September 15, 2005


The proposal to register and control some 30,000 chemical substances
in the EU, known as REACH, is entering a decisive voting phase in
Parliament this autumn (EurActiv, 5 August 2005).

The proposal would require health and environmental assessments for
more than 30,000 chemicals and substances. It proposes reversing the
burden of proof from the authorities to the companies instead of the
opposite as is now the case. In future, the idea is that companies
would have to provide health and safety data for each one of these
products or substances.


The UK Presidency has circulated the outlines of a compromise
proposal on the draft REACH legislation on chemicals that it hopes
could lead to an early political agreement at a ministers' meeting
scheduled on 28-29 November.

At a press briefing on 15 September, the UK Presidency said the
proposed deal would allow exemptions to the scope of the legislation
to exclude waste, certain recycled materials, metal ores and ore

An earlier British-Hungarian proposal to allow businesses to share
data for registering chemicals substances in a consortium -- the so-
called One Substance One Registration (OSOR) proposal -- would be the
key to the whole system.

The mandatory sharing of data submitted by companies in a consortium
under an updated version of OSOR would be the general rule, the UK
Presidency told the press on 15 September.

But there would be mechanisms and safeguards to protect the
confidentiality of data that are highly sensitive for the protection
of business secrets and intellectual property. For instance,
information such as the specific usage of a substance submitted for
registration or the production process needed to manufacture it would
not be required.

However, other companies in the consortium would have a right to voice
disagreement and ask the agency to assess whether the data should be
shared or not. In such cases, characteristics such as hazard or
flammability would be compelling arguments for the agency to impose
mandatory sharing, the UK Presidency indicated.

An industry request for an opt-out allowing a company to go it alone
and register a product separately to bypass consortium and keep its
data secret was ruled out as such.

In another key proposal, the Presidency suggested lighter data
requirements for chemicals produced or imported in small volumes (1-10
ton range) based on the so-called Maltese-Slovenian proposal. However,
the proposed compromise would make it simpler, the UK Presidency said.

For these chemicals, companies would be allowed to submit only their
available data to the agency unless some simple criteria highlight
them as being of very high concern (such as persistent,
bioaccumulative and toxic substances -- PBTs). Three additional safety
tests -- acute toxicity, biodegradability and algal toxicity -- have
been added "to ensure an adequate assessment of the risks can be

The UK Presidency admitted that this provision would apply to around
20,000 chemical substances out of the 30,000 that are to be tested
under REACH but pointed out that it would probably be much less in
terms of volumes.

As was suggested by MEP Guido Sacconi, the risk-based approach was
generally strengthened by adding substances identified as potentially
Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and
very Bioaccumulative (vPvB) to the first three-year registration phase
- along with the high tonnage. However, this would only apply to
chemicals imported or produced over one tonne per year (around 100-200
substances, according to the UK Presidency).

Finally, it is proposed that information on risk and hazard is passed
up and down the supply chain, to ensure that substances are handled
safely. The information should also "certainly" be made available at
the request of consumer organisations, the UK Presidency indicated.

Furthermore, in order to avoid loopholes in the system, the agency
would submit registered substances to a regular review and monitoring.

Reacting to the outcome of votes in EP committees that took place this
week (EurActiv, 15 Sept. 2005), the European Chemical Industry
Council (CEFIC) said the REACH proposal was "making a step in the
right direction". "The risk-based approach is taken into account
better than in the Commission's proposal, and the role of the Central
Agency has been strengthened," it notes. However, CEFIC believes the
proposal could be further refined by applying the risk-based approach
"throughout the process, notably in the authorisation and restriction
of chemicals".

The European SME organisation UEAPME hailed the UK Presidency
compromise proposal on mandatory data sharing. "Introducing the
compulsory sharing of all data, as the UK Presidency has proposed,
will help overcome" problems for downstream users of chemicals, UEAPME
said in a statement.

According to the Wall Street Journal Europe, the US Chamber of
Commerce is planning to mount a legal challenge against the REACH
legislation after its final adoption. The American business lobby
claims that the new EU law will "disrupt international trade and
supply change and greatly increase costs".
Latest & next steps:


* Chemicals Policy review (REACH)

* 4 October: Environment Committee vote on REACH
* 16 November: Likely date for vote in Parliament plenary, Strasbourg


Official Documents

DG Enterprise: The new EU chemicals legislation -- REACH

DG Environment: REACH


UK Presidency: UK Presidency Compromise REACH Text [summary paper
only, not an official text] (Sept. 2005)

UK DEFRA: Future EU Chemicals Policy

UK DEFRA: One Substance, One Registration: a joint proposal from
Hungary and the UK

EU Actors positions

European Chemical Industry Council (CEFIC): Outcome of votes in
European Parliament Committees is a step in the right direction for
REACH (15 Sept. 2005)

UEAPME: Chemicals law moving in the right direction (15 Sept. 2005)

WWF / FoE / EPHA: IMCO and ITRE votes fatally undermine REACH (13
Sept. 2005)

Related Documents

Two EP committees streamline EU chemicals law (15 September 2005)

MEP: Do not expect a major swing on REACH (14 September 2005)

Key lawmaker ready for compromise on REACH (13 September 2005)

Chemicals found in babies heat up REACH debate (09 September 2005)

Chemicals debate coming to the boil in the autumn (05 August 2005)

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