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31990L0422

Council Directive 90/422/EEC of 26 june 1990 amending Directive 64/432/EEC as regards enzootic bovine leukosis

Official Journal L 224 , 18/08/1990 P. 0009 - 0012 Finnish special edition: Chapter 3 Volume 33 P. 0125  Swedish special edition: Chapter 3 Volume 33 P. 0125

COUNCIL DIRECTIVE of 26 June 1990 amending Directive 64/432/EEC as regards enzootic bovine leukosis (90/422/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Directive 88/406/EEC (4), which amends Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (5), as last amended by Directive 89/662/EEC (6), lays down common health  guarantees regarding enzootic bovine leukosis as applicable to certain categories of bovine animals intended for intra-Community trade which will apply from 1 July 1990;  Whereas Article 4 of Directive 88/406/EEC requires that proposals be made to lay down the criteria permitting a Member State or part of the territory of a Member State to be recognized as being free from enzootic bovine leukosis, the conditions to be  implemented to guarantee the maintenance of such status and the rules applicable to trade conducted from such regions;   Whereas, from surveys carried out to date, it would appear that certain Member States and regions are free from enzootic bovine leukosis whereas it is necessary to define, on a Community basis, how these areas shall be defined and the conditions under  which they shall be maintained as being free from enzootic bovine leukosis and the conditions in relation to trade;  Whereas it appears necessary that Member States be granted an additional period of time in order to conform to the requirements of Directive 64/432/EEC as thus amended,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 64/432/EEC is hereby amended as follows:  1.  Article 2 (s) is replaced by the following:  '(s)  "Enzootic bovine leukosis free herd" shall mean a herd which satisfies the conditions laid down in Annex G, Chapter I, section A.' 2.  The following is added to Article 2:  '(t)  "enzootic bovine leukosis free Member State or region" shall mean a region or Member State which meets the requirements laid down in Annex G, Chapter I, section B.' 3.  Article 3 (3) (e) is replaced by the following:  '(e)  in addition to the condition under (d), where they are over 12 months of age and come from a region or Member State which does not have enzootic bovine leukosis free status, have reacted negatively to an individual test carried out in accordance  with Annex G, Chapter II, during the 30 days before they were loaded;' 4.  The following paragraph is added to Article 3:  '15. By way of derogation from the requirements laid down in Annex G, Chapter I, section B (2), a Member State or region of a Member State declared enzootic bovine leukosis free within the meaning of Article 2 (t) may be authorized, in accordance with  the procedure laid down in Article 12, to lower the inspection level in respect of animals more than two years of age provided that tests have shown that the following requirements are met:  - no case of enzootic bovine leukosis has been recorded in a proportion of one herd out of 10 000 for at least three years,  - all cattle which have reacted positively to an immuno-diffusion test have been slaughtered and the herd has remained subject to restrictions until re-establishment of its status pursuant to Annex G, Chapter I, C (1) or (2),  - all cattle slaughtered within the territory of that Member State or region have been submitted to a post mortem examination by an official veterinarian who must issue notification of all tumours with a view to laboratory examination.  If one of the conditions provided for in the first subparagraph ceases to be fulfilled - especially in the case provided for in Annex G, Chapter I, section C (3) - the Commission, after assessing the circumstances of the recrudescence of enzootic bovine  leukosis, and if its assessment gives grounds for so doing, shall adopt a decision in accordance with the same procedure to rescind the derogation decision taken in respect of that Member State or region(s) of that Member State.' 5.  In Article 8 (2), the second sentence of the second subparagraph is replaced by the following:  'However, such guarantees shall not be required upon the introduction of animals from an enzootic bovine leukosis free Member State, region or holding.' 6.  The following subparagraph is added to Article 8a (1) (b):  'This test shall not be required in respect of animals from an enzootic bovine leukosis free Member State or region or holding.' 7.  The present wording of Annex G becomes Chapter II of the said Annex; section A (2) (j) of Chapter II is replaced by the following:  '(j) Spain:  Subdirrección general de sanidad animal. Laboratorio de sanidad y producción animal ALGETE (Madrid);' 8.  The Annex to this Directive is incorporated as Chapter I of Annex G.  Article 2 In Articles 2 and 5 of Directive 88/406/EEC, '1 July 1990' is replaced by '1 July 1991'.  However, from 1 July 1990 to 30 June 1991, Member States which have thus qualified all or part of their herds are authorized - in order to maintain that qualification - to make introduction into enzootic bovine leukosis free herds subject, in respect of  animals of the bovine species other than slaughter animals, to the following conditions:  (a)  the animals must come from an enzootic bovine leukosis free herd; or (b)  the animals must have been born and raised in a herd in which all the bovine animals over 24 months of age at the time of the test and forming part of the bovine herd from which the animals come have reacted negatively during the last 12 months to  a test carried out pursuant to Annex G.  Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1990 as far as Article 2 is concerned and not later than 1 October 1990 as concerns the other provisions. They shall forthwith inform the Commission thereof.  Article 4 This Directive is addressed to the Member States.   Done at Luxembourg, 26 June 1990.  For the Council The President M. O'KENNEDY  (1) OJ No C 17, 24. 1. 1990, p. 11. (2) OJ No C 113, 7. 5. 1990, p. 205. (3) OJ No C 112, 7. 5. 1990, p. 31. (4) OJ No L 194, 22. 7. 1988, p. 1. (5) OJ No 121, 29. 7. 1964, p. 1977/64. (6) OJ No L 395, 30. 12. 1989, p. 13.   ANNEX   'CHAPTER I ENZOOTIC BOVINE LEUKOSIS FREE HERDS, MEMBER STATES AND REGIONS  A.  "Enzootic bovine leukosis free herd" means:  1.  a herd in which:  ii(i)  there is no evidence, either clinical or as a result of a test carried out in accordance with Chapter II, of any case of enzootic bovine leukosis and in which no such case has been confirmed in the previous two years, and i(ii)  all animals over 24 months of age have previously reacted negatively during the preceding 12 months to two tests carried out in accordance with this Annex, at intervals of at least four months, and (iii)  following the tests referred to in (ii), there are only animals born in the herd, or which have come from an enzootic bovine leukosis free herd and in which, after qualification, the animals over 24 months of age have continued to react negatively to one of the tests carried out in accordance with Chapter II at intervals of three years and the conditions provided for in (i) and (iii) continue  to be fulfilled;  2.  a herd situated in an enzootic bovine leukosis free Member State or region.  B.  "Enzootic bovine leukosis free Member State or region" means:  A Member State or a region, within the meaning of Article 2 (o), of that Member State 1.  in which:  (a)  at least 99,8 % of the bovine herds are enzootic bovine leukosis free herds within the meaning of subparagraph (s),  or (b)  on the one hand, no case of enzootic bovine leukosis has been notified or confirmed in any way whatever in the five years preceding the date of notification of this Directive or in the last three years after that date, and, on the other hand, in  the last two years:  i(i)  random checks on a national scale carried out in accordance with Chapter II have been conducted over a period of two years on all the animals over 24 months of age in at least 10 % of herds, with negative results, and (ii) all animals over 24 months of age have undergone a test as provided for in Chapter II at least once, with negative results;  2.  in which, having satisfied the conditions provided for in 1,  i(i)  every year either a random sample with a confidence rating of 99 % has established that less than 0,2 % of the herds were infected or not less than 20 % of bovine animals over two years of age have reacted negatively to a test carried out in  accordance with Chapter II, and (ii)  the conditions set in A (1) continue to be fulfilled.  C.  Suspension of leukosis free status after an outbreak of the disease 1.  If an animal in an enzootic bovine leukosis free herd has reacted positively to one of the tests referred to in (ii), the enzootic bovine leukosis free status of the herd shall be suspended until the following measures have been taken:  ii(i)  the animal which has reacted positively, and, in the case of a cow, any calf it may have produced, must have left the herd for slaughter under the supervision of the veterinary authorities;  i(ii)  the remaining animals have reacted negatively to a serological test carried out in accordance with Chapter II three months at least after elimination of the positive animal and any possible progeny thereof;  (iii)  an epidemiological enquiry must be conducted and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in (ii);  However, the competent authority may grant a derogation from the obligation to slaughter the calf of an infected cow where it was separated from its mother after calving. In this case, the calf must be made subject to the requirements provided for in 2  (ii).  2.  Where more than one animal from an enzootic bovine leukosis free herd has reacted positively, the leukosis free status of the herd shall be suspended until the following measures have been taken:  ii(i)  the infected animals and, in the case of an infected cow, except in the event of a derogation granted by the competent authority pursuant to the second subparagraph of 1 (iii), their calves must be removed for slaughter under the supervision of  the veterinary authorities;  i(ii)  the remaining animals - including, where such is the case, the calves of infected animals - of less than six months of age must, after identification, remain on the holding until they have satisfied the tests referred to in A (1) (ii);  (iii)  the herd must remain under official supervision until the conditions provided for under A (1) (ii) and (iii) are again fulfilled;  (iv)  an epidemiological enquiry must be conducted, and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in A (1) (ii);  3.  If enzootic bovine leukosis is detected and confirmed in more than 0,2 % of herds in the region or Member State, leukosis free status of that region or Member State shall be suspended and, in addition to the measures provided for in paragraph 1 or  2, 20 % of the other herds in the region or Member State must, within the time limits stipulated in A (1) (ii), undergo one of the tests referred to in Chapter II.  Leukosis free status shall be re-established if, on completion of the measures provided for in the preceding points, the tests provided for therein have proved negative.'


