Cross-border - - - - - .) www.practicallaw.com/9-503-3680 decisions of the ECHA and its BoA; Council. the or Commission the by adopted measures other result in the identification of SVHCs and restrictions result in the identification legislation; under other EU product-specific registration and evaluation pro data gathered from the for example, cedures will generate new measures under, regime for food contact materials. the EU’s „ „ „ panies to appeal certain ECHA decisions. The BoA is an in panies to appeal certain ECHA decisions. three members dependent body within ECHA, consisting of with legal and technical expertise. the General Private parties can take legal action before Union (CoJ) Court and the Court of Justice of the European against: „ „ Opportunities to comment during the adoption of REACH and CLP decisions and other measures. Internal administrative review procedure before the BoA and ECHA. Challenges before EU courts. Recommendations and practical steps during REACH and CLP administrative procedures. „ the and ECHA the require Regulation CLP the and REACH interested of comments the consider to Commission European measures. and decisions their of many adopting when parties allows com REACH creates a Board of Appeal (BoA) and „ „ „ „ „ „ „ See also, box, REACH administrative and judicial rights mit mit comments during ECHA, Commission and Council adoption submitted all take must bodies These measures. and of decisions account. into evidence Participation in these procedures goods. all virtually in used substances of treatment the influence can affect outcomes In addition, and whether a company participates and the quality of „ This chapter provides an overview of the: „ „ „ „ ( OPPORTUNITIES TOADOPTION DECISIONSOF OTHERANDMEASURES COMMENT UNDER REACH DURING AND CLP THE and Companies other parties can interested and participate sub However, companies, their competitors and non-governmental or non-governmental and competitors their companies, However, ganisations (NGOs) will also have opportunities to participate in the processes under REACH and CLP and obtain administrative and judicial review of the resulting decisions: „ „ Cross-border Environment Handbook 2010/11 2010/11 Handbook Environment Cross-border

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and is reproduced with the permission of the publisher, Practical Law Company. Company. Law Practical publisher, the of permission the with reproduced is and © This article was first published in the the in published first was article This © trigger proposals to ban the import of articles (objects) containing them; registrations of substances may trigger proposals for harmonised classification decisions, which in turn may decisions on the authorisation of the marketing and use of substances on their own or in mixtures may

„ „ „ „ Trigger the application of other procedures and obligations under under obligations and procedures other of application the example: For Trigger legislation. product-specific EU other and REACH Restrict the manufacture, marketing and use of substances and goods containing them. Affect companies’ confidential business information. Impose obligations on companies. Eventual marketing and use restrictions. Identification of substances of very high concern (SVHCs). Prior marketing authorisations of SVHCs. Reporting of chemical classification of substances. Reporting of chemical classification of substances. substance Registration compliance checks and detailed evaluations. Data sharing within the Substance Information Exchange Fora. Fora. Exchange Information Substance the within sharing Data substances. and use of Eventually restrict the manufacture, marketing some of these substances. Review the human and environmental safety of thousands of Review the human and environmental safety traders of substances and goods containing substances. traders of substances and goods containing Establishes the European Chemicals Agency (ECHA). Establishes the European Chemicals Agency and Imposes obligations on manufacturers, importers

„ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ ECHA, (Commission) and Council of the (Council) decisions and measures, which will: „ „ numerous in result will procedures CLP and REACH different The „ „ „ „ These procedures include: „ „ in registration deadline of 30 November 2010. intended to: deadline is only the first step in several procedures However, this „ on classification, labelling and packagingmixtures (CLP Regulation). of substances and phase- REACH first the on focused currently are companies Most REACH is complemented by Council Regulation (EU) 1272/2008 (EU) Regulation Council by complemented is REACH governs the manufacture, marketing and use of substances. REACH: REACH: substances. of use and marketing manufacture, the governs „ „ Council Regulation Council (EC) Regulation the 1907/2006 concerning registration, evaluation, authorisation and restriction of chemicals (REACH) Cándido García Molyneux and Georg Berrisch Cándido García LLP Covington & Burling under REACH and the CLP Regulations CLP the and REACH under Cross-border rights judicial and Administrative Environment Handbook 2010/11 2010/11 Handbook Environment 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. , 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, Appeals before the BoA).

