India Regulatory News

On 23 May 2023 the Central Government of India published a notice in the Indian Gazette delaying the start date for the Quality Control Orders (QCOs) for vinyl acetate monomer, methyl acrylate, and et...

On 23 May 2023 the Central Government of India published a notice in the Indian Gazette delaying the start date for the Quality Control Orders (QCOs) for vinyl acetate monomer, methyl acrylate, and ethyl acrylate. The initial enforcement date for the substances was 31 May 2023 and the new enforcement date for all three substances is 29 February 2024.

The Quality Control Order is the regulation that requires concerned substances to carry the certification mark of the Bureau of Indian Standards (BIS).

For further information on BIS compliance, visit GPCgateway or contact GPC at compliance@gpcregulatory.com

On 15 May 2023 the Indian Ministry of Health and Family Welfare (MHFW) published a notification in the Gazette of India concerning amendments of the Cosmetic Rules, 2020. The MHFW is accepting comment...

On 15 May 2023 the Indian Ministry of Health and Family Welfare (MHFW) published a notification in the Gazette of India concerning amendments of the Cosmetic Rules, 2020. The MHFW is accepting comments for 45 days, i.e. until 29 June 2023.

The following are some of the changes proposed in the amendment:

The Cosmetic Rules, 2020 came into force on 15 December 2020 but an 18-month extension was granted to comply with the rules. The Rules are a part of the Drugs and Cosmetics Act, 1945.

The notification can be found here: https://egazette.nic.in/WriteReadData/2023/245904.pdf

On 18 May 2023 the Indian Standards Bureau (BIS) published a draft revised standard regarding polyethylene terephthalate (PET) bottles for packaging of edible oils. PET, a plastic resin formed by poly...

On 18 May 2023 the Indian Standards Bureau (BIS) published a draft revised standard regarding polyethylene terephthalate (PET) bottles for packaging of edible oils. PET, a plastic resin formed by poly-condensation reaction of ethylene glycol with either terephthalic acid or dimethyl terephthalate, is a commonly used material for FCM. BIS will be accepting comments on this draft until 17 July 2023. 

In India Food Contact Materials (FCMs) are regulated under Food Safety and Standards Act (2006) and its related regulations such as Food Safety and Standards (Labelling and Display) Regulations (2020) and Food Safety and Standards (Packaging) Regulations (2018). Last year, the authority also published a Direction regarding the use of recycled plastics. In addition to the FCM regulations, the Indian government also uses BIS standards to address individual materials used for packing food or have direct contact with food.  

The draft revised standard prescribes the requirements and methods of sampling and testing for PET bottles up to 5 kg or 5 liters of edible oil and has a total migration limit for all compounds of 60 mg/kg,  

Additionally, the updated draft sets the following precise limitations for heavy metals and the phthalate DEHP: 

According to the specification, PET material must be virgin grade and in compliance with Indian Standard (IS) 12252:2017. For bottles to be recyclable, additives for biodegradability or compostability must be avoided. High density polyethylene (HDPE) or another virgin food-grade polymer must be used for plastic bottle caps. The IS 15495 standard must be followed for all printing inks and coating chemicals used on labels, and all inks, coatings, glues, and adhesives must be bisphenol-free. 

In April 2023 the Bureau of Indian Standards (BIS) published a draft Indian Standard, Chloroform Pure and Technical, and is consulting on this until 4 June 2023. Other than the well-known anestheti...

In April 2023 the Bureau of Indian Standards (BIS) published a draft Indian Standard, Chloroform Pure and Technical, and is consulting on this until 4 June 2023.

Other than the well-known anesthetic uses, chloroform (systematic name trichloromethane) is used as follows:

• As solvent for waxes, fats, oils, rubber, and resins

• As a cleansing agent

• In fire extinguishers to lower the freezing temperature of carbon tetrachloride

• In the manufacture of chloro-fluoro methane refrigerants

The BIS standard for chloroform was originally published in 1969 and has since been revised 2 times. In this third revision the following changes are included:

• The requirement of purity has been incorporated with limit of 99.5 % by mass
  for pure grade chloroform and 98 % by mass for technical grade chloroform, which is to be tested by gas chromatographic method.

• The gas chromatography method has been modified for better separation,
  low level detection and quantification of impurities and referred as test method for
  determination of purity.

• Since, the gas chromatography method is more authentic and accurate the
  distillation range characteristics has been made optional parameter to be tested.

• The test method for free chlorine has been modified.

• An alternative test method for colour determination has been incorporated.

• The test for foreign organic matter has been deleted as the synthesis is purely chemical and no biological origin material, stones, sands, lumps of soil are used
  in manufacturing of chloroform.

• The limit for acidity for pure grade has been modified as 0.0005.

The complete draft Standard can be found here: https://www.services.bis.gov.in/tmp/WCPCD5122260_05042023_1.pdf

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions lis...

At the 11th meeting of the Conference of the Parties (COP) to the Stockholm Convention on 5 May 2023, more than 120 countries agreed to add 2 plastic chemicals and one pesticide to the Conventions list of substances for global elimination (Annex A). The delegates to the COP found that the chemicals, the plastic additive UV-328, the flame retardant Dechlorane Plus (also often used in plastics), and the pesticide methoxychlor all meet the Convention criteria as persistent organic pollutants (POPs) required for a global ban.

