Call for the submission of data for the re-evaluation of peroxides in the BfRshort forGerman Federal Institute for Risk Assessment recommendation on food contact materials

The German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) is initiating a cross-material re-evaluation of peroxides in the BfRshort forGerman Federal Institute for Risk Assessment recommendation on food contact materials. By carrying out this simultaneous re-evaluation of peroxides for use in various materials, the BfRshort forGerman Federal Institute for Risk Assessment is pursuing a new approach as a pilot project. The background to this is that a single applicant cannot provide all the necessary data. The BfRshort forGerman Federal Institute for Risk Assessment is therefore asking each stakeholder to contribute the data at their disposal. The BfRshort forGerman Federal Institute for Risk Assessment acts as the coordinating body and, using the information received from various companies, compiles a data set for risk assessment for each individual substance.

Initially, the BfRshort forGerman Federal Institute for Risk Assessment is conducting an assessment of peroxides used as cross-linking agents, as – unlike initiators and catalysts – the amounts used are generally higher. These peroxides include the substances listed in the table below:

Where substances could not be assessed again due to a deficiency of data, these substances will be removed from the recommendations as of 31 May 2029; this applies to all uses of the peroxides mentioned.

The BfRshort forGerman Federal Institute for Risk Assessment therefore asks manufacturers and users of peroxides to submit information and analytical data with the aim of answering the following questions:

• Which peroxides are still in use and which are not?
• What contaminations are present?
• What degradation products are formed?
• Are these the same for all relevant materials/applications? What factors play a role?
• What amounts of peroxides and degradation or reaction products are present in the various materials?
• In what amounts do peroxides and degradation or reaction products migrate from the various materials into food (or food simulants)?

The data submitted will be treated as confidential by the BfRshort forGerman Federal Institute for Risk Assessment. Companies will receive individual feedback. At set intervals, there will be closed-door meetings for the contributing stakeholders to discuss progress and identify any missing data. 

The BfRshort forGerman Federal Institute for Risk Assessment will conduct an evaluation of which analytical/toxicological data still needs to be submitted for the assessment. With regard to the general requirements for analytical and toxicological data, the BfRshort forGerman Federal Institute for Risk Assessment refers to the guidance document on the safety assessment of substances used in the manufacture of food contact materials (External Link:https://www.bfr.bund.de/cm/349/guideline-for-the-safety-assessment-of-substances-for-the-manufacture-of-food-contact-materials-and-articles.pdf).

All the peroxides mentioned above – regardless of whether they are used as cross-linking agents or initiators – are subject to a three-year deadline for re-evaluation in the recommendations. In the first year, data on use and analysis are to be collected; in the second year, the plan is to complete the collection of toxicological data so that, in the third year, the risk assessment and the BfR’s recommendations can be updated accordingly. 

For further information, stakeholders should contact fcm@bfr.bund.de.

In addition, further peroxides are to be re-evaluated in the BfRshort forGerman Federal Institute for Risk Assessment recommendation with a view to publishing a comprehensive recommendation on catalysts and initiators. Stakeholders are therefore advised to take up important peroxides not featured in the above-mentioned list in this pilot project for a cross- assessment of materials. 

Should the list of peroxides to be subject to assessment be expanded, this will be announced on the BfRshort forGerman Federal Institute for Risk Assessment website (External Link:https://empfehlungen.bfr.bund.de/info).