Classification, Labeling and SDS
Almost every region of the world has a legal framework and 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 TSCA is a risk based system. The data and regulatory arguments supporting the same chemical in both jurisdictions therefore require different tactics.
Navigating your chemical onto the global market can therefore 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. That means anticipating regulatory hurdles and having clear mitigation plans from the start.
- An experienced team of cross-functional staff specializing in regulatory science in relation to classification labelling and safety data sheets (SDSs)
- A proven track record in classification labelling compliance across multiple jurisdictions worldwide
- Expertise in safety assessments exposure scenarios and interpretation in safety data sheets
Complying with classification labelling for your chemical
Manufacturers, importers and retailers all need to ensure that a chemical conforms to the correct classification and that labelling and SDSs are compliant. That not only means 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 a standard layout and information requirements; however, these vary between jurisdictions. You need to know what each regulator in each market looks for and that you follow their recommended template. You also can’t just cut and paste between safety data sheets for different regulators as they all vary slightly. This can therefore take time, 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 labelling across all jurisdictions worldwide. Working in partnership with you, we can:
- advise on a strategic approach to classification labelling 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 labelling needed for your target markets including signal words, hazard pictograms, hazard and precautionary statements
- develop documentation to comply with classification labelling requirements
- draw up safety data sheets 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 labelling compliance across all global jurisdictions
Covance has a proven track record of supporting customers with classification labelling 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 safety data sheets (SDS) 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 developing:
- SDS for CLP under REACH
- Material Safety Data Sheets (MSDS) for the US