India REACH Within Reach, Final Draft Coming Soon

By Fanyu Zhang, EHS Fellow for IPC Global Government Relations

The government of India is nearing completion of European-style regulations on chemical substances. A sixth and expected-to-be final draft of a new Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) rule – similar to the European Union’s REACH legislation – will be released later this year by India’s Ministry of Chemicals and Fertilizers.

Under the rule, existing and new chemical substances manufactured, imported, or used within India are required to be notified, registered, and reported under certain circumstances by manufacturers, importers, or authorized representatives (AR). The rule would have far-reaching impacts for businesses in India and some of their suppliers, including in the electronics sector.

Here is what we know about what is emerging.

Initial notification process

An Initial 180-day Notification Period (INP) will start one year from the effective date of the rule. All chemical substances notified within the INP would be considered existing chemical substances, others will be considered as new chemical substances. If a new chemical substance is to be placed on the market in India, it will need to go through a notification process within 60 days prior to its placement.

An annual report will be required from importers, manufacturers or ARs that have notified a substance within 60 days of every calendar year, which is by February 29 or March 1 each year.

Registration process for priority substances

Upon notification, each substance will be evaluated to determine if it falls within the “priority substance” category. During evaluation, chemical substances may be recommended for “addition to” or “deletion from” Schedule II (List of Priority Substance). Priority substances include:

• Any substance which falls under any of the following hazard classifications of the eighth revision of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS Rev. 8):
  • Carcinogenicity and/or germ cell mutagenicity and/or reproductive toxicity and categorized as Category 1 or 2; or
  • Specific target organ toxicity (repeated exposure or single exposure) Category 1 or 2.
• Any substance which fulfills the criteria of persistent, bio-accumulative and toxic or very persistent or very bio-accumulative, as set out in Schedule I of the rule; and/or
• Any substance listed in Schedule II of the rule (750 substances).

All manufacturers, importers, and ARs that have placed or intend to place priority substances on the Indian market in quantities that exceed 1 ton per year must register the substance within 18 months from the date of inclusion of the substance in Schedule II. Requirements for registration of priority substances under 1 ton per year will be based on the recommendation of the authority.

Articles, i.e., products, would need to be registered if they entail an intended release of priority substances and are manufactured or imported in quantities in excess of 1 ton per year.

Intermediates shall also comply with the same notification and registration requirements. Registrations of transported intermediates that are priority substances manufactured or imported in excess of 1,000 tons per year shall contain all information as required in the Technical Dossier and the Chemical Safety Report. Transported intermediates that are priority substances under 1,000 tons per year shall only contain details regarding the physical and chemical properties in the Technical Dossier.

Assessment and evaluation processes

Manufacturers, importers, and ARs which place priority substances on the market in India in quantities greater than 10 tons per year would be required to perform a Chemical Safety Assessment (CSA) and submit a Chemical Safety Report (CSR) at the time of notification or registration. Manufacturers, importers, and ARs which place priority substances on the market in India in quantities less than or equal to 10 tons per year, but more than 1 ton per year would be required to submit an Exposure Scenario.

The available data of registered substances will be assessed to evaluate whether they pose an unacceptable risk to human health or the environment during various uses in India. If the risk posed by the use of a priority substance is substantial, the use of the substance may be restricted or prohibited.

Restricted and hazardous substances

Upon registration, an evaluation will be conducted to determine if the substances meet the criteria for a hazardous substance, restricted substance, or prohibited substance. Based on the evaluation, a substance may be added or deleted from Schedules X, XI or XII (Lists of Hazardous Substances) or Schedule IV (List of Restricted or Prohibited Substances). Once restricted, authorization will be required for a substance to be imported or manufactured, along with other requirements for transportation, storage, and labeling.

Here is the full text of the Rule’s fifth draft.

IPC will continue to monitor progress toward the final REACH rule in India and will provide updates as necessary. Please let us know if you have any questions. The point of contact is Kelly Scanlon, IPC’s director of environment, health and safety policy and research.