg (20)
67360	067649-65-4	Tris (isooctil mercaptoacetate) mono-n-dodecyltin	LME (T) = 0,05 mg/kg in food (41) (as sum of tris (isooctil mercaptoacetate) mono-n-do decyltin, bis (isooctyl mercaptoacetate) of di-n dodecyltin, mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono-and di-dodecyltin
67515	057583-34-3	Tris (ethylhexyl tioglycolate) monome-tiltin	LME (T) = 0.18 mg/kg (16) (expressed as tin)
67520	054849-38-6	Tris (isooctyl tioglycolate) monome-tiltin	LME (T) = 0.18 mg/kg (16) (ex-sated as tin)
67600	~	Tris [alkyl (C10-C16) tioglycolate] demono-n-octyltin	LME (T) = 1,2 mg/kg (18) (ex-pre-sated as tin)
67680	027107-89-7	T)
67760	026401-86-5	Tris (isooctyl tioglycolate) of mono-n-octyltin	LME (T) = 1,2 mg/kg (18) (ex-pre-sated as tin)
67896	020336-96-3	Lithium Myristicinate	LME (T) = 0.6 mg/kg (8) (ex-sated as lithium)
68320	002082-79-3	3-3,5-di-tert-butyl-4-hydroxyphenyl) own-octadeco-nato	LME = 6 mg/kg
68400	010094-45-8	Octadeclerucamide	LME = 5 mg/kg
68860	004724-48-5	n-octylphosphonic acid	LME = 0.05 mg/kg
69160	014666-94-5	cobalt Oleate	LME (T) = 0.05 mg/kg (14) (ex-pre-sated as cobalt)
69840	016260-09-6	LME = 5 mg/kg
71935	007601-89-0	Sodium perchlorate monohydrate	LME = 0.05 mg/kg (31)
72081/10		Oil Hydrocarbon Resins (hydrogenated)	LME = 5 mg/kg (1) and according to the specifications set out in Annex V
72160	000948-65-2	2-Fenilindol	LME = 15 mg/kg
72800	001241-94-7	Diffenyl phosphate 2-ethylhexyl	LME = 2.4 mg/kg
73040	013763-32-1	Lithium phosphate	LME (T) = 0.6 mg/kg (8) (ex-preed as lithium)
73120	010124-54-6	manganese phosphate	(10) (ex-presated as manganese)
	74400	-		LME = 30 mg/kg
-	polyethylene eglycol diricinoleate	LME = 42 mg/kg
77520	061791-12-6	polyethylene glycol ester with castor oil	LME = 42 mg/kg
78320	009004-97-1	LME = 42 mg/kg	LME = 42 mg/kg
81200	071878-19-8	Poli [6-[(1,1,3,3-tetramethylbutyl) amino] -1,3,5-triazine-2,4-diyl-[(2,2,6,6,-Tetra Methyl-4-piperidyl) imino-hexamethylene [(2,2,6,6-tetramethyl-4-piperidyl) imino	LME = 3 mg/kg
81680	007681-11-0	Potassium Iohard	LME (T) = 1 mg/kg (11) (expressed as iodine)
82020	019019-51-3	cobalt-propionate	LME (T) = 0.05 mg/kg (14) (ex-pre-sated as cobalt)
83595	119345-01-6	phosphonite reaction product di-tert-butyl with diphenyl, obtained by condensation of 2,4-di-tert butylphenol with the product of the reaction Friedel Craft of phosphorous phosphorous condiphenyl	LME = 18 mg/kg. According to the specifications in Annex V
83700	000141-22-0	ricinoleic acid	LME = 42 mg/kg
84800	000087-18-3	4-tert-butylphenyl	LME = 12 mg/kg
84880	000119-36-8	methyl Salicate	LME = 30 mg/kg
85760	012068-40-5	Aluminium lithium silicate (2:1: 1)	LME (T) = 0.6 mg/kg (8) (ex-preed as lithium)
85920	012627-14-4	Lithium Silicate	LME (T) = 0.6 mg/kg (8) (ex-sated as lithium)
85950	037296-97-2	Magnesium-sodium-fluoride silicate	LME = 0.15 mg/kg (expressed as fluoride). It should only be used in those layers of objects of multi-layer materials that do not come into direct contact with food
86480	007631-90-5	Sodium bisulfite	LME (T) = 10 mg/kg (30) (ex-pre-sated as SO2
86800	007681-82-5	LME (T) 1 mg/kg (11) (expressed as iodine)
86880		SML = 9
		LME = 9 mg/kg
Table_table_izq"> 86920	007632-00-0	Sodium Nitrite	LME = 0.6 mg/kg
86960	007757-83-7	Sodium Sulfite	LME (T) = 10 mg/kg (30) (ex-pre-sated as SO2
87120	007772-98-7	sodium	LME (T) = 10 mg/kg (30) (exposed as SO2
89170	013586-84-0	cobalt stearate	LME (T) = 0.05 mg/kg (14)(ex-pre-sated as cobalt)
92000	007727-43-7	barium Sulphate	LME (T) = 1 mg/kg (12)(expressed as barium)
	92320		Ether of tetradecyl-polyoxyethylene (OE=3-8) glycolic acid	LME = 15 mg/kg
92560	038613-77-3		LME = 18 mg/kg
92800	000096-69-5	4.4 '-Tiobis (6-tert-butyl-3-methylphenol)	LME = 0.48 mg/kg
92880	041484-35-9	Bis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate] tiodiethanol	LME = 2.4 mg/kg
93120	000123-28-4	didodecyl Tiodipropionate	LME (T) = 5 mg/kg (21)
93280	000693-36-7	(T)
93970		Bis (hexahydrophthalate) tricyclodecane-dimethanol	LME = 0.05 mg/kg
94400	036443-68-2	Bis [3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate] triethylene glycol	LME = 9 mg/kg
94560	000122-20-3	Triisopropanolamine	LME = 5 mg/kg
95265	227099-60-7	1,3,5-Tris (4-benzoylphenyl) benzene	LME = 0.05 mg/kg
95280	040601-76-1	1,3,5-Tris (4-tert-butyl-3-hydroxy-2,6-dimethyl-benzyl)-1,3,5-triazine-2,4,6 (1H, 3H, 5H) trione	LME = 6 mg/kg
95360	027676-62-6	1,3,5-Tris (3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6 (1H, 3H, 5H)-trione	LME = 5 mg/kg
95600	001843-03-4	1,1,3-Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane	LME = 5 mg/kg

