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32002L0060

Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever (Text with EEA relevance)

Official Journal L 192 , 20/07/2002 P. 0027 - 0046

Council Directive 2002/60/ECof 27 June 2002laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever(Text with EEA relevance)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease(1), and in particular Article 15 and Article 24(1) thereof,Having regard to the proposal from the Commission,Whereas:(1) The general measures laid down in Directive 92/119/EEC are aimed at preventing the further spread of certain animal diseases of major economic importance and in particular at controlling the movement of animals and products liable to spread the infection.(2) The International Office of Epizootics (OIE) is the technical reference body for animal health recognised by the World Trade Organisation. It has drawn up a list of epidemic animal diseases of major economic importance (List A).(3) It is necessary and appropriate that Directive 92/119/EEC should apply to all the epidemic diseases on List A, with the exception of those for which specific provision has already been made at Community level.(4) Teschen disease is no longer included in List A. It is therefore appropriate to delete that disease from the list set out in Annex I to Directive 92/119/EEC.(5) African swine fever is a disease of major economic importance, included in List A, which occurs in certain limited areas of the Community. It is therefore appropriate to establish Community measures for the control of that disease.(6) African swine fever should be included in the list set out in Annex I to Directive 92/119/EEC and specific provisions for its control should be laid down in accordance with Article 15 of that Directive.(7) Measures should be adopted to control the movement of pigs and their products from areas subject to restrictions arising from an outbreak of African swine fever. Such measures should be similar to those established at Community level for the control of other pig diseases such as swine vesicular disease and classical swine fever.(8) In particular, Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(2) should be used as a model for the establishment of specific measures for the control of African swine fever. However, adjustments should be made particularly because of the differences between the two diseases, the current lack of vaccines and especially the incubation period for African swine fever and the possibility that this disease is transmitted by vectors.(9) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(3),HAS ADOPTED THIS DIRECTIVE:Article 1Subject-matterThis Directive lays down the minimum Community measures for the control of African swine fever.It removes Teschen disease from the group of diseases to which the general control measures laid down in Directive 92/119/EEC apply.Article 2DefinitionsFor the purposes of this Directive:(a) "pig" shall mean any animal of the Suidae family, including feral pigs;(b) "feral pig" shall mean a pig which is not kept or bred on a holding;(c) "holding" shall mean any agricultural or other premises located in the territory of a Member State where pigs are being bred or kept on a permanent or temporary basis. This definition does not include slaughterhouses, means of transport and fenced areas where feral pigs are kept and may be hunted; these fenced areas must be of a size and structure that makes the measures laid down in Article 5(1) not applicable;(d) "diagnostic manual" shall mean the diagnostic manual referred to in Article 18(3);(e) "pig suspected of being infected with African swine fever virus" shall mean any pig or pig carcase exhibiting clinical symptoms or showing post mortem lesions or reactions to laboratory tests carried out in accordance with the diagnostic manual which indicate the possible presence of African swine fever;(f) "case of African swine fever" or "pig infected with African swine fever" shall mean any pig or pig carcase:- in which clinical symptoms or post mortem lesions of African swine fever have been officially confirmed, or- in which the presence of the disease has been officially confirmed as the result of a laboratory examination carried out in accordance with the diagnostic manual;(g) "outbreak of African swine fever" shall mean the holding where one or more cases of African swine fever has or have been detected;(h) "primary outbreak" shall mean the outbreak within the meaning of Article 2(d) of Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community(4);(i) "infected area" shall mean the area of a Member State where, following the confirmation of one or more cases of African swine fever in feral pigs, disease eradication measures are in place in accordance with Article 15 or 16;(j) "primary case of African swine fever in feral pigs" shall mean any case of African swine fever which is detected in feral pigs in an area in which no measures are in place in accordance with Article 15 or 16;(k) "contact holding" shall mean a holding where African swine fever may have been introduced, whether as a result of the location, movement of persons, pigs or vehicles or in any other way;(l) "owner" shall mean any person or persons, either natural or legal, having ownership of the pigs, or charged with keeping the said animals, whether or not for financial reward;(m) "competent authority" shall mean the competent authority within the meaning of Article 2(6) of Directive 90/425/EEC(5);(n) "official veterinarian" shall mean the veterinarian designated by the competent authority of the Member State;(o) "processing" shall mean one of the treatments for high risk material laid down in Article 3 of Directive 90/667/EEC(6), applied in such a way as to avoid the risk of spread of the African swine fever virus;(p) "killing" shall mean the killing of pigs within the meaning of Article 2(6) of Directive 93/119/EEC(7);(q) "slaughter" shall mean the slaughter of pigs within the meaning of Article 2(7) of Directive 93/119/EEC;(r) "vector" shall mean a tick of the species Ornithodorus erraticus.Article 3African swine fever notification1. Member States shall ensure that the presence or the suspected presence of African swine fever is compulsorily and immediately notifiable to the competent authority.2. Without prejudice to existing Community provisions on notification of outbreaks of animal diseases, the Member State in whose territory African swine fever is confirmed shall:(a) give notification of the disease and provide information to the Commission and the other Member States in accordance with Annex I on:- the outbreaks of African swine fever which are confirmed in holdings,- the cases of African swine fever which are confirmed in a slaughterhouse or in means of transport,- the primary cases of African swine fever which are confirmed in feral pigs,- the results of the epidemiological inquiry carried out in accordance with Article 8;(b) provide information to the Commission and the other Member States on the further cases confirmed in feral pigs in an African swine fever infected area in accordance with Article 16(3)(a) and (4).Article 4Measures in cases where the presence of African swine fever on a holding is suspected1. Where a holding contains one or more pigs suspected of being infected with African swine fever virus, Member States shall ensure that the competent authority immediately sets in motion official means of investigation to confirm or rule out the presence of the said disease in accordance with the procedures laid down in the diagnostic manual.When the holding is visited by an official veterinarian, a check of the register and of the pig identification marks referred to in Articles 4 and 5 of Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals(8) shall also be carried out.2. When the competent authority considers that the presence of African swine fever in a holding cannot be ruled out, it shall immediately have the holding placed under official surveillance and shall in particular order that:(a) all the pigs in the various categories on the holding are to be counted and a list compiled of the number of pigs already sick, dead or likely to be infected in each category; the list shall be updated to take account of pig births and deaths during the period of suspicion; the information on the list shall be produced upon request and may be checked at each visit;(b) all the pigs on the holding shall be restricted to their living quarters or confined in some other place where they can be isolated;(c) no pigs may enter or leave the holding. The competent authority may, if necessary, extend the ban on leaving the holding to cover other species of animals and require the application of appropriate measures to destroy rodents or insects;(d) no pig carcases may leave the holding without an authorisation issued by the competent authority;(e) no meat, pig products, semen, ova or embryos of pigs, animal feed, utensils, materials or waste likely to transmit African swine fever may leave the holding without an authorisation issued by the competent authority; meat, pig products, semen, ova or embryos shall not be moved from the holding for intra-Community trade;(f) the movement of persons to or from the holding shall be subject to written authorisation by the competent authority;(g) the movement of vehicles to or from the holding shall be subject to written authorisation by the competent authority;(h) appropriate means of disinfection shall be used at the entrances and exits of buildings housing pigs and of the holding itself; any person entering or leaving pig holdings shall comply with appropriate hygiene measures necessary to reduce the risk of African swine fever virus spreading. Furthermore, all means of transport shall be carefully disinfected before leaving the holding;(i) an epidemiological inquiry shall be carried out in accordance with Article 8.3. Where required by the epidemiological situation, the competent authority:(a) may apply the measures provided for in Article 5(1) in the holding referred to in paragraph 2 of this Article; however, the competent authority may, where it considers that conditions permit, limit the application of these measures only to the pigs suspected of being infected or contaminated with African swine fever virus and the part of the holding where they were kept, provided that those pigs have been housed, kept and fed completely separately from the other pigs in the holding. In any case, a sufficient number of samples shall be taken from the pigs when they are killed in order that the presence of African swine fever virus can be confirmed or ruled out, in accordance with the diagnostic manual;(b) may establish a temporary control zone around the holding referred to in paragraph 2; some or all the measures referred to in paragraphs 1 or 2 shall be applied in the pig holdings within this zone.4. Once adopted, the measures provided for in paragraph 2 shall not be lifted until the presence of African swine fever has been officially ruled out.Article 5Measures in cases where the presence of African swine fever on a holding is confirmed1. In cases where the presence of African swine fever is officially confirmed in a holding, Member States shall ensure that, in addition to the measures referred to in Article 4(2), the competent authority prescribes that:(a) all pigs on the holding are to be killed without delay under official supervision and in such a way as to avoid the risk of African swine fever virus spreading during transport or killing;(b) a sufficient number of samples are to be taken, in accordance with the diagnostic manual, from the pigs when they are killed, in order that the manner of introduction of African swine fever virus into the holding and the length of time during which it may have existed on the holding before the disease was notified may be established;(c) the carcases of pigs which have died or have been killed are to be processed under official supervision;(d) meat of pigs slaughtered during the period between the probable introduction of the disease into the holding and the taking of official measures is wherever possible to be traced and processed under official supervision;(e) semen, ova or embryos of pigs collected from the holding during the period between the probable introduction of disease into the holding and the taking of official measures are to be traced and destroyed