India Regulatory News

  On January 11, 2021, a stakeholder consultation meeting was organized by Additional Secretary (Chem) to discuss BIS standards of 12 chemicals. Nine of the twelve standards under consider...

On January 11, 2021, a stakeholder consultation meeting was organized by Additional Secretary (Chem) to discuss BIS standards of 12 chemicals. Nine of the twelve standards under consideration are concluded to be made mandatory. The 12 BIS standards that are being considered are:

1. Carbon Black IS 17440:2020 (HS Code 2803 0000)
2. Calcined Alumina IS 17441:2020 (HS Code2818 2010)
3. Anhydrous Ammonia IS 662:2020 (HS Code 2814 1000)
4. 1,3 Phenylenediamine IS 17450:2020 (HS Code 29215120)
5. Pearlescent Pigment (HS Code 3206 1110) coated with Titanium dioxide more than 80%. The BIS standard of Titanium Dioxide is available under IS 411:2020 (HS Code 28230010)
6. Lauric Acid IS 10931:1984 (HS Code 29159090)
7. Acid Oil IS 12029:1986 (HS Code 38231900)
8. Palm Fatty Acids IS 12067:1987 (HS Code 38231900)
9. Rice Bran Fatty Acids IS 12068:1987 (HS Code 38231900)
10. Coconut Fatty Acids IS 12069:1987 (HS Code 38231900)
11. Rubber seed Fatty Acids IS 12124:1987 (HS Code 38231900)
12. Hydrogenated Rice Bran Fatty Acids IS 12361: 1988 (HS Code 38231900)

Summary of individual Standards is as follows:

Carbon Black: After consultation with industry members, Additional Secretary (Chem) required the industry representatives to clearly specify what amendments are needed to be made in BIS standards (IS 17440:2020). He also stressed that Industry should not make a general request that BIS standards have to directly adapt ASTM standards and it is for BIS to decide. A six-week timeline was given to the industry for the same.

Calcined Alumina: AS (Chem) advised opportunities to be provided to stakeholders who have given written comments to BIS for discussion in Technical committees irrespective of if they are members or not of the technical committee. It proposed to take a final position within a month to consider making standard as mandatory.

Anhydrous Ammonia: No inputs were provided by the fertilizer or refrigeration industry, its therefore concluded that discuss this item in the next meeting with representative from Fertilizer and Refrigeration industry.

1,3 Phenylenediamine: After deliberation, the committee decided to make BIS standard mandatory for 1,3 Phenylenediamine.

Titanium Dioxide: No representative from Paint association attended the meeting. AS(Chem) stated that Standard of Titanium dioxide should be made mandatory, keeping in view the human health and environment consideration, and considerable imports and production within India (Titanium dioxide, the main component of pearlescent pigment (higher than 80%)).

Pearlescent Pigment: No representative from Paint association attended the meeting. AS (Chem) directed that BIS can also explore standard for Pearlescent Pigment.

Fatty Acids: Lauric Acid, Acid Oil, Palm Fatty Acids, Rice Bran Fatty Acids, Coconut Fatty Acids, Rubber seed Fatty Acids, Hydrogenated Rice Bran Fatty Acids: The standards for these fatty acids, a chemical commonly used in manufacturing soaps and other similar industries, are old and have been reaffirmed by BIS. The committee has decided to make standards of the above-mentioned Fatty Acid as mandatory.

Source: Minutes of the Stakeholder Consultation Meeting, the Chairmanship of Additional Secretary (Chem), Department of Chemicals & Petrochemicals, India

Update: 2021-01-21

The Central Government of India in exercising its powers conferred by section 16 of the Bureau of Indian Standards (BIS) Act (2016) prepared the following amendments in the orders that were publis...

