REACH - EU chemicals regime

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1 Practice note Maintained note (pdf generated on 26 March 2009) REACH - EU chemicals regime This Practice note provides a summary of the EU chemicals regime, REACH. REACH stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals. OVERVIEW OF THE REACH REGIME Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals ( (the REACH Regulation) was adopted on 18 December 2006 and came into force on 1 June Its requirements are being phased in over several years (see Timetable below). The REACH Regulation was first published in the Official Journal of the European Union on 30 December 2006 and ran to over 800 pages. The Regulation was then republished on 29 May 2007 in a different format but with the same content and now runs to less than 300 pages. The version we have linked to in this note is the May 2007 version. Please note that the May 2007 version of the REACH Regulation is not a consolidated version and so will need to be read in conjunction with any corrigenda and other amendments that have been made to the Regulation since that date. For an example of a corrigendum, see Legal update, REACH: amendment to the definition of NLP phase-in substances ( Please note also that the REACH Regulation should not be confused with Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures ( which aligns the EU regime on the classification, labelling and packaging of chemicals with the UN's Globally Harmonised System (GHS) of classification criteria and labelling requirements, and is intended to sit alongside the REACH Regulation. For further information, see Legal update, EU Regulation harmonising classification, labelling and packaging of chemicals introduced ( The REACH Regulation is directly applicable, meaning that national authorities can require the relevant parties to comply with the requirements of the REACH regime without the member states having to implement the Regulation into national law (unlike EU Directives). Having said that, the UK has adopted national regulations to enable the Health and Safety Executive (HSE) to enforce the requirements of the REACH regime in full (see Legal update, REACH enforcement regulations come into force on 1 December 2008 ( 2055)). The REACH Regulation creates a new regime for the regulation of chemicals in the EU. It is one of the most significant, and complex, pieces of environmental legislation to have emerged from the EU in recent years. The new regime has significant cost implications for manufacturers, importers and downstream users of a wide range of chemicals used in industrial, commercial and household applications (including chemicals contained in products and articles). The REACH Regulation replaces 40 existing pieces of legislation with a single regime. The previous regime (which was based primarily on Directives 67/548/EEC and 88/379/EEC) was widely criticised, in particular for: Imposing different requirements depending on whether a chemical was placed on the market before or after Placing the burden of testing the safety of chemicals on national authorities. Imposing excessive testing requirements. Resulting in gaps in important information about a chemical's effects on human health and the environment.

2 Environment 2 The new regime applies to all chemicals manufactured or marketed in the EU, including chemicals registered on the European Inventory of Existing Commercial Chemical Substances, and any new chemicals manufactured for the first time. It applies to substances: On their own. In preparations. In articles. The new regime consists of four main limbs: Registration. Evaluation. Authorisation. Restrictions. The REACH Regulation imposes obligations on three main types of persons (referred to in the REACH Regulation as "actors"): Manufacturers. Importers. Downstream users. For ease of reference, manufacturers and importers are referred to collectively in this note as "suppliers". The underlying objective of the REACH regime is to ensure that chemicals are used in a way that minimises unacceptable risks to human health and the wider environment. The communication of information about the uses and hazards associated with chemicals up and down the supply chain is crucial to the operation of the new regime. Under the REACH regime, the burden of proof for demonstrating that the use of a chemical does not pose unacceptable risks to human health or the environment will be transferred from the relevant national authorities to industry. The chemicals industry provides raw materials for the manufacture of a vast range of products (such as plastics, adhesives and sealants, textiles, paints, printing inks, food packaging, cleaning products and appliances such as TVs, to name but a few). The effects on the manufacturers, importers and downstream users will therefore be considerable. The industry has maintained throughout that it supports the introduction of a new chemicals regime, particularly as the existing regime has not provided the necessary confidence to either industry or consumers. On the whole, the chemicals industry considers that the final text of the REACH Regulation strikes a reasonable balance between protecting human health and the environment and ensuring industry competitiveness, but acknowledges that the new regime will have a substantial impact on businesses. NGOs on the other hand are concerned that the REACH regime will still allow many chemicals they consider to be dangerous (such as carcinogens and endocrine disruptors) to continue to be used. REGISTRATION Suppliers (manufacturers and importers) of substances (including substances in preparations and articles) in quantities greater than one tonne per year must register those substances with the European Chemicals Agency ( ) (ECHA). It is estimated that there are currently around 30,000 substances in the EU market in volumes above one tonne. Registration involves the submission of a dossier containing all relevant information about each individual use of a substance. Where a substance is manufactured or imported in excess of 10 tonnes per year, the registration dossier must include a chemical safety report. The REACH Regulation sets out rules for registration of a substance that is manufactured or imported by several different companies (the concept of "one substance one registration"). There are a number of exemptions to the requirement to register (for example, in respect of intermediates and substances used in research and development). Different deadlines apply for registration, depending on whether the substance is new or existing (referred to as "phasein substances"), its volume and hazardousness. For further information, see Timetable below. In order to benefit from the longer deadlines for full registration, suppliers of phase-in substances needed to have pre-registered those substances with ECHA by 1 December The longer deadlines will run from 2010 to 2018 depending on the tonnage and type of substance. For further information, see Legal update, REACH: What next, as pre-registration deadline passes? ( If more than one person has submitted information as part of the pre-registration or registration of the same substance, then there is an obligation to participate in a Substance Information Exchange Forum (SIEF), which may in some cases require par-

