Authorisation procedure for additives, enzymes and flavourings

SUMMARY OF:

Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings

Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain

WHAT IS THE AIM OF THE REGULATIONS?

Regulation (EC) No 1331/2008 introduces a harmonised, effective, fast and transparent authorisation procedure for food additives, food enzymes and food flavourings in the EU, aiming to facilitate the free movement of food while assuring consumer health. It does not apply to smoke flavourings.
The procedure is based on a risk assessment by the European Food Safety Authority (EFSA), set up under Regulation (EC) No 178/2002, and leads to the updating of a Community (EU) list for each of the 3 categories of substance.
Amending Regulation (EU) 2019/1381 introduces new rules on transparency and confidentiality in risk assessment.

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).

FROM WHEN DO THE REGULATIONS APPLY?

Regulation (EC) No 1331/2008 has applied since 20 January 2009.

Amending Regulation (EU) 2019/1381 applies from 27 March 2021.

BACKGROUND

For more information, see:

European Food Safety Authority
Common authorisation procedure (European Commission).

MAIN DOCUMENTS

Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, pp. 1-6)

Successive amendments to Regulation (EU) No 1331/2008 have been incorporated in the basic text. This consolidated version is of documentary value only.

Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, pp. 1-28)