(a) the minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease of whatever type of virus; (b) certain preventative measures aimed at increasing awareness and preparedness of the competent authorities and the farming community for foot-and-mouth disease.
Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance.)
Modified by
- Commission Decisionof 16 August 2005amending Annex XI to Council Directive 2003/85/EC with regard to national laboratories in certain Member States(notified under document number C(2005) 3121)(Text with EEA relevance)(2005/615/EC), 32005D0615, August 18, 2005
- Commission Decisionof 3 August 2006amending Annex XI to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus for vaccine production(notified under document number C(2006) 3447)(Text with EEA relevance)(2006/552/EC), 32006D0552, August 8, 2006
- Council Directive 2006/104/ECof 20 November 2006adapting certain Directives in the field of agriculture (veterinary and phytosanitary legislation), by reason of the accession of Bulgaria and Romania, 32006L0104, December 20, 2006
- Commission Decisionof 25 April 2008amending Annex XI to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus(notified under document number C(2008) 1577)(Text with EEA relevance)(2008/339/EC), 32008D0339, April 29, 2008
- Commission Decisionof 27 November 2009amending Annexes XI, XII, XV and XVI to Council Directive 2003/85/EC as regards the list of and minimum security standards applicable to laboratories authorised to handle live foot-and-mouth disease virus(notified under document C(2009) 9094)(Text with EEA relevance)(2009/869/EC), 32009D0869, December 2, 2009
- Commission Decisionof 9 August 2010amending Annex XI to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus(notified under document C(2010) 5420)(Text with EEA relevance)(2010/435/EU), 32010D0435, August 10, 2010
- Commission Decisionof 7 January 2011amending Annex XI to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus(notified under document C(2010) 9592)(Text with EEA relevance)(2011/7/EU), 32011D0007, January 8, 2011
- Commission Implementing Decisionof 27 June 2011amending Part A of Annex XI to Council Directive 2003/85/EC as regards the list of national laboratories authorised to handle live foot-and-mouth disease virus(notified under document C(2011) 4385)(Text with EEA relevance)(2011/378/EU), 32011D0378, June 28, 2011
- Commission Implementing Decisionof 7 December 2012amending Part A of Annex XI to Council Directive 2003/85/EC as regards the list of national laboratories authorised to handle live foot-and-mouth disease virus(notified under document C(2012) 8900)(Text with EEA relevance)(2012/766/EU), 32012D0766, December 11, 2012
- Council Directive 2013/20/EUof 13 May 2013adapting certain directives in the field of food safety, veterinary and phytosanitary policy, by reason of the accession of the Republic of Croatia, 32013L0020, June 10, 2013
- Commission Implementing Decision (EU) 2015/1358of 4 August 2015amending Annexes XI, XII and XV to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus and minimum bio-security standards applicable to them(notified under document C(2015) 5341)(Text with EEA relevance), 32015D1358, August 6, 2015
Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine speciesOJ L 194, 22.7.1988, p. 10 . Directive as last amended by the 2003 Act of Accession.Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importations from third countries of embryos of domestic animals of the bovine speciesOJ L 302, 19.10.1989, p. 1 . Directive as last amended by Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23 ).Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EECOJ L 268, 14.9.1992, p. 54 . Directive as last amended by Commission Regulation (EC) No 1282/2002 (OJ L 187, 16.7.2002, p. 13 ).
Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meatOJ 121, 29.7.1964, p. 2012/64 . Directive as last amended by Directive 95/23/EC (OJ L 243, 11.10.1995, p. 7 ).Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the intra-Community trade of meat products originOJ L 26, 31.1.1977, p. 85 . Directive as last amended by Directive 97/76/EC (OJ L 10, 16.1.1998, p. 25 ).Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat productsOJ L 47, 21.2.1980, p. 4 . Directive as last amended by the 2003 Act of Accession.Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meatOJ L 268, 24.9.1991, p. 41 . Directive as last amended by Directive 94/65/EC (OJ L 368, 31.12.1994, p. 10 ).Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparationsOJ L 368, 31.12.1994, p. 10 .Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumptionOJ L 18, 23.1.2003, p. 11 . Directive as last amended by the 2003 Act of Accession.
(a) "animal of a susceptible species" means any domestic or wild animal of the suborders Ruminantia ,Suina , andTylopoda of the orderArtiodactyla ;For specific measures, notably in application of Article 1(2), Article 15 and Article 85(2), other animals, such as for example of the order Rodentia orProboscidae , may be considered susceptible to foot-and-mouth disease in accordance with scientific evidence.(b) "holding" means any agricultural or other premises, including circuses, located in the national territory of a Member State where animals of susceptible species are being bred or kept on a permanent or temporary basis. However, for the purpose of Article 10(l) this definition does not include living areas for humans on such premises, unless animals of susceptible species, including those referred to in Article 85(2), are kept on a permanent or temporary basis therein, slaughterhouses, means of transport, border inspection posts or fenced areas where animals of susceptible species are kept and may be hunted, if such fenced areas are of a size which makes the measures provided for in Article 10 inapplicable; (c) "herd" means an animal or group of animals kept on a holding as an epidemiological unit; if more than one herd is kept on a holding, each of these herds shall form a distinct unit and shall have the same health status; (d) "owner" means any person or persons, either natural or legal, having ownership of an animal of a susceptible species, or charged with keeping such animals, whether or not for financial reward; (e) "competent authority" means the authority of a Member State competent to carry out veterinary or zootechnical checks or any authority to which it has delegated that competence; (f) "official veterinarian" means the veterinarian designated by the competent authority of the Member State; (g) "authorisation" means a written authorisation given by the competent authorities, of which the necessary copies must be available for subsequent inspections in accordance with the appropriate legislation in the Member State concerned; (h) "incubation period" means the length of the time between infection and the occurrence of clinical signs of foot-and-mouth disease. Namely, for the purposes of this Directive, 14 days for bovine and porcine animals, and 21 days for ovine and caprine animals and any other animal of susceptible species; (i) "animal suspected of being infected" means any animal of a susceptible species exhibiting clinical symptoms or showing post-mortem lesions or reactions to laboratory tests which are such that the presence of foot-and-mouth disease may reasonably be suspected; (j) "animal suspected of being contaminated" means any animal of a susceptible species which, according to the epidemiological information collected, may have been directly or indirectly exposed to the foot-and-mouth disease virus; (k) "case of foot-and-mouth disease" or "animal infected with foot-and-mouth disease" means any animal of a susceptible species or carcass of such animal in which foot-and-mouth disease has been officially confirmed, taking into account the definitions in Annex I: either on clinical symptoms or post-mortem lesions consistent with foot-and-mouth disease have been officially confirmed, or as the result of a laboratory examination carried out in accordance with Annex XIII;
(l) "outbreak of foot-and-mouth disease" means a holding where animals of susceptible species are kept, which meets one or more of the criteria set out in Annex I; (m) "primary outbreak" means the outbreak within the meaning of Article 2(d) of Directive 82/894/EEC; (n) "killing" means the killing of animals within the meaning of Article 2(6) of Directive 93/119/EEC; (o) "emergency slaughter" means the slaughter in emergency cases within the meaning of Article 2(7) of Directive 93/119/EEC of animals which on the basis of epidemiological data or clinical diagnosis or results of laboratory testing are not considered infected or contaminated with foot-and mouth disease virus, including slaughter for reasons of animal welfare; (p) "processing" means one of the treatments for high risk material laid down in Regulation (EC) No 1774/2002, and any implementing legislation thereof, applied in such a way as to avoid the risk of spread of foot-and-mouth disease virus; (q) "regionalisation" means the delimitation of a restricted zone in which restrictions are applied on the movements of or trade in certain animals or animal products as provided for in Article 45 in order to prevent the spread of foot-and-mouth disease into the free zone where no restrictions are applied in accordance with this Directive; (r) "region" means an area as defined in Article 2(2) (p) of Directive 64/432/EEC; (s) "sub-region" means an area specified in the Annex to Decision 2000/807/EC; (t) "Community antigen and vaccine bank" means appropriate premises designated in accordance with this Directive for the storage of Community reserves of both concentrated inactivated antigen of the foot-and-mouth disease virus for the production of foot-and-mouth disease vaccines and veterinary immunological products (vaccines) reconstituted from such antigens and authorised in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal productsOJ L 311, 28.11.2001, p. 1 .(u) "emergency vaccination" means vaccination in accordance with Article 50(1); (v) "protective vaccination" means emergency vaccination carried out on holdings in a designated area in order to protect animals of susceptible species within this area against airborne spread or spread through fomites of foot-and-mouth disease virus and where the animals are intended to be kept alive following vaccination; (w) "suppressive vaccination" means emergency vaccination which is carried out exclusively in conjunction with a stamping-out policy in a holding or area where there is an urgent need to reduce the amount of foot-and-mouth disease virus circulating and to reduce the risk of it spreading beyond the perimeters of the holding or the area and where the animals are intended to be destroyed following vaccination; (x) "wild animal" means an animal of a susceptible species living outside holdings as defined in Article 2(b) or premises referred to in Articles 15 and 16; (y) "primary case of foot-and-mouth disease in wild animals" means any case of foot-and-mouth disease which is detected in a wild animal in an area in which no measures are in place in accordance with Article 85(3) or (4).
