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Exports to
the EU
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Live
animals and animal products export regime
How to access the EU market
To ensure that imported products live up to EU food
safety standards, imports are only allowed from
“listed” countries and establishments. This means
that their compliance with EU food safety rules has
been checked and they appear on a list managed by
the European Commission on behalf of the EU Member
States. The EU imports from 100 countries around the
world. A large country like Brazil has 473 listed
establishments while smaller countries often also
have a significant number of establishments approved
for trade with the EU. For example, Ghana has 67
establishments listed for fishery products. The
Commission maintains direct contact with the
competent authorities and embassies of the countries
wishing to be listed for exports to the EU.
Establishments wishing to be listed must contact the
appropriate national authority in their country.
Regionalisation: flexibility without compromising
safety
Without compromising the overall objective of
ensuring food safety, the EU shows flexibility where
possible. For example, regarding outbreaks of highly
infectious animal diseases like foot-and-mouth
disease, the EU will not risk accepting imports
under unsafe conditions. However, where it is
feasible, the EU applies the principle of
regionalisation.
This means that the EU can allow imports of fresh
beef from countries like Brazil, Argentina and South
Africa while banning imports from certain regions in
those countries where the disease is present. This
flexible approach is generally not copied by other
developed countries nor by most developing
countries, which means that in return the EU often
faces discriminatory practices whereby an outbreak
of a disease in one Member State might lead to
exports from the whole of the EU being banned.
Guidelines to facilitate trade
The clear food safety rules necessary for trade are
established at the EU level. Guidelines to explain
the EU’s import requirements for animals and animal
products have been produced by the European
Commission’s Food and Veterinary Office (FVO) as
part of efforts to facilitate safe food trade with
third countries. They spell out in non-legal
language what the EU expects from companies wishing
to export to the EU. The guidelines are based on
existing legislative requirements and specific needs
identified by FVO inspectors in their contacts with
third country partners. The aim is to provide
service-oriented explanations of the sometimes
complex EU legislation. A particular focus has been
put on clearly explaining the steps that developing
countries must take, thereby facilitating access to
the EU market for their products.
In addition, the European Commission recently
upgraded its EU Export Helpdesk for Developing
Countries (http://export-help.cec.eu.int), with
detailed information on import requirements (SPS
measures, standards, labelling, customs documents
and applied taxes among others), in addition to
other relevant information concerning exports to the
EU, such as import tariffs, customs documents
required and Rules of Origin, plus trade statistics
with the EU Member States. The information is
displayed for the product requested by its HS Code.
1. General Principles
Approvals may cover either all or part of a third
country, reflecting the animal health situation and
the nature of the animals/products for which the
approval is sought.
In most cases, an on-the-spot inspection by the
Commission’s services (Food and Veterinary Office –
FVO) is required before approval can be considered.
This is designed to evaluate whether the animal
health situation, the official services, the legal
provisions, the control systems and production
standards meet EU requirements.
For most commodities, the national authorities must
be able to demonstrate that the following
fundamental principles are satisfied, before
approval can be considered:
• the animal health situation satisfies EU
requirements for imports of the animals/products in
question;
• they can provide rapid, regular, information on
the existence of certain infectious or contagious
animal diseases on their territory, in particular
those diseases mentioned in lists A and B of the
International Office of Epizootic Diseases;
• there is effective legislation on the use of
substances, in particular concerning the prohibition
or authorisation of substances, their distribution,
release onto the market and their rules covering
administration and inspection;
• there is an acceptable programme to monitor for
the presence of certain substances and the residues
thereof in the live animals and animal products for
which export approval is sought;
• their veterinary services are capable of enforcing
the necessary health controls;
• there are effective measures to prevent and
control certain infectious or contagious animal
diseases.
In addition, for animal products intended for human
consumption, the national authorities must guarantee
that the processing establishments proposed for
approval satisfy EU requirements.
For most commodities, where a request for approval
is received by the Commission, a preliminary
questionnaire, relating to the animals/products in
question, will be sent to the national authorities.
This is designed to assess whether the EU
requirements can be satisfied, and to gather
information prior to a possible on-the-spot
inspection by the Food and Veterinary Office.
Where the information provided by the national
authorities is considered satisfactory, and the
FVO’s inspection leads to a favourable
recommendation, the Commission will adopt the
necessary legislation to grant approval for imports
after receiving a favourable opinion of the Standing
Committee on the Food Chain and Animal Health
(comprising representatives of the Member States).
2. Residue Control
The EU has detailed legislative controls in place
over the use of, and monitoring for, a wide range of
veterinary drugs and other substances in all classes
of animals and products intended for human
consumption. Legal controls over prohibited
substances in respect of the animals and products
intended for export must be in place in the third
country.
It is a fundamental requirement for all third
countries wishing to export to the EU that they have
in place a monitoring programme for these substances
that meets the requirements of this legislation in
respect of the animals and/or animal products
concerned. This programme must be submitted to the
European Commission for initial approval, before any
other part of the approval procedure can be started.
Subsequently the results of each year’s programme,
together with an updated programme for the coming
year, must be submitted to the European Commission
on an annual basis.
Laboratory facilities, meeting the standards in EU
legislation, must be available.
