2002L0072 — EN — 20.04.2007 — 004.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B ▼C1 COMMISSION DIRECTIVE 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance) ▼B (OJ L 220, 15.8.2002, p.18)

Amended by:





Corrected by:









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COMMISSION DIRECTIVE 2002/72/EC

of 6 August 2002

relating to plastic materials and articles intended to come into contact with foodstuffs

(Text with EEA relevance)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs ( 1 ), and in particular Article 3 thereof, After consulting the Scientific Committee on Food, Whereas: (1) Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs ( 2 ), as last amended by Directive 2002/17/EC ( 3 ), has been frequently and substantially amended; for reasons of clarity and rationality, it should therefore be consolidated. (2) Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs. (3) In order to achieve this objective in the case of plastic materials and articles, a suitable instrument is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC, the general provisions of which are also applicable to the case in question. (4) The scope of this Directive must coincide with that of Council Directive 82/711/EEC ( 4 ). (5) Since the rules established in this Directive are not suitable for ion-exchange resins, these materials and articles will be covered by a subsequent specific Directive. (6) Silicones should be regarded as elastomeric materials rather than plastic materials and therefore should be excluded from the definition of plastic. (7) The establishment of a list of approved substances accompanied by a limit on overall migration and, where necessary, by other specific restrictions will be sufficient to achieve the objective laid down in Article 2 of Directive 89/109/EEC. (8) Besides the monomers and other starting substances fully evaluated and authorised at Community level, there are also monomers and starting substances evaluated and authorised in at least one Member State which may continue to be used pending their evaluation by the Scientific Committee on Food and the decision on their inclusion in the Community list; this Directive will accordingly be extended in due course to the substances and sectors provisionally excluded. (9) The current list of additives is an incomplete list inasmuch as it does not contain all the substances which are currently accepted in one or more Member States; accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list. (10) This Directive establishes specifications for only a few substances. The other substances, which may require specifications, therefore remain regulated in this respect by national laws pending a decision at Community level. (11) For certain additives the restrictions established in this Directive cannot yet be applied in all situations pending the collection and evaluation of all the data needed for a better estimation of the exposure of the consumer in some specific situations; therefore, these additives appear in a list other than that of the additives fully regulated at Community level. (12) Directive 82/711/EEC lays down the basic rules necessary for testing migration of the constituents of plastic materials and articles and Council Directive 85/572/EEC ( 5 ) establishes the list of simulants to be used in the migration tests. (13) The determination of a quantity of a substance in a finished material or article is simpler than the determination of its specific migration level. The verification of compliance through the determination of quantity rather than specific migration level should therefore be permitted under certain conditions. (14) For certain types of plastics the availability of generally recognised diffusion models based on experimental data allows the estimation of the migration level of a substance under certain conditions, therefore avoiding complex, costly and time-consuming testing. (15) The overall migration limit is a measure of the inertness of the material and prevents an unacceptable change in the composition of the foodstuffs, and, moreover, reduces the need for a large number of specific migration limits or other restrictions, thus giving effective control. (16) Council Directive 78/142/EEC ( 6 ) lays down limits for the quantity of vinyl chloride present in plastic materials and articles prepared with this substance and for the quantity of vinyl chloride released by these materials and articles, and Commission Directives 80/766/EEC ( 7 ) and 81/432/EEC ( 8 ) establish the Community methods of analysis for controlling these limits. (17) In view of potential liability, there is a need for the written declaration provided for in Article 6(5) of Directive 89/109/EEC whenever professional use is made of plastic materials and articles which are not by their nature clearly intended for food use. (18) Commission Directive 80/590/EEC ( 9 ) determines the symbol that may accompany any material and article intended to come into contact with foodstuffs. (19) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring the free movement of plastic materials and articles intended to come into contact with foodstuffs, to lay down rules on the definition of plastics and permitted substances. This Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty. (20) In accordance with Article 3 of Directive 89/109/EEC, the Scientific Committee on Food has been consulted on the provisions liable to affect public health. (21) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. (22) This Directive should be without prejudice to the deadlines set out in Annex VII, Part B within which the Member States are to comply with Directive 90/128/EEC, and the acts amending it, Whereas: HAS ADOPTED THIS DIRECTIVE:







Article 1

1. This Directive is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC.

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2. This Directive shall apply to the following materials and articles which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose (hereafter referred to as ‘plastic materials and articles’):

(a) materials and articles and parts thereof consisting exclusively of plastics;

(b) plastic multi-layer materials and articles;

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

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3. For the purposes of this Directive, ‘plastics’ shall mean the organic macromolecular compounds obtained by polymerisation, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Other substances or matter may be added to such macromolecular compounds.

However, the following shall not be regarded as ‘plastics’:

(a) varnished or unvarnished regenerated cellulose film, covered by Commission Directive 93/10/EEC ( 10 );

(b) elastomers and natural and synthetic rubber;

(c) paper and paperboard, whether modified or not by the addition of plastics;

(d) surface coatings obtained from: — paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes, — mixtures of the waxes listed in the first indent with each other and/or with plastics,

(e) ion-exchange resins;

(f) silicones.

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4. Without prejudice to paragraph 2(c), this Directive shall not apply to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics.

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Article 1a

For the purpose of this Directive the following definitions shall apply:

(a) ‘plastic multi-layer material or article’ means a plastic material or article composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by other means;

(b) ‘plastic functional barrier’ means a barrier consisting of one or more layers of plastics which ensures that the finished material or article complies with Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council ( 11 ) and with this Directive;

(c) ‘non-fatty foods’ means foods for which in migration testing simulants other than simulant D are laid down in Directive 85/572/EEC.

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Article 2

1. Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 60 milligrams of the constituents released per kilogram of foodstuff or food simulant (mg/kg) (overall migration limit).

However, this limit shall be 10 milligrams per square decimetre of surface area of material or article (mg/dm2) in the case of the following:

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

(b) sheet, film or other material or articles which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such material or article and the quantity of food in contact therewith.

2. For plastic materials and articles intended to be brought into contact with or already in contact with food intended for infants and young children, as defined by Commission Directives 91/321/EEC ( 12 ) and 96/5/EC ( 13 ), the overall migration limit shall always be 60 mg/kg.

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Article 3

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1. Only those monomers and other starting substances listed in Annex II, section A may be used for the manufacture of plastic materials and articles subject to the restrictions set out therein.

2. By way of derogation from paragraph 1, the monomers and other starting substances listed in Annex II, section B may continue to be used until 31 December 2004 at the latest, pending their evaluation by the European Food Safety Authority (hereinafter referred to as the Authority).

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3. The list in Annex II, Section A, may be amended:

— either by adding substances listed in Annex II, Section B, according to the criteria in Annex II of Directive 89/109/EEC, or

— by including ‘new substances’, i.e. substances which are listed neither in Section A nor in Section B of Annex II, according to Article 3 of Directive 89/109/EEC.

4. No Member State shall authorise any new substance for use within its territory except under the procedure in Article 4 of Directive 89/109/EEC.

5. The lists appearing in Annex II, Sections A and B, do not yet include monomers and other starting substances used only in the manufacture of:

— surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc.,

— epoxy resins,

— adhesives and adhesion promoters,

— printing inks.

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Article 4

1. A list of additives which may be used for the manufacture of plastic materials and articles, together with the restrictions and/or specifications on their use, is set out in Annex III.

That list of additives shall be considered to be an incomplete list until the Commission decides, in accordance with Article 4a, that it shall become a positive Community list of authorised additives, to the exclusion of all others.

The Commission shall establish, by 31 December 2007 at the latest, the date when that list shall become a positive list.

2. For the additives listed in Annex III, section B, the verification of compliance with the specific migration limits in simulant D or in test media of substitute tests as laid down in Article 3(1), second subparagraph of Directive 82/711/EEC and Article 1 of Directive 85/572/EEC shall apply from ►M4 ►C2 1 May 2008 ◄ ◄ .

3. The lists in Annex III, sections A and B do not yet include the following additives:

(a) additives used only in the manufacture of: — surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, — epoxy resins, — adhesives and adhesion promoters, — printing inks;

(b) colorants;

(c) solvents.

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Article 4a

1. A new additive may always be added to the list of substances referred to in Article 4(1) following an evaluation of its safety by the Authority.

2. Member States shall provide that any person interested in the inclusion in the list referred to in Article 4(1) of an additive, which is already placed on the market in one or more of the Member States, shall submit data for the evaluation of its safety by the Authority by 31 December 2006 at the latest.

For the submission of the required data, the applicant shall consult the ‘Guidelines of the European Food Safety Authority for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation’.

3. If during the examination of the data referred to in paragraph 2, the Authority calls for supplementary information, the additive may continue to be used subject to national law until the Authority has issued an opinion, provided that the information is submitted within the time limits specified by the Authority.

4. The Commission shall establish, by 31 December 2007 at the latest, a provisional list of additives which may continue to be used after 31 December 2007 subject to national law until the Authority has evaluated them.

5. The inclusion of an additive in the provisional list is subject to the following conditions:

(a) the additive must be permitted in one or more of the Member States no later than 31 December 2006;

(b) the data referred to in paragraph 2 concerning that additive must have been supplied in accordance with the Authority requirements no later than 31 December 2006.

Article 4b

Without prejudice to Article 4 of Directive 89/109/EEC, Member States may not authorise after 31 December 2006 additives referred to in Article 4(1) which were never evaluated by the Scientific Committee on Food or the Authority.

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Article 4c

For the use of additives for the manufacture of plastic layers or plastic coatings in lids referred to in Article 1(2)(c), the following rules shall apply:

(a) for the additives listed in Annex III, the restrictions and/or specifications on their use set out in that Annex shall apply, without prejudice to Article 4(2);

(b) by way of derogation from Article 4(1) and Article 4a(1) and (5), additives not listed in Annex III may continue to be used, until further review, subject to national law;

(c) by way of derogation from Article 4b Member States may continue to authorise additives for the manufacture of plastic layers or plastic coatings in lids referred to in Article 1(2)(c) at national level.

Article 4d

For the use of additives exclusively acting as polymerisation production aids which are not intended to remain in the finished article (hereinafter PPAs), for the manufacture of plastic materials and articles, the following rules shall apply:

(a) for the PPAs listed in Annex III, the restrictions and/or specifications on their use set out in Annex III shall apply, without prejudice to Article 4(2);

(b) by way of derogation from Article 4(1) and Article 4a(1) and (5), the PPAs not listed in Annex III may continue to be used, until further review, subject to national law;

(c) by way of derogation from Article 4b, Member States may continue to authorise PPAs at national level.

Article 4e

The use of azodicarbonamide, Ref. No 36640 (CAS No 000123-77-3) in the manufacture of plastic materials and articles is prohibited.

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Article 5

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

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Article 5a

1. Additives referred to in Article 4, which are authorised as food additives by Council Directive 89/107/EEC ( 14 ) or flavourings by Council Directive 88/388/EEC ( 15 ) shall not migrate into:

(a) foodstuffs in quantities having a technological function in the final foodstuffs;

(b) foodstuffs for which their use is authorised as food additives or flavourings, in quantities exceeding the restrictions provided for in Directive 89/107/EEC or in Directive 88/388/EEC or in Article 4 of this Directive, whichever is the lower;

(c) foodstuffs for which their use is not authorised as food additives or flavourings, in quantities exceeding the restrictions set out in Article 4 of this Directive.

