Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council 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)"

(2000/C 204/18)

On 10 April 2000, the Council decided to consult the Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentionned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 5 April 2000. The rapporteur was Mrs Williams.

At its 373rd plenary session (meeting of 25 May 2000), the Economic and Social Committee adopted the following opinion by 73 votes to none, with 1 abstention.

1. Introduction

1.1. This proposal from the Commission on the marketing and use of certain dangerous products concerns the health and safety of both consumers and workers. Its motivation is essentially to protect human health by prohibiting the use of dangerous azo dyes so that those textiles and leather goods which are coloured by them are no longer placed on the market. Some of these products, such as toys, clothes and shoes can affect the most vulnerable of consumers, in particular pregnant women and small children.

1.2. The proposal is yet another safety amendment to the existing Directive on dangerous substances(1), with its text supplemented by technical annexes.

1.3. The proposal also underlines the importance of harmonisation in the Internal Market. Since some Member States have already enacted restrictions of marketing and use of certain carcinogenic azo dyes, there is a compelling need for co-ordinated, common action to create EU legislation which will ensure harmonisation which will also apply to candidate countries.

1.4. The proposal must also be seen in the context of the World Trade Organisation's requirements, so that any limitations on the use of azo dyes must be supported by well-identified risks to consumers.

2. Background information

2.1. Azo colourants (both dyes and pigments) are the most widely used organic colouring materials. They all contain at least one azo link. This azo link can be reduced in the body to form the corresponding aromatic amine. The Proposal therefore is not to restrict all azo colours but only those soluble azo dyes which would break down or cleave to form any of the 21 listed amines which are carcinogens. Most azo pigments are not affected since they are virtually insoluble and therefore do not cleave under normal conditions.

2.2. Azo dyes give very good coloration to all kinds of articles including some gloves, bags, briefcases, chair covers, shoes and straps made from leather, as well as clothes, bedding, hats, toys and even wigs made from textiles.

2.3. Since the dangers of certain azo dyes became apparent, these have been largely replaced by other dyes (including other azo dyes) though these alternatives are often more expensive. This replacement has gone far in the EU but less far in some other countries.

2.4. Since national legislation requiring a ban on certain azo dyes exists in some Member States, the Commission has already taken positive action. It has initiated studies on risk assessment, on cost-benefit analysis, and on an evaluation of the effects of a ban in supplying countries. In addition, the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) delivered an Opinion in January 1999 which concluded that the use of certain azo dyes gave cause for concern. And in March 1999 the Working Group on Limitations on Marketing and Use of Dangerous Substances accordingly supported the Commission's proposal for a ban on dangerous azo dyes. The Group also suggested test methods demonstrating compliance with the legal requirements.

3. General comments: the Committee's view

3.1. Directive 76/769/EEC on certain dangerous substances has now been modified very many times and has become difficult to use. The Commission should therefore urgently recast and update the whole base Directive.

3.2. The Committee supports the Commission's proposal. It recognises that the emphasis is on the protection of human health, which relates both to consumers and workers. It may well be, however, that it is workers who are at the greater risk in the processing of products containing the potentially dangerous azo dyes, since their exposure is longer, more frequent and possibly at higher concentrations. The Committee therefore recommends the adoption of specific measures at the level of the enterprise.

3.3. The Committee draws attention to the need for management to keep records of workers who may already be adversely affected by dangerous azo colourants, or who may be affected at some time in the future, bearing in mind direct causal links.

3.4. The Committee is also concerned about the use and production of these potentially dangerous azo dyes in third countries where safety standards are not necessarily as high as those in the EU. In the first instance, this concern relates to the protection, training and education of workers. In the second, it concerns the import into the EU of consumer products which have been made still using dangerous dyes. In the Far East and Africa, for example, azo dyes can be used and manufactured on a very local basis, with no controls, no production statistics, and no official communication of the types of colorants used.

3.5. The Committee therefore calls for stringent control, effective monitoring, and sampling at the first point of entry of both products and dyes themselves imported from all third countries.

3.5.1. The Committee also urges the Commission to ask Member States to propose to the WTO and ILO the prohibition of the future production of dangerous azo-colourants.

4. Specific comments

4.1. Ambit of the Proposal

4.1.1. This needs to be more clearly defined.

4.1.2. The second paragraph of Section 2 of the Explanatory Memorandum clearly states "only the soluble azo colourants ... pose a risk to human health. ... the azo dyes which by definition are soluble plus a very small fraction of azo pigments which are also soluble. As those pigments were not yet risk assessed they are not the subject of the specific provisions of this directive ...".

4.1.3. The distinction between soluble azo dyes and insoluble azo pigments does not appear clearly in the present Proposal. The text therefore needs amending to clarify this.

4.2. Article 2

4.2.1. This contains two alternative dates for adoption by Member States. Both are unrealistically short, given the EU and national legal processes. Application should be two years after entry into force of the Directive.

4.3. Annex

4.3.1. First table, second column: In English this starts correctly with "Azodyes". In several other languages the distinction between azodyes and azocolourants has been lost. The Commission therefore needs to check that all language versions reflect the intention of the Directive.

4.4. Appendix B: Analytical methods

4.4.1. The analytical methods in the Annex are copied from one Member State only. There have been some problems with the reproducibility of these methods. They have therefore been evaluated by work carried out under the MTI (Measurement, Testing and Infrastructure) Programme of the fourth Framework research programme and improved methods are being agreed. The methods in the Proposal therefore should be replaced by EU ones as soon as these have been finalised.

Brussels, 25 May 2000.

The President

of the Economic and Social Committee

Beatrice Rangoni Machiavelli

(1) 76/769/EEC, OJ L 262, 27.9.1976, p. 201.