The uses and hazards of the 3 substances are:

However, time-limited exemptions were agreed on for the use of UV-328 and Dechlorane Plus. The exemptions are summarised in the tables below.

Several countries called for labelling of products that contain the 2 plastic additives while others opposed. The Convention’s Scientific Review Committee plans to evaluate options for identifying POPs in products and waste.

On 2 May 2023, the Indian Ministry of Environment, Forest and Climate Change (MoEF) published a draft notification in the Gazette of India for bringing out regulations for Extended Producer Responsibi...

On 2 May 2023, the Indian Ministry of Environment, Forest and Climate Change (MoEF) published a draft notification in the Gazette of India for bringing out regulations for Extended Producer Responsibility (EPR) for used oil. The public and other stakeholders have 60 days from the date of publication of the draft to make any objection or suggestions on the proposals contained in the draft notification.

Used oil is a major environmental hazard if it is not disposed of properly. One litre of used oil can contaminate 1 million litres of fresh water. The aim of the draft notification is to promote circular economy for used oil such as re-refining of used lubricants which could have both environmental and economic benefits.

The EPR for used oil is notified under the Hazardous and Other Wastes (Management
and Transboundary Movement) Rules, 2016. The latest amendment of these rules is the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2023 which will come into force on 1 April 2024.

The definition of used oil is defined in subrule 36 of rule 6 of Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 as:

• Any oil derived from crude oil or mixtures containing synthetic oil including spent oil,
  used engine oil, gear oil, hydraulic oil, turbine oil, compressor oil, industrial
  gear oil, heat transfer oil, transformer oil and their tank bottom sludges.

• Any oil suitable for reprocessing, i.e. oil that does not include waste oil and meets the limits for polychlorinated biphenyls (PCBs), lead, arsenic, cadmium, chromium, nickel and polyaromatic hydrocarbons (PAH).

Under the draft notification producers, collection agents, recyclers and used oil importers will have to register on the online system developed by the Central Pollution Control Board. The portal will also be used for filing quarterly and annual returns, EPR certificate and tracing of oil produced or generated by the stakeholders.

EPR obligations for producers of base oil or lubrication starts at 10 % of the oil sold or imported in the year 2022-2023 and increases by 10 % for each of the following 5 years. EPR obligations for used oil importers is 100 % of the imported oil. The import of used oil is permitted only for the purpose of re-refining.

The complete text of the draft notification can be found here: https://egazette.nic.in/WriteReadData/2023/245597.pdf

On 27 April 2023 the Indian Ministry of Environment, Forest and Climate Change published a notification in the Gazette of India announcing the Plastic Waste Management (Amendment) Rules, 2023. The Rul...

On 27 April 2023 the Indian Ministry of Environment, Forest and Climate Change published a notification in the Gazette of India announcing the Plastic Waste Management (Amendment) Rules, 2023. The Rules came into force on the day of publication in the Gazette and are an amendment to the Plastic Waste Management Rules, 2016 previously amended by the Plastic Waste Management
(Second Amendment) Rules, 2022.

The following amendments have been made to the Plastic Waste Management Second Amendment Rules, 2022:

Rule 10. Protocols for compostable and biodegradable plastic materials.

The deadline for the provisional certificates for biodegradable plastics issued by the Central Pollution Control Board (subrule 5) has been prolonged by one year. The provisional certificates shall be valid till 30 June 2024 with the condition that production or import of biodegradable plastic shall cease after 31 March 2024.

Rule 11. Marking and labelling

The rule that each plastic carry bag must have name, registration number of the producer or brand owner, and the thickness in case of carry bag and plastic packaging does now not apply to ‘rigid plastic packaging’.

Rule 13. Registration of producer, recyclers and manufacturer

Every producer or importer shall for the purpose of registration make an application as per the guidelines specified in Schedule II. The renewal of registration has been omitted (from Subrule 2). The registration granted under this rule shall be changed only on the request of Producers, Importers
& Brand owners, under the existing Extended Producer Responsibility registration. The registration granted under this rule shall be valid for a period of one year, unless revoked,
suspended or cancelled and shall subsequently be granted for three years.

Schedule II. Guidelines on Extended Producers Responsibility (EPR) for Plastic Packaging

• Clause 6.6: The details regarding registration on the EPR portal have been modified. The following is now valid: While registering, the entities shall have to provide PAN Number, GST Number, CIN Number of the company in case of company and the entities may provide Aadhar Number and shall provide PAN Number of authorized person or representative and any other necessary information as required.

• Clause 10.6: Producers, importers and brand-owners must file annual returns on the collected plastic packaging waste on the EPR portal by 30 June of the next financial year. Provided that the last date for filing of annual returns for the financial year 2022-2023 is the 31 October 2023.

• Clause 11.2: Plastic waste processors (recyclers or other waste processors including composting facilities) must submit annual returns after the end of each financial year by 30 April. Provided that the last date for filing of annual returns for the financial year 2022-2023 is the 31 July 2023.

The Offcial Gazzette can be found here: https://egazette.nic.in/WriteReadData/2023/245496.pdf