India Regulatory News

Following consultation with the Bureau of Indian Standards (BIS), the government decided to defer implementation of of two essential quality control orders (QCO), according to an announcement by the D...

Following consultation with the Bureau of Indian Standards (BIS), the government decided to defer implementation of of two essential quality control orders (QCO), according to an announcement by the Department of Chemicals and Petrochemicals (DCPC) that was published in the Gazette of India on June 21, 2023 (full notice can be found here. 

The execution of the two QCOs has been further delayed till December 22, 2023, by India's Department of Chemicals and Petrochemicals (DCPC). 

Originally set to go into effect on December 21, 2022, the QCOs were later postponed until June 22, 2023. They include: 

• N-Butyl Acrylate is used to make solvents, varnishes, adhesives, paints, binders, emulsifiers, polymers and resins for finishing leather and textiles. 

• Toluene is a chemical that is used in the production of paint, paint thinner, lacquers, adhesives, rubber, and methods for tanning leather. 

The two chemicals continue to be subject to the current norms and regulations until December 22, 2023. 

A new code of practice for safeguarding employees from chemical airborne pollutants in the workplace is being discussed in India.  In May 2023 the Bureau of Indian Standards (BIS) published the dr...

A new code of practice for safeguarding employees from chemical airborne pollutants in the workplace is being discussed in India. 

In May 2023 the Bureau of Indian Standards (BIS) published the draft Indian Standard, Work Environment Monitoring (Airborne pollutants) - Code of Practice and is accepting comments on it until 23 July 2023. The draft contains standards for monitoring data of chemical variables responsible for airborne pollutants, frequency and kind of sample collection, and data interpretation. The complete draft can be found here. 

The guidelines state that: 

• Environmental monitoring in a plant shall take place under normal process conditions and ideally every day and throughout the day. 

• Airborne contaminants shall be identified by monitoring all situations where it is possible that a person can be exposed.  

• The total duration of a process shall be estimated when a process or operation is carried out repeatedly. 

• When two or more contaminants are present simultaneously, they shall be monitored individually and simultaneously. 

The draft suggests that the exact threshold limit value for individual contaminants may be obtained from relevant literature such as the American Council of Governmental Industrial Hygienists' (ACGIH) list of chemical pollutants' threshold limit values (TLV).  

The Bureau of Indian Standards (BIS) asked for comments until 2 June 2023 on a new revised standard for vinyl acetate monomer, which is used in adhesives, emulsion paints, wood coatings, lacquers, and...

The Bureau of Indian Standards (BIS) asked for comments until 2 June 2023 on a new revised standard for vinyl acetate monomer, which is used in adhesives, emulsion paints, wood coatings, lacquers, and inks. 

The standard for vinyl acetate monomer was originally published in 1988. The revision incorporates alternate methods for determination of aldehyde, distillation range and specific gravity. 

The chemical should be stored in mild steel drums, according to the updated draft, which also suggests the required use of "dangerous goods" labels coupled with visual markings (in accordance with Indian Standards 1260). Additionally, the container must clearly state that it contains "vapours and liquid dangerous to eyes." 

The BIS updated standard establishes the following precise specifications for the substance: 

Additionally, substance containers must be marked with manufacturing information including the name of the material, the manufacturer's name, the product's gross and net weight, the month and year it was made, and its shelf life.    

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. 

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 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

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

In April 2023 the Bureau of Indian Standards (BIS) published a draft Indian Standard, Chloroform Pure and Technical, and is asking for comments 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