COUNCIL DIRECTIVE of 19 July 1971 amending the Directive of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (71/285/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof;

Having regard to the proposal from the Commission;

Having regard to the Opinion of the European Parliament;

Having regard to the Opinion of the Economic and Social Committee;

Whereas the Council Directive of 26 June 19641 on animal health problems affecting intra-Community trade in bovine animals and swine entered into force on 30 June 1965 and was amended by the Directives of 25 October 19662 and 13 July 19703;

Whereas the incorporation of those Directives in the laws of each Member State and their application in the Community has shown that their provisions should be adopted in the light of new technical and scientific data and the experience gained;

Whereas, in particular, it is necessary to initiate the harmonisation of animal health measures to be applied in the event of the outbreak of certain diseases ; whereas these measures must in particular provide for the establishment for a specific period of protective areas around holdings affected by such diseases and for prohibiting the removal of animals from such areas save in the case of removal for immediate slaughter;

Whereas in order to be recognised as free, or officially free, from brucellosis as the case may be, animals for breeding or production must have a certain brucella count, recorded after a sero-agglutination test ; whereas as a result of advances in scientific knowledge an additional diagnostic test can be provided for to determine whether these animals are brucellosis-free ; whereas standards should be fixed for administering that test;

Whereas the requirements of the Directive now in force as regards brucellosis and tuberculosis an, if necessary, be relaxed for animals for slaughter, without incurring a health risk;

Whereas that Directive recognises the right of each Member State to prohibit the introduction of bovine animals and swine into its territory from a Member State in which there has been an outbreak of an epizootic disease ; whereas, depending on the nature and character of that epizootic disease, such prohibition must either be restricted to bovine animals and swine coming from part of the territory of the exporting country or may extend to the whole of that territory ; whereas, in the event of the outbreak of contagious or infectious disease on the territory of a Member State, appropriate measures must quickly be taken to combat such disease ; whereas the dangers of such diseases and the protective measures required should be assessed in the same way throughout the Community ; whereas a Community procedure must be instituted for this purpose within the Standing Veterinary Committee set up by the Council Decision of 15 October 19684 under which any measures taken by a Member State may be examined and, where necessary, amended or repealed, in close co-operation between the Member States and the Commission; 1 OJ No 121, 29.7.1964, p. 1977/64. 2 OJ No 192, 27.10.1966, p. 3294/66. 3 OJ No L 157, 18.7.1970, p. 40. 4 OJ No L 255, 18.10.1968, p. 23.

Whereas, so as not to hinder intra-Community trade, the same procedure should be used to assess the health guarantees which Member States would wish to require on importation and which relate to diseases other than those which are compulsorily notifiable under this Directive;

Whereas any alterations required in health certificates by reason of amendments to the Articles and Annexes of the Directive should be made;

HAS ADOPTED THIS DIRECTIVE:

Article 1

The Council Directive of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine, as amended by the Council Directives of 25 October 1966 and 13 July 1970, shall be amended as indicated in the following Articles

Article 2

Subparagraphs (d) and (f) of Article 2 shall be deleted.

Article 3

In Article 3: 1. In the last line of paragraph 1 the words "in paragraph 2 to 6" shall be substituted for the words "in paragraphs 3 to 6".

2. Paragraph 2 shall be amended as follows: (a) The following new subparagraph (b) shall be inserted after subparagraph (a):

"(b) not have been obtained either from a holding which for health reasons is subject to prohibition as a result of the outbreak of the following diseases to which the animals in question are susceptible:

foot-and-mouth disease, swine fever, contagious swine paralysis, bovine brucellosis, swine brucellosis or anthrax, or from an area in which the measures referred to under (ii) are applied, it being understood that: (i) if all the animals of species susceptible to the disease have not been slaughtered and the premises disinfected, the period of prohibition must be at least thirty days from the date of the last recorded case in the case of foot-and-mouth disease, at least forty days in the case of swine fever or contagious swine paralysis, at least six weeks in the case of bovine or swine brucellosis and at least fifteen days in the case of anthrax;

(ii) in cases of swine fever, foot-and-mouth disease or contagious swine paralysis : if all the animals of species susceptible to the infection have been slaughtered and the premises disinfected, a protective area with a radius of 2 km shall be established around the holding for a period of fifteen days ; if all the animals of species susceptible to the infection have not been slaughtered, a protective area with a radius of 2 km shall be established around the holding and maintained for as long as the latter is subject to prohibition measures.

