SPS TBT Barriers

1. SPS TBT Barriers Export Inspection Agency - Delhi

2. SPS/TBT

3. Residue Monitoring System • Residues • Substances having pharmacological action (both prohibited and permitted substances) (SUBSTANCES HAVING ANABOLIC EFFECT AND UNAUTHORISED SUBSTANCES, VETERINARY DRUGS (1) AND CONTAMINANTS) • Metabolites of substances • Substances transmitted to animal products (Heavy metals, pesticides, toxins, PCBs, dioxins, etc.) • Substances formed by biological action (bacterial toxins, aflatoxins, etc.)

4. Residue Monitoring System • Preventing prohibited substances getting into the food chain, which are harmful or likely to be harmful to human health. • Monitoring of substances which are harmful or likely to be harmful to human health to ensure that the level is within the prescribed limit (based on scientifically established risk analysis) in the particular food.

5. Systems of Residue Control NRCP :EIC is implementing through MPEDA in aquaculture products RMP : EIC’s Annual Residue Monitoring Plans (RMP). Implemented by EIC in Egg Products, Milk Products, poultry meat products and honey

6. Why NRCP and RMP? • WTO Agreement: • SPS Agreement: Compliance of Sanitary and Phyto-Sanitary requirements of importing country. • TBT Agreement: No importing country should impose Technical Barrier to Trade. The important requirement for global food trade is Food Safety (The food free from health hazards). Consumer is entitled for safe, sound and wholesome food free from any physical, chemical and microbiological hazards • Requirement of Harmonization SPS and TBT agreements require National Standards to Harmonize with International ones

7. NRCP and RMP • Objective: • Monitoring and insurance of the acceptable residue levels of drugs, pesticides and contaminants in the food products. • Detection of any illegal treatment (s) • Establishing a system of corrective action in the event of detection of residues higher that the prescribed limits by issuing alert information and follow up visits • To ensure that the food products exported from India meet the prescribed regulatory requirements of the importing countries. • Scope: • Animals or animal origin products and processing meant for export by the approved processing establishments having implemented HACCP based own check system.

8. NRCP/RMP for EU • To fulfill the requirements of EU • EC is responsible to ensure high level of human health protection through Food & Feed regulations. • EU food safety policy as 178/2002/EC for food and feed with integrated "farm to fork" approach, aims to harmonise existing national requirements in order to ensure the free movement of food and feed in the EU. • For import from third countries, - EC seeks guarantees equivalent to EC requirements on residues of veterinary drugs, pesticides and contaminants

9. Basis of animal origin products • Council Directive 96/23/EC dated 29.04.1996 – requirements in relation to the planning and execution of national residue control plans (NRCP) for live animals and products of animal origin • Commission Regulation (EC) No. 136/2004 – authorizes CAs of member states of EU to test samples for residues at BIPs (Border Inspection Posts) • Directive 97/78/EC - EU or the individual member state may reinforce checks at the point of import on identification of residue problem • As per the Council Directive 96/23/EC, residue monitoring requirements for third countries wishing to export food of animal origin to the EU are met including the requirements stipulated in the Council Directive 96/22/EC as amended by Council Directive 2003/74/EC

10. NRCP/RMP for EU • Council Directive 86/363/EEC and Commission Regulation (EC) 1881/2006 - Maximum Residue Levels (MRLs) for a wide range of pesticides and maximum levels (MLs) for certain environmental contaminants, respectively. • Annual submission – RMP for each food commodity from third countries to EC, (plans + previous year results by the 31st March every year) • Approval of Plan by EC- listed in the Commission Decision 2004/432/EC, (updated). • According to the last update India is eligible for export the products of aquaculture, eggs to EU.