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

⁽⁸⁾ SML (T) means in this case that the sum of the migration of the following substances, noted with reference nos 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, should not exceed the indicated constraint.

⁽¹⁰⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 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 (expressed as iodine) of the following substances, marked with the ref's. 45200, 64320, 81680, and 86800, must not exceed the indicated constraint.

⁽¹²⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 36720, 36800, 36840, and 92000, must not exceed the indicated constraint.

⁽¹³⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 39090 and 39120, must not exceed the indicated constraint.

⁽¹⁴⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 44960, 68078, 69160, 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 ref's. 15970, 48640, 48720, 48880, 61280, 61360, and 61600, must not exceed the indicated constraint.

⁽¹⁶⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 49595, 49600, 67520, 67515, and 83599, must not exceed the indicated constraint.

⁽¹⁷⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040, and 51120, must 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 ref's. 67600, 67680, and 67760, must not exceed the indicated constraint.

⁽¹⁹⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 60400, 60480, and 61440, must not exceed the indicated constraint.

⁽²⁰⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 66400 and 66480, must not exceed the indicated constraint.

⁽²¹⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 93120 and 93280, must not exceed the indicated constraint.

⁽²²⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 17260, 18670, 54880, and 59280, must not exceed the indicated constraint.

⁽²⁵⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 16650 and 51570, must not exceed the indicated constraint.

⁽³⁰⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 86480, 86960, and 87120, must not exceed the indicated constraint.

⁽³¹⁾ When there is a fatty contact, compliance will be evaluated using simulants of saturated fatty foods such as D.

⁽³⁴⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 55200, 55280, and 55360, must not exceed the indicated constraint.

⁽³⁶⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 10690, 10750, 10780, 10810, 10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980 and 31500, must not exceed the indicated restriction.

⁽³⁹⁾ The migration limit can be exceeded at very high temperature.

⁽⁴⁰⁾ SML (T) means in this case that the sum of the migration of the following substances, marked with the ref's. 38940 and 40020, must not exceed the indicated constraint.

⁽⁴¹⁾ LME (T) means in this case that the sum of the migration of the following substances, marked with reference nos 47600 and 67360, must not exceed the indicated restriction.

ANNEX IV

Products obtained by bacterial fermentation

The list contains the following data:

(a) Column 1 (Ref. number): the EEC reference number of the substance of the packaging material, in the list.

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

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

d) Column 4 (Restrictions and/or Specifications).

N. Ref. (1)	CAS (2)	Name (3)	Restrictions and/or Specifications (4)
18888	080181-31-3	Copolymer of 3-hydroxybute-noic acids and 3-hydroxycentanoic	According to the specifications included in Annex V

ANNEX V

Specifications

PART A: General specifications

Plastic materials and articles should not release primary aromatic amines in detectable quantity (LD = 0.01 mg/kg food or food simulant). The migration of the primary aromatic amines included in the lists in Annexes II and III is excluded from this restriction.

