ARCHIVE: 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

The UK REACH Competent Authority Steering Committee

The Competent Authority is overseen by a Steering Committee which comprises representatives of the four responsible authorities for REACH in the UK (i.e. the Secretary of State for the Environment, Food, and Rural Affairs, Scottish Government ministers, Welsh Assembly Government ministers, and Northern Ireland ministers), and other Government Departments with a significant interest in the implementation of REACH.  The Committee agrees the policies that the UK representatives put forward at EU-level REACH meetings, and also advises, supports, and holds to account the UK REACH Competent Authority as it delivers its tasks.  The Committee operates to Terms of Reference (PDF 80 KB), and copies of its meeting minutes are publicly available.

Minutes of Meetings

For earlier minutes, please contact the Defra REACH team by email at reachteam@defra.gsi.gov.uk

Current REACH issues

Registration: Looking forward to 2013 and beyond

The first phase-in registration deadline of 1 December 2010 has passed, and is generally being seen as a success both for industry and for ECHA.  A total of 24,675 dossiers were submitted by the deadline, covering 3,400 phase-in substances.  These figures were in line with Commission and ECHA estimates, although the number of substances registered was lower than anticipated.  UK industry came in second overall in the EU, with 2,430 dossiers (or 12% of the total).  Germany led with 4,727 dossiers (23% of the total).

For those companies that submitted registrations close to or on the deadline date of 30 November, receipt of an electronic confirmation from ECHA of a “successful submission” means that you have met the requirements of the deadline.  You should have received an invoice from ECHA which is payable within 30 days.  Your registration will be checked by ECHA, and if all is well, you will receive your registration number in due course.  If the registration is incomplete, ECHA will notify you of that and give you a deadline by which it should be rectified – but you can still continue manufacturing or importing while this happens.  However, if you do not meet the deadline for rectifying your registration, it will fail, and you will have to stop manufacturing or importing until you have submitted a successful registration.

For successful registrants, the focus should now be on communicating updates to Safety Data Sheets (SDSs) in your supply chains.  This includes extending them by adding an annex with exposure scenarios, together with any new information on the properties of the substances coming out of the registrations under the relevant SDS headings.  SDSs issued after 1 December 2010 must conform to the new revised format of REACH Annex II, and existing SDSs must be revised into the new format when updates are issued.  An option might be to use the services of a dedicated SDS delivery system, which are now becoming available.  More information on SDSs is available on the UK REACH Competent Authority website.

Conclusions from the first registration are emerging that companies should be aware of as they prepare for the next registration deadline of 1 June 2013.  Good supply chain communication is vital between suppliers and downstream users to ensure all the relevant information for registration is gathered.  Don’t wait for someone else to take charge if nothing seems to be happening – be proactive and be prepared to make the first move; time wasted early on is very hard to make up later.  Be alert to what your Lead Registrant is, or is not, doing – and vote against them if you think they are only out to make a profit from the process (some consultants are acting very quickly to set themselves up as Lead Registrants), if they are acting without the consent of the other SIEF members, or if you are dissatisfied with their nomination to the role for any other reason.  Such things need to really be resolved by April 2011 so that no time is wasted getting the registration dossier prepared – even if you have to become the Lead registrant yourself.  You cannot afford to do nothing; it costs money, but that will pay back over the next couple of years.

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.

In the run-up to the next registration deadline of 1 June 2013, registrants should take care to avoid some of the problems faced by SIEFs during the first registration exercise.  These include

  • ensuring that there is good functioning leadership early on to prevent attempts to run SIEFs for commercial benefit,
  • ensuring that good communications are established early on – an option might be to use the services of an online hub provider.
  • discuss substance sameness early on, so that work on preparing the joint dossier can go ahead in plenty of time,
  • allow plenty of time for compiling hazard data and building the IUCLID file,
  • allow plenty of time for the chemical safety report, which uses hazard data, gathering use and exposure information, assessing the risks, and involving downstream users early on if exposure scenarios are needed,

making sure data sharing costs are fair, transparent, and non-discriminatory – only pay for the data your company needs (based on tonnage or type of registration) and be clear what you are getting for your money.  Included in this is participation in any communications platform that the Lead Registrant is using.