11. Basis for plant products • In the EU, as from 1 September 2008, a new legislative framework (Regulation (EC) No 396/2005 of the European Parliament and of the Council) on pesticide residues is applicable, covering approximately 1100 pesticides currently or formerly used in agriculture in or outside the EU. It lists MRLs for 315 agricultural products. These MRLs also apply to processed products, adjusted to take account of dilution or concentration during processing. • To access the database, http://ec.europa.eu/sanco_pesticides/public/index.cfm • EFSA is responsible for the safety assessment, which is based on the properties of the pesticide, on the maximum levels expected on food and on the different diets of European consumers

12. Benefits of implementation of RMP Food products of animal origin • Supplier / farmer - food safety measures - safe food products • Establishment - controls / monitoring over farmer / supplier at primary production, storage and transportation levels. • All the stakeholders in the food chain - safe food products for human consumption • FP meant for export - free from prohibited substances. • Permitted level of Veterinary drugs / pharmacologically active substances, Pesticide residues, Heavy metals, etc. would be monitored. • Increase in Demand of safe food products – Increase in Export earning • Farmers - benefited from safe production - employment and earnings

13. NRCP – Salient features Implemented by MPEDA • EIC - CCA • Sampling from aquaculture farms and testing, as per schedule - by MPEDA • Test results compiled and submitted to EIC. • In case of failure of sample, if any, EIA concerned will initiate appropriate action to find root cause and prevent recurrence. • EIA furnishes action taken report to EIC

14. RMP – Salient features Implemented by EIC • EIC – CCA, EIA- CA Responsibilities of processors • Responsibility - The processor ensure that the registered feed mills supplying feed to the producers / farmers and farms / producers supplying animal products) – records – EIA M.O Sampling Procedure: • Multiple sampling of same matrix from same source - avoided • The Representative samples - traceable to source of farm / producer • Samples - collected and secured in clean and inert containers & labelled • Details of samples should be recorded. • Samples should be sent to designated EIA lab/ EIC approved lab under controlled conditions.

15. RMP – Salient features Analysis and handling of samples: • The sample - secured storage at appropriate storage condition. • Analysis - as per the protocol given in the RMP by EIC. • Remaining samples - stored securely at appropriate condition. • Initial test - positive, the remaining sample shall be analysed for confirmation of results. • The test results shall be reported in the prescribed format • In case of failure, the results communicated immediately to the EIA concerned

16. RMP – Salient features • Corrective Action in case of failure of samples: • Processor to be kept on ‘Internal On-Alert’ and advisory issued to exporters, for; • Identification of the exact source • Stop procurement of raw material from the source. • Refrain from exporting the products processed from the identified source • Find the root cause for the failure of the samples from the identified source • Take corrective actions to prevent recurrence • Review the HACCP and revise if necessary • Conduct regular training for farmers / producers / suppliers to prevent recurrence

17. RMP – Salient features • Corrective Action in case of failure of samples: (Contd.) • Assessment by the EIA official to find out the source and root cause of the contamination including backward linkages and assists in identifying preventative measure to stop the recurrence • The live stock concerned and the product is kept under official control • The source producer/farm is subjected to more checks

18. RMP – Salient features • Provision for re-testing of positive samples • Re-testing of the positive samples - on request from the unit for re-confirmation. • The control sample shall be tested in two different EIA labs./ EIC approved labs other than one tested earlier. • The result shall be treated as positive even if one of the two samples is found to be positive on re-testing. • In case both the samples pass the MRL requirement on re-testing, the concerned EIA shall withdraw internal alert , which shall take effect from that date. • Recording and reporting: • All records relevant to planning, sampling and testing shll be maintained at EIAs. • monthly / quarterly summary in the prescribed format shall be submitted by the Sub-office to the EIA concerned • The EIA concerned shall submit the compiled monthly summary to EIC in the prescribed format.

