Ministers show support for substitution under REACH

EU Environment Ministers have agreed that a significant tightening of rules on authorising the highest-risk substances under the proposed REACH Regulation is required. In the meantime, the politics of REACH are set to heat up over the summer with rumours flying of parts of the European Commission trying to water down the proposal. The European Parliament's first vote on REACH has been postponed until November pushing it close to the deadline set by the UK Presidency for a ministerial political agreement.

The last big act on REACH of the outgoing Luxembourg Presidency was to arrange an orientation debate at the Environment Council on 24 June (see pp 47 ). The aim was to discuss the "authorisation procedure" of REACH under which companies must seek approval to continue to sell substances that are considered to pose a high risk to human health and the environment.

As it stands in the draft REACH Regulation, the procedure would allow companies to continue to sell such substances if they can show they can maintain adequate control over their risks. Failing this, they could still win approval if they could show that there is a socio-economic need for the substance and that there is no alternative substance or technology available.

Many feel that this process is not stringent enough to spur substitution of the highest risk substances. In the UK, Greenpeace, the Confederation of British Industry and the Chemical Industries Association issued a joint statement calling on the Government to push for limited stronger measures on substitution, including time-limits set on authorisation periods (ENDS Report 358, p 8 ).

This gave the UK Government the political backing it needed to come forward with a detailed paper on how the authorisation process could be strengthened shortly before it assumed the EU Presidency (ENDS Report 363, pp 46-48 ).

The debate held at the Environment Council confirmed Member States' support for key elements of this proposal. Ministers were asked their views on four key questions:

  • Scope of authorisation: Ministers indicated that strict scientific criteria must be applied to deciding which substances are required to undergo authorisation. Their effects must be equivalent to those groups already highlighted for consideration, namely carcinogenic substances, mutagens, reproductive toxins, persistent, bioaccumulative and toxic substances (PBT) and very persistent and very bioaccumulative (vPvB) substances.

    The UK's advisory committee on hazardous substances is working on defining "equivalence" under the authorisation procedure (ENDS Report 363, pp 46-48 ).

    Some Member States indicated that they would like to see certain sensitisers and allergens added to the list.

  • Listing candidates for authorisation: There was said to be a "largely positive attitude" among Ministers towards the idea of publishing in advance a list of chemicals considered to meet the criteria for authorisation, whether or not these candidates go on to receive authorisation for whatever reason. This was one of the UK's key proposals in a bid to spur users to recognise that substances are considered high risk and to consider alternatives.

    Industry groups have expressed concern at encouraging such decisions before decisions on authorisation are taken.

  • Mandatory requirement to consider substitution: Ministers agreed that there needs to be stronger support for the principle of substitution under the authorisation procedure and that the availability of alternatives should be considered before taking a decision on authorisation.

    However, some warned that authorities should have to take account of industry production cycles in considering whether substitutes are suitable, allowing companies sufficient time to switch to alternatives.

  • Conditions of authorisation: In support of increasing control over the risks of the highest-risk substances and encouraging their phase-out, Ministers agreed that strict conditions should be applied, including a time-limit on the length of authorisation, review periods and a new requirement for companies to monitor risks posed by substances still on the market.

    Ministers finally agreed to carry on working towards reaching a first political agreement on REACH by the end of the year, once MEPs have delivered their first reading and proposed amendments.

    In July, however, the European Parliament's Environment Committee stated that it is "likely to endorse a short delay" in adopting its draft report due to "translation delays" in other committees. It now aims to vote on the report on 3-4 October, which means that a vote by the full Parliament will need to be postponed until its plenary session on 14-17 November.

    Given that the UK Presidency was hoping to achieve political agreement at the Competitiveness Council at the end of November, things are looking a little tight. However, a source at the UK Presidency said that it was closely tracking the Parliamentary negotiations and taking account of them.

    Guido Sacconi, rapporteur for the Parliament's environment committee, indicated in May that he had received more than 1,200 amendments to the 111 he initially proposed (ENDS Report 362, pp 56-57 ).

    The most vexed issue for MEPs is that of changing the basis for prioritising those chemicals to be registered under REACH from a volume-based to a risk-based approach.

    In April, Hartmut Nassaeur, REACH rapporteur on the Parliament's industry committee, issued a press release claiming that his centre-right EPP party, which is the biggest political group within the Parliament, had agreed to push for risk-based prioritisation. However, some have expressed doubt that there is sufficient unity within the EPP.

    NGOs and others fear that risk-based prioritisation would take things back to the pre-REACH era when the absence of sufficient risk data meant that barely any progress was made in assessing chemicals.

    Industry groups say that risk-based prioritisation is possible based on a limited amount of risk data but critics say the data being proposed are too limited to achieve a safe prioritisation and could mean that some chemicals escape the net altogether.

    The Maltese and Slovenian governments have recently added weight to the risk-based approach by suggesting registration be permitted for low-volume substances - between 1-10 tonnes per annum - on the basis of limited data available, followed by more detailed evaluation for those chemicals considered to pose a higher risk over 16 years.

    NGOs have opposed the proposal, saying it turns on its head the key REACH principle that companies must supply sufficient risk data in order to be registered to sell products. Instead, it says it will be back to the system of Member States having to ask them for further data.

    Meanwhile, a row between the Enterprise and Environment Directorates of the European Commission became public in July.

    It centres on Industry Commissioner Günter Verheugen allegedly calling for the data requirements for chemicals produced at 10-100 tonnes per year to be pared down to those required for 1-10 tonne chemicals in the interests of reducing the burden on industry. This would affect the majority of the chemicals intended to be caught by the REACH net.

    Environment Commissioner Stavros Dimas is said to oppose such a radical watering down of REACH. Commission President José Manuel Barroso is believed to have stepped into the fray.

    To effect such a change, the Commission would most likely have to include it in its response to the Parliament's first reading in November. It would have to secure sufficient support among MEPs, which is likely to be far from straightforward.

    While acknowledging the row, a UK Presidency source pointed out that despite the involvement of actors from many different spheres in the Council's ad hoc working group on chemicals - the main forum for Member States' discussions on REACH - none had shown an appetite for the road proposed by Commissioner Verheugen.

    The Presidency will send Member States away over the summer to read a document outlining options for the registration, evaluation and authorisation provisions of REACH, before it begins work on a compromise text in September. They will also consider the findings of the REACH pilot trial following a Presidency workshop on 22 July (see pp 49 ).

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