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2. At the marketing stages other than the retail stages, plastic materials and articles which are 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 9.

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3. By way of derogation from paragraph 1, when the substances referred to in point (a) of paragraph 1 are used as active components of active food contact materials and articles, they may be subject to national provisions pending the adoption of Community provisions.

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Article 6

1. General specifications related to plastic materials and articles are laid down in Annex V, Part A. Other specifications related to some substances appearing in Annexes II, III and IV are laid down in Annex V, Part B.

2. The meaning of the numbers between brackets appearing in the column ‘Restrictions and/or specifications’ is explained in Annex VI.

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Article 7

The specific migration limits in the list set out in Annexes II and III are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases:

(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 l;

(b) sheet, film or other material or articles which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such material or article and the quantity of food in contact therewith.

In those cases, the limits set out in Annexes II and III, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2.

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For plastic materials and articles intended to be brought into contact with or already in contact with food for infants and young children, as defined by Directives 91/321/EEC and 96/5/EC, the SMLs shall always be applied as mg/kg.

Article 7a

1. In a plastic multi-layer material or article, the composition of each plastic layer shall comply with this Directive.

2. By way of derogation from paragraph 1, a layer which is not in direct contact with food and is separated from the food by a plastic functional barrier, may, provided that the finished material or article complies with the specific and overall migration limits specified in this Directive:

(a) not comply with the restrictions and specifications set in this Directive,

(b) be manufactured with substances other than those included in this Directive or in the national lists concerning the plastic materials and articles intended to come into contact with food.

3. The migration of the substances referred to in paragraph 2(b) into food or simulant shall not exceed 0,01 mg/kg, measured with statistical certainty by a method of analysis in accordance with Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council ( 16 ). This limit shall always be expressed as concentration in foods or simulants. It shall apply to a group of compounds, if they are structurally and toxicologically related, in particular isomers or compounds with the same relevant functional group, and shall include possible set-off transfer.

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

(a) substances classified as proved or suspect ‘carcinogenic’, ‘mutagenic’ or ‘toxic to reproduction’ substances in Annex I to Council Directive 67/548/EEC ( 17 );

(b) substances classified under the self-responsibility criteria as ‘carcinogenic’, ‘mutagenic’ or ‘toxic to reproduction’ according to the rules of Annex VI to Directive 67/548/EEC.

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Article 8

1. Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC and the further provisions set out in Annex I.

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2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if the value of overall migration determination implies that the specific migration limits referred to in that paragraph are not exceeded.

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3. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that, by assuming complete migration of the residual substance in the material or article, it cannot exceed the specific limit of migration.

4. The verification of compliance with the specific migration limits provided for in paragraph 1 may be ensured by the determination of the quantity of a substance in the finished material or article provided that a relationship between that quantity and the value of the specific migration of the substance has been established either by an adequate experimentation or by the application of generally recognised diffusion models based on scientific evidence. To demonstrate the non-compliance of a material or article, confirmation of the estimated migration value by experimental testing is obligatory.

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5. Notwithstanding paragraph 1, for phthalates (Ref. No 74640, 74880, 74560, 75100, 75105) referred to in Annex III Section B, the verification of the SML shall only be performed in food simulants. However, verification of the SML may be performed in food where the food has not already been in contact with the material or article and is pre-tested for the phthalate and the level is not statistically significant or greater than or equal to the limit of quantification.

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Article 9

1. At the marketing stages other than the retail stage, plastic materials and articles 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 declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex VIa.

3. Appropriate documentation to demonstrate that the materials and articles as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Directive shall be made available by the business operator to the national competent authorities on request. That documentation shall contain the conditions and results of testing, calculations, other analysis, and evidence on the safety or reasoning demonstrating compliance.

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Article 10

1. Directive 90/128/EEC, as amended by the Directives set out in Annex VII, Part A, is hereby repealed without prejudice to the obligations of the Member States in respect of the deadlines for transposition and application laid down in Annex VII, Part B.

2. References to the repealed Directives shall be construed as references to this Directive and be read in accordance with the correlation table set out in Annex VIII.

Article 11

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

Article 12

This Directive is addressed to the Member States.









ANNEX I

FURTHER PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS

General provisions

1. When comparing the results of the migration tests specified in the Annex to Directive 82/711/EEC, the specific gravity of all the simulants should conventionally be assumed to be 1. Milligrams of substance(s) released per litre of simulant (mg/l) will thus correspond numerically to milligrams of substance(s) released per kilogram of simulant and, taking into account the provisions laid down in Directive 85/572/EEC, to milligrams of substance(s) 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 for the purpose, and the quantities of foodstuff or simulant placed in contact with the sample differ from those employed in the actual conditions under which the material or article is used, the results obtained should be corrected by applying the following formula: Where: M is the migration in mg/kg; m is the mass in mg of substance released by the sample as determined by the migration test; a1 is the surface area in dm2 of the sample in contact with the foodstuff or simulant during the migration test; a2 is the surface area in dm2 of the material or article in real conditions of use; q is the quantity in grams of foodstuff in contact with the material or article in real conditions of use.

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2a. Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF): ‘Fat Reduction Factor’ (FRF) is a factor between 1 and 5 by which measured migration of lipophilic substances into a fatty food or simulant D and its substitutes shall be divided before comparison with the specific migration limits. General rules Substances considered ‘lipophilic’ for the application of the FRF are listed in Annex IVa. The specific migration of lipophilic substances in mg/kg (M) shall 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 and FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100 This correction by the FRF is not applicable in the following cases: (a) when the material or article is or is intended to be brought in contact with food containing less than 20 % fat; (b) when the material or article is or is intended to be brought in contact with food intended for infants and young children as defined by Directives 91/321/EEC and 96/5/EC; (c) for substances in the Community lists in Annexes II and III having a restriction in column (4) SML= ND or non-listed substances used behind a plastic functional barrier with a migration limit of 0,01 mg/kg; (d) for materials and articles for which it is impracticable to estimate the relationship between the surface area and the quantity of food in contact therewith, for example due to their shape or use, and the migration is calculated using the conventional surface area/volume conversion factor of 6 dm2/kg. This correction by the FRF is applicable under certain conditions in the following case: For containers and other fillable articles with a capacity of less than 500 millilitres or more than 10 litres and for sheets and films in contact with foods containing more than 20 % fat, either the migration is calculated as concentration in the food or food simulant (mg/kg) and corrected by the FRF, or it is re-calculated as mg/dm2 without applying the FRF. If one of the two values is below the SML, the material or article shall be considered in compliance. The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.

2b. Correction of specific migration in food simulant D: The specific migration of lipophilic substances into simulant D and its substitutes shall be corrected by the following factors: (a) the reduction factor referred to in point 3 of the Annex to Directive 85/572/EEC, hereinafter termed simulant D Reduction Factor (DRF). The DRF may not be applicable when the specific migration into simulant D is higher than 80 % of the content of the substance in the finished material or article (for example thin films). Scientific or experimental evidence (for example testing with the most critical foods) is required to determine whether the DRF is applicable. It is also not applicable for substances in the Community lists having a restriction in column (4) SML = ND or non-listed substances used behind a plastic functional barrier with a migration limit of 0,01 mg/kg. (b) the FRF is applicable to migration into simulants, provided the fat content of the food to be packed is known and the requirements mentioned in point 2a are fulfilled. (c) the Total Reduction Factor (TRF) is the factor, with a maximum value of 5, by which a measured specific migration into simulant D or a substitute shall be divided before comparison with the legal limit. It is obtained by multiplying the DRF by the FRF, when both factors are applicable.

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3. The determination of migration is carried out on the material or article or, if that is impracticable, using either specimens taken from the material or article or, where appropriate, specimens representative of this material or article. The sample shall be placed in contact with the foodstuff or simulant in a manner representing the contact conditions in actual use. For this purpose, the test shall be performed in such a way that only those parts of the sample intended to come into contact with foodstuffs in actual use will be in contact with the foodstuff or simulant. This condition is particularly important in the case of materials and articles comprising several layers, for closures, etc. The migration testing of caps, gaskets, stoppers or similar devices for sealing must be carried out on these articles by applying them to the containers for which they are intended in a manner which corresponds to the conditions of closing in normal or foreseeable use. It shall in all cases be permissible to demonstrate compliance with migration limits by the use of a more severe test.

4. In accordance with the provisions set out in Article 8 of the present Directive, the sample of the material or article is placed in contact with the foodstuff or appropriate simulant for a period and at a temperature which are chosen by reference to the contact conditions in actual use, in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC. At the end of the prescribed time, the analytical determination of the total quantity of substances (overall migration) and/or the specific quantity of one or more substances (specific migration) released by the sample is carried out on the foodstuff or simulant.

5. Where a material or article is intended to come into repeated contact with foodstuffs, the migration test(s) shall be carried out three times on a single sample in accordance with the conditions laid down in Directive 82/711/EEC using another sample of the food or simulant(s) on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the migration limit(s) is (are) not exceeded on the first test, no further test is necessary.

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5a. Caps, lids, gaskets, stoppers and similar sealing articles: (a) If the intended use is known, such articles shall be tested by applying them to the containers for which they are intended under conditions of closure corresponding to the normal or foreseeable use. It is assumed that these articles are in contact with a quantity of food filling the container. The results shall be expressed in mg/kg or mg/dm2 in accordance to the rules of Articles 2 and 7 taking into account the whole contact surface of sealing article and container. (b) If the intended use of these articles is unknown, such articles shall be tested in a separate test and the result be expressed in mg/article. The value obtained shall be added, if appropriate, to the quantity migrated from the container for which it is intended to be used.

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Special provisions relating to overall migration

6. If the aqueous simulants specified in Directives 82/711/EEC and 85/572/EEC are used, the analytical determination of the total quantity of substances released by the sample may be carried out by evaporation of the simulant and weighing of the residue. If rectified olive oil or any of its substitutes is used, the procedure given below may be followed. The sample of the material or article is weighed before and after contact with the simulant. The simulant absorbed by the sample is extracted and determined quantitatively. The quantity of simulant found is subtracted from the weight of the sample measured after contact with the simulant. The difference between the initial and corrected final weights represents the overall migration of the sample examined. Where 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 5, modifications to that test are acceptable, provided that they enable the level of migration occurring during the third test to be determined. One of these possible modifications is described below. The test is carried out on three identical samples of the material or article. One of these shall be subjected to the appropriate test and the overall migration determined (M1). The second and third samples shall be subjected to the same conditions of temperature but the period of contact shall be two and three times that specified and overall migration determined in each case (M2 and M3, respectively). The material or article shall be deemed to be in compliance provided that either M1 or M3 - M2 does not exceed the overall migration limit.