(a) foot-and-mouth disease is listed by the competent authority as a compulsorily notifiable disease; (b) the owner and any person attending animals, accompanying animals during transport or looking after animals shall be obliged to notify without delay to the competent authority or the official veterinarian the presence or suspected presence of foot-and-mouth disease and keep animals infected with foot-and-mouth disease or animals suspected of being infected, away from places where other animals of susceptible species are at risk of being infected or contaminated with the foot-and-mouth disease virus; (c) veterinary practitioners, official veterinarians, senior staff of veterinary or other official or private laboratories and any person with a occupational relation to animals of susceptible species or products derived from such animals shall be obliged to notify without delay to the competent authority any knowledge of the presence or suspected presence of foot-and-mouth disease they have obtained prior to official intervention within the framework of this Directive.
(a) a census is made of all categories of animals on the holding and that, in respect of each category of animals of susceptible species, the number of animals that are already dead and the animals suspected of being infected or of being contaminated, is recorded; (b) the census as referred to in point (a) is kept up to date to take account of those animals of susceptible species born or dying during the period of suspicion. Such information is produced by the owner on request of the competent authority and is checked by that authority at each visit; (c) all stocks of milk, milk products, meat, meat products, carcasses, hides and skins, wool, semen, embryos, ova, slurry, manure as well as animal feed and litter on the holding are recorded and those records are maintained; (d) no animals of susceptible species enter or leave the holding, except in cases of holdings consisting of different epidemiological production units referred to in Article 18, and that all animals of susceptible species on the holding are kept in their living quarters or another place where they can be isolated; (e) appropriate means of disinfection are used at the entrances and exits of buildings or places housing animals of susceptible species and of the holding itself; (f) an epidemiological inquiry is carried out in accordance with Article 13; (g) to facilitate the epidemiological inquiry, the necessary samples shall be taken for laboratory testing in accordance with point 2.1.1.1 of Annex III.
(a) movement from the holding of meat or carcasses, meat products, milk or milk products, semen, ova or embryos of animals of susceptible species or of animal feed, utensils, objects or other substance, such as wool, hides and skins, bristles or animal waste, slurry, manure or anything liable to transmit foot-and-mouth disease virus; (b) movement of animals of species not susceptible to foot-and-mouth disease; (c) movement of persons onto or out of the holding; (d) movement of vehicles onto or out of the holding.
(a) All animals of susceptible species shall be killed on-the-spot. In exceptional circumstances the animals of susceptible species may be killed at the nearest suitable place for that purpose under official supervision and in such a way as to avoid the risk of spreading foot-and-mouth disease virus during transport and killing. The Member State concerned shall notify the Commission about the existence of such exceptional circumstances, and the action taken. (b) The official veterinarian shall ensure that before or during the killing of the animals of susceptible species all appropriate samples needed for the epidemiological inquiry referred to in Article 13 have been taken in accordance with point 2.1.1.1 of Annex III, and in sufficient numbers. The competent authority may decide that Article 4(2) shall not apply in cases of appearance of a secondary source which is epidemiologically linked with a primary source for which samples have already been taken in accordance to that Article, provided that appropriate and sufficient numbers of samples needed for the epidemiological inquiry referred to in Article 13 have been taken. (c) The carcasses of animals of susceptible species which have died on the holding and the carcasses of animals which have been killed in accordance with point (a) shall be processed without undue delay under official supervision in such a way that there is no risk of spreading foot-and-mouth disease virus. Where particular circumstances require the carcasses to be buried or burned, on site or off site, such operations shall be carried out in conformity with the instructions prepared in advance in the framework of the contingency plans referred to in Article 72. (d) All products and substances referred to in Article 4(3)(c) shall be isolated until contamination can be ruled out, or treated in accordance with the instructions of the official veterinarian in such a way as to ensure the destruction of any foot-and-mouth disease virus, or processed.
(a) the buildings used for housing animals of susceptible species, their surroundings and the vehicles used for their transportation, as well as all other buildings and equipment likely to be contaminated shall be cleaned and disinfected in accordance with Article 11; (b) in addition, where there is a reasonable suspicion that the living area for humans or the office area of the holding are contaminated with the foot-and-mouth disease virus, these areas shall also be disinfected by appropriate means; (c) restocking of animals is carried out in accordance with Annex V.
(a) the length of time during which the foot-and-mouth disease may have been present on a holding before being suspected or notified; (b) the possible origin of the foot-and-mouth disease virus on a holding and the identification of other holdings where there are animals suspected of being infected or animals suspected of being contaminated from the same source; (c) the possible extent to which animals of susceptible species other than bovine and porcine animals may have been infected or contaminated; (d) the movement of animals, persons, vehicles and the substances referred to in Article 4(3)(c) likely to have carried the foot-and-mouth disease virus to or from the holdings in question.
(a) all animals of susceptible species in such premises or means of transport shall be killed without delay; (b) the carcasses of the animals referred to in paragraph (a) shall be processed under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading; (c) other animal waste, including offal, of infected or suspected of being infected and contaminated animals shall be processed under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading; (d) dung, manure and slurry shall be subject to disinfection and shall only be removed for treatment in accordance with point 5 of Section II in Part A of Chapter III of Annex VIII to Regulation (EC) No 1774/2002; (e) cleansing and disinfection of buildings and equipment, including vehicles or means of transport, shall take place under the supervision of the official veterinarian in accordance with Article 11 and with the instructions laid down by the competent authority; (f) an epidemiological inquiry shall be carried out in accordance with Article 13.
(a) the structure, including the administration, and size of the premises allow a complete separation of housing and keeping for the distinct herds of animals of susceptible species, including separate air space; (b) the operations on the different production units, and in particular stable and pasture management, feeding, removal of dung or manure are completely separated and carried out by different personnel; (c) the machinery, working animals of species not susceptible to foot-and-mouth disease, equipment, installations, instruments and disinfection facilities used in the production units are completely separate.
(a) such holding complies with the conditions set out in paragraph 2, and (b) milking in each unit is carried out separately, and (c) depending on the intended use, the milk is subject to at least one of the treatments described in Part A or Part B of Annex IX.
(a) the registration of all holdings with animals of susceptible species and the establishment of a census of all animals present on these holdings shall be carried out as soon as possible and kept up to date; (b) all holdings with animals of susceptible species shall periodically undergo a veterinary inspection, carried out in such a way as to avoid the spread of foot-and-mouth disease virus possibly present on the holdings, which shall include in particular the relevant documentation, notably the records referred to in subparagraph (a) and the measures applied to prevent the introduction or escape of foot-and-mouth disease virus and which may include clinical inspection as described in point 1 of Annex III or taking of samples from animals of susceptible species in accordance with point 2.1.1.1 of Annex III; (c) animals of susceptible species shall not be removed from the holding on which they are kept.
(a) movement between holdings and transport of animals of susceptible species; (b) fairs, markets, shows and other gatherings of animals including collection and dispersion of susceptible species; (c) itinerant service for breeding of animals of susceptible species; (d) artificial insemination of and collection of ova and embryos from animals of susceptible species.
(a) movement or transport of animals of non-susceptible species between holdings situated within the zone or out of or into the protection zone; (b) transit of animals of all species through the protection zone; (c) events with gatherings of people with possible contact with animals of susceptible species, where there is a risk of spreading the foot-and-mouth disease virus; (d) artificial insemination of or collection of ova and embryos from animals of species not susceptible to foot-and-mouth disease; (e) movement of means of transport designed for the transportation of animals; (f) the slaughter on the holding of animals of susceptible species for private consumption; (g) transport of goods referred to in Article 33 to holdings keeping animals of susceptible species.
(a) the transit of animals of all species through the protection zone undertaken exclusively via major highways or mainline railways; (b) the transport of animals of susceptible species which have been certified by the official veterinarian as coming from holdings outside the protection zone and transported on designated routes directly to designated slaughterhouses for immediate slaughter, provided that the means of transport are cleansed and disinfected after delivery under official supervision at the slaughterhouse and such decontamination of transport is recorded in the logbook of the means of transport; (c) the artificial insemination of animals on a holding carried out by the personnel of that holding by use of semen collected from animals on that holding or semen stored on that holding or semen delivered from a semen collection centre to the outside perimeter of that holding; (d) the movement and transport of equidae taking into account the conditions set out in Annex VI. (e) the transport, under certain conditions, of goods referred to in Article 33 to holdings keeping animals of susceptible species.
(a) the establishment shall be operated under strict veterinary control; (b) only fresh meat, minced meat or meat preparations as described in paragraph 4, or fresh meat, minced meat or meat preparations obtained from animals reared and slaughtered outside the protection zone or from animals transported to the establishment and slaughtered therein in accordance with the provisions in Article 24(2)(b) shall be processed in the establishment; (c) all such fresh meat, minced meat or meat preparations, must bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to Directive 94/65/EC; (d) during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the protection zone in accordance with this Directive.
(a) the establishment shall be operated under permanent and strict official control; (b) all milk used in the establishment shall either comply with paragraphs 3 and 4 or the raw milk shall be obtained from animals outside the protection zone; (c) during the whole production process the milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not destined for dispatch outside the protection zone; (d) transport of raw milk from holdings situated outside the protection zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection zone keeping animals of susceptible species.
