Common Authorisation Procedure

Common Authorisation 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

Procedure

  1. Applicants send their applications to the Commission (see "News", below)
  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 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.

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.

News

To ensure the business continuity during the COVID-19 outbreak any data (e.g. applications, replies to DG SANTE calls for data related to the follow-up on the safety re-evaluation of food additives) should be submitted to the Commission by using the online platform CIRCABC. These measures will remain in place until further notice. No parallel or later submission of the same data in a physical medium (as well as paper copies) is required.

Please check the Guidance for online data submission on Food Improvement Agents via CIRCABC Sante-Cad-In Group for further practical information on how to use the CIRCABC platform for the online submissions.