7. A material or article that exceeds the overall migration limit by an amount not greater than the analytical tolerance mentioned below should therefore be deemed to be in compliance with this Directive. The following analytical tolerances have been observed: — 20 mg/kg or 3 mg/dm2 in migration tests using rectified olive oil or substitutes, — 12 mg/kg or 2 mg/dm2 in migration tests using the other simulants referred to in Directives 82/711/EEC and 85/572/EEC.

8. Without prejudice to the provisions of Article 3(2) of Directive 82/711/EEC, migration tests using rectified olive oil or substitutes shall not be carried out to check compliance with the overall migration limit in cases where there is conclusive proof that the specified analytical method is inadequate from a technical standpoint. In any such case, for substances exempt from specific migration limits or other restrictions in the list provided in Annex II, a generic specific migration limit of 60 mg/kg or 10 mg/dm2, according to the case, is applied. However, the sum of all specific migrations determined shall not exceed the overall migration limit.









ANNEX II

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES

GENERAL INTRODUCTION

1. This Annex contains the list of monomers or other starting substances. The list includes: — substances undergoing polymerisation, which includes polycondensation, polyaddition or any other similar process, to manufacture macromolecules, — natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required to synthesise them are not included in the list, — substances used to modify existing natural or synthetic macromolecular substances.

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2. The following substances are not included even if they are intentionally used and are authorised: (a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing ‘… acid(s), salts’ appear in the lists, if the corresponding free acid(s) is (are) not mentioned; (b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to: (i) substances whose name contains ‘… acid(s), salts’ which appear in the lists, if the corresponding free acid(s) is (are) not mentioned, (ii) substances referred to in note 38 of Annex VI.

▼C1

3. The list also does not include the following substances although they may be present: (a) substances which could be present in the finished product as: — impurities in the substances used, — reaction intermediates, — decomposition 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 included in the list; (c) mixtures of the authorised substances. The materials and articles which contain the substances indicated under points (a), (b) and (c) shall comply with the requirements stated in Article 2 of Directive 89/109/EEC.

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

5. The list contains the following information: — column 1 (Ref. No): the EEC packaging material reference number of the substances on the list, — column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number, — column 3 (Name): the chemical name, — column 4 (Restrictions and/or specifications): These may include: — — specific migration limit (SML), — maximum permitted quantity of the substance in the finished material or article (QM), — maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA), — any other restriction specifically mentioned, — any type of specifications related to the substance or to the polymer.

6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.

7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS and the CAS Registry, the CAS number in the CAS Registry shall apply.

8. A number of abbreviations or expressions are used in column 4 of the table, the meanings of which are as follows: DL = Detection limit of the method of analysis; FP = Finished material or article; NCO = Isocyanate moiety; ND = not detectable. For the purpose of this Directive ‘not detectable’ means that the substance should not be detected by a validated method of analysis which should detect it at the detection limit (DL) specified. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the detection limit may be used, pending the development of a validated method; ▼M2 QM = Maximum permitted quantity of the ‘residual’ substance in the material or article. For the purpose of this Directive the quantity of the substance in the material or article shall be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method; ▼C1 QM(T) = Maximum permitted quantity of the ‘residual’ substance in the material or article expressed as total of moiety or substance(s) indicated. For the purpose of this Directive the quantity of the substance in the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method; QMA = Maximum permitted quantity of the ‘residual’ substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs. For the purpose of this Directive the quantity of the substance in the surface of the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method; QMA(T) = Maximum permitted quantity of the ‘residual’ substance in the material or article expressed as mg of total of moiety or substance(s) indicated per 6 dm2 of the surface in contact with foodstuffs. For the purpose of this Directive the quantity of the substance in the surface of the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method; SML = Specific migration limit in food or in food simulant, unless it is specified otherwise. For the purpose of this Directive the specific migration of the substance should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method; SML(T) = Specific migration limit in food or in food simulant expressed as total of moiety or substance(s) indicated. For the purpose of this Directive the specific migration of the substances should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.

