traceability & other requirements by major importing blockstotal traceability ©2008 foodreg ag...

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© 2008 FoodReg AG – All rights reserved

Traceability & Other Requirements by Major Importing Blocks

Audrey YongSelamat Traceability Workshop

12‐13 May 2008

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Traceability & Other Requirements by Major

Importing Blocks

Fishery Products

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Agenda

1. Major Importing Blocks

2. Traceability Requirements

3. EU

4. USA

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1. Major Importing Blocks

EU & USA

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GDP Definition

Gross Domestic Product (GDP) • GDP, of a country is one of the ways of measuring the size of its economy

• the value of all final goods and services produced within a nation in a given year

GDP = Consumption + Gross Investment + Government Spending + (Exports − Imports)

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GDP (PPP) Definition

Purchasing Powder Parity (PPP)• the PPP theory uses the long‐term equilibrium exchange rate of two currencies to equalize their purchasing powder

GDP dollar estimates given on following pages are derived from Purchasing Powder Parity (PPP) calculations

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Major Importing Blocks

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World GDP (PPP)

List by the International Monetary Fund (2007) List by the World Bank (2005) List by the CIA World Factbook (2007)

Source: Wikipedia

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Major Importing Blocks

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2. Traceability Requirements

Other Legal Requirements

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Regulations ‐ Traceability

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Regulations ‐ HACCP

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EU ‐ Health Legislation

Source: http://ec.europa.eu/fisheries/legislation/other/food_hygiene_en.htm

Import of Fishery Products

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USA – 21 CFR 123

Source:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Fish & Fishery Products

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USA – 21 CFR 161

Fish & ShellfishSource:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

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3. EU Requirements

Fishery Products

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EU Requirements

Source: http://ec.europa.eu/food/international/trade/index_en.htm

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EU Import Conditions

•The European Commission’s Directorate‐General for Health and Consumer Protection (SANCO) is responsible for food safety in the European Union

•All imports fulfil the same high standards as products from the EU Member States ‐ with respect to hygiene and consumer safety and, if relevant, also to the animal health status

Fishery Products

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General Rules

•Imports of fishery products into the European Union are subject to official certification

•Official certification is based on the recognition of the competent authority of the non‐EU country by the European Commission

•The competent authority of a non‐EU country will only be recognized if:

•It has the necessary legal powers and resources•It is able to ensure credible inspection and controls throughout the production chain

Fishery Products

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Specific Key Elements

•Countries of origin must be on a positive list of eligiblecountries for the relevant product

• Exporting countries must have a competent authority

• Live fish, their eggs and gametes intended for breeding and live bivalve molluscs must fulfil the relevant animal health standards

•The national authorities must also guarantee that the relevant hygiene and public health requirements are met.

Fishery Products

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Specific Key Elements (continue)

•Specific conditions apply for imports of live or processed bivalve molluscs (e.g. mussels and clams), echinoderms (e.g. sea urchins) or marine gastropods (e.g. sea‐snails and conchs)

• National authorities of exporting countries are required to give guarantees on the classification of these products and the close monitoring of the production zones

•exclude contamination with certain marine biotoxins causing shellfish poisoning

Shellfish Products

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•aquaculture products, a control plan on heavy metals, contaminants, residues of pesticides and veterinary drugs must be in place to verify compliance with EU requirements

•A suitable control plan must be designed by the competent authority and submitted to the European Commission for initial approval and yearly renewal

Aquaculture Products

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•Imports are only authorised from approved vessels and establishments (e.g. processing plants, freezer or factory vessels, cold stores), which have been inspected by the competent authority of the exporting country and found to meet EU requirements

•Inspections by the Commission’s Food and Veterinary Office are necessary to confirm compliance with the above requirements.

