S.O 729 and S.O.730 dated 21-08-1995-S (FISH)

REGD. NO. D.L.—-33004/95 The Gazette of India EXTRAORDINARY

PART II—Section 3—Sub-Section (ii) PUBLISHED BY AUTHORITY No. 489] NEW DELHI, MONDAY, AUGUST 21, 1995/SRAVANA 30, 1917 2055 Gl/95—1 (1) 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PA?.T II—SEC 3(II)] 3 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] *i 6 THE GAZET1E OF INDIA : EXTRAORDINARY LPARI U—SLC. 3(ii)J 7 MINISTRY OF COMMERCE ORDER New Delhi, the 21st August 1995 S.O. 729(EJ.—Whereas for the development of the export trade of India, certain proposals for subjecting Fresh, Frozen and Processed Fish & Fishery Products 1o quality control and inspection prior, to cxpoit, were published a required by sub-rule (2) of rule 11 of the Export (Quality Control and Inspection) Rnies, 1964 in the Gazette of India, Part-11, Section 3, Sub-section (ii) dated 1st November, 1994 under the Order of the Government of India in the Ministry of Commerce No. S. O. 785 (E) dated the 1-11-1994;

2. And. whereas, the objections and suggestions were invited from all persons likely to be affected thereby within a period of forty five days of the date of publication of the said order in the Official Gazette;

3. And, whereas, the coppies of the said Gazette were made available to the public on .1-11-1994;

4. And, whereas, the objections and suggestions received from the public on the said draft have been LcnM'clered by the Central Government;

5. And, whereas, it is necessary to maintain the highest quality standards as per the health requirement?; oi the importing countries that would encompass the standards like unified directive No. 91|49*3| EEC ilat<=d the 22 July, 1991 of the European Community, tbc proposed HACCP of United States of America, Quality Assurance Standards of Japan.

6. Ami, whereas, fish and fishery products freshly caught axe in principle free of contamination with micro-prgciniztn;

7. And, whereas, however, contamination und f.uhsecjuent decomposition may occur when handled ai'.d frcaleii unhygienically;

S. And, whereas, therefore, the essential requirements should be laid down f,or correct hygienic handling of Fresh, Frozen and Processed Fish and Fishery Products at all stages of production and during j-torage and transport;

9. And whereas, it is the responsibility primarily of (he foheries industry to ensure that fishery products meet the health requirements (aid down in this notification:

If). And whereas, it is expedient that these control meaiiiircs should bn introduced to guarantee the unifoim application and to ensure smooth operation (if the provisins of this notification and that the me;t;LiiL's apply in an identical manner;

11. And whereas, provisions should, therefore, IK m;idc for procedure for monitoring to ensure the above conditions of equivalence with reference to the requirements of importing countries;

12. And whereas, the Government nominated competent authority should ensure the effective compliance ot the qualiy standards in the country;

& THE GAZETTE OF INDIA : EXTRAORDINARY | P v : - II—SEC. 3fii)J

13. Now, therefore, in exercise of the powers conferred by section 6 of the Export (Quality Control and Inspection) Act, 1963 (22 of 1963) and in supcrcessicn of the Notification in the Ministry of Commerce No. S.O. 1153 dated the 9th April, 1988 relating lo Frozen Fish and Fishery Products, S.O.

952 dated 30-3-1987 relating lo Frozen Claim Meat and S.O. 862 dated 12-2-1983 relating to Canned Fish & Fishery Products, the Central Government, after consulting the Export Inspection Council, being of the opinion that it is necessary and expedient to do so for the development of the export trade of India, hereby :—

(i) notifies that Fresh, Frozen and Processed Fish and Fishery Products shall be subject to quality control, inspection and monitoring prior to export.

(ii) specifies that the type of quality control, inspection and monitoring shall be in accordance with the export of Fresh Frozen end Processed Fish and Fishery Products (Quality Control, Inspection and Monitoring) Rules, 1995 as the type of quality control, inspection and monitoring which shall be applied to such Fresh, Frozen and Proccsed Fish & Fishery Products prior to their export.

(iii,) recognises the specifications as set out in Schedule 1 appended to this Order as the standard specifications for Fresh, Frozen and Processed Fish and Fishery Products.

(iv) prohibits the expon of Fresh, Frozen and Processed Fish & Fishery Products by a unit in the course of international trade unices it conforms to the standard specifications applicable to it, and is accompanied by a certificate seating that such unit is approved and monitored by the Export Inspection Agencies established under Section 7(1) of the Export (Quality Control & Inspection) Act, 1963 (the competeni authority).

14. In this Order, Fresh. Frozen and Processed F 's'n u. Fishery Products means :— all sea water aud fresh water animals or part thereof, including their roes, in fresh, chilled, frozen or processed form, but excluding Frogs.

[F. No. 6|2|94-BI&EP1 A. DIDAR SINGH, Jt. Secy.

Font Note : The principal notifications were published vide No. S. O. 1153 dated 9-4-88, S.O. No. 862 dated 12-2-83 and 952 dated 30-3-1987.

SCHEDULE—I Specifications for Fresh, Frozen and Processed Fish and Fishery Products recognised as per Section 6(C) of the Export (Quality Control and Inspection) Aci. 1963 shall be —

(a) National standards of the importing countries.

or ( b ; Contractual specifications agreed to between the foreign buyer and the exporter provided the same is satisfying the health and other requirements of the importing country;

(c) In the absence of (a) or (b) above, the minimum specifications notified in this order as Appendix to this Schedule;

(d) In the case of any Fresh, Frozen & Procesed Fish and Fishery Products for which no standard is available at (a) , (.b) &

(c) above, the standard formulated by an Expert Committee coasisting of the following members shall be made applicable :— — Representative from Export Inspection Agency (Chairman) - - Representative from the Marine Products Export Development Authority.

— Representative from the Seaiood Exporters' Association of India.

— Representative from Central Institute of Fishcrv Research Institute.

— Representative from Central Institute of Fisheries Technology.

— Representative from Central Marine Fishery Research Institute.

Appendix to Schedule—1 SPECIFICATIONS

1. SPECIFICATIONS FOR SHRIMPS'PRAWNS

(a) General : Appearance and colour shall be characteristic to the particular type|form of fresh| freshly cooked shrimps[prawns as the case may be The material shall be reasonably free from dehydration, discolouration and black spots. The material shall not show any sign of deterioration and shall be free from off odour and foreign odour. The texture of meat shall be soft and cnsistent and shall have characteristic flavour oF Frcsh|Coolcec' Shrimps [Prawns.

The prorhid shall be free from extraneous matter.

(h) E

(1)

(2)

(3) iacteriological ] Total plate count at 37'C per gm.

maximum E. coli count per gm. max.

Coagulase positive staphylococcus per gm. max Salmonella & S.

arizona per 25 gms.

Fresh]ChiJI.;c1 Frozen 5,00.000 20 100 Nil Cooked | Boiled 1,00,000 Nil 100 Nil 9 II. SPECIFICATIONS FOR LOBSTERS IN ANY FORM

(a) General : Appearance and colour shall be characteristic to the particular typeiform of fresh [ freshly cooked lobsters as the case may be. The material shall be reasonably free from dehydration, discolouration and extraneous matter. The product shall not ,'how any sign of deterioration. The product shall be free from off odour and any foreign odour.

The material shall be free from extraneous matter like sand, dirt, etc. The material shall be free from eggs unless permitted by the buyer. Lobsters of uniform size shall be packed together. Texture of the meat shall be aoft and consistent.

(b) B

(1)

(2)

(3)

(4) •acterioiogical Total plate count al 3TC per gm.

maximum E. coli per gm. max.

Coagulasc positive sfaphylococcus per gm. max.

Salmonella & S.

arizona per 25 gms.

FreshjChiiiedi Frozen 5,00,000 20 100 Nil Cocked!

Boiled 1,00,000 Nil 100 Nil III. SPECIFICATIONS FOR CEPHALOPODS (CUTTLEFISH. SQUID, OCTOPUS ETC.)

AND THEIR BODY PARTS INCLUDING ROES

(a) General : Cephalopods of different varieties shall not be packed together. Material of uniform colour and size sh-?*! be packed together. The oroduct shall be clean and shall be characteristic to the particular typejform appearance, colour and odour of freshjfreshiv coked cephalopods. The products shall be reasonably free from dehydration, discolouration and extraneous matter. The produc' shall not show any sign oi deterioration and shall be free from off odour and any foreign odour. The texture of meat sha.ll be soft and consistent.

(b)

(1)

(2)

(3)

(4) Bacteriological Total Plate count at 37°C per gm. max.

E.Coli count per gm. max.

Coagulase positive staphy :

lococcus count per gm. maximum Salmonella & S. arizona per 25 gms.

Fresh/Chilled/Frozen

5.00,000 2,00,000 for products meant for raw Consumption 20 100 Nil Cooked/ Boiled 1,00,COO Nil 100 Nil IV. SPECIFICATIONS FOR FISHES—WHOLE DRESSED, FILLETS OR ANY OTHER TYPE (POMFRETS, SEER, PEARL SPOT, SARDINE, MACKEREL, HILSA ETC.)

(a) General : FIsbesjFillets of uniform size and colour shall be packed together, FishesiFillets of different species shall not be packed together. The products shall be clean and shall have appearance, colour and odour characteristic to the particular typejform of freshjfreshly cooked fishes. The products shall be free from dehydration and discolouration. The products shall not show any sign of deterioration and shall be free from off odour and any foreign odour. The products shall be free from softening of texture and any objectionable extraneous matter.

V. SPECIFICATIONS FOR CRAB AND CRAB MEAT

(a) General : CrabJCrab Meat of uniform colour shall be packed together. Body meat and clawmeat shall be packed separately or as sandwich pack or any other manner as required by the buyer. The material shall be clean having characteristic of the particular typejform appearance, colour and odour of freshjfreshly cooked crabs as the case may be and shall not have deterioration, off odour or any" foreign odour. The products shall be reasonably free from dehydration, discolouration and objectionable extraneous matter and shall be soft and consistent.

(b) :

0)

(2)

(3)

(4) Bacteriological Total Plate count at 37°C Per gm. maximum E.coSi count per gm. Max.

Coagulase positive stapbylococcus count per gm.

maximum Salmonella & S. arizona per 25 gms.

Fresh/Chilled/ Frozen 10,00,000 20 100 Nil Cooked /Boiled 1,CO,COC Nil 100 Nil

(b)

(1)

(2)

(3)

(4) Bacteriological Total Plate count at 37°C per gm. Maximum E.coli per gm. max.

