Sector

Industrial Chemicals

Industrial and specialty chemicals are regulated in the US by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA). In the EU, these chemicals are subject to the Registration, Evaluation, Authorization, and Restriction of Chemicals Regulation (EC) No 1907/2006 – better known as REACH. Tens of thousands of chemical substances fall under these regulations.

We have significant expertise in the registration of industrial and specialty chemicals in the US and Europe and have been providing support to this sector for over 20 years. The REACH Regulation has presented a unique challenge to the chemical industry throughout the world. CSI has been actively involved with REACH since before the Regulation came into force in 2007 and offers a comprehensive service to companies and consortia faced with its demands. Now that the UK has left the EU, we can also help you comply with UK REACH to allow or maintain access to the UK market.

Experienced Support For:

  • Global Regulatory Strategy
  • Dossier Preparation & Submission
  • Regulatory Agency Liaison
  • TSCA Pre-Manufacture Notification (PMN) & Chemical Data Reporting (CDR)
  • EU & UK REACH Compliance
  • Only Representative (OR) & Third Party Representation
  • Chemical Safety Assessments (CSA) & Chemical Safety Reports (CSR)
  • Task Force Representation & Administration

CSI has a thorough understanding of the TSCA Inventory and the criteria used to determine the listing of a substance on the TSCA Inventory. In addressing the requirements of TSCA, CSI supports Pre-Manufacture Notifications (PMNs), High Production Volume (HPV) projects, and test rule requirements on various chemical classes.

 

Pre-Manufacture Notification (PMN)

  • Determine if a substance is listed on the TSCA Inventory
  • Support a "Bona Fide Intent" (BFI) search for chemical substances on the Inventory which have confidential identities by generic names
  • Identify if a substance is exempted from PMN Notification based on category
  • Complete necessary PMN forms and appendices, including required test data and claims of confidentiality. Our service includes consultation on your behalf with the EPA prior to PMN submission and during notice review. We can also place and monitor additional testing that may be deemed necessary by EPA's review.
  • Submission of PMN to EPA for new chemical substances in bulk form or as part of a mixture

Chemical Data Reporting (CDR)

The purpose of Chemical Data Reporting (CDR), formerly known as Inventory Update Reporting (IUR), is to collect quality screening-level, exposure-related information on chemical substances and to make that information available for use by EPA and, to the extent possible, the public. The rule requires manufacturers and importers to provide EPA with information on the production and use of chemicals in commerce in large quantities. CSI can assist businesses who are required to comply with the CDR regulation, including reporting data electronically using e-CDRweb, the CDR web-based reporting tool, and EPA's Central Data Exchange (CDX) system.

The REACH Regulation applies to the European Economic Area (EEA) - the 27 EU Member States, plus Iceland, Liechtenstein and Norway - and imposes significant obligations on companies placing cosmetics on the EEA market.

Our team of regulatory scientists has accumulated a wealth of experience in dealing with all scientific and regulatory aspects of REACH and specializes in the provision of technical and administrative support for compliance with the REACH Regulation.  We are therefore ideally equipped to assist our clients in ensuring that they meet their REACH obligations in a timely and cost-effective manner. Key activities are outlined below.

 

Only Representative (OR) / Third Party Representative

  • OR role for non-EU companies, independent Third Party support for handling confidential information
  • Quantitative Structure-Activity Relationship (QSAR)/structural read-across proposals and registration assistance

Registration Dossier Submission

  • Preparation of technical dossiers, Safety Data Sheets (SDS), Chemical Safety Assessments (CSA), Chemical Safety Reports (CSR) and supporting International Uniform ChemicaL Information Database (IUCLID) databases
  • Submission of documentation to the European Chemicals Agency (ECHA)

Chemical Safety Assessments (CSA) / Chemical Safety Reports (CSR)

  • Hazard assessment, exposure assessment, and risk characterization
  • Review of existing data, identification of data gaps, development of testing strategies
  • Placement and monitoring of studies at Contract Research Organizations (CRO)