PART B: Other Specifications

PM/REF Number

Other
11530	2-hydroxypropyl acrylate May contain up to 25% (m/m) of 2-hydroxysopropyl acrylate (Cas No 002918-23-2)
16690	Divinylbenzene May contain up to 45% (m/m) of ethylvinylbenzene
18888	Copolymer of 3-hydroxybutanoic and 3-hydroxypentanoic 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 Alcaligenes eutrophus strain HI6 NCIMB 10442. Master strains of this organism are stored in lyophilized ampoules. From the master 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 under a microscope and any changes in the colonial morphology are observed 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 melt-formed granules containing additives such as nucleating agents, plasticizers, filler material, stabilizers and pigments, all of which comply with the specifications. general and concrete
	Chemical name: Poli (3-D-hydroxybutanoate-co-3-D-hydroxyentanoate) Number: CAS 080181-31-3 Structural formula: (-O-CH (CH3) -CH2-CO-)m-(O-CH (CH2-CH3) -CH2-CO-)n where n/(m + n) > 0 and n/(m + n) ≤ 0,25 Average molecular weight: Not less than 150 000 dalton (measured by gel permeability chromatography) Composition: Not less than 98% of poly (3-D-hydroxybutanoate-co-3-Dhydroxyentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic acid and 3-D-hydroxycentanoic acid Description: White or whitened 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 Restriction: The CMA for crotonic acid is 0.05 mg/6 dm2 Purity: Before granulation, raw copolymer powder must have a content:
	• Nitrogen: Less than 2 500 mg/kg plastic • Zinc: Less than 100 mg/kg plastic • Copper: Less than 5 mg/kg plastic • Lead: Less than 2 mg/kg plastic • Arsenic: Less than 1 mg/kg plastic • Chromium: Less than 1 mg/kg plastic
23547	Polidimethylsiloxane (PM> 6 800) Minimum viscosity: 100 × 10-6 m2/s (= 100 centistokes) at 25 ° C
24903	Jarabes, hydrolyzed starch, hydrogenated According to the purity criteria established for maltitol syrup E-965 (ii) by Royal Decree 2106/1996, September
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/quantity of formulation)
42080	Coal Black Specifications: • Removable toluene content: maximum of 0,1%, determined in accordance with the ISO 6209 method. • UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a method of analysis with general recognition. • Benzo (a) pyrene content: maximum of 0,25 mg/kg of carbon black. • Maximum level of use of carbon black in the polymer: 2.5% w/w
43480	Carbon activated For PET use only at a maximum of 10 mg/kg polymer. The same purity requirements as those laid down for charcoal (E-153) by Royal Decree 2107/1996 of 20 September, with the exception of ash content, which can be reached at 10% (w/w)
43680	Chlorodifluoromethane Chlorofluoromethane content of less than 1 mg/kg of the substance
47210	Ddrawn acid polymer Molecular Unit = (C8H18S3Sn2)n (n = 1.5-2)
64990	Sodium salt of the copolymer styrene and maleic anhydride Fraction PM <1000 is less than 0.05% (w/w)
67155	4-(2-benzoxazolyl) -4 '-(5-methyl-2-benzoxazolyl) stilbene 4,4 '-bis (2-benzoxazolyl) stilbene and 4,4'-bis (5 methyl-2-benzoxazolyl) stilbene The ratio of the mixture obtained from the manufacturing process should be (58-62%): (23-27%): (13-17%), which is the
72081/10	Oil Hydrocarbon (hydrogenated) Resins Specifications: The hydrogenated petroleum hydrocarbon resins are produced by the catalytic or thermal polymerization of dienes and olefins of aliphatic, alicyclic and/or monobenzenic arylalkene from distillates of petroleum stocks with a boiling range not exceeding 220 °C, as well as the pure monomers found in these distillate flows, followed by distillation, hydrogenation and further processing Properties Viscosity: > 3 Pa. s at 120 ° C. Softening point: > 95 ° C determined by method E 28-67ASTM Bromine Number: < 40 (ASTM D1159) The color of a 50% solution in toluene < 11 on the Gardner scale Residual aromatic monomers ≤ 50 ppm
76721	Polidimethylsiloxane (PM> 6 800) Minimum viscosity: 100 × 10-6 m2/s (= 100 centistokes) at 25 ° C
76845	1,4-butanediol polyester with caprolactone PM fraction <1000 is less than 0.5% (w/w)
76815	Polyester esters of adipic acid with glycerol or pentaerythritol, with fatty acids C12-C22 unbranched with number pair of carbon atoms PM <1000 fraction is less than 5% (w/w)
77895	monoalkyl Eter (C16-C18) of polyethylene eglycol (EO = 2-6) The composition of this mixture is as follows: • monoalkyl (C16-C18) polyethylene eglycol (EO = 2-6) ether (approx. 28%) • fatty alcohols (C16-C18) (approx. 48%) • Monoalkyl (C16-C18) ethylene glycol ether (approx. 24%)
79600	Polyethylene Glycol Ether Tridecyl Phosphate Polyethylene glycol phosphate (EO≤11) tridecyl ether (monoalkyl and dialkyl ester) with a maximum content of 10% polyethylene glycol (EO≤11) tridecyl
81500	Polivinylpyrrolidone The substance must meet the purity criteria set out in Royal Decree 1917/97
83595	Reaction product di-ter-butylphosphonite 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 No 38613-77-3) (36-46% w/w) (*) • 4,3 '-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (Cas No 118421-00-4) (17-23% w/w) (*) • 3,3 '-Biphenylene-bis [0,0-bis (2,4-di-tert-butylphenyl) phosphonite] (Cas No 118421-01-5) (1-5% w/w) (*) • 4-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (Cas No 91362-37-7) (11-19% w/w) (*) • Tris (2,4-di-tert-butylphenyl) phosphite (Cas No 31570-04-4) (9-18% w/w) (*) • 4,4 '-Biphenylene-0,0-bis (2,4-di-tert-butylphenyl) phosphonate-0,0-bis (2,4-di-tert-butylphenyl) phosphonite (Cas No 112949-97-0) (< 5% w/w) (*) Other specifications: • Phosphorus content: min. 5.4%, max. 5.9% • Rate of acidity: max. 10 mg KOH/g • Merge interval: 85-110 ° C
88640	epoxidated soybean oil Oxirane < 8%, iodine number < 6
95859	Rerefined Ceras derived from petroleum or synthetic hydrocarbon 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 ° C • Average molecular weight not less than 500
95883	White mineral oils, paraffinic, petroleum-based hydrocarbon derivatives 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 ° C • Average molecular weight not less than 480

