Guidelines for Certificate of Compliance for Aquaculture Inputs

2068 GI/202 4 (1) EXTRAORDINARY PART II —Section 3 —Sub-section ( ii) PUBLISHED BY AUTHORITY No. 1390] NEW DELHI, SATURDAY , MARCH 1 6, 2024 /PHALGUNA 26, 1945 CG-DL-E-18032024-253201 (1) (2) (3) 1. 2. 3. 4. 5. (1) (2) 1. 2. 3. 4. 5. (1) (2) 1. 2. 3. 4. 5. MINISTRY OF FISHERIES, ANIMAL HUSBANDRY AND DAIRYING (Department of Fisheries ) NOTIFICATION New Delhi, the 15th March , 2024 S.O. 1 456(E).— In pursuance of section 3 of the Coastal Aquaculture Authority Act, 2005 (24 of 2005) , read with clause (e) of rule 3 of the Coastal Aquaculture Authority Rules, 2024 , the Central Government hereby notifies the following guidelines, namely: - 1. Short t itle and commencement. – (1) These guidelines may be called the Guidelines for certificate of compliance for aquaculture inputs. (2) They shall come into force from the date of their publication in the Official Gazette. Guidelines for Certificate of Compli ance for Aquaculture Inputs 1. Certificate of compliance. - (1) The certificate of compliance for aquaculture inputs shall be issued, if - (a) it is free from such pharmacologically active substance, antimicrobial agent or other material which may cause harm to human health as specified by an order of the Authority under section 12A of the Coastal Aquaculture Authority Act, 2005 and rule 18 of Coastal Aquaculture Authority Rules, 2024 ; (b) complies with the standards specified by the Authority under rule 18 of the s aid rules, (hereinafter referred to as the said rules). (2) All coastal aquaculture inputs made available or used in coastal aquaculture activities, except those specifically exempted by the Authority from the requirement of certification shall have valid certificate of compliance issued under sub -rule ( 6) of rule 18 of the said rules.. (3) All coastal aquaculture inputs that have not obtained certificate of compliance, shall submit the application for grant of certificate within six months from the date of publication of this notification in the official Gazette and shall comply with all requirements within one year from such date. (4) Both Indian manufacturers and importers or distributors of overseas aquaculture inputs and other supplements f or aquaculture use shall obtain a certificate of compliance from the Authority. (5) A certificate of compliance shall not be transferrable. (6) The certificate of compliance shall be valid for a period of five years from the date of issue which shall be renewable for a similar period in the manner specified in paragraph ( 8). (7) A non -refundable processing fee of ten thousand rupees (Rs. 10,000/-) for each application shall be paid either electronically or in the form of demand draft drawn in favour of the Coastal Aquaculture Authority. 2. Labelling standards, - (1) The labels on packages or containers of aquaculture inputs in addition to other statutory requirements on labelling, without any duplication, shall contain particulars specified in sub -paragraph (4), and displayed at a conspicuous position on the container in which the substance is packed and every other covering in which that container is packed. (2) The labels shall clearly indicate the basic composition of the aquaculture input, dosage, batch n umber, expiry date and other important details as specified in sub-paragraph ( 4), provided that brochures shall be mandatory in case the label has limited information. (3) The portion in the label showing content shall not contain generic terms like, vitam ins, minerals, essential nutrients etc., instead, specific scientific name of vitamins, minerals, etc., shall be mentioned; (4) The label shall contain but not limited to the following particulars, in the following manner namely: - (a) name of the aquaculture input : Trade name of the aquaculture input shall be in capital letters or prominent font as mentioned in the certificate of compliance issued by the Authority; (b) net quantity of contents : (i) A correct statement of the net content in terms of weight, measu re, volume, number of units of contents and number of units of activity, as the case may be, shall be indicated. (ii) The indicated values shall be in Metric system; (c) name and composition of ingredients : Scientific name of all major ingredients of the aqua culture input shall be mentioned with approximate concentration, composition expressed in appropriate unit, as applicable; (d) recommendations for use : The label shall clearly indicate the intended benefit, prescribed dosage and schedule of application to achi eve the desired benefit; (e) method of application : (i) Method of application of aquaculture input as feed top dressing, broadcasting throughout the pond or any other method shall be provided; (ii) Pre-treatments like, soaking in water or overnight fermentat ion, if any before application shall be clearly mentioned; (iii) This can be limited to brochure to save space in the label and brochure is compulsory with such aquaculture input; (f) contraindications (if any) : Information not suitable with any other aquacult ure input or not to be used in particular culture systems, species or growth stages shall be clearly indicated with pictorial representation in the label. (g) batch number : (i) A distinctive traceable batch number in which the aquaculture input was produced a t the manufacturing unit shall be indicated on the label; (ii) The