FSA Consultation Letter, 4 September 2006
[Note: Copies of the Commission proposals are available on this site: COM/2006/0423, COM/2006/0425, COM/2006/0427, COM/2006/0428]
The Agency seeks comments on proposed European Commission regulations establishing a common authorisation procedure for food additives, food enzymes and food flavourings ('the common procedures regulation'). Responses are requested by: 27 November 2006
On 28 July 2006 , the European Commission published proposals for European Parliament and Council Regulations aimed at clarifying and updating the existing legislation on food additives and flavourings. This introduces new EU-wide rules on food enzymes, together with a proposal for common authorisation procedures for all three, based on scientific opinions from the European Food Safety Authority (EFSA). The key elements of each of the proposals are set out below.
EU-wide rules would be laid down for the evaluation, approval and control of enzymes used in food. Currently, food enzymes used during the processing of foods, but not active in the final product (processing aids) are not covered by EU legislation, and in the UK are regulated under General Food Law.
The draft regulation would allow for the establishment of a positive list of all food enzymes used in food for a technological purpose, based on favourable scientific opinions from EFSA. The proposal also includes requirements for the labelling of food enzymes other than those used as processing aids.
The new legislation aims to simplify and streamline the food additive approval system laid down in Directive 89/107/EEC. The three current Directives covering sweeteners, colours and 'miscellaneous additives' will be repealed and incorporated into the new Regulation.
The approval of new additives, and all changes to the existing legislation, are currently required to be made under the co-decision procedure, involving approval by the Council and European Parliament, which is time consuming.
Under the new proposal, changes to the legislation will be able to be made by comitology. This allows the Commission to update and add to the EU positive list of food additives, following Member State approval at Standing Committee and a right of scrutiny by the European Parliament.
All approvals will be based on a safety evaluation carried out by EFSA. The proposal also sets out a re-evaluation system for all additives currently on the EU market, based on risk assessments from EFSA, and envisages a review of the technological aspects of all current food additive authorisations. It also includes new harmonised EU provisions for additives used in other additives.
The new legislation aims to update the general rules set out in Directive 88/388/EEC to reflect technological and scientific developments. The proposed Regulation sets out clearer rules on maximum levels for undesirable substances in line with EFSA opinions. Definitions are clarified, and stricter conditions are also introduced for the use of the term 'natural'.
The proposed Regulation introducing a single common procedure for the approval of additives, flavourings and enzymes includes a safety evaluation by EFSA. The benefits of this common approach include simplified legislation and more consistency in the approval procedures.
The purpose of this written consultation is to seek stakeholders' views on (1) the Commissions proposals, and (2) the FSA's Regulatory Impact Assessments (avaialbel from the FSA website):
Council Working Group discussions in Brussels on the proposals are planned to commence under the Finnish Presidency on 20 September. Responses before this date would be particularly welcome, as they will help to inform the UK negotiating line during discussions. However, full account will be taken of all responses received before the consultation deadline of 27 November.