19. Issuance of Health Certificates • What is HC? - a document for a consignment of food product certifying that the consignment has been processed under proper sanitary and hygienic conditions and that the food product is safe for human consumption. issued by a competent authority, acceptable to the health authority of the importing country, • Who demands? – Importing countries insist on Health / Veterinary / Sanitary / Phytosanitary • Why ? - provides confidence to the health authorities of the importing country • Issuing authority: Competent authority specified by the importing country. • For F&FP meant for export to EU, the CA is Export Inspection Council of India. • For F&FP meant for countries other than EU, EIA issues HC • Some countries accept HC issued by official veterinary authorities • EIAs issue HC for F&FP consignments meant for EU on behalf of EIC using the official rubber stamp (seal) of EIC • If an EU approved establishment obtains HC from any body other than EIC/EIA, its approval is liable to be withdrawn

20. Requisites to issue HC • On the basis of controls carried out, - on or before the date of shipment • EU does not accept HC issued after the date of shipment indicated in the Bill of Lading • On request from approved processor/exporter Note: HC is issued only for F&FP processed in establishments/factory vessels/freezer vessels approved by EIC/EIA

21. HC for consignments of F&FP meant for export to non-EU countries shall be issued by the EIA concerned in the prescribed format given at Annexure XXII(A) of EI • If any country has prescribed format of HC, the specific format will be used as required by the importing country. • HC for Australia will be in the format prescribed for the purpose

22. Formats of HC • COMMISSION REGULATION (EC) No 1664/2006 – for HONEY AND OTHER APICULTURE PRODUCTS • COMMISSION REGULATION (EC) No 1250/2008 - FISHERY PRODUCTS INTENDED FOR HUMAN CONSUMPTION • COMMISSION REGULATION (EU) No 364/2011- for egg products (EP) • Multilingual HC format is used for EU • English/French/Italian for UK/France/Italy/Luxembourg/Belgium/Ireland • English/Swedish/Danish/Finnish for UK/Sweden/Denmark/Finland • English/German/Dutch for UK/Germany/Netherlands/Austria • English/Spanish/Greek/Portuguese for UK/Spain/Greece/Portugal HC is prepared in triplicate: Original (White) for importer; Duplicate (Pink) for HO; Triplicate (Blue) for office record

23. Certificate of Analysis for Aquaculture Shrimps meant for export to Japan • If processor/exporter approach EIA for testing consignments of Aquaculture Shrimps meant for export to Japan for Antibiotic Residues including Nitrofuran Metabolites, the samples shall be drawn by an authorised EIA officer and the same shall be tested in EIA lab under its jurisdiction. However, the parameters which cannot be tested in EIA lab, may be got tested in EIC approved labs. The cost of testing to be borne by the processor. • Format of Certificate of Analysis to be issued is given at Annexure XXVIII of Ex. Instructions.

24. Best Agriculture Practices in export • Reforming agriculture and making the produce internationally competitive in quality & food safety. • Green revolution – uncontrolled usage of chemical fertilizers, irrigation water & pest control products – adverse environment impact, degradation & increased salinity in soil, deforestation and depletion of water resources.

25. GAP- role in export • Structured methodology, innovative technology without its adverse impact on environment, health & safety of people. • GAP – collection of principles – on farm production, post production processes – • - integrated pest management • - integrated fertilizer management & • - conservation agriculture

26. Basic elements of GAP • Farm selection & Farm management • Rational use & application of pesticides • Judicious use of fertilizers • Soil conservation & soil management • Irrigation & water conservation • Integrated pest management • Produce storage & handling • Pre – harvest application of pesticides • Harvesting practices

27. Basic elements of GAP Contd…. • Post harvest treatment • Workers health, safety & welfare • Traceability – from farm to fork/back tracking from fork to farm, batch/lot recall • Protection of environment

28. Standardization of good agricultural Practices • GlobalGAP - key reference for GAP in global market place- GLOBALGAP Secretariat • GlobalGAP standards cover entire range of agriculture including animal husbandry & fisheries – (next slide) • Consists of set of normative documents covering GLOBALGAP general regulations, the GLOBALGAP control points & Compliance criteria and the GLOBALGAP checklist.

29. GLOBALGAP Standard Structure