3 Environment 3 ties to share potentially commercially sensitive information. For further information on SIEFs, see: ECHA: Guidance Fact Sheet: Data Sharing ( pdf). Legal update, REACH guidance on SIEFs published ( Downstream users of substances are encouraged to provide their suppliers with information about how they and their customers use the substance so that the relevant information can be included in the supplier's registration dossier when this is submitted to ECHA. Downstream users will be required to produce their own dossier and risk assessments, and register the relevant information with ECHA, if the necessary information has not been covered in a supplier's registration dossier. In addition, downstream users will be required to apply any risk management measures identified by the supplier. Failure to register will mean the substance (whether on its own, in preparations or in articles) cannot be manufactured, imported or put on the EU market. It goes without saying that this could have significant, and costly, implications for the entire supply chain. EVALUATION Evaluation is the process by which ECHA and the relevant national authorities decide whether further testing and information about a substance is needed. The relevant national authority in the UK is the HSE. This stage of the process also allows ECHA and the national authorities to decide whether the substance in question requires an authorisation or whether restrictions should be imposed. AUTHORISATION The manufacture, importation or use of a substance may require an authorisation. It is expected that authorisations will be required for substances which are of very high concern (SVHCs). These are divided into four broad categories, namely substances that: Are carcinogenic, mutagenic or toxic to reproduction (CMRs). Are persistent, bio-accumulative and toxic (PBTs). Are very persistent and very bio-accumulative (vpvbs). Give rise to similar concerns as CMRs, PBTs and vpvbs (such as endocrine disruptors). Before applying for an authorisation, a supplier will need to assess whether a suitable substitute for the substance in question is available. If there is a suitable substitute, the supplier will be required to submit a substitution plan. If there is no suitable substitute, he will have to inform ECHA of any research and development activities. Certain CMRs: Authorisation will only be granted if the supplier can show that the risks from the relevant use of the substance can be adequately controlled. Other CMRs: If adequate control is not possible, an authorisation will only be granted if no safer alternative exists and if the TIMETABLE The requirements in the REACH Regulation are being phased in gradually: 1 June 2007 REACH Regulation enters into force. 1 June 2008 ECHA becomes operational. 1 June - 1 December 2008 Pre-registration of phase-in substances. 30 November 2010 Deadline for registration of: Substances of 1,000 tonnes or more per year. CMRs of 1 tonne or more per year. Substances of 100 tonnes or more per year that are classified as very toxic to aquatic environment. 31 May 2013 Deadline for registration of substances of 100 tonnes or more per year. 31 May 2018 Deadline for registration of substances of 1 tonne or more per year.

4 Environment 4 FURTHER INFORMATION For further information on the REACH regime, see the following materials. PLC materials Article, Chemicals: regulation extends its REACH ( Article, REACH - basic principles and practical issues ( Article, The REACH of EU chemical rules ( Article, Product liability: the REACH regime's impact ( Article, Impact of REACH on downstream users ( We also produce a number of Legal updates on the latest developments relevant to the REACH regime. To search these, please click on the topic called Chemicals and other hazardous substances ( on the PLC Environment homepage and select the tab called "Legal updates". External websites European Commission website: REACH ( ECHA website ( HSE website: REACH ( This website includes a number of case studies ( reach/casestudies/index.htm) and a helpdesk ( Department for Environment, Food and Rural Affairs website: Chemicals ( Chemical Business Association website ( Chemical Industries Association website ( REACHReady website ( This is a company set up by the Chemical Industries Association to help industry and businesses in the UK understand and comply with the REACH regime. socio-economic benefits of the use outweigh the risks to human health and the environment. PBTs and vpvbs: Authorisation will only be granted if no suitable substitute is available and if the socio-economic benefits outweigh the risks to human health and the environment. The European Commission expects that authorisation will be required in respect of approximately 1,500 substances. For further information on the authorisation process, see Legal update, REACH: public consultation on inclusion of substances of very high concern in the authorisation list (www. practicallaw.com/ ). RESTRICTION The manufacture, importation or use of certain substances may be restricted or banned (for example, asbestos).

5 Environment 5

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