SLIDE 1
- The Overall Objectives of the Package:
MEUSAC Consultation Session COM (2013) 265: Proposal for a - - PowerPoint PPT Presentation
MEUSAC Consultation Session COM (2013) 265: Proposal for a - - PowerPoint PPT Presentation
MEUSAC Consultation Session COM (2013) 265: Proposal for a Regulation to strengthen the agri-food chain in Europe 3 December 2013 Dr Roberto Andrea Balbo Director Veterinary Regulation Parliamentary Secretariat for Agriculture, Fisheries,
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The Aim of Proposed Regulation COM (2013) 265
The Proposal revises the legislation - Regulation (EC)
No 882/2004, on official controls to overcome shortcomings identified in its wording and in its application.
It aims to put in place a robust, transparent and
sustainable regulatory framework that is better 'fit for purpose'.
The Proposal replaces and repeals the Regulation and a
number of sectoral acts and provisions which will be made redundant by its adoption.
SLIDE 4
Animal Health Law – Overview
The Implementation of the Animal Health Strategy (2007-2013) "Prevention is better than cure"
This Strategy focuses on issues which are inextricably linked to animal health, such as public health, food safety, animal welfare, sustainable development and research.
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Animal Health Law – New Elements
More emphasis on prevention Biosecurity at farm level & broader Enhanced surveillance and disease notification and
reporting
Clearer policy for the use of vaccines, and in relation to
disease control & diagnosis also some other veterinary medicines
Enhanced convergence with international standards on
animal health
Requirements for export
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Animal Health Law – The Scope
Transmissible diseases Kept and wild animals (not only production animals) and their
products
Terrestrial and aquatic animals Responsibilities of keepers, operators, veterinarians, competent
authorities, etc.
Risk based approach
Categorization/prioritisation of diseases for EU intervention
Improved response to emerging diseases
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Animal Health Law – Added Flexibility
Objective
Better response to new threats and adjustment to local circumstances
More flexibility for
Different sizes and types of establishments, types of animal
production
Local circumstances (registration, approval, etc.) Systems providing equal guarantees (for animal movements,
traceability, etc.)
Climate changes and emerging risks International standards and scientific developments
SLIDE 8
Official Controls on Animals and Goods Entering the European Union
The proposed legislation aims to create a common set of rules
applicable to all controls performed on animals and goods entering the Union.
An integrated approach will increase efficiency savings and
should help in prioritising controls on the basis of risk.
The law will lay down the categories of animals and goods
arriving from third countries that require controls at entry into the Union.
Empowerments will allow the Commission to modify the above
mentioned categories and to establish a list detailing which specific animals and goods (including their respective CN codes) should be controlled.
The Commission will also be given the power to define the cases
and conditions under which animals and goods can be exempted from said controls.
SLIDE 9
Border control Post and CHED
Border Control Posts (BCPs) will replace the different entities
currently tasked with border control duties. Common requirements for BCPs shall be established with the possibility for the Commission to further refine such requirements to take account of specific features related to the different categories of animals and goods being controlled. Harmonised rules for the designation, listing, withdrawal and suspension of BCPs will also be laid down.
A Common Health Entry Document (CHED) will be established
and governed by rules based on current practices. The CHED will be used by operators for the mandatory prior notification of arrival
- f consignments of animals and goods and by competent
authorities to record controls on such consignments and any decisions taken.
The Commission shall be empowered to establish the format of
the CHED, the modalities for its use, and the minimum time requirements for the prior notification of consignments to Border Control Posts
SLIDE 10
Rules
A common set of rules for controls on consignments
(including those of a non-commercial nature) of animals and goods subject to controls at borders will also be laid down. Controls will, in principle, be performed by the BCP authorities to whom the consignment is first presented although the Commission will be allowed to establish exceptions to this rule in certain cases.
All consignments shall be subject to documentary and
identity checks whilst physical checks will be performed at a frequency depending on the risk posed by each specific animal/good or category of animals/goods.
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Changes
The provisions detailing the actions to be taken in case of
suspicion and in case of non-compliant consignments have been amended.
