Royal Decree 866/2008 Of 23 May, Which Approves The List Of Permitted Substances For The Manufacture Of Plastic Materials And Articles Intended To Come Into Contact With Foodstuffs And Certain Test Conditions Are Regulated.

Original Language Title: Real Decreto 866/2008, de 23 de mayo, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo.

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The Royal Decree 118/2003, 31 January, whereby is approved the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with foodstuffs and regulate certain test conditions, has been amended three times, being the last time through the order SCO/3508/2006, of 10 November which modify the annexes of the Royal Decree 118/2003, 31 January, which approves the list of permitted substances for the manufacture of plastic materials and articles intended to come into contact with foodstuffs and certain test conditions are regulated.

This Royal Decree incorporates the Community provisions contained in Directive 78/142/EEC of the Council of 30 January 1978, concerning the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer, intended to come into contact with foodstuffs, Directive 82/711/EEC of the Council of 18 October 1982 , which sets the basic rules necessary for testing migration of the constituents of the materials and plastic articles intended to come into contact with foodstuffs, Directive 85/572/EEC of the Council of 19 December 1985, by which determines the list of simulants to be used for testing migration of the constituents of the materials and objects from plastic material intended to come into contact with foodstuffs and Directive 2002/72/EC of the Commission of 6 August 2002, concerning the plastic materials and articles intended to come into contact with foodstuffs.

Directive 2007/19/EC of the Commission of April 2, 2007, that amending the Directive 2002/72/EC concerning the plastic materials and articles intended to come into contact with foodstuffs and Directive 85/572/EEC of the Council which determines the list of simulants to be used for testing migration of the constituents of the materials and objects from plastic material intended to come into contact with food products, introduces important changes in Community legislation on plastic materials in contact with food, to modify substantial-mind the articles of Directive 2002/72/EC and update the annexes of the two directives.

This Royal Decree incorporates into our legal system Directive 2007/19/EC, but, for the sake of greater simplification and clarity, has consolidated in a new text along with the Royal Decree 118/2003 and its subsequent amendments.

On the other hand, the Royal Decree 1425 / 1988, of November 25, 1988, which approves health technical regulations for developing circulation and trade of plastic materials intended to come into contact with food and food products, appears referenced repeatedly in the Royal Decree 118/2003. Taking into account that this Royal Decree is repealed by the application of Community regulations and the own Royal Decree 118/2003, is required to replace these terms with the current. For greater legal clarity and simplification of legislation is the repeal of this Royal Decree.

In processing the autonomous communities, the sectors concerned, consumer associations have been heard and it has issued mandatory report of the inter-ministerial Commission for food management.

By virtue, on the proposal of the Ministers of health and environment, and Rural and Marine Affairs, according to the Council of State and after deliberation by the Council of Ministers at its meeting of May 23, 2008, D I S P O N G O: article 1. Object.

This Royal Decree aims at the adoption of the positive list of monomers and starting substances authorised for the manufacture of plastic materials and articles intended to come into contact with foodstuffs, their maximum permitted migrations ceded in migration testing, either globally or for a specific constituent, and determine the conditions of the same test.

Article 2. Definitions.

1 a purpose of this Royal Decree, means: to) plastic: organic macromolecular compound obtained by polymerization, polycondensation, polyaddition or other similar process from molecules of lower molecular weight or by chemical modification of natural macromolecules. Other substances or materials, considered additives may be added to such macromolecular compound.

(b) additive: any substance incorporated into polymers during the processes of synthesis, processing or transformation, in order to facilitate these processes and/or conveniently modify the final properties of the finished product. These additives, with the exception of dyes, shall be included in the corresponding positive lists.

(c) materials or plastics of several layers: a material or a plastic object composed of two or more layers of materials, each of which is made up exclusively of plastics, which are bound together Yes by means of adhesives or by any other means.

(d) plastic functional barrier: a barrier that consists of one or more layers of plastics which ensures that material or final object comply with provisions of article 3 of Regulation (EC) No. 1935 / 2004 of the European Parliament and the Council in this Royal Decree.

(e) non-fatty foods: foods for which is set out in annex VIII of this Royal Decree of the simulant simulants D to carry out the migration tests.

(f) support for the production of polymerization: additives used in the curing process, either for direct intervention in reaction (auxiliary of polymerization, as catalysts and primers) or to create a suitable means (auxiliaries for the production of polymers, such as suspension agents and pH regulators) to this. These brackets are not intended to remain in the finished object or have a technological effect in it.

2. the so-called complexes formed by layers of different plastics shall be deemed, for the specific purposes of this Royal Decree, as a unique and not only which is in contact with the food, although each one of them must meet separately the General or specific conditions that apply to you.

3 However, plastic materials will not be considered: a) regenerated cellulose films, varnished and not painted, as governed by the Royal Decree 1413 / 1994, of 25 June.

(b) elastomers and natural and synthetic rubbers.

(c) paper and paperboard, modified or not by the addition of plastic.

(d) surface coatings obtained from: 1 paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes.

2. mixtures of the waxes listed in the first indent, each other and/or with plastics.

(e) ion-exchange resins.

(f) Silicones.

Article 3. Scope of application.

1 this Royal Decree is applicable to the following materials and articles which, in the finished product State, are intended to come into contact or contact with foodstuffs, and are intended for this use: to) materials and objects, and parts thereof consisting exclusively of plastics b) materials and articles of plastic multi-layer c) plastic layers or plastic coatings that form seals on lids that together, are composed of two or more layers of different types of materials 2. Without prejudice to the provisions of point (c)) of the previous paragraph, this Royal Decree shall not apply to materials and articles composed of two or more layers, when at least one of them is not exclusively made up of plastics, even if the intended to come into direct contact with foodstuffs consists of exclusively plastic.

Article 4. Overall migration limit.

1 materials and plastic articles must not transfer constituents to foodstuffs in quantities exceeding 60 milligrams of the constituents released per kilogram of foodstuff or simulante foodstuff (mg/kg) (overall migration limit).

Still, such limit shall be 10 milligrams per square decimetre of surface area of material or article (mg/dm2) in the following cases: to) objects which are containers or are comparable to containers or which can fill, of a capacity of less than 500 millilitres (ml) or more than 10 litres (l);

(b) sheet, film or other materials or objects that should not be filled or for which it was not possible to calculate the relationship between its surface and the quantity of food in contact therewith.

2. as regards the plastic materials and articles intended to come into contact with food intended for infants and young children, or which are in contact with them, as defined in the Royal Decree 490/1998, 27 March, which approved the Reglamentación specific of the foods prepared from cereal and baby foods for infants and young children and the Royal Decree 72/1998 January 23, which approves the specific Reglamentación preparations for infant formula and prepared continuing, the overall migration limit will always be 60 mg/kg.

Article 5. Limits of specific migration (LME).

1. the specific migration limits in the 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 containers or are comparable to containers or which can fill, of a capacity of less than 500 millilitres (ml) or more than 10 litres.

(b) sheet, film or other materials that should not be filled or for which it was not possible to calculate the relationship between the surface of such materials and the quantity of foodstuff in contact with them.

2. in the cases considered in paragraph 1, the limits specified in annexes II and III, expressed in mg/kg shall be divided by six, as conventional conversion factor, to express them in mg/dm2.

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

Article 6. Conditions for migration testing.

1. the migration tests can be well in foods or simulants.

2. the verification of compliance with the migration limits shall be carried out in accordance with annexes I and VIII of this Royal Decree. In addition, it may be through the determination of the amount of a substance in the material or the finished object, provided that you have defined a relationship between the quantity and the value of the specific migration of the substance through an adequate experimentation or by applying commonly recognized diffusion models based on scientific evidence.

To demonstrate the non-compliance of a material or object it will be required to confirm the estimated migration value by means of experimental analysis.

3 will not be mandatory verification of compliance with the limits of specific migration provided for in paragraph 2 where it can be shown to one of the following: to) that the value of overall migration determination implies that you do not exceed the specific migration limits referred to in that paragraph.

(b) that the amount of the residual substance in the material or article, even considering the migration complete the substance, do not exceed the specific migration limit.

4. trials to see whether migration to food products conforms to the maximum limits allowed will be held in conditions of extreme length and temperature foreseeable in actual use.

5. Notwithstanding the provisions of paragraph 2, which refers to phthalates (74640, 74880, 74560, 75100 and 75105 reference numbers) referred to in section A of annex III, verification of the LME will only take place at the food simulants. However, the verification of the LME may be in foods when food has not yet been in contact with the material or object, and is made a prior test of phthalates and the level is not statistically significant, i.e. above or equal to the limit of quantification.

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

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

2 a effects of this Royal Decree, the list contained in the annex II does not include the monomers and other starting substances used only in the manufacture of: to) surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc.

(b) epoxy resin.

(c) adhesives and adhesion promoters.

(d) printing inks.

Article 8. Positive list of additives.

1 additives that can be used in the manufacture of plastic materials and articles, together with the restrictions and, where appropriate, designated specifications, are those that are listed in annex III, as well as those included in the resolution of the Undersecretary for health, of 4 November 1982, amended by order of 3 July 1985 are not foreseen in this Royal Decree.

Likewise, authorizing the use of supports for the production of polymerization, as defined in the letter f) of paragraph 1 of article 2, which are legally authorised in other Member States of the European Union, with identical restrictions and limitations that there exist, for that same purpose, in accordance with the principle of mutual recognition established by the Treaty establishing the European Community.

2. for substances of section B of annex III, the verification of compliance with the specific migration limits shall apply from 1 may of 2008 when carry out in simulants D or evidence of alternative analysis, in accordance with annex IX.

3 the lists contained in sections A and B of annex III do not include the following additives: to) additives used only to manufacture: 1 surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints.

2nd epoxy resins.

3rd adhesives and adhesion promoters.

4th printing inks.

(b) colorants.

(c) solvents.

4. to the supported values for specific migration of additives functional duality of monomer can occur in people or substance of departure and additive, shall apply the criteria laid down in this Decree.

Article 9. Products obtained by means of bacterial fermentation.

Only may be used in food contact products obtained by means of bacterial fermentation listed in annex IV.

Article 10. Food additives and flavours.

1. additives referred to in article 8 which are authorised as food additives under the law of food additives, namely, the Royal Decree 3177/1983, of 16 November, which approves are the Reglamentación additives, or as flavourings in accordance with the Royal Decree 1477 / 1990, of 2 November, which approves are the Reglamentación of flavourings used in foodstuffs and basic material (for its production, should not migrate: to) to foodstuffs in quantities having a technological effect in the final food product.

(b) to foodstuffs in which their use is authorised as additives or flavourings, in quantities exceeding the restrictions provided by the law of food additives by Royal Decree 142/2002, of February 1, which approves the positive list of additives other than colorants and sweeteners for use in the manufacture of food products , as well as their conditions of use, by Royal Decree 2001 / 1995, 7 December, which approves the list of positive colorants authorized for use in the manufacture of food products, as well as their conditions of use, and by the Royal Decree 2002 / 1995 of 7 December, which approves the positive list of additives sweeteners approved for use in the manufacture of food products as well as their conditions of use; or flavourings according to the provisions of the Royal Decree 1477 / 1990, of 2 November; or in article 8 of this Royal Decree, according to which set the greater restriction.

(c) to foodstuffs which are not authorized their use as additives or aromas of food in quantities exceeding the restrictions laid down in article 8.

2. in stages of marketing that are not phases of sale to the retail, materials and plastic articles intended to be placed in contact with foodstuffs and which contain additives referred to in paragraph 1 shall be accompanied by a written declaration containing the information referred to in article 13.

Article 11. Functional barriers.

1. in a material or object of multi-layered plastic, the composition of each layer of plastic shall conform to the provisions of this Royal Decree.

2 Notwithstanding the provisions of paragraph 1, a layer that is not in direct contact with a food and is separated from it by a plastic functional barrier, may, provided that the material or finished article meets the global and specific migration limits established by Royal Decree: to) do not comply with the restrictions and specifications set forth in Royal Decree b) be manufactured with substances other than those included in this Royal Decree or in the resolution of 4 November 1982, of the Undersecretary for health.

(3. the migration of the substances referred to in paragraph 2, point (b)), to a food or a 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 always will be expressed as a concentration in foods or simulants shall apply to a group of compounds, if they are structural and toxicologically related, in particular isomers or compounds with the same relevant functional group, and will include possible unwanted transfers.

4 substances referred to in paragraph 2, point (b)), must not belong to the following categories:


((a) substances classified as substances which are proven or suspected that they are 'carcinogenic', "mutagenic" or "toxic to reproduction' in annex I of Royal Decree 363/1995, of 10 March, which approves the regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances or b) substances classified according to the criterion of self-reliance as 'carcinogenic' "mutagenic" or "toxic to reproduction" in accordance with the rules of article 6 of the Royal Decree 363/1995, of 10 March.

Article 12. Specifications.

In part A of annex V are general specifications relating to materials and plastic objects. In part B of annex V are set other specifications on certain substances listed in annexes II, III and IV.

Article 13. Statement for marketing.

1. in stages of marketing that are not phases of sale to the retail, materials and plastics, as well as the substances intended for the manufacturing of those materials and articles, shall be accompanied by a written declaration in accordance with article 16 of Regulation (EC) No. 1935 / 2004.

2. the Manager of the company will issue the Declaration referred to in paragraph 1, which shall contain the information provided for in annex VII. The Manager of the company shall put at the disposal of the competent authorities, if they request it, the appropriate documentation showing that the materials and objects, as well as the substances intended for the manufacturing of these materials and articles, meet the requirements of this Royal Decree. Such documentation must include conditions and the results of tests and calculations, other analyses, tests on safety, either reasoning demonstrating compliance.

Article 14. Sanctioning regime.

1. without prejudice to other provisions which may result from the application, non-compliance with the provisions of this Royal Decree shall be subject to sanction, administrative instruction of the appropriate administrative proceedings, in accordance with the provisions of Chapter VI, title I, of the Act 14/1986 of 25 April, General health.

2. in particular, failure to comply with the provisions relating to the overall and specific migration limits and Declaration of conformity referred to in articles 4, 5 and 13, shall be regarded as a serious infringement, in accordance with the provisions of article 35, B), 1, of law 14/1986, General health.

(3. Likewise, failure to comply with the provisions relating to the use of monomers, additives and other substances from starting and products obtained by means of bacterial fermentation specified in articles 7, 8 and 9, shall be regarded as a very serious infringement, in accordance with article 35, C), 1, of law 14/1986, General health.

Sole transitional provision. Extension of marketing.

The plastic materials and articles intended to come into contact with foodstuffs manufactured prior to July 1, 2008, with respect to the products referred to in paragraphs 1 and 2 of the first final provision, and before May 1, 2009, in regard to other materials, and which conform to the provisions of the regulations in force prior to the entry into force of this Royal Decree they may continue trading until the end of your holdings.

Sole repeal provision. Repeal legislation.

The Royal Decree 118/2003, of 31 January 2003, which approves the list of substances permitted for the manufacture of plastic materials and articles intended to come into contact with food shall be repealed and regulate certain test conditions, and the Royal Decree 1425 / 1988, of November 25, 1988, which approves health technical regulations for developing circulation and trade of plastic materials destined to be in contact with food and food products.

First final provision. Prohibition of import and manufacture.

