CHAPTER II

CONTROL OF OUTBREAKS OF FOOT-AND-MOUTH DISEASE
SECTION 6

PROTECTION AND SURVEILLANCE ZONES

Establishment of protection and surveillance zones
Article 21
1
Member States shall ensure that, without prejudice to measures provided for in Article 7, at least the measures laid down in paragraphs 2, 3 and 4 below are taken immediately after an outbreak of foot-and-mouth disease is confirmed.
2
The competent authority shall establish a protection zone based on a minimum radius of 3 km and a surveillance zone based on a minimum radius of 10 km centred on the outbreak of foot-and-mouth disease referred to in paragraph 1. The geographical delimitation of those zones shall take account of administrative boundaries, natural barriers, supervision facilities and technological progress which makes it possible to predict the probable dispersion of the foot-and-mouth disease virus by air or any other means. That delimitation shall be reviewed, if necessary, in the light of such elements.
3
The competent authority shall ensure that the protection and surveillance zones are marked by posting signs of sufficient size on roads entering the zones.
4
In order to ensure full coordination of all measures necessary to eradicate foot-and-mouth disease as quickly as possible, national and local disease control centres as referred to in Articles 74 and 76 shall be established. For the purpose of carrying out the epidemiological inquiry as provided for in Article 13, those centres shall be assisted by an expert group as provided for in Article 78.
5
Member States shall without delay trace animals dispatched from the zones during the period of at least 21 days before the estimated date of earliest infection on a holding in the protection zone and they shall inform the competent authorities in other Member States and the Commission about their results from tracing of animals.
6
Member States shall collaborate in tracing fresh meat, meat products, raw milk and raw milk products derived from animals of susceptible species originating in the protection zone and produced between the date of estimated introduction of the foot-and-mouth disease virus until the date the measures provided for in paragraph 2 come into force. Such fresh meat, meat products, raw milk and raw milk products shall be treated in accordance with Articles 25, 26 and 27 respectively or detained until possible contamination with the foot-and-mouth disease virus is officially ruled out.

Measures to be applied to holdings in the protection zone
Article 22
1
Member States shall ensure that at least the following measures are applied in the protection zone without delay:
a
the registration of all holdings with animals of susceptible species and the establishment of a census of all animals present on these holdings shall be carried out as soon as possible and kept up to date;
b
all holdings with animals of susceptible species shall periodically undergo a veterinary inspection, carried out in such a way as to avoid the spread of foot-and-mouth disease virus possibly present on the holdings, which shall include in particular the relevant documentation, notably the records referred to in subparagraph (a) and the measures applied to prevent the introduction or escape of foot-and-mouth disease virus and which may include clinical inspection as described in point 1 of Annex III or taking of samples from animals of susceptible species in accordance with point 2.1.1.1 of Annex III;
c
animals of susceptible species shall not be removed from the holding on which they are kept.
2
By way of derogation from paragraph 1(c), animals of susceptible species may be transported under official supervision for the purpose of emergency slaughter directly to a slaughterhouse situated inside the same protection zone or, if that zone has no slaughterhouse to a slaughterhouse outside the zone designated by the competent authority in means of transport cleansed and disinfected under official control after each transport operation.
The movement referred to in the first subparagraph shall only be authorised if the competent authority is satisfied on the basis of a clinical examination in accordance with point 1 of Annex III by the official veterinarian of all the animals of susceptible species present on the holding and after evaluation of epidemiological circumstances that there is no reason to suspect the presence of infected or contaminated animals on the holding. The meat of such animals shall be subject to the measures provided for in Article 25.

Movement and transport of animals and their products in the protection zone
Article 23
Member States shall ensure that the following activities are prohibited within the protection zone:
1. movement between holdings and transport of animals of susceptible species;
2. fairs, markets, shows and other gatherings of animals including collection and dispersion of susceptible species;
3. itinerant service for breeding of animals of susceptible species;
4. artificial insemination of and collection of ova and embryos from animals of susceptible species.

