India Regulatory News

The Government of India has taken a step towards ensuring the quality and safety of biostimulants used in agriculture. A new amendment, the Fertiliser (Inorganic, Organic or Mixed) (Control) (Third) A...

The Government of India has taken a step towards ensuring the quality and safety of biostimulants used in agriculture. A new amendment, the Fertiliser (Inorganic, Organic or Mixed) (Control) (Third) Amendment Order, 2024, establishes a stricter regulatory framework for these emerging agricultural products.

Key Changes in the Amendment:

• In Clause 20 C, relating to Specifications in respect of Biostimulants, the term ‘tracer elements’ is added along with active ingredient.

• The new category, ‘Live micro-organisms excluding biofertilizers and biopesticides’ has been added to Schedule VI. The addition of this new category by the Ministry is a positive step for companies in this field. It paves the way for clearer regulations, increased market potential, and ultimately the development of beneficial products for Indian agriculture.

• Toxicity Testing: To support their claims, manufacturers can submit not only the name of the testing institute but also details of the relevant report or publication. Acute and ecotoxicity tests are required, with exemptions for specific categories such as protein hydrolysates and seaweed extracts. Only the manufacturer/importer should submit an affidavit to the effect that their product is non-toxic and shall be safely used as biostimulants.

• Stricter Testing: Manufacturers will need to submit detailed data on the product's composition, effectiveness on crops (bio-efficacy), and potential risks to the environment and human health (toxicity). As more data becomes available on a biostimulant's chemistry effectiveness on crops (bio-efficacy), it may be grouped with similar products and potentially exempted from some testing requirements for specific crops.

• Focus on Safety: The amendment raises the permissible limit for pesticide residues in biostimulants from 0.01 ppm to 1 ppm. It also exempts certain low-risk categories from submitting full toxicity data.

• Manufacturing/Import Restriction: Only approved biostimulants listed in Schedule VI can be manufactured or imported.

Impact:

This amendment is expected to:

• Increase farmer confidence in the quality and safety of biostimulants.

• Encourage the responsible development and marketing of effective biostimulant products.

• Streamline the regulatory environment for manufacturers and importers of biostimulants.

The increased focus on safety and efficacy testing may initially slow the introduction of new biostimulants. However, it is expected to benefit farmers in the long run by ensuring access to reliable and effective products that can improve their agricultural productivity These changes aim to ensure the safety, quality and efficacy of biostimulants used in Indian agriculture.

Source

The Government of India has amended the Fertiliser (Inorganic, Organic, or Mixed) (Control) Order, 1985 to include several additional fertiliser alternatives. This amendment is aimed at providing farm...

The Government of India has amended the Fertiliser (Inorganic, Organic, or Mixed) (Control) Order, 1985 to include several additional fertiliser alternatives. This amendment is aimed at providing farmers with more options to meet their individual crop demands.

Key & new additions to the Schedule include:

• Dispersible Granular Sulfur: This new fertilizer provides a readily available source of sulfur, a crucial nutrient for plant growth.

• NPK, Si, Ca, Mg and NPK, Si, Ca, B Fertilizers: These multi-nutrient blends combine nitrogen (N), phosphorus (P) and potassium (K) with additional elements like silicon (Si), calcium (Ca), magnesium (Mg) and boron (B). These combinations can address specific soil deficiencies and promote overall plant health.

• Sulfur with Zinc Granules: This option combines sulfur with zinc, another essential micronutrient for many crops.

• Liquid Urea Ammonium Sulphate: This liquid fertilizer provides a readily soluble source of nitrogen and sulfur for efficient nutrient uptake.

• Potassium Nitrate with Iodine: This specialized fertilizer provides potassium, nitroge and iodine, which can be beneficial for certain crops and potentially improve their nutritional value.

Furthermore, the amendment changes the ''specifications'' for nano nitrogen fertilisers, allowing for a wider range of particle sizes.

These modifications should help farmers by giving them additional alternatives to tailor fertiliser applications to specific crops and soil conditions. This could potentially contribute to higher agricultural yields and quality. As part of the nano fertilizers category, nano zinc and nano copper are also included with their specifications.

