Special Focus
European Commission Drafts Proposal On Recycled Plastic Materials Intended for Contact with Food
Jun 2004
Joan Sylvain Baughan
The European Commission currently is working on a proposal concerning the use of recycled plastics in contact with food; the latest version of the draft ("Commission Directive on recycled plastic materials and articles intended to come into contact with foodstuffs," EMB/955 Rev. 3 (Jan. 12, 2004)) may be accessed via the United Kingdom's Food Standards Agency website, at http://www.foodstandards.gov.uk/multimedia/pdfs/recyledplastic.pdf. (We note that the current proposal is set up as a Directive. However, according to a recent presentation made by Dr. Luigi Rossi of the European Commission, the proposal will take the form of a Regulation, as opposed to a Directive.) The Commission's proposal applies to mechanical processes for recycling food-contact plastic for use in future food-contact applications. The term "mechanical recycling process" refers to the grinding and cleaning of post consumer-use plastic. The draft proposal specifies that the recycling process must demonstrate that it can efficiently reduce contamination to a level that does not pose a risk to human health.
Other processes for recycling plastics ( i.e., monomers and starting substances that are obtained from chemical depolymerization and re-use of virgin in-house plastic production scrap) are not subject to this draft directive. These processes are subject to rules under the European Union's (EU) Plastics Directive (Directive 2002/72/EC on plastic materials and articles intended to come into contact with food). Companies using chemical depolymerization technologies should ensure that their processes do not result in any impurities in the finished resin that would pose a health or safety concern, and that the finished article meets the overall migration limit and any specific migration or residual quantity limitations for the monomers and additives set forth in the Plastics Directive. Similarly, the monomer and oligomers resulting from chemical recycling are not treated differently from monomers manufactured by chemical synthesis. Therefore, they also are covered by the Plastics Directive.
Article 4 of the proposal on Recycled Plastics, applying to mechanical processes for recycling food-contact plastics for use in future food-contact applications, enumerates certain requirements. It specifies that the recycling process shall use only input containing plastic materials and articles that have been manufactured in accordance with the Plastics Directive (2002/72/EC), and that have only been in contact with food. Interestingly, it specifies that sorting efficiency shall be at least 99%, but notes that stricter rules may be set for the specific authorized process and does not specify what rules, or when they will be applied. The authorized recycling process also must be accompanied by a quality assurance system that demonstrates that the process complies with the requirements set out in the authorization.
According to the most recent draft of the proposal on Recycled Plastics, to obtain an authorization, an applicant must submit to the European Food Safety Authority (EFSA) a petition containing a technical dossier, summary of the dossier, and a "reasoned statement" that the material complies with the requirements laid down in Article 4. (In a recent presentation, Dr. Rossi of the European Commission indicated that, when adopted, the Regulation may require that the application first be submitted to a Member State authority and checked for completeness before being forwarded to EFSA.) EFSA shall acknowledge receipt of the application in writing within 14 days of receipt, and will inform the Member States and the Commission of the request. Then, within six months, the EFSA shall issue an opinion on whether the recycling process complies with the requirements of the Regulation. The time period for issuing an opinion may be extended for as long as an additional year, provided an explanation for the delay is given to the applicant, the Commission, and the Member States.
Once an opinion is issued, the EFSA will make the opinion public, after deletion of any information identified as confidential. Information may be indicated as confidential if its disclosure would significantly harm competitive position. However, the name and address of the applicant and the name of the recycling process, information of direct relevance to the assessment of the safety of the recycling process, and the analytical methods may not be claimed as confidential (Article 15). Furthermore, under the data protection provisions (Article 16), information in an application may not be used for the benefit of another applicant, without the approval of the authorization holder that such information may be used.
Once the EFSA opinion is provided, the Commission, within three months, shall draft a measure to be adopted with respect to the application for inclusion in a publicly available Community Register of approved recycling processes. This draft would take into account the requirements of the Regulation, Community law, and other "legitimate" factors relevant to the matter under consideration. The Community Register would identify the name of the applicant, a description of the process, and any restrictions or conditions. The authorization would be valid for five years, and could be renewed for an additional five-year period, provided the authorization holder applies to the EFSA at least one year before the expiration of the initial authorization.
