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EU: REACH Decision Draws Closer

Decision time edging closer for EU-chemicals law

05.10.2006 |Daniela Rosche




“The Commission's initial impact assessment estimated the overall costs to the chemicals industry and its downstream users at 2.3 billion euro over an 11-year period (or 0.05 per cent of the sector's annual turnover). But the bickering continued until a final study was published in April 2005, only to confirm the Commission's initial findings that it would not ruin the chemicals industry…”

Euractiv
October 2, 2006

In Short:
One of the EU's most hotly debated legislative proposals, REACH, enters its critical second-reading phase in Parliament this week. EurActiv looks back at the history of a proposal with origins in a Council meeting almost ten years ago.

Background:
What's the problem with chemicals?
There is a general lack of knowledge regarding the 99% of chemicals (around 100,000 substances) that were placed on the market before 1981 ('existing substances'). This is because prior to that date, no stringent health and safety tests were needed to market chemicals. There are 3,000 so-called 'new substances' which had to go through a more stringent safety screening after 1981.

While some well-known chemicals, such as asbestos, are already banned, the Commission believes that the rising incidence of diseases such as cancer and leukaemia could be linked to chemicals. Blood tests in humans and animals have shown contamination by known toxic substances, raising questions as to how they enter the body and the extent of the damage that they could cause.

What will REACH do about it?
The regulation will put in place a single regulatory framework called REACH (Registration, Evaluation and Authorisation of CHemicals) to cover both "existing" and "new" chemicals over an 11-year period.

Producers and importers of chemicals, not authorities as is currently the case, will need to show that substances are safe before they can be placed on the market (reversal of burden of proof). An agency will be set up to authorise or reject the applications. Safety screening and registration will take place in three stages, based on two broad sets of criteria:
  • Volumes produced or imported per year: >1000 tonnes within 3 years; 100 - 1000 tonnes within 6 years; 1 - 100 tonnes: within 11 years, and;
  • risk: substances that are carcinogenic, mutagenic or toxic to reproduction shall be assessed in priority within the first three years.
How many substances will be assessed?
The REACH proposal covers about 30,000 of the 100,000 'existing substances' placed on the market before 1981. This is because it leaves out substances that are imported or produced in less than one tonne per year. Under the previous system, 'new substances' had to go through safety screening if they were imported or produced in quantities of more than 10kg per year.

Where does REACH come from?
Early work on REACH started in April 1998 at an informal meeting of EU environment ministers (Chester, UK) which recognised the need to review the current chemicals policy to test all substances on the market. Meetings with regulators, scientists, environmental NGOs and industry followed and in June 1999, the Council adopted conclusions on a future EU-chemicals strategy, asking for a review of the existing legal instruments.

Actual legislative work began in February 2001 with a Commission White Paper, outlining the main elements of the future strategy.

The paper reflected concerns about "the serious damage to human health" caused by certain chemicals. At the same time, it acknowledged the importance of the chemical industry as Europe's third largest manufacturing sector, employing 1.7 million people directly and generating a trade surplus of 41 billion euro for the EU. It was hoped that a new regulatory framework would further improve Europe's competitiveness on world markets by prompting innovation in safer chemicals.

In June 2001, EU ministers endorsed the twin concerns of health protection and competitiveness, saying that the precautionary principle should form the basis of the new policy.

Issues:
The consultation phase that came prior to the proposal gave rise to what has often been described as the fiercest lobbying battle in EU history. From May to October 2003, the Commission received more than 6,000 contributions from industry associations, NGOs and governments. EU trade partners such as the USA and Japan also contributed and the Commission's proposal was finally tabled in October 2003 (EurActiv 28 Oct. 2003).

Most of the attention - and lobbying - focused on the estimated costs and benefits of the system. Initial assessments by the Commission were contested by industry, which warned that millions of jobs were at risk (EurActiv 16 Aug. 2003). Meanwhile, health organisations, environmental NGOs and trade unions pointed to the huge savings in health costs, describing industry tactics as "scaremongering".

The Commission's initial impact assessment estimated the overall costs to the chemicals industry and its downstream users at 2.3 billion euro over an 11-year period (or 0.05 per cent of the sector's annual turnover). But the bickering continued until a final study was published in April 2005, only to confirm the Commission's initial findings that it would not ruin the chemicals industry (EurActiv 27 April 2005).
The impact-assessment battle illustrated a fundamental trend in the REACH debate - the issues have remained remarkably stable over time. When the Commission tabled its proposal in October 2003, it had already introduced a number of key changes to take account of the concerns raised during the consultation process (EurActiv 25 Sept. 2003). The most important ones concerned:

Scope of the system
Polymers were exempted from registration; the requirements for registering a substance within finished  products ('substances in articles') have been softened.

Legal certainty
The "duty of care" provision for industry has been more clearly defined as companies feared they would be confronted with open-ended liability claims; the European Chemicals Agency will have a Board of Appeal.

Costs
For downstream users of chemicals, the obligation to produce safety assessments and reports was strictly limited; registration for chemicals produced or imported in the 1-10 tonne range was made simpler.

Powers of the Agency
The Agency will be the sole responsible with more and clearer responsibilities.

Confidentiality
Stricter protection for sensitive and confidential business information was agreed; all information that is non-confidential will be available on request; the Agency will have more powers as to decisions on data sharing, R&D exemptions and protection of sensitive business confidentiality;

Substitution
Companies will be encouraged to present substitution plans; this may influence decisions on authorisations.

Animal testing
REACH should not lead to an increase in animal testing.

Two years later, when the bill entered the European Parliament for its first reading, the issues had remained largely unchanged, with the debate focusing on the practical 'workability' of the system (EurActiv 17 Nov. 2005). When the Council voted the proposal in December, a number of key elements had been agreed (EurActiv 13 Dec. 2005):

The substitution principle applies as a general rule, meaning that hazardous substances are to be replaced by safer alternatives whenever possible. However, a number of exceptions are introduced with the debate focusing on time-limtations to these, and; group applications: 'one substance, one registration' (OSOR) principle requires companies to submit safety data jointly in a consortia when registering similar substances with the agency.

Registration is made simpler in the 1-10 tonne range and waiver option for safety tests is introduced in the 10-100 tonne range

Most of these issues will remain at second reading with the Parliament's Rapporteur, Guido Sacconi MEP, focusing his efforts on maintaining a strong substitution principle. But after so many years of discussion, most observers agree that there is little room left for manoeuvre.

"The positions of the Parliament and the Council are not that far apart", says Sacconi who believes a compromise can be found before the Plenary in November.

Latest & next steps:
4 October 2006: debate in Parliament environment committee
10 October 2006: vote in Parliament environment committee
14 November 2006: expected vote in Parliament plenary
4 December 2006: probable vote in Council (Competitiveness) and final approval of REACH