This update to the fertiliser list gives farmers more tools to meet the specific needs of their crops. These amendments can maximise plant health, increase yields and even improve the nutritional content of crops by adding high-sulphur varieties, micronutrients and combinations designed to address certain deficiencies.

Source

On 19 April 2024, the Ministry of Steel, Government of India, after consultation with the Bureau of Indian Standards (BIS), notified the World Trade Organization (WTO) of the Quality Control Order (QC...

On 19 April 2024, the Ministry of Steel, Government of India, after consultation with the Bureau of Indian Standards (BIS), notified the World Trade Organization (WTO) of the Quality Control Order (QCO) on steel and steel products listed in the table below. The notification is open for comments for 60 days.  

Application and Enforcement: The purpose of this QCO is to verify that the steel and steel products listed in the table above comply with the prescribed Indian Standards. The Order requires all manufacturers in India and abroad who intend to export to India steel and steel products listed in the table above to obtain a valid licence from the Bureau of Indian Standards for the use of the Standard Mark before starting regular production of such items. Furthermore, no person shall manufacture, import, distribute, sell, hire, lease, store or display for sale any steel or steel products listed in the table which does not conform to the prescribed standards and does not bear the Bureau's standard mark. 

Objective: To improve the standard of steel and steel-related products for the benefit of the public to protect human health and safety as well as the nation's housing, infrastructure and engineering goods. 

Penalty for Contravention: Any person who contravenes the provisions of this order shall be punishable under Section 29 of the Bureau of Indian Standards Act, 2016 (11 of 2016). 

On 13 April 2024, the Department of Chemicals and Petrochemicals (DCPC) of India published the Ortho Phosphoric Acid (Quality Control) Amendment Order, 2024. Background to the Amendment The Orth...

On 13 April 2024, the Department of Chemicals and Petrochemicals (DCPC) of India published the Ortho Phosphoric Acid (Quality Control) Amendment Order, 2024.

Background to the Amendment

The Ortho Phosphoric Acid (Quality Control) Order, 2021 was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), vide number S.O. 2335(E), dated 15 June 2021 and subsequently amended vide notification numbers S.O. 4914(E), dated 29 November 2021 and S.O. 2225(E), dated 13 May 2022.

Key Provision of the Amendment

The following provision shall be inserted after the table in the Ortho Phosphoric Acid (Quality Control) Order, 2021: "Provided that, nothing in this Order shall apply to the Ortho Phosphoric Acid when used as a raw material in the production of fertilizers for a period of ninety days from the date of publication of this notification."

Application and Enforcement

The QCO applies to export chemicals and requires them to conform to IS 798: 2020 Orthophosphoric Acid — Specification and bear the Compulsory Registration Scheme (CRS) Mark under the licence of the Bureau of Indian Standards (BIS). Violations will result in penalties under the BIS Act, 2016.

The published draft came into force on 13 April 2024.

On March 15, 2024, the Ministry of Environment, Forest and Climate Change (MOEFCC) notified the rules further amending the Plastic Waste Management Rules, 2016 namely the Plastic Waste Management (A...

On March 15, 2024, the Ministry of Environment, Forest and Climate Change (MOEFCC) notified the rules further amending the Plastic Waste Management Rules, 2016 namely the Plastic Waste Management (Amendment) Rules, 2024 in the Gazette of India.  

The amendment came into force from the date of publication in the Gazette. With this amendment India is taking a significant step towards tackling plastic pollution. 

The draft rules to amend the Plastic Waste Management Rules, 2016, were first published in the Gazette of India on October 16, 2023, inviting objections and suggestions from the public within a period of sixty days. 

Amendments Introduced 

In the amended rules, a few sections have been replaced with new clauses, including for biodegradable plastics under Extended producer Responsibility (EPR). 

 EPR is a waste and pollution management concept that encourages companies to design more sustainable and recyclable products and manufacturing processes. It also places the responsibility on manufacturers to minimize the environmental impact of their products throughout their lifecycle.  

In Rule 3, a few clauses are replaced and added relating to biodegradable plastics, importers, manufacturers, producers and sellers. Similarly, amendments are introduced in the several rules of the Plastic Waste Management (Amendment) Rules, 2016. 

The following amendments are also included: 

• Requirements for labelling and certification of compostable or biodegradable plastics. 

• Requirements for reporting on quantities of goods placed in the market and pre-consumer waste generated. 

