*Last update: 21Sep2022
While the drafting process of the ICMSR is well advanced, some industry concerns have been put forward on the basis of the current draft. Additionally, a process of ministerial vetting must take place to ensure the proper fit of ICMSR with existing regulations.
Once a final draft is produced, it must be submitted to the WTO and officially adopted by the Central Government (including a Gazette Notification).
This will mark the entry into force of ICMSR, from when different periods will start to count, most importantly:
- The Initial Notification Period (which lasts for 6 months and starts 12 months after the ICMSR’s entry into force).
- The registration deadline for Substances in Schedule II (18 months after the entry into force, coinciding therefore with the end of the Initial Notification Period).
Another key period is the establishment of the Indian National Chemicals Authority (INCA), which is the leading authority in implementing ICMSR. While the Rules do not contain a clear timeline for this, it will involve the setting up of the Authority, the setting up of the system for Notification and Registration, and the issuance of relevant guidance.
ICMSR would be adopted under Sections 3,6 and 25 of the Environment (Protection) Act, 1986. The Act gives the power to the Central Government to enact rules to protect human health and the environment. By minimizing the adverse effects of substances and improving chemicals management, ICMSR contributes to said objectives.
Under ICMSR, registrations are generally individual. Therefore, there is no obligation to submit registrations jointly.
However, joint registration is possible under Rule 10, sub-rule (10). Joint registrants must reach their own agreement with regards to the specifics of joint registration (including the Lead Registrant). This agreement is concluded between business parties, and does not involve the Government of India.
Joint registrations have the same compliance obligations as individual registrations, but the joint registrants benefit from fee reductions.
Further clarification on the specifics of joint registration will be provided when the rules are finalized.
Instead of Pre-registration, ICMSR has a Notification requirement, that covers all substances and has more extensive data requirements than Pre-registration under EU REACH. Notifications must be updated annually through the submission of an annual report.
Registration under ICMSR does not cover all substances, but only those included under Schedule II. There are no tonnage band-specific data requirements for Registration (beyond the Chemical Safety Report requirement above the 10 TPA threshold).
Additionally, imports of some substances (substances requiring Registration and Hazardous Chemicals) are subjected to prior import notification.
The responsible authority for the implementation of ICMSR will be the Indian National Chemical Authority (INCA).
INCA will be established after the entry into force of ICMSR, as it is created I the rules.
Therefore, no contact details are available at the moment.
ICMSR (Indian REACH) contains obligations for all actors in the supply chain (manufacturers, importers, and downstream users).
While domestic manufacturers are covered by the rules (for instance, they must notify substances that they place in the market), compliance for imported substances falls on the Indian importers.
Foreign manufacturers can appoint an Authorised Representative (AR) to comply with ICMSR on their behalf. This shifts the compliance obligations from the Indian importers to the AR of the foreign provider.
The current draft of ICMSR does not contain details on how the submission of information is to be done.
Rule 14 refers to an interactive digital platform that is to be established by the Chemical Regulatory Division for the implementation of the rules. However, the content of the rule is focused on the dissemination of information by the authorities.
Further details may be clarified in future drafts, or once the Chemical Regulatory Division has been established after the entry into force of ICMSR (Indian REACH).
Tonnage bands refer to substances placed in the market. This includes substances manufactured in India by a company, or imported into India by the same company.
The notified tonnage band is chosen by companies according to the quantity of their substance that they will put in the market.
Given that the tonnage band is included in the notification or there is an element of uncertainty as to the real amount of the substance that the company will eventually place in the market (given that notification and registration take place before market placement).
To account for that, companies must submit an annual report within the first 60 days of the calendar year. In that report, they must include, together with other information, the actual quantity of substance placed in the market. If the actual quantity falls outside the notified tonnage band, the corresponding fees must be paid.
Tonnage bands are calculated for every calendar year (January to December). It is retroactively assessed on the basis of annual updates for notifications. These updates are submitted within the first 60 days of the calendar year and contain information on the actual quantity of placed substances.
In the case of mixtures, all ingredients exceeding 1 tonne per year should comply with ICMSR, including notification and registration where applicable.
As for polymers, the current draft of the ICMSR does not contain specific provisions relating to them. In those circumstances, they may be treated as substances and have similar obligations to any chemical substance.
For less than 10 tonnes per annum, registration should include an exposure scenario. For more than 10 tons per annum, a Chemical Safety Report (CSR) is required for registration. This requirement is similar to EU-REACH.
Yes, there is a legal option for Joint Registration. Importers, Manufacturers and Authorised Representatives can reach agreements to jointly register a substance.
Joint Registrations have the same compliance obligations as individual Registrations.
The fee structure is the same as for individual registrations; fees are based on the substance’s tonnage band and the company’s size.
However, Joint Registrants will benefit from a reduction in fees as established in Schedule XIX. In the current draft, fees – which must be paid by each Joint Registrant – are a 30% lower than the fees for individual registrations.
The structure for the Technical Dossier is established in Schedule VII of the ICMSR.
Information must be provided on the following points:
- Registrant details
- Chemical identifiers
- Chemical structural details
- Identified chemical uses
- Classification and labelling information
- Robust study summaries
- Main use category
- Specification for industrial and professional use
- Significant route(s) of exposure
- Environmental exposure
- Pattern of exposure
Schedule VII further details the content of each of these headlines.
In addition to the Technical Dossier, Registrants of a substance above 10 tonne per annum must also submit a Chemical Safety Report (the contents of which are listed in Schedule VIII).
This structure is very similar to that of EU REACH, although the endpoints related to Robust Study Summaries are not yet elaborated, and tonnage-specific data and Robust Study Summary requirements are not yet disclosed.
It is expected that the submission and dissemination portal shall be in English language, in addition it may also be available in Hindi or any other local language.
Importers of mixtures must notify the substances within the mixtures, if they are above the 1 TPA threshold.
This requires that importers are aware of what substances make up the mixture and in what quantity.
If the company which is exporting this mixture is not ready to share these details, it can comply with ICMSR using an Authorised Representative.
The manufacturer is eligible to apply and receive an unique registration number which is linked to manufacturer, location of factory, product and brand.
The BIS Rules require a valid test report (not older than 90 days) from any BIS recognized test laboratory and this has to be submitted while applying for Compulsory Registration. The test reports issued by BIS Recognized Labs as per the notified Indian Standards are only accepted for Registration.
The Standard Mark shall be placed on both product and packaging. However, in case it is not possible to place on the product due to size constraints, it can be put on the packaging only. For the products with display screen, provisions of e-labelling of products is also available.
The registration number provided by BIS is unique for each manufacturing location. Hence, separate application must be made for each location and supported with a test report for product from the location where the product is that manufactured.
FMCS is a certification scheme for a Foreign manufacturer who wants to obtain BIS License. The scheme is for certification of products other than Electronic and Information Technology Products. For Electronic and IT products please refer to Registration Scheme.
Yes, company(manufacturer) needs to apply for BIS registration before the product reaches in India. Else, Indian customs will not clear the shipment without BIS certificate.
For Scheme I (ISI certificate), it will take 6 months approximately and factory audit is required. For Scheme II (CRS) it takes less time approximately 6-8 weeks as factory audit is not required.
Yes, there is list of chemicals under BIS mandatory list.