National Green Tribunal
Him Jagriti Uttaranchal Welfare ... vs Union Of India on 8 January, 2021
Author: Adarsh Kumar Goel
Bench: Adarsh Kumar Goel
Item No. 02 Court No. 1
BEFORE THE NATIONAL GREEN TRIBUNAL
PRINCIPAL BENCH, NEW DELHI
Original Application No. 15/2014
(With reports dated 12.10.2020, 30.08.2020,
14.02.2020, 12.10.2020 and 12.11.2020)
Him Jagriti Uttaranchal Welfare Society Applicant
Versus
Union of India & Ors. Respondent(s)
Date of hearing: 08.01.2021
CORAM: HON'BLE MR. JUSTICE ADARSH KUMAR GOEL, CHAIRPERSON
HON'BLE MR. JUSTICE SHEO KUMAR SINGH, JUDICIAL MEMBER
HON'BLE DR. NAGIN NANDA, EXPERT MEMBER
Applicant: Mr. Ritwick Dutta, Advocate
Respondent(s): Mr. K.K. Singh, Advocate for MoEF&CC
Mr. Raj Kumar, Advocate for CPCB
Mr. Rishikant, Advocate for DGHS
Mr. Suransh Choudhary, Advocate for FSSAI
Ms. Deepika Nandakumar, Advocate for BIS
ORDER
1. Issue for consideration is restriction on use of plastic bottles and multi layered plastic packages for packaging of carbonated soft drink, liquor and other items, in view of the adverse impact of such packaging on the environment and public health.
2. Vide order dated 14.10.2019, the Tribunal considered the report dated 30.08.2019 by the Expert Committee comprising the Food Safety and Standards Authority of India (FSSAI), Bureau of Indian Standards (BIS), Central Pollution Control Board (CPCB) and Directorate General of Health Services (DGHS) suggesting an action plan with 12 specific points, after considering the areas of concern on the subject. The 1 Tribunal also noted the steps taken by FSSAI. The relevant extracts from the said order are as follows:-
"2. The matter was last dealt with by this Tribunal vide order dated 31.05.2019. After taking note of the Notification dated 24.12.2018, issued by the Ministry of Health and Family Welfare under Section 92 of Food Safety and Standards Act, 2006, Food Safety and Standards (Packaging) Regulations, 2018 and the Food Safety and Standards (Labelling and Display) Regulations, 2018 regulations, the Tribunal constituted an Expert Committee comprising of the representatives of FSSAI, BIS, CPCB and DGHS to consider whether any further regulatory provisions are required on the subject of restrictions on the packaging by use of plastic material and if so to what extent. The Nodal agency for coordination was the FSSAI.
3. Accordingly, a report dated 30.08.2019 has been filed by the Expert Committee. The Committee noted following key areas of concern:
"1) Continued use of multi polymer plastic (MPP) or multi layered plastic (MLP) with associated difficulties in its recycling.
2) Increasing use of small packages such as bottles used for beverages, sachets, pouches which are not viable to collect and recycle.
3) High capital cost involved in the presently available techniques in recycling plastics.
4) Inadequate reach of Extended Producer Responsibility (EPR).
5) Non availability of economically viable substitutes to the plastics.
6) Lack of consumer awareness for proper disposal of plastics and litter management.
7) Absence of joint regulatory mechanism with respect to plastic waste management."
It proposed a systematic action plan with 12 specific points as follows:
"(A) Manufacturer / User Industries of Plastic Packaging Materials.
(1) Institute concept of 'plastic footprint': What gets measured is managed. Therefore, in order to encourage businesses to reduce use of plastics through innovation and redesigning of their packaging, a system of quantifying the use of plastics per unit of final product (say kg of plastic used in 1000 kg/kiloliter of final product) may be put in place. A deflator or inflator may be used for use of recyclable plastics, biodegradable/compostable plastics or multilayered plastic as the case may be. A system of periodic assessments of plastic footprint for each product category may be done. In food and beverages, these 2 categories could include confectionery and bakery products (biscuits, ice-creams, bakery products and chewing gum), namkeens (chips, namkeen, nuts/peanuts), instant noodles and cereals, beverages (cold drinks, juices, energy drinks and hot drinks) and dairy products (milk, paneer, yoghurt and flavoured milk). Plastic footprint for each category may be benchmarked with the market average of use of plastic.
