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India – REACH & Changes to REACH (EU) Requirements

By April 29, 2022 No Comments

For many chemicals important toxicological and ecotoxicological studies have never been carried out. As the lack of knowledge about toxicity is not labelled, these chemicals appear to be safe. However, there is a continuous focus on making the environment safer for ourselves and the for the generations to come. 

India has recently circulated Draft – Chemical (Management and Safety) Rules, 20xx, “India- REACH” (or ICMS Rules or CMS Rules) which will replace existing Manufacture, Storage and Import of Hazardous Chemicals (MSIHC) Rules 1989 and Chemical Accidents (Emergency Planning, Preparedness and Response) (CAEPPR) Rules 1996. These rules are framed in exercise of the powers conferred by Sections 3, 6 and 25 of the Environment (Protection) Act, 1986 (29 of 1986). 

This was slated to come out in 2021 but due to covid there has been a delay and it is now expected in 2022. Indian Manufacturers, Indian Importers and Authorized Representative/AR – located in India appointed by Foreign Manufacturers will need to comply once this comes into force.

Recently, REACH the European chemicals legislation (Registration, Evaluation and Authorization of Chemicals) has proposed amendments and revisions and the changes related to this revision will begin to apply in October 2022. 

This will lead to far more chemicals undergoing comprehensive testing. All existing substances (i.e. substances placed on the market before 1981) with production or import volumes of more than 1 tonne per year must now be systematically tested with regard to their dangerous properties. Both consumers and workers who come into contact with chemicals will benefit and the onus will be on industry for the safe handling of its products.

What will change as a consequence of REACH?

Changes to REACH requirements

12 April 2022 – 0 Submitted by Andrew Warmington

The European Commission has revised certain information requirements for registering chemicals under REACH. It advised companies to start preparing as the changes will start to apply in October. Further advice will be issued in 2H and changes will be made accordingly in Iuclid.

The main changes concern requirements and specific rules for the adaptation of

  • In vitro and in vivo studies, when further studies are needed based on mutagenicity concerns
  • Reproductive toxicity studies, specifying the preferred animal species and administration routes, and clarifying the conditions triggering the need for further studies
  • Aquatic toxicity studies, clarifying when long-term studies must be performed instead of short-term studies or in addition to them
  • Toxicity studies on terrestrial and sediment organisms, specifying when long- term studies are needed instead of short-term studies and clarifying that long- term testing must investigate both degradation and transformation products
  • Degradation and bioaccumulation studies, specifying when further testing is needed, including investigation of both degradation and transformation products

There are also additional substance identification information requirements, including

  • Describing the compositions, nanoform or set of similar nanoforms related to information submitted to fulfil information requirements under Annexes VII-X
  • Reporting a crystal structure and for reporting compositions for substances with unknown or variable composition, complex reaction products or of biological materials
  • Clarified requirements for reporting constituents, impurities, additives and analytical information

Credit: As appeared in Speciality Chemicals issue dated 12th April 2022. https://www.specchemonline.com/changes-reach-requirements

I R Tubes Private Ltd., Pune are distributors for quality chemicals of Deutsche Oelfabrik of Germany, Omya UK Ltd., Robinson Brothers, UK, Emery Oleochemicals Ltd and Aquaspersions. Our chemicals are used in the manufacture of Rubber, Plastics, Latex, Adhesives and Sealants. All our products are REACH registered and ROHS compliant

I R Tubes Private Ltd., Pune are distributors for quality chemicals of Deutsche Oelfabrik of Germany, Omya UK Ltd., Robinson Brothers, UK, Emery Oleochemicals Ltd and Aquaspersions. Our chemicals are used in the manufacture of Rubber, Plastics, Latex, Adhesives and Sealants.

All our products are REACH registered and ROHS compliant

Raju Jethmalani
IRTubes Pvt. Ltd., Pune

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