Preamble - EXPORT OF CRUSHED BONES, OSSEIN AND GELATINE (QUALITY CONTROL, INSPECTION AND MONITORING) RULES, 2012

PREAMBLE

In exercise of the powers conferred by section 17 of the Export (Quality Control and Inspection) Act,1963 (22 of 1963), the Central Government hereby makes the following rules, namely:-

Rule 1 - Short, title and commencement

1. Short, title and commencement.- 

(1) These rules may be called the Export Of Crushed Bones, Ossein And Gelatine (Quality Control, Inspection And Monitoring) Rules, 2012.

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

Rule 2 - Definitions

2. Definitions:- 

In these rules, unless the context otherwise requires,-

(a) "Act" means the Export (Quality Control and Inspection) Act, 1963 (22 of 1963);

(b) "Bone Mill" means a premise where bones are crushed. A bone mill may have integrated collection centre,

(c) "Central Competent Authority" means the Export inspection Council established under the section 3of the Act;

(d) "Collection Center" means premises used for collection of bones, hides, skin tendons and sinews of animals and their transportation to the establishments;

(e) "Competent Authority" means any authority authorized or designated or, recognized by the Central Competent Authority for approval and monitoring of establishment processing Crushed Bones, Ossein and Gelatine intended for exports;

(f) "Crushed Bones" means crushed bones of animals of bovine origin in different sizes for use in the production of Ossein and Gelatine and includes degreased bones chips and gel bones;

(g) "Director" means the Director of Inspection and Quality Control appointed by the Central Government under section 4 of the Act;

(h) "Establishment" means any premises where Crushed Bones or Ossein or Gelatine are prepared, processed, packaged or stored,

(i) "Gelatine" means the natural, soluble protein, gelling or non-gelling intended for human consumption or not intended for human consumption obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals.

(j) 'Health Certificate" means a certificate issued as per the requirements of the importing country;

(k) "Ossein" means the organic matrix of the bone left behind when the mineral salts are dissolved in dilute acid. It is chemically similar to collagen after de mineralizing the bones with dilute hydrochloric acid;

(l) "Slaughter house" means the building, premises or place which is approved by the local authority of the State Government or competent authority for the slaughtering the animals;

Rule 3 - Basis of compliance

3. Basis of compliance:- 

(1) It shall be the primary responsibility of the collection centre to ensure that bones, hides, skin, tendons and sinews of animals are handled, stored and transported in hygienic conditions.

(2) It shall be the primary responsibility of the establishment to ensure that the Crushed Bones, Ossein and Gelatine intended for export are handled and processed at all stages of production, storage and transportation under hygienic conditions so that the health requirements laid down under these rules are met and the product conforms to the specifications given in the Order by the Central Government under section 6 of the Act. For this purpose, the establishment shall adopt Good Manufacturing Practices, Good Hygiene Practices and Hazard Analysis and Critical Control Point system, as applicable to it.

(3) The Central Competent Authority shall issue necessary instructions from time to lime for registration, approval, monitoring and withdrawal of approval of collection centres, bone mills and establishments.

(4) Ossein and Gelatine shall not contain residues of notified substances in excess of the permitted levels or as fixed by the importing countries.

Rule 4 - Conditions to be complied for export of Crushed Bones, Ossein and Gelatine

4. Conditions to be complied for export of Crushed Bones, Ossein and Gelatine.- 

(1) Any statutory restriction including commercial, environmental or conservation measure imposed from time to time by Central or State Government authorities.

(2) Raw materials used for the manufacture of Crushed Bones, Ossein or Gelatine must be derived from animals slaughtered in a slaughter house and whose carcasses have been found fit for human consumption following ante and post-mortem inspection or, in the case of hides and skins, from animals found fit for human consumption.

(3) The collection centers shall comply with the requirements given in Annexure I.

(4) The slaughter houses integrated with establishment shall comply with the requirements given in Annexure II. Other slaughter houses must be approved by the State Governments and complying with the norms prescribed by the Food Safety and Standards Authority of India.

