On April 15, 2024, the Food Packaging Forum (FPF), submitted its comments to the European Commission regarding proposed amendments to EU regulations on food contact plastics. These amendments pertain specifically to EU Regulation 10/2011 and EU Regulation 2023/2006 on good manufacturing practices for food contact materials (FCMs).
FPF acknowledges the significance of food contact materials and articles (FCMs) as a notable source of human exposure to food contact chemicals (FCCs). Over the past five decades, numerous studies have demonstrated the migration of FCCs under normal conditions of FCM use, indicating chronic exposure to these substances. FPF emphasizes the need for regulations that align with the EU’s Chemicals Strategy for Sustainability (CSS) and its Farm to Fork Strategy (F2F), both of which advocate for the phased reduction of hazardous chemicals in FCMs due to their adverse health impacts (FPF reported).
We express concern that the proposed amendments do not sufficiently address this need for reduction. Specifically, we critique the suggested threshold of 0.15 parts per billion (ppb) for non-intentionally added substances (NIAS) as lacking scientific basis. This threshold, which is based on an EFSA Scientific Opinion nearly two decades old, fails to uphold modern scientific standards.
We highlight methodological flaws in the derivation of the 0.15 ppb threshold, particularly concerning assumptions of linear dose-response relationships and the relevance of high-dose rodent studies to human exposure. Contemporary scientific understanding, including EFSA’s recognition of non-monotonic dose responses, necessitates a reevaluation of such thresholds to adequately protect human health.
Furthermore, FPF criticizes provisions in the draft regulation that may weaken safety standards for FCMs, such as the designation of substances used in plastic manufacturing as “of a high degree of purity” based on unspecified thresholds for unknown contaminants. We argue that such provisions diverge from efforts to enhance FCM safety, especially for recycled and reusable plastics.
While we acknowledge certain improvements in the proposed amendments, such as enhanced specifications for migration testing and clarification on the scope of FCM regulations, we assert that additional measures are necessary to address emerging concerns, such as the long-term effects of repeated use on FCMs and the ambiguity surrounding definitions of waste materials.
Note: There was a mistake in the comment submitted to the EU, in the comment it says that the limit was 1.5 ppb instead of the proposed 0.15 ppb. The text here has been altered to reflect the correct value.
References
Food Packaging Forum (April 15, 2024). “FPF feedback on plastic food contact materials update to quality control rules.”
European Commission (March 13, 2024). “Food safety – plastic food contact materials (FCMs) (update to quality control rules).”
Read more
Keller & Heckman (March 14, 2024). “Draft European Commission proposal may significantly impact plastic food-contact materials.”
Eline Schaart (March 15, 2024). “European Commission proposes stricter requirements for plastics in FCMs.” Chemical Watch News & Insight
SAFE (April 15, 2024). “SAFE response to public consultation on food safety – plastic food contact materials (FCMs) (update to quality control rules).”
Vanessa Zainzinger (April 16, 2024). “European plastics industry opposes ‘extreme’ purity requirements for FCMs.”