(*) Quantity of substance used/amount of formulation.

ANNEX VI

Lipophilic substances to which the FRF applies

Ref.

38515

isooctyl mercaptoacetate)

68400

CAS	Name
31520	061167-58-6	2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl
31530	123968-25-2
31920	000103-23-1	bis (2-ethylhexyl)
38240	000119-61-9	38515
38515 Table_table_izq"> 001533-45-5	4.4 ' Bis (2-benzoxazolyl) stilbene
38560	007128-64-5	2,5-bis (5-tert-butyl-2-benzoxazolyl) thiophene
38700	063397-60-4	2-carbobutoxyethyl) tin
38800	032687-78-8	N, N '-Bis [3-(3,5-di-terc-butyl-4-hydroxyphenyl) propionyl] hydrazide
38810	080693-00-1	bis (2,6-di-terc-butyl-B4-methylphenyl) pentaerythritol
38820	026741-53-7	bis (2,4-di-terc-butylphenyl) pentaerythritol Diphosphite
38840	154862-43-8	bis (2,4-dicumilphenyl) pentaerythritol
39060	035958-30-6	1,1-Bis (2-hydroxy-3,5-di-terc-butylphenyl) ethane
39925	129228-21-3	3,3-Bis (methoxymethyl) -2,5-dimethylhexane
40000	000991-84-4	2,4-Bis (octyltio)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine
40020	110553-27-0	2,4-Bis (octyltiomethyl) -6-methylphenol
40800	013003-12-8	4,4 '-butylidenbis (6-tert-butyl-3-methylphenyl-ditridecyl phosphite)
42000	063438-80-2	45450
	45450
45450	45450	45450 P-cresol-dicyclopentadiene-isobutylene
	45705	166412-78-8	1,2-cyclohexanedicarboxylic acid, diisononil ester
46720	004130-42-1	2.6-di-terc-butyl-4-ethylphenol
47540	027458-90-8	di-tert-dodecyl disulfide
47600	084030-61-5	Bis (isooctil mercaptoacetate) di-n-dodecyltin
48800	000097-23-4	2.2 '-Dihydroxy-5,5'-dichlorodiphenylmethane
48880	000131-53-3	2.2 ' -Dihydroxy-4-methoxybenzophenone
49485	134701-20-5	49840
	002500-88-1
Disulfide	51680
		000102-08-9	N, N ' -Diphenyltiourea
52320	052047-59-3	2-(4-Dodecylphenyl) indol
53200	023949-66-8	54300
	118337-09-0	2,2 ' Etylidenbis (4,6-di-tert-butylphenyl) fluorophosphonic
59120	023128-74-7	1.6-Hexamethylenis [3-(3,5-di-terc-butyl-4-hydroxyphenyl) propionamide]
59200	035074-77-2	1.6-Hexamethylenis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]
60320	070321-86-7	2-[2-Hydroxy-3,5-bis (1,1-dimethylbenzyl) phenyl] benzotriazole
60400	003896-11-5	2-(2 '-Hydroxy-3'-tert-butyl-5 '-methylphenyl) -5-chlorobenzotriazole
60480	003864-99-1	2-(2 '-Hydroxy-3,5'-di-tert-butyl-phenyl)-5-chlorobenzotriazole
61280	003293-97-8	2-Hydroxy-4-n-hexiloxybenzophenone
61360	000131-57-7	2-Hydroxy-4-methoxybenzophenone
61600	001843-05-6	66360
	085209-91-2	2,2 '-methylenbis (4,6-di-tert-butylphenyl) sodium
66400	000088-24-4	2.2 '-Metilenbis (4-ethyl-6-terc-butylphenol)
66480	000119-47-1	2.2 '-Metilenbis (4-methyl-6-terc-butylphenol)
66560	004066-02-8	2.2 ' Metilenbis (4-methyl-6-cyclohexylphenol)
66580	000077-62-3	2.2 ' Methylenbis [4-methyl-6-(1-methylcyclohexyl) phenol]
68145	080410-33-9	2.2 ', 2' '-Nitrile [triethyl tris (3,3 ', 5,5'-tetra-tert-butyl-1,1 '-biphenyl-2,2'-diyl) phosphite]
68320	002082-79-3
010094-45-8	Octadecilerucamide
69840	016260-09-6	Oleilpalmitamide
71670	178671-58-4	Tetrakis (2-cyano-3,3-diphenylacrylate) pentaerythritol
72081/10	-	Oil Hydrocarbon (hydrogenated) Resins
72160	000948-65-2	2-Fenilindol
72800	001241-94-7	2-ethylhexyl diphenyl
73160	-	mono-and di-n-alkyl phosphates (C16 and C18
74010	145650-60-8	bis (2,4-di-tert-butyl-6-methylphenyl)
	-	- Tris (nonil-and/or dinonilphenyl)
76866	-	Polyesters 1,2-propanediol and/or 1,3-and/or 1,4-butanediol and/or polyproylene glycol with adipic acid, in addition to the end encapsulated with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol
77440	-	78320
	009004-97-1	009004-97-1	78320	81200
	071878-19-8		81200		81200	Body_table_izq"> Poli [6-[(1,1,3,3-tetramethylbutyl) amino] -1,3,5-triazine-2,4-diyl- [(2,2,6,6,-tetramethyl-4-piperidyl) iminohexamethylene-[(2,2,6,6-tetramethyl-4-piperidyl) imino
83599	068442-12-6	2-mercaptoethyl oleate reaction products with dichlorodimethyltin, sodium sulfide, and trichloromethyltin
83700	000141-22-0	ricinoleic
84800	000087-18-3	4-tert-butylphenyl Salicilate
92320	-	Eter of tetradecyl-polyoxyethylene (OE=3-8) glycolic
92560	038613-77-3	Diphosphonito tetrakis (2,4-di-tert-butylphenyl)-4,4 '-biphenylene
92700	078301-43-6	Polymer 2 ,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadies-piro [5.1.11.2]-henecosan-21-one
92800	000096-69-5	4,4 '-Tiobis (6-tert-butyl-3-methylphenol)
92880	041484-35-9	Bis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate] of thiodiethanol
93120	000123-28-4	didodecyl Tiodipropionate
93280	000693-36-7	95270
	161717-32-4
Fosfito 2,4,6-tris (tert-butyl) phenyl 2-butyl-2-ethyl-1,3-propanediol
95280	040601-76-1	1,3,5-Tris (4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6 (1H, 3H, 5H)-trione
95360	027676-62-6	1,3,5-Tris (3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6 (1H, 3H, 5H)-trione
95600	001843-03-4	1,1,3-Tris (2-methyl-4-hydroxy-5-tert-butylphenyl) butane

