India Regulatory News

The Central Government of India has issued the Acrylonitrile-Butadiene Styrene (ABS) (Quality Control) Amendment Order, 2024, which amends the Acrylonitrile-Butadiene Styrene (ABS) (Quality Control) O...

The Central Government of India has issued the Acrylonitrile-Butadiene Styrene (ABS) (Quality Control) Amendment Order, 2024, which amends the Acrylonitrile-Butadiene Styrene (ABS) (Quality Control) Order, 2021. This amendment came effect upon publication in the Official Gazette on 20 November 2024. It introduces a significant change in the regulation of ABS materials.

Exemption for Toco Transducer Materials

The most significant change in the new order is the addition of a provision that exempts ABS Moulding and Extrusion Materials specifically used in the production of toco transducers from the requirements of the initial Quality Control Order. This means that ABS materials intended for use in the manufacture of toco transducers, a device typically used for monitoring fetal well-being, will no longer be subject to the same regulatory controls.

Streamlined Regulations for Specialized Applications

This amendment follows consultations with the Bureau of Indian Standards (BIS) and is seen as a step towards streamlining regulations in sectors where certain ABS materials are required for specialized applications.

Implications for Industry

This move is expected to have implications for manufacturers of toco transducers, as they will no longer have to comply with the broader scope of the Quality Control Order, potentially reducing compliance burdens for companies in this specific segment.

On October 23, 2024, India’s Ministry of Textiles issued the Medical Textiles (Quality Control) Order, 2024, under the Bureau of Indian Standards Act, 2016, replacing the previous order from 2023. T...

On October 23, 2024, India’s Ministry of Textiles issued the Medical Textiles (Quality Control) Order, 2024, under the Bureau of Indian Standards Act, 2016, replacing the previous order from 2023. This new Order, which came into effect following its publication in the Official Gazette, mandates stringent quality standards for various medical textiles, including products such as sanitary napkins, baby diapers, and medical bedding. 

Scope and Exemptions 

The Order applies to specific medical textiles listed in the Schedules, but excludes products intended for export and those produced by self-help groups, as listed in Schedule-A. Self-help groups are informal groups of 10 to 20 individuals who come together voluntarily for collective savings, resource management and mutual benefit. In rural or tribal areas, smaller groups of at least five members are also considered self-help groups. 

Mandatory Compliance and Certification 

Standard Mark: The items listed in column (2) of the Schedules must comply with the relevant Indian Standard outlined in column (3) and bear the Standard Mark. The mark must be obtained through a license issued by the Bureau of Indian Standards in accordance with the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. 

Certification:  The Bureau of Indian Standards and the Textiles Committee, under the Ministry of Textiles, will be responsible for certifying and enforcing compliance for the goods or articles listed in column (2) of the Schedules. 

Schedules and Implementation Deadlines 

The Order sets out compliance requirements for a range of medical textiles in Schedule A (consumer-oriented products) and Schedule B (industrial and healthcare products), specifying Indian Standards and timelines for implementation: 

SCHEDULE A 

SCHEDULE B 

Significance of the Order 

This Order enforces compliance with Indian Standards for medical textiles, ensuring quality manufacturing and improving public health and consumer safety. Domestic manufacturers must ensure compliance to access the Indian market, while exporters and self-help groups are exempted. 

For more details, see the full gazette notification here. 

In a significant move to enhance food safety, India’s Bureau of Indian Standards (BIS) has launched a public consultation on the country’s first-ever standard for paper-based materials used in the...

In a significant move to enhance food safety, India’s Bureau of Indian Standards (BIS) has launched a public consultation on the country’s first-ever standard for paper-based materials used in the delivery and serving of food and drink. The consultation, which is open until December 30, 2024, aims to establish clear guidelines to ensure that food packaging and materials that come into direct or indirect contact with food are safe for human consumption. 

Purpose of the Standard 

The standard focuses on setting limits for the migration of substances from packaging into food and beverages. It defines the "overall migration limit," which measures the maximum allowed amount of non-volatile substances, such as monomers, additives and pigments, that can leach from paper-based materials into food. This measure aims to protect consumers from exposure to harmful chemicals. 

Testing Requirements 

Under the proposed guidelines, paper-based materials intended for food contact must pass an overall migration test, as outlined in Indian Standard (IS) 9845. This applies to conditions where the food contact time is less than 24 hours. The migration of non-volatile substances from the material layer must not exceed 60 mg/kg and there must be no visible color migration during the test. 

Proposed Migration Limits for Substances  

The proposed standard sets specific migration limits for various heavy metals and chemicals, including:

Scope of the Proposed Standard 

The migration limits will apply to both direct and indirect food contact materials (FCMs), including items such as wraps, bags, pouches, carton boxes, plates, trays, cups, and bowls used for serving or delivery. However, the new standard does not cover materials intended for long-term food storage. 

Material Requirements 

The proposed standard has strict material requirements for paper-based products. Only virgin pulp is allowed in the manufacturing process, and materials must be free from optical brightening agents. Coating materials used on the paper must be derived from bio-based polymers such as PLA, PBS or PHA, or be made from water/solvent-based emulsions. 

