Transcript Health & Consumers Directorate General

EU REQUIREMENTS FOR THIRD
COUNTRIES
EXPORTING FOOD TO THE EU
CTA Briefing on Food Safety Standards
Brussels 11/05/2009
Jacky Le Goslès
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Scope of presentation
SPS agreement and equivalence
Requirements for third countries exporting food
to the EU
Key components for a residue control system
Import controls
FVO inspections
BTFS programme
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The European Union is the world’s
largest importer of agricultural and
fishery products
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Sanitary & Phytosanitary Agreement
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SPS Agreement
Art. 2.2.measures taken to protect public health…should be
Science based and appropriate.
Art. 2.3. … should not be an unjustified barrier to trade.
Art. 3.1. … based on international standards, guidelines or
recommendations, where they exist.
Art 3.2. ..higher level of SPS protection possible if there is
scientific justification
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SPS - equivalence
Art. 4.1.
Members shall accept SPS measures of other Members as
equivalent... if the exporting Member objectively
demonstrates
… that its measures achieve the
importing Member's appropriate level of SPS
protection.
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EU Food Law (Regulation (EC) No 178/2002)
Equivalence enshrined in Community Food Law
Articles 11 and 12: Food and feed imported to the
Community shall comply with the relevant
requirements
of food law or conditions
recognised by the Community
to be at least
equivalent with requirements contained
therein
Food shall not be placed on
the market if it is unsafe
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Requirements for third countries exporting food of
animal origin to the EU
Every country wishing to export food of animal
origin (FAO) to the EU must satisfy certain
animal health, public health, veterinary
certification and residues requirements.
Appear on ‘lists of authorised third countries’
Entire country or region
Authorised commodities
Approved establishments
Use of model certificates
Food produced in accordance with EU rules
NOT ON RESIDUES LIST = NO EXPORTS
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Import of FAO From Third Countries
Import
control of
products
(BIP)
import
specific requirements (e.g.
control plan)
control missions
country
establishment
Vessel ZV/FV
Listing
(FVO)
Specific
listing
general listing
general import & control legislation
+
product specific legislation
Directive 97/78/EC imposes a veterinary control of food and
feed products coming from third countries.
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Import FAO From Third Countries
Request from
the third
Country
Technical
Documentation
Decision No 1:
Addition to the list of third
countries
Decision No 2:
Specific requirements
Decision No 3:
Health certificates (AH and PH)
Decision No 4
List of establishments
LISTING
Standing Committee on
the Food Chain and
animal health
Adoption by college of
Commissioners
Official
Journal
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Why does the EU require residues controls
in FAO both from Member States and trading
partners?
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BECAUSE
Legislative requirement in EU
Public health - food safety
To detect and prevent abuse of drugs
To facilitate trade in animals and animal products
Equivalent standards expected from the EU’s
trading partners: Art. 11, Directive 96/22/EC
and Art. 29, Directive 96/23/EC)
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Control system
Border inspection
posts in the EU
Member States
Residue
Surveillance
(Monitoring Plan)
Residue testing
Laboratories
Licensing and
controls on use of
veterinary
medicines
Elements of a residue control system
FVO scrutiny
On-thespot
Desk
study
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For third countries
An approved residue plan is a prerequisite for
export of food of animal origin to the EU.
Approved countries are listed in Commission
Decision 2004/432/EC
Plans must be submitted to the Commission
and approved annually
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What food is tested for residues?
Food of animal origin
Laid down in Community law
Council Directive 96/23/EC
Member States test domestic and imported
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Residue monitoring plan evaluation - outcome
Commission Decision 2004/432/EC revised twice in 2007 and
twice in 2008
In 2008
10 countries delisted for total of 15 commodities
8 countries were newly listed or relisted for a total of 13
commodities
83 countries now listed
Improved understanding by third countries of EU
requirements
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IMPORT CONTROLS IN EU BORDER
INSPECTION POSTS (BIP)
BIPs are approved by the European Commission
BIPs are run by Member States
3 fold control, identification (i), documentary (d) and
physical (p)
All consignments should be (i) and (d) controlled.
