Environmental Protection: Chemicals
EU chemicals policy - REACH
Questions and answers: Implementation and preparatory activities - general information
How is the REACH legislation organised?
The REACH legislative text is organised into fifteen Titles. The first eight Titles refer to the registration, evaluation, authorisation and restriction processes. The remaining seven Titles detail the administrative elements of REACH, such as setting up a European Chemicals Agency, confidentiality of data, and enforcement issues. A number of Annexes detail the technical obligations. The text and Annexes will be supplemented by Technical Guidance Documents.
How will the REACH process work?
In brief, manufacturers or importers of all substances (within scope) manufactured in, or imported into, the EU in quantities of 1 tonne or more per year will need to submit a registration to the European Chemicals Agency (the Agency). For existing substances (substances that were in use before 1981 – also known as phase-in substances) deadlines apply largely on the basis of tonnage. The Agency will manage a database which will contain the registration dossiers and other information generated by REACH and co-ordinate the implementation of REACH.
Once a substance is registered, the Agency will perform a “completeness” check of the registration dossier. For a minimum of 5% of dossiers the Agency will perform an evaluation of the quality of the registration dossier. All proposals for additional testing will be evaluated. The Agency, in conjunction with Competent Authorities located in each Member State, may perform substance evaluations (as opposed to evaluations of dossiers) if the substance is considered to be of potential concern. For a substance evaluation, Member States and the Commission agree on an annual list of substances for in-depth assessment. National Competent Authorities and the Agency work together to carry out the substance evaluations, which may lead to new control measures, or no further action.
A sub-set of substances identified as being of very high concern to human health or the environment will be subject to authorisation. This means that the substance will be banned unless a company can justify its continued use. In addition, the restriction process allows EU-wide control of substances identified as causing a risk to human health or the environment.
Which substances are within the scope of REACH?
Substances manufactured in, or imported into, the EU will be subject to REACH, unless they are exempt. The term “substance” refers to all chemicals, including metals. REACH will apply to substances in preparations, as well as certain substances contained in articles. Some obligations (i.e. those relating to Safety Data Sheets) also apply to preparations themselves.
Which substances are exempt from REACH?
A number of substances will be exempt from various stages of the REACH process because the risk is expected to be low, or registration would be a disproportionate requirement, or because they are already controlled through another regulatory regime. The precise definitions and conditions for each exemption are detailed in the legislation, in particular Article 2 and Annexes IV and V. An exemption will generally apply to only some of the REACH procedures, e.g. some exemptions apply to registration but not to the authorisation process.
The REACH Regulation provides for exemptions or reduced registration requirements to be granted for:
In addition, certain exemptions may apply to substances covered under existing European Community legislation, for example:
Why are metal ores exempted from registration?
Annex V of the REACH Regulation says that naturally occurring minerals, ores and ore concentrates are exempt from the requirements of registration and evaluation. It was considered that putting these through the REACH process would be inappropriate or unnecessary and that the exemption would not adversely affect the aims of REACH. However, once they are chemically modified, e.g. by refining into metals, they will be subject to registration and evaluation.
Why are metals not exempt?
There are technical limitations in assessing the risks to human health and the environment from exposure to certain metals and alloys. On the other hand, many metals such as lead, mercury or cadmium are already known to be hazardous and are currently the subject of restrictions on their use. The UK Government is working with other Member States and industry to develop suitable risk assessment and management methodologies.
Metals are regulated under the existing chemicals regulations, so it is right that they should continue to be regulated in this way through REACH. To exempt them now would leave a regulatory loophole.
For the purpose of REACH, alloys are considered “preparations” and do not, therefore, require registration although the constituent metals will.
What is the timeline for implementing REACH?
From 1 June 2008, new substances within the scope of REACH that are manufactured in, or imported into, the EU for the first time (‘non phase-in’ substances) will need to be registered with the Agency. Before that, the current system of notification of new substances will apply. All other relevant ‘phase-in’ substances (broadly speaking what are currently known as “existing” substances) must be pre-registered by manufacturers and importers. There is a six-month pre-registration period between 1 June and 1 December 2008 for pre-registration of ‘phase-in’ substances. This will facilitate the operation of ‘One Substance, One Registration’.
