Executive Summary:
This document contains amendments to the Food Safety and Standards Contaminants, Toxins and Residues Regulations, 2011, specifically concerning contaminants and biotoxins in fish and fishery products. It was published by the Food Safety and Standards Authority of India on January 6, 2016, and the amendments came into force on the date of their final publication in the Official Gazette. The regulations address polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAHs), and biotoxins in fish and fishery products.
Key Points / Main Content:
* **Amendment Title:** Food Safety and Standards Contaminants, Toxins and Residues Amendment Regulations, 2016.
* **Effective Date:** The date of final publication in the Official Gazette.
* **Amendments to Regulation 2.2 (Crop Contaminants and Naturally Occurring Toxic Substances):**
* **Polychlorinated biphenyls (PCBs) and Polycyclic Aromatic Hydrocarbon (PAH) compounds in Fish and Fishery Products:**
* Limits for PCBs (sum of PCB28, PCB52, PCB101, PCB138, PCB153, and PCB180):
* Inland and Migratory Fish: 2.0 ppm
* Marine Fish, Crustaceans, and Molluscs: 0.5 ppm
* Limit for Benzoapyrene in Smoked Fishery Products: 5.0 ppb
* **New Regulation 2.4 (Limits of Biotoxins in Fish and Fishery Products):**
* **Limits for Biotoxins (g/kg):**
* Paralytic Shellfish Poison (PSP) in Bivalve Molluscs: 80 g/100g Saxitoxin Equivalent
* Amnesic Shellfish Poison (ASP) in Bivalve Molluscs: 20 gg Domoic acid equivalent
* Diarrhetic Shellfish Poison (DSP) in Bivalve Molluscs: 160 g of Okadaic acid equivalent/Kg
* Azaspiracid Poison (AZP) in Bivalve Molluscs: 160 g of azaspiracid equivalent/Kg
* Brevetoxin (BTX) in Bivalve Molluscs: 200 mouse units or equivalent/Kg
Impact Analysis:
* **Fish and Fishery Product Industry:**
* *Impact:* The industry must adhere to the new limits for contaminants (PCBs, PAHs) and biotoxins in fish and fishery products.
* *Action Required:* Modify testing and production processes to ensure compliance with the amended regulations; implement monitoring programs to ensure contaminant and biotoxin levels stay within prescribed limits.
* **Food Safety and Standards Authority of India (FSSAI):**
* *Impact:* Responsible for enforcing the amended regulations.
* *Action Required:* Monitor industry compliance, conduct inspections, and update guidance documents as necessary.
* **Consumers:**
* *Impact:* Increased safety of fish and fishery products due to regulated limits of contaminants and toxins.
* *Action Required:* Be aware of food safety standards and report any concerns to relevant authorities.
Key Entities Referenced
Food Safety and Standards Authority of India: An authority responsible for food safety and standards in India.
Food Safety and Standards Act, 2006: The legislative act governing food safety and standards in India.
Food Safety and Standards Contaminants, toxins and Residues Regulations, 2011: Regulations related to contaminants, toxins, and residues in food products.
Food Safety and Standards Contaminants, toxins and Residues Amendment Regulations, 2016: Amendment regulations to the Food Safety and Standards Contaminants, toxins and Residues Regulations, 2011.
New Delhi: The location where the notification was issued.
Polychlorinated biphenyls: A group of man-made chemicals that are a type of contaminant.
Polycyclic Aromatic Hydrocarbon: A chemical compound that are a type of contaminant.
Gazette of India: The official government gazette of India in which the notification was published.
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EXTRAORDINARY
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अअअअििििधधधधससससचचूूचचूू ननननाााा
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. .
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संभावना ह,ै उ0 अिधसूचना के राजप# क(cid:27) (cid:25)ितया ं जनता को उपल2ध होन े क(cid:27) तारीख से साठ .दन(cid:24) क(cid:27) अविध
के भीतर आ(cid:7)ेप और सुझाव आमंि#त .कए गए थे;
और राजप# क(cid:27) (cid:25)ितया ं जनता को 7 जुलाई ,,,, 2015 को उपल2ध करा दी गई थ7;
और उ0 (cid:25)ा(cid:26)प िविनयम(cid:24) के सबं ंध म $ (cid:25)ा8 आ(cid:7)ेप(cid:24) और सुझाव(cid:24) पर खा(cid:3) सुर(cid:7)ा और मानक (cid:25)ािधकरण
!ारा िवचार कर िलया गया ह;ै
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अथा?त ् ::::----
60 GI/2016 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
ििििववववििििननननययययमममम
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अविशB) संशोधन िविनयम, 2016 ह ै ।
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ऐरोमे:टक हाइNोकाब?न (पीएएच) िमO ण:
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(1) (2) (3) (4)
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(पीसीबी28, पीसीबी52,
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पीसीबी101, पीसीबी138,
पीसीबी153 और पीसीबी180)
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अथा?त:्--
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(1) (2) (3) (4)
पैरािल :ट क शैल.फ श बॉइवाLव मोLस क 80 Hयू जी/100Tाम
1.
पॉइसन (पीएसपी) (साIस ीटोिIस न इकुयवू ेल$ट)
एमिन िसक शैल.फ श बॉइवाLव मोLस क 20 Hयू जी/Tा. (डोमोइक एिस ड
2.
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3.
पॉइसन (डीएसपी) इकुयूवले $ट/.क. Tा.
