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.
- Applicants send their applications to the Commission.
- 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.
- EFSA must give an opinion within 9 months of receipt of a valid application.
- The Commission submits a draft regulation to the Standing Committee.
- 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.
See the Practical guidance for applicants for addresses, contact points and the relevant documents for risk assessment.