(5) Crushed bones, Ossein or Gelatine intended for export shall be processed and packed only by an approved establishment. Such establishments shall adopt Good Manufacturing Practices, Good Hygiene Practices and Hazard Analysis and Critical Control Point system, as applicable to them.

(6) The establishment processing Crushed Bones shall comply with the requirements given in Annexure III. Such establishments shall procure bones only from bone collection centers registered with Chemical and Allied Export Promotion Council of India (CAPEXIL) or any other authority designated for the purpose by the Central Competent Authority.

(7) The establishment processing Ossein shall comply with the requirements given in Annexure IV. Such establishments shall procure crushed bones only from bone mills registered with Chemical and Allied Export Promotion Council of India (CAPEXIL) or any other authority designated for the purpose by the Central Competent Authority.

(8) The establishment processing Gelatine shall comply with the requirements given in Annexure V. Such establishments shall procure crushed bones, hides, skin, tendons and sinews of animals only from bone mills / collection centres registered with Chemical and Allied Export Promotion Council of India (CAPEXIL) or any other authority designated for the purpose by the Central Competent Authority.

(9) The establishments processing Crushed Bones, Ossein and Gelatine shall comply with the specific requirements of the importing country as per the Instructions issued by the Central Competent Authority.

(10) An establishment shall have a responsible person empowered to take all necessary measures at all stages of production to ensure that all requirements prescribed for the establishment are complied with.

Rule 5 - Approval, inspection and monitoring of collection centres and establishments

5. Approval, inspection and monitoring of collection centres and establishments.-

(1) Having satisfied itself that the establishment meets the requirements with regard to nature of activities it out, the Competent Authority shall accord approval to such establishment. The approved establishment shall be allotted an approval number.

(2) If the establishment decides to carry out activities other than those for which it has been approved, it shall obtain specific approval of the Central Competent Authority prior to the commencement of the new activity.

(3) The Competent Authority shall periodically draw a fist of establishments approved by it and forward the same to the Central Competent Authority. Subsequent changes made in the, list shall also be communicated to the Central Compelent Authority.

(4) The registered bone mils / collection centres and approved establishments shall be regularly monitored by the Competent Authority.

(5) The Competent Authority shall take necessary measures if the requirements cease to be met.

(6) The Central Competent Authority shall ensure that the Competent Authority carries out its responsibilities as per the instructions issued by it from time to time. For this purpose, the Central Competent Authority shall conduct corporate audit of the Competent Authority at least once in a year.

(7) The Central Competent Authority shall notify appropriate authorities of the list of approved establishments.

(8) The Central Competent Authority shall conduct supervisory audits of the registered bone mills / collection centres and approved establishments to ensure that their registration, approval and monitoring is being carried out by the Competent Authority in accordance with the instructions issued by it and the provisions of these rules.

(9) The Central Competent Authority and the Competent Authority shall, at all times, have free access to all parts of the collection centres and approved establishments including their records pertaining to implementation of requirements of this notification.

Rule 6 - Certification

6. Certification .- 

On request from the exporter, the Central Competent Authority shall issue health / veterinary certificate, in the prescribed Performa after satisfying itself that the Crushed Bone, Ossein and Gelatine was processed in the approved establishment having valid approval number issued by the Competent Authority as per the requirements of these rules.

Rule 7 - Fee

7. Fee.- 

(1) Fee for Assessment: An assessment fee at the rate of rupees three thousand shall be paid by the bone mills / collection centres and rupees five thousand by Ossein and Gelatine establishments to the competant authority every two years.

(2) Fee for Health or Veterinary Certificate. - A. fee at the rate given here under shah be paid by the exporter to the central competent Authority for every consignment of Crushed Bone Ossein and Gelatine intended for human consumption.

(i) Crushed Bones: Rupees one thousand

(ii) Ossein and Gelatine : Rupees five thousand

A fee at the rate given hereunder shall be paid by the exporter to the Central Competent Authority for every consignment of Crushed Bones, Ossein and Gelatine intended for technical end use.