1. from July 1, 2008 shall be prohibited the manufacture and import of lids containing a shutter that does not meet the restrictions and specifications for substances with references no. 30340, 30401, 56800, 76815, 76866 88640 and 93760 laid down in section A of annex III.

2 starting from July 1, 2008 shall be prohibited 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 (74560, 74640, 74880, 75100 and 75105 reference no.) laid down in section A of annex III.

3. Notwithstanding the provisions of paragraphs 1 and 2, as of May 1, 2009 shall be prohibited the manufacture and import of the plastic materials and articles intended to come into contact with foods that do not conform to the provisions of this Royal Decree.

Second final provision. Skill-related title.

This Royal Decree is issued under cover of the provisions of article 149.1.16. ª of the Constitution, which attributes to the State competition in bases and general health coordination, and in accordance with the provisions of article 40, paragraphs 2 and 4 of the Act 14/1986 of 25 April, General health.

Third final provision. Schools of development.

It authorizes the Ministers of health and of environment and Rural and Marine Affairs to issue, in the field of its competences, the necessary arrangements for the updating and amendment of the annexes of this Royal Decree in accordance with the progress of the cono-cimientos scientists and technicians and to adapt them to the provisions and modifications introduced by the regulations of the European Union.

Fourth final provision. Incorporation of European Union law.

By this Royal Decree is it incorporated into Spanish law Directive 2007/19/EC of the Commission of April 2, 2007, and is updated the transposal of directives 2002/72/EC concerning the plastic materials and articles intended to come into contact with food, and 85/572/EEC of the Council of 19 December, which determines the list of simulants to be used for testing migration of constituents materials and objects of plastic materials intended to come into contact with foodstuffs, modified by it.

Fifth final provision. Entry into force.

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

Given in Madrid, on May 23, 2008.

JUAN CARLOS R.

The first Vice-President of the Government and Minister of the Presidency, MARÍA TERESA FERNÁNDEZ DE LA VEGA SANZ annex I provisions additional applicable to the control of the compliance with the limits of migration i. General provisions 1. When comparing the results of the migration tests specified in the annex IX must accept conventional so that the specific gravity of all the simulantes is 1 g/cm3. Thus, the milligrams of substance per litre of simulant (mg/l), migrated correspond numerically to milligrams of substance or substances released per kilogram of simulant and, in accordance with the conditions laid down in annex IX, to milligrams of substance or substances released per kilogram of foodstuff.

2. where the migration tests are carried out on samples taken from the material or article or on samples manufactured by the way and the quantities of foodstuff or simulante positions in contact with the sample differ from which are used in the actual conditions in which use of material or object, we will have to correct the results obtained by applying the following formula : M = m • a2 • 1000 g where: M = is the migration in mg/Kg.

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

A1 = will be the surface in dm2 of the sample in contact with food or in migration testing simulants.

A2 = will be the surface in dm2 of the material or article in real conditions of use.

q = is the amount expressed in grams of foodstuff in contact with the material or article in real conditions of use.

3. correction of specific migration in foods containing more than 20% fat fat Fat Reduction Factor (FRF) reduction coefficient: «Fat reduction coefficient» (FRF) is a rating between 1 and 5 by which measured migration of substances must divide lipophilic in a fatty food or a simulant D and its substitutes before making a comparison with the specific migration limits.

General rules the substances considered "lipophilic" for the application of the FRF are listed in annex VI. The specific migration of the substances lipophilic in mg/kg (M) will be corrected by the FRF variable between 1 and 5 (MFRF). The following equations shall be applied before comparison with the legal limit: MFRF = M/FRF FRF =(g de grasa en alimento/kg de alimento)/200 = (% FAT × 5) / 100 this correction with the FRF shall not apply in the following cases: to) when the material or object is in contact with foods that contain less than 20% fat , or is intended to be it;


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

(c) in the case of substances in the lists in annexes II and III for which included a restriction in column 4 LME = ND, or substances not included in the lists used behind a functional barrier plastic with a limit of 0.01 mg/kg migration;

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

This correction by the FRF shall apply if met a series of conditions in the following case: in regards to packaging or other articles which can be filled and with a capacity of less than 500 millilitres or more than 10 litres, and films and movies that are in contact with foods containing more than 20% fat the migration is calculated as concentration in the food or food simulant (mg/kg) corrected by the FRF, or else are recalculated as mg/dm2 without applying the FRF. If one of the two values is less than the LME, is deemed the material or object to meet the requirements.

Application of the FRF will not lead to a specific migration exceeding the overall migration limit.

4 correction of specific migration in food simulant D: the specific migration of lipophilic to the simulant substance D and its substitutes shall be corrected by the following factors: to) the reduction coefficient referred to in point 3 of annex VIII, hereinafter called coefficient of reduction of the simulant D (Simulant D Reduction Factor-DRF).

The DRF may not be applicable when the specific migration to the simulant D is higher than 80% of the content of the substance in the material or finished object (for example, thin films). Scientific or experimental evidence (for example, trials with the most critical foods) is required to determine whether the DRF is applicable. Is not applicable to substances in the community lists for which included a restriction in column 4 LME = ND or on substances not included in the lists used behind a plastic functional barrier with a migration of 0.01 mg/kg limit;

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

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

5. the determination of migration will take place on the material or article or, if this is not possible, using samples taken from the material or article or, where appropriate, specimens representative of this material or object.

The sample will be in contact with the foodstuff or simulant the equivalent to the actual conditions of contact form. To do this, testing shall be conducted so that only come into contact with the foodstuff or simulant the parts of samples intended for contact with food products in actual use. This condition is particularly important in the case of materials or objects that are composed of different layers, closures, etc.

Migration tests conducted on caps, plugs, caps, or similar devices used with closure shall carry out putting these objects in contact with the containers for which they are intended so that they correspond to the normal or foreseeable conditions of use.

In all these cases, it will be permissible to demonstrate compliance with the limits of migration by tougher tests.

6. in accordance with the provisions of article 6 of the present Royal Decree, the sample of the material or article is placed in contact with foodstuff or appropriate for a period of time and at a temperature simulant chosen in relation to the conditions of contact in actual use, in accordance with the rules laid down in annex IX. At the end of the prescribed time, will be held on the foodstuff or the simulant the analytical determination of the total amount of substance (global migration) and/or the specific quantity of one or more substances (specific migration) released by the sample.

7. when a material or article is intended to come into contact again with food products, test or evidence of migration must be carried out three times on the same sample in accordance with the conditions laid down in annex IX using another sample of the food or simulant in each test. The conformity of such material or object with the limits will be checked on the basis of the level of migration that is found in the third test. However, if there is conclusive proof that the level of migration does not increase in the second and third tests and if it does not exceed the limit or limits of migration in the first test will not be necessary as follows.

8 caps, caps, plugs, caps and similar closing devices: to) if the intended use is known, these objects will be tested by applying them to the containers to which they are intended under conditions of closure corresponding to a normal or foreseeable use. It is assumed that these objects are in contact with a certain amount of food in the container. The results are expressed in mg/kg or mg/dm2 in accordance with the rules of articles 4 and 5, taking into account all the contact surface of the locking device and container.

(b) if the intended use of these objects is unknown, they undergo a test in a separate trial and the result is expressed in mg/object. In your case, the retrieved value will be added to the quantity migrated from the container in which they are intended.

II. Special provisions related to global migration 1. If using the aqueous simulants specified in annex VIII, the determination of the total quantity of the substance released by the sample may be carried out by evaporation of the simulant and determination of the weight of the residue.

If using rectified olive oil or any substitute products can follow the following procedure: weighed sample or object before and after contact with the simulant. The amount of this absorbed by the sample will be extracted and determined quantitatively. The quantity of simulant that is subtracted from the weight of the sample measured after contact with the simulant. The difference between the weights fixed start and end will represent the global migration of the examined sample.

When a material or article 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 provided that they allow 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 conducted in three identical samples of material or object. One of these will undergo appropriate tests and determined the global migration (M1); the second and third samples shall be subjected to the same conditions of temperature, but periods of contact shall be respectively two and three times higher than specified and shall be determined in each case global migration (M2 and M3, respectively).

He is considered to be material or object as long as M1 or M3-M2 do not exceed the overall migration limit.

2. a material or article that exceeds the limit of global migration in amounts not greater than the analytical tolerance mentioned below should be considered in accordance with this Royal Decree.

The following analytical tolerances are allowed: a) 20 mg/Kg or 3 mg/dm2 in migration tests using olive oil rectified or substitute products.

b) 12 mg/Kg or 2 mg/dm2 in migration tests using the other simulants that referred to in annex VIII.

3. not shall be carried out migration tests using olive oil or substitutes to verify compliance with the limit of global migration in the cases in which it has shown conclusively that the specified analytical method is inadequate from a technical point of view.

In such cases, substances that do not have limits of specific migration or other restrictions in the list collection in annex II applies to a generic limits of specific migration of 60 mg/Kg or 10 mg/dm2, according to the case. The sum of all specific migrations determined shall not exceed, however, 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 establishes the list of monomers and other starting substances. This list contains: to) substances intended to be subjected to polymerization, which includes polycondensation, polyaddition or any other similar process, to produce macromolecules.


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

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

2 substances listed below are not included but they are authorized and used intentionally: a) sales (be considered double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of acids, phenols or alcohols authorized; However appear in the list of names that contain the word 'acid (s) [...], salt (s)' in case the / corresponding (s) (s) acid free (s) are not listed (n);

(b) salts (will be considered double salts and acid salts) of zinc of acids, phenols or alcohols authorized. These salts is applied a group LME = 25 mg/kg (expressed as Zn). The restriction for Zn applies also to: i) substances whose name contains 'acid (s) [...], salt (s)' that appear in the lists, if the / corresponding (s) (s) acid free (s) are not listed (n), ii) substances referred to in Note 38 of annex III.

3 the list also includes the following substances that could be found in the finished product: to) substances that may be encountered in the product completed as: i) impurities in the substances used.

(ii) intermediate reaction products.

(iii) breakdown products.

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

(c) mixtures of the authorised substances.

Materials and articles which contain the substances referred to in paragraphs a), b), 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 that repealing directives 80/590/EEC and 89/109/EEC.

4. the authorized substances shall be of good technical quality, in terms of the purity criteria.

5 the list contains the following information: a) column 1 (number Ref.): reference number EEC of the substance of the packaging, the list.

b) column 2 (CAS number): the CAS (Chemical Abstracts Service) registry number.

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

d) column 4 (restrictions and/or specifications).

These may include: a) the limits of specific migration (LME).

(b) maximum allowable number of substance in the material or object completed (CM).

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

(d) any other restriction specifically mentioned.

(e) any other type of specifications related to the substance or to the polymer.

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

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

8. in column 4 of the table are used a series of abbreviations whose meaning is as follows: LD = detection limit of the analytical method.

PT = material or finished article.

NCO = isocyanate functional group.

ND = not detectable. For the purposes of this Royal Decree the term «not detectable» means substance you should not detect by a validated analytical method you find it with the indicated limit of detection (LD). If there is no such method at the time of the analysis, you can use an analytical method with appropriate characteristics to the limit of detection, waiting for to develop a validated method.

CM = allowed maximum quantity of the «residual» substance in the material or object. For the purposes of this Royal Decree, the amount of substance in the material or article should be determined by a validated method of analysis. There is no currently this method, could use an analytical method that possess the adequate sensitivity to reliably determine the specified limit while prepares a validated method.

CM (T) = maximum amount permitted of the «residual» substance in the material or object, expressed as total of groups or substances indicated; for purposes of this Royal Decree, the amount of the substance in the material or article shall be determined by a validated method of analysis; If it did not exist at the moment such method, you can use an analytical method that possess the necessary sensitivity to reliably determine the specified limit, waiting for it to develop a validated method.

CMA = maximum permitted quantity of the substance in the material or finished object, expressed as mg per 6 dm2 of the surface in contact with foodstuffs; for the purposes of this Royal Decree, the quantity of the substance on the surface of the material or article shall be determined by a validated method of analysis; If it did not exist at the moment such method, you can use an analytical method that possess the necessary sensitivity to reliably determine the specified limit, waiting for it to develop a validated method.

QMA(t) = maximum amount permitted of the «residual» substance in the material or object, expressed as total of groups or substances indicated per 6 dm2 of the surface in contact with foodstuffs; for purposes of this Royal Decree, the amount of the substance in the material or article shall be determined by a validated method of analysis; If it did not exist at the moment such method, you can use an analytical method that possess the necessary sensitivity to reliably determine the specified limit, waiting for it to develop a validated method.

LME = limits of specific migration in food or food simulants, unless stated otherwise; for the purposes of this Royal Decree, the specific migration of the substance shall be determined by a validated method of analysis; If it did not exist at the moment such method, you can use an analytical method that possess the necessary sensitivity to reliably determine the specified limit, waiting for it to develop a validated method.

SML(t) = specific migration in food or food simulants limit, expressed as total of groups or substances indicated; for the purposes of this Royal Decree, the specific migration of the substances shall be determined by a validated method of analysis; If it did not exist at the moment such method, you can use an analytical method that possess the necessary sensitivity to reliably determine the specified limit, waiting for it to develop a validated method.

