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October 2, 2006


Related: Chemicals Policy review (REACH)

[Rachel's introduction: As U.S. activists try to decide what kind of
comprehensive chemical reform they favor, one possible approach would
be to copy the European proposal called REACH. This article looks
back at the history of the REACH proposal which had its origins in a
meeting of the European Council almost ten years ago.]


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

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 10 kg 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

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.


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

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


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

Powers of the Agency

The Agency will be the sole responsible with more and clearer


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;


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

"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


EU official documents

First reading

Council: Common position on REACH [Full text, 674 pages] (12 June

Parliament: Texts adopted: REACH (17 Nov. 2005)

Second reading

Parliament: Draft recommendation for second reading -- REACH (23
June 2006)

Related Documents

US mounts coalition to defeat EU chemical safety reform (REACH) (12
June 2006)

US states in push for EU-style chemicals law (10 May 2006)

US companies fear 'black list' effect of REACH (28 April 2006)

EU concludes on safety of chemical thought to cause child cancer (24
April 2006)

EU research to look into chemical exposure of babies (24 February

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