(i) Crushed Bones: Rupees five hundred

(ii) Ossein and Gelatine: Rupees two thousand five hundred

However no fee shall be payable for export of bonafide samples not exceeding five kilograms net weight.

¹[(3) Fees shall be paid by the processor or the exporter to the concerned Export Inspection Agency with a maximum of Rs.25 lakhs per annum per exporter or processor.

Note : The amount of monitoring fee and service tax(s), as applicable, for each consignment paid by the exporter shall be rounded off to the nearest rupee and, for this purpose, where such amount contains a part of a rupee consisting of paise, then, if such part is fifty paise or more, it shall be increased to one rupee and if each part is less than fifty paise, it shall be ignored.]

1. Inserted by Export of Crushed Bones, Ossein and Gelatine (Quality Control and Inspection and Monitoring) Amendment Rules, 2018, vide Notification No. SO80(E), dated 28.12.2018.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rule 8 - Appeal

8. Appeal.-

(1) Appeal against the decision of the Competent Authority.

(a) Any person aggrieved by the decision of the Competent Authority either not to accord it approval under sub-rule (1) of rule 5 or to withdraw approval under sub-rule (5) of rule 5 may prefer an appeal within forty-five days of the receipt of such communication to the Central Competent Authority.

(b) The appeal shall be disposed of within thirty days of its receipt,

(2) Appeal against the decision of the Central Competent Authority.

(a) Any person aggrieved by the decision of the Central Competent Authority either not to accord it approval under sub-rule (1) of rule 5 or not to issue health or veterinary certificate under rule 6 may prefer an appeal within forty five days of the receipt of such communication to an Appellate Authority appointed by the Central Government.

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

(c) The quorum for any meeting at the Appellate Authority shall be three.

(d) The appeal shall be disposed of within thirty days of its receipt.

Annexure I - ANNEXURE I

ANNEXURE I

REQUIREMENT FOR COLLECTION CENTERS

(a) They must have covered place to receive bones, hides, skin, tendons and sinews of animals and their transportation to the establishments.

(b) They must have adequate facilities for cleaning and disinfection of the containers in which bones, hides, skin, tendons and sinews of animals are received as well as the vehicles used for their transportation.

(c) They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and where appropriate, provided with refrigeration facilities.

(d) The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

Annexure II - ANNEXURE II

ANNEXURE II

REQUIREMENT FOR SLAUGHTER HOUSE INTEGRATED WITH ESTABLISHMENT

Requirement for Slaughter House

1. The construction, layout and equipment of slaughterhouse shall comply with the following:

a. Slaughterhouses shall have adequate and hygienic lairage facilities or climate permitting, waiting pens that are easy to clean and disinfect. These facilities shall be equipped for watering the animals and, if necessary, feeding them. 

b. They shall also have separate facilities for sick or suspect animals to avoid contamination of other animals.

c. The lay out of the lairage shall facilitate ante-mortem inspections.

d. The floor shall be water 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.

e. The walls of the meat handling area shall be durable and have smooth surface which are easy to clean, and impermeable waterproof and tight colored.

f. Walls shall be free from projection, all pipes and cables shall be neatly covered. Wail to wall and wall to floor junctions shall be rounded off to facilitate proper cleaning.

g. Ceiling shall be free from cracks, open joints and shall be smooth, free from rafters other than carcasses hanging devices, waterproof, light colored and easy to clean.

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

i. All entry points shall be provided with feet washing pit of suitable size. The pit shall be provided with water and disinfectant. The Pit-water shall be changed at frequent interval.

j. 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, wash with water and disinfectants.

k. They must have facilities for disinfecting tools with hot water supplied at not less than 82?C, or an alternative system having an equivalent effect.

l. The equipment for washing hands used by the staff engaged in handling exposed meat must have aps designed to prevent the spread of contamination.

m. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

2. To avoid contaminating meat, the slaughterhouses must have-

a) sufficient number of rooms, appropriate to the operations being carried out;

b) separate room for the emptying and cleaning of stomachs and intestines;

c) installations that prevent contact between the meat and floors, walls and fixtures; and

d) slaughter lines (where operated) that are designed to allow constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination.

