India Regulatory News

In October 2022 the Bureau of Indian Standards (BIS) published a draft asking for comments on ‘Ionomer resins for its safe use in contact with foodstuffs pharmaceuticals and drinking water’. The c...

In October 2022 the Bureau of Indian Standards (BIS) published a draft asking for comments on ‘Ionomer resins for its safe use in contact with foodstuffs pharmaceuticals and drinking water’. The consultation is open until 6 December 2022.

Plastics are widely used for packing food and pharmaceuticals. Because the polymers in plastic have high molecular mass, are inert, and essentially insoluble in food, they do not pose a toxic hazard even when they come into direct contact with food. It is, however, possible that polymer additives such as monomers, residues from catalysts, or residual polymerization solvents may transfer into food because they have low molecular mass. It is unlikely that acute toxicity arising from plastic materials being in contact with food will occur, but the effects caused by the accumulation of the toxic substances may be serious.

Ionomer resins are very useful for packaging applications because of their superior barrier properties. They are known for their high clarity, ease of fabrication, toughness, and cost effectiveness. Ionomer resins are highly resistant to oil penetrations, have a low sealing temperature, and can be combined with a number of other polymers to give film structures such as nylon/ionomer, HDPE (high density polyethylene)/ionomer, and polyester/aluminium/ionomer.

The BIS draft lists specific requirements, methods of sampling, and testing for ionomer resins used when manufacturing of plastic items that will come into contact with foodstuffs, pharmaceuticals, and drinking waters

Some of the requirements listed in the draft are:

• No limits on the proportions of the ionomeric co- and ter-polymers that may be blended.
• The composition of some polymers is limited as follows:

• When pigments or colorants are used for food packaging, they must comply with the limits given in IS 9833.
• The limit for overall migration is 60 mg/kg for solid food and 60 mg/l for liquids. The test methods are given in IS 9845. A limit of 10 mg/dm² is set for containers smaller than 250 ml and for foils and other articles where the ratio between surface area of the material and the quantity of foodstuffs in contact can not be calculated.

The Government of India has on 29 September 2022, extended the date of enforcement of the existing Quality Control Order for Ethylene Vinyl Acetate Copolymers, Maleic Anhydride, Styrene (Vinyl B...

The Government of India has on 29 September 2022, extended the date of enforcement of the existing Quality Control Order for Ethylene Vinyl Acetate Copolymers, Maleic Anhydride, Styrene (Vinyl Benzene), Acrylonitrile, Polyethylene Material, Linear Alkyl Benzene, and Polyester yarns. Producers of this product will now have additional time to obtain Bureau of Indian Standards (BIS) certification for their products.  

The date of entry into force of the existing Quality Control Order for the following chemicals has been extended: 

As per the notifications, producers of these chemicals will now have additional time to secure BIS certification before these Orders come into force. Once these Orders come into force, both domestic and foreign manufacturers of these products will only be able to export/sell in India with a valid BIS license in place. 

To obtain such license, both foreign producers and domestic manufacturers of these products will need to submit an application to the BIS seeking certification. Furthermore, the process of certification will also require physical testing and inspection of the relevant chemicals at the factory premises as well as parallel testing by a BIS-authorized laboratory in India to verify the same. BIS certification is a time-consuming process and therefore it is recommended that interested producers make applications for certification at the earliest in cases wherein Quality Control Orders have been issued and are pending enforcement. 

For the electric vehicle (EV) batteries India’s Ministry of Road Transport and Highways has extended the deadline for implementation of mandatory standards and testing norms.  The testing norms ...

For the electric vehicle (EV) batteries India’s Ministry of Road Transport and Highways has extended the deadline for implementation of mandatory standards and testing norms. 

The testing norms were supposed to come into effect from the 1st of October 2022, However, The Ministry through modifications to certain rules like the Automobile Industry Standards (AIS) Rule 156 and the AIS Rule 039 have now stipulated battery standards and testing norms to come into effect in 2 phases. The first phase is from the 1st of December 2022 and the other components are from the 31st of March 2023, in the second phase. 

In order to ensure that original equipment manufacturers (OEMs) of EV makers are well equipped to meet standards under the AIS 156 and AIS 039, the ministry stated that implementing new standards and testing norms for EV batteries has been extended. 

