A positive EFSA opinion is not an authorisation decision. Under Regulation (EU) 2022/1616, distinguish the recycling process from the installation operating it, and check the applicable authorisation, registration and transitional conditions.
Does a positive EFSA opinion mean that a recycler already holds an individual PET process authorisation?
No. EFSA carries out the scientific assessment of the process, while the European Commission takes the authorisation decision. Under Regulation (EU) 2022/1616, the recycling process must also be distinguished from the physical installation at a particular facility and from registration of operators and installations in the EU system.
1. Why mechanical PET recycling requires individual assessment
Decontamination efficiency depends on the detailed process configuration and its operating conditions. Annex I therefore identifies post-consumer mechanical PET recycling as a technology whose individual processes require authorisation.
A general statement that a facility uses “mechanical PET recycling” is insufficient.
2. The applicant is responsible for developing the process
The authorisation procedure concerns a specific process. The application contains the technical information needed to assess its ability to produce safe recycled plastic.
Knowledge of the configuration, decontamination stages, critical parameters and evidence of efficiency is essential.
3. EFSA performs the scientific assessment
After receiving a valid application, EFSA assesses whether the process applies the technology in a way that can produce materials meeting the general food contact material requirements and microbiological safety requirements.
The assessment includes decontamination efficiency and may draw on challenge test results. EFSA may also identify restrictions, specifications and parameters requiring monitoring.
4. The European Commission takes the authorisation decision
Taking account of the EFSA opinion, EU law and other relevant factors, the Commission assesses whether the individual process should be authorised. Its decision may set conditions and restrictions on use.
The EFSA opinion and the Commission decision must therefore be identified as different documents.
5. Authorisation concerns the process; the installation must match it
A recycling installation is the actual arrangement of equipment at a particular facility. Its configuration and operation should correspond to the process on which it is based.
The recycler is responsible for operating the installation in accordance with the process requirements, documenting parameters and keeping appropriate records.
6. Decontamination installations are registered and controlled
The Regulation establishes a Union Register covering, among other entities, recyclers, processes, schemes and decontamination installations. It serves market participants and authorities carrying out official controls.
Registration numbers help connect documentation and specific production with the relevant operator and installation.
Registration update, 5 October 2026: the Commission reports that registration and update forms have been offline since 11 September during a system upgrade. The public register remains accessible but is temporarily frozen; a replacement system is expected towards the end of October. Follow the Commission’s current instructions and those of the competent authority. This notice does not itself establish an extension of legal deadlines.
7. CMSS connects the formal process with actual plant operation
For each relevant decontamination installation, the recycler prepares a Compliance Monitoring Summary Sheet (CMSS). It describes the installation, operations, procedures, quality control, batch monitoring and record system.
The competent authority uses the CMSS when verifying the operation of the installation.
8. Transitional provisions matter for earlier applications
Article 31 provides transitional arrangements for specified processes whose applications were submitted in time, including by 10 July 2023 in the cases covered. Subject to the applicable conditions, the relevant materials may remain on the market until the application is withdrawn or the Commission takes a decision.
In 2026, the status of each process must therefore be checked individually. The absence of a final decision should not be assumed to have the same legal consequences in every case.
9. Process authorisation is not management system certification
A process decision does not replace the recycler’s internal quality system, good manufacturing practice, parameter control or documentation obligations.
Similarly, RecyClass certification does not replace an authorisation decision. The two mechanisms can apply to the same plant while addressing different questions.
10. Process or installation modifications require change control
If a modification could affect decontamination efficiency or the authorisation conditions, its significance must be assessed before implementation. The Regulation includes mechanisms for modifying authorised processes.
In practice, change records should explain why a modification remains within validated conditions or identify the further actions required.
11. Packaging manufacturers should be able to verify supplier status
An rPET buyer does not need every technical detail of the process. It should, however, receive information and documents identifying the recycler, material and batch, restrictions on use, and the applicable status of the process and installation.
The Union Register, identification information, Declaration of Compliance and supplier documentation help provide this evidence.
Frequently asked questions
Who issues the scientific opinion on process safety?
EFSA performs the scientific assessment.
Who grants individual process authorisation?
The European Commission takes the decision under the procedure established by the Regulation.
Does process authorisation automatically approve every installation?
No. A process and an installation are different. The installation must be appropriately registered, correspond to the process and be subject to control.
Can a process with an application submitted before 10 July 2023 operate without a final decision?
Article 31 provides specific transitional arrangements. The status and applicable conditions of the individual process must be checked.
Can RecyClass Module A2 replace authorisation?
No. It is an additional certification scope assessing specified process controls, not a regulatory decision by the Commission.