On December 1-3, 2020, Smithers Pira held its annual conference on “Plastics & Paper in Contact with Foodstuffs.” The event took place in a completely virtual format and included presentations by speakers from various industries, consultancies, government agencies, legislators, and non-governmental organizations. Two representatives of the European Commission (EC) informed about the latest developments with respect to food contact materials (FCMs).
Jonathan Briggs, legislative officer at the Directorate General for Health and Food Safety (DG SANTE) at the EC presented the latest developments on the evaluation and revisions of the EU rules on FCMs. After providing background information on the ongoing evaluation process which started in the year 2018, Briggs summarized the consultation activities organized by the EC (FPF reported). During this process, several issues were identified, such as the lack of specific rules at EU levels for most FCM materials and the lack of focus on all substances present in an FCM, which need to be addressed in the future. Furthermore, there are difficulties in demonstrating compliance, enforcing the legal requirements, and aligning the FCM legislation and the European Chemicals Regulation (REACH). Therefore, Briggs concluded that further data and supporting evidence are still needed before the staff working document can be published. Besides the current evaluation, other actions by the EC touch upon other FCM-related legislation, such as the Farm to Fork strategy (FPF reported), the Circular Economy Action Plan (FPF reported), and the Chemicals Strategy for Sustainability (FPF reported). At the end of his talk, Briggs displayed a timetable and announced the publication of the Inception Impact Assessment by the end of 2020 or the beginning of 2021. The consultation period will then last four weeks, and a webinar will be organized by the EC to give stakeholders the opportunity to clarify open questions. For 2021, an Impact Assessment (IA) is planned. The results of the evaluation and IA of the FCM legislation will hopefully lead to the adoption of a new regulation by the end of 2022, Briggs concluded.
In another presentation, Bastiaan Schupp, legislative officer at DG SANTE, highlighted the ongoing activities on plastic and recycled plastic FCMs at the EC. In the beginning, Schupp addressed open questions that refer to the interaction of the Framework Regulation (EC) 1935/2004 on FCMs and the Commission Regulation (EU) No 10/2011 on plastic FCMs, such as how to handle the provisions on non-intentionally added substances, include new toxicity data, and implement a conservative and appropriate risk assessment. Schupp then summarized the 15th amendment to Commission Regulation (EU) No 10/2011 on plastic FCMs (FPF reported). In his presentation, he especially focused on the changes in the annexes of the plastics regulation and explained their practical relevance. Since developments in analytical chemistry led to lower levels of detection for many substances, the non-detect limits for specific migration of 1,3-phenylenediamine (CAS 108-45-2) and primary aromatic amines were decreased in Annexes I and II, respectively. Furthermore, Schupp stressed that (i) the chemicals listed in Annex II are not authorized for intentional use, (ii) the amendments of Annex IV specify that any changes in Annex I and II also apply to intermediate stages of the supply chain, including non-intentionally added substances, and (iii) repeated-use materials and articles are not compliant if the specific migration limit of a substance is exceeded in any of the three subsequent test results or increases from the first to the third migration test. Subsequently, Schupp focused on the 16th amendment that is going to include microbial fermentation processes, handling of off-cuts and scraps, and labeling of restrictions. Additional topics under discussion include an update on phthalates and the deletion of authorizations for wood flour (FPF reported), salicylic acid (CAS 69-72-7), lauric acid (CAS 143-07-7), and vinyl ester from Annex I of the plastics regulation. Future amendments may address the addition of new substances to Annex I, a reassessment of styrene (FPF reported) providing a template for the Declaration of Compliance, and the integration of biocides into the FCM legislation. Furthermore, 450 Annex I substances without a specific migration limit are to be assessed after being prioritized (FPF reported). In the coming year, an amendment to Commission Regulation (EC) No 282/2008 on recycled plastic in FCMs is foreseen, and the authorization decisions of recycling processes are planned to be notified to applicants, Schupp concluded.
Smithers Pira (December 1-3, 2020). “Plastics & Paper in Contact with Foodstuffs.”