This would encourage companies to adopt packaging reduction strategies that may include reducing weight of packaging, eliminating unnecessary packaging, using lightweight packaging materials, optimizing packaging size and use of recyclable (compostable) and reusable packaging material. Through a system of recognition, rewards and perhaps eventually penalties, it is hoped that the companies would work towards continuous reduction of plastics, product by product and enable businesses to demonstrate their commitment to safer environment.
(2) Discourage small pack sizes: Lighter, portable, and cost-
effective nature of single serve sachets/pouches/bottles continues to make them an attractive proposition for the low-income consumers as well as young and active millennials. Smaller pack sizes/single serve packaging also have brought better quality and premium products affordable to all the sections of the society. But on the other hand it constitutes to the major plastic waste and litter, as their collection is economically non-viable. Hence, in consultation with Legal Metrology Dept. the small pack sizes such as small water bottles, pouches, cups which constitute a considerable amount of plastic waste may not be allowed.
(3) Reducing plastic content in multi-layered plastic (MLP):
Ideal packaging materials had been tailored by combining different material with customized functionality to sufficiently protect sensitive food products and thus obtain extended shelf life. Latest feasible techniques and technologies may be employed to cut down the use of multiple polymers/plastics. More research in this area is required to be done by scientific institutions. Use of Single polymer/layer recyclable packaging materials shall be encouraged in this case. (4) Encourage alternatives to plastics: Bio-plastics and biodegradable plastics like Poly Lactic Acid (PLA) made from fermented plant starch etc. can be a sustainable alternative to conventional plastics. However there are limitations with the availability of resources for such material. More research in the area to reduce the cost of PLA is required to be done. There is also need to create awareness on biodegradable, compostable or bio-based plastics since their degradation requires conditions like appropriate temperature, light, hydration and/or microbial presence. Hence these have to be separately marked and disaggregated. In case, the biodegradable &compostable or bio-based plastics remain unsegregated and go in landfills just like that, it is 3 unlikely to meet these conditions and serves no purpose. Existing packaging systems of paper based cartons with minimal plastics as coatings, composite and reusable containers made up of glass, tin, metal and paper maybe promoted as replacements. A list of alternatives to plastic packaging materials as suggested by Centre for Science and Environment (CSE) is at Annexure-2.
(5) Effective Extended Producer's Responsibility (EPR) framework: The current Plastic Waste Management Rules mandate the "producer of packaging products and branded consumer goods to dispose plastic packaging waste generated due to their business activities". Even though the policy framed under these rules is fairly good but it has been confined to selected few big businesses. It is understood that National Framework on EPR for plastic waste management is being finalized. The framework may consider a system of monitoring as well as penalty provision for its non-
compliance may be explored. The companies may be encouraged to use their downstream supply chain of distribution and retail for collection and aggregation of plastics for recycling. This may be quite easy in direct selling entities that use multi-layered marketing, distribution networks.
(B) Final consumers/Users of plastic packaged articles and food stuff.
Establishments, agencies, institutions, organizations including government/nongovernment, food/non-food operators such as roadways, railways, airlines, schools, colleges and university campuses, E-commerce groups, corporate campuses, hotels, marriage, banquet and community halls under this head shall take-up responsibilities on the following;
(6) Eliminate/Ban single use plastics: should eliminate and prohibit the usage of single serve/use plastics within their ecosystems. Recent ban by the Parliament and Indian railways is worth emulating.
(7) Alternatives to plastics: They shall encourage the use of reusable and recyclable environment friendly alternatives such as jute and cloth bags, bamboo and wooden cutlery, leaf based plates, glass and metal containers etc. (8) Improved Litter Management: They should take up the responsibility of collecting all the waste in their campuses, sorting out dry and wet waste. They could also encourage their staff, teachers and students to bring such plastic waste from homes and help in collection and aggregation of such waste by tying up with businesses in plastic recycling. Dry waste can be segregated into recyclable and non-recyclable and accordingly processed. Wet waste may be sent to composting, which can be done in-house. This activity could be made a part of the social responsibility system. 4 (9) Better Plastic Disposal: Initiatives are to be taken up, to dispose plastic waste by forming groups/clusters to set up/identify energy recovering systems such as incineration and pyrolysis. Getting adequate quantities of suitable plastics waste is seen as most important factor in success of such units. More organized efforts and encouragement is required for this proper disposal. (C) Municipal bodies/other organizations promoting circular economy.
(10) All municipal bodies must be made responsible for development and setting up of infrastructure for segregation, collection, storage, transportation, processing and disposal of the plastic waste either on its own or by engaging agencies or producers as mentioned in the Plastic Waste Management Rules. (D) Citizens and consumers.