Member States shall ensure that animals of species susceptible to the disease recorded in the protective area can leave that area only if they are being taken to a slaughterhouse under official control for immediate slaughter.

Subparagraphs (b) to (h) shall be renumbered (c) to (i). References in the Directive of 26 June 1964 to those subparagraphs shall be amended accordingly.

(b) The beginning of the first sentence of subparagraph (c) shall read as follows:

"(c) in the case of animals for breeding or production, have been obtained from a holding which officially fulfils".

(c) The following shall be added to sub-paragraph (g):

"transport vehicles must be so arranged that the animals "faeces, litter or fodder cannot flow or fall out of the vehicle during transportation".

(d) The following shall be added to subparagraph (i):

"This certificate shall consist of a single sheet".

3. Paragraph 3 shall be amended as follows: (a) in subparagraph (b) the words "be tuberculosis-free" shall be deleted, the words "carried out during the thirty days before loading and" shall be inserted after the words "have reacted negatively to an intradermal tuberculin test" and the words "of Annex B" shall be substituted for the words "of Annexes A and B".

(b) in subparagraph (c) the words "be brucellosis-free" shall be deleted, the words "carried out during the thirty days before loading and" shall be inserted after the words "when given a sero-agglutination test" and the words "of Annex C" shall be substituted for the words "of Annexes A and C".

4. Paragraph 4 shall read as follows:

"4. Swine for breeding or production must moreover come from brucellosis-free stock. If the swine concerned weigh more than 25 kilogrammes they must have shown, in tests carried out during the thirty days before loading: (i) a brucella count lower than 30 international units of agglutination per millilitre when given a sero-agglutination test in accordance with the provisions of Annex C;

(ii) a negative complement fixation reaction when given a serological examination in accordance with the provisions of Annex C."

5. Paragraph 5 shall be amended as follows:

In the first line the words "for slaughter" shall be deleted.

6. Paragraph 7 shall be amended as follows: (a) in subparagraph (b) the remainder of the sentence from "and in a place" shall be deleted;

(b) in subparagraph (c) the following sentence shall be added after the second sentence:

"However, the intradermal tuberculin test and the sero-agglutination test required under paragraph 3 (b) and (c) need not necessarily have been carried out before introduction on the market."

and the words "6 days" shall be substituted for the words "4 days" in the last line of the third subparagraph.

Article 4

The following shall be substituted for the last sentence of Article 5:

"If it proves necessary to adopt Community measures these shall be decided upon in the light of the national measures referred to above in accordance with the procedure laid down in Article 13".

Article 5

Article 7 shall read as follows:

"1. Countries of destination may grant to one or more exporting country general authorisations or authorisations restricted to specific cases for the introduction into their territory of: A. In the case of bovine animals for breeding, production or slaughter: (a) those animals which, by way of derogation from Article 3 (3) (a) or (6) (a), have not been vaccinated against foot-and-mouth disease, if no case of foot-and-mouth disease has been officially recorded in the exporting country and in the transit countries concerned for at least six months from the date of loading;

(b) those animals which, by way of derogation from Article 3 (3) (a) or (6) (a), have received anti-foot-and-mouth disease serum treatment not more than ten days before loading with anti-foot-and-mouth disease serum approved and controlled by the competent authority of the exporting country and authorised by the competent authority of the country of destination.