details of such batches and retention sample shall be available at the manufacturing facility or distribution unit or warehouse facility for traceability; (iii) The figure representing the batch number shall be prefixed with ‘Batch No’; (h) import licence number (if imported) : Aquaculture inputs manufactured with imported ingredients and aquaculture inputs as a whole imported and marketed in India shall bear on the label, the license number or Sanitary Import Permit number, wherever applicable, under which the aquaculture input is imported, prefixed with ‘Import License Number’ or Sanitary Import Permit number and contact details of the company importing and marketing the aquaculture input shall also be clearly mentioned; (i) manufacture date: The date of manufacture shall be in terms of month and year; (j) expiry date: (i) The date of expiry shall be in terms of month and year and it shall mean that the aquaculture input is recommended till the last da y of the month. (ii) The date of expiry shall be prefixed with ‘Expiry date’. (iii) It required, “Best Before” in terms of month and year shall be indicated depending on the aquaculture inputs; (k) storage conditions: Appropriate storage conditions like cool, dark place, avoiding from sun light etc., required to maintain the potential of the aquaculture input till the expiry date shall be mentioned clearly; (l) indication of ‘Not for Human Consumption’: The label shall have ‘Not for Human Consumption’ in the botto m strip with bigger font size to avoid any possible consumption by humans; (m) indication of ‘Aquatic Animal Use Only’: The label shall bear a SYMBOL depicting an appropriate image of the aquatic animals for which the aquaculture input is to be administered; (n) name and address of manufacturer and Importer: Complete name and address of the manufacturer and importer shall be provided as submitted to the Coastal Aquaculture Authority including the name of the place or village, taluk, district, state and the PIN code ; (o) Indication ‘Does not contain antibiotics” or “Free from Antibiotics” : The label shall have ‘ Does not contain antibiotics’ or ‘Free from Antibiotics’ in the bottom strip with bigger font size conspicuously displayed in a box with distinct colour; (p) certif ication number: Every aquaculture input except those exempted by the Authority under sub -rule ( 3) of rule 18 of the said rules, manufactured or marketed in India shall bear on its label the certification number issued by the Authority for that aquaculture input with a caption in bold letters as “CAA Certified Aquaculture Input” or any water mark as may be specified by the Authority. 3. Certification process. – (1) Separate application for each aquaculture input shall be made in Form -III of the said rules fo r grant of certificate of compliance for that aquaculture input, which may be downloaded from Authority website – www.caa.gov.in and shall be submitted along with all required documents as specified in Schedule -III of the said rules. (2) Only the manufacturers of aquaculture inputs and other supplements for aquaculture use shall be eligible to apply for the certificate of compliance, if such aquaculture inputs are manufactured in India. (3) Only the importer of the aqu aculture inputs and other supplements for aquaculture use shall be eligible to apply for grant of certificate of compliance. (4) All documents as required by the Authority shall be submitted before completion of sixty calendar days from the date of receipt of application by the Authority failing which the application shall be closed as defective under intimation to the applicant and the processing fee of rupees ten thousand shall be forfeited and deposited in the Authority’s accounts. (5) The application s hall be submitted afresh, if the earlier application is closed as defective. 4. Details of documents required under Schedule III, - (1) The following documents shall be commonly required for both manufacturers and importers, namely: - (a) antibiotic test repor t of the aquaculture input in ORIGINAL for test done not earlier than a month from the date of submission of application, for the presence of antibiotics, their parent compounds and metabolites specified by the Authority from any National Accreditation Boa rd for Testing and Calibration Laboratories accredited Government or private laboratory with a scope for testing said antibiotic residues using Liquid Chromatography with tandem mass spectrometry method; (b) retention sample of not less than 500 grams or 500 milligram of each aquaculture input from each batch of manufacturing or importing shall be retained at the manufacturing or distribution unit for a period not exceeding the expiry of such aquaculture input and the documentary evidence such as scanned copy o f the latest page of the sample retention record for each aquaculture input which shows the details of the latest sample stored and photographs of such storage facility and furnish declaration in Form -E-1. (2) All the certified aquaculture inputs shall be subjected to a random testing by Authority at least once before the expiry of its certification; (3). The manufacturer may design their own seal or tamper proof mechanism to ensure the same is not duplicated by any other party and it shall be mentioned in the application to the Authority by the applicant to confirm the genuineness of the aquaculture