Notification according to Article 95(4) of the EC Treaty

Request for authorisation to maintain national provisions derogating from a Community harmonisation measure

(2003/C 185/03)

(Text with EEA relevance)

1. By letter of 21 May 2003 the Federal Republic of Germany notified the Commission according to Article 95(4) of the EC Treaty of its national provisions that it deems necessary to maintain concerning the use of azodyes derogating from the provisions of Directive 76/769/EEC(1) relating to restrictions on the marketing and use of certain dangerous substances and preparations, as amended by Directive 2002/61/EC(2) regarding the marketing and use of azocolourants.

2. Article 95(4) provides that "if, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 30, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them".

3. According to Article 95(6), the Commission shall, within six months of the notification, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they shall constitute an obstacle to the functioning of the internal market.

4. With the second ordinance of 15 July 1994 amending the Consumer Goods Ordinance the Federal Republic of Germany banned the use of harmful azodyes in certain articles which are in prolonged contact with the body, given that these dyes can break down into substances which are potentially carcinogenic. The national regulation was introduced to protect the consumer against health risks and prohibited the use of azodyes which can form one of 20 specified amines by breaking down into one or more azo groups for the commercial manufacture or treatment of eight groups of articles which come into prolonged contact with the body.

5. Given that textile and leather articles containing certain azodyes have the capacity to release certain aromatic amines which may pose cancer risks, Directive 2002/61/EC has prohibited the use of azodyes, which may release one or more of the 22 specified aromatic amines in concentrations above 30 ppm in the finished articles, in textile and leather articles which have the potential of coming into direct and prolonged contact with the human skin or oral cavity and the placing on the market of some articles coloured with such dyes, in order to protect human health.

6. The Federal Republic of Germany intends to retain the national ban on certain azodyes for the eight groups of articles which come into direct and prolonged contact with the body, in so far as these do not consist of textile or leather, as Directive 2002/61/EC refers only to textile and leather articles which come into direct and prolonged contact with human skin or the oral cavity. The national ban on azodyes enacted in 1994 aimed to prevent any direct contact with the body with the azodyes which could break down into carcinogenic amines, regardless of the material of which the article with which the consumer comes into prolonged contacte is made. The Federal Republic of Germany takes the view that the danger to health from azodyes, which can break down into harmful amines, also applies regardless of whether the dyed objects are produced from textiles, leather or another material. It considers that renunciation of an existing protection for the consumer against harmful azodyes from articles made of materials other than textiles and leather is not acceptable on the grounds of health protection.

7. The Commission reminds interested parties that possible observations on the notification submitted later than one month after the publication of this Notice in the Official Journal of the European Union are in principle unlikely to be considered. Furthermore, the Commission reserves the right to communicate any observations that may be submitted to it to the Federal Republic of Germany.

8. Further information regarding this notification can be obtained from the authorities of the Federal Republic of Germany: Dr. Karl-Wolfgang Evers Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft Postfach 14 02 70 D - 53107 Bonn Tel. (49-18 88) 529 46 64 Fax (49-18 88) 529 49 67 E-mail: karl-wolfgang.evers@bmvel.bund.de

The contact point inside the European Commission is: Claire Koeniguer European Commission Directorate General Enterprise

Unit E3 "Chemicals"

AN88 04/012 B - 1049 Brussels Tel. (32-2) 295 91 93 Fax (32-2) 295 02 81 E-mail: claire.koeniguer@cec.eu.int

(1) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (OJ L 262, 27.9.1976, p. 201).

(2) Directive 2002/61/EC of the European Parliament and of the Council of 19 July 2002 amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants) (OJ L 243, 11.9.2002, p. 15).