PURPOSE: to recast Directive 78/25/EEC on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products.

LEGISLATIVE ACT: Directive 2009/35/EC of the European Parliament and of the Council on the colouring matters which may be added to medicinal products (recast).

CONTENT: having reached agreement with the Parliament at first reading, the Council recasts and adapts Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products has been initiated by the Commission. The new Directive was to have superseded the various acts incorporated in it.

In the meantime, Council Decision 1999/468/EC which lays down the procedures for the exercise of implementing powers conferred on the Commission (comitology) has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the codecision procedure.

Consequently, the codification of Directive 78/25/EEC has been transformed into a recast in order to incorporate the amendments necessary for the adjustment to the regulatory procedure with scrutiny.

The new Directive empowers the Commission to amend the limited period of use of medicinal products following the regulatory procedure with scrutiny.

ENTRY INTO FORCE: 20/05/2009.

The European Parliament adopted, by 638 votes to 16 with 16 abstentions, a legislative resolution approving the proposal for a directive of the European Parliament and of the Council on the colouring matters which may be added to medicinal products (recast). The report had been tabled for consideration in plenary by József SZAJER (EPP-ED, HU) on behalf of the Committee on Legal Affairs. The proposal was approved as adapted to the recommendations of the Consultative Working Party of the Legal Services of the European Parliament, the Council and the Commission.

The Committee on Legal Affairs adopted a report drafted by József SZAJER (EPP-ED, HU) and approved the proposal for a directive of the European Parliament and of the Council on the colouring matters which may be added to medicinal products (recast). The proposal was approved as adapted to the recommendations of the Consultative Working Party of the Legal Services of the European Parliament, the Council and the Commission.

PURPOSE: recast of the Directive 78/25/EEC on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products.

PROPOSED ACT: Directive of the European Parliament and of the Council.

CONTENT: the codification of Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products has been initiated by the Commission. The new Directive was to have superseded the various acts incorporated in it.

In the meantime, Council Decision 1999/468/EC which lays down the procedures for the exercise of implementing powers conferred on the Commission (comitology) has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the codecision procedure.

In accordance with the joint statement of the European Parliament, the Council and the Commission on Decision 2006/512/EC, for this new procedure to be applicable to instruments adopted in accordance with the codecision procedure, those instruments must be adjusted in accordance with the applicable procedures.

It is therefore appropriate to transform the codification of Directive 78/25/EEC into a recast in order to incorporate the amendments necessary for the adjustment to the regulatory procedure with scrutiny.

PURPOSE: recast of the Directive 78/25/EEC on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products.

PROPOSED ACT: Directive of the European Parliament and of the Council.

CONTENT: the codification of Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products has been initiated by the Commission. The new Directive was to have superseded the various acts incorporated in it.

In the meantime, Council Decision 1999/468/EC which lays down the procedures for the exercise of implementing powers conferred on the Commission (comitology) has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the codecision procedure.

In accordance with the joint statement of the European Parliament, the Council and the Commission on Decision 2006/512/EC, for this new procedure to be applicable to instruments adopted in accordance with the codecision procedure, those instruments must be adjusted in accordance with the applicable procedures.

It is therefore appropriate to transform the codification of Directive 78/25/EEC into a recast in order to incorporate the amendments necessary for the adjustment to the regulatory procedure with scrutiny.