On December 16, 2021 the Food Packaging Forum (FPF) submitted comments to the European Food Safety Authority (EFSA) regarding its draft Scientific Opinion on “Identification and prioritisation for risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food“ (FPF reported).
FPF specifically commented on the lack of a clear recommendation from EFSA to address chemicals with severe hazard properties, namely the phthalates that are known to be CMR substances (carcinogenic, mutagenic, or toxic to reproduction). At present, these chemicals are legally allowed for use in food contact materials (FCMs) and articles (FCAs), and they are found in different types of FCMs and FCAs. The EU Chemicals Strategy for Sustainability (CSS; FPF reported) foresees that such chemicals with severe hazard properties are no longer present in consumer products, like FCAs. However, EFSA recommends that “the substances included in this group are suggested to be brought forward for risk assessment only if, following the implementation of risk management measures in accordance with the CSS, consumers may be exposed due to the use of the substance(s) in FCMs.” This reasoning is indeed not in accordance with the CSS, as FPF’s comments explain.
Further, FPF commented on methodological aspects of the prioritization. Firstly, a number of chemicals that could be used as plasticizers and therefore as alternatives for the phthalates were dismissed without clear elaboration of criteria for this step. Therefore, FPF recommended that details are provided in the Scientific Opinion, together with a list of the excluded chemicals. And secondly, prioritization of remaining chemicals was carried out based on the date of their last risk assessment. This is again not in line with CSS requirements, which would instead foresee that these chemicals are prioritized firstly on their intrinsic hazard propertied. In those cases, where pertinent hazard data are not available, chemicals without hazard data should be grouped for further data collection.
FPF (December 16, 2021). “Comment to the EFSA public consultation on ‘Identification and prioritisation for risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food’.” (pdf)
EFSA (November 5, 2021). “Phthalates: draft opinion and exposure protocol open for public consultation.”