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 MINISTRY OF COMMERCE AND INDUSTRY
(DEPARTMENT OF COMMERCE)
ORDER
New Delhi, the 15th September, 2021

S.O. 4368(E).—Whereas, for the development of export trade of India, certain draft order for superseding the Order of the Government of India in the Ministry of Commerce and Industry (Department of Commerce) number S.O. 2077, dated the 04th August, 1997 were published as required under section 6 of the Export (Quality Control and Inspection) Act, 1963 read with sub-rule (2) of the rule 11 of the Export (Quality Control and Inspection) Rules, 1964 in the Gazette of India, Extraordinary Part-II, section 3, sub-section (ii), dated the 22nd February, 2021 by the Government of India in Ministry of Commerce and Industry (Department of Commerce) vide number S.O. 831 (E), dated the 22nd February, 2021 inviting objections and suggestions from all the persons likely to be affected thereby within a period of thirty days from the date of publication of the said draft Order in the Official Gazette;

And Whereas copies of the Gazette containing the said draft Order were made available to the public on the 22nd February, 2021;

And Whereas, the objections and suggestions as received from the public on the said proposal have been duly considered by the Central Government;

Egg & egg products subjected to pre-export quality control or inspection

And, Whereas, it is necessary to maintain the highest quality standards and stipulate health requirements that would encompass the requirement of importing regulatory authorities;

And, Whereas, health requirements should be laid down for the production storage and transport of egg and egg products, and whereas, in particular, it is important that rules be laid down governing the approval of establishment;

And, Whereas, it is important also that the health requirements to be met by egg and egg products be laid down;

And, Whereas, it is the responsibility primarily of the processors to ensure that egg and egg products meet the health requirements laid down in this order and whereas, the Competent Authority shall by carrying out quality control, inspection and monitoring to ensure that processors comply with the above mentioned requirements; and whereas, the rules governing these quality control, inspections and monitoring shall take account into the demands of the international market;

And, Whereas, a random check shall be made to detect the presence of residues of substances liable to be harmful to human health;

And, Whereas, provisions should, therefore, be made for procedure for monitoring to ensure the above conditions of equivalence with reference to the requirements of the importing countries;

And, Whereas, Central Government nominated Competent Authority should ensure the effective compliance of the quality standards in the Country;

Now, therefore, in exercise of the powers conferred by section 6 of the Export Inspection Council (Quality Control and Inspection) Act, 1963 (22 of 1963) and in supersession of the notification of the Government of India in the Ministry of Commerce, Department of Commerce published in the Official Gazette vide number S.O. 2077, dated the 4th August, 1997, except as respects things done or omitted to be done before such supersession, the Central Government, after consulting the Export Inspection Council, is of the opinion that it is necessary and expedient so to do for the development of the export trade of India hereby,-

(a) notifies that the egg and egg products shall be subjected to quality control or inspection or both prior to export;

(b) specifies that the type of quality control, inspection and monitoring shall be in accordance with the Export of Egg and Egg products (Quality, Control , Inspection and Monitoring) Rules, 2021 as the type of Quality Control, Inspection and Monitoring which shall be applied to such egg and egg products prior to export;

(c) recognises the specifications,-

(i) National Standard of the importing countries in absence of which codex standards of Codex Alimentarius Commission;

(ii) In absence of (i), specification prescribed in the Food Safety and Standard Authority of India Act, 2006 and rules and regulation made thereunder shall apply;

(iii) In the absence of (i) and (ii) above, contractual specifications between the foreign buyer and the exporters shall be applicable provided the same is not below the national standards;

(iv) In case of any egg and egg products for which no standard is available at (i) (ii) and (iii) above, the standard formulated for these products by the standing Committee of the following members shall be made applicable, namely:-

1. Chairman, Export Inspection Council Chairman
2. Representative from Agricultural and Processed Food Products Export Development Authority Member
3. Representative from Department of Animal Husbandry and Dairying, Ministry of Agriculture and farmer’s Welfare Member
4. Representative from Food Safety and Standards Authority of India Member
5. Representative from Indian Egg Association Member;
6. Representative of Export Inspection Council Member

(d) prohibits the export of egg and egg products in the course of international trade unless it conforms to the standards applicable to it and each and every consignment of such egg and egg product meant for export is accompanied by a certificate of export worthiness issued by the Agency;

(e) specifies the maximum residual limits (MRLs) for antibiotics, organochlorine compounds and pyrethroids in egg powder as given below-

(1) Antibiotics:

