Explanatory Memorandum to COM(2008)1 - Colouring matters which may be added to medicinal products (Recast)

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dossier	COM(2008)1 - Colouring matters which may be added to medicinal products (Recast).
source	COM(2008)1
date	11-01-2008

1. On 1 April 1987 the Commission decided¹ to instruct its staff that all legislative acts should be codified after no more than ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the texts for which they are responsible, to ensure that the Community rules are clear and readily understandable.

2. The codification of 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 products² has been initiated by the Commission . The new Directive was to have superseded the various acts incorporated in it³.

3. In the meantime Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission⁴ 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 procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

4. In accordance with the joint statement of the European Parliament, the Council and the Commission⁵ on Decision 2006/512/EC, for this new procedure to be applicable to instruments adopted in accordance with the procedure laid down in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.

5. 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.

ê 78/25/EEC (adapted)

1.
COM(87) 868 PV.
2.
Carried out pursuant to the Communication from the Commission to the European Parliament and the Council
3.
See Annex I, Part A of this proposal.
4.
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).
5.
OJ C 255, 21.10.2006, p. 1.
6.
OJ C
7.
OJ C
8.
OJ C
9.
OJ L 11, 14.1.1978, p. 18. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
10.
See Annex I, Part A.
11.
OJ L 226, 22.9.1995, p. 1. Directive as last amended by Directive 2006/33/EC (OJ L 82, 21.3.2006, p. 10).
12.
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200 of 22.7.2006, p. 11).
13.
OJ L 311, 28.11.2001, p. 67.
14.
OJ L 311, 28.11.2001, p. 1.
15.
OJ L 257, 10.9.1981, p. 1.
16.
Carried out pursuant to the Communication from the Commission to the European Parliament and the Council
17.
COM(87) 868 PV.
18.
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).
19.
OJ L 184, 17.7.1999, p. 23.
20.
OJ C
21.
Pursuant to Article 7(2) of Directive 78/25/EEC:
22.
COM(87) 868 PV.
23.
COM(87) 868 PV.
24.
COM(87) 868 PV.
25.
Carried out pursuant to the Communication from the Commission to the European Parliament and the Council
26.
Carried out pursuant to the Communication from the Commission to the European Parliament and the Council
27.
See Annex I, Part A of this proposal.
28.
COM(87) 868 PV.
29.
See Annex I, Part A of this proposal.
30.
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).