TSG

REACH (Registration, Evaluation, Authorization and restriction of Chemicals) (Regulation (EC) No 1907/2006) entered into force on June 1, 2007. The Regulation will have a significant impact on manufacturers and exporters to the European Union (EU). REACH Timetable

Some chemical products, such as pharmaceuticals, biocides and pesticides are partially exempt but the companies involved must still assess their obligations under REACH.

The key stages of REACH involve:

• Pre-registration: of ‘phase-in' (existing) substances (to be completed by December 2008)
• Registration: submission of a dossier by specific deadlines depending on annual tonnage and on certain hazardous properties of the individual substances
• Evaluation: dossier review by the European Chemicals Agency and the Member States Competent Authorities
• Authorization: authorization of substances of concern (such as CMRs, PBTs, vPvBs and other substances of equivalent concern [i] ) by specific uses, under specific conditions, for specific time periods
• Restriction: regulation of substances – covering manufacturing, marketing and/or conditions of use.

‘Pre-registration' will be required and registration will follow soon after for relevant chemicals.  Companies must plan and prepare now.  Other important procedures, such as the first recommendations for priority substances to be included in “Annex XIV”, will occur within three years of entry into force.  To protect their interests, companies need to be aware of the consequences of such procedures and to take the appropriate action now.  Timely preparation and action can reduce costs, remove the uncertainty associated with the impact of REACH, and strengthen a company's long-term competitiveness within the European marketplace.

Consortia based on Substance Information Exchange Forum (SIEF) will play a key role in the REACH process from registration to authorization or restriction. Amongst their roles, successful consortia will facilitate exchanges of information, avoid duplication of studies and facilitate agreements on classification and labeling. Based on our extensive experience with consortia in other regulated chemical sectors TSGE and TSG are well placed to help establish and manage consortia, represent companies, and provide independent advice.

For scientific issues under REACH, our human health, environmental and chemistry experts can assist with:

• Design and implementation of technical strategies for supporting substances through REACH
• Assessment of chemical inventories for data compliance (upstream and downstream companies)
• Evaluation of existing data, devise and commissioning new studies and programs
• Running seminars on REACH, its implications and implementation
• Providing advice and strategy to address data deficiencies (from QSARs, read-across [ii] , waivers, public domain data, data sharing etc).  

TSG's REACH Services

TSG and our European affiliate, TSGE, are able to offer assistance and consultancy in all aspects of the requirements of REACH.  We offer REACH-based consultancy services tailored to the particular requirements of companies and examples of this are listed below.

General advice on the obligations and impact that REACH imposes on businesses, which measures should be undertaken and when:

• Early stage training
• Advice on the obligations of companies
• Seeking potential consortium partners ^[iii]
• Establishing consortia; avoiding pitfalls
• Representation in the early stages of consortium establishment
• Establishing TSGE  as an ‘only representative' or a ‘third party representative' [iv]
• Coordination of establishing an EU enterprise

  REACH services required early in the process:

• Establishing an inventory of all substances, substances in preparations and in articles
• Listing possible pre-registration candidates
• Reviewing and updating Safety Data Sheets (SDSs)
• Establishing known properties (physical, environmental, toxicological)
• Identifying the potential classification of substances,  within the scope of REACH and assessing their properties (CMR, PBT, vPvB)
• Designing and implementing strategies for these substances under REACH
• Contacting suppliers and customers to determine their REACH readiness
• Contacting customers to determine their product uses
• Contacting suppliers to confirm your product uses
• Collating and establishing the value of data (public domain, proprietary)
• Evaluating quality and relevance of existing data, development of strategies to support existing data
• Determining potential for data waivers, undertaking of QSAR, read-across strategies as a surrogate for new studies
• Establishing strategies for use and exposure scenarios

 REACH services required following entry into force:

• Pre-registration preparation and submission
• Designing, commissioning and monitoring scientific testing
• Evaluating and developing supporting strategies for data packages for completeness, quality and relevance
• Registration dossier preparation and submission
• Chemical safety assessments and preparation of the CSR and SDS
• Preparation of testing proposals
• Negotiation with CA or with ECA consortia formation and representation
• Consortia formation and representation

 Contact TSG or TSGE for information on our REACH consultancy services.

Technology Sciences Group Inc. (TSG)
Washington, DC
Robert R. Stewart ▪ (202) 828-8963 ▪ RStewart@TSGUSA.com

Sacramento, CA
Arthur Lawyer ▪ (530) 757-1298 ▪ ALawyer@TSGUSA.com

WEB:  www.TSGUSA.com

Technology Sciences (Europe) Ltd. (TSGE)
Knaresborough, United Kingdom
Louis Wyness ▪ Matthew Curl ▪ Vicky Atkinson ▪ +44 (0) 1423-799-172 ▪ REACH@TSGEurope.com

WEB:  www.TSGEurope.com