under official supervision in such a way as to avoid the risk of African swine fever virus spreading;(f) all substances and waste likely to be contaminated, such as feedingstuffs, are to be processed; all materials for single use which may be contaminated and in particular those used for the killing operations are to be destroyed; these actions are to be carried out in accordance with the instructions of the official veterinarian;(g) after the pigs have been eliminated, the buildings used for housing the pigs, the vehicles used for transporting them or their carcases and the equipment, bedding, manure and slurry likely to be contaminated are to be cleaned, if necessary disinsectised, disinfected and treated in accordance with Article 12;(h) in the case of a primary outbreak of disease, the African swine fever virus isolate is to be subject to the laboratory procedure laid down in the diagnostic manual to identify the genetic type;(i) an epidemiological inquiry is to be carried out in accordance with Article 8.2. In cases where an outbreak has been confirmed in a laboratory, a zoo, a wild life park or a fenced area where pigs are kept for scientific purposes or purposes related to conservation of species or conservation of rare breeds, the Member State concerned may decide to derogate from paragraphs 1(a) and 1(e), provided that basic Community interests are not adversely affected.Such a decision shall immediately be notified to the Commission.The Commission shall in all cases immediately review the situation with the Member State concerned and in the Standing Veterinary Committee at the earliest possible opportunity. If necessary, measures to prevent the disease spreading shall be adopted in accordance with the procedure referred to in Article 24(2).Article 6Measures in cases where the presence of African swine fever is confirmed in holdings consisting of various production units1. Where the presence of African swine fever is confirmed in holdings which consist of two or more separate production units and in order that the fattening of pigs may be completed, the competent authority may decide to derogate from the provisions of Article 5(1)(a) as regards healthy pig production units on a holding which is infected provided that the official veterinarian confirms that the structure, size and distance apart of these production units and the operations carried out there are such that the production units provide completely separate facilities for housing, keeping and feeding, so that the virus cannot spread from one production unit to another.2. If use is made of the derogation referred to in paragraph 1, Member States shall draw up detailed rules for applying it in the light of the animal health guarantees which can be secured.3. Member States which make use of this derogation shall immediately notify the Commission thereof. The Commission shall in all cases immediately review the situation with the Member State concerned and in the Standing Veterinary Committee at the earliest possible opportunity. If necessary, measures to prevent the disease spreading shall be adopted in accordance with the procedure laid down in Article 24(2).Article 7Measures in contact holdings1. Holdings shall be recognised as contact holdings where the official veterinarian finds, or considers on the basis of the epidemiological inquiry carried out in accordance with Article 8, that African swine fever may have been introduced, either from other holdings to the holding referred to in Article 4 or 5, or from the latter holding to other holdings.Article 4 shall be applied in such holdings until the presence of African swine fever has been officially ruled out.2. The competent authority shall apply the measures provided for in Article 5(1) in the contact holdings referred to in paragraph 1 of this Article if the epidemiological situation so requires.A sufficient number of samples shall be taken from the pigs, in accordance with the diagnostic manual, when they are killed in order that the presence of African swine fever virus in these holdings can be confirmed or ruled out.Article 8Epidemiological inquiryMember States shall ensure that the epidemiological inquiry in relation to suspected cases or outbreaks of African swine fever is carried out on the basis of questionnaires, prepared within the framework of the contingency plans referred to in Article 21.Such an inquiry shall deal at least with:(a) the length of time during which African swine fever virus may have existed on the holding before the disease was notified or suspected;(b) the possible origin of African swine fever on the holding and the identification of other holdings in which pigs may have become infected or contaminated from the same source;(c) the movement of persons, vehicles, pigs, carcases, semen, meat or any material which could have carried the virus to or from the holdings in question;(d) the possibility that vectors or feral pigs cause the disease to spread.If the results of this inquiry suggest that African swine fever may have spread from or to holdings located in other Member States, the Commission and the Member States concerned shall be immediately informed.Article 9Establishment of protection and surveillance zones1. Immediately after the diagnosis of African swine fever has been officially confirmed in pigs on a holding, the competent authority shall establish a protection zone with a radius of at least three kilometres around the outbreak site, which shall itself be included in a surveillance zone of a radius of at least 10 kilometres.The measures referred to in Articles 10 and 11 shall be applied in the respective zones.2. When establishing zones, the competent authority must take account of:(a) the results of the epidemiological inquiry carried out in accordance with Article 8;(b) the geographical situation, particularly natural or artificial boundaries;(c) the location and proximity of holdings;(d) patterns of movements and trade in pigs and the availability of slaughterhouses and facilities for processing carcases;(e) the facilities and personnel available to control any movement of pigs within the zones, in particular if the pigs to be killed have to be moved away from their holding of origin.3. If a zone includes parts of the territory of several Member States, the competent authorities of the Member States concerned shall collaborate to establish the zone.4. The competent authority shall take all necessary measures, including the use of prominent signs and warning notices and the use of media resources, such as the press and television, to ensure that all persons in the protection and surveillance zones are fully aware of the restrictions in force in accordance with Articles 10 and 11, and shall take such measures as it considers appropriate to ensure the adequate enforcement of these measures.Article 10Measures in the established protection zone1. Member States shall ensure that the following measures are applied in the protection zone:(a) a census of all the holdings shall be carried out as soon as possible; after the establishment of the protection zone these holdings shall be visited by an official veterinarian within not more than seven days in order to conduct a clinical examination of the pigs and to check the register and the pig identification marks referred to in Articles 4 and 5 of Directive 92/102/EEC;(b) the movement and transport of pigs on public or private roads, excluding when necessary the service roads of holdings, shall be prohibited unless approved by the competent authority when allowing the movements referred to in point (f). This prohibition need not be applied to the transit of pigs by road or rail without unloading or stopping. Furthermore, in accordance with the procedure referred to in Article 24(2), a derogation may be granted for slaughter pigs coming from outside the protection zone and on their way to a slaughterhouse situated in the said zone for immediate slaughter;(c) trucks and other vehicles and equipment, which are used to transport pigs or other livestock or material which may be contaminated (such as carcases, feedingstuff, manure, slurry and so forth) shall be cleaned, disinfected, if necessary disinsectised and treated as soon as possible after contamination, in accordance with Article 12. No truck or vehicle which has been used for the transport of pigs may leave the zone without being cleaned and disinfected and then inspected and re-authorised for transport by the competent authority;(d) no other domestic animal may enter or leave a holding without the authorisation of the competent authority;(e) all dead or diseased pigs on a holding shall be immediately notified to the competent authority, which shall carry out appropriate investigations in accordance with the procedures laid down in the diagnostic manual;(f) pigs may not be removed from the holding in which they are kept for at least 40 days after the completion of the preliminary cleansing and disinfection, and, if necessary, disinsectisation of the infected holdings. After 40 days, subject to the conditions referred to in paragraph 3, the competent authority may authorise the removal of pigs from the said holding to be directly transported to:- a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone for the purpose of immediate slaughter,- a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision,- in exceptional circumstances, to other premises located within the protection zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee;(g) semen, ova or embryos of pigs shall not leave the holdings situated within the protection zone;(h) any person entering or leaving pig holdings shall comply with appropriate hygiene measures as necessary to reduce the risk of African swine fever virus spreading.2. Where the prohibitions provided for in paragraph 1 are maintained beyond 40 days because of further outbreaks of the disease and as a result animal welfare or other problems arise in keeping the pigs, subject to the conditions referred to in paragraph 3, the competent authority may, following a reasoned application by the owner, authorise the removal of pigs from a holding within the protection zone, to be directly transported to:(a) a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone for the purpose of immediate slaughter;(b) a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision;(c) in exceptional circumstances, to other premises located within the protection zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee.3. Where reference is made to this paragraph, the competent authority may authorise the removal of pigs from the holding concerned, on condition that:(a) an official veterinarian has carried out a clinical examination of the pigs in the holding and in particular of those to be moved, including the taking of the body temperature in accordance with the procedures laid down in the diagnostic manual and a check of the register and the pig identification marks referred to in Articles 4 and 5 of Directive 92/102/EEC;(b) the checks and examinations referred to in point (a) have shown no evidence of African swine fever and compliance with Directive 92/102/EEC;(c) the pigs are transported in vehicles sealed by the competent authority;(d) the vehicle and equipment which have been involved in the transport of the pigs are immediately cleaned and disinfected after the transport in accordance with the provisions referred to in Article 12;(e) if the pigs are to be slaughtered or killed, a sufficient number of samples is then taken from the pigs in accordance with the diagnostic manual in order that the presence of African swine fever virus in these holdings can be confirmed or ruled out;(f) if the pigs are to be transported to a slaughterhouse:- the competent authority responsible for the slaughterhouse has been informed of the intention to send the pigs and notifies the dispatching competent authority of their arrival,- on arrival at the slaughterhouse, these pigs are kept and slaughtered separately from other pigs,- during ante and post mortem inspection carried out at the designated slaughterhouse, the competent authority takes into account any signs of the presence of African swine fever,- the fresh meat from these pigs is either processed or marked with the special mark referred to in Article 5a of Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat(9), and is processed separately in accordance with the rules laid