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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) Official Journal L 220 , 15/08/2002 P. 0018 - 0058

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, HAS ADOPTED THIS DIRECTIVE: Article 1 1. This Directive is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC. 2. This Directive shall apply to plastic materials and articles and parts thereof: (a) consisting exclusively of plastics; or (b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means, which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs are intended for that purpose. 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. 4. This Directive shall not apply, until further action by the Commission, 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. Article 2 Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). However, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff (mg/kg) in the following cases: (a) articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres (ml) and not more than 10 litres (l); (b) articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs; (c) caps, gaskets, stoppers or similar devices for sealing. Article 3 1. Only those monomers and other starting substances listed in Annex II, Sections A and B, may be used for the manufacture of plastic materials and articles subject to the restrictions specified. 2. By way of derogation from the first paragraph the monomers and other starting substances listed in Annex II, Section B, may continue to be used until 31 December 2004 at latest, pending their evaluation by the Scientific Committee on Food. 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. Article 4 An incomplete 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, Sections A and B. For the substances in Annex III, Section B, the specific migration limits are applied as from 1 January 2004 when the verification of compliance is carried out in simulant D or in test media of substitute tests as laid down in Directives 82/711/EEC and 85/572/EEC. Article 5 Only the products obtained by means of bacterial fermentation listed in Annex IV may be used in contact with foodstuffs. 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. Article 7 The specific migration limits in the list set out in Annex II 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 materials which cannot be filled of for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuffs in contact therewith. In these cases, the limits set out in Annex II, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2. 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. 2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits are not exceeded. 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. Article 9 1. At the marketing stages other than the retail stages, the plastic materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6(5) of Directive 89/109/EEC. 2. Paragraph 1 does not apply to plastic materials and articles, which by their nature are clearly intended to come into contact with foodstuffs. 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. Done at Brussels, 6 August 2002. For the Commission David Byrne Member of the Commission (1) OJ L 40, 11.2.1989, p. 38. (2) OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990, p. 26. (3) OJ L 58, 28.2.2002, p. 19. (4) OJ L 297, 23.10.1982, p. 26. Directive as last amended by Directive 97/48/EC (OJ L 222, 12.8.1997, p. 10). (5) OJ L 372, 31.12.1985, p. 14. (6) OJ L 44, 15.2.1978, p. 15. (7) OJ L 213, 16.8.1980, p. 42. (8) OJ L 167, 24.6.1981, p. 6. (9) OJ L 151, 19.6.1980, p. 21. (10) OJ L 93, 17.4.1993, p. 27. Directive amended by Directive 93/111/EC (OJ L 310, 14.12.1993, p. 41). 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 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: >PIC FILE= "L_2002220EN.002202.TIF"> >TABLE> 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. 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 do 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 substances. 2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised. However, names containing "... acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In each case the meaning of the term "salts" is "salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc". 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; QM= Maximum permitted quantity of the "residual" substance in the material or article; 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 >TABLE> Section B List of monomers and other starting substances which may continue to be used pending a decision on inclusion in Section A >TABLE> ANNEX III INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES GENERAL INTRODUCTION 1. This Annex contains the list of: (a) substances which are incorporated into plastics to achieve a technical effect in the finished product. They are intended to be present in the finished articles; (b) substances used to provide a suitable medium in which polymerization occurs (e.g. emulsifiers, surfactants, buffering agents etc.). The list does not include the substances, which directly influence the formation of polymers (e.g. the catalytic system). 2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised. However, names containing "...acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In such cases the meaning of the term "salts" is "salts of aluminium ammonium, calcium, iron, magnesium, potassium, sodium and zinc". 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 >TABLE> Section B Incomplete list of additives referred to in Article 4, second paragraph >TABLE> ANNEX IV PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION >TABLE> ANNEX V SPECIFICATIONS Part A: General specifications The material and article manufactured by using aromatic isocyanates or colorants prepared by diazo-coupling, shall not release primary aromatic amines (expressed as aniline) in a detectable quantity (DL = 0,02 mg/kg of food or food simulant, analytical tolerance included). However, the migration value of the primary aromatic amines listed in this Directive are excluded from this restriction. Part B: Other specifications >TABLE> ANNEX VI NOTES RELATED TO THE COLUMN "RESTRICTIONS AND/OR SPECIFICATIONS" (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24) (25)(26) (1) Warning: there is a risk that the SML could be exceeded in fatty food simulants. (2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 10060 and 23920. (3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 15760, 16990, 47680, 53650 and 89440. (4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 19540, 19960 and 64800. (5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 14200, 14230 and 41840. (6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 66560 and 66580. (7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030. (8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 42400, 64320, 73040, 85760, 85840, 85920 and 95725. (9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EEC. (10) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120. (11) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 45200, 64320, 81680 and 86800. (12) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 36720, 36800, 36840, and 92000. (13) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 39090 and 39120. (14) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 44960, 68078, 82020 and 89170. (15) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 15970, 48640, 48720, 48880, 61280, 61360 and 61600. (16) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 49600, 67520 and 83599. (17) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120. (18) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 67600, 67680 and 67760. (19) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 60400, 60480 and 61440. (20) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 66400 and 66480. (21) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 93120 and 93280. (22) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 17260 and 18670. (23) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 13620, 36840, 40320 and 87040. (24) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 13720 and 40580. (25) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 16650 and 51570. (26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as Ref. Nos: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270. ANNEX VII Part A REPEALED DIRECTIVE AND ITS AMENDMENTS (Referred to by Article 10(1)) Commission Directive 90/128/EEC (OJ L 349, 13.12.1990, p. 26) Commission Directive 92/39/EEC (OJ L 168, 23.6.1992, p. 21) Commission Directive 93/9/EEC (OJ L 90, 14.4.1993, p. 26) Commission Directive 95/3/EC (OJ L 41, 23.2.1995, p. 44) Commission Directive 96/11/EC (OJ L 61, 12.3.1996, p. 26) Commission Directive 1999/91/EC (OJ L 310, 4.12.1999, p. 41) Commission Directive 2001/62/EC (OJ L 221, 17.8.2001, p. 18) Commission Directive 2002/17/EC (OJ L 58, 28.2.2002, p. 19) Part B DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW (Referred to by Article 10(1)) >TABLE> ANNEX VIII CORRELATION TABLE >TABLE>

