India Regulatory News

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

In August 2020, the 5th draft of the Chemicals Management & Safety Rules (CMS Rules) was published by the Government of India. These draft rules are based on the EU REACH legislation and the e...

In August 2020, the 5th draft of the Chemicals Management & Safety Rules (CMS Rules) was published by the Government of India. These draft rules are based on the EU REACH legislation and the existing Manufacture, Storage and Import of Hazardous Chemical Rules (MSIHC) 1989 and THE CHEMICAL ACCIDENTS (EMERGENCY PLANNING, PREPAREDNESS, AND RESPONSE) RULES, 1996. This new draft is progressively forward-looking and lays optimum emphasis on data. “No Data, No Market.”

In a paper recently published by the Indian government on Circular Economy in Toxic and Hazardous Industrial Waste, CMSR was mentioned as one of the main focuses to enhance India’s chemical management. The report acknowledges the need to implement the CMS Rules and also highlights that India is one of the large chemical economies that is not a signatory to the UN’s GHS (Global Harmonized System of Classification and Labelling of Chemicals). These draft rules envision that change by incorporating GHS in the final draft due later this year (2021).

It also considers that minimizing hazardous waste will regulate and limit the toxic chemicals entering the economic cycle. This emphasises the need for a regulatory framework that promotes and facilitates the circular economy (CE) with compliance and competitiveness of the industry as the core. Lifecycle management of chemicals, extended producer’s responsibility, and precautionary principles are emphasised as necessary tools to address the issue of Hazardous waste and toxic chemicals and also, for the development of an appropriate regulatory framework.

In May 2021, India also published a policy paper on the circular economy in the electronics and electrical sector. These actions show that the government is actively taking steps to change from a linear to a circular economy. As intended, a circular economy path in Toxic and Hazardous Industrial Waste and other vital sectors will bring massive reduction of pollution and congestion. This will also lead to resource efficiency, reduces operating cost, builds competitiveness and self-reliance and most importantly, CE is less damaging to the environment.

In view of the above information, specifically regarding India and the new CMS rules, it becomes imperative that it is necessary to define what circularity and recycling mean in order to recommend an appropriate action plan for implementing a circular economy in toxic and hazardous industrial waste.

Date: 2021-07-06