down in Article 4(1)(a)(i) of Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products(10). This must be done at an establishment designated by the competent authority. The meat must be sent to the said establishment on condition that the consignment is sealed before departure and remains sealed throughout the transport.4. The measures in the protection zone shall continue to be applied at least until:(a) cleansing, disinfection and, if necessary, disinsectisation in the infected holdings have been carried out;(b) pigs on all holdings have undergone clinical and laboratory examinations carried out in accordance with the diagnostic manual in order to detect the possible presence of African swine fever virus.The examinations referred to in point (b) shall not take place until 45 days have elapsed since the completion of preliminary cleansing, disinfection and, if necessary, disinsectisation measures on the infected holdings.5. However, by way of derogation from paragraphs 1(f), and from paragraphs 2 and 4, the 40- and 45-day periods stipulated therein may be reduced to 30 days if, in accordance with the diagnostic manual, the Member States have applied an intensive sampling and testing programme making it possible to rule out the presence of African swine fever on the holding in question.Article 11Measures in the established surveillance zone1. Member States shall ensure that the following measures are applied in the surveillance zone:(a) a census shall be taken of all pig holdings;(b) the movement and transport of pigs on public or private roads, excluding when necessary the service roads of holdings, shall be prohibited, unless approved by the competent authority. This prohibition need not be applied to the transit of pigs by road or rail, without unloading or stopping, or to slaughter pigs coming from outside the surveillance zone and on their way to a slaughterhouse situated in the said zone for immediate slaughter;(c) trucks and other vehicles and equipment which are used to transport pigs or other livestock or material which may be contaminated (such as carcases, feedingstuff, manure, slurry and so forth) shall be cleaned, disinfected, if necessary disinsectised and treated as soon as possible after contamination, in accordance with Article 12. No truck or vehicle which has been used in the transport of pigs may leave the zone without having been cleaned and disinfected;(d) no other domestic animal may enter or leave a holding during the first seven days after establishment of the zone without the authorisation of the competent authority;(e) all dead or diseased pigs on a holding shall be immediately notified to the competent authority, which shall carry out appropriate investigations in accordance with the procedures laid down in the diagnostic manual;(f) pigs may not be removed from the holding in which they are kept for at least 30 days after the completion of the preliminary cleansing, disinfection and, if necessary, disinsectisation of the infected holdings. After 30 days, subject to the conditions set out in Article 10(3), the competent authority may authorise the removal of the pigs from the said holding to be directly transported to:- a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone, for the purpose of immediate slaughter,- a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision, or- in exceptional circumstances, other premises located within the protection or surveillance zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee.However, if the pigs are to be transported to a slaughterhouse, at the request of a Member State, accompanied by appropriate justification, and in accordance with the procedure referred to in Article 24(2), derogations from Article 10(3)(e) and (f), fourth indent, may be authorised, in particular with respect to the marking of the meat from these pigs and its subsequent use, and the destination of the treated products;(g) semen, ova or embryos of pigs shall not leave the holdings situated within the surveillance zone;(h) any person entering or leaving pig holdings shall comply with appropriate hygienic measures as necessary to reduce the risk of African swine fever virus spreading.2. Where the prohibitions provided for in paragraph 1 are maintained beyond 40 days because of further outbreaks of the disease, and where as a result animal welfare or other problems arise in keeping the pigs, subject to the conditions referred to in Article 10(3), the competent authority may, following a reasoned application by the owner, authorise the removal of pigs from a holding within the surveillance zone to be directly transported to:(a) a slaughterhouse designated by the competent authority, preferably within the protection or surveillance zone, for the purpose of immediate slaughter;(b) a processing plant or a suitable place where the pigs are immediately killed and their carcases are processed under official supervision, or(c) in exceptional circumstances, other premises located within the protection or surveillance zone. Member States making use of this provision shall immediately inform the Commission thereof in the Standing Veterinary Committee.3. The measures in the surveillance zone shall continue to be applied at least until:(a) cleansing, disinfection and, if necessary, disinsectisation in the infected holdings have been carried out;(b) pigs on all holdings have undergone clinical and, where necessary, laboratory examinations as laid down in the diagnostic manual in order to detect the eventual presence of African swine fever virus.The examinations referred to in point (b) shall not take place until 40 days have elapsed since the completion of preliminary cleansing, disinfection and, if necessary, disinsectisation measures on the infected holdings.4. However, by way of derogation from paragraph 1(f), and from paragraphs 2 and 3, the 30-day periods stipulated in paragraph 1(f) and the 40-day periods stipulated in paragraphs 2 and 3 may be reduced respectively to 21, 30 and 20 days if, in accordance with the diagnostic manual, the Member States have applied an intensive sampling and testing programme making it possible to rule out the presence of African swine fever on the holding in question.Article 12Cleansing, disinfection and treatment with insecticidesMember States shall ensure that:(a) the disinfectants and insecticides to be used and their concentrations are officially approved by the competent authority;(b) the cleansing, disinfection and, if necessary, insecticide operations are carried out under official supervision in accordance with:- the instructions given by the official veterinarian; and- the principles and procedures laid down in Annex II.Article 13Repopulation of pig holdings following disease outbreaks1. The reintroduction of pigs to holdings referred to in Article 5 shall not take place until at least 40 days after completion of the cleansing, disinfection and, if necessary, disinsectisation operations in the holding in question in accordance with paragraphs 2 to 5 of this Article.2. The reintroduction of pigs shall take account of the type of farming practised on the holding concerned, and shall conform to one of the procedures set out in paragraphs 3 and 4.3. In the case of holdings where the occurrence of disease has not been linked to vectors, the following procedure shall apply:(a) as regards open-air holdings, the reintroduction of pigs shall start with the introduction of sentinel pigs which have been checked and found negative for the presence of antibodies against African swine fever virus or which come from holdings not subjected to any restrictions related to African swine fever. The sentinel pigs shall be placed, in accordance with the requirements of the competent authority, throughout the infected holding and shall be sampled 45 days later, and shall be tested for the presence of antibodies, in accordance with the diagnostic manual. No pig may leave the holding before the negative results of the serological tests are available; if none of the pigs has developed antibodies against African swine fever virus, full repopulation may then take place;(b) as regards all other forms of rearing, the reintroduction of pigs shall either take place in accordance with the measures provided for in point (a) or shall be based on total repopulation, provided that:- all the pigs arrive within a period of 20 days and come from holdings not subjected to any restrictions related to African swine fever,- pigs in the repopulated herd shall be subjected to a serological examination in accordance with the diagnostic manual. Sampling for that examination shall be carried out at the earliest 45 days after the arrival of the last pigs,- no pig may leave the holding before the negative results of the serological examination are available.4. In the case of holdings where the occurrence of disease has been linked to vectors, restocking shall not take place for at least six years unless:(a) specific operations to eliminate the vector from the premises and places where the pigs are to be kept or can come into contact with the vector have been successfully carried out under official supervision, or(b) it has been possible to show that the persistence of the vector no longer represents a significant risk of African swine fever being transmitted.Thereafter, the measures laid down in paragraph 3(a) shall apply.In addition to those measures, however, no pig may leave the holding in question after full repopulation until further serological examinations for African swine fever have been carried out with negative results on samples collected from the pigs in the holding at the earliest 60 days after full repopulation, in accordance with the diagnostic manual.5. Where the occurrence of disease has not been linked to vectors, and if more than six months have elapsed since the completion of the cleansing and disinfection operations in the holding, the competent authority may authorise derogation from paragraph 3, taking into account the epidemiological situation.6. The reintroduction of domestic animals of species other than pigs to the holdings described in Article 5 shall be subject to authorisation by the competent authority, which shall take account of the risk of spreading the infection or of the persistence of vectors presented by such reintroduction.Article 14Measures in cases where African swine fever is suspected or confirmed in a slaughterhouse or means of transport1. Where there is a suspicion of African swine fever in a slaughterhouse or means of transport, Member States shall ensure that the competent authority immediately sets in motion official means of investigation to confirm or to rule out the presence of the disease in accordance with the procedures laid down in the diagnostic manual.2. Should a case of African swine fever be detected in a slaughterhouse or means of transport, the competent authority shall ensure that:(a) all susceptible animals in the slaughterhouse or in the means of transport are killed without delay;(b) the carcases, offal and animal waste of possibly infected and contaminated animals are processed under official supervision;(c) cleansing, disinfection and, if necessary, disinsectisation of buildings and equipment, including vehicles, takes place under the supervision of the official veterinarian in accordance with Article 12;(d) an epidemiological inquiry is carried out as provided in Article 8 mutatis mutandis;(e) the African swine fever virus isolate is subject to the laboratory procedure laid down in the diagnostic manual, to identify the genetic type of virus;(f) the measures referred to in Article 7 are applied in the holding where the infected pigs or carcases came from and in the other contact holdings. Unless otherwise indicated by the epidemiological inquiry, the measures laid down in Article 5(1) shall be applied in the holding of origin of the infected pigs or carcases;(g) no animals are reintroduced for slaughter or transport until at least 24 hours after completion of the cleansing, disinfection and, if necessary, disinsectisation operations conducted in accordance with Article 12.Article 15Measures in cases where African swine fever is suspected or confirmed in feral pigs1. Immediately after the competent authority of a Member State has information that feral pigs are suspected of being infected, it shall take all appropriate measures to confirm or rule out the presence of the disease, by