The actual registration of ‘phase-in’ substances will be organised according to three phase-in periods spanning 11 years. Registration of substances in articles will follow the same timelines.
The three phase-in periods for registration are set mainly according the quantity of a substance that a company manufactures in, or imports into, the EU market per year. However, substances known to be dangerous are prioritised. The deadlines are as follows:
Who does REACH apply to?
Any company producing, importing, using or placing a substance, preparation or article on the EU market will be responsible for ensuring that it is in compliance with REACH. The legislation therefore covers EUmanufacturers, chemical suppliers, distributors and downstream users, as well as EU enterprises importing products to the European Community market.
A non-EU manufacturer will have the option of appointing an Only Representative to meet the registration requirements of REACH on its behalf for all its EU importers of a substance. If this option is not taken, each importer will have to comply with REACH independently (OSOR and data sharing requirements notwithstanding). Similarly, a group of companies in a Substance Information Exchange Forum may appoint a leader, or a third party, to organise and co-ordinate the registration process. A manufacturer, importer, or downstream user can use representatives when participating in a Substance Information Exchange Forum. The purpose of this is to balance the benefits of One Substance, One Registration with commercial confidentiality.
How will REACH relate to other European or Member State legislation?
REACH will apply harmonised standards to production and products on the EU market in order to ensure protection of human health and the environment from chemical risks. It is therefore based on Article 95 of the European Community (EC) Treaty which relates to the free movement of goods on the internal market. This is also why the REACH legislation is in the form of a Regulation that applies directly in all Member States rather than a Directive that must be transposed into national legislation.However, supporting legislation will be needed in the UK to implement REACH in relation to enforcement and penalties. This is in the process of being prepared, and must be in place by 1 December 2008.
Other EU legislation relating to the protection of human health and the environment is often based on Articles 175 (environment), 138 (occupational), or 153 (consumer) of the EC Treaty. Many chemical risks are also controlled through these other pieces of legislation, so it is important that REACH takes account of existing systems and control measures. In addition to a number of exemptions, information generated through other EU and international instruments can be included in registration dossiers and taken into account during the evaluation, authorisation, and restriction procedures.
REACH will require companies to perform Chemical Safety Assessments that inter-link with obligations under other legislation. Therefore, a substance risk assessment completed under occupational or environmental legislation can serve as a reference for ensuring compliance with a REACH Chemical Safety Report. In many cases, the data generated by REACH will serve to ensure that sufficient risk assessment data is available for companies to meet duties under existing legislation (e.g. risk assessments under the Chemical Agents Directive – implemented as the Control of Substances Hazardous to Health (COSHH) Regulations in the UK).
REACH is a complicated piece of legislation. What help will be given to stakeholders in implementing its requirements?
To promote efficient regulatory implementation the European Commission is undertaking seven REACH Implementation Projects (RIPs):
Further information on the RIPs is available via the European Chemicals Bureau website, and the final guidance documents are available on the European Chemicals Agency website.
Within the UK, the Health & Safety Executive (HSE) has been appointed by the Government to be the Competent Authority. The Competent Authority has set up a national Helpdesk to provide industry and downstream users with advice on applying REACH. The HSE will also enforce compliance with REACH (along with other established enforcement bodies, such as the Environment Agency, and Local Authority Trading Standards Officers), evaluate priority substances alongside the European Chemicals Agency, and identify substances requiring authorisation decisions. The Competent Authority provides UK representatives for various EU REACH committees.
What other preparatory activities are being conducted?
A number of programmes have been completed or launched, and others anticipated, to facilitate the development and implementation of REACH. These include:
How can companies prepare for REACH?
How a company prepares for REACH will depend on its commercial activities. Examples of preparatory activities that companies are currently taking include:
Many trade associations are already generating information and advice to help their members. Some trade associations will also provide advice to non-members.
How is the Government preparing for REACH implementation?
The Government is preparing for REACH implementation through a number of actions:
Page published: 4 January 2008