On July 13, 2017, the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE) released a new document pertaining to the latest meeting of the Working Group on food contact materials (FCMs), held on May 4-5, 2017 in Brussels, Belgium (FPF reported). The document refers to the “Discussion on the Union Measure on printed food contact materials” (agenda item 5). Summarized in a slide deck, the state of play and problems associated with regulating printed FCMs are described. The measure on printed FCMs’ objective is “to protect against constituents of printing inks” migrating into foods at unacceptable levels.

Since printing is applied on substrates, a new measure aims to cover all types of substrates with respect to the applied inks, and states that compliance should be verified on substrates. The outlined problems with regulating printed FCMs include (i) compliance by (small) food business operators (FBOs), (ii) complexity and communication difficulties in the supply chain, (iii) the very high number of substances used, (iv) substrate materials, e.g. (recycled) paper and board, as additional source of substances to be regulated, (v) lack of rules for verification of compliance, and (vi) the need to ensure transparent risk assessment.

Two different regulatory approaches are discussed: (i) the “traditional approach” (similar to the Plastics Regulation EU 10/2011), and (ii) an entirely new approach.

The “traditional structure” is “presently considered problematic” because it requires “several decades work” to authorize the multitude of substances used in printed FCMs and raises “problems hard to resolve” with regard to compliance verification. On the other hand, the new approach shifts the responsibilities for ensuring compliance to “designated bodies” which can be either commercial laboratories or consultants appointed by Member States after accreditation. Their activities will include, for example, “identification of (migrating) substances, migration testing, toxicology testing . . . [and its] interpretation (partially a new regulated activity), evaluation of applicable rules [and] decision on safety (partially a new regulated activity).” The designated bodies should be independent from FCM manufactures to ensure “impartiality and confidentiality,” and they will be “responsible for certifying compliance work.” There may also be a possibility for “some self-certification,” for example for FBOs, retailers, or distributors.

The new approach foresees the development of a “rule base directing the work”, which will include “legislation, standards, guidance, internal rules.” There will also be a central database, accessible by public authorities, which will be used “to facilitate exchange of information in [the] supply chain.” The “governance committee” will consist of the “European Commission, Member States, designated bodies, [and] stakeholders.” The main bulk of compliance work will be carried out by designated bodies.

The key changes in the proposed new approach with respect to the current approach for regulating FCMs include formalization of rules for supporting documentation, further formalization of risk assessment, as well as “no detailed compliance rules” (since certification by designated body would mean that the material is compliant). Positive listing will be applied only “in case of problematic use,” and there will be a formal role for a governance committee covering “detailed risk management & procedural matters.”

Accordingly, the long term benefits of taking the “new approach to compliance” as detailed in the Commission’s document include “increased transparency & better access” thanks to a “formalized approach to assessment and documentation,” and decentralization of technical and scientific work, while authorities will “focus at norm-setting.” Risk assessments by European Food Safety Authority (EFSA) will become an exception as they will be carried out “only [for] those cases that really require it.” The new approach would also provide “flexibility and speed for business” by ensuring “clarity in the supply chain.”

The next steps will include hiring a contractor to identify labs and consultants which could act as designated bodies, as well as reaching an official decision on which of the two approaches to choose, the traditional or the new one, and then drafting the regulation. Currently, the EC is “not yet committed to any approach,” and the slide deck has been provided as a way to raise awareness for a potential new approach. Currently, the measure will concern only printed FCMs, but in the future this same approach may be considered for other FCMs as well. In a parallel process, the EU Commission is preparing a roadmap for evaluating the EU FCM framework regulation (EC 1935/2004) (FPF reported).

Read more

EC (May 5, 2017). “p-FCM. Regulating Printed Food Contact Materials.” (published July 13, 2017) (pdf)

Vanessa Zainzinger (July 19, 2017). “DG Sante proposes options for printed food contact measure.