The Council states that its position confirms the objectives proposed by the Commission and incorporates the majority of the European Parliament's first-reading amendments, either verbatim, in part or in spirit. The Council's position also includes a number of changes other than those envisaged in the European Parliament's first-reading opinion. These changes have been thoroughly negotiated with the European Parliament, which has confirmed its provisional agreement on the full text by a letter.
The main amendments to the Commission proposal are as follows:
Authorisation of persons: with the aim of reducing administrative burden and in order to cater more efficiently for different types of operators, the Council removed the proposed mandatory authorisation of persons carrying out or supervising procedures. Instead it put the emphasis on the requirements on competence of staff. These requirements include the obligation to specify in the authorisation of each breeder, supplier and user a person responsible for ensuring the adequate education, competence and continuous training of the staff.
Union Reference Laboratory: in line with an amendment of the Parliament, the Council strengthened the promotion of alternative methods at Union level by the introduction of a centralised Union Reference Laboratory, assigning it a set of responsibilities, including coordination and validation of alternative approaches and acting as a focal point for the exchange of information on their development.
Safeguard clauses: the Council introduced two additional safeguard clauses to take into account possible future situations where, for scientifically justifiable grounds, Member States deem it is necessary to authorise the use of nonhuman primates in areas not linked with debilitating and life-threatening conditions in humans or to surpass the upper limit for severity of procedures. This authorisation could only be provisional and would be subject to a Union control procedure.
Classification of the severity of procedures: sharing Parliament’s approach, the Council introduced into the Directive a system for a uniform classification of severity of procedures.