(11) Citizens, especially the socially engaged ones living in urban areas with wide access to information, have adopted more environmentally conscious consumption habits oriented toward recycling, reusing and composting the waste that derives from their domestic consumption. This segment of socially discerned consumers, appreciate brands that demonstrate a commitment to environmental sustainability. A more intensive public campaign, however, is needed to mainstream this kind of behavioral change to a wider public segment. Further approach of incentivizing the customers can also be explored to encourage them for plastic waste management.
(E) Science and Research Institution.
(12) Science and research institutions must be encouraged for working in the direction of developing environmental friendly packaging materials and plastic waste management systems which can be used on commercial basis. Start-ups may also be encouraged to work in this area. For the food and beverages sector, FSSAI may create a group of institutions and experts to coordinate new work in this area with leading institutions like the Indian Institute of Packaging, CIPET, IIT Delhi, IIT Guwahati, Indian Institute of Toxicological Research (IITR), National Chemical Laboratory, Pune and others."
4. The Committee further noted that these are not only environmental issues but also public health issues. In that view of the matter, FSSAI has taken steps to reduce the use of plastic in packaging of foods and beverages as follows:
"(1) FSSAI has decided to permit use of liquid nitrogen dosing in PET bottles during the packaging of drinking 5 water. This would help in strengthening the bottle thereby facilitating the manufacture with the use of bottles with lower wall thickness.
(2) FSSAI has initiated the process of removing the restriction on the use of returnable bottles for packaging of artificially sweetened beverages.
(3) FSSAI is promoting the use of bamboo as an alternative to plastics such as straws, plates, bowls, cutlery etc. (4) Allow and enable hotels to keep in-house packed glass bottles in place of plastic bottles in hotel rooms."
5. The FSSAI has also established a separate 'Scientific Panel on Packaging and Food Contact Materials'. The Committee thereafter made following specific recommendations on regulatory aspects:
"(1) Food Safety and Standards (Packaging) Regulations, 2018: To review the limits of heavy metals in PET and fix the limits of specific migration limits of Antimony and DEHP (Diethylhexyl-phthalate). In addition to this also explore the possibility of setting limits for Cadmium and chromium.
(2) Food Safety and Standards (Packaging) Regulations, 2018 and IS 14543 (Packaged Drinking water): To remove the restriction on the use non-transparent bottle for drinking water to enable businesses to explore the possibilities of use of alternatives other than the PET currently in use.
(3) Food Safety and Standards (Packaging) Regulations, 2018; IS 14534 (Guidelines for Recycling of Plastics);
and Plastic Waste Management Rules, 2016: The European Food Safety Authority (EFSA) permits the use of recycled PET in food packaging under certain set protocols. EC recommends to explore the possibilities for removal of ban on use of recycled plastic in food packaging after a scientifically validated method of pre- cleaning of plastic waste is developed to ensure that the final product using recycled material does not pose any health risk.
(4) Legal Metrology (Packaged Commodities) Rules 2011:
To explore the possibilities of restricting small packs of commodities such as water, shampoo, sauce, pickle etc."
6. On the subject of review and monitoring, the Committee observed:
"8. The Expert Committee noted that while regulatory provisions for restrictions on the packaging by use of plastic material are mostly in place, there is lack of coordinated approach and implementation of these provisions is poor. It suggested putting in place sector- specific mechanisms to review and monitor the use of plastics in packaging and commitment of businesses under 'Extended Producer Responsibility (EPR)' framework, managing plastic footprints, and related 6 issues. In this, sector-specific regulators such as FSSAI (for food and beverage packaging), CDSCO (for drugs and cosmetics packaging), Ministry of Textile (for textile packaging) etc. and the Central Pollution Control Board (CPCB) could work together to ensure better coordination. Related ministries and the Ministry of Housing and Urban Affairs and Department of Drinking Water and Sanitation could also be associated for better coordination with Swachh Bharat Mission."
7. In view of the above report, we direct FSSAI, BIS, CPCB, DGHS and MoEF&CC to take further follow up action based on the above report within three months and furnish an action taken report before this Tribunal by e-mail at judicial- [email protected] before the next date."
3. Thereafter, the matter was taken up on 28.07.2020 but no action taken report was filed by FSSAI, BIS, CPCB and DGHS. Only report filed by the Ministry of Environment, Forest and Climate Change (MoEF&CC) on 14.02.2020 was that the issue of single use plastic was referred to the Committee of Secretaries which was yet to take further decision.