Antibiotics Maximum residues limits
Erythomycin 150 µg/kg
Tylosin 200 µg/kg
Lincomycin 50 µg/kg
Neomycin 500 µg/kg
Colistin 300 µg/kg
Chlortetracycline 200 µg/kg
Oxyteracycline 200 µg/kg
Tetracycline 200 µg/kg
Spectinomycin 200 µg/kg
Tiamulin 1000 µg/kg
Josamycin 200 µg/kg
Oxolinic Acid 50 µg/kg

(2) Anti-parasitic agents piperazne derivatives:

Anti piperazne Agent MRL
Piperazine 2000 µg/kg
Flubendazole 400 µg/kg
Amprolium 1000 µg/kg

(3) Organochlorine Compounds:

Compound MRL (mg/kg)
Aldrin and Dieldrin combined
expressed as dieldrin
0.02 (Combined limit)
Chrorthalonil 0.01
DDT (all isomers) 0.05 (Combined limit)
Dicofol (sum of p,p’ and o,p’ isomers) 0.05
Endosulfan (sum of alpha and beta-isomers and endosulfan-sulphate expressed as endosulfan) 0.005
Endrin 0.005
HCH (all isomers) 0.03 (combined limit) α0.02 β0.01
Lindane (γ-HCH) 0.1
Methoxychlor 0.01
PCB 0.01

(4) Pyrethroids:

Compound MRL
Cypermethrin 0.05
Deltamethrin 0.05
Permethrin 0.05
aplha-cypermethrin 0.05;

(f) provides that the use of following antibiotics and other pharmacological active substances shall be prohibited in manufacture of feed, medication of chicken and poultry, or at any stage of production, namely:-

(ii) Chloramphenicol;

(iii) Dimetridazole;

(iv) Metronidazone;

(v) Nitrofurans Metabolites including 3-Amino-2-Oxalidinone (AOZ), Semi Carbazide (SEM), 5-Methyl-Morpholino-3Amino-2Oxalididone (AMOZ) and 1-amino-hydantion Anticoccidials including nitroimidazoles:

Provided that if the MRLs fixed by the importing countries are more stringent than the limits herein specified, the MRLs specified by the importing countries shall be complied with;

(g) provides that “Fresh Eggs” shall have clean and sound shell and free from cracks, leaks and fecal contamination. Mandatory testing for table eggs: Salmonella, E.Coli, Enterobateriaceae;

(h) specifies that the type of quality control and inspection shall be in accordance with the Export of Egg and Egg Products (Quality Control, Inspection and Monitoring) (Amendment) Rules, 2021 as the type of quality control, inspection and monitoring which shall be applied to such Egg and Egg products prior to export.

Note:- (1) Nothing in this order shall apply to the export by land or sea or air of bonafide samples of egg and egg products to prospective buyers the value of which shall not exceed the permissible limits as laid down in the Foreign Trade Policy from time to time.

(2) In this order,-

(i) “egg” Products” means the Products obtained from eggs and their various components or mixtures thereof after removal of the shell and membranes, intended for human consumption and they may be partially supplemented by other foodstuffs or additives or they may be liquid, concentrated, dried, crystallized, frozen, quick-frozen or coagulated.

(ii) “egg” means the Fresh eggs which have not been washed or dry-cleaned and which are collected at least once weekly and shall be packed and graded not later than the first working day after arrival at the packing station.

[F.No. K-16012/15/2019-Export Inspection]
DIWAKAR NATH MISRA, Jt. Secy.

NOTIFICATION

New Delhi, the 15th September, 2021

S.O. 4369(E).—In exercise of the powers conferred by section 17 of the Export (Quality Control and Inspection) Act, 1963 (22 of 1963) and in supersession of the Export of Egg and Egg Products (Quality Control and Inspection and Monitoring) Rules, 2019 except as respects things done or omitted to be done before such supersession, the Central Government hereby makes the following rules, namely:-

(1) Short title and commencement: (a) These rules may be called the Export of Egg and Egg Products (Quality Control, Inspection and Monitoring) Rules, 2021.

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

(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) “Annexure” means an annexure appended to these rules;

(c) “Batch” means a quantity of egg products which have been prepared under the same conditions and in particular treated in single continuous operations;

(d) “Competent Authority” means any one of the Export Inspection Agencies at Mumbai, Kolkata, Kochi, Delhi and Chennai established under section 7 of the Act;

(e) “consignment” means a quantity of egg or egg products for a single delivery to one destination for further processing by the food industry or intended for direct human consumption;

(f) “country of Destination” means the country to which egg products are dispatched from India;

(g) “country of Despatch” means India;

(h) “Merchant Exporter” means an exporter who buy the egg or egg products from the approved egg processing plants under these rules for the purpose of exports;

(i) “farm of production” means Farm supplying eggs intended for manufacture of egg products or direct human consumption;

(j) “potable Water” means water that has been approved by State Health Authority or other Agency or Laboratory acceptable the Competent Authority as safe for drinking and suitable for food processing;

(k) “incubator reject” means an egg that has been subjected to incubation and has been removed from incubation during the hatching operations as infertile or otherwise unhatchable.

