Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011
Whereas in exercise of the powers conferred by clause (q) of sub-section (2) of Section 92 read with Sections 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 insofar 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, Section 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,
Chapter 1
GENERAL
Section 1.1: Short title and commencement
1.1: Short title and commencement
1.1.1: These regulations may be called the Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011.
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
Section 2.1: Notified Laboratories for Import
2.1.12[The sample of any imported article will be sent by Authorised officer for analysis to the Food Analyst of any of the laboratories authorised for this purpose 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) Andhra Pradesh (iii) Arunachal Pradesh (iv) Assam (v) Bihar (vi) 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 (ii) Assam (iii) Bihar (iv) Manipur (v) Meghalaya (vi) Mizoram (vii) Nagaland (viii) Sikkim (ix) Tripura (x) West Bengal |
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| 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 (viii) Rajasthan (ix) Uttar Pradesh (x) Chhattisgarh (xi) 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 |
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| 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 |
2.2.1: 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.
1. 3[The Food Authority shall authorize laboratories to carry out functions of referral laboratory for specified areas and to carry out such other functions as entrusted to it by the Food Authority under the Act].
| Name of the Referral Laboratories |
Local Areas/State/UT's |
|
| 1. |
Referral Food Laboratory, Kolkata-700 016 |
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 -570 013 |
Gujarat, Haryana, Himachal Pradesh, Maharashtra, Punjab, Uttar Pradesh and Union Terriory of Chandigarh |
| 3. |
Referral Food Laboratory, Pune-411 001 |
Andhra Pradesh, Delhi, Jammu and Kashmir, Karnataka, Kerala, Rajasthan and Tamil Nadu |
| 4. |
Referral Food Laboratory, Ghaziabad- 201 001 |
Bihar, Goa, Jharkhand, Madhya Pradesh, West Bengal, Union Territories of Dadar and Nagar Haveli, Daman & Diu and Puducherry. |
4[* * *]
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.
| Sl. No. |
Article of Food |
Approximate Quantity to be supplied |
|---|---|---|
| (1) |
(2) |
|
| 1. |
Milk |
500 ml |
| 2. |
Sterilized Milk/UHT Milk |
500 ml |
| 3. |
Malai/Dahi |
200 gms |
| 4. |
Yoghurt/Sweetened Dahi |
500 gms |
| 5. |
Chhana/Paneer/Khoya/Shrikhand |
250 gms |
| 6. |
Cheese/Cheesespread |
200 gms |
| 7. |
Evaporated Milk/Condensed Milk |
200 gms |
| 8. |
Ice-Cream/Softy/Kulfi/Ice Candy/Ice Lolly |
300 gms |
| 9. |
Milk Powder/Skimmed Milk Powder |
250 gms |
| 10. |
Infant Food/Weaning Food |
500 gms |
| 11. |
Malt Food/Malted Milk Food |
300 gms |
| 12. |
Butter/Butter Oi1/Ghee/Margarine/Cream/Bakery Shortening |
200 gms |
| 13. |
Vanaspati, Edible Oils/Fats |
400 gms |
| 14. |
Carbonated Water |
3 litre |
| 15. |
Baking Powder |
100 gms |
| 16. |
Arrowroot/Sago |
250 gms |
| 17. |
Corn flakes/Macaroni Products/Corn Flour/ Custard Powder |
200 gms |
| 18. |
Spices, Condiments and Mixed Masala (Whole) |
500 gms |
| 19. |
Spices, Condiments and Mixed Masala (Powder) |
500 gms |
| 20. |
Nutmeg/Mace |
250 gms |
| 21. |
Asafoetida |
100 gms |
| 22. |
Compounded Asafoetida |
150 gms |
| 23. |
Saffron |
20 gms |
| 24. |
Gur/jaggery, Icing Sugar, Honey, Synthetic Syrup, Bura |
250 gms |
| 25. |
Cane Sugar/Refined Sugar/Cube Sugar, Dextrose, Misri/Dried Glucose Syrup. |
200 gms |
| 26. |
Artificial Sweetener |
100 gm |
| 27. |
Fruit Juice/Fruit Drink/Fruit Squash |
1 ltr |
| 28. |
Tomato Sauce/Ketchup/Tomato Paste, Jam/Jelly/ Marmalade/Tomato Puree/Vegetable Sauce |
300 gms |
| 29. |
Non-Fruit Jellies |
200 gms |
| 30. |
Pickles and Chutneys |
250 gms |
| 31. |
Oilseeds/Nuts/Dry Fruits |
250 gms |
| 32. |
Tea/Roasted Coffee/Roasted Chicory |
500 gms |
| 33. |
Instant Tea/Instant Coffee/Instant Coffee-Chicory Mixture |
100 gms |
| 34. |
Sugar Confectionery/Chewing Gum/Bubble Gum |
200 gms |
| 35. |
Chocolates |
200 gms |
| 36. |
Edible Salt |
200 gms |
| 37. |
Iodised Salt/Iron Fortified Salt |
200 gms |
| 38. |
Food Grains and Pulses (Whole and Split) |
1 kg |
| 39. |
Atta/Maida/Suji/Besan/Other Milled Product/ Paushtik Fortified Atta/Maida |
500 gms |
| 40. |
Biscuits and Rusks |
200 gms |
| 41. |
Bread/Cakes/Pastries |
250 gms |
| 42. |
Gelatin |
150 gms |
| 43. |
Catechu |
150 gms |
| 44. |
Vinegar/Synthetic Vinegar |
300 gms |
| 45. |
Food Colour |
25 gms |
| 46. |
Food colour preparation (Solid/Liquid) |
25 gm Solid/100 ml liquid |
| 47. |
Natural Mineral Water/Packaged Drinking Water |
4000 ml in three minimum original sealed packs |
| 48. |
Silver Leafs |
2 gm |
| 49 |
Prepared Food |
500 gms |
| 50. |
Proprietary Food, (Non Standardised Foods) |
500 gms |
| 51. |
Canned Foods |
6 sealed cans |
| 52. |
Food not specified |
500 gms |
5[2. After test or analysis, the certificate thereof duly signed by the Director of the Referral Food Laboratory or the report signed by the Food Analyst shall be supplied forthwith to the sender in Form A or Form B as the case may be.]
6[3 The fees payable in respect of such Certificate shall be Rs. 1000 per sample of food analyzed or as prescribed by the authority.]
7[4]. 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 per cent 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.