(a) processing in establishments situated outside the protection zone of raw milk produced from animals of susceptible species kept within the protection zone shall be authorised by the competent authorities; (b) the authorisation shall include instructions on and designation of the transport route to the designated establishment; (c) transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (d) before leaving the holding from where milk of animals of susceptible species was collected the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the protection zone the vehicle had no subsequent contact with holdings in the protection zone keeping animals of susceptible species; (e) the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.
(a) all the measures relating to the outbreak of foot-and-mouth disease have been removed in accordance with Article 36, and (b) all animals accommodated in the semen collection centre have undergone a clinical examination, and samples taken in accordance with point 2.2 of Annex III have been subjected to a serological test to substantiate the absence of infection in the semen collection centre concerned, and (c) the donor animal has been subjected with negative result to a serological test for the detection of antibodies against the foot-and-mouth disease virus on a sample taken not earlier than 28 days after the collection of the semen.
(a) the entire volume of manure has been produced at least 21 days before the estimated date of earliest infection on a holding in the protection zone and the manure or dung is distributed close to the ground and in sufficient distance from holdings keeping animals of susceptible species and immediately incorporated into the ground, or (b) in the case of manure from bovine animals or pigs: (i) an examination by an official veterinarian of all the animals on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus, and (ii) the entire volume of manure has been produced at least 4 days prior to the examination referred to in point (i), and (iii) the manure is incorporated into the ground on designated fields close to the holding of origin and in sufficient distance to other holdings keeping animals of susceptible species in the protection zone.
(a) were produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1), and that have been stored separately from hides and skins produced after that date; or (b) comply with the requirements laid down in point 2 in Part A of Annex VII.
(a) were produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1) and have been stored separately from wool, hair and bristles produced after that date; or (b) comply with the requirements laid down in point 3 in Part A of Annex VII.
(a) either have been produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1) and have been stored and transported separately from products produced after that date, or (b) have undergone the treatment in accordance with point 4 in Part A of Annex VII, or (c) for specific products, comply with the appropriate requirements in points 5 to 9 in Part A of Annex VII, or (d) are composite products which are not subject to further treatment containing products of animal origin which either have undergone a treatment ensuring destruction of possible foot-and-mouth disease virus or have been obtained from animals not subject to restrictions under the provisions of this Directive, or (e) are packed products intended for use as in-vitro diagnostic or laboratory reagents.
(a) produced at least 21 days before the estimated date of infection on holdings referred to in Article 10(1), and stored and transported separately from feed, forage, hay and straw produced after that date; or (b) intended for use within the protection zone, subject to authorisation by the competent authorities; or (c) produced on premises not keeping animals of susceptible species; or (d) produced in establishments not keeping animals of susceptible species and sourcing the raw material from premises referred to in paragraph (c) or from premises situated outside the protection zone.
(a) at least 15 days have elapsed since the killing and safe disposal of all the animals of susceptible species from the holding referred to in Article 10(1) and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with Article 11; (b) a survey has been concluded with negative results in all holdings keeping animals of susceptible species and situated within the protection zone.
(a) the records referred to in Article 22(1) have been subjected to official control, and the epidemiological situation of the holding does not indicate any suspicion of infection or contamination with the foot-and-mouth disease virus, and (b) all the animals of susceptible species on the holding have been subjected with negative result to an inspection by the official veterinarian, and (c) a representative number of animals, taking into account the statistical parameters in point 2.2 of Annex III, has been subjected to thorough clinical examination to rule out the presence or suspicion of clinically infected animals, and (d) the slaughterhouse is designated by the competent authority and located as near to the surveillance zone as possible, and (e) the meat produced from such animals shall be subject to the treatment specified in Article 39.
(a) for leading them without coming into contact with animals of susceptible species of different holdings to pasture situated within the surveillance zone not earlier than 15 days after the last outbreak of foot-and-mouth disease has been recorded in the protection zone; (b) for transporting them directly and under official supervision for the purpose of slaughter to a slaughterhouse located inside the same zone; (c) for transporting them in accordance with Article 37(2); (d) for transporting them in accordance with Article 24(2)(a) and (b).
(a) the establishment shall be operated under strict veterinary control; (b) only fresh meat, minced meat or meat preparations as described in paragraph 4 and subject to the additional conditions provided for in Part B of Annex VIII or obtained from animals reared and slaughtered outside the surveillance zone or obtained from animals transported in accordance with the provisions in Article 24(2)(b) shall be processed in the establishment; (c) all such fresh meat, minced meat or meat preparations must bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to Directive 95/65/EC; (d) during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the surveillance zone in accordance with this Directive.
(a) the establishment shall be operated under strict veterinary control; (b) all milk used in the establishment shall either comply with paragraph 4 or be obtained from animals outside the surveillance and protection zone; (c) throughout the production process the milk shall be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch outside the surveillance zone; (d) transport of raw milk from holdings situated outside the protection and surveillance zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species.
(a) processing in establishments situated outside the protection and surveillance zones of raw milk produced from animals of susceptible species kept within the surveillance zone shall be authorised by the competent authorities; (b) the authorisation shall include instructions on and designation of the transport route to the designated establishment; (c) transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (d) before leaving the holding from where milk of animals of susceptible species was collected, the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the surveillance zone the vehicle had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species; (e) the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.
(a) either an examination by an official veterinarian of all the animals of susceptible species on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus and the manure or dung is distributed close to the ground to avoid the generation of aerosols and immediately ploughed into the ground, or (b) a clinical inspection by an official veterinarian of all the animals of susceptible species on the holding has been carried out with negative result and the manure is injected into ground, or; (c) manure is subject to the provision of Article 29(2).
(a) at least 30 days have elapsed since the killing and safe disposal of all animals of susceptible species from the holding referred to in Article 10(1) and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with Article 11; (b) the requirements provided for in Article 36 have been met in the protection zone; (c) a survey has been concluded with negative results.
(a) control within the restricted zone of transport and movement of animals of susceptible species, animal products and goods and of the movement of means of transport as potential carriers of foot-and-mouth disease virus; (b) tracing and marking in accordance with Community legislation of fresh meat and raw milk and as far as possible other products in stock not eligible for dispatch outside the restricted zone; (c) specific certification of animals of susceptible species and products derived from such animals and health marking, in accordance with Community legislation, of products for human consumption intended and eligible for dispatch outside the restricted zone.
(a) owners shall supply the competent authority, on request of that authority, with appropriate information concerning animals entering or leaving their holding. That information shall, in relation to all animals of susceptible species, include at least the details required by Article 14 of Directive 64/432/EEC; (b) persons engaged in the transport or marketing of animals of susceptible species shall supply the competent authority, on request of that authority, with appropriate information concerning the movements of such animals which they have transported or marketed. That information shall include at least the details required by Articles 12(2) and 13(1)(b) of Directive 64/432/EEC.
(a) the use of foot-and-mouth disease vaccines and the administration of hyperimmune sera against foot-and-mouth disease are prohibited on their territory except as provided for in this Directive; (b) the production, storage, supply, distribution and sale of foot-and-mouth disease vaccines on their territory are carried out under official control; (c) the marketing of foot-and-mouth disease vaccines is under the supervision of the competent authorities in accordance with Community legislation; (d) the use of foot-and-mouth disease vaccines for purposes other than to induce active immunity in animals of susceptible species, notably laboratory investigations, scientific research or testing of vaccines, is authorised by the competent authorities and carried out under appropriate bio-security conditions.
(a) outbreaks of foot-and-mouth disease have been confirmed and threaten to become widespread in the Member State where such outbreaks have been confirmed; (b) other Member States are at risk due to the geographical situation of or the prevailing meteorological conditions in relation to reported outbreaks of foot-and-mouth disease in a Member State; (c) other Member States are at risk due to epidemiologically relevant contacts between holdings on their territories and holdings keeping animals of susceptible species in a Member State where there are outbreaks of foot-and-mouth disease; (d) Member States are at risk due to the geographical situation or the prevailing meteorological conditions in a neighbouring third country where there are outbreaks of foot-and-mouth disease.
(a) either by the Member State referred to in paragraph 1(a), or (b) by a Member State referred to in paragraph 1(b), (c) or (d).
(a) the delimitation in accordance with Article 45 of the geographical area in which emergency vaccination is to be carried out; (b) the species and the age of the animals to be vaccinated; (c) the duration of the vaccination campaign; (d) a specific prohibition on movements of vaccinated and non-vaccinated animals of susceptible species and their products; (e) the special additional and permanent identification and special registration of the vaccinated animals pursuant to Article 47(2); (f) other matters appropriate to the emergency situation.
(a) the vaccination zone shall be regionalised in accordance with Article 45, where necessary in close cooperation with neighbouring Member States; (b) vaccination shall be carried out swiftly and in conformity with the rules of hygiene and bio-security so as to avoid the spread of foot-and-mouth disease virus; (c) all measures applied in the vaccination zone shall be carried out without prejudice to the measures provided for in Section 7; (d) where the vaccination zone includes parts of or the entire protection or surveillance zone: (i) the measures applicable for the protection zone or surveillance zone in accordance with this Directive shall be maintained within that part of the vaccination zone until such measures have been removed in accordance with Article 36 or Article 44; (ii) after the measures applied in the protection zone and surveillance zone have been removed, the measures applicable for the vaccination zone as provided for in Articles 54 to 58 shall continue to apply.