(l) “label” means a display of any printed, graphic or other method of identification upon the shipping container if any, or upon the immediate container;

(m) “pasteurise” means subjecting of each particle of egg products to heat or other treatments to destroy harmful viable microorganisms by such processes as may be laid down by these rules;

(n) “plant” means any premises where eggs are packed or egg products are processed;

(o) “processing” means manufacturing of egg products, including breaking eggs or filtering, mixing, blending, pasteurizing, stabilising, cooling, freezing or drying or packaging egg products at plants approved by the Competent Authority;

(p) “sampling” means the act of taking samples of any product for inspection or analysis;

(q) “sanitise” means the application of bactericidal treatment which is approved as being effective in destroying microorganisms, including pathogens;

(r) “shipping Container” means any container used in packaging a product;

(s) “stabilisation” means the subjection of any egg product to a desugaring processing;

(t) “white or albumen” means for the purpose of this part, the product obtained from the egg as broken from the shell and separated from the yolk;

(u) “condition” means any condition (including but not limited to the state of preservation, cleanliness, soundness, wholesomeness or fitness for human food) of any product which affects its merchant ability or any condition, including but not being limited to the processing handling or packaging which affects products;

(v) “container” or “Package” includes any box, can, tin, plastic or other receptacle, wrapper or cover.

(3) Basis of compliance.- (i) It shall be the responsibility of the processors to ensure that the egg or egg products intended for exports are handled, processed at all stages of production, storage and transport under proper hygienic conditions so as to meet the health requirements laid down under these rules and that the products conforms to the specifications given in the Order of the Central Government issued in exercise of the powers conferred by section 6 of the Act in this regard.

(2) For effective monitoring of the scheme Council shall issue necessary instructions in this regard from time to time.

(4) Procedure for Quality Control, Inspection and Certification.-(1)An exporter intending to export egg or egg products may,-

(a) apply for the approval of its establishment where the intended egg or egg product is prepared or processed as per Food Safety Management System based Inspection system ,applicable for export to all countries; or

(b) follow the consignment-wise inspection applicable for export to countries other than European Union subject to the requirements of the importing countries from time to time.

(2) (i)The exporter covered under clause (a) of sub-rule (1) intending to export egg or egg product shall apply to the nearest office of the Export Inspection Agency(established under sub-section(1),of section 7 of the Act) for approval of its establishment including their facility to store or handle or transportation or process or pack egg or egg products for exports.

(ii) It shall be the primary responsibility of exporter that the establishment for which the application under this rule has been made, ensures that the egg and egg products intended for export are prepared , processed and preserved at all stages of production, storage and transport based on good manufacturing practices and good hygiene practices and the food products intended to export confirms to the standard specification recognised by the Central Government under section 6 of the Act, and any other restrictions imposed by the Central Government or, as the case may be, the State Government in respect to commercial, environmental or conservation measure, from time to time.

(iii) The Export Inspection Agency shall, on satisfying itself on the basis of assessment carried out in the manner laid down by the Council, that the establishment meets the requirements with regards to nature of activities carried out, accord an approval to the establishment and issue the certificate of approval:

Provided that the approval shall be valid for a period of three years and the establishment shall be assessed for consideration for renewal of approval on request:

provided further that if the Export Inspection Agency is not satisfied, it shall refuse to grant the approval to the establishment and communicate such refusal in writing within a period of ten days from the date of assessment to the establishment along with the reasons therefore.

(iv) The Export Inspection Agency shall, ensure that the establishments approved under this rule, continue to comply with the requirements by regular quality control, Inspection and monitoring of the establishments for which the Export Inspection Agency shall at all times have free access to all parts of the establishments and records pertaining to the control exercised by the establishment for hygienic handling and processing of food products during all staged of production, storage and transport.

(v) The Council shall maintain the list of all approved establishments, each of which shall have an Official number.

