REACH: DESCRIPTION

The EU REACH Regulation (Registration, Evaluation and Authorization of Chemicals) was adopted in December 2006, and entered into force on June 1, 2007. REACH impacts all manufacturers, EU importers, and downstream users of chemical substances, as well as manufacturers and EU importers of articles. It indirectly, but significantly, affects non-EU exporters and their suppliers.

Timely REACH preparation and planning by affected companies is needed to ensure compliance and can reduce both potential costs and the impact of REACH on present and future business. REACH may also offer opportunities for those stakeholders who quickly grasp and meet their REACH obligations, thereby turning business challenges into competitive advantages.

The environmental attorneys in the Brussels and Washington D.C. offices of McKenna Long & Aldridge LLP (MLA), supplemented by MLA technical consulting subsidiary, TSGE, provide a broad spectrum of REACH-related advice and services to our clients in core areas, including:

• counseling on the most significant REACH implementation and compliance issues;
• supporting efforts to assess the impacts of REACH on business; and
• working to minimize costs and impacts of REACH by developing strategic action plans.

As REACH has progressed from early proposals to the final legislative package and entry into force, we have developed comprehensive REACH legal services including:

Training

• On-site training sessions: For executives, business managers, general counsel, regulatory specialists, purchasing and marketing managers, and others with responsibilities that are impacted by REACH.

Impact and/or Compliance Audit

• Pre-audit: Preparation of a detailed questionnaire taking into account the company’s structure, business units and products.
• Audit: Analysis of the information received (including if necessary on-site visits and interviews with relevant personnel).
• REACH compliance report: Analysis featuring information about REACH tailored to what is relevant to each company; recommended actions per product, business unit and legal entity; and estimated timeline for implementation and cost.

REACH Manual

• Company-specific or industry association-specific manual: Description of relevant REACH provisions, recommendations for specific steps to be taken to ensure compliance, sample of a REACH chemicals inventory, outline of registration obligations, consortia formation and functioning of Substance Information Exchange Fora (SIEFs) including data sharing obligations, protection of know-how and other confidential data, training, record-keeping, other REACH implementation steps (review of contracts, etc.), flowchart on relevant REACH timelines and related obligations.

Product Defense

• Development of strategies to obtain most preferable status under REACH: Assess notification under current scheme versus registration, assess pre-registration versus direct registration, and assess individual versus joint registration.  
• Devising strategies to address potentially threatened substances: Analysis of exemptions, restrictions,authorizations, voluntary agreements, classification, candidate lists, defense and litigation.

Representation in SIEF/Consortium Management

• Addressing legal, technical and financial implications: Based on many years of related experience, our REACH team provides counsel to companies on task force formation, including data sharing and data compensation.

• Consortia and SIEF strategy: Identification of potential consortium partners (prior to SIEFs), representation in SIEF or other consortia, and development of SIEF strategies (e.g., data protection/data compensation). 
• Document development: Drafting of preliminary and/or model consortia agreements, confidentiality agreements, letters of access, and compensation formulas. 
• Establishment of EU entities: Assist with setting up EU entities, as well as setting up “only representatives” or “third-party representatives.” 
• “Opt out” assessments: Assessment of justification for “opt out” of joint registration dossiers.  
• Establishment of consortia and management of consortia: Provide consortium management services through well-known and well-respected advisers with significant industry and task force experience.  Also handle the accounting of consortia, internally or, as necessary, through outside auditors.

Other Services

• Representation before European institutions: European Commission, European Chemicals Agency, and national competent authorities.
• Appeals/litigation: Appeals before the Agency board of appeal and litigation before the European courts.
• Assistance with REACH issues in relation to mergers and acquisitions: Due diligence, pricing, substance registration continuity issues in case of asset deals, representations and warranties. 
• Commercial contracts / insurance coverage: Drafting of REACH clauses for commercial contracts and review of insurance coverage for REACH.

Why Pick MLA's REACH Team?

• Significant depth of expertise and relevant experience in Brussels and Washington DC offices.
• MLA Brussels office attorneys represent a variety of national and language backgrounds (e.g., Belgium, France, Germany, Italy, the Netherlands, Poland, Romania, Sweden and the United Kingdom) and various industry sector experiences (including both upstream and downstream user industries) who focus on EU product regulatory law and advise clients on REACH related matters.
• Extensive experience with numerous  industry sectors impacted by REACH, including chemicals, solvents, pharmaceuticals, pesticides, biocides,  biotechnology, automotive, aerospace, toys, cement, cosmetics, electronics, food, food packaging, industrial minerals, medical devices, packaging, personal protective equipment, sporting equipment and textiles.
• Strong EU regulatory litigation practice defending products whose marketing or authorizations are threatened (particularly relevant for REACH authorizations and restrictions).
• Recognized leaders in task force and consortia formation and management, well-versed in drawing up founding documents and operating rules and in addressing competition law aspects in the framework of the EU legislation on biocides and pesticides (widely considered the precedent for REACH).
• Alliances with attorneys and consultants in other EU and non-EU jurisdictions including China, Denmark, Finland, France, Germany, Italy, Japan, Lebanon, Montenegro, Norway, Portugal, Russia, Serbia, Spain, South Africa, Turkey, the United Arab Emirates, United Kingdom and beyond.
• Significant experience working with other service providers such as risk assessors, ecotoxicologists, technical specialists, lobbying/PR firms and specialized auditors (joint service proposals available upon request).