The 2017 “Plastics and paper in contact with foodstuffsSmithers Pira conference took place on December 5-7, 2017 in Berlin, Germany. Conference speakers gave an overview and updates on the regulation of food contact materials (FCMs) in the U.S., China (FPF reported), and India (FPF reported). By far the most attention was dedicated to FCMs’ regulation in Europe.

Alistair Irvine of food contact consultancy Smithers Pira summarized the changes introduced by the recent amendments to the Plastics Regulation (EU) No 10/2011, particularly the 6th (FPF reported), 7th (FPF reported), and 9th amendments (FPF reported). The latter amendment has been notified to the World Trade Organization (WTO) in September 2017 (FPF reported) and is currently with the European Parliament (EP) for a three-month scrutiny period. Its publication is expected in February 2018. The draft 10th amendment has been discussed at a meeting of the EU technical expert group for FCMs in September 2017 (FPF reported).

Irvine further informed on the status of the EU “draft guideline on interpretation of testing rules” for Regulation (EU) No 10/2011. This document elaborates on the choice of food simulants, screening and modeling approaches, and use of functional barriers, among other topics. An annex on multilayer materials was also planned. The last announced expected publication date for this document was autumn 2016. However, currently it appears that the Legal Services unit of the European Commission (EC) has “raised objections” to publishing this guideline, so no progress has been made since, and no further information is currently available.

Further, according to Irvine, the EC’s approval of recycling processes for food contact plastics (FPF reported), as well as a publication of a positive list of ingredients for active & intelligent (A&I) FCMs “may be expected quite soon.” A draft regulation on bisphenol A (BPA, CAS 80-05-7) in FCMs was published in August 2017 (FPF reported), and the process for a systematic re-evaluation of new scientific evidence on BPA has been adopted recently by the European Food Safety Authority’s (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF Panel) (FPF reported).

An area where little progress has been made so far concerns the EU regulation of non-harmonized FCMs. About six years ago, the EU launched a consultation process to determine the next materials to regulate, but “this has come to a halt.” There is, therefore, a risk that EU Member States will “lose patience,” choosing to “go forward with national regulations,” so Irvine. An example of this is the German draft ordinance on printing inks (FPF reported), which is currently halted following the EC’s announcement of its plans to develop a new legislative piece for printed FCMs (FPF reported).

Rachida Semail, partner at law firm Keller and Heckman LLP, gave a detailed overview of the EC’s plans to regulate printed FCMs, based on the presentations released in May 2017 (FPF reported) and September 2017 (FPF reported). She further shared her personal view on this proposal. While she agrees that the need for harmonization is justified, she pointed out that the EC could have done more to enforce the principle of mutual recognition for non-harmonized FCMs, which is currently in effect but “does not seem to work” for various reasons. Semail further addressed the questions of whether the EC-proposed approach to regulate printed FCMs is “proportionate,” “efficient,” “consistent,” and “enforceable,” and presented arguments in support of a negative answer to all of the above. In Semail’s opinion, the EC’s current proposal was largely inspired by the publications of Koni Grob calling for a change in FCM regulation in Europe (FPF reported). She disagrees with Grob’s view that “industry is not doing enough,” and pledges for a broader acceptance of industry self-assessment procedures. Semail further criticized the “lack of transparency” on behalf of the EC in that it does not allow law associates to participate in technical meetings. However, industry representatives do have access to technical meetings on FCMs (FPF reported), unlike the representatives of non-governmental organizations (FPF reported). Currently, the EC considers creating an FCM stakeholder forum for public interest groups (FPF reported). Lastly, Semail gave an overview of legislative procedures to be carried out in drafting and adopting the printed FCMs measure, and concluded that the currently planned publication of this regulation by the end of 2018 is “unrealistic.”

Read more

Smithers Pira (2017). “Plastics & paper in contact with foodstuffs.

Tammy Lovell (December 7, 2017). “Member states ‘may legislate’ if EU stalls on harmonizing FCM.Chemical Watch