India Regulatory News

On November 15 and 16, 2021, the Committee on Technical Barriers to Trade, India published and submitted eight chemicals’ notifications to the World Trade Organization (WTO). BIS certificatio...

On November 15 and 16, 2021, the Committee on Technical Barriers to Trade, India published and submitted eight chemicals’ notifications to the World Trade Organization (WTO).

BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification. Product certification includes two schemes, that is, Product Certification Schemes: Scheme 1 - Indian Standards Institution (ISI) and Scheme 2 - Compulsory registration scheme (CRS). According to the BIS official website, there are 27 chemicals (Scheme I and II) that requires BIS mandatory certification. For the newly notified eight chemicals, all the notifications do not have a proposed date of adoption yet. However, the proposed date of entry into force is in 6 months from adoption. The final date for comment is 60 days from the notification, which is on January 15.

The notified substances are as follows:

1. Coconut Fatty Acids (IS 12069:1987) are produced by the hydrolysis of Coconut Oil. Coconut Fatty Acids consist of about 90% saturated fatty acids. The main fatty acids are Lauric Acid, which constitutes about 50% of total fatty acids obtained from coconut oil. Coconut Fatty Acids are used in the manufacture of Soaps and their derivatives like coco diethanol amide and coco mono ethanolamide.

2. Hydrogenated Rice Bran Fatty Acids (IS 12361:1988) is obtained by splitting, distillation, and hydrogenation of rice bran oil or by hydrogenation of distilled fatty acids obtained by splitting of rice bran oil. Rice Bran Fatty acids are used in the manufacture of soaps.

3. Lauric Acid (IS 10931:1984) is a saturated fatty acid having 12 carbon atoms. It is a raw material for making Lauryl Alcohol, which is used in the detergent industry. It is also used in Alkyd resins, Lauryl peroxides, ethanol amides etc. It is obtained by splitting coconut oils, Palm Kernel Oil etc. 

4. Palm Fatty Acids (IS 12067:1987) are obtained by hydrolysis of Palm Oils. Palm Oils are obtained from the fleshy part of Palm Fruits. Palm Fatty Acids consist of saturated and unsaturated fatty acids in equal amounts, Palmitic Acid and Oleic Acids are being the main fatty acids. Palm Fatty Acids are used in the soap industry.

5. Rice Bran Fatty Acids (IS 12068:1987) are produced by the hydrolysis of Rice Bran Oil. Rice Bran Oil is produced by solvent extraction of the layer around the endosperm of rice, known as Rice Bran. It contains 20-25% of saturated and 75-80% of unsaturated fatty acids. The main unsaturated fatty acids are Oleic Acids (40-50%) and Linolenic Acids (28-42%). These fatty acids are used in the manufacture of soaps.

6. Rubberseed Fatty Acids (IS 12124:1987) are produced by hydrolysis of Rubber seed Oil. Rubber seed oil is obtained from seed kernels of Rubber trees. Rubber Seed Fatty Acids contain Linolenic Acis (30-40%), Oleic Acid (17-30%) and Linoleic Acid (22- 24%) and other saturated fatty Acids like Palmitic acid and Stearic Acids.

7. 1,3 Phenylenediamine (IS 17450:2020) is an important dye-intermediate, polymer additive, fibre intermediate and used in photography. Since it is used in dyestuffs required for dyeing of textiles, it is very important to adhere to purity levels indicated in the standard. The excess impurities in the dyes may enter the human chain through textiles, impacting the health. If the technical parameters indicated in the standard are not observed, it shall be detrimental to plant life and environment.

8. Acid Oil (IS 12029:1986) is produced by acidification of soap stock obtained during refining of oils. It is used for producing low grade soaps. The large quantity usage and imports of Fatty acids and possible health impact of low purity.

For non-Indian manufacturers to comply with BIS certification, companies can appoint Authorized Indian Representative (AIR) to fulfil their obligations. For chemical compliance under BIS, companies should also conform to the individual Indian standards. Manufacturers of the products listed on Scheme 2 should apply for registration from Bureau of Indian Standards (BIS) after getting their product tested from BIS recognized labs. After registration, manufacturers are then allowed to put the Standard Mark on their products.

Contact GPC for BIS related compliance advice, compliance@gpcregulatory.com

Last Update: 2021-12-21

According to the Indian researchers who compiled the chemicals’ database, there is a need for better risk assessment and regulation of fragrance substances in children's products.  D...

According to the Indian researchers who compiled the chemicals’ database, there is a need for better risk assessment and regulation of fragrance substances in children's products. 

Due to the collaboration between two Research Institutes: the Institute of Mathematical Sciences in Chennai, India and the Max Planck Institute for Mathematics in the Sciences in Leipzig, Germany; a Fragrance Chemicals in Children's Products (FCCP) database of 153 fragrance substances has been created using published literature. 

The team, led by Areejit Samal, classified the substances based on their structure. Several of the fragrance chemicals were discovered to be potential carcinogens, endocrine disruptors, neurotoxicants, and skin sensitizers. In vitro data from the US Environmental Protection Agency's ToxCast programme helped in identifying seven skin sensitising chemicals in the FCCP database. 

It is pointed out that children can be exposed to fragrance chemicals through their skin, inhalation, or ingestion. However, the fragrance industry's safety testing has primarily focused on dermal exposure, therefore, more research is needed on toxicological or disease pathways associated with other routes of fragrance chemical exposure in children. 