Changes aim to increase efficiency by simplifying the decision-
making of BCPs, clarifying the steps that the competent authorities of such BCPs should take and by ensuring that the specificities of the sectors being brought under the Regulation are fully taken into account.
Such rules will also be applicable to official controls performed
- n animals and goods arriving from third countries which are
not subject to specific controls at borders.
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Cooperation
A new provision is introduced requiring close
cooperation between competent authorities, customs authorities and other authorities involved in the handling of animals and goods arriving from third countries.
Moreover, an empowerment will allow the Commission
to establish the modalities of cooperation between the said authorities with a view to ensuring the timely and proper access to information, the synchronisation of relevant data sets, and the rapid communication of decisions taken
SLIDE 13
Financing of Official Controls
As regards the financing of official controls, the Regulation confirms the general principle according to which MS should allocate appropriate financial resources to official controls, and also the obligation for MS to collect, in certain areas, so-called 'control fees' to recover from business operators the costs incurred for the performance of official controls.
Current rules require that mandatory inspection fees be charged only for
- fficial control activities on businesses handling meat, fishery products, and
milk and for the approval of feed establishments and for (most) controls at borders.
Historically, these were the areas where methods of controls by MS competent authorities (CAs) were first harmonised at EU level; the legislator assumed that in those areas operators benefiting from the added value represented by the assurances provided by the official controls should be called upon to compensate the costs incurred by the States because of such controls.
As it is the case under the current rules, Member States will decide at what level (local, regional, national) the fees are established and collected, depending on the organisation of their competent authorities.
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Mandatory fees will be collected to cover the costs occasioned by:
Official control activities performed on food and feed businesses registered and
- r approved under either or both of Regulation (EC) No 852/2004 (food
hygiene) and Regulation (EC) No 183/2005 (feed hygiene), on operators defined in the future Plant Health Regulation and on those defined in the future Regulation on Plant Reproductive Material, in order to verify compliance with Union 'agri-food chain' rules (feed and food law, animal health and animal welfare, plant heath and plant reproductive material rules);
Controls performed in view of issuing an official certificate or to supervise the issuance of an official attestation of compliance;
Official control activities performed to verify that the conditions to obtain or maintain approval are met
Official control activities performed with respect to border controls (including cost of controls with regard to plant health requirements, which will be transferred to the new official controls regulation);
Official control activities performed to verify compliance with emergency measures adopted by the Commission in accordance with so called 'safeguard' provisions, where the decision establishing the measures so requires.
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Cost recovery
Mandatory fee levels shall be calculated so as to enable the
competent authorities performing the official control activities to fully recover costs resulting from official controls.
Operators have to be charged a flat-rate fee and they will benefit
from recognition of good performance by requiring that the rate
- f fee applied to each operator shall be adjusted to take account
- f the operator's record of compliance as ascertained through
- fficial controls.
As a rule, fees applied to consistently compliant operators should
be lower than those applied to non-compliant ones.
Enterprises employing fewer than 10 persons and whose annual
turnover or balance sheet does not exceed EUR 2 million (micro-businesses) will be exempted from the payment of mandatory fee
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Dissuasive Financial Penalties
A new provision in former Article 55 (on sanctions for non-
compliance) will require MS to ensure that financial penalties applicable to intentional infringements offset the economic advantage sought by the perpetrator of the violation.
Member States will also be required to ensure the application of
appropriate criminal and/or administrative penalties to operators who fail to cooperate during an official control.
