EU EFSA Food Contact Recycled Plastics Compliance

The European Union maintains a strict framework to ensure that recycled plastic materials intended for food contact meet the same safety standards as virgin plastics. On October 10, 2022, Regulation (EU) 2022/1616 entered into force, replacing the previous Regulation (EC) 282/2008. This regulation focuses on the decontamination efficiency of recycling processes and the safety of the final plastic articles.

The core objective is to prevent chemical or microbiological contaminants from the previous use of the plastic from migrating into food. All recycled plastics must comply with the general safety requirements of Regulation (EC) 1935/2004 and the specific measures for plastic materials in Regulation (EU) 10/2011.

Suitable vs. Novel Technologies

The EU classifies recycling technologies into two groups to determine the level of regulatory oversight required:

1. Suitable Technologies

These are technologies officially recognized as capable of producing safe recycled plastic. Currently, the most prominent suitable technologies are:

• Post-consumer mechanical PET recycling: Systems that recycle food-grade PET collected separately.
• Recycling from product loops: Systems operating in a closed and controlled chain, such as reusable crate schemes.

2. Novel Technologies

Any recycling technology not yet listed as "suitable" in Annex I of the regulation is considered a Novel Technology. Developers of these technologies must:

• Notify the European Commission (EC) and relevant national authorities.
• Publish a detailed initial report on the safety of the manufactured plastics.
• Monitor and report on contamination levels to prove the technology's long-term safety before it can be reclassified as "suitable."

Scientific Opinion and EFSA Assessment

Except for closed-loop systems, individual recycling processes must undergo a rigorous safety assessment by the European Food Safety Authority (EFSA).

• EFSA Evaluation: EFSA assesses the input materials, the decontamination efficiency of the equipment, and the intended food-contact conditions.
• Scientific Opinion: Following the assessment, EFSA issues a scientific opinion. A favorable opinion is necessary for the EC to formally authorize the specific recycling process.
• The Union Register: Once authorized, the process, the recycler, and the decontamination installation are listed in the public Union Register of the European Commission.

Compliance Requirements for Operators

To place recycled plastic on the EU market, businesses must fulfill several technical and administrative mandates:

• Separation and Collection

Plastic waste must be collected separately and strictly controlled to ensure the quality of the "plastic input."

• Declaration of Conformity (DoC)

Recyclers must provide a DoC for every batch, detailing the authorized process used and providing safety instructions for downstream converters.

• Decontamination Efficiency

Processes must be validated through Challenge Tests (Surrogate Contaminant Testing) to prove they can effectively remove potential chemical contaminants.

• Quality Assurance

Facilities must implement a robust quality assurance system (as per Regulation (EC) 2023/2006) to ensure full traceability from waste collection to the final product.

Proregulations' EU Recycled Plastics Services

• Pre-application Regulatory Analysis
  We analyze your technology and input materials to determine if it falls under "suitable" or "novel" categories and develop a corresponding compliance roadmap.
• EFSA Scientific Opinion Application
  Our team manages the entire application process, including dossier compilation and submission via the ESFC e-submission system, and handles all technical queries from EFSA.
• Challenge Test Supervision
  We provide expert oversight for surrogate contaminant testing, ensuring that laboratory protocols and data meet the rigorous scientific standards required by EFSA.
• Declaration of Conformity (DoC) Support
  Assisting recyclers and converters in drafting and maintaining compliant DoCs and technical documentation required throughout the supply chain.
• Registration and Monitoring
  Handling the registration of facilities and units in the Union Register and assisting with the mandatory monitoring of contamination levels.
• Continuous Regulatory Monitoring
  Keeping your business informed of the latest updates, such as amendments in EU 2025/2269, to ensure uninterrupted market access and compliance.

If you need to ensure your recycled plastic products meet EFSA standards or require assistance with the scientific opinion application process, please contact us.