The Council’s common position introduced several changes to the initial proposal, some of them inspired by amendments proposed by the European Parliament. Of the 31 amendments proposed by Parliament in July 2007, the Council has incorporated, in full or in principle, 11 of them in its common position.
Amendments accepted:
Procedures: The Council agrees to introduce the regulatory procedure with scrutiny as well as the “urgency procedure” for the removal of substances from the list of authorised substances and for adding, changing or removing conditions for the use in order to protect human health. In addition, the efficiency procedure has been introduced for adding a substance to the Community list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of the substance on the Community list.
Smoke flavourings: The common position clarifies that authorisation for smoke flavourings will be excluded from the scope of the proposed Regulation.
Environmental Protection: The common position clarifies that risk management will also need to take account of other legitimate factors, such as the environment.
Confidentiality: The Council clarifies what can be kept confidential for the purpose of maintaining competitiveness.
Member State information: The Council accepts that the Member States should be provided with information on what stage the procedure is at. Parliamentary amendments referring to the principle of “exceptional extension of deadlines” has been incorporated into Article 10.
Amendments not introduced:
Those amendments that have not been taken on board in the common position, refer, in summary to:
Issues that are already regulated elsewhere: This refers to independent risk assessment, given that transparency in the context of handling food is of a general nature. Under Regulation (EC) No178/2002, the primary responsibility for food safety rests with food business operators.
Stakeholder consultation: Amendments proposed by Parliament relating to stakeholder consultation have been rejected on the grounds that other legislative acts already cover such requirements. For example, Regulation 178/2002 as well as other documents of a general nature.
Criteria for authorisation: The Council has decided that any new provisions relating to the general criteria for the authorisation of substances for each sector is a repetition of what general legislation already provides for.
Reference to consumer protection and public health: The proposal already deals with procedural arrangements for updating the list of authorised substances. References that take account of human health, consumer interests and fair practices in food trade and taking account of the environment, are set out in the proposed Regulations for each sector.
Data protection: The Council argues that a provision on the protection of data would complicate administrative procedures and is thus not compatible with the principle of regulatory simplification. As a result, amendments referring to data protection, have not been incorporated into the common position.
Deadline for an EFSA opinion: Although proposed by the Parliament, the Council has decided not to extend the time limit for an EFSA opinion from 6 to 9 months.
Extension of the 6 months deadline when additional information is required: The common position extends the deadline in justified cases only.
To conclude, the Council is of the view that the common position represents a balance of concerns and interests that respects the Regulation’s core objectives. It looks forward to a constructive discussion with the European Parliament with a view to the early adoption of the Regulation.