4. The matter was thereafter considered on 10.09.2020 and after noting that no further report had yet been furnished, the Tribunal directed furnishing of action taken report by the FSSAI, DGHS, MoEF&CC, the CPCB and the BIS. It was made clear that no individual party was required to be heard as the Tribunal was to consider remedial action taken by the statutory authorities as per law and individual parties were free to take remedies against such action, if they were aggrieved.
5. Accordingly, reports have been furnished by the CPCB, BIS, FSSAI, MoEF&CC and DGHS which we may refer seriatim.
6. Report of the CPCB dated 12.10.2020 mentions the steps taken which are as follows:
" xxx xxx xxx 7 2.1 Registration of Brand Owners/Producers:
CPCB has issued registration to 162 Brand-Owners (BO) and 4 Producers under provisions of Plastic Waste Management Rules, 2018 having total Extended Producer Responsibility (EPR) target for collection and disposal of approx. 7 Lac TPA plastic waste.
2.2 Directions to SPCBs/PCCs:
Directions under Section 5 of Environment (Protection) Act, 1986 have been issued to all SPCBs/PCCs for identification of the Brand owners/ producers who are operating without Registration from SPSB/PCC/ CPCB in their State/UT and to take action against the defaulting units as per provisions of PWM Rules, 2018 which shall include closure of their operations, and levying Environmental Compensation. List of Brand owners whose application for registration with CPCB is pending with applicants for long and are non-compliant during this period has also been forwarded to SPCBs/PCCs for necessary action.
2.3 Show Cause Notices for Closure of operations & Levying Environment Compensation:
CPCB has issued Show Cause Notices to 6 Brand Owners/Producer (namely Mis. Bisleri International Pvt. Ltd., Mis. Hindustan Coca Cola Beverages Pvt. Ltd., M/s. Pepsico India Holding Pvt. Ltd., M/s. Flipkart Private limited, M/s. Patanjali Peya Pvt. Ltd. and M/s. Nourish Co. Beverages (Limited) for non-compliance of Provisions of PWM Rules, 2018 in October,2020.
3.0 Institute Concept of Plastic Foot Print:
The concept of Plastic Foot Print was discussed during Expert Committee meeting in August 2020 and concerned industries were identified (Annexure-8). However, CPCB has not received any data on subject matter from the industry /FSSAI as stated against actionable point no.1 of last report dated 15-2-2020. The subject matter is also not addressed in PWM Rules,2018. FSSAI may provide further details/requisite data on the matter to CPCB for consideration."
7. The issue of compliance of Plastic Waste Management Rules, 2016 including the Extended Producer Responsibility (EPR) is being dealt with by separate order today in Execution Application No. 13/2019 in OA 247/2017, Central Pollution Control Board v. State of Andaman & Nicobar & Ors. alongwith OA 997/2019, Aditya Dubey (Minor) v. Amazon Retail India Private Limited & Ors., OA 28/2020, Aditya Dubey (Minor) through his Legal Guardian Mrs. Anu Dubey & Anr. v. Coca-Cola india Pvt. Ltd.8
(CCIPL) & Ors., OA 29/2020, Avani Mishra v. Union of India & Ors. and OA 42/2020, Shubham Khatri v. Union of India & Ors. The present matter is limited to restricted use of plastic in packaging of liquids. The reports filed to some extent go beyond the scope of the present matter but we notice the reports as filed but will deal with the specific issue of restrictions on use and safeguards in the interest of health.
8. The report of the BIS filed on 30.08.2020 gives the status of action taken by the FSSAI and BIS in relation to Expert Committee recommendations dated 15.02.2020 in terms of order of this Tribunal dated 31.05.2019. The status has been given as follows:
"STATUS:
a) Indian Standards published by BIS:
BIS has published the following Indian Standards which may be used as alternatives to plastics:
i) IS/ ISO 17088:2012 Specifications for Compostable Plastics
ii) IS 1107:1986 Aerated water glass bottles crown finish type
iii) IS 11984:1986 Glass bottles for free flowing liquids
iv) IS 14407: 1996 Aluminium cans for beverages - Specification
b) Formulation of new Indian Standard:
The following subjects were identified for the formulation of Indian Standards as alternatives to plastics:
i) Indian Standards on 'Paper based multilayer composite carton for processed liquid food products'.
Draft Indian Standard on 'Paper based multilayer composite carton for processed liquid food products' has been issued into Wide Circulation with last date of comment 22/01/2020. Comments received on the draft were discussed in the meeting of Paper based Packaging materials Sectional Committee, CHD 16 held on 21-08-2020. Based on the deliberation held during the meeting, it was decided that the concerned panel CHD 16 : P 5 would redraft the document which would again be sent into wide circulation after obtaining the approval of the Chairman, CHD 16.
ii) Indian Standard on 'Compostable plastics bottles/ containers for the Packaging of Natural Mineral Water and Drinking Water'.