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,

HAS ADOPTED THIS DIRECTIVE:

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

2. This Directive shall apply to plastic materials and articles and parts thereof:

(a) consisting exclusively of plastics; or

(b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means,

which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs are intended for that purpose.

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.

4. This Directive shall not apply, until further action by the Commission, 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.

Article 2

Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). However, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff (mg/kg) in the following cases:

(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres (ml) and not more than 10 litres (l);

(b) articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs;

(c) caps, gaskets, stoppers or similar devices for sealing.

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

2. By way of derogation from the first paragraph the monomers and other starting substances listed in Annex II, Section B, may continue to be used until 31 December 2004 at latest, pending their evaluation by the Scientific Committee on Food.

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.

An incomplete 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, Sections A and B.

For the substances in Annex III, Section B, the specific migration limits are applied as from 1 January 2004 when the verification of compliance is carried out in simulant D or in test media of substitute tests as laid down in Directives 82/711/EEC and 85/572/EEC.

Article 5

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

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.

Article 7

The specific migration limits in the list set out in Annex II 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 materials which cannot be filled of for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuffs in contact therewith.

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

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.

2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits are not exceeded.

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.

Article 9

1. At the marketing stages other than the retail stages, the plastic materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6(5) of Directive 89/109/EEC.

2. Paragraph 1 does not apply to plastic materials and articles, which by their nature are clearly intended to come into contact with foodstuffs.

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.

Done at Brussels, 6 August 2002.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 40, 11.2.1989, p. 38.

(2) OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990, p. 26.

(3) OJ L 58, 28.2.2002, p. 19.

(4) OJ L 297, 23.10.1982, p. 26. Directive as last amended by Directive 97/48/EC (OJ L 222, 12.8.1997, p. 10).

(5) OJ L 372, 31.12.1985, p. 14.

