EU Chemicals policy: REACH

The EU Registration, Evaluation, Authorisation and Restriction of Chemicals  (REACH) entered into force on 1 June 2007. It is being implemented in stages up to 1 June 2018.

Its main objective is a high level of protection of human health and the environment, while maintaining the competitiveness and innovation of the EU chemicals industry. REACH provides a single regulatory framework for the control of chemicals, replacing the previous patchwork of controls, and ensures information on the properties of chemicals is transmitted down the supply chain , and enabling them to be safely handled.

REACH covers both "new" and "existing" substances. With a few exceptions, all chemicals produced or imported into the EU in quantities above 1 tonne per year need to be registered in a central database held by the European Chemicals Agency (ECHA) based in Helsinki.  It is important to be aware that this may include some substances not normally thought of as “chemicals” such as different forms of carbon such as Charcoal, Carbon black, and so on . The REACH helpdesk (see below) can provide information and guidance on whether REACH applies in any given situation. Chemicals deemed to be of most concern will need an authorisation. This will require industry to gain specific permission for particular uses, otherwise the chemicals will be prohibited, and removed from the market.

REACH provides the tools necessary to provide detailed information on some 30,000 substances used in the EU in quantities of one tonne or more per year, while strengthening the controls  covering the substances of most concern, including their progressive substitution with safer alternatives. This will ensure a greater awareness of the impact of chemicals, and the highest protection for European citizens.

The enforcement of REACH within the UK is being lead by the Health and Safety Executive (HSE) who are the UK’s REACH Competent Authority. The Competent Authority is responsible for ensuring effective implementation of REACH in the UK, and also works with ECHA, which oversees REACH operations across the EU. For more information on the UK REACH Competent Authority please visit their website at (www.hse.gov.uk/reach) where you can find much more information and advice on REACH, as well as links to other useful sites and sources of information. There is also a Helpdesk to provide UK businesses with technical advice and information on the implementation of REACH. The Helpdesk can be contacted by email at ukreachca@hse.gsi.gov.uk. You can also contact the Defra REACH team by email at reachteam@defra.gsi.gov.uk

Current REACH issues

Impacts of REACH Registration process on Downstream Users

With registration preparations well underway across industry, concerns have been raised by downstream users about potentially adverse impacts on their businesses arising from non-availability of substances they use after the first registration deadline of 30 November 2010, or their uses of substances not being covered by the registration dossiers that are being submitted to the European Chemicals Agency.  The Government is urging registrants to be open about their registration intentions for substances that their downstream users need, and where uses are being excluded from registration dossiers that this complies with the conditions set out in the REACH Regulation.

Substance Information Exchange Fora (SIEFs)

With the end of the pre-registration period in December 2008, the process of forming SIEFs began in January 2009 as the next stage of REACH implementation after pre-registration.

Businesses that pre-registered a substance with ECHA are automatically members of the SIEF for that substance. A SIEF is a forum for potential registrants to share data and other information on a given substance for the preparation of a single registration dossier. Each SIEF must appoint a Lead Registrant (LR) by the agreement of all the members.  The LR is responsible for the running of the SIEF, and coordinating the preparation and submission to ECHA of the joint registration dossier, as well as any proposals for additional testing of the substance. REACH places the responsibility on industry to organise and run SIEFs, and does not give national regulatory authorities or ECHA a role in the process. However, they can offer general advice and suggestions on what might constitute best practice. 

Further information and guidance on SIEFs can be found on the Defra website the ECHA website and on the UK REACH Competent Authority’s website. The Competent Authority also runs a national Helpdesk to provide information and advice on the application of REACH and its obligations. The Helpdesk can be contacted at ukreachca@hse.gsi.gov.uk , but remember that the regulatory authorities have no legal role in SIEFs, it can only offer general suggestions, and not detailed and specific advice on how to operate within a particular SIEF. That remains a  business decision for each company involved.

Animal Testing

REACH makes it mandatory to share all existing animal test data within SIEFs to avoid the need for duplicate tests. REACH has strong provisions to minimise the use of animal testing, and the numbers of animals used in tests. The UK played a leading role in getting these provisions incorporated into the REACH text.

When putting together proposals for additional testing of substances, businesses must comply with REACH requirements on the use of animal testing. REACH is clear that animal tests must only be used as a last resort, when no suitable non-animal alternative tests are available. Where animal tests are necessary, once done they may not be repeated. The preferred means of obtaining information on the properties of a substance must always be by use of non-animal test methods wherever possible. Further information and guidance can be found on the Defra web site and from the UK REACH Competent Authority’s website.

Authorisation

When they are listed in REACH Annex XIV, Authorisation applies regardless of tonnage to all substances that are category 1 and 2 carcinogens, mutagens, and reproductive toxicants (CMRs); substances that are persistent, bioaccumulative, and toxic to the environment (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances that are of an equivalent concern (where there is scientific evidence of probable serious effects, such as endocrine disruptors).  Substances with these hazardous properties are collectively known in REACH as “Substances of Very High Concern”, or SVHCs.