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Definitions:
For the purpose of this Regulation, the following definitions shall apply:
'animals' means vertebrate and invertebrate animals;
'terrestrial animals' means birds, terrestrial mammals, bees and bumble bees;
'aquatic animals' means animals of the following species, at all life stages, including eggs, sperm and gametes:
(i) fish belonging to the superclass Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii;
(ii) aquatic molluscs belonging to the phylum Mollusca;
(iii) aquatic crustaceans belonging to the subphylum Crustacea;
'other animals' means animals of species other than those defined as terrestrial and aquatic animals
'kept animals' means animals which are kept by humans; in the case of aquatic animals, aquaculture animals
'aquaculture’ means the rearing of aquatic animals using techniques designed to increase the production of those animals beyond the natural capacity of the environment and where the animals remain the property of one or more natural or legal persons throughout the rearing or culture stages, up to and including harvesting, excluding the harvesting or catching for the purposes of human consumption of wild aquatic animals which are subsequently temporarily kept awaiting slaughter without being fed;
'aquaculture animals' means aquatic animals subject to aquaculture
'wild animals' means animals which are not kept animals
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Definitions
'poultry' means birds that are reared or kept in captivity for
a)
the production of: (i) meat; (ii) eggs for consumption; (iii) other products;
(b) restocking supplies of game birds; (c) the purposes of breeding of birds used for the types of production referred to in point (a);
'captive birds' means any birds other than poultry that are kept in captivity for any reason other than those referred to in point (9) including those that are kept for shows, races, exhibitions, competitions, breeding or selling;
'pet animal' means an animal of the species listed in Annex I, which:
(a)
is kept in a household, or in the case of aquatic animals, kept in non- commercial ornamental aquaria;
(b)
when moved, accompanies for the purpose of a non-commercial movement the pet keeper, or a natural person acting on behalf of and in agreement with the pet keeper, and which remains during such non-commercial movement under the responsibility of the pet keeper or such person;
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Definitions
'pet keeper' means a natural person keeping a pet animal 'non-commercial movement' means any movement of pet animals
which does not involve or aim, directly or indirectly, at a financial gain or a transfer of ownership;
'disease' means the occurrence of infections and infestations in
animals, with or without clinical or pathological manifestations, caused by one or more disease agents transmissible to animals or to humans;
'listed diseases' mean diseases listed in accordance with Article 5(2); 'emerging disease' means a disease other than a listed disease which
has the potential to meet the criteria for listed diseases provided for in Article 6(1)(a) due to:
(a) a new disease resulting from the evolution or change of an existing disease agent;
(b) a known disease spreading to a new geographic area or a new population; or
(c) a previously unrecognised disease agent or a disease diagnosed for the first time;:
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Definitions
'disease profile' means the criteria of a disease referred to in Article
6(1)(a);
'listed species' means animal species or group of animal species listed
in accordance with Article 7(2), or, in the case of emerging diseases, animal species or groups of animal species, which meet the criteria for listed species laid down in Article 7(2);
'hazard' means a disease agent in, or a condition of, an animal or
product with the potential to have an adverse health effect in humans
- r animals;
'risk' means the likelihood of the occurrence and the likely magnitude
- f the biological and economic consequences of an adverse effect on
animal or public health;
'biosecurity' means the sum of management and physical measures
designed to reduce the risk of the introduction, development and spread of diseases to, from and within
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Definitions
(a) an animal population, or
(b) an establishment, zone, compartment, means of transport or any other facilities, premises
- r location;
'operator' means a natural or legal person , having animals and products
under their responsibility, including animal keepers and transporters, but excluding pet keepers and veterinarians;
'animal professional' means a natural or legal person, with an occupational
relationship with animals or products, other than operator or veterinarians;
'establishment' means any premises, structure, or any environment, in which
animals or germinal products are kept, except for:
(a) households keeping pet animals;
(b) non-commercial aquaria keeping aquatic animals ;
(c) veterinary practices or clinics;
'germinal products' means:
(a) sperm, semen, oocytes and embryos intended for artificial reproduction;
(b) hatching eggs;
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Definitions
'products of animal origin' means:
(a) food of animal origin, including honey[ and blood;
(b) live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and
(c) animals other than those referred to in (b) destined to be prepared with a view to being supplied live to the final consumer;
'animal by-products' means entire bodies or parts of animals, products
- f animal origin or other products obtained from animals which are
not intended for human consumption, excluding germinal products;