The Central Government of India in exercising its powers conferred by section 16 of the Bureau of Indian Standards (BIS) Act (2016) prepared the following amendments in the orders that were published by the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals:

1. Pyridine (Quality Control) Order, 2020
2. Gamma Picoline (Quality Control) Order, 2020
3. Beta Picoline (Quality Control) Order, 2020
4. Potassium Carbonate (Quality Control) Order, 2020
5. Sodium Tripolyphosphate (Quality Control) Order, 2020 and
6. Hydrogen Peroxide (Quality Control) Order, 2020

Due to Covid-19 disruptions, the Government of India has postponed the implementation date of these orders from 4th Dec. 2020 to 13th June 2021. 

Safety of Toys has been brought under compulsory BIS Certification as per Toys ((Quality Control) Order from 1 September 2020. The order was notified to the WTO in February this year. For BIS Certific...

Safety of Toys has been brought under compulsory BIS Certification as per Toys ((Quality Control) Order from 1 September 2020. The order was notified to the WTO in February this year. For BIS Certification, toys have classified into two categories: (1) Non-Electric Toys and (2) Electric Toys.

The chemicals and the standards with which they must conform are:

• Acrylonitrile – used in the production of plastics (IS 12540:1988);
• Maleic anhydride – used in the production of plastics (IS 5149: 2020);
• Methyl acrylate – used to manufacture carpet fibres (IS 14707: 1999);
• Ethyl acrylate – a precursor to polymers and other monomers (IS 14709:1999);
• N-butyl acrylate – used in paints, coatings, adhesives, textiles and plastics (IS 14709:1999); and
• Styrene (vinyl benzene) – used as a precursor in the manufacture of polystyrene (IS 4105:2020).

Products containing any of these chemicals will require certification to prove conformity, and companies will need to display the BIS mark (Bureau of Indian Standards) on all packaging.

See more on BIS Certification on Toy

The Union Cabinet ratified ban on seven Persistent Organic Pollutants (POP) listed under Stockholm Convention. The Stockholm Convention is a global treaty to protect human health and environment fr...

The Union Cabinet ratified ban on seven Persistent Organic Pollutants (POP) listed under Stockholm Convention.

The Stockholm Convention is a global treaty to protect human health and environment from POPs, which are identified chemical substances that persist in the environment, bio-accumulate in living organisms, adversely affect human health/ environment and have the property of long-range environmental transport (LRET).

The Cabinet’s approval for ratification of POPs demonstrates India’s commitment to meet its international obligations with regard to protection of environment and human health.

India is finalizing plans to increase the number of chemicals and petrochemicals to be covered by mandatory certification. The Ministry of Chemicals and Fertilisers, the responsible authority to issue...

India is finalizing plans to increase the number of chemicals and petrochemicals to be covered by mandatory certification. The Ministry of Chemicals and Fertilisers, the responsible authority to issue list of products on which mandatory certification is to be required, plans to make 72 chemicals and petrochemical standards mandatory. Within these standards, domestic and foreign companies will be required to obtain permits before they can import, manufacture, or use the affected substances. 

Since 2018 India has notified 29 mandatory standards covering 32 substances to WTO:

• Notification for Phthalic Anhydride, Poly Aluminium Chloride and Caustic Soda (with notification deadline for comments in Feb. 2018, June 2019 and Jan. 2020)
• 21 standards (covering 22 substances) notified to WTO (with deadline for comments of April 2020)
• 5 standards (covering 7 substances) were notified to WTO (with deadline for comments of Sep. 2020)

The purpose is to standardise the chemicals to conform with the harmonised system of coding, which is followed internationally and make it more transparent in order to reduce fake and substandard quality. The Bureau of Indian standards (BIS), the national Standards Body of India, will be responsible for the certifying and enforcing agency for these mandatory standards.

The final draft of the Indian Chemicals Management and Safety Rules (CMSR – India REACH) is out now! Next Step: After final optimization, Indian CMSR will go for the World Trade Organization ...

The final draft of the Indian Chemicals Management and Safety Rules (CMSR – India REACH) is out now!