Additional measures and derogations
Article 24
1
The competent authority may extend the prohibitions in Article 23 to:
a
movement or transport of animals of non-susceptible species between holdings situated within the zone or out of or into the protection zone;
b
transit of animals of all species through the protection zone;
c
events with gatherings of people with possible contact with animals of susceptible species, where there is a risk of spreading the foot-and-mouth disease virus;
d
artificial insemination of or collection of ova and embryos from animals of species not susceptible to foot-and-mouth disease;
e
movement of means of transport designed for the transportation of animals;
f
the slaughter on the holding of animals of susceptible species for private consumption;
g
transport of goods referred to in Article 33 to holdings keeping animals of susceptible species.
2
The competent authorities may authorise:
a
the transit of animals of all species through the protection zone undertaken exclusively via major highways or mainline railways;
b
the transport of animals of susceptible species which have been certified by the official veterinarian as coming from holdings outside the protection zone and transported on designated routes directly to designated slaughterhouses for immediate slaughter, provided that the means of transport are cleansed and disinfected after delivery under official supervision at the slaughterhouse and such decontamination of transport is recorded in the logbook of the means of transport;
c
the artificial insemination of animals on a holding carried out by the personnel of that holding by use of semen collected from animals on that holding or semen stored on that holding or semen delivered from a semen collection centre to the outside perimeter of that holding;
d
the movement and transport of equidae taking into account the conditions set out in Annex VI.
e
the transport, under certain conditions, of goods referred to in Article 33 to holdings keeping animals of susceptible species.

Measures in relation to fresh meat produced in the protection zone
Article 25
1
Member States shall ensure that the placing on the market of fresh meat, minced meat and meat preparations, derived from animals of susceptible species originating in the protection zone shall be prohibited.
2
Member States shall ensure that the placing on the market of fresh meat, minced meat and meat preparations from animals of susceptible species produced in establishments situated in the protection zone shall be prohibited.
3
Member States shall ensure that fresh meat, minced meat and meat preparations as referred to in paragraph 1, shall be marked in accordance with Directive 2002/99/EC and subsequently transported in sealed containers to an establishment designated by the competent authorities for transformation into meat products treated in accordance with point 1 in Part A of Annex VII of this Directive.
4
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the protection zone and which since production have been stored and transported separately from such meats produced after that date. Such meats must be readily distinguished from meats not eligible for dispatch outside the protection zone by means of clear mark established in conformity with Community legislation.
5
By way of derogation, the prohibition provided for in paragraph 2, shall not apply to fresh meat, minced meat or meat preparations obtained from establishments situated in the protection zone under the following conditions:
a
the establishment shall be operated under strict veterinary control;
b
only fresh meat, minced meat or meat preparations as described in paragraph 4, or fresh meat, minced meat or meat preparations obtained from animals reared and slaughtered outside the protection zone or from animals transported to the establishment and slaughtered therein in accordance with the provisions in Article 24(2)(b) shall be processed in the establishment;
c
all such fresh meat, minced meat or meat preparations, must bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to Directive 94/65/EC;
d
during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the protection zone in accordance with this Directive.
6
Compliance with the conditions in paragraph 5 shall be certified by the competent authority for fresh meat, minced meat and meat preparations intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-Community trade, communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification.
7
Derogation from the prohibition provided for in paragraph 1 may be granted subject to specific conditions adopted in accordance with the procedure referred to in Article 89(3), in particular with regard to the health marking of meat produced from animals of susceptible species originating in protection zones maintained for more than 30 days.

Measures in relation to meat products produced in the protection zone
Article 26
1
Member States shall ensure that the placing on the market of meat products produced from meat derived from animals of susceptible species originating in the protection zone shall be prohibited.
2
By way of derogation, the prohibition in paragraph 1 shall not apply to meat products which have either undergone one of the treatments as set out in point 1 in Part A of Annex VII or which have been produced from meats referred to in Article 25(4).

Measures in relation to milk and milk products produced in the protection zone
Article 27
1
Member States shall ensure that the placing on the market of milk derived from animals of susceptible species originating in the protection zone and of milk products produced from such milk shall be prohibited.
2
Member States shall ensure that the placing on the market of milk and milk products from animals of susceptible species produced in an establishment situated in the protection zone shall be prohibited.
3
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk and milk products derived from animals of susceptible species originating in the protection zone which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the protection zone and which since production have been stored and transported separately from milk and milk products produced after that date.
4
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk derived from animals of susceptible species originating in the protection zone and milk products produced from such milk which have undergone one of the treatments as set out in Parts A or B of Annex IX, depending on the use of the milk or milk products. The treatment shall be carried out under the conditions set out in paragraph 6 in establishments referred to in paragraph 5 or, if there is no establishment situated in the protection zone, in establishments situated outside the protection zone under the conditions set down in paragraph 8.
5
By way of derogation, the prohibition provided for in paragraph 2 shall not apply to milk and milk products which have been prepared in establishments situated in the protection zone under the conditions set out in paragraph 6.
6
Establishments referred to in paragraphs 4 and 5 shall comply with the following conditions:
a
the establishment shall be operated under permanent and strict official control;
b
all milk used in the establishment shall either comply with paragraphs 3 and 4 or the raw milk shall be obtained from animals outside the protection zone;
c
during the whole production process the milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not destined for dispatch outside the protection zone;
d
transport of raw milk from holdings situated outside the protection zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection zone keeping animals of susceptible species.
7
Compliance with the conditions in paragraph 6 shall be certified by the competent authority for milk intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-Community trade, communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification.
8
Transport of raw milk from holdings situated within the protection zone to establishments situated outside the protection zone and the processing of that milk shall be subject to the following conditions:
a
processing in establishments situated outside the protection zone of raw milk produced from animals of susceptible species kept within the protection zone shall be authorised by the competent authorities;
b
the authorisation shall include instructions on and designation of the transport route to the designated establishment;
c
transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk;
d
before leaving the holding from where milk of animals of susceptible species was collected the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the protection zone the vehicle had no subsequent contact with holdings in the protection zone keeping animals of susceptible species;
e
the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.
9
The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the protection zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be forbidden.