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31986L0604

Council Directive 86/604/EEC of 8 December 1986 amending Directive 65/66/EEC laying down specific criteria of purity for the preservatives authorized for use in foodstuffs intended for human consumption

Official Journal L 352 , 13/12/1986 P. 0045 - 0045 Finnish special edition: Chapter 13 Volume 16 P. 0047  Swedish special edition: Chapter 13 Volume 16 P. 0047

*****COUNCIL  DIRECTIVE  of 8 December 1986  amending Directive 65/66/EEC laying down specific criteria of purity for the preservatives authorized for use in foodstuffs intended for human consumption  (86/604/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 64/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption (1), as last amended by Directive 85/585/EEC (2), and in particular Article 8 thereof,  Having regard to the proposal from the Commission,  Whereas Council Directive 65/66/EEC (3), as last amended by Directive 76/463/EEC (4), laid down specific criteria of purity for the preservatives listed in the Annex to Directive 64/54/EEC; whereas that Annex was supplemented by Directive 85/585/EEC, which added potassium acid sulphite (potassium bisulphite) to the list of authorized preservatives;  Whereas it is necessary to lay down specific criteria of purity for this preservative,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The following specifications are hereby inserted between Nos E 227 and E 230 of the Annex to Directive 65/66/EEC:  E 228 - Potassium acid sulphite (potassium bisulphite)  1.2 // Appearance:   // Clear colourless solution prepared by bubbling sulphur dioxide (SO2) (E 220) in an aqueous solution of potassium hydroxide (KOH) as used in foodstuffs  // Chemical formula:   // KHSO3 in aqueous solution (1)  // Content:   // Not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)   // Sodium:   // Not more than 1 % of the SO2 content   // Selenium:   // Not more than 10 mg/kg of the SO2 content   // Chloride:   // Not more than 1 000 mg/kg expressed as Cl.  (1) Other potassium salts of sulphur dioxide may be present following deterioration due to storage in open containers.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1988. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 8 December 1986.  For the Council  The President  M. JOPLING  (1) OJ No 12, 27. 1. 1964, p. 161/64.  (2) OJ No L 372, 31. 12. 1985, p. 43.  (3) OJ No 22, 9. 2. 1965, p. 373/65.  (4) OJ No L 126, 14. 5. 1976, p. 33.