giving information to the owners of pigs and to hunters, and by investigations of all feral pigs shot or found dead, including laboratory testing.2. As soon as confirmation of a primary case of African swine fever in feral pigs has taken place, in order to reduce the spread of disease, the competent authority of a Member State shall immediately:(a) establish an expert group including veterinarians, hunters, wild life biologists and epidemiologists. The expert group shall assist the competent authority in:- studying the epidemiological situation and defining an infected area in accordance with Article 16(3)(b),- establishing appropriate measures to be applied in the infected area in addition to the ones referred to in points (b) and (c); these measures may include suspension of hunting and a ban on feeding feral pigs,- drawing up the eradication plan to be submitted to the Commission in accordance with Article 16,- carrying out checks to verify the effectiveness of the measures adopted to eradicate African swine fever from the infected area;(b) place under official surveillance pig holdings in the defined infected area, and shall in particular order that:- an official census be carried out of all categories of pigs 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 pig holdings, the first census carried out may be done on the basis of an estimate,- all pigs on the holding be kept in their living quarters or some other place where they can be isolated from feral pigs. Feral pigs must not have access to any material which may subsequently come in contact with the pigs on the holding,- no pigs enter or leave the holding, except where authorised by the competent authority having regard to the epidemiological situation,- appropriate means of disinfection and if necessary disinsectisation be used at the entrance and exits of buildings housing pigs and of the holding itself,- appropriate hygiene measures be applied by all persons coming into contact with feral pigs, to reduce the risk of African swine fever virus spreading,- all dead or diseased pigs with African swine fever symptoms on a holding be tested for the presence of African swine fever,- no part of any feral pig, whether shot or found dead, nor any material or equipment which could be contaminated with African swine fever virus, shall be brought into a pig holding,- pigs, their semen, embryos or ova shall not be moved from the infected area for intra-Community trade;(c) arrange that all feral pigs shot or found dead in the defined infected area are inspected by an official veterinarian and examined for African swine fever in accordance with the diagnostic manual. Carcases of all animals found positive shall be processed under official supervision. Where such testing proves negative as regards African swine fever, Member States shall apply the measures laid down in Article 11(2) of Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat(11). Parts not intended for human consumption shall be processed under official supervision;(d) ensure that the African swine fever virus isolate is subject to the laboratory procedure indicated in the diagnostic manual, to identify the genetic type of virus.3. If a case of African swine fever has occurred in feral pigs in an area of a Member State close to the territory of another Member State, the Member States concerned shall collaborate in the establishment of disease control measures.Article 16Plans for the eradication of African swine fever from a feral pig population1. Without prejudice to the measures laid down in Article 15, Member States shall submit to the Commission within 90 days of the confirmation of a primary case of African swine fever in feral pigs a written plan of the measures taken to eradicate the disease in the area defined as infected, and of the measures applied on the holdings in that area.The Commission shall examine the plan in order to determine whether it permits the desired objective to be attained. The plan, if necessary with amendments, shall be approved in accordance with the procedure referred to in Article 24(2).The plan may subsequently be amended or supplemented to take account of developments in the situation.If these amendments concern the re-definition of the infected area, Member States shall ensure that the Commission and the other Member States are informed of these amendments without delay.If the amendments concern other provisions of the plan, Member States shall submit the amended plan to the Commission for examination and eventual approval in accordance with the procedure referred to in Article 24(2).2. After the measures provided for in the plan mentioned in paragraph 1 have been approved, they shall replace the initial measures laid down in Article 15, on a date which shall be decided upon when approval is given.3. The plan mentioned in paragraph 1 shall contain information on:(a) the results of the epidemiological investigations and controls carried out in accordance with Article 15 and the geographical distribution of the disease;(b) the definition of the infected area within the territory of the Member State concerned. When defining the infected area, the competent authority shall take into account:- the results of the epidemiological investigations carried out and the geographical distribution of the disease,- the feral pig population in the area,- the existence of major natural or artificial obstacles to movements of feral pigs;(c) the organisation of close cooperation between biologists, hunters, hunting organisations, the wildlife services and veterinary authorities (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 extent of the infection in the feral pig population, by investigating feral pigs shot by hunters or found dead, and by laboratory testing, including age-stratified epidemiological investigations;(f) the requirements to be complied with by hunters in order to avoid any spread of the disease;(g) the method of removal of feral pigs found dead or shot, which shall be based on:- processing under official supervision, or- inspection by an official veterinarian and laboratory tests as provided for in the diagnostic manual. Carcases of all animals found positive shall be processed under official supervision. Where such testing proves negative as regards African swine fever, 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;(h) the epidemiological inquiry which is carried out on each feral pig, whether shot or found dead. This inquiry must include the completion of a questionnaire which supplies information about:- the geographical area where the animal was found dead or shot,- the date on which the animal was found dead or shot,- the person who found or shot the animal,- the age and sex of the pig,- if shot: symptoms before shooting,- if found dead: the state of the carcase,- laboratory findings;(i) surveillance programmes and prevention measures applicable to the holdings situated in the defined infected area, and, if necessary, in its surroundings, including the transport and movement of animals within, from and to the area; these measures shall at least include the ban on moving pigs, their semen, embryos or ova from the infected area for intra-Community trade and may include a temporary ban on pig production and on the establishment of new holdings;(j) other criteria to be applied for lifting the measures taken;(k) the authority with responsibility for supervising and coordinating the departments responsible for implementing the plan;(l) the information system established in order that the expert group appointed in accordance with Article 15(2)(a) can review on a regular basis the results of the eradication plan;(m) the disease monitoring measures which shall be enforced at the earliest 12 months after diagnosis of the last case of African swine fever in feral pigs in the defined infected area; these monitoring measures shall stay in place for at least 12 additional months and shall at least include the provisions already enforced in accordance with points (e), (g) and (h).4. A report concerning the epidemiological situation in the defined area and the results of the eradication plan shall be transmitted to the Commission and to the other Member States in the Committee referred to in Article 23 every six months.More detailed rules relating to the information to be provided by the Member States on this matter may be adopted in accordance with the procedure referred to in Article 23(2).Article 17Measures to prevent the spread of African swine fever virus by means of vectors1. Should the presence of vectors be possible or suspected on a holding where African swine fever has been confirmed, the competent authority shall ensure that:(a) the infected building and its surroundings are checked for the presence of vectors, by means of physical inspection and, if necessary, the trapping of specimens in accordance with Annex III;(b) where the presence of vectors is confirmed:- appropriate laboratory tests are carried out to confirm or rule out the presence of African swine fever virus in the vectors,- further appropriate monitoring, checking and control measures are established in the holding and in the area around the holding;(c) where the presence of vectors is confirmed but its control is impracticable, pigs and if necessary other domestic animals are not kept on the holding for at least six years.2. Information on the implementation of paragraph 1 shall be provided by the Member State concerned to the Commission and to the other Member States in the framework of the Standing Veterinary Committee.3. Further measures for the monitoring and control of vectors and for the prevention of African swine fever may be adopted in accordance with the procedure referred to in Article 24(2).Article 18Diagnostic procedures and bio-safety requirements1. Member States shall ensure that:(a) diagnostic procedures, sampling and laboratory testing to detect the presence of African swine fever are carried out in accordance with the diagnostic manual;(b) a national laboratory is responsible for coordinating standards and methods of diagnosis in each Member State in accordance with Annex IV.2. The national laboratories referred to in Annex IV shall liaise with the Community reference laboratory as indicated in Annex V. Without prejudice to the provisions of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(12), and in particular Article 28 thereof, the powers and duties of the laboratory shall be those described in that Annex.3. In order to ensure uniform procedures to diagnose African swine fever and an appropriate differential diagnosis with classical swine fever, within six months of the date when this Directive enters into force and in accordance with the procedure referred to in Article 23(2), an African swine fever diagnostic manual shall be adopted to establish at least:(a) minimum quality standards to be observed by African swine fever diagnostic laboratories and for the transport of samples;(b) criteria and procedures to be followed when clinical or post mortem examinations are carried out to confirm or exclude the presence of African swine fever;(c) criteria and procedures to be followed for the collection of samples from live pigs or their carcases, to confirm or exclude African swine fever by laboratory examinations, including sampling methods for serological or virological screenings carried out in the framework of the application of the measures provided for in this Directive;(d) laboratory tests to be used for the diagnosis of African swine fever, including criteria for evaluating the results of the laboratory tests;(e) laboratory techniques for the genetic typing of the African swine fever virus isolate.4. In order that appropriate bio-safety conditions are guaranteed to protect animal health, the African swine fever virus, its genome and antigens and vaccines for research, diagnosis or manufacture shall be manipulated or used only in places, establishments or laboratories approved by the competent authority.The list of approved places, establishments or laboratories shall be transmitted to the Commission not later than 1 January 2004 and shall be kept updated thereafter.5. Annexes IV and V and the diagnostic manual may be supplemented or amended in accordance with the procedure referred to in Article 23(2).Article 19Use, manufacture and sale of African swine fever vaccinesMember States shall ensure that:(a) the use of African