Measures in relation to semen, ova and embryos collected from animals of susceptible species in the protection zone
Article 28
1
Member States shall ensure that the placing on the market of semen, ova and embryos derived from animals of susceptible species originating in the protection zone shall be prohibited.
2
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to frozen semen, ova and embryos collected and stored at least 21 days before the estimated date of earliest infection with the foot-and-mouth disease virus on a holding in the zone.
3
Frozen semen collected in accordance with Community legislation after the date of infection referred to in paragraph 2, shall be stored separately and shall only be released after:
a
all the measures relating to the outbreak of foot-and-mouth disease have been removed in accordance with Article 36, and
b
all animals accommodated in the semen collection centre have undergone a clinical examination, and samples taken in accordance with point 2.2 of Annex III have been subjected to a serological test to substantiate the absence of infection in the semen collection centre concerned, and
c
the donor animal has been subjected with negative result to a serological test for the detection of antibodies against the foot-and-mouth disease virus on a sample taken not earlier than 28 days after the collection of the semen.

Transport and distribution of dung and manure of animals of susceptible species produced in the protection zone
Article 29
1
Member States shall ensure that the transport and distribution of dung or manure from holdings and premises or means of transport referred to in Article 16 situated in the protection zone where animals of susceptible species are kept, shall be prohibited within the protection zone.
2
By way of derogation from the prohibition in paragraph 1 the competent authority may authorise the removal of manure of animals of susceptible species from a holding situated in the protection zone to a designated plant for treatment in accordance with point 5 of Section II in Part A of Chapter III of Annex VIII to Regulation (EC) No 1774/2002 or for intermediate storage.
3
By way of derogation from the prohibition in paragraph 1 the competent authority may authorise the removal of manure of animals of susceptible species from holdings situated in the protection zone which are not subject to the measures provided for in Articles 4 or 10 for distribution on designated fields under the following conditions:
a
the entire volume of manure has been produced at least 21 days before the estimated date of earliest infection on a holding in the protection zone and the manure or dung is distributed close to the ground and in sufficient distance from holdings keeping animals of susceptible species and immediately incorporated into the ground, or
b
in the case of manure from bovine animals or pigs:
1. an examination by an official veterinarian of all the animals on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus, and
2. the entire volume of manure has been produced at least 4 days prior to the examination referred to in point (i), and
3. the manure is incorporated into the ground on designated fields close to the holding of origin and in sufficient distance to other holdings keeping animals of susceptible species in the protection zone.
4
Member states shall ensure that any authorisation to remove dung or manure from a holding keeping animals of susceptible species is subject to stringent measures to avoid spread of the foot-and-mouth disease virus, in particular by ensuring cleansing and disinfection of the leak-proof transport vehicles after loading and before leaving the holding.

Measures in relation to hides and skins from animals of susceptible species in the protection zone
Article 30
1
Member States shall ensure that the placing on the market of hides and skins of animals of susceptible species originating in the protection zone shall be prohibited.
2
By way of derogation, the prohibition as provided for in paragraph 1 shall not apply to hides and skins which either:
a
were produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1), and that have been stored separately from hides and skins produced after that date; or
b
comply with the requirements laid down in point 2 in Part A of Annex VII.

