India Regulatory News

In January the Bureau of Indian Standards (BIS) released for public consultation the revised draft Indian Standard for Specification of Polyethylene Terephthalate (PET) Bottles for Packaging of Alcoho...

In January the Bureau of Indian Standards (BIS) released for public consultation the revised draft Indian Standard for Specification of Polyethylene Terephthalate (PET) Bottles for Packaging of Alcoholic Beverages (First Revision of IS 14537). 

Scope of the Standard 

This standard specifies the conditions, procedures, and test methods for poly(ethylene terephthalate) (PET) bottles used in the packaging of both distilled and non-distilled alcoholic beverages. Distilled alcoholic beverages include brandy, gin, whiskey, and rum. Non-distilled alcoholic beverages can be carbonated (i.e. beer and sparkling wine) or non-carbonated (i.e. wine). 

Main changes in the revised Standard 

This standard (IS 14537) was first released in 1998. This revision takes into account editorial alignment and compliance with several relevant rules. The main changes in this revision are the following: 

•  The material requirement has been changed.  

•  Recyclability and other requirements for plastics must be in compliance with the Plastic Waste Management Rules, 2016, as amended.  

• Specific migration limits as per Food Safety and Standards (Packaging) Regulation 2018 and its amendments have been incorporated. 

• The marking/labelling clause has been revised to a marking/packing clause with labelling requirements in accordance with the Food Safety and Standards (Labelling and Display) Regulation, 2020 and its amendments and Part 5 (Specific Labelling Requirements for Alcoholic Beverages) of the Food Safety and  Standards (Alcoholic Beverages) Regulations, 2018. 

Migration test 

Overall migration: When tested in according to  IS 9845, the total migration limit must not be exceeded and must be 60 mg/kg or 10 mg/dm2 with no discernible colour migration. In the case of colored plastics, colour that has migrated into the simulant shall not be visible to the naked eye (see IS 9833). Even if the extraction value is below the overall migration limit, such materials are not suitable if the colour migration is clearly visible.Specific migration: Specific migration is tested to determine the amount of a specific substance that can migrate from a food packaging material or food container into food. Specific migration limits are usually expressed as mg/kg of food. The migration limits for the specified substances in the simulant are given in the table below. 

Timeline 

The Bureau of Indian Standards (BIS) is consulting on the revised standard for polyethylene terephthalate (PET) bottles, used for packaging alcoholic drinks until 8 February 2024. 

The Department of Chemicals and Petrochemicals (DCPC) published a notification in the Official Gazette on 30 January, 2024, deferring the implementation of Quality Control Orders (QCO’s) for four ch...

The Department of Chemicals and Petrochemicals (DCPC) published a notification in the Official Gazette on 30 January, 2024, deferring the implementation of Quality Control Orders (QCO’s) for four chemicals. 

The four chemicals and their previous and new implementation dates are listed below: 

The Orders do not apply to chemicals intended for export only. The chemical products meeting to the requirements of the Orders must bear the standard mark under a license of the Bureau of Indian Standards. Those who fails to comply with the provisions of the order shall be penalized in accordance with the provisions of the Bureau of Indian Standards Act (BIS Act), 2016. 

The Bureau of Indian Standards (BIS) published the revised draft of Specification for Petroleum Jelly for the Cosmetic Industry (Second Revision of IS 4887) in December 2023. Petroleum jelly, a sof...

The Bureau of Indian Standards (BIS) published the revised draft of Specification for Petroleum Jelly for the Cosmetic Industry (Second Revision of IS 4887) in December 2023.

Petroleum jelly, a soft, semi-solid substance produced from petroleum oils, is used to make creams, lipsticks, lubricating creams, hair dressings, foundation creams, and emollients for chapped skin.

Specification for Petroleum Jelly for the Cosmetic Industry

The Indian Standard (Specification for Petroleum Jelly for the Cosmetic Industry), first published in 1968, underwent its first revision in 1980. This second revision includes an increase in the melting range (the upper limit has been increased from 56°C to 80°C), a new requirement for mercury, and alternative test methods for the determination of arsenic. Cross-referred standards and the marking clause have also been updated.

Amendments in the second revised IS 4887

Table of requirements for petroleum jelly for the cosmetics industry

Containers must be labelled with the following information (requirement 5-8 are new compared to the first revision of the standard):

1. Name of the material

2. Name of the manufacturer and his registered/recognized trademark, if any

3. Net mass of the material

4. Month and year of manufacturing/packing

5. Batch number in a manner to enable traceability including its date of manufacture

6. Use before or expiry date as per statutory requirements

7. List of ingredients as per statutory requirements

8. Any other information required by statutory authorities

Deadline for comments

The Bureau of Indian Standards (BIS) is consulting on the new standard for petroleum jelly used in cosmetic products until March 12, 2024.