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Lodging the appeal suspends the appealed Confidentiality The appeal can challenge the ECHA’s: the ECHA’s: The appeal can challenge The notice of appeal must, among other things, include things, other among must, appeal of notice The Parties must file a notice of appeal against an ECHA The notice of appeal must be accompanied by proof of Remedies sought. Date of its publication. Number of the appeal. Language of the case. Appealed decision. decision, pro Submission that gave rise to the appealed vided it is one of the languages of the EU. Name of the appellant. Subject matter of the appeal. The date the decision was notified to them. The date the decision of the decision, the date on If they are not the addressee known to them. which the decision became of the facts. Establishment and assessment Assessment of the law. not correctly identified. Was a Did not give a valid justification for not completing dossier. specific information field of the IUCLID Pleas in law. Arguments of fact and law relied on. Nature of any evidence offered. „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ See also, below, It must identify any information in the appeal that the appellant wishes to be treated as confidential. For example, the appellant can request that its name and that of the substance concerned be kept confidential. The appeal must be lodged in the language of either the: „ „ Fee. appealed of type the on depending varies which fee a of payment decision and the appellant appellant is successful, the ECHA must refund this fee. company’s size. However, if the Effect of lodgement. decision. This can be very important in relation to certain deci sions, such as those affecting completeness of registration dos the In appellant the siers. until this BoA case, its takes decision, can to continue and manufacture import the after substance the incomplete. is dossier registration the if even deadline, registration The ECHA must publish an announcement of the appeal on its website, including the: „ „ Filing of the appeal before the BoA appeal before the Filing of the Timing. either: three months from decision within „ „ Challenge. „ „ rejecting decision ECHA an challenge can appeal an example, For that the substance: a registration on the grounds „ „ Content. the: „ „ „ - - - about this publication, please visit please publication, this about - about Practical Law Company, please visit visit please Company, Law Practical about see below, Other Other see below,

). A o data holders (if the ECHA decides that a third party can reached not has he if even registration his with continue an agreement with the data holder); another that decides ECHA the (if SIEF a of members others). all of behalf on testing out carry should member there is no proposal for amendment of the draft decision; or decision; draft the of amendment for proposal no is there the Member State Committee reaches a unanimous agreement on the draft decision. „ „ „ „ „ Any other person with a “direct and individual concern”. These include, among others: „ The addressee of the decision. „ only where either: „ Proposals on the testing on vertebrate animals, compli Proposals on the testing on vertebrate animals, to submit ance checks of registration dossiers and requests substance, but further information for the evaluation of a Information Exchange Forum (SIEF). testing on Potential registrants’ obligation to carry out behalf of all other members of the SIEF. registrants where there is no agreement on data sharing. registrants where there is no agreement on on verte Disputes between data owners involving testing the Substance brate animals and other registrants within registration for substances used in PPORD. Completeness checks of registration dossiers. data of previous Requests to refer in registration dossiers to stances used in product- and process-oriented research and stances used in product- and process-oriented development (PPORD). from Requests for extensions of the five-year exemption The conditions on an exemption from registration for sub The conditions on an exemption from registration administrative review procedures administrative A review by the ECHA’s Executive Director ( Executive Director the ECHA’s A review by „ „ „ „ „ „ „ „ „ „ For more information more For supplier. Downstream users should also consider claiming direct and indi vidual concern where the ECHA rejects the registration of their „ An appeal can be lodged by: „ Parties that can appeal before the BoA „ „ „ „ „ „ Decisions that can be appealed before the BoA regarding the following issues: include those „ APPEALS BEFORE THE B BoA Decisions that can be appealed before the also also by third that parties concerned. are and directly individually This for provides opportunities third parties, but procedures. also constitutes REACH to subject companies for challenges significant Internal review processes and applications before the General Court Court General the before applications and processes review Internal can be initiated not only by the addressee of the decision, but be challengeable in an action before the General Court only after only Court General the before action an in challengeable be completion of the internal review. Other decisions that are not challenged be cases, certain in can, review internal an to subject Court. directly before the General Decisions subject to these internal review processes are likely to Cross-border „ Environment Handbook 2010/11 2010/11 Handbook Environment Environment Handbook 2010/11 Cross-border

Confidentiality. The Chairman must decide whether to grant any BoA’s deliberations and decision. The BoA’s deliberations are requests for confidentiality contained in the notice of appeal and, secret and must be adopted by a majority of votes of the three if appropriate, ensure that the confidential information is not members of the BoA. These decisions can: included in the announcement. „„ Correct the ECHA’s decision.

