CELEX: 51978FC0025
Language: en
Date: 2006-12-08
Title: Proposition de Directive …/…/CE du Parlement européen et du Conseil du […] relative aux matières pouvant être ajoutées aux médicaments en vue de leur coloration (Version codifiée)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        COM

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                        on the colouring matters which may be added to medicinal products

                                                                (Codified version)

                                                              EXPLANATORY MEMORANDUM

1.    In the context of a people’s Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make  it
       clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the  specific  rights
       it gives him.

       This aim cannot be achieved so long as numerous provisions that have  been  amended  several  times,  often  quite  substantially,  remain
       scattered, so that they must be sought partly in the original instrument and partly in later amending ones.  Considerable  research  work,
       comparing many different instruments, is thus needed to identify the current rules.

       For this reason a codification of rules that have frequently been amended  is  also  essential  if  Community  law  is  to  be  clear  and
       transparent.

2.    On 1 April 1987 the Commission therefore decided[1] 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.

3.    The Conclusions of the Presidency of the Edinburgh  European  Council  (December 1992)  confirmed  this[2],  stressing  the  importance  of
       codification as it offers certainty as to the law applicable to a given matter at a given time.

       Codification must be undertaken in full compliance with the normal Community legislative procedure.

       Given that no changes of substance may be made to the instruments affected by codification, the European Parliament, the Council  and  the
       Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-
       track adoption of codification instruments.

4.    The purpose of this proposal is to undertake a codification of Council Directive 78/25/EEC of 12 December 1977  on  the  colouring  matters
       which may be added to medicinal products [3]. The new Directive will supersede the various acts incorporated in it[4];this proposal  fully
       preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments  as  are
       required by the codification exercise itself.

5.    The codification proposal was drawn up on the basis of a preliminary consolidation, in all official languages, of Directive  78/25/EEC  and
       the instruments amending it, carried out by the Office for Official Publications  of  the  European  Communities,  by  means  of  a  data-
       processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table
       contained in Annex II to the codified Directive.

                                            ê 78/25/EEC (adapted)

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                        on the colouring matters which may be added to medicinal products

                                                            (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article Ö 95 Õ thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee[5],

Acting in accordance with the procedure laid down in Article 251 of the Treaty[6],

Whereas:

                                            ê .

   1) 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[7] has been substantially amended several times[8]. In the interests of  clarity  and  rationality
      the said Directive should be codified.

                                            ê 78/25/EEC recital 1

   2) The primary purpose of any laws concerning medicinal products must be to safeguard public health. However, this objective must be  attained
      by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.

                                            ê 78/25/EEC recital 2 (adapted)

   3) Although Directive Ö 94/36/EC of the European Parliament and of the Council Õ[9], established a single list of colouring matters authorized
      for use in foodstuffs, the disparities between the laws of Member States concerning the colouring of medicinal products still exist.

                                            ê 78/25/EEC recital 3 (adapted)

   4) These disparities tend to hinder trade in medicinal products within the Community and trade in colouring matters  which  may  be  added  to
      these products: Such disparities therefore directly affect the functioning of the internal market.

                                            ê 78/25/EEC recital 4 (adapted)

   5) Experience has shown that on health grounds there is no reason why the colouring matters authorized for use in foodstuffs should  not  also
      be authorized for use in medicinal products. Consequently, as they stand Ö Annex I of Directive 94/36/EC as well as the Annex to Commission
      Directive 95/45/EC laying down specific purity criteria concerning colours for use  in  foodstuffs[10] Õor  as  they  subsequently  may  be
      amended, should also apply for medicinal products.

                                            ê 78/25/EEC recital 5

   6) When the use of a colouring matter in foodstuffs and medicinal products is prohibited in order to safeguard  public  health,  technological
      and economic disturbances should be avoided as far as is possible. To this end a procedure  should  be  provided  which  establishes  close
      cooperation between the Member States and the Commission within a Committee for the adjustment to technical progress of the  Directives  on
      the elimination of technical barriers to trade in the sector of colouring matters which may be added to medicinal products.

                                            ê.

   7) When enacting this Directive the necessary measures should be put in place in order to conform with Council Decision 1999/468/EC of 28 June
      1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[11]

   8) This Directive should be without prejudice to the obligations of the Member States relating  to  the  time-limits  for  transposition  into
      national law of the Directives set out in Annex I, Part C,

                                            ê 78/25/EEC (adapted)

HAVE ADOPTED THIS DIRECTIVE:

                                                                    Article 1

Member States shall not authorize, for the colouring of medicinal products for human and veterinary use as defined in Article  1  of  Ö Directive
2001/83/EC of the European Parliament and of the Council Õ[12] Ö and in Article 1 of Directive 2001/82/EC of the European Parliament and  of  the
Council[13]Õ any colouring matters other than those covered by Annex I of Directive 94/36/EC.

                                            ê 78/25/EEC

                                                                    Article 2

Member States shall take all measures necessary to ensure that the colouring matters covered by Annex I to the Directive of 94/36/EC satisfy  the
general and specific criteria of purity laid down in the Annex to Directive 95/45/EC.

                                            ê 78/25/EEC (adapted)

                                                                    Article 3

The methods of analysis needed to verify that the general and specific criteria of purity adopted Ö pursuant to the  first  Commission  Directive
81/712/EEC[14] are Õ satisfied shall also apply for the purpose of this Directive.