input while sampling. (4) In the case of aquaculture inputs manufactured in India, any application for certificate of compliance shall be accompanied with the following documents in addition to those specified in sub -paragraph ( 1), namely: - (a) Details of company/firm, as under: - (i) company incorporation proof (Address proof for company); (ii) Micro, Small and Medium Enterprises; and (iii) Goods and Services Tax certificate . (b) Details of the manufacturing facility, as under: - (i) certificate of registration of the manufacturing unit or factory etc., from the competent authority; (ii) licence to work as factory; (iii) proof of any facility certification; (iv) any process cert ification such as International Organization for Standardization or Best Aquaculture Practices or Good Manufacturing Practice or Hazard Analysis Critical Control Points etc. (c) other documents, as under: - (i) detailed process flowchart which shall be, but not limited to the checkpoints that are linked with testing process as a part of the in -process quality control system adopted by the manufacturer in the production (ii) process certification that ensures antibiotic free production or a notarised self -declara tion in Form -E-2 for antibiotic free ingredients as well as production process; (iii) list of records maintained in the unit pertaining to the aquaculture input and production process; (iv) in case the aquaculture input is manufactured under an agreement (3) as merchant manufacturer, in a facility not owned by the applicant, copy of such agreement shall be submitted and in such case, the responsibility of compliances shall be on both the parties . (5) In the case of aquaculture inputs imported from abroad, every application for certificate of compliance shall be accompanied with the following documents in addition to those specified in sub - paragraph ( 1), namely: - (i) proof of registration of the importing company in India such as certificate of incorporatio n, importer licence, Micro, Small and Medium Enterprises, Goods and Services Tax, etc.; (ii) health certificate or veterinary certificate from the competent authority showing antibiotic - free status of the aquaculture input while importing or any antibiotic -free certificate from competent authority of the country of origin and in the absence of such certificate, a duly notarised declaration from the manufacturer in Form -E-2; (iii) details or list of records maintained by the importer on the imported aquacult ure inputs, the originals of which may be produced on demand; (iv) copy of authorisation for distributing the aquaculture input or copy of the agreement between the overseas principal manufacturer and Indian importer; (v) manufacturing process stepwise (Fl ow chart) along with testing procedures followed within the unit or any such relevant document from the overseas manufacturer; (vi) any process certification such as International Organization for Standardization or Best Aquaculture Practices or Good Manuf acturing Practice or Hazard Analysis Critical Control Points from the overseas manufacturer; (vii) proof of any facility certification. 5. Renewal of certificate of compliance . - (1) Application in Form -III of the said rules shall be submitted for renewal of certificate of compliance for aquaculture inputs three months before the expiry of such certificate with a non -refundable processing fee for ten thousand rupees (Rs. 10,000/-) shall be paid either electronically or in the form of demand draft drawn in favour of the Coastal Aquaculture Authority, along with the following documents as specified in Schedule -III of the said rules, namely; - (i) antibiotic test report of the aquaculture input in ORIGINAL for test done not earlier than a month from the date of sub mission of application, for the presence of antibiotic, their parent and metabolites from any National Accreditation Board for Testing and Calibration Laboratories accredited Government or private laboratory with a scope for testing said antibiotic residue s using Liquid Chromatography with tandem mass spectrometry method; (ii) revised labels and brochures, in case of change, if any, in compliance with the requirements specified in paragraph ( 5); (iii) a notarised self -declaration in Form -E-3. (2) In case any deficienc y in the application is observed by the Authority, the rectification or additional documentary requirements shall be submitted within forty -five calendar days before the expiry of such certification failing which the application shall be closed as defectiv e and the processing fee of ten thousand rupees (Rs. 10,000/-) shall be forfeited and deposited with the Authority’s account under intimation to the applicant. (3) Upon satisfactory compliance with the requirements of this paragraph, the Authority shall renew the certificate of compliance within a period of sixty days from the date of receipt of the application by it. 6. Enforcement mechanism. - (1) There shall be an inspection committee headed by the Director Technical of the Authority including represen tatives from the following institutions, namely: - (i) Sub Divisional or District Level Committees or Department of Fisheries of State concerned; (ii) representative for Central Drugs Standard Control Organisation not below the rank of Assistant Drug Inspec tor; (iii) representative from Marine Products Export Development Authority; (iv) representative