India Regulatory News

On 16 February 2022, the Ministry of Environment, Forest and Climate Change published the Plastic Waste Management (Amendment) Rules, 2022, amending the Plastic Waste Management Rules, 2016. The Rul...

On 16 February 2022, the Ministry of Environment, Forest and Climate Change published the Plastic Waste Management (Amendment) Rules, 2022, amending the Plastic Waste Management Rules, 2016. The Rules brought in Extended Producer Responsibility (EPR) to ensure a collective system of plastic wastes by the producer and brand owners.

The amended guideline provides the framework for further implementation of EPR and the prohibition of identified single-use plastic items with effect from July 01, 2022. Generators of plastic waste have to minimize plastic waste generation, not litter the environment with plastic waste and store them according to the rules.

The Rules affect importers, brand owners and plastic waste processors as the entities that fall under the category of Extended Producer Responsibility. They have to register in the centralized portal developed by Central Pollution Control Board (CPCB). The new rules classify plastics into four categories and mandate recycling and reusing a certain percentage of plastic produced and used by manufacturers, importers, and brand owners. From 2018 to 2021, 310 companies have been approved as brand owners and four companies have been approved as producers.

Brand Owners (BO) include online platforms/marketplaces, supermarkets/retail chains other than those, micro and small enterprises as per the criteria of Ministry of Micro, Small and Medium Enterprises, Government of India.

CPCB is also preparing an online portal and this will be the single point for the registration as well as filing of annual reports by producers, importers, brand-owners, and plastic waste processors of plastic packaging waste. The portal is expected to be ready by March 31, 2022.

The amended Rules also lay out a roadmap for upcoming activities (see below Table). 

For example, Category I needs to comply with 50% recycling and reusing of plastics by 2025 and Category III needs to comply with 30% recycling and reusing by 2025.

According to the Standard Operating Procedure (SOP) for Producers, Importers, and Brand Owners (PIBOs) that was amended and published in March 2021, registrants need to provide documents such as proof of selling in more than two states, valid consents under Air and Water Act (if the unit has ap production facility), documents related to Action Plan and others.

PIBOs are expected to submit progress reports half-yearly, addressing their management of plastic waste for each State in their Extended Producers Responsibility action plan. The submission should be done within 15 days from completing the preceding half-year team. The report should indicate the quantity as well as the type of plastic waste, the evidence of state-wise collection of waste according to EPR target and the details of your plastic waste collection, management, and processing.

PIBOs must provide the details of recycling certificates only from registered recyclers, as well as the quantity sent for end-of-life disposal, by June 30 of the next fiscal year, while making yearly returns on the online portal.

To know your compliance requirements, contact compliance@gpcregulatory.com 

Click here to view the Official Gazette 

At the UN Environment Assembly that happened from 28th February to 2nd March, along with Japan, India has placed another proposal on the table which states an alternative resolution on single use p...

At the UN Environment Assembly that happened from 28^th February to 2^nd March, along with Japan, India has placed another proposal on the table which states an alternative resolution on single use plastics. It focuses on a voluntary framework rather than a mandate for the creation of a legally binding global agreement.

The resolution, introduced on October 20 by Rwanda and Peru and co-sponsored by 53 countries including Norway, Chile, Pakistan, and the EU, is considered the most ambitious and calls for a full life cycle approach to plastics, addressing plastic production as well as harmful additives and waste management. It proposes an open mandate for a negotiating committee, which means that as discussions progress, negotiators could work on a wide range of issues related to plastic pollution, such as "product design and use, including compounds, additives, and harmful substances, as well as intentionally added microplastics."

A second resolution, submitted by Japan on December 6 and supported by Antigua and Barbuda, Cambodia, Palau, and Sri Lanka, is more limited in scope. The resolution focuses on plastic waste management (rather than production) and proposes a closed mandate, which means that negotiators could only address this aspect of plastic pollution when negotiating an agreement. Meanwhile, India jumped into the fray at the last minute with an alternative resolution on single-use plastics, which was published on January 31. Unlike the other proposals, India's document emphasises a voluntary framework rather than a mandate to create a legally binding global agreement. Several UN member states have requested that the two original proposals be combined prior to the main meeting. In January, more than 70 consumer brands, including Coca-Cola, PepsiCo, Unilever, and Ikea, issued a joint statement outlining plans to reduce plastic production and use.

Till the 16th of March 2022, the Bureau of Indian Standards (BIS) consults on the draft Indian Standard (IS) for 3,4-dichlorophenyl isocyanate. BIS published a daft in February, describing the subs...

Till the 16^th of March 2022, the Bureau of Indian Standards (BIS) consults on the draft Indian Standard (IS) for 3,4-dichlorophenyl isocyanate. BIS published a daft in February, describing the substance as an organic compound (formula: C7H3CI2NO) used as an intermediate in organic synthesis.

This compound is irritant to many tissues which include the eyes and mucous membranes. Also, inhaling the chemical dust can result in respiratory harm. The draft includes requirements, methods of sampling and testing for the chemical. In addition to that, one has to adhere to the provisions in the following standards:

The other proposals in the draft include the following:

·       For packing, the substance should be kept in suitable drums, tankers, ISO containers, etc. depending on the agreement between the purchaser and supplier.

·       For marking, the container should bear the name of the material, name of the manufacturer and his/her recognized trademark, month and year of manufacture, lot/batch number, net weight & gross weight, label (acute toxic, irritant, & health hazard), and any other statutory requirement.

It is important to note that if the draft is approved, it will be an additional substance that requires BIS certifications. Currently, there are 52 chemical substances under compulsory BIS certification, this includes the marking on the product’s packaging.

The Department of Chemicals and Petrochemicals (DCPC) in India has pushed back the deadlines for implementing quality control orders (QCOs) issued by the Bureau of Indian Standards (BIS) for five su...

The Department of Chemicals and Petrochemicals (DCPC) in India has pushed back the deadlines for implementing quality control orders (QCOs) issued by the Bureau of Indian Standards (BIS) for five substances. These substances are tagged ‘specialty’ chemicals by the BIS and the deadline is now June 22, 2022, rather than December 21, 2021, as originally planned.

These five substances are:  

· Phthalic anhydride 

· Ethylene glycol

· Toluene 

· Terephthalic acid, and 

· N-butyl acrylate. 

The DCPC, on the 24^th of December, issues separate notifications for each chemical saying the government, after consultation with BIS, agrees that an extension is needed in the public interest. This is also attributed to the difficulties government officials are facing regarding samples collection, laboratory tests, products certification due to COVID related travel restrictions.

Therefore, manufacturers, importers, and traders of these chemicals can continue to operate under prevailing trade regulations until the new deadline set as June 22, 2022. Until then, manufacturers and distributors will have to carry relevant BIS Indian Standard (IS) specification numbers and markings on their packaging and labels.

Last Update: 2022-02-16

On January 31, 2022, the Bureau of Indian Standards (BIS) released a Gazette notification for Extension in the Implementation date of Chemicals under mandatory certification Scheme I. The chemica...

On January 31, 2022, the Bureau of Indian Standards (BIS) released a Gazette notification for Extension in the Implementation date of Chemicals under mandatory certification Scheme I. The chemicals with extended implementation dates are Acetic acid, Methanol, Aniline, and Morpholine. For Acetic acid, Methanol, and Aniline, the implementation date extends from January 2022 to August 3,  2022. Whereas, for Morpholine, it is extended till August 1, 2022.

GPC has BIS-related services and can help you (end-to-end) in getting a BIS registration certificate for your product. 

Gazette notification for Extension

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