(a) in which vaccination is prohibited; (b) in which intensified surveillance is carried out; (c) in which the movement of animals of susceptible species is subject to controls by the competent authorities; (d) which remains in place until the foot-and-mouth disease and infection free status is recovered in accordance with Article 61.
(a) only within a protection zone; (b) only on clearly identified holdings subject to the measures provided for in Article 10(1) and in particular subparagraph (a) thereof.
(a) bear the mark provided for in Directive 2002/99/EC; (b) be stored and transported separately from meat not bearing the mark referred to in point (a), and shall subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with point 1 in Part A of Annex VII.
(a) the establishment shall be operated under permanent and strict official control; (b) all milk used in the establishment shall either comply with paragraph 4 or the raw milk shall be obtained from animals outside the vaccination zone; (c) during the whole production process the milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not destined for dispatch outside the vaccination zone; (d) transport of raw milk from holdings situated outside the vaccination zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in a restricted zone keeping animals of susceptible species.
(a) processing in establishments situated outside the vaccination zone of raw milk produced from animals of susceptible species kept within the vaccination zone shall be authorised by the competent authorities; (b) the authorisation shall include instructions on and designation of the transport route to the designated establishment; (c) transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (d) before leaving the holding from where milk of animals of susceptible species was collected, the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the vaccination zone the vehicle had no subsequent contact with holdings in the vaccination zone keeping animals of susceptible species; (e) the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.
(a) it is ensured that the semen collected during the period referred to in paragraph 1 is stored separately for at least 30 days, and (b) prior to dispatch of the semen: (1) either the donor animal has not been vaccinated and the conditions of Article 28(3)(b) and (c) apply, or (2) the donor animal has been vaccinated following a negative test for antibodies against foot-and-mouth disease virus carried out prior to vaccination; and (i) a negative result has been achieved in a test for the detection of either virus or viral genome or an approved test for the detection of antibody against non-structural proteins, carried out at the end of the quarantine period for the semen on samples taken from all animals of susceptible species present at that time on the semen collection centre, and (ii) the semen complies with the conditions of Article 4(3) of Chapter II of Directive 88/407/EEC.
(a) during transport and in the slaughterhouse those animals shall not come into contact with other animals of susceptible species; (b) the animals shall be accompanied by an official document certifying that all animals of susceptible species on the holding of origin or dispatch have undergone a survey provided for in Article 56(2); (c) the transport vehicles shall be cleansed and disinfected before loading and after the animals have been delivered, with the date and time of the cleaning and disinfection being recorded in the logbook of the means of transport; (d) the animals shall have passed the ante-mortem health inspection at the slaughterhouse during the 24 hours before slaughter and have in particular undergone examination for mouth and feet disease and not shown signs of that disease.
(a) the establishment shall be operated under strict veterinary control; (b) only fresh meat, excluding offal, which was subjected to the treatment described in points 1, 3 and 4 in Part A of Annex VIII or fresh meat obtained from animals reared and slaughtered outside the vaccination zone shall be processed in the establishment; (c) all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or, in the case of meat from other biungulates, the health mark provided for in Chapter III of Annex I of Directive 91/495/EEC, or, in the case of minced meat and meat preparations, the health mark provided for in Chapter VI of Annex I of Directive 94/65/EC; (d) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with this Directive.
(a) testing for infection with the foot-and-mouth disease virus, either by an assay for antibodies against non-structural proteins of the foot-and-mouth disease virus, or by another approved method, shall meet criteria for sampling on holdings set out in point 2.2 of Annex III. Where the competent authorities use in addition sentinel animals, the conditions for restocking of infected holdings in Annex V shall be taken into account; (b) testing for antibodies against non-structural proteins of the foot-and-mouth disease virus shall be carried out on samples taken from all vaccinated animals of susceptible species and their non-vaccinated offspring in all herds in the vaccination zone.
(a) are classified according to the outcome of the survey referred to in Article 56(2) and the criteria set out in Annex I; (b) comply with the measures set out in paragraphs 2 to 4.
(a) animals of susceptible species on the holding shall: (1) either be killed and the carcasses processed, or (2) the animals shall be classified and (i) the animals positive to at least one of the approved tests referred to in Article 56(3) shall be killed and their carcasses processed, and (ii) the remaining animals of susceptible species on the holding shall be slaughtered under conditions authorised by the competent authorities;
(b) cleansing and disinfection of the holdings in accordance with Article 11; (c) restocking of animals in accordance with Annex V.
(a) fresh meat produced from the animals referred to in paragraph 3(2)(ii) shall be subject to Article 55(4), for meat from ruminants, and (6), for meat from porcine animals, respectively; (b) milk and milk products produced from the animals referred to in paragraph 3(2)(ii) shall undergo at least one of the treatments specified in Parts A and B of Annex IX depending on the intended use and in compliance with the provisions in Article 54(4) to (8).
(a) within 24 hours of loading, all animals of susceptible species on the holding have been subjected to clinical examination and have not shown clinical signs of foot-and-mouth disease, and (b) the animals have completed a standstill on the holding of origin of at least 30 days during which no animal of susceptible species has been introduced onto the holding, and (c) the holding of origin is not situated in a protection or surveillance zone, and (d) the animals intended for transport were either individually subjected with negative results to tests for the detection of antibodies against the foot-and-mouth disease virus at the end of the isolation period, or a serological survey was completed on that holding in accordance with point 2.2 of Annex III irrespective of the species concerned; (e) the animals were not exposed to any source of infection during their transportation from the holding of origin to the place of destination.
(a) a holding within the vaccination zone of the same health status as the holding of origin; (b) a slaughterhouse for immediate slaughter; (c) a holding designated by the competent authority, from which the offspring are to be sent directly to the slaughterhouse; (d) any holding, after having obtained a negative result in a serological test for the detection of antibody against the foot-and-mouth disease virus carried out on a sample of blood taken prior to dispatch from the holding of origin.
(a) either the measures provided for in Article 57(3) have been completed in the entire vaccination zone or the animals are transported to the slaughterhouse under the conditions provided for in paragraph 3 or 4(d), and; (b) the establishment shall be operated under strict veterinary control; (c) only fresh meat produced from animals referred to in point (a) or from animals reared and/or slaughtered outside the vaccination zone or fresh meat referred to in paragraph 8 shall be processed in the establishment; (d) all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates, the health mark provided for in Chapter III of Annex I of Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark provided for in Chapter VI of Annex I of Directive 94/65/EC; (e) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with this Directive.
(a) the establishment shall be operated under strict veterinary control; (b) only fresh meat excluding offal, which was subjected to the treatment described in point 1, 3 and 4 in Part A of Annex VIII or fresh meat referred to in paragraph 6 or produced from animals reared and/or slaughtered outside the vaccination zone are processed in the establishment; (c) all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark provided for in Chapter VI of Annex I to Directive 94/65/EC; (d) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat which is of different animal health status in accordance with this Directive.
(a) the establishment shall be operated under strict veterinary control; (b) only fresh meat from animals originating in holdings complying with the conditions in Article 57(5) or fresh meat obtained from animals reared and slaughtered outside the vaccination zone are processed in the establishment; (c) all such fresh meat shall bear a health mark to be decided in accordance with Article 4(3) of Directive 2002/99/EC; (d) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with this Directive.
(a) all the measures provided for in Articles 36 and 44 have been completed, and (b) at least one of the following conditions applies: (i) the relevant recommendations in the foot-and-mouth disease Chapter, as last amended, of the Animal Health Code of the OIE are met; (ii) at least three months have elapsed after the last recorded outbreak of foot-and-mouth disease and clinical and laboratory surveillance carried out in accordance with Annex III has confirmed the absence of infection with the foot-and-mouth disease virus in the Member State or region concerned.
(a) all the measures provided for in Articles 36, 44, 54, 55, 56 and 57 have been completed, and (b) at least one of the following conditions applies: (i) the relevant recommendations in the foot-and-mouth disease Chapter, as last amended, of the Animal Health Code of the OIE are met; (ii) at least three months have elapsed since the slaughter of the last vaccinated animal and serological surveillance has been carried out in accordance with the guidelines established in accordance with Article 70(3); (iii) at least six months have elapsed since the last outbreak of foot-and-mouth disease or the completion of emergency vaccination, what ever event occurred later, and in accordance with the guidelines established in accordance with Article 70(3), a serological survey based on the detection of antibodies against non-structural proteins of the foot-and-mouth disease virus has demonstrated the absence of infection in vaccinated animals.
(a) have not been vaccinated and are consigned directly to a slaughter house for immediate slaughter; or (b) have been isolated for at least 30 days immediately prior to loading and have undergone a serological test for the detection of antibody against foot-and-mouth disease virus structural proteins, carried out with negative results on samples taken during the 10 days prior to loading.
