Steptoe & Johnson LLP

Contact: James Searles

Avenue Louise 240, Box 5
B-1050 Brussels

Phone: +32 2 626 0500
Fax: +32 2 626 0510
Email: jsearles@N0SPAM.steptoe.com
Web: http://www.steptoe.com

Steptoe & Johnson is an international law firm recognized as a leader in providing trade and regulatory advice to global clients. Lawyers in its Brussels office have over 30 years experience dealing with EU trade and regulatory matters and notably chemicals regulatory issues. We are known for our effective advocacy before the EU institutions and are active in administrative proceedings before the Commission and in cases before the European Courts.

Regarding REACH, our Brussels office has provided companies and industry associations with strategic analysis and representation on REACH since its legislative conception. Since its adoption at the end of 2006, we have been advising on the legal/regulatory, technical and strategic elements of compliance, especially on behalf of non-EU-based manufacturers. REACH clients include companies in the electronics, fragrances, metals, plastics, polymers, textiles, biocides and pesticides sectors. Our integrated REACH team, comprised of both lawyers and technicians, enables us to provide a comprehensive approach to REACH compliance. We will be pleased to discuss our REACH services in detail; an outline is provided below.

Our REACH services include:
· Acting as “Only Representative” (OR)
· Acting as “Third Party Representative”(TPR)
· Overall coordination and implementation of REACH compliance strategy
· Responding to ad hoc strategic/legal regulatory questions

Legal
· Preparation and negotiation of Confidentiality, Data- and Cost-Sharing and Lead Registrant Agreements for the relevant SIEF(s)
· SIEF (and pre-SIEF) activities – participation directly as OR or TPR; indirect support for client’s own participation in SIEF meetings raising legal issues (technical and other SIEF activities covered by our technical colleagues)
· Consortia – Preparation/review and negotiation of Consortia Agreements; participation in relevant steering and legal affairs activities

Technical
· Preparation for Pre-Registration: Compilation of REACH substance portfolio or review of portfolio, as needed (assessment, inter alia, of substances exempt, substances to be pre-registered, registered, authorized, etc.)
· Preparation of Registration Dossier
· Review of adequacy of Pre-Registration and Registration activities
· Preparation of Chemical Safety Reports (CSRs) and Safety Data Sheets (SDSs)
· SIEF (and pre-SIEF) activities – Participation as OR or TPR (technical group and general representation when legal support is not necessary) or technical support to client’s participation
· Consortia – Participation in technical affairs activities
· Development of strategy for sourcing data to fill data gaps (if any), including:
* Literature search and review
* Data valuation
* Recommend study protocols, provision of cost estimates, sourcing CROs and studies (e.g., acquisition from other SIEF members, further testing, etc.)

Steptoe & Johnson LLP provides counsel and representation in a wide range of legal fields. In more than 60 years of practice, the firm has gained a national and international reputation for vigorous representation of clients before governmental agencies, successful advocacy in litigation and arbitration, and creative and practical advice in guiding business transactions. The firm has offices in Washington, New York, Chicago, Phoenix, Los Angeles, Century City, London, and Brussels.