Preamble - EXPORT OF FEED ADDITIVES AND PREMIXTURES (QUALITY CONTROL, INSPECTION AND MONITORING) RULES, 2013

EXPORT OF FEED ADDITIVES AND PREMIXTURES (QUALITY CONTROL, INSPECTION AND MONITORING) RULES, 2013

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

(a) These rules may be called the Export of Feed Additives and Premixtures (Quality Control, Inspection and Monitoring) Rules, 2013.

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

Rule 2 - Definitions

In these rules, unless the context otherwise requires,--

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

Feed additives and Premixtures before its export and the manner of registration, approval and monitoring of establishments dealing with such feed additives and premises, namely:--

(b) "Agency" means the Export Inspection Agency established under section 7 of Act, for registration, approval, monitoring, inspection or certification intended for export;

(c) "Council" means the Export Inspection Council of India;

(d) "Establishment" means any premises where Feed Additives or Premixtures or ingredients for it are prepared, processed, packaged or stored unit of a feed businesses;

(e) "Country of despatch" means India;

(f) "Country of destination" means the country to which goods are dispatched from India;

(g) "Certificate" means certificate issued under sub-section (3) of section 7 of the Act stating that the commodity conforms to the conditions regarding quality control and inspection;

(h) "Competent Authority" means Export Inspection Agencies (EIAs) at Mumbai, Kolkata, Chennai, Delhi, and Kochi established under section 7 of the Export (Quality Control and Inspection) Act, 1963 (22 of 1963);

(i) "feed additives" means substances, microorganisms or preparation, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, one or more functions;

(j) "premixtures" means mixtures of feed additives or mixture of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals;

(k) "feed materials" means various products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing additives, which are intended for use in oral animal feeding either directly as such, or after processing, in the preparation of compound feedingstuffs or as carriers of premixtures;

(l) "Microorganism" means, colony-forming microorganisms or;

(m) "feedingstuffs" means products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding;

(n) "Compound feedingstuffs" means mixtures of feed materials, whether or not containing additives, for oral animal feeding in the form of complete or complementary feedingstuffs;

(o) "Complete feedingstuffs" means mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;

(p) "Complementary feedingstuffs" means mixtures of feedingstuffs which have a high content of certain substances but which, by reason of their composition, are sufficient for a daily ration only if used in combination with other feedingstuffs;

(q) "daily ration" means the average total quantity of feedingstuffs, calculated on a moisture content of twelve percent, required daily by an animal of a given species, age category and yield, to satisfy all its needs;

(r) "Processing aids" means any substance not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfill a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed;

(s) "Veterinary medicinal product" means,--

(i) any substance or combination of substances presented as having properties or treating or preventing disease in animals;

(ii) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

(t) "animals" means animals belonging to species normally nourished and kept or consumed by man as well as animals living freely in the wild in cases where they are nourished with feedingstuffs;

(u) "antimicrobials" means substances produced either synthetically or naturally, used to kill or inhibit the growth of micro-organisms including bacteria viruses or fungi, or parasites, in particular protozoa;

(v) "antibiotics" means antimicrobials produced by, or derived from, a micro-organism, which destroys or inhibits the growth of other micro-organisms;

(w) "coccidiostats and histomonostats" means substances intended to kill or inhibit protozoa;

(x) "maximum residual limit" means the maximum concentration of residue from the use of an additives in animal nutrition which may be accepted by the community as being legally permitted or recognized as acceptable in or on a food.

Rule 3 - Basis of compliance

(1) It shall be the primary responsibility of the processors to ensure that the feed additives and premixtures intended for exports are handled and processed at all stages of procurement, production, storage, packing and transport under proper hygienic conditions so as to meet the health requirements laid down in these rules as per international standards and that the product conforms to the specifications recognized in the Order published by the Central Government under section 6 of the Act and any statutory restrictions imposed by the State Government or Central Government with respect to commercial or environmental or conservation measures.

(2) The competent authority shall ensure that the processor, manufacturer and exporter comply with the requirements by regular monitoring of the registered and approved establishment as the control measures prescribed in the rule 4.

(3) The Council shall, for the purpose of effective inspection, quality control and certification, issue necessary instructions from time to time.