swine fever vaccines is prohibited;(b) the manipulation, manufacture, storage, supply, distribution or sale of African swine fever vaccines in the territory of the Community is carried out under official control.However, to take account of developments in scientific and technical research into the production of such a vaccine, the Commission shall submit to the Council a report accompanied if necessary by appropriate proposals to update this Directive.Article 20Community controlsExperts from the Commission may make on-the-spot checks in cooperation with the competent authorities of the Member States, in so far as this is necessary to ensure uniform application of this Directive. The Member State in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.The rules of application of this Article and in particular those governing the procedure for cooperation with the national authorities shall be adopted in accordance with the procedure referred to in Article 23(2).Article 21Contingency plans1. Each Member State shall draw up a contingency plan specifying the national measures to be implemented in the event of an outbreak of African swine fever, taking into account local factors, such as, in particular, the density of pigs, which are likely to influence the spread of African swine fever.This plan shall allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak.2. The criteria and requirements to be applied for drawing up the contingency plan shall be those set out in Annex VI.In accordance with the procedure referred to in Article 23(2), those criteria and requirements may be amended or supplemented to take into account the specific nature of African swine fever and the progress made in the development of disease control measures.3. The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required, in particular to ensure that they are compatible with those of the other Member States.The plans, if necessary amended, shall be approved in accordance with the procedure referred to in Article 23(2).The plans may be subsequently amended or supplemented, in accordance with the procedure referred to in Article 23(2), to take into account developments in the situation. In any event, every five years each Member State shall update the plan and submit it to the Commission for approval in accordance with the procedure referred to in Article 23(2).Article 22Disease control centres and expert groups1. Member States shall ensure that a fully functional national disease control centre can be immediately set up in the event of any outbreaks of African swine fever.2. 2. The national disease control centre shall direct and monitor the operations of the local disease control centres referred to in paragraph 3. It shall be responsible, inter alia, for:(a) defining the necessary control measures;(b) ensuring the prompt and efficient implementation of the abovementioned measures by the local disease control centres;(c) allocating staff and other resources to local disease control centres;(d) providing information to the Commission, to other Member States, the national veterinary organisations, national authorities and the agricultural and trading bodies;(e) liasing with diagnostic laboratories;(f) liasing with the press and other media;(g) liasing with the police authorities to ensure that specific legal measures are taken.3. Member States shall ensure that fully functional local disease control centres can be immediately set up in the event of any outbreaks of African swine fever.4. Certain functions of the national disease control centre may, however, be delegated to the local disease control centre operating at an administrative level as provided for in Article 2(2)(p) of Directive 64/432/EEC(13) or at another level, provided the objectives of the national disease control centre are not thereby compromised.5. Member States shall create a permanently operational expert group to maintain the expertise needed to assist the competent authority in ensuring disease preparedness.In the event of an outbreak the expert group shall assist the competent authority at least in:(a) the epidemiological enquiry;(b) sampling, testing and interpretation of results of laboratory tests;(c) establishment of disease control measures.6. Member States shall ensure that the national and local disease control centres and the expert group have staff, facilities and equipment including communication systems as necessary, and a clear and effective chain of command and management to ensure the prompt implementation of the disease control measures laid down in this Directive.Details regarding staff, facilities, equipment, chain of command and management of the national and local disease control centres and of the expert group shall be laid down in the contingency plans referred to in Article 21.7. Further criteria and requirements concerning the function and duties of the national disease control centres, local disease control centres and expert groups may be laid down in accordance with the procedure provided for in Article 23(2).Article 23Normal regulatory procedure1. The Commission shall be assisted by a Committee.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.3. The Committee shall adopt its rules of procedure.Article 24Accelerated regulatory procedure1. The Commission shall be assisted by a Committee.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.The period provided for in Article 5(6) of Decision 1999/468/EC shall be 15 days.3. The Committee shall adopt its rules of procedure.Article 25Amendment of Annex I to Directive 92/119/EECIn Annex I to Directive 92/119/EC the words "Teschen disease" shall be replaced by the words "African swine fever".Article 26Implementing measures1. Annexes I to VI to this Directive shall be amended in accordance with the procedure laid down in Article 23(2).2. Any detailed rules necessary for the implementation of this Directive may be adopted in accordance with the procedure laid down in Article 23(2) or when the epidemiological situation so requires, in accordance with the procedure laid down in Article 24(2).Article 27Transitional provisionsPending the application of this Directive, transitional provisions on the control of African swine fever may be adopted in accordance with the procedure referred to in Article 23(2).Article 28Transposition into national lawMember States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2003. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 July 2003.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making a reference shall be laid down by Member States.Article 29Entry into forceThis Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 30AddresseesThis Directive is addressed to the Member States.Done at Luxembourg, 27 June 2002.For the CouncilThe PresidentM. Arias Cañete(1) OJ L 62,15.3.1993, p. 69. Directive as last amended by the 1994 Act of Accession.(2) OJ L 316, 1.12.2001, p. 5.(3) OJ L 184, 17.7.1999, p. 23.(4) OJ L 378, 31.12.1982, p. 58. Directive as last amended by Commission Decision 2000/556/EC (OJ L 235, 19.9.2000, p. 27).(5) Council Directive of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (OJ L 224, 18.8.1990, p. 29). Directive as last amended by Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).(6) Council Directive of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (OJ L 363, 27.12.1990, p. 51). Directive as last amended by the 1994 Act of Accession.(7) Council Directive of 22 December 1993 on the protection of animals at the time of slaughter or killing (OJ L 340, 31.12.1993, p. 21).(8) OJ L 355, 5.12.1992, p. 32. Directive as amended by the 1994 Act of Accession.(9) OJ L 302, 31.12.1972, p. 24 (S.E. SER. I (1972) p. 3). Directive as amended by the 1994 Act of Accession.(10) OJ L 47, 21.2.1980, p. 4. Directive as amended by the 1994 Act of Accession.(11) OJ L 268, 14.9.1992, p. 35. Directive as last amended by Directive 97/79/EC (OJ L 24, 30.1.1998, p. 31).(12) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision 2001/572/EC (OJ L 203, 28.7.2001, p. 16).(13) Council Directive of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977) (S.E. SER.I (1963-1964) p. 164). Directive as last amended by Commission Regulation (EC) No 535/2002 (OJ L 80, 23.3.2002, p. 22).ANNEX INotification of disease and further epidemiological information to be provided by the Member State where African swine fever has been confirmed1. Within 24 hours of the confirmation of any primary outbreak, primary case in feral pigs or case in a slaughterhouse or means of transport, the Member State concerned must notify by means of the Animal Disease Notification System established in accordance with Article 5 of Directive 82/894/EEC:(a) the date of dispatch;(b) the time of dispatch;(c) the name of Member State;(d) the name of disease;(e) the number of the outbreak or case;(f) the date on which African swine fever was suspected;(g) the date of confirmation;(h) the methods used for confirmation;(i) whether the disease has been confirmed in feral pigs or in pigs in a holding, slaughterhouse or means of transport;(j) the geographical location where the outbreak or the case of African swine fever has been confirmed;(k) the disease control measures applied.2. In the case of primary outbreaks or cases in slaughterhouses or means of transport, the Member State concerned must forward the following information in addition to the data referred to in point 1:(a) the number of susceptible pigs in the outbreak, slaughterhouse or means of transport;(b) the number of dead pigs of each category in the holding, slaughterhouse or means of transport;(c) for each category, the morbidity of the disease and the number of pigs in which African swine fever has been confirmed;(d) the number of pigs killed in the outbreak, or in the slaughterhouse or means of transport;(e) the number of carcases processed;(f) in the case of an outbreak, its distance from the nearest pig holding;(g) if African swine fever was confirmed in a slaughterhouse or means of transport, the location of the holding or holdings of origin of the infected pigs or carcases.3. In the case of secondary outbreaks, the information referred to in points 1 and 2 must be forwarded within the time limits laid down in Article 4 of Directive 82/894/EEC.4. The Member State concerned shall ensure that the information to be provided in accordance with points 1, 2 and 3, in relation to any outbreak or case of African swine fever in a holding, slaughterhouse or means of transport is followed as soon as possible by a written report to the Commission and the other Member States including at least:(a) the date on which the pigs in the holding, slaughterhouse or means of transport were killed and their carcases processed;(b) the results of the tests carried out on samples taken when pigs were killed;(c) where the derogation provided for in Article 6(1) has been applied, the number of pigs killed and processed, and the number of pigs which are to be slaughtered at a later date together with the time limit laid down for their slaughter;(d) any information relating to the possible origin of the disease or, if ascertained, its actual origin;(e) information on the control system established to ensure that the measures laid down in Articles 10 and 11 for the control of animal movements are effectively implemented;(f) in the case of a primary outbreak or of a case of African swine fever in a slaughterhouse or means of transport, the genetic type of virus responsible for the outbreak or for the case;(g) where pigs have been killed in contact holdings or in holdings containing pigs suspected of being infected with African swine fever virus, information on:- the date of killing and the number of pigs of each category killed in each holding,- the epidemiological link between the outbreak or case of African swine fever and each contact holding or the other reasons that have induced the suspicion that African swine fever is present in each suspected holding,- the results of the laboratory tests carried out on the samples taken from the pigs in the holdings and when such pigs were killed,where pigs in contact holdings have not been killed, information must be provided concerning the reasons for this decision.ANNEX IIPrinciples and procedures for cleansing, disinfection and treatment with insecticides1. General principles and procedures:(a) the cleansing and disinfection operations and, where necessary, the measures to destroy