Now that the European Chemicals Agency (ECHA) has opened its doors, registration of substances falling within the EU’s Regulation on the Registration, Evaluation, Authorisation and restriction of CHemicals (Regulation 1907/2006) (REACH) can begin – a process which is likely to continue for the next 10 years.
The pre-registration of “phase-in” substances commenced on 1 June and will continue until 30 November 2008. Substances that are not pre-registered by this date will not be able to be manufactured in or imported into the EU without first being the subject of full registration.
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.
With the deadline for pre-registration of “phase-in” substances looming, this briefing note provides an introduction to the key requirements of REACH for manufacturers, importers, downstream users, distributors and consumers.
Which chemical substances does REACH apply to?
REACH applies 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 apply to both existing and new substances, as well as substances which are discovered in the future. The EU estimates that REACH applies to approximately 30,000 substances in use today.
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.
Key requirements – Manufacturers and importers
The main requirements under REACH are placed on manufacturers and importers of substances. Manufacturers are natural or legal persons (such as companies) established within the EU who produce or extract substances in the EU. Importers are natural or legal persons established within the EU who are responsible for bringing substances into the customs territory of the EU. (This means that a business based outside the EU, manufacturing a substance in a non-member state and then exporting that substance to the EU will not be obligated under REACH. The primary obligations are likely to fall on the importer of the substance.)
REACH imposes requirements in four main areas.
Pre-registration and full registration
REACH requires, in certain circumstances, that manufacturers and importers register the substances they manufacture or import with the ECHA. In setting registration deadlines, REACH distinguishes between “phase-in” and “non phase-in” substances.
“Phase-in” substances are substances which fulfil at least one of the following criteria.
1 Substances listed in the European INventory of Existing Commercial Chemical Substances (“EINECS”).
2 Substances that have been manufactured in the EU but have not been placed on the EU market since 1 June 1992.
3 Substances that qualify as so-called “no longer polymer” substances.
Those who manufacture or import phase-in substances can pre-register those substances free of charge – they have until 30 November 2008 to do this.
Pre-registration is a relatively straightforward process requiring the registrant to submit information about itself, the name of the substance it wishes to register and the tonnage band (set out in REACH) within which the manufactured or imported substance is likely to fall. The ECHA will use this information to establish “Substance Information Exchange Forums” (“SIEFs”) where potential registrants of the same substance 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.
The main advantage of pre-registration is that more generous full registration deadlines apply to pre-registered phase-in substances, meaning that businesses can continue to manufacture/import phase-in substances until the relevant registration deadline and there will be no interruption in the supply of substances to downstream users.
The more generous full registration deadlines are as follows.
1 30 November 2010 – for those 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.
2 31 May 2013 – for those substances manufactured or imported in quantities of 100 tonnes or more.
3 31 May 2018 – for those substances manufactured or imported in quantities of 1 tonne or more.
Phase-in substances which are not pre-registered will be subject to full registration from 1 December 2008, the day after the period for pre-registration ends. REACH prevents the manufacture of substances in the EU, as well as the import of substances which have been manufactured outside the EU, in quantities of one tonne or more per year unless those substances have been the subject of full registration.
To enable downstream users to establish whether or not a substance has been pre-registered, the ECHA will publish a list of pre-registered substances by 1 January 2009.
“Non phase-in” substances are those substances which do not satisfy any of the criteria for phase-in substances referred to above. These substances must be registered before they are manufactured, imported or placed on the EU market. Non phase-in substances became capable of registration on 1 June 2008.
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). Some so called “new” substances are deemed to be registered under REACH already. This is the case for substances which were notified to the relevant regulatory authority in accordance with national legislation implementing Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances. The reason for this is that the information contained in a notification is similar to that which must be included as part of the REACH registration dossier. However, only the entity which made the notification under that Directive is able to benefit from being considered registered. Other manufacturers and importers are likely to have to register.
This occurs at the time of full registration and is a two stage process.
1 Technical dossier evaluation – this is carried out by the ECHA 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.
2 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 ECHA 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 ECHA 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 ECHA 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.
Key requirements – Downstream users, distributors and consumers
Any business which uses chemicals in the course of its industrial or professional activities will be considered a “downstream user”. Downstream users who do not manufacture or import substances do not have any registration obligations, but they do have the right to make their use of a particular substance known to its supplier (and they may also join SIEFs). This information will then need to be passed up the supply chain to the registrant (ie the manufacturer or importer). Information provided by downstream users will be reflected in the chemical safety report prepared by the registrant and submitted to the ECHA 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 required to implement any recommendations made by their suppliers in order to reduce the risks associated with their use of substances and they must comply with any restrictions which REACH places on the use of a particular substance.
Distributors (ie, natural or legal persons established within the EU, including retailers, who only store and place on the market substances for third parties) 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.
REACH has direct effect3 in the UK, although individual Member States are responsible for making national rules on enforcement. The UK must have an enforcement regime in place by 1 December 2008.
DEFRA (the Department for the Environment, Food and Rural Affairs) has published draft regulations which set out the legislative framework within which the UK regulating authorities will operate. (The regulating authorities in England and Wales will be the Health and Safety Executive, the Environment Agency and local authorities. DEFRA is proposing that a Memorandum of Understanding (MoU) be put in place between the HSE and the Environment Agency to govern the working arrangements between them. DEFRA believes that sufficient arrangements already exist between central government and local authorities, meaning that local authorities do not need to be party to the MoU.)
The draft regulations contain provisions requiring manufacturers and importers to have a valid registration, provisions relating to the passing of information up and down the supply chain and provisions requiring those using substances to do so in accordance with any control measures put in place during the registration process.
Breach of one of the REACH provisions set out in the draft regulations will be a criminal offence, which will be “triable either way”, ie triable in either the Magistrates’ Court or, where the matter is more serious, in the Crown Court. DEFRA is proposing that the penalties on conviction will be a £5000 and/or three months’ imprisonment in the Magistrates’ Court or an unlimited fine and or two years’ imprisonment in the Crown Court. These maximum penalties will be the same for all offences.
REACH places a heavy burden on businesses manufacturing chemicals in or importing chemicals into the EU as they, rather than the regulatory authorities, will be responsible for assessing the risks which those substances pose. Downstream users and other organisations involved in the supply chain will also have responsibilities under REACH.
Businesses should be checking to make sure that any phase-in substances which they manufacture or import are registered by the 30 November 2008 deadline. Failure to pre-register will trigger the need to fully register the substance before further manufacturing or importing takes place, unless the substance in question is manufactured or imported in quantities of less than one tonne per year. Now is also a good time to start gathering information from downstream users about their use of substances to assist during the full registration process.
The EU has prepared technical guidance documents to help the industry implement the requirements of REACH. All guidance documents can be found on the ECHA’s website.
A link to the full text of REACH can be found by clicking here.
The Health and Safety Executive 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.