                                                                    Article 4

Where a colouring matter is deleted from Annex I to Directive 94/36/EC but the marketing  of  foodstuffs  containing  this  colouring  matter  is
permitted to continue for a limited period, this provision shall also apply to medicinal products. This limited period  of  use  may  however  be
amended for medicinal products according to the procedure Ö referred to Õ in Article 5(2) Ö of this Directive Õ.

                                            ê 807/2003 Art. 1 Annex III, pt. 25 (adapted)

                                                                    Article 5

1. The Commission shall be assisted by the committee for the adaptation to technical progress of the Directives on the elimination  of  technical
barriers to trade in the sector of colouring matters which may be added to medicinal products, Ö established in  accordance  with  Article  5  of
78/25/EEC Õ, hereafter referred to as “the committee”.

2. Where reference is made to this Ö paragraph Õ, Articles 5 and 7 of Decision 1999/468/ECshall apply, Ö in respect to the provisions of  Article
8 thereof Õ.

                                            ê 807/2003 Art. 1 Annex III, pt. 25

The period set out in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The committee shall adopt its rules of procedure.

                                            ê 78/25/EEC (adapted)

Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered  by  this
Directive.

                                            ê .

                                                                    Article 7

Directive 78/25/EEC, as amended by the acts listed in Annex I, is repealed, without prejudice to the obligations of the  Member  States  relating
to the time-limits for transposition into national law of the Directives set out in Annex I, Part C.

References to the repealed Directive shall be construed as references to this Directive and shall be read  in  accordance  with  the  correlation
table in Annex II.

                                                                    Article 8

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

                                            ê 78/25/EEC

                                                                    Article 9

This Directive is addressed to the Member States.

Done at Brussels, […]

For the European Parliament  For the Council
The President    The President
[…]   […]

                                            é

                                                                     ANNEX I

                                                                      Part A

                                                Repealed Directive with its successive amendments
                                                            (referred to in Article 7)

|Council Directive 78/25/EEC                                                           |                                                   |
|(OJ L 11, 14.1.1978, p. 18)                                                           |                                                   |
|Council Directive 81/464/EEC                                                  |                                                   |
|(OJ L 183, 4.7.1981, p. 33)                                                   |                                                   |
|Council Regulation (EC) No. 807/2003                                          |Annex III, point 25 only.                          |
|(OJ L 122,16.5.2003, p. 36)                                                   |                                                   |

                                                                      Part B

                                                             Non-repealed amendments

Act of Accession 1979

Act of Accession 1985

                                                                      Part C

                                             List of time-limits for transposition into national law
                                                            (referred to in Article 7)

|Directive                                                            |Time limit for transposition                                         |
|78/25/EEC                                                            |15.6.1979[15]                                                        |
|81/464/EEC                                                           |30.9.1981                                                            |

                                                                __________________

                                                                     ANNEX II

                                                                Correlation Table

|Directive 78/25/EEC                                                  |This Directive                                                       |
|Article 1, first paragraph                                           |Article 1                                                            |
|Article 1, second paragraph                                          |______                                                               |
|Articles 2, 3 and 4                                                  |Articles 2, 3 and 4                                                  |
|Article 5(1)                                                         |______                                                               |
|Article 6                                                            |Article 5                                                            |
|Article 7(1)                                                         |______                                                               |
|Article 7(2)                                                         |______                                                               |
|Article 7(3)                                                         |______                                                               |
|Article 7(4)                                                         |Article 6                                                            |
|______                                                               |Article 7                                                            |
|______                                                               |Article 8                                                            |
|Article 8                                                            |Article 9                                                            |
|______                                                               |Annex I                                                              |
|______                                                               |Annex II                                                             |

                                                                    __________

                                                             -----------------------
[1]   COM(87) 868 PV.
[2]   See Annex 3 to Part A of the Conclusions.
[3]   Carried out pursuant to the Communication from the Commission to the European Parliament and the  Council  –  Codification  of  the  Acquis
      communautaire, COM(2001) 645 final.
[4]   See Annex I, Parts A and B of this proposal.
[5]   OJ C
[6]   OJ C
[7]   OJ L 11, 14.1.1978, p18. Directive as last amended by Regulation (EC) No. 807/2003 (OJ L 122, 16.5.2003, p. 36).
[8]   See Annex I, Parts A and B.
[9]   OJ L 237, 10.9.1994, p.13. Directive as last amended by Regulation(EC) No.1882/2003 (OJ L 284, 31.10.2003, p. 1).
[10]  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)
[11]  OJ L 184, 17.7.1999, p.23.
[12]  OJ L 311, 28.11.2001, p. 67.
[13]  OJ L 311, 28.11.2001, p.1.
[14]  OJ L 257, 10.9.1981, p.1.
[15]  Pursuant to Article 7(2) of Directive 78/25/EEC : ‘2. However, any Member State may permit, on its  own  territory,  until  the  end  of  a
      period of four years from the notification of this Directive, the marketing of medicinal products containing colouring matters which do not
      comply with the requirements of this Directive so long as these colouring matters were authorized in that Member State before the  adoption
      of the Directive.’