rodents and insects using officially authorised products must be carried out under official supervision and in accordance with the instructions given by the official veterinarian;(b) the disinfectants to be used and their concentrations must be officially approved by the competent authority to ensure destruction of African swine fever virus;(c) the efficacy of disinfectants must be regularly checked before use, as the efficacity of certain disinfectants is diminished by prolonged storage;(d) the choice of disinfectants, insecticides and of procedures for disinfection and disinsectisation must be made taking into account the nature of the premises, vehicles and objects which are to be treated;(e) the conditions under which degreasing agents, disinfectants and insecticides are used must ensure that their efficacy is not impaired. In particular technical parameters indicated by the manufacturer, such as pressure, minimum temperature and required contact time must be observed;(f) irrespective of the disinfectant used, the following general rules should be applied:- thorough soaking of bedding and litter as well as faecal matter with the disinfectant,- washing and cleansing by careful brushing and scrubbing of the ground, floor, ramps and walls, if possible after the removal or dismantling of equipment or installations so as not to impair the effective cleansing and disinfection procedures,- then, further application of disinfectant for a minimum contact time as stipulated in the manufacturer's recommendations,- the water used for cleaning operations must be disposed of in such a way as to avoid any risk of spreading the virus, in accordance with the instructions of the official veterinarian;(g) where washing is carried out with liquids applied under pressure, re-contamination of the previously cleansed parts must be avoided;(h) washing, disinfecting or destroying of equipment, installations, articles or compartments likely to be contaminated must be included;(i) following the disinfection procedures, re-contamination must be avoided;(j) cleansing, disinfection and disinsectisation required in the framework of this Directive must be documented in the holding or vehicle register and where official approval is required, be certified by the supervising official veterinarian.2. Special provisions on the cleansing and disinfection of infected holdings:(a) preliminary cleansing and disinfection:- during the killing of the animals, all necessary measures must be taken to avoid or minimise the spread of African swine fever virus. Those measures include, inter alia, the installation of temporary disinfection equipment, supply of protective clothing, showers, decontamination of used equipment, instruments and facilities and the interruption of power supply to the ventilation,- carcases of killed animals must be sprayed with disinfectant,- if the carcases have to be removed from the holding for processing, covered and leak proof containers must be used,- as soon as the carcases of the pigs have been removed for processing, those parts of the holding in which the animals were housed and any parts of other buildings, yards etc., contaminated during killing, or post-mortem examination must be sprayed with disinfectants approved in accordance with Article 12,- any tissue or blood spilled during slaughter or post-mortem or gross contamination of buildings, yards, utensils etc. must be carefully collected and processed with the carcases,- the disinfectant must remain on the surface for at least 24 hours;(b) final cleansing and disinfection:- manure and used bedding must be removed and treated as provided in point 3(a),- grease and dirt must be removed from all surfaces by the application of a degreasing agent and the surfaces washed with water,- after washing with cold water, further spraying with disinfectant must be applied,- after seven days the premises must be treated with a degreasing agent, rinsed with water, sprayed with disinfectant and rinsed again with water.3. Disinfection of contaminated bedding, manure and slurry:(a) manure and used bedding must be stacked to heat, sprayed with disinfectant and left for at least 42 days or destroyed by burning or burying;(b) slurry must be stored for at least 60 days after the last addition of infective material, unless the competent authorities authorise a reduced storage period for slurry which has been effectively treated in accordance with the instructions given by the official veterinarian so as to ensure the destruction of the virus.4. However, by way of derogation from points 1 and 2, in the case of open-air holdings the competent authority may establish specific procedures for cleansing and disinfection, taking into account the type of holding and the climatic conditions.ANNEX IIIGuidelines for the retrieval of vectors1. The search for vectors must be carried out in the pigs' living and resting quarters and in the surrounding area.Vectors are generally to be found in old buildings, in the shade where conditions in terms of temperature and humidity are favourable.The best results will be achieved if the search takes place in late spring, during the summer and early autumn, periods during which vectors are most active.2. Two methods should be used:(a) search for vectors in soil, sand or dust extracted from the spaces between stones (in the case of stone-built areas) or from the interstices or crevices in the walls under the tiles or from the ground of the premises by means of a brush or any other appropriate tool. Earth and sand should be sifted as necessary. A magnifying glass may be useful when searching for young larvae;(b) search for vectors by means of CO2 traps. The traps must be placed for several hours in the pig stalls preferably during the night and in any event in shady areas out of the daylight. The traps should be constructed in such a way that the vectors are brought close enough to the CO2 source for it to be impossible for them to return to their habitat.ANNEX IVNational African swine fever laboratories and their responsibilities1. The national African swine fever laboratories are as follows:BelgiumCentre d'étude et de recherche vétérinaires et agrochimiques, 1180 BruxellesDenmarkDanmarks Veterinære Institut - Afdeling for Virologi, Lindholm, 4771 KalvehaveGermanyBundesforschungsanstalt für Viruskrankheiten der Tiere, Tübingen, 17498 RiemsGreeceVeterinary Institute of Infectious and Parasitic Diseases, 15310 Ag. ParaskeviSpainCentro de Investigación en Sanidad Animal, 28130 Valdeolmos (Madrid)FranceAFSSA-Ploufragan, Zoopole des Côtes d'Armor, 22440 PloufraganIrelandVeterinary Research Laboratory, Abbotstown, Castleknock, Dublin 15ItalyIstituto Zooprofilattico Sperimentale dell'Umbria e delle Marche, 06100 PerugiaLuxembourgLaboratoire de médecine vétérinaire de l'État, 1020 LuxembourgThe NetherlandsCentral Institute for animal disease control (CIDC-Lelystad), P.O. Box 2004, 8203 AA LelystadAustriaBundessanstalt für veterinärmedizinische Untersuchungen in Mödling, Robert Koch-Gasse 17, 2340 MödlingPortugalLaboratório Nacional de Investigação Veterinária, 1500 LisboaFinlandEläinlääkintä- ja elintarviketutkimuslaitos, 00231 HelsinkiForskningsanstalten för veterinärmedicin och livsmedel, 00231 HelsingforsSwedenStatens Veterinärmedicinska Anstalt, 75189 UppsalaUnited KingdomInstitute for Animal Health, Pirbright, Woking, Surrey GU24 ONF2. National African swine fever laboratories are responsible for ensuring that in each Member State the laboratory testing to detect the presence of African swine fever and the identification of the genetic type of virus isolates are carried out in accordance with the diagnostic manual. To this end, they may make special agreements with the Community Reference Laboratory or with other national laboratories.3. The national African swine fever laboratory in each Member State is responsible for coordinating the standards and diagnostic methods in each African swine fever diagnostic laboratory within that State. To this end:(a) they may provide diagnostic reagents to individual laboratories;(b) they shall control the quality of all diagnostic reagents used in that Member State;(c) they shall arrange comparative tests periodically;(d) they shall hold isolates of African swine fever virus from cases and outbreaks confirmed in that Member State.ANNEX VCommunity Reference Laboratory for African swine fever1. The Community Reference Laboratory for African swine fever is: Centro de Investigación en Sanidad Animal, 28130 Valdeolmos, Madrid, Spain.2. The functions and duties of the Community Reference Laboratory for African swine fever are:(a) to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing African swine fever, specifically by:- storing and supplying cell cultures for use in diagnosis,- typing, storing and supplying strains of African swine fever virus for serological tests and the preparation of anti-sera,- supplying standardised sera, conjugate sera and other reference reagents to the national laboratories in order to standardise the tests and reagents employed in the Member States,- building up and holding an African swine fever virus collection,- organising periodic comparative tests of diagnostic procedures at Community level,- collecting and collating data and information on the methods of diagnosis used and the results of tests carried out,- characterising isolates of the virus by the most up-to-date methods available to allow greater understanding of the epizootiology of African swine fever,- keeping abreast of developments in African swine fever surveillance, epizootiology and prevention throughout the world,- retaining expertise on the virus causing African swine fever and other pertinent viruses to enable rapid differential diagnosis;(b) to make the necessary arrangements for training or re-training experts in laboratory diagnosis with a view to harmonising diagnostic techniques;(c) to have trained personnel available for emergency situations occurring within the Community;(d) to perform research activities and whenever possible coordinate research activities directed towards an improved control of African swine fever;(e) to draw up technical protocols relating to procedures to verify the efficacy of disinfectants against the African swine virus.3. The Community Reference Laboratories for classical swine fever and African swine fever shall organise their activities in such a way so as to ensure proper coordination of the comparative tests organised at Community level for the diagnosis of these two diseases.ANNEX VICriteria and requirements relating to contingency plansMember States are to ensure that contingency plans meet the following criteria and requirements at least:(a) the adoption of measures to ensure that the legal powers necessary for the implementation of contingency plans exist and make it possible to carry out a rapid and effective eradication campaign;(b) the adoption of measures that will ensure access to emergency funds, budgetary means and financial resources in order to cover all aspects of the fight against an epidemic outbreak of African swine fever;(c) a chain of command must be set up to ensure that in the event of the outbreak of an epidemic the decision-taking procedure for an epizootic is rapid and effective. If necessary, the chain of command must be placed under the authority of a central decision-taking unit responsible for directing all the strategies for the fight against the disease. The director of the veterinary services must be a member of that unit and act as a link between the central decision-taking unit and the national disease control centre provided for in Article 22;(d) the adoption of measures to ensure that appropriate resources are available for a rapid and effective campaign, including laboratory staff, equipment and infrastructure;(e) an instruction manual must be provided. It must give a full and detailed practical description of all the procedures, instructions and measures to be employed in the event of an outbreak of African swine fever;(f) the staff must regularly take part in:(i) training schemes covering the clinical signs of African swine fever, epidemiological surveys and the control of the disease;(ii) alarm drills organised at least twice a year;(iii) training in communications techniques in order to organise information campaigns concerning the current outbreak of the epidemic disease, aimed at authorities, farmers and veterinarians.