Note, however, that even after an applicant has obtained the listing of the process on the Community Register, the holder of the authorization must have the recycling company audited by an approved auditor prior to placing the output on the market. The auditor must verify that the recycling process corresponds to the one authorized and that an effective quality assurance system is in place. The auditor must then submit a report to the national competent authority, which then has three months to decide whether the quality assurance system is sufficient. If the authorization holder licenses the process to another company, this licensee must also be audited by an approved auditor.
The proposal contains further specifications regarding the approval of auditors. Member States shall notify the other Member States and the Commission of the proposed auditor, and, provided there is no objection to the auditor by a Member State competent authority, the Commission shall publish the name on the list of approved auditors, updating it once a year to reflect any changes. Annex V ("Criteria to be Met for Designation of Approved Auditors") declares that the auditor must have sound training, knowledge of the rules of the proposal, and the ability to draw up required records and certificates. The auditor may not be directly involved in the recycling process, nor represent the recyclers, ( i.e., must be independent and impartial, and must observe professional secrecy with regard to all information gained in the performance of duty).
The proposal also requires that all materials that contain more than 5% recycled plastic must be labeled with a chasing arrow symbol with a glass and fork in the middle as set forth in Annex III of the proposal. Further, the proposal would require the traceability of the recycled plastic materials to be established at all stages of manufacture, processing, and distribution. The proposal also contains traceability and recordkeeping provisions that are basically consistent with the provisions found in other directives and recent proposals for food-contact materials legislation.
Part of the purpose of this draft proposal is to harmonize the regulation of food-contact articles containing recycled plastic content that are placed on the market in the EU. The proposal notes that differences between national laws, regulations, and administrative provisions concerning the safety assessment and the authorization of recycling processes used in the manufacture of materials and articles intended to come into contact with food may hinder the free movement of these materials and articles throughout the EU, creating conditions of unequal and unfair competition. Currently, food-contact plastics that contain recycled plastic content are subject to regulation under the national laws of the individual Member States. Some Member States, such as Belgium and France, require premarket approval of the recycling process before recycled output may be used in food-contact plastics. At least two Member States, Spain and Italy, have generally prohibited the use of recycled content in food contact plastics, although this ban does not apply to post-consumer recycled content obtained from chemical depolymerization procedures. In addition, without a Community-wide approval process, processors have been forced by some customers to try to obtain approvals for specific recycling processes individually from the competent authorities in the EU Member States. Therefore the proposal seeks to create an authorization procedure at the Community level. The Commission plans to publish detailed guidance concerning the preparation and submission of an application.
Once a recycling process is authorized, a written declaration of compliance is required, and it must include: (1) the identity and address of the company that manufactures or imports into the EU the finished recycled plastic materials, (2) references to applicable national regulations and EU Directives, (3) a declaration that only plastic output from an authorized recycling process has been used, (4) the name and address of the recycler, (5) confirmation that the finished recycled plastic material meets the requirements of the relevant EU Directives, and (6) a detailed compliance statement concerning the relevant restrictions in the Plastics Directive.
A footnote in Annex IV details the times that need to be included in the declaration of compliance for plastic output and for recycled plastic materials and articles and notes that recyclers from outside the EU also should obtain authorization. Compliance with the proposal and the procedures for applying for EFSA authorization should not be overly burdensome for recyclers importing into the EU. The process is intended to be the same as for any application from within the EU, and also would be valid once granted for 5 years. Recyclers from outside the EU, however, should bear in mind the extra burden of complying with the audit provisions. After setting up the authorized recycling process, but prior to placing the output on the market, the authorization holder of the recycling process must have the company audited by an approved auditor. However, approved auditors must be included on the list of approved auditors. Additionally, Article 18 of the proposal states that Member States shall demonstrate the competence of the auditors, and that other Member States have the right to challenge the competence of an auditor. Thus, not being within an EU Member State could have decided disadvantages, and could slow considerably the ability of importers to market recycled product in the EU. Thus, it may be prudent for recyclers outside the EU to consider who could perform their audit, and to start the process of obtaining approval of the auditor at the outset of the authorization process.
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