from any Indian Council of Agriculture Research Fisheries Institute in the region Central Institute of Brackishwater Aquaculture, Central Marine Fisheries Rese arch Institute and Central Institute of Fisheries Education. (2) The committee shall randomly inspect the storage or manufacturing facilities of the manufacturers or importers for conforming the compliance. (3) A task force shall be constituted by the Auth ority including representatives from the Authority, District Level Committees and the Marine Products Export Development Authority, for monitoring of aquaculture inputs manufactured or marketed in India. (4) The Task Force constituted by the Authority shal l collect aquaculture input samples randomly from manufacturing facility or storage facility, aqua shops, farms, hatcheries, etc. and the manufacturer or importer company shall reimburse the cost of the sample collected by the Authority to the facility fro m where the sample is collected. (5) In case of aquaculture inputs for which the seal or tamper proof mechanism is declared by the manufacturer, the task force shall during sampling, open the packaging of the input for ensuring the intactness of the seal o r tamper proof mechanism amalgamated with the packaging as mentioned in the application and samples shall be sealed in the presence of the task force to ensure the genuineness of the aquaculture input at the time of submission for testing. (6) The Authorit y shall empanel laboratories for testing the aquaculture inputs. (7) The person representing the Authority the task force shall submit the samples collected by task force to the laboratories empanelled and approved by the Authority and the laboratories sha ll submit the report to the Authority directly for necessary action. (8) The frequency of collection of sample and testing of a aquaculture input shall be reduced if it maintains antibiotic -free status in multiple tests conducted by the Authority over a pe riod of two consecutive years. (9) The Authority shall specify by an order, a protocol for sampling and testing, outlining the roles of the task force. (10) In case any aquaculture input is tested positive or reported by the task force or any competent aut horities under any National Regulatory Programme such as National Residue Control Plan for antibiotic residues, the certificate of such aquaculture input shall stand suspended with immediate effect and such aquaculture input shall be delisted from the act ive list of certified aquaculture inputs. (11) The Authority shall, after providing reasonable opportunities for being heard from manufacturer or importer of such aquaculture input , impose the penalties as provided under section 14 of the said Act. Form -E-1 [See paragraph 4 (1) ( b)] [To be printed on Rs. 100/- Non-judicial stamp paper] Date: DECLARATION We – (name of the company) undertake to declare that a sample not less than 500grams or 500miligrams of each aquaculture input from each batch of manufac turing is being retained for the aquaculture inputs listed below with necessary information and adequate safety and storage precautions for maintaining this input , till the expiry of its validity of the respective batch for each aquaculture input sample. Sl.No. Name of the aquaculture input Period of retention (from the date of sampling) (1) (2) (3) 1. 2. 3. 4. 5. Further, we undertake to reimburse the cost of the samples collected by Coastal Aquaculture Authority to the end user concerned . (Name of the authorised signatory with company seal) Form -E-2 [See paragraph 4(4) ( c) (ii) and 4(5) ( ii)] [To be printed on Rs. 100/- Non-judicial stamp paper] Date: DECLARATION We – (name of the company) do solemnly affirm that the ingredients used fo r the manufacturing of the following aquaculture input s are free from the antibiotics banned for use in aquaculture. We also affirm that the process with which the following aquaculture inputs manufactured are designed to produce the aquaculture input s without the inclusion of any antibiotic in any form: Sl.No. Name of the aquaculture input (1) (2) 1. 2. 3. 4. 5. Further, we do authorise the Coastal Aquaculture Authority or any person, team or committee authorised by the Authority to enter and i nspect the storage premises or manufacturing facility of the company and to collect aquaculture input samples at any time without any prior notice . (Name of the authorised signatory with company seal) Form -E-3 [See paragraph 5 (1) ( iii)] [To be printed on Rs. 100/- Non-judicial stamp paper] Date: DECLARATION We – (name of the company) do solemnly affirm that the ingredients used for the manufacturing of the following aquaculture inputs are free from the antibiotics banned for use in aquaculture. We also affirm that the process with which the following aquaculture input s manufactured are designed to produce the aquaculture inputs without the inclusion of any antibiotic in any form: Sl.No. Name of the aquaculture input (1) (2) 1. 2. 3. 4. 5. Further, we declare that the aquaculture input composition, name, period of expiry, dosage, method of application and all other aspect of the above mentioned aquaculture input , furnished at the time of certification remains the same. (Name of the authorise d signatory with company seal) [F. No. j -1903336/2/2024 -DOF (E -23648 )] NEETU KUMARI PRASAD, J t. Secy . Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.