Interventions „„ Request the ECHA to take further action. Third parties with an interest in the result of an appeal can file „„ Make an award for the costs of taking evidence and refund an application to intervene in the proceedings within two weeks the appeal’s fees. following the publication. For example, competitors can inter- vene where a company appeals against an ECHA decision on an The decision must also state the admissibility of the appeal (if exemption from registration for PPORD. the BoA’s Chairman did not decide on this). Procedures before the BoA Opportunity to correct the decision. Before the BoA reviews the OTHER ADMINISTRATIVE REVIEW PROCEDURES case, the ECHA’s Executive Director reviews the case and can rec- If the ECHA denies a registrant’s request for confidentiality of tify the ECHA’s decision. In particular, if the Executive Director information, the registrant must ask the ECHA to review the decision considers an appeal admissible and well founded, after consult- before challenging it before the General Court. The request must be ing the BoA’s Chairman, he can rectify the ECHA’s decision within 30 days from the filing of the notice of appeal. If the Executive submitted within two months from the decision, and the ECHA must Director does not rectify the decision, the BoA’s Chairman can adopt a decision on the confidentiality request within two months decide whether the appeal is admissible within 30 days. of the submission. The ECHA’s decision must inform the applicant of his right to challenge the decision before the General Court. Defence. If the Chairman considers that the appeal is admissible Importantly, the submission of a request entails the suspension of or does not decide, the ECHA can lodge a defence within two publication of the information until the ECHA adopts a final decision. months from being served the notice of appeal. The defence must include, among other things: Private parties can also submit confirmatory applications to the: Cross-border „„ The pleas of law. „„ Executive Director of the ECHA (and the BoA’s Chairman) in relation to ECHA decisions denying access to its documents. „„ Arguments of law and fact. „„ BoA’s Chairman in relation to decisions of the BoA’s „„ The nature of any evidence offered. registrar denying access to BoA documents. The ECHA hires private law firms to represent it in certain cases. NGOs can also request that the ECHA and the Commission review Language. Written submissions must be in the language of the no- any of their REACH decisions, other than legislative measures, tice of appeal. The submitting party must translate documents sub- under Council Regulation (EC) 1367/2006 on the application mitted in another language into the language of the case. In prac- of the provisions of the Aarhus Convention (Aarhus Regulation). tice, all documents submitted to the BoA are translated into English. Examples of reviewable decisions include:

„„ ECHA or Commission decisions on proposals for testing on Evidence. No further evidence can be introduced in the proceed- vertebrate animals. ings after the first exchange of written pleadings, unless the BoA decides that it is based on new matters of law that have become „„ Commission decisions granting authorisations. relevant during the course of the proceedings. „„ ECHA listing of substances in the candidate list of SVHCs During the proceedings, the BoA can also take evidence through: for authorisation.

„„ Requests for information. CHALLENGES BEFORE EU COURTS „„ The production of documents and materials. Decisions and measures that can be challenged before EU „„ Hearing the parties or witnesses. courts „„ Opinions by experts. The following decisions and measures can be challenged before the General Court: However, the parties can object to an expert or witness on grounds of lack of competence. They can also put questions to the witness „„ ECHA or Commission decisions or other measures that are or expert. not subject to an appeal before the BoA or other adminis- trative review procedures in the ECHA or Commission. For Form of hearing. All parties can make an oral presentation before example, the following are not subject to appeal to the BoA the BoA and can be represented by external legal counsel. The or review by ECHA but arguably can be challenged before hearing is public unless the BoA decides there is a compelling the General Court: reason for confidentiality. An official language of the EU other than the language of the case can be used during the hearing, „„ ECHA decisions relating to responses to requests for if the BoA allows it on request of a party. The BoA can also hold reduced fees or fee waivers; hearings by video conference or other communication technology.

