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 chemicals 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

Although the UK left the EU on 31^st 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