B. In the case of bovine animals for breeding or production: (a) those animals which, by way of derogation from Article 3 (3) (a), have been revaccinated during the preceding twelve months against types A, O and C of the foot-and-mouth disease virus, if they come from Member States in which such animals are vaccinated yearly and systematically slaughtered if there is an outbreak of foot-and-mouth disease and in which no case of foot-and-mouth disease has been officially recorded for at least six months from the date of loading;

(b) those animals which, by way of derogation from Article 3 (3) (c), come from a brucellosis-free herd.

C. In the case of bovine animals for meat production under 30 months old which, by way of derogation from Article 3 (3) (c), do not come from an officially brucellosis-free or brucellosis-free herd. However, these animals must have shown a brucella count of less than 30 international units (IU) of agglutination per millilitre when given a sero-agglutination test in accordance with the provisions of Annex C. They must bear a special identification mark. The Member State of destination shall take all necessary measures to prevent contamination of indigenous herds.

This provision shall apply until 31 December 1971 unless an extension is decided upon by the Council on a proposal from the Commission.

D. In the case of bovine animals for slaughter:

Those animals which, by way of derogation from Article 3 (6) (c), showed a brucella count equal to or higher than 30 international units of agglutination per millilitre when given a sero-agglutination test in accordance with the provisions of Annex C.

2. When a country of destination grants a general authorisation under paragraph 1, it shall forthwith inform the other Member States and the Commission thereof.

3. When a country of destination grants any authorisation under paragraph 1, a corresponding authorisation must, in the case of transit operations, be obtained from the transit countries concerned.

4. The exporting countries shall take all measures necessary to ensure that the health certificates, specimens of which are given in Annex F (Models I and II), mention that use has been made of one of the possibilities provided in paragraph 1."

Article 6

The text of Article 8 shall be numbered paragraph 1 of Article 8 and the following paragraph 2 shall be added to that Article:

"2. Pending the entry into force of any provisions adopted by the European Economic Community, a Member State may be authorised, under the procedure laid down in Article 12 and the conditions fixed under that procedure, to apply, for intra-Community trade, health guarantees equivalent at most to those required by that Member State within the framework of a national programme for the prevention of a contagious or infectious bovine or swine disease which is not referred to in Annex E of this Directive."

Article 7

Article 9 shall read as follows:

"1. A Member State may, if there is a danger of animal diseases spreading as a result of the introduction of bovine animals or swine into its territory from another Member State, take the following measures: (a) in the event of an outbreak of an epizootic disease in the other Member State, temporarily prohibit or restrict the introduction of bovine animals or swine from the affected areas of that Member State;

(b) if an epizootic disease becomes widespread or if there is an outbreak of a new serious contagious animal disease, temporarily prohibit or restrict the introduction of bovine animals or swine from the entire territory of that State.

2. Each Member State must immediately inform the other Member States and the Commission of the outbreak on its territory of any disease referred to in paragraph 1, and of the measures taken to control it. It must also notify them immediately of the elimination of the disease.

3. Measures taken by the Member States under paragraph 1 and the repeal of such measures must be communicated immediately to the other Member States and the Commission together with the reasons therefor.

Under the procedure laid down in Article 13, a decision may be taken to repeal or amend those measures in particular in order to co-ordinate them with measures adopted by other Member States.

4. If the situation envisaged in paragraph 1 arises and if it appears necessary that other Member States also apply the measures taken under that paragraph, amended, where necessary, pursuant to paragraph 3, appropriate measures shall be adopted under the procedure laid down in Article 13."

Article 8

The following new Articles shall be inserted after Article 11:

"Article 12

1. Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called the "Committee") set up by the Council Decision of 15 October 1968.

2. Within the Committee the votes of Member States shall be weighted as provided in Article 148 (2) of the Treaty. The Chairman shall not vote.

3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within a time limit set by the Chairman according to the urgency of the matters concerned. Opinions shall be delivered by a majority of twelve votes.

4. The Commission shall adopt the measures and shall apply them immediately where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.

If, within three months from the date on which the proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures and apply them immediately, save where the Council has decided by a simple majority against those measures.

