India released the fifth draft of the Chemical (Management and Safety) Rules (ICMSR) on August 24, 2020. The ICMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. ICMSR is also known as India REACH.
Notification is required for all substances that are in quantity above 1 Tonne Per Annum (TPA). Additionally, only substances that are listed in "Priority Substances Required to be Registered" in Schedule II of the ICMSR need to be registered.
The ICMSR (India REACH) is expected to be notified to WTO in 2022 and come into force after 60 days of notification. India REACH will require Indian manufacturers and importers to comply with the regulation which includes notification and substance registration. For foreign manufacturers, they may appoint an Authorized Representation (AR) on their behalf to comply with the ICMSR (India REACH).
The BIS in BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.
The aims of the BIS Act include harmonious development of the activities of standardization, conformity assessment and quality assurance of goods, articles, processes, systems, and services. The responsible authority is the Bureau of Indian Standards
BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification.
Product certification includes two schemes:
The list of products that requires BIS certification is constantly being extended. See our summary on BIS Mandatory Product list: for Scheme II and Scheme II.
For non-Indian manufacturers to comply with BIS certification, Authorized Indian Representative (AIR) can be appointed to assist the application process, including:
FSS: The Food Safety and Standards Act of 2006. With the vision of developing a system to integrate and consolidate the already existing laws regarding food and food articles into a single science based system which would include the regulatory schemes and ensure the safety of materials FSSAI was formed.
FSSAI: The Food Safety and Standards Authority of India. This organisation is responsible for conducting all the checks including all the regulatory schemes, methodology for the evaluation of food and food contact materials, providing guidelines for new materials being introduced, also providing guidance with the risks involved and providing appropriate responses to ensure food safety. Moreover further development of this new regulatory scheme, draft regulations were published by the Ministry of Health and Family Welfare in the Gazette of India Extraordinary, part 3; in 2010 and were updated in August 2011.
Food Safety and Standards are divided into Six individual legislative titles: -
Overall Migration: The material shall also comply with the overall migration limits as detailed below when tested by the method prescribed in IS: 9845-19817.
However, the value of the overall migration limit shall be equal to 10 mg/dm” of the surface of the material or article in the following cases:
Containers or articles which are similar to containers or which in any case may be filled to a capacity less than 250 ml provided it is possible to calculate the surface area of contact with the foodstuff.
Sheets, foils and other non-fillable articles for which ratio between the surface area of the material or article and the quantity of foodstuffs in contact may not be calculated.
Milk and Milk Products
Fruits and Vegetable Products
Canned Meat Products
Drinking water (Mineral and Packaged)
All packaging materials of plastic origin shall pass the prescribed Overall Migration and Colour Migration limits.
Identification of compliance requirements under various guidelines including all data requirements.
Data gap analysis and pre-assessment support
Technical documentation support
Pre and post submission support and technical liaison with authorities.