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Food Safety

Common Authorisation Procedure

About the procedure

The Commission, an EU country or an interested party can start the procedure through an application for updating the EU lists of authorised food additives, food enzymes and flavourings.

"Updating the Union list" means:

  • Adding a substance and/or removing a substance

  • Adding, removing or changing conditions, specifications or restrictions related to the presence of a substance

The Common Authorisation Procedure is described in Regulation (EC) No 1331/2008. That Regulation was amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended with effect from 27 March 2021. Further information on the implementation of that Regulation can be found on DG SANTE’s website.

Procedure

  1. Applicants send their applications to the Commission
  2. If the requested use is liable to have an effect on human health, the Commission will ask the European Food Safety Authority (EFSA) for an opinion
  3. EFSA must give an opinion within 9 months of receipt of a valid application
  4. The Commission submits a draft regulation to the Standing Committee
  5. The proposed regulation can be adopted with regulatory procedure with scrutiny (Art. 5a of Decision 1999/468/EC)

Requirements for the application

  • Administrative data

  • General data required for risk assessment

  • Specific data required for risk assessment

  • Data required for risk management of food additives, food enzymes and flavourings

Requirements are set in Regulation EU 234/2011 as amended by Commission Implementing Regulation (EU) No 562/2012 and Commission Implementing Regulation (EU) 2020/1823 including:

  • Measures on the content, drafting and presentation of applications

  • How to check the validity of applications

  • Information that should be included in the opinion of EFSA

Practical guidance

Please refer to the practical guidance for applicants for addresses, contact points and the relevant documents for risk assessment.

Submission of applications

Applications must be submitted 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.

Protection of your Personal Data

To view the privacy statement which provides information about the processing and the protection of your personal data, please click here.

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