AGREEMENT ON NEW EU CHEMICALS REGULATION WELCOMED

The Minister for Labour Affairs, Mr Tony Killeen, T.D., today (Wednesday 13^th December 2006) welcomed the European Parliament’s endorsement of the new EU Regulation for the registration, evaluation, authorization and restriction of chemicals, known as REACH.

“What has been agreed today in the European Parliament reflects the outcome of very intensive negotiations. What is important for everyone concerned is that we now have a Regulation which will enter into force on 1 June next year, so everyone now knows what the rules will be. Ireland had sought from the outset of negotiations to ensure that rules being put in place would be proportionate; being sufficiently strong to protect the health and safety of people and clear enough to provide certainty for industry.

The Minister added “Our next challenge is to ensure that all of industry which will be affected by this new Regulation – and that includes in particular small manufacturing industry which uses chemical substances in their manufacturing processes – is aware of its obligations. We have already started down this path. The Government’s decision from last year to nominate the Health and Safety Authority as the interim competent authority for REACH, with an additional 44 staff to carry out this work, means that Ireland has been able to play a key role in developing implementation guidelines at EU level. We are well placed in this country to ensure that our industry base is aware of its obligations. The Health and Safety Authority as the national competent authority will play its part in informing industry of the new requirements.”

“I particularly welcome”, Minister Killeen said, “the initiative of the Irish Business and Employers Confederation [IBEC] in establishing a helpline for industry and its programme of dissemination of information. This new chemicals Regulation has been 3 years in negotiation among the countries of the European Union. The outcome can truly be said to represent a new era for the regulation and control of chemicals.”

Note for Editors

REACH [Registration, Evaluation, Authorisation and restriction of CHemical substances] is the acronym for the new EU Chemicals Regulation, which is due to enter into force on 1 June 2007.

On 29 October 2003, the EU Commission formally tabled its proposal to replace the current 40 legislative texts with a single regulation establishing a single system called REACH.

REACH will replace the current dual system which differentiates between chemical substances placed on the market before and after 1981, and will mean that information of some 30,000 chemical substances will become available under the REACH registration requirements. The burden of proof regarding testing and evaluation of the risks of chemicals will now lie with industry, thus freeing up the resources of national competent authorities to focus on enforcement of the legislation.

Main objective of the proposed Regulation is to secure a high level of protection for human health and the environment, while ensuring the efficient functioning of the internal market and stimulating innovation and competitiveness in the chemical industry. Regulation aims to

increase the level of knowledge in regard to chemical substances placed on the market and to help ensure that substances are used safely at all stages in their life cycle through better information in chemical safety data sheets;
encourage substitution of the most dangerous substances; and
make industry more responsible for the substances they manufacture and use.

REACH – MAIN PROVISIONS

Scope

In general, all chemical substances above 1 tonne per annum [but some provisions apply regardless of tonnage].

Implementation

New European Chemicals Agency to be set up (to be located in Helsinki).
Competent authorities in Member States to work with the new Agency [in Ireland, the HSA].
Directly applicable Regulation - full implementation 12 years after entry into force.

Registration

All substances above 1 tonne.
Obligation on manufacturers and importers to obtain information on their substances and to use this knowledge to ensure responsible and well-informed management of the risks they pose to human health and the environment
Pre-registration of all substances within 18 months
Targeted approach to low volume substances (1-10 tonnes per year) - need only supply existing information unless they present a risk. (Ease burden on industry, particularly SME’s)
Possibility of waiving certain tests in 10-100 tonne range
Data sharing; possibility of joint registration by corsortia.

Evaluation

new Agency will be responsible for co-ordinating among the Competent Authorities, the evaluation of substances, which constitute a risk to health or the environment, and the examination of testing proposals submitted by industry at Registration.

Authorisation

Substances of very high concern will require authorisations from the Commission for any use, irrespective of tonnage.
Substances of very high concern include chemicals that cause cancer, mutations or reproductive problems, or that accumulate in the body and in the environment.
If the risks emanating from the use of such substances are adequately controlled – that is, used in tightly controlled processes with little or no chance of exposure, then authorisation will be granted.
If it is not possible to demonstrate adequate control, authorisation may still be possible if an assessment of the socio-economic importance of the substance outweighs potential risks, and if a comprehensive analysis of alternatives shows that there are no real alternatives.
Information on alternatives required in all cases.

Restrictions

This isthe safety net.
The Commission will be able to introduce restrictionson substances that needed to be managed at an EU-wide level to ensure that the risks they pose are acceptable. This will provide for the conditional use or a ban on the use of substances that pose unacceptable risk across the EU.

Preparation for implementation of REACH in Ireland

The Government agreed in July last year to the appointment of the Health and Safety Authority as the interim competent authority under REACH. This included agreement for an additional 44 staff. These are highly demanding jobs, and will be mainly for post-graduates with a number of years of experience in industry and/or regulatory experience. The first phase of recruitment of 21 is now completed. The remaining recruitment is planned to take place over the next two years.

Ireland was ahead of all EU member state partners in identifying and providing resources for the implementation and enforcement of REACH. The Health and Safety Authority has been involved in a number of the so-called REACH Implementation Projects, which has put Ireland in a position of proactively shaping the approach to implementing and enforcing REACH across the EU, and which will be invaluable to Irish industry which will have to learn the new rules very quickly.

The Health and Safety Authority has put in place a strategy to implement REACH which importantly will include setting up an information help desk for SME, and participating in an information campaign for industry in collaboration with representative bodies and government enterprise agencies.

ENDS

LA 222

Last modified: 13/12/2006

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