India Regulatory News

A draft standard was issued by the Bureau of Indian Standards (BIS) on May 6, 2022, for tooth whitening and bleaching products. The authorities invite comments till July 5, 2022.  The standard pr...

A draft standard was issued by the Bureau of Indian Standards (BIS) on May 6, 2022, for tooth whitening and bleaching products. The authorities invite comments till July 5, 2022. 

The standard prescribes requirements and test methods for external tooth whitening and bleaching products, especially for direct, professional use on the outer surfaces of the teeth. Under the regulation of this draft, caution marks are required on the packaging of tooth bleaching products applicable not to be used on a person under the age of 18 and to be sold only to dental practitioners.

For other requirements, please refer to the table below.

India has launched a consultation to update standards for titanium (rutile grade) and barium sulphate pigments, both of which are used in paints and varnishes. The draft amended standards, which were ...

India has launched a consultation to update standards for titanium (rutile grade) and barium sulphate pigments, both of which are used in paints and varnishes. The draft amended standards, which were published on April 27 by the Bureau of Indian Standards (BIS), establish comment dates of:

• Barium sulphate is due on June 30th, and
• Titanium (rutile grade) is due on July 5th.

Both chemicals should have no more than 90ppm lead or lead compounds, according to the draft. Also, separately or in combination, limiting the following substances in them to a maximum of 0.1 percent by weight:

• mercury,
• mercury compounds,
• cadmium,
• arsenic,
• chromium VI,
• antimony, and
• their oxides

For barytes (naturally occurring barium sulphate) and blanc fixe pigments, the draft offers requirements as well as sampling and testing techniques (the precipitated barium sulphate). The substance is designed to be used as a paint extender. The substance, according to the draft, is:

• Type 1 (naturally occurring) or
• Type 2 (precipitated form) classification; and
• Lead or lead compound content, which was determined using the relevant Indian standard.

The titanium dioxide (rutile grade) draft establishes sampling and testing standards for rutile titanium dioxide, which is used as a pigment in the paint industry. It also suggests that:

• graded content is categorised as R1, R2, or R3; and
• in the form of a powder

Both drafts recommend that packaging be marked or labelled with the following information:

• The substance's name, maker, and trademark, if applicable,
• The month and year of manufacture; the substance's net mass,
• The batch and lot number,
• The maximum lead content,
• The toxic heavy metals content, and
• Any cautionary notes.

If the draft is approved, BIS will certify products that meet their requirements and place a conformity mark on the packaging.

On the 27th of April 2022, India published a Quality Control Order (QCO) for a national standard encompassing the intermediate 1, 3 phenylenediamine. Manufacturers and importers of the substance must ...

On the 27^th of April 2022, India published a Quality Control Order (QCO) for a national standard encompassing the intermediate 1, 3 phenylenediamine. Manufacturers and importers of the substance must guarantee that it meets the standards given in Indian Standard (IS) 17450:2020 as of October 25. The QCO was published in the country's Official Gazette by the Department of Chemicals and Petrochemicals (DCPC).

The compound is primarily employed as an intermediary in the production of dyes, notably permanent hair dyes, and as a polymer additive. Depending on the amount of exposure, it might induce skin sensitivities, disorientation, liver and kidney damage.

Manufacturers, traders, and importers will be required to comply with the standards set out in the applicable standard by the Bureau of Indian Standards (BIS).

This includes limiting the usage of certain 1, 3 phenylenediamine compounds, such as:

• Maximum use of arsenic is 2ppm, and
• Mercury is 1ppm.

The standard also limits the amount of mercury in 1, 3 phenylenediamine used in permanent black hair colours to no more than 4% by mass, and no more than 3% by mass in brown and other coloured hair dyes. The BIS Act of 2016 will penalise anyone who violate the QCO's provisions.

The Ministry of Environment, Forest and Climate Change (MoEFCC) and the Central Pollution Control Board (CPCB) have developed an integrated guidance framework for chemical safety in isolated storage a...

The Ministry of Environment, Forest and Climate Change (MoEFCC) and the Central Pollution Control Board (CPCB) have developed an integrated guidance framework for chemical safety in isolated storage and industries subject to the Manufacture, Storage, and Import of Hazardous Chemicals Rules, 1989 (MSIHC Rules).This is in accordance with the National Environmental Court Order dated June 11, 2021.

This framework covers chemical accident scenarios such as hazardous chemical spills/leaks, fires, explosions, or other accidents resulting from hazardous chemical handling, and it provides guidance to industrial units for conducting safety audits in accordance with the Indian Standard IS14489: 2018 Code of Practice on Occupational Safety and Health Audit.

