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A strategic scientific approach combined with regulatory insight optimizes ED testing and allows us build compelling regulatory arguments from a strong evidence base
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Extensive in vitro and in vivo testing capabilities deliver robust and credible data acceptable to regulators around the world including the EPA, EFSA and ECHA
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Cutting-edge techniques answer the most challenging questions related to thyroid hormone analysis
Almost every region of the world has a legal framework and a statutory body that regulates the manufacture, importation or marketing of chemicals.
Many regulatory endpoints are based on harmonized testing methodologies, although their application can be subtly different across regulators. In addition, the interpretation and usage of the resulting data can vary. A good example of this is the comparison between the regulatory approaches of the EU/ECHA and the US/EPA. EU-REACH is a hazard-based system, while the TSCA is a risk-based system. Therefore, in these jurisdictions, the data and regulatory arguments supporting the same chemical require different tactics.
Navigating your chemical onto the global market can be challenging. You need a broad and deep understanding of different regulations and strategic insight to help you leverage your data in the most efficient and cost-effective manner. You also need to ensure that your chemical’s regulatory journey to approval is as rapid and smooth as possible. This means anticipating regulatory hurdles and having clear mitigation plans from the start.
Complying with classification labeling for your chemical
Manufacturers, importers and retailers need to ensure that a chemical conforms to the correct classification and that labeling and SDSs are compliant. This means not only knowing what is appropriate for your chemical in each market, but also supporting it with the correct documentation. In most cases, compliance is simple if you follow the guidance provided by authorities; however, it can be time consuming and a drain on administrative resources, especially for ongoing monitoring.
Characterizing and communicating chemical safety and risk assessments
Safety data sheets usually conform to standard layout and information requirements; however, these vary between jurisdictions. You need to know what each regulator in each market looks for and then follow their recommended template. You aren’t able just to cut and paste between SDSs for different regulators, as they all vary slightly. This can, therefore, take time and focus and requires good insight into global regulations.
End-to-end support for classification labelling across your chemical portfolio
Our expert team can help guide you step by step through the complexities of classification labeling across all jurisdictions worldwide. Working in partnership with you, we can:
- advise on a strategic approach to classification labeling across your chemical portfolio and range of target markets
- classify an individual chemical based on existing data or draw up proposals for filling data gaps
- establish labeling needed for your target markets including signal words, hazard pictograms, hazard and precautionary statements
- develop documentation to comply with classification labeling requirements
- draw up SDSs or chemical safety reports in line with requirements in target jurisdictions and exposure scenarios
- submit or notify relevant authorities
- provide ongoing monitoring support for your chemical
Supporting classification labeling compliance across all global jurisdictions
We have a proven track record of supporting customers with classification labeling across a range of global jurisdictions including:
- EU/EEA: Classification, Labelling and Packaging (CLP)
- USA: Toxic Substances Control Act (TSCA) or Federal Hazardous Substances Act (FHSA)
- Rest of world: GHS
Expertise in drafting compliant safety assessments in line with regulatory requirements
Our team has experience in developing SDSs or chemical safety assessments for various jurisdictions. From the possible exposure scenarios you supply, we can generate risk assessments to include within the SDS. A factor critical to success with safety assessment is understanding how different regulators interpret data and apply their regulations. We have experience of developing:
- SDS for CLP under REACH
- material safety data sheets (MSDS) for the US