Implementing the EU’s new chemicals law (REACH)

Following Parliament and Council’s final agreement on REACH in late 2006, the focus has now shifted to the implementation of the EU’s chemicals legislation.

Background

The regulation on the Registration, Evaluation and Authorisation of Chemicals (REACH) will replace the current dual system in place for:

  • "Existing" chemicals placed on market before 1981 (around 100,000 substances), and; 
  • "new" chemicals that were marketed later (some 2,700 substances). 

Prior to 1981, substances could be commercialised without proper health and safety testing. According to the Commission, safety information is "sketchy for around 99%" of these, raising questions about their possible impact on human health.

Under the proposed new system, all substances will need to go through at least basic health and safety screening over an 11-year period.

The regulation was approved by both Parliament and Council in late 2006 and the law will enter into force in spring 2007. The European Chemicals Agency in Helsinki will become operational a year later, to start the screening process.

Issues

An interim strategy was put in place by the Commission as early as 2004 to ensure smooth implementation of the legislation once it is adopted. So-called REACH implementation projects (RIPs) will be running until the agency becomes fully operational in 2008. Work focuses on five key areas:

  • RIP 1: REACH process description;

  • RIP 2
    : development of an IT system;
  • RIP 3: development of guidance documents for industry;
  • RIP 4: development of guidance documents for authorities;
  • RIP 5/6: setting up the European chemicals agency; 

In September 2006, the Commission held a workshop to provide guidance to producers and downstream-users of chemicals under REACH. The programme included an overview of timelines and obligations to establish the safe use of a chemical.

Meanwhile, a series of trial runs with business stakeholders took place last year to simulate how REACH would actually work in practice.

  • The first, called SPORT, simulated "in real life" situation, the whole process from pre-registration to dossier evaluations within the future chemicals agency. The trial run, which involved 29 chemical manufacturers, nine member states and 25 downstream users of chemicals, concluded that the overall system was working more or less satisfactorily. The final report made a series of 40 recommendations to clarify some specific aspects of REACH and make it more 'workable' in practice (EURACTIV 8 July 2005).
  • The second, called PRODUCE, looked at downstream users who use chemicals as ingredients in consumer products as well as product labelling issues. It published its final report in January, making more than 30 recommendations to make REACH more 'workable'. A series of appendices deal with safety data sheets, and labelling requirements for individual products such as air fresheners, fragrances or all-purpose cleaners.

The results of both these exercises were fed into the Commission's REACH Implementation Projects (RIPs).

Firms have been urged by the Commission to pre-register chemicals before 1 December 2008 in order to avoid a possible disruption in the manufacturing and/or importing of substances. The deadline is particularly crucial for companies wishing to place new substances on the market (EURACTIV 14/04/08).

The fee structure used for chemicals registration has also been made public, with fees ranging between €1600 for volumes less than 10 tonnes and up to €31000 for substances above 1000 tonnes.

Positions

Despite the efforts made, not everybody seems satisfied with the Commission's moves to facilitate REACH implementation.

On 13 September, the United States Council for International Business - a trade body whose membership includes some 300 leading US companies with combined annual revenues in excess of $3 trillion - hit out at the Commission's proposed guidelines for REACH implementation.

The final guidelines, known as RIP 3.8, relate to substances that are contained in finished products, or 'substances in articles' in REACH jargon. But with the number of chemicals in finished products, such as computers, sometimes amounting to 100 or more, registration can become somewhat complicated.

"We are concerned that these guidelines are neither workable nor proportionate," said Andrea Fava, USCIB's manager of environmental affairs. USCIB recommended the revision of the proposed guidelines, saying that its members are "concerned about the workability of the draft from both the compliance and enforcement perspectives". USCIB has also expressed concern that the guidelines go beyond the scope of the draft chemicals legislation.

"We urge that further input be considered and that the guidance for articles be revised," said the USCIB statement.

In June 2006, the European Chemicals Industry Council (CEFIC) launched ReachCentrum, a help desk to support companies along the value chain to fulfil the requirements of REACH.

CEFIC said the Brussels-based ReachCentrum will draw from experience gained with European Commission projects that is says have given CEFIC "unique expertise on REACH". 

"CEFIC is now turning this expertise into practical help to companies." Services provided will include consortia management, "including Chinese walls facility to preserve confidentiality" and a registration service to handle submissions of dossiers to the future chemicals agency.

In response to the passing of the regulation itself, CEFIC Director-General Alain Perroy called on EU institutions "to continue developing the technical guidance and instruments needed to secure the successful implementation of REACH.” In this context, Perroy said it will be “of paramount importance to establish an efficient and cost-effective agency".

UEAPMEthe European small-businesses association - which represents both small chemical producers and downstream manufacturers who use chemicals in their products – praised moves supporting their implementation of the legislation.

But overall, UEAPME said the end result is "quite disappointing." "The issues of data sharing and data liberalisation have been sidelined during the debate, and legal certainty on cost sharing is left to future guidelines. More could have been done," said Guido Lena, environmental policy director at UEAPME.

For the WWF, "the effective implementation of the substitution principle will be decisive in assessing whether REACH has been a real improvement over the current system".

Timeline

  • Dec 2006: Parliament and Council agree on REACH (EURACTIV 13/12/06)
  • June 2007: REACH regulation comes into force
  • The Commission is planning to review REACH shortly after it is adopted. This could include amendments to the various annexes of the regulation (I, II, IV, V and XI) and, if appropriate, drafting of specific implementing legislation (e.g. regulations for fees and test methods)
  • 12 June 2007: Commission provides new software (IUCLID5) to help companies supply their data under REACH
  • 11 July 2007: FEFCO (European Federation of Corrugated Board Manufacturers) published a guide to help board manufacturers comply with REACH
  • June 2008: European Chemicals Agency becomes operational, pre-registration phase starts
  • June 2018: Registration phase closes with substances produced in smaller quantities (1-10 tonnes) 

Further Reading

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