1.1 The new Regulation on the Registration, Evaluation, Authorisation and restriction of CHemicals (Regulation 1907/2006) (“REACH”), enacted by the European Parliament and Council on 30 December 2006, came into force on 1 June 2007. However, to allow for the establishment of the European Chemicals Agency (“the ECA”), which will administer REACH, the main provisions will not apply until 1 June 2008.
2 Which chemical substances will REACH apply to?
2.1 REACH will apply to all “substances” (defined as a chemical element and its compounds, whether natural or manufactured), whether they are on their own, in preparations (mixtures of two or more substances) or in articles (manufactured objects). The requirements under REACH will apply to both existing and new substances, as well as substances that are discovered in the future. The EU estimates that REACH will apply to approximately 30,000 substances in use today.
2.2 A number of substances are specifically excluded from the scope of REACH. Examples include radioactive substances, waste1, some substances that are in transit and will not undergo any treatment or processing within the EU as well as some substances which occur naturally and pose only a limited risk to human health and/or the environment.
3 Key Requirements
REACH’s main aims are to protect human health and the environment from the use of chemicals, whilst at the same time facilitating the free movement of chemicals within the EU market. REACH imposes requirements on manufacturers and importers of chemicals in four main areas.
a) REACH requires, in certain circumstances, that manufacturers and importers of “substances” register the substances they manufacture or import with the ECA. In setting registration deadlines, REACH distinguishes between “phase-in” and “non phase-in” substances.
b) In the case of phase-in substances (i.e. those substances already being manufactured or which were being placed on the EU market before the entry into force of REACH on 1 June 2007), the following three registration deadlines apply if the substance is pre-registered with the ECA before 1 December 2008.
- 1 December 2010 – substances manufactured or imported in quantities of 1000 tonnes or more, or manufactured in smaller quantities but considered to be particularly harmful to human health or the environment.
- 1 June 2013 – substances manufactured or imported in quantities of 100 tonnes or more.
- 1 June 2018 – substances manufactured or imported in quantities of 1 tonne or more.
c) Manufacturers and importers can pre-register their phase-in substances with the ECA between 1 June 2008 and 1 December 2008.
d) Pre-registration will require the registrant to submit information about itself, the name of the substance it wishes to register and the tonnage band within which the manufactured or imported substance will fall. The ECA will use this information to establish “Substance Information Exchange Forums” (“SIEFs”) where potential registrants of the same substances can work together to produce the information required for (and share the costs involved in) full registration. This will ensure that each substance is only the subject of one registration.
e) REACH will prevent the manufacture of substances in the EU, as well as the import of substances which have been manufactured outside the EU, unless those substances have been registered by the relevant deadline.
f) For non phase-in substances (i.e. those substances which have not previously been placed on the EU market) and those phase-in substances which have not been pre-registered, there are no extended registration deadlines. These substances must be registered before they are manufactured, imported or placed on the EU market. Non phase-in substances will be capable of registration from 1 June 2008 onwards.
g) For full registration, manufacturers and importers will need to submit a technical dossier (which will include, for example, information on the manufacture and safe use of the substance as well as any test results) and (for substances manufactured or imported in quantities of 10 tonnes or more) a chemical safety report (which will include, for example, a human and environmental hazard assessment).
This is a two stage process.
(a) Technical dossier evaluation – this is carried out by the ECA and involves the examination of the testing proposals set out in the registration documentation as well as a compliance check to ensure that all of the information submitted with the registration complies with the technical requirements of REACH.
(b) Substance evaluation – this will be carried out where the substance in question may pose a risk to human health and/or the environment and will involve either the ECA or the Health & Safety Executive (the UK competent authority) considering whether further information is required or whether additional testing should be carried out by the registrant.
Certain dangerous substances, deemed to be of “very high concern” will require an EU wide authorisation from the ECA before they can be either manufactured in the EU or imported into the EU market. Examples of substances of “very high concern” include substances which are carcinogenic, mutagenic or toxic. Authorisation will only be given where the risks associated with the particular substance are adequately controlled or where the benefits of using the substance outweigh the risks and there are no suitable alternatives. Manufacturers and importers seeking an authorisation will need to have investigated whether or not there are any safer alternatives to the substance in question. If safer alternatives are available, the ECA is unlikely to grant an authorisation.
REACH imposes specific restrictions on the use of certain substances. These substances cannot be manufactured in the EU, placed on the EU market or used in the EU unless the substance in question complies with the restriction2.
4 Downstream users, distributors and consumers
4.1 Any business which uses chemicals will be considered a “downstream user”. Downstream users will have the right to make their use of a particular substance known to its supplier. This information will then need to be passed up the supply chain to the registrant. The information provided by the downstream user will be reflected in the chemical safety report prepared by the registrant and submitted to the ECA as part of the registration process. The aim of this procedure is to reduce the risks associated with that downstream user’s particular use of a substance. Downstream users will be able to join SIEFs if the downstream users considers that this would be appropriate.
4.2 Downstream users will also be required to implement any recommendations made by their suppliers in order to reduce the risks associated with their use of substances. In addition, downstream users will be required to comply with any restrictions which REACH places on the use of a particular substance.
4.3 Distributors and ultimate consumers are not considered downstream users for the purposes of REACH. However, distributors have an obligation to pass information provided by downstream users up the supply chain to their suppliers. They may also be required to pass information down the supply chain to their customers relating to potential hazards associated with particular substances.
5.1 REACH has direct effect3 in the UK, although individual Member States are responsible for enforcement. The UK is required to have an enforcement regime in place by 1 December 2008. It is anticipated that a statutory instrument containing UK enforcement provisions will be drafted by the end of 2007, with a consultation to be held in early 2008. (DEFRA, together with the Welsh Assembly Government, the Scottish Executive and the Devolved Administration in Northern Ireland has already carried out a consultation to consider the enforcement powers that will be needed and the level and type of penalties required for breaches of REACH. A link to the consultation document and a summary of responses can be found by clicking here.)
5.2 Breach of one of the requirements in REACH will be a criminal offence. The UK government has considered a two tier system whereby a higher penalty will be available to the courts for a breach of an obligation which could lead to a significant health or environmental incident. A lower penalty would be available for breach of other obligations which primarily relate to the transfer of information.
6.1 REACH will place a heavy burden on companies manufacturing chemicals in the EU or importing chemicals into the EU as they, rather than the regulatory authorities, will be responsible for assessing the risks of particular substances. Downstream users and other entities involved in the supply chain will also have responsibilities under REACH.
6.2 Despite the fact that the registration deadlines are some way off, manufacturers and importers should be thinking about whether or not they will have obligations under REACH, when they will have to comply and what they will need to do.
6.3 The EU has prepared technical guidance documents to help the industry implement the requirements of REACH. All guidance documents can be found on the ECA’s website.
6.4 A link to the full text of REACH can be found by clicking here.
6.5 The Health and Safety Executive (the UK competent authority) has set up an interim helpdesk to assist businesses with general queries relating to the implementation of REACH. The HSE’s helpdesk can be contacted by telephone on 0845 408 9575, or by e-mail at firstname.lastname@example.org.