Opinion on the proposal for a Council Directive amending for the first time Directive 90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work ()

(96/C 97/07)

On 10 October 1995, the Council decided to consult the Economic and Social Committee, under Article 118a of the Treaty establishing the European Union, on the above-mentioned proposal.

The Section for Social, Family, Educational and Cultural Affairs, which was responsible for preparing the Committee's work on the subject, adopted the Opinion on 18 January 1996. The Rapporteur was Mr Etty.

At its 332nd Plenary Session (meeting of 31 January 1996), the Economic and Social Committee adopted the following Opinion unanimously.

1. Introduction

1.1. The Commission proposal is presented as an amending Directive to the individual Directive on the protection of workers from the risks related to exposure to carcinogens at work (90/394) already adopted under the Framework Directive of 12 June 1989. That Directive provides the basis for the protection of the health and safety of workers against risk from chemical, physical and biological agents at work, reflected in a series of specific directives.

1.2. The Economic and Social Committee has continuously participated in the development of these measures; in recent years it has recorded Opinions on proposals for amendment to the Biological Agents Directive, a Physical Agents Directive and a Chemical Agents Directive ().

1.3. The current Carcinogens Directive provides for a series of general measures by employers to ensure that the exposure of workers to carcinogens is reduced to as low a level as is technically possible. (In this context, 'carcinogen' is meant to address chemicals capable of causing cancer; physical agents and biological agents with this hazard are not covered in the current Directive nor in the proposed amendment.)

1.4. The current Carcinogens Directive (Article 16) provided for the establishment by the Council of limit values on the basis of information, including scientific and technical data, in respect of all those carcinogens where this is possible, and, where necessary, other directly-related provisions. No such limits have yet been set. The proposed amendment therefore begins this process by setting a limit for benzene, a known human carcinogen, clearly demonstrated by epidemiological studies. At present, different limit values for benzene are applied in different European and other countries.

1.5. The amendment proposal recognizes four important aspects of setting a limit value for benzene:

(i) the need for compromise between the technical requirements for worker protection and a feasible step forward at this time;

(ii)

the need for temporary derogations so that those industries and workplaces which would require technical adjustments to meet the standard have time to do so, provided the worker-protection provisions of Directive 90/394 are observed;

(iii)

the need for uniformity within the European Union by providing a minimum level of protection of all workers in the Community which avoids any possible distortion in the area of competitiveness;

(iv)

the fact that further actions to lower exposure will not be required as legal provisions already exist in most Member States to restrict or prohibit the use of benzene.

1.6. Apart from the issue of limit values in general and that of benzene in particular as an exemplar for the setting of limit values for carcinogens, the proposal effects a major extension of the scope of the Carcinogens Directive by removal of restrictions implicit in the wording of the current instrument.

1.7. The current Directive identifies carcinogens as substances under Directive 67/548 and preparations under Directive 88/369 which have been allocated the risk-phrase R45 'may cause cancer' together with certain specified substances, preparations or processes in a short list in Annex 1. The new proposal would extend the scope of the Directive to medicinal and veterinary products, cosmetic products, mixed substances in waste, pesticides, munitions and intended explosive products. The proposal would thus prevent different levels of protection for workers exposed to carcinogens whether as substances or as preparations.

1.8. The proposal also corrects two specific faults in the current Directive:

(i) it contains precise provisions for the protection against polycyclic aromatic hydrocarbons (PAH);

(ii)

it provides for the risk of skin absorption (and not just skin contact) in addition to other routes of exposure.

1.9. In summary, the proposed amendment is a logical step within the principles of the Framework Directive to advance protection of workers against the risks of exposure to carcinogens at work.

2. General comments

2.1. The Committee generally considers the Commission proposal for an amendment to the Carcinogens Directive to be a valuable advance in worker protection and an enhancement of regulatory controls provided that

(i) it in no way conflicts with the effect of established Health and Safety Directives;

(ii)

the Committee is informed by the Commission on the arrangements foreseen for extending the list of substances to which specific limit values will be applied and the methods by which these will be agreed and established within the European Union. In this context, the Committee reiterates its Opinion made on the proposal for a Chemical Agents Directive:

'The Committee considers ... that limit values should be set by procedures involving full consultation with social partners, the Economic and Social Committee and the European Parliament.'

The Committee notes the reference to the Advisory Committee on Safety, Hygiene and Health at Work and its support in general for the proposed amendment, and also the views of the members of that Committee on the proposed limit value for benzene. The Economic and Social Committee understands that, although there are differences in view on the limit which might now be set for benzene, the Commission proposal of 1 ppm, supported by a series of derogations limited in time, would be the most feasible action at this time. In supporting this view, the Committee has been informed on levels applied or under discussion both within and outside the European Union. The provisions proposed in the proposal, as those in the Carcinogens Directive, are minimum provisions. The Committee urges employers to take improved protective measures if possible.

