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Dynamic analysis of the latest GHS regulations in India

Posted Date:2023/11/29

India's Chemicals (Management and Safety) Regulations will come into force in August 2022

The draft Indian Chemicals (Regulation and Safety) Rules have also undergone several revisions, the latest of which was published in August 2020, to the notification, registration and restriction, or prohibition, as well as labelling and package-related use requirements for the assessment of substances, substances in mixtures, articles and substances in intermediates that have been or are intended to be placed on the Indian market. And introduce registration requirements similar to REACH for certain priority substances ≥= 1t/y. This rule is also known as "REACH India".

The draft will be notified to the World Trade Organization (WTO) in May or June 2022 and enter into force in August this year. Foreign manufacturers can fulfill regulatory obligations on their behalf by authorizing a legal entity in India to act as the sole representative (" AR ", similar to the sole representative "OR" under the EU REACH regulation), who is responsible for various registration, notification and other compliance work to the competent authorities.

Notification

All manufacturers or importers (or authorized representatives acting on behalf of foreign entities) shall notify the National Chemical Authority of all existing substances which they place in the territory of India in quantities exceeding 1 tonne per year. The notification program begins one year from the date of implementation of the rule and ends 180 days after its entry into force. After this period, any unnotified substance will be considered a new substance.

Registration

All manufacturers, importers and authorized representatives (for foreign manufacturers) of substances that have released or intend to release into the territory of India an amount of a Schedule II substance exceeding 1 tonne per year must register the substance within one and a half years from the date of listing the substance in Schedule II.

Schedule 2 is a list of priority substances that require registration. There are currently 750 hazardous substances on the list, including benzene and methanol.

For registration, a technical file consisting of physicochemical data, toxicant, ecotoxicant data and chemical safety reports (for 10t/y substances only) is required.

Evaluation and limitation

The priority substance unit of the competent authority shall assess the available data to assess whether the substance registered for various uses in India poses an unacceptable risk to human safety or the environment and, if that risk is unacceptable, may propose to restrict the use of the substance or ban the substance.

A list of restricted/prohibited substances is given in Schedule VI. Only one substance is currently restricted: phosgene.

Priorities are defined as:

(1) Substances that fall under any of the following hazard classifications of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals, Eighth Edition (GHS Revision 8) : carcinogenicity and/or germline mutagenicity and/or reproductive toxicity, classified as Group 1 or 2; Specific target organ toxicity (repeated exposure or single exposure) category 1 or 2.

(2) Any substance that meets the criteria for persistent, bioaccumulative and toxic or very persistent or very bioaccumulative as set out in Schedule I to these Rules.

(3) Any substance listed in Schedule II.

Import of priority substances or hazardous chemicals

(a) the name and address of the person receiving the goods in India;

(b) Ports of entry in India;

(c) Mode of transport from the exporting country to India;

(d) Names and quantities of priority substances or hazardous chemicals imported;

(e) All relevant product safety information, including safety data sheets.

Labeling and packaging

Manufacturers, importers or downstream users should ensure that all priority substances, hazardous chemicals and mixtures containing more than 10% (w/w) of any priority substance or hazardous chemical comply with labeling and packaging requirements. Manufacturers, importers or downstream users shall ensure that all product identifiers, hazard descriptions and pictograms, signal words and precautions used in their labels of priority substances placed on Indian territory shall comply with the Eighth edition of the United Nations Globally Harmonized Classification System (UN GHS).

List of important attachments in the regulations

Schedule I – PBT and vPvB Assessment Criteria

Schedule II – List of Priority Substances required to be Registered

Schedule III – Concerned Authorities

Schedule IV - Substances Exempt from Notification and Registration

Schedule V - Information to be provided for Notification

Schedule VI – Restricted or Prohibited Substances

Schedule VII - Contents of Technical Dossier

Schedule VIII - Format for Chemical Safety Report

Schedule IX – Safety Data Sheet