title: Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application (Text with EEA relevance)

text:
               25.11.2009

               EN

               Official Journal of the European Union

               L 310/29

      DIRECTIVE 2009/127/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 21 October 2009
   amending Directive 2006/42/EC with regard to machinery for pesticide application
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               The use of pesticides is recognised as posing threats both to human health and the environment. In its Communication of 12 July 2006 entitled ‘A Thematic Strategy on the Sustainable Use of Pesticides’, the Commission adopted a strategy aiming at reducing the risks to human health and the environment resulting from the use of pesticides. Furthermore, the European Parliament and the Council have adopted Directive 2009/128/EC of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (3) (the ‘Framework Directive’).

               (2)

               The design, construction and maintenance of machinery for pesticide application play a significant role in reducing the adverse effects of pesticides on human health and the environment. Regarding pesticide application equipment already in professional use, the Framework Directive introduces requirements for the inspection and maintenance to be carried out on such equipment.

               (3)

               The Framework Directive applies to pesticides which are plant protection products. It is therefore appropriate to limit the scope of this Directive to machinery for the application of pesticides that are plant protection products. However, since it is anticipated that the scope of the Framework Directive will be extended to cover biocidal products, the extension of the scope of the environmental protection requirements to machinery for the application of biocidal products should be examined by the Commission by 31 December 2012.

               (4)

               The requirements for the protection of the health and safety of persons and, where appropriate, domestic animals and property are already covered by Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (4). It is therefore appropriate that essential environmental protection requirements for the design and construction of new machinery for pesticide application are included in the Directive 2006/42/EC, while ensuring that these requirements are consistent with those of the Framework Directive relating to maintenance and inspection.

               (5)

               For this purpose, it is also necessary to include a reference to the protection of the environment in Directive 2006/42/EC, while limiting this objective to the category of machinery and to the risks subject to specific environmental protection requirements.

               (6)

               Machinery for pesticide application includes self-propelled, towed, vehicle-mounted, semi-mounted and airborne machinery, as well as stationary machinery intended for pesticide application, both for professional and non-professional use. It also includes powered or manually-operated portable and handheld machinery with a pressure chamber.

               (7)

               This Directive is limited to the essential requirements with which machinery for pesticide application must comply before being placed on the market and/or put into service, while the European standardisation organisations are responsible for drawing up harmonised standards providing detailed specifications for the various categories of such machinery in order to enable manufacturers to comply with those requirements.

               (8)

               It is essential that all interested parties, including industry, farmers and environmental organisations, are equally involved in the establishment of such harmonised standards, so as to ensure that they are adopted on the basis of a clear consensus amongst all stakeholders.