ANNEX VII

Declaration of Compliance

The written declaration provided for in Article 13 with-will have the following information:

1) The identity and address of the operator of a food business manufacturing or importing plastic materials or articles as well as substances intended for the manufacture of such materials and articles.

2) The identity of the materials, objects or substances intended for the manufacture of such materials and articles.

3) The date of the declaration.

4) Confirmation that plastic materials or articles meet the relevant requirements set out in this royal decree and in Regulation 1935/2004.

5) Appropriate information on the substances used for which restrictions and/or specifications exist in accordance with this Royal Decree in order to allow operators of undertakings to use them later on products ensure compliance with these restrictions.

6) Appropriate information on substances that are subject to a food restriction, obtained by means of experimental data or theoretical calculations on the level of their specific migration and, where appropriate, the criteria for purity in accordance with Royal Decree 2106/1996 of 20 September 1996 laying down the rules for the identity and purity of sweeteners used in foodstuffs, Royal Decree 2107/1996 of 20 September 1996 1996, laying down the rules for the identity and purity of the colours used in foodstuffs and Royal Decree 1917 /1997 of 19 December 1997 laying down the rules for the identity and purity of food additives other than colours and sweeteners for use in foodstuffs, and to allow users of these materials or articles to comply with the relevant Community provisions or, in the absence thereof, the national provisions applicable to food.

7) Specifications on the use of the material or object, such as:

i) type or types of food that you are expected to come into contact with,

ii) duration and temperature of treatment and storage in contact with food,

iii) relationship between the surface in contact with the food and the volume that has been used to determine that the material or object meets the requirements.

8. Where a functional plastic barrier is used in a multi-layer plastic material or object, confirmation that the material or object complies with the requirements of Article 11 (2), (3) and (4) of this Regulation decree.

The written declaration must allow for easy identification of the materials, objects or substances for which it has been drawn up, and must be renewed when substantial changes in production occur. cause changes in migration, or when new scientific data is available.

