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Single authorisation procedure for additives, enzymes and flavourings
The European Commission has proposed a general system for authorising and marketing additives, enzymes and flavourings in the European Union (EU). The new system provides for the introduction of a common procedure for assessing and authorising these substances. Only substances which are included in one of the harmonised lists will be authorised. This future legislation will, for the first time at European level, regulate the use of enzymes in food. Manufacturers will also be able to initiate an authorisation procedure directly with the European Commission.
Proposal for a Regulation of the European Parliament and of the Council of 28 July 2006 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
The future Regulation will establish a common authorisation procedure for additives, enzymes and flavourings.
The Commission shall propose and approve a Community list for each type of product; only the products included in the lists will be authorised.
Simplification of the authorisation procedure
Private operators will be able to submit a request directly to the Commission for the authorisation of an enzyme, additive or flavouring. The operator may represent several interested parties.
Risk assessment for new authorisation requests shall be carried out by the European Food Safety Authority (EFSA).
The Authority must give its opinion within six months.
Updating the lists
Within nine months of the Authority giving its opinion, the Commission shall submit a new regulation amending the lists.
The Commission may request additional information from applicants on matters concerning risk management.
The Commission may at any time suspend the updating procedure if it considers it unnecessary.
The Commission shall approve the new product or the amendment of the list (withdrawal of a product or amendment of the specifications of the authorised substances) following the Authority's assessment and in accordance with the comitology procedure.
All non-confidential data should be made available to the public. Applicants shall indicate in their request the information which they wish to be treated as confidential. The Commission shall then decide which information can remain confidential and notify applicants accordingly. After being made aware of the Commission's position, applicants may withdraw their request so as to preserve the confidentiality of the information, if they do not agree. Information relating to the following shall not, in any case, be considered confidential:
- the name and address of the applicant;
- a description of the substance and the conditions for its use;
- information that is relevant to the safety of the substances;
- the method of analysis.
In the event of an emergency concerning a substance on the Community lists, the Commission shall take measures in accordance with food safety procedures.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health for the purpose of updating the list of additives, enzymes and flavourings.