SECTION to authoritative list of monomers and other starting Ref No. substances.
(1) CAS No. (2) name (3) restrictions and/or specifications (4) 10030 10060 abietic acid 000514-10-3 000075-07-0 acetaldehyde SML(t) = 6 mg/kg (2) 10090 000064-19-7 acetic acid 10120 000108-05-4 vinyl LME = 12 mg/kg 10150 acetate 000108-24-7-acetic anhydride 10210 000074-86-2 acetylene 10599/90A 061788-89-4 distillates Dimers of unsaturated fatty acids (C18) CMA (T) = 0,05 mg / 6 dm 2 (27) 10599/91 061788-89-4 Dimers without distillation of unsaturated fatty acids (C18) CMA (T) = 0,05 mg/6 dm2 (27) 10599/92A 068783-41-5 distilled hydrogenated Dimers of unsaturated fatty acids (C18) CMA (T) = 0,05 mg/6 dm2 (27) 10599/93 068783-41-5 hydrogenated Dimers without distillation of unsaturated fatty acids (C18) CMA (T) = 0,05 mg/6 dm2 (27) 10630 000079-06-1 acrylamide LME = ND (DL = 0,01 mg/Kg) 10660 015214-89-8 acid 2-water-2-metilpropanosulfo-nico LME = 0,05 mg/kg 10690 000079-10-7





Acrylic acid SML(t) = 6 mg/kg (36) 10750 002495-35-4 acrylate benzyl SML(t) = 6 mg/kg (36) 10780 000141-32-2 acrylate n-butyl SML(t) = 6 mg/kg (36) 10810 002998-08-5 acrylate of s-butyl SML(t) = 6 mg/kg (36) 10840 001663-39-4 acrylate of tert-butyl SML(t) = 6 mg/kg (36) 11005 012542-30-2






CMA = 0,05 mg/6 dm2 11245 diciclopentenilo acrylate 002156-97-0 acrylate dodecyl LME = 0,05 mg/kg (1) 11470 000140-88-5 acrylate ethyl SML(t) = 6 mg/kg (36) 11500 000103-11-7 LME = 0,05 mg/kg 11510 2-ethylhexyl acrylate 000818-61-1 acrylate hydroxyethyl see «etilengli-col Monoacrilato» 11530 00999-61-1 CMA 2-hydroxypropyl acrylate = 0,05 mg/6 dm2 for the sum of acrylate 2-hydro-xipropilo and 2-hydro-xiisopropilo acrylate and in accordance with the specifications this-blecidas in Annex V 11590 000106-63-8 acrylate isobutyl SML(t) = 6 mg/kg (36) 11680 000689-12-3 acrylate isopropyl SML(t) = 6 mg/kg (36) 11710 000096-33-3 Methylacrylate SML(t) = 6 mg/kg (36) 11830 000818-61-1 Monoacrilato of ethylene glycol SML(t) = 6 mg/kg (36) 11890 002499-59-4 acrylate n-Octyl SML(t) = 6 mg/kg (36) 11980 000925-60-0 acrylate propyl SML(t) = 6 mg/kg (36) 12100 000107-13-1 Acrilonitrilo LME = ND (LD = 0.020 mg/kg (, analytical tolerance included) 12130 000124-04-9. 004074-90-2 Adipate 12265 adipic acid of divinyl CM = 5 mg/kg in PT. For use only as comonomer 12280 002035-75-8 adipic anhydride 12310 albumin 12340 albumin, coagulated by formaldehyde 12375 MONOHYDRIC ALCOHOLS aliphatic saturated, linear, primary (C4-C22) 12670 002855-13-2 1-Amino-3-aminometil-3,5,5-trimetilciclo-hexano LME = 6 mg/kg 12761 000693-57-2 acid 12-aminododecanoic LME = 0,05 mg/kg 12763 000141-43-5 2-Aminoethanol LME = 0,05 mg/kg.
Substance not for use in polymers contacting foods for which the simulant is set D in annex VIII and only for indirect contact with food, behind the PET 12765 084434 layer - 12 - 8 N-(2-Aminoetil)-beta-alaninato of sodium LME = 0,05 mg/kg 12786 000919-30-2 3-aminopropiltrietoxisilane residual extractable content of 3-Aminopropiltrietoxisilane should be less than 3 mg/kg filler when used to increase the reactivity of the surface of inorganic filler materials and LME = 0,05 mg/kg when used for the surface treatment of materials and objects 12788 002432-99-7 acid 11-aminoundecanoic LME = 5 mg/kg 12789 007664-41-7 ammonia 12820 000123-99-9 12970 azelaic acid azelaic anhydride 004196-95-6 13000 001477-55-0 1, 3-Bencenodimetanamina LME = 0,05 mg/kg 13060 trichloride 004422-95-1 of the acid 1,3,5-bencenotricar-boxilico CMA = 0,05 mg/6 dm2 (determi-swim as acid 1,3,5-ben-cenotricarboxilico) 13075 000091-76-9





Benzoguanamine see «2,4-Diamino-6-fenil-1,3,5-triazina» 13090 000065-85-0 acid benzoic 13150 000100-51-6 Alcohol benzyl 13180 000498-66-8 bicycle [2.2.1] hept-2-Ene (= norborneno) LME = 0,05 mg/kg 13210 001761-71-3 Bis(4-aminociclohexil) methane LME = 0,05 mg/kg 13317 132459-54-2 N, N'-Bis [4-(etoxicarbonil) phenyl] - 1, 4, 5, 8-naftalenotetracarboxidiimida 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 1, 3-bis (2-hidroxietoxi) benzene LME = 0,05 mg/kg 13326 000111-46-6 ether bis(2-hidroxietílico) see «Diethylene glycol» 13380 000077-99-6 2, 2-Bis (hydroxymethyl) - 1-butanol see «1,1,1-Trimetilolpropano» 13390 000105-08-8 1, 4-Bis (hydroxymethyl) cyclohexane 13395 004767-03-7 acid 2, 2-bis (hydroxymethyl) propionic CMA = 0,05 mg/6 dm2 13480 000080-05-7 2, propane 2-bis(4-hidroxifenil) SML(t) = 0,6 mg/kg (28) 13510 001675-54-3»





2,2-bis (4-hydroxyphenyl) propane bis(2,3-epoxipropil) 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 Bis(anhídrido ftálico) of 2, 2-bis(4-hidroxi-fenil) propane LME = 0,05 mg/kg 13550 000110-98-5 ether Bis (hidroxipropílico) see 13560 «Dipropilengicol» 0005124-30-1 Bis(4-isocianatociclohexil) methane see «4, 4' - diisocyanate dici-clohexilmetano» 13600 047465-97-4 3,3-Bis(3-metil-4-hidroxifenil)-2- Indo-linona LME = 1.8 mg/kg 13607 000080-05-7 Bisphenol A Ver '2, 2-Bis (4-hydroxyphenyl) pro-cloth' 13610 001675-54-3 ether Bisphenol A Ver bis(2,3-epoxipropílico) «ether bis (2, 3-epoxipropílico) 2, 2-bis (4-hydroxyphenyl) propane» 13614 038103-06-9 Bis(anhídrido ftálico) of Bisphenol A view «Bis(anhídrido ftálico) of 2, 2-bis (4-hydroxyphenyl) propane» 13617 000080-09-1 Bisphenol S see ' 4, 4' - Dihidroxidifenilsulfona» 13620 010043-35-3 acid boric SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice to the provisions of the Real Decree 140/2003 of 7 February, establishing the health criteria of the quality of water for human consumption 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-epoxipropil) CM = 1 mg/kg (expressed as epoxy group PT (, PM = 43) 13810 000505-65-7 1, 4-Butanodiolformal 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) solely for use as comonomer for the preparation of poly-numeric additive 14020 000098-54-4 4-tert-butylphenol LME = 0,05 mg/kg 14110 butyraldehyde 000123-72-8






 






14140 000107-92-6 butyric 14170 000106-31-0 anhydride butyric acid 14200 000105-60-2 caprolactam SML(t) = 15 mg/kg (5) 14230 caprolactam 002123-24-2, salt of sodium SML(t) = 15 mg/kg (5) (expre-sado as caprolactam) 14260 000502-44-3 Caprolactona LME = 0,05 mg/kg (expressed as the sum of caprolactona and 6-hidroxihexanoico acid) 14320 Caprylic acid 000124-07-2 14350 000630-08-0 carbon 14380 monoxide





000075-44-5 CM Carbonyl chloride = 1 mg/kg in PT 14411 008001-79-4 Castor 14500 oil 009004-34-6 cellulose 14530 007782-50-5 chlorine 14570 000106-89-8 1-Cloro - 2, 3-epoxypropane see «Epichlorohydrin» 14650 000079-38-9 Clorotrifluoretileno CMA = 0.5 mg/6 dm2 14680 000077-92-9 citric acid 14710 000108-39-4 m - Cresol 14740 000095-48-7 o-Cresol





 






14770 000106-44-5 p-Cresol 14800 003724-65-0 acid Croton QMA(t) = 0,05 mg/6 dm2 (33) 14841 000599-64-4 4-Cumilfenol LME = 0,05 mg/kg 14880 000105-08-8 1, 4-Ciclohexanodimetanol see '1, 4-Bis (hydroxymethyl) ciclo-hexano' 14950 003173-53-3 isocyanate of cyclohexyl CM (T) = 1 mg/kg in PT (expressed as NCO) (26) 15030 000931-88-4 Cicloocteno LME = 0,05 mg/kg. For use only in polymers contacting foods for which simulant A in annex VIII 15070 001647-16-1 is set 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 - Deceno LME = 0,05 mg/kg 15250 000110-60-1 1, 4-Diaminobutane 15267 000080-08-0 4 4-diaminodiphenyl Sulfone LME = 5 mg/kg 15272 000107-15-3 1, 2-Diaminoetano see «Ethylenediamine» 15274





000124-09-4 1, 6-Diaminohexane see «Hexamethylenediamine» 15310 000091-76-9 2,4-Diamino-6-fenil-1,3,5-triazina CMA = 5 mg/6 dm2 15565 000106-46-7 1, 4-dichlorobenzene LME = 12 mg/kg 15610 000080-07-9 4, 4' - Diclorodifenilsulfona LME = 0,05 mg/kg 15700 005124-30-1 4, 4' - diisocyanate diciclohexilmetano CM (T) = 1 mg/kg (expressed as NCO) (26) 15760 000111-46-6 diethylene glycol SML(t) = 30 mg/kg (3) 15790 000111-40-0 Diethylenetriamine LME = 5 mg/kg 15820 000345-92-6





4, 4' - Difluorobenzofenona 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' - Dihidroxibenzofenona LME (T) = 6 mg/kg (15) 16000 000092-88-6 4, 4' - Dihidroxidifenilo LME = 6 mg/kg 16090 000080-09-1 4, 4' - Dihidroxidifenilsulfona LME = 0,05 mg/kg 16150 000108-01-0 Dimethylaminoethanol LME = 18 mg/kg






16210 006864-37-5 3, 3' - dimethyl-4, 4' - diaminodiciclohexilme-tano LME = 0,05 mg/kg (32). For use only in polyamides 16240 000091-97-4 4, 4' - diisocyanate de 3, 3' - dimetilbifenilo CM (T) = 1 mg/kg (expressed as NCO) (26) 16360 000576-26-1 2, 6-Dimitilfenol LME = 0,05 mg/kg 16390 000126-30-7 2, 2' - dimethyl-1, 3-Propanediol LME = 0,05 mg/kg 16450 000646-06-0 1, 3-Dioxolano LME = 5 mg/kg 16480 000126-58-9 Dipentaerythritol 16540 000102-09-0 LME = 0,05 mg/kg 16570 diphenyl carbonate 004128-73-8 4, 4' - diisocyanate ether diphenyl 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 Difenilsulfona SML(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 divinilben - breast and etilvinilbenceno and in accordance with the specifications laid down in annex V 16694





013811-50-2 n, N'-diethylene-2-imidazolidinona CM = 5 mg/kg in PT 16697 000693-23-2 acid n-dodecanedioic 16704 000112-41-4 1-Dodeceno LME = 0,05 mg/kg 16750 000106-89-8 Epichlorohydrin CM = 1 mg/kg in PT 16780 000064-17-5 ethanol 16950 000074-85-1 ethylene 16955 000096-49-1 carbonate from ethylene residual content = 5 mg/kg Hydrogel at a maximum of 10 g of Hydrogel ratio per 1 kg of product will increas-ticio. The hydrolysate contains ethylene glycol with LME = 30 mg / kg 16960 000107-15-3 ethylenediamine LME = 12 mg/kg 16990 000107-21-1 ethylene glycol SML(t) = 30 mg/kg (3) 17005 000151-56-4 Ethyleneimine LME = ND (LD = 0.01 mg / kg) 17020 000075-21-8 CM ethylene oxide = 1 mg/kg in PT 17050 000104-76-7 2-ethyl-1-hexanol LME = 30 mg/kg 17110 016219-75-3 5-etilidenbiciclo [2.2.1] hept-2-Ene CMA = 0,05 mg/6 dm2. The ratio surface/quantity of food should be lower-back 2 dm2/kg 17160 000097-53-0 Eugenol LME = ND (LD = 0,02 mg/kg, analytical tolerance included) 17170 061788-47-4






17200 coconut oil fatty acids 068308-53-2 17230 soybean oil fatty acids 061790-12-3 17260 tall oil fatty acids 000050-00-0 formaldehyde SML(t) = 15 mg/kg (22) 17290 fumaric acid 000110-17-8 17530 000050-99-7 glucose 18010 000110-94-1 18070 glutaric acid glutaric anhydride 000108-55-4 18100 glycerol 000056-81-5





 






18220 068564-88-5 acid N-heptilaminoundecanoico LME = 0,05 mg/kg (1) 18250 000115-28-6 acid hexacloroendometilentetrahidrof-talico LME = ND (LD = 0.01 mg/kg) 18280 anhydride 000115-27-5 hexacloroendometilentetrahi-droftalico LME = ND (LD = 0.01 mg/kg) 18310 036653-82-4 1-Hexadecanol 18430 000116-15-4 Hexafluoropropileno LME = ND (LD = 0.01 mg/kg) 18460 000124-09-4 Hexamethylendiamine LME = 2.4 mg/kg 18640 000822-06-0 diisocyanate hexamethylene CM (T) = 1 mg/kg (expressed as NCO) (26) 18670 000100-97-0 Hexamethylenetetramine SML(t) = 15 mg/kg (22) (expre-sado as formaldehyde) 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 hydroquinone see ' 1, 4-Dihydroxybenzene» 18880 000099-96-7 acid p-hydroxybenzoic 18896 001679-51-2 4-(hydroxymethyl) - 1 - cyclohexene LME = 0,05 mg/kg 18897 016712-64-4-6-hydroxy-2-naftalenocarboxilico acid LME = 0,05 mg/kg 18898





000103-90-2 n-(4-hydroxyphenyl) acetamide LME = 0,05 mg/kg 19000 000115-11-7 isobutene 19060 000109-53-5 ether isobutilvinilico CM = 5 mg/kg in PT 19110 004098-71-9 1-Isocianato-3-isocianatometil-3,5,5-tri-metilciclohexano CM (T) = 1 mg/kg (expressed as NCO) (26) 19150 000121-91-5 isophthaloyl LME = 5 mg/kg 19210 001459-93-4 LME = 0,05 mg/kg 19243 dimethyl Isophthalate 000078-79-5 isoprene see «2-methyl-1, 3-butadiene» 19270 000097-65-4 acid ita conical 19460 000050-21-5 19470 lactic acid 000143-07-7 lauric acid 19480 002146-71-6 laurate vinyl 19490 000947-04-6 Laurolactama LME = 5 mg/kg 19510 011132-73-3 lignocellulose 19540 000110-16-7 maleic acid SML(t) = 30 mg/kg (4) 19960 maleic anhydride 000108-31-6 SML(t) = 30 mg/kg (4) (expressed as maleic acid) 19975 000108-78-1 melamine see "2, «4 6-Triamino-1, 3, 5-triazine» 19990 000079-39-0 Metalcrilamida LME = ND (LD = 0,02 mg/kg, analytical tolerance included) 20020 methacrylic acid 000079-41-4 SML(t) = 6 mg/kg (37) 20050 000096-05-9 methacrylate allyl LME = 0,05 mg/kg 20080 002495-37-6 methacrylate benzyl SML(t) = 6 mg/kg (37) 20110 000097-88-1 methacrylate butyl SML(t) = 6 mg/kg (37) 20140 002998-18-7 methacrylate of sec-butyl SML(t) = 6 mg/kg (37) 20170 tert-butyl SML(t) methacrylate 000585-07-9 ) = 6 mg/kg (37) 20260 LME = 0,05 mg/kg 20410 cyclohexyl methacrylate 000101-43-9 002082-81-7 Dimethacrylate of 1,4-Butanediol LME = 0,05 mg/kg 20440 LME = 0,05 mg/kg 20530 ethylene glycol Dimethacrylate 000097-90-5 002867-47-2 2-(dimethylamino) ethyl methacrylate LME = ND (LD = 0,02 mg / kg, analytical tolerance included) 20590 000106-91-2 methacrylate 2,3-epoxypropyl CMA = 0,02 mg/6 dm2 20890 000097-63-2 methacrylate ethyl SML(t) = 6 mg/kg (37) 21010 000097-86-9 isobu methacrylate Tilo SML(t) = 6 mg/kg (37) 21100 004655-34-9 methacrylate isopropyl SML(t) = 6 mg/kg (37) 21130 000080-62-6 methacrylate methyl SML(t) = 6 mg/kg (37) 21190 000868-77-9 Monometacrilato of ethylene glycol SML(t) = 6 mg/kg (37) 21280 0-70-002177 methacrylate phenyl SML(t) = 6 mg/kg (37) 21340 002210-28-8 methacrylate propyl SML(t) = 6 mg/kg (37) 21370 010595-80-9 2-sulfoetilo 21400 methacrylate methacrylate 054276-35-6 of sulfopropilo CMA = 0, 05 mg/6 dm2 21460 methacrylic anhydride 000760-93-0 SML(t) = 6 mg/kg (37) 21490 000126-98-7 Metacrilonitrilo LME = ND 21520 (LD = 0.020 mg/kg, analytical tolerance included) 001561-92-8 Metalilsulfonato sodium LME = 5 mg/kg 21550 000067-56-1 methanol 21640 000078-79-5 2-methyl-1, 3-butadiene CM = 1 mg/kg in PT or LME = ND (LD = 0,02 mg / kg, analytical tolerance included) 21730 000563-45-1 3-methyl-1-butene CMA = 0.006 mg/6 dm2. For use only in polypropylene 21765 106246-33-7 4, 4' - Metilenbis(3-cloro-2,6-dietilanilina) CMA = 0,05 mg/6 dm2 21821 000505-65-7 1, 4-(Methylendioxy) butane see ' 1, 4-Butanodiolformal» 21940 000924-42-5 N - Metilolacrilamida LME = ND (LD = 0.01 mg/kg) 21970 000923-02-4 N - Metilolmetacrilamida LME = 0,05 mg/kg 22150 000691-37-2 4-methyl-1-polymethylpentene LME = 0,05 mg/kg 22210 000098-83-9 alpha-methylstyrene LME = 0,05 mg/kg 22331 025513-64-8 mixture of (35-45% w/w) 1, 6-diamino-2 2, 4-trimetilhexano and (55-65% w/w) 1, 6-diamino-2, 4, 4 – trimetilhexano CMA = 5 mg/6 dm2







