Services
Chemistry
Our chemists have many years of industrial and Contract Research Organisation (CRO) experience in testing, evaluating, and supporting active substance and product registrations, making us ideally positioned to deal with US, EU, and global challenges across the crop protection, biocides and antimicrobials, industrial chemicals, cosmetics, crop nutrition, and animal health sectors.
We provide assistance for key sections of registration dossiers including identity, physical and chemical properties, and analytical methods, technical equivalence assessments, preparation of Safety Data Sheets (SDS) and labels, and compliance with Classification, Labelling and Packaging (CLP) legislation.
Experienced Support For:
- Classification & Labelling
- Preparation of Safety Data Sheets (SDS)
- Study Design, Placement & Monitoring
- Preparation of Key Dossier Sections Including Identity, Physical & Chemical Properties & Analytical Methods
- Technical Equivalence
Classification & Labelling
- Support for clients manufacturing, importing, using or distributing chemical substances or mixtures into the European Economic Area (EEA) (EU27 plus Iceland, Liechtenstein and Norway) and the UK market including review to ensure compliance with the Classification, Labelling and Packaging (CLP) Regulation (EC 1272/2008).
- Support for clients to ensure products are appropriately classified, labelled and packaged in accordance with the US Consumer Product Safety Commission (CPSC) requirements under the Federal Hazardous Substances Act (FHSA) and Health Canada’s requirements under the Consumer Chemicals and Containers Regulations (CCCR, 2001), Consumer Packaging and Labelling Act (CPLA) and the Canada Consumer Product Safety Act (CCPSA).
Safety Data Sheets (SDS)
- SDS preparation in accordance with the UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS), US Occupational Safety & Health Administration (OSHA) standards, REACH (Regulation 2006/1907/EC) and CLP (Regulation 2008/1272/EC).
- Assessment of physical and chemical properties, toxicology and ecotoxicology hazards to support classification.
Study Design, Placement & Monitoring
- Design, placement, and monitoring of required chemistry studies to support registration at Contract Research Organizations (CRO).
- Review and interpretation of study results, and Good Laboratory Practice (GLP) compliance consulting.
Identity
- Review of purity/impurity profile and setting of active substance technical specifications.
- Review of five batch analyses.
- Preparation of data waivers and read-across arguments.
- In silico prediction modeling e.g. Quantitative Structure-Activity Relationship (QSAR) to determine (eco)toxicity profile of impurities.
- Dossier preparation, including confidential sections, to support regulatory submission.
Physical & Chemical Properties
- Data gap analysis to support active substance approval / product authorization.
- Preparation of data waivers and read-across arguments.
- Advice on appropriate testing methods (e.g. CIPAC, EC, OECD) to support registration.
- Study design and monitoring of studies to assess physical and chemical properties including storage stability studies.
- In silico prediction modeling e.g. (Q)SAR to address phys-chem endpoints.
- Dossier preparation, including physical hazard classification, to support regulatory submission.
Analytical Methods
- Data gap analysis to support active substance approval / product authorization.
- Preparation of data waivers and read-across arguments.
- Advice on appropriate analytical methods to support pre-approval data, post-approval control and monitoring, analysis of the active substance / product, and risk assessment.
- Dossier preparation to support regulatory submission.
Technical Equivalence
- Preparation and submission of technical equivalence evaluations to compare chemical composition and hazard profile in support of existing or alternative sources of active substance.
- Tier I (Chemical equivalence) and Tier II (Toxicology / Ecotoxicology) assessments as necessary.
- Liaison with regulatory authorities.
Resources:
Chemistry Experts
Steven Andrews
Senior Consultant
United Kingdom