अज़ा+ पीरािस ड पॉइसन बॉइवाLव मोLस क 160 Hयू जी ऑफ अज़ा+ पीरािस ड
4.
(एजेडपी) इकुयूवले $ट/.क. Tा.
WीवटोिI स न (बीटीएI स) बॉइवाLव मोLस क 200 माउस यूिनट अथवा
5.
इकुयूवले $ट/.क. Tा.''
[िव(cid:11)ा. III/4/असा.]
पवन कुमार अTवाल, मु(य कायक? ारी अिध कारी
(cid:21)(cid:21)(cid:21)(cid:21)टटटट (cid:23)(cid:23) (cid:23) (cid:23)पप पप णणणण:::: मूल िव िनय म भारत के राजप#, असाधारण, भाग-III, खंड 4 म$ अिध सूचना सं( यांक फा.
सं. 2-15015/30/2010, तारीख 1 अग+त , 2011 !ारा (cid:25)कािश त .क ए गए थे उसके पGच ात ् िनH निल िख त
अिधस ूचना सं. !ारा संशोधन .क ए गए:
(i)
फा. सं. 1-12/एससीआई.पैनल/(अिधसूचना)/एफएसएसएआई/2012, तारीख 3 .दसबं र, 2014;
(ii)
फा. सं. पी.15025/264/13-पीए/एफएसएसएआई, तारीख 4 नवबं र, 2015;
(iii)
फा. स.ं 1-99/1/एसपी(संदषू क)/एफएसएसएआई/2009, तारीख 4 नवबं र, 2015;
(iv)
फा. स.ं 1-99/4/एसपी(संदषू क)/एफएसएसएआई/2014, तारीख 4 नवबं र, 2015 ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Food Safety and Standards Authority of India)
NOTIFICATION
New Delhi, the 4th January, 2016
F. No. 1-10(6)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013,—Whereas the draft of the Food
Safety and Standards (Contaminants, toxins and Residues) Amendment Regulations, 2015 were published as required
under sub-section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the
Food Safety and Standards Authority of India number F. No. 1-10(6)/Standards/SP(Fish and Fisheries Products)/
FSSAI-2013 dated the 12th June, 2015 in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and
suggestions from the persons likely to be affected thereby, before the expiry of the period of sixty days from the date on
which the copies of the Official Gazette containing the said notification were made available to the public;
And whereas the copies of the said Gazette were made available to the public on the 7th July, 2015;
And whereas the objections and suggestions received from the public in respect of the said draft regulations
have been considered by the Food Safety and Standards Authority of India;
Now, therefore, in exercise of the powers conferred by clause (i) of sub- section (2) of section 92 read with
section 20 and 21 of the said Act, the Food Safety and Standards Authority of India hereby makes the following
regulations further to amend the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011,
namely:-4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
REGULATIONS
1. Short title and commencement. - (1) These regulations may be called the Food Safety and Standards (Contaminants,
toxins and Residues) Amendment Regulations, 2016.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011, in regulation 2.2 relating to
“crop contaminants and naturally occurring toxic substances”:-
(a) in sub-regulation 2.2.1, after clause 2 relating to “Naturally Occurring Toxic Substances”, the following clause
shall be inserted, namely:-
“3. Polychlorinated biphenyls (PCBs) and Polycyclic Aromatic Hydrocarbon (PAH) compounds in Fish and Fishery
Products:
Sl.No. Name of the contaminants Article of food Limit
(1) (2) (3) (4)
1. Polychlorinated biphenyls (Sum of PCB28, PCB52, Inland and Migratory Fish 2.0 ppm
PCB101, PCB138, PCB153 and PCB180)
2. Polychlorinated biphenyls (Sum of PCB28, PCB52, Marine Fish, Crustaceans and 0.5 ppm
PCB101, PCB138, PCB153 and PCB180) molluscs
3. Benzo(a)pyrene Smoked Fishery Products 5.0 ppb.”
3. After regulation 2.3 relating to “Residues”, the following regulation shall be inserted namely:-
“2.4. Limits of biotoxins in fish and fishery products:
Sl. No. Name of the contaminants Article of food Limit (µg/kg)
(1) (2) (3) (4)
1. Paralytic Shellfish Poison (PSP) Bivalve Molluscs 80 µg/100g (Saxitoxin
Equivalent)
2. Amnesic Shellfish Poison (ASP) Bivalve Molluscs 20 µg/g (Domoic acid
equivalent)
3. Diarrhetic shellfish poison (DSP) Bivalve Molluscs 160 µg of Okadaic acid
equivalent/Kg
4. Azaspiracid poison (AZP) Bivalve Molluscs 160 µg of azaspiracid
equivalent/Kg
5. Brevetoxin (BTX) Bivalve Molluscs 200 mouse units or
equivalent/Kg.”
[ADVT.III/4/Exty./]
PAWAN KUMAR AGARWAL, Chief Executive Officer
Note. -The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4 vide
notification number F. No. 2-15015/30/2010, dated the 1st August, 2011 and subsequently amended vide notification
numbers:
(i) F. No. 1-12/Sci.panel/(Notification)/FSSAI/2012, dated 3rd December, 2014;
(ii) F. No. P. 15025/264/13-PA/FSSAI, dated 4th November, 2015;
(iii) F. No. 1-99/1/SP(contaminants)/FSSAI/2009, dated 4th November, 2015;
(iv) F. No. 1-99/4/SP(Contaminants)/FSSAI/2014, dated 4th November, 2015.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.