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EXPORT INSPECTION AGENCY - DELHI Residue Monitoring System Residue Monitoring System Issuance of Health Certificate Issuance of Health Certificate GAP including ethical practices GAP including ethical practices in export in export MAMTA RANI MAMTA RANI ASSISTANT DIRECTOR ASSISTANT DIRECTOR 06 September 2011 06 September 2011 06/15/22 1

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Page 1: EXPORT INSPECTION AGENCY - DELHI Residue Monitoring System Issuance of Health Certificate GAP including ethical practices in export MAMTA RANI ASSISTANT

EXPORT INSPECTION AGENCY - DELHI

Residue Monitoring SystemResidue Monitoring SystemIssuance of Health CertificateIssuance of Health Certificate

GAP including ethical practices in GAP including ethical practices in exportexport

MAMTA RANIMAMTA RANIASSISTANT DIRECTORASSISTANT DIRECTOR06 September 201106 September 2011

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EXPORT INSPECTION AGENCY - DELHI

About Us• Export (QC&I) Act, 1963 – The Act governing Export (QC&I) Act, 1963 – The Act governing

quality of exportsquality of exports• EIC set up to advise Govt. on measures for sound EIC set up to advise Govt. on measures for sound

development of exports through QC & I to development of exports through QC & I to include notification of standards & certification include notification of standards & certification systemssystems

• Powers of Central Government under the ActPowers of Central Government under the Act Notify commodities for compulsory PSINotify commodities for compulsory PSI Specify standards for export and type of QC & I Specify standards for export and type of QC & I Establish or recognize Agencies for QC & IEstablish or recognize Agencies for QC & I

• Nearly 1000 commodities were notified.Nearly 1000 commodities were notified.

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EIC (CA)-STRUCTUREEIC (CA)-STRUCTURE• Apex Body – Council, Chairman, 18 members,Apex Body – Council, Chairman, 18 members,

Member Secretary- Member Secretary- Director, EICDirector, EIC

• Specialist Committees Specialist Committees • EIC – The Central Competent AuthorityEIC – The Central Competent Authority

CEO Director, office at DelhiCEO Director, office at Delhi Regional Competent Authorities– 5 EIAs at Mumbai, Regional Competent Authorities– 5 EIAs at Mumbai,

Kochi, Kolkata, Delhi and Chennai, under Kochi, Kolkata, Delhi and Chennai, under administrative & technical control of EICadministrative & technical control of EIC

28 Sub-offices & labs28 Sub-offices & labs

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EXPORT INSPECTION AGENCY - DELHI

SYSTEMS OF EXPORT SYSTEMS OF EXPORT INSPECTION & INSPECTION & CERTIFICATIONCERTIFICATION

• Consignment wise inspectionConsignment wise inspection• In-Process Quality Control In-Process Quality Control • Self-CertificationSelf-Certification

• Approval and monitoring of Approval and monitoring of processing and manufacturing processing and manufacturing units based on food safety units based on food safety management systems such as management systems such as GMP/ GHP / HACCP.GMP/ GHP / HACCP.

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EIC-ROLE IN WTO REGIMEEIC-ROLE IN WTO REGIME

• Regulatory role to address health & safety concerns of importing countries compulsory certification for Marine products, Egg products,

Milk products, Honey products, Poultry Meat products etc. • Voluntary export certification – Tea, F&V, Spices,

Basmati Rice• Equivalence Agreements/MOUs with trading partners for

recognition of EIC’s certification• Certificate of Health (Food items), Authenticity (Basmati

Rice-EC)• Laboratory Testing

Support for Export Inspection & Certification Commercial testing (facilities extended to industry) Import testing of food items-EIA Labs identified by MoH&FW

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EIC - ROLE IN WTO REGIME EIC - ROLE IN WTO REGIME CONTD….CONTD….

• Training and technical assistance to industry to upgrade to International standards

• Represent India’s interests in International standards bodies/ WTO - views based on practical experience

• Continuous dialogue with importing countries for problem solving on non-tariff related issues

• Problem oriented research – studies on issues related to quality of Indian exports

• Maintain information database on regulatory requirements of trading partners

• Issue of Certificates of Origin under various preferential tariff schemes for duty concessions for exporters by foreign customs

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INTERNATIONAL INTERNATIONAL RECOGNITIONSRECOGNITIONS• EC - CA for marine products and issuance of authenticity

certificate for basmati rice; egg products, dialogue on for dairy products, poultry meat & honey

• Italy- MOU for marine products.• USA (USFDA) - recognized for Black Pepper; initiated dialogue for

others.• Australia (AQIS) - recognized for marine products –seeking for

dairy products, spices etc.• Sri Lanka (SLSI) - recognized for 85 products regulated by Sri

Lanka (food, cement, engineering items, electrical appliances, milk products etc.

