Proposal for a Directive of the European Parliament and of the Council on the colouring matters which may be added to medicinal products (Recast)
Date: 2008-01-11
Institutions: European Commission
Subjects: approximation of laws, drug surveillance, dyestuff, marketing, medicinal product, pharmaceutical legislation

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.1.2008 
COM(2008) 1 final 

2008/0001 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the colouring matters which may be added to medicinal products 

(Recast) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

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. 

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Directive was to have superseded the various acts incorporated in it3. 

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. 

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.  

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. 

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COM(87) 868 PV. 
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. 
See Annex I, Part A of this proposal. 
OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 
OJ C 255, 21.10.2006, p. 1. 

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(cid:208) 78/25/EEC (adapted) 

2008/0001 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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 ⌦ 95 ⌫ thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

Whereas: 

(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  products4  has  been  substantially  amended  several  times5.  Since  further 
amendments are to be made, it should be recast in the interests of clarity. 

(cid:216) new 

(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 

(cid:208) 78/25/EEC Recital 1 

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OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
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). 
See Annex I, Part A. 

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hinder the development of the pharmaceutical industry or trade in medicinal products 
within the Community. 

(3) 

Although  Directive  ⌦ 94/36/EC  of  the  European  Parliament  and  of  the  Council  of 
30 June 1994 on colours for use in foodstuffs ⌫6 established a single list of colouring 
matters authorised  for use in foodstuffs, the disparities  between the  laws of  Member 
States concerning the colouring of medicinal products still exist.  

(cid:208) 78/25/EEC Recital 2 (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. 

(cid:208) 78/25/EEC Recital 3 (adapted) 

(cid:208) 78/25/EEC Recital 4 (adapted) 

(5) 

Experience  has  shown  that  on  health  grounds  there  is  no  reason  why  the  colouring 
matters  authorised  for  use  in  foodstuffs  should  not  also  be  authorised  for  use  in 
medicinal  products.  Consequently, ⌦ 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 foodstuffs7 ⌫ should also apply for medicinal products. 

(cid:208) 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. 

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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). 
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). 

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(cid:216) new 

(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 Commission8. 

(8) 

Power  should  be  conferred  on  the  Commission  in  particular  to  amend  the  limited 
period of use of medicinal products. Since those measures are of general scope and are 
designed to amend non-essential elements of this Directive, they should be adopted in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of 
Decision 1999/468/EC. 

(9) 

The  new  elements  introduced  into  this  Directive  only  concern  the  committee 
procedures. They therefore do not need to be transposed by the Member States. 

(10)  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 B, 

(cid:208)  

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

(cid:208) 78/25/EEC (adapted) 

Member  States  shall  not  authorise,  for  the  colouring  of  medicinal  products  for  human  and 
veterinary use as defined in Article 1 of ⌦ Directive 2001/83/EC of the European Parliament 
and of the Council9 and in Article 1 of Directive 2001/82/EC of the European Parliament and 
of  the  Council10⌫  any  colouring  matters  other  than  those  covered  by  Annex  I  of 
Directive 94/36/EC. 

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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). 
OJ L 311, 28.11.2001, p. 67. 
OJ L 311, 28.11.2001, p. 1. 

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(cid:208) 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. 

(cid:208) 78/25/EEC (adapted) 

Article 3 

The  methods  of  analysis  needed  to  verify  that  the  general  and  specific  criteria  of  purity 
adopted ⌦ pursuant  to  the  first  Commission  Directive  81/712/EEC11  are ⌫  satisfied  shall 
also apply for the purpose of this Directive. 

(cid:208) 78/25/EEC (adapted) 
(cid:214) new 

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 (cid:214) by the Commission  for medicinal 
products. 

(cid:214) Those measures designed to amend non-essential elements of this Directive, by completing 
it,  shall  be  adopted  in  accordance  with  the  regulatory   procedure  (cid:214) with  scrutiny  
⌦ referred to ⌫ in Article 5(2) ⌦ of this Directive ⌫. 

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OJ L 257, 10.9.1981, p. 1. 

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(cid:208) 807/2003  Art.  3  Annex  III, 
pt. 25 (adapted) 
(cid:214) new 

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,  ⌦ established  in  accordance  with 
Article 5 of Directive 78/25/EEC ⌫, hereafter referred to as “the committee”. 

(cid:214) 2.  Where  reference  is  made  to  this  paragraph,  Articles  5a(1)  to  (4)  and  Article  7  of 
Decision 1999/468/ECshall apply, in respect to the provisions of Article 8 thereof.  

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC12 shall 
apply. 

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. 

(cid:208) 78/25/EEC (adapted) 

Article 6 

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.  

(cid:208) 78/25/EEC 

(cid:208)  

Article 7 

Directive 78/25/EEC,  as  amended  by  the acts listed in Annex I, Part A 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 B. 

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. 

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OJ L 184, 17.7.1999, p. 23. 

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

Article 8 

(cid:208) 78/25/EEC 

Article 9 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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(cid:207) 

ANNEX I 

Part A 

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

Council Directive 78/25/EEC 
(OJ L 11, 14.1.1978, p. 18) 

Section X, point D, of Annex I of the 1979 Act 
of Accession 
(OJ L 291 of 19.11.1979, p. 108) 

Council Directive 81/464/EEC 
(OJ L 183, 4.7.1981, p. 33) 

Section IX, point C of Annex I of the 1985 Act 
of Accession 
(OJ L 302, of 15.11.1985, p. 217) 

Council Regulation (EC) No 807/2003 
(OJ L 122,16.5.2003, p. 36) 

Annex III, point 25 only 

Part B 

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

Directive 

Time limit for transposition 

78/25/EEC 

81/464/EEC 

15.6.19791 

30.9.1981 

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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 authorised in that Member State 
before the adoption of the Directive.’ 

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ANNEX II 

CORRELATION TABLE 

Directive 78/25/EEC 

This Directive 

Article 1, first paragraph 

Article 1, second paragraph 

Article 1 

______ 

Articles 2 and 3 

Articles 2 and 3  

Article 4, first sentence 

Article 4, first subparagraph 

Article 4, second sentence, first part 

Article 4, second subparagraph  

Article 4, second sentence, second part 

Article 4, third subparagraph 

Article 5(1) 

Article 6 (1) 

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Article 6(2) 

Article 6(3) 

Article 7(1) to (3) 

Article 7(4) 

______ 

______ 

Article 8 

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______ 

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Article 5(1) 

Article 5(2) 

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______ 

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Article 6 

Article 7 

Article 8 

Article 9 

Annex I 

Annex II 

__________ 

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