9 During 29th Meeting of Plastics Packaging Sectional Committee (PCD 21) held on 06 Dec 2019, the Committee considered the Hon'ble NGT order dated 14/10/2019. Further, the Committee noted that this a new type of material for packaging purposes and to know about the characteristic of the material and product, manufacturers of the bottle/ experts should be invited in the next meeting for representation/ discussion.
c) Amendment to IS 14543:2016 'Packaged Drinking Water (Other than Packaged Natural Mineral Water) and IS 13428:2005 'Packaged Natural Mineral Water'. The Drinks & Drinking Water Sectional Committee, FAD 14 in its 27th meeting held on 03/12/2019 took note of the directions of the Hon'ble NGT order dated 14/10/19 in the matter to remove the restriction on the use non-transparent bottle for drinking water to enable businesses to explore the possibilities of use of alternatives other than the PET currently in use.
The Committee was of the opinion that the transparency requirements are prescribed in the FSSAI's Packaging Regulations and decided that appropriate amendments to IS 14543 as well as IS 13428 may be issued for printing/ publication by BIS directly by waiving-off wide circulation (considering harmonization with the National Regulations and compliance to the directions of the Hon'ble NGT on the matter) as soon as a notification to this effect is issued by FSSAI. The Committee further decided to recommend that alternative food-grade packaging materials (such as Paper Based Multilayer packaging, metal cans, etc.) suitable for drinking water may be considered for incorporation in IS 14543 & IS 13428 after the above developments take place. FSSAI had issued Directions dated 07th Feb 2020 under Section 16 (5) of Food Safety and Standards Act, 2006 regarding operationalization of Food Safety and Standards (Packaging) Amendment Regulations, 2020 relating to Specific Migration Limits of Antimony and DEHP and Packaging of Drinking Water. The para 2 (1) of the said draft regulations state that 'Other food grade packaging materials compatible with the water to be packaged may also be used. In such cases, requirement of transparent bottle would not apply'. FSSAI was requested by BIS to further clarity on para 2 (1) of the said draft regulations for 'Other food grade packaging materials compatible with the water....' w.r.t. its mode of implementation, testing/ verification and enforcement before the same could be considered for amendments in IS 14543 & IS 13428. Based on the response received from FSSAI on the matter vide their mail dated 08 July 2020 the following was elucidated:
a. The amended/ revised sub-regulation (4) of Regulation (4) of Food Safety and Standards (Packaging) Regulations, 10 2018 pertains to Plastic materials intended to come in contact with food products.
b. In this case, the 'other food packaging material' may include the following:
i) Paper-based Multilayer packaging with plastic as primary food contact layer with water
ii) Biodegradable and compostable plastics c. The testing of such materials may be done as per the existing BIS standards/ methods which are followed for testing for conventional plastics excluding transparency and physical properties. Biodegradability and composability tests may be done additionally in case of Biodegradable/ compostable plastics.
d. The size/ capacity of such materials may be considered accordingly.
The draft amendments to these ISs would be taken up with the FAD 14 Committee for deliberations.
2) Food Safety and Standards (Packaging) Regulations, 2018; IS 14534 (Guidelines for Recycling of Plastics); and Plastic Waste Management Rules, 2016: The European Food Safety Authority (EFSA) permits the use of recycled PET in food packaging under certain set protocols. To explore the possibilities for removal of ban on use of recycled plastic in food packaging after a scientifically validated method of pre-cleaning of plastic waste is developed to ensure that the final product using recycled material does not pose any health risk [Action to be taken up by the - FSSAI&BIS].
STATUS:
BIS has published IS 16630 (Part 1): 2018 'Plastics- Post Consumer Poly Ethylene Terepthalate PET Bottle Recyclates Part 1 Designation System and Basis for Specifications'.
This standard establishes a designation system for post-consumer poly (ethylene terephthalate) (PET) bottle recyclates, which may be used as the basis for specifications. This standard is applicable to all PET bottle recyclates. It applies to material ready for normal use in the form of powder, flakes or pellets.
However, BIS will participate in the development of a processes, which may be used to produce recycled PET intended for food packaging applications by FSSAI.
Further, IS 14534:2016 'Plastics -- Guidelines for the Recovery and Recycling of Plastics Waste' will be amended after removal of ban on use of recycled PET in food packaging by MoEF&CC and FSSAI."
