Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council amending for the 24th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (pentabromodiphenyl ether)"

(2001/C 193/05)

On 12 February 2001, the Council decided to consult the Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentioned 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 10 April 2001. The rapporteur was Mr Colombo.

At its 381st plenary session (meeting of 25 April 2001), the Economic and Social Committee adopted the following opinion by 65 votes in favour, with one abstention.

1. Aim of the proposal

1.1. This proposal amending Directive 76/769/EEC(1) aims to introduce harmonised provisions on the marketing and use of pentabromodiphenyl ether (pentaBDE).

1.2. The proposal's objective is to protect human health and the environment by prohibiting the use and marketing of articles containing pentaBDE.

2. Introduction

2.1. PentaBDE is a brominated flame retardant used almost exclusively (approximately 95 %) in the manufacture of flexible polyurethane foam used in various sectors for the production of consumer goods. It is also used, to a limited extent, as a flame retardant additive in epoxy and phenol resins, unsaturated polyesters and textiles.

2.2. There are other flame retardants used in the production of flexible polyurethane foam that were introduced following regulations issued by the European Union and the individual Member States restricting the use of pentaBDE. The most common is tris (2-chloro-1-methylethyl) phosphate, which is on the fourth risk evaluation priority list.

2.3. Data on the environmental risks show the presence of high concentrations of pentaBDE in fish and earthworms in places close to polyurethane foam production sites.

2.4. The risks to human health, assessed in accordance with the Community regulation (EEC) No 793/93(2), are unclear owing to a lack of relevant data, in particular on workers exposed to pentaBDE. Although there is some data on these workers (on the presence of chloracne), there is an urgent need for more research into the effects of pentaBDE when absorbed by the skin.

2.5. Meanwhile, certain toxicity studies on animals demonstrate significant disturbance to the metabolism and the liver, and other animal studies suggest that pentaBDE can bioaccumulate in fat tissue.

2.6. PentaBDE has also been shown to be present in breast milk, but the origins and toxikinetics of this level of exposure remain a mystery. Further toxicity studies are therefore essential.

3. General comments

3.1. On the basis of the risk evaluation recommended in the Community regulation (EEC) No 793/93, in accordance with the precautionary principle adopted by the Community, following consultation of the industry and other interested parties and their positive response, and given the scale of the potential risks posed by pentaBDE to human health and the environment, the Committee agrees with the Commission's proposal to restrict the marketing, use and placing on the market of products containing this substance.

3.2. In view of the limited understanding of the effects on human health, the Committee also urges the Commission to make arrangements for epidemiological studies to monitor the health of workers who come into contact with pentaBDE during their working life, in particular to ascertain the effects of bioaccumulation in fat tissues.

3.3. Furthermore, given the concern shown by the Scientific Committee on toxicity, ecotoxicity and the environment (CSTEE), and on the basis of the data on the exposure of breast-fed children to pentaBDE, the ESC calls for a scientific research programme to ascertain and assess what other protective measures may be necessary.

3.4. Although the risk assessment on octabromodiphenyl ether (octaBDE) mentioned in the fifth recital is not yet complete, the Committee calls on the Commission to assess whether there is a case for applying the precautionary principle to this product as well.

Brussels, 25 April 2001.

The President

of the Economic and Social Committee

Göke Frerichs

(1) OJ L 262, 27.9.1976, pp. 201-203.

(2) OJ L 224, 3.9.1993, p. 34.