Commission keeps cards close to its chest for chemicals policy review

An assessment of four Directives which form the backbone of the EC's regime for controlling chemical hazards was published by the European Commission on 18 November in the latest step in the review of EC chemicals policy. Most of the paper's proposals are vague, and would involve fine-tuning of the existing instruments rather than radical change - although a single reference to the precautionary principle was probably included only after a struggle within the Commission.

The review of chemicals policy was initiated by Environment Ministers in April (ENDS Report 279, pp 39-40 ). They will discuss the Commission's paper at their meeting in December. The debate will be followed by a "brainstorming" workshop for stakeholders early next year. The Commission will then set out proposals for action in a formal Communication.

In April, five Member States called for a comprehensive overhaul of chemicals legislation, with a framework Directive setting out new principles for minimising chemical risks. The Commission's paper is a much more modest affair.

The paper acknowledges that there is "growing public concern" about the effects of chemicals on human health and the environment, including emerging hazards such as endocrine disruption. The concern, it says, is "exacerbated by the so-called 'burden of the past'" - the tens of thousands of chemicals which were on sale before pre-market testing requirements were introduced in 1981.

The paper's focus, however, is on evaluating and improving the efficiency and effectiveness of the four main Directives on dangerous substances and preparations in protecting humans and the environment and eliminating barriers to trade, rather than a strategic overview of how EC policy might be adapted to match changing perspectives of chemical hazards and how they should be addressed.

  • The 1967 Directive on classification, packaging and labelling of dangerous substances is a key instrument which has been amended or adapted to technical progress 31 times.

    Under this legislation, harmonised classification and labelling rules for some 4,500 substances have been laid down - most recently with a Directive published in November. 1 The 1979 "Seventh Amendment" introduced pre-market testing and notification requirements for "new" substances, some 2,100 of which have been notified since 1981.

    Several problems with this regime are identified by the Commission. Agreeing and publishing classification and labelling requirements for dangerous substances takes "too long" at between one and two years, and the requirements are "not sufficiently applied and enforced" by Member States. And "there is no adequate follow-up" - meaning marketing or use restrictions - for substances classified as carcinogens, mutagens or teratogens.

    On the pre-market notification regime, the paper notes that some "new" substances are being marketed illegally. Over the past four years, two EC-wide studies, the NONS and SENSE projects, have found that 37% of new dyestuffs and 5% of a sample of other industrial chemicals had been placed on the market without notification. Widespread breaches of EC classification and labelling rules were also detected (ENDS Reports 262, pp 17-18 , and 279, p 8 ).

    At the same time, some features of the regime are unfavourable to the chemical industry. Manufacturers have been complaining for years that the pre-market testing and notification requirements are unduly onerous for intermediates, polymers and substances used in research and development. Circulation of companies' notification dossiers among national authorities also takes "too long", with 10% taking more than one year.

    From the authorities' perspective, the risk assessment process for new substances "requires inordinate effort in terms of staff resources and time," the paper says.

    The Commission's proposals for rectifying these shortcomings are vague. It highlights a "need" to "address operational weaknesses in the implementation and enforcement" of the 1967 Directive, and to restructure it so as to "give it the necessary clarity and transparency" and reduce constraints on the chemical industry's competitiveness.

    In equally opaque terms, the paper also identifies a need "to ensure that Member States consider liability as well as withdrawal of substances as a means to improve compliance."

  • The 1993 Regulation on risk assessment and management of "existing" substances - those on the EC market before September 1981 - has been the subject of sustained criticism over the past year. Risk assessments have not been published for any of the 110 substances on the first three priority lists issued since 1994. This autumn, the European chemical industry proposed measures to accelerate the rate of progress as the EC's contribution to an international programme to complete testing and risk assessment of over 2,000 chemicals produced in larger volumes over the next six years (ENDS Report 285, pp 23-26 ).

    As reported last month, the Commission attributes the slow progress to a lack of commitment and resources from Member States and industry. The "burden of proof" on the authorities to demonstrate that a substance is hazardous is another obstacle. The new paper also notes that the 1993 Regulation "is not intended to rapidly manage urgent or emerging new problems for those 'existing' chemicals which are not already on the priority lists."

    The paper goes on to identify several "needs". These include a clarification of Member States' commitment to the work on existing chemicals, and ascertaining the number of these substances whose hazardous properties should be identified for subsequent risk assessment and management. The "burden of proof" also needs to be addressed. The paper offers no view of the chemical industry's proposal for a voluntary testing and risk assessment programme.

  • The 1988 Directive on dangerous preparations, which lays down rules for manufacturers and importers to identify those compounds which are "dangerous", label and package them appropriately, and provide a safety data sheet for industrial users.

    The Commission identifies several problems with this regime. "Some preparations on the market," it says, "have not been classified, and some are classified differently by different manufacturers." The Directive also does not cover pesticides or preparations dangerous to the environment, nor deal systematically with non-classified preparations which may present dangers to users.

    Most of these issues are addressed in a revision of the Directive proposed in 1996 (ENDS Report 258, pp 39-40 ), on which Ministers reached a common position this autumn. 2 The new Directive will enter into force three years after it is finally adopted.

    In addition, the Commission proposes that the causes of non-compliance with the Directive should be identified, with Member States to "consider withdrawal of preparations as a means to improve compliance."

  • The 1976 Directive on the marketing and use of dangerous substances and preparations - the main instrument for introducing harmonised restrictions on dangerous chemicals. Some 42 substances or groups of substances have been restricted since 1976.

    The Directive has been seen as the vehicle for dealing with chemicals for which marketing or use restrictions are identified as necessary under the "existing" substances Regulation. However, the need to have such measures approved by the Council and Parliament makes it an unsuitable instrument for introducing controls quickly. An alternative and swifter procedure, under which controls can be agreed by a committee of national officials, has scarcely been used.

    Harmonisation of national controls has also been difficult to achieve for some substances. A case in point is chrysotile asbestos, on which bans or severe restrictions have been introduced in eight EC countries while a dispute about the safety of substitutes and the economic impacts of a ban has raged at EC level.

    The Commission proposes that adoption of new restrictions under the Directive should be accelerated by giving preference to the committee procedure, and by "improving risk assessment procedures" in cases "characterised by scientific uncertainty or high economic costs as in the current case of asbestos." Other proposals include a restructuring of the Directive to give it a clearer scope, precise definitions and a "safeguard clause" - presumably allowing explicitly for interim national restrictions pending an EC decision.

    The very last sentence of the paper almost certainly provoked a tussle between the Environment and Industry Directorates. It proposes that "the precautionary principle is given full consideration in the introduction of marketing and use restrictions." This is the paper's only reference to the principle - but how the Commission envisages that it might be applied in practice is anyone's guess.

  • The European Parliament has called for more urgent controls on endocrine-disrupting chemicals. In a resolution adopted on 20 October, it urged the Commission to draw up a list of such substances and ensure their withdrawal from the market.

    Priority should be given to identifying hormone-mimicking chemicals in cosmetics, toys, detergents, foods, pesticides and chemicals liable to migrate into food.

    Transport Commissioner Neil Kinnock responded by interpreting the resolution as a call for a "reinforced research strategy", provision of information to the public, and EC participation in international efforts to "address the problem."

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