The Norms that will be applicable from the 1st December 2022 are the following: 

• The battery management system (BMS) shall be a microprocessor/microcontroller-based circuit. 

• BMS shall be verified for the following safety features: a) Over-charge protection, b) Over-discharge protection, c) Over-temperature protection, d) Overcurrent protection, and e) Short circuit protection 

• The charger shall have: a) charge voltage cut-off to avoid overcharging, b) soft-start function every time the battery is connected for charging, c) pre-charge function to detect deep discharge condition, d) input supply variation (230 VAC +/- 10%) protection, and e) earth leakage detection as per Class 1 of Indian Standards (IS) 12640. 

• Cells used to make batteries shall undergo a minimum 1 cycle of charge-discharge at C/3 current rate. Data of this cycling shall be maintained by the battery pack manufacturer. 

• Sufficient cell-to-cell spacing distance shall be maintained for effective heat transfer from the cell and also isolate the cells in case of thermal runaway in the battery. The inter-cell gap shall be decided based on the type of cell geometry used viz., cylindrical, prismatic, or pouch, and the capacity of the cells. 

• Battery shall have an additional safety fuse or circuit breaker in addition to the features available in BMS. 

• Each battery manufactured shall have a traceability document in which the details of the cells, BMS, and the charger used along with serial/batch number, charge-discharge data values, etc. shall be maintained with the manufacturer. 

• Adequate protection of the cells in case of regenerative braking shall be considered in the design. 

 The Norms that will be applicable from the 31st March 2023 are the following: 

• BMS shall comply with EMC (Electromagnetic Compatibility) requirements as per AIS 004 Part 3 or AIS 004 Part 3 Rev 1 as applicable at the EMC (Electromagnetic Compatibility) level. 

• This procedure is added to evaluate the ability of the battery to withstand thermal propagation which is triggered by an internal short circuit leading to a single-cell thermal runaway and subsequent thermal propagation and shall not result in fire and explosion of the battery. 

• The manufacturing date of battery cells shall be clearly visible on the cells used to build the battery pack with a clear month and year of manufacture. If the manufacturing date is in the form of code on the cells, then the manufacturer shall print the manufacturing date on the pack and shall maintain a record of the manufacturing date(s) of cells used in the assembly of the pack. 

• Cells used shall be certified as per IS 16893 Part 2 and Part 3 

• Battery must have a pressure release vent provided, to avoid building up of internal pressure and release of gases in case of an internal single cell short circuit. 

• Battery should also have active paralleling circuits for the parallel connection of strings to eliminate circulating currents. These power semiconductor devices used for interconnecting strings will also act as protection/safety switches which will detect any faulty strings and isolate them. They will allow the bidirectional flow of currents to charge and discharge the pack. The parallel strings will get isolated if it is detected to be faulty. Therefore, active paralleling circuits shall be mandatory. 

• Data on critical parameters of the battery pack shall be logged by BMS and the latest data for at least one month shall be maintained. Alternatively, the latest data can be stored on the cloud (remote server) at least for one month. 

The Director General of the Society for Manufacture of Electric Vehicle stated that “they are requesting all the EV battery manufacturers to immediately draw up a plan to implement the new standards as per the policy guidelines so as to ensure that they gear up their capabilities and capacities to ensure sufficient quantities of safer batteries to meet the exponential demand of EVs” 

India’s Department of Chemicals & Petrochemicals published the Gazette Notifications for Quality Control Orders (QCOs) of three Chemicals: Trimethyl Phosphite, 1, 3 Phenylenediamine and Rubberseed ...

India’s Department of Chemicals & Petrochemicals published the Gazette Notifications for Quality Control Orders (QCOs) of three Chemicals: Trimethyl Phosphite, 1, 3 Phenylenediamine and Rubberseed Fatty Acids. According to the orders, manufacturers and importers should conform to the corresponding Indian Standards and include the Standard Mark under a license from the Bureau of Indian Standards (BIS) from October 2022 (See table below). The notification for QCOs of these three chemicals were published in April 2022.

Read more on BIS compliance.  

India’s Department of Chemicals & Petrochemicals (DCPC) has delayed the implementation of the Quality Control Orders (QCOs) for six chemicals. The notification came on October 21, 2022, and accordin...