Measures in relation to sheep wool, ruminant hair and pig bristles produced in the protection zone
Article 31
1
Member States shall ensure that the placing on the market of sheep wool, ruminant hair and pig bristles originating in the protection zone shall be prohibited.
2
By way of derogation, the prohibition as provided for in paragraph 1 shall not apply to unprocessed wool, hair and bristles which:
a
were produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1) and have been stored separately from wool, hair and bristles produced after that date; or
b
comply with the requirements laid down in point 3 in Part A of Annex VII.

Measures in relation to other animal products produced in the protection zone
Article 32
1
Member States shall ensure that the placing on the market of animal products derived from animals of susceptible species not referred to in Articles 25 to 31 shall be prohibited.
2
By way of derogation, the prohibitions provided for in paragraph 1 shall not apply to products referred to in paragraph 1 which:
a
either have been produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1) and have been stored and transported separately from products produced after that date, or
b
have undergone the treatment in accordance with point 4 in Part A of Annex VII, or
c
for specific products, comply with the appropriate requirements in points 5 to 9 in Part A of Annex VII, or
d
are composite products which are not subject to further treatment containing products of animal origin which either have undergone a treatment ensuring destruction of possible foot-and-mouth disease virus or have been obtained from animals not subject to restrictions under the provisions of this Directive, or
e
are packed products intended for use as in-vitro diagnostic or laboratory reagents.

Measures in relation to feed, forage, hay and straw produced in the protection zone
Article 33
1
Member State shall ensure that the placing on the market of feed, forage, hay and straw originating in the protection zone shall be prohibited.
2
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to feed, forage, hay and straw:
a
produced at least 21 days before the estimated date of infection on holdings referred to in Article 10(1), and stored and transported separately from feed, forage, hay and straw produced after that date; or
b
intended for use within the protection zone, subject to authorisation by the competent authorities; or
c
produced on premises not keeping animals of susceptible species; or
d
produced in establishments not keeping animals of susceptible species and sourcing the raw material from premises referred to in paragraph (c) or from premises situated outside the protection zone.
3
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to forage and straw produced on holdings keeping animals of susceptible species which comply with the requirements in point 1 in Part B of Annex VII.

Granting of derogations and additional certification
Article 34
1
Any derogation from the prohibitions provided for in Articles 24 to 33 shall be granted by a specific decision of the competent authority only after it has satisfied itself that all relevant requirements have been met for a sufficient period before the products leave the protection zone, and that there is no risk of spreading the foot-and-mouth disease virus.
2
Any derogation from the prohibitions provided for in Articles 25 to 33 requires, in the case of intra-Community trade, additional certification by the competent authority.
3
Detailed rules for the implementation of the measures provided for in paragraph 2 may be adopted in accordance with the procedure referred to in Article 89(2).

Additional measures applied by Member States in the protection zone
Article 35
In addition to the measures applicable in the protection zone in accordance with this Directive, Member States may take additional national measures which are deemed necessary and proportionate to contain the foot-and-mouth disease virus taking into account the particular epidemiological, animal husbandry, commercial and social conditions prevailing in the affected area. Member States shall inform the Commission and the other Member States about such additional measures.

Removal of measures in the protection zone
Article 36
1
Member States shall ensure that the measures applied in the protection zone are maintained until the following requirements have been met:
a
at least 15 days have elapsed since the killing and safe disposal of all the animals of susceptible species from the holding referred to in Article 10(1) and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with Article 11;
b
a survey has been concluded with negative results in all holdings keeping animals of susceptible species and situated within the protection zone.
2
After the removal of the measures specific to the protection zone, the measures applied in the surveillance zone as provided for in Articles 37 to 42, shall continue to apply for at least 15 days until those measures are removed in accordance with Article 44.
3
The survey referred to in paragraph 1(b) shall be carried out to substantiate the absence of infection and at least in compliance with the criteria of point 1 of Annex III and shall include the measures provided for in point 2.3 of Annex III based on the criteria set out in points 2.1.1. and 2.1.3. of Annex III.

Measures to be applied to holdings in the surveillance zone
Article 37
1
Member States shall ensure that the measures provided for in Article 22(1) are applied in the surveillance zone.
2
By way of derogation from the prohibition provided for in Article 22(1)(c) and where there is no or insufficient slaughter capacity available within the surveillance zone, the competent authorities may authorise the removal from holdings situated in the surveillance zone of animals of susceptible species for transporting them directly and under official supervision for slaughter to a slaughterhouse located outside the surveillance zone, subject to the following conditions:
a
the records referred to in Article 22(1) have been subjected to official control, and the epidemiological situation of the holding does not indicate any suspicion of infection or contamination with the foot-and-mouth disease virus, and
b
all the animals of susceptible species on the holding have been subjected with negative result to an inspection by the official veterinarian, and
c
a representative number of animals, taking into account the statistical parameters in point 2.2 of Annex III, has been subjected to thorough clinical examination to rule out the presence or suspicion of clinically infected animals, and
d
the slaughterhouse is designated by the competent authority and located as near to the surveillance zone as possible, and
e
the meat produced from such animals shall be subject to the treatment specified in Article 39.