Section A







List of authorised monomers and other starting substances Ref. No. CAS No Name Restrictions and/or specifications (1) (2) (3) (4) 10030 000514-10-3 Abietic acid 10060 000075-07-0 Acetaldehyde SML(T) = 6 mg/kg (2) 10090 000064-19-7 Acetic acid 10120 000108-05-4 Acetic acid, vinyl ester SML = 12 mg/kg 10150 000108-24-7 Acetic anhydride 10210 000074-86-2 Acetylene ▼M2 10599/90A 061788-89-4 Acids, fatty, unsaturated (C18), dimers, distilled QMA(T) = 0,05 mg/6 dm2 (27) 10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers, non distilled QMA(T) = 0,05 mg/6 dm2 (27) 10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled QMA(T) = 0,05 mg/6 dm2 (27) 10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled QMA(T) = 0,05 mg/6 dm2 (27) ▼C1 10630 000079-06-1 Acrylamide SML = ND (DL = 0,01 mg/kg) 10660 015214-89-8 2-Acrylamido-2-methylpropanesulphonic acid SML = 0,05 mg/kg 10690 000079-10-7 Acrylic acid ►M3 SML(T) = 6 mg/kg (36) ◄ 10750 002495-35-4 Acrylic acid, benzyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 10780 000141-32-2 Acrylic acid, n-butyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 10810 002998-08-5 Acrylic acid, sec-butyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 10840 001663-39-4 Acrylic acid, tert-butyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ ▼M3 ————— ▼M3 11005 012542-30-2 Acrylic acid, dicyclopentenyl ester QMA = 0,05 mg/6 dm2 ▼C1 11245 002156-97-0 Acrylic acid, dodecyl ester SML = 0,05 mg/kg (1) 11470 000140-88-5 Acrylic acid, ethyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ ▼M3 11500 000103-11-7 Acrylic acid, 2-ethylhexyl ester SML = 0,05 mg/kg ▼C1 11510 000818-61-1 Acrylic acid, hydroxyethyl ester See ‘Acrylic acid, monoester with ethyleneglycol’ 11530 ►M2 00999-61-1 ◄ Acrylic acid, 2-hydroxypropyl ester ►M2 QMA = 0,05 mg/6 dm2 for the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester and in compliance with the specifications laid down in Annex V ◄ 11590 000106-63-8 Acrylic acid, isobutyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 11680 000689-12-3 Acrylic acid, isopropyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 11710 000096-33-3 Acrylic acid, methyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 11830 000818-61-1 Acrylic acid, monoester with ethyleneglycol ►M3 SML(T) = 6 mg/kg (36) ◄ 11890 002499-59-4 Acrylic acid, n-octyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 11980 000925-60-0 Acrylic acid, propyl ester ►M3 SML(T) = 6 mg/kg (36) ◄ 12100 000107-13-1 Acrylonitrile SML = ND (DL= 0,020 mg/kg, analytical tolerance included) 12130 000124-04-9 Adipic acid 12265 004074-90-2 Adipic acid, divinyl ester QM = 5 mg/kg in FP. Or use only as comonomer 12280 002035-75-8 Adipic anhydride 12310 Albumin 12340 Albumin, coagulated by formaldehyde 12375 Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22) 12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane SML = 6 mg/kg 12761 000693-57-2 12-Aminododecanoic acid SML= 0,05 mg/kg 12763 000141-43-5 2-Aminoethanol SML = 0,05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer 12765 084434-12-8 N-(2-Aminoethyl)-beta-alanine, sodium salt SML= 0,05 mg/kg ▼M3 12786 000919-30-2 3-Aminopropyltriethoxysilane ►M4 ►C2 Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers and SML = 0,05 mg/kg when used for the surface treatment of materials and articles. ◄ ◄ ▼C1 12788 002432-99-7 11-Aminoundecanoic acid SML= 5 mg/kg 12789 007664-41-7 Ammonia 12820 000123-99-9 Azelaic acid 12970 004196-95-6 Azelaic anhydride 13000 001477-55-0 1,3-Benzenedimethanamine SML= 0,05 mg/kg 13060 004422-95-1 1,3,5-Benzenetricarboxylic acid trichloride QMA = 0,05 mg/6 dm2 (measured as 1,3,5-Benzenetricarboxylic acid) 13075 000091-76-9 Benzoguanamine See ‘2,4-Diamino-6-phenyl-1,3,5-triazine’ 13090 000065-85-0 Benzoic acid 13150 000100-51-6 Benzyl alcohol 13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene (=Norbornene) SML= 0,05 mg/kg 13210 001761-71-3 Bis(4-aminocyclohexyl)methane SML= 0,05 mg/kg ▼M3 13317 132459-54-2 N,N′-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide SML = 0,05 mg/kg. Purity > 98,1 % (w/w). To be used only as co-monomer (max 4 %) for polyesters (PET, PBT) ▼M2 13323 000102-40-9 1,3-Bis(2-hydroxyethoxy)benzene SML = 0,05 mg/kg ▼C1 13326 000111-46-6 Bis(2-hydroxyethyl)ether See ‘Diethyleneglycol’ 13380 000077-99-6 2,2-Bis(hydroxymethyl)-1-butanol See ‘1,1,1-Trimethylolpropane’ 13390 000105-08-8 1,4-Bis(hydroxymethyl)cyclohexane 13395 004767-03-7 2,2-Bis(hydroxymethyl)propionic acid QMA = 0,05 mg/6 dm2 13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane ►M2 SML(T) = 0,6 mg/kg (28) ◄ 13510 001675-54-3 2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE) According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs (OJ L 51, 22.2.2002, p. 27) 13530 038103-06-9 2,2-Bis(4-hydroxyphenyl)propane bis(phthalic anhydride) SML = 0,05 mg/kg 13550 000110-98-5 Bis(hydroxypropyl) ether See ‘Dipropyleneglycol’ 13560 0005124-30-1 Bis(4-isocyanatocyclohexyl)methane See ‘Dicyclohexylmethane-4,4′-diisocyanate’ 13600 047465-97-4 3,3-Bis(3-methyl-4-hydroxyphenyl)2-indolinone SML = 1,8 mg/kg 13607 000080-05-7 Bisphenol A See ‘2,2-Bis(4-hydroxyphenyl)propane’ 13610 001675-54-3 Bisphenol A bis(2,3-epoxypropyl) ether See ‘2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether’ 13614 038103-06-9 Bisphenol A bis(phthalic anhydride) See ‘2,2-Bis(4-hydroxyphenyl)propane bis(phthalic anhydride)’ 13617 000080-09-1 Bisphenol S See ‘4,4′-Dihydroxydiphenyl sulphone’ 13620 010043-35-3 Boric acid SML(T) = 6 mg/kg (23) (expressed as Boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption (OJ L 330, 5.12.1998, p. 32). 13630 000106-99-0 Butadiene QM = 1 mg/kg in FP or SML = not detectable (DL = 0,020 mg/kg, analytical tolerance included) 13690 000107-88-0 1,3-Butanediol 13720 000110-63-4 1,4-Butanediol ►M3 SML(T) = 5 mg/kg (24) ◄ 13780 002425-79-8 1,4-Butanediol bis(2,3-epoxypropyl)ether QM = 1 mg/kg in FP (expressed as Epoxy group, Mw = 43) 13810 000505-65-7 1,4-Butanediol formal QMA = 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 QMA = ND (DL = 0,02 mg/6 dm2) To be used only as a comonomer for the preparation of polymeric additive 14020 000098-54-4 4-tert-Butylphenol SML = 0,05 mg/kg 14110 000123-72-8 Butyraldehyde 14140 000107-92-6 Butyric acid 14170 000106-31-0 Butyric anhydride 14200 000105-60-2 Caprolactam SML(T) = 15 mg/kg (5) 14230 002123-24-2 Caprolactam, sodium salt SML(T) = 15 mg/kg (5) (expressed as Caprolactam) ▼M3 14260 000502-44-3 Caprolactone SML = 0,05 mg/kg (expressed as the sum of caprolactone and 6-hydroxyhexanoic acid) ▼C1 14320 000124-07-2 Caprylic acid 14350 000630-08-0 Carbon monoxide 14380 000075-44-5 Carbonyl chloride QM = 1 mg/kg in FP 14411 008001-79-4 Castor oil 14500 009004-34-6 Cellulose 14530 007782-50-5 Chlorine 14570 000106-89-8 1-Chloro-2,3-epoxypropane See ‘Epichlorohydrin’ 14650 000079-38-9 Chlorotrifluoroethylene QMA = 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 ▼M2 14800 003724-65-0 Crotonic acid QMA(T) = 0,05 mg/6 dm2 (33) ▼C1 14841 000599-64-4 4-Cumylphenol SML = 0,05 mg/kg 14880 000105-08-8 1,4-Cyclohexanedimethanol See ‘1,4-Bis(hydroxymethyl)cyclohexane’ 14950 003173-53-3 Cyclohexyl isocyanate ►M2 QM(T) = 1 mg/kg in FP (expressed as NCO) (26) ◄ 15030 000931-88-4 Cyclooctene SML = 0,05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Directive 85/572/EEC 15070 001647-16-1 1,9-Decadiene SML = 0,05 mg/kg 15095 000334-48-5 Decanoic acid 15100 000112-30-1 1-Decanol 15130 000872-05-9 1-Decene SML = 0,05 mg/kg 15250 000110-60-1 1,4-Diaminobutane ▼M4 15267 000080-08-0 4,4′-Diaminodiphenyl sulphone SML = 5 mg/kg ▼C1 15272 000107-15-3 1,2-Diaminoethane See ‘Ethylenediamine’ 15274 000124-09-4 1,6-Diaminohexane See ‘Hexamethylenediamine’ 15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazine QMA = 5 mg/6 dm2 ▼M2 ————— ▼C1 15565 000106-46-7 1,4-Dichlorobenzene SML = 12 mg/kg 15610 000080-07-9 4,4′-Dichlorodiphenyl sulphone SML = 0,05 mg/kg 15700 005124-30-1 Dicyclohexylmethane-4,4′-diisocyanate QM(T) = 1 mg/kg (expressed as NCO (26) 15760 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3) 15790 000111-40-0 Diethylenetriamine SML = 5 mg/kg 15820 000345-92-6 4,4′-Difluorobenzophenone SML = 0,05 mg/kg 15880 000120-80-9 1,2-Dihydroxybenzene SML = 6 mg/kg 15910 000108-46-3 1,3-Dihydroxybenzene SML = 2,4 mg/kg 15940 000123-31-9 1,4-Dihydroxybenzene SML = 0,6 mg/kg 15970 000611-99-4 4,4′-Dihydroxybenzophenone SML(T) = 6 mg/kg (15) 16000 000092-88-6 4,4′-Dihydroxybiphenyl SML = 6 mg/kg 16090 000080-09-1 4,4′-Dihydroxydiphenyl sulphone SML = 0,05 mg/kg 16150 000108-01-0 Dimethylaminoethanol SML = 18 mg/kg ▼M2 16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane SML = 0,05 mg/kg (32). To be used only in polyamides. ▼C1 16240 000091-97-4 3,3′-Dimethyl-4,4′-diisocyanatobiphenyl QM(T) = 1 mg/kg (expressed as NCO) (26) 16360 000576-26-1 2,6-Dimethylphenol SML = 0,05 mg/kg 16390 000126-30-7 2,2-Dimethyl-1,3-propanediol SML = 0,05 mg/kg 16450 000646-06-0 1,3-Dioxolane ►M4 ►C2 SML = 5 mg/kg ◄ ◄ 16480 000126-58-9 Dipentaerythritol ▼M2 16540 000102-09-0 Diphenyl carbonate SML = 0,05 mg/kg ▼C1 16570 004128-73-8 Diphenylether-4,4′-diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 16600 005873-54-1 Diphenylmethane-2,4′-diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 16630 000101-68-8 Diphenylmethane-4,4′-diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 16650 000127-63-9 Diphenyl sulphone SML(T) = 3 mg/kg (25) 16660 000110-98-5 Dipropyleneglycol 16690 001321-74-0 Divinylbenzene QMA = 0,01 mg/6 dm2 or SML = ND (DL = 0,02 mg/kg, analytical tolerance included) for the sum of divinylbenzene and ethylvinylbenzene and in compliance with the specifications laid down in Annex V 16694 013811-50-2 N,N′-Divinyl-2-imidazolidinone QM = 5 mg/kg in FP 16697 000693-23-2 n-Dodecanedioic acid 16704 000112-41-4 1-Dodecene SML = 0,05 mg/kg 16750 000106-89-8 Epichlorohydrin QM = 1 mg/kg in FP 16780 000064-17-5 Ethanol 16950 000074-85-1 Ethylene ▼M3 16955 000096-49-1 Ethylene carbonate Residual content = 5 mg/kg of hydrogel at a maximum ratio of 10 g of hydrogel to 1 kg of food. The hydrolysate contains ethyleneglycol having an SML = 30 mg/kg ▼C1 16960 000107-15-3 Ethylenediamine SML = 12 mg/kg 16990 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3) 17005 000151-56-4 Ethyleneneimine SML = ND (DL = 0,01 mg/kg) 17020 000075-21-8 Ethylene oxide QM = 1 mg/kg in FP 17050 000104-76-7 2-Ethyl-1-hexanol SML = 30 mg/kg ▼M2 17110 016219-75-3 5-Ethylidenebicyclo[2,2,1]hept-2-ene QMA = 0,05 mg/6 dm2. The ratio surface/quantity of food shall be lower than 2 dm2/kg ▼C1 17160 000097-53-0 Eugenol SML = ND (DL = 0,02 mg/kg, analytical tolerance included) 17170 061788-47-4 Fatty acids, coco 17200 068308-53-2 Fatty acids, soya 17230 061790-12-3 Fatty acids, tall oil 17260 000050-00-0 Formaldehyde SML(T) = 15 mg/kg (22) 17290 000110-17-8 Fumaric acid 17530 000050-99-7 Glucose 18010 000110-94-1 Glutaric acid 18070 000108-55-4 Glutaric anhydride 18100 000056-81-5 Glycerol 18220 068564-88-5 N-Heptylaminoundecanoic acid SML = 0,05 mg/kg (1) 18250 000115-28-6 Hexachloroendomethylenetetrahydrophthalic acid SML = ND (DL = 0,01 mg/kg) 18280 000115-27-5 Hexachloroendomethylenetetrahydrophthalic anhydride SML = ND (DL = 0,01 mg/kg) 18310 036653-82-4 1-Hexadecanol 18430 000116-15-4 Hexafluoropropylene SML = ND (DL = 0,01 mg/kg) 18460 000124-09-4 Hexamethylenediamine SML = 2,4 mg/kg 18640 000822-06-0 Hexamethylene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 18670 000100-97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (22) (expressed as Formaldehyde) ▼M2 18700 000629-11-8 1,6-Hexanediol SML = 0,05 mg/kg ▼C1 18820 000592-41-6 1-Hexene SML = 3 mg/kg 18867 000123-31-9 Hydroquinone See ‘1,4-Dihydroxybenzene’ 18880 000099-96-7 p-Hydroxybenzoic acid ▼M2 18896 001679-51-2 4-(Hydroxymethyl)-1-cyclohexene SML = 0,05 mg/kg ▼C1 18897 016712-64-4 6-Hydroxy-2-naphthalenecarboxylic acid SML = 0,05 mg/kg 18898 000103-90-2 N-(4-Hydroxyphenyl) acetamide ►M2 SML = 0,05 mg/kg ◄ 19000 000115-11-7 Isobutene 19060 000109-53-5 Isobutyl vinyl ether QM = 5 mg/kg in FP 19110 004098-71-9 1-Isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane QM(T) = 1 mg/kg (expressed as NCO) (26) 19150 000121-91-5 Isophthalic acid SML = 5 mg/kg 19210 001459-93-4 Isophthalic acid, dimethyl ester SML = 0,05 mg/kg 19243 000078-79-5 Isoprene See ‘2-Methyl-1,3-butadiene’ 19270 000097-65-4 Itaconic acid 19460 000050-21-5 Lactic acid 19470 000143-07-7 Lauric acid 19480 002146-71-6 Lauric acid, vinyl ester 19490 000947-04-6 Laurolactam SML = 5 mg/kg 19510 011132-73-3 Lignocellulose 19540 000110-16-7 Maleic acid SML(T) = 30 mg/kg (4) 19960 000108-31-6 Maleic anhydride SML(T) = 30 mg/kg (4) (expressed as maleic acid) 19975 000108-78-1 Melamine See ‘2,4,6-triamino-1,3,5-triazine’ 19990 000079-39-0 Methacrylamide SML = ND (DL = 0,02 mg/kg, analytical tolerance included) 20020 000079-41-4 Methacrylic acid ►M3 SML(T) = 6 mg/kg (37) ◄ 20050 000096-05-9 Methacrylic acid, allyl ester SML = 0,05 mg/kg 20080 002495-37-6 Methacrylic acid, benzyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 20110 000097-88-1 Methacrylic acid, butyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 20140 002998-18-7 Methacrylic acid, sec-butyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 20170 000585-07-9 Methacrylic acid, tert-butyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 20260 000101-43-9 Methacrylic acid, cyclohexyl ester SML = 0,05 mg/kg 20410 002082-81-7 Methacrylic acid, diester with 1,4-butanediol SML = 0,05 mg/kg ▼M2 20440 000097-90-5 Methacrylic acid, diester with ethyleneglycol SML = 0,05 mg/kg ▼C1 20530 002867-47-2 Methacrylic acid, 2-(dimethylamino)-ethyl ester SML = ND (DL = 0,02 mg/kg, analytical tolerance included) 20590 000106-91-2 Methacrylic acid, 2,3-epoxypropyl ester QMA = 0,02 mg/6 dm2 20890 000097-63-2 Methacrylic acid, ethyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 21010 000097-86-9 Methacrylic acid, isobutyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 21100 004655-34-9 Methacrylic acid, isopropyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 21130 000080-62-6 Methacrylic acid, methyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 21190 000868-77-9 Methacrylic acid, monoester with ethyleneglycol ►M3 SML(T) = 6 mg/kg (37) ◄ 21280 002177-70-0 Methacrylic acid, phenyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ 21340 002210-28-8 Methacrylic acid, propyl ester ►M3 SML(T) = 6 mg/kg (37) ◄ ▼M3 21370 010595-80-9 Methacrylic acid, 2-sulphoethyl ester QMA = ND (DL = 0,02 mg/6 dm2) ▼M2 21400 054276-35-6 Methacrylic acid, sulphopropyl ester QMA = 0,05 mg/6 dm2 ▼C1 21460 000760-93-0 Methacrylic anhydride ►M3 SML(T) = 6 mg/kg (37) ◄ 21490 000126-98-7 Methacrylonitrile SML = ND (DL = 0,020 mg/kg, analytical tolerance included) 21520 001561-92-8 Methallylsulphonic acid, sodium salt SML = 5 mg/kg 21550 000067-56-1 Methanol 21640 000078-79-5 2-Methyl-1,3-butadiene QM = 1 mg/kg in FP or SML = ND (DL = 0,02 mg/kg, analytical tolerance included) 21730 000563-45-1 3-Methyl-1-butene QMA = 0,006 mg/6 dm2. For use only in Polypropylene 21765 106246-33-7 4,4′-Methylenebis(3-chloro-2,6-diethylaniline) QMA = 0,05 mg/6 dm2 21821 000505-65-7 1,4-(Methylenedioxy)butane See ‘1,4-Butanediol formal’ 21940 000924-42-5 N-Methylolacrylamide SML = ND (DL = 0,01 mg/kg) ▼M4 21970 000923-02-4 N-Methylolmethacrylamide SML = 0,05 mg/kg ▼C1 22150 000691-37-2 4-Methyl-1-pentene ►M2 SML = 0,05 mg/kg ◄ ▼M3 22210 000098-83-9 alpha-Methylstyrene SML = 0,05 mg/kg ▼C1 22331 025513-64-8 ►M2 Mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane ◄ QMA = 5 mg/6 dm2 22332 ►M2 — ◄ Mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 22350 000544-63-8 Myristic acid 22360 001141-38-4 2,6-Naphthalenedicarboxylic acid SML = 5 mg/kg 22390 000840-65-3 2,6-Naphthalenedicarboxylic acid, dimethyl ester SML = 0,05 mg/kg 22420 003173-72-6 1,5-Naphthalene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 22437 000126-30-7 Neopentylglycol See ‘2,2-Dimethyl-1,3-propanediol’ 22450 009004-70-0 Nitrocellulose 22480 000143-08-8 1-Nonanol 22550 000498-66-8 Norbornene See ‘Bicyclo[2.2.1]hept-2-ene’ 22570 000112-96-9 Octadecyl isocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 22600 000111-87-5 1-Octanol 22660 000111-66-0 1-Octene SML = 15 mg/kg 22763 000112-80-1 Oleic acid ▼M2 22775 000144-62-7 Oxalic acid SML(T) = 6 mg/kg (29) ▼C1 22778 007456-68-0 4,4′-Oxybis(benzenesulphonyl azide) QMA = 0,05 mg/6 dm2 22780 000057-10-3 Palmitic acid 22840 000115-77-5 Pentaerythritol 22870 000071-41-0 1-Pentanol 22900 000109-67-1 1-Pentene SML = 5 mg/kg ▼M3 22932 001187-93-5 Perfluoromethyl perfluorovinyl ether SML = 0,05 mg/kg. Only to be used for anti-stick coatings ▼C1 22937 001623-05-8 Perfluoropropylperfluorovinyl ether SML = 0,05 mg/kg 22960 000108-95-2 Phenol 23050 000108-45-2 1,3-Phenylenediamine SML = ND (DL = 0,02 mg/kg, analytical tolerance included) ▼M2 23070 000102-39-6 (1,3-Phenylenedioxy)diacetic acid QMA = 0,05 mg/6 dm2 ▼C1 23155 000075-44-5 Phosgene See ‘Carbonyl chloride’ 23170 007664-38-2 Phosphoric acid 23175 000122-52-1 Phosphorous acid, triethyl ester QM = ND (DL = 1 mg/kg in FP) 23187 Phthalic acid See ‘Terephthalic acid’ 23200 000088-99-3 o-Phthalic acid 23230 000131-17-9 Phthalic acid, diallyl ester SML = ND (DL = 0,01 mg/kg) 23380 000085-44-9 Phthalic anhydride 23470 000080-56-8 alpha-Pinene 23500 000127-91-3 beta-Pinene 23547 009016-00-6 063148-62-9 Polydimethylsiloxane (Mw > 6 800) In compliance with the specifications laid down in Annex V 23590 025322-68-3 Polyethyleneglycol 23651 025322-69-4 Polypropyleneglycol 23740 000057-55-6 1,2-Propanediol 23770 000504-63-2 1,3-Propanediol SML = 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 Propionic acid, vinyl ester SML(T) = 6 mg/kg (2) (expressed as Acetaldehyde) 23950 000123-62-6 Propionic anhydride 23980 000115-07-1 Propylene 24010 000075-56-9 Propylene oxide QM = 1 mg/kg in FP 24051 000120-80-9 Pyrocatechol See ‘1,2-Dihydroxybenzene’ 24057 000089-32-7 Pyromellitic anhydride SML = 0,05 mg/kg (expressed as Pyromellitic acid) 24070 073138-82-6 Resin acids and Rosin acids 24072 000108-46-3 Resorcinol See ‘1,3-Dihydroxybenzene’ 24073 000101-90-6 Resorcinol diglycidyl ether QMA = 0,005 mg/6 dm2. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer. 24100 008050-09-7 Rosin 24130 008050-09-7 Rosin gum See ‘Rosin’ 24160 008052-10-6 Rosin tall oil 24190 ►M3 008050-09-7 ◄ Rosin wood ►M3 See ‘Rosin’ (Reference No 24100) ◄ 24250 009006-04-6 Rubber, natural 24270 000069-72-7 Salicylic acid 24280 000111-20-6 Sebacic acid 24430 002561-88-8 Sebacic anhydride 24475 001313-82-2 Sodium sulphide 24490 000050-70-4 Sorbitol 24520 008001-22-7 Soybean oil 24540 009005-25-8 Starch, edible 24550 000057-11-4 Stearic acid 24610 000100-42-5 Styrene 24760 026914-43-2 Styrenesuphonic acid SML = 0,05 mg/kg 24820 000110-15-6 Succinic acid 24850 000108-30-5 Succinic anhydride 24880 000057-50-1 Sucrose ▼M4 24886 046728-75-0 5-Sulphoisophthalic acid, monolithium salt SML = 5 mg/kg and for lithium SML(T) = 0,6 mg/kg (8) (expressed as lithium) ▼C1 24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt SML = 5 mg/kg 24888 003965-55-7 5-Sulphoisophthalic acid, monosodium salt, dimethyl ester SML = 0,05 mg/kg ▼M3 24903 068425-17-2 Syrups, hydrolysed starch, hydrogenated In compliance with the specifications laid down in Annex V ▼C1 24910 000100-21-0 Terephthalic acid SML = 7,5 mg/kg 24940 000100-20-9 Terephthalic acid dichloride SML(T) = 7,5 mg/kg (expressed as Terephthalic acid) 24970 000120-61-6 Terephthalic acid, dimethyl ester 25080 001120-36-1 1-Tetradecene SML = 0,05 mg/kg 25090 000112-60-7 Tetraethyleneglycol 25120 000116-14-3 Tetrafluoroethylene SML = 0,05 mg/kg 25150 000109-99-9 Tetrahydrofuran SML = 0,6 mg/kg 25180 000102-60-3 N,N,N′,N′,-Tetrakis(2-hydroxypropyl)ethylenediamine 25210 000584-84-9 2,4-Toluene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 25240 000091-08-7 2,6-Toluene diisocyanate QM(T) = 1 mg/kg (expressed as NCO) (26) 25270 026747-90-0 2,4-Toluene diisocyanate dimer QM(T) = 1 mg/kg (expressed as NCO) (26) 25360 Trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester QM = 1 mg/kg in FP (expressed as Epoxy group, Mw = 43) 25380 — Trialkyl acetic acid (C7-C17), vinyl esters (= Vinyl versatate) QMA = 0,05 mg/6 dm2 25385 000102-70-5 Triallyamine In compliance with the specifications laid down in Annex V 25420 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg 25450 026896-48-0 Tricyclodecanedimethanol SML = 0,05 mg/kg 25510 000112-27-6 Triethyleneglycol ▼M3 25540 000528-44-9 Trimellitic acid SML(T) = 5 mg/kg (35) 25550 000552-30-7 Trimellitic anhydride SML(T) = 5 mg/kg (35) (expressed as trimellitic acid) ▼C1 25600 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg 25840 003290-92-4 1,1,1-Trimethylolpropane trimethacrylate SML = 0,05 mg/kg 25900 000110-88-3 Trioxane ►M4 ►C2 SML = 5 mg/kg ◄ ◄ 25910 024800-44-0 Tripropyleneglycol 25927 027955-94-8 1,1,1-Tris(4-hydroxyphenol)ethane QM= 0,5 mg/kg in FP. For use only in polycarbonates 25960 000057-13-6 Urea 26050 000075-01-4 Vinyl chloride See Council Directive 78/142/EEC 26110 000075-35-4 Vinylidene chloride QM = 5 mg/kg in FP or SML = ND (DL = 0,05 mg/kg) 26140 000075-38-7 Vinylidene fluoride SML = 5 mg/kg 26155 001072-63-5 1-Vinylimidazole QM = 5 mg/kg in FP 26170 003195-78-6 N-Vinyl-N-methylacetamide QM = 2 mg/kg in FP 26320 002768-02-7 Vinyltrimethoxysilane QM = 5 mg/kg in FP 26360 007732-18-5 Water In compliance with Directive 98/83/EC

