Food Safety and Standards (Laboratory and Sampling Analysis) Regulation, 2011

MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the 1st August, 2011 F.No. 2-15015/30/2010 whereas in exercise of the powers conferred by clause (q) of sub section (2) of section 92 read with section 40 and 43 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far as they relates to Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of India Extraordinary Part III – Sec. 4 dated 20th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21st October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby makes the following Regulations, namely,— FOOD SAFETY AND STANDARDS (LABORATORY AND SAMPLE ANALYSIS) REGULATIONS, 2011 CHAPTER 1 GENERAL 1.1: Short title and commencement- 1.1.1: These regulations may be called the Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 1.1.2: These regulations shall come into force on or after 5th August, 2011 1.2: Definitions- 1.2.1: In these regulations unless the context otherwise requires: 1. “Notified laboratory” means any of the laboratories notified by the Food Authority under sub-sections (1) and (2) of section 43 of the Act. 2. “Referral laboratory” means any of the laboratories established and/or recognized by the Food Authority by notification under sub section (2) of section 43 of the Act. CHAPTER 2 LABORATORY AND SAMPLE ANALYSIS 2.1: Notified Laboratories for Import 2.1.1 The sample of any imported article will be sent by the Authorized Officer for analysis. The Food Analyst of any of the following notified laboratories or any other laboratories notified by the Food Authority from time to time. having jurisdiction over the area in which the sample was taken. Sl No. Name of the laboratories Local Areas 1. Central Food Laboratory, Kolkata 1. All Seaports/Airports/inland Container Depots in the Union Territories/ States of - (i) The Andaman and Nicobar Islands (ii) Manipur (vii) Meghalaya (viii) Mizoram (ix) Nagaland (x) Orissa (xi) Sikkim (xii) Tripura (xiii) West Bengal and (xiv) Jharkhand 2. International borders in the States of - (i) Arunachal Pradesh (vii) Nagaland (viii) Sikkim (ix) Tripura (x) West Bengal 2. Central Food Laboratory, Ghaziabad 1. All Airports / inland Container Depots in the Union Territories/ States of - (i) Chandigarh (ii) Delhi (iii) Haryana (iv) Himachal Pradesh (v) Jammu and Kashmir (vi) Madhya Pradesh (vii) Punjab Uttarakhand 2. All International borders in the States of (i) Himachal Pradesh (ii) Rajasthan (iii) Jammu and Kashmir (iv) Punjab (v) Uttar Pradesh (vi) and Uttarakhand 3. Central Food Laboratory, Mysore All Airports/ Sea ports/inland Container Depots in the Union territories State of (i) Karnataka, (ii) Kerala, (iii) Lakshadweep, (iv) Puducherry and (v) Tamil Nadu 4. Central Food Laboratory, Pune 1. All Airports/ Sea ports/inland Container Depots in the Union Territories/ States of (i) Dadra and Nagar Haveli (ii) Daman and Diu (iii) Goa (iv) Gujarat and (v) Maharashtra 2. All International borders in the States of (i) Gujarat 2.2: Referral Laboratory 2.2.1: Functions- In addition to the functions entrusted to it under the Act, the Referral Laboratory shall carry out the following functions, namely: 1) analysis of samples of food sent by any officer or authority authorized by the Food Authority for the purpose and submission of the certificate of analysis to the authorities concerned; 2) investigation for the purpose of fixation of standard of any article of food; 3) investigation in collaboration with the laboratories of Food analysts in the various States and such other laboratories and institutions which the Food Authority may approve on its behalf, for the purpose of standardizing methods of analysis. 4) ensuring that the laboratory follows the scientific protocols laid down for handling/testing the articles of food. 5) maintaining high standards of accuracy, reliability and credibility in the operation of the laboratory and achieving and maintaining the required levels of accreditation and reliability. 6) laying down mechanism for ensuring that personnel of the laboratory adhere to high professional standards and discipline. 7) Such other conditions, as the Authority may lay down for Referral Laboratories. 8) Capacity building by way of organizing professional training, workshops and seminars for the Food analyst, laboratory personnel in the states specified by the Food authority. 2.2.2: State/ Union Territory/ Local Area of Referral Laboratory 1. The laboratory specified in Column (1) of Table I below, shall carry out the functions entrusted to it by the Act or these regulations in respect of the local areas specified in the corresponding entry in Column (2) thereof. Name of the Referral Laboratories Local Areas/ State / UT’s 1. Referral Food Laboratory, Kolkata -700016 Arunachal Pradesh, Assam, Chhattisgarh, Manipur, Meghalaya, Mizoram, Nagaland, Orissa, Sikkim, Tripura, Uttarakhand and Union Territories of Andaman and Nicobar Island and Lakshadweep 2. Referral Food Laboratory, Mysore – 570013 Gujarat, Haryana, Himachal Pradesh, Maharashtra, Punjab, Uttar Pradesh and Union Terriory of Chandigarh 3. Referral Food Laboratory, Pune-411001 Andhra Pradesh, Delhi, Jammu and Kashmir, Karnataka, Kerala, Rajasthan and Tamil Nadu 4. Referral Food Laboratory, Ghaziabad- 201001 Bihar, Goa, Jharkhand, Madhya Pradesh, West Bengal, Union Territories of Dadar and Nagar Haveli, Daman & Diu and Puducherry. 