India Regulatory News

On the 13th of May 2022, the Central Government of India extended the enforcement date for three substances under the Quality Control Order (QCO). The Quality Control Order is the regulation that ...

On the 13^th of May 2022, the Central Government of India extended the enforcement date for three substances under the Quality Control Order (QCO).

The Quality Control Order is the regulation that requires concerned substances/chemicals to carry the Bureau of Indian Standards (BIS) certification mark. This mark certifies the substance/product’s quality and safety to the end-users and environment.

For this new extension, the concerned chemicals and their new dates are Methylene Chloride (November 20, 2022), Ortho Phosphoric Acid (December 10, 2022) and Polyphosphoric Acid (December 22, 2022). The delays, according to the DCPC, are due to a backlog of outstanding QCOs caused by COVID-related staff shortages and travel limitations, which have resulted in delays in inspections, sampling, testing, and certification of substances and goods. 

There are about 52 chemicals in total, under the BIS mandatory certification scheme. 

Recently, the Bureau of Indian Standards (BIS) published several updates for BIS standards. The updates address the following:   Grant of All India First License for “Plastic-Acrylonitrile...

Recently, the Bureau of Indian Standards (BIS) published several updates for BIS standards. The updates address the following:

1. Grant of All India First License for “Plastic-Acrylonitrile-Butadiene styrene (ABS) Moulding and Extrusion Materials Part 1 Designation System and Basis for Specifications” as per IS 17077 (Part 1):2019;
2. Grant of All India First License for “Linear Alkyl Benzene” as per IS 12795:2020;
3. Grant of All India First License for “White Cement Based Polymeric Putty” as per IS 17545:2021;
4. Calcined Alumina - Specification IS 17441 Part 1 Non-Metallurgical Grade, Indian standard is available for public comment now.

These grants, which are released by BIS when the first BIS registration certificate is released for any standard, indicate that there will be no extension for the implementation date against that standard. It does serve as a wake-up call to the industry to get their BIS registration certificate as soon as possible for compliance with the standards. As for International audits for the mandatory certificate products in similar lines,  there has been no official statement released by BIS up to date.

Penalties for cases where the products fail to be certified prior to the deadline under the mandatory scheme are not pre-defined. If any non-compliance act is found by BIS in their raids, the penalties charged from the culprit might likely serve as punishment, which is usually defined on the degree of non-compliance and the volume of products seized.

To date, a total of 39752 BIS registration certificates have been released to Indian manufacturers and for foreign manufacturers, 1018 BIS registration certificates have been released. Another Indian standard, Calcined Alumina - Specification IS 17441 Part 1 Non-Metallurgical Grade, is now available for public comment.

In total, 52 chemicals are currently under BIS mandatory certification scheme.

On April 5, 2022, a Quality Control Order (QCO) for a national standard covering the intermediate trimethyl phosphite has been released in India. Published by the Bureau of Indian Standards (BIS), man...

On April 5, 2022, a Quality Control Order (QCO) for a national standard covering the intermediate trimethyl phosphite has been released in India. Published by the Bureau of Indian Standards (BIS), manufacturers and importers of the substance must guarantee that it meets the standards given in Indian Standard (IS) 17412:2020 as of 5th October 2022.

At industrial locations and in production, trimethyl phosphite is utilised in formulation or repackaging.IS 17412:2020 (technical grade trimethyl phosphite) specifies the rules for using the material in products and other technical specifications. Under the BIS (Compliance Assessment) Regulations, 2018, enterprises manufacturing or importing trimethyl phosphite will need BIS certification to verify conformity and must display the BIS logo on all packaging starting in October.

The BIS Act of 2016 will penalise anyone who violates the QCO's provisions. However, this does not apply to items meant for export.

This new QCO came after the American Chemistry Council (ACC) chastised the Indian government for developing "antiquated, specific to the Indian market, and not based on worldwide norms" chemicals standards.

On April 27, 2022, the Department of Chemicals and Petrochemicals of the Ministry of Chemicals and Fertilizers, India, published the Quality Control Orders (QCOs) in Gazette notifications for eight ch...

On April 27, 2022, the Department of Chemicals and Petrochemicals of the Ministry of Chemicals and Fertilizers, India, published the Quality Control Orders (QCOs) in Gazette notifications for eight chemicals in order to make Bureau of Indian Standards (BIS) standard mandatory.

The orders come in order on the 181st day from this publication in the Official Gazette (October 24, 2022), and each order applies to goods or articles specified yet shall not apply to such meant for export. Penalty for contravention of the provisions of each order would be ruled under the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016).

The concerned substances are:

• 1,3 Phenylenediamine (Quality Control) Order, 2022

1,3 Phenylenediamine shall conform to the corresponding Indian Standard specified; namely, IS 17450:2020, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title 1,3 Phenylenediamine — Specification.  The BIS is to certify and enforce authority respecting substance 1,3 Phenylenediamine as specified.

