REACH + Global Product Stewardship

ICF International helps corporations that conduct business in Europe understand REACH requirements, navigate through the registration and authorization process, prepare registration dossiers, meet critical deadlines, and implement necessary changes to achieve effective global product stewardship.

 

 

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the European Commission's regulatory system for approximately 30,000 chemicals. It requires companies to register new substances, as well as many substances already in commerce, with the European Chemicals Agency. 

REACH transfers responsibility for gathering data and carrying out risk assessments from the European authorities and places the burden on industry. The regulation went into effect in June 2007 and has already passed two significant milestones: the Pre-registration period completed on December 1, 2009, and the registration period for the highest tonnage volume band substances (and substances of Very High Concern) on December 1, 2010. Registration deadlines for substances above 100 metric tonnes and above 1 metric tonne occur on June 1, 2013, and June 1, 2018, respectively. By all accounts, the next deadline in June 2013 will affect even more businesses and substances. 

Manufacturers, importers, and downstream users will need to demonstrate and document that the manufacture, import, or use of a substance does not adversely affect human health or the environment and that risks are adequately controlled. The stakes are high, as compliance costs can be significant, and noncompliant products will not be allowed in the European market. 

The European Chemicals Agency (ECHA) and European authorities are currently involved in the Evaluation aspect of REACH registration dossiers submitted in the highest volume bands. The evaluation process may result in requests for additional information from industry, modifications to submitted dossiers, or restrictions on import, use, or production in the European market.

ICF and our strategic partner Penman Consulting BVBA provided award-winning program management, science, legal, and logistical support to several major organizations throughout the 2010 REACH Registration. We helped these organizations communicate and coordinate among their various members, develop policies on data sharing and data access costs, prepare and submit dossiers, and develop or modify critical documents such as Chemical Safety Assessments and Reports. We are now helping organizations implement changes in labeling and other product stewardship that follow from REACH, as well as preparing methodologies and management plans for handling requests for additional information from ECHA and competent authorities. 

REACH and Global Product Stewardship

The next REACH volume band—those substances manufactured or imported in quantities above 100 metric tonnes—must be registered before June 1, 2013. We are working closely with clients to ensure that they are able to meet the 2013 registration deadline and are applying lessons learned and a refined methodology to ensure that our client's 2013 registration process is as successful as the 2010 deadline. 

 

Related Resources

Business Strategy Consulting

ICF can help you understand and implement confusing and complicated REACH requirements, including those on collaboration and internal and external communication of information. For organizations in the planning stages for REACH, we can facilitate and conduct business process design projects and develop implementation strategies that incorporate people, process, and technology.

Operational Support to SIEFS and Consortia

ICF has award-winning experience supporting active REACH Substance Information Exchange Forums (SIEFs) and consortia. ICF and our partners focus on achieving the most important objective: complying with the REACH requirements as efficiently, accurately, and quickly as possible.

Grouping Chemicals for Dossier Production

ICF has developed strategies for grouping chemicals to reduce the costs associated with dossier production process. Careful grouping facilitates extrapolation (read-across) to other structurally similar data-rich substances or classes of substances and the use of expert judgment and weight-of-evidence arguments to make classification and labeling recommendations. 

Preparation, Entry, and Review of Data in IUCLID

For several European chemical consortia, ICF provided data review, extraction from primary sources, and entry into the International Uniform ChemicaL Information Database (IUCLID5) for all required human health, environmental fate, ecological, and physical/chemical endpoints. This support included extensive quality control and analysis of the data, which subsequently were used to prepare Chemical Safety Assessments and Reports.

Technical Dossier Production

ICF had a direct technical role or provided related support in preparing dossiers for more than 10 percent of the substances registered in 2010. We understand how to prepare and integrate the complex set of information needed for a dossier, including uses, exposure scenarios, physical/chemical properties, toxicity, environmental fate, hazard assessment, and risk characterization.

Toxicology and Exposure Assessment

ICF has more than 30 years of experience and more than 200 scientific staff focused on toxicology, chemistry/environmental fate, exposure assessment, risk characterization, and risk management. Our experts have applied this knowledge and experience in preparing chemical dossiers and safety reports that meet the specific requirements of REACH.

Chemical Safety Assessment/Report Preparation

For several European chemical consortia, ICF helped prepare chemical safety assessments (CSAs) and chemical safety reports (CSRs) to support the 2010 REACH product registration. We compile substance inventories; evaluated the chemical, physical, and toxicological test data; designed and performed literature searches to supplement available data; identified exposure scenarios; and conducted exposure assessments using measured data and modeling.