Rule 4 - Conditions and procedure for quality control, inspection and monitoring

1) The applicant shall have the facility in India and shall comply with any statutory restrictions imposed by the State Government or Central Government with respect to commercial or environmental or conservation measures.

2) The establishment shall have implemented own-check system based on Good Manufacturing Practice, Good Hygienic Practice, Hazard Analysis and Critical Control Point or any other internationally accepted relevant quality management system to ensure elimination or reduction of the hazards and risks identified and specified in the standards.

3) The product shall be in compliance to the requirements and standards of the importing country where it is destined for:

(a) provided that the establishment shall-- demonstrate compliance with respect to the required infrastructure and equipment facilities, procedures and records in place;

(b) exercise proper control measures at all stages of production, storage and transportation of feed additives and premixtures;

(c) identify and maintains traceability at all stages of storage, handling and processing of the product including raw material sourcing and maintains appropriate records therefore;

(d) have procedure in place in case of non-compliance due to test results, rejection at any time including from importing country.

4) The product shall meet--

a) the standards and requirements set out in these rules, including the general conditions set out in the First Schedule to these rules, unless otherwise provided for in the registration or approval of the establishment, and in the certification of the product as per the importing country's requirements;

b) the labeling standards set out in the second schedule to these rules unless otherwise provided by importing country.

Rule 5 - Establishment to obtain registration or approval

1) A processor or manufacturer intending to export feed additive and premixtures shall apply in writing to the nearest Agency, as per the instructions issued by the Council, from time to time, for registration or approval of the establishment including the facility to process, manufacture and pack the feed additives and premixes.

2) The applicant shall, for the purpose of registration and approval of the establishment, submit a declaration accordingly in the form set out Third Schedule to these rules.

3) The applicant shall apply for registration or approval, as the case may be, for each of its activity as specified in the Fourth Schedule to these rules.

4) The Agency shall, on satisfying itself, on the basis of declaration along with supporting documents submitted by the applicant and inspection and such testing carried out in the manner laid down by the Council, that the establishment meets the requirements specified in these rules and any other instructions issued by the council, from time to time, grant registration or approval, as the case may be, to such establishment:

Provided that if the establishment decides to carry out activities other than those for which it has received registration or approval, as the case may be, specific registration or approval from the Agency shall be obtained for that purpose:

Provided further that if the Agency is not satisfied, it shall refuse to grant the registration or approval, as the case may be, to the establishment and communicate such refusal in writing to the establishment along with the reasons therefor;

5) The Agency shall ensure that the establishments registered or approved under this sub-rule, continue to comply with the requirements by regular inspection, quality control and monitoring of the establishments for which the 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 stages of production, storage and transport.

6) The Agency shall take necessary measures if the establishment ceases to meet the requirement, which may include refusal, renewal, modification, suspension, withdrawal of the registration or approval, as the case may be, granted to the establishment, as per the instructions issued by the Council from time to time.

Rule 6 - Suspension or revocation or modification of registration or approval of establishment

(1) The Agency may, its own initiative based on international and national requirements or following a request received from a competent authority of importing country, modify, suspend or revoke the registration or approval, as the case may be, granted to the establishment, with the prior approval of the Council.

(2) The Council shall examine the proposal of the Agency and decision on the modification, suspension or revocation of a registration or an approval shall be taken in accordance with the procedure.

(3) If the establishment proposes any change by submitting an application to the Agency, accompanied by the relevant data supporting the request for the change, the Agency shall carry out assessment and, on being satisfied itself, grant registration or approval, accordingly.

Rule 7 - List of establishment

The Council shall maintain the list of all registered and approved establishments, each of which shall have an official number.

Rule 8 - Establishment to comply with conditions and restrictions

(1) Every establishment shall comply with the conditions or restrictions, which have been imposed.

(2) Every establishment, where monitoring requirements have been imposed, shall ensure that monitoring is carried out and submit reports to the Agency and it shall forthwith communicate to the Agency,--

(a) any new information that might influence the evaluation of the safety in use of the feed additive, in particular health sensitivities of specific categories of consumers;

(b) any prohibition or restriction imposed by the competent authority of the importing country to which the feed additive is exported.

Rule 9 - Renewal of registration and approval of establishment

(1) The registration or approval, as the case may be, granted to an establishment shall be renewable an expiry of every two years.

