India Regulatory News

At the end of June 2023, the Bureau of Indian Standards (BIS) published a draft amended standard for surface cleansers that contain quaternary ammonium compounds (QUACs). BIS is accepting comments on ...

At the end of June 2023, the Bureau of Indian Standards (BIS) published a draft amended standard for surface cleansers that contain quaternary ammonium compounds (QUACs). BIS is accepting comments on the draft until August 31. This is the standard's first change since 1996. In this first revision, the requirements for total non-volatile matter, pH and QAC content have been modified. Furthermore, the packing and marking clauses have been updated. 

QUATs are antibacterial agents that can be added to conventional liquid cleaners based on soap and detergents to deal with bacteria. A product of this type helps to create hygienic environment through cleaning and reducing the effect of bioburden (i.e. the number of bacteria living on a surface that has not been sterilized). The quaternary ammonium compounds (QAC) may be cetylpyridinium chloride, cetalkonium chloride, benzalkonium chloride, or any quaternary ammonium compound, suitable for the purpose. 

• The following are the suggested specifications for cleaners containing QUACs:   

The draft standard indicates that the cleaners containing QUACs should be contained in glass bottles or suitable plastic containers, provided with a pilfer proof cap made of either metal or plastic and be marked with the following: 

a) Indication of the source of manufacture 

b) Net content of the material 

c) Name of the material 

d) Month and year of manufacture, and Batch No. or Code No. 

e) Direction for use 

f) Cautionary label 'DO NOT MIX WITH HOUSEHOLD SOAP AND DETERGENTS'. 

On June 7, 2023, the Indian Central Board of Indirect Taxes & Customs (CBIC) issued Circular No. 15/2023 which makes it mandatory to provide additional parameters for imported goods such as scientific...

On June 7, 2023, the Indian Central Board of Indirect Taxes & Customs (CBIC) issued Circular No. 15/2023 which makes it mandatory to provide additional parameters for imported goods such as scientific names, IUPAC names, brand name, CAS number, etc. along with the complete details of imported products. The requirements were to come into force on July 1, 2023. However, on June 30, 2023, the CBIC introduced an amendment to the circular deferring the date for the mandatory additional requirements for import/export of certain products from July 1, 2023, to October 1, 2023.  

The circular was further discussed with the Department of Chemicals and Petrochemicals, the Ministry of AYUSH, and the Directorate General of Foreign Trade (DGFT). It was concluded that providing the complete details of the products on import/export declarations can clear the way for effectiveness in assessment, avoidance of queries, and speed up clearance processes. 

Following mandatory requirements are added for import/export declarations: 

• The declaration of IUPAC name and CAS number of the constituent chemicals for imports. 

• The declaration of the name of the medicinal plant, for exports of parts of plants. 

• The declaration of the name of the formulation, for exports of formulations of different streams of medicine. 

• The declaration of the surface material that comes into contact with the chemical, for exports of various products. 

On June 21, 2023, the Bureau of Indian Standards (BIS) published a revised draft standard for soap noodles. BIS will take comments on the draft till August 31, 2023. The draft is an updated version of...

On June 21, 2023, the Bureau of Indian Standards (BIS) published a revised draft standard for soap noodles. BIS will take comments on the draft till August 31, 2023. The draft is an updated version of IS10513, which was first issued in 1983, has been approved by BIS for use with soap noodles. The standard covers requirement for “soap noodles” used as an intermediate product for subsequent conversion into marketable soaps. The phrase "Sodium oleostearate noodles" has been changed to "Soap noodles" in this revision, since soap noodles presently are made from different blends of oils and benefit ingredients.

The 1983 version of the standard did not differentiate between soaps used for personal care, laundry, or other purposes, like those used in the industry. In this revision 3 categories of soaps are included: Type 1 personal care soaps (pure soap noodles), Type 2 laundry soaps, and Type 3 is “other soap noodles” which covers different combinations of soap and other beneficial ingredients as agreed between the manufacturer and supplier.  According to Cosmetic Rules 2020, all ingredients used in cosmetic products, such as personal care soap, must adhere to Indian Standards (IS) 4707 (Part 1 and Part 2), the Drugs and Cosmetics Act 1940 & Rules 1945.

The revision gives the following restrictions for heavy metals and other chemicals for the three product categories:

The draft furthermore addresses ingredients like fatty acids, oils, and electrolytes that are used in the manufacturing processes.

In addition, the manufacturer's name, the date of manufacture, the name and type of substance, the lot and batch number, and other requirements have been standardized for packaging and labels. 

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.