Article 13

1. Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called the "Committee") set up by the Council Decision of 15 October 1968.

2. Within the Committee the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The Chairman shall not vote.

3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within two days. Opinions shall be delivered by a majority of twelve votes.

4. The Commission shall adopt the measures and shall apply them immediately where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.

If within fifteen days from the date on which the proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures and apply them immediately, save where the Council has decided by a simple majority against those measures.

Article 14

The provisions of Articles 12 and 13 shall apply for eighteen months from the date on which a matter was first referred to the Committee either under Article 12 (1) or 13 (1) or under any corresponding rules."

Article 9

1. The following shall be substituted for the text of Annex A I:

"I. Tuberculosis-free bovine herd

A bovine herd is considered to be officially tuberculosis-free if: (a) all the animals are free from clinical signs of tuberculosis;

(b) all the animals over six weeks old have reacted negatively to at least two official intradermal tuberculin tests carried out in accordance with Annex B, the first one six months after completion of disinfection of the herd, the second one six months later and the remainder at one-yearly intervals. Where in a Member State all of whose bovine herds are subject to official operations to combat tuberculosis, the percentage of bovine herds infected with tuberculosis is not more than 1 % during two successive supervisory periods separated by an interval of one year, that interval may be increased to two years. If the percentage of infected bovine herds is not more than 0 72 % during two successive supervisory periods separated by an interval of two years, that interval may be increased to three years;

(c) no bovine animal has been introduced without a certificate from an official veterinarian showing that the animal comes from an officially tuberculosis-free bovine herd and, in the case of animals over six weeks old, that it has reacted negatively to an intradermal tuberculin test assessed according to the criteria set out in Annex B 21 (a); (i) Intradermal tuberculin testing shall not, however, be required in Member States in which the percentage of holdings containing bovine animals infected with tuberculosis is less than 0 72 % and where a certificate from the official veterinarian indicates that the animal: 1. is properly identified;

2. comes from an officially tuberculosis-free bovine herd within that Member State;

3. has not during transportation come into contact with bovine animals which do not come from officially tuberculosis-free bovine herds.

(ii) The certificate provided for in (i) need not be required in a Member State where for not less than four years: - at least 99 780 % of the bovine herds have been officially recognised as being tuberculosis-free, and where

- herds which are not officially tuberculosis-free have been under official supervision, the transfer of bovine animals from those herds being prohibited except when they are taken under official supervision for slaughter."

2. The following shall be substituted for the text of Annex A II:

"II. Brucellosis-free swine and brucellosis-free bovine and swine herds

A. Bovine herds 1. A bovine herd is considered to be officially brucellosis-free if: (a) it contains no bovine animals which have been vaccinated against brucellosis, save females which have been vaccinated at least three years previously;

(b) all the bovine animals have been free from clinical signs of brucellosis for at least six months;

(c) all the bovine animals over twelve months old: (i) have shown a brucella count lower than 30 IU of agglutination per millilitre when given two official sero-agglutination tests at intervals of at least three months and at most twelve months complying with Annex C ; the first sero-agglutination test may be replaced by three ring-tests carried out at three-monthly intervals provided, however, that the second sero-agglutination test is carried out not less than six weeks after the third ring-test;

(ii) are checked annually to establish that brucellosis is not present by three ring-tests carried out at intervals of at least three months or two ring-tests at an interval of at least three months and one sero-agglutination test carried out not less than six weeks after the second ring-test. If ring-tests cannot be made, two sero-agglutination tests shall be carried out each year at an interval of at least three months and not more than six months.