22332 mixture of (40% w/w) 1, 2,2,4-trimetilhexano 6-diisocyanate and (60% w/w) 1, 6-dii socianato 2,4,4-trimetilhexano CM (T) = 1 mg/kg (expressed as NCO) (26) 22350 myristic acid 000544-63-8 22360 001141-38-4 acid 2, 6-naftalendicarboxilico LME = 5 mg/kg 22390 000840-65-3 2, 6-dimethyl LME = 0,05 mg/kg 22420 Naftalenodicarboxilato 003173-72-6 1, 5-diisocyanate naphthalene CM (T) = 1 mg/kg (expressed as NCO) (26) 22437 000126-30-7 Neopentyl see "2, 2-dimethyl-1 3-propane-diol» 22450 009004-70-0 nitrocellulose 22480 000143-08-8 1-Nonanol 22550 000498-66-8 Norborneno see «bicycle [2.2.1] hept-2-Ene» 22570 000112-96-9 isocyanate octadecilo CM (T) = 1 mg/kg (expressed as NCO) (26) 22600 000111-87-5 1-Octanol 22660 000111-66 - 0 1-Octene LME = 15 mg/kg 22763 000112-80-1 oleic acid 22775 LME oxalic acid 000144-62-7 (T) = 6 mg/kg (29)






22778 007456-68-0 4, 4' - oxibis (bencenosulfonilazida) CMA = 0,05 mg/6 dm2 22780 000057-10-3 22840 Palmitic acid 000115-77-5 pentaerythritol 22870 000071-41-0 1-Pentanol 22900 000109-67-1 1-Polymethylpentene LME = 5 mg/kg 22932 001187-93-5 ether perfluorometil perfluorovinilico LME = 0,05 mg/kg. Should only be used for non-stick coatings 22937 001623-05-8 ether perfluoropropilperfluorovinilico LME = 0,05 mg/kg 22960 000108-95-2 phenol 23050 000108-45-2 1, 3-Fenilendiamina LME = ND (LD = 0,02 mg/kg, analytical tolerance included) 23070 000102-39-6 acid (1, 3-fenilenedioxi) diacetic CMA = 0,05 mg/6 dm2 23155 000075-44-5 phosgene see «Carbonyl chloride» 23170 007664-38-2 acid phosphoric 23175 000122-52-1 CM triethyl Phosphite = ND (LD = 1 mg/kg in PT) 23187 phthalic acid see «Terephthalic acid» 23200 000088-99-3. 000131-17-9 phthalate 23230 o-phthalic acid of diallyl LME = ND (LD = 0.01 mg/kg) 23380 000085-44-9 phthalic anhydride 23470 000080-56-8 alpha-pinene 23500 000127-91-3 thread 23547 009016-00-6 063148-62-9 Polydimethylsiloxane (PM > 6 800) in accordance with the specified-tions of annex V 23590 025322-68-3 polyethylene glycol





 






23651 025322-69-4 Polipropilenoglicol 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 Propionaldehyde 23890 000079-09-4 propionic acid 23920 000105-38-4 propionate vinyl SML(t) = 6 mg/kg (2) (expressed as acetaldehyde)






23950 propionic anhydride 000123-62-6 23980 000115-07-1 propylene 24010 000075-56-9 CM propylene oxide = 1 mg/kg in PT 24051 000120-80-9 Pirocatecol see ' 1, 2-Dihydroxybenzene» 24057 000089-32-7 anhydride dianhydride LME = 0,05 mg/kg (expressed as acid dianhydride) 24070 073138-82-6 acids 24072 Rosin and resin acids see Resorcinol 000108-46-3 ' 1, 3-Dihydroxybenzene» 24073 000101-90-6 ether diglicidilic the CMA = 0.005 mg/6 dm2 resorcinol or. Substance not for use in polymers contacting foods for which the simulant is set D in annex VIII and only for indirect contact with food, behind the PET 24100 layer 008050-09-7 Rosin 24130 008050-09-7 gum Rosin see «Rosin» 24160 24190 tall oil Rosin 008052-10-6 008050-09-7 wood Rosin see «Rosin» (Nº of REF. 24100) 24250 009006-04-6 natural rubber 24270 000069-72-7 acid Salicylic 24280 000111-20-6





24430 sebacic acid sebacic anhydride 002561-88-8 24475 001313-82-2 sulfide sodium 24490 000050-70-4 Sorbitol 24520 008001-22-7 soybean 24540 009005-25-8 starch, food grade 24550 000057-11-4 stearic acid 24610 000100-42-5 styrene 24760 026914-43-2 acid estirenosulfonico LME = 0,05 mg/kg 24820





000110-15-6 succinic acid 24850 000108-30-5 anhydride succinic 24880 000057-50-1 sucrose 24886 046728-75-0 5-Sulfoisoftalico acid, salt monolithic LME = 5 mg/kg, and for lithium SML(t) = 0,6 mg/kg (8)(expresado como litio) 24887 006362-79-4 5-Sulfoisoftalico acid, monosodium salt LME = 5 mg/kg 24888 dimethyl, LME = 0,05 mg/kg 24903 mono-sodica salt 003965-55-7 5-Sulfoisoftalato 068425-17-2 syrups, hydrolyzed starch , concerns-laminates according to the specifi-cations laid down in annex V 24910 Terephthalic acid 000100-21-0 LME = 7,5 mg/kg 24940 Terephthalic acid dichloride 000100-20-9






SML(t) = 7,5 mg/kg (expressed as Terephthalic acid) 24970 000120-61-6 25080 dimethyl terephthalate 001120-36-1 1-Tetradeceno LME = 0,05 mg/kg 25090 000112-60-7 Tetraetilenglicol 25120 000116-14-3. Tetrafluoroethylene LME = 0,05 mg/kg 25150 000109-99-9 tetrahydrofuran LME = 0.6 mg/kg 25180 000102-60-3 N, N, N ', N'-Tetrakis(2-hidroxipropil) ethylenediamine 25210 000584-84-9 2 4-diisocyanate toluene CM (T) = 1 mg/kg (expressed as NCO) (26)






25240 000091-08-7 2 6-diisocyanate toluene CM (T) = 1 mg/kg (expressed as NCO) (26) 25270 026747-90-0 2 4-diisocyanate toluene, dimmer CM (T) = 1 mg/kg (expressed as NCO) (26) 25360 Trialquil (C5-C15) acetate of 2, 3-epo-xipropilo CM = 1 mg/kg in PT (expressed as epoxy group, molecular weight = 43) 25380 Trialquil(C7-C17) vinyl acetate (= versatato of vinyl) CMA = 0,05 mg/6 dm2 25385 000102-70-5 Trialilamina of in accordance with the specifi-cations of annex V 25420 000108-78-1 2,4,6-Triamino-1 3, 5-triazine LME = 30 mg/kg 25450 026896-48-0 Triciclodecanodimetanol LME = 0,05 mg/kg 25510 000112-27-6 triethylene glycol 25540 000528-44-9 trimellitic acid SML(t) = 5 mg/kg (35) 25550 trimellitic anhydride 000552-30-7 SML(t) = 5 mg/kg (35) (expressed as trimellitic acid) 25600 000077-99-6 1,1,1-Trimetilolpropano LME = 6 mg/kg 25840 003290-92-4 Trimetacrilato of 1,1,1-trimetilolpropano LME = 0,05 mg/kg 25900 000110-88-3 trioxane LME = 5 mg/kg






25910 024800-44-0 Tripropilenglicol 25927 027955-94-8 1,1,1-Tris(4-hidroxifenol)etano CM = 0.5 mg/kg in PT. For use only in polycarbonates 25960 000057-13-6 Urea 26050 000075-01-4 CM vinyl chloride = 1 mg/Kg in PT. LME = 0, 01 mg/Kg.






26110 000075-35-4 chloride vinylidene CM = 5 mg/kg in PT or LME = ND (LD = 0.05 mg / kg) 26140 000075-38-7 LME = 5 mg/kg 26155 vinylidene fluoride 001072-63-5 1-Watersoluble CM = 5 mg/kg in PT 26170 003195-78-6 N - vinyl-N-metilacetamida CM = 2 mg/kg in PT 26320 002768-02-7 Viniltrimetoxisilano CM = 5 mg/kg in PT 26360 007732-18-5 water in accordance with the Royal Decree 140/2003 , 7 February, establishing sanitary criteria of the quality of water for human consumption (1) warning: risk of overcome the LME in fatty food simulants.

(2) SCI (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 10060 and 23920, must not exceed the specified restriction.

(3) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 15760, 16990, 47680, 53650 and 89440, must not exceed the specified restriction.

(4) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 19540, 19960 and 64800, must not exceed the specified restriction.

(5) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 14200, 14230 and 41840, must not exceed the specified restriction.

(8) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the US reference 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, must not exceed the specified restriction.

(15) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 15970, 48640, 48720, 48880, 61280, 61360 and 61600, must not exceed the specified restriction.

(22) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 17260, 18670, 54880 and 59280, must not exceed the specified restriction.

(23) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 13620, 36840, 40320 and 87040, must not exceed the specified restriction.

(24) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 13720 and 40580, must not exceed the specified restriction.

(25) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 16650 and 51570, must not exceed the specified restriction.

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

(27) CMA (T) means in this case that the sum of the residual quantities of the following substances, identified with the us of ref. 10599/90A, 10599/91, 10599/92A and 10599/93, should not exceed the indicated constraint.

(28) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 13480 and 39680, must not exceed the specified restriction.

(29) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 22775 and 69920, must not exceed the specified restriction.

(32) when there is a fat contact, conformity shall be assessed using isoctane as a substitute for the simulant D (unstable).

(33) CMA (T) means in this case that the sum of the residual quantities of the following substances, identified with the us of ref. 14800 and 45600, must not exceed the specified restriction.

(35) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 25540 and 25550, must not exceed the specified restriction.

(36) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 10690, 10750, 10780, 10810,10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980 and 31500, must not exceed the specified restriction.

(37) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 20020, 20080, 20110, 20140, 20170, 20890, 21010, 21100, 21130, 21190, 21280, 21340 and 21460, must not exceed the specified restriction.

SECTION B list of monomers or other starting substances which may continue being used until they decide their inclusion in the section to # Ref.
(1) CAS No. (2) name (3) restrictions and/or specifications (4) 13050 1,2,4-bencenotricarboxilico acid 000528-44-9, see «Trimellitic acid» 15730 000077-73-6 dicyclopentadiene 18370 000592-45-0 1, 4-Hexadieno 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: to) substances which are incorporated into plastics to produce a technical effect in the finished product, including 'polymeric additives'; they are designed to be present in the finished objects;

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

(For the purposes of this annex, the substances mentioned in a) and b) are hereinafter «additives».


For the purposes of this annex, «polymer 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 absence of other polymers as the main structural component of finished objects and materials. It also includes substances that can be added to the medium in which polymerization takes place.

The list is not complete: to) substances which directly influence the formation of polymers;

(b) colorants;

(c) solvents.

2 substances listed below are not included but they are authorized and used intentionally: a) sales (be considered double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of acids, phenols or alcohols authorized; However appear in the list of names that contain the word 'acid (s) [...], salt (s)' in case the / corresponding (s) (s) acid free (s) are not listed (n);

(b) salts (will be considered double salts and acid salts) of zinc of acids, phenols or alcohols authorized. These salts is applied a group LME = 25 mg/kg (expressed as Zn). The restriction for Zn applies also to: i) substances whose name contains 'acid (s) [...], salt (s)' that appear in the lists, if the / corresponding (s) (s) acid free (s) are not listed (n), ii) substances referred to in the note 38 3. The list does not include the following substances although they may be present: to) substances that may be present in the finished product, such as: impurities of the substance, reaction intermediates and products of decomposition.

(b) mixtures of the authorised substances.

(Materials and articles which contain 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 that repealing directives 80/590/EEC and 89/109/EEC.

4. the substances must be of good technical quality criteria of purity.

5 the list contains the following information: a) column 1 (number Ref.): reference number EEC of materials of packaging of the substance referred to in the list.

b) column 2 (CAS number): the CAS (Chemical Abstracts Service) registry number.

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

(d) column 4 (restrictions and/or specifications): these may include: i) the limits of specific migration (LME).

(ii) maximum allowable number of substance in the material or object completed (CM).

(iii) maximum allowable number of the substance in the material or finished article, expressed per unit area in contact with foodstuffs (CMA), for example mg (of substance) / 6 dm2 (of surface in contact with foodstuffs).

(iv) any other restriction specifically mentioned.

(v) any other type of specifications related to the substance or to the polymer.

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

7. in the event of a disagreement between the CAS number and the chemical name, the latter shall prevail against the first. If there is disagreement between the CAS number collected in EINECS and the CAS registry, the CAS number in the CAS registry shall apply.