Labelling Requirements 

Any paper-based material intended for food or beverage should be clearly labelled with essential information, including the source of manufacture, batch number, and the date of manufacture. Furthermore, any claims of compostability must be substantiated by a registration number from the Central Pollution Control Board (CPCB), along with an approved QR code. 

Towards Safer Food Contact Materials 

This initiative by BIS is an important step towards ensuring the safety and quality of food contact materials in India, with the aim of protecting consumers from potential health risks associated with harmful chemicals in food packaging. During the consultation period, stakeholders are encouraged to provide feedback to help finalize this important standard, which aims to ensure that food contact materials are safe, effective and environmentally responsible. 

For more details, the proposed standard can be accessed here.

India’s Bureau of Indian Standards (BIS) is seeking public consultation on the first revision of its standard for poster colors, which are commonly used in commercial design and artwork. Established...

India’s Bureau of Indian Standards (BIS) is seeking public consultation on the first revision of its standard for poster colors, which are commonly used in commercial design and artwork. Established in 1976, the revision of the BIS standard for poster colors aims to incorporate technological advancements and ensure safer and more reliable products for consumers by regulating the composition and lead content in products. The deadline for comments is 10 December 2024. 

Proposed Lead Limit for Poster Colors  

The revised standard proposes that poster colors should not contain more than 10 parts per million (ppm) of lead when tested using approved methods. 

Content of the Composition 

The new guidelines also state that poster colors should be a semi-viscous paste consisting of water-soluble or dispersible binders, pigments (with or without extenders), plasticizers, and preservatives. It emphasizes that the pigment should be finely ground and must not separate from the base substance, known as the ‘vehicle,’ which typically consists of oils that help the paint to spread evenly. 

Packaging and Labeling Requirements 

Packaging requirements are also specified, with poster colors to be sold in securely capped glass or plastic containers of various sizes, including 15ml, 30ml, 120ml, 225ml and 450ml. Each container must be clearly labeled with essential information such as product name, color, net content, manufacturing date, manufacturer’s details or trademark, and batch number for traceability. 

Detailed Color Range  

The updated standard focuses on 26 specific colors, including magenta, turquoise green, carmine, mauve, dark green, pink, cobalt blue, permanent yellow, burnt sienna, prussian blue, lemon yellow, burnt umber, cerulean blue, yellow ochre, vandyke brown, ultramarine blue, orange, grey, light green, crimson lake, black, medium green, scarlet lake, white, deep green and vermilion. 

This revision aims to protect public health by limiting harmful substances in widely used art supplies, ensuring better quality control and product safety for consumers. 

For more details, the proposed standard is available here.

India’s Bureau of Indian Standards (BIS) is currently seeking feedback on several revised standards for key chemicals used across industries, including metallic zinc powder, potassium iodate and bar...

India’s Bureau of Indian Standards (BIS) is currently seeking feedback on several revised standards for key chemicals used across industries, including metallic zinc powder, potassium iodate and barium chloride. ThesBIS is seeking feedback on updated standards for key chemicals like zinc powder, potassium iodate, and barium chloride.e revisions aim to improve quality control, packaging, and labeling requirements, while addressing safety concerns related to heavy metals and impurities. The following are the most important updates for the 3 substances: 

1. Revised Standard for Metallic Zinc Powder (Zinc Dust) 

Consultation Deadline: 9 December 2024 

BIS has released a third revision of the standard for metallic zinc powder, a critical substance in the chemical industry used in protective coatings, organic reactions, and the production of synthetic dyes. Key revisions include: 

• New Test Methods: Includes testing for chlorides, iron, lead, and copper. 

• Grade Classification: The standard defines two grades: 

• Grade 1: Used in the manufacture of hydrosulphites and related products. 

• Grade 2: For chemical and protective coatings. 

• Packaging and Labeling: The substance should be packaged in air-tight metal drums or double polyethylene-lined bags. Packaging must include specific information such as the material’s grade, source of manufacture, and batch traceability. 

Specifications for Zinc Powder: 

2. Revised Standard for Potassium Iodate 

Consultation Deadline: 9 December 2024 

BIS is revising the standard for potassium iodate, which is widely used in the iodization of table salt and in iodometry. The new revision introduces three grades: Analytical Reagent (AR), Food Grade (FD), and Technical Grade (TECH). The revised standard also specifies maximum permissible limits for heavy metals and modifies packaging requirements. Key updates include: 

• Grade Specifications: 

• AR grade: Strict limits on impurities such as bromate, chlorides and iron. 

• FD grade: Used in food products with lower limits on contaminants. 

• TECH grade: More lenient limits suitable for industrial use. 

• Packaging: The substance must be packaged in airtight bottles or for bulk in steel or fiber drums. 