Section B







List of monomers and other starting substances which may continue to be used pending a decision on inclusion in Section A Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) ▼M2 ————— ▼M3 ————— ▼C1 13050 000528-44-9 1,2,4-Benzenetricarboxylic acid See ‘Trimellitic acid’ ▼M3 ————— ▼M2 ————— ▼C1 15730 000077-73-6 Dicyclopentadiene ▼M2 ————— ▼C1 18370 000592-45-0 1,4-Hexadiene ▼M2 ————— ▼M3 ————— ▼M2 ————— ▼M4 ————— ▼M3 ————— ▼C1 26230 000088-12-0 Vinylpyrrolidone









ANNEX III

INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES

GENERAL INTRODUCTION

▼M2

1. This Annex contains the list of: (a) substances which are incorporated into plastics to achieve a technical effect in the finished product, including ‘polymeric additives’. They are intended to be present in the finished articles; (b) substances used to provide a suitable medium in which polymerisation occurs. For the purposes of this Annex, the substances referred to in (a) and (b) are hereinafter referred to as ‘additives’. For the purpose of this Annex, ‘Polymeric additives’ means any polymer and/or prepolymer and/or oligomer which may be added to plastics in order to achieve a technical effect but which cannot be used in absence of other polymers as the main structural component of finished materials and articles. It includes also substances which may be added to the medium in which polymerisation occurs. The list does not include: (a) the substances which directly influence the formation of polymers; (b) colorants; (c) solvents.

