Authorisation procedure for additives, enzymes and flavourings
The European Commission is to lay down a common, effective, fast and transparent procedure for the authorisation of food additives, food enzymes and food flavourings in the Community. This procedure is based on a risk assessment by the European Food Safety Authority (EFSA). It leads to the establishment, management and updating of a Community list for each of the three categories of substances.
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.
The Regulation lays down a common procedure for the assessment and common authorisation of food additives, enzymes and food flavourings. This procedure facilitates the free movement of food while guaranteeing the health and welfare of consumers.
The common procedure lays down the arrangements for drawing up and updating the Community lists for each category of substances. Only substances included in these lists are authorised on the Community market.
Main stages of the common procedure
The common procedure for updating the Community list may be started either on the initiative of the Commission or following an application by a Member State or an interested party. Applications shall be sent to the Commission.
The Commission shall forward the applications to the European Food Safety Authority (EFSA) for risk assessment. The EFSA shall give its opinion within nine months of receipt of the application. That period may be extended if the Authority requests additional information from the applicant.
The common procedure shall end with the adoption by the Commission of a Regulation updating the list of substances within nine months of receipt of the EFSA’s opinion. That period may be extended if the Commission requests additional information concerning aspects of risk management. The new period shall be determined together with the applicant.
The Commission may end the common procedure at any time, irrespective of the stage it has reached. In this case, it shall inform the applicant and the Member States if necessary, stating the reasons for its decision.
Six months after the entry into force of each sectoral food law, the EFSA shall present a proposal to the Commission concerning the data required for risk assessment of the substances concerned with a view to the adoption of the implementing measures of this Regulation.
The EFSA shall ensure the transparency of its activities by making public its opinions and any extensions of periods for the provision of additional information.
The manufacturer shall indicate which information is confidential when the application is submitted. The Commission shall then determine which information in the application for authorisation is confidential and shall notify the applicant accordingly. After being made aware of the Commission’s opinion on the confidential aspects, the applicant may withdraw its application so as to preserve that confidentiality if it does not agree with that opinion.
The following information shall not, in any circumstances, be regarded as confidential:
- the name and address of the applicant;
- the name and description of the substance;
- the justification for the use of the substance;
- the information concerning the safety of the substances;
- where applicable, the analysis method.
If an emergency is connected with one of the substances on the authorised lists, the Commission shall initiate the procedures relating to food safety.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health for the updating of the list of additives, enzymes and flavourings.
List of competent authorities
Six months after the entry into force of each sectoral food law, Member States shall forward to the Commission the name and address of the national competent authority and a contact point.
This Regulation meets the objectives laid down in the 2000 White Paper on Food Safety, in which the Commission announced its intention to update and supplement the existing legislation on additives and flavourings and to establish specific provisions on enzymes.
In parallel, the Commission has developed three other proposals for Regulations which make the placing of these substances on the Community market subject to compliance with harmonised criteria and the granting of an authorisation:
- Regulation (EC) No 1332/2008 on food enzymes;
- Regulation (EC) No 1333/2008 on food additives;
- Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods.
This sectoral food legislation shall be supplemented by the establishment of a common authorisation procedure to harmonise the differing national authorisation procedures which may hinder the free movement of the substances and lead to unfair competition.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1331/2008||20.1.2009||-||OJ L 354 of 31.12.2008|
Further information is available on the website of the Directorate-General for Health and Consumers.