SIEF Coordination / Consortia Management

  • Communication with Substance Information Exchange Fora (SIEF) members and assistance with consortia formation
  • Communication with suppliers, downstream users, and legal advisors.
  • Administrative and technical support for consortia

REACH Chemical Safety Assessment

  • Hazard Assessment
  • Exposure Assessment
  • Risk Characterization
  • Final Exposure Scenario
  • Chemical Safety Report (CSR)
  • Technical Dossier Preparation & Submission
  • IUCLID 6 Format Experience

Although the UK left the EU on 31st January 2020, the REACH Regulation was transposed into UK law almost unchanged, so the provisions of the Regulation apply in full in the UK. Key activities are outlined below:

 

Only Representative (OR) / Third Party Representative

  • Only Representative role for non-EU companies, independent third party support for handling confidential information
  • Quantitative Structure-Activity Relationship (QSAR)/structural read-across proposals and registration assistance

Registration Dossier Submission

  • Preparation of technical dossiers, Safety Data Sheets (SDS), Chemical Safety Assessments (CSA), Chemical Safety Reports (CSR) and supporting International Uniform ChemicaL Information Database (IUCLID)
  • Submission of documentation via UK REACH submission platform

Chemical Safety Assessments (CSA) / Chemical Safety Reports (CSR)

  • Hazard assessment, exposure assessment, and risk characterization
  • Review of existing data, identification of data gaps, development of testing strategies
  • Placement and monitoring of studies at Contract Research Organizations (CRO)

SIEF Coordination / Consortia Management

  • Communication with Substance Information Exchange Fora (SIEF) members and assistance with consortia formation
  • Communication with suppliers, downstream users, and legal advisors
  • Administrative and technical support for consortia

REACH Chemical Safety Assessment

  • Hazard Assessment
  • Exposure Assessment
  • Risk Characterization
  • Final Exposure Scenario
  • Chemical Safety Report (CSR)
  • Technical Dossier Preparation & Submission
  • IUCLID 6 Format Experience

Is Your UK Company Importing Chemical Substances From The European Economic Area?

Following the UK’s exit from the EU, CSI can assist you with all aspects of UK REACH and EU REACH – from initial consultation and substance review, through notification, to registration dossier composition and submission.

Industrial Chemicals Contacts

Warren Scott's Picture

Warren Scott

Principal Consultant

Scotland

Jeremy Wilson's Picture

Jeremy Wilson

Business Development

Oregon

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Warren Scott
Principal Business Development Consultant

Expertise: Business Development & Regulatory Consulting

Warren shares a direct consulting role for Industrial Chemicals (REACH), Biocides and Cosmetics, with a Business Development remit for CSI’s European office.

Warren has over 30 years’ experience in laboratory contract research, business development for contract research organizations, and the consulting sector. His experience encompasses projects in various business sectors including plant protection, chemical, biocidal and cosmetic products. Warren qualified as a Soil Scientist and prior to joining CSI held scientific and business development positions at Inveresk Research and Wildlife International.

EDUCATION
BSc (Hons) Soil Science, University of Aberdeen.

Jeremy Wilson
Business Development

Expertise: Business Development & Marketing

Jeremy leads marketing and business development efforts in North America and Latin America. He represents CSI at various industry trade associations and professional societies.

Jeremy has over 23 years of experience in regulatory affairs and product registration compliance with Federal, State, and International chemical regulations. His experience includes government agency interactions and determination of appropriate regulatory pathways to meet product registration objectives. He has prepared numerous registration submissions, placed and monitored necessary Good Laboratory Practice (GLP) studies to develop data and documentation, and served as the primary agency liaison for the registration process. Jeremy has expertise with biorational/biopesticide registration and Latin America regulatory requirements.

EDUCATION
BS, Environmental Science; Minor in Biology, Washington State University.