Where, in a Member State of whose bovine herds are subject to official operations to combat brucellosis, the percentage of bovine herds infected is not more than 1 %, it will be sufficient to carry out each year two ring-tests at an interval of at least three months or, if they cannot be made, one sero-agglutination test;

(d) no bovine animal has been introduced without a certificate from an official veterinarian showing that the animal comes from an officially brucellosis-free bovine herd and, in the case of animals over twelve months old, that it has shown a brucella count of less than 30 IU of agglutination per millilitre when given a sero-agglutination test in accordance with Annex C not more than 30 days before it was taken into the herd; (i) Sero-agglutination testing need not, however, be required in Member States where the percentage of bovine herds infected with brucellosis has not exceeded 0 72 for at least two years and where a certificate from an official veterinarian indicates that the animal: 1. is properly identified;

2. comes from an officially brucellosis-free bovine herd within that Member State;

3. has not during transportation come into contact with bovine animals which do not come from officially brucellosis-free bovine herds;

(ii) The certificate provided for in (i) need not be required in a Member State where for not less than four years: - at least 99 780 % of the bovine herds have been officially recognised as being brucellosis-free, and where

- herds which are not officially brucellosis-free have been under official supervision, the transfer of bovine animals from those herds being prohibited except when they are taken under official supervision for slaughter.

2. A bovine herd is considered to be brucellosis-free if: (a) it contains no male bovine animals which have been vaccinated against brucellosis;

(b) all or some of the female bovine animals have been vaccinated at not more than six months old with live Buck 19 vaccine or other vaccines approved under the procedure laid down in Article 12;

(c) all the bovine animals satisfy the conditions laid down in 1 (b) and (c), it being understood that the bovine animals which are under thirty months old may show a brucella count equal to or higher than 30 IU of agglutination per millilitre but lower than 80 IU of agglutination wer millilitre provided they show, when the complement fixation reaction is tested: - a count lower than 30 EEC units, in the case of females vaccinated less than twelve months previously,

- a count lower than 20 EEC units in all other cases;

(d) no bovine animal has been introduced without a certificate from an official veterinarian showing either that the conditions laid down in 1 (d) apply to it or that it comes from a bovine herd recognised as brucellosis-free and, in that case, if it is over twelve months old, that it has shown in the thirty days before it was taken into the herd in accordance with Annex C a count lower than 30 IU of agglutination per millilitre and a negative complement fixation reaction.

However, if the bovine animal concerned has been vaccinated and is under thirty months old, it may show a brucella count equal to or higher than 30 IU of agglutination per millilitre but less than 80 IU per millilitre, provided it shows, when the complement fixation reaction is tested: - a count lower than 30 EEC units, in the case of a female vaccinated less than twelve months previously,

- a count lower than 20 EEC units after the twelfth month following vaccination.

3. A brucellosis-free bovine herd may qualify as an officially brucellosis-free bovine herd after a minimum period of three years if: (a) it contains no animal which has been vaccinated against brucellosis within the preceding three years;

(b) the conditions laid down in 2 (c) have been fulfilled without interruption during those three years;

(c) at the end of the third year, the animals over twelve months old have shown a brucella count lower than 30 IU of agglutination per millilitre when given a sero-agglutination test and a negative result when given a complement fixation reaction test, these tests being carried out in accordance with Annex C.

4. Bovine animals from a brucellosis-free bovine herd may also be introduced into an officially recognised brucellosis-free bovine herd if: - they are at least eighteen months old at the time they are introduced therein;

- if they have been vaccinated against brucellosis, the vaccination was effected more than a year previously;

- not more than 30 days before introduction they have shown, in accordance with Annex C, a brucella count lower than 30 IU of agglutination per millilitre and a negative result when given a complement fixation reaction test.

If, in accordance with the first subparagraph, a bovine animal is introduced into an officially recognised brucellosis-free bovine herd for intra-Community trade, that herd shall be considered to be brucellosis-free for two years from the date on which the animal was introduced.

5. If one or more bovine animals in an officially brucellosis-free herd are suspected of having brucellosis, the qualification of the herd may be provisionally suspended, rather than withdrawn, if the animal or animals are immediately destroyed or isolated.

The provisional suspension may be lifted if two sero-agglutination tests, carried out in accordance with Annex C at an interval of six to eight weeks on all the animals over twelve months old, show a count lower than 30 IU of agglutination per millilitre.