The aim of Authorisation is to ensure that SVHCs are properly controlled, and progressively replaced by more suitable substances or technologies, with the intention of reducing risks to human health and the environment.  Uses of substances that are subject to Authorisation will be banned unless industry can justify continued use through demonstrating either that:

  • The risks to human health and the environment are adequately controlled, or
  • The socio-economic benefits outweigh the risks.

Where there is a suitable safer alternative substance or technology available, Authorisation will lead to the hazardous substance being substituted and removed from the market.

Substances identified as meeting the REACH SVHC criteria can be nominated by EU Member States and the European Commission to be added by ECHA to the Candidate List of substances requiring Authorisation, which will eventually be placed on REACH Annex XIV (where Authorisable substances are legally listed).  Each nomination of a substance must be accompanied by a thorough scientific justification in the form of a dossier produced according to the requirements set out in REACH Annex XV.  From the Candidate List, ECHA draws up a Priority List of substances each year with a recommendation to the Commission that they are placed on Annex XIV.  The first Candidate List of substances was published in October 2008, with the first Priority List submitted to the Commission on 1 June 2009.  A second set of substances was added to the Candidate List in October 2009, and the first set of substances listed on Annex XIV is expected to be announced by the Commission early in 2010.

All applications from industry for an Authorisation must be accompanied by an analysis of possible alternatives which considers their risks and the technical and economic feasibility of substitution.  Additionally, where the analysis shows that suitable alternatives are available, a substitution plan must be included detailing the timetable for replacement.  All Authorisations are subject to a time-limited review, the length of which is determined on a case-by-case basis taking account of relevant factors, including the risk posed by the use of the substance and the availability of alternatives (or the likelihood of these being developed/available).  Authorisations may be reviewed at any time should a third party supply new information on possible substitutes to ECHA.

Restriction

Restriction is an alternative method in REACH of controlling hazardous substances that do not fully meet the REACH criteria for Authorisation.  This imposes harmonised controls on the uses of substances across the EU, up to and including a complete ban as appropriate.  As with Authorisation, Member States and the Commission may submit a proposal for a Restriction to ECHA, supported by an Annex XV dossier of scientific evidence.  Once approved, the Restriction is added to REACH Annex XVII, where all Restrictions are listed.

Guidance on the Reach Processes

Due to the complex nature of implementing REACH there are a series of guidance documents that are aimed to help all stakeholders with their preparation for fulfilling their obligations under the REACH Regulation. These documents cover detailed guidance for a range of essential REACH process as well as for some specific scientific and/or technical methods that industry or authorities need to make use of under REACH.

These documents have been developed with the participation of many stakeholders: Industry, Member States and NGOs. The objective of these documents is to facilitate the implementation of REACH by describing good practice on how to fulfil their obligations. Further information can be found at the ECHA website and at the UK REACH Competent Authority’s website.

UK Enforcement Regime for REACH

In the UK, Defra has the policy lead on REACH and developed the enforcement arrangements, acting with the Department for Business, Innovation and Skills (BIS), existing regulation enforcement authorities (HSE, EA, Local authorities), and the Devolved Administrations for Scotland, Wales and Northern Ireland.

The REACH Enforcement Regulations 2008 (SI 2008 No.2852) provide for the enforcement of REACH by;

  • Allocating responsibility for REACH to a number of enforcing authorities
  • Providing these enforcing authorities with the powers they need; requiring enforcing authorities to cooperate and share information with other bodies connected to REACH enforcement and
  • Setting the offences and penalties for contraventions of REACH requirements.

Further information on the UK Enforcement Regime for REACH and frequently asked questions can be found at the UK REACH Competent Authority’s website.

Evaluation of the EU REACH Regulation

REACH requires each EU Member State to report to the European Commission every five years, starting from 1 June 2010, on the operation of REACH in their respective territories. Within the UK, queries on REACH operation and impacts may also come from a number of sources, such as Parliament, governments, industry, and non-governmental stakeholders.

To help identify the information that is most likely to be needed to evaluate the impact of REACH in the UK, and the ways in which that information may be gathered and assessed, Defra commissioned a scoping study to examine possible indicators and baselines from which to measure them, which reported in August 2009. The study took account of the main objectives of REACH to provide a high level of protection for human health and the environment, enhancing competitiveness and innovation in industry, increased transparency of information on chemicals, development of non-animals alternative test methods, and the efficient implementation of REACH requirements.

The study drew up a detailed list of possible indicators, likely costs, what the confounding factors may be in measuring them successfully, and thus their feasibility and suitability for reporting on REACH impacts.  Defra is now considering how best to use this information in developing a system for monitoring and evaluating the operation and impact of REACH in the UK.  A copy of the scoping study is available here.

Latest REACH Implementation Updates

22 October 2010: REACH Registration preparations – impacts on Downstream Users

24 February 2010: REACH Registration preparations - minimising animal testing

See also

Page last modified: 25 October 2010
Page published: 4 December 2002