February 26 2007
REACH Policy Objectives
Registration by Manufacturers or Importers
Content of Registrations
Data and Cost Sharing
Substances in Articles
Authorization of Substances of Very High Concern
Information in the Supply Chain
Classification and Labelling Inventory
In December 2006 agreement was reached on the new EU chemicals regulatory regime. Set out in the EC Regulation Concerning the Registration, Evaluation and Authorization of Chemicals (REACH) (1907/2006), it comprises 141 articles and 17 annexes, covering a total of 849 pages. It is mammoth in its concept, in its detailed rules and in the burden imposed on parties in the supply chain that must comply. It is expected to affect the placing of around 30,000 chemical substances on the EU market, imposing major administrative responsibilities and costs on EU producers and importers of these substances. Downstream users, including producers of finished articles incorporating these substances, will also be significantly affected.
This update summarizes the key elements of REACH; however, a detailed examination is essential to ensure that the necessary steps are taken to comply with the various requirements within the relevant deadlines and to ensure ongoing compliance. Manufacturers and importers cannot place a substance on the EU market unless it is registered in a timely fashion and, if necessary, has secured authorization (the 'no data, no market' principle). This prohibition also concerns the use of substances by EU downstream users and by non-EU producers that wish to export products containing a given substance to the European Union. Every party in the supply chain must be aware of how REACH can affect its operations and must ensure that all requirements are fulfilled at all stages of the supply chain. REACH will enter into force on June 1 2007, so suppliers and users must actively prepare themselves.
The central policy objective is to transfer responsibility for the generation of data on the safety of chemical substances from governmental authorities to the parties placing the substances on the EU market. This objective covers substances used on their own, used in preparations or incorporated into finished articles. 'Placing on the market' means supplying or making available to a third party, whether for payment or at no cost, including importation into the European Union. Another key objective is transparency, to be achieved initially by requiring registration with the newly established European Chemicals Agency of all chemical substances placed on the market. Registration will entail the submission of detailed information about the substance, its uses, related risks and guidance on safe use. Transparency also entails making certain (non-confidential) information available throughout the supply chain as well as to final consumers (eg, concerning certain dangerous substances ('substances of very high concern') in the finished products they purchase).
The registration of substances manufactured or imported in quantities of one tonne or more - whether on their own, in preparations or finished articles or as intermediates - is the fundamental requirement of REACH. The specific information to be submitted for registration and when the registration must be made depend on the hazard posed by the substance in question and the volume manufactured or imported. REACH provides for transitional registration periods for phase-in substances (mainly substances listed in the European Inventory of Existing Commercial Chemical Substances) according to the volumes manufactured or imported, but only if the substances in question are pre-registered between June 1 2008 and December 1 2008.
Downstream users of a substance that has not been pre-registered may ask the agency to extend the pre-registration period by six months to give them time to find a supplier or to pre-register the substance themselves. A 'downstream user' is defined as any EU natural or legal entity that uses a substance in the course of its industrial or commercial activities, excluding distributors and consumers. The agency must publish a list of pre-registered substances by January 1 2009 and downstream users will be able to see from the list whether the substance of concern has been pre-registered. If properly pre-registered, the transitional deadlines for the registration of phase-in substances are as follows:
Substances that must be registered but that miss the pre-registration period cannot benefit from these transitional deadlines and instead become subject to the 'no registration, no market' rule - that is, the party is barred from placing the substance on the EU market pending proper registration.
The data required for pre-registration is not extensive (ie, name of substance, including Chemicals Abstracts Service number and European Inventory of Existing Commercial Chemical Substances number; contact body; foreseen deadline for registration and tonnage band). However, many companies will have to carry out substantial work to identify all their substances (ie, substances on their own, in preparations and in finished products) that are subject to the REACH registration requirements and to prepare the files for pre-registration. Each substance needs to be individually pre-registered.
All registrations must include, at minimum, the technical dossier. The technical dossier contains:
Study summaries (or robust study summaries in specified cases) must also be provided concerning information derived from testing required under Annexes VII to XI. The level of testing required varies according to the tonnages manufactured or imported (eg, the most extensive testing applies for substances manufactured or imported in quantities of more than 1,000 tonnes a year). If further testing is needed, proposals must be submitted first.
In addition, chemical safety assessments and a chemical safety report are required for substances manufactured or imported in quantities of more than 10 tonnes a year. The chemical safety report sets out the hazards and classification of the substance and whether it is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative. The chemical safety report must also provide exposure scenarios, including recommendations for measures to ensure that risks to humans and the environment are adequately controlled, regarding the registrant's own uses and all uses identified by downsteam users in the chain. If the assessment is required but a downstream user does not notify its use to its supplier or registrant, or uses a substance outside the conditions covered in the registrant's chemical safety report, the downstream user itself must perform the safety assessment concerning its uses.