'derived products’ means products obtained from one or more
treatments, transformations or steps of the processing of animal by- products;
'products' means:
(a) germinal products;
(b) products of animal origin ;
(c) animal by-products and derived products;
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Definitions
'official control' means an official control as defined in
point (1) of Article 2 of Regulation (EU) XXX/XXX [Publication office – Number to be added: on official controls and
- ther official activities.];
'health status' means the disease status as regards all the
listed diseases for a particular listed species with respect to:
(a) an animal;
(b) the animals within:
(i) an establishment;
(ii) a compartment;
(iii) a zone;
(iv) a Member State;
(v) a third country or territory;
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Definitions
'zone' means: (a)
for terrestrial animals a clearly defined part of a Member State, third country or territory containing an animal subpopulation with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance, disease control and biosecurity measures;
(b) for aquatic animals a contiguous hydrological system with a
distinct health status with respect to a specific disease or specific diseases that forms an area that is referred to in one of the following:
(i)
an entire water catchment from the source of a waterway to the estuary or lake;
(ii) more than one water catchment; (iii) part of a water catchment from the source of a waterway to a
barrier that prevents the introduction of a specific disease or diseases;
(iv) part of a coastal area with a precise geographical delimitation; (v) an estuary with a precise geographical delimitation;
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Definitions
'water catchment' means an area or basin of land bounded by natural
features such as hills or mountains, into which all run-off water flows;
'compartment' means an animal subpopulation contained in one or more
establishments and in the case of aquatic animals in one or more aquaculture establishments, under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance, disease control and biosecurity measures;
'quarantine' means the maintaining of animals in isolation under the
control of the competent authority with no direct or indirect contact with
- ther animals, for the purposes of ensuring that there is no spread of
diseases while the animals are undergoing observation for a specified length of time and, if appropriate, testing and treatment;
'epidemiological unit' means a group of animals with the same likelihood
- f exposure to a disease agent;
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Definitions
'outbreak' means one or more cases in an establishment, household or
- ther place where animals are kept or located;
'case' means the official confirmation of the presence of a listed disease or
an emerging disease in a live or dead animal;
'restricted zone' means a zone in which restrictions on the movements of
certain animals or products and other disease control measures are applied, with a view to preventing the spread of a particular disease into areas where no restrictions are applied; a restricted zone may, when relevant, include protection and surveillance zones;
'protection zone' means a zone with one or more disease cases which is
established after the official confirmation of an outbreak, and where disease control measures are applied in order to prevent the spread of the disease from that zone;
'surveillance zone' means a zone, established after the official
confirmation of an outbreak and which is situated around the protection zone, and where disease control measures are applied in order to prevent the spread of the disease from that zone and the protection zone;
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Definitions
'hatching eggs' means eggs, laid by poultry, intended for incubation; 'ungulates' means the animals listed in Annex II; 'germinal product establishment' means:
(a) an establishment for the collection, production, processing and storage of germinal products;
(b) a hatchery;
'hatchery' means an establishment which collects, stores, incubates and hatches eggs for
the supply of:
(a) eggs for incubation;
(b) day-old chicks or hatchlings of other species;
'transporter' means an operator transporting animals on its own account, or for a third
party;
'confined establishment' means any permanent, geographically limited establishment,
created on a voluntary basis, and approved for the purpose of movements, where the animals are:
kept or bred for the purposes of exhibitions, education, the conservation of species or
research;
confined and separated from the surrounding environment; subject to strict animal health surveillance and biosecurity measures;
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Definitions
'assembly operation' means the assembling of kept terrestrial animals
from more than one establishments for a period shorter than the required residency period for that species of animals;
'residency period' means the minimum period an animal is required to
stay at an establishment prior to being moved from that establishment;
'IMSOC' means the computerised information management system
provided for by Article 130(1) of Regulation (EU) No. XXX/XXX [Publication office: Number to be added -on official controls and other official activities];
'disease control aquatic food establishment' means a food business
approved in accordance with the following provisions:
(a) Article 4 of Regulation (EC) No 853/2004, for processing aquaculture animals for food purposes;
(b) Article 177 of this Regulation for the slaughter of aquatic animals for disease control purposes in accordance with Title II of Part III.