2.2. The Committee stresses that the protective measures in the Carcinogens Directive of 1990 are in no way affected by the present proposal. They must also be observed in those sectors and activities selected for derogations. The Committee further reminds the Commission of the criticisms and suggestions expressed in its 1988 Opinion on the proposal for the Carcinogens Directive and urges the Commission to take further action on the basis of it.

2.3. The proposal must not lead to unnecessarily costly measures and the Committee notes that the Commission confirms that this will not be the case. The Committee emphasizes the application of risk-assessments in line with Article 6 of the Framework Directive 89/391. The Commission must provide more information on both the health-protection benefits and the cost implications of the consequential extensions in scope.

2.4. The Committee recognizes that carcinogenic risks are one aspect of adverse chemical effects. It also brings to the attention of the Commission that others are involved of an equally serious nature like genetic risks, which could require future Community action.

3. Specific comments

3.1. Article 1

3.1.1. The Committee considers that in view of the complexity of the subject and the extensions in scope arising from the revised definition in the proposed replacement for Article 2, the Commission should provide a guidance note which would assist employers and workers in understanding the application of the revised Directive to their circumstances of work. This will be of particular help to improve the working conditions in small and medium-sized enterprises. The Committee understands that the basis of classification is that the designation of a substance or preparation as a Category 1 or 2 Carcinogen to which the provisions of the Directive (as amended by the proposal) applies is:

Category 1: Substances known to be carcinogenic to man where there is sufficient evidence to establish a causal connection between human exposure to a substance and the development of cancer i.e. on the basis of epidemiological data.

Category 2: Substances which should be regarded as if they are carcinogenic to man. There is sufficient evidence to provide a strong presumption that human exposure to a substance may result in the development of cancer i.e. generally on the basis of animal experiments or other relevant data.

The Commission must ensure the application of these criteria for the implementation of the Directive and for any future proposals for limit values for substances.

The Committee recommends that in Article 2(a) explicit reference is made to substances classified with the label R 49 and to preparations classified as R 45.

3.1.2. The Committee supports the amendment to Article 3(3) (point 2 in the amendment) which recognizes that the risk from skin exposure is not confined to the skin alone but may extend to absorption into and through the skin.

3.1.3. The Committee accepts the derogations proposed under Annex III. It notes the statement of the Commission on the extension of the Directive to, a.o. different forms of waste.

3.1.4. The Committee thinks that point 3 in the amendment needs clarification. The Committee understands that the time-limited derogations are to provide for non-compliance with the proposed limit value for benzene by certain sectors of activity but do not extend to exemption from compliance with all the other protection measures laid down in the current Directive. It is not clear what additional safeguards are provided by this addition.

3.1.5. The Committee supports point 4 of the amendment which resolves problems in interpretation which led in some States to the incorrect inclusion of coal dust, with coal soot, coal tar and coal pitch in the definitions of Annex 1 'List of substances, preparations and processes work involving exposure to aromatic polycyclic hydrocarbons'. This important group of chemical agents includes some recognized carcinogens, which the Committee hopes the Commission will pay attention to in the near future.

3.1.6. With specific regard to benzene and the proposed limit value in the replacement for Annex III reference is made to 1.5 above. The Committee reiterates its support for the Commission proposal for an occupational exposure limit of 1 ppm, measured or calculated as drafted in Note 5, Part A of Annex III, subject to justifiable derogations for specific activities or sectors of activity where implementation may be difficult to meet within the date specified (31 December 1998). The Committee recommends that the Commission explores the feasibility of amending, as quickly as possible after 31 December 1998, Annex III with a view to further reduction of the limit value.

The Committee requests information from the Commission on the availability of measurement instruments and technical experts to assist employers, particularly in small and mediumsized enterprises, to comply with the limit value.

3.1.7. The Committee is aware of the fact that benzene is used as a reactant and/or a reaction intermediate in certain industries such as the fragrance industry, where its uses are acceptable provided that they are under control.

3.1.8. The Committee finds it essential that a uniform measuring procedure should be found for application throughout the European Union.

3.1.9. In earlier Opinions, notably the Opinion on the Proposal for a Council Regulation (EEC) establishing a European Agency for Safety and Health at Work (), the Committee has said that it attaches great importance to the improvement of exchange of information and experience and of cooperation with and between specialized institutes and other bodies in the field of occupational safety and health, and that it is a task of major importance to ensure that national data on safety and health at the workplace are comparable. The Committee wishes to reiterate that point in the context of the present Opinion.

Done at Brussels, 31 January 1996.

The President

of the Economic and Social Committee

Carlos FERRER

() OJ No C 317, 28. 11. 1995, p. 16.

() OJ No C 56, 6. 3. 1989, p. 38; OJ No 249, 13. 9. 1993, p. 28; OJ No. C 34, 2. 2. 1994, p. 42.

() OJ No C 169, 6. 7. 1992, p. 42.