• Singapore – The MRA’s covers Food & Agriculture.• Korea- Recognized for certifying food products• Japan- Recognized for certifying F& FP, Poultry products• Russia – Recognized for Marine Products Others - Other EU countries, Canada, Argentina etc- under

negotiation

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EXPORT INSPECTION AGENCY - DELHI

Our website (www.eicindia.org)

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SPS/TBT

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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.)

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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.

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Basis of Residue Monitoring

• GoI Notifications on products of animal origin:

EXPORT INSPECTION AGENCY - DELHI

S.O. 729(E) & S.O. 730(E) both dated 21st August 1995

Fish and Fishery Products

S.O. 1377 (E) & S.O. 1378 (E) both dated 30th 121212December 2002

Fresh Poultry Meat and Poultry Meat Products

S.O. 276 (E) & S.O. 277 (E) both dated 4th March 2002

Honey

S.O. 2719 & S.O. 2720 both dated 28th November 2000

Milk Products

S.O. 2077 & S.O. 2078 both dated 4th August 1997

Egg Products

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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

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Why NRCP and RMP?

• WTO Agreement:1. SPS Agreement: Compliance of Sanitary and Phyto-Sanitary

requirements of importing country- setting up country specific standards based on risk assessment & scientific evidences, Harmonization, Transparency, Mutual recognition

2. TBT Agreement: No importing country should impose Technical Barrier to Trade.

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 HarmonizationSPS and TBT agreements require National Standards to Harmonize with International ones

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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.

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NRCP/RMP for EU• To fulfill the requirements of EU

– EC is responsible to ensure high level of human health protection through its 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

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Basis of animal origin products

Council Directive 96/23/EC dated 29.04.1996, stipulated in the Council Directive 96/22/EC as amended by Council Directive 2003/74/EC – requirements in relation to the planning and execution of national residue control plans (NRCP) for live animals and products of animal origin (third countries)

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

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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.

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Basis for plant products

• In the EU, as from 1 September 2008, a new legislative framework (Regulation (EC) No 396/2005 on pesticide residues is applicable,

• Covering approx. 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 - responsible for the safety assessment.

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Benefits of RMP implementationFood 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

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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. Also, furnishes action taken report to EIC

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RMP – Salient features

Implemented by EIC - EIC – CCA, EIA- RCAResponsibilities of processors- To 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• Samples should be sent to designated EIA lab/ EIC

approved lab under controlled conditions.

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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

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RMP – Salient features

Corrective Action in case of failure of samples:

Processor to be kept on ‘ 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 sourceFind the root cause for the failure of the samples

from the identified sourceTake corrective actions to prevent recurrenceReview the HACCP and revise if necessaryConduct regular training for farmers / producers /

suppliers to prevent recurrence

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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

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RMP – Salient features

• Provision for re-testing of positive samples Re-testing of the positive samples - on request from the unit ( re-

confirmation). The control sample - tested in two different EIA labs/ EIC approved

labs other than one tested earlier. The result to 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 to be

maintained at EIAs. monthly / quarterly summary in the prescribed format to be

submitted by the Sub-office to the EIA concerned, in the end to EIC

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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.

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Health Certificates

• Who demands? – Importing countries insist on Health / Veterinary / Sanitary/ Phyto-sanitary .

• Why ? - provides confidence to the health authorities of the importing country

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Health Certificates• Issuing authority?: Competent authority

specified by the importing country.

– Export Inspection Council of India – CA for F&FP meant for export to EU, countries other than EU.

– EIA issues HC on behalf of EIC using the official rubber stamp (seal) of EIC

– Some countries accept HC issued by official veterinary authorities.

– If an EU approved establishment obtains HC from any– body other than EIC/EIA, its approval is liable to be

withdrawn

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Requisites to issue HC

• On request from approved processor/exporter

• On the basis of controls carried out, - on or before the date of shipment

• HC not issued after the date of shipment (indicated in the Bill of Lading)

Note: HC is issued only for F&FP processed in establishments/factory vessels/freezer vessels approved by EIC/EIA, likewise milk products, egg products, honey etc.

