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Background
India’s Chemicals (Management & Safety) Rules have been drafted for years, and when implemented, the rules will have a great impact on stakeholders handling chemicals in the Indian market. After circulating previous versions of drafts to selected chemical industry bodies on December 12, 2019, and February 6, 2020 respectively. The final draft was shared with 12 industry bodies on March 16, 2020, and comments have been received until March 31, 2020. There is no timeline for public consultation. As planned, it will be notified to the WTO this year and come into force on the date when it is published in the Official Gazette.
The Rules require manufacturers and importers to notify new and existing substances and register priority substances that need registration. In addition, separate existing rules regarding chemical regulations, the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 and the Chemical Accidents (Emergency Planning, Preparedness, and Response) Rules, 1996 are consolidated into this Rules.
Authoritative body
A new division named Chemical Regulatory Division will be established to manage all the functions related to the implementation of the Rules, including evaluation of notifications and registrations, preparation and maintenance of an information database, public information dissemination, etc. Below are 8 Units of the Division:
Chemistry Unit
Toxicology Unit
Chemical Accidents Unit
Packaging and Labelling Unit
Techno-legal Unit
Priority Substance Unit
Information Technology Unit; and
Socio-Economic Unit
In addition, three committees will be set up, including the steering committee, scientific committee, and risk assessment committee. The steering committee will oversee the activities of the Division and approve the annual budget. The Division will evaluate notification and registrations in concurrence with the scientific committee and the risk assessment committee and identify substances that require registration, authorization, and restriction of uses.
Notification
All existing substances in quantities above 1 tonne per year require notification by manufacturers and importers (or Authorised Representative designated on behalf of the foreign manufacturer) within 180 days from the date of the commencement of the “Initial Notification Period." It will start a year after the Rules take effect.
The initial notification will facilitate the production of the national inventory. New chemicals shall be notified 90 days prior to being placed on the Indian market.
According to Schedule V, the notification includes information on the substance's identity, uses, quantity, downstream users, and classification, etc. In addition, all notifiers are also required to submit an SDS in the format of Schedule IX and share it with downstream users. A downstream user shall notify the Division of use and submit an SDS in relation to such use if the use of a notified substance is not included in its notification.
The notifications shall be updated each year no later than 30 days after the end of each calendar year, including quantities of the substance placed on the market in the previous calendar year and any changes/additions to the information submitted in the notification.
The notifier will be given 30 days to make supplementation if requested by the Division. In case the notifier is unable to finish it within the allotted time, another 30 days will be given after obtaining consent from the Division. If approved, a notification number and a certificate (in the form of Schedule XVIII) will be issued to the notifier.
Registration
Thirty-seven substances that have been listed in Schedule VI as substances need to be registered if manufactured or imported in quantities above 1 tonne per year. The designated substances comprise vPvB substances, PBT substances, and carcinogenic substances, chemicals that are toxic for reproduction or of endocrine-disrupting properties.
The Chemistry Unit set up under the Division will evaluate the notification data and the risks posed by the substances, thus to identify substances that require registration in addition to the 37 substances. The Unit may recommend to the Scientific Committee for the addition or deletion of substances from Schedule VI.
The contents required for registration dossier are specified in Schedule VII. In addition, a Chemical Safety Assessment Report is required for those in quantities above 10 tonnes per year. The information for CSR is outlined in Schedule VIII.
Joint registration is accepted but not mandatory. An entity registered in India or a citizen can be appointed as an ‘authorized representative’ (AR) to comply with the Rules on behalf of foreign manufacturers, which is similar to OR under EU REACH.
The Chemistry and Toxicology Units of the Division shall evaluate the registration dossier within 90 days. The registrant shall supplement information within 90 days of being informed of the omission of data. Registrants can apply to the Chemistry Unit for an additional 90 days if it is not enough. If the registration is approved, a registration number and a certificate (in the form of Schedule XVIII) will be issued to the registrant. The registrant is obliged to update the registered information within 30 days after being made aware of the changes.
The final draft removes the previously proposed timeline for registration of substances based on the tonnage band and only gives a timeline of one and half years to register substances on Schedule VI from the date of its inclusion.
For importation of priority substances or hazardous substances, upon completion of the relevant notification and registration requirements, the importer shall submit information to the concerned authority (see Schedule III) at least 15 days before import, including substance identification, quantity, the port of entry, mode of transport, SDS, etc.
Chemical Safety Assessment
A priority substance is defined as one that falls under any of the following hazard classifications:
CMR, category 1 or 2 (according to GHS Rev.8);
specific target organ toxicity, category 1 or 2 (repeated exposure or single exposure) (according to GHS Rev.8); or
persistent, bioaccumulative and toxic (PBT) or very persistent or very bioaccumulative (vPvB) substances (see criteria in Schedule I)
The final draft has listed 730 substances as priority substances in Schedule II. The manufacturers and importers (or Authorised Representative designated on behalf of the foreign manufacturer) shall perform a Chemical Safety Assessment and submit the CSR at the same time of notification or registration if the priority substances are in quantities above 10 tonnes per year. For those in quantities below 10 tonnes per year, exposure scenario information should be submitted.
Restriction/Authorization
The Priority Substance Unit of the Division will evaluate all notified substances in concurrence with the Scientific Committee and the Risk Assessment Committee, and identify substances that fall under the definition of priority substances. The candidates will be recommended to the Steering Committee for inclusion in Schedule II. The Unit will assess the priority substances in Schedule II and see if they are subject to restriction or authorization as posing unacceptable risks to human health and the environment. The final decision will be made by the Risk Assessment Committee based on socio-economic impact assessment and availability of suitable alternatives. The company can apply for authorization to use a restricted substance. If approved, a period of four years will be granted, and it can be extended for another four years once only.
CBI
Notification and registration information can be claimed as confidential, except for the classification of the substance and the endpoint summaries. A CBI application needs to clearly identify (1) which information is to be kept confidential, and (2) the reason why such information should be kept confidential. If the information provided is not sufficient, the Division will ask for further information. However, a maximum duration of confidentiality protection hasn’t been provided in the draft.
Fee
Schedule XIX outlines the fees for registration (individual & joint registration) and notification based on tonnage band, updating tonnage band, obtaining authorization to use a restricted substance, confidentiality application, filing an appeal, etc. SMEs are granted a reduction in administrative fees.
GHS
India hasn't adopted UN GHS yet, and there is no indication when it will implement GHS. The draft Rules refer directly to UN GHS Rev.8 for chemical classification.
All notifiers of a substance shall maintain an up-to-date SDS in English or Hindi, and share it with downstream users. Priority substances in Schedule II (750 substances) and hazardous chemicals in Schedule X (669 substances) are also subject to SDS requirements, as well as mixtures where a priority substance is present as above a concentration of 0.1% (w/w). However, the SDS format (Schedule IX) is not aligned with GHS Rev.8.
The draft also requires labeling for priority substances and for mixtures where a priority substance is present as above a concentration of 10% (w/w). The label elements are specified in Schedule XVII. A label shall not be required when the label elements are shown clearly on the packaging itself.
Conclusion
Although this is a final draft refined based on the industry's comments, there are still ambiguities and questions worthy of further discussion. The timeline for registration of substances based on the tonnage band is not provided, and one and half years is not long enough to complete a full registration. In addition, except for the fees, there are no differences in minimum test data for registration in different tonnage bands. The lab requirement is too strict, and only qualified labs in India are able to supply data. There are no specifications on the extent that diversified data can be accepted. Adoption of GHS is also an issue of major concern and has been one of the most frequently asked questions by overseas exporters.
