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European Commission Outlines Possible New Approach to Regulating Printed FCMs

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The European Commission (EC) is considering using designated bodies to certify intermediate and final food contact materials (FCMs) before they can be placed on the EU market as an alternative approach to regulating printed FCMs by way of a traditional positive list system. The designated bodies—consisting of commercial laboratories or other consultants—would be approved by Member States and would be responsible for certifying compliance at “each stage of manufacturing.” They also could carry out the compliance work themselves.

Under a designated bodies approach, Member States would verify the work of the designated bodies and have the right to overrule a certificate granted by a designated body. This approach would be supported by sharing information through a database that would be accessible to competent authorities and the European Food Safety Authority (EFSA). Designated bodies would have access to relevant dossiers, while FCM and food business operators could have access to “basic information.” The public would possibly have access to selected information.

Legislation would establish the main obligations (i.e., procedures that need to be followed and rules on hazard/exposure and risk assessment), standards, and guidance, while the designated bodies would be responsible for:

  • Identifying migrating substances
  • Migration testing
  • Toxicology, to include testing where data is not available, and interpretation of data
  • Evaluation of applicable rules
  • Decisions on safety

A “governance committee” with members from EFSA, Member States, designated bodies, and industry could be established. It would be tasked with determining where further rules are needed and discussing specific dossiers.

This approach was outlined in a presentation on the main problems that the EC expects to encounter during the drafting of a measure on printed FCMs. The presentation, which was recently released by the EC, was given during a meeting of the Working Group on food contact materials of the toxicological safety section of the Standing Committee on Plants, Animals, Food and Feed (SC-PAFF), held May 4-5, 2017.

The designated bodies approach was suggested as an alternative to developing a regulation similar to the Plastics Regulation, (EU) No 10/2011, for FCMs other than plastic. According to the EC, the problems in developing a regulation like the Plastics Regulation include the amount of time needed to create a positive list, and the significant effort associated with developing the limitations/specifications for substances on the positive list and rules for documentation.

The EC suggested that long-term benefits of a designated body approach include: increased transparency and better access, decentralization of technical work, and the ability of EFSA to conduct risk assessments only on an as needed basis. The Commission stressed that the adoption of a designated bodies approach is not its official position, rather this approach was presented to facilitate discussion on future legislation governing printed FCMs. However, the EC mentioned that this approach could possibly be used to regulate other FCMs.