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He complied with his procedural obligations. He complained about the procedural violation in due time. procedure or Commission’s The outcome of the ECHA’s would have been different had the applicant been allowed to fully exercise his rights. Respect the procedural rights of the parties. Respect the procedural rights of the parties. aspects of the Carefully and impartially examine all relevant case. evidence Base their decisions on cogent and consistent capable of supporting the conclusions reached. without any Address all important aspects of the case contradictions in their reasoning. Reasoning of the decision. Evidence put to the authority when it adopted the decision. Inform the parties about all relevant aspects of the case. Give the parties the opportunity to comment. Procedural issues. Basic principles of EU law. and the Grant wide discretion to the ECHA, the BoA under REACH. Commission relating to decisions adopted technical issues. Not substitute their own assessment of the „ „ „ „ „ „ „ „ „ „ „ „ „ „ „ procedural rights violation only if the applicant shows that: „ „ „ However, However, the courts will insist that the ECHA, the BoA and the Commission: „ „ „ „ The courts make this assessment solely on the basis of the: „ „ evidence of basis the on decision adverse an aside set not will They that private parties failed to submit during procedures before the ECHA and Commission. the administrative The obligation to respect the procedural rights requires the ECHA and Commission to: of the parties „ „ However, the courts will overturn a measure on the basis of a is is served. Appeals before the CoJ can take ruling between 18 preliminary the months through challenges Indirect years. three and years. three and two between take usually procedure effect, suspensive have not do Court General the before Challenges if harm irreparable the before General can measures for apply interim suffer but applicants will they that demonstrate can they if Court challenges Indirect judgment. final the for wait to required are they suspensive have only can procedure ruling preliminary the through challenged. is measure the where state member the in effect Standard of review Legal challenges before the EU courts arguments referring to: should focus on legal „ „ The General Court and CoJ only review whether a decision of the ECHA, BoA or Commission is lawful, not whether it is good reasonable. it In is particular, likely or that, in contrast to the BoA, EU courts will: „ „ - - - about this publication, please visit please publication, this about - about Practical Law Company, please visit visit please Company, Law Practical about

the listing of a substance in the Annex XIV of the listing of a substance in the Annex XIV substances subject to authorisation. the listing of a substance in the candidate list of SVHCs the listing of a substance in the candidate for authorisation; qualifies as a regulatory act; is of direct concern to the applicant; and does not require any implementing measures. of existing authorisations. of existing Commission decisions relating to testing proposals, decisions relating to Commission and reviews applications for authorisation rejections of „ „ „ „ „ „ Measure’s publication or notification. Measure’s Day that it became known to the party concerned. „ „ that do not require any implementing measures. For exam that do not require any implementing measures. the following ple, if the court follows a broad interpretation, may qualify as such measures: „ what types of The EU courts are in the process of deciding to applicants measures are regulatory acts of direct concern „ „ basis of information included in the prior application of the basis of information included in the prior application authorisation holder without his permission. The decision: They are “directly and individually concerned”. For ex They are “directly and individually concerned”. Commission ample, prior authorisation holders where the on the grants an authorisation to a subsequent applicant decisions following an internal review procedure. decisions following an BoA decisions on appeals and other ECHA or Commission ECHA or Commission on appeals and other BoA decisions „ „ „ „ „ „ For more information more For procedure. General Court decisions can be appealed before the CoJ CoJ the before appealed be can decisions Court General procedure. judgment Court’s General the after days ten and months two within Proceedings Proceedings before the General Court usually take two years or may be an applicant circumstances certain under although more, an expedited under a or less year within a decision to obtain able „ „ Timing Applications before the General Court against REACH measures must be lodged within two months and ten days from either the: For example, a Commission decision to include a substance in the list of substances subject to harmonised classification could be challenged through this procedure. measure, an indirect challenge may still be possible. This is done is This possible. be still may challenge indirect an measure, the on CoJ the to question a refer to court national a requesting by validity of a measure through the preliminary ruling procedure. If a company cannot directly challenge a REACH measure before measure REACH a challenge directly cannot company a If the General Court because it is not directly concerned by the „ „ Parties that can appeal before the General Court Parties that can appeal Addressees of decisions of the ECHA, the BoA mission have standing to appeal the decision before and the General the Com decision if either: Court. Third parties can also challenge the must produce legal effects (that is, affect the legal position of the of position legal the affect is, (that effects legal produce must act). party challenging the lenge ECHA’s and EU Institutions’ responses to their requests for requests their to responses Institutions’ EU and ECHA’s lenge Court. review before the General To qualify as challengeable, an ECHA or Commission measure The Aarhus Regulation also specifically entitles NGOs to chal „ Cross-border Environment Handbook 2010/11 2010/11 Handbook Environment Environment Handbook 2010/11 Cross-border