Coagulate positive staphylococcus per gm.

Salmonella & S. arizona per 25 gms.

Fresh/Chilled/ /Frozen 5,CO,CO0 20 100 Ni!

Cooked/ Boiled 1,00,000 Nil 100 Nil NOTE :

(1) Crab dipped in boiled water for the purpose of extracting meat shall not be treated as cooked variety.

2055 GIJ95—2.

THE GAZETTE OF INDIA^ EXTRAORDINARY IPM^-S^ H«|l_ m Cooked crab meat shall bs prepared by boiling the enviscerated and cleaned crab for sufficient length of time to make it ht for direct consumption.

VI. SPECIFICATIONS FOR WHELK (->) General : Appearance, colour and odour shalf'be" characteristic to the particular type!form of fresh'cooked whelk as the case may be. The products iiha-1 reasonably be free from dehydration and discolouration and shall net have any sign of deterioration off odour or any foreign odour. The products shall be free- from extraneous matter end sand and "hall not show grittiness. Texture shall be soft end consistent of whelk meat shall be reasonably free from shell or shell pieces.

NOTE :

The Whelk treated with hot water for removing the meat from the shell shall be treated as raw.

VII. SPECIFICATIONS FOR CLAMjMUSSEL MEAT

(a) General.—Appearance and colour of 'he product shall be characteristic to the particular type1, form of fresh'cooked dam [cooked mussel as the case may be. The product shall reasonably be free from dehydration and discolouration. The product shall have characteristic odour of freshjeooked clam!

mussel. The product shall not show any sign of deterioration. The product shall be free from off colour, foreign odour|sand (gr'tiness detected by chewing) and objectionable foreign matter. The texture of meat shall be soft and consistent.

(b)

(1)

(2)

(3)

(4) Bacteriologiocal ' Total Plate count at 37° C per gm. max.

E. Coll Count per gin. max.

Coagulase positive staphyloccccus count par »m. inaximutT Sal-.io:'eila & S. arizona per 25 grns.

Fresh/Chilled/ Frozen

10.00,000 20 l- 100 Nil Cooked/ Boiled 1,00,0C0 Nil 100 Nil NOTE : Ckm|Mussel treated with hot water for opening the shell and the meat then packed, shall noi be treated as cockediboiled variety.

VIII. SPECIFICATIONS K>R «** J J J (SHRIMPS) CANNED IN BRINE OR IN A M OTHER INTERNATIONALLY APPROVED MEDIUM OR DRY PACK

1. Raw material

1.1 The raw material used for preparation of Prawns (Shrimps.) canned in brine shall be fresh, sound, wholesome, properly cleaned and free from cn'rails.

1.2 Only refined salt conforming to IS : 594—1962 shall be used.

2. Cans :

2.1 The material shall be packed in suitable infernally and uniformly lacquered cans. The cans may also be lacquered externally. The lacquer used shall be such that it does not impart any foreign unpleasant taste and smell to (he contends of the can and does not peal off during processing and storage. The lacquer shall not be soluble in brine to any extent. The can exterior shall be free from major dents, rust, perforations and seam distortions.

2.2 The cans after sealing harmetically shall not show leaking, panelling or swell. The interior of the Can on opening shall not show any visible black discolouration, rust or pitting and the inside lacquer shall be in good condition.

3. Brine :

3.1 The brine, if used shall be clear and shall not be discoloured.

4. Packing and Labelling

4.1 Only material of the same species shall be packd in a Can.

4.2 The labels, if used, shall be in accordance with the rules and regulations of the country to which the material is to be exported.

5. Drained weight and size grade :

5.1 The net drained weight of contents shall not be less than the declared weights ' The size count (Number of pieces per unit weight) shall conform to the size grade declared on the Can.

6. Organoloptic Quality :

6.1 The contents of the Can on opening shall present a good appearance and shall not display any appreciable disintegration places from which portions have separated out would be treated as disintegrated shrimps.

6.2 The surface of the prawns shall not be slimy to the touch. The meat shall be soft but firm and shall not crumble to granular forms when pressed between fingers.

6.3 The prawn pieces shall not appear to be pressed together and it should be possible to separate the

(b) 0)

(2)

(3)

(4) 3?ct& riological £ Total Plate count at 37° C per gm. max.

E.Coli count per gm. max.

Colagulase positive staphylococcus count per gm.

maximum Salmonella & S. arizona pet 25 gms.

Fresh/Chilled/ Frozen

10.00,000 20 100 RNil Cooked/ Boiled 1,00,000 Nil 100 JNH;

pieces easily. The pieces shall be of uniform size and shall be clean and free from loose hanging pieces of meat.

6.4 The material shall have the odour and flavour of fresh and cooked prawn meat and shall be free from scorched, bkter or any other objectionable flavour.

6.5 The material shall be free from pale bleached colour wi'h. a greenish yellow tint indicative of preprocessed spoilage. The material shall also be free from any black discolouration.

6.6 The material *shall be free from sand, dirt, insect, hair or any other extraneous matter. It shall be reasonably free from bits of veins, shall particles and pieces of appendages.

6.7 The material shall be free from any poisonous and deleterious substances.

6.8 The Cans on opening shall not give any odour, indicative of bactarial spoilage, shall not show liquafaction of confents and shall not show blackening.

6.9 The product shall also conform to the following requirements :

SI. C No.

(1)

(i) (U) OH)

(iv)

(v)

(vi) fvii) (vjii) (13*) Characteristics

(2) Vacuum af the can in mm Hag. min.

Drained weight of the contents of the can, as percentage by weight of thewater capacity of the can, min.

Sodium chloride in brine per cent fW/V) Max.

Acidity of brine as citric acid (anydrous) per cent (W/V ) Arsenic parts per million max, Lead parts, per million, max.

Copper, parts per million, max.

Zinc, parts per million, max.

Tin, parts per million, max.

Requirements 223 <

(3) 100 64

3.5

0.06 to

0.20 1 5 10 50 250 Methods of test Rcf. to Appendix in IS: i >i960»* (4> A B C D —« — — — ; Appendix n IS :

2168- J971*

(5) — — B C D E F

7. Bacteriological Requirements :

7.1 The initial incubation of the sampled Cans s be done at 37 ±1 °C for seven days or 35 ± 1°C fen days. After this incubation, necessary quan of the liquid portion is aseepticaUy pipetted out r inoculated into thioglycollate cystine broth and cubated at 37 ±1"C for 18 hours. The incubai broth shall not show bacterial growth.

8. Coding ;

8.1 The can shall be embossed with the markin of grade, size, drained weight, name of th& manufa lute'r, or his factory code, year, month and batch manufacture. An illustration for embossing the cof in the abbreviated form is given below :

TV5 X 4 BOS T5 stands for 'Tiny' packed with 5 oz. drained weigh' 'X1 stands for tho name of the manufacturer in tliabbreviated form or the facfory code. '4' stands fo.

the year of manufacture, and in this illustration it signifies the year 1994. 'B* stands for the month of manufacture (here is signifies -he month of February) and '05' stands for the date of manufacture during the month. In case POD material is used for running, the letter 'U' shall be embossed' prior to the marking for size grade. For the purpose of denoting (he size grade and the drained weight, the following nomenclature shall be followed :

(A) Size-Grade* :

Nomenclature Colossal (Supwme Jumbo) Jumbo Large Medium Small Tiny Cocktail/Mini/Sealed Broken/Whole & Broken Count/ A* 100 gms.

Below 8 9 to 13 14 to 22 23 to 36 37 to 63 64 to 102 103 to above No limit 'breviation ~~C/3J J L M S T CT/MI SD B/WB *Pack having more than 10% broken pieces by weight irrespective of the total number of pieces in the can shall be treated as 'Broken'. Any pieco showing less than 4 segments shall be treated a;.

broken.

(B) Drained weight:

Except in the case of 4.5 oz. pack, which being the standard pack, the actual drained weight shall be embossed in oz. on the Cans.

(C) The mon*h of manufacture shall be designated as— Month January February March Apiil May June Abbreviation A B C D E F Month Abbreviation July O August II September J October K November L December M 1 2 THE GAZETTE OF INDIA : EXTRAORDINARY FPART II—SEC. 3fii)1 iX. SPECIFICATIONS FOR CRAB MEAT CANN- ED IN ©RINE OR ANY OTHER INTERNA- TIONALLY APPROVED MEDIUM

1. Raw material:

1.1 The meat used for canning shall be obtained from healthy freshly caught, crabs of the species Scylla serreta, Por'unus pelagicus, Neptunus pelagicus and Neptunus sanquinolenitus.

2. Cans :

2.1 The material shall be packed* in suitable interjially and uniformly lacquered Cans. The Cans may also be lacquered externally. The lacquer used shall be such that if does not impart any foreign unpleasant taste to the contents of the Can and does not peel off during processing and storage. The lacquer shall not be soluble in brine to any extent. The Can interior shall be free from major dents, rust, perforations and seam distortions.

2.2 The cans after sealing hermetically shall not show leaking, panelling or swell. The interior of 'he can on opening shall not show any visible black (bluish discolouration, rusting or pitting. The inside lacauer shall be in good condition.

3. Brine.

3.1 Vaccum dried salt or common salt conforming to IS : 594—1962 shall be used for preparing brine.

The sodium chloride content of the brine, if used, shall not exceed 2% W(V, maximum.

3.2 Acidity of brine as Citric acid (Anhydrous) shall be 0.20% W|V. maximum.

4. Packing and Labelling :

4.1 Crab meat shall be packed using parchment paper lining.

4.2 The body meat and claw meat of the crab shall be packed according to the terms of contract agreed upon between the buyer and seller.

In the absence of contractual specifications, the claw meat shall be packed on the top and at the bottom in distinctly separate layers,

4.3 Only the meat of one species of crab shall be packed in a particular Can. The meat obtained from crabs caught from back waters and sea shall not be mixed or packed in a particular Can.

5. Drained Weight:

5.1 The net water capacity of the Can shall be as per the requirements of the importing country.

5.2 The drained weight of the meat shall not be less than the declared weight.

6. Requirements for finished products :

6.1 The content of the Can on opening shall present *he characteristic colour and odour of crab meat and shall not give any foreign odour.

6.2 The material shall be free from scorched, bitter or any objectionable flavour.

6.3 The material shall be free from stains, dirt, insect, hair or any other extreneous matter. It shall be free from veina, membrance shall particles and piecus of appendages.