8[Refer Regulation (2) of 2.3.1]
| Certificate No |
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| Certified 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: |
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| . |
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| . |
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| 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 |
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| . |
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| Analysis Report |
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| (i) Sample Description |
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| . |
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| (ii) Physical Appearance |
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| .. |
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| (iii) Label . |
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| 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, 2011 |
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| (b) As per label declaration for proprietary foods |
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| (c) As per the provisions of the Act and regulations, for both above |
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| 1. |
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| 2. |
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| 3. |
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| 4. |
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| 5. |
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| 6. |
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| Opinion** |
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| Place: |
Signature |
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| Date: |
Director Referral Food Laboratory |
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| (Seal) |
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| * Strike out whichever is not applicable |
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| ** When opinion and interpretation are included, document the basis upon which the opinions/ interpretations have been made. |
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9[Refer Regulation (2) of 2.3.1]
| Report No. |
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| 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. |
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| The condition of seals on the container and the outer covering on receipt was as follows: |
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|
|
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| 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: |
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| Reasons: |
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| .. |
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|
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| Analysis report |
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| (i) Sample Description |
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| .. |
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| (ii) Physical Appearance |
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| . |
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| (iii) Label |
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| . |
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| 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, 2011 |
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| (b) As per label declaration for proprietary food |
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| (c) As per the provisions of the Act, rules and regulations for both above |
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| 1. |
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| 2. |
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| 3. |
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| 4. |
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| 5. |
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| 6. |
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| Opinion*** |
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| Signed this .. day of 20 |
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| (Sd) Food Analyst |
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| Address: |
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| * Give the details of the senders |
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| ** Strike out whichever is not applicable |
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| *** When opinion and interpretation are included, document the basis upon which the opinions/interpretations have been made. |
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1. Vide by Noti. No. F. No. 2-15015/30/2010, dated August 1, 2011 published in Gazette of India, Extra. Part III, Section 4, dated 1st August, 2011, pp. 9-15, No. 157.
2. Corrected by Noti. No. F. No. 3/15015/30/2011, dt. 21-12-2011.
3. Corrected by Noti. No. F. No. 3/15015/30/2011, dt. 21-12-2011.
4. Omitted by Noti. No. F. No. 4/15015/30/2011, dt. 8-2-2013 (w.e.f. 8-2-2013).
5. Corrected by Noti. No. F. No. 3/15015/30/2011, dt. 21-12-2011.
6. Corrected by Noti. No. F. No. 3/15015/30/2011, dt. 21-12-2011.
7. Corrected by Noti. No. F. No. 3/15015/30/2011, dt. 21-12-2011.
8. Corrected by Noti. No. F. No. 3/15015/30/2011, dt. 21-12-2011.
9. Corrected by Noti. No. F. No. 3/15015/30/2011, dt. 21-12-2011.