On 24th August 2020, India has released the fifth draft of upcoming Chemicals (Management & Safety) Rules, 20xx. As the framework is similar to EU REACh, it is also known as India REACh regulation. The regulation will replace 2 existing rules – Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 and Chemical Accidents (Emergency Planning. Preparedness and Response) Rules, 1996. It shall come into force on the date of their publication in the official gazette, which is expected to be around 2021. The main objective of these rules is to ensure a high level of protection for human health and the environment.

Scope & Exemptions

It covers all Substances, Substances in Mixtures and Intermediates that are Manufactured, Imported, placed, or intended to be placed in Indian Territory. Anyway, certain exemptions are also allowed for the below-listed substances:

1. Radioactive Substances
2. Substances under the customs supervision, not being placed in Indian Territory.
3. Substances stored in customs-free zones with aim of re-exporting.
4. Wastes, having no commercial value.
5. Substances used for defense.
6. Substances used as food or feeding stuff for human beings or animals, including human or animal nutrition.
7. Substances set out in Schedule IV.

Duty holders & Authoritative body

It requires all manufacturers/ importers to submit a notification for all substances and registration only for substances meeting CMR properties. Restriction or prohibition of uses of certain substances may be placed, if found to pose unacceptable risks to human health and the environment after proper evaluation.

Similar to the “Only representative” concept in EU REACh, here also a foreign manufacturer can appoint an Authorized Representative, who shall be an Indian national or an entity registered in India. In such cases, the authorized representative will be responsible for ensuring compliance with the regulation.

A Chemical Regulatory Division will also be established (similar to the European Chemicals Agency –ECHA) for the evaluation of notifications/registrations and take decisions on the accuracy of the data submitted, and to identify Substance that requires Registration, authorization under Restricted Use and prohibition from Use.

Obligations

As per the final draft, there are certain steps to be taken by the duty holders to comply with and continue their business in Indian Market in the future.

a. Notification

This step is relevant for all substances placed in the Indian Territory. The Chemical regulatory division will prescribe an initial notification period for the notification of all existing substances, imported or manufactured at a volume ≥ of 1 tonne per year. Once this period is over, then for all new substances, notification needs to be submitted at least 90 days before the date they are placed in the Indian Territory. The substance will be notified for certain uses and it is the responsibility of downstream users to notify the Chemical Regulatory Division (CRD) if the intended use is not notified.

As part of the Notification, the duty holder has to submit a safety data sheet (SDS) in the format of Schedule IX. India is proposing that the classification, labeling, and SDS align with the United Nations 8th Revised Edition of the Globally Harmonized System of Classification and Labelling of Chemical (UN GHS Rev. 8).

The Division will further review the notifications and may determine if the notified substance is deemed a high priority and/or subject to registration.

b. Registration

It is applicable for all priority substances listed out in Schedule II which are manufactured, imported, and/or placed in India Territory > 1 tonne per year. Currently, they are 750 substances included and it will be further updated. For newly added substances in Schedule II, registrations need to be submitted within 18 months after inclusion.

A technical dossier needs to be prepared as part of registration. If the quantity is exceeding 10 TPA, a Chemical Safety Assessment report including exposure scenario (ES) is also required to submit along with the technical dossier. Joint Registration is valid for the same substance. The registration fee will depend on the tonnage band and company size.

c. Annual Reporting

It is required for both Notification and Registration. The report should contain the quantity of substance placed in the India Territory in the previous calendar year and changes to the information submitted at the time of notification/registration. The annual report should be completed before the 29th Feb / 1st Mar of each calendar year.

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