India’s Chemicals (Management & Safety) Rules, a REACH-like regulation, has been in progress for years. 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 were 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 apply to “all substances, substances in mixtures and intermediates that are manufactured, imported, placed or intended to be placed in Indian Territory”. It requires manufacturers, importers or Authorized Representatives (designated on behalf of the foreign manufacturer, similar to “Only Representative” under EU REACH) to notify new and existing substances and register substances that need registration. Restriction or prohibition of uses of certain substances may be required if they are evaluated and found posing unacceptable risks to human health and the environment.
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 also consolidated into the Rules.
The Rules does not apply to substances fall under one of the following items:
Substances under customs supervision, not being placed in Indian Territory;
Substances stored in customs free zones with aim of re-exporting;
Wastes, as defined in Hazardous Waste Management Rules 2016;
Substances used for the purposes of defense;
Substances used as food or feeding stuff for human beings or animals, including human or animal nutrition;
Substances set out in Schedule IV.
A new division named Chemical Regulatory Division (similar role as the European Chemicals Agency) 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 Chemical Regulatory Division:
Chemical Accidents Unit
Packaging and Labelling Unit
Priority Substance Unit
Information Technology Unit; and
In addition, three committees will be set up, 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 to identify substances that require registration and restriction or prohibition of uses.
How to Comply
Notification (apply to existing substances ≥ 1t/yr and all new substances)
The Initial Notification will start a year after the Rules take effect and terminate 180 days from the commencement. All existing substances in quantities above 1 tonne per year require notification during the initial notification period by manufacturers, importers or Authorized Representatives. The initial notification will facilitate the production of the national inventory. New substances shall be notified 60 days prior to being placed on the Indian market.
*“Existing substances” are substances or intermediates that are already being manufactured, imported, supplied or used in India or has already been placed in Indian Territory prior to the expiry of the Initial Notification Period. “New substances” are all substances and intermediates that are placed in Indian Territory after the expiry of the Initial Notification Period.
Schedule V specifies the information required for notification, including substance's identity, uses, quantity, downstream users, and hazard classification, etc. In addition, all notifiers are also required to submit a Safety Data Sheet (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 notifier will be given 30 days to make supplementation if requested by the Division during the review. 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. The Division will determine if the notified substance is deemed high priority and/or is subject to registration.
Annual reporting (apply to all notified substances)
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.
Registration (apply to substances listed in Schedule VI)
37 substances have been listed in Schedule II as prioritized 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. It should be noted that joint registration is accepted but not mandatory.
The Chemistry Unit set up under the Division will evaluate the notification data and the risks posed by the substances, 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 (CSR) is required for those in quantities above 10 tonnes per year. The information for CSR is outlined in Schedule VIII.
This 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.
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.
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.
Chemical Safety Assessment (apply to priority substances ≥ 1t/yr)
The manufacturers, importers or Authorized Representatives shall perform a Chemical Safety Assessment and submit the CSR at the same time of notification or registration if a priority substance is in quantities above 10 tonnes per year. For those in quantities below 10 tonnes per year, exposure scenario information should be submitted.
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 (repeated or single exposure), category 1 or 2 (according to GHS Rev.8); or
Persistent, bioaccumulative and toxic (PBT) or very persistent or very bioaccumulative (vPvB) substances (As per criteria in Schedule I)
Any substances listed in Schedule II (750 substances drafted).
Evaluation and Restriction
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 prohibition as posing unacceptable risks to human health and the environment. In addition, the substances may also be recommended to be added or deleted from Schedule X, XI and XII (Hazardous Chemicals) and other lists. The final decision will be made by the Risk Assessment Committee based on socio-economic impact assessment and availability of suitable alternatives. Companies 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 only once.
Management of Hazardous Chemicals
Hazardous chemicals refer to:
Any substances which satisfies any of the criteria laid down in Part I of Schedule X or any substances listed in Part II of Schedule X;
Any substances listed in column 2 of Schedule XI;
Any substances listed in column 2 of Schedule XII.
The draft Rules also provide provisions regarding transport of hazardous chemicals, notification of industrial activity, import control, preparation of site safety report, safety audit report and on-site/off site emergency plan, notification of chemical accident, etc. More details are stipulated in Chapter IV Safety and Accident Preparedness.
India hasn't adopted UN GHS yet, and there is no indication when it will implement GHS. However, the draft Rules refers 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.
Summary of Obligations
Below are the major obligations may be of your concern.
Existing substances ≥ 1t/yr; all new substances
Start a year after the Rules take effect and terminate 180 days from the commencement
Substance's identity, uses, quantity, downstream users, and hazard classification, etc. As per Schedule V; and SDS
All notified substances (existing substances ≥ 1t/yr; all new substances)
No later than 30 days after the end of each calendar year
Quantities of the substance placed on the market in the previous calendar year and any changes/additions to the information submitted in the notification
Substances listed in Schedule VI ≥ 1t/yr
1.5 years from the date of its inclusion in Schedule VI (timelines based on tonnage band were deleted in this draft);
A registration dossier as per Schedule VII; For ≥ 10t/yr, Chemical Safety Report as per Schedule VIII
Chemical safety assessment
Priority substances > 10t/yr
At the time of Notification or Registration
Chemical Safety Report as per Schedule VIII
Priority substances ≤ 10t/yr
Authorization for use of restricted substances
Before using the substances for restricted applications
Update registration dossier
Within 30 days after being made aware of the changes
Priority substances or hazardous substances
Upon completion of the relevant notification and registration requirements, at least 15 days before import
Name and address of the person receiving the consignment in India, the port of entry, mode of transport, name and quantity of the substance, SDS, etc.
Although this is a final draft refined based on the industry's comments, there are still ambiguities and questions worthy of further discussion. For example:
The timeline for registration of substances based on the tonnage band is not provided, and one and half year is not long enough to complete a full registration.
There are no differences in minimum test data for registration in different tonnage bands. There are no specifications on the extent that diversified data can be accepted.
The lab requirement is too strict, and only qualified labs in India are able to supply data.
Adoption of GHS in India is also an issue of major concern.
As planned, the draft will be notified to the WTO this year. However, there will be an inevitably delay due to the COVID-19 outbreak.