(a) laboratories and establishments in which live foot-and-mouth disease virus, its genome, antigens or vaccines produced from such antigens are handled for research, diagnosis or manufacture are strictly controlled by the competent authorities; (b) the handling of live foot-and-mouth disease virus for research and diagnosis is carried out only in approved laboratories listed in Part A of Annex XI; (c) the handling of live foot-and-mouth disease virus for the manufacturing of either inactivated antigens for the production of vaccines or vaccines and related research is carried out only in the approved establishments and laboratories listed in Part B of Annex XI; (d) the laboratories and establishments referred to in points (b) and (c) are operated at least according to the bio-security standards set out in Annex XII.
(a) laboratory testing for foot-and-mouth disease is carried out in laboratories authorised for such testing by the competent authorities; (b) laboratory testing to confirm the presence of foot-and-mouth disease virus or other vesicular disease viruses is carried out in accordance with Article 71 by one of the laboratories listed in Part A of Annex XI; (c) one of the laboratories listed in Part A of Annex XI shall be designated as the national reference laboratory for the Member State on whose territory it is situated, and it shall be responsible for coordinating standards and methods of diagnosis in that Member State; (d) the national reference laboratory carries out at least the functions and duties set out in Annex XV; (e) the national reference laboratory referred to in point (c) liases with the Community Reference Laboratory provided for in Article 69 and in particular ensures the sending of appropriate samples to the Community Reference Laboratory.
(a) the vaccine requirements considered necessary in the event of emergency vaccination, and (b) the regions containing densely populated livestock areas, taking into account the criteria set down in Annex X.
(a) designing the necessary control measures; (b) ensuring the prompt and efficient implementation of those measures by the local disease control centres; (c) deploying staff and other resources to local disease control centres; (d) providing information to the Commission, to the competent authorities of other Member States and other national authorities including competent environmental authorities and bodies, as well as veterinary, agricultural and trading organisations and bodies; (e) organising an emergency vaccination campaign and also the delimitation of vaccination zones; (f) liasing with diagnostic laboratories; (g) liasing with competent environmental authorities to coordinate the actions on veterinary and environmental safety; (h) liasing with the media; (i) liasing with the enforcement bodies to ensure adequate implementation of specific legal measures.
(a) a herd identifier and animal location system, preferably computerised; (b) all suitable means of communication including telephones, fax and if possible facilities for communication with the media; (c) a communication system allowing exchange of information with the local disease control centres, the laboratories and other relevant organisations, preferably computerised; (d) maps and other sources of information that can be used in directing control measures; (e) a shared daily journal which shall be maintained to record in chronological order all the events associated with an outbreak of foot-and-mouth disease and allowing different activities to be linked and coordinated; (f) lists of national and international organisations and laboratories that are interested in an outbreak of foot-and-mouth and shall be contacted in such an event; (g) lists of staff and other persons who may be called upon immediately to serve at local disease control centres or in expert groups provided for in Article 78 in the event of an outbreak of foot-and-mouth disease; (h) lists of competent environmental protection authorities and bodies to contact in the event of an outbreak of foot-and-mouth disease; (i) maps identifying appropriate processing site areas; (j) lists of treatment and processing undertakings authorised to treat or process animal carcasses and animal waste that could be commissioned in the event of an outbreak of foot-and-mouth disease, in particular, indicating their capacity, address and other contact details; (k) lists of measures to monitor and control disinfectant run-off as well as body tissue and fluid displacement into the surrounding environment as a result of carcass decomposition, particularly into surface waters and groundwaters.
(a) one telephone line reserved for communication with the national disease control centre accessible phone lines where farmers and other rural residents can obtain recent, accurate information about the measures taken; (b) field staff equipped with necessary tools for communication and effective management of all necessary data; (c) a record system, preferably computer-based, connected to the national disease control centre and to all necessary databases, laboratories and other organisations; (d) a shared daily journal which shall be maintained to record in chronological order all the events associated with an outbreak of foot-and-mouth and allowing different activities to be linked and coordinated; (e) up-to-date lists of persons, including private veterinarians, and local organisations in each region who shall be contacted and may be involved in the event of an outbreak of foot-and-mouth disease; (f) up-to-date lists of holdings to which the provisions of Article 15 and 18 may be applied in the case of an outbreak of foot-and-mouth disease; (g) up-to-date inventories of possible burning or burial places for animals killed in accordance with this Directive and to be processed in accordance with Community and national legislation on the protection of the environment; (h) up-to-date list of competent environmental authorities in each region, as well as other environmental bodies who must be contacted and are to be involved in the event of an outbreak of foot-and-mouth disease; (i) maps identifying suitable disposal sites for burial of carcasses that will not present a risk of harm to the environment, in particular to surface waters or groundwaters; (j) list of treatment and disposal undertakings authorised to treat or dispose of animal carcasses and animal waste; (k) list of measures to monitor and control disinfectant run-off as well as body tissue and fluid displacement into the surrounding environment as a result of carcass decomposition, particularly into surface waters and groundwaters.
(a) evaluate the clinical picture and the epidemiological situation; (b) give advice regarding the sampling and analyses needed for diagnosing the foot-and-mouth disease together with the additional actions and measures to be taken.
(a) conduct at least in the index case and if necessary on the spot, an evaluation of the clinical picture and an analysis of the epidemiological inquiry in order to collect the necessary data for determining: (i) the origin of the infection; (ii) the date of introduction of the infectious agent; (iii) the possible spread of the disease;
(b) report to the Chief Veterinary Officer and the national disease control centre; (c) give advice on screening, sampling, test procedures, control and the other measures to be applied and on the strategy to be implemented, including advice on bio-security measures on holdings or on premises referred to in Article 16, and in relation to emergency vaccination; (d) follow up and guide the epidemiological inquiry; (e) supplement the epidemiological data with geographical, meteorological and other necessary information; (f) analyse the epidemiological data and perform risk assessments at regular intervals; (g) assist in ensuring that the processing of animal carcasses and animal waste is done with a minimum of detrimental effect on the environment.
(a) conditions for supply of quantities and subtypes of concentrated inactivated antigen; (b) conditions for secure storage of antigen and authorised vaccines; (c) guarantees and conditions of rapid formulation, production, bottling, labelling and distribution of vaccines.
1. Foot-and-mouth disease virus has been isolated from an animal, any product derived from that animal, or its environment. 2. Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species, and the viral antigen or viral ribonucleic acid (RNA) specific to one or more of the serotypes of foot-and-mouth disease virus has been detected and identified in samples collected from the animal or animals of the same epidemiological group. 3. Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species and the animal or its cohorts are positive for antibody to foot-and-mouth disease virus structural or non-structural proteins, provided that previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity. 4. Viral antigen or viral RNA specific to one or more of the serotypes of foot-and-mouth disease virus has been detected and identified in samples collected from animals of susceptible species and the animals are positive for antibody to foot-and-mouth disease virus structural or non-structural proteins, provided that in the case of antibodies to structural proteins previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity. 5. An epidemiological link has been established to a confirmed foot-and-mouth disease outbreak and at least one of the following conditions applies: (a) one or more animals are positive for antibody to foot-and-mouth disease virus structural or non-structural proteins, provided that previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity; (b) viral antigen or viral RNA specific to one or more of the serotypes of foot-and-mouth disease virus has been detected and identified in samples collected from one or more animals of susceptible species; (c) serological evidence of active infection with foot-and-mouth disease by detection of seroconversion from negative to positive for antibody to foot-and-mouth disease virus structural or non-structural proteins has been established in one or more animals of susceptible species, and previous vaccination, residual maternal antibodies or non-specific reactions can be excluded as possible causes of seropositivity. Where a previously seronegative status cannot be reasonably expected, this detection of seroconversion is to be carried out in paired samples collected from the same animals on two or more occasions at least 5 days apart, in the case of structural proteins, and at least 21 days apart, in the case of non-structural proteins. (d) Clinical signs consistent with foot-and-mouth disease are observed in an animal of a susceptible species
(a) date of dispatch; (b) time of dispatch; (c) country of origin; (d) name of disease and type of virus, where appropriate; (e) serial number of outbreak; (f) type of outbreak; (g) reference number of outbreak linked to this outbreak; (h) region and geographical location of the holding; (i) other region affected by restrictions; (j) date of confirmation and method used for confirmation; (k) date of suspicion; (l) date of estimation of first infection; (m) origin of disease, as far as can be indicated; (n) disease control measures taken.
(a) the number of animals of each susceptible species in the outbreak, or premises and means of transport referred to in Article 16; (b) for each species and type (breeding, fattening, slaughter, etc.), the number of dead animals of susceptible species on the holding, slaughterhouse or means of transport; (c) for each type (breeding, fattening, slaughter, etc.), the morbidity of the disease and the number of animals of susceptible species in which foot-and-mouth disease has been confirmed; (d) the number of animals of susceptible species killed in the outbreak, slaughterhouse or means of transport; (e) the number of carcasses processed and disposed of; (f) the distance of the outbreak from the nearest holding on which animals of susceptible species are kept; (g) if foot-and-mouth disease was confirmed in a slaughterhouse or means of transport, the location of the holding or holdings of origin of the infected animals or carcasses.