Socioeconomic Analysis

ICF has a long history of preparing substitutes, cost-benefit, and socio-economic analyses for various chemical substances, including persistent organic pollutants (POPs), chlorofluorocarbons (CFCs) and hydro-chlorofluorocarbons (HCFCs); other ozone depleters; and some pesticides. Our economists and engineers are experienced in analyzing chemical uses and substitutes, often within the European regulatory framework, and understand how the REACH process works.

Classification and Labeling

ICF has made classification and labeling recommendations for hundreds of industrial chemicals for European chemical consortia and international chemical companies in accordance with the Classification, Labeling, and Packaging of Substances and Mixtures (CLP), as well as the Globally Harmonized System (GHS) of Classification and Labeling. These recommendations have been used to populate Safety Data Sheets (SDSs), Material Safety Data Sheets (MSDSs), and REACH chemical registration dossiers.

Business Process Improvement

ICF has more than 30 years of experience and more than 950 professionals providing IT and management solutions to evaluate, design, reengineer, and implement business processes and information management strategies. Organizations complying with REACH have opportunities to improve existing business processes and develop new ways to respond to new and emerging REACH data requirements. ICF's IT and management professionals include experts with decades of experience designing, developing, and implementing product stewardship information management solutions, including many of the leading commercially available systems.

Economic Impact Modeling/Analysis

ICF specializes in estimating the wider economic impacts of policies or changes in economic activity. Economic analysis of these wider impacts is crucial for understanding the full implications of changes to product markets that would result from the scenarios in an analysis of alternatives. ICF estimates three distinct kinds of economic impacts: direct, indirect, and induced. 

Risk and Uncertainty Analysis

ICF economists are eminently skilled in the application of analytical frameworks designed for estimating highly uncertain costs and benefits such as those arising from changes to human health and the environment. ICF specializes in performing Monte Carlo simulations and other kinds of sensitivity analysis to estimate the effects of uncertainty and risk on changes in market activity. ICF economists are experienced in applying state-of-the-art tools, such as @Risk and Crystal Ball, and in creating econometric and spreadsheet models that use uncertain input values and produce outcomes with easily interpretable results.

  • Project

    Classification and Labeling

    ICF has made classification and labeling recommendations for hundreds of industrial chemicals for several European-based chemical consortia and international chemical companies. ICF’s experience using read-across strategies and weight-of-evidence arguments has provided our clients with recommendations in accordance with classification, labeling, and packaging (CLP) and Globally Harmonized System (GHS) regulations.

  • Project

    Dossier Preparation, Including IUCLID Data Entry and Chemical Safety Assessment/Report Production

    ICF provided comprehensive technical support for International Chemical Information Database (IUCLID) dossier preparation in advance of the 2010 substance registration deadlines for several European-based chemical consortia and international chemical companies. ICF reviewed available technical information and ensured their completeness, compared exposure estimates with derived-no-effect-levels (DNELs) and predicted-no-effect-concentrations (PNECs) for scenarios of potential concern, and drafted chapters for Chemical Safety Reports Assessments and Reports.

  • Project

    REACH Consortia and SIEF Management

    ICF provided operational support for several European chemical company consortia, representing hundreds of member companies and substances, as well as Substance Information Exchange Forum (SIEF) management for several consortia.

Contact Info

Email:
info (at) icfi (dot) com

Phone:
+1.703.934.3603 or +1.800.532.4783

Address:
9300 Lee Highway, Fairfax, VA 22031-1207 USA

Find an ICF Office near you »

Penman Consulting BVBA

Michael Penman of Penman Consulting has more than 30 years of experience in managing toxicology, regulatory affairs, and information technology. He has led science and regulatory teams in the areas of synthetic rubber, olefins, plasticisers, and oil refining streams. He has supported the development of regulatory databases such as the International Uniform ChemicaL Information Database (IUCLID) and in developing novel approaches for the risk assessment of chemicals and in regulatory developments.

Mr. Penman has performed trade association work on REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and chaired the consortia management group contracted to the European Union to provide a scoping study on information requirements (RIP 3.3-1). He was also a member of the Programme Management Group for the subsequent final report.

Prior to establishing Penman Consulting, he spent nearly a decade at ExxonMobil, initially as Senior Toxicology Adviser for Europe, and subsequently as the Technical REACH/Globally Harmonized System (GHS) Implementation Manager. Mr. Penman began his career at ICI Group, providing toxicological and regulatory information services to the whole ICI Group, and then as Senior Toxicology and Product Regulatory Adviser to specific businesses. Mr. Penman was named MBE by Queen Elizabeth II for "Services to Environmental Safety."

 
 

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