               (9)

               Directive 2006/42/EC should be therefore amended accordingly.

               (10)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (5), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (11)

               Where the available scientific evidence is insufficient to allow an accurate risk assessment, Member States, when taking measures under this Directive, should apply the precautionary principle, which is a principle of Community law outlined, inter alia, in the Communication from the Commission of 2 February 2000, while taking due consideration of the other rules and principles contained in Directive 2006/42/EC, such as the free movement of goods and the presumption of conformity,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1

      Amendments to Directive 2006/42/EC

   Directive 2006/42/EC is hereby amended as follows:

               1.

               in the second paragraph of Article 2, the following point shall be added:

                           ‘(m)

                           “essential health and safety requirements” means mandatory provisions relating to the design and construction of the products subject to this Directive to ensure a high level of protection of the health and safety of persons and, where appropriate, of domestic animals and property and, where applicable, of the environment.
                           The essential health and safety requirements are set out in Annex I. Essential health and safety requirements for the protection of the environment are applicable only to the machinery referred to in section 2.4 of that Annex.’;

               2.

               Article 4(1) shall be replaced by the following:
               ‘1.   Member States shall take all appropriate measures to ensure that machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment, when properly installed and maintained and used for its intended purpose or under reasonably foreseeable conditions.’;

               3.

               in Article 9(3), the first subparagraph shall be replaced by the following:
               ‘In the cases referred to in paragraph 1, the Commission shall consult the Member States and other interested parties, indicating the measures it intends to take in order to ensure, at Community level, a high level of protection of the health and safety of persons and, where appropriate, of domestic animals and property and, where applicable, of the environment.’;

               4.

               Article 11(1) shall be replaced by the following:
               ‘1.   Where a Member State ascertains that machinery covered by this Directive, bearing the CE marking, accompanied by the EC declaration of conformity and used in accordance with its intended purpose or under reasonably foreseeable conditions, is liable to endanger the health or safety of persons or, where appropriate, domestic animals or property or, where applicable, the environment, it shall take all appropriate measures to withdraw such machinery from the market, to prohibit the placing on the market and/or putting into service of such machinery or to restrict the free movement thereof.’;

               5.

               Annex I shall be amended as follows:

                           (a)

                           in the General Principles, point 4 shall be replaced by the following:

                                       ‘4.

                                       This Annex is organised in several parts. The first one is of general scope and applicable to all kinds of machinery. The other parts refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the relevant essential requirements. When machinery is being designed, the requirements of the general part and the requirements of one or more of the other parts shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles. Essential health and safety requirements for the protection of the environment are applicable only to the machinery referred to in section 2.4.’;

                           (b)

                           Chapter 2 shall be amended as follows:

                                       (i)

                                       the first paragraph shall be replaced by the following:
                                       ‘Foodstuffs machinery, machinery for cosmetics or pharmaceutical products, hand-held and/or hand-guided machinery, portable fixing and other impact machinery, machinery for working wood and material with similar physical characteristics and machinery for pesticide application must meet all the essential health and safety requirements set out in this chapter (see General Principles, point 4).’;

                                       (ii)

                                       the following Section shall be added:
                                       ‘2.4.   MACHINERY FOR PESTICIDE APPLICATION
                                       2.4.1.
                                             Definition

                                       “Machinery for pesticide application” means machinery specifically intended for the application of plant protection products within the meaning of Article 2(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (6).
                                       2.4.2.
                                             General

                                       The manufacturer of machinery for pesticide application or his authorised representative must ensure that an assessment is carried out of the risks of unintended exposure of the environment to pesticides, in accordance with the process of risk assessment and risk reduction referred to in the General Principles, point 1.
                                       Machinery for pesticide application must be designed and constructed taking into account the results of the risk assessment referred to in the first paragraph so that the machinery can be operated, adjusted and maintained without unintended exposure of the environment to pesticides.
                                       Leakage must be prevented at all times.
                                       2.4.3.
                                             Controls and monitoring

                                       It must be possible to easily and accurately control, monitor and immediately stop the pesticide application from the operating positions.
                                       2.4.4.
                                             Filling and emptying

                                       The machinery must be designed and constructed to facilitate precise filling with the necessary quantity of pesticide and to ensure easy and complete emptying, while preventing spillage of pesticide and avoiding the contamination of the water source during such operations.
                                       2.4.5.
                                             Application of pesticides

                                       2.4.5.1.   Application rate

                                       The machinery must be fitted with means of adjusting the application rate easily, accurately and reliably.
                                       2.4.5.2.   Distribution, deposition and drift of pesticide

                                       The machinery must be designed and constructed to ensure that pesticide is deposited on target areas, to minimise losses to other areas and to prevent drift of pesticide to the environment. Where appropriate, an even distribution and homogeneous deposition must be ensured.
                                       2.4.5.3.   Tests

                                       In order to verify that the relevant parts of the machinery comply with the requirements set out in sections 2.4.5.1 and 2.4.5.2 the manufacturer or his authorised representative must, for each type of machinery concerned, perform appropriate tests, or have such tests performed.
                                       2.4.5.4.   Losses during stoppage

                                       The machinery must be designed and constructed to prevent losses while the pesticide application function is stopped.
                                       2.4.6.
                                             Maintenance

                                       2.4.6.1.   Cleaning

                                       The machinery must be designed and constructed to allow its easy and thorough cleaning without contamination of the environment.
                                       2.4.6.2.   Servicing

                                       The machinery must be designed and constructed to facilitate the changing of worn parts without contamination of the environment.
                                       2.4.7.
                                             Inspections

                                       It must be possible to easily connect the necessary measuring instruments to the machinery to check the correct functioning of the machinery.
                                       2.4.8.
                                             Marking of nozzles, strainers and filters

                                       Nozzles, strainers and filters must be marked so that their type and size can be clearly identified.
                                       2.4.9.
                                             Indication of pesticide in use

                                       Where appropriate, the machinery must be fitted with a specific mounting on which the operator can place the name of the pesticide in use.
                                       2.4.10.
                                             Instructions

                                       The instructions must provide the following information:

                                                   (a)

                                                   precautions to be taken during mixing, loading, application, emptying, cleaning, servicing and transport operations in order to avoid contamination of the environment;

                                                   (b)

                                                   detailed conditions of use for the different operating environments envisaged, including the corresponding preparation and adjustments required to ensure the deposition of pesticide on target areas while minimising losses to other areas, to prevent drift to the environment and, where appropriate, to ensure an even distribution and homogeneous deposition of pesticide;

                                                   (c)

                                                   the range of types and sizes of nozzles, strainers and filters that can be used with the machinery;

                                                   (d)

                                                   the frequency of checks and the criteria and method for the replacement of parts subject to wear that affect the correct functioning of the machinery, such as nozzles, strainers and filters;

                                                   (e)

                                                   specification of calibration, daily maintenance, winter preparation and other checks necessary to ensure the correct functioning of the machinery;

                                                   (f)

                                                   types of pesticides that may cause incorrect functioning of the machinery;

                                                   (g)

                                                   an indication that the operator should keep updated the name of the pesticide in use on the specific mounting referred to in section 2.4.9;

                                                   (h)

                                                   the connexion and use of any special equipment or accessories, and the necessary precautions to be taken;

                                                   (i)

                                                   an indication that the machinery may be subject to national requirements for regular inspection by designated bodies, as provided for in Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (7);

                                                   (j)

                                                   the features of the machinery which must be inspected to ensure its correct functioning;

                                                   (k)

                                                   instructions for connecting the necessary measuring instruments.

         Article 2
   Transposition
   1.   Member States shall adopt and publish the provisions necessary to comply with this Directive by 15 June 2011 at the latest. They shall forthwith inform the Commission thereof.
   They shall apply those provisions from 15 December 2011.
   When those provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 21 October 2009.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         C. MALMSTRÖM

      (1)  OJ C 182, 4.8.2009, p. 44.

      (2)  Opinion of the European Parliament of 22 April 2009 (not yet published in the Official Journal) and Council Decision of 24 September 2009.

      (3)  OJ L 309, 24.11.2009, p. 71.

      (4)  OJ L 157, 9.6.2006, p. 24.

      (5)  OJ C 321, 31.12.2003, p. 1.

      (6)  OJ L 309, 24.11.2009, p. 1.

      (7)  OJ L 309, 24.11.2009, p. 71.’