(vi) The Export Inspection Agency shall take necessary steps to ensure that egg and egg products exported by approved establishments comply to following requirements, namely:-

(a) they have been obtained from hens, ducks, geese, turkeys, guinea fowls or quail eggs, but not a mixture of eggs of different species;

(b) they have been an indication of the percentage of egg ingredient they contain when they are partially supplemented by other food stuffs;

(c) they have been treated and prepared in an approved plant which complies with Annexures I and II and satisfy the requirements of these rules;

(d) they have been prepared under hygiene conditions complying with Annexures III and V from eggs meeting the requirements laid down in Annexure IV;

(e) they have undergone a treatment process which enables them to meet inter alia the analytical specifications laid down in Annexure VI;

(f) they have undergone a health check in accordance with Annexure VII;

(g) they have been packed in accordance with Annexure VIII;

(h) they have been stored and transported in accordance with Annexures IX and X;

(i) they have meet the requirements of importing regulatory authorities;

(j) samples for laboratory examination are taken in order to check the analytical specifications as set out in Part I of the Annexure VI;

(k) egg products that may not be kept at the ambient temperature are transported or stored at the temperature stipulated in Annexures IX and X;

(l) the period during which the conservation of egg products is assured as indicated by the processor;

(m) theresult of the various checks and tests are recorded and kept for presentation to the competent authority for a period of three years.

(n) to detect any residues of substances having a pharmacological or hormonal action and of antibiotics, pesticides, detergents and other substances which are harmful or which might alter the organoleptic characteristics of egg and egg products or make their consumption dangerous or harmful to human health;

(o) if the egg products examined show traces of residues in excess of the permitted levels fixed they shall not be allowed either for the manufacture of foodstuffs or for direct human consumption;

(p) tests for residues shall be carried out in accordance with proven and scientifically recognised methods;

(q) having satisfied itself that the plant meets the requirements with regards to the nature of the activities it carries out, the competent authority shall accord approval to such plant;

(r) the Competent Authority may take the assistance of a representative each from Agricultural and Processed Food Products Export Development Authority (APEDA), Food Safety and Standards Authority of India, Directorate of Marketing and Inspection (DMI), Ministry of Food Processing Industries, Department of Animal Husbandry and Dairying under Ministry of Fisheries, Animal Husbandry and Dairying Veterinary College or Institute in the matter of approval of processing plants;

(s) the Competent authority shall draw up a list of the approved plants each of which have an official number and the competent authority shall furnish to appropriate authorities the list of approved plants and subsequent change thereof;

(t) the inspection and monitoring of plant and packaging centres shall be carried out regularly by the competent authority which shall at all times have free access to all parts of the plant in order to ensure that these rules are being observed;

(u) the Council may seek the assistance of the Agricultural and Processed Food Products Export Development Authority (APEDA) or any other organisation approved by it for residue monitoring.

(3) (a) Any exporter covered under clause (b) of sub-rule (1) and intending to export egg and egg product shall submit an intimation in the laid down proforma by giving particulars of consignment intended to be exported to the nearest office of the Agency to carry out the consignment wise inspection.

(b) Every intimation under clause (a) shall be given,-

(i) not less than three days before the inspection is to be carried out at the establishment situated at the same station where the office of the agency is located; and

(ii) not less than five days before the inspection is to be carried out at the Establishment which is not situated at the same station where the officers of the agency is located.

(c) On receipt of the intimation under clause (a), the Agency shall inspect the consignment of egg and egg product meant for export by inspection and drawing samples for testing.

(d) The agency on satisfying itself that the consignment of the egg and egg product conforms to the standard specifications recognised for the purpose on the basis of inspection and testing carried out in the manner laid down by the Council, shall issue the health certificate declaring such consignment is fit for human consumption and export worthy and shall also issue veterinary certificate, if requested by the exporter, in the specified pro forma desired by importing country:

Provided that it shall be lawful for the Agency to supervise, oversee and secure compliance of the requirement of the above provision and refuse to issue certificate in respect of egg product in any form intended for export not complying with the requirement and communicate such refusal in writing within a period of five days from the date of inspection along with the reason therefore.

(e) The Agency shall have right to reassess the quality of the consignment in storage, transit or at the ports, after issuance of any type of certificate and in the event of consignment being found not conforming to the standard specification, at any stage, the certificate originally issued shall be withdrawn.

(f) Inspection for the purpose of these rules shall be carried out at any premises of the exporter or processor and the applicant shall ensure that adequate facilities for the purpose exist therein.

(5) CERTIFICATION.-The Competent Authority shall also issue health certificates and other certificates on request from the processor or exporter after satisfying itself that the requirements of the relevant standards are met.

