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.