EFSA Issues Guidance on Safety Assessment of Post-consumer Mechanical PET Recycling Processes

On July 30, 2024, the European Food Safety Authority (EFSA) released a new Guidance titled "Scientific Guidance on the criteria for the evaluation and on the preparation of applications for the safety assessment of post-consumer mechanical PET recycling processes intended to be used for manufacture of materials and articles in contact with food". 

This new Guidance is regarded as a supporting document for the implementation of the EU's new recycled plastic food contact materials (FCMs) regulation, Commission Regulation (EU) 2022/1616, which was issued on September 20, 2022. To be specific, this Guidance will assist applicants in the preparation of applications for the authorisation or for the modification of an existing authorisation of a "post‐consumer mechanical PET" recycling process. As of its publication date, stakeholders shall prepare dossiers as per this new guidance.

Compared to the previous assessment guidance, the new Guidance has more specific requirements regarding the equipment and the operation. For example, the new Guidance demands that:

1. The design and assembly of the main and auxiliary equipment pieces (e.g. reactors, stirring systems, vessels, extruders, crystallisers, preheaters, pelletisers) should be described in detail and supported by technical drawings and photos. The following aspects should be clearly addressed, and supported by data:

• Design and position of stirring tools; set-up of stirring system, including number and type of rotating tools, if any

• Heating/cooling systems, vacuum or flowing gas, position and design of gas and vacuum ports, purification of circulated gases

• …

2. The technical dossier shall contain information on the operation of all equipment parts belonging to the same process. In particular, the following aspects should be clearly addressed in the technical dossier, and supported by data:

• capacity, load and filling level

• temperature gradient along the axes of the reactor

• ...

Recommended material

• Food-pedia: EU Food Contact Materials Regulation

ChemLinked Solutions

FCM team of REACH24H Consulting Group, the founder of ChemLinked, is professional in regulatory compliance services in the U.S., EU, China, Canada, MERCOSUR, Switzerland, etc. With successful experience, we have helped numerous customers solve their food contact material compliance problems in the above-mentioned countries and regions, including but not limited to ESFA/FDA Post-Consumer Recycled (PCR) Plastic for FCMs Registration Service, Declaration of Compliance (DoC) Editing/Checking, U.S. FCN Application, and China/EU New Food Contact Substance Application. For any assistance, please feel free to contact [email protected].