India REACH: Fifth Draft of the Chemicals Management and Safety Rules Released

India released the fifth draft of the Chemicals (Management and Safety) Rules^[1] (known as “India REACH”) on August 24, 2020. This fifth draft is believed to be the final draft, despite the fourth draft issued in March 2020 was claimed as the final draft (ChemLinked news^[2]). As planned, it will be notified to the WTO for a 60-day consultation and come into force early next year.

Several notable amendments in the fifth draft are highlighted as below.

Notification

Existing substances that have placed in Indian Territory in quantities more than 1 tonne per year should be notified during the “Initial Notification Period". Any new substances that intended to be manufactured or imported into India after the “Initial Notification Period”should be notified at 60 days before the manufacture or import.

Substances to be registered/restricted

The Schedule II is changed from “list of priority substances” to “list of priority substances required to be registered”. The 750 priority substances that are listed in Schedule II need to be registered within one and half years if manufactured or imported in quantities above 1 tonne per year, while in the fourth draft only 37 substances that are listed in Schedule VI are required for registration. The Schedule VI is now changed from “substances to be registered” to “restricted or prohibited substances”. Only one substance, Phosgene, remains in the list as restricted and the other 36 substances were removed.

New authority

A new authority named National Chemical Authority will be established, consisting of the Steering Committee, the Scientific Committee, Risk Assessment Committee and the Chemical Regulatory Division. There will be some teething issues and it is necessary to have a new overarching authority to manage the functions related to the implementation of the Rules.

Authorized Representative

Foreign Companies (previously only foreign manufacturers) can appoint an Authorized Representative (AR, similar to an Only Representative under EU REACH) to fulfil compliance requirements. However, the qualification of AR that he shall be " with sufficient background in practical handling of substances and with minimum average net worth of ten times the average value of substances handled during the last calendar/financial year" is unclear, leaving stakeholders with open questions, e.g. does the “substances” means the specific substances to be notified or registered, how to calculate the “average value of substances handled during the last calendar/financial year”, etc. 

Timeline

The timelines for notification, annual reporting and dossier review are revised, including:

• Notification after the “Initial Notification Period”: decrease the notification period from 90 to 60 days prior to manufacture or import;

• Annual reporting: extend the annual reporting deadline from “no later than 30 days” to “no later than 60 days” after the end of the calendar year;

• Dossier evaluation: increase the review period from 90 days to one year upon the submission of the dossier, and offer longer time (increase from 90 days to 120 days) to supplement additional test data if requested by the authority.

Testing

The fifth draft deletes the geographic restrictions of “in India” for testing institutes that are eligible for generating data for India REACH. As proposed, test must be carried out in NABL^[3] accredited or GLP certificated laboratories. In addition, provisions regarding reduction of animal testing have been incorporated into the draft. Existing test data must be considered as a priority and animal testing should be a last resort. The registrant must propose a testing strategy and get it approved by the Division before conducting any new test.

GHS

The fifth draft makes it clear that hazard classification and labelling of substances shall be in accordance with UN GHS Rev.8.