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REACH Regulations for Manufacturers & Importers of Substances

REACH is a new EU regulation which came into force across the UK in June 07, and has a requirement for manufacturers or importers of substances to register with a central European Chemicals Agency (ECHA).

 

Those who do not register their substances will no longer be able to manufacture or supply them.

 

REACH is the Registration, Evaluation, Authorisation & Restriction of Chemicals, and aims to replace a number of European directives and regulations with a single system.

 

REACH aims to:

 

- protect health & the environment

-  make manufacturers & importers responsible for the risks

-  allow free movement of substances on the EU market

-  enhance innovation & competitiveness

-  promote alternative methods for assessing hazardous substances

 

Those who are aware of their responsibilities and opportunities under REACH will have a business advantage over those who are unaware and miss key deadlines.

 


REACH - SCOPE & EXEMPTIONS

 

 

REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more. It generally applies to all individual chemical substances on their own, in preparations or in articles (if the substance is intended to be released during normal and reasonably foreseeable conditions of use from an article). Some substances are specifically excluded include:

 

-  Radioactive substances
-  Substances under customs supervision
-  The transport of substances
-  Non-isolated intermediates
-  Waste
-  Some naturally occurring low-hazard substances

 

Some substances, covered by more specific legislation, have tailored provisions, including:

 

-  Human & veterinary medicines
-  Food & foodstuff additives
-  Plant protection products & biocides

Other substances have tailored provisions within the REACH legislation, as long they are used in specified conditions:

-  Isolated intermediates
-  Substances used for research & development

 

The main difference between REACH and the previous regime for regulating chemicals is that it treats existing substances on an even footing with new substances, in terms of data requirements. There are potentially around 30,000 substances on the market today which REACH will require information to be provided on in the next several years, if they are to remain on the market.

 


 

WHAT MANFACTURERS & IMPORTERS OF SUBSTANCES NEED TO DO

 

The crucial REACH milestone of 2008 is the one-off pre-registration period for existing substances, which runs from 1st June - 30th November 08.

 

Manufacturers & importers (into the EU) of substances which come under the scope of REACH must pre-register with the European Chemicals Agency within this period if they wish to continue the marketing and use of those substances after 1st December 08.

 

Pre-registration is free and requires very little technical information - it is a declaration of intent to submit a full registration dossier at a later date.

 

Following the pre-registration period, all pre-registrants of a particular substance in the EU will be put in contact with one another to pool their resources and submit a single full registration for that substance by the appropriate deadline.

 

However, if the pre-registration deadline is missed, full registration is required immediately if the substance is to remain on the market.

 

Users of chemicals do not need to pre-register or register, but they do need to ensure that the manufacturer or importer further up the supply chain intends to do so, and is aware of the uses to which the substance is being put.  Otherwise the supply of a substance that is critical to the business may dry up, or that particular use prohibited.

 


 

FURTHER INFORMATION

 

For further information on what businesses need to do, contact the UK Competent Authority helpdesk on Tel: 0845 408 9575 Email: ukreachca@hse.gsi.gov.uk

 

 

Alternatively please visit the Health & Safety Executive (HSE) website's REACH mini-site at: www.hse.gov.uk/reach - which includes an outline of REACH, the role of businesses, what individuals need to do, when to comply, case studies, frequently asked questions, a glossary, events and sources of further information.

 

 

For further information on the EU regulation please visit: http://echa.europa.eu/reach_en.html