Next Step: After final optimization, Indian CMSR will go for the World Trade Organization (WTO) Notification (60 Days)

The Indian CMSR would likely come into force from the first quarter of 2021.

Updates from the previous (4th Draft) version includes:

• National Chemical Authority to be Established
• All substances to be Notified
• 1st List - 750 Priority substances to be Registered
• Foreign Companies to Appoint Authorized Representative
• Pre-Import Notification required for substances designated as Hazardous

You can download the Final Draft of the Indian CMSR here

GPC India is fully equipped to provide an end to end regulatory compliance solution to companies in and outside India.

For further details on Indian CMSR please contact us at compliance@in.gpcregulatory.com

What is CMSR? India released the fourth draft of the Chemical (Management and Safety) Rules (CMSR) on March 16, 2020. The CMSR will regulate Substances, Substances in Mixture, Substance in Articles...

What is CMSR?

India released the fourth draft of the Chemical (Management and Safety) Rules (CMSR) on March 16, 2020. The CMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. The legal basis of the CMSR is section 3, 6, and 25 of Environmental Protection Act (1986) ; Further enactment of CMSR will result in suspension of two existing rules - Manufacture, Storage and Import of Hazardous Chemical Rules (1989) and Chemical Accidents (Emergency Planning, Preparedness and Response) Rules (1996). The CMSR is expected to come into force in 2020-2021. Indian manufacturers, importers and authorized representation (AR – acting on behalf of a foreign manufacturer) with an Indian legal entity, can comply with the CMSR..

How to Comply?

Notification

Notification is required for all substances that are in quantity above 1 TPA. Data Requirement for Notification: Submit Chemical information, Spectral data, Hazard Classification, Uses details, details of DU, Tonnage band, Storage capacity and SDS. A certificate of Notification along with Notification number will be issued once the notified substance is evaluated for its completeness by the Chemical Regulatory Division. Annual reporting is required for all Notified substances, to be submitted on 30th of Jan each year, and any change in tonnage band or other notified information will required to be promptly updated and may attract tonnage band change fee.  All New Chemical Substances must be notified at least 90 days prior to the date they are placed in Indian territory.

Registration

Only identified substances meeting criteria of “Substances To Be Registered” in Schedule VI of the CMSR and with the tonnage exceeding 1 TPA need to be registered. Currently, there are 37 Substances in Schedule VI and this list will be updated on regular basis. Registration should be carried out within 18 months after a substance is included in Schedule VI. Technical dossiers should be submitted while registering substance. For substance with a tonnage band more than 10 TPA, a Chemical Safety Assessment is also required to be submitted along with Technical dossier. Registration fee will depend on tonnage band and company size. Joint submission is a recommended option. The Intermediates with the tonnage band less than 1000 TPA should be registered with only the physical and chemical properties in the Technical Dossiers. Whereas Intermediates with the tonnage band above 1000 TPA should register with full information in the Technical Dossier along the Chemical Safety Report. Priority Substances in Article with the tonnage that exceeding 1 TPA will also need to register.

Annual Reporting

An annual report applies to all notified existing and new substances. The report should contain the quantity of substance place in India Territory in the previous calendar year and changes of information submitted at the time of notification. This should be done before the 30th of January of each calendar year.

Foreign Manufacturer and Authorized Representative

Foreign Manufacturers of substance, substance in mixture and priority substance in article should appoint an Authorized Representative that has an Indian legal entity to comply with the CMSR.

Actions for Manufacturers, Importers and Downstream Users

• Set up a regulatory team 
• Prepare an Inventory of substances being handled
• Identify the quantity placed in India
• Initiate communication with downstream users -
• Update SDS in accordance with GHS Rev. 8
• Stay updated on the CMSR
• Internal training on the CMSR
• Follow up on the Substance lists (Substances to be registered (Schedule VI), Priority Substance (Schedule II) and Hazardous Substance (Schedule X, XI, XII)) with us on gpcgateway.com