Movement of animals of susceptible species within the surveillance zone
Article 38
1
Member States shall ensure that animals of susceptible species shall not be removed from holdings within the surveillance zone.
2
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to movement of animals for one of the following purposes:
a
for leading them without coming into contact with animals of susceptible species of different holdings to pasture situated within the surveillance zone not earlier than 15 days after the last outbreak of foot-and-mouth disease has been recorded in the protection zone;
b
for transporting them directly and under official supervision for the purpose of slaughter to a slaughterhouse located inside the same zone;
c
for transporting them in accordance with Article 37(2);
d
for transporting them in accordance with Article 24(2)(a) and (b).
3
Movements of animals provided for in paragraph 2(a) shall be authorised by the competent authority only after an examination by an official veterinarian of all the animals of susceptible species on the holding, including testing of samples taken in accordance with point 2.2 of Annex III, has ruled out the presence of animals suspected of being infected or animals suspected of being contaminated.
4
Movements of animals provided for in paragraph 2(b) shall be authorised by the competent authority only after the measures provided for in Article 37(2)(a) and (b) have been completed with satisfactory results.
5
Member States shall without delay trace animals of susceptible species dispatched from the surveillance zone during a period of least 21 days before the estimated date of earliest infection on a holding in the surveillance zone and they shall inform the competent authorities in other Member States about their results from tracing animals.

Measures to be applied to fresh meat of animals of susceptible species originating in the surveillance zone and meat products produced from such meat
Article 39
1
Member States shall ensure that the placing on the market of fresh meat, minced meat and meat preparations derived from animals of susceptible species originating in the surveillance zone and of meat products produced from such meats shall be prohibited.
2
Member States shall ensure that the placing on the market of fresh meat, minced meat, meat preparations and meat products from animals of susceptible species produced in establishments situated in the surveillance zone shall be prohibited.
3
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the corresponding protection zone and which since production have been stored and transported separately from such meats produced after that date. Such meats must be readily distinguished from meats not eligible for dispatch outside the surveillance zone by means of clear mark established in conformity with Community legislation.
4
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which were produced from animals transported to the slaughterhouse under conditions at least as strict as provided for in Article 37(2)(a) to (e) under the condition that the meat is subject to the measures provided for in paragraph 5.
5
By way of derogation, the prohibition provided for in paragraph 2, shall not apply to fresh meat, minced meat or meat preparations obtained from establishments situated in the surveillance zone under the following conditions:
a
the establishment shall be operated under strict veterinary control;
b
only fresh meat, minced meat or meat preparations as described in paragraph 4 and subject to the additional conditions provided for in Part B of Annex VIII or obtained from animals reared and slaughtered outside the surveillance zone or obtained from animals transported in accordance with the provisions in Article 24(2)(b) shall be processed in the establishment;
c
all such fresh meat, minced meat or meat preparations must bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to Directive 95/65/EC;
d
during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the surveillance zone in accordance with this Directive.
6
By way of derogation, the prohibition provided for in paragraph 1, shall not apply to meat products produced from fresh meat obtained from animals of susceptible species originating in the surveillance zone which was marked with the health mark provided for Directive 2002/99/EC and transported under official supervision to a designated establishment for treatment in accordance with point 1 in Part A of Annex VII.
7
By way of derogation, the prohibition provided for in paragraph 2, shall not apply to meat products produced in establishments situated in the surveillance zone and either complying with the provisions in paragraph 6, or produced from meat complying with paragraph 5.
8
Compliance with the conditions in paragraphs 5 and 7 shall be certified by the competent authority for fresh meat, minced meat and meat preparations intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and in the case of intra-Community trade communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification.
9
Derogation from the prohibition provided for in paragraph 1 may be granted subject to specific conditions adopted in accordance with the procedure referred to in Article 89(3), in particular with regard to the health marking of meat produced from animals of susceptible species originating in surveillance zone maintained for more than 30 days.