(a) the date on which the animals of susceptible species on the holding, slaughterhouse or means of transport were killed and their carcasses processed; (b) the results of the tests carried out on samples taken when animals of susceptible species were killed; (c) where the derogation provided for in Article 18 has been applied, the number of animals of susceptible animals killed and processed and where applicable the number of animals of susceptible species which are to be slaughtered at a later date and the time limit laid down for their slaughter; (d) any information relating to the possible origin of the disease or the origin of the disease if this has been ascertained; (e) in the case of a primary outbreak or a case of foot-and-mouth disease in a slaughterhouse or means of transport, the genetic type of virus responsible for the outbreak or the case; (f) in cases where animals of susceptible species have been killed in contact holdings or in holdings containing animals of susceptible species suspected of being infected with foot-and-mouth disease virus, information on: (i) the date of killing and the number of animals of susceptible species of each category killed in each holding and in cases where animals of susceptible species in contact holdings were not killed, information must be provided on the reasons for this decision, (ii) the epidemiological link between the outbreak or case of foot-and-mouth disease and each contact holding or the reasons that have induced suspicion of foot-and-mouth disease in each suspected holding, (iii) the results of the laboratory tests carried out on the samples taken from the animals of susceptible species in the holdings and when they were killed.
(a) either a heat treatment in a hermetically sealed container with an Fo value of 3,00 or more; or (b) a heat treatment in which the centre temperature is raised to at least 70 °C for at least 60 minutes.
(a) either has undergone the action of (i) steam in a closed chamber for at least 10 minutes and at a minimum temperature of 80 °C, or (ii) formalin fumes (formaldehyde gas) produced in a chamber kept closed for at least 8 hours and at a minimum temperature of 19 °C, using commercial-type solutions at 35-40 % concentration, or
(b) has been stored in package or bales under shelter at premises situated not closer than 2 km to the nearest outbreak of foot-and-mouth disease and is not released from the premises before at least three months have elapsed following the completion of cleansing and disinfection measures provided for in Article 11 and in any case not before the end of the restrictions in the protection zone.
heart from which lymphatic glands, connective tissue and adhering fat have been completely removed; liver from which lymphatic glands, adhering connective tissue and fat have been completely removed; whole masseter muscles, incised in accordance with paragraph 41(a) of Chapter VIII of Annex I to Directive 64/433/EEC, from which lymphatic glands, connective tissue and adhering fat have been completely removed; tongues with epithelium and without bone, cartilage and tonsils; lungs from which the trachea and main bronchi and the mediastinal and bronchial lymphatic glands have been removed; other offal without bone or cartilage from which lymphatic glands, connective tissue, adhering fat and mucous membrane have been completely removed.
maturation of carcasses at a temperature of more than + 2 °C for at least 24 hours; pH value in the middle of Longissimus dorsi muscle recorded as less than 6,0.
(a) in the case of ruminants: (i) the animals have been subjected to the controls provided for in Article 24(2), and (ii) the meat is subject to the treatment provided for in points 1, 3 and 4 of Part A;
(b) in the case of all animals of susceptible species: (i) the animals have been resident on the holding for at least 21 days and are identified so as to allow the tracing of the holding of origin, and (ii) the animals have been subjected to the controls provided for in Article 24(2), and (iii) the meat is clearly identified and detained under official supervision for at least 7 days and is not released until any suspicion of infection with the foot-and-mouth disease virus on the holding of origin has been officially ruled out at the end of the detention period;
(c) in the case of all animals of susceptible species: (i) the animals have completed a 21-day standstill on the holding of origin during which no animal of a species susceptible to foot-and-mouth disease has been introduced onto the holding, and (ii) the animals have been subjected to the controls provided for in Article 24(2) within 24 hours of loading, and (iii) samples taken in accordance with the statistical requirements provided for in point 2.2 of Annex III within 48 hours of loading have been tested with negative result in an assay for the detection of antibodies against the foot-and-mouth disease virus, and (iv) the meat is detained under official control for 24 hours and not released before a repeat inspection of the animals in the holding of origin has ruled out on clinical inspection the presence of infected or suspected of being infected animals.
| Criteria | Decision | |
|---|---|---|
| For vaccination | Against vaccination | |
| Population density of susceptible animals | High | Low |
| Predominant species clinically affected | pigs | ruminants |
| Movement of potentially infected animals or products out of the protection zone | Evidence | No evidence |
| Predicted airborne spread of virus from infected holdings | High | Low or absent |
| Suitable vaccine | Available | Not available |
| Origin of outbreaks (traceability) | Unknown | Known |
| Incidence slope of outbreaks | Rising rapidly | Shallow or slow rise |
| Distribution of outbreaks | Widespread | Restricted |
| Public reaction to total stamping out policy | Strong | Weak |
| Acceptance of regionalisation after vaccination | Yes | No |
| Criteria | Decision | |
|---|---|---|
| For vaccination | Against vaccination | |
| Acceptance of regionalisation by third countries | known | unknown |
| Economic assessment of competing control strategies | If it is foreseeable that a control strategy without emergency vaccination would lead to significantly higher economic losses in the agricultural and non-agricultural sectors | If it is foreseeable that a control strategy with emergency vaccination would lead to significantly higher economic losses in the agricultural and non-agricultural sectors |
| It is foreseeable that the 24/48 hours rule cannot be implemented effectively for two consecutive days | Yes | No |
| Significant social and psychological impact of total stamping out policy | Yes | No |
| Existence of large holdings of intensive livestock production in a non-densely populated livestock area | Yes | No |
| Member State where laboratory is located | Laboratory | Member States using the services of laboratory | |
|---|---|---|---|
| ISO code | Name | ||
| AT | Austria | Österreichische Agentur für Gesundheit und Ernährungssicherheit Veterinärmedizinische Untersuchungen Mödling | Austria |
| BE | Belgium | Veterinary and Agrochemical Research Centre CODA-CERVA-VAR, Uccle | |
| CZ | Czech Republic | Státní veterinární ústav Praha, Praha | Czech Republic |
| DE | Germany | ||
| DK | Denmark | ||
| EL | Greece | Διεύθυνση Κτηνιατρικού Κέντρου Αθηνών, Τμήμα Μοριακής Διαγνωστικής, Αφθώδους Πυρετού, Ιολογικών και Εξωτικών Νοσημάτων, Αγία Παρασκευή Αττικής | Greece |
| ES | Spain |
| Spain |
| FR | France | Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Laboratoire de santé animale de Maisons-Alfort | France |
| HU | Hungary | Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állategészségügyi Diagnosztikai Igazgatóság (NÉBIH-ÁDI), Budapest | Hungary |
| IT | Italy | Istituto zooprofilattico sperimentale della Lombardia e dell'Emilia-Romagna, Brescia | |
| NL | Netherlands | Centraal Veterinair Instituut, Lelystad (CVI- Lelystad) | Netherlands |
| PL | Poland | Zakład Pryszczycy Państwowego Instytutu Weterynaryjnego — Państwowego Instytutu Badawczego, Zduńska Wola | Poland |
| RO | Romania | Institutul de Diagnostic și Sănătate Animală, București | Romania |
| UK | United Kingdom | The Pirbright Institute | |
| Member State where laboratory is located | Laboratory | |
|---|---|---|
| ISO code | Name | |
| DE | Germany | Intervet International GmbH/MSD Animal Health, Köln |
| NL | Netherlands | Merial S.A.S., Lelystad Laboratory, Lelystad |
| UK | United Kingdom | Merial, S.A.S., Pirbright Laboratory, Pirbright |
(a) each antigen consists of a single homogeneous batch; (b) each batch is split in order to permit it to be stored at two separate geographical sites under the responsibility of the designated premises of the Community antigen and vaccine bank; (c) the antigen meets at least the requirements of the European Pharmacopoeia and the relevant provisions of the OIE Manual; (d) the principles of Good Manufacturing Practise are maintained throughout the production process and this shall include the storage and finishing of the vaccine reconstituted from the antigens in store; (e) if not otherwise specified in the texts referred to in point (c), the antigen is purified to remove non-structural proteins of the foot-and-mouth disease virus. The purification shall at least ensure that the residual content of non-structural proteins in vaccines reconstituted from such antigen does not induce detectable levels of antibody against non-structural proteins in animals which had received one initial and one subsequent booster vaccination.
(a) rapid formulation into vaccine of the antigen referred to in Article 81; (b) production of a safe, sterile and efficient vaccine with a potency of at least 6 PD 50 in accordance with the tests prescribed by the European Pharmacopoeia, and suitable for use in case of emergency vaccination of ruminants and pigs;(c) a capacity to formulate from concentrated inactivated antigen in stock: (i) up to one million doses of vaccine within four days of instruction from the Commission; (ii) additionally, up to four million doses of vaccine within 10 days of instruction from the Commission;
(d) rapid bottling, labelling and distribution of the vaccine according to the specific needs of the area where vaccination is to be carried out.