6.4 The material shall be free from blush (black colour.

6.5 The material shall be free from any poisonous snd deleterious substance.

6.6 Crab meat canned in brine should conform to the following requirements also :

SI.

No

(1)

(2)

(3)

(4) Characteristic Vaccqm in can in mm, min. Hg.

Sodium Chojoride in brine per cent by weight Acidity of brine as citric acid anhydrous) per cent (W/V)max imti m Acid insoluble asch, per ecu by weight max.

Limits 150 2%

0.2% it 2% Methods of test Retito Appendix of IS 7143 1973* A 1S2236 1968** A C D - * Specifications or Crab meat canned in brine "Specifications or prawns/ Shrimps canned in brine (First Revision) TABLE-II LIMITS OF MEATLLIC IMPURITIES IN CRAB MEAT CANNED IN BRINE SI..

No

(1)

(2)

(3)

(4)

(5) Characteristic Arsenic, ppm Wax.

Lead, ppm. Max :

Copper ppm max.

Zinc ppm, max.

Tin ppm max.

Limits 1 5 10 50 250 Method «£test Re. to Appendix In 2168—1971* B C D E F * Specifications or pomfret caned in oij (First revision)

7. Bacteriological requirements :

The initial incubation of the sampled Cans shall be done at 37 ± 1" C for seven days or at 35 ± 1 ° C for ten days. After this initial incubation, the brine ot «he Cans, on inoculation into, thioglycollate cystine broth and incubation at 37 ± 1° C for 40 hours, shall not show any sign of bacterial growth, table

8. Coding:

8.1 The Cans shall be embossed with the markings of the drained weight, name of the manufacturer or his factory code and year, month and date of manufacture. An illustration for embossing the code in the abbreviated form is given below :

C B 5 X 4 B05 In the above illustration 'CB' stands for Crab Meat Canned in brine "5" stands for drained weight and, in this illustration, it signifies 5 oz. drained weight, "X" stands for the name of the manufacturer in the abbreviated form or his factory code "4" stands for the year of the manufacture and in this illustration, it signifies the year 1994. "B" stands for the month of manufacture and, in this illustration, it signifies month of February. "05" stands for the date of manufacture during the montk 13 The1 months of manufacture shall be designated as :

Month January February March April Muy June Abbreviation A B C D E F Month July August September October November December Abbreviation G H J K L M

8.2 Drained Weight :

Except in the case of 4.5 oz. pack, which being the siandard pack, the actual drained weight shall be embossed in oz. on the cans.

14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)J 15 16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART IT—Set. 3(ii)l 17 2055 GI/95—3

1.S THE GAZETTE OF INDJA : EXTRAORDINARY P A R T II—Sfx. 3(ii)J \?

50 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)J 21 22 THE G A ^ E H F , OF INDIA i EXTRAORDINARY (PARF If—SEC. 3 u i ) f 23 24 THE GAZETTE OF !NDTA : EXTRAORDINARY (PAST I I - -SEC ?fii)J 25 2055 GI/95-4 26 THF: GAZETTE OF 'ND1A : FXTRAORDINARY IP SKI I I - -S tc 3>'ii) 1 27 2b THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)> 29 30 THE GAZER E. OJh INDIA : EXTRAORDINARY IPARJ II—She. 3 u i \ MINISTRY OF COMMERCE NOTIFICATION New Delhi, the 21st August, 1995 S.O. 730(E).—In exercise of the powers conferred by Section 17 of the Export (duality Control and Inspection) Act, 1963 (22 of 1963) and in supersession of Notification No. S. O. 1153 (a) , dated 9-4-1988 relating to Frozen Fish and Fishery Product (Quality Control and Inspection) Rules, 1987 and Notification No. S. O. 863, dated 12-2-1983 relating to canned Fish & Fishery Products (Quality Control and Inspection) Rules, 1983, and Notification Nu. S. O. 953, dated 30-3-1987 relating to Frozen claim Meat (Quality Control and Inspection) Rule;;. 1987, except in respect of ihings done or omitted to be done before such supersession, the Central Government hereby makes the following rules, namely :—

1. Short title and commencement •—(1) These rules may be called Export of Fresh, Frozen and Processed Fish and Fishery Products (Quality Control and Inspection and Monitoring) Rules, 1995.

(2) They shall come into force i.n the date of their publication in the Official Gazette.

2 lo r the purpose of Ihese rules unless the context otherwise requires, the following definitions shall be applicable :

2.1 'Act' means the Export (Quality Contiol end Inspection) Act, 1963 (22 of 1963). ' :.j

2.2 'Afcncy* njeans any one of the Export Inspection Agencies at Bombay, Calcutta, Cochin, Delhi and Madras established under Section 7 of the Act,

2.3 'Council' means the Export Inspection Council established under Section 3 of the Export (Quality Control and Inspection) Act, 1963.

2.4 'Fresh' Frozen and Processed Fish and Fishery Products' means all sea water, fresh water animals or part thereof, including their roes, in fresh, chilled.

frozen or processed form, but excluding frogs.

2.5 'Aqua culture Products' means all fishery p r o ducts born and raised in controlled conditions until placed on the market as a foodstuff. However, seawater or fresh water fish or crustaceans eaueht in their natural environment when juvenile and kept until they reach the desired commercial size for human consumption are also considered to be equaculture products. Fish and crustaceans of commercial size caught in their natural environment and kept alive to be sold at a later date are not considered to be aquaculturc products if they are merely kept alive without any attempt being made :o increase their size or we ight ;

2.6 'Chilling' means the process of cooling fishery products tc a temperature approaching that of melting ice.

2.7 'Fresh Products' means any fishery products whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, which have not undergone any treatment to ensure preservation other than chilling.

2.8 'Prepared Products' means any fishery product which has undergone an operation affecting its anatomical wholeness, such as gutting, heading, slicing, filleting, chopping etc.

2.9 'Processed Products' means any fishery product which has undergone a chemical or physical process such as the heating, smoking, salting, dehydration or marinating, chilling, frozen etc. whether or not associated with other foodstuffs or a combination of these various processes.

2.10 'Preserve' means the process whereoy products are packaged in hermatically sealed containers and subjected to heat treatment to the extent that any micvo-organisms that might proliferu'e are destroyed, or inactivated, irrespective of the temperature ot which the product is to be stored.

2.11 'Frozen Products' means any fishery product which has undergone a freezing process to ieach a core temperature of —18"C or lower after temperature stabilization,

2.12 'Packaging' means the procedure of piotecting fishery products by a wrappc, a container or any other suitable device,

2.13 'Batch'/'Code' means the quantity of fishery products processed under practically identical circuniitancLS during a discrete period of time, however, not exceeding one calender day.

2.14 'Consignment' means the quantity of fishery products bound for one customer in the country of destiint'cr. and convrwr! by one mean1! of transport only.

2.15 'Means of Transport' means ttiose parts set aside for goods in automobile vehicles, rail vehicles and aircraft, the holds of vessels, and containers for transport by land, s6a or air.

2.16 'Competent Authority' means any one of the Expoit Inspection Agencies at Bombay, Calcutta, Cochin, Delhi & Madras established under Section 7 of the E_\port (Quality Control and Inspection) Act, 1903.

2.17 'F-stablishmcnt' means any premises where fishery products are prepared, processed, chilled, frozen, packaged or stored.

2.18 'Clean Sea-water' means Sea water or bring wrjter which is free from microbiological contamination, harmful substances and/or toxic marine plank- U'n in such quantities as may affect health and safety aspect of fishery products and which is used under the conditions laid down in this notification.

2.19 'Potable water' means Water used for processing which meet tolerance levels as per EEC Directive No, 80/778-EEC (Quality tolerances for v-alcr intended for food industry).

2.20 'Factory Vessel' means any vessel on which fishery products undergo one or more of the following operations followed by packaging : filleting, slicing, skinning, mincing, freezing or processing.

The following are not deemed to be 'factory vessels* :

— Fishing vessels in which only shrimps and molluscs are cooked on board ;

- - Fishing vessels on board on which only ficczing is carried out.

3. Basis of compliance :-— II is the primary responsibility of the industry to ensure that the fresh frozen and processed fishery products intended for export are hapdled, processed at all stages of production, storage and transport under proper hygienic conditions so as to meet ihe health requirements laid down under these Rules and that the products confojm to the specifications given in ihe order by the Central Cluveinment under Section 6 of the Act.

The Competent Authority shall ensure that the pocessor<; comply with the requirements, by regular monitoring of the establishments as per the control measures prescribed in Clause 13 of these rules.

For effective monitoring of the scheme, Export Inspection Council will issue nccessaiy instructions in this regiud.

4. The fresh, frozen and processed nish mid fishery products for export shall be subjected to the following conditions :

4.L Any statutory restrictions imposed by any State /Central Governments with respect to commercial/environmental (conservation measures from time to time sfcall strictly be adhered to.

32 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3<Y,)] 4:2 They raust bave b&eu caught arid where appropriate, handled for bleeding, beading, gutting and removal of fins, chilled or frozen on board vessels jn accodaiicc with prescribed hygiene rules.

4.3 They must have where appropriate been handled in factoryy vessels approved by the competent authority as per and in accordance with the requiictncnts specified in Annexure4.

4.4 During and after landing they must have been handled in accordance with ANNEXURE-II.

4.5 They must have been handled and, where appropriate, packaged, prepared, processed, frozen, tlcfros'-.Y! or stored hygienically in establishments approved in accordance with ANNEXURE-III i>nd ANNUXURE-IV.

"4 .6 They must have undergone health check in accordance with ANNEXURE-V.

4.7 They must have been appropriately packaged in accordance with ANNEXURE-VI.

4.8 They must have been given an identification niLirk in accordance wilh ANNEXURE-VII.

4.9 The) must have been stored and transported under satisfactory conditions of hygiene in accordance with ANNEXURE-VIII.

5. Whejc vetting is required from a technical and Cojnrncicial view point it must be carried out as quiukfy as possible after the products have been caught or landed.

6. The aquacuKure products shall be subject to the following conditions :

(i.l 'ITu-y must either be made headon, shcllon shrimp or beheaded, deshelkd, gutted, cleaned, deveined etc. under proper conditions of hygiene.

They must not have been soiled with earth, slime or iaeces or otherwise contaminated. If not processed immediately after having been preprocessed they Must have been chilled.

