Diferencias que subjetivan: Tratamiento de la diferencia en las acciones

Good manufacturing practice (GMP) requirements are set forth in Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food, which became applicable from 1 August 2008. The GMP Regulation applies to all sectors and all stages of manufacture of food contact materials, except starting substances. The elements of GMP are defined as the establishment, implementation and adherence to appropriate quality assurance, quality con- trol and documentation systems.

Food contact materials (FCMs) are subject to the requirements of Regula- tion (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (the Framework Regulation). Article 3 of the Framework Regulation requires

that all FCMs be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of food, or deteriorate the organoleptic characteristics of food. The Regulation also allows for the adoption of specific measures for a group of materials and articles identified in Annex I to the Regulation. Plastics are among the groups of materials for which specific measures have been adopted under the Framework Regulation.

Plastics are subject to the Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs, known as the Plastics Directive. The Plastics Directive applies to materials comprised exclusively of plastics, and subjects plastic food-contact articles to the overall migration limit (OML) set forth in Article 2 of the Directive, which prohibits an overall, cumulative, migration into contacted food of all constituents of the finished plastic article in quantities exceeding 10 mg dm 2or 60 mg kg 1.

The Plastics Directive also sets forth a positive list of authorised monomers (Article 3) and additives (Article 4) that may be used in the manufacture of plastics. The list of permitted monomers and other starting substances of the Plastics Directive is a strict positive list. That is, only substances listed in Annex II of the Directive are permitted for use as starting substances in the manu- facture of plastics. However, the list of permitted additives in Annex III of the Directive is currently considered to be incomplete. This means that unlisted additives may be used today in compliance with applicable EU legislation, provided that they are safe for their intended use and that these additives and the finished product in which they are used comply with the applicable national legislation of the Member States in which they are marketed, subject to the principle of mutual recognition.

The principle of mutual recognition allows for the legal importation and sale in a Member State of products that are legally marketed in another Member State even if the products do not comply with the specific regulatory require- ments of the country of import, unless authorities of the country of import can demonstrate that the products raise legitimate health or safety concerns. A Regulation confirming the applicability of the principle of mutual recognition to all industrially manufactured or agricultural products, and establishing minimum procedural guarantees for companies marketing their products on the basis of mutual recognition, was adopted by the Council of the European Union on 23 June 2008. The Regulation has entered into force 9 months after its publication in the Official Journal of the European Union.

However, the fifth amendment to the Plastics Directive, Directive 2008/39/ EC (Commission Directive 2008/39/EC of 6 March 2008 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food, OJ L63, 7.3.2008, p. 6.), establishes the date when the additives list becomes a positive list as 1 January 2010. As of that date, only additives listed as permitted components in the Directive, and additives listed in 159 Small Ingredients in a Big Picture: Regulatory Perspectives on Nanotechnologies

the provisional list of components that were petitioned for inclusion into the Directive before 31 December 2006, can be used.34

In addition to the condition of the additives list, various exemptions from the positive listing requirement currently exist for both monomers (Article 3.5) and additives (Article 4.3). These exemptions are based on the applications in which they are used. Of course, in all cases the substances present in the food contact plastics must still permit the finished plastic to comply with the general requirements of the Framework Regulation (safety, no unacceptable change in composition or deterioration of the quality of the food), even if they are not required to be listed in the Directive. Because these exempted uses fall outside of the scope of harmonised EU law, they must also comply with applicable national legislation of the Member States in which they are marketed, subject to the principle of mutual recognition.

The most straightforward way of demonstrating that a substance used in the manufacture of FCMs complies with the general safety requirements of Article 3 of the Framework Regulation is to establish that it is covered by an applicable listing in the Plastics Directive and that it is used in accordance with the potential restrictions that may be established for that substance under the Directive. Indeed, it is the very purpose of the Directive, as a specific measure under the Framework Regulation, to establish requirements implementing the general safety requirements of the Regulation when applied specifically to food contact plastics. The listing of a substance as a permitted component of plastics under the Directive presupposes a review and determination by the EFSA or its predecessor the EU Scientific Committee on Food (SCF) that the substance could be considered safe in the applications of interest provided potentially applicable restrictions are met.

For the same reason, a reference to a listing in the Plastics Directive is another effective way of demonstrating that a substance is ‘safe’ and therefore, in compliance with Article 3 of the Framework Regulation. This should occur even if the substance is intended for use in an application that is not subject to the Plastics Directive (for example, rubber, paper and board or silicones) or is intended for a use that is not covered in the positive list of authorised mono- mers and additives (for example, adhesives, coatings, or solvents). This is especially true in several Member States where the lists of authorised substances in the Directive, as implemented into their national legislation, may be applied to materials that are beyond the scope of the Directive but subject to national positive list requirements. Based on the foregoing, a Plastics Directive listing, even when not required under EU law, may be used to establish safety and compliance with national requirements.

Substances that are not listed in the Plastics Directive can be demonstrated to be safe by reference to a favourable listing in a national positive list of an EU Member State. Alternatively, other national positive listings can be considered that may not be directly applicable to the intended conditions of use of the substance, but that nevertheless may have some relevance to the safety of the material by, for example, clearing its use in similar applications or in appli- cations that would result in similar levels of exposure.

Alternatively, a conclusion of safety can be based upon a favourable listing by a competent authority of another (non-EU) country, such as the US FDA, or recommendations of intra-governmental organisations such as the Council of Europe, or upon a self-assessment providing a conclusion based upon well- accepted scientific principles.

Hence, under the existing regulatory scheme FCMs have to be safe for the intended application in all conditions. To establish safety is the responsibility of the manufacturer, as clearly required by the GMP Regulation.

10.2.5

Regulatory Status of FCMs Produced by