Measures to be applied to milk and milk products of animals of susceptible species produced in the surveillance zone
Article 40
1
Member States shall ensure that placing on the market of milk derived from animals of susceptible species originating in the surveillance zone and of milk products produced from such milk shall be prohibited.
2
Member States shall ensure that the placing on the market of milk and milk products from animals of susceptible species produced in the surveillance zone shall be prohibited.
3
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk and milk products derived from animals of susceptible species originating in the surveillance zone which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the corresponding protection zone and which since production have been stored and transported separately from milk and milk products produced after that date.
4
By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk derived from animals of susceptible species originating in the surveillance zone and milk products produced from such milk which have undergone one of the treatments as set out in Parts A or B of Annex IX depending on the use of the milk or milk products. The treatment shall be carried out under the condition set out in paragraph 6 in establishments referred to in paragraph 5 or, if there is no establishment situated in the surveillance zone, in establishments designated by the competent authorities and situated outside the protection and surveillance zones.
5
By way of derogation, the prohibition provided for in paragraph 2 shall not apply to milk and milk products which have been prepared in establishments situated in the surveillance zone under the conditions set out in paragraph 6.
6
Establishments referred to in paragraphs 4 and 5 shall comply with the following conditions:
a
the establishment shall be operated under strict veterinary control;
b
all milk used in the establishment shall either comply with paragraph 4 or be obtained from animals outside the surveillance and protection zone;
c
throughout the production process the milk shall be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch outside the surveillance zone;
d
transport of raw milk from holdings situated outside the protection and surveillance zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species.
7
Compliance with the conditions in paragraph 6 shall be certified by the competent authority for milk intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-Community trade, communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification.
8
Transport of raw milk from holdings situated within the surveillance zone to establishments situated outside the protection and surveillance zones and the processing of that milk shall be subject to the following conditions:
a
processing in establishments situated outside the protection and surveillance zones of raw milk produced from animals of susceptible species kept within the surveillance zone shall be authorised by the competent authorities;
b
the authorisation shall include instructions on and designation of the transport route to the designated establishment;
c
transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk;
d
before leaving the holding from where milk of animals of susceptible species was collected, the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the surveillance zone the vehicle had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species;
e
the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision.
9
The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the surveillance zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be subject to official authorisation and measures to avoid any spread of possible foot-and-mouth disease virus.

Transport and distribution of dung and manure of animals of susceptible species produced in the surveillance zone
Article 41
1
Member States shall ensure that the transport and distribution of dung or manure from holdings and other premises such as those mentioned in Article 16 situated in the surveillance zone where animals of susceptible species are kept shall be prohibited within and outside that zone.
2
By way of derogation from the prohibition provided for in paragraph 1 the competent authorities may in exceptional circumstances authorise the transport of dung or manure in means of transport thoroughly cleansed and disinfected prior to and after use for distribution in designated areas within the surveillance zone and at sufficient distance to holdings where animals of susceptible species are kept under the following alternative conditions:
a
either an examination by an official veterinarian of all the animals of susceptible species on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus and the manure or dung is distributed close to the ground to avoid the generation of aerosols and immediately ploughed into the ground, or
b
a clinical inspection by an official veterinarian of all the animals of susceptible species on the holding has been carried out with negative result and the manure is injected into ground, or;
c
manure is subject to the provision of Article 29(2).

Measures in relation to other animal products produced in the surveillance zone
Article 42
Member State shall ensure that the placing on the market of products of animal origin other than those referred to in Articles 39 to 41 shall be subject to the conditions provided for in Articles 28 and 30 to 32.

Additional measures applied by Member States in the surveillance zone
Article 43
In addition to the measures provided for in Articles 37 to 42, Member States may take additional national measures which are deemed necessary and proportionate to contain foot-and-mouth disease virus taking into account the particular epidemiological, animal husbandry, commercial and social conditions prevailing in the affected area. Where specific measures to restrict the movement of equidae are considered necessary, such measures shall take into account those provided for in Annex VI.

Removal of measures in the surveillance zone
Article 44
1
Member states shall ensure that the measures applied in the surveillance zone are maintained until the following requirements have been met:
a
at least 30 days have elapsed since the killing and safe disposal of all animals of susceptible species from the holding referred to in Article 10(1) and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with Article 11;
b
the requirements provided for in Article 36 have been met in the protection zone;
c
a survey has been concluded with negative results.
2
The survey referred to in paragraph 1(c) shall be carried out to substantiate the absence of infection in the surveillance zone in compliance with the criteria of point 1 of Annex III and shall include the measures provided for in point 2.4 of Annex III based on the criteria of point 2.1 of Annex III.