6.2 The) must in addition, comply with the appropriate Requirements laid down under 4.3 to 4.7.

7. The following Fishery Products shall be for- Hdrlen h ) export.

(I) Poisonous fish of the following families :

— Tetra udontidae, Molidae, Diodontidae, Canthigasteridae.

(ii) Fishery products containing biotoxins such as ciguatera toxins or muscle paralysing Toxins.

8.1 In the case of export of bivalve molluscs in processed condition, harvesting, transport, relaying, purification and processing shall be carried out in accordance with the requirements of the importing countries,

5.2 The activities at 8.1 shall be approved ana regnlnHy monitored by the competent authority which may take the assistance of representatives from MPEDA SFEAI and the local fisheries department 'fishing harbour.

9. The industry shall etisure that persons icponsible for the establishment take all necessary measures so that at all stages of production if fish products the specifications arc complied with and to that end the said persons must carry out their own checks based on the following requirements :

9.1 Identification of critical points in their establishment on the basis of the manufacuring process used.

9.2 Establishment and implementation of methods for monitoring and checking such critical points.

9.3 Taking samples for analysis in an approved laboratory by the recognised competent authority for the purpose of checking the cleaning and uis-infeclion methods and for the purpose of checking compliance with the requirements m this notification.

9.4 Keeping a written record or record register in indelible fashion of the preceding points with a view to submitting them to the compete.it autho'itv.

The results of the different checks and tests will in particular be kept for a period of at least 2 years.

9.5 Detailed rules for application ef *his clause have Ken given in ANNEXURE-IX.

9.6 The establishment shall have compctc.it and qualified technologist duly approved by the competent authority to conduct own checks and aUied du'ies referred at Clause 9 above.

9.6.1 The person responsible for the establishment shall possess one of the qualifications and experience [ training as the case may be.

(i) Graduate|Post Graduate in Fishery Science, Fishery Management, Industrial Fisheries or Fish Processing;

(ii) a. Graduate|Post Graduate in Marine Bioloev.

Fishery Biology, Microbiology, Chemistry.

Zoology Biology, Biochemistry, Bioscience or Food Proccsing Technology; and b. One years experience in Fish Processing and Quality Control or Training for minimum 6 months duration in a Government recotmised institute in 'Fish Process) ni; and Quality Control,

10. If the results of own checks or anv information at the disposal of the persons responsible referred to above reveal the risk of health or suggest that one micht exist, appropriate measures shall be taken under official supervision of the recognised competent authority.

11. Having satisfied itself that the establishmeni •;

factory vessels meet the requirements with regard to the nature of the activities they carry out the competent authority shah" accord approval to such establishments/factory vessels. If the establishments| factory vessels, decide to carry out activities other lhan those for which it has received approval, specific approval from competent authority shall be obtained for that purpose.

12. The competent authority may take the assistance of representatives from Marine Products Export Development Authority (MPEDA) and Seafood Exrxrrs' Association of India CSEAI) of Industry in the matter of approval of establishment/factory vessel.

33

12.1 Recognised competent authority shall take necessary measures if the requirements cease to bt met.

12.2 The recognised competent agency shall draw up a list of the approved establishmentjfactorv vessels, each of which shall have an official riumber and the recognised competent authority shall notify appropriate authorities of its list of approved establishments] factory vessels and any subsequent change thereof.

13. The inspection and monitoring of establishmert| factory vessel shall be carried out regularly under the responsibility of the recognised competent authority which shall at all times have free access to all parts of the cstublishments|foctory vessel and records pertaining to application of this notification in order to ensure compliance with the requirements of tlvs notification.

14. For inspection and monitoring of bivalve molluscs pre-processing centres and landing centres of other tish products, the competent authority may take th; askance of representatives of MPEDA & S1EAI.

15. Certification :

On request from the processor/exporter, the competent authority shall issue Health|veterinary certificate in the prescribed proforma after satisfying itself that the Fresh, Frozen, Processed Fish and Fisery Products are processed in approved establishments|factory vessels having valid approval number and after satisfying the relevant requirements.

15.1 The competent authority shall issue certificates on request from the exportcr|processor after satisfying itself that the requirements of the relevant standards are mel.

16. Fees.

16.1 A fee of Rs. 2,000|- shall be paid by the Processing Establishment|Factory Vessel along with the application for approval as per Clause No. 11 of these rules.

16.2 A monitoring fee at the following rate shall also be paid by the Processing Establishment/Factory Vessel, to the EIA :

Unit Export Turn Over Under Rs. 10 crores per annum.

Rs. 10 crores and above per annum.

Monitoring Fee

0.2r'c of F.O.B. value of exports.

0.15"c with a minimum of Rs, 2 kikbs and a maximum of Rs. 5 lakhs.

17. Appeal

17.1 Any person aggrieved b y t

(i) Decision of the competent authority not to accord approval as per rule 11 of this notification:

(ii) Decision of the Competent Authority to withdraw approval as per Rule 12.] of this notification;

(iii) Refusal of Competent Authority to issue Health[Veterinary Certificate as per Rule 15 of this notification-— May prefer an appeal within 10 days of receipt of such communication to an Appellate Authority appointed by the Central Government.

17.2 At least two-thirds of the total membership of the Appellate Authority shall consist of non-officials.

17.3 The quorum for any meeting at the Appellato Authority shall be three.

17.4 The appeal shall be disposed of within 15 days of its receipt.

ANNEXURE—\ CONDITIONS APPLICABLE TO FACTORY VESSELS ]. Conditions concerning design and equipment.

1. The minimum requirements for factory vesseli are i's follows :

J.I A reception area set aside for taking fishery products onboard designed and arranged into pounds or pens that are large enough to allow each successive catch to be separated. The reception area and its movable parts must be easy to clean. It must be designed in such a way as to protect the products from the sun or the elements and from any source of dirt or contamination.

1.2 A system for conveying fishery products from the reception area to the work area that conform* with rules of hygiene ;

1.3 Work areas that are large enough for the preparation and processing of fishery products in proper conditions of hygiene. They must be designed and arranged in such a way as to prevent any contamination of the products;

1.4 Storage for the finished products that are large enough and designed so that they are easy to clean.

If a Waste processing Unit operates on board a separate hold must be designated for the storage of these by-products ;

1.5 A place for storing packaging materials that is separate from the product preparation and processing areas;

1.6 Special equipment for pumping, was'e or fishery products that are unfit for human consumption either directly into the sea or, where circumstances so require, in to a water tight tank reserved for that purpose. If waste is stored and processed on board with a view to cleaning, separate areas must be allocated for that purpose;

1.7 Sufficient supply of potable water or pressurized clean sea water shall be provided. The sea wa'er intake must be situated in a position where it is not potable for the water being taken into be affected by discharge in to the sea of waste water, was'e and engine coolent outlets y 1-8 A suiable number of changing rooms, wash basins and toilets, the latter not opening directly on, to areas wthcre fishery products are prepared, procesed or stored. The wash basins must be equipped with 2055 GI/95—5 3-1 THE GAZETTE OF INDIA : EXTRAORDINARY [i\\Rr II—SEC 3(iij] appliances for washing and drying the hands that comply with hygiene requirements," the wash-basin tap must not be hand-opcrabb.

2. Areas used for the preparation and processing or freezinglquiek-frjczing of fishery products must have;

2.1 A non-slip floor that is also easy to clean and disinfect aid equipped for easy drainage of water, Structures and fixtures must have limber holds that are large enough not to be obstructed by fish waste and to allow water to drain freely;

2.2 Walls and ceilings that are easy to clean, partj- .ilarly where there are pipes, chains or electricity co.iduits;

2.3 The hydraulic circuits must be arranged or protected in such a way as to ensure that it is not possible lor any leakage of oil to contaminate fishery products .

2.4 Adequate ventilation and, where necessary, proper vapour extraction;

2.5 Adequate lighting;

2.6 Appliances for clean;ng and disinfectinc tools, equipment and fittings;

2.7 Appliances for cleaning and disinfecting the hands with taps that are not hand-operable and with single use towels.

3. Equipments and tools such as tables, cutting benches, containers, conveyors, gutting or filleting machines, etc. must be resistant to sea water corrosion, easy to clean and disinfect and well maintained.

4. Factory vessels which freeze fishery products must have;

4.1 A refrigeration plant sufficiently powerful to lower the temperature rapidly so as to achieve a core temperature that complies with the specifications of this notification;

4.2 Refrigeration plants sufficiently powerful to keep fishery products in the storage holds at a temperature that complies with the specifications of this notification. The storage holds must be equipped with nil automatic temperature receding system placed so lhat il can easily be read.

l\. Conditions of hygiene relating to o.i board handling and storage of fishery products.

1. A qualified person on board the factory vcsel must be responsible for applying good fishery pmducts manufacturing practices. That person shall have the authority to ensure that the provisions of this notification are applied and shall make available to inspectors the programme for inspecting and checking critical points as applied on board, a register containing that persons'* comments and the temperature recordings that may be required.

2. The general conditions of hygiene applicable to a-eas and equipments shall be those laid down in ANNEXURE-III, Scction-II.

3. The general conditions of hygiene applicable to staff shall be those, laid down in Annexure-lll. Scctiontl(2).

4. Heading, gut rug and filiciinc; niusl be carried out under the conditions of hygiene laid down in Annexurc-lV, Section 1(2), (3) a.ul (4).

5. On-board processing of fishery products must be carried out under the conditions of hygiene laid down i.i Annexure-TV. Section-Ill, IV & V.

6. Fishery products must be \v;app:d and packed under the conditions of hygiene laid down in Anncxure VI.

7. On-board storage of fishery products must be be carried out u.ider the condiiions of hvg5eiif laid down in Annexurc-VIIT Para (1) and (2), ANNEXURE—II REQUIREMENTS DURING AND AFTER LANDING

1. Unloading and landing equipment must be constructed of material which is easy to clean and disinfect, and must be kept in a good state of repair and cleanliness.

2. During unloading and landing, contamination of fishery produc's must be avoided. It must in particular be ensured lhat :

2.1 Unloading and landing operations proceed rapidly ;

2.2 fishery products are placed without unnecessary delay in a protected environment a* the .emperaturc required on the basis of the nature of the product and, where necessary, in ice, in transport, storage or in an establishment;

2.3 equipment and handling practices that cause unnecessary damage to the edible pars of the fishery products are not authorized.