9. The report of the FSSAI filed on 14.02.2020 mentions the steps taken by the MoEF&CC for regulation and recycling of plastic. It is stated that "Standard Guidelines for Single-Use Plastic" have been issued on 11 21.01.2019 for improving the waste management and prohibiting Single-
Use Plastic (SUP). Instructions were issued to Chief Electoral Officers during General Elections 2019 to phase out SUP. Instructions were also issued to Ministries, Department, offices under the jurisdiction of the Governments. Regional offices, Schools, Corporates, Major PSUs, Institutions in 2018 & 2019 to prohibit SUP products including water bottles, take away coffee cups, lunch wrapped in disposable plastic packaging, plastic bags, disposable food containers, plates and containers made of polystyrene foam, plastic straws etc. from their offices. Provision has been made for proper regulation and sound recycling of plastic, provisions have been made for registration of all plastic recyclers with respective State/UT Pollution Control Boards/Committees. Every Urban Local body has been made responsible for setting up of infrastructure for collection, segregation and processing, including recycling and disposal of plastic waste. The local bodies have also been mandated to create awareness among all stakeholders about their respective responsibilities. The Rules mandate the producer, importers and brand owners to work out modalities for waste collection system based on the principle of Extended Producers Responsibility involving the State Urban Development Departments. The Rules further mandates the Producers, Importers and Brand Owners for collection of used multi-layered plastic sachet or pouches or packaging, who introduces such products in the market. The Rules prescribe them to establish a system for collecting back the plastic waste generated due to their products. The State Governments have also issued their own instructions to ban SUP items to encourage alternate use of plastics i.e. compostable plastic, oxo-biodegradable plastics, the Ministry has requested CIPET & CPCB to carry out studies on SUP. Department of 12 Chemicals and Petro Chemicals conducted a study on Single Use Plastic. As per the draft report submitted by the Expert Committee to DCPC (CIPET report), single use plastic items were categorized based on a logical process. This categorization resulted in a group of SUP items being identified as having serious environmental impacts. The most common single-use plastics found in the environment are plastic drinking bottles, plastic bottle caps, food wrappers, cigarette butts, plastic carry and grocery bags, plastic lids, straws and stirrers, other types of plastic bags, and foam take-away containers. These are the waste products of a throwaway culture that treats plastic as a disposable material. The environmentally problematic products with low utility value and high environmental impact were identified. Considering the high environmental costs associated with management of single-use plastics, particularly the adverse effect on marine environment, and the need for a definitive response supplementing actions undertaken by various States/UTs to combat single-use plastic pollution, it is proposed that a prohibition on the manufacture, use, sale, import and handling of single- use plastic products may be introduced at the Central level. However, a comprehensive list of all Single use plastic items, with even a narrow definition of Single Use Plastic would be very large and could encompass a major portion of all economic activities in the country. It may not be feasible to impose a comprehensive ban on all SUPs. Therefore, it shall be prudent to identify list of SUP items which have the least 'Utility' and the Most Environmental Impact', to prohibit. This could be introduced by 2022. The matter regarding banning of Single Use Plastic is being discussed in the meeting of Committee of Secretaries (COS) at the apex level at Cabinet Secretariat on the measures taken by the MoEF&CC and its line Ministries. It is pointed out during the hearing that with regard to 13 packaging of water, carbonated soft drinks, beverages and other consumable food/drink items, FSSAI has issued direction under Section 16 (5) of Food Safety and Standards Act, 2006 dated 07th February 2020 regarding operationalization of Food Safety and Standards (Packaging) Amendment Regulations, 2020 relating to Specific Migration Limits of Antinomy and DEHP and Packaging of Drinking Water. Therein, it is stated that the draft regulations were in the process of being finalised under section 92 of the Food Safety and Standards Act, 2006.
10. The report of the MoEF&CC dated 12.10.2020 which practically repeats the contents of the report of the FSSAI already quoted above.
11. The report of the DGHS dated 12.11.2020 filed in the form of additional affidavit of the Joint Drug Controller (India), Central Drug Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, Govt. of India. The relevant extracts from the report are:
"1. xxx xxx xxx
2. A representation was received from the Him Jagriti, to impose a complete ban on usage of PET bottles (both coloured and uncolored) as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups was considered by Drug Technical Advisory Board (DTAB) a statutory body under the Drug and Cosmetics Act, 1940. Subsequently, Ministry of Health and Family Welfare published draft rules vide Gazette Notification No. G.S.R 701 (E) dated 29.09.2014 for prohibition of use of Polyethylene Terephthalate or plastic containers in liquid oral formulations for primary packaging of drug formulations for pediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group.
