Administrative and Judicial Rights Under REACH and the CLP
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Environment Handbook 2010/11 Cross-border Administrative and judicial rights under REACH and the CLP Regulations Cándido García Molyneux and Georg Berrisch www.practicallaw.com/9-503-3680 Covington & Burling LLP Council Regulation (EC) 1907/2006 concerning the registration, result in the identification of SVHCs and restrictions evaluation, authorisation and restriction of chemicals (REACH) under other EU product-specific legislation; governs the manufacture, marketing and use of substances. REACH: data gathered from the registration and evaluation pro- Establishes the European Chemicals Agency (ECHA). cedures will generate new measures under, for example, the EU’s regime for food contact materials. Imposes obligations on manufacturers, importers and traders of substances and goods containing substances. However, companies, their competitors and non-governmental or- ganisations (NGOs) will also have opportunities to participate in REACH is complemented by Council Regulation (EU) 1272/2008 the processes under REACH and CLP and obtain administrative Cross-border on classification, labelling and packaging of substances and and judicial review of the resulting decisions: mixtures (CLP Regulation). REACH and the CLP Regulation require the ECHA and the Most companies are currently focused on the first REACH phase- European Commission to consider the comments of interested in registration deadline of 30 November 2010. However, this parties when adopting many of their decisions and measures. deadline is only the first step in several procedures intended to: REACH creates a Board of Appeal (BoA) and allows com- Review the human and environmental safety of thousands of panies to appeal certain ECHA decisions. The BoA is an in- substances. dependent body within ECHA, consisting of three members with legal and technical expertise. Eventually restrict the manufacture, marketing and use of some of these substances. Private parties can take legal action before the General Court and the Court of Justice of the European Union (CoJ) These procedures include: against: Data sharing within the Substance Information Exchange Fora. decisions of the ECHA and its BoA; Reporting of chemical classification of substances. other measures adopted by the Commission or the Council. Registration compliance checks and detailed substance This chapter provides an overview of the: evaluations. Opportunities to comment during the adoption of REACH Identification of substances of very high concern (SVHCs). and CLP decisions and other measures. Prior marketing authorisations of SVHCs. Internal administrative review procedure before the BoA and ECHA. Eventual marketing and use restrictions. Challenges before EU courts. The different REACH and CLP procedures will result in numerous Recommendations and practical steps during REACH and ECHA, European Commission (Commission) and Council of the CLP administrative procedures. European Union (Council) decisions and measures, which will: Impose obligations on companies. (See also, box, REACH administrative and judicial rights.) Restrict the manufacture, marketing and use of substances and goods containing them. OPPORTUNITIES TO COMMENT DURING THE ADOPTION OF DECISIONS AND OTHER MEASURES Affect companies’ confidential business information. UNDER REACH AND CLP Trigger the application of other procedures and obligations under Companies and other interested parties can participate and sub- REACH and other EU product-specific legislation. For example: mit comments during ECHA, Commission and Council adoption decisions on the authorisation of the marketing and of decisions and measures. These bodies must take all submitted use of substances on their own or in mixtures may evidence into account. trigger proposals to ban the import of articles (objects) containing them; Participation in these procedures can affect outcomes and influence the treatment of substances used in virtually all goods. registrations of substances may trigger proposals for In addition, whether a company participates and the quality of harmonised classification decisions, which in turn may © This article was first published in thePLC Cross-border Environment Handbook 2010/11 and is reproduced with the permission of the publisher, Practical Law Company. Environment Handbook 2010/11 Cross-border the evidence it submits significantly affects the chances of a must be given an opportunity to comment on a member state successful legal challenge of any adverse decision (see below). draft decision requiring the submission of further information. In most cases, commenting parties: Identification of SVHCs and authorisation measures Must submit a non-confidential version of their comments, The following can participate in the identification of SVHCs and studies or other information. The ECHA can make these adoption of authorisation measures: comments publicly available. All interested parties can comment on member state or ECHA Can also submit confidential versions, which must only be dossiers on the identification of a substance as an SVHC (and disclosed to the ECHA and its Committees, if they justify its inclusion in the REACH Candidate List of SVHCs Subject the need for confidentiality. to Authorisation). The submission of comments in this case is particularly important. This is because the ECHA can only The ECHA may not accept anonymous comments, although the include a substance in the Candidate List without any further submitting party can request that his name not be disclosed to debate in the Member State Committee if no interested the public. parties or member states raise comments. In addition, the ECHA may include substances for which no comments have Companies and other interested parties can comment during the been made in its recommendations on the list of substances following procedures. subject to prior authorisation. Interested parties can comment on the ECHA’s draft recom- Harmonised classification and labelling of substances mendations to the Commission for the inclusion of SVHCs in Any manufacturer, importer or downstream user of a substance the Annex XIV list of substances subject to prior authorisation. can submit a proposal for the harmonised classification of that substance as: Interested parties can submit information on alternative substances or technologies concerning substances for which A category 1A, 1B or 2 carcinogen mutagen, or toxic to authorisation applications have been submitted. reproduction substance. Authorisation applicants must be given an opportunity to A respiratory sensitiser. Cross-border comment on the draft opinions of ECHA’s Committees on Falling under other hazard classes if justification is provided Risk Assessment and Socio-Economic Analysis on their demonstrating the need for an EU harmonised classification. applications. All interested parties can comment on harmonised classification Marketing and use restrictions proposals presented by private parties or member states. Interested parties can comment on ECHA and member state pro- posals to restrict the marketing and use of particular substances. Registration exception for PPORD Comments can refer to the: Companies can request registration exemptions for product and Scientific dossier of the proposals and the proposed restrictions. process-oriented research and development. For example, this can apply in relation to clinical trials with investigational medicines Socio-economic impact of the restrictions. or medical devices. When assessing these requests, ECHA may require notifiers to submit additional evidence when deciding Interested parties can also submit general comments on the whether to grant, or impose conditions on, the exemptions. Committee on Socio-Economic Analysis’s draft opinion on the proposed restrictions. Testing proposals Access to information All interested parties can comment on registrants’ proposals for testing on vertebrate animals for the purpose of complying with If the ECHA receives an application for access to documents orig- specific data requirements. inating from a third party (for example, an authorisation applicant or registrant), the ECHA must consult the third party unless: Registrants and downstream users of the substance concerned The party has already disclosed the relevant documents un- must also be given an opportunity to comment on an ECHA draft der Council Regulation (EC) 1049/2001 on public access to decision on their testing proposal. European Parliament, Council and Commission documents. Registration compliance checks It is obvious that it does not affect one of the interests Any party can submit information to the ECHA regarding sub- protected by the exceptions provided for in that Regulation. stances that are listed as registered on the ECHA’s website. This information can be used to target specific registered substances OVERVIEW OF LEGAL REMEDIES for registration compliance checks. An action for annulment before the General Court is the typical Registrants and downstream users of the substance concerned remedy available to private parties against decisions adopted by must be given an opportunity to comment on an ECHA draft EU institutions and its agencies, such as the ECHA. However, decision regarding a compliance check. one of the main innovations of REACH is that it provides for an internal review process for certain of the ECHA’s decisions, either Substance evaluation in the form of: Registrants and downstream users of the substance concerned An appeal to the BoA (see below,