• Lauric Acid (Quality Control) Order, 2022

Lauric Acid shall conform to the corresponding Indian Standard specified; namely, IS 10931:1984, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Lauric Acid — Specification. The BIS is to certify and enforce authority respecting substance Lauric Acid as specified.

• Acid Oil (Quality Control) Order, 2022

Acid Oil shall conform to the corresponding Indian Standard specified; namely, IS 12029:1986, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Acid Oil— Specification. The BIS is to certify and enforce authority respecting substance Acid Oil as specified.

• Palm fatty Acids (Quality Control) Order, 2022

Palm Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12067:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Palm Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Palm Fatty Acids as specified.

• Rice Bran Fatty Acids (Quality Control) Order, 2022

Rice Bran Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12068:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Rice Bran Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Rice Bran Fatty Acids as specified.

• Coconut Fatty Acids (Quality Control) Order, 2022

Coconut Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12069:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Coconut Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Coconut Fatty Acids as specified.

• Rubberseed Fatty Acids (Quality Control) Order, 2022

Rubberseed Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12124:1987, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Rubberseed Fatty Acids — Specification. The BIS is to certify and enforce authority respecting substance Rubberseed Fatty Acids as specified.

• Hydrogenated Rice Bran Fatty Acids (Quality Control) Order, 2022

Hydrogenated Rice Bran Fatty Acids shall conform to the corresponding Indian Standard specified; namely, IS 12361: 1988, with the compulsory use of Standard Mark under a license from the BIS according to Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018 and title Hydrogenated Rice Bran Fatty Acids— Specification. The BIS is to certify and enforce authority respecting substance Hydrogenated Rice Bran Fatty Acids as specified.

Contact GPC for BIS related compliance advice, compliance@gpcregulatory.com

The Bureau of Indian Standards (BIS) is reinvestigating the use of eight chemical standards in plastics, resins, moulding, and extrusion materials. The standards cover:  Subst...

The Bureau of Indian Standards (BIS) is reinvestigating the use of eight chemical standards in plastics, resins, moulding, and extrusion materials.

The standards cover: 

The standards outline all the procedures, sampling methods, and tests that companies must employ while working with these compounds.

The BIS also proposed changing some of the requirements, sample techniques, and testing in the following standards:

• polycarbonate moulding and extrusion materials(comment deadline: 21 May)  
• the 2018 positive list of colourants in FCMs (comment deadline: 19 June) 
• polyalkylene terephthalate (PET and PBT), their copolymers and list of constituents in raw materials and end products in FCMs (comment deadline: 20 May); and 
• styrene (vinyl benzene) (comment deadline: 17 June). 

The Bureau of Indian Standards (BIS) is holding a consultation process until May 11 on a proposed amended standard for ready-mixed paint, air drying, and red oxide-zinc chrome priming, which would ext...

The Bureau of Indian Standards (BIS) is holding a consultation process until May 11 on a proposed amended standard for ready-mixed paint, air drying, and red oxide-zinc chrome priming, which would extend lead content limitations in place for domestic purposes to the industrial sector. Lead, lead compounds, and lead combinations would be limited to no more than 90 parts per million (ppm).

This is currently set at 1,000ppm for industrial use and 90ppm for domestic use. To eliminate consumer confusion and raise attention to the health and safety risks linked with lead, a BIS technical committee has proposed a "unified single allowable level."

The draft establishes material standards, as well as the sampling and testing techniques. It is used "as a primer in the enamel painting system for metal surfaces and also to keep steelwork in good shape for home and decorative purposes, as well as in coastal and inland outdoor environments." says the BIS. If approved, Indian Standard (IS) 2074 for ready-mixed paint, air drying, red oxide – zinc chrome, priming – specification' will be revised for the fourth time. In addition, the draught suggests quantities for substances utilised in its production, such as:

• Minimum zinc chrome content of 16 percent by mass, 6.88 percent by mass chromic anhydride content, and zinc oxide content of 5.84 percent by mass;
• minimum synthetic red oxide or natural red oxide content of 50% by mass.

The official draft document can be accessed here

The Bureau of Indian Standards (BIS) has granted licences to 661 domestic toy manufacturers after determining that they comply with a 2020 quality control order that limits the use of certain heavy me...

The Bureau of Indian Standards (BIS) has granted licences to 661 domestic toy manufacturers after determining that they comply with a 2020 quality control order that limits the use of certain heavy metals, phthalates, and flame retardants. Companies must apply to the standards bureau and allow its auditors to inspect manufacturing facilities and test product samples to obtain a licence. If they are granted a licence, they must then purchase a quality certification logo demonstrating that their products do not exceed the limits for restricted substances specified in Indian Standard (IS) 9873.

Licences are valid for one year and can be renewed subject to additional inspections. Anyone found in violation of the Quality Control Order (QCO), which went into effect on January 1, 2021, faces up to two years in prison and a minimum fine of 200,000 Indian rupees ($2,627). According to a press release issued by the Ministry of Consumer Affairs, Food, and Public Distribution on April 6, 630 – or 95 percent – of the licences granted were to small and medium-sized businesses.