3. That in view of the large number of objections and suggestions from various stakeholders on said draft rules the Ministry of Health and Family Welfare constituted a high-level committee under the chairmanship of Prof. M.K Bhan, the former Secretary, DBT, to review the safety of Polyethylene terephthalate (PET) and its containers for the packaging of pharmaceuticals.14
4. It is respectfully submitted that this Hon'ble Tribunal in its order dated 14.10.2019, considered the report dated 30.08.2019 of the expert committee comprising FSSAI, BIS, CPCP and DGHS to consider whether any further regulatory provisions are required on the subject of restrictions on the packaging by use of plastic material and if so to what extent. Further the Hon'ble court in view of the report, directed to take further follow up action based on the said report and furnish an action taken report before the Tribunal.
5. It is respectfully submitted that for compliance of this Hon'ble Tribunal order dated 14.10.20191 FSSAI had requested the concerned agencies/departments including CDSCO vide Letter No. 1-
95/stds/Misc/SP (L&C/A)/FSSAI-2015(pt-4) dated 05.11.2019 to initiate necessary action and accordingly to submit an Action taken report to FSSAI so that same could be compiled and submitted to the Hon'ble NGT by them.
6. It is respectfully submitted that on the basis of the recommendations of the M. K. Bhan committee, Indian Pharmacopoeia Commission, MoH&FW, Ghaziabad has examined the issue through an expert Committee under the Chairmanship of Prof. Y. K. Gupta, former Head of Dept. of Pharmacology, AIIMS, New Delhi, and revised the Chapter on "Primary Packages for Pharmaceutical Articles" and same has been published in Volume-I, Page No.-1019 of 8th Edition of Indian Pharmacopoeia (IP), 2018. It includes standards of PET (Polyethylene terephthalate) as well as standards of other polymers/plastic containers and primary packaging of pharmaceuticals. Labels of on the containers are also revised to meet the requirements of Drug and Cosmetics Act, 1940 and Rules made there under.
A copy of Volume-I, Page No.-1019 to 1060 of 8th Edition of Indian Pharmacopoeia (IP), 2018 is annexed and marked as Annexure-Al.
7. It is respectfully submitted that accordingly the "Chapter 6. Primary Packages for Pharmaceutical Articles" of the IP has been harmonized at par with global Pharmacopoeias for ensuring safe use of plastics for packaging of pharmaceuticals.
8. Accordingly, CDSCO had submitted the Action taken report in respect of use Plastics for packaging of Pharmaceuticals to the FSSAI vide Letter No. 29/Misc./38/2019-DC dated 27.01.2020, comprising the reply received from Indian Pharmacopoeia Commission, MoH8LFW, Ghaziabad, as to "whether any further regulatory provisions are required on the use of plastics for packaging of pharmaceuticals, after the steps already taken, and if so, to what extent (copy attached).
A copy of letter dated 27.01.2020 is annexed and marked as Annexure-A2.
9. It is respectfully submitted that manufacture, marketing & sale of Drugs are regulated under the provisions of Drugs and 15 Cosmetics Act, 1940 and Rules made there under. Good manufacturing Practices and requirements of premises, plant and equipment for manufacture of Pharmaceutical products are specified in Schedule M to the Drugs and Cosmetics Rules, 1945.
10. As per the Schedule M to the said rules, all containers and closures intended for use shall comply with the Pharmacopeia and other specified requirements. Suitable sample sizes, specifications, test methods, cleaning procedures and sterilization procedures, shall be used to assure that containers, closures and other component parts of drug packages are suitable and are not reactive, additive, adsorptive or leachable or presents the risk of toxicity to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used. Pharmaceutical manufacturers are required to follow the Standards laid down in Indian Pharmacopoeia."
12. Thus, revision of Indian Pharmacopoeia (IP) Chapter 6, for standards of plastic containers and primary packaging of Pharmaceutical Articles stands carried out. It includes standards of PET (Polyethylene Terephthalate) as well as standards of other polymers/plastic containers and primary packaging of pharmaceuticals.
13. We have heard learned Counsel for the applicant as well as the CPCB, BIS, FSSAI, MoEF&CC and DGHS and given due consideration to the issue involved.
