Ensuring compliance in China for new and hazardous chemical substances and according to GHS

Decree 591 - Hazardous Chemical Management

The Regulations on Safe Management of Hazardous Chemicals (Decree 591) came into force in 2011 and is the overarching law on the control of hazardous chemicals in China.

Decree 591 is supported by a number of catalogues and ministerial regulations that help to manage hazardous chemicals across the supply chain. These include the “Catalogue of Hazardous Chemicals”, registration of hazardous chemicals under “SAWS Order 53” and various other SAWS regulations on hazardous Chemical testing and licensing.

MEP Order 7 - New Chemical Substance Notification (NCSN)

China’s Provisions for the Environmental Administration of New Chemical Substances (MEP Order 7), unofficially known as “China REACH”, was released by the Chinese Ministry of Environmental Protection (MEP) and came into force on 15 October 2010.

MEP Order 7 requires manufacturers and importers of a “new substance” to submit a new chemical substance notification (NCSN) to the MEP’s Solid Waste and Chemical Management Centre (MEP-SCC) before manufacture or import. A new substance is defined as a chemical that is not listed on the Inventory of Existing Chemical Substances in China (IECSC), excluding substances subject to exemptions.

China’s Globally Harmonised System

China implements the 4th revised edition of the UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS). There are requirements under Decree 591 and MEP Order 7 to provide SDS according to China GHS for hazardous and new chemical substances.




How can we help?

Regulatory Impact Assessment

We can help to assess your company’s chemical substances and products, identify which duties apply and advise on the best strategy towards compliance. Our Regulatory Impact Assessments summarise the process, costs and timelines for registration, allowing you to make effective business decisions about your products.

Registration

The Yordas Group has significant experience in submitting Registrations for a wide range of substances. Our regulatory consultants work very closely with our scientific experts throughout the Registration process on:

  • Substance Identity and “Sameness” checks
  • Data Gap Analysis, Testing Strategies, Read-across Justifications,
  • Expert Assessments, QSAR Modelling and Waivers
  • Commissioning testing and study monitoring
  • Human and Environmental Health Hazard, Exposure and Risk Modelling
  • Chemical Safety Assessment/Report and Exposure Scenarios

In-country Representation

To submit a New Chemical Substance Notification under MEP Order 7, non-Chinese companies must appoint a Chinese Representative Agent (similar to the ‘Only Representative’ role in the EU). Yordas can provide an Only Representative to represent your company for the purpose of submitting notifications.

We can also support your importers/manufacturers in China to prepare registrations under Decree 591 in the dataset in the language and format required.

Preparation of Chinese Safety Data Sheets and labels

Yordas can support you at every stage, from classification of substances and mixtures, advising on labelling requirements (including font or hazard pictogram size, hazard and precautionary statement selection) and authoring Safety Data Sheets in the format and language required. We also can research and fill any gaps in your data.

Other Services

  • Application to check the confidential portion of the IECSC
  • Guidance on exemptions and small volume notifications
  • Support to carry out post-notification obligations

Downloads & Resources

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