SPS TBT Barriers
MAMTA RANI
ASSISTANT DIRECTOR
06 september 2011
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About Us
• Export (QC&I) Act, 1963 – The Act governing
quality of exports
• EIC set up to advise Govt. on measures for sound
development of exports through QC & I to include
notification of standards & certification systems
• Powers of Central Government under the Act
 Notify commodities for compulsory PSI
 Specify standards for export and type of QC & I
 Establish or recognize Agencies for QC & I
• Nearly 1000 commodities were notified.
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EIC (CA)-STRUCTURE
• Apex Body – Council, Chairman, 18 members,
Member Secretary- Director, EIC
• Specialist Committees
• EIC – The Central Competent Authority
 CEO Director, office at Delhi
 Regional Competent Authorities– 5 EIAs at Mumbai,
Kochi, Kolkata, Delhi and Chennai, under administrative &
technical control of EIC
 28 Sub-offices & labs
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SYSTEMS OF EXPORT
INSPECTION &
CERTIFICATION
• Consignment wise inspection
• In-Process Quality Control
• Self-Certification
• Approval and monitoring of processing
and manufacturing units based on food
safety management systems such as
GMP/ GHP / HACCP.
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EIC-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 RiceEC)
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
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
RECOGNITIONS
•
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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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Our website
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SPS/TBT Measures
SPS/TBT
Application
Protection of Human/animal/Plant
Life (indirect effect on
environment/quality control)
Additives, Contaminants, toxins or disease
causing organisms in their food, beverages,
feedstuffs; plants or animal carried diseases
(zoonoses), pests, diseases or disease
causing organisms, effect/damage to
country by the entry , establishment or
spread of pests
Basis – Scientific risk Assessment
Doesn’t apply to SPS measures,
government procurement.
Goods
National security
requirements, prevention of
deceptive practices, protection
of human health (not covered
in SPS), environment.
Meeting quality standards &
other conformity assessment
requirements
Basis: Legitimate objective
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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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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 Harmonization
SPS 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.cf
m
• EFSA - responsible for the safety assessment.
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Benefits of RMP
implementation
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
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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- RCA
Responsibilities 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:
•
•
•
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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 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 /
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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 ( reconfirmation).

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
consumption.
is
safe
for
human
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 HC
1.
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
•
•
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•
•
•
•
•
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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 All Farms
Farm
Base
Assurance
standard
Crops Base Fruit & vegetables
Combinable crops
Flower & Ornamentals
Green Coffee
Tea
Live –
Cattle &
Dairy
stock base Sheep
Pig
Poultry
Aquacultur Salmon
e base
Shrimps
Tilapia
Feed Manufacture standard
Propagation Material standard
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Live- stock
Transport
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 Criteria
 Certification Process
 Certification 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
o
o
o
o
Selection of farms for GAP certification
Assigning identification number to the different units of the farm
Establish legal identity & registration
Selection of certification model depending upon nature of operation
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/auditors
o Conducting internal evaluation and appraisal of the system by trained
farm inspectors
o Taking corrective action and improving the situation
o 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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