Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance)

Directive 2009/35/EC · Directive · 11 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Member States shall not authorise, for the colouring of medicinal products for human and veterinary use as defined in Article 1 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 8 ) and in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 9 ) , any colouring matters other than those covered by Annex I to Directive 94/36/EC.

Article 2

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

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/EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity ( 10 ) are 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 by the Commission as regards medicinal products. Those measures designed to amend non-essential elements of this Directive, by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 5(2).

Article 5

1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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.

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.

Article 8

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union .

Article 9

This Directive is addressed to the Member States.

Supplementary provisions

ANNEX ISupplementary provisions

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 ) 1979 Act of Accession, Annex I, Section X, point D ( OJ L 291, 19.11.1979, p. 108 ) Council Directive 81/464/EEC ( OJ L 183, 4.7.1981, p. 33 ) 1985 Act of Accession, Annex I, Section IX, point C ( OJ L 302, 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 15 June 1979 ( 1 ) 81/464/EEC 30 September 1981 ( 1 ) 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.’

ANNEX IISupplementary provisions

ANNEX II Correlation table Directive 78/25/EEC This Directive Article 1, first paragraph Article 1 Article 1, second paragraph — Articles 2 and 3 Articles 2 and 3 Article 4, first sentence Article 4, first paragraph Article 4, second sentence, first part Article 4, second paragraph Article 4, second sentence, second part Article 4, third paragraph Articles 5(1) and 6(1) and (2) Article 5 Article 6(3) — Article 7(1), (2) and (3) — Article 7(4) Article 6 — Article 7 — Article 8 Article 8 Article 9 — Annex I — Annex II

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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