Ä¢¹½tv

Capabilities & Services

• REACH Dossier Update Obligations

  Ä¢¹½tv assists companies looking to improve the quality of REACH registrations or to help mitigate the risk of European Chemical Agency (ECHA) requests for additional test data.

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• Risk Management of Industrial Chemicals in the EU

  From our offices in Europe, the U.S., and Asia, Ä¢¹½tv offers a wide range of technical and regulatory expertise to help companies prepare their authorization applications and manage risk compliantly as required by the European Chemicals Agency.

• REACH Authorization & Restriction

  REACH restrictions can impose specific use conditions or limit or ban the manufacture, import, sale, or use of a substance, and Ä¢¹½tv assists companies whose substances are under scrutiny to ensure regulatory compliance.

• Chemistry Services for Plant Protection Products, Biocides and Chemicals in the EU

  The Ä¢¹½tv Chemical Regulation and Food Safety chemistry team has significant expertise in testing, evaluating, and supporting registrations of active substances and formulated products in the EU, for Plant Protection Products (Regulation 1107/2009), Biocidal Products (Regulation 528/2012) and Industrial Chemicals (REACH Regulation 1907/2006).

• Environmental Risk Assessment of Plant Protection Products, Biocides, Chemicals, Veterinary Medicines & Pharmaceuticals in the EU

  Assessing the potential effects on individual organisms, natural communities and ecosystems is integral to the regulation of pesticides, biocides and industrial chemicals, and Ä¢¹½tv can assist with your environmental risk assessments by choosing the appropriate course of action, providing laboratory support for your study, and monitoring the study to ensure a robust data package.

• REACH Obligations for Substances of Very High Concern and Articles

  REACH registration obligations do not cease after initial dossier submission; amid concerns of non-compliance, the European Chemical Agency (ECHA) requires registrants to share any new information frequently, and Ä¢¹½tv assists companies looking to improve the quality of their registrations or to help mitigate the risk of ECHA requests for additional test data.

• Human Health Risk Assessments for Plant Protection Products, Biocides & Chemicals Under REACH Regulations

  Human health risk assessments use modeling and data to predict the exposure of operators, workers, residents, and bystanders to chemicals in products. Ä¢¹½tv has extensive experience using the regulatory models required for risk assessment for plant protection products, biocides, and chemicals subject to Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation in the EU and the U.K.

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• Summary of Services

  For 50+ years, we've thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

  • Regulatory strategy and advice — tailored to the individual requirements of the client
  • Program and project management — efficient communication and regular updates
  • Co-registrant and consortia management — full co-registrant / consortium management or participation
  • Data evaluation and gap analysis — determination of available data held within the SIEF and in the public domain; evaluation of their suitability (including Klimisch rating) and identification of data gaps
  • Use of integrated testing strategies (ITS) — consideration of grouping and read across, exposure based and technical data waivers, expert statements, and QSAR modelling
  • Study placement and monitoring — independent advice on choice of laboratory
  • Dossier preparation and submission — complete dossier in IUCLID including preparation of robust study summaries, end point summaries, inquiry dossiers, testing proposals, classification, and labelling, and toxicokinetics assessment
  • Chemical safety reports (CSR) — identification of uses and exposure routes including development of use descriptors, hazard assessment, DNEL/PNEC derivation, PBT/vPvB assessment, exposure assessment and development of exposure scenarios, risk characterization and recommendations on risk management measures
  • Evaluation and authorization services — post submission support, negotiation with European Chemicals Agency, socio-economic analysis
  • CLP — Notification, harmonized classification dossiers
  • Extended safety data sheets — incorporating exposure scenarios
  • Only representative and third-party representative services