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Reach: an introduction

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  Reach: an introduction
 
     

This is one of three articles on REACH. The others are written for manufacturers of chemicals and business users of chemicals. If you manufacture chemicals, we recommend you read the first article mentioned above. If you are a business, you probably use chemicals without realising.

 

These articles are useful reading for all manufacturers of chemicals of any sort and all small business owners and managers.

 

What is REACH?

REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of chemicals. It took effect from 1st June 2007 and replaces a number of European Directives and Regulations with a single system.

 

Its aims are to:

  • provide a high level of protection of human health and the environment from the use of chemicals.
  • to make the people who place chemicals on the market responsible for understanding and managing the risks associated with their use.
  • to enhance innovation in and the competitiveness of the EU chemicals industry.

Register to comply

Under the REACH regulations, manufacturers and importers of substances must register them with a central European Chemicals Agency (ECHA).  If you do not register you will no longer be able to manufacture or supply those chemicals legally!

 

Which chemicals does it apply to?

REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more. Generally, it applies to all individual chemical substances. Some substances are specifically excluded:

  • 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 and veterinary medicines
  • Food and foodstuff additives
  • Plant protection products and biocides

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

Pre-registration

It is estimated that there are around 30,000 substances on the European Market in quantities of 1 tonne or more per year.   It would certainly be a difficult task to register all these at once.  So to allow the system to cope, there will be three phases of registration, spread over eleven years. By pre-registering the chemicals you use, the system of registration will be easier as it is spread over a longer period of time. It is not a legal requirement to pre-register.

 

Registration

You must register the chemicals properly according to the time line set out below.

 

Authorisation

In order to use or put on the market, chemicals that are of "very high concern" you must apply for an authorisation. The European Chemicals Agency (ECHA) in Helsinki will publish a list containing substances to be considered for the authorisation process by 1 June 2009. A company wishing to market or use such a substance must submit an application to the ECHA f demonstrating that the risks are adequately controlled or that the socio-economic benefits of their use outweigh the risks.  Applicants must also analyse whether there are safer suitable alternatives or technologies.

 

Substances of Very High Concern

Some substances may be carcinogenic, or may gradually build up in animals (bioaccumulative). These are 'substances of high concern'. This category also includes substances demonstrated to be of equivalent concern, such as ¡°endocrine disruptors¡±. One of the aims of REACH is to control the use of such substances via authorisation and encourage businesses to substitute these substances for safer ones.

 

How does it affect me?

Almost every business in the UK will have a new responsibility under REACH. There are three main types of REACH duty holder:

 

Manufacturers/Importers

Businesses that manufacture or import (from outside the EU) 1 tonne or more of any given substance each year are responsible for registering a dossier of information about that substance with the European Chemicals Agency. Because substances in articles also count (if these substances are intended to be released), it's possible that some manufacturers/importers of such articles will be registrants.

 

The registrant directs downstream users in the appropriate risk management measures for any particular use of the substance and responds to other players on other aspects of REACH. Registrants should consider pre-registration of substances between 1st June 2008 and 30th November 2008.

 

Business users

Business users include any business using chemicals, which probably includes most businesses in some way. Companies that use chemicals have a duty to use them in a safe way, and according to the information on risk management measures that should be passed down the supply chain. There is also an opportunity to pass information about use back to registrants so that this can be taken account of when assessing the risks of chemical used.
Downstream users may need to supply risk assessment and risk management measures to the European Chemicals Agency if they don¡¯t want their supplier to know about how they use the chemicals. Some users may also be importers and have a duty to register.

Other actors in the supply chain (i.e. distributors, suppliers)

Businesses that sell chemicals have specific duties to pass information down to their customers, and also to pass information back to their own suppliers when customers ask them to do so. For more information look at the overview for actors in REACH on the ECHA page.

 

When do I register?

When you register depends on the type of chemicals you use.

 

 

 

Date

 

 

Action

 

 

1 June 2008

 

Pre-registration for existing (¡®phase-in¡¯) substances starts


Registration for new (¡®non phase-in¡¯) substances starts

 

 

30 November 2008

 

 

Pre-registration for ¡®phase-in¡¯ substances ends

 

1 December 2008

 

 

Registration for existing substances (that have not been pre-registered) starts

 

 

1 January 2009

 

 

List of pre-registered substances published and SIEFs are formed

 

 

1 June 2009

 

First recommendation of priority substances to be considered for authorisation published by ECHA

 

 

1 December 2010: Phase 1

 

 

The following pre-registered ¡®phase-in¡¯ substances should have been registered when supplied at:

  • ¡Ý 1000 tonnes per annum (tpa) or;
  • ¡Ý 100 tpa and classified under CHIP as very toxic to aquatic organisms or;
  • ¡Ý 1 tpa and classified under CHIP as Cat 1 or 2 carcinogens, mutagens or reproductive toxicants

 

 

1 June 2013: Phase 2

 

 

Deadline for registration of substances supplied at ¡Ý 100 tpa

 

1 June 2018: Phase 3

 

Deadline for registration of substances supplied at ¡Ý 1 tpa

 

 

 

Relevant Net Lawman documents:

 

Relevant Net Lawman articles:

 


If by chance you find some error of law or fact in any Net Lawman information page, do please tell us. We should also welcome your suggestions for new subjects for information pages. These notes:

  • do not provide a complete or authoritative statement of the law.
  • do not constitute legal advice by Net Lawman.
  • do not create a contractual relationship.
  • do not form part of any other advice, whether paid or free.
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