▼M3

2. The following substances are not included even if they are intentionally used and are authorised: (a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing ‘… acid(s), salts’ appear in the lists, if the corresponding free acid(s) is (are) not mentioned; (b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to: (i) substances whose name contains ‘… acid(s), salts’ which appear in the lists, if the corresponding free acid(s) is (are) not mentioned, (ii) substances referred to in note 38 of Annex VI.

▼C1

3. The list does not include the following substances although they may be present: (a) substances which could be present in the finished product such as: — impurities in the substances used, — reaction intermediates, — decomposition products; (b) mixtures of the authorised substances. The materials and articles which contain the substances indicated in (a) and (b) shall comply with the requirements stated in article 2 of Directive 89/109/EEC.

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

5. The list contains the following information: — column 1 (Ref. No): the EEC packaging material reference number of the substances on the list, — column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number, — column 3 (Name): the chemical name, — column 4 (Restrictions and/or specifications). These may include: — — specific migration limit (SML), — maximum permitted quantity of the substance in the finished material or article (QM), — maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA), — any other restriction specifically laid down, — any type of specification related to the substance or polymer.

6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.

7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS and the CAS registry, the CAS number in the CAS registry shall apply.

Section A







Incomplete list of additives fully harmonised at Community level Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) 30000 000064-19-7 Acetic acid 30045 000123-86-4 Acetic acid, butyl ester 30080 004180-12-5 Acetic acid, copper salt ►M3 SML(T) = 5 mg/kg (7) (expressed as Copper) ◄ 30140 000141-78-6 Acetic acid, ethyl ester 30280 000108-24-7 Acetic anhydride 30295 000067-64-1 Acetone ▼M3 30340 330198-91-9 12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester ▼C1 30370 — Acetylacetic acid, salts ▼M3 ————— ▼M3 30401 — Acetylated mono- and diglycerides of fatty acids ▼C1 30610 — Acids, C2-C24, aliphatic, linear, monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included) 30612 — Acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters 30960 — Acids, aliph., monocarb. (C6-C22), esters with polyglycerol 31328 — Acids, fatty, from animal or vegetable food fats and oils 31530 123968-25-2 Acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester SML = 5 mg/kg ▼M3 31542 174254-23-0 Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters QM = 0,5 % (w/w) in FP ▼C1 31730 000124-04-9 Adipic acid 33120 — Alcohols, aliph, monoh., sat., linear, primary (C4-C24) 33350 009005-32-7 Alginic acid 33801 — n-Alkyl(C10-C13)benzenesulphonic acid SML = 30 mg/kg 34240 — Alkyl(C10-C20)sulphonic acid, esters with phenols SML = 6 mg/kg. Authorised until 1 January 2002 34281 — Alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms 34475 — Aluminum calcium hydroxide phosphite, hydrate 34480 — Aluminium fibers, flakes and powders 34560 021645-51-2 Aluminium hydroxide 34690 011097-59-9 Aluminium magnesium carbonate hydroxide 34720 001344-28-1 Aluminium oxide ▼M2 34850 143925-92-2 Amines, bis(hydrogenated tallow alkyl) oxidised QM = For use only: (a) in polyolefines at 0,1 % (w/w) but not in LDPE when it is in contact with foods for which the Directive 85/572/EEC establishes a reduction factor less than 3; (b) in PETat 0,25 % (w/w) in contact with foods other of those for which the simulant D is laid down in Directive 85/572/EEC 85/572/EEC 34895 000088-68-6 2-Aminobenzamide SML = 0,05 mg/kg. To be used only for PET for water and beverages ▼C1 35120 013560-49-1 3-Aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether 35160 006642-31-5 6-Amino-1,3-dimethyluracil SML = 5 mg/kg 35170 000141-43-5 2-Aminoethanol SML = 0,05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer 35284 000111-41-1 N-(2-aminoethyl)ethanolamine SML = 0,05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer. 35320 007664-41-7 Ammonia 35440 001214-97-9 Ammonium bromide 35600 001336-21-6 Ammonium hydroxide 35840 000506-30-9 Arachidic acid 35845 007771-44-0 Arachidonic acid 36000 000050-81-7 Ascorbic acid 36080 000137-66-6 Ascorbyl palmitate 36160 010605-09-1 Ascorbyl stearate 36640 000123-77-3 Azodicarbonamide ►M1 For use only as blowing agent. Use prohibited as from 2 August 2005. ◄ 36840 012007-55-5 Barium tetraborate 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 Directive 98/83/EC on water for human consumption (OJ L 330, 5.12.1998, p. 32). 36880 008012-89-3 Beeswax 36960 003061-75-4 Behenamide 37040 000112-85-6 Behenic acid 37280 001302-78-9 Bentonite 37360 000100-52-7 Benzaldehyde In compliance with note 9 in Annex VI 37600 000065-85-0 Benzoic acid 37680 000136-60-7 Benzoic acid, butyl ester 37840 000093-89-0 Benzoic acid, ethyl ester 38080 000093-58-3 Benzoic acid, methyl ester 38160 002315-68-6 Benzoic acid, propyl ester ▼M3 ————— ▼C1 38510 136504-96-6 1,2-Bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine SML = 5 mg/kg 38515 001533-45-5 4,4'-Bis(2-benzoxazolyl)stilbene SML = 0,05 mg/kg (1) 38810 080693-00-1 Bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite SML = 5 mg/kg (sum of phosphite and phosphate) 38840 154862-43-8 Bis(2,4-dicumylphenyl)pentaerythritol-diphosphite SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)). 38879 135861-56-2 Bis(3,4-dimethylbenzylidene)sorbitol ▼M4 38885 002725-22-6 2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine SML = 0,05 mg/kg. For aqueous foods only. ▼C1 38950 079072-96-1 Bis(4-ethylbenzylidene)sorbitol 39200 006200-40-4 Bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride SML = 1,8 mg/kg ▼M2 39680 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane SML(T) = 0,6 mg/kg (28) ▼C1 39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene QMA = 0,05 mg/6 dm2 39890 087826-41-3 069158-41-4 054686-97-4 081541-12-0 Bis(methylbenzylidene)sorbitol 39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5-dimethylhexane SML = 0,05 mg/kg 40120 068951-50-8 Bis(polyethyleneglycol)hydroxymethylphosphonate SML = 0,6 mg/kg 40320 010043-35-3 Boric acid SML(T) = 6 mg/kg (23) (expressed as Boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption (OJ L 330, 5.12.1998, p.32). 40400 010043-11-5 Boron nitride 40570 000106-97-8 Butane 40580 000110-63-4 1,4-Butanediol ►M3 SML(T) = 5 mg/kg (24) ◄ 41040 005743-36-2 Calcium butyrate 41120 010043-52-4 Calcium chloride 41280 001305-62-0 Calcium hydroxide 41520 001305-78-8 Calcium oxide 41600 012004-14-7 037293-22-4 Calcium sulphoaluminate 41680 000076-22-2 Camphor In compliance with note 9 in Annex VI 41760 008006-44-8 Candelilla wax 41840 000105-60-2 Caprolactam SML(T) = 15 mg/kg (5) 41960 000124-07-2 Caprylic acid ▼M4 42080 001333-86-4 Carbon black In compliance with the specifications laid down in Annex V. ▼C1 42160 000124-38-9 Carbon dioxide 42320 007492-68-4 Carbonic acid, copper salt ►M3 SML(T) = 5 mg/kg (7) (expressed as Copper) ◄ 42500 — Carbonic acid, salts 42640 009000-11-7 Carboxymethylcellulose 42720 008015-86-9 Carnauba wax 42800 009000-71-9 Casein ▼M2 42880 008001-79-4 Castor oil ▼C1 42960 064147-40-6 Castor oil, dehydrated 43200 — Castor oil, mono- and diglycerides 43280 009004-34-6 Cellulose 43300 009004-36-8 Cellulose acetate butyrate 43360 068442-85-3 Cellulose, regenerated 43440 008001-75-0 Ceresin ▼M3 43480 064365-11-3 ►M4 ►C2 Charcoal, activated ◄ ◄ ►M4 ►C2 In compliance with the specifications laid down in Annex V. ◄ ◄ ▼C1 43515 — Chlorides of choline esters of coconut oil fatty acids QMA = 0,9 mg/6 dm2 44160 000077-92-9 Citric acid 44640 000077-93-0 Citric acid, triethyl ester 45195 007787-70-4 Copper bromide ►M3 SML(T) = 5 mg/kg (7) (expressed as Copper) ◄ 45200 001335-23-5 ►M4 ►C2 Copper iodide ◄ ◄ ►M4 ►C2 SML(T) = 5 mg/kg (7) (expressed as copper) and SML = 1 mg/kg (11) (expressed as iodine) ◄ ◄ 45280 — Cotton fibers 45450 068610-51-5 p-Cresol-dicyclopentadiene-isobutylene, copolymer ►M2 SML = 5 mg/kg ◄ 45560 014464-46-1 Cristobalite ▼M2 45600 003724-65-0 Crotonic acid QMA(T) = 0,05 mg/6 dm2 (33) 45640 005232-99-5 2-Cyano-3,3-diphenylacrylic acid, ethyl ester SML = 0,05 mg/kg ▼M4 45705 166412-78-8 1,2-cyclohexanedicarboxylic acid, diisononyl ester ▼C1 45760 000108-91-8 Cyclohexylamine 45920 009000-16-2 Dammar 45940 000334-48-5 n-Decanoic acid 46070 010016-20-3 alpha-Dextrin 46080 007585-39-9 beta-Dextrin 46375 061790-53-2 Diatomaceous earth 46380 068855-54-9 Diatomaceous earth, soda ash flux-calcined 46480 032647-67-9 Dibenzylidene sorbitol ▼M2 46700 — 5,7-di-tert-Butyl-3-(3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100 % w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20 % w/w) SML = 5 mg/kg 46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol QMA = 4,8 mg/6 dm2 ▼C1 46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester 46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester 46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester 46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt SML = 6 mg/kg 47210 026427-07-6 Dibutylthiostannoic acid polymer [= Thiobis(butyl-tin sulphide), polymer] In compliance with the specifications laid down in Annex V. 47440 000461-58-5 Dicyanodiamide 47540 027458-90-8 Di-tert-dodecyl disulphide SML = 0,05 mg/kg 47680 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3) 48460 000075-37-6 1,1-Difluoroethane 48620 000123-31-9 1,4-Dihydroxybenzene SML = 0,6 mg/kg 48720 000611-99-4 4,4'-Dihydroxybenzophenone SML(T) = 6 mg/kg (15) 49485 134701-20-5 2,4-Dimethyl-6-(1-methylpentadecyl)phenol SML = 1 mg/kg 49540 000067-68-5 Dimethyl sulphoxide 51200 000126-58-9 Dipentaerythritol 51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol SML = 0,05 mg/kg 51760 025265-71-8 000110-98-5 Dipropyleneglycol 52640 016389-88-1 Dolomite 52645 010436-08-5 cis-11-Eicosenamide 52720 000112-84-5 Erucamide 52730 000112-86-7 Erucic acid 52800 000064-17-5 Ethanol 53270 037205-99-5 Ethylcarboxymethylcellulose 53280 009004-57-3 Ethylcellulose 53360 000110-31-6 N,N'-Ethylenebisoleamide 53440 005518-18-3 N,N'-Ethylenebispalmitamide 53520 000110-30-5 N,N'-Ethylenebisstearamide 53600 000060-00-4 Ethylenediaminetetraacetic acid 53610 054453-03-1 Ethylenediaminetetraacetic acid, copper salt ►M3 SML(T) = 5 mg/kg (7) (expressed as Copper) ◄ 53650 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3) 54005 005136-44-7 Ethylene-N-palmitamide-N'-stearamide 54260 009004-58-4 Ethylhydroxyethylcellulose 54270 — Ethylhydroxymethylcellulose 54280 — Ethylhydroxypropylcellulose 54300 118337-09-0 2,2'-Ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite SML = 6 mg/kg 54450 — Fats and oils, from animal or vegetable food sources 54480 — Fats and oils, hydrogenated, from animal or vegetable food sources 54930 025359-91-5 Formaldehyde-1-naphthol, copolymer [=poly(1-hydroxynaphthylmethane)] SML = 0,05 mg/kg 55040 000064-18-6 Formic acid 55120 000110-17-8 Fumaric acid 55190 029204-02-2 Gadoleic acid 55440 009000-70-8 Gelatin 55520 — Glass fibers 55600 — Glass microballs 55680 000110-94-1 Glutaric acid 55920 000056-81-5 Glycerol 56020 099880-64-5 Glycerol dibehenate 56360 — Glycerol, esters with acetic acid 56486 — Glycerol, esters with acids, aliph., sat., linear, with an even number of carbon atoms (C14-C18) and with acids, aliph., unsat., linear, with an even number of carbon atoms (C16-C18) 56487 — Glycerol, esters with butyric acid 56490 — Glycerol, esters with erucic acid 56495 — Glycerol, esters with 12-hydroxystearic acid 56500 — Glycerol, esters with lauric acid 56510 — Glycerol, esters with linoleic acid 56520 — Glycerol, esters with myristic acid ▼M2 56535 — Glycerol, esters with nonanoic acid ▼C1 56540 — Glycerol, esters with oleic acid 56550 — Glycerol, esters with palmitic acid ▼M2 ————— ▼C1 56570 — Glycerol, esters with propionic acid 56580 — Glycerol, esters with ricinoleic acid 56585 — Glycerol, esters with stearic acid 56610 030233-64-8 Glycerol monobehenate 56720 026402-23-3 Glycerol monohexanoate 56800 030899-62-8 Glycerol monolaurate diacetate 56880 026402-26-6 Glycerol monooctanoate 57040 — Glycerol monooleate, ester with ascorbic acid 57120 — Glycerol monooleate, ester with citric acid 57200 — Glycerol monopalmitate, ester with ascorbic acid 57280 — Glycerol monopalmitate, ester with citric acid 57600 — Glycerol monostearate, ester with ascorbic acid 57680 — Glycerol monostearate, ester with citric acid 57800 018641-57-1 Glycerol tribehenate 57920 000620-67-7 Glycerol triheptanoate 58300 — Glycine, salts 58320 007782-42-5 Graphite 58400 009000-30-0 Guar gum 58480 009000-01-5 Gum arabic 58720 000111-14-8 Heptanoic acid ▼M2 59280 000100-97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (22) (expressed as Formaldehyde) ▼C1 59360 000142-62-1 Hexanoic acid 59760 019569-21-2 Huntite 59990 007647-01-0 Hydrochloric acid 60030 012072-90-1 Hydromagnesite 60080 012304-65-3 Hydrotalcite 60160 000120-47-8 4-Hydroxybenzoic acid, ethyl ester 60180 004191-73-5 4-Hydroxybenzoic acid, isopropyl ester 60200 000099-76-3 4-Hydroxybenzoic acid, methyl ester 60240 000094-13-3 4-Hydroxybenzoic acid, propyl ester 60480 003864-99-1 2-(2'-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole SML(T) = 30 mg/kg (19) 60560 009004-62-0 Hydroxyethylcellulose 60880 009032-42-2 Hydroxyethylmethylcellulose 61120 009005-27-0 Hydroxyethyl starch 61390 