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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

As part of its drive to use safer alternatives, India has imposed restrictions on certain hydrofluorocarbons (HFCs) and ozone-depleting substances (ODSs), requiring importers and exporters to obtain g...

As part of its drive to use safer alternatives, India has imposed restrictions on certain hydrofluorocarbons (HFCs) and ozone-depleting substances (ODSs), requiring importers and exporters to obtain government permission before trading.

The new rules, which were introduced as amendments to India's existing HFC export and import policies, went into effect on March 9 for importers and March 23 for exporters via Directorate General for Foreign Trade (DGFT) notifications. Before entering into agreements with overseas buyers or suppliers, domestic HFC and ODS manufacturers, exporters, and importers must obtain "no objection certificates" (NOCs) from the Ministry of Environment, Forests, and Climate Change (MoEFCC). In August of last year, India ratified the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, committing to an 85 percent reduction in HFC production and consumption by 2047. According to a MoEFCC spokesperson, the international trade restrictions are intended to "align domestic HFC user industries with the government's goal of reducing use of the substances and a gradual shift to the use of alternatives."

The Food Safety and Standards Authority of India (FSSAI) amended the Food Safety and Standards (Packaging) Regulations 2018, allowing for the use of recycled plastics in food contact materials (FCM) w...

The Food Safety and Standards Authority of India (FSSAI) amended the Food Safety and Standards (Packaging) Regulations 2018, allowing for the use of recycled plastics in food contact materials (FCM) with certain restrictions. The update clarifies the ambiguity caused by an amendment to India's plastic waste management rules published last September. The amendment permitted the use of recycled plastic in FCMs, in contrast to the 2018 packaging regulations, which prohibited its use. The amendment serves as a stopgap measure until the draught Food Safety and Standards (Packaging) Amendment Regulations 2022 are completed. However, it is unknown how long it will take for the new legislation to take effect.

In 2016, the Food Safety and Standards Authority of India prohibited the use of recycled plastics in food contact. The recent change has "shocked experts and environmental activists," according to The Times of India. According to Vijay Habbu of the Institute of Chemical Technology, when a plastic product is recycled, "there is some degradation of the plastic with the generation of contaminants or impurities." Most of the time, the contaminants are unknown. As a result, there are no reliable test methods for detecting and determining impurities that can seriously endanger human life and the environment."

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.

The Indian Government proposes a new Draft National Policy for Medical Devices, 2022, to reduce India's reliance on high-end medical device imports. The government intends to adopt public-private p...

The Indian Government proposes a new Draft National Policy for Medical Devices, 2022, to reduce India's reliance on high-end medical device imports. The government intends to adopt public-private partnerships to reduce healthcare costs, increase efficiency, and improve the quality of medical devices manufactured in the country.

Among the key proposals are:

·       The use of tax breaks and refunds to encourage the export of medical devices and related technology projects.

·       Increasing government spending on "high-risk" medical device projects

·       A single-window clearance system to be used for the licencing of medical devices.

·       Pricing environment with no price control on newly developed sector innovation

·       A dedicated fund to be established for encouraging collaborative research among existing industry players, reputable academic institutions, and start-ups.

·       Incorporate a framework for consistent pricing regulation to make high-quality, cost-effective medical devices available to all citizens at reasonable prices.

·       The National Pharmaceutical Pricing Authority (NPPA) will be strengthened with adequate manpower and appropriate expertise to provide effective price regulation while balancing the needs of patients and industries.