India REACH
India is in the process of drawing up its landmark Chemicals (Management and Safety) Rules, commonly referred to as “India REACH”. The Rules are currently in draft form, and there are rumours that the Rules will enter into force in 2022, but this has not been confirmed by official sources.
Who needs to comply with India REACH?
The following businesses are able to notify/register under India REACH once it enters into force:
Indian Manufacturers
Indian Importers
Indian Authorised Representative/AR – appointed by Foreign Manufacturers
Yordas is gearing up to ensure our clients can continue to place products on the market in India.
For more insight into our services or to stay on top of India REACH updates, reach out to us here:
Which is the latest version of India REACH?
The latest disseminated version is the 5th draft of India REACH. A 6th draft is being discussed...
Who is the competent authority?
The Chemical Regulatory Division (CRD) will be established as the competent authority for chemical management in India.
What are the requirements according to the 5th draft?
Notification
Companies must notify substances manufactured or imported ≥1 tonne/year unless exemptions apply
The Notification period will start 1 year after India REACH is published. The Notification window will last 6 months.
After this Notification period, substances must be notified before placing on the market above 1 t/y.
Data requirements: Includes spectral data, hazard classification, uses, info on Downstream Users, actual quantities per year, SDS.
Notification fees apply.
Annual Reporting
The notification must be updated annually (annual reporting) during the first 60 days of the calendar year.
Registration of Priority Substances
Companies must register Schedule II listed substances manufactured or imported ≥1 t/y (750 substances).
The registration deadline is 18 months from the date of inclusion in Schedule II.
Data requirements include information on hazards (incl. robust study summaries) and exposure (exposure scenarios).
Chemical Safety Reports (CSR) are required for these substances ≥10 t/y.
Joint submission is possible but detailed rules on data sharing etc. have not yet been published.
Import Control
At least 15 days before import of a Schedule II substance or Hazardous Substance ≥1 tonne/year, an importer must notify the following information:
Name and address of consignee in India
Port of entry
Mode of transport from exporting country to India
Name and quantity of Priority / Hazardous substance
All relevant product safety info, including SDS
Evaluation
The relevant units of the CRD will evaluate the dossiers within 1 year of submission. If a substance is found to pose an unreasonable risk to human safety or the environment, it may lead to Restriction or Prohibition of substances or a recommendation to add to Schedule X, XI or XII.
Restriction/Prohibition
Substances listed on Schedule VI (Restricted or prohibited substances) must undergo authorisation before they are used
Hazardous Chemicals
Listed in Schedule X, XI and XII
Indian companies handling these substances may be subject to:
Import control
Safety Audit Report
On-site / Off-site emergency plans
Site Safety report
Notification of Industrial Activity
Notification of Chemical Accidents
SDS and Labelling
Manufacturers, Importers and Downstream Users of products containing >10% w/w Priority substances or Hazardous substances must:
bear labels according to Schedule XVII
be packaged according to Rule 34
use hazard statements, pictograms, signal words and precautionary statements according to GHS Revision 8
be in English and Hindi
All notifiers of Schedule II substances and Hazardous Substances or Intermediates and all importers of articles containing Schedule II Substances >1.0% w/w must maintain and submit an up-to-date SDS and share the SDS with DSUs.
Literature
Webinar: India “REACH” – what we know so far
Topics covered in this webinar:
Introduction to India REACH
Roles and responsibilities
Scope and exemptions
Key requirements
Regulatory deadlines
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