SECTION to list of additives fully harmonised at Community level (1) CAS No. Ref No. (2) name (3) restrictions and/or specifications (4) 30000 000064-19-7 acetic acid 30045 000123-86-4 butyl 30080 acetate 004180-12-5 acetate copper SML(t) = 5 mg/kg (7) (expressed as copper) 30140 000141-78-6 ethyl 30280 acetate 000108-24-7-acetic anhydride 30295 000067-64-1 acetone 30340 330198-91-9





12-(Acetoxy) 2 stearate, 3-bis (acetoxy) propyl 30370 - acetilacetico acid, salts 30401 - Mono and diglycerides of fatty acids, ACETYLATED mannans 30610 - acids, C2-C24, aliphatic, linear, monocarboxylic, obtained from fats and natural oils, and their esters with mono-, di and triglicerol (including fatty acids branched at levels that occur naturally) 30612 - acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic , and their esters with mono-, di - and triglicerol 30960 - esters of acids alif. monocarb. (C6-C22) with polyglycerol 31328 - fatty acids obtained from fats and oils food animal or vegetable 31530 123968-25-2 2,4-di-terc-pentil-6-[1-(3,5-di-terc-pentil-2-hidroxi-fenil)etil)fenilo LME = 5 mg/kg 31542 acrylate 174254-23-0 methyl acrylate, Telomere with 1-dode-ca - notiol, alkyl esters C16-C18 CM = 0.5% (w/w) in PT 31730 000124-04-9 acid adipic 33120 - MONOHYDRIC ALCOHOLS alif. sat. linear, prima rivers (C4-C24) 33350 009005-32-7 alginic acid 33801 - acid n-alkyl (C10-C13) bencenolsulfo-nico LME = 30 mg/kg 34281 - acid alkyl (C8-C22) sulphuric primary linear, with an even number of carbons 34475 - Hidroxifosfito of aluminum and calcium, hydrate 34480 - aluminum (fibres, flakes and powders) 34560 021645-51-2 34690 aluminum hydroxide bioactive 011097-59-9 of aluminium and magnesium





 






34720 34850 aluminum oxide 001344-28-1 143925-92-2 amines, bis (hydrogenated tallow alkyl) oxidised CM = only to be used in: to) polyolefines at 0,1% (w/w), except in low density polyethylene when in contact with food for which annex VIII sets a «factor of reduction of the simulant D» less than 3;
(b) PET 0.25% (w/w) in contact with different food, for which annex VIII sets the simulant D 34895 000088-68-6 2-aminobenzamide LME = 0,05 mg/kg. Only for use in PET for water and beverages 35120 013560-49-1. Diester of 3-aminocrotonico acid with ether (2-hydroxyethyl) 35160 tiobis 006642-31-5 6-amino-1, 3-dimetiluracilo LME = 5 mg/kg 35170 000141-43-5 2-aminoethanol LME = 0,05 mg/kg. Substance not for use in polymers contacting foods for which the simulant is set D in annex VIII and for indirect food contact, only behind the layer of PET 35284 000111-41-1 N-(2-aminoethyl) ethanolamine LME = 0,05 mg/kg. Substance not for use in polymers contacting foods for which the simulant is set D in annex VIII and only for indirect contact with food, behind the layer of PET 35320 007664-41-7 ammonia 35440 001214-97-9 35600 ammonium bromide 35840 ammonium hydroxide 001336-21-6 arachidonic acid 000506-30-9 35845 36000 arachidonic acid 007771-44-0 Ascorbic acid 000050-81-7 36080 ASCORBYL PALMITATE 000137-66-6





 






36160 010605-09-1






36840 ASCORBYL stearate 012007-55-5 Tetraborate barium SML(t) = 1 mg/kg expressed as barium (12) and SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice to the provisions of the Royal Decree 140/2003 of 7 February, by which establish the sanitary quality of water for human consumption 36880 criteria 008012-89-3 beeswax 36960 003061-75-4 Behenamida 37040 000112-85-6 behenic acid 37280 001302-78-9 bentonite 37360 000100-52-7 benzaldehyde pursuant to the provided in note 9 37600 000065-85-0 benzoic acid 37680 000136-60-7 37840 butyl benzoate 000093-89-0 38080 ethyl benzoate 38160 methyl benzoate 000093-58-3 002315-68-6 38510 propyl benzoate 136504-96-6 1, 2-Bis(3-aminopropil) ethylenediamine, polymer with N-butyl-2, 2-6, 6-tetramethyl 4-piperidinamina and 2,4,6-tricloro-1,3,5 triazine LME = 5 mg/kg 38515 001533-45-5 4, 4'-Bis (2-benzoxazolil) stilbene LME = 0,05 mg/kg (1) 3 8810 080693-00-1 Difosfito of bis (2,6-di-terc-butil-4-metilfenil) pentaerythritol LME = 5 mg/kg (as sum of phosphite and phosphate) 38840 154862-43-8 Difosfito of bis (2, 4-dicumilfenil) pentaerythritol LME = 5 mg/kg (as sum of the substance itself, its oxidized form [phosphate of bis (2, 4-dicumilfenil) pentaeri tritol] and its hydrolysis product [2, 4-dicumilfenol]) 38879 135861-56-2 Bis(3,4-dimetilbencilideno) sorbitol 38885 002725-22-6 2,4-Bis(2,4-dimetilfenil)-6-(2-hidroxi-4-n-octiloxifenil)-1,3,5-triazina LME = 0,05 mg/kg. Only for aqueous foods 38950 079072-96-1 Bis(4-etilbencilideno) sorbitol 39200 bis(2-hidroxietil)-2-hidroxi-propil-3-(dodeciloxi chloride 006200-40-4) metilamonio LME = 1.8 mg/kg 39680 000080-05-7 2,2-bis (4-hydroxyphenyl) propane SML(t) = 0,6 mg/kg (28) 39815 182121-12-6 9, 9-Bis (methoxymethyl) Fluorene CMA = 0,05 mg/6 dm2 39890 087826-41-3 069158-41-4 054686-97-4 081541-12-0 Bis (metilbencilideno) sorbitol 39925 129228-21-3 3, 3-Bis (methoxymethyl) - 2, 5-dimethylhexane LME = 0,05 mg/kg 068951-40120 - 50-8 Hidroximetilfosfonato of bis(polietilen-glicol) LME = 0.6 mg/kg 40320 010043-35-3 acid boric SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice to the provisions of the Royal Decree 140/2003 of 7 February, establishing the health criteria of the quality of water for human consumption 40400 010043-11-5 40570 Boron Nitride 000106-97-8 butane 40580 000110-63-4 1, 4-Butanediol LME (T) = 5 mg/kg (24) 41040 005743-36-2 butyrate calcium 41120 010043-52-4 chloride from calcium 41280 001305-62-0 calcium 41520 hydroxide oxide 001305-78-8 calcium 41600 012004-14-7 037293-22-4 41680 calcium Sulfoaluminate 000076-22-2 camphor with according to the provisions of note 9 41760 008006-44-8 41840 candelilla wax 000105-60-2 caprolactam SML(t) = 15 mg/kg (5) 41960 Caprylic acid 000124-07-2 42080 001333-86-4 carbon black





In accordance with the specifications laid down in annex V 42160 000124-38-9 carbon 42320 dioxide 007492-68-4 carbonate of copper SML(t) = 5 mg/kg (7) (expressed as copper) 42500 - carbonic acid, salts 42640 009000-11-7 carboxymethylcellulose 42720 008015-86-9 wax Carnauba 42800 009000-71-9 casein 42880 008001-79-4 42960 castor oil castor oil 064147-40-6 deshidratad or 43200 - Mono - and diglycerides of 43280 castor oil 009004-34-6 cellulose 43360 43300 cellulose acetate-butyrate 009004-36-8 068442-85-3 regenerated cellulose 43440 008001-75-0 Ceresina 43480 064365-11-3 activated Carbon according to the specifications set forth in annex 43515 - esters of fatty acids of coconut oil with CMA = 0.9 mg/6 dm2 choline chloride 44160 000077-92 - 9 citric acid 44640 000077-93-0 45195 triethyl citrate 007787-70-4 bromide copper SML(t) = 5 mg/kg (7) (expressed as copper) 45200 001335-23-5 iodide copper SML(t) = 5 mg/kg (7) (expressed as copper) yLME = 1 mg/kg (11) (expressed as iodine) 45280 ~ 45450 cotton fibers 068610-51-5 p-cresol-dicyclopentadie-noisobutileno copolymer LME = 5 mg/kg 45560 014464-46-1 cristobalite 45600 003724-65-0 acid Croton





QMA(t) = 0,05 mg/6 dm2 (33) 45640 005232-99-5 2-cyano-3, 3-difenilacrilato ethyl LME = 0,05 mg/kg 45705 166412-78-8 acid 1, 2-ciclohexanodicarboxilico, diisononil ester 45760 000108-91-8 Cyclohexylamine 45920 009000-16-2 Dammar 45940 000334-48-5 acid n-decanoico 46070 010016-20-3 alfa-Dextrina 46080 007585-39-9 beta-Dextrina 46375 061790-53-2 diatomaceous earth





 






46380 068855-54-9 of diatomaceous earth with sodium carbonate 46480 flux-calcined 032647-67-9






Dibencilidensorbitol 46700 5,7-di-terc-butil-3-(3,4-and 2, 3-dimethyl-phenyl) - 3 H - benzofuran - 2 - ona with: a) 5,7-di-tercbutil-3-(3,4-dimetilfenil)-3H benzofuran-2-one (80 to 100% w/w) and (b)) 5,7-di-terc-butil-3-(2,3-dimetilfenil)-3H-benzofuran-2-ona (0 to 20% w/w) LME = 5 mg/kg 46720 004130-42-1 2,6-di-terc-butil-4-etilfenol CMA = 4.8 mg/6 dm2 46790 004221-80-1 3,5-Di-terc-butil-4-hidroxibenzoato of 2, 4-di-tert-monosodium 46800 067845-93-6 3,5-Di-terc-butil-4-hidroxibenzoato of hexadecilo 46870 003135-18-0 3,5-Di-terc-butil-4-hidroxibencilfosfona to dioctadecilo





 






46880 065140-91-2 3,5-Di-terc-butil-4-hidroxibencilfosfona-of monoetilo, LME = 6 mg/kg 47210 calcium salt of dibutiltiostannoico acid 026427-07-6, polymer [= Tiobis (butilestano sulfide) polymer] according to the specifi cations of the annex V 47440 47540 Dicyandiamide 000461-58-5 027458-90-8 disulfide of di-tert-dodecyl LME = 0,05 mg/kg 47680 000111-46-6 diethylene glycol SML(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' - Dihidroxibenzofenona SML(t) = 6 mg/kg (15) 49485 134701-20-5-2, 4-dimethyl-6--(1-metilpentadecil) phenol LME = 1 mg/kg 49540 000067-68-5 dimethyl sulfoxide 51200 000126-58-9 Dipentaerythritol 51700 147315-50-2 2-(4,6-Difenil-1,3,5-triazin-2-il)-5-(hexiloxi) 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-Eicosenamida 52720 000112-84-5 Erucamide 52730 000112-86-7 erucic acid 52800 000064-17-5 ethanol 53270 037205-99-5 Etilcarboximetilcelulosa 53280 009004-57-3 ethylcellulose 53360 000110-31-6 N, N'-ethylene-bis-oleamida 53440 005518-18-3 N, N'-ethylene-bis-palmitamida 53520 000110-30-5 N, N'-ethylene-bis-estearamida 53600





53610 ethylenediaminetetraacetic acid 000060-00-4 054453-03-1 Etilendiaminotetraacetato of copper SML(t) = 5 mg/kg (7) (expressed as copper) 53650 000107-21-1 ethylene glycol SML(t) = 30 mg/kg (3) 54005 005136-44-7 Etileno-N - palmitamida-N'-estearamida 54260 009004-58-4 Etilhidroxietilcelulosa 54270 - Etilhidroximetilcelulosa 54280 - Etilhidroxipropilcelulosa 54300 118337-09-0 2, 2'Etilidenbis(4,6-di-terc-butilfenil) f luorofosfonito LME = 6 mg/kg 54450 – fats and oils of animal or vegetable food origin 54480 - fats and oils hydrogenated animal or vegetable food source 54930 025359-91-5 copolymer formaldehyde-1-naphthol [= poly (1-hidroxinaftilmetano)] LME = 0,05 mg/kg 55040 000064-18-6 55120 formic acid 000110-17-8 fumaric acid 55190 gadoleic acid 029204-02-2 55440 55520 gelatin 009000-70-8





-Fiberglass 55600 - glass micro-55680 glutaric acid 000110-94-1 55920 000056-81-5 glycerol 56020 099880-64-5 Dibehenato of glycerol 56360 - 56486 glycerol with acetic acid esters - esters of glycerol with acid alif. sat.Lineales with an odd number of carbons (C14-C18) and acids alif. INSAT. linear with an odd number of carbons (C16-C18) 56487 - 56490 with butyric acid glycerol esters - esters of glycerol with erucic acid 56495 - 56535 esters of glycerol with acid 12-hi droxiestearico - esters of glycerol with acid nonanoic 56500 - 56510 glycerol with lauric acid esters - esters of glycerol with linoleic acid 56520 - esters of glycerol with myristic acid 56540





-Esters of glycerol with oleic acid 56550 - esters of glycerol with Palmitic acid 56570 - 56580 with propionic acid glycerol esters - esters of glycerol with ricinoleic acid 56585 - 030233-64-8 Monobehenato 56610 with stearic acid glycerol esters of glycerol 56720 026402-23-3 Monohexanoato of glycerol 56800 030899-62-8 Monolaurate glycerol diacetate





 






56880 026402-26-6 Monooctanoato of glycerol 57040 - glycerol, ester with Ascorbic acid 57120 Monooleate - Monooleate of glycerol, ester with citric acid 57200 - glycerol, ester with Ascorbic acid 57280 halogen - halogen of glycerol, ester with citric acid 57600 - monostearate of glycerol, ester with Ascorbic acid 57680 - monostearate of glycerol, ester with citric acid 57800 018641-57-1





Tribehenato of glycerol 57920 000620-67-7 Triheptanoato of glycerol






 






58300 - Glycine, salts 58320 007782-42-5 graphite 58400 009000-30-0 guar gum 58480 009000-01-5 Gum Arabic 58720 000111-14-8 acid heptanoic 59280 000100-97-0 Hexamethylenetetramine SML(t) = 15 mg/kg (22) (expressed as formal dehido) 59360 59760 hexanoic acid 000142-62-1 019569-21-2 Huntita 59990 007647-01-0





Acid hydrochloric 60030 012072-90-1 Hydromagnesite 60080 012304-65-3 Hidrotalcita 60160 000120-47-8 60180 ethyl 4-Hydroxybenzoate 60200 isopropyl 4-Hydroxybenzoate 004191-73-5 methyl 60240 000099-76-3 4-Hydroxybenzoate 60480 propyl 4-Hydroxybenzoate 000094-13-3 003864-99-1 2-(2'-Hidroxi-3,5'-di-terc-butil-fenil)-5-clorobenzotriazol SML(t) = 30 mg/kg (19) 60560





009004-62-0 Hydroxyethylcellulose 60880 009032-42-2 Hidroxietilmetil cellulose 61120 009005-27-0 hydroxyethyl 61390 61680 Hidroximetilcelulosa 037353-59-6 009004-64-2 hydroxypropyl cellulose 61800 009049-76-7 hydroxypropyl starch 61840 000106-14-9 acid 12 - 62020 hidroxiestearico 007620-77-1 12-hidroxiestearico acid, salt of lithium SML(t) = 0,6 mg/kg (8) (expressed as lithium) 62140





