India Regulatory News

On 6 July 2023 the Bureau of Indian Standards (BIS) published a draft revised standard for Glauber salt (sodium sulphate, decahydrate). The last date for comments is 7 September 2023.  In 1950, th...

On 6 July 2023 the Bureau of Indian Standards (BIS) published a draft revised standard for Glauber salt (sodium sulphate, decahydrate). The last date for comments is 7 September 2023. 

In 1950, the BIS published a draft for Glauber salt involving the maximum acceptable limits for some heavy metals.  

Glauber salt also known as mirabilite is used in textiles, glass, paper and pulp, dyestuff, leather, and metallurgical industries. In these sectors, it is for example used in the manufacture of plate and sheet partially glass, it serves as an agent to promote even distribution of dye of common salt in curing hides, and is also used for separation of nickel from copper. 

The draft standard was eventually revised in 1972. The first revision involves the limit values for sodium sulphate and zinc.  

• For sodium sulphate the defined minimum limit was 98.5 percent. 

• For zinc: the maximum limit was given to be 0.4 percent.  

The current second revision involves test methods for chloride and iron determination. The draft consists of following two annexes: 

• Annex A: provides method of testing for Glauber salt 

• Annex B: contains details on sampling of Glauber salt 

Also, a subsection for packing and marking is mentioned in the draft. The product must be marked with the BIS standard mark and the packages must be marked with the following details: 

a) Name and grade of the material; 

b) Net weight of contents;  

c) Year of manufacture;  

d) Manufacturer’s name and/or his recognized trade-mark, if any; and  

e) Batch number to enable the lot of manufacture to be traced from records 

Further details on the methods, packing and marking can be found here: 

https://www.services.bis.gov.in/tmp/WCCHD17022844_06072023_1.pdf 

The Central Government of India has extended the enforcement date for 10 substances under the Quality Control Order (QCO). The amended enforcement dates were published by the Ministry of Chemicals and...

The Central Government of India has extended the enforcement date for 10 substances under the Quality Control Order (QCO). The amended enforcement dates were published by the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals in the Indian Gazette on 21 July 2023. The Quality Control Order is the regulation that requires concerned substances to carry the certification mark of the Bureau of Indian Standards (BIS). The 10 substances and their previous and new enforcement dates are listed in the table below.

The full text of the Gazette notification for the 10 substances can be found here.

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. 

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 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).