(6) FEE.- (i) A fee of five thousand rupees shall be paid by the processer along with the application for approval of the egg and egg processing plant.

(ii) In case processing plant is approved by Agency, a monitoring fee at the rate of 0.20 percent of free on board (F.O.B) value shall be paid by the processor or the exporter to the concerned Export Inspection Agency with a maximum of twenty five lakhs rupees per annum per exporter or processor.

(iii) In case of Consignment Wise Inspection (CWI), a fee at the rate of 0.40 percent of free on 00.9 95 board (F.O.B) value shall be payable subject to a minimum of five hundred rupees per consignment of egg or egg products to the Agency.

(iv) The amount of monitoring fee for each consignment payable by the exporter shall be rounded, off to the nearest rupee and for this purpose, where such amount contains a part of fifty paise or more, it shall be increased to one rupee and if each part is less than fifty paise, it shall be ignored.

(7) The Competent Authority shall take necessary measures as specified in the Act, if the requirement ceases to be met and the Council shall issue necessary instructions.

(8) APPEAL.- (i) Any person aggrieved by the ,-

(a) decision of the Competent Authority for not to accord approval;

(b) decision of the Competent Authority to withdraw approval;

(c) refusal of Competent Authority to issue Health or Veterinary Certificate,

may prefer an appeal within forty- five days from the date on which the decision or order is served on such person to an Appellate Authority appointed by the Central Government.

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

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

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

[F.No. K-16012/ 15/2019-Export Inspection]
DIWAKAR NATH MISRA, Jt. Secy.

ANNEXURE I

GENERAL CONDITIONS OF APPROVAL AND OPERATION

1. ESTABLISHMENTS SHALL POSSESS AT LEAST,-

1. in areas where eggs are stored and where egg products are manufactured or stored:

(1) water proof flooring which is easy to clean and disinfect, rat proof and laid in such a way as to facilitate the draining of water and the water shall be channelled towards drains fitted with gratings and traps to prevent odours;

(2) smooth, durable, impermeable walls, with a light coloured, washable coating up to a height of at least two meters and upto at least storage height chilling or refrigeration rooms and in stores. Wall to floor junctions must be rounded or similarly finished in such a way as to facilitate cleaning;

(3) doors should be of material that does not deteriorate and if made of wood than it should with a smooth and impermeable covering on both sides;

(4) ceiling which are easy to clean and which have been built and finished in such a way as to prevent the accumulation of dirt and the formation of mould the possible peeling of paint-work and the condensation of water vapour;

(5) adequate ventilation and if necessary good steam extraction;

(6) adequate natural or artificial lighting;

(7) as near as possible to the work stations;

(8) an adequate number of facilities for the cleaning and disinfecting of hands and the cleaning of equipment with hot water. Taps shall not be operable by hand or the arms. For the cleaning of hands these facilities shall be provided with hot and cold running water premixed to a suitable temperature, cleaning and disinfecting products and hand towels which can be used once only;

(9) Facilities for the disinfection of tools shall be provided.

2. An appropriate number of changing rooms, with smooth, impermeable and washable walls and floors, washbasins and flush lavatories. The latter, shall not give directly on to the work-area. Wash-basins shall have hot and cold running water or water premixed to suitable temperature materials for cleaning and disinfecting hands, and hand towels which can be used once only. Wash-basin taps shall not be hand operable. There shall be a sufficient number of wash-basins close to the lavatories.

3. A separate area and adequate facilities for cleaning and disinfecting fixed and mobile containers and tanks. However, this area and these facilities shall not be required if there are provisions for the cleaning and disinfecting of containers and tanks at other centres.

4. Facilities for the supply of potable water. However, facilities supplying non- potable water are authorised for steam production, fire fighting and the cooling of refrigeration equipment, provided that the pipe installed for this purpose preclude the use of such water for other purposes and present no risk of contamination to the egg products. The steam and water concerned may not come in to contact with the egg or be used for cleaning or disinfecting containers, plant or equipment which comes into contact with egg products. Pipes carrying non-potable water must be clearly distinguished from those carrying potable water.

5. Appropriate equipment for protecting against pests such as insects and rodents.

6. Equipment, couplings and instruments or their surfaces which are intended to come into contact with egg products must be made of smooth material which is easy to wash, clean and disinfected, resistant to corrosion and does not transfer substances to the egg products in such quantities as to endanger human health, cause deterioration in the composition of the egg products or adversely affect their organoleptic characteristics.