006303-21-5 62240 hypophosphorous acid 001332-37-2 62245 iron oxide 012751-22-3 phosphide iron only for polymers and copolymers of PET 62450 000078-78-4 Isopentane 62640 008001-39-6 Japanese wax 62720 001332-58-7 kaolin 62800 - kaolin calcined 62960 000050-21-5 acid lactic 63040 000138-22-7 butyl lactate





 






63280 lauric acid 000143-07-7 63760 008002-43-5 lecithin 63840 000123-76-2 levulinic acid 63920 lignoceric acid 000557-59-5 64015 64150 linoleic acid 000060-33-3 linolenic acid 028290-79-1 64500 - lysine, salts 64640 001309-42-8 magnesium 64720 hydroxide magnesium oxide 001309-48-4





 






64800 maleic acid 00110-16-7 SML(t) = 30 mg/kg (4) 64990 025736-61-2 sodium salt of copolymer of styrene and anhydride maleic with according to the specified-tions set out in annex V 65020 006915-15-7 65040 Malic acid 000141-82-2 malonic acid 65520 000087-78-5 mannitol 65920 copolymers 066822-60-4 N-metacriloilo chloride xietil-N, N-dimethyl-N-carboximetilamonio salt of sodium - octadecilo methacrylate - methacrylate of ethyl - methacrylate-cyclohexyl - N-vinyl-2-pyrrolidone 66 200 037206-01-2 Metilcarboximetilcelulosa 66240 009004-67-5 methylcellulose 66560 004066-02-8 2, 2'Metilenbis(4-metil-6-ciclohexilfe-nol) SML(t) = 3 mg/kg (6) 66580 000077-62-3 2, 2'-methylenebis [4-metil-6-(1-metilciclo-hexil) phenol] SML(t) = 3 mg/kg (6) 66640 009004-59-5 Metiletilcelulosa 66695 - Metilhidroximetilcelulosa 66700 009004-65-3 Methylhydroxypropylcellulose 66755 002682-20-4 2-Metil-4-isotiazolin-3-ona





LME = ND (LD = 0,02 mg / kg, analytical tolerance included) 66905 000872-50-4 N-66930 metilpirrolidona 068554-70-1 residual monomer Metilsilsesquioxano in methyl-silsesquioxane: < 1 mg methyltrimethoxysilane/kg metilsilsesquioxano 67120 012001-26-2 Mica 67155 - 4-(2-benzoxazolil)-4'-(5-metil-2-mix benzoxazolil) stilbene, 4, 4'bis(2-ben-zoxa-zolil) stilbene and 4,4'-bis(5-metil-2-benzoxa-zolil)estilbeno not more than 0.05% w/w (quantity of substance used / quantity of formulation). According to the specified-tions set out in annex V 67180 - mixture of n-say it for n-Octyl phthalate (50% w/w), phthalate di-n-say it for (25% w/w) and di-n-Octyl phthalate (25% w/w) LME = 5 mg/kg (1) 67200 67840 molybdenum disulfide 001317-33-5 - montanicos acids and/or their esters conetilenglicol or 1, 3-Butanediol and/or glycerol 67850 008002-53-7 wax 67891 000544-63-8 myristic acid 68040 003333-62-8 7-[2-H-Nafto-(1,2-D)triazol-2-il]-3-fenilcumarina 68078 027253-3 1-2 Neodecanoate cobalt SML(t) = 0,05 mg/kg (expressed as neo-decanoic acid) and SML(t) = 0,05 mg/kg (14) (expressed as cobalt). Should not be used in food contact polymers for which annex VIII sets the simulant D 68125 037244-96-5 nepheline syenite 68145 080410-33-9 2, 2', 2 '' - nitrile [tris(3,3',5,5'-tetra-terc-butil-1,1'-bifenil-2,2'-diil)fosfito triethyl] LME = 5 mg/kg (as sum of phosphite and phosphate) 68960 000301-02-0 Oleamida 69040 000112-80-1 oleic acid 69760 000143-28-2 Alcohol oleilico 69920 000144-62-7 acid oxalic SML(t) = 6 mg/kg (29) 70000 070331-94-1






(2,2'-Oxamidobis[etil-3-(3,5-di-terc-butil 4-hidroxifenil) propionate] 70240 012198-93-5 Ozocerita 70400 000057-10-3 acid Palmitic 71020 000373-49-9 palmitoleic acid 71440 009000-69-5 pectin 71600 000115-77-5 71635 pentaerythritol Dioleate 025151-96-6 of pentaerythritol LME = 0,05 mg/kg. Pentaerythritol LME = 0,05 mg/kg 71680 (Sustancia no para uso en polímeros en contacto con alimentos para los cuales está establecido el simulante D en el anexo VIII 71670 178671-58-4 Tetrakis (2-ciano-3,3-difenilacrilato) 006683-19-8 Tetrakis[3-(3,5-di-terc-butil-4-hidroxi phenyl) propionate] pentaerythritol 71720 000109-66-0 pentane 71960 003825-26-1 perfluorooctanoico acid, salt of master-nio only applies to objects of repeated use (, sintered at high temperatures 72640 007664-38-2 phosphoric acid 73160 - phosphates of mono - and di-n-alkyl (C16 and C18) LME = 0,05 mg/kg 73720 000115-96-8 phosphate tricloroetilo LME = ND (LD = 0,02 mg/kg, analytical tolerance included) 74010 bis(2,4-di-terc-butil-6-metilfe-nilo Phosphite 145650-60-8) ethyl LME = 5 mg/kg (as sum of phosphite and phosphate) 74240 031570-04-4 tris(2,4-di-terc-butilfenilo) 74480 Phosphite 000088-99-3-o-phthalic acid 74560 phthalate 000085-68-7 of (bencilbutilo will only be used: to) as plasticizer in materials and objects of repeated use; (b) as a plasticizer-sing on materials and single-use objects that are in contact with food not fatty except for preparations for infant formula and follow-on formulae as defined in the Royal Decree 72/1998, 23 January, and products in accordance with Royal Decree 490/1998 of 27 March; (c) as agent technical support at concentrations up to 0.1% in the final product. (LME = 30 mg/kg food simulant 74640 000117-81-7 bis(2-etilhexilo) phthalate is used only: to) as plasticizer in materials and repeated use objects that are in contact with non-fatty foods; (b) as agent technical support at concentrations up to 0.1% in the final product. (LME = 1.5 mg/kg food simulant 74880 000084-74-2 dibutyl phthalate is used only: to) as plasticizer in materials and repeated use objects that are in contact with non-fatty foods; (b) as agent technical support in polyolefines in concentrations of up to 0.05% in the final product. (LME = 0.3 mg/kg food simulant 75100 068515-48-0 028553-12-0 Diesters of branched-chain primary alcohols with phthalic acid, saturated C8-C10, more than 60% C9 will be used only: to) as plasticizer in materials and objects of repeated use; (b) as a plasticizer in materials and single-use objects that are in contact with non-fatty foods except for preparations for infant formula and follow-on formulae as defined in the Royal Decree 72/1998, 23 January, and products in accordance with Royal Decree 490/1998 of 27 March; (c) as agent technical support at concentrations up to 0.1% in the final product. SML(t) = 9 mg/kg food simulant (42) 75105 068515-49-1 026761-40-0 Diesters of primary alcohols with phthalic acid, saturated C9-C11, more than 90% C10 will be used only: to) as plasticizer in materials and objects of repeated use; (b) as a plasticizer in materials and single-use objects that are in contact with non-fatty foods except for preparations for infant formula and follow-on formulae as defined in the Royal Decree 72/1998, 23 January, and products in accordance with Royal Decree 490/1998 of 27 March; (c) as agent technical support at concentrations up to 0.1% in the final product. SML(t) = 9 mg/kg food simu-lante (42) 76320 000085-44-9 anhydride phthalic 76415 019455-79-9 Pimelato calcium 76721 009016-00-6 063148-62-9 Polydimethylsiloxane (PM > 6800) in accordance with the specified-tions of annex V 76730 - Polydimethylsiloxane, gamma-hidroxipro-milled LME = 6 mg/kg 76815 - esters of polyester of adipic acid with glycerol or pentaerythritol, C12-C22 fatty acids not branched with even number of carbon atoms according to the specified-tions set out in annex V 76845 031831-53-5 polyester 1, 4-butanodio l with capro-Lactone restriction for the No. 14260 and 13720 reference number must be respected. In accordance with the specifications laid down in annex V 76866-1 polyesters, 2-propandiol or 1.3 - o1, 4-butandiol or polipropilenglicol with adipic acid, which may have the end encapsulated in acetic acid fatty oacidos C12-C18 or n-octanol or n decanol LME = 30 mg/kg 76960 025322-68-3 polyethylene glycol 77370 070142-34-6 Polietilenglicol-30 dipolihidroxiestea time 77600 061788-85-0 Ester of polyethylene glycol with 77702 hydrogenated castor oil - esters of polyethylene glycol with aliphatic monocarboxylic acids (C6-C22) and their ammonium and sodium sulphates





 






77895 068439-49-6 ether monoalquilico (C16-C18) of Polyethylen-lenglicol (OE = 2 - 6) LME = 0,05 mg/kg and in accordance with the specifications laid down in annex V 79040 009005-64-5 Monolaurate of polyethylene glycol sorbi - tano 79120 009005-65-6 polyethylene glycol sorbi - tano 79200 Monooleate 009005-66-7 halogen of polyethylene glycol sor - bitano 79280 009005-67-8 sor - bitano 79360 polyethylene glycol monostearate 009005-70-3 polyethylene glycol sorbitano 79440 Trioleate 009005-71-4 Tries tearato of polyethylene glycol sorbi - tano 79600 009046-01-9 of polyethylene glycol ether phosphate trideci-lico LME = 5 mg/kg. Only for materials and articles intended to come into contact with aqueous foods. Pursuant to the specifications establishment - das 009003-11-6 in annex V 79920 106392-12-5 poly (ethylene propylene) glycol 80000 009002-88-4 wax polyethylene 80240 80640 polyglycerol Ricinoleate 029894-35-7 - Polioxialquil (C2-C4) dimethylpolysiloxane 80720 008017-16-1 80800 polyphosphoric acids 025322-69-4 Polipropilenoglicol 81060 009003-07-0 polypropylene 81220 wax 192268-64-7






[Poli-[[6-[N-(2,2,6,6-tetrametil-4-piperidinil)-N-butilamino]1,3,5-triazina-2,4-diil] [2,2,6,6-tetrametil-4-piperidinil)imino] 1.6 hexanodiil [(2,2,6,6-tetrametil-4 piperidinil) imino]] Alpha-["N, N, N ', N' - tetrabutil-N ' (2,2,6,6-tetrametil-4-piperidinil)-N»-[6(2,2,6,6-tetrametil-4-piperidinilamino)-hexil][1,3,5triazina-2,4,6-triamina]-omega N,N,N',N'-tetrabutil-1,3,5-triazina-2,4-dia mine LME = 5 mg/kg 81500 Polyvinylpyrrolidone 9003-39-8 with according to the specified-tions set out in annex V 81515 087189-25-1 Poli(glicerolato de cinc) SML(t) = 25 mg/kg (38) (expressed as zinc) 81520 007758-02-3 bromide of] potassium 81600 001310-58-3 81760 potassium hydroxide - powders, flakes and fibres of brass, bronze, copper, stainless steel, Tin and alloys of copper, Tin and iron SML(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 propionic acid 000079-09-4 82080 009005-37-2 82240 1,2-propylene glycol alginate 022788-19-8 Dilaurate of 1,2-propylene glycol 82400 000105-62-4 Dioleate of 1,2-propylene glycol 82560 033587-20-1 1,2-propylene glycol 82720 Dipalmitate 1 006182-11-2 Distearate, 2-propylene glycol





 






82800 027194-74-7 82960 1,2-propylene glycol Monolaurate 001330-80-9 1,2-propylene glycol 83120 Monooleate 029013-28-3 1,2-propylene glycol 83300 halogen 001323-39-3 1,2-propylene glycol 83320 - Propilhidroxietilcelulosa 83325 - monostearate Propilhidroximetilcelulosa 83330-83440 Propilhidroxipropilcelulosa pyrophosphoric acid 002466-09-3





 






83455 pirofosforoso acid 013445-56-2 83460 83470 pyrophyllite 012269-78-2 014808-60-7 quartz 83599 068442-12-6 reaction products of oleate 2-mercaptoetilo with diclorodimetilestano, sulfide sodium and triclorometilestano SML(t) = 0,18 mg/kg (16) (expressed as Tin) 83610 073138-82-6 acid resin and acid of the Colophon 83840 nia 008050-09-7 Rosin 84000 008050-31-5 Ester of rosin glycerol 84080





008050-26-8 ester of rosin pentaerythritol 84210 with 065997-06-0 hydrogenated Rosin 84240 065997-13-9 with gli cerol 84320 hydrogenated Rosin Ester 008050-15-5 Ester of hydrogenated Rosin with me crimsonkratos 84400 064365-17-9 with 84560 pentaerythritol hydrogenated Rosin Ester 009006-04-6 natural rubber 84640 000069-72-7 acid Salicylic 85360 000109-43-3 dibutyl Sebacate





 






85601 natural silicates (except the cough asbes) 85610 - natural silicates silanados (except asbestos) 85680 001343-98-2 silicic acid 85840 053320-86-8 lithium magnesium silicate sodium SML(t) = 0,6 mg/kg (8) (expressed as lithium) 86000 - silicic acid sililado 86160 000409-21-2 carbide Silicon 86240 007631-86-9 86285 silicon dioxide - silanado silicon dioxide





 






86560 007647-15-6 bromide sodium 86720 001310-73-2 sodium 87040 hydroxide 001330-43-4 Tetraborate sodium SML(t) = 6 mg/kg (23) (expressed as boron) without prejudice in Real Decreto140/2003, 7 February, establishing the health criteria of the quality of water for human consumption 87200 87280 sorbic acid 000110-44-1 029116-98-1 sorbitano 87520 Dioleate 062568-11-0 Monobehenato of sorbitano 87600 001338-39-2 Monolaurate of sorbitano 87680 001338-43-8 sorbitano 87760 Monooleate 026266-57-9 sorbitano 87840 halogen 87920 sorbitano monostearate 001338-41-6 061752-68-9 Tetraestearato of sorbitano 88080 026266-58-0 sorbitano 88160 Trioleate 054140-20-4 sorbitano 88240 Tripalmitato 026658-19-5 sorbitano 88320 Tristearate Sorbitol 000050-70-4





 






88600 026836-47-5 88640 sorbitol monostearate 008013-07-8 soybean oil epoxidized LME = 60 mg/kg. However, in the case of PVC shutters used to seal glass jars containing infant formulae and follow-on formulae, as defined in the Royal Decree 72/1998, 23 January, or foods prepared from cereal and baby food for infants and young children, as defined in the Royal Decree 490/1998 , March 27, the LME is reduced to 30 mg/kg according to the specified-tions set out in annex V 88800 009005-25-8 starch, food grade 88880 068412-29-3-88960 hydrolysed starch 000124-26-5 Estearamida 89040 000057-11-4 acid stearic 89200 007617-31-4 stearate copper SML(t) = 5 mg/kg (7) (expressed as copper) 89440 - esters of stearic acid with ethylene-glycol SML(t) = 30 mg/kg (3) 90720 058446-52-9 Estearoilbenzoilmetano