3. Parts of aucMon or wholesale markets where fishery products are displayed for sale must;

3.1 be covered, and have walls which are easy to clean;

3.2 have waterproof flooring which is easy to wash and disinfect, and laid in such a way as to facilitate the drainage of wa'.er and have a hygienic waste water disposal system;

3.3 be equipped with sani'ary facilities with an appropriate number of wash basins and flush lavatoiics. Wash basins shall be supplied with materials for cleaning the hands and single use handtowcls;

3.4 be well lit to facilitate the inspeclion of fishery products;

3.5 when they are used for display or storage of fishery products, not be used for other purposes, vehicles amitting exhaust' fames which may impair the quality of the fishery products must not be admitted to markets, undesirable an:ma1s must not be admitted ;

~i.fi be cleaned regularly and at least after each sale, crates must after each sale, be cleaned and rinsed inside and outside with potable water or clean scawatcr; where required, they must be disinfected; .

35

3.7 have displayed in a prominent position signs:

prohibiting smoking, spitting, ea ing and drinking;

3.8 have facilities to provide adequate water supplies; ,

3.9 have special watertight receptacles made of corrosion resistant materials for fishery products which are unfit for human consumplicn ; / 4, After landing or, where appropria'e, after first sale, fishery products must be transported without delay at temperature of melting ict. „

5. The; general conditions of hygiene laid down in Anncxnre-lll, Section-II, with the exception of point

2.1.1 shall apply muta'is mutandis to the markets in| which fishery products are displayed for sale or stored.

6, The wholesale markets in which fishery products arc displayed for sale or stored shall be subject to the same cond'i ions as those laid down in points 3 & 5 of this Annexu're and to those set out in pom's 2, 11, 12, of Si'ction-I of Annexure-Ill.

7. The general conditions of hygiene laid down in .

Annexure-111, Scction-11 shall apply mu'atis mutandis to wholesale markets.

ANNEXURE III I. GENERAL CONDITIONS RELATING TO* PREMISES, BUILDING AND EQUIPMENTS I1. Premises and building

1.1 The immediate approaches of the processing | areas shall bo concreted or tarred or turfed to prevent wind blown dust.

1.2 The processing establishment shall be housed in a building of permanent nature; affording sufficieri' protection from normal climatic hazards like wind blown dust and rain and shall be of sufficient size for work to be carried out under adequate hygienic conditions. Their design and layout shall be such as to preclude contamination of the product. Clean and contaminated parts of the building shall be properly separate.

1.3 The food handling areas shall be comple ely separated from the area used for residentii.il purpose.

1.4 The layout of different sections shall be in such a way as to facilitate the smoo'h and orderly flow of work to prevent possible cross contamination.

1.5 There should be adequate natural or artificial lighting. The bulbs and tubes should have protective covering.

1.6 There shall be adequate facilitate for na'urai or mechanical ventilation system to provide fresh air and where necessary good steam and water vapour extraction facilities shall be provided. Ventilation opening shall be provided with fly proofing arrangemen's.

2. Fly-proofing, vermin and animal control

2.1 The processing areas including the raw material receiving and storing area shall be provided wi'h effective fly-proofing akrangements. Suitable steps shall also be raken to prevent the entry of insects, rodents, birds and animals in'o the processing area.

3. Receiving area

3.1 There shall be a raised platform to unload the raw material before being taken to (he raw material receiviug area. The sides and top of this platform shall be sufficiently protected from ex'raneous contamination.

3.2 The area in which the raw material is received mid s'orcd shall be so separated from the area in which the finished product is prepared or packed as to eliminate contamination.

4. Ceiling, wall and floor of work rooms.

4.1 The floor of the food handling area shall be wa'er proof, easy to clean and disinfect and laid down in such a way as to facilitate the drainage of the water easily or provided with equipment to remove water.

There shall be no water stagnation on the floor.

4.2 The internal walls of the food handling area shall be durable and have smooth surface which are easy to clean, and impermeable waterproof and light coloured.

4.3 Walls shall bo free from projection and all pipes and cables shall be neatly covered.

4.4 Wall to wall and wall to floor junctions shall be rounded off to facilitate proper cleaning.

4.5 Ceiling shall be free from cracks and open join** and shall be smooth, waterproof, light coloured and easy to clean.

4.6 All doors and windows shall be durable and made of corrosion resistant material and shall be of self closing type and easy to clean wi h fly proofing arrangements.

4.7 All window sills shall be sloping inwards.

4.8 All entry poin's into the processing area shall be provided with feet washing pit of sui able size. The pit shall be provided with potable waier and disintcctant. The s'agnant: water shall be changed at frequent intervals.

4.9 All entry points into the processing area shall be, provided with adequate facilities for cleaning and disinfecting hands.

4.10 Instruments and working equipments such as tables, containers, conveyor belts, knives and other utensils used shall be of smooth corrosion resistant materials, easy, to clean and d:sinfecL.

4.11 Utensils used for inedible or contaminated materials shall be identified by specific mark or colour or shape and shall not be used for handling edible producs. Adequa'o waste receptacles shall be provided for frequent removal of waste from the working areas.

4.12 Ice crusher or flaFe ice machine shall bs provided.

3 6 THE GAZETTE OF INDIA : EXTRAORDINARY LPAUT II—SEC. 3tii)J

5. Machinery

5.1 Freezing equipments sufficiently powerful to achieve a rapid reduction in the temperature so that the required core temperature is obtained within the minimum period shall be provided.

5.2 The freeing equipment shall be fitted with guages to indicate temperature and pressure.

6. Cold rooms | Storage

6.1 Chill room and ice store shall be provided wherever necessary.

6.2 The cold rooms wher the finished products ar« stored shall have sufficiency powerful refrigeration plant to keep products at temperature prescribed.

6.3 The floor of the cold rooms shall be wa'e'r proof, easy to clean and disinfect and laid-down in such a manner as to facilitate the drainage of water or shall be provided with equipment to remove water.

6.4 Walls shall have Vraoo'h surface and shall be durable, impermeable and easy to clean.

6.5 Ceiling or proof linings shall be easy to clean.

6.6 Doors shall be of durable material and easy to clean. /

6.7 There shall be adequate lighting.

6.8 The ideal temperature of the cold s'oragt shall be minus 18° Celsius or below.

6.9 The cold storage shall be fitted with automatic temperature recording device.

6.10 The cold storage shall have suitable arrangement on the floor and walls to facilitate free circulation of arr.

6.11 An ante-room of suitable size shall be provided.

6.12 There shall be an efficient alarm system.

6.13 Air curtains shall be provided at the entrance of the ante-room and cold sforage.

6.14 The cold storage shall be maintained in good hygienic conditions.

7. Facilities for adequate supplies of potable water or alternatively, clean sea-water or sea-water treated by an appropriate system, under pressure and w sufficient quantity shall be provided. However, by way of exception, a supply of non-drinking water is permissible for the production of steam, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for the purpose prccJuue the use of such water for other purpose and present no risk of contamination of the products.

Non-drinking water pipes shall be clearly distinguished frcm those used for drinking water or clean seawater.

8. Arrangements for hygienic waste water disposal shall be provided.

9. Facilities to provide sufficient quantities of good quality ice manufactured from potable water in crushed form or flake/chunk ice.

10. An adequate number of changing-rooms wilh smooth, wi-iler-proof, washable walls and floors, wash basins. Hush lavatories and lockable cupboards shall be provided. The lavatories shall not open directly on to the work rooms. The wash basin must have materials for cleaning the hands and disposable towejs, ihe wash basin taps must not be hand-operable.

11. 1/ the volume of products treated requires regular or permanent presence an adequately equipped lockable room for the exclusive use of the inspection service shall be provided.

12. There shall be adequate facilities for cleaning and disinfecting means of transport.

13. Establishments keeping live animals such as Crustaceans and fish must have appropriate fittings ensuring the best survival conditions provided with water of a quality such that no harmful organisms or substances are transferred to the aninuls.

II. General conditions of hygiene.

1. General conditions of hygiene applicable to premises and equipment :

1.1 Floors, walls and partitions, ceilings or roof linings, equipment and instruments used for working uii fishery products must be kept in a satisfactory state of cleanliness and repair, so that they do not ci'i'Stitutc a source of contamination for the produels.

1.2 Rodents, insects and any other vermin must be ,\ystcmalically exterminated in the premises or on the equipments, Rodenticides, insecticides, disinfectents and any other potentially toxic substances must be stored in permises or cupboards which can be locked ; their use must not present any risk of conamination oi the product.

1.3 Working arris, instruments and working cqirpmcnt must be used only for work on fishery pioducts. However, on authorisation by the compel- iit authority the} may be used for work on other joixistuff.fi also.

1.4 i'olablc water or clean sea-water must be used lor all purposes. However, by way of an ex- ^cp;.\;";. uon-poUiblc water may be used for steam production, fire-fighting and the cooling of refrigei-at';'ii equipment, provided that the pipes installed Jor the purpose preclude the use of such water for other purposes and present no risk of contamination of the products.

1.5 Dftergcn";, disinfectants and similar substances must be approved by the competent authority and used in such a way that they do not have adverse effects on the machinery, equipment and products.

2. General conditions of hygiene applicable to .itaff :

2.1 The highest possible standard cf cleanliness is required of staff. More specifically :

2.1.1 Staff must wear suitable clean working clothes and headgear which completely encloses the hair. This applies particularly to persons handling exposed fishery products ;

•J-

2.1.2 Stall assigned to the handling and preparation nf fishery products must be required to wash their hand at least each lime to work is resumed, wounds «n the hands, musi be covered by a water procf dressing ;

2.1.3 Smoking, spitting, eating and drinking in •work ;md storage premises of fishery products must be prohibited.

2,2 The employer shalj take all the requisite measures to prevent persons liable to contaminate Jiishery products from working on and handling t'icm, until there is evidence that such persons can do so without risk.

W'icn recruited, any person working on and handling fishery products shall be required to prove, by a medical certificate, that there is no impediment to such employment. The medical supervision of such a person shall be governed by toe national legislation in force.

ANNEXURE—IV FISHERY PRODUCTS ON SHORE I. Conditions for fresh products :

1. Where chilled, unpackaged products are not despa'ched, prepared or processed immediately after reaching the establishment they must be stored under ice in the establishment's cold room. Re-icing must be carried out as often as is necessary; the ice used, wirh oi without sail, must be made from potable water or clean sea-water and be stored under hygienic conditions in receptacles provided for the purpose; such receptacles must be kept clean and in good slate of repair. Prepacked fresh products must be chiUed with ice or mechanical refrigeration plant creating similar temperature conditions.