Furthermore, in 1948, India enacted the Factories Act to ensure the occupational safety, health, and welfare of workers in factories registered under the Act. The Control of Industrial Major Accident Hazards (CIMAH) Rules, established under Section 41B of the Factories Act, prescribe "Safety Reports" and "Safety Audit Reports" for facilities where serious accidents are a possibility. The MSIHC and CIMAH rules are enforced by the government of each state or union territory's Chief Inspector of Factories (CIF) or Directorate of Industrial Safety and Health (DISH). The government of the state or union territory has control over the details of companies that fail safety audits and the actions taken against such companies.

On the 13th of May 2022, the Central Government of India extended the enforcement date for three substances under the Quality Control Order (QCO). The Quality Control Order is the regulation that ...

On the 13^th of May 2022, the Central Government of India extended the enforcement date for three substances under the Quality Control Order (QCO).

The Quality Control Order is the regulation that requires concerned substances/chemicals to carry the Bureau of Indian Standards (BIS) certification mark. This mark certifies the substance/product’s quality and safety to the end-users and environment.

For this new extension, the concerned chemicals and their new dates are Methylene Chloride (November 20, 2022), Ortho Phosphoric Acid (December 10, 2022) and Polyphosphoric Acid (December 22, 2022). The delays, according to the DCPC, are due to a backlog of outstanding QCOs caused by COVID-related staff shortages and travel limitations, which have resulted in delays in inspections, sampling, testing, and certification of substances and goods. 

There are about 52 chemicals in total, under the BIS mandatory certification scheme. 

Recently, the Bureau of Indian Standards (BIS) published several updates for BIS standards. The updates address the following:   Grant of All India First License for “Plastic-Acrylonitrile...

Recently, the Bureau of Indian Standards (BIS) published several updates for BIS standards. The updates address the following:

1. Grant of All India First License for “Plastic-Acrylonitrile-Butadiene styrene (ABS) Moulding and Extrusion Materials Part 1 Designation System and Basis for Specifications” as per IS 17077 (Part 1):2019;
2. Grant of All India First License for “Linear Alkyl Benzene” as per IS 12795:2020;
3. Grant of All India First License for “White Cement Based Polymeric Putty” as per IS 17545:2021;
4. Calcined Alumina - Specification IS 17441 Part 1 Non-Metallurgical Grade, Indian standard is available for public comment now.

These grants, which are released by BIS when the first BIS registration certificate is released for any standard, indicate that there will be no extension for the implementation date against that standard. It does serve as a wake-up call to the industry to get their BIS registration certificate as soon as possible for compliance with the standards. As for International audits for the mandatory certificate products in similar lines,  there has been no official statement released by BIS up to date.

Penalties for cases where the products fail to be certified prior to the deadline under the mandatory scheme are not pre-defined. If any non-compliance act is found by BIS in their raids, the penalties charged from the culprit might likely serve as punishment, which is usually defined on the degree of non-compliance and the volume of products seized.

To date, a total of 39752 BIS registration certificates have been released to Indian manufacturers and for foreign manufacturers, 1018 BIS registration certificates have been released. Another Indian standard, Calcined Alumina - Specification IS 17441 Part 1 Non-Metallurgical Grade, is now available for public comment.

In total, 52 chemicals are currently under BIS mandatory certification scheme.

On April 5, 2022, a Quality Control Order (QCO) for a national standard covering the intermediate trimethyl phosphite has been released in India. Published by the Bureau of Indian Standards (BIS), man...

On April 5, 2022, a Quality Control Order (QCO) for a national standard covering the intermediate trimethyl phosphite has been released in India. Published by the Bureau of Indian Standards (BIS), manufacturers and importers of the substance must guarantee that it meets the standards given in Indian Standard (IS) 17412:2020 as of 5th October 2022.

At industrial locations and in production, trimethyl phosphite is utilised in formulation or repackaging.IS 17412:2020 (technical grade trimethyl phosphite) specifies the rules for using the material in products and other technical specifications. Under the BIS (Compliance Assessment) Regulations, 2018, enterprises manufacturing or importing trimethyl phosphite will need BIS certification to verify conformity and must display the BIS logo on all packaging starting in October.

The BIS Act of 2016 will penalise anyone who violates the QCO's provisions. However, this does not apply to items meant for export.

This new QCO came after the American Chemistry Council (ACC) chastised the Indian government for developing "antiquated, specific to the Indian market, and not based on worldwide norms" chemicals standards.