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India’s final draft of Chemicals (Management and Safety) Rules was circulated to a limited number of industry associations by the Ministry of Chemicals and Fertilizers on March 16th, 2020. The draft hasn’t been officially published for public comments. As planned it will come into force on the date when it is published in the Official Gazette.
A new division named Chemical Regulatory Division will be established to manage all the functions related to implementation of the Rules, including evaluation of notifications and registrations, preparation and maintenance of an information database, public information dissemination, etc. In addition, three committees will be set up, including steering committee, scientific committee and risk assessment committee.
Notification
India’s notification mechanism will be similar to pre-registration under EU REACH. All existing substance in quantities above 1 tonne per year require notification by manufacturers and importers within 180 days from the date of the commencement of the notification. New chemicals shall be notified 90 days prior to being placed on the Indian market. The notifcation requires information including substance’s identity, uses, quantity, downstream users, and classification information, etc. (see Schedule V). India hasn't adopted UN GHS yet, and the draft refers directly to UN GHS Rev.8 for chemical classification.
A downstream user shall notify the Division of use and submit a SDS in relation to such use if the use of a notified substance is not included in its notification.
As proposed the new requirement will come into force one year after the implementation of the Rules. In addition, notifications shall be updated each year.
Registration of existing priority substances
The notified substances will be assessed by the Priority Substance Unit under the Division in concurrence with the Scientific Committee and the Risk Assessment Committee to see if they fall within the definition of priority substances and shall be listed in Schedule II. So far 750 priority substances have been listed in Schedule II, of which 37 substances have been listed in Schedule VI as priority substances that need to be registered.
Registration is required for priority substances listed in Schedule VI in quantities above 1 tonne per year. The contents of a technical dossier for registration are specified in Schedule VII. In addition, a Chemical Safety Assessment Report is required for those in quantities above 10 tonnes per year.
An only representative (OR) can be appointed to comply with the Rules on behalf of foreign manufacturers. Registrants can do joint registration of a same substance, while no details are provided for establishing consortium and data sharing, etc.
The priority substances listed in Schedule II will be subject to authorization and restriction after further assessment by the Priority Substance Unit.
For years India has been working on formulating a REACH-like regulation for chemical management and obviously there are many aspects awaiting further clarification. We hope professionals can have your say on the regulation and play an active role in promoting sound regulations for chemical management in India.