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31992L0063

Commission Directive 92/63/EEC of 10 July 1992 amending the Annexes to Council Directive 74/63/EEC on undesirable substances and products in animal nutrition

Official Journal L 221 , 06/08/1992 P. 0049 - 0050 Finnish special edition: Chapter 3 Volume 44 P. 0113  Swedish special edition: Chapter 3 Volume 44 P. 0113

COMMISSION DIRECTIVE 92/63/EEC  of 10 July 1992  amending the Annexes to Council Directive 74/63/EEC on undesirable substances and products in animal nutritionTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (1), as last amended by Directive 87/519/EEC (2), and in particular Article 6 thereof,  Whereas Directive 74/63/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge;  Whereas there are grounds to reduce the level of cadmium and to limit the level of arsenic in phosphates used as raw materials in compound feedingstuffs in order to improve the protection for animal and human health;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Comittee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex II to Directive 74/63/EEC is hereby amended as set out in the Annex hereto.  Article 2  Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 March 1993. They shall immediately inform the Commission thereof.  When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 10 July 1992. For the Commission  Ray MAC SHARRY  Member of the Commission   (1) OJ No L 38, 11. 2. 1974, p. 31. (2) OJ No L 304, 27. 10. 1987, p. 38.    ANNEX  In Annex II, Part A:  1. in item 2 'Cadmium', the number '15' in column 3 is replaced by the number '10' and in the note at the bottom of the page the number '0,75' is replaced by the number '0,50';  2. the following item is added:       Substances/Products  Raw materials  Maximum content in mg/kg (ppm) of raw material, referred a moisture content of 12 %      (1)  (2)  (3)      '3. Arsenic  Phosphates  20'


title: Council Directive 85/649/EEC of 31 December 1985 prohibiting the use in livestock farming of certain substances having a hormonal action