037353-59-6 Hydroxymethylcellulose 61680 009004-64-2 Hydroxypropylcellulose 61800 009049-76-7 Hydroxypropyl starch 61840 000106-14-9 12-Hydroxystearic acid ▼M4 62020 007620-77-1 12-Hydroxystearic acid, lithium salt SML(T) = 0,6 mg/kg (8) (expressed as lithium) ▼C1 62140 006303-21-5 Hypophosphorous acid 62240 001332-37-2 Iron oxide ▼M3 62245 012751-22-3 Iron phosphide For PET polymers and copolymers only ▼C1 62450 000078-78-4 Isopentane 62640 008001-39-6 Japan wax 62720 001332-58-7 Kaolin 62800 — Kaolin, calcined 62960 000050-21-5 Lactic acid 63040 000138-22-7 Lactic acid, butyl ester 63280 000143-07-7 Lauric acid 63760 008002-43-5 Lecithin 63840 000123-76-2 Levulinic acid 63920 000557-59-5 Lignoceric acid 64015 000060-33-3 Linoleic acid 64150 028290-79-1 Linolenic acid 64500 — Lysine, salts 64640 001309-42-8 Magnesium hydroxide 64720 001309-48-4 Magnesium oxide 64800 00110-16-7 Maleic acid SML(T) = 30 mg/kg (4) ▼M3 64990 025736-61-2 Maleic anhydride-styrene, copolymer, sodium salt In compliance with specifications laid down in Annex V ▼C1 65020 006915-15-7 Malic acid 65040 000141-82-2 Malonic acid 65520 000087-78-5 Mannitol 65920 066822-60-4 N-Methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers 66200 037206-01-2 Methylcarboxymethylcellulose 66240 009004-67-5 Methylcellulose 66560 004066-02-8 2,2'-Methylenebis(4-methyl-6-cyclohexylphenol) SML(T) = 3 mg/kg (6) 66580 000077-62-3 2,2'-Methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol) SML(T) = 3 mg/kg (6) 66640 009004-59-5 Methylethylcellulose 66695 — Methylhydroxymethylcellulose 66700 009004-65-3 Methylhydroxypropylcellulose 66755 002682-20-4 2-Methyl-4-isothiazolin-3-one SML = ND (DL = 0,02 mg/kg, analytical tolerance included) ▼M3 66905 000872-50-4 N-Methylpyrrolidone 66930 068554-70-1 Methylsilsesquioxane Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane ▼C1 67120 012001-26-2 Mica ▼M3 67155 — Mixture of 4-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene) Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation). In compliance with the specifications laid down in Annex V ▼M2 ————— ▼M4 67180 — Mixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n- octyl ester. SML = 5 mg/kg (1) ▼C1 67200 001317-33-5 Molybdenum disulphide 67840 — Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol 67850 008002-53-7 Montan wax 67891 000544-63-8 Myristic acid 68040 003333-62-8 7-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin ▼M2 68078 027253-31-2 Neodecanoic acid, cobalt salt SML(T) = 0,05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0,05 mg/kg (14) (expressed as Cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC. ▼C1 68125 037244-96-5 Nepheline syenite 68145 080410-33-9 2,2',2"-Nitrilo(triethyl tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite) SML =5 mg/kg (sum of phosphite and phosphate) 68960 000301-02-0 Oleamide 69040 000112-80-1 Oleic acid 69760 000143-28-2 Oleyl alcohol ▼M2 69920 000144-62-7 Oxalic acid SML(T) = 6 mg/kg (29) ▼C1 70000 070331-94-1 2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] 70240 012198-93-5 Ozokerite 70400 000057-10-3 Palmitic acid 71020 000373-49-9 Palmitoleic acid 71440 009000-69-5 Pectin 71600 000115-77-5 Pentaerythritol 71635 025151-96-6 Pentaerythritol dioleate SML = 0,05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC 71670 178671-58-4 Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate) SML = 0,05 mg/kg 71680 006683-19-8 Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] 71720 000109-66-0 Pentane ▼M4 71960 003825-26-1 Perfluorooctanoic acid, ammonium salt Only to be used in repeated use articles, sintered at high temperatures. ▼C1 72640 007664-38-2 Phosphoric acid 73160 — Phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters SML = 0,05 mg/kg 73720 000115-96-8 Phosphoric acid, trichloroethyl ester SML = ND (DL = 0,02 mg/kg, analytical tolerance included) 74010 145650-60-8 Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester SML =5 mg/kg (sum of phosphite and phosphate) 74240 031570-04-4 Phosphorous acid, tris(2,4-di-tert-butylphenyl)ester 74480 000088-99-3 o-Phthalic acid ▼M4 74560 000085-68-7 Phthalic acid, benzyl butyl ester To be used only as: (a) plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC; (c) technical support agent in concentrations up to 0,1 % in the final product. SML = 30 mg/kg food simulant. 74640 000117-81-7 Phthalic acid, bis (2-ethylhexyl) ester To be used only as: (a) plasticizer in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in concentrations up to 0,1 % in the final product. SML = 1,5 mg/kg food simulant. 74880 000084-74-2 Phthalic acid, dibutyl ester To be used only as: (a) plasticizer in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in polyolefines in concentrations up to 0,05 % in the final product. SML = 0,3 mg/kg food simulant. 75100 068515-48-0 028553-12-0 Phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9. To be used only as: (a) plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC; (c) technical support agent in concentrations up to 0,1 % in the final product. SML(T) = 9 mg/kg food simulant (42). 75105 068515-49-1 026761-40-0 Phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10 To be used only as: (a) plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC; (c) technical support agent in concentrations up to 0,1 % in the final product. SML(T) = 9 mg/kg food simulant (42). ▼C1 76320 000085-44-9 Phthalic anhydride ▼M3 76415 019455-79-9 Pimelic acid, calcium salt ▼C1 76721 009016-00-6 063148-62-9 Polydimethylsiloxane (Mw > 6800) In compliance with the specifications laid down in Annex V 76730 — Polydimethylsiloxane, gamma-hydroxypropylated SML = 6 mg/kg ▼M3 76815 — Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids In compliance with the specifications laid down in Annex V 76845 031831-53-5 ►M4 ►C2 Polyester of 1,4-butanediol with caprolactone ◄ ◄ ►M4 ►C2 The restriction for Ref. No 14260 and Ref. No 13720 shall be respected. In compliance with the specifications laid down in Annex V. ◄ ◄ ▼M2 ————— ▼M2 76866 — Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol SML = 30 mg/kg ▼C1 76960 025322-68-3 Polyethyleneglycol ▼M3 77370 070142-34-6 Polyethyleneglycol-30 dipolyhydroxystearate ▼C1 77600 061788-85-0 Polyethyleneglycol ester of hydrogenated castor oil 77702 — Polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulphates 77895 068439-49-6 Polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether ►M2 SML = 0,05 mg/kg and in compliance with the specifications laid down in Annex V ◄ 79040 009005-64-5 Polyethyleneglycol sorbitan monolaurate 79120 009005-65-6 Polyethyleneglycol sorbitan monooleate 79200 009005-66-7 Polyethyleneglycol sorbitan monopalmitate 79280 009005-67-8 Polyethyleneglycol sorbitan monostearate 79360 009005-70-3 Polyethyleneglycol sorbitan trioleate 79440 009005-71-4 Polyethyleneglycol sorbitan tristearate ▼M3 79600 009046-01-9 Polyethyleneglycol tridecyl ether phosphate SML = 5 mg/kg. For materials and articles intended for contact with aqueous foods only. In compliance with the specification laid down in Annex V ▼M4 79920 009003-11-6 106392-12-5 Poly(ethylene propylene) glycol ▼M3 80000 009002-88-4 Polyethylene wax ▼C1 80240 029894-35-7 Polyglycerol ricinoleate 80640 — Polyoxyalkyl (C2-C4) dimethylpolysiloxane 80720 008017-16-1 Polyphosphoric acids 80800 025322-69-4 Polypropyleneglycol ▼M3 81060 009003-07-0 Polypropylene wax ▼C1 81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-alpha-[N,N,N',N'-tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6-(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-triamine]-omega-N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine] SML = 5 mg/kg ▼M4 81500 9003-39-8 Polyvinylpyrrolidone In compliance with the specifications laid down in Annex V. ▼C1 81515 087189-25-1 Poly(zinc glycerolate) ►M3 SML(T) = 25 mg/kg (38) (as Zinc) ◄ 81520 007758-02-3 Potassium bromide 81600 001310-58-3 Potassium hydroxide 81760 — ►M4 ►C2 Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron ◄ ◄ ►M4 ►C2 SML(T) = 5 mg/kg (7) (expressed as copper); SML = 48 mg/kg (expressed as iron) ◄ ◄ 81840 000057-55-6 1,2-Propanediol 81882 000067-63-0 2-Propanol 82000 000079-09-4 Propionic acid 82080 009005-37-2 1,2-Propyleneglycol alginate 82240 022788-19-8 1,2-Propyleneglycol dilaurate 82400 000105-62-4 1,2-Propyleneglycol dioleate 82560 033587-20-1 1,2-Propyleneglycol dipalmitate 82720 006182-11-2 1,2-Propyleneglycol distearate 82800 027194-74-7 1,2-Propyleneglycol monolaurate 82960 001330-80-9 1,2-Propyleneglycol monooleate 83120 029013-28-3 1,2-Propyleneglycol monopalmitate 83300 001323-39-3 1,2-Propyleneglycol monostearate 83320 — Propylhydroxyethylcellulose 83325 — Propylhydroxymethylcellulose 83330 — Propylhydroxypropylcellulose 83440 002466-09-3 Pyrophosphoric acid 83455 013445-56-2 Pyrophosphorous acid 83460 012269-78-2 Pyrophyllite 83470 014808-60-7 Quartz 83599 068442-12-6 Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin SML(T) = 0,18 mg/kg (16) (expressed as Tin) 83610 073138-82-6 Resin acids and Rosin acids 83840 008050-09-7 Rosin 84000 008050-31-5 Rosin, ester with glycerol 84080 008050-26-8 Rosin, ester with pentaerythritol 84210 065997-06-0 Rosin, hydrogenated 84240 065997-13-9 Rosin, hydrogenated, ester with glycerol 84320 008050-15-5 Rosin, hydrogenated, ester with methanol 84400 064365-17-9 Rosin, hydrogenated, ester with pentaerythritol 84560 009006-04-6 Rubber, natural 84640 000069-72-7 Salicylic acid 85360 000109-43-3 Sebacic acid, dibutyl ester ▼M2 ————— ▼M2 85601 — Silicates, natural (with the exception of asbestos) ▼C1 85610 — Silicates, natural, silanated (with the exception of asbestos) 85680 001343-98-2 Silicic acid 85840 053320-86-8 Silicic acid, lithium magnesium sodium salt SML(T) = 0,6 mg/kg (8) (expressed as Lithium) 86000 — Silicic acid, silylated 86160 000409-21-2 Silicon carbide 86240 007631-86-9 Silicon dioxide 86285 — Silicon dioxide, silanated 86560 007647-15-6 Sodium bromide 86720 001310-73-2 Sodium hydroxide 87040 001330-43-4 Sodium tetraborate SML(T) = 6 mg/kg (23) (expressed as Boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption (OJ L 330, 5.12.1998, p.32). 87200 000110-44-1 Sorbic acid 87280 029116-98-1 Sorbitan dioleate 87520 062568-11-0 Sorbitan monobehenate 87600 001338-39-2 Sorbitan monolaurate 87680 001338-43-8 Sorbitan monooleate 87760 026266-57-9 Sorbitan monopalmitate 87840 001338-41-6 Sorbitan monostearate 87920 061752-68-9 Sorbitan tetrastearate 88080 026266-58-0 Sorbitan trioleate 88160 054140-20-4 Sorbitan tripalmitate 88240 026658-19-5 Sorbitan tristearate 88320 000050-70-4 Sorbitol 88600 026836-47-5 Sorbitol monostearate 88640 008013-07-8 ►M4 ►C2 Soybean oil, epoxidised ◄ ◄ ►M4 ►C2 SML = 60 mg/kg. However in the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 91/321/EEC or containing processed cereal-based foods and baby foods for infants and young children as defined by Directive 96/5/EC, the SML is lowered to 30 mg/kg. In compliance with the specifications laid down in Annex V. ◄ ◄ 88800 009005-25-8 Starch, edible 88880 068412-29-3 Starch, hydrolysed 88960 000124-26-5 Stearamide 89040 000057-11-4 Stearic acid 89200 007617-31-4 Stearic acid, copper salt ►M3 SML(T) = 5 mg/kg (7) (expressed as Copper) ◄ 89440 — Stearic acid, esters with ethyleneglycol SML(T) = 30 mg/kg (3) 90720 058446-52-9 Stearoylbenzoylmethane 90800 005793-94-2 Stearoyl-2-lactylic acid, calcium salt 90960 000110-15-6 Succinic acid 91200 000126-13-6 Sucrose acetate isobutyrate 91360 000126-14-7 Sucrose octaacetate 91840 007704-34-9 Sulphur 91920 007664-93-9 Sulphuric acid 92030 010124-44-4 Sulphuric acid, copper salt ►M3 SML(T) = 5 mg/kg (7) (expressed as Copper) ◄ 92080 014807-96-6 Talc 92150 001401-55-4 Tannic acids According to the JECFA specifications 92160 000087-69-4 Tartaric acid 92195 — Taurine, salts 92205 057569-40-1 Terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol) 92350 000112-60-7 Tetraethyleneglycol 92640 000102-60-3 N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine 92700 078301-43-6 2,2,4,4-Tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer SML = 5 mg/kg 92930 120218-34-0 Thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate) SML = 6 mg/kg 93440 013463-67-7 Titanium dioxide 93520 000059-02-9 010191-41-0 alpha-Tocopherol 93680 009000-65-1 Tragacanth gum 93720 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg ▼M4 93760 000077-90-7 Tri-n-butyl acetyl citrate ▼C1 94320 000112-27-6 Triethyleneglycol 94960 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg ▼M2 95000 028931-67-1 Trimethylolpropane trimethacrylate-methyl methacrylate copolymer ▼M4 95020 6846-50-0 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate SML = 5 mg/kg food. To be used in single-use gloves only. ▼C1 95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene 95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP) ▼M4 95420 745070-61-5 1,3,5-tris (2,2-dimethylpropanamido)benzene SML = 0,05 mg/kg food. ▼C1 95725 110638-71-6 Vermiculite, reaction product with citric acid, lithium salt SML(T) = 0,6 mg/kg (8) (expressed as Lithium) 95855 007732-18-5 Water In compliance with Directive 98/83/EEC 95859 — Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks In compliance with the specifications laid down in Annex V 95883 — White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks In compliance with the specifications laid down in Annex V 95905 013983-17-0 Wollastonite 95920 — Wood flour and fibers, untreated 95935 011138-66-2 Xanthan gum 96190 020427-58-1 Zinc hydroxide ►M3 SML(T) = 25 mg/kg (38) (as Zinc) ◄ 96240 001314-13-2 Zinc oxide ►M3 SML(T) = 25 mg/kg (38) (as Zinc) ◄ 96320 001314-98-3 Zinc sulphide ►M3 SML(T) = 25 mg/kg (38) (as Zinc) ◄