ANNEXURE II

SPECIAL CONDITIONS FOR THE APPROVAL OF PLANT

In addition to the general conditions laid down to Annexure I establishments shall have at least,-

1. Suitable rooms large enough for the separate storage of the eggs and the finished egg products where necessary with refrigeration equipment to keep the egg products at the appropriate temperature cold stores must be equipped with a thermometer or a remote recording thermometer.

2. Where dirty eggs are used facilities for washing and disinfecting the eggs a list of products authorized for performing this disinfection shall be drawn.

3. (i) a special room with appropriate facilities for breaking eggs collecting their contents and removing the parts of shell and membrane;

(ii) a separate room for operations other than those referred to in (i). Where egg products are pasteurized, pasteurization may be carried out in the room referred to in (i), when the establishment has a closed pasteurization system; in other cases pasteurization shall be carried out in a separate (room referred to (ii)). In the latter case every step must be taken to prevent the contamination of egg products after their pasteurization.

4. Suitable facilities for in-plant conveying of egg contents.

5. In the cases, provided for in these rules, equipment approved by the competent authority for the treatment of egg products, fitted at least with,-

(i) in the case of pasteurization,-

—Automatic temperature control;

—A recording thermometer control;

—An automatic safe device preventing insufficient heating;

(ii) in the case of a continuous pasteurization system the equipment shall also be fitted with,-

(a) adequate safety system preventing the mixture of pasteurized egg products with incompletely pasteurized egg products; and

(b) an automatic safety recording device preventing the aforementioned mixture.

6. A separate room for the storage of other food stuffs and additives.

7. Where the products are packed in disposable containers an appropriate and, if necessary, separate area for the storage of such containers and the raw materials intended for their manufacture.

8. Facilities for the immediate removal and separate storage of empty shells, and of eggs and products which are unfit for human consumption.

9. Suitable equipment for the hygienic packaging of egg and egg products.

10. To carry out analysis and examinations in accordance with the requirements of these rules on raw materials and egg products, the plant must have a laboratory. If it does not then it shall secure the services of a laboratory that fulfils there requirements. In the latter case, it shall inform the competent authority accordingly.

11. Where required suitable equipment for the thawing of frozen egg products which must undergo treatment and further handling in an approved plant.

12. A separate room for the storage of cleaning and disinfection of products.

ANNEXURE III

HYGIENE REQUIRMENTS RELATING TO THE PREMISES, EQUIPMENT AND STAFF

The highest degree of cleanliness shall be required of staff, premises and equipment:

1. Staff who treat or handle eggs and egg products must in particular, wear clean working clothes and headgear. They shall wash and disinfect their hands several times in the course of each working day and on each working day and on each resumption of work. It shall be forbidden to smoke, eat, spit and chew in area where eggs and egg products are handled and stored.

2. No animal should enter in the plant. Any rodents, insects or other vermin found shall be systematically destroyed.

3. Premises, equipment and instruments used for working on egg and egg products shall be kept clean and in a good condition. Equipment and instruments shall be carefully cleaned and disinfected several times if necessary during the working day, at the end of the day’s work and before being reused where they have been soiled. Closed pipeline systems for conveying egg products must be provided with an appropriate cleaning system which ensures their cleaning and disinfection in all parts. After having been cleaned and disinfected, pipes shall be rinsed out with potable water.

4. Premises, instruments and equipments must not be used for purpose other than the processing of egg products except the processing of other foodstuffs either simultaneously or at different times after the authorisation of the competent authority has been obtained, provided that all appropriate measure are taken to prevent contamination of or adverse changes in the products covered by these rules.

5. Portable water shall be used for all purposes, however non-potable water may be used in exceptional cases for steam production provided that the pipes installed for this purpose preclude the use of this water for other purposes and present no danger of contamination of eggs or egg products. In addition, the use of non- potable water may be authorized in exceptional cases for the cooling of refrigeration equipments, Non-potable water pipes shall be clearly distinguished from pipes used for potable water.

6. Detergents, disinfectants and similar substances shall be used and stored in such a way that instruments, equipment and egg products are not adversely affected. Their use shall be followed thorough rinsing of such instruments, equipment with potable water.

7. Persons who are possible sources of contamination shall be prohibited from working with or handling eggs or egg products.

8. Any person employed to work or handle eggs or egg products shall be required to produce a medical certificate. The medical certificate shall be renewed yearly unless another staff medical checkup scheme offering similar guarantees is recognised by the Competent Authority.