(2) An establishment shall make an application to the Agency, for renewal of registration or approval as the case may be, along with desired particulars and documents including the information on safety and a proposal for amending or supplementing the conditions, if any, at the latest four months before the date of expiry of the registration or approval, as the case may be.

(3) The Agency shall, on satisfying itself that the establishment this requirement of these rules and that the establishment has not contravened any provision of these rules or conditions laid down on the registration or approval, renew the registration or approval, as the case may be.

(4) The provisions of rule 5 relation to registration and approval shall, mutatis mutandi, apply to renewal of registration and approval.

Rule 10 - Provisional approval of export of an additive

In specific cases, where urgent registration or approval is required based on assessment and request from the competent authority of importing country, the Agency, with the prior approval of the Council, may provisionally approve the export of an additive for a period not exceeding of three months.

Rule 11 - Conditions of registration or approval

(1) No feed additive shall be registered or approved for export unless the applicant for such registration or approval has adequately and sufficiently demonstrated meeting the requirements specified in these rules and conditions specified in the instructions issued by the Council, from time to time, for the export of the additive.

(2) The feed additive shall satisfy the requirements of sub-rule 3 and shall bear at least one of the characteristics specified in sub-rule 4.

(3) The feed additive or premixtures shall not.--

(i) have an adverse effect on animal health, human health or the environment;

(ii) be presented in a manner which may mislead the user;

(iii) harm the consumer by impairing the distinctive features of animal products or mislead the consumer with regard to the distinctive features of animal products.

(4) The feed additive or premixtures shall.--

(i) favorably affect the characteristics of feed;

(ii) favourably affect the characteristics of animal products;

(iii) favourably affect the colour of ornamental fish and birds;

(iv) satisfy the nutritional needs of animals;

(v) favourably affect the environmental consequences of animal production;

(vi) favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs; or

(vii) have a coccidiostatic or histomonostatic effect.

(5) Antibiotics, other than coccidiostats or histomonostats, shall not be registered or approved as feed additives or its premixtures.

Rule 12 - Categories of feed additives

(1) A processor and manufacturer shall be registered or approved to export one or more of the following feed additive categories, depending on its functions and properties, in accordance with the procedure specified in Annexure IV, namely:--

(i) technological additives, that is to say, any substance added to feed for a technological purpose;

(ii) sensory additives, that is to say, any substance, the addition of which to feed improves or changes the organoleptic properties of the feed, or the visual characteristics of the food derived from animals;

(iii) nutritional additives;

(iv) zootechnical additives, that is to say, any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment;

(v) coccidiostats and histomonostats.

(2) (a) processor or manufacturer shall be registered or approved, as the case may be, to export feed additives within one or more of the functional groups categorized in sub-rule (1), according to its principal function or functions.

(3) Where appropriate, the applicant shall specify the requirements of the feed additives for food-producing animals or other animals, in particular pets.

Rule 13 - Certification

(1) The Agency shall authorize the registered or approved processor or manufacturer for the issuance of certificate for export of additives and premixtures, on payment of the fee specified in rule 14, and after satisfying itself that the requirements of the standards applicable to such additive and premixtures are met.

(2) On request from the processor or exporter along with applicable fee, for issuance of any other relevant certificate, the Agency shall issue the same after satisfying itself that the requirements of the standards are met.

Rule 14 - Fee

(1) Every application for registration or as the case may be, approval of the establishment or shall accompany a fee of five thousand rupees payable by a bank draft.

(2) The processor or manufacturer or exporter shall pay a monitoring fee to the Agency at the rate of 0.2 per cent of fee on board value of export subject to a minimum of two thousand rupees per consignment of feed additives or premixtures.

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

Rule 15 - Appeal

a) Any person aggrieved by the decision of the Competent Authority, either not to accord it approval as per sub-rule (4) of rule 5 of this notification or to withdraw approval as per sub-rule (6) of rule 5 of this notification or not to issue certificate of export or any other relevant certificate as per rule 13 may prefer an appeal within 15 days of the receipt of such communication to an Appellate Authority appointed by Central Government.

b) The Appeal shall be disposed of within 15 days of its receipt.