text:
 No L 382/228                           Official Journal of the European Communities                                 31 . 12 . 85
                                                   COUNCIL DIRECTIVE
                                                     of 31 December 1985
                 prohibiting the use in livestock farming of certain substances having a hormonal action
                                                        (85/649/EEC)
 THE COUNCIL OF THE EUROPEAN                                       Whereas the use of hormonal substances for fattening
 COMMUNITIES ,                                                     purposes should therefore be prohibited ; whereas the
                                                                   use of certain substances for therapeutic purposes may
                                                                   be authorized but must be strictly controlled in order
 Having regard to the Treaty establishing the European             to prevent any mistfse of them ;
 Economic Community, and in particular Article 43
thereof,
                                                                   Whereas, furthermore, since it would be difficult to be
 Having regard to the proposal from the Commission,                certain of correct operation of the scheme as a whole
                                                                   if animals so treated and the meat from such animals
 Having regard to the opinion of the European Parlia              were to be traded, this should as a general rule be
 ment ( ! ),                                                       prohibited ; whereas, however, derogations from this
                                                                   rule may be allowed where satisfactory guarantees can
                                                                  be provided ;
 Having regard to the opinion of the Economic and
 Social Committee (2),
 Whereas the administration to farm animals of certain             Whereas as part of the adoption of harmonized rules
substances having a hormonal action is at present                 in the Community arrangements for importation from
regulated in different ways in the Member States ;                third countries that offer equivalent guarantees should
whereas while their immediate effect on animals from              be introduced ; whereas these guarantees can be
the farmer's point of view is clear, assessments of theii:        required under          Directives      72/462/ EEC (3)   and
effect on human health vary and this is reflected in              85/358/ EEC (4);
the regulations governing their use ; whereas this diver
gence distorts the conditions of competition in pro ¬
ducts that are the subject of common market organiza ¬
tions and is a serious barrier to intra-Community                 Whereas in order to ensure that the provisions of this
trade ;
                                                                  Directive can be implemented effectively the latest
                                                                  date for introduction of the provisions of Directive
                                                                  85 /358 / EEC should be made to fall before that for
Whereas these distortions of competition and barriers
to trade, must therefore be removed by ensuring that              introduction of the provisions of this Directive ; whe
all consumers are able to buy the products in question            reas Community control measures should ensure uni
under largely identical conditions of supply and that             form application in all Member States of the rules
these products correspond to their anxieties and                  applicable on administration of substances having a
expectations in the best possible manner ; whereas                hormonal or thyrostatic action,
such a course of action is bound to bring about an
increase in consumption of the product in question ;
(») OJ No C 288, 11.11 . 1985, p. 158 .                           (3) OJ No L 302, 31 . 12. 1972, p. 28 .
(2) OJ No C 44, 15.2. 1985, p. 14.                                (4) OJ No L 191 , 23 . 7 . 1985, p. 46.
 ---pagebreak--- 31 . 12 . 85                            Official Journal of the European Communities                           No L 382/229
HAS ADOPTED THIS DIRECTIVE :                                             Pending the decisions referred to in the first sub
                                                                        paragraph, products which have already received
                                                                        authorization to be placed on the market shall
                                                                        continue to be authorized .
                            Article 1
                                                                         Products authorized pursuant to the above provi
                                                                        sions shall be subject to the rules of Articles 24 to
For the purposes of implementation of this Directive                     50 of Directive 8 1 /851 /EEC, with the exception of
the definitions ot meats and of farm animals given in                   those which relate to national marketing authori
Article 1 of Directive 81 /602/EEC (*) shall apply .                    zations ;
For the purposes of implementation of this Directive
and of Directive 81 /602/EEC 'therapeutic treatment'               (b) products used for therapeutic treatment may be
shall mean the administering to an individual farm                      administered only by a veterinarian, in the form
animal of any of the substances authorized in                           of an injection — to the exclusion of implantation
Article 3 of this Directive to treat a fertility problem                — to farm animals which have been clearly identi
diagnosed, on examination, by a veterinarian . Such                     fied .
therapeutic treatment shall be prohibited for animals
intended for fattening.                                                 Treatment of identified animals must be registered
                                                                        by the veterinarian . An animal which has been
                                                                        treated may not be slaughtered before expiry of
                                                                        the period fixed pursuant to the provisions set out
                            Article 2                                   in (a);
                                                                   (c) any decision on the possible inclusion in the
Without prejudice to Article 4 of Directive 81 /602/                    group of substances referred to in Article 2 of any
EEC, Member States may not authorize any deroga                        new substance having a direct or indirect oestro
tion from Article 2 of the said Directive. However, the                 genic, androgenic or gestagenic action shall be
administering to farm animals for therapeutic pur                      taken by the Council acting on a proposal from
poses of oestradiol - 17-P, testosterone and progeste                  the Commission in accordance with the voting
rone and those derivatives which readily yield the                      procedure laid down in Article 43(2) of the Treaty.
parent compound on hydrolysis after absorption at                       Any new substance must, in order to be able to be