(6) OJ L 44, 15.2.1978, p. 15.

(7) OJ L 213, 16.8.1980, p. 42.

(8) OJ L 167, 24.6.1981, p. 6.

(9) OJ L 151, 19.6.1980, p. 21.

(10) OJ L 93, 17.4.1993, p. 27. Directive amended by Directive 93/111/EC (OJ L 310, 14.12.1993, p. 41).

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 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:

>PIC FILE= "L_2002220EN.002202.TIF">

>TABLE>

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.

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 do 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 substances.

2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised. However, names containing "... acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In each case the meaning of the term "salts" is "salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc".

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;

QM= Maximum permitted quantity of the "residual" substance in the material or article;

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

>TABLE>

Section B

List of monomers and other starting substances which may continue to be used pending a decision on inclusion in Section A

>TABLE>

ANNEX III

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

GENERAL INTRODUCTION

1. This Annex contains the list of:

(a) substances which are incorporated into plastics to achieve a technical effect in the finished product. They are intended to be present in the finished articles;

(b) substances used to provide a suitable medium in which polymerization occurs (e.g. emulsifiers, surfactants, buffering agents etc.).

The list does not include the substances, which directly influence the formation of polymers (e.g. the catalytic system).

2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised. However, names containing "...acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In such cases the meaning of the term "salts" is "salts of aluminium ammonium, calcium, iron, magnesium, potassium, sodium and zinc".

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

>TABLE>

Section B

Incomplete list of additives referred to in Article 4, second paragraph

>TABLE>

ANNEX IV

PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION

>TABLE>

ANNEX V

SPECIFICATIONS

Part A: General specifications

The material and article manufactured by using aromatic isocyanates or colorants prepared by diazo-coupling, shall not release primary aromatic amines (expressed as aniline) in a detectable quantity (DL = 0,02 mg/kg of food or food simulant, analytical tolerance included). However, the migration value of the primary aromatic amines listed in this Directive are excluded from this restriction.

Part B: Other specifications

>TABLE>

ANNEX VI

NOTES RELATED TO THE COLUMN "RESTRICTIONS AND/OR SPECIFICATIONS"

(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24) (25)(26)

(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.

(2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 10060 and 23920.

(3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 15760, 16990, 47680, 53650 and 89440.

(4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 19540, 19960 and 64800.

(5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 14200, 14230 and 41840.

(6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 66560 and 66580.

(7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.

(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 42400, 64320, 73040, 85760, 85840, 85920 and 95725.

(9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EEC.

(10) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.

(11) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 45200, 64320, 81680 and 86800.

(12) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 36720, 36800, 36840, and 92000.

(13) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 39090 and 39120.

(14) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 44960, 68078, 82020 and 89170.

(15) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(16) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 49600, 67520 and 83599.

(17) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.

(18) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 67600, 67680 and 67760.

(19) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 60400, 60480 and 61440.

(20) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 66400 and 66480.

(21) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 93120 and 93280.

(22) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 17260 and 18670.

(23) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 13620, 36840, 40320 and 87040.

(24) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 13720 and 40580.

(25) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 16650 and 51570.

(26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as Ref. Nos: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

ANNEX VII

Part A

REPEALED DIRECTIVE AND ITS AMENDMENTS

(Referred to by Article 10(1))

Commission Directive 90/128/EEC (OJ L 349, 13.12.1990, p. 26)

Commission Directive 92/39/EEC (OJ L 168, 23.6.1992, p. 21)

Commission Directive 93/9/EEC (OJ L 90, 14.4.1993, p. 26)

Commission Directive 95/3/EC (OJ L 41, 23.2.1995, p. 44)

Commission Directive 96/11/EC (OJ L 61, 12.3.1996, p. 26)

Commission Directive 1999/91/EC (OJ L 310, 4.12.1999, p. 41)

Commission Directive 2001/62/EC (OJ L 221, 17.8.2001, p. 18)

Commission Directive 2002/17/EC (OJ L 58, 28.2.2002, p. 19)

Part B

DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW

(Referred to by Article 10(1))

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ANNEX VIII

CORRELATION TABLE

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