Key Specifications for Potassium Iodate: 

3. Revised Standard for Barium Chloride 

Consultation Deadline: 25 December 2024 

BIS is revising the standard for barium chloride, a substance used in the manufacture of pigments and dyes and the removal of sulphate ions from brine. The revision introduces alternative test methods for determining copper, iron, and lead content, as well as updated packaging and labeling requirements. Key updates include:  

• Two Grades: The standard proposes two grades—Technical (TECH) and Analytical Reagent (AR). 

• Packaging: The TECH grade must be packaged in clean jute bags lined with polyethylene, while the AR grade must be packaged in glass bottles. 

• Heavy Metals Limits: The revision includes limits for heavy metals and impurities such as calcium and strontium salts. 

Key Specifications for Barium Chloride: 

Packaging and Labeling Requirements for All Chemicals 

For all three substances, BIS has updated the packaging and labeling requirements, which now require clear identification of: 

• Name and grade of the material 

• Source of manufacture 

• Net weight of the material 

• Lot or batch number 

• Date of manufacture 

Conclusion 

Bis’s revised standards aim to enhance the safety, quality, and traceability of these chemicals which are used in a wide range of industries. Stakeholders are invited to provide feedback, with the consultation deadlines approaching in December 2024. The updates are expected to improve quality control, reduce contamination risks, and ensure greater transparency in the chemical industry. 

On 14 November 2024, the Department of Chemicals and Petrochemicals (DCPC), in consultation with the Bureau of Indian Standards (BIS), issued a notification to implement Quality Control Orders (QCOs) ...

On 14 November 2024, the Department of Chemicals and Petrochemicals (DCPC), in consultation with the Bureau of Indian Standards (BIS), issued a notification to implement Quality Control Orders (QCOs) for three critical chemicals: H Acid (CAS No: 90-20-0), K Acid (Cas No: 118-03-6), and Vinyl Sulphone (CAS No: 16071-86-6). These orders aim to enhance safety and quality in the industrial chemicals sector and are based on drafts published on 26 July 2024. 

Key Requirements under the New QCOs 

These chemicals must conform to Indian Standards and must bear the standard mark under a license from the Bureau of Indian Standards as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The Bureau of Indian Standards Act, 2016 governs the use of Standard Marks, with the Bureau of Indian Standards as the certifying and enforcing authority. Chemicals intended for export are exempted from this order. 

Standards for the notified chemicals 

Date of Enforcement 

The QCOs will come into force on 13 May 2025 (180 days after publication). The full text of the Gazette Notification can be found here. 

On October 24, 2024, the Ministry of Chemicals and Fertilizers, through the Department of Chemicals and Petrochemicals, issued amendments to the Quality Control Orders (QCOs) for acrylonitrile, maleic...

On October 24, 2024, the Ministry of Chemicals and Fertilizers, through the Department of Chemicals and Petrochemicals, issued amendments to the Quality Control Orders (QCOs) for acrylonitrile, maleic anhydride and styrene, reinforcing the government's commitment to maintaining high standards in chemical manufacturing. In addition, the QCO for morpholine was amended on October 30, 2024. 

Key Amendments 

• Acrylonitrile (Quality Control) Order, 2022: The new implementation date is October 24, 2025. 

Note: The principal Order was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), vide notification number S.O. 1646(E) on April 5, 2022, and subsequently amended by notifications S.O. 4600(E) on September 29, 2022, S.O. 1787(E) on April 18, 2023, and S.O. 1464(E) on March 18, 2024. 

• Maleic Anhydride (Quality Control) Order, 2022: The new implementation date is also October 24, 2025. 

Note: The principal Order was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), vide notification number S.O. 1644(E) on April 5, 2022, and subsequently amended by notifications S.O. 4598(E) on September 29, 2022, S.O. 1788(E) on April 18, 2023, S.O. 1986(E) (Corrigendum) on May 1, 2023, S.O. 4233(E) on September 26, 2023, and S.O. 1466(E) on March 18, 2024. 

• Styrene (Vinyl Benzene) (Quality Control) Order, 2022: The new implementation date is also October 24, 2025. 

Note: The principal Order was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), vide notification number S.O. 1645(E), dated April 5, 2022 and subsequently amended vide notification numbers S.O. 4599(E), dated September 29, 2022, S.O. 1786(E), dated April 18, 2023 and S.O. 1465(E), dated March 18, 2024. 

• Morpholine (Quality Control) Order, 2020:  Implementation date extended to May 1, 2025. 

Note: The principal Order for Morpholine was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii) vide notification number S.O. 1893(E) on June 16, 2020, and subsequently amended by notifications S.O. 2030(E) on May 25, 2021, S.O. 399(E) on January 31, 2022, S.O. 3457(E) on July 27, 2022, S.O. 529(E) on February 2, 2023, S.O. 3291(E) on July 21, 2023, S.O. 373(E) on January 30, 2024, and S.O. 3076(E) on August 1, 2024. 

These amendments are part of the Central Government's ongoing efforts to enhance public safety and industry standards by ensuring that chemicals used in various applications meet stringent quality benchmarks. 

For more details, stakeholders and interested parties are encouraged to refer to the notifications published in the Official Gazette here and here.