ANNEXURE IV

REQUIREMENTS CONCERNING EGGS INTENDED FOR THE MANUFACTURE OF EGG PRODUCTS

1. Eggs used for the manufacture of egg products shall be put up in suitable packaging.

2. (i) For the manufacturing of egg products, only non-incubated eggs which are fit for human consumption may be used and their shells shall be fully developed and contain no breaks:

(ii) by way of derogating from (i), cracked eggs may be used for the manufacture of egg products provided they are delivered directly from and the farm of production to an approved plant and where they shall be broken as quickly as possible.

3. Eggs and egg products which are unfit for human consumption shall be removed and denatured in such a way that they cannot be re-used for human consumption.

4. They shall immediately be placed in the room provided for in item(8) of Annexure- II.

ANNEXURE V

SPECIAL HYGIENE REQUIREMENTS FOR PRODUCING EGG AND EGG PRODUCTS

All operations shall be carried out in such a way as to avoid all contamination during the production handling and storage of egg products and in particular,-

1. Egg and Egg products presented for subsequent treatment at an approved plant shall be stored immediately on arrival in the rooms provided for in item (1) of Annexure-II I until they are processed. The temperature of these rooms shall be such as to ensure that they are not contaminated. Trays of shall eggs should not be placed directly on the floor;

2. Eggs shall be unpacked and if necessary, washed and disinfected in a room which is separate from the breaking room, packaging material should not be taken into the breaking room.

3. Eggs shall be broken in the room provided for in of item 3(i) of Annexure-II cracked eggs as mentioned in item 2(ii) of Annexure-IV shall be processed without delay.

4. Dirty eggs shall be cleaned before being broken; this must be carried out in a room which is separate from the breaking room or from any room where exposed egg contents are handled. Cleaning procedure shall be such as to prevent contamination or adulteration of the egg contents. Shells shall be sufficiently dry at the time of breaking to prevent adulteration of the egg contents by the remains of the cleaning water.

5. Eggs other than hen eggs or those of turkeys or guinea fowl shall be handled and processed separately. All equipment shall be clean and disinfected when processing of hen eggs and those of turkeys and guinea fowl is resumed.

6. Breaking, whatever procedure is used, shall be carried out in such a way as to avoid as far as possible contamination of the egg contents. To that end, the contents of egg may not be obtained by the centrifugation or crushing of eggs, nor may centrifugation be used to obtain the remains of shells or membranes shall be kept out of the egg product as far as possible and must not exceed the quantity specified in item 3(iii) of Annexure-VI.

7. After breaking, each particle of egg product shall undergo treatment as quickly as possible; heat treatment consists of treating the egg product at an appropriate temperature for an appropriate period in order to eliminate any pathogenic organisms present. During heat treatment temperatures shall be registered continuously. The records of each batch having undergone treatment shall be kept at the disposed of the competent authority for three years. A batch which has been insufficiently treated may immediately undergo treatment again in the same plant provided that the new treatment renders it fit for human consumption should be found to be unfit for human consumption it must be denatured in accordance with item 3 of Annexure-IV.

8. Where treatment is not carried out immediately after breaking the egg contents shall be stored under satisfactory hygienic conditions either frozen or at a temperature of not more than four degree Celsius. The storage period at four degree Celsius must not be exceeding forty eight hours, except in the case of ingredients to be desugared:

9. They shall be packaged checked, transported and handled in accordance with the requirements of these rules

10. The processing operations after treatment shall ensure that there is no recontamination of the egg products: liquid products or concentrated products which have not been stabilised so as to keep at room temperature must be either dried or cooled to a temperature not exceeding four degree Celsius immediately, or after undergoing a fermentation process; products for freezing must be frozen immediately after treatment.

11. Egg products shall be kept at the temperatures required by these rules until they are used for the manufacture of other foodstuffs.

12. In approved plants, the preparation of egg products from raw materials which are not suitable for the manufacture of foodstuffs is prohibited even for non-food purposes.

ANNEXURE VI

ANALYTICAL SPECIFICATIONS

1. MICROBIOLOGICAL CRITERIA:

All batches of egg or egg products shall after treatment undergo microbiological checks by sampling in treatment plants in order to guarantee that they meet the following criteria, namely:-

(i) Salmonellae absence in 25 g or ml of egg products;

(ii) Other Criteria:

(i) Mesophilic aerobic bacteria: M=105 in 1g or 1ml,

(ii) Enterobactriacene: M=102 in 1g or 1ml,

(iii) Staphylococci product: absence in 1g of egg products

(iv) M= value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more sample units if M or more.