Burden of proof Commission and the BoA. The stronger the evidence and arguments The burden of proof before the EU courts depends on the REACH that a party submits during these administrative procedures, the measure that is being challenged. For example: more difficult it will be for the ECHA, the Commission and the BoA to adopt an adverse decision that the courts will accept. „„ In a challenge against a Commission measure listing a substance in the Annex XVII to REACH, the applicant must Companies must assert and exercise their procedural rights show that the Commission failed to prove that both: during the administrative procedures if they want to be able to rely on procedural defects in a subsequent case before the „„ the substance poses an unacceptable risk to human health or the environment; EU courts. Companies must also immediately notify the ECHA and Commission if they believe that their procedural rights have „„ this risk that must be addressed on a Community-wide been violated. For example, affected parties should immediately basis. complain to the ECHA and Commission if the ECHA:

„„ In a challenge against a Commission rejection of an authorisa- „„ Unjustifiably ignores evidence submitted by an authorisation tion application, the applicant must prove that the Commission applicant. wrongly concluded that the applicant failed to show that, for example, the risks to human health or the environment from „„ Fails to investigate relevant information on available the use of the substance are adequately controlled. substitutes brought by a third party during the authorisation procedure.

RECOMMENDATIONS AND PRACTICAL STEPS The exercise of procedural rights should not only be towards the DURING REACH ADMINISTRATIVE PROCEDURES ECHA and EU institutions, but also third parties, including suppli- The manner in which a company acts before the ECHA, the Commis- ers, competitors and NGOs. For example, a downstream user may sion and third parties can significantly affect its chances of success be able to challenge a supplier’s registration that does not include on appeal before the BoA and courts. In many cases, legal counsel the downstream user’s use of the substance, if the downstream user should supervise the company’s REACH compliance programmes adequately identified the use to his supplier in a timely manner. and submissions to the ECHA and Commission, to ensure that all Companies’ submissions before the ECHA and Commission

Cross-border objections and comments are properly lodged in a timely manner. should be clear, succinct and supported by all available pertinent Recommendations evidence. This will force the ECHA and Commission to address and refute the arguments and evidence in their decisions. The basis for a successful appeal to the General Court is laid during the company’s prior submission of comments to the ECHA, the See also, box, Practical steps.

PRACTICAL STEPS

Companies should take the following precautions when trying „„ Anticipate the sensitive issues that may end up in litigation. to ensure the REACH compliance of a substance that is of „„ Prepare strong evidence in support of the substance and competitive importance: of the company’s position well in advance. Where possible, „„ Identify the priority substances that the company should ensure that this evidence is backed by independent and defend. reputable experts.

„„ Identify the REACH and CLP procedures to which the „„ Submit comments and comply with the REACH and CLP substance may be subjected and the opportunities that the requirements in due time. Generally, the more comments company will have to participate. submitted and the higher their quality, the more difficult will be for the ECHA and Commission to adopt an adverse decision. „„ Assess the regulatory implications that any measure resulting from the different REACH and CLP procedures „„ Immediately complain to the ECHA and Commission if may have on the substance. Beware that decisions under there is a violation of the company’s procedural rights. one procedure may trigger the initiation of other procedures „„ During the procedure, consider submitting a request for and even measures under other EU legislation. access to documents to the ECHA and Commission to „„ Identify all parties (including competitors, member states identify the evidence that these bodies are considering. and NGOs) who might be interested in the outcome of a „„ Document all communications with the ECHA, Commission procedure affecting a substance. Anticipate the arguments and third parties. that each of these parties is likely to make.