For most of the authorised TC only for 20% of the
consignments are submitted to (p) control
Samples are taken and relevant analyses carried out only
randomly (consignments kept until analyses results)
Positive results :rejection or destruction and RASF
information
Protective measures (e.g. Histamine analyses on 100%
of tuna swordfish consignments)
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http://ec.europa.eu/food/internat
ional/trade/guide_thirdcountries
2006_en.pdf
All relevant Community
legislation may be obtained
from:
http://europa.eu.int/eurlex/lex/en/index.htm
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FVO MISSION INSPECTION/AUDIT METHODS
METHOD: EVALUATION OF THE EFFECTIVENESS OF THE
OFFICIAL CONTROL SYSTEM OF FAO EXPORTED TO THE
EU (documented system ensuring the 2 above
mentioned objectives)
EVALUATION OF THE CA CONTROL ACTIVITY IN ITS
OFFICE, files of at least the visited farms, vessels and
establishments
SAMPLE OF FARMS/VESSELS/ESTABLISHMENTS IN ORDER
TO VERIFY CA CONTROL ACTIVITIES
SOME CHOSEN BY THE CA
SOME CHOSEN BY THE FVO: RASFF, FOLLOW UP
OF A PREVIOUS MISSION OR TARGETTED
MISSION
VERIFICATION IN SITU (FARMS/VESSELS,
ESTABLISHMENTS)
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E.G. MAIN FINDINGS RELATING TO FISHERY PRODUCTS
EXPORTED TO THE EU
KNOWLEDGE, IMPLEMENTATION, CONTROL,
ENFORCEMENT OF COMMUNITY REQUIREMENTS
CA EFFICIENCY, i.e. inspection frequency, scope,
depth, follow-up, enforcement
BUDGET for CONTROLS/ANALYSES
LAB CAPACITIES/QUALITY OF ANALYSES
RESIDUE MONITORING PLAN FOR EXPORTED
AQUACULTURE PRODUCTS
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E.G. MAIN FINDINGS RELATING TO FISHERY PRODUCTS
EXPORTED TO THE EU (cont.)
RUNNING/POTABLE/CLEAN WATER (ICE)
FRESHNESS OF FISH LANDED
HYGIENE OF OPERATIONS
COLD CHAIN
HYPER-CHLORINATED WATER USE
FP TRACEABILITY:
• FROM VESSELS TO PLANTS
• WITHIN PLANTS
• RAW MATERIAL IMPORTED OR COMING FROM NON « EU
APPROVED » VESSELS OR ESTABLISHMENTS
HACCP Plan inappropriate, inadequate/insufficient documentation
NUMBER OF OWN-CHECK ANALYSES AND OFFICIAL ANALYSES
ADDITIVES (crustaceans)
HEALTH STATUS OF STAFF
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FOOD of VEGETAL ORIGIN
Principal results from reports
General
Lack of control by CA
Dependance on private standards
Poor performance in laboratories
No/poor controls at export
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Principal Results
Pesticides
High frequency of use
Lack of control on GAP or on registered users
Lack of control in application or follow up
Variable MRLs
Poor equipment/analytical capability and poor
quality control in laboratories
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Principal Results
Phytosanitary Controls
Problems with understanding of community
regulations
Monitoring and official controls limited
Lack of documentation/ tracability
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HOW TO IMPROVE THE SITUATION
Pressure on TC: pre-listing on hold,
appropriate and proportionate
protective measures, action plans and
follow-up (on-desk exercise and FVO
missions)
CA official training: SANCO programmes,
« Better Training for Safer Food »
(Indonesia, Colombia and Senegal in
2006, Morocco, Mauritius, UAE, Chile
and Viet Nam in 2007, Philippines and
Jamaica in 2008)
technical assistance provided by
Commission services (DEV, AIDCO,
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TRADE, SANCO) following TC requests
Import From Third Countries
Import Control: reinforced measures
Listing of
• countries
• establishments
Results
significantly
not conform
and/or
negative
report from
FVO
Legislation and controls guarantee that
exported products comply with EU legislation
and consequently that their safety is not
compromised
 Test on each arrival/lot
 Additional costs supported by importers
Safegard
clause
Results significantly not
conform
De-listing
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BTFS programme
The programme started in 2005-2006. Commission Communication
COM (2006) 519 has identified a long-term steady state of 6,000
participants and budget of €15million annually (around 2011-2012)
Estimated trend of participants
7000
6500
Steady state
6000
5500
5000
4500
4000
3500
3000
2500
2000
Starting-up phase
1500
1000
500
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0
2005
2006
2007
2008
2009
2010
2011
201.
