Authorisation procedure for additives, enzymes and flavourings

KEY POINTS

Common procedure

• Only substances authorised for the EU market are on the EU list, which is updated on the initiative of the European Commission, of an EU country or of another interested party through an official application.
• The Commission forwards applications for substances to be included on the list to EFSA for risk assessment (mandatory where there could be an effect on human health). EFSA must normally respond within 9 months. In justified cases where EFSA requests additional information from applicants, the period may be extended. EFSA makes public, under the 2019 amendment, any additional information supplied by the applicant.
• The Commission issues a draft regulation updating the EU list within 9 months of receiving EFSA’s opinion.
• The process may be halted by the Commission at any time. In urgent cases, there are special arrangements for adding, removing or changing conditions for substances on the list.
• The Commission is assisted by the Standing Committee on Plants, Animals, Food and Feed in updating the EU list.

Implementation

The Commission had 2 years from the adoption of the regulations on additives, enzymes and flavourings, after consultation with EFSA on risk assessment, to finalise how it would deal with applications, including:

• content, drafting and presentation;
• checking the validity of applications;
• the type of information to be included.

Transparency

• Under Regulation (EC) No 1331/2008, EFSA ensures the transparency of its activities in accordance with Regulation (EC) No 178/2002.
• Amending Regulation (EU) 2019/1381 introduces new rules on transparency requiring EFSA, where the Commission requests its opinion, to make the application public without delay, including relevant supporting information and additional information supplied by the applicant, as well as its scientific opinions. EFSA makes public any request for its opinion as well as any extension of time limits for its work.

Confidentiality

• Under Regulation (EC) No 1331/2008, applicants may request certain parts of their applications to be treated as confidential, along with verifiable justification.
• Amending Regulation (EU) 2019/1381 allows EFSA to also grant confidentiality for the following, where applicable, if the applicant demonstrates that disclosure could significantly harm its interests (except for information relevant to the assessment of safety):
  • information provided on material used to manufacture the substance concerned;
  • information on the materials or products in which the applicant intends to use the substance;
  • detailed analytical information on the variability and stability of individual production batches.

Emergencies

If there is an emergency connected with a substance on the list, the Commission initiates EFSA food safety procedures.

Companion legislation

The 2008 regulation was adopted at the same time as the following companion legislation, which goes into more detail on the 3 categories:

• Regulation (EC) No 1332/2008 on food enzymes (see summary);
• Regulation (EC) No 1333/2008 on food additives (see summary);
• Regulation (EC) No 1334/2008 on flavourings (see summary).