• Responsibility of manufacturers, producers, importers and brand owners for the collection of plastic packaging introduced. 

• Guidelines for working with local authorities on a voluntary basis. 

• Annual reporting mechanisms for various entities involved in plastic waste management. 

Extended Producer Responsibility Targets 

In Schedule II of the Rules, the Extended Producer Responsibility target, category-wise, is given in the table below, as follows:

Minimum level of recycling (excluding end-of-life disposal) of plastic packaging waste 

                                                    (% of Extended Producer Responsibility target) 

The categories are defined as follows: 

Category I: Rigid plastic packaging 

Category II: Flexible plastic packaging of single layer or multilayer, plastic sheets or like and covers made of plastic sheet, carry bags, plastics sachet or pouches. 

Category III: Multilayered plastic packaging (at least one layer of plastic and at least one layer of material other than plastic). 

Further details of the amendments introduced can be found here: 

https://moef.gov.in/wp-content/uploads/2024/03/GSR201(E)-[14032024]-Plastic-Waste-Mangement-Rules-2024.pdf 

On March 7, 2024, India’s Directorate General of Foreign Trade (DGFT) published notification 69/2023. The notification explains the provisions for the import of inputs that are subjected to mandator...

On March 7, 2024, India’s Directorate General of Foreign Trade (DGFT) published notification 69/2023. The notification explains the provisions for the import of inputs that are subjected to mandatory Quality Control Orders (QCOs) by advance authorization (AA) holders and registered export-oriented units (EOUs).

The DGFT has announced exemptions for duty-free imports of goods for final exports, including those in special economic zones (SEZs) and EOUs. However, goods not used for export production will be destroyed by customs officials.

CHEMEXCIL, India's trade body council that represents basic chemicals, cosmetics, and dye exporters, has been consulting with its members regarding this initiative.

While the CHEMEXCIL secretariat has expressed support for the DGFT notification allowing the import of items without mandatory QCOs under AA and SEZ schemes, industry representatives have advocated for mandatory QCOs for all imports, requesting detailed representation.

In a consultation that closed on March 28, 2024, CHEMEXCIL members were asked to share their views on the following questions for onward submission. 

• Do we support the current notification allowing import of specific items without mandatory QCOs under AA and EOU please provide the reasons?

• Are there any concerns regarding potential quality issues due to this policy?

• If we support mandatory QCOs for all imports, then please provide your rationale.

The Bureau of Indian Standards (BIS) has issued a draft Indian Standard for Polystyrene (Crystal and High Impact) to ensure its safe use with food, pharmaceuticals, and drinking water. The standard, a...

The Bureau of Indian Standards (BIS) has issued a draft Indian Standard for Polystyrene (Crystal and High Impact) to ensure its safe use with food, pharmaceuticals, and drinking water. The standard, a revision of IS 10142, focuses on preventing toxic hazards from polymer additives and impurities. Comments are invited until 13 April 2024.

Addressing Safety Concerns in the Use of Polystyrene

The standard emphasizes the inert nature of polystyrene but recognizes the potential for additives and impurities to migrate into packaged materials, posing risks to consumers over time. It is based on the original standard of 1982 and the first revision of 1999 and is in line with international regulations such as the FDA regulations in the USA and EU directives. This second revision introduces modifications to Clause 4.1 on basic resins and updates cross-referenced standards.

In addition, the standard is designed to complement existing Indian Standards on plastics for food contact applications and to improve quality monitoring of polystyrene materials. It emphasises the importance of using these standards together to ensure consumer safety and health.

Promoting Compliance and Consumer Safety

Polystyrene materials that comply with these standards are considered safe for various applications, including packaging, manufacturing, and processing of food, pharmaceuticals, and drinking water. Compliance with the standards is essential for manufacturers and fabricators of thermoplastic packaging materials as it provides a framework for regulatory compliance and assuring consumer safety.

The draft standard outlines requirements for basic resin, residual monomer content, materials, pigments, total migration, storage, and control. It also defines sampling methods and conformity assessment criteria.

Inviting Stakeholder Input

Interested stakeholders are encouraged to provide feedback on the draft standard, which aims to promote the safe and responsible use of polystyrene materials in contact with consumables.