Certain legislation on Food Contact Materials (FCM), such as the Regulation on plastic materials and articles, provides for listing of substances. Once these are listed they are permitted for use taking account of restrictions and specifications.
Through this listing, these substances hence become 'authorised'. For recycled plastics a very similar procedure is in place, although this authorises recycling processes via individual decisions.
The authorisation process consists of the following key steps:
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A business operator who wants to use the substance will prepare a dossier following the guidance provided by EFSA. See also EFSAs applications workflow. Further information can be obtained from EFSAs applications helpdesk.
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The business operator sends this dossier with a request for authorisation to one of the competent authorities of the Member States. National contacts for applications for authorisation of substances to be used in food contact materials and applications for authorisation of recycling processes to produce recycled plastic
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Via the Member State, EFSA receives the dossier. If the dossier is valid, EFSA will evaluate it, and provide an opinion on the safety of that substance taking account of its intended use
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The Commission will as risk manager use the published opinion as basis for deciding on its authorisation.
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The substance is authorised through an amendment of the list of substances under the applicable legislation, most often an amendment of Annex I to Regulation (EU) No 10/2011 (example). Once authorised, the substance can be used by everyone, subject to the restrictions set out in its authorisation. For recycling processes individual decisions are foreseen, addressed only to the applicant.
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The applicant or any business operator using the authorised substance must immediately inform the Commission of any new scientific or technical information, which might affect the safety assessment of the authorised substance in relation to human health (SANTE-fcm
ec [dot] europa [dot] eu (an e-mail suffices)). It is possible to apply for an extension of the existing authorisation through a Member State, similar as for the addition of new substances.
For further detail, please consult the full authorisation procedure set out in Article 8-12 of Regulation (EC) No 1935/2004.
The document referred to in footnote(1) to Article 9(2) of that Regulation should no longer be consulted for applications, as EFSA published guidelines.
Please note that Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended Regulation (EC) No 178/2002 and Regulation (EC) No 1935/2004. These new provisions are applicable to applications submitted from 27 March 2021. Further information on the implementation of that Regulation can be found on DG SANTE's website.
EFSA also published an explanation of the general administrative procedures it follows for applications for regulated products. Please note that in case of food contact materials EFSA has a 6 months deadline, and applications should be send through a Member State Competent Authority, as described above. EFSA can extend the deadline by another 6 months.
Further information can be found in the applicable legislation.
Submission of applications
Applications may be submitted to the competent authorities of the Member States through the electronic submission system: E-Submission Food Chain Platform
The electronic submission system allows applicants to submit applications online. With this system applicants are able to follow-up their applications from the submission until the outcome.
Training and support on the E-submission Food Chain Platform is available on DG SANTE's dedicated webpage.
Before 2002 the Scientific Committee on Food evaluated scientific and technical questions concerning consumer health and food safety associated with the consumption of food products.
In particular, questions relating to toxicology and hygiene in the entire food production chain, nutrition, and applications of agrifood technologies, as well as those relating to materials coming into contact with foodstuffs, such as packaging. Please refer to 'Reports' and 'Outcome of Decisions' of the Scientific Committee on Food.