Given the extent of data that must be generated for an individual registration, the regulation provides for the sharing of data, tasks and costs. For example, the pre-registration of phase-in substances results in the establishment of a substance information exchange forum (SIEF) for each substance. Each SIEF will group together all intended registrants of the particular substance (eg, manufacturer, importer and potentially also downstream users or other holders of information on the substance), enabling them to share certain information and determine, for example, which studies are available and/or still need to be carried out. Owners of full-study reports are required to permit reference to existing vertebrate testing reports and, if requested, non-vertebrate testing reports. The SIEF parties must agree on the generation of any required new testing. Costs for testing must be shared fairly. Fines may be imposed if a study owner refuses to provide either proof of the cost of its study (for the purposes of cost sharing and, on payment, granting permission for the other party to refer to the full-study report in its own registration) or the study itself.
In the case of non-phase-in substances and registrants of phase-in substances that have not pre-registered, each potential registrant must inquire from the agency whether a registration has already been submitted for the substance in question. If so, it will be put in contact with previous registrants so that information and costs can be shared if necessary in order to make the registration.
In another move to help to reduce registration costs, the regulation provides that certain data (eg, on hazardous properties of the substance and classification) should be submitted jointly. Thus, a lead registrant would submit the data with the agreement of the other registrants. Specified other data must be submitted individually. Certain data, including the chemical safety report, can be submitted jointly but nonetheless may be submitted separately if, for example, joint submission would result in the disclosure of commercially sensitive information or would be disproportionately costly to the company in question.
A special regime applies to substances contained in articles. 'Articles' include finished products ranging from clothing, marker pens and toys to air conditioners, computers and vehicles. Clearly, many articles placed on the EU market contain a large number of substances that are subject to REACH, with some of these substances being potentially dangerous if released from the article during its use.
REACH requires that all substances intended to be released from articles under normal and reasonably foreseeable conditions of use (eg, ink from cartridges) must be registered by the producer or importer according to the normal REACH rules (including pre-registration, volume deadlines and information rules) if those substances are present in the articles at a quantity greater than one tonne per year per producer or importer.
In addition, the producer or importer must notify the agency and provide certain specified information for each substance in the article that is contained in the list of substances considered by the agency to meet the criteria for substances of very high concern if three conditions apply:
On notification, the agency can further require full registration of any substance in the article if the volume criterion is met and the agency has grounds to suspect that the substance has in fact been released and presents a risk to humans or the environment.
These provisions on the registration and notification of substances in articles do not apply to substances that have already been registered for that use. Importantly, non-EU manufacturers can appoint a single natural or legal person in the European Union to fulfil the REACH obligations that must otherwise be carried out by each importer in the manufacturer's supply chain; in such cases the actual importers are deemed to be downstream users.
Annex XIV of REACH will comprise a list of substances determined to be of very high concern in respect of human and environmental safety. Substances to be listed in Annex XIV are those which meet the criteria set out in Article 57, including:
A producer, importer or downstream user can place a substance on the market which is included in Annex XIV only if the use(s) of that substance on its own or in a preparation, or the incorporation of the substance into an article, has been properly authorized.
Applications for authorization can:
The application must include an analysis of potential alternative substances (including any relevant research and development undertaken by the applicant) and, if suitable alternatives exist, a substitution plan including a timetable for actions proposed by the applicant.
The provisions on authorization criteria distinguish between the different hazard classifications and situations where safety thresholds can or cannot be determined. In general, authorizations will be granted if the risk to humans or the environment is "adequately controlled". However, more restrictive conditions apply concerning:
In such cases authorization can be granted only if it is shown that socio-economic benefits outweigh the risk to human health or the environment and there are no suitable alternative substances or technologies. In this context consideration will be given to the information submitted by the applicant and/or other parties concerning alternatives.
Decisions on the suitability of alternatives will take into account technical and economic feasibility for the applicant and whether substitution would actually result in reduced overall risks. When granted, authorizations will be subject to time-limited reviews determined on a case-by-case basis and subject to conditions such as monitoring.
Suppliers of substances and preparations must provide recipients with safety data sheets whenever a substance or preparation:
Instances are also specified for when a safety data sheet is required. Importantly, REACH requires any supplier of an article containing a substance of very high concern to provide recipients (at no cost) with available information to allow safe use including, at minimum, the name of the substance. In addition, in these circumstances the supplier must provide the same information to any consumer who requests it.
Any manufacturer, producer of articles or importer which places a substance requiring registration on the market must provide information to the agency to enable it to compile and keep updated a classification and labelling inventory that will be publicly accessible. The obligation to supply this information will apply from December 1 2010.
REACH imposes significant and complex obligations on all parties placing chemical substances on the EU market, whether on their own, in preparations or in finished articles. It is essential for companies to understand all the requirements that apply to them and their supply chain, and to prepare for compliance by taking the following steps:
The commission is due to publish technical guidance documents for industry in mid-2007 and roll out new software packages to facilitate compliance; however, preparatory measures can and should be undertaken. Previous experience in achieving compliance with other EU substance control regulations (eg, hazardous substances in electrical and electronic products) confirms that early action is crucial.
For further information on this topic please contact Jim Searles or Darren Abrahams at Steptoe & Johnson LLP by telephone (+32 2626 0500) or by fax (+32 2626 0510) or by email (firstname.lastname@example.org or email@example.com).
This update is based on an article to be published in The International Comparative Legal Guide to Environmental Law 2007 (Global Legal Group), entitled "EU Environmental Challenges for the Electronics Sector".
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James H Searles