REACH negotiations enter crucial year

EU competition and environment Ministers each held public debates on the European Commission’s proposed REACH chemicals registration regime at the end of 2004. They fell short of achieving the Dutch Presidency’s objective of an informal agreement on the first three titles of REACH, but they homed in on key areas for further discussion. Meanwhile, MEPs are gearing up for formal debates, with rapporteurs for two committees signalling that they want to see risk-based prioritisation of existing chemicals for registration, in place of the Commission’s cruder tonnage-based proposal.

The Dutch Presidency signalled at the start of its tenure that it was aiming for an informal agreement on the first three titles of the REACH proposal - constituting the main provisions on registration of chemicals and data-sharing among firms. It failed to achieve this but it valiantly pressed Member State experts to address the nitty-gritty of the legislation, giving rise to several detailed government proposals for amendments to the text and moving forward thinking on practicability.

The Presidency steered political debate at the Competitiveness and Environment Councils on 26 November and 20 December to cover five key issues:

  • National impact assessments: Ministers welcomed and said they would continue to take note of the conclusions of a Dutch-sponsored workshop last October that summarised and made recommendations based on the findings of 36 studies on the likely impacts of REACH. The studies were carried out by EU governments and industry and environmental groups.

    An official report put the direct costs to industry at some €4bn, almost double the Commission’s estimate. The report also recommended several steps to reduce costs, including a pre-registration phase and data sharing.

    The European Commission is continuing to work on a comprehensive impact assessment together with European industry bodies, the results of which should have been published at the end of last year and are now expected before the spring.

  • Risk-based prioritisation: Many governments and industry groups are uncomfortable with the Commission’s proposal simply to prioritise registration of existing chemicals based on the quantities in which they are produced. Several have put forward alternative suggestions based on various means of estimating the risks posed by chemicals, although the Commission and NGOs fear that these could bog down the registration system.

    Ministers concluded that further exploration of alternative systems is necessary, in particular to ensure that substances of very high concern are assessed as early as possible. Specifically, Ministers proposed exploring the possibility for early assessment of substances that are potentially persistent, bioaccumulative and toxic (PBT) and those that are potentially very persistent and very bioaccumulative (vPvB) - in addition to potential carcinogens and reproductive toxins as required by the Commission’s proposal.

  • Substances in articles: This is one of the most intractable points of the Commission proposal, intended to cover the introduction of substances in products. Few think that the Commission’s approach of distinguishing products based on whether they are intended to or likely to release chemicals is workable.

    The Swedish government has done the most thinking on this issue, fuelled by a national policy goal to label all finished products to indicate whether they contain dangerous substances by 2010.

    It has put forward a series of amendments which would require product suppliers to tell professional customers of any "substances of very high concern" intentionally present in those articles over a certain limit. This provision, Sweden proposes, should come into legal effect five years after the Regulation’s entry into force.

    In parallel, it wants to introduce for professional customers a "right to know" of the presence of dangerous substances in products they buy, entitling them to request such information from suppliers. While this is likely to increase the workload for some suppliers, Sweden argues that it is preferable to the difficulties and costs of dealing with the release of substances and making substitutions further down the supply chain.

    Sweden argues that such a provision would bring REACH into line with the pan-European Aarhus Convention which requires parties to ensure that sufficient product information is made available to enable consumers to make informed environmental choices.

    Sweden also proposes that articles from which substances are intended to be released during normal use should be treated in exactly the same way for registration purposes as the substances themselves, saying it sees "no valid reason" not to.

    It suggests that articles containing "substances of very high concern" in quantities exceeding more than one tonne per year in total should have to be registered regardless of whether they are intended or likely to be released during normal use.

    Environment Ministers were clearly interested in Sweden’s ideas, instructing their experts to examine them in more detail.

  • Mandatory sharing of non-animal test data: The joint proposal by the UK and Hungary that producers of substances should be required to share core, non-confidential test data goes beyond the Commission’s proposal requiring the sharing of animal test data (ENDS Report 356, pp 42-43 ). Member States broadly accept the logic of increasing efficiency by having one set of registration data for each substance regardless of the number of companies producing it, but many balk at proposals to make companies share data.

    At the Competition Council, Ministers were asked by the Presidency to consider whether mandatory sharing of such data is justifiable in the public interest, given the risk of infringement to intellectual property rights. They were also asked to consider whether mandatory sharing is justified given that industry has a responsibility to generate accessible and reliable risk data for its chemicals, or whether it should be allowed to proceed on a voluntary basis.

    Finally, Ministers were asked to consider whether, in the event of data-sharing, the costs should be distributed between companies based on guidance alone, or whether strict rules need to be embedded into the REACH Regulation itself.

    Ministers appeared particularly struck by the support of SMEs for the idea of mandatory sharing of data. They sent the issue to the Council’s legal service for examination.

  • More information on low-volume substances: The Commission’s proposal requires producers to prepare chemical safety reports with details of risk management approaches for substances produced in quantities over 10 tonnes per year. Several Member States feel that this limit should be lowered to one tonne per year but they are concerned about the potential impacts on SMEs. One suggestion is that consideration of a lowering of the limit could be deferred until the REACH Regulation is reviewed. The issue is to be examined further by the Council’s ad hoc working group on chemicals.

    As Member States continue their deliberations, they will be keeping one eye on the debates now getting under way in the European Parliament at last. These officially begin with a "stakeholder hearing" at which industry, academics and environmental groups will be questioned in public by MEPs and in particular by the rapporteurs of three of the Parliament’s committees - industry, internal market and the environment.

    Rapporteurs for the industry and internal market committees published "non-papers" at the close of 2004 setting out their initial thinking on REACH. Both argued strongly for a change of the basis for prioritising existing chemicals for registration, saying this should reflect an estimation of the risks posed by the chemicals, not simply tonnage bands.

    The Parliament is aiming to deliver the conclusions of its first reading in the autumn. In the meantime, Luxembourg and the UK are coordinating their EU Presidencies through 2005 to achieve agreement on outstanding issues and to consider the rest of the REACH proposal. Whatever the outcome, in 2005 the final shape of the REACH regime should at least become much clearer.