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Yes Yes Depends on the EU court’s Depends on the EU court’s interpretation of regulatory acts that do not require implementing measures and are of direct concern to applicants See above, Listing of substance in candidate list of SVHCs Yes See above, Listing of substance in candidate list of SVHCs See above, Listing of substance in candidate list of SVHCs Yes Yes Standing before General Court Standing before Yes Yes Yes Yes Yes www.practicallaw.com/about/practicallaw www.practicallaw.com/about/handbooks

Executive Director of ECHA decides No No No No No No ECHA decides Executive Director of ECHA or Chairman of the BoA decide on confirmatory application Board of Appeal or Internal Review Yes Yes No Yes Only if there is no proposal for amendment of the draft decision or the Member State Committee reaches a unanimous agreement about this publication, please visit please publication, this about about Practical Law Company, please visit visit please Company, Law Practical about

Third party author of the document may comment ECHA may request NGO to submit additional information No Yes Yes Yes No Yes Yes given an opportunity to given an opportunity complete the dossier ECHA may ask notifier to submit additional information No No Yes Formal Right to Comment to Right Formal Registrant must be REACH ADMINISTRATIVE AND JUDICIAL RIGHTS Substance evaluation Registration compliance check proposal Testing Applications for fee waivers or reductions or waivers fee for Applications NGO Aarhus requests for internal review Access to information Requests for confidentiality Harmonised classification (CLP Regulation) Restrictions Decisions on granting authorisations Listing of substance authorisation as subject to Listing of substance in candidate list of list candidate in substance of Listing SVHCs Measures on evaluation Data sharing Agency’s decision Agency’s to require registration of substances in articles Exemption from registration for PPORD Exemption from registration Completeness check of registration Completeness check For more information more For Cross-border Environment Handbook 2010/11 2010/11 Handbook Environment Environment Handbook 2010/11 Cross-border

CONTRIBUTOR DETAILS

CÁNDIDO GARCÍA GEORG M BERRISCH MOLYNEUX Covington & Burling LLP Covington & Burling LLP T +32 2 549 5230 T +32 2 549 5261 F +32 2 549 1040 F +32 2 549 1040 E [email protected] E [email protected] W www.cov.com W www.cov.com

Qualified.Spain, 1994 Qualified.Germany, 1991 Areas of practice. EU environmental and chemicals law; Areas of practice. Litigation before the European courts; Spanish food and drug law; international trade law. international trade law. Recent transactions Recent transactions „„ Legislative advice to associations of paper „„ Represented public and private sector clients in more than manufacturers, non-woven materials, chemicals and 100 cases before the European courts, in a wide range of pharmaceuticals on REACH. procedures (annulment actions, damage actions, interim measures, appeals and preliminary rulings) and subject „„ Regulatory, contractual and strategic advice to chemical matters (environment, pharmaceuticals, regulatory, state manufacturers and downstream users in their efforts to aid, trade, customs and competition). ensure REACH compliance.

Cross-border „„ Specific focus on administrative review cases. „„ Advice to cosmetic manufacturers on EC chemical classification procedures and their impact under „„ Acted for Merck and Schering Plough in two cases REACH and specific product legislation. involving marketing authorisations for medicinal products.

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Covington provides legal, strategic, and advocacy advice on EU’s REACH and other legislative regulations. We are particularly active in ensuring our clients’ rights in preparation of the REACH and other chemical legislation registration and authorization requirements. We also advise clients on contractual and legal issues related to data sharing, protection of confidential business information, and antitrust concerns.

B e i j i n g In cooperation with our Government Affairs practice, we provide legal and advocacy advice on the defense of particular substances B r u s s e l s and products in administrative and legislative procedures before the European Chemicals Agency, Commission, Parliament, and l o n d o n Council. And in cooperation with our litigation team, we work with clients to prepare the ground for a successful judicial action against n e w Y o r k potentially negative decisions on substances and products and, where necessary, represent clients before the EU Courts. We also s a n d i e g o advise on how best to ensure REACH compliance and to deal with EU authorities in case of an enforcement action. s a n F r a n c i s c o Lawyers in our European Environmental, REACH, and Government s i l i c o n V a l l e Y Affairs practices are recognised for their practical know-how, formidable academic background, quality of advice, and standard w a s h i n gto n of client service by:

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