1. All national laboratories handling live foot-and-mouth disease virus must operate at least according to the bio-security standards referred to in point 1 of Annex XII. 2. National Laboratories must provide an uninterrupted service for diagnosing vesicular viral diseases and must be equipped and skilled for providing a rapid initial diagnosis. 3. National Laboratories, designated as the National Reference Laboratories in accordance with Article 68(1)(c), must keep inactivated reference strains of all serotypes of foot-and-mouth disease virus, and immune sera against the viruses, as well as all other reagents necessary for a rapid diagnosis. Appropriate cell cultures should be in constant readiness for confirming a negative diagnosis. 4. National Laboratories must be equipped and skilled for large-scale serological surveillance. 5. In all suspected primary outbreaks appropriate samples must be collected and quickly transported, according to a set protocol, to a National Laboratory. In anticipation of a suspicion of foot-and-mouth disease, the National Authority shall ensure that the necessary equipment and materials for sample collection and transportation to a National Laboratory are stored in readiness at local sites. 6. Antigenic typing and genomic characterisation must be carried out on all viruses responsible for new incursions into the Community. This can be performed by the National Laboratory, if facilities exist. Otherwise, at the earliest possible occasion, the National Laboratory must send a sample of virus from the primary case to the Community Reference Laboratory for confirmation and further characterisation, including advice on the antigenic relationship of the field strain to vaccine strains in the Community antigen and vaccine banks. The same procedure should be followed for viruses received by National Laboratories from third countries in situations where characterisation of the virus is likely to be of benefit to the Community. 7. National Laboratories should provide disease data to their State Veterinary Service, which shall provide these data to the Community Reference Laboratory. 8. National Laboratories should collaborate with the Community Reference Laboratory in ensuring that members of the field section of State Veterinary Services have the opportunity of seeing clinical cases of foot-and-mouth disease in National Laboratories as part of their training. 9. National Laboratories shall collaborate with the Community Reference Laboratory and other National Laboratories to develop improved diagnostic methods and exchange relevant materials and information. 10. National Laboratories shall participate in external quality assurance and standardisation exercises organised by the Community Reference Laboratory. 11. National Laboratories shall use tests and standards that meet or exceed the criteria laid down in Annex XIII. National Laboratories shall provide the Commission on request with data proving that the tests in use meet or exceed the requirements. 12. National Laboratories should have the competence to identify all vesicular disease viruses and encephalomyocarditis virus in order to avoid delays in diagnosis and consequently in implementing control measures by the competent authorities. 13. National Laboratories shall cooperate with other laboratories designated by the competent authorities, and listed in the contingency plans for foot-and-mouth disease as referred to in Article 72, for performing tests, for example serological tests, that do not involve handling of live foot-and-mouth disease virus. These laboratories shall not carry out virus isolation (by infection of cells or animals) from samples taken from suspect cases of vesicular diseases. Such laboratories must have established procedures which ensure that the possible spread of foot-and-mouth disease virus is effectively prevented, taking into account the recommendations in Section II of the "Minimum biorisk management standards for laboratories working with foot-and-mouth disease virus in vitro and in vivo" in Appendix 7 to the report adopted by the 40th General Session of the European Commission for the control of foot-and-mouth disease (EuFMD) on 22 -24 April 2013 in Rome (bio-security standards)http://www.fao.org/fileadmin/user_upload/eufmd/Lab_guidelines/FMD_Minimumstandards_2013_Final_version.pdf. Samples giving inconclusive results in tests must be transmitted to the National Reference Laboratory for carrying out confirmatory tests.
(i) with a minimum risk to soil, air, surface and groundwater, to plants and animals, (ii) with a minimum nuisance through noise or odours, (iii) with a minimum adverse effect to the countryside or places of special interest.
(a) notify the primary case in accordance with Annex II; (b) epidemiologists. The expert group shall assist the competent authority in: (i) studying the epidemiological situation and defining an infected area, in accordance with the provisions laid down in point 4(b) of Part B, (ii) establishing appropriate measures to be applied in the infected area in addition to the ones referred to in points (c) and (d); these measures may include suspension of hunting and a ban in feeding wild animals, (iii) drawing up the eradication plan to be submitted to the Commission in accordance with Part B, (iv) carrying out audits to verify the effectiveness of the measures adopted to eradicate foot-and-mouth disease from the infected area;
(c) immediately place under official surveillance holdings keeping animals of susceptible species in the defined infected area and shall in particular order that: (i) an official census be carried out of all species and categories of animals of susceptible species on all holdings; the census shall be kept up to date by the owner. The information in the census shall be produced on request and may be checked at each inspection. However, as regards open-air holdings, the first census carried out may be done on the basis of an estimate, (ii) all animals of susceptible species on the holdings situated in the infected area be kept in their living quarters or some other place where they can be isolated from wild animals. Wild animals must not have access to any material which may subsequently come in contact with animals of susceptible species on the holdings, (iii) no animal of a susceptible species enter or leave the holding save where authorised by the competent authority having regard to the epidemiological situation, (iv) appropriate means of disinfection be used at the entrance and exits of buildings housing animals of susceptible species and of the holding itself, (v) appropriate hygiene measures be applied by all persons coming in contact with wild animals, to reduce the risk of spread of foot-and-mouth disease virus, which may include a temporary ban on persons having been in contact with wild animals from entering a holding keeping animals of susceptible species, (vi) all dead or diseased animals of susceptible species with foot-and-mouth disease symptoms on a holding be tested for the presence of foot-and-mouth disease, (vii) no part of any wild animals, whether shot or found dead, as well as any material or equipment which could be contaminated with foot-and-mouth disease virus shall be brought into a holding keeping animals of susceptible species, (viii) animals of susceptible species, their semen, embryos or ova shall not be moved from the infected area for the purpose of intra-Community trade;
(d) arrange that all wild animals shot or found dead in the defined infected area are inspected by an official veterinarian and examined for foot-and-mouth disease to officially rule out or confirm foot-and-mouth disease in accordance with the definition for an outbreak in Annex I. Carcasses of all wild animals found positive as regards foot-and-mouth disease shall be processed under official supervision. Where such testing proves negative as regards foot-and-mouth disease, Member States shall apply the measures laid down in Article 11(2) of Directive 92/45/EEC. Parts not intended for human consumption shall be processed under official supervision; (e) ensure that the foot-and-mouth disease virus isolate is subject to the laboratory procedure required to identify the genetic type of virus and its antigenic characteristic in relation to existing vaccines strains.
(a) the results of the epidemiological investigations and controls carried out in accordance with Part A and the geographical distribution of the disease; (b) a defined infected area within the territory of the Member State concerned. When defining the infected area, the competent authority shall take into account: (i) the results of the epidemiological investigations carried out and the geographical distribution of the disease, (ii) the wild animal population in the area, (iii) the existence of major natural or artificial obstacles to movements of wild animals;
(c) the organisation of close cooperation between wildlife biologists, hunters, hunting organisations, the wildlife protection services and veterinary services (animal health and public health); (d) the information campaign to be enforced to increase hunters' awareness of the measures they have to adopt in the framework of the eradication plan; (e) specific efforts made to determine the number and location of groups of wild animals with limited contacts to other groups of wild animals in and around the infected area; (f) the approximate number of groups of wild animals referred to in paragraph (e) and their size in and around the infected area; (g) specific efforts made to determine the extent of the infection in wild animals, by investigation of wild animals shot by hunters or found dead, and by laboratory testing, including age-stratified epidemiological investigations; (h) the measures adopted to reduce spread of disease due to movements of wild animals and/or contact between groups of wild animals; these measures may include a prohibition of hunting; (i) the measures adopted to reduce the population of wild animals and in particular young animals of susceptible species in the wild animal population; (j) the requirements to be complied with by hunters in order to avoid any spread of the disease; (k) the method of removal of wild animals found dead or shot, which shall be based on: (i) processing under official supervision, or (ii) inspection by an official veterinarian and laboratory tests as provided for in Annex XIII. Carcasses of all wild animals found positive as regards foot-and-mouth disease shall be processed under official supervision. Where such testing proves negative as regards foot-and-mouth disease, Member States shall apply the measures laid down in Article 11(2) of Directive 92/45/EEC. Parts not intended for human consumption shall be processed under official supervision;
(l) the epidemiological enquiry which is carried out on each wild animal of a susceptible species, whether shot or found dead. This enquiry must include the completion of a questionnaire which supplies information about: (i) the geographical area where the animal was found dead or shot, (ii) the date on which the animal was found dead or shot, (iii) the person who found or shot the animal, (iv) the age and sex of the animal, (v) if shot: symptoms before shooting, (vi) if found dead: the state of the carcass, (vii) laboratory findings;
(m) surveillance programmes and prevention measures applicable to the holdings keeping animals of susceptible species situated in the defined infected area, and if necessary, in its surroundings, including the transport and movement of animals of susceptible species within, from and to the area; these measures shall at least include the ban of moving animals of susceptible species, their semen, embryos or ova from the infected area for the purposes of intra-Community trade; (n) other criteria to be applied for lifting the measures taken to eradicate the disease in the defined area and the measures applied to holdings in the area; (o) the authority charged with supervising and coordinating the departments responsible for implementing the plan; (p) the system established in order that the expert group appointed in accordance with point 1(b) in Part A can review on a regular basis the results of the eradication plan; (q) the disease monitoring measures that shall be enforced after a period of at least 12 months has elapsed from the last confirmed case of foot-and-mouth disease in wild animals in the defined infected area; these monitoring measures shall stay in place for at least 12 months and shall at least include the measures already enforced in accordance with points (g), (k) and (l).