Schedule I - SCHEDULE I

FIRST SCHEDULE

[See rule 4 (4) (a)]

General Conditions of Use

1. The quantity of additives which also exists in the natural state in certain feed materials shall be calculated so that the total of the elements added and the elements present naturally does not exceed the maximum level provided for in the registration or approval, as the case may be.

2. Mixing of additives shall be permitted only in premixtures and feedingstuffs where there is physico-chemical and biological compatibility between the components of the mixture in relation to the effects desired.

3. Supplementary feedingstuffs, diluted as specified, may not contain levels of the additives which exceed those fixed for complete feedingstuffs.

4. In the case of premixtures containing silage additives the words "of silage additives" shall clearly be added on the label after 'PREMIXTURE'.

Schedule II - SCHEDULE II

SECOND SCHEDULE

[See rule 4 (4) (b)]

Labelling and packaging of feed additives and premixtures

1. The packaging or container of a feed additive or a premixture of additives for export shall be labelled by packer or producer with all information as desired by the importing country's requirements and international standards, in a conspicuous, clearly legible and indelible manner, in English and if desired, in the language of the country of destination.

2. The labelling information shall include the following, namely:-

(a) the specific name given to the additives upon registration or approval, preceded by the name of the functional group as mentioned in the registration or approval, as the case may be,

(b) the name and the address or registered office of the registered or approved establishment and the exporter;

(c) the net weight or, in the case of liquid additives and premixtures, either the net volume or the net weight;

(d) where appropriate, the approval number or registration number assigned by the Agency to the establishment;

(e) directions for use, and any safety recommendations regarding the use and, where applicable, the specific requirements mentioned in the registration or approval, including animal species and categories for which the additive or premixture of additives is intended;

(f) the identification number;

(g) the batch reference number and date of manufacture in the format 'DD/MM/YY'.

3. For flavouring compounds, the list of additives may be replaced by the words 'mixture of flavouring compounds'. This shall not apply to flavouring compounds subject to a quantitative limitation when used in feed and drinking water.

4. Moreover, in the case of premixtures, the word 'PREMIXTURE' (in capital letters) must appear clearly on the label, and the carrier substance must be declared and, where water is used as a carrier, the moisture content of the premixture shall be declared. Only one minimum storage life may be indicated in respect of each premixture as a whole; such minimum storage life shall be determined on the basis of the minimum storage life of each of its components.

5. Additives and premixtures shall be exported only in closed packages or closed containers which must be closed in such a way that the fastener is damaged on opening and cannot be re-used.

6. In addition to the information specified in "2" above, packaging or container of certain feed additives and for premixtures belonging to a functional group shall bear specific information on the labels as follows:

(1) Zootechnical additives, coccidiostats and histomonostats:

(a) the expiry date of the guarantee or the storage life from the date of manufacture,

(b) the directions for use, and

(c) the concentration;

(2) Enzymes, in addition to the abovementioned indications:

(a) the specific name of the active component or components in accordance with their enzyme activities, in conformity with the authorisation given,

(b) the International Union of Biochemistry identification number, and

(c) instead of concentration: units of activity (units of activity per gram or units of activity per milliliter);

(3) Micro-organisms:

(a) the expiry date of the guarantee or the storage life from the date of manufacture,

(b) the directions for use,

(c) the strain identification number, and

(d) the number of colony-forming units per gram;

(4) Nutritional additives:

(a) the active-substance level, and

(b) the expiry date of the guarantee of that level or storage life from the date of manufacture;

(5) Technological and sensory additives with the exception of flavouring compounds: the active substance level;

(6) Flavouring compounds: the incorporation rate in premixtures.

Schedule III - SCHEDULE III

THIRD SCHEDULE

[See rule 5 (3)]

Functional Groups of Additives in Different Categories

1. Functional groups in Technological additives category:

2. Functional groups in Sensory additives category:

3. Functional groups in Nutritional additives category:

(a) vitamins, pro-vitamins and chemically well-defined substances having similar effect;

(b) compounds of trace elements;

(c) amino acids, their salts and analogues; and

(d) urea and its derivatives.

4. Functional groups in Zootechnical additives category:

(a) digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through action on target feed materials;

(b) gut flora stabilisers: micro-organisms or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora;

(c) substances which favorably affect the environment; and

(d) other zootechnical additives.