ANNEX VIII

List of simulants to be used to control the migration of components of materials and objects of plastic material intended to come into contact with food products

1. The list, not exhaustive, of foodstuffs, which is included below, sets out the simulants to be used in the migration tests with regard to a food product or a group of food products and 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: 10 per 100 (V/V) ethanol, in aqueous solution.

Simulation D: rectified olive oil (see paragraph 8.a)). Where, for technical reasons linked to the method of analysis, other simulants must be used, olive oil must be replaced by a mixture of synthetic triglycerides (see paragraph 8.b)) or sunflower oil (see paragraph 8.c). If all simulants cited as simulant D are inappropriate, other simulants as well as other time and temperature conditions may be used.

However, simulant A should be used only 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 will be required for that item or subheading.

3. Where the X sign is followed by a figure, which is separated by an oblique stripe, the result of the migration tests shall be divided by that figure. In the case of certain types of fatty foods, this conventional figure, known as the "Simulator D Reduction Factor (DRF) simulant", will be used to take into account the greater extractive capacity of the simulant in comparison with the food.

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. Where the letter (b) after the X sign is enclosed in brackets, the indicated test shall be carried out with 50% ethanol (v/v).

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

7. Where the food product or group of foodstuffs is not included in the list of foodstuffs which is included below, the in-use shall be made using the food simulants referred to in paragraph 1. 1, those that most closely resemble the actual behavior of the food.

8. Characteristics to be collected by the products covered under the simulant heading D:

a) Characteristics of rectified olive oil:

Iodine Index (Wijs) = 80-88

Refractive Index at 25ºC = 1,4665-1,4679

Acidity (expressed as percentage of oleic acid) = 0.5 per 100 maximum

Peroxides index (expressed as oxygen milliequivalents per Kg of oil) = 10 maximum

b) Composition of the synthetic triglic mixture:

Fatty acid distribution:

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

Diglyceride content (determined by enzymatic pathway): ≤ 2,0 per 100

Non-saponifiable materials: ≤ 0,2 per 100

Iodine index (Wijs): ≤ 0.1 per 100

Acidity index: ≤ 0,1 per 100

Water content (K. Fischer): ≤ 0,1 per 100

Merge point: 28 ± 2 ° C

Typical absorption spectrum (1 cm bucket; reference: water at 35 ° C)

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 light transmittance at 310 nm (1 cm bucket; reference: water at 35 ° C)

c) Sunflower oil characteristics:

Iodine Index (Wijs): 120-145

Refractive Index at 20 ° C: 1,474-1,476

Saponification Index: 188-193

Density relative to 20 ° C: 0.918-0.925

Non-saponifiable materials: 0.5 per 100-1.5 per 100.