2. If they arc not carried out on board, operations such .;s heading and gutting must be caried out hygienically. The products must be washed throughly with polable water or clean seawater immediately after such operations.

3. Operations such as filleting and slicing must be carried out in such a way as to avoid the contamination or apoihtge of fillets and slices, and in a plnee other than that used for heading and gutting operations. Fillets and slices must not remain on work tables any longer than is necessary for their preparation. Fillets and slices to be sold fresh must Lv chilled as quickly as possible after preparation.

4. U7J(S and parts that may constitute a danger to public health must be separated from and removed from the vicinity of products intended for human consumption.

5. Containers used for the despatch or storage of fresh fishery products must be designed in such c way as to ensure both their protection from contamination and their prcscrvaion under hygienic condJiicus and more particularly they must provide adequate drainage of melt water.

6. Unless special facilities are provided for the continuous disposal of waste, the latter must be placed in leakproof, covered containers which ore easy to clsan and disinfect.

Waste must not be allowed to accumulate in working areas. It must be removed either continuously cr a> soon as the containers are full. At the end of i-uJh working day, the waste Containers shalL b<?

shifted to premises intended for storage of such container. The containers, receptacles andlor premises set aside for waste must always be thoroughly cleaned and, if appropriate, disinfected after use. Waste stored there niusi, not tonstilute a source of contamination for the establishment or of pollution of its surroundings.

11. Conditions for frozen products :

1. Plants must have ;

1.1 Freezing equpiment sufficiently powerful to achieve a rapid reduction in the temperature so that the lempcraurts laid down in this notification cap tw obtained in the product;

1.2 iicezing equipment sufficiently powerful to keep products in storage rooms at a temperature not exceeding those laid down in this notification, what' i-ver tne ambient temperaure may be.

However, for technical reasons) related to the jnctJird of freezing and to the handling off such products, for whole fish frozen in brine a .id intended lor canning, higher temperatures than those laid down in ihis notification are acceptable although they may not exceed—9°C.

2. J lesh products to be frozen or quick frozen muft comply With the requirements of Scction-I of of this Annexure.

3. Storage rooms must have a temperature recording device in a place where it can easily be read.

The temperature sensor of the recorder must be located in the area furthest away from the cold soiiixc. i.e. where the temperature in the storage I'oonj is the highest. Temperature charts must be available for inspection by the supervisory authorities utiewt during the period in which the products are sioati.

(i'L Conditions for thawing products :

FstabJishnients that carry out thawing operations must comply with the following requirements :

( I ) fishery products must be thawed under hygienic conditions; their contamination must be avoided and there must be adequate drainage for any melt water produced;

During thawing, the temperature of the products must not increase excessively;

1,2) after thawing, fishery products must be bandied in accordance with the requirements of this notification, when they are prepared of procesed, these operations must be carried out without delay.

IV. CcndiLions for processed products :

J. Fresh, frozen and thawed products used for preceding must comply with the requirements of Sedicns-l or II of this Annexure;

1. Where the processing treatment is carried out to yih'bi! £h>; development of pathogenic micro- 38 THE GAZETTE OF INDIA .:. EXTRAORDINARY [PART 11—SEC. 3(ii)] orgai:isms, or if it is a significant factor in the preservation of the product, the treatment must be sc;enificaliy recognised by the law in force and! or uppiovcd by the competent authority;

The person, responsible for an establishment urns' keep a register of the processing carried out.

Depending on the type of process employed heating time and temperature, salt content, PH. water content, etc. niust be monitored and controlled. Records must be kept atleast for the expected storage life of the products and be available to the competent authority.

3. For products which are preserved for a limited period by a treatment such as salting, smoking, drying or marinating the appropriate conditions for storage must be clearly marked on the packaging.

4. Caning :

In the case of fishery products which have been subjected to sterilization in hermetically sealed containers;

4.1 The water used for the preparations of cans must be potable water;

4 2. The process used for the heat treatment must be appioptiatc, having regard to such major criteria as. the heating time, temperature, filling, size of containers, etc.. a record of which must be kept; the heat tieaimenf must be capable of destroying or inacav&iing pa'hogenic organisms and the spores of pathogen c micro-organisms. The heating equipment must be fitted with devides for verifying whether the containers have in fact undergone appropriate heat treament. Potable water must be used to cool con'ainers after heat treatment, without prejudice to the presence of any chemical additives used in accordance wiih good technological practice to preven* corrosion of the equipment and containers ;

4.3. Further checks must be carried out at random by the manufacturer to ensure that the processed products have undergone appropriate heat trea'inent. viz. I r.Sj —- incubation tests, incubation mast be carried out at 37 ± 1°C for seven days or at • 35 i 1CC for ten days;

— microbiological examination of contents and containers in the establishment's laboratory or in another approved laboratory.

4.4 Samples must be taken of production each days at predetermined intervals, to ensure the effie'ency of sealing. For that purpose appropriate equipmen': must be available for the examination of crc's sections of the can—seams.

4.5 Checks are carried out in order to ensure that con'linef: are not damaged ;

4.6 All containers which have undergone heat treatment under practically identical conditions must be given a batch identification mark.

5. Smoking.

Smoking mu?.t be carried out in separate, premises or a special place equipped, if necessary, with a ventilation system to prevent the smoke and heat from the combustion from affecting other premises or places where fishery products are prepared, processed or stored.

5.1 Materials used to produce smoke for the smoking of fish must be stored away from the place of smoking .and must be used in "such a way that they do not contaminate the products.

5.2 Malerials used to produce smoke by burning wood that has been painted, varnished, glued or has undergone any chemical preservation treatment must be prohibited.

5.3 After smoking, products must be cooled rapidly to the temperature required for their preservation before being packaged.

6. Salting.

6.1 Salting operations must take place in different premises and sufficiently removed from the premises where the other operations are carried out.

6.2 Salt used in the treatment of fishery products must be clean and stored in such a way as to proelude contamination. It must not be re-used

6.3 Any container used for salting or brining must be constructed in such a way as to preclude contamination during the salting or bringing process.

6.4 Containers or areas used for salting or brining must be cleaned before use.

?. Cooked crustaceans and molluscan shellfish products.-—Crustaceans and molluscan shellfish must be cocked as follows :

7.1 iiuy cooking must be followed by rapid cooling, water used for this purpose mus be po able water or clean sea-water. If no other method of preservation is used, cooling must continue until the temperature approaching that of melting ice is leached.

7.2 shelling or shucking must be carried out under hyg\en:c conditions avoiding the contamination of the product. Where such operations are done by hand, workers must pay particular attention to the washing cf their hands and all working surfaces must be cleaned thoroughly. If machines are used, they must be cleaned at frequent intervals and disinfected after each working day. After shelling or shucking, cooked products must immediately be.frozen or/kept chilled at s temperature which will preclude the growth of pathogens, and be stored in appropriate premises :

7.3 every manufacturer must carry out microb'oiogical checks on his production at regular interval;,, complying with the standards.

8. Mechanically recovered fish flesh.

The mechanical recovery of fish flesh must be carried cut under the following conditions :

8.1 mechanical recovery of gutted fish must take place without undue delay after fille'ing, using raw 39 materials tree of guts. Where whole lish are used, they must be gutted and washed beforehand ;

8.2 the macirnery must be cleaned at frequent r>i(ev>:;ijs and at least every two hours ';

H.3 after recovery, machinically recovered flesh must be frozen as quickly as possible or incorporated in a picduct intended for freezing or establishing treatment.

V. C'cndtions concerning parasites.

!. During production and before they are released for human consumption, fish and fishery products inus! be subject to a visual inspection for the purpose of detecting and removing anv parasites that are visible. Fish or parts of fish which are obviously infested with parasites, and which are removed, must not be packed for human consumption.

2. The fish and fishery products referred to >n point 3 which arc to be consumed as they are, must, in addition, be subjected to freezing at a temperature of not more than —20"C in all parts of the product for not les than 24 hours. Products subjected to this freezing process must be either raw or finished.

3. Fish and fishery products subject to the conditions in point 2 ;

3.1 fish to be consumed raw or almost raw, e. g.

r:iw herrng 'Maatje' ;

3.2 the following species, if they are to undergo a cold smoking process at which the internal temperature of the fish is less than 60°C.

— mackerel.

— sprat.

3.3 marinated and/or salted herring where this process is insufficient to destroy the larvae of nematodes.

Criteria shall be laid down which must enable the process which are deemed sufficient or insufficient to destroy nomatodes to be defined.

4. Manufacturers must ensure that fish and fish products listed in point 3 or the raw materials for use in their manufacture are subjected to the treatment dercribed in point 2, prior to their release tor consumption.

ANNEXURE—V HEALTH CONTROL AND MONITORING OF PRODUCTION CONDITIONS I. Genera! Monitoring :

The competent authority shall make adequate arrangements for checking and monitoring in order to establish that the requirements laid down in these roles are complied with.

Such arrangements shall include in particular :—

(1) a suitable check on the fishing vessels, on the under standing that such checks may be carried out during the stay of the vessel in port;

(2) c suitable cheek on the conditions of landing and first sale;

(3) suitable checks on harvesting, transport, relaying and purification areas of bivalve T.olluscs of pre-processing and processi/g centres.

(4) an inspection at regular intervals of establishment to check ha particular;

(a) .whether .pre-processed material has been processed from pre-processing premises having an adequate hygiene conditions.

(b whether the conditions for approval are still fulfilled;

.(c), whether the fresh, frozen and processed fish and fishery products are handled correctly:

(d) whether the cleanliness of the prenr'ses facilities and instruments and staff hygiene are maintained.

(e) whether identification marks are put on correctly.

(5) A check on storage and transport conditions.

II. Special Checks :

1. Organoleptic checks :• The competent authority shall carry out inspection at the time of landing or before first sale and also during subsequent stages of processing, storage and transport to check, whether the products are fit for human consumption. The inspection comprises orgar.oleptic checks carried out by sampling.

1.1 If the Organoleptic examination reveals that the fishery products are not fi: for human consumption, measures shall be taken to withdraw them from sale and to dispose them off in such way that the rejected material is not used for export.

1.2 If the organolaptic examination reveals any dout as to the freshness of the fishery products, use may be nutue of chemical checks or microbiological analysis. . • •

2. Parasru, checks :

Before they are released for human consumption, fisn ana nsnery products must be subjected to a visual inspection by way of sample, for the purpose of detecting any parasites that are visible. Fish or parts of fisn which are obviously infested with parasites, and which are removed shall be disposed of in such a way that such material is not used for export.