 






90800 calcium 005793-94-2-Stearoyl-2-Lactylate






 






90960 000110-15-6. 000126-13-6 Acetoisobutirato 91200 succinic acid from sucrose 91360 000126-14-7 Octaacetato of sucrose 91840 007704-34-9 sulfur 91920 007664-93-9 acid sulfuric 92030 010124-44-4 sulfate of copper SML(t) = 5 mg/kg (7) (expressed as copper) 92080 014807-96-6 TALC 92150 tannic acid 001401-55-4 according to the JECFA specifications






92160 000087-69-4 tartaric acid 92195 - TAURINE, salts 92205 057569-40-1. Diester of Terephthalic acid with 2, 2' - me - tilenobis (4-methyl-6-tert-butylphenol) 92350 000112-60-7 Tetraetilenglicol 92640 000102-60-3 N, N, N ', N' - Tetrakis(2-hidroxipropil) ethylenediamine 92700 078301-43-6 polymer 2,2,4,4-tetrametil-20-(2,3-epoxipropil)-7-oxa-3,20-diazadies-piro[5.1.11.2]-henecosan-21-ona LME = 5 mg/kg 92930 120218-34-0 Tiodietanolbis(5-metoxicarbonil-2,6-di-metil-1,4-dihidropiridin a-3-carboxylate) LME = 6 mg/kg 93440 013463-67-7 Titanium 93520 dioxide 000059-02-9 010191-41-0 alpha-tocopherol 93680 009000-65-1 gum tragacanth 93720 000108-78-1 2,4,6-Triamino-1,3,5-triazina LME = 30 mg/kg 93760 000077-90-7 citrate of tri-n-butyl acetyl 94320 000112-27-6 triethylene glycol 94960 000077-99-6 1,1,1-Trimetilolpropano LME = 6 mg/kg 95000 028931-67-1 copolymer d e trimetracrilato trimetill propane and methylmethacrylate 95020 6846-50-0 Diisobutirato of 2,2,4-trimetil-1,3-pen-tanediol LME = 5 mg/kg of food. Only be used in gloves of single use 95200 001709-70-2 1,3,5-Trimetil-2,4,6-tris(3,5-di-terc-butil 4-hidroxibenzil) benzene 95270 LME 2-butil-2-etil-1,3-propanodiol 2,4,6-tris(terc-butil)fenilo Phosphite 161717-32-4 = 2 mg/kg (as sum of phosphite, phosphate and hydrolysis product = TTBP) 95420 745070-61-5 1,3,5-tris(2,2-dimetilpropanamido)-benceno LME = 0,05 mg/kg food 95725 vermiculite 110638-71-6 , reaction product with citrate lithium SML(t) = 0,6 mg/kg (8) (expressed as lithium) 95855 007732-18-5 water in accordance with the Royal Decree 140/2003 95859 - waxes, high purity, derived from petroleum based synthetic hydrocarbon raw materials according to the specifies-tions of annex V 95883 - White mineral oils, paraffinic, derived from petroleum based hydrocarbon raw materials according to the specified-tions of annex V 95905 013983-17-0 wollastonite 95920 - flour and wood fibres untreated 95935 011138-66-2 xanthan gum 96190 020427-58-1 hydroxide zinc SML(t) = 25 mg/kg (38) (as zinc expre-SDH) 96240 001314-13-2 oxide of zinc SML(t) = 25 mg/kg (38) (as zinc expre-SDH) 96320 001314-98-3 sulfide zinc SML(t) = 25 mg/kg (38) (as zinc expre-SDH) (1) warning: risk of overcome the LME in fatty food simulants.

(3) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 15760, 16990, 47680, 53650 and 89440, must not exceed the specified restriction.

(4) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 19540, 19960 and 64800, must not exceed the specified restriction.

(5) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 14200, 14230 and 41840, must not exceed the specified restriction.

(6) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 66560 and 66580, must not exceed the specified restriction.

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

(8) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the US reference 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, must not exceed the specified restriction.

(((9) warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food that is in contact and that, therefore, the finished product does not respect provisions of the letters b)) and (c) of paragraph 1 of article 3 of the 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 that repealing directives 80/590/EEC and 89/109/EEC.

(11) LME (T) means in this case that the sum of the migration (expressed as iodine) of the following substances, identified with the us of ref. 45200, 64320, 81680 and 86800, must not exceed the specified restriction.

(12) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 36720, 36800, 36840 and 92000, must not exceed the specified restriction.

(14) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 44960, 68078, 69160, 82020 and 89170, must not exceed the specified restriction.

(15) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 15970, 48640, 48720, 48880, 61280, 61360 and 61600, must not exceed the specified restriction.

(16) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 49595, 49600, 67520, 67515 and 83599, must not exceed the specified restriction.

(19) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 60400, 60480 and 61440, must not exceed the specified restriction.

(22) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 17260, 18670, 54880 and 59280, must not exceed the specified restriction.

(23) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 13620, 36840, 40320 and 87040, must not exceed the specified restriction.

(24) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 13720 and 40580, must not exceed the specified restriction.

(28) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 13480 and 39680, must not exceed the specified restriction.

(29) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 22775 and 69920, must not exceed the specified restriction.

(33) CMA (T) means in this case that the sum of the residual quantities of the following substances, identified with the us of ref. 14800 and 45600, must not exceed the specified restriction.


(38) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 81515, 96190, 96240 and 96320, as well as of salts (including double salts and acid salts) of zinc of acids, phenols or alcohols authorized, must not exceed the indicated constraint. Restriction for Zn applies equally to substances whose name includes "... acid (s), salt (s)» that appear in the lists, if the / corresponding (s) (s) acid free (s) are not listed (n).

(42) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the US reference 75100 and 75105, must not exceed the specified restriction.

SECTION B list of additives whose specific migration limits shall apply as of May 1, 2008, pursuant to article 8(2) of this Royal Decree.




Ref No..
(1) CAS No. (2) name (3) restrictions and/or specifications (4) 30180 002180-18-9 acetate of manganese SML(t) = 0,6 mg/kg (10) (expressed as man ganeso) 31500 025134-51-4 copolymer of acrylic acid and acrylate 2-ethylhexyl SML(t) = 6 mg/kg (36) (expressed as acrylic acid) and LME = 0,05 mg / kg (expressed as 2-ethyl Hexyl acrylate) 31520 061167-58-6 2-terc-butil-6-(3-terc-butil-2-hidroxi-5-metilbencil)-4-metilfenilo LME = 6 mg/kg 31920 acrylate 000103-23-1 bis(2-etilhexilo) Adipate





LME = 18 mg/kg (1) 34230 - acid alquil(C8-C22) sulfonic LME = 6 mg/kg 34650 151841-65-5 phosphate hidroxibis [2, 2' - methylenebis (4, 6-di-tert-butilfenil)] aluminum LME = 5 mg/kg 35760 001309-64-4 antimony LME trioxide = 0,04 mg/kg (39) (expressed as antimo nio) 36720 017194-00-2 hydroxide barium SML(t) = 1 mg/kg (12) (expressed as barium) 36800 010022-31-8 nitrate barium SML(t) = 1 mg/kg (12) (expressed as barium) 38000 000553-54-8 benzoate lithium SML(t) = 0,6 mg/kg) (8) (expressed as lithium) 38240 000119-61-9 Benzophenone LME = 0.6 mg/kg 38505 351870-33-2 salt disodium acid cis-endo-biciclo[2.2.1]heptano-2,3-dicarboxi-lico LME = 5 mg/kg. You should not uti-made with polyethylene in touch with products will increas-ticios acids. Purity ≥96% 38560 007128-64-5 2,5-Bis(5-terc-butil-2-benzoxazolil) tiofe not-LME = 0.6 mg/kg 38700 063397-60-4 Bis(isooctilo tioglicolato) of bis(2-carbo-bu-toxietil) Tin LME = 18 mg/kg 38800 032687-78-8 N,N'-Bis[3-(3,5-di-terc-butil-4-hidroxifenil)propionil]hidrazida LME = 15 mg/kg 38820 026741-53-7 Difosfito of bis(2,4-di-terc-butilfenil) pentaerythritol LME = 0.6 mg/kg 38940 110675-26-8 2, 4-Bis (dodeciltiometil) - 6 - methylphenol SML(t) = 5 mg/kg (40) 39060 035958-30-6 1, 1-Bis (2 - hydroxy - 3). (, 5-di-tert - butilfenil) ethane LME = 5 mg/kg 39090 - N, N-Bis (2 - hydroxyethyl) alkyl (C8-C18) amine SML(t) = 1,2 mg/kg (13) 39120 - N hydrochloride, N-Bis(2-hidroxietil) alkyl (C8-C18) amine SML(t) = 1,2 mg/kg (13) expressed as tertiary Amine (excluding HCl) 40000 000991-84-4 2,4-Bis(octiltio)-6-(4-hidroxi-3,5-di-terc-butilanilino)-1,3,5-triazina LME = 30 mg/kg 40020 110553-27-0 2, 4-Bis (octiltiometil) - 6 - methylphenol SML(t) = 5 mg/kg (40) 40160 061269-61-2 copolymer N (, N'-Bis (2,2,6,6-tetrametil-4-piperidil) hexamethylenediamine-1, 2-dibromoethane LME = 2.4 mg/kg 40720 025013-16-5-tert-butyl-4-hydroxyanisole (= BHA) LME = 30 mg/kg 40800 013003-12-8 4,4'-butilidenbis(6-terc-butil-3-metilfenilditridecilo phosphite) LME = 6 mg/kg 40980 019664-95-0 butyrate manganese SML(t) = 0,6 mg/kg (10) (expressed as manga-neso) 42000 063438-80-2 (2-carbobutoxietil) Tris (isooctyl thioglycolate) Tin LME = 30 mg/kg 42400 010377-37-4 carbonate lithium SML(t) = 0,6 mg/kg (8) (expre-sado as lithium) 42480 carbonate 000584-09-8 LME = 12 mg/kg 43600 rubidium chloride 004080-31-3 1-(3-cloroalil)-3,5,7-triaza-1-azoniaadamantano LME = 0.3 mg/kg 43680 000075-45-6 chlorodifluoromethane LME = 6 mg/kg; in accordance with the specifications of annex V 44960 011104-61-3, oxide of cobalt SML(t) = 0,05 mg/kg (14) (expressed as cobalt) 45440 - cresols, butilados, styrene LME = 12 mg/kg 45650 006197-30-4 2-is Ester of 2-cyano-3, 3-difenilacrilico LME = 0,05 mg/kg 46640-acid 2,6-di-terc-butil-p-cresol 000128-37-0 (= BHT) LME = 3,0 mg/kg 47500 153250-52-3 N, N'-Dicyclohexyl-2, 6-naftalendicarboxamida LME = 5 mg/kg.






47600 084030-61-5 Bis(isooctilo tioglicolato) of di-n-dode-cilestano SML(t) = 0,05 mg/kg food (41) (as sum of tris (isooctil mercaptoacetato) of mono-n-dodecilestano, di-n-dodecilestano bis(isooctil mercaptoacetato), mono-do-trichloride decilestano and di-dodecilestano dichloride) expressed as the sum of mono - and di-dodecilestano 48640 chloride 000131-56-6 2, 4-Dihidroxibenzofenona LME (T) = 6 mg/kg (15) 48800 000097-23-4 2, 2' - dihydroxy-5, 5' - diclorodifenilmetano LME = 12 mg/kg 48880 000131-53-3 2, 2' - dihydroxy-4-methoxybenzophenone SML(t) = 6 mg/kg (15) 49595 057583-35-4 Bis(etilhexilo tioglicolato) of dimetiles-tano SML(t) = 0,18 mg/kg (16) (expre-sado as Tin) 49600 026636-01-1 Bis(isooctilo tioglicolato) of dimetiles-tano SML(t) = 0,18 mg/kg (16) (expre-sado as Tin) 49840 002500-88-1 dioctadecilo LME = 3 mg/kg 50160 disulfide - Bis [n - alquilo(C10-C16) thioglycolate] di-n-octilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50240 010039-33-5 Bis(2-etilhexilo maleato) of di-n-octiles-tano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50320 015571-58-1 Bis(2-etilhexilo tioglicolato) of di-n-oc-tilestano SML(t) = 0,006 mg / kg (17) (expressed as Tin) 50360 - Bis(etilo maleato) of di-n-octilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50400 033568-99-9 Bis(isooctilo maleato) of di-n-octilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50480 026401-97-8 Bis(isooctilo tioglicolato) of di-n-octiles-tano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50560 - 1,4-Butanediol bis (thioglycolate) di-n-octilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50640 003648-18-8 Dilaurate of di-n-octilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50720 015571-60-5






Htmt of di-n-octilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50800 - Htmt of di-n-octilestano esterified SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50880 - Htmt of di-n-octilestano, Pol-ros (N = 2-4) SML(t) = 0,006 mg/kg (17) (expressed as Tin) 50960 069226-44-4 Etlienglicol bis (thioglycolate) di-n-oc-tilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 51040 Thioglycolate 015535-79-2 di-n-octilestano SML(t) = 0,006 mg/kg (17) (expressed as Tin) 51120 - (Tiobenzoato) (2-ethylhexyl thioglycolate) of di-n-octilestano LME) (T) = 0,006 mg/kg (17) (expressed as Tin) 51570 000127-63-9 Difenilsulfona SML(t) = 3 mg/kg (25) 51680 000102-08-9 N, N'-Dimethylthiourea LME = 3 mg/kg 52000 dodecylbenzenesulphonic acid 027176-87-0 LME = 30 mg/kg 52320 052047-59-3 2-(4-Dodecilfenil) indole LME = 0.06 mg/kg 52880 LME = 3.6 mg/kg 53200 ethyl 023676-09-7 4-Etoxibenzoato 023949-66-8 2 - Ethoxy - 2'-etiloxanilida LME = 30 mg/kg 54880 000050-00-0 formaldehyde SML(t) = 15 mg/kg (22) 55200