Number
Reference

01.01

02.01

08.13

Designation of the food products	Simulations to be
	A	B	C	D
	01	Drinks
Non-alcoholic beverages or alcoholic beverages with an alcoholic strength of less than 5% vol:
	Waters, ciders, fruit or vegetable juices, 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 whose alcoholic strength is 5% vol or more:
	Drinks classified under heading number 01.01 but whose alcoholic strength is 5% vol or more: Wines, spirits, spirits.		X*			01.03
Miscellaneous: Undenatured ethyl alcohol
	X*	X* *
02	Cerals, derived from cereals, products from
Almidones and Fechules.
02.02	Natural, flaked, flaked state cereals (including swollen corn and corn and other petals).
02.03	Cereals and Semolas.
02.04
02.05	Dry Products Bakery, gallerteria and dry pastry products:
	A. That they present fats on their surface.				X/5
	B. Others.
02.06	Fresh bakery and pastry products:
	A. That they present fats on their surface.			X/5
		B. Other	X
03	Chocolates, sugars and their derivatives, confectionery products.
03.01	Chocolates, chocolate-coated products, substitutes, and substitute products.				X/5
03.02	Confectionery products:
	A. In solid form:
	I. That they present fats on their surface.				X/5
	II. Others.
	B. In the form of paste:
	I. That they present fats on their surface.				X/3
	II. Wet.	X
03.03	Sugar and confectionery items:
	A. In solid form.
	B. Honey and the like.	X
	C. Sugar molasses or syrups.	X
04	Fruit, vegetables, and their derivatives.
04.01	Entire, fresh, or refrigerated paths.
04.02	Transformer paths:
	A. Dried or dehydrated fruits, whole or in the form of flour or powder.
	B. Fruit in pieces, or in the form of puree or paste.	X (a)	X (a)
	C. Preserved fruit (jams and similar products, whole fruit or in pieces, in the form of flour or powder, preserved in a liquid medium):
	I. In an aqueous media.	X (a)	X (a)
	II. In an oil medium	X (a)	X (a)		X
	III. In an alcoholic medium (≥ 5 per 100 vol)		X*	X
	04.03	Unshell fruits (peanuts, chestnuts, almonds, hazelnuts, common nuts, pinions, and others):
	A. No shell, dried.
	B. No shell and toast.				X/5 * **
	C. In the form of paste or cream.	X			X/3 * **
04.04	Entire, fresh, or chilled Hortons.
04.05	Transprocessed Horms:
	A. Dried or dehydrated vegetables, whole, in the form of flour or powder.
	B. Vegetables in pieces, in the form of pure.	X (a)	X (a)
	C. Vegetables in preserves:
	I. In an aqueous media.	X (a)	X (a)
	II. In an oil medium.	X (a)	X (a)		X
	III. In an alcoholic medium (≥ 5 per 100 vol).		X*	X
		05
05.01	Animal and vegetable, natural, or processed animal and vegetable oils (including cocoa butter, butter, melted butter).				X
05.02	Margarine, butter, and other composite fats water emulsions in oil.				06
	products and eggs.			06	06	06	06	06	06
06.01	Fish:
	A. Fresh, chilled, salted, smoked.	X
	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.	X
06.03	Carnes of all zoological species (including poultry and hunting):				X/4
	A. Fresh, chilled, salted, smoked.	X			X/4
	B. In the form of pasta, cream.	X
06.04	Meat-based transformed products (ham, micron, bacon, and others).	X			06.05
	06.05	06.05	06.05
	A. In an aqueous media.	X (a)	X (a)
	B. In an oil medium.	X (a)	X (a)		X
06.06	Unshell eggs:
	A. Powder or dried.
	B. Others.	X
06.07	Egg yolk.
	A. Liquid	X
	B. Powder or frozen
06.08	Secada egg Clara.
7	Dairy Products
07.01	Milk:
	A. integer				X (b)
	B. Partially dehydrated				X (b)
	C. partial or fully skimmed
		D. fully dehydrated
07.02	fermented milk, such as yogurt, whipped milk, and similar products		X			07.03
Nata and acidic cream			(b)
07.04	07.04	The_table_izq"> Ques:
	A. integers, with non-edible bark
		B. All others	X (a)	X (a)		X/3 *
07.05	Cuajo
	A. liquid or pasty	X (a)	X (a)
	B. powder or drying
08	Miscellaneous products.
08.01	Vinagre.		X
08.02	fried or roasted foods:
	A. Crisps, bunuelos and others.				X/5
	B. Animal source.				X/4
08.03	Preparing soups, potages, or prepared caldos (extracts, concentrates), homogenized heterogeneous feed preparations, dishes prepared:
	A. Powder or dried:
	I. That they present fats on their surface.				X/5
	II. Others
	B. Liquids or pasty:
	I. That they present fatty materials on their surface.	X (a)	X (a)		X/3
	II. Others.	X (a)	X (a)
08.04	Lashes or fermentants.
	A. In paste.	X (a)	X (a)
	B. Dry.
08.05	Cooking salt.
08.06	Salsas:
	A. Do not present fatty materials on their surface.	X (a)	X (a)
		B. Mayonnaise, mayonnaise-derived sauces, 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	Mostaces (with the exception of the dust musts of heading number 08.17).	X (a)	X (a)		X/3 * **
	08.08	Bread slices, sandwiches, toast, and others containing any food class:
	A. That they present fats on their surface.				X/5
	B. Others.
08.09	Helados.	X
08.10	Dry food:
	A. That they present fats on their surface.
		B. Others.				X/5
08.11	Frozen or superfrozen foods.
08.12	Concentrated extracts whose alcoholic strength is 5 per 100 of alcohol vol or more.			X
Cacao:
	A. Cocoa powder.				X/5 * **
	B. Paste cocoa.				X/3 * **
08.14	Coffee, even roasted or decaffeinated or soluble, granulated or powdered coffee-damage.
	08.15	Extracts of liquid coffee.	X
08.16	aromatic plants and other plants: chamomile, malva, mint, tea, tila, and others.
08.17	Species and aromas in their normal state: cinnamon, cloves, mustard powder, pepper, vanilla, saffron, and others.

Notes:

(*) This test shall be performed only in case 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 percent 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.

ANNEX IX

Basic rules for global and specific migration verification

Introduction

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 carried out on those or those who, in the particular case under 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. Their description is given in Table 2, together with 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	Food Simulator	Abbreviation
Foods (That Is, Aqueous Foods That Have A PH > 4, 5).	Products food whose test is only prescribed with the A simulant	Water distilled or water of equivalent quality.
foods (i.e., aqueous foods that have a pH) 4, 5).	Food products whose test is only prescribed with the simulant B.	3% acetic acid (w/v).	Alcoholics.		Food products whose test is only prescribed with the C simulant
Ethanol to 10% (v/v). This concentration will be adjusted to the actual alcoholic strength of the food if it is greater than 10% (v/v).	C.
foods.	Food products whose test is only prescribed with the D.	rectified olive oil or other fatty food simulants.	D.
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) 3 percent acetic acid (w/v) in aqueous solution.

b) 10 percent ethanol (v/v) in aqueous solution.

