EFSA provides scientific advice on the safety evaluation of substances used in food contact materials (FCM) including active and intelligent materials and of the recycling processes for recycled plastics used in FCM.
Frequently Asked Questions
1. I have submitted a food contact materials (FCM) application for safety evaluation by EFSA. How can I check the status of my application?
All applications received by EFSA are given an application number and assigned an EFSA Question number (e.g. EFSA-Q-2009-12345) in the Register of Questions (ROQ), which describes the status and progress of EFSA’s scientific work. To find an application, click on the ‘Question’ option in the top menu of the ROQ, then in the ‘Question type’ field select ‘Application’ and select the relevant ‘Food sector area’ (i.e. Food contact materials’). You can then search using key words or a Question number if you know it. After locating your application, the ‘Status’ column indicates the present stage of the evaluation. When a question is ‘Finished’, EFSA publishes an opinion adopted by its Panel on Food Contact Materials, Enzymes and Processing Aids (CEP). If the opinion has been published, it is available via the ‘View’ link.
While EFSA is undertaking its evaluation, you can further monitor the progress of an application in the agendas and minutes of the Working Groups of the CEP Panel and of its plenary meetings.
2. I am not sure if my food contact material requires authorisation. Who should I contact?
If you have any questions related to need for the authorisation of substances in FCM or about recycling processes for recycled plastics used in FCM, please contact: Directorate-General for Health and Food safety (DG SANTE), European Commission. EFSA’s topic on food contact materials also contains relevant background information.
3. I am not sure whether the material or substance in contact with food or its specific use falls within the scope of the EU legislation. What should I do?
Regulation EC 1935/2004 sets out the grounds for submission of an application to EFSA for food contact materials. When the intended substance or material, although falling in the scope of this Regulation, is not subject for inclusion in an EU union list, the EU Member State(s) national provisions apply (e.g. when the “Specific measures for groups of materials and articles” mentioned in Art. 5 of Regulation EC 1935/2004 have not been adopted yet).
In such cases you should contact the national competent authority of a Member State to ask for information on the specific requirements for preparing and submitting an application.
4. Is there an official list of all authorised food contact materials?
Authorisations of individual substances for use in FCM are published in the Official Journal of the European Union once authorised. At EU level, there are positive lists for substances used in the manufacture of plastics and regenerated cellulose. These are updated to include newly authorised substances.The European Commission also maintains a Food Contact Materials database including all substances authorised in plastics, however, it has no legal basis and is intended for information purposes only. Further information is available on the European Commission’s website.
5. I am a new applicant. How do I prepare an application?
The application procedure is described in Regulation EC 1935/2004. The technical dossier of an application submitted under Regulation EC 1935/2004 must be compiled according to the relevant EFSA’s guidance. Applications should be submitted to the national competent authority of a Member State, which will transmit your application to EFSA.
6. Are the requirements the same for all food contact material evaluations?
The application procedure set down in Regulation EC 1935/2004 in EFSA’s guidance applies the same administrative and technical requirements to all substances (and recycling processes for recycled plastics) used in FCM. There are, however, additional scientific requirements for:
- Plastic materials – Regulation EC 10/2011 sets out specific requirements for substances intended to be used in plastic food contact materials and EFSA has published a scientific guidance and an administrative guidance to help applicants in preparing an application.
Recycling processes for recycled plastics used in FCM – Regulation EC 282/2008 lays down additional requirements for these processes and EFSA has published guidelines on recycling processes for recycled plastics that are essential reading for completing the related technical dossiers (see also the scientific opinion on the scientific criteria for PET recycling for recycled FCMs). The European Commission has also published an informative Q&A on recycling processes as an aid for applicants.
Active and intelligent substances – Guidelines on submission of an application. Until a Union list is established by the European Commission the general six-month period for risk assessment does not apply for active and intelligent substances.
Legislation, guidance and other documents on these and other specific materials and processes is also available on the European Commission website.
7. What happens to my application when EFSA has received it?
Completeness check – Following receipt of an application, an acknowledgement letter is sent to the applicant and EFSA performs a check to verify its completeness. Within six weeks of receiving the application forwarded by a Member State, EFSA verifies that the application submitted by the applicant complies with Regulation EC 1935/2004 and the relevant EFSA guidelines and guidance. During this completeness check, the status of an application in EFSA’s Register of Questions (ROQ) is described as ‘Registration not yet completed’ or ‘Under Consideration’.
Incomplete or invalid applications – Applicants should make every effort to include all information, data and full study reports as requested in the respective guidance documents, when they first submit their application. If information is missing or incomplete, the applicant is asked to provide the missing information and the status bar in the ROQ reads ‘Waiting for full dossier’. If, however, there are serious gaps in the administrative information or in the scientific dataset, the application is considered incomplete and the applicant is asked to re-submit a new application with the missing data. In this case the status of the application in EFSA’s ROQ changes to ‘Not accepted’. If and when a new application is received, it is assigned a new question number.
Valid applications – If the application is complete, it is considered valid and EFSA can start its scientific assessment, which is done by its Food Contact Materials, Enzymes and Processing Aids (CEP). The status in the ROQ then changes to ‘In progress’.
8. How long does EFSA’s evaluation take?
EFSA’s Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) must endeavour to adopt an opinion within a six-month deadline, from the moment the application is confirmed as valid, for priority issues. These time limits can be extended whenever EFSA requests additional information from the applicant. EFSA’s work ends with the publication of a scientific opinion and the status of the application in EFSA’s Register of Questions is described as ‘Finished’. If appropriate the Commission subsequently prepares a draft of a specific measure to authorise the substance evaluated by EFSA. This draft takes into account the EFSA opinion, relevant provisions of EU law and other legitimate factors relevant to authorisation.
9. Do I need to pay?
Currently, EFSA does not charge a fee for its scientific evaluations. However, this practice is under review by the EU decision-makers.
10. Does EFSA authorise food contact materials?
No. The authorisation of these materials is not within EFSA’s remit. In the European food safety system, scientific risk assessment is done independently from risk management, which includes authorisation of substances, products, claims, processes or organisms for their placing or use on the European Union market. EFSA’s scientific advice is available in the adopted scientific opinions of the CEP Panel. If you require further information on the authorisation of these materials as well as other administrative or market-related issues, such as import requirements, information on specific brands or products on the market etc, please contact: Unit E6 – Innovation and Sustainability, Directorate-General for Health and Food safety (DG SANTE), European Commission.
11. Short cuts for applicants
- Application procedure for Food Contact Materials: Regulation EC 1935/2004
- Application procedure for Plastic materials: Regulation EC 10/2011
- Application procedure for Recycling processes for recycled plastics used in FCM: Regulation EC 282/2008
- Submission to the Competent authority of a Member State
- EFSA’s guidance documents
- Requirements for plastic materials: scientific guidance and administrative guidance
- Requirements for recycling processes: guidance and scientific criteria
- European Commission Q&A on recycling processes
- Requirements for active and intelligent substances
- Status, information and supporting documents about a request: Register of Questions (ROQ); ROQ Tutorial video
- Food contact materials Working Groups
- CEP Panel Plenary meetings
- Adopted scientific opinions of the CEP Panel
- Official Journal of the European Union
- Legislation, guidance and other documents (European Commission - DG SANTE)
- Positive lists for substances used in the manufacture of plastics and regenerated cellulose
- European Commission Food contact materials database
- Contact regarding authorisation: Unit E6 – Innovation and Sustainability - Directorate-General for Health and Food Safety (DG SANTE)