[([(001166-52-5 gallate dodecyl SML(t) = 30 mg/kg (34) 55280 gallate 001034-01-1 of Octyl SML(t) = 30 mg/kg (34) 55360 000121-79-9 gallate propyl SML(t) = 30 mg/kg (34) 58960 000057-09-0 bromide hexadecyltrimethylammonium LME = 6 mg/kg 59120 1,6-Hexametilenbis[3-(3,5-di-terc-butil-4-hidroxifenil 023128-74-7) metabolism] LME = 45 mg/kg 59200 035074-77-2 1,6-Hexametilenbis[3-(3,5-di-terc-butil-4-hidroxifenil) propionate] LME = 6 mg/kg 60320 070321-86-7 2-[2-hydroxy-3 [, 5-bis (1, 1-dimetilbencil) phenyl] BENZOTRIAZOLE LME = 1.5 mg/kg 60400 003896-11-5 2-(2'-Hidroxi-3'-terc-butil-5'-metilfenil)-5-clorobenzotriazol SML(t) = 30 mg/kg (19) 60800 065447-77-0. 1-(2-hidroxietil)-4-hidroxi-2,2,6,6-tetrametilpiperidina copolymer - LME = 30 mg/kg 61280 dimethyl succinate 003293-97-8 2-hydroxy-4-n-hexiloxibenzofenona SML(t) = 6 mg/kg (15) 61360 000131-57-7 2-hydroxy-4-methoxybenzophenone SML(t) = 6 mg/kg (15) 61440 002440-22-4 2-(2'-Hidroxi-5'-metilfenil) BENZOTRIAZOLE SML(t) = 30 mg/kg (19) 61600 001843-05-6 2-hydroxy-4-n-oct iloxibenzofenona SML(t) = 6 mg/kg (15) 63200 051877-53-3 lactate manganese SML(t) = 0,6 mg/kg (10) (expressed as manga-neso) 63940 lignosulphonic acid 008062-15-5 LME = 0.24 mg/kg. Should only be used as a dispersant for plastic dispersions 64320 010377-51-2 iodide lithium SML(t) = 1 mg/kg (11) (expressed as iodine) and SML(t) = 0,6 mg/kg (8) (expressed as lithium) 65120 007773-01-5 chloride manganese SML(t) = 0,6 mg/kg (10) (expre-sado as manganese) 65200 012626-88-9 hydroxide manganese SML(t) = 0,6 mg/kg (10) (expre-sado as manganese) 65280 010043-84-2 Hypophosphite manganese SML(t) = 0,6 mg/kg (10) (expre-sado as manganese) 65360 011129-60-5 LME manganese oxide) (((T) = 0.6 mg/kg (10) (expre-sado as manganese) 65440 - Pirofosfito of manganese SML(t) = 0,6 mg/kg (10) (expre-sado as manganese) 66350 085209-93-4 2, 2' - metilenbis(4,6-di-terc-butilfenil) Lithium phosphate LME = 5 mg/kg and SML(t) = 0,6 mg/kg (8) (expressed as lithium) 66360 085209-91-2 2, 2' - metilenbis(4,6-di-terc-butilfenil) sodium phosphate LME = 5 mg/kg 66400 000088-24-4 2,2'-metilenbis(4-etil-6-terc-butilfenol) SML(t) = 1.5 mg/kg (20) 66480 000119-47-1 2,2'-metilenbis(4-metil-6-terc-butilfe-nol) SML(t) = 1.5 mg/kg (20) 67360 Tris 067649-65-4) isooctil mercaptoacetato) mono-n - dodecilestano SML(t) = 0,05 mg/kg food (41) (as sum of mono-n - do decilestano (isooctil mercaptoacetato) tris, bis (isooctil mercaptoacetato) di-n dodecilestano, mono-dodecilestano trichloride and di-dodecilestano dichloride) expressed as the sum of mono - and di-dodecilestano 67515 chloride 057583-34-3 Tris (ethylhexyl thioglycolate) of monome-tilestano SML(t) = 0,18 mg/kg (16) (expressed as Tin) 67520 054849-38-6 Tris (isooctyl thioglycolate) of monome-tilestano SML(t) = 0,18 mg/kg (16) (expre-sado as Tin) 67600 ~ Tris [alquilo(C10-C16) thioglycolate] Mono-n-octilestano SML(t) = 1,2 mg/kg (18) (expre-sado as Tin) 67680 027107-89-7 Tris (2-ethylhexyl thioglycolate) of mono-n - octilestano SML(t) = 1,2 mg/kg (18) (expressed as Tin) 67760 026401-86-5 Tris (isooctyl thioglycolate) of mono-n - octilestano SML(t) = 1,2 mg/kg (18) (expre-sado as Tin) 67896 020336-96-3 Miristicinato of lithium SML(t) = 0,6 mg/kg (8) (expre-sado as lithium) 68320 002082-79-3 3-3,5-di-terc-butil-4-hidroxifenil)propio-nato of octadecilo LME = 6 mg/kg 68400 010094-45-8 Octadecilerucamida LME = 5 mg/kg 68860 004724-48 -N-octylphosphonic acid 5 LME = 0,05 mg/kg 69160 014666-94-5 oleate cobalt SML(t) = 0,05 mg/kg (14) (expre-sado as cobalt) 69840 016260-09-6 Oleilpalmitamida LME = 5 mg/kg 71935 perchlorate monohydrate sodium LME = 0,05 mg/kg (31) 007601-89-0 72081/10 - petroleum hydrocarbon resins (hydrogenated) LME = 5 mg/kg (1) and in accordance with the specifications laid down in annex V 72160 000948-65-2 2-Phenylindole LME = 15 mg/kg 72800 001241-94-7 phosphate diphenyl 2-ethylhexyl LME = 2.4 mg/kg 73040 013763-32-1 phosphate lithium SML(t) = 0,6 mg/kg (8) (expre-sado as lithium) 73120 010124-54-6 phosphate manganese SML(t) = 0,6 mg/kg (10) (expre-sado as manganese) 74400 - Phosphite tris(nonil-y/o dinonilfenilo) LME = 30 mg/kg 77440 - LME = 42 mg/kg 77520 polietileneglicol Diricinoleato 061791-12-6 Ester of polyethylene glycol with LME = 42 mg/kg 78320 castor oil 009004-97-1 Monoricinoleato of LME = 42 mg/kg 81200 polietileneglicol 071878-19-8






Poly [6-[(1,1,3,3-tetrametilbutil) amino] - 1, 3, 5-triazine-2, 4-diil-imino-hexamethylene [(2,2,6,6,-tetra metil-4-piperidil) [(LME = 3 mg/kg 81680 2,2,6,6-tetrametil-4-piperidil)imino 007681-11-0 iodide of potassium SML(t) = 1 mg/kg (11) (expressed as iodine) 82020 019019-51-3 propionate cobalt SML(t) = 0,05 mg/kg (14) (expre-sado as cobalt) 83595 119345-01-6 reaction product of fosfonito of di-tert-butyl with diphenyl, obtained by condensation of 2, 4-di-tert-butylphenol with Friedel Craft reaction of phosphorus trichloride product)]]] condifenilo LME = 18 mg/kg. In accordance with the specifications of annex V 83700 LME ricinoleic acid 000141-22-0 = 42 mg/kg 84800 salicylate 000087-18-3 of 4-tert-monosodium LME = 12 mg/kg 84880 000119-36-8 LME = 30 mg/kg 85760 Methyl salicylate 012068-40-5 lithium silicate aluminum (2:1:1) LME (T) = 0.6 mg/kg (8) (expre-sado as lithium) 85920 012627-14-4 silicate lithium SML(t) = 0,6 mg/kg (8) (expre-sado as lithium) 85950 037296-97-2 silicate magnesio-sodio - fluoride LME = 0,15 mg/kg (expressed as fluoride). Should only be used in those layers of objects of materials of several layers that do not come into direct contact with foodstuffs 86480 007631-90-5 bisulfite sodium SML(t) = 10 mg/kg (30) (expre-sado as SO2) 86800 007681-82-5 iodide sodium SML(t) = 1 mg/kg (11) (expressed as iodine) 86880 - LME = 9 mg/kg 86920 sodium salt Dialquilfenoxibencenodisulfonato of monoalquilo, 007632-00-0 nitrite of sodium LME = 0.6 mg/kg 86960 007757-83-7 sulfite sodium SML(t) = 10 mg/kg) ((30) (expre-sado as SO2) 87120 007772-98-7 Thiosulphate sodium SML(t) = 10 mg/kg (30) (expre-sado as SO2) 89170 013586-84-0 stearate cobalt SML(t) = 0,05 mg/kg (14)(expre-sado como cobalto) 92000 007727-43-7 sulfate barium SML(t) = 1 mg/kg (12)(expresado como bario) 92320 - tetradecyl polyoxyethylene ether (OE = 3-8) of glycolic acid LME = 15 mg/kg 92560 038613-77-3 Difosfonito of tetrakis(2,4-di-terc-butil-fenil)-4,4'-bifenileno LME = 18 mg/kg 92800 000096-69-5 4,4'-Tiobis(6-terc-butil-3-metilfenol) LME = 0.48 mg/kg






92880 041484-35-9 bis [3-(3,5-di-terc-butil-4-hidroxifenil)propionato] de tiodietanol LME = 2.4 mg/kg 93120 Thiodipropionate 000123-28-4 of didodecilo SML(t) = 5 mg/kg (21) 93280 Thiodipropionate 000693-36-7 of dioctadecilo SML(t) = 5 mg/kg (21) 93970 - Bis (hexahidroftalato) of triciclodecano-dimetanol LME = 0,05 mg/kg 94400 036443-68-2 Bis [3-(3-terc-butil-4-hidroxi-5-metilfenil)propionato] of triethylene glycol LME = 9 mg/kg 94560 000122-20-3 Triisopropanolamine LME = 5 mg/kg 95265 227099-60-7 1,3,5-Tris(4-be (nzoilfenil) benzene LME = 0,05 mg/kg 95280 040601-76-1 1,3,5-Tris(4-terc-butil-3-hidroxi-2,6-dimetil-bencil)-1,3,5-triazina-2,4,6(1H,3H,5H) triona LME = 6 mg/kg 95360 027676-62-6 1,3,5-Tris(3,5-di-terc-butil-4-hidroxibencil)-1,3,5-triazina-2,4,6(1H,3H,5H)-triona LME = 5 mg/kg 95600 001843-03-4 1,1,3-Tris(2-metil-4-hidroxi-5-terc-butilfenil)butano LME = 5 mg/kg (1) warning: risk of overcome the LME in fatty food simulants.

(8) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the US reference 24886, 38000, 42400, 62020, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725, must not exceed the specified restriction.

(10) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120, must not exceed the specified restriction.

(11) LME (T) means in this case that the sum of the migration (expressed as iodine) of the following substances, identified with the us of ref. 45200, 64320, 81680 and 86800, must not exceed the specified restriction.

(12) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 36720, 36800, 36840 and 92000, must not exceed the specified restriction.

(13) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 39090 and 39120, must not exceed the specified restriction.

(14) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 44960, 68078, 69160, 82020 and 89170, must not exceed the specified restriction.

(15) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 15970, 48640, 48720, 48880, 61280, 61360 and 61600, must not exceed the specified restriction.

(16) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 49595, 49600, 67520, 67515 and 83599, must not exceed the specified restriction.

(17) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120, must not exceed the specified restriction.

(18) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 67600, 67680 and 67760, must not exceed the specified restriction.

(19) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 60400, 60480 and 61440, must not exceed the specified restriction.

(20) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 66400 and 66480, must not exceed the specified restriction.

(21) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 93120 and 93280, must not exceed the specified restriction.

(22) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 17260, 18670, 54880 and 59280, must not exceed the specified restriction.

(25) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 16650 and 51570, must not exceed the specified restriction.

(30) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 86480, 86960 and 87120, must not exceed the specified restriction.

(31) when there is a fat contact, conformity shall be assessed using simulants of fatty foods saturated as simulant D.

(34) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 55200, 55280 and 55360, must not exceed the specified restriction.

(36) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 10690, 10750, 10780, 10810, 10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980 and 31500, must not exceed the specified restriction.

(39) the migration limit can be overcome at a very high temperature.

(40) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the us of ref. 38940 and 40020, must not exceed the specified restriction.

(41) LME (T) means in this case that the sum of the migration levels of the following substances, identified with the US reference 47600 and 67360, must not exceed the specified restriction.

(Annex IV products obtained by means of bacterial fermentation, the list contains the following information: a) column 1 (issue No.): reference number EEC of the substance of the packaging, the list.

b) column 2 (CAS number): the CAS (Chemical Abstracts Service) registry number.

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


d) column 4 (restrictions and/or specifications).




Ref No..
(1) CAS No. (2) name (3) restrictions and/or specifications (4) 18888 copolymer 080181-31-3, 3-hidroxipentanoico and 3-hidroxibuta-noico acids according to the specified-tions included in annex V annex V specifications Part A: General materials and plastic objects shall not release primary aromatic amines in a detectable quantity (LD = 0.01 mg/kg of food or food simulant). The migration of the primary aromatic amines listed in the lists in annexes II and III is excluded from this restriction.

PART B: other specifications other PM/REF number specifications 11530 2-hydroxypropyl acrylate can contain up to 25% (m/m) of acrylate 2-hidroxisopropilo (CAS no 002918-23-2) 16690 Divinylbenzene can contain up to a 45% (m/m) of 18888 the 3-hydroxybutanoic acid copolymer etilvinilbenceno and 3-hidroxipentanoico definition: these copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been manipulated genetically and comes from a single natural organism Alcaligenes eutrophus strain HI6 NCIMB 10442. Master strains of this organism are stored in freeze-dried ampoules. From the master strain prepares a high strain of work that is preserved in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples are daily examined under a microscope and you notice any change in the colonial morphology in a series of agars at different temperatures. Copolymers are isolated of bacteria treated with heat by controlled digestion of other cellular components, washing and drying. These copolymers are normally formed by melting granules containing additives such as nucleating, plasticizers, material filling, stabilizers and pigments, all of which conform to the General and particular specifications chemical name: Poli(3-D-hidroxibutanoato-co-3-D-hidroxipentanoato) number: CAS 080181-31-3 structural Formula: (-O-CH(CH3)-CH2-CO-)m-(O-CH(CH2-CH3)-CH2-CO-)n where n / (n) > 0 and n ≤0 /(m + n) (, 25 average molecular weight: not less than 150 000 dalton (measured by permeability of gel chromatography) composition: not less than 98% of poli(3-D-hidroxibutanoato-co-3-Dhidroxipentanoato) analysed after hydrolysis as a mixture of 3-D-hidroxipentanoico and D-3-hydroxybutanoic acid Description: white or bleached powder after isolation characteristics identification solubility tests: Soluble in hydrocarbons chlorinated as chloroform or dichloromethane but practically insoluble in ethanol , aliphatic alkanes and water restriction: the CMA for the acid Croton is 0,05 mg/6 dm2 purity: before the granulation, gross copolymer powder must have a content: • nitrogen: less than 2 500 mg/kg of plastic • Zinc: less than 100 mg/kg of plastic • copper: less than 5 mg/kg of plastic • lead: less than 2 mg/kg of plastic • arsenic : Less than 1 mg/kg of plastic • chromium: less than 1 mg/kg of plastic 23547 Polydimethylsiloxane (PM > 6 800) minimum viscosity: 100 × 10-6 m2/s (= 100 centistokes) at 25 ° C 24903 syrups, hydrolysed starch, hydrogenated in accordance with the purity criteria for E-965 maltitol syrup (ii) by the Royal Decree 2106 / 1996, of 20 September 25385 Trialilamina 40 mg/kg of Hydrogel in the proportion of 1 kg of foodstuff for a maximum 1.5 g of Hydrogel. It should only be used in Hydrogel not intended to come into direct contact with foodstuffs 38320 4-(2-Benzoxazolil)-4'-(5-metil-2-benzoxazolil)estilbeno not more than 0.05% w/w (quantity of substance used / quantity of formulation) 42080 black coal specifications: • removable toluene content: maximum of 0,1%, determined in accordance with the ISO 6209 method.
• UV absorption of extract of cyclohexane at 386 nm:

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