On May 12, 2022, the European Food Safety Authority (EFSA) published the final version of its scientific opinion on the prioritization for risk assessment of phthalates and similar plasticizers in food contact materials (FCMs) as well as the protocol “for assessing the exposure of EU consumers to the plasticizer substances.” The work was carried out at the request of the European Commission to “re-evaluate the risks to public health related to the presence of plasticizers such as phthalates, structurally similar substances, and replacement substances, as a consequence of migration from food contact materials.”
The final scientific opinion is largely the same as the draft published in November 2021 (FPF reported) with the addition of a few more substances in the prioritization scheme. The final opinion offers an overview of substances determined to potentially be used as plasticizers in FCMs with more details, compared to the draft, on the steps of the process to create the final list. EFSA categorizes the substances into groups of high, medium, or low priority levels for further risk assessment based on the date of their most recent risk assessment.
Substances last assessed before 2001 were placed in the highest priority group, and substances assessed since 2011 in the lowest priority group. Only substances authorized for use in FCMs at the EU or national level were considered for the prioritization. “For the EU stream, the 76 substances were split into 59 high-, 14 medium- and 3 low-priority substances. For the nationally authorised stream, the split of the 72 substances is 66, 3 and 3, respectively.”
The Food Packaging Forum (FPF) commented on the draft opinion about 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) (FPF reported). A paragraph was added in the final opinion clarifying EFSA’s process stating that “the use of these hazard properties for the purpose of the exclusion group was the only use of hazard information made in this prioritisation exercise. A more extensive use of hazard properties as possible prioritisation criteria would require a review of the available literature, which is outside the remit of this mandate.”
Now that EFSA has finished its prioritization and evaluation protocol for phthalates and other plasticizers, the agency is seeking information on the substances to be assessed. “National food authorities, research institutions, academia, food business operators and other stakeholders are invited to submit data on migration or occurrence of plasticisers (phthalates, structurally similar substances and replacement substances) in FCMs.” EFSA provides a list of the specific substances on their webpage. The data collection portal will be open from June 1 to November 1, 2022.
References
EFSA (May 12, 2022). “Phthalates and other plasticisers: priorities for reassessment.”
EFSA CEP Panel, et al. (May 2022). “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.” EFSA Journal DOI: 10.2903/j.efsa.2022.7231
EFSA (May 5, 2022). “Call for collection of data on phthalates, structurally similar substances and replacement substances migrating from or occurring in food contact materials (Plasticisers_FCM_2022).”
Read more
Andrew Turley (May 19, 2022). “Efsa issues final list of plasticisers in FCMs prioritised for risk assessment.” Chemical Watch
Emma Davies (May 11, 2022). “Efsa seeks data on plasticisers in food contact materials.” Chemical Watch