14. Learned Counsel for the applicant has referred to submissions filed on 20.03.2020 and 13.10.2020 by way of objections to the reports of the above referred authorities. It is submitted that the main concern is health consequences from the use of plastic for packaging and not with the management of plastic packaging as waste. The said issue has still not been addressed by the authorities. Heavy metals and plasticizers like DEHP are present in plastic beyond prescribed limits which is detrimental to the health. Thus, use of plastic packaging including polyethylene phthalates (PET) bottles and multi-layer packs such as Tetra packs has to be banned particularly for packaging of carbonated 16 soft drink and liquor and gradually for all non-essential items also. The applicant has referred to reports highlighting adverse consequences on health, i.e. draft notification published by the Ministry of Health and Family Welfare on 29.09.2014, report published by the Indian Council of Medical Research, report published by the Indian Institute of Toxicology Research, report submitted by the All-India Institute of Hygiene and Public Health, Drugs and Technical Advisory Board and National Test House. The report of the ICMR has noted that PET bottles should not be used for drugs meant for use of vulnerable groups such as pediatric age group and for pregnant women. It was further submitted on behalf of the applicant that the standards imposed by FSSAI for antimony and DEHP are not in consonance with National or International Standards. The Expert Committee has erroneously classified tetra-based packaging as 'paper-based packaging' despite the fact that out of the 6/7 layers, 4 layers are plastics. The first and second layers, which come in contact with the food products, are plastic and the outer most layer which comes in contact with food is also plastics (so it is effectively a multi layered plastic packaging instead of paper packaging). In the note filed on 13.10.2020, the applicant has further stated that as per findings of the Indian Institute of Toxicology Research (IITR), there is migration of phthalates, DEHP and additives, which are above permissible limits, as per both Indian and International standards. In view of the said findings, there is need to ban plastic packaging of food and medicinal products to avoid adverse impact on human health. It was submitted that if first layer of packaging in multi-layer packaging involves contact with the food items, leaching cannot be avoided. While it is claimed that tetra packs are 100% recyclable, in actual practice, only 5% of such packaging is recycled. There is huge gap in segregation and collection of such waste as 17 against the requirement of doing so. Majority of tetra packaging are ending up in landfills. Similar is the situation in respect of plastic bottles.
15. As against above, learned Counsel for the statutory regulators submitted that the issues have been duly dealt with. Learned Counsel for the DGHS pointed out that the Drugs and Cosmetics Act, 1940 deals with the standards for safe use. Vide Notification dated 29.09.2014, the Ministry of Health has published draft rules for prohibition of use of Polyethylene Teraphthalate or plastic containers in liquid oral formulations for primary packaging of drug formulations for pediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group. Objections were filed against such rules which led to constitution of M.K. Bhan Committee and thereafter Prof. Y.K. Gupta Committee which has led to revision of Chapter on "Primary Packages for Pharmaceutical Articles" published on 24.01.2020. In the process, the said Chapter has been brought in harmony with global Pharmacopoeias for ensuring safe use of plastics for packaging of pharmaceuticals. Schedule M to the Drugs and Cosmetics Rules, 1945 provides for compliance with the Pharmacopeia and pharmaceutical manufacturers are required to follow the same. The containers or other parts of the packaging are required to be suitable and are not reactive, additive, adsorptive or leachable or presenting risk of toxicity to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used. Pharmaceutical manufacturers are required to follow the Standards laid down in Indian Pharmacopoeia.
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16. In view of revision of the Pharmacopeia, the adverse health effect of plastic packaging has been regulated to an extent. While further steps may be desirable, the same need to be considered in phases as may be found viable. The matter being required to be primarily dealt with by the concerned Executive authorities, we do not consider it necessary to pass any further order in exercise of jurisdiction under Sections 14 and 15 of the National Green Tribunal Act, 2010. However, it is necessary to ensure that compliance of the norms is duly monitored at appropriate level of the Health Ministry to safeguard the health of the citizens.
17. The issue so far considered appears to deal only with the remedial action against adverse effect of packaging of drugs for vulnerable groups but the issue of use of plastic bottles and multi layered plastic packages for packaging of carbonated soft drinks, liquor and other items also needs to be further considered by the concerned authorities, including the BIS, FSSAI and MoEF&CC. The FSSAI may finalize the draft regulations mentioned in para 9 above as far as possible within three months from today which may be enforced and monitored through a credible monitoring mechanism.
A copy of this order be forwarded to the MoEF&CC, Ministry of Health, FSSAI, BIS, DGHS and CPCB by e-mail for compliance.
The application is disposed of.
Adarsh Kumar Goel, CP S.K. Singh, JM Dr. Nagin Nanda, EM January 08, 2021 Original Application No. 15/2014 DV 19