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  Food Additives, Enzymes and Flavourings - Applying for an authorisationslide
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The Commission, a 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;
  • 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.
  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

See the Practical guidance for applicants PDF for addresses, contact points and the relevant documents for risk assessment.

 
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