2. OTHER CRITERIA:

All batched of egg or egg products must undergo checks by sampling in treatment establishments in order to guarantee that they meet the following criteria, namely:-

(i) the concentration of 3 OH-butyric acids must not exceed 10mg/kg in the dry matter of the unmodified egg products;

(ii) in order to ensure the hygienic handling eggs and egg products before treatment, the following standard shall apply, namely:-

(a) the lactic acid content shall not exceed 1000 mg/kg of egg products dry matter (applicable only to the untreated products);

(b) The zucchini acid content shall not exceed 25 mg/kg of egg products dry matter;

(c) in the case of fermented products, however, these values are those recorded before the fermentation process;

(iii) the quantity of egg shell remains, egg membrane and any other particles in the egg produce shall not exceed 100 mg/kg of egg product;

(iv) the residual quantities of the substances may not exceed the tolerances limits.

ANNEXURE VII

HEALTH CONTROL AND SUPERVISION OF PRODUCTION

1. Plants shall be subject to supervision by the Competent Authority. Supervision by the Competent Authority shall include any supervision measures considered necessary to ensure that manufactures of egg products meet the requirements of these rules, and in particular,-

(a) checks on the origin of eggs and the destination of egg products and of the records;

(b) inspection of eggs intended for the manufacture of egg products;

(c) inspection egg products on dispatch from the plants;

(d) verification of the cleanliness of the premises, facilities and instruments and of staff hygiene;

(e) taking of any samples required for laboratory tests to ensure that eggs and egg products comply with the requirements of these rules the results of such test such tests shall be entered in a register and notified to the egg products manufacturer;

2. At the request of the Competent Authority, manufactures of egg products shall increase the frequency of the laboratory tests where this is considered necessary to ensure hygiene production of the egg products;

ANNEXURE VIII

PACKAGING OF EGG AND EGG PRODUCTS

1. Egg and Egg product shall be packaged in satisfactory hygiene conditions so as to ensure that they are not contaminated.

2. Containers shall comply with all rules of hygiene, including the flowing, namely :-

(a) They shall not be such to impair the organoleptic characteristics of the egg products;

(b) They shall not be capable of transmitting to the egg products substances harmful to human health.

(c) They shall be strong enough to protect the egg product the egg products adequately.

2. The room in which containers are stored shall be dust and vermin free and material for making disposable containers shall not be stored on the floor.

3. Containers used for egg products shall be cleaned prior to being filled; re- useable for making disposable containers shall be stored on the floor.

4. Containers shall be brought into the work room in a hygienic manner and shall be used without undue delay.

5. Immediately after packaging, the containers shall be closed and placed in the storage rooms referred to in item (I) ofAnnexure-II.

6. Containers intended for egg products may be used for other foodstuffs if required, provided they are cleaned and disinfected so as not to contaminate the egg products.

7. Containers which are to be used for the transport of egg products in bulk shall comply with all the rules of hygiene, and in particular the flowing, namely:-

(a) their inside surfaces and any other part which may come into contract with the egg product shall be made of a smooth material which is easy to wash, clean and disinfect, resists corrosion and does not transfer substances to the egg product in such quantities as to endanger human health, cause deterioration in the composition of the egg product or adversely affect its organoleptic characteristics;

(b) they shall be designed so that the egg product can be removed completely, if they are fitted with taps, these must be easy to remove, dismantle, wash, clean and disinfected;

(c) they shall be washed, cleaned, disinfected and rinsed immediately after each use and if necessary, before re-use;

(d) they shall be appropriately sealed after being filled and remain sealed during transportation until they are used;

(e) they shall be reserved for the transport of egg products.

ANNEXURE IX

STORAGE

1. Egg and Egg products shall be stored in the storage rooms referred to in item I of Annexure-II.

2. Egg and Egg products for which certain storage temperatures are required shall be maintained at those temperatures. This storage temperatures shall be recorded continuously, the cooling rate shall be such that the products reached the required temperatures as quickly as possible and the containers shall be stored in such a way that air can freely circulate round them.

3. The temperature in storage must not exceed the following values, namely:-

(a) deep frozen products -18 Degree Celsius;

(b) frozen products -12 Degree Celsius;

(c) chilled products + 4 Degree Celsius;

(d) dehydrated products (excluding egg whites) -15 Degree Celsius.

ANNEXURE X

TRANSPORT

1. Vehicles and containers for the transport of Egg and Egg products shall be designed and equipped in such way that the temperature required by these rules can be maintained continuously throughout the period of transport.

2. Egg and Egg products shall be dispatched in such a way that they are adequately protected during transportation from anything which may be detrimental to them.

3. The temperature prescribed in item(3) of Annexure –IX, shall be maintained during transport.

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