India’s Department of Chemicals & Petrochemicals (DCPC) has delayed the implementation of the Quality Control Orders (QCOs) for six chemicals. The notification came on October 21, 2022, and according to the amended QCOs these orders will be in place in 24 April next year.

These six chemicals are mainly used in soup and other personal care. The chemicals are:  

1. Lauric Acid

2. Acid Oil

3. Palm fatty Acids

4. Rice Bran Fatty Acids

5. Coconut Fatty Acids

6. Hydrogenated Rice Bran Fatty Acids 

The delays are mainly due to revisions to some Indian standards and travel bans of factory auditing due to Covid pandemic. This is in particular the cases for foreign manufacturers.  

On 14 September 2022, the Ministry of Commerce and Industry of India published Notification No.32/2015-2020. This notification permits the import of PET Flakes. However, there are certain conditions. ...

On 14 September 2022, the Ministry of Commerce and Industry of India published Notification No.32/2015-2020. This notification permits the import of PET Flakes. However, there are certain conditions.

The import of PET flakes has been permitted subject to NOC (No Objection Certificate) from the Ministry of Environment, Forest, and Climate Change (MoEFCC) and authorization from the Directorate General of Foreign Trade (DGFT).

This was in connection with the ban on all plastic imports as notified in the ‘Hazardous and Other Wastes (Management & Transboundary Movement) Amendment Rules, 2019’ by the MOEFCC.

In March 2019 the Ministry of Environment Forests and Climate Change imposed a ban on the importation of PET bottles to India, along with other electronic items. The ban aimed to strengthen the waste management infrastructure and prevent the country from turning into a global dump yard. Additionally, the ministry’s Hazardous Substance Management (HSM) Division banned the import citing that India has enough waste which can be processed by recyclers.

Once upon a time, India was one of the largest importers of PET bottle scrap, after China. India imported large volumes of PET scrap from the USA, Europe, and the Gulf countries. The booming recycling industry heavily relied on PET imports, i.e. nearly 70-80% of the demand was fulfilled by imports. However, this led to the waste generated locally being left unaddressed.

In the wake of the National Green Tribunal directions, the MoEFCC took an action to effectively ban the import of all types of plastics, household waste, and electronic waste into India. The three-year ban was, however, partially lifted in March 2022, allowing only PET flakes to be imported. Since the import was opposed by many stakeholders, including Recycle India Foundation and Mumbai-based Pandit Deendayal Upadhyay Smiriti Manch (PDUSM), the issue was referred by the environment ministry to a technical review committee which has now recommended the import with certain specific conditions. The ministry accepted the recommendations, allowing the import of 95,105 tonnes of PET flakes, on August 24, 2022.

From 1 October 2022, Rechargeable Electric Energy Storage Systems (REESS) and electric vehicle makers would need to comply with new amendments to specific technical requirements for REESS or batteries...

From 1 October 2022, Rechargeable Electric Energy Storage Systems (REESS) and electric vehicle makers would need to comply with new amendments to specific technical requirements for REESS or batteries for electric vehicles of categories ‘M’ and ‘N”.  ‘M’ denotes electric four-wheel motor vehicles used for carrying a passenger and ‘N’ denotes electric four-wheel motor vehicles used for carrying both goods and passengers. These amendments were announced on 1 September 2022, by India’s Ministry of Road Transport and Highways. Earlier the ministry through a draft notification issued on 25 August 2022, had announced the amendments to the Central Motor Vehicle Rules 1989.

These amendments provide for additional safety requirements related to battery management systems (BMS), onboard chargers, battery pack design, and thermal propagation due to internal cell short circuits leading to fires, based on the report by an expert committee constituted by the Road Transport Ministry.

Amendment 2 to Automotive Industry Standard AIS 156 comprises specific requirements for motor vehicles of the L category- motor vehicles with less than four wheels and an electric power train.

Amendment 2 to AIS 038 Rev.2 lists specific requirements for electric power trains of M category vehicles and N category motor vehicles.

The ministry also issued draft notification GSR 659 (E) to amend Sub-rule 4 of Rule 124 of Central Motor Vehicles Rules (CMVR) 1989 for mandating Conformity of production for traction batteries used in electric power train vehicles.