India’s Chemicals (Management And Safety) Rules
India’s Chemicals (Management And Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures, and intermediates that are manufactured, imported or placed on the market in the Indian territory at quantities greater than 1 tonne per year.
Regulatory compliance requirements will apply within 18 months of coming into force, and all Indian manufacturers and importers will need to comply. Non-Indian entities who wish to place their chemical products on the market in India will need to appoint an authorised representative (AR) located in India to act on their behalf (similar to EU REACH OR).
If your company is currently manufacturing chemicals in India or exporting chemicals to India,
ICMSR will affect you. CEHTRA-India registered office in New Delhi is well positioned to act as your AR and service provider and can help you secure the Notification or Registration certificate for your chemicals from India’s Chemical Regulatory Division.
The main requirements are:
Notification and annual updating
All existing and new substances manufactured or imported in India in quantities ≥ 1 tonne per year must be notified to The Chemical Regulatory Division (CRD). Existing substances should be notified within 180 days from the date of commencement of the Initial Notification Period (i.e. commences one year from the date of enforcement of ICMSR Rules). New substances must be notified at least 60 days prior to the date they are placed on the market in India. Notifiers shall update the information submitted annually, no later than 60 days after the end of each calendar year.
All priority substances listed in ICMSR Schedule II (currently 750) manufactured or imported (or intended or likely to be released from articles) in India in quantities ≥1 tonne per year will require the submission of a technical dossier within 18 months from the date of their inclusion in Schedule II. Substances manufactured or imported in India in quantities <1 tonne per year may also need to be registered; further details are yet to be published. Substances listed in Schedule II will be subject to authorization and restriction after further assessment.
Safety Data Sheet (SDS)
All Notifiers of a substance or an intermediate listed in Schedule II or a hazardous chemical will need to maintain and submit an up-to-date SDS in the UN-GHS format and will have to share such SDS with the Downstream User of the substance.
Site Safety Report
An occupier who has control of an industrial activity in which a hazardous chemical is handled is required to provide the evidence of identification and prevention of accidental hazards within 30 days of commencement of the activity or within 30 days of coming into force of these Rules, whichever is later. Depending on the threshold of quantities of hazardous chemicals, a site safety report or an independent safety audit report may also be required to be submitted within 90-180 days from the date of coming into force of these Rules.
After completion of notification or registration, importers of priority substances or hazardous chemicals must inform the concerned authority at least 15 days before the import of such substances in quantities greater than the lowest of 1 tonne, the quantity specified in column 3 of Schedule XII and column 3 of Schedule XI.
Notification / Registration & update
Preparation and update of Notification and Registration dossiers for individual or joint submissions
Safety Data Sheets (SDS)
Preparation and/or update of SDS in latest UN-GHS format
Authorized Representative (AR) service
Representation of non-Indian companies through our Indian entity
Arrangement of data on substances already registered with any foreign regulator in other jurisdictions
PRIMO tool to optimize management and follow-up of complex worldwide registration projects
Experienced data sharing negotiators
Scientific and Regulatory expert advice
GHS Classification of substances