3. Histamine check :

Wherever necessary samples shall be drawn and tested for Histamine conten*.

Nine samples must be taken from each batch.

this must fulfil the following requirements :

— the mean value must not exceed 100 ppm;

40 THE GAZETTE OF' J \DIA : EXTRAORDINARY [PART II—SHC. 3(iii] — two samples may have a value of more1 than 100 ppm; but less than 200 pprn;

-~ no samples may have a value exceeding 200 ppin.

these limits apply only to Jish speojes of the following families ; Scombridge and ClupeJdae. Howowr, fish belonging to these families which have undergone onzymt ripening treatment in brine may na\e higher histaminc levels but not more than twice the above value. Examinations must be carried out in accordance with reliable, scientifically r;- ccanised methods, such as high-performance liquid ch rcmatogt aphy (HPLC).

4. Contaminants present in the aquatic environments :

Without prejudice to the rules concerning water protection and management and in particular thnse concerning pollution of the aquatic environment, ;he 11811617 products must not contain in their edible parts contaminants present in the aquatic environment such us heavy metals and organochlorinatcd subst.inces ut such a level that the calculated distaiy intake exceeds the acceptable daily or weekly intake for humans.

A monitoring system must be established by the competent uuthority to check the level of contamination of fishery products.

5. Microbiological analysis :

Wherever necessary, samples shall be drawn and tested for microbiological factors.

Sampling plans, methods of analysis and acceptance criteria for this purpose shall be :

(a) As per the requirements of importing countries or

(b) As par the microbiological Manual issued hy Export Inspection Council.

ANNEXURE—VI PACKAGING

1. Packaging must be carried out under satisfactory conditions of hygiene, to preclude contamination of Ihe fishery produces.

2. Packaging materials and products liable to enter into contact with fishery produces must comply with all the uilcs of hygiene and in particular :

- - they must not be such as to impair the orgaDoleptic characteristic of the fishery products;

— they must not be capable of transmitting to the fishery products substances harmful it) human health;

— they must be strong enough to protect the fishery products adequately.

3. Containers used for transport of raw material to the processing plant shall not be used to store the accepted raw materials and also in subsequent processing such containers shall be identifiable by suitable colour or marks.

4. Wnh ihe exception of certain containers mode <\l impervious, smooth and corrosion resistant material whxh arc easy to clean and disinfact, which may be re-used after cleaning and disinfacting, packaging materials my not be r,e-used. Packaging matevials used for fresh products held under ice must provide adequate drainage for melt water.

5. fJnused packaging materials must be stored in premises awny from the production area and be pwected from dust and contamination.

ANNEXURR—VII t. Identification mark :

1.1. The packages of Fresh, Frozen & Processed Fish jjiid Hshcry Products and accompanying documents shall bear the numerical processor Code (approval number) allotted by the competent ajthority followed by an abbreviation or full description of <hf name and type of the product year, month & date of production. An illustration is given below :

520 FSPO 4 A 10 - - 520 the numerical code allotted by the competent authority to the processor;

— FS : name of the product (Frozen Shrimp) — P D : type of the product (Pooled & Dcvsined) — 4 : year of processing (the last digit of 1994) — A : the month processing (First month i.e. January) — 10 : data of processing (10th day of the month)

1.2. The following abbreviations shall be used for the Tn<\th of the year — January February March April May June July August September October November December — A — B — C — D — E — F — G — H — J — K L — M ANNEXURE—VIII STORAGE AND TRANSPORT

1. Fresh, Frozen and Processed Fish and Fi/hery Products must, during storage and transport, be kept at the temperature laid down in this notification and in particular :— •— Fresh or thawed fishery products and cooked and chilled crustanccan and moluscan shellfish products must be kept at the tempreture of melting ice;

41 —- Frozen Fisheries Products with the exception of frozen fish in brine infended lor the manufacture of Canned Foods, must be kept at an even temperature of — 1 8 C cr less in a]] parts of the product, allowing for the possibility of brief, upward fluctuations of not mote than 5"<"', during transport;

— processed products must be kept at the temperature specified by the manufacturer, when the cnxurnstances so require.

2. Where frozen fishery products are transported from a cold storage (plant to an approved establishment to be thawed arrival for the purposes of preparation andjor processing and where the distance to be covered is short, not exceeding 50 km., or 1 hour journey, the competent authority may grant a derogation from the conditions laid rlowrj in point 1, second para.

3. Products may not be stored or transported with other products which may contaminate them or affect their hygien, unless they are packaged in such a way as IQ provide satisfactory protection,

4. Vehicles used for the transport of fishery products must be constructed and equipped in such a way that the temperature laid down in this notification can be maintained through out the period of tiunfcpoit. If ice is used to chill the products, adequate drainage must be provided in order to ensure that water from melted ice does not stay in contact with the products. The inside surfaces of the means of transport must be finished in such a way that they do not adversely affect the fresh, frozen and processed fish and fishery products. They must be smooth and easy to clean and disinfect

5. Means of transport used for fresh, frozen and processed fish and fishery products may not be used for transporting other products likely to impair or contaminate fishery products, except when fishery products can be guaranteed uncoutarninated as a result of such transport being thoroughly cleaned and disinfected.

6. Fresh, frozen and processed fish and fishery products may not be transported in a vehicle or container which is not clean or which should have b'*en disinfected.

7. The transport conditions of Fresh, Frozen and Processed Fish and Fishery Products to be exported shall be such that they do not adversely affect the products.

ANNEXURE—IX In accordance with Clause 9 of the Notification- guidelines must be laid down for application of principles on which own checks are to be based. It is also necessary to define what is meant by identification of critical points and the establishment and implementation of methods|monitoring such critical points. It has also been prescribed that laboratories must be approved by the competent authority and written records must be maintained containing all information relating to the establishment of own checks and the results of these checks. Even though, the design and introduction of own checks will differ from one establishment to another, it is necessary to issue some guidelines to facilitate the uniform application of Clause No. 9 of this notification.

1. "Own checks" means all those actions aimed at ensuring and demonstrating that fresh Frozen and processed fishery products satisfy the requirements of the Notification. These actions must correspond to an approach internal to the establishment and they must be developed and implemented by the persons responsible for each unit.

1.1 As part of internal approach the establishment may use guides of Good Manufacturing Practices drawn up by appropriate professional organisation and acceptable tcr the competent authority.

1.2 The persons responsible for the establishment must ensure that all staff concerned for "own checks" receive adequate training in order to effectively participate in the implementation process.

2. "Critical Point" means any point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels. AH critical , points which are useful for ensuring compliance with the hygiene requirements of this Notification must be identified. For the purpose of identifying these critical points, Appendix-I of this Annexure shall apply.

2.1 The critical points are specific to each establishment depending on the raw materials, its-uses and on its manufacturing process, structrues and equipments, end products and monitoring system.

3. "Monitoring and checking such critical points" includes all those of observations | and | or measurements necessary to ensure that critical points are kept under control. Monitoring and checking critical control noint does not include veryfying that end products conform with the standards laid down in this notification. For the purpose of introducing and implementing monitoring and checking Appendix-II of this Annexure shall apply.

4. Sampling for laboratory analysis referred to Clause 9.3 of this Notification is intended to confirm that the own checks system complies effectively with Clause 1, 2 and 3 above.

4.1. The persons responsible for the establishment must make provision for a sampling programme which though not concerning systemati- 2055 GII95-6.

42 THE GAZETTE OF INDTA : FXTRAORDINARY [PAHI JI—SEC. 3(iO] tally every production batch|code, nevertheless allows:

(a) Validation of the own check system when first set up:

(b) It necessary, invalidation of the system in case of change to the characteristics of the product or to the manufacturing process;

(c) Veriiication at specific intervals that all provisions Lire still appropriate and properly complied with.

4.2 Own checks system shall be confirmed in accordance with the provisions set out in Appendix- I l l of this Annexure.

5. For the approval of laboratories mentioned in Clause 4.3 of this Notification, the competent authority shall take into account the requirements of CN 45001!ISO auidc 25JNABL Criteria standards or the equipvalent requirements. However, for the approval of establishments internal laboratories the competent authority may base on less restrictive principles.

6, In order to keep a "Written record" or record registered in an indelible fashion referred to in the Clause 9.4 of this Notification, the persons responsible for the establishment must document all information relating to the implementation of own-checks and their verification.

6.1 The documentation referred to at (6) above must include the following 2 types of information to be kept for submission to the competent authority:

(a,) A detailed and comprehensive document including:

description of the product:

— description of the manufacturing process indicating critical points;

— for each critical point, identified hazards assessment of risks and control measures;

— Procedures for monitoring and checking at each such critical point with identification of critical limits for parameters that need to be controlled and corrective action to be taken in the case of loss of control;

procedures for verification and review.

(b) Records of observations and'or measurements referred to at (?) above, the results of verification referred to in (4) above reports and written accounts of decisions relating to corrective action when taken. An appropriate document management system should be provided for easy retrieval of all documents relating to an identified production batch (code.

7, The competent authorities shall ensure appropriate training of inspection staff authorised to perform official checks to allow them to assess own-checks system set up by the persons responsible for the establihment on the basis of the documents submitted.

GENERAL PRINCIPLES It is recommended that a model of logical approach be followed, of which the following principles form the essential components:

— identification of hazards, analysis of risks and determination of measures necessary to control them;

— identification of critical paints;

— establishment of critical limtis for each crtical point;

— establishment of corrective action to be taken when necessary;

— establishment of monitoring and checking procedures;

•— establishment of verification and review procedures;

— establishment of documentation concerning all procedures and records;

Such a model, or the principles on which it is based, should be used with the flexibility appropriate to each situation.

APPENDIX 1 IDENTIFICATION O F CRITICAL POINTS It is recommended to proceed to the following activities in sequence.

1. Assembly of a multidisciplinary team.—This team, which involves all parts of the enterprises concerned with the product, needs to include the whole range of specific knowledge and expertise appropriate to the product under consideration, its production (manufacture, storage, and distribution), its consumption and the associated potential hazards.

Where necessary, the team will be assisted by specialists who will help it to solve its difficulties as regards assessment and control of critical points.

The team may consist of:

— a quality control specialist who understands the biological, chemical or physical hazards connected with a particular product group;

43 — a production specialist who has responsibility for, or is closely involved with, the technical process of manufacturing the product under study;

— a technician who has a working knowledge of the hygiene and operation of the process plant and equipment;

— any other person with specialist knowledge of microbiology, hygiene and food technology.

