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WHAT IS REACH?

A brief guide to REACH.


REACH - a single system for the regulation of substances

REACH is the acronym used for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) 1907/2006.  This new Regulation is by far the most significant piece of chemicals legislation to be implemented in recent years and imposes new obligations on the majority of manufacturers, importers and downstream users of chemicals within the EU.

REACH came into force on June 1st 2007.  It is a regulation, not a directive, and so it is being implemented across all EU member states at the same time. REACH has also been adopted by Iceland, Liechtenstein and Norway who are not members of EU but part of the European Economic Area. 

In future there will be a single system for the regulation of most substances across the EU.  The old categories of “existing” and “new” substances are gone, and substances are now described as either phase-in or non-phase-in.   Phase-in substances are primarily those already listed in EINECS

REACH aims:·        

  • to improve the protection of human health and the environment from the risks of chemicals, and
  • enhance the competitiveness of the EU chemicals industry, by promoting its reputation as a responsible industry and encouraging innovation.

There are an estimated 100,000 substances commonly in use in the EU.  Many of these have been in use for a long time, but there is very little information available on them, particularly concerning their effect on the environment.  Over the next 11 years REACH will evaluate around 30,000 of these substances.  

REACH is based on the idea that industry itself is best placed to ensure that the chemicals it manufactures or puts on the market do not adversely affect human health or the environment.”

(Reach in Brief, European Commission Feb, 2006)

REACH places the responsibility for the control and safe use of substances firmly on the shoulders of industry.   It is up to industry to prove that their substances are safe and adequately controlled.

“NO DATA, NO MARKET”

(REACH, Regulation (EC) No 1907/2006, Art. 5)

Manufacturers and Importers (M/I) must register all substances which they manufacture, import or supply within the EU, in quantities of 1 tonne per year or more.  This applies to substances

  • on their own;
  • as intermediates;
  • in preparations (e.g. inks);
  • in articles (e.g. tyres, scented candles), where there is an intended or foreseeable release during normal use.

For phase-in substances registration deadlines are phased over a period of 11 years and are dependent on tonnage and classification.  Non-phase-in substances must be registered before they are manufactured, imported or supplied above the 1 tonne threshold. 

Registration involves preparing a Technical Dossier and Chemical Safety Report (CSR) covering information on properties, uses, hazards, exposure scenarios and risk control measures. If a substance is not registered it can not be manufactured or placed on the market within the EU, i.e. “No Data, No Market”.

Downstream Users (DU) have obligations under REACH too.   Whilst they are not required to register substances themselves, DUs may be asked to provide information on typical exposures and how they use substances to support substance registrations.  They are responsible for implementing any hazard and risk management measures identified by their suppliers, and for ensuring this information is communicated downstream.  In some instances downstream users may be required to carry out their own chemical safety assesssment and prepare their own CSR.

THE EUROPEAN CHEMICALS AGENCY

REACH is overseen by the European Chemicals Agency, ECHA, which is located in Helsinki, Finland.

ECHA is responsible for managing the REACH process at a Community level, and for maintaining a public database of safety information for all registered substances.  Whereas in the past new substance notifications where made to national bodies, registrations and notifications for all substances will now be made to ECHA.

ECHA maintains a REACH helpdesk whose primary function is to support Member State REACH Competent Authorities (MSCAs).  In turn, each Member State has a duty to provide a national helpdesk to advise industry on its obligations under REACH.

ECHA are not responsible for the enforcement of REACH.  Enforcement is the responsibility of each MSCA.

All communications with ECHA are made via the REACH-IT system which has been developed specifically to meet the needs of REACH and related regulatory requirements. 

For more information visit their website at  http://echa.europa.eu/

THE REACH PROCESS

REACH provides for the:

  • Registration - of all substances, either on their own, in preparations (e.g. inks)  or in articles (e.g. tyres) , that are manufactured, imported, or used as intermediates within the EU in volumes of 1 tonne per year or more;
  • Evaluation - of registration dossiers by the European Chemicals Agency (ECHA) and Member State Competent Authorities (MSCAs) to assess the nature of hazards and risks;
  • Authorisation - for the use of substances deemed to be of very high concern to human health or the environment, but only where safer alternatives are unavailable and/or socio-economic considerations outweigh the risks;
  • Restriction - of manufacture, import or use across the EU of substances where the risks to human health or the environment cannot be acceptably controlled.

Not all of these processes will apply to all substances.   Authorisation and restriction will be used to minimise the risks from substances of very high concern (SVHC) for human health and the environment, including those which are exempt from registration under REACH and regardless of tonnage.

ECHA and MSCAs will work together to evaluate substances and make recommendations to the Commission on SVHC and how thye should be regulated.

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COMMUNICATION THROUGH THE SUPPLY CHAIN

REACH aims to improve the quality of substance data, hazard information and risk management measures communicated throughout the supply chain. The regulation lays down principals by which information should be communicated both up and downstream, and places obligations on each actor in the supply chain. 

The provision of Safety Data Sheets (SDSs) is now covered by REACH, and the SDS Directive 91/155/EEC is repealed.   There are some changes to the format. Hazard information is promoted, and extended safety data sheets (eSDS) will include typical exposure scenarios and recommended risk management measures that should be implemented by the user. The new rules on SDSs will apply to all substances regardless of annual tonnage.

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CLASSIFICATION & LABELLING INVENTORY

REACH provides for the establishment of a ‘Classification and Labelling Inventory’ with the aim of harmonising the classification and labelling of dangerous substances within the EU.   Manufacturers and importers of the same substance are expected to reach agreement on how there substance is classified.

Manufacturers and importers of any substance that must registered or is classified as dangerous are required to submit a classification and labelling notification to ECHA by 30 November 2010.  This also applies to substances manufactured/supplied below the 1 tonne per year threshold for registration.

The inventory will be maintained by ECHA, and based upon the information provided by manufacturers/importers of substances, preparations and articles.  

This requirement of REACH is intended to dovetail with the new Classification, Labelling and Packaging Regulation (CLP) implementing the UN Globally Harmonised System (GHS) for the classification and packaging of substances and preparations.  CLP will introduce new labelling schemes and extend the Classification and Labelling Inventory to cover preparations.  

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Last Updated ( Sunday, 01 February 2009 )
 
© 2017 REACH Regulation: Registration, Evaluation, Authorization and Restriction of Chemicals: REACH Legislation