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

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 migration limits, it will 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) Where the material or object is accompanied, in accordance with the rules laid down in Article 15 of Regulation 1935/2004 of the European Parliament and of the Council of 27 October 2004, of a specific indication indicating which types of material or foods described in Table 1 may or may not be used, for example "for aqueous food only".

(c) Where the material or object is accompanied, in accordance with the rules laid down in Article 15 of Regulation 1935/2004 of the European Parliament and of the Council of 27 October 2004, of a specific indication indicating which products food or groups of foodstuffs mentioned in the list of food and simulant product names may or may not be used. This indication shall be expressed:

(i) 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 simulants cited above.

ii) In the retail stage, using an indication that refers only to a few food 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 referred to 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 food products or groups of foodstuffs are not included in the list referred to, the item 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 that calculation exceed the limits, then the material is unfit 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

	foods	Simulator
aqueous foods	Simulator A
Foods Only	B Simulator
Only Alcoholic Foods	C Simulator
foods only	D Simulator
All aqueous and acidic foods		All aqueous and alcoholic foods
C Simulator
All acidic and Alcoholic foods	Simulations B and C
All aqueous and fatty foods	Simulations A and D
All acidic foods and Fatty	Simulations B and D
All aqueous, alcoholic, and fatty foods	Simulations C and D
All acidic, alcoholic and fatty foods	Simulators B, C, and D

CHAPTER II

Conventional conditions for food simulant migration testing

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 for 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 expected temperature and contact time in the actual conditions of use, the tests shall be carried out using, according to the type of food, the simulants A and/or B and/or C for four hours at 100 ° C or for four hours at the reflux temperature, and/or the simulant D for two hours only at 175 ° C.

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: 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 ° C for 10 days. These conditions of time and temperature are by convention considered the most stringent.

III. 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 predictable.

IV. Special cases

1. 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 the table. 3.

2. If, as a result of the tests under the contact conditions specified in Table 3, physical or other changes occur in the sample which do not occur in the worst foreseeable conditions of use of the material or object examined, the migration tests shall be carried out in the worst foreseeable conditions of use in which these physical or other changes do not take place.

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

4. 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 ° C 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 possible contact conditions for the materials or objects of plastic material to be examined.

Table 3. Conventional conditions for migration testing with food simulants

Conditions predictable usage conditions	Test
duration:	Duration of the essay:
t ≤ 5 min.	See conditions set out in IV.4.
5 min < t ≤ 0.5 hours	0.5 hours.
0.5 h < t ≤ 1 time	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 ° C	5 ° C
5 ° C	20 °
20ºC	40ºC
40ºC	70 °
70ºC	100 ° C or reflux
100ºC	121 ° C (*)
121ºC	130 ° C (*)
130ºC	150 ° C (*)
T > 150 ° C	175 ° C (*)

(*) 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 ° C or at reflux temperature for four times the time selected according to the standards. General provisions of paragraph I.

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 the same rules as prescribed in Chapters I and II for the simulant D. In each test medium, the reduction coefficients set out in the list of food products and simulants should be used. To ensure that all migration limits are met, the highest value obtained using all the 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 the replacement tests

0.5 h-60 ° C

Conditions with the D Simulator	Isoctane Test Conditions	95 percent ethanol test conditions	Test conditions with MPPO (*)
10 d-5 ° C	0.5 d-5 ° C	10 d-5 ° C	-
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 ° C	0.5 h-40 ° C	-	-
0.5 h-60 ° C (**)	2.5 h-60 ° C	0.5 h-100 ° C
1 h-100 ° C	1.0 h-60 ° C (**)	3.0 h-60 ° C (**)	1 h-100
2 h-100 ºC	1.5 h-60 ° C (**)	3.5 h-60 ° C (**)	2 h-100 ° C
0.5 h-121 ° C	1.5 h-60 ° C (**)	3.5 h-60 ° C (**)	0.5 h-121 °
1 h-121 ° C	2 h-60 ° C (**)	4 h-60 ° C (**)	1 h-121 ° C
2 h-121 ° C	2.5 h-60 ° C (**)	4.5 h-60 ° C (**)	2 h-121 ° C
0.5 h-130 ° C	2.0 h-60 ° C (**)	4.0 h-60 ° C (**)	0.5 h-130 °
1 h-130 ° C	2.5 h-60 ° C (**)	4.5 h-60 ° C (**)	1 h-130
2 h-150 ºC	3.0 h-60 ° C (**)	5.0 h-60 ° C (**)	2 h-150
2 h-175 ° C	4.0 h-60 ° C (**)	6.0 h-60 ° C (**)	2 h-175 °

(*) MPPO = modified polyphenylene oxide.

(**) Volatile test means are used up to a maximum temperature of 60 ° C. 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 tests does not exceed the migration limits, once the appropriate reduction coefficients have been applied, as set out in the table of food and simulants in the Annex VIII.

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

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:

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

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