2. The certificate of analysis to be provided by the referral food laboratory shall be as per Form A. 2.3 Procedure of Sampling 2.3.1: Quantity of sample to be sent to the Food Analyst:- (1) The quantity of sample of food to be sent to the Food Analyst /Director for analysis shall be as specified in the table below. Table Sr. No Article of Food Approximate Quantity to be supplied 1. Milk 500 ml. 2. Sterilized Milk / UHT Milk 500 ml. 4. Yoghurt / Sweetened Dahi 500 gms.. 5. Chhana / Paneer / Khoya / Shrikhand 250 gms. 14. Carbonated Water 3 litre 18. Spices, Condiments and Mixed Masala (Whole) 500 gms. 19. Spices, Condiments and Mixed Masala (Powder) 500 gms. 21. Asafoetida 100 gms. 23. Saffron 20 gms. 24. Gur/jaggery, Icing Sugar, Honey, Synthetic Syrup, Bura 250 gms. Puree/Vegetable Sauce 29. Non Fruit Jellies 200 gms. 30. Pickles and Chutneys 250 gms. 35. Chocolates 200 gms. 38. Food Grains and Pulses (Whole and Split) 1 kg. 40. Biscuits and Rusks 200 gms. 42. Gelatin 150 gms. 43. Catechu 150 gms. 47. Natural Mineral Water/Packaged Drinking Water 4000ml in three minimum original sealed packs. 50. Proprietary Food, (Non Standardised Foods) 500 gms. 51. Canned Foods 6 sealed cans 52. Food not specified 500 gms 2. After test or analysis, the certificate thereof shall be supplied forthwith to the sender in Form B. 3. The fees payable in respect of such a certificate shall be (Rs. 1000) per sample of food analysed as prescribed by the Food Authority. 4. Certificates issued under these regulations by the Laboratory shall be signed by the Director. 5. The preservative used in the case of samples of any milk (including toned, separated and skimmed milk), standardized milk chhana, skimmed milk chhana, cream, ice-candy, dahi, khoa or khoa based and Paneer based sweets, such as Kalakand and Burfi, Chutney and prepared foods, gur prepared coffee and tea in liquid or semi- liquid form shall be the liquid commonly known as “formalin”, that is to say, liquid containing about 40 per cent of formaldehyde in aqueous solution in the proportion of 0.1 ml. (two drops) for 25 ml. or 25 grams. Provided that in case of samples of ice-cream and mixed ice-cream, the preservative used shall be liquid commonly known as formalin, that is to say, a liquid containing about 40 percent of formaldehyde in aqueous solution in the proportion of 0.6 ml. for 100 ml. or 100 gms. Provided further that in case of the unspecified products, the quantity drawn shall be determined in consultation with the Food Analyst. FORM A (Refer regulation 2.2.2) CERTIFICATE OF ANALYSIS BY THE REFERRAL FOOD LABORATORY Certificate No. ……………………. Certificate that the sample , bearing number ……..purporting to be a sample/of ……….. was received on ………….. with Memorandum No. ……. Dated ………….. From ……… [Name of the Court] ………… for analysis. The condition of seals on the container and the outer covering on the receipt was as follows: I …………….. (name of the Director)_ …………….. found the sample to be ……………….. (Category of food sample) ……………… falling under Regulation No. ……….. of Food Safety and Standards(Food Products and Food Additive) Regulations, 2011. The sample was in a condition fit for analysis and has been analyzed on ………….. (Give date of starting and completion of analysis)……………… and the result of its analysis is given below /*was not in a condition fit for analysis for the reasons given below:— Reason:— Analysis Report:— (i) Sample Description:— (iii) Label:— ………………………………………………………………………… Sl.No. Quality Characteristics Name of the Method of the test used Results Prescribed Standards as per:- (a) As per Food Safety and Standards (Food Products and Food Additive) Regulations, (b) As per label declaration for proprietary foods (c)As per the provisions of the Act and Regulations, for both above Opinion ** Place: (Signature) Date: Director Referral Food Laboratory (Seal) * Strike out whichever is not applicable ** When opinion and interpretation are included, document the basis upon which the opinions/interpretations have been made. FORM B Report of the Food Analyst (Refer Regulation (ii) of 2.3.1) Report No._______. Certified that I ___________ (name of the Food Analyst) duly appointed under the provisions of Food Safety and Standards Act, 2006 (34 of 2006), for _____ (name of the local area) received from _______* a sample of ____, bearing Code number and Serial Number _____ of Designated Officer of _____ area* on_________(date of receipt of sample) for analysis. The condition of seals on the container and the outer covering on receipt was as follows: I found the sample to be …….. (category of the sample) falling under Regulation No.____ of Food Safety and Standards (Food Products and Food additive )Regulations, 2011. The sample **was in a condition fit for analysis and has been analysed on _____ (give date of starting and completion of analysis) and the result of its analysis is given below/ ** was not in a condition fit for analysis for the reason given below: Reasons: Analysis report (i) Sample Description (iii) Label Sl.No. Quality Characteristics Name of the Method of the test used Results Prescribed Standards as per (a) Food Safety and Standards (Food Products and Food additive ) Regulations, (b) As per label declaration for proprietary food (c) As per provisions of the Act , rules and regulations for both the above. Signed this _____ day of ______ 20 Address: (Sd/-) Food Analyst. * Give the details of the senders ** Strike out whichever is not applicable *** When opinion and interpretation are included, document the basis upon which the opinions/interpretations have been made. [F.No. 2-15015/30/2010] V.N. GAUR, Chief Executive Officer