BTFS
Evolution 2006-2008
budget
Number of training activities
training days
Number of participants
4.000
800
2.900
615
1.400
71
9 M€
255
41
110
7.0 M€
3.5 M€
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BTFS
Food hygiene and controls
 3 modules of 5 five-day courses on:
 Meat and meat products
 Milk and dairy products
 Fishery products
 25 participants per workshop
 Theoretical sessions, practical exercises, site
visits, discussion as appropriate
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BTFS
Hygiene and controls of fishery products (main subjects)
Organisation of official controls
Live Bivalve Molluscs: controls and applicable
legislation
Controls of marine bio-toxins
Primary production
Hygiene requirements in freezers, vessels,
processing establishments, fish farms and cold
storage
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Africa-EU Joint Strategy
Capacity building activities
in the SPS field in Africa
2009-2010 (€10M)
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Activity 1 (OIE)
Evaluation of Performance of Veterinary Services + follow-ups
Activity 2 (OIE)
Improvement of national / regional legal framework
Activity 3 (OIE)
Laboratory capacity (twinning)
Activity 4 (OIE)
Training of CVOs / National Focal Points
Activity 5 (AESA Cons.)
-12 five-day Regional ‘training of trainers’ workshops:
-2 one-day (opening and closing) conferences
Activity 6 (AESA Cons.)
Sustained missions and ad hoc assistance (e.g. SMEs):
1,560 days / 12 experts / 6 Regions (~ 26 countries)
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EU SPS rules
for import of food
of animal origin from Third Countries
to the EU
SUMMARY
CTA Briefing on Food Safety Standards
Brussels 11/05/2009
J. Le Gosles Adviser DG SANCO
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Main Points to keep in mind
Food safety has become more important in the
EU
EU first food importer in the world, e.g. More
than 50% of fish consumed in EU are imported from
TC/DC
Increase of establishments approved for export
to the EU ( including freezer and factory vessels
in TC)
More added value processed products imported
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Main Points to keep in mind
EU rules based on SPS Agreement principles
Art. 2.2.measures taken to protect public health… should be Science based
and appropriate.
Art. 2.3. … should not be an unjustified barrier to trade.
Art. 3.1. … based on international standards, guidelines or
recommendations, where they exist.
Art 3.2. ..higher level of SPS protection possible if there is scientific
justification
Art. 4.1. : Members shall accept SPS measures of other Members as
equivalent... if the exporting Member objectively demonstrates
… that its
measures achieve the importing Member's appropriate level of SPS
protection.
EU and EQUIVALENCE
Equivalence enshrined in Community Food Law (Regulation (EC) No
178/2002)
Articles 11 and 12: Food and feed imported to the Community shall comply
with the relevant requirements of food law or conditions recognised by the
Community to be at least equivalent with requirements contained therein
35 of 36
Main Points to keep in mind
Import of FAO From Third Countries
Import control of
products (BIP)
specific requirements (e.g. residue
monitoring programme)
control missions
(FVO)
import
Specific
listing
country
establishment
Vessel ZV/FV
Listing
control
missions
(FVO)
general
listing
general import & control legislation
+
product specific legislation
Directive 97/78/EC imposes a veterinary control of food and
feed products coming from third countries.
36 of 36
Main Points to keep in mind
Import of FAO From Third Countries
Request from
the third
Country
Technical
Documentation
Decision No 1:
Addition to the list of third
countries
Decision No 2:
Specific requirements
Decision No 3:
Health certificates (AH and PH)
Decision No 4
List of establishments
LISTING
Standing Committee on
the Food Chain and
animal health
Adoption by college of
Commissioners
Official
Journal
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Main Points to keep in mind
A Competent Authority (or more but need for a very good
cooperation/coordination) and laboratory capacities;
Official (documented) controls all along the FAO production
chain, including primary production and sampling/analyses
Residue and environmental contaminant monitoring
programme;
FBO Establishments
: Structures and equipment requirements, Good Hygiene
Practices (SSOPs) and HACCP system in place
Ensuring the eligibility of the FAO exported to the EU
(« sanitary » traceability) from primary production to exported
consignments;
Better Training for Safer Food (BTFS) programme and
Technical Assistance (TA )
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