On 4 January 2024, the Department of Chemicals and Petrochemicals (DCPC) of India, in accordance with the Bureau of Indian Standards (BIS) has issued a Quality Control Order (QCO) for polyethylene use...

On 4 January 2024, the Department of Chemicals and Petrochemicals (DCPC) of India, in accordance with the Bureau of Indian Standards (BIS) has issued a Quality Control Order (QCO) for polyethylene used in moulding and extrusion. The QCO came into force on the day of publication. 

The order was originally scheduled to come into force in April 2022, but was extended by the DPDC. The revised order is called the Polyethylene Material for Moulding and Extrusion (Quality Control) Amendment Order, 2024 and amends the Polyethylene Material for Moulding and Extrusion (Quality Control) Order, 2022. 

The amendment adds the following grades of polyethylene material utilized in moulding and extrusions to the QCO: 

• Low Density Polyethylene Extrusion (LDPE) Coating; 

• Low Density Polyethylene (LDPE) Film Grades (Blown/ Cast) or Pharma; 

• Linear Low-Density Polyethylene (LLDPE) Butene Grades; 

• Linear Low-Density Polyethylene (LLDPE) Hexene/ Octene Grades; 

• Metallocene Polyethylene Grades; 

• Base Resins of Power Cable, Jacketing and other applications; and 

• compounds for Cable Jacketing/ Sheathing/ Polyethylene-80 and Polyethylene-100 (Black and Pigmented)/ Reinforcement Fillers”. 

The Central Drugs Standard Control Organization (CDSCO) has launched the ‘National Single Window System (NSWS)’ site, which is a significant step in streamlining the process of obtaining medical d...

The Central Drugs Standard Control Organization (CDSCO) has launched the ‘National Single Window System (NSWS)’ site, which is a significant step in streamlining the process of obtaining medical device approvals in India. The federal government created this platform to serve as a one-stop shop for all investor-related clearances, making it easier to do business in the medical device sector.

Key Features of the NSWS Portal-

The NSWS portal works independently of the current SUGAM portal, providing a specialized platform for medical device approvals. The following three activities have been established in response to the 2017 medical device rule and are now LIVE on ‘NSWS portal’ effective from 01.01.2024.

• Form MD-01: Application for a grant of certificate of registration of a notified body
• Form MD-12: Application for a license to manufacture a medical device for clinical research, testing, evaluation, examination, demonstration, or training.
• Form MD-16: Application for license to import medical devices for clinical investigations, testing, evaluation, demonstration, or training.

More functionalities are expected to be added in the future.

Benefits for Stakeholders-

The launch of the ‘NSWS portal’ is expected to benefit various stakeholders in the medical device industry. In light of the foregoing, it is asked that all involved stakeholders submit applications for the mentioned three activities (i.e. MD-01, MD-12, MD- 16) through the ‘NSWS portal’ only, as the previous 'cdscomdonline' portal for the stated activities would be disabled from 15.01.2024.

Overall, the CDSCO's ‘NSWS portal’ is a positive step towards creating a more efficient and transparent regulatory environment for medical devices in India. This initiative is expected to boost the medical device industry and contribute to improving healthcare outcomes for the country.

For more information, please reach out to https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTE=

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On 6 December 2023, the Central Government of India, after consultation with the Bureau of Indian Standards (BIS), published a Gazette Notification regarding the Quality Control Order (QCO) for the fi...

On 6 December 2023, the Central Government of India, after consultation with the Bureau of Indian Standards (BIS), published a Gazette Notification regarding the Quality Control Order (QCO) for the five polymer products listed in the table below. 

Timeline: 

It shall come into force on the expiry of one hundred and eighty days from the date of its publication in the Official Gazette. 

  The Department of Chemicals and Petrochemicals (DCPC) has announced its plan to implement Quality Control Orders (QCOs) for a list of 10 chemicals. This initiative falls under the provisions of ...

The Department of Chemicals and Petrochemicals (DCPC) has announced its plan to implement Quality Control Orders (QCOs) for a list of 10 chemicals. This initiative falls under the provisions of the Bureau of Indian Standards Act, 2016. The enforcement of these QCOs will begin on specified dates for each chemical, as outlined below:

In light of this development, the DCPC is inviting comments and feedback from stakeholders on the proposed QCOs. The deadline for submitting any remarks or suggestions is set for 5th January 2024. This proactive engagement aims to ensure comprehensive input and consideration from all relevant parties before the enforcement of these quality standards.