The isolated animals may be reintroduced into the herd if, in the six to eight weeks interval, two sero-agglutination tests have shown a count lower than 30 IU of agglutination per millilitre and two complement fixation reaction tests have given a negative result, these tests being carried out in accordance with Annex C.

The foregoing provisions also apply to brucellosis-free herds in cases where one or more bovine animals over thirty months old are suspected of the disease.

6. The foregoing provisions relating to animals belonging to a brucellosis-free herd also apply to animals which, before the date of implementation of the provisions of this Directive in each Member State, have been vaccinated between the ages of five and eight months.

B. Swine and swine herds 1. A swine is considered to be brucellosis-free if: (a) it shows no clinical signs of that disease;

(b) weighing more than 25 kilogrammes, it shows during serological tests carried out simultaneously and in accordance with Annex C: (i) a brucella count lower than 30 IU of agglutination per millilitre when given a sero-agglutination test;

(ii) a negative result when given a complement fixation reaction test.

2. A swine herd is considered to be brucellosis-free if: (a) all the swine have been free from clinical signs of the disease for at least one year;

(b) bovine animals kept at the same time on the holding belong to an officially brucellosis-free or brucellosis-free herd."

Article 10

In Annex C: (a) the word "bovine" in the title shall be deleted,

(b) after section A a new section B shall be inserted as follows:

"B. Complement fixation reaction test 1. The standard serum is the same as that under A 1 of this Annex. In addition to its content in international agglutinating units, 1 millilitre of this lyophilised bovine serum must contain 1000 sensitising units which fix the complement. These sensitising units are called EEC sensitising units.

2. The standard serum must be supplied by the Bundesgesundheitsamt, Berlin.

3. A serum's level of antibodies which fix the complement must be expressed in EEC sensitising units (for example : serum X = 60 EEC sensitising units per millilitre).

4. A serum containing 20 or more EEC sensitising units (i.e. an activity equal to 20 % of that of the standard serum) per millilitre, must be considered to be positive.

5. Serums must be inactivated as follows: (a) bovine serum : 56 to 60 °C for 30 t 50 minutes,

(b) swine serum : 60 °C for 30 to 50 minutes.

6. Weybridge Strain No 99 or USDA Strain 1119 must be used for the preparation of the antigen. The antigen represents a bacterial suspension in a physiological serum at 0 785 % or in a veronal loading solution.

7. In order to carry out the reaction test a complementary dose higher than the minimum necessary for total hemolysis should be used.

8. In carrying out the complement fixation reaction test, the following controls must be made each time: (a) control of the anti-complementary effect of the serum,

(b) control of the antigen,

(c) control of sensitised red blood corpuscles,

(d) control of the complement,

(e) control, using a positive serum, of sensitivity at the start of the reaction,

(f) control of the specificity of the reaction using a negative serum.

9. The supervision and official control of standard serums and antigens shall be carried out by the bodies listed in A 9 of this Annex.

10. Antigens may be delivered in the concentrated state provided the dilution factor to be used is indicated on the bottle label.

(c) Section B shall be restyled section C and paragraphs 12 to 19 shall be renumbered 1 to 8. In paragraph 8, for the sign "%o" there shall be substituted the sign " % ".

Article 11

For the certificates appearing in Annex F there shall be substituted the certificates appearing in the Annex to this Directive.

Article 12

The Member States shall bring into force the measures necessary to comply with this Directive within twelve months following its notification and shall forthwith inform the Commission thereof.

Article 13

This Directive is addressed to the Member States.

Done at Brussels, 19 July 1971.

For the Council

The President

L. NATALI

ANNEX

"ANNEX F

>PIC FILE= "T0038170"> >PIC FILE= "T0038171">

>PIC FILE= "T0038172">

>PIC FILE= "T0038173">

>PIC FILE= "T0038174">

>PIC FILE= "T0038175">

>PIC FILE= "T0038176">

>PIC FILE= "T0038177">

>PIC FILE= "T0038178">