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EFSA Phthalates Consultations 11-21

Stacks of binders of regulations

The European Food Safety Authority’s (EFSA) Food Ingredients and Packaging (FIP) Unit launched consultations on a draft opinion and a draft protocol related to plasticizers in food-contact materials and articles. These consultations are in response to a request from the European Commission to conduct preparatory work for the re-evaluation of the risks to public health from the presence of plasticizers, such as phthalates, structurally similar substances, and replacement substances in FCMs. Only substances authorized for use in FCMs at the EU or national level were prioritized.

EFSA’s draft opinion is titled, “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.” It provides an overview of substances potentially used as plasticizers in FCMs and categorizes them into groups of high, medium, and low priority for future risk assessment. The draft opinion also mentions that EFSA will issue requests in 2022 for data related to the prioritized substances, such as their occurrence in FCMs and their potential migration to food.  

EFSA’s draft protocol is on the exposure assessment as part of the safety assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticizers in materials and articles intended to come into contact with food. This draft protocol addresses: 

  1. Dietary exposure to potential plasticizers used in FCMs, 
  2. Contribution of FCMs to dietary exposure, and
  3. Contribution of FCMs to overall (dietary and non-dietary) exposure. 

Comments are due on both the draft opinion and the draft protocol by December 16, 2021.