| Directive | Deadline for transposition |
|---|---|
| 85/511/EEC | |
| 90/423/EEC |
| This Directive | Directive 85/511/EEC |
|---|---|
| Article 1, paragraph 1 (a) | Article 1 |
| Article 1, paragraph 1 (b) | — |
| Article 1, paragraph 2 | — |
| Article 2 (a) | Article 2 (a) |
| Article 2 (b) to (h) and (l) to (y) | — |
| Article 2 (i) | Article 2 (d) |
| Article 2 (j) | Article 2 (e) |
| Article 2 (k) | Article 2 (c) |
| Article 3 (1) (a) | Article 3 |
| Article 3 (1) (b) and (c) | — |
| Article 3 (2) | — |
| Article 4 (1) | — |
| Article 4 (2) | Article 4 (1), first subparagraph |
| Article 4 (3) first sentence | Article 4 (1) second subparagraph |
| Article 4 (3) (a) | Article 4 (1) second subparagraph first indent, first part of sentence |
| Article 4 (3) (b) | Article 4 (1) second subparagraph first indent, second part of sentence |
| Article 4 (3) (c) | — |
| Article 4 (3) (d) | Article 4 (1) second subparagraph second and third indent |
| Article 4 (3) (e) | Article 4 (1) second subparagraph ninth indent |
| Article 4 (3) (f) | Article 4 (1) second subparagraph tenth indent |
| Article 4 (3) (g) | — |
| Article 5 (1) (a) | Article 4 (1) second subparagraph fifth indent |
| Article 5 (1) (b) | Article 4 (1) second subparagraph fourth indent |
| Article 5 (1) (c) | Article 4 (1) second subparagraph seventh indent |
| Article 5 (1) (d) | Article 4 (1) second subparagraph eighth indent |
| Article 5 (2) | Article 4 (1) second subparagraph sixth indent |
| Article 5 (3) | — |
| Article 6 (1) | Article 4 (2) |
| Article 6 (2) | — |
| Article 7 | — |
| Article 8 | — |
| Article 9 | Article 4 (3) |
| Article 10 (1) (a) first sentence | Article 5 (2) first indent |
| Article 10 (1) (a) second sentence | — |
| Article 10 (1) (b) first subparagraph | Article 5 (1) |
| Article 10 (1) (b) second subparagraph | Article 5 (3) |
| Article 10 (1) (c) first sentence | Article 5 (2) second and fourth indent |
| Article 10 (1) (c) second and third sentences | — |
| Article 10 (1) (d) | Article 5 (2) fifth and sixth indent |
| Article 10 (2) (a) | Article 5 (2) seventh indent |
| Article 10 (2) (b) | — |
| Article 10 (2) (c) | Article 5 (2) eighth indent |
| Article 11 (1) | Article 10 |
| Article 11 (2) | — |
| Article 11 (3) | — |
| Article 11 (4) | — |
| Article 12 (relating to meat) | Article 5 (2) third indent |
| Article 12 (relating to other substances) | — |
| Article 13 (1) | Article 5 (2) ninth indent and Article 7 |
| Article 13 (2) | — |
| Article 14 | — |
| Article 15 | — |
| Article 16 | — |
| Article 17 | — |
| Article 18 (1) | Article 6 |
| Article 18 (2) | Decision 88/397/EEC |
| Article 18 (3) | Article 6 (1) second subparagraph |
| Article 18 (4) | — |
| Article 19 (1) to (4) | Article 8 |
| Article 19 (5) | — |
| Article 20 | Article 6 (3) |
| Article 21 (1) | — |
| Article 21 (2) | Article 9 (1) |
| Article 21 (3) | — |
| Article 21 (4) to (6) | — |
| Article 22 (1) (a) | Article 9 (2) (a) first indent |
| Article 22 (1) (b) | Article 9 (2) (a) second indent |
| Article 22 (1) (c) | Article 9 (2) (a) third indent first part of sentence |
| Article 22 (2) | Article 9 (2) (a) third indent second part of sentence |
| Article 23 (a) | Article 9 (2) (a) fifth to sixth indent |
| Article 23 (b) | — |
| Article 23 (c) | — |
| Article 23 (d) | — |
| Article 24 (1) (a) | — |
| Article 24 (1) (b) to (f) | — |
| Article 24 (2) (a) | Article 9 (2) (a) seventh indent last part of sentence |
| Article 24 (2) (b) | — |
| Article 24 (2) (c) | Article 9 (2) (a) fourth indent |
| Article 24 (2) (d) | — |
| Article 25 | — |
| Article 26 | — |
| Article 27 | — |
| Article 28 | — |
| Article 29 | — |
| Article 30 | — |
| Article 31 | — |
| Article 32 | — |
| Article 33 | — |
| Article 34 | — |
| Article 35 | — |
| Article 36 (1) (a) | Article 9 (2) (b) first sentence |
| Article 36 (1) (b) | — |
| Article 36 (2) | Article 9 (2) (b) second sentence |
| Article 36 (3) | — |
| Article 37 (1) | — |
| Article 37 (2) | Article 9 (3) (a) |
| Article 38 (1) | Article 9 (3) (a) second indent first part |
| Article 38 (2) (a) | Article 9 (3) (a) second indent last part |
| Article 38 (2) (b) to (d) | — |
| Article 38 (3) | — |
| Article 38 (4) | — |
| Article 38 (5) | — |
| Article 39 | — |
| Article 40 | — |
| Article 41 | — |
| Article 42 | — |
| Article 43 | — |
| Article 44 (1) (a) | Article 9 (3) (b) |
| Article 44 (1) (b) and (c) | — |
| Article 44 (2) | — |
| Article 45 | — |
| Article 46 | — |
| Article 47 (1) | Article 12, first indent |
| Article 47 (2) | — |
| Article 48 | Article 12, second and third indent |
| Article 49 (a) | Article 13 (1) first indent |
| Article 49 (b) | Article 13 (1) third indent |
| Article 49 (c) and (d) | — |
| Article 50 (1) (a) | Article 13 (3) first subparagraph first sentence |
| Article 50 (1) (b), (c) and (d) | — |
| Article 50 (2) | — |
| Article 50 (3) | Article 13 (3) second subparagraph |
| Article 50 (4) and (5) | Article 13 (3) third subparagraph |
| Article 50 (6) | — |
| Article 51 (1) | Article 13 (3) first subparagraph first to sixth indent |
| Article 51 (2) | — |
| Article 52 | — |
| Article 53 | — |
| Article 54 | — |
| Article 55 | — |
| Article 56 | — |
| Article 57 | — |
| Article 58 | — |
| Article 59 | — |
| Article 60 | — |
| Article 61 | — |
| Article 62 | — |
| Article 63 | — |
| Article 64 | — |
| Article 65 (a), (b) and (c) | Article 13 (1) second indent |
| Article 65 (d) | Article 13 (1) fourth indent |
| Article 66 | Article 13 (2) first and second subparagraph |
| Article 67 | Article 13 (2) second subparagraph |
| Article 68(1) (a) and (b) | Article 11 (1) first indent |
| Article 68 (1) (c) and (e) | Article 11 (1) second and third indent |
| Article 68 (1) (d) | — |
| Article 68 (2), (3) and (4) | — |
| Article 69 | Council Decision 89/531/EEC |
| Article 70 (1) | — |
| Article 70 (2) | Article 13 (2) third subparagraph |
| Article 71 | — |
| Article 72 | Article 5 of Directive 90/423/EEC |
| Article 73 | — |
| Article 74 | — |
| Article 75 | — |
| Article 76 | — |
| Article 77 | — |
| Article 78 | — |
| Article 79 (1) | Article 14 (1) first subparagraph second half sentence |
| Article 79 (2) | Article 14 (1) third subparagraph second half sentence |
| Article 79 (3) | — |
| Article 79 (4) | — |
| Article 80 | Decision 91/666/EEC |
| Article 81 | — |
| Article 82 | — |
| Article 83 | — |
| Article 84 | Decision 91/665/EEC |
| Article 85 | — |
| Article 86 | — |
| Article 87 | — |
| Article 88 | — |
| Article 89 | Articles 16 and 17 |
| Article 90 | — |
| Article 91 | — |
| Article 92 (1) | Article 6 of Directive 90/423/EEC |
| Article 92 (2) first subparagraph | — |
| Article 92 (2) second and third subparagraphs | Article 5(4) of Directive 90/423/EEC |
| Article 93 | Article 19 |
| Article 94 | — |
| Article 95 | Article 20 |
| Annex I | — |
| Annex II | — |
| Annex III | — |
| Annex IV | — |
| Annex V | — |
| Annex VI | — |
| Annex VII | — |
| Annex VIII | — |
| Annex IX Part A | — |
| Annex IX Part B | — |
| Annex X | — |
| Annex XI Part A | Annex B |
| Annex XI Part B | Annex A |
| Annex XII | — |
| Annex XIII | — |
| Annex XIV | Decision 91/666/EEC |
| Annex XV | — |
| Annex XVI | Decision 89/531/EEC |
| Annex XVII | Decision 91/42/EEC |
| Annex XVIII | — |
| Annex XIX | — |
| Annex XX | — |
| Financial Statement | — |