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Analysis of the Chemical Management Regulations: REACH and CLP

The safe use of chemicals, chemical substances, and their mixtures is governed by multiple regulations at both EU and national levels. It can be challenging to elucidate the specific meanings of the EU REACH and CLP regulations within the complex regulatory framework and to determine the applicability of relevant obligations to one's business operations.

The production, importation into the EU, downstream use, and distribution of chemicals are integral parts of daily operations for many enterprises across various industries. The primary chemical legislation of the European Union comprises the EU REACH Regulation and the CLP Regulation enforced by the European Chemicals Agency (ECHA). The CLP Regulation mandates enterprises to identify and classify the hazardous properties of chemical substances and their mixtures, as well as to label and package them in accordance with the hazardous classification.

Scope of REACH Regulation:

  • Chemical substances (e.g., acetone, nickel, wood tar)
  • Mixtures (e.g., paint, cleaner, concrete)
  • Articles (e.g., kettles, car tires, batteries)

Key topics related to chemical regulations include the circular economy, SCIP assessments and notifications for products, and new substances such as nanomaterials. Substances post-waste disposal (End-of-Waste, EoW) must also comply with REACH Regulation requirements. Recently, the circular economy has introduced new demands regarding the interpretation of chemical regulations. The REACH Regulation includes certain exemptions for by-products meeting specific criteria and substances that were previously registered.

There are also exemptions for scientific research and development purposes. However, in practice, even small quantities of substances used for scientific research and development must be reported by producers or importers to the European Chemicals Agency via the classification and labeling inventory. This requirement is often overlooked.

Articles containing specific hazardous substances (Substances of Very High Concern, SVHC) must be reported to the SCIP database managed by the European Chemicals Agency. As of July 19, 2021, Finland has made SCIP notification a mandatory requirement.

Furthermore, REACH obligations for manufacturers and importers also apply to nanomaterials (1-100 nanometers). Environmental and health impact information, as well as safety data sheets, are required for nanomaterials.

Chemical substances and their mixtures classified as hazardous materials, regardless of quantity, require the preparation of safety data sheets. The obligation to provide safety data sheets applies to all batches and scales, irrespective of the quantity of substances involved.

Analysis of the Chemical Management Regulations: REACH and CLP

HYSD Bio

Shanghai Haoyi Shuada Biotechnology Co., Ltd. is a comprehensive and technology-centered biopharmaceutical company with a focus on innovation. As a customer-centric and quality-driven enterprise, Haoyi Shuada provides global biopharmaceutical companies with end-to-end services covering laboratory research, production, process scaling, and technology transfer.