Slaughter Hygiene

3.  Live animals brought in to the slaughter house shall comply with the followings:-

a. Only live, healthy animals shall be brought for slaughter that met with an accident.

b. During their collection and transportation, the animals shall be handled carefully without causing unnecessary distress.

c. Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public heath importance may only be transported to the slaughterhouse when the competent authority so permits.

4.  After arrival in the slaughter house, the slaughter of the animals must not be unduly delayed.

5. Animals must be clean.

6. Every animal to be slaughtered shall undergo ante-mortem inspection by the veterinarian.

7. Stunning, bleeding, skinning, evisceration and other dressing shall be carried out without undue delay and in a manner that avoids contaminating the meat.

8. Post-mortem inspection of all slaughtered animals shall be carried in accordance with the instructions issued by the competent authority.

9. After post-mortem inspection:

(a) parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment,

(b) meat detained or declared unfit for human consumption and inedible byproducts must not come into contact with meat declared fit for human consumption; and

(c) viscera or parts of viscera remaining in the carcass, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorized by the competent authority.

10. After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4?C as soon as possible, unless the meat is cut while warm.

11. The carcasses must not contain visible fecal contamination and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat.

12. Carcasses and offal must not come into contact with floors, walls or work stands.

Annexure III - Annexure III

Annexure III

REQUIREMENT FOR ESTABLISHMENT PROCESSING CRUSHED BONES

The establishment shall have:

1. defined cartilage and clean area;

2. no stagnant water or signs of any rodent harborage inside the premises;

3. roads tarred or turfed to prevent windblown dust;

4. adequate covered place to receive raw bones;

5. hard smooth and washable floor to store the raw bones;

6. proper drainage facility in the raw bone storage area;

7. permanent structure to store Crushed Bones;

8. the walls smooth, light colored and without crevices;

9. waterproof and cleanable switches and other installation of the wall;

10. adequate lavatories, changing rooms and wash basins for staff and these shall be away from the main processing portions;

11. adequate arrangement for protection against pests such as insects, rodents and birds;

12.a drainage facility to meet hygiene requirements;

13. adequate facility for cleaning and disinfecting the container vehicles carrying bones, and

14. adequate facilities for cleaning and disinfecting the containers or receptacles in which raw bones are received and the vehicles in which they are transported.

Annexure IV - Annexure IV

Annexure IV

REQUIREMENT FOR ESTABLISHMENT PROCESSING PROCESSING OSSEIN

The establishment shall have:

1.  defined cartilage and clean area;

2. no stagnant water or signs of any rodent harbor4e inside the premises;

3. roads tarred or turfed to prevent wind-blown dust;

4. designed in such a way to prevent accumulation of dirt, contact with toxic materials, the shedding of particles into food and formation of condensation or undesirable moulds on the surfaces;

5. separate covered area to receive Crushed Bones, which is easy to clean and disinfect;

6. adequate lavatories, changing rooms and wash basins for staff,

7. separation between receiving area, processing area and storage of finished products;

8. adequate provisions for degreasing and for receiving degreased and dried bone;

9. sufficient production capacity for hot water / steam for processing of Crushed Bones;

10. measuring equipment to monitor temperature against time, if necessary, pressure at critical points with adequate safety system to prevent insufficient heating;

11. adequate storage facility for cleaning materials and disinfectants;

12. adequate drainage facility to avoid risk of contamination,

13.waste water disposal system meeting the central / state pollution control board requirements.