3. National Authorities Standards
It is essential that the national authority (often
referred to as the “competent authority”) is able to
deliver the level of veterinary controls required.
Any shortfall would mean that approval could not be
considered, or that an existing approval might have
to be revoked.
As part of the approval process, a detailed
questionnaire, relating to the sector for which
approval is sought, is sent to the national
authority. Amongst the various issues raised, the
following are of particular importance in evaluating
the authority’s performance:
• Management structure.
• Independence.
• Resources, Personnel, Recruitment and Training.
• Legal/enforcement powers.
• Prioritisation and documentation of controls.
• Laboratory services.
• Import controls.
• Animal health controls.
• Food safety controls.
4. Food Safety Standards in Processing
Establishments
Standards in individual establishments proposed for
approval must be at least equivalent to the
requirements of the relevant EU legislation. These
are the same as those laid down for establishments
in Member States.
It is particularly important that the national
authority is confident that the above standards are
met before an establishment is put forward to the
Commission for approval. If this is found not to be
the case at any subsequent on-the-spot inspection,
this will reflect unfavourably on the evaluation of
the authority’s ability to deliver EU standards.
Particular attention must be paid to the
installation and operation of an effective official
control system, including documented records of
control actions and their outcome, as this is
essential if confidence is to be established in the
establishment’s ability to comply with EU standards.
5. Health Certification
Imports of animals and animal products into the EU
must, as a general rule, be accompanied by the
health certification laid down in EU legislation.
This sets out the conditions that must be satisfied,
and the checks that must have been undertaken, if
imports are to be allowed. The details of the
certification required are set out in specific EU
legislation, which includes models of the
certificates to be used.
The certification must be signed by an official
veterinarian or official inspector (as indicated in
the relevant certificate), and must respect the
provisions of Council Directive 96/93/EC. Strict
rules apply to the production, signing and issuing
of certificates, as they confirm compliance with EU
rules.
Each category of animal and product has its own set
of animal and/or public health requirements, which
may include welfare requirements (e.g. at stunning
and slaughter). Particular attention must be paid to
ensure that the correct certification is used, and
that all of its provisions have been met.
6. Country Approval Procedure
The following sequence is generally followed
(although it may vary according to the
animal/product concerned):
(1) National authority submits a formal request for
approval to the Commission services. This should
include at least the following information:
• Type of animal/product for which approval is
sought. Full details of all animal-origin products
should be given
• Anticipated volume of trade and main importing EU
countries
• Class of animals (eg. breeding, fattening,
slaughter) involved
• Description of minimum treatment (heat,
maturation, acidification etc) applied to the
products
• Number and type of establishments considered to
meet EU requirements
• It should also include confirmation that all
proposed establishments satisfy EU requirements.
(2) Commission acknowledges request and sends the
relevant questionnaires.
(3) National authority submits completed
questionnaire, with the proposed residues monitoring
programme for approval, and with copies of the
national legislation applicable to the
animals/products concerned.
(4) Bilateral contacts between the national
authorities and the Commission to resolve
outstanding issues.
(5) If the Commission is satisfied with the
information provided, an on-the-spot inspection is
(in most cases) organised by the FVO.
(6) Following completion of the FVO inspection, a
copy of its report is sent to the national
authorities, the relevant Commission services, the
European Parliament and the Member States.
(7) If the outcome of the mission is satisfactory,
and any other outstanding issues have been resolved,
the Commission prepares draft legislation:
• to approve the residues monitoring programme;
• to add the third country to the list of third
countries from which imports of the animal/product
are approved;
• to draw up the necessary animal health
certification based on the country or part of the
country’s health situation to accompany imports,
(generic public health certificates are already laid
down in Community legislation);
• to set up an initial list of approved
establishments.
(8) The proposed legislative texts are adopted by
the Commission, and published in the Official
Journal, after a favourable opinion of the Standing
Committee on the Food Chain and Animal Health has
been received.
(9) If an implementation date is not specified in
the legislative text, then it will be the date of
official notification of the text by the Commission
to Member States.
Approved Establishments for Egypt
Egypt is currently allowed to export to the EU
animal casings (15 establishments) and fishery
products (4 establishments).
Concerning fisheries, until January 1999, Egypt
exported both marine and aqua-cultural fisheries to
the EU, but due to stricter EU regulations, Egypt
was then taken from the list of countries authorised
to export fish to the EU. With support of the EU,
Egypt has taken various initiatives to comply with
the new regulations, and since 17 January 2004 Egypt
figures again on the list of authorised fishery
products’ exporters (Commission Decision
3004/36/EC). Commission Decision 2004/38/EC
establishes the especial conditions governing
imports of fishery products from Egypt.
The 4 authorised establishments are accredited to
export maritime, lake and Nile fish and fishery
products to the EU. Molluscs and aquaculture
products are excluded from entering the EU, as the
Egyptian authorities first have to present a waste
management plan and comply with different EU
sanitary requirements.
Ministerial Decree 1909/2001 jointly issued by the
Ministry of Agriculture and Land Reclamation and the
Ministry of Economy and Foreign Trade, established
the regulations and procedures related to fish and
maritime products to be exported to the EU,
following EU requirements to allow exportation of
such products to the EU.
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