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 Candidate List of substances was first published in October 2008, with more substances added usually twice a year.  The first set of six Annex XIV authorisable substances was published on 18 February 2011, and will be added to on a regular ongoing basis.  Use of all six will be banned unless covered by an authorisation after their “sunset” dates, which range from 2014 to 2015.  The list of authorisable substances can be found on the ECHA website, together with their sunset dates and latest application dates.

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.

Guidance on how to apply for an authorisation is published on the ECHA website, and information is also available on the UK REACH Competent Authority website.  Companies wishing to apply for an authorisation are strongly advised to begin work on their applications as soon as possible, to meet the corresponding latest application date for submission to ECHA.  Companies are also reminded that the current standard authorisation application fee is €50,000 per substance, with reductions available for SMEs (see the Commission Fees and Charges Regulation (EC) No. 340/2008 for full details).

Evaluation

Now that the first registration deadline is gone, the evaluation element of REACH starts to work.  There are two parts to evaluation – dossier evaluation, where testing proposals are assessed and registration dossiers are checked for compliance, and substance evaluation, where substances considered to be of concern may be further examined by Member State Competent Authorities.  Substance evaluation will begin in earnest in 2012, but dossier evaluation is starting now.

ECHA has primary responsibility for dossier evaluation, and the main task at this stage is to assess whether further testing proposals put forward as part of the registration dossiers are necessary and should go ahead.  This is especially the case where animal tests have been proposed, since REACH strongly discourages animal tests (except as a last resort) in favour of suitable non-animal alternative tests where available.  ECHA can come to one of four possible decisions – approve the test as proposed; approve it with certain modifications; approve it with additional tests to be done; or reject the test proposal.  ECHA can also request the companies in a joint registration to agree who should carry the test out, and if agreement is not forthcoming after 90 days then order one of them to do it.

ECHA also conducts compliance checks on registration dossiers that have been submitted, to see whether the information provided meets the requirements set out in REACH.  ECHA is required to check a minimum of 5% of dossiers for each tonnage band, selected at random.

Once ECHA issues a draft decision following testing proposal examination or dossier compliance check, the registrant has 30 days to comment, after which Member States may also comment on the draft decision and any registrant comments within a further 30 days.  ECHA may amends the draft decision in light of the registrant’s comments and adopt a final decision (which is appealable by the registrant if necessary).  Where amendments are put forward by Member States, then ECHA must put the amended draft decision to the Member State Committee for a final decision within 60 days.  If there is not a unanimous decision by the Committee, then it goes to the Commission for resolution through the comitology procedure.

Companies that registered by the first deadline of 1 December 2010 should therefore be prepared to respond to draft decisions they may receive from ECHA within the 30 days allowed.  For joint registrants, they should also be prepared to agree who should carry out any testing that has been proposed and approved by ECHA, otherwise ECHA will designate one of them to do it which cannot be challenged.  It is recommended that sharing of the costs of testing is also agreed between registrants – any disputes will have to be resolved through the national courts, which will be lengthy and create additional costs.

There is further information on evaluation available on the ECHA website.

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.

Charges for companies wrongly registering as SMEs

From 1 December 2010, ECHA will be charging an administrative charge to companies that have wrongly registered as being SMEs, and thus are not entitled to claim the reduced fees or waivers applying to SMEs.  In addition, companies so found to have mis-registered their size will also have to pay the difference between the SME fee they have paid and the fee that should properly apply to them.

The administrative charges are as follows:

Large (non-SME) €20,700
Medium  €14,500
Small €8,300
Micro (fee waivers only) €2,070

When defining company size, ownership, voting rights, and relationships with other companies are important.  Only Representatives must indicate the size of the company they represent, and not their own size.

If a company realises that it has mis-identified its size before its registration number comes through, then there is a chance to rectify the error with ECHA and avoid the charge.  This is not possible once the registration number has been issued.  More details on these charges can be found on the ECHA 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.

See also

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