The researchers believe their database will be useful to regulatory agencies as it will enable future toxicological and exposome research and facilitate risk assessment of fragrance chemicals. 

Last update: 2021-12-17

The Indian Department for Promotion of Industry and Internal Trade (DPIIT) amendment of the storage, handling, and packaging rules and stock reporting system for ammonium nitrate and calcium carbide c...

The Indian Department for Promotion of Industry and Internal Trade (DPIIT) amendment of the storage, handling, and packaging rules and stock reporting system for ammonium nitrate and calcium carbide came into effect on the 2nd of September, 2021.

Ammonium nitrate is a substance widely used as a fertiliser, however, it is also a major component for explosives and nitrous oxide, popularly known as laughing gas. Calcium carbide is used in manufacturing acetylene gas and generating acetylene in carbide lamps. It is also used for manufacturing chemicals used in steelmaking and as fertlisers.

The ministry sets a new safety framework to ensure that these substances are well reviewed when handling, storing, or reporting them. Considering the huge importation of ammonium nitrate in India, the new rule covers all possible risks from the point where the substance lands to its last consumption point. The new ammonium nitrate rules stipulate that:

• A single package’s weight limit is 500 tonnes and packages must be stored two metres apart at the very least.
• Only captive consumption are permitted for importation and storage is at least 500 metres from the port’s vicinity.
• Importers must be licensed by the relevant authorities. Compusorily, they must file returns on consumption, stocks, identification of consignments and traceability at every point of transportation.
• A verification of transporters and handlers must be done by the police. Each substance consignment must have at least one security guard go with it.
• A licence issued by the Directorate General of Mines Safety must be provided for transporting ammonium nitrate from one premises to another.
• An on-site fire fighting personnel and equipment must be available.

So also, the new calcium carbide rules require importers to:

• Provide location-based data where the calcium carbide is stored and used;
• Daily file accounts of receipt and sale of the substance with the relevant district authorities and the Directorate General of Mines Safety.
• Provide the coordinates of the premises to facilitate geo-mapping.

Last Update: 2021-11-30

On the 17th of September 2021, India overturned its ban of recycled plastic in 2018, now allowing the use of recycled plastic in Food Contact Materials (FCMs). The exception to the new rule is that it...

On the 17th of September 2021, India overturned its ban of recycled plastic in 2018, now allowing the use of recycled plastic in Food Contact Materials (FCMs). The exception to the new rule is that it doesn’t include chemical migration limits, that is, manufacturers can also recycle plastics containing harmful substances and use them for food packages.

The amendment, which came into effect six days after, states that recycled plastics may be used for storing, dispensing, and packaging ready-to-eat foods and drinks if it meets FSSAI appropriate standards and regulations.

The document by FDA makes it clear that it is a current thinking on the topic and so, should not be legally enforced but viewed as recommendations. It also states that recyclers of plastics intended for food packaging should submit process information to the FDA for evaluation and comment, though not legally binding.

A draft notice has also been published by FSSAI to set specific migration limits for the use of three substances in all FCMs. This is inclusive of plastics used for drinking water packages. The substances and migration limits include:

• antimony – 0.04 milligrams per kilogram (mg/kg);
• phthalic acid – 1.5mg/kg; and
• bis(2-ethylhexyl) phthalate – 1.5mg/kg.

For this period, objections, suggestions, and feedback can be submitted. The authority declared it will consider the proposed amendment to be effective 60 days from its publication in the country’s Official Gazette.

Last Update: 2021-10-21

In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below). ...

In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below).

These chemicals are added to the BIS Mandatory Certification list, indicating that manufacturers or importers who place these chemicals in the Indian market would need to comply with BIS and receive a BIS registration certificate before the activity. This requirement applies to both Indian and foreign manufacturers. The order comes into force after 180 days of its publication in the Official Gazette. To take 100 percent Polyester Spun Grey and White Yarn (PSY) as an example, manufacturers or importers would need to comply with BIS after October 13, 2021 (including this date), if they intend to continue using PSY in India.

Indian Government is proposing to bring out a ‘Reference Document for Carriage of Dangerous Goods by Road’. These Dangerous Goods (DG) refer to substances that pose risks to health, sa...

Indian Government is proposing to bring out a ‘Reference Document for Carriage of Dangerous Goods by Road’. These Dangerous Goods (DG) refer to substances that pose risks to health, safety, property, and the environment when transported.  

The main factors contributing to this action include: 

- Misdeclarations

- Incorrect or inadequate packaging

- Incorrect stowage

- Misrepresentations

- Mishandling and negligence

This is aimed at helping the industry, transporters and other users proactively take measures for safe and efficient transportation of hazardous goods. 

In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below)....

In April 2021, the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, India, published several orders regarding BIS certification of 13 chemicals (see Table below).

These chemicals are added to the BIS Mandatory Certification list, indicating that manufacturers or importers who place these chemicals in the Indian market would need to comply with BIS and receive a BIS registration certificate before the activity. This requirement applies to both Indian and foreign manufacturers. The order comes into force after 180 days of its publication in the Official Gazette. To take 100 percent Polyester Spun Grey and White Yarn (PSY) as an example, manufacturers or importers would need to comply with BIS after October 13, 2021 (including this date), if they intend to continue using PSY in India. 

Last update: 2021-07-19