India REACH Regulation Services
Intertek can successfully guide your new/existing chemicals through the India REACH notification/registration process.
India REACH is the country’s national chemicals law which is referred to as the “Chemicals (Management and Safety) Rules”. There have been several amendments to the Rules since their release, but the latest draft amendment (Fifth Draft) was released on 24 Aug 2020.
This latest draft includes specific requirements for notification and annual reporting, registration, restrictions/prohibitions, import control, labelling and packaging, and more.
The draft Rules are meant to come into force on the date of their official publication (expected in 2022), and will apply to “all Substances, Substances in Mixtures and Intermediates that are Manufactured, Imported, Placed or intended to be Placed in Indian Territory”.
Chemical manufacturers, importers, or authorized representatives acting on behalf of foreign companies are required to notify all existing substances that are placed on the Indian market in quantities greater than 1 tonne per year to the National Chemical Authority. All new substances have to be notified at least 30 days prior to the date on which they are placed on the Indian market. In addition, a safety data sheet (SDS) and specific information outlined in Schedule V must be submitted. The notification period will begin 1 year after the enforcement date of the Rules and will end 180 days later. Any substances that are notified after this period will be categorized as new substances.
All notifiers must provide an annual update to the National Chemical Authority regarding the substance volume placed on the Indian market in the previous calendar year and must report any change or addition in the information submitted since the notification period, no later than 60 days after the end of each calendar year.
If a substance on the List of Priority Substances in Schedule II of the Rules is manufactured, imported, and/or placed on the Indian market in quantities greater than 1 tonne per year, registration is required within 1.5 years from the date of the Substance’s inclusion in Schedule II.
The National Chemical Authority’s Priority Substance Unit is responsible for evaluating registered substances using available data to determine if the substance poses any risks to human safety or the environment. The guidelines for safety are covered in Schedule VI of the draft Chemicals (Management and Safety) Rules. If the risk is too great, the substance may be restricted/prohibited for use in India and will be added to the list of restricted/prohibited substances in Schedule VI.
Industrial Activity and Site Safety Report
There are a number of other obligations covered under Schedule IV, which outlines requirements for Site Safety Reports, Safety Audit Reports, Notifications of Industrial Activity, On-site/Off-site Emergency Plans, and Notifications of Chemical Accidents.
750 substances listed in Schedule II of the Rules are classified as Priority Substances. Importers must notify the Concerned Authorities [Chief inspector of Dock Safety appointed under the Dock workers (Safety, Health & Welfare) Act 1986] at least 15 days before importation if their product contains a priority substance. In addition, any company importing or manufacturing a priority substance in quantities greater than 10 tonnes per year will be required to submit a chemical safety report containing the information outlined in Schedule VIII of the draft.
Labelling and Packaging
Chemical manufacturers, importers, or downstream users must ensure that their Priority Substances, or Hazardous Chemicals and Mixtures containing more than 10% w/w of a Priority Substance or Hazardous Chemical, have all the relevant product identifiers and hazard statements listed in Schedule XVII on their labels. These labels must also be in accordance with the eighth revision of the United Nations Global Harmonised System of Classification (UN GHS) to be placed on the Indian market.
We’re here to help!
Intertek is the single-source solution for complying with the notification, registration, SDS, testing, and documentation requirements of India REACH. We provide chemical and regulatory services to the producers, suppliers, and users of industrial, commercial, and consumer chemicals.
Our services include:
- India REACH Authorized Representation
- Notification and registration submissions
- Registration strategies
- Chemical Notification consultation
- Classification and labelling of substances
- Support with testing requirements
- Training and advisory services