14. well-equipped in-house laboratory to conduct analyses or make use of services of external laboratories approved by Central Competent Authority;

15. established control for movement of personnel between clean and unclean area;

16. documented pest control program;

17. hygiene control program, which include inspections of environment, equipment and inspection schedules and its results maintained for at least two years;

18. storage area for storing of finished product to preclude contamination,

19. established and documented cleaning procedure for all parts of the establishment;

20. system to dispose any material suspected or known to be contaminated;

21. provision for separately storing the Ossein intended and not intended for human consumption and are identifiable during production and transportation;

Annexure V - Annexure V

Annexure V

REQUIREMENTS FOR ESTABLISHMENTS PROCESSING GELATINE

A. Raw Material

1. For the production of Gelatine, any of the following raw material/ materials shall be used.

a) ossein;

b) crushed bones;

c) hides and skins of bovine animals, provided they have not undergone any tanning process;

d) pig skins:

e) poultry skin;

f) tendons and sinews; and

g) fish skin, scales and bones.

2. Ossein shall be procured from approved ossein establishments, crushed bones from bone mills and other raw materials from collection centres registered with CAPEXIL or any other authority designated for the purpose by the Central Competent Authority.

3. Raw material procured by the establishment shall be accompanied by a document containing their origin and related information essential to maintain traceability.

B. Hygiene Requirements - 

The establishments shall ?

1. have a covered space to receive the raw material for processing gelatine;

2. have a clean and unclean sector, adequately separated;

3. be constructed in such a way that it is easy to clean and disinfect;

4.  have smooth floor surface and the floor laid down in such a way so as to facilitate the draining of liquids;

5. have adequate lavatories, changing rooms and wash basins with hand washing facilities with running water;

6. have appropriate arrangements for protection against pests, such as insects, rodents and birds;

7. have a waste disposal system;

8. have its own laboratory or make use of the service of an external laboratory approved by the Central Competent Authority to carry out necessary analysis;

9. ensure that persons working in un-cleaned sector do not enter the clean sector without changing their working clothes and footwear;

10. ensure that equipment and utensils are not taken from the un-cleaned sector to clean sector without cleaning and disinfection;

11. ensure that plant hygiene is controlled through regular inspection of the environment and equipments; and

12.ensure that installations and equipments are kept in good state of repair and measuring equipments are calibrated at regular intervals.

C. Production process:

The production process of gelatine shall ensure that:

(a) all bone material is crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4% and pH<1.5) over a period of at least 2 days. This treatment shall be followed either by-

(i) an alkaline treatment of saturated lime solution (pH>12.5) for a period of at least 20 days with a heat treatment step of 138?C minimum during at least four seconds; or

(ii) an acid treatment ten hours minimum with a heat treatment step of 138-140?C minimum at least four seconds, or

(iii) a heat-and-pressure process for at least 20 minutes with saturated steam of 133?C at more than 3 bars ,or

(iv) any approved equivalent process.

(b) other raw materials are subjected to a treatment with acid or alkali, followed by one or more rinses. The pH shall be adjusted subsequently. Gelatine shall be extracted by heating one or more times in succession, followed by purification by means of filtration and heat treatment.

(c) gelatine, whether intended for human consumption or not intended for human consumption, is produced and stored in the same establishment provided that the raw materials and production process comply with requirements applying to gelatine intended for human consumption

(d) the use of preservatives other than sulphur dioxide / hydrogen peroxide is prohibited.

D. Requirements for finished products:

Each production batch of gelatine shall be subjected to tests to ensure that it meets the following criteria

1. Microbiological criteria:

2. Residues:   

E. Identification:

a. The processor shall ensure that Gelatine intended for human consumption is kept separately and is identifiable during production, storage and transportation. During storage and transportation, a label shall be affixed / attached to the container, carton or other packaging material, clearly indicating whether it is intended for human consumption' or 'not intended for human consumption'. Packages containing Gelatine fit for human consumption shall also indicate the date of minimum durability.

b. Each export package shall be legibly and indelibly marked with the following:

(i) Name and address of establishment with approval number;

(ii) Name and address of exporter, if different from the establishment,

(iii) Batch or lot number;

(iv) Year, month of processing or manufacturing;

(v) Date of minimum durability;

(vi) Gross weight and net weight;

(vii) "GELATINE INTENDED FOR HUMAN CONSUMPTION" or "GELATINE SUITABLE FOR ANIMAL CONSUMPTION/ TECHNICAL PURPOSES", depending upon the end use; and

(viii) Product of India.