Reach for a new policy

Dr Joanne Lloyd, head of group products and health for the CIA, discusses the debate surrounding chemical management

Chemical management has been top of the chemical industry’s agenda since the publication of the European Commission White Paper Strategy for a future Chemicals Policy in February 2001, which laid out the principles behind the proposed REACH (Registration, Evaluation and Authorisation of Chemicals) Regulation.

The REACH debate is now more than half-way through the political process and this year there has already been a quickening of pace and a sense that REACH will shortly become a legislative reality. The European Parliament has formally begun its first reading process on the Commission’s adopted 2003 proposal, which it planned to have completed in the autumn.

Moving swiftly on

This timing fits well with that of the European Council, which is working towards reaching a common position in November. This would mean REACH being formally adopted in the first half of 2006 and becoming law in 2007.

Throughout the legislative process, the Chemical Industries Association has fully supported the Commission’s aims of developing a new chemical regulatory system and we will be continuing to do so in the months ahead. The CIA believes that in the quest for a sustainable future, it has a
responsibility to its workers, its customers and to the public to ensure all of its products are safe and it believes new legislation is needed to achieve this.

The debate continues

As the REACH debate rumbles on, common sense seems to have been left behind by some quarters. As proposals are made for even more data, in an ambitious timespan involving an ever-increasing number of players, some have failed to stop and consider what is actually needed for REACH to deliver on its objectives. In fact, no criteria for success have ever been suggested.

The chemical industry’s concerns now come down to the fundamental issues of workability and the potentially disastrous impact the regulations are likely to have on European Union manufacturing if these are not addressed. These include:

  • prioritisation;
  • data sharing;
  • preservation of confidential business information; and
  • substitution.
  • It is estimated that a total of 30,000 substances or more will need to be progressed through REACH and some regard the proposed system, where production volume is used as an approximation for risk, as the simplest way to prioritise.
    The CIA disagrees and, along with its counterparts in Europe, believes there is a better way. The CIA proposes a system that combines the volume thresholds suggested by the Commission with an identification and early registration of substances of potential high risk.

    Taking the first step

    The first step in this process is a simple 18-month postcard pre-registration step for all substances at the same time – declaring:

  • company name,;
  • substance name/CAS number;
  • manufactured/import volume;
  • availability of vertebrate animal studies; and
  • classification and labelling information.
  • This would then be published to foster data sharing and consortia formation.
    Core information is then produced within the first five years for all substances, which will provide the basis for registration and prioritisation. High production volume substances and all known category one and two CMR (carcinogen, mutagen or reproductive toxin) substances are also registered at this time.

    Two years later, substances whose ‘core data set’ suggests they could pose a risk, will be registered as well as substances in the 1,000-100 tonne volume band. Nine years after REACH comes into force, 100-10 tonne volume band substances will be registered and those in the 10-1 tonne band after 11 years.

    Requirements for SMEs

    As the requirements for SMEs would be stricter than those laid down by the European Commission, the CIA proposes that for low-volume substances – between 1-10 tonnes – appropriate data for prioritisation will be produced rather than a full core data set.

    Improvements also need to be made to the way data is shared between companies to generate a registration dossier; much of the debate to date fails to recognise how inextricably linked commercial interests are to any sources of data – the sharing of hazard data being no exception.

    Registering substances

    The Commission’s proposals compel the sharing of vertebrate test data, which has never been disputed, but also encourage companies that manufacture or import the same substance to form a consortium for registration of that substance.

    There is a real fear if sufficient safeguards are not introduced, company intellectual property and confidential business information relating to novel uses and markets could be lost, contravening UK and EU competition law.

    One substance one registration

    However, the UK government is championing a proposal that goes even further. It suggests an approach known as “one substance, one registration” (OSOR), which is designed to reduce the duplication of all testing and share the costs of registration between all companies that produce or import the same compound by mandatory sharing of all hazard data. Though laudable as a principle, the fact that it is mandatory concerns us.

    Manufacturers, distributors, importers and formulators are competing companies and it is inevitable that there will be cases where a mandatory system will lead to a loss of trade secrets. The CIA likes the idea, and in the majority of cases OSOR will be the logical way forward for companies to generate their registration dossier – but it should not be a mandatory approach.

    Substance authorisation

    One of the more contentious issues over the coming months could be substance authorisation and the substitution of chemicals of concern within that process. This is an issue on which the CIA and the CBI has held a series of discussion with Greenpeace, which culminated in an agreed text on our common ground.

    We all agreed substitution required the commitment of the whole supply chain, that an alternative must possess an acceptable level of performance, safety and cost, and that authorisations should be time-limited appropriately for uses of substances of very high concern. This common position is now being debated with a range of stakeholders in an effort to widen its representation and to promote better understanding between what are often legitimately divergent views.

    The CIA will continue to make suggestions on how REACH can be made to work as the political debate moves forward, and do its best to achieve an improved REACH that delivers on its objectives.

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