For Fishery Products

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List of Approved CountriesFishery Products

•A list of Approved Establishments in Third Countries is:• Maintained by the European Commission•Published on its website

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List of Approved CountriesFishery Products

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List of Approved Establishments

Fishery Products

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Documentary Check

•To examine the accompanying documents•Health Certificate

•Frequency•Every consignment

• Requirements for Health Certificate• Original•Refer to an approved country•Correspond to an approved establishment•Certificate date is close to the date of despatch


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Identity Check

•To ensure that the accompanying document tally with the product itself

• Product in Health Certificate is the same as consignment

•Frequency•Every consignment

• Identity Check may include checking on• Seal of containers •Dates on the seals and the certificates tally•Country and Establishment of origin are clearly marker and tally with the certificate


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Physical Check

•To ascertain that the products comply with the requirements of EU and are fit to be used for the purpose specified in the accompanying certificate.

•Frequency•Depends on Risk Profile of Product•Results of the previous check

• Physical Check may include checking on• Checks on temperature, packaging, etc•Sensory evaluation (i.e. Appearance, Aroma, etc)•Laboratory analysis on residues, pathogen, contaminants, etc


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After Boarder Inspection

•Consignments are free to circulate in the EU if they are compliance with EU legislation, they may be

•Market as food or feed•Used for food or feed production•Used for industrial purpose•Re‐export to other countries


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What if Non Compliant?

•Consignments which are found not in compliance with EU legislation shall be

•Destroyed or•Re‐despatched within 60 days (under certain conditions)


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Rapid Alert System for Food & Feed

•It is a network

•Notification of direct or indirect risks to human health

•Deriving from food and feed

•Including Pet Food

RASFF

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News Notification

Notification Types

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Notification by CountryNotification by Country of Origin of Product

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4. USA

Fishery Products

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USA Requirements

Source: http://www.cfsan.fda.gov/~lrd/import.html

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USA Import Conditions

•The US FDA is the national regulatory body for fishery products regulation and consumer safety

•Title 21 CFR Parts Containing FDA Food Standards : •161 Fish and shellfish •http://www.gpoaccess.gov/cfr/index.html

•All imported products are required to meet the same standards as domestic goods

•Imported products must be pure, wholesome, safe to eat, produced under sanitary conditions and labelled and correctly


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Registration of Facilities

•Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food or food (subject to FDA (FDA’s jurisdiction) for human or animal consumption in the U.S.

•Foreign facilities are required to have a U.S. agent

•FDA strongly encourages electronic registration at: •http://www.access.fda.gov

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Prior Notice of Imported Food

•Unless excepted, all food for humans and animals that is imported or offered for import into the United States for use, storage, or distribution in the US

•Time prior notice must be submitted and prior confirmed for review is based on mode of transportation:

•Arrival via road: 2 hours•Arrival via rail or air: 4 hours•Arrival via water: 8 hours

•Cannot submit PN > 5 days before arrival (except for mail)

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Arrival at the Port

•Customs, USDA/APHIS, and FDA inspectors

•OASIS makes the first cut •May proceed •Detain Without Physical Examination (DWPE) •Hold for sampling

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FDA Import Procedures

Source:http://www.cfsan.fda.gov/~lrd/import.html

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Sampling

•FDA field personnel are trained in examination and sampling techniques

•Most ports have FDA personnel present

•FDA works daily with Customs & Border Protection and other US regulatory agencies (e.g. FSIS & APHIS)

•Samples analyzed by FDA laboratories

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What if Non Compliant?

•Only 2% of imported foods are sampled at entry

•If imported product is found to be out of compliance after entry into U.S. commerce, FDA can exercise normal domestic enforcement options

•Seizure •Recall, usually by importer

•Future shipments will be more closely monitored and may require laboratory evidence that future shipments are in compliance

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Notice of Detention and Hearing

•Issued Notice of Detention to the importer when shipment appears to be in violation

•Importer is given opportunity to present evidence that the product:

•Is in compliance•Can be brought into compliance through reconditioning

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Notice of Refusal of Admission

• Notice of Refusal of Admission is issued when:•Response to Notice of Detention and Hearing is not received in time or•Evidence presented at the hearing supports a finding of non non‐compliance or•Reconditioning was not successful

•Impossible for further action to salvage product

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Import Alerts

Source: http://www.fda.gov/ora/fiars/ora_import_alerts.html

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Alerts by Country

Number of Alerts by Country

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