Section B







Incomplete list of additives referred to in Article 4, second paragraph Ref. No CAS No Name Restrictions and/or specifications (1) (2) (3) (4) 30180 002180-18-9 Acetic acid, manganese salt SML(T) = 0,6 mg/kg (10) (expressed as Manganese) ▼M3 31500 025134-51-4 Acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer SML(T) = 6 mg/kg (36) (expressed as acrylic acid) and SML = 0,05 mg/kg (expressed as acrylic acid, 2-ethylhexyl ester) ▼C1 31520 061167-58-6 Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester SML = 6 mg/kg 31920 000103-23-1 Adipic acid, bis(2-ethylhexyl) ester SML = 18 mg/kg (1) 34230 — Alkyl(C8-C22)sulphonic acids SML = 6 mg/kg ▼M2 34650 151841-65-5 Aluminium hydroxybis [2,2'-methylenebis (4,6-di-tert.butylphenyl) phosphate SML = 5 mg/kg ▼M4 35760 001309-64-4 antimony trioxide SML = 0,04 mg/kg (39) (expressed as antimony) ▼C1 36720 017194-00-2 Barium hydroxide SML(T) = 1 mg/kg (12) (expressed as Barium) 36800 010022-31-8 Barium nitrate SML(T) = 1 mg/kg (12) (expressed as Barium) ▼M2 38000 000553-54-8 Benzoic acid, lithium salt SML(T) = 0,6 mg/kg (8) (expressed as Lithium) ▼C1 38240 000119-61-9 Benzophenone SML = 0,6 mg/kg ▼M3 38505 351870-33-2 cis-endo-Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, disodium salt SML = 5 mg/kg. Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 % ▼C1 38560 007128-64-5 2,5-Bis(5-tert-butyl-2-benzoxazolyl)thiophene SML = 0,6 mg/kg 38700 063397-60-4 Bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate) SML = 18 mg/kg 38800 032687-78-8 N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide SML = 15 mg/kg 38820 026741-53-7 Bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite SML = 0,6 mg/kg ▼M3 38940 110675-26-8 2,4-Bis(dodecylthiomethyl)-6-methylphenol SML(T) = 5 mg/kg (40) ▼C1 39060 035958-30-6 1,1-Bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane SML = 5 mg/kg 39090 — N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine SML(T) = 1,2 mg/kg (13) 39120 — N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides SML(T) = 1,2 mg/kg (13) expressed as Tertiary amine (expressed excluding HCl) 40000 000991-84-4 2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine SML = 30 mg/kg 40020 110553-27-0 2,4-Bis(octylthiomethyl)-