One person may fulfil several of these roles, provided all relevant inofrmation is available to the team and is used to ensure that the ownchecks system developed is reliable. Where expertise is not available in the establishment, advice should be obtained from other sources (consultancy, guides of good manufacturing practices, etc).

2. Description of the product.

The end product should be described in terms of:

— Composition (e.g. raw materials, ingredients, additives, etc.);

— structure and physico-chemical characteristics (e.g. solid, liquid, gas, emulsion.

AW, Ph, etc.);

— Processing (e.g. heating, freezing, drying, salting, smoking, etc. and to what extent);

— Packaging (e.g. hermetic, vaccum, modified atmosphere);

— storage and distribution conditions:

— required shelf life (e.g. sell by date and best before date);

— instructions for use;

— any microbiological or chemical criteria applicable.

3. Identification of intended use.—The multidisciplinary team should also define the normal or expected use of the product by the customer and the consumer target groups for which the product is intended. In specific cases, the suitability of the product for particular groups of consumers, such as institutional caterers, travellers, etc.

and for vulnerable groups of the population may have to be considered.

4. Construction of a flow diagram (Description of manufacturing process).—Whatever the format chosen, all steps involved in the process, including delays during or between steps, from receiving the raw materials to placing the end product on the market, through preparation, processing, packaging, storage and distribution, should be studied in sequence and presented in a detailed flow diagram with sufficient technical data.

Type of data may include but are not limited to:

— Plan of working premises and ancillary premises;

— equipment layout and characteristics;

— sequence of all process steps (including the incorporation of raw materials, ingredients, or additives vnd delays during or between steps);

— technical parameters ot, operations (in particular time and temperature, including delays);

— flow of products (including potential cross-contamination);

— segregation of clain and dirty areas (or high [low risk areas);

—. cleaning and disinfection procedures;

— hygienic environment of the establishment;

— personnel routes and hygiene prectices;

— product storage and distribution conditions.

5. On-site confirmation of flmv diagram.—After the flow diagram has been drawn up, the multidisciplinary team should confirm it on site during operating hours. Any observed deviation must result in an amendment of the original How diagram to make it accurate.

6. Listing of hazards and control measures.— Using the confirmed flow diagram as a guide, the team should:

6.1 List all potential biological, chemical ot physical hazards that may -be reasonably expected to occur at each process step (including acquisition and storage of raw materials and ingredients and delays during manufacture).

A hazard is a potential to cause harm to health and is anything covered by the hygiene objectives of this notification. Specifically, it can be any of the following:

— unacceptable contamination (or recontamination) of a biological (micro organisms, parasites), chemcial or physical nature of raw materials, intermediate products or final products, — unacceptable survival or multiplication of pathogenic micro-organisms and unacceptable generation of chemcials in intermediate products, final products, production line or line environment.

— unacceptable production or persistance of toxins or other undersirable products of microbial metabolism.

44 THE GAZETTE OF INDIA : EXTRAORDINARY [PART IT—SEC. 3 (ii)] For inclusion in the Hst, hazards, must be of a nature such that their elimination or reduction to acceptable levels is essential to the production of safe food.

6.2 Consider and describe what control measures, if any, exist which can be applied for each hazard.—Control measures are those actions and activities that can be used to prevent hazards, eliminate those or reduce their impact or occurrence to acceptable levels.

More than one control measure may be required to control an identified hazard and more than one hazard may be controlled by one control measure. For instance, pesteurization or controlled heat treatment may provide sufficient assurance of reduction of the level of both solmonells and listens. Control measures need to be supported by detailed procedures and specifications to ensure their effective implementation. For instance, detailed cleaning schedules precise hecft treatment « specifications, maximum concentrations of preservatives used in compliance with the applicable rules on additives of the importing countries.

7. Methods for identification of critical points.- The identification of a critical point for the control of a hazard requires a logical approach. Such an approach can be faciliated by the use of the following decision tree (other: methods can be used by the team, according to their knowledge and experience).

Decision tree for the identification of critical points.—-Answer each question in sequence, at each step and for each identified hazard.

For the application of the decision tree, each process step identified in the flow diagram should be considered in sequence. At each step, the.

decision tree must be applied to each hazard that may be reasonably expected to occur or be introduced and each control measure identified.

Application of the decision tree should be flexible and requires common sense, having consider.

ation for the whole manufacturing process in oirder to avoid, whenever possible, unnecessiarv critical points.

8. Action to be taken following identification of a critical point.—The identification of critical points has two consequences for the multidisciplinary team which should then:

— Ensure that appropriate control measures are effectively designed and implemented. In particular, if a hazard has been identified at a step where control is necessary for product safety and no control measure exists at that step, or at any other, then the product or proces should be modified at that step, or at an earlier or later stage, to include a control measure;

— establish and implement a monitoring and checking system at each critical point.

45 APPENDIX-II ESTABLISHMENT AND IMPLEMENTA- TION OF MONITORING AND CHECKING CRITICAL POINTS An appropriate monitoring and checking system is essential to ensure the effective control of each critical point. To develop such a system, it is recommended to proceed to the following activities:—

1. Establishment of critical limits for each control measure associated with each critical point.—Each control measure associated with a critical point should give rise to the specification of critical limits. These critical limits correspond to the extreme values acceptable with regard .to product safety. They separate acceptability from unacceptability. They are set for observable or measurable parameters which can readily demonstrate that the critical point is under control; they should be based on substantiated evidence that chosen values will result in process control.

Examples of such parameters include temperature, time, pH, moisture level, additive, preservative or salt level, sensory parameters such as visual appearance or texture, etc.

In some cases, to reduce the risk of exceeding a critical limit due to process variations, it may be necessary to specify more stringent levels (i.e.

target levels) to assure that critical limits are observed.

Critical limits may be derived from a; variety of sources.

When not taken from regulatory standards (e.g. frozen storage temperature) or from existing and validated guides of good manufacturing practices, the team should ascertain their validity relative to the control of identified hazard and critical points.

2. Establishment of a monitoring and checking system for each critical point.—An essential part of own-checks is a programme of observations or measurements performed at each critical point to ensure compliance with specified critical limits.

•The programme should describe the methods, the frequency of observations ot measurement and the recording procedure.

Observations or measurements must be able to detect loss of control of critical points and provide information in time for corrective action to be taken.

Observations or measurements may be made preferably continuously. When observations or measurements are not continuous, it is necessary to establish a frequency of observations or measurements which provides reliable information.

The programme of observations or measurements should properly identify for each critical point :

— who is to perform monitoring and checking, — when monitoring and checking is performed, — how monitoring and checking is performed.

3. Establishment of a corrective action plan Observations or measurements may indicate :

— that the parameter monitored tends to deviate from its specified critical limits, indicating a trend toward loss of control.

Appropriate corrective action to maintain control must be taken before the occurence of hazard.

— that the parameter monitored has deviated from its specified critical limits indicating a loss of control. It is necessary to take appropriate corrective action to regain control. Corrective action has to be planned in advance by the multidisciplinary team, for each critical point, so that it can be taken without hesitation when a deviation is observed.

Such corrective action should include :

— proper identification of the person (s) responsible for the implementation of the corrective action, — description of means and action required to correct the observed deviation, — action to be taken with regard to products that have been manufactured during the period when the process was out of control, — written record of measures taken, APPENDIX-III VERIFICATION OF OWN-CHECKS SYSTEM Own checks system verification is necessary to ensure that they are working effectively. The multidisciplinary team should specify the methods and procedures to be used. Usable method may include in particular random sampling and analysis, reinforced analysis or tests at selected critical points, intensified analysis of intermediate or final products, surveys on actual condition during storage, distribution and sale and on actual use of the product. Verification procedures may include :

inspection of operations, validation of critical limits, review of deviations, corrective action and measures taken with regard to the product, audits of the own-checks system and its records.

46 THE GAZETTE OF INDIA : EXTRAORDINARY [PART U—SEC. 3(ii)] Verification should provide for confirmation of the suitability of the own-checks system established and ensure, afterwards, with an appropriate frequency, that the provisions laid down are still being properly applied.

In addition, it is necessary to revive the system, to ensure that it is (or will be) still valid in case of change. Examples of change include :

— change in raw material or in product, processing conditions (factory layout and environment, process equipment, cleaning and disinfection programme), — change in packaging, storage or distribution conditions, — change in consumer use, — receipt of any information on a new hazard associated with the product.

Where necessary, such a review must result in the amendment of the provisions laid down.

Any change to the own-checks system arising should be fully incorporated into the documentation and record-keeping system in order to ensure that accurate up-to-date information is available.

Where criteria are specified in regulations, such criteria are to be used as reference values for the verification process.

[F. No. 6|2|94-EI&EP] A. D1DAR SINGH, Jt. Secy.

NOTIFICATION New Delhi, the 21st August, 1995 S.O. 731(E).—In exercise of the powers conferred by sub-section (1J of Section 16A of the Export (Quality Control and Inspection) Act, 1963 (22 of 1963), and in supersession of the Notification bearing S.O. 929(E) dated 4th December, 1990, the Central Government hereby directs that the sub-section (d) of Section 6 of the Act shall not apply from the date of publication of this notification in the Official Gazette, for export of commodities notified under section 6 of the Act.

excepting fish and fishery products by industrial units set up in the Export Processing Zones, Free Trade Zones and 100 per cent Export Oriented Units approved by the Central Goverment.

[F. No. 6[22|90-EI&EP1 A. DIDAR SINGH, Jt. Secy.

NOTIFICATION New Delhi, the 21st August, 1995 S.O. 732(E),—In exercise of powers conferred by sub-section (1) of section 16A of the Export (Quality Control and Inspection) Act, 1963 (22 of 1963), the Central Government hereby directs that the following amendment shall be made in the Notification of the Government of India in the Ministry of Commerce, No. S.O. 482(E) dated the 25th July, 1991, namely:— In the said Notification, for the words, '"Agriculture and Food Products, Fruit Products, Fish & Fishery, Products, Chemicals & Allied Products", the following words, "Agriculture & Food Products, Fruit Products, Chemicals & Allied Products" shall be substituted.

[F. No. 6|5|91-EI&EP|(ii)l A. DIDAR SINGH, Jt. Secy.

47 NOTIFICATION New Delhi, the 21st August, 1995 S.O. 733(E).—In exercise of powers conferred by sub-section (1) of section 16A of the Export (Quality Control and Inspection) Act, 1963 (22 of 1963), the Central Government hereby directs that the following amendment shall be made in the N