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Requisites to issue HC• HC for consignments of F&FP meant

for non-EU countries to 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. For e.g. Australia

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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)

HC is prepared in triplicate: Original (White) for importer; Duplicate (Pink) for HO; Triplicate (Blue) for office record

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Formats of HC1. Multilingual HC format is used for EU

English/French/Italian for UK / France / Italy / Luxembourg / Belgium / Ireland

English/Swedish/Danish/Finnis For UK / Sweden / Denmark / Finland

English/German/Dutch for UK / Germany / Netherlands /Austria

English/Spanish/Greek/Portuguese

for UK/Spain/Greece/Portuga

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Certificate of Analysis for Aquaculture Shrimps meant

for export to Japan

• If processor/exporter approaches EIA - consignments of Aquaculture Shrimps meant for export to Japan

• for the samples shall be drawn by an authorized EIA officer and the same shall be tested for Antibiotic Residues including Nitrofuran Metabolites, in EIA lab under its jurisdiction.

• 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.

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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.

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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

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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

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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

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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.

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GLOBALGAP STANDARD STRUCTURE

Integrated Farm Assurance standard

All Farms Base

Crops Base

Fruit & vegetablesCombinable cropsFlower & OrnamentalsGreen CoffeeTea

Live – stock base

Cattle & Sheep

Dairy Live- stock TransportPig

PoultryAquaculture base

SalmonShrimpsTilapia

Feed Manufacture standardPropagation Material standard

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Harmonization with GLOBALGAP• Variations In Agriculture Practices –

Country/Region Wise• Agro climatic variations, Cultural practices,

regulatory framework• Two routes:- • Introducing national requirements in GLOBALGAP

Standards and getting its approval by Global GAP secretariat through National Technical working Group

• Benchmarking national standards such as IndiaGAP, MalaysiaGAP, KenyaGAP etc.- address essential elements good agriculture practices covered under GlobalGAP

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Harmonization with GLOBALGAP• In India, both the streams of standards

– under the aegis of NTWG set up by QCI and another FSSAI with assistance from QCI

• India GAP standards prepared - GAP-Basic requirements, fresh fruits & vegetables, combinable crops, green coffee, & tea

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Certification of Good Agricultural Practices

• More than 100 independent and accredited certification bodies in more than 80 countries.

• Open to all producers worldwide• FSSAI led IndiaGAP cover:Certification CriteriaCertification ProcessCertification body requirements‘Draft available at QCI website’

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Certification of Good Agricultural Practices

• NABCB (National Accreditation Board for Certification Bodies) of QCI –

• Accreditation of certification bodies based on ISO Guide 65 along with relevant scheme – GlobalGAP or IndiaGAP

• Two options: Individual certification: Multisite without

implementation of QMS, Multisite with implementation of QMS, Basic progressive model

Group certification

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Certification of Good Agricultural Practices

• Ensure conformity to standards on IndiaGAP standards IndiaGAP-Standard intending for Bench marking with GlobalGAP IndiaGAP – basic requirements (progressive in nature)

• Evaluation against control points and compliance criteria (CPCC)

• Compliance to relevant statutory and regulatory requirement applicable in area of operation

• Before certification process applicant shall:-o Selection of farms for GAP certificationo Assigning identification number to the different units of the farmo Establish legal identity & registrationo Selection of certification model depending upon nature of

operationo Training on IndiaGAP to farmers

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Certification of Good Agricultural Practices

o Establishing documented system to meet the requirements & its implementation

o Training of inspectors/auditorso Conducting internal evaluation and appraisal of the system by

trained farm inspectorso Taking corrective action and improving the situationo Appointment of certification body

• Documents for introducing IndiaGAP certification:• IGAP-01 – certification criteria (voluntary)• IGAP-02 – Certification process (voluntary)• IGAP-03- group certification (voluntary)• IGAP -04 – basic module (voluntary)• IGAP -05 – certification body requirements (voluntary)

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GAP Certification Process

Applicant → Application↓

Scrutiny Application↓

Review of application↓

Farm Inspection Audit↓

Farm Inspection Audit Report↓

Decision on certification↓

Award of certificate → surveillance → Renewal

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