the site of application may be authorized .                             subject to such a decision, satisfy the relevant
                                                                        principles and criteria of Directives 8 1 /851 /EEC
                                                                        and 81 /852/ EEC .
                            Article 3
For the purposes of implementation of this Directive:
                                                                                Article 4
(a) there shall be established, after the Committee for
     Veterinary Medicinal Products has given its opin
     ion on the measures provided for in the first two             The Member States shall prescribe that undertakings
     indents, and in accordance with the procedure laid            producing substances having a thyrostatic, ©estro
     down in Article 8 :                                           genic, androgenic or gestagenic action and those auth
    — a list of the products containing as active                  orized for whatever purpose to market those substan
         substances     the    substances   referred  to  in       ces, and undertakings producing pharmaceutical and
         Article 2 and satisfying the relevant principles          veterinary products based on those substances, must
         and criteria of Directive 8 1 /851 /EEC (2) and         _ keep a register detailing, in chronological order, quan
         81 /852/ EEC (3) that may be authorized by the            tities produced or acquired and those sold or used for
         Member States,                                            the production of pharmaceutical and veterinary pro
                                                                   ducts .
    — the conditions of use of these products, in
         particular the waiting period necessary and
         detailed provisions concerning the control of
         these conditions of use,
    — the means of identification of animals .                                                Article 5
                                                                   Member States must ensure, that no animals are
(0 OJ No L 222, 7 . 8 . 1981 , p. 32.                              dispatched from their territory to that of another
(2) OJ No L 317, 6. 11 . 1981 , p. 1 .                             Member State which have had administered to them
(3) OJ No L 317, 6. 11 . 1981 , p. 16.                             in any way whatsoever substances with a thyro
 ---pagebreak---   No L 382 / 230                      Official Journal of the European Communities                               31 . 12 . 85
 static, oestrogenic, androgenic or gestagenic action ,          7.    In accordance with the procedure laid down in
 and that no meat from such animals is dispatched .              Article 8 , a control programme shall be drawn up
 They shall reserve the Community stamp for meat                 regarding imports from third countries, to ensure that
 from untreated animals .                                        imports do not receive more favourable treatment
                                                                 than Community products .
 With effect from the date of notification of this
 Directive and until the measures adopted pursuant to            With regard to routine inspections, this programme:
 Articles 2 and 6 are applicable:                                — will establish the frequency of controls on imports
 — national provisions governing produce intended                    from each third country,
     for Member States ' domestic markets shall not be           — will take account of the guarantees offered by the
     affected,                                                       inspection regulations of third countries .
 — Member States which prohibit the use of the sub
     stances   referred to    in Article  5   of Directive       In the event of positive results, imports from third
     81 /602/ EEC for fattening may restrict entry into          countries will be subject to systematic inspections until
                                                                 the situation is re-established .
     their territory to untreated fattening animals and
     meat from untreated fattening animals .
                                                                                Article 7
                         Article 6
                                                                 The Council, acting by a qualified majority on a
 1.    Member States shall prohibit importation from
 third countries of animals and of meat from animals             proposal from the Commission, may adopt deroga
                                                                 tions from Articles 5 and 6 in respect of trade in
to which have been administered in any way whatsoe
                                                                 animals intended for reproduction and reproductive
 ver substances with a thyrostatic, oestrogenic, andro
                                                                 animals at the end of their career which, in the course
 genic or gestagenic action .
                                                                 of their existence, have been treated under the provi
                                                                 sions of Article 4 of Directive 81 /602/ EEC and in
2.     To this end the decisions to be taken for imple          respect of meat from these various animals, taking
mentation of Directive 72/462/ EEC, taking account               into account the guarantees given .
of Article 13 of Directive 85 /358/ EEC in the case of
meat, and of the equivalent guarantee in the case of
live animals, must be adopted before 1 January 1988 .
                                                                                Article 8
3.     Member States shall ensure that imported fresh
meat coming from approved slaughterhouses in third
countries in respect of which a decision within the              1.    Where the procedure laid down in this Article is
meaning of paragraph 2 has been taken is, without               to be used, matters shall without delay be referred by
prejudice to animal health measures, circulated in the          the Chairman, either on his own initiative or at the
Community in accordance with Article 25 of Directive            request of a Member State, to the Standing Veterinary
72/462/ EEC .
                                                                Committee (hereinafter called 'the Commitee') set up
                                                                by the Council Decision of 15 October 1968 .
4.     National rules on substances with a hormonal
action dealing with imports from third countries shall          2.     The representative of the Commission shall sub
remain applicable, with due regard for the general              mit to the Committee a draft of the measures to be
provisions of the Treaty, until each of the decisions           adopted . The Committee shall deliver its opinion on
referred to in paragraph 2 comes into force.                    the draft within a time limit which the Chairman may
                                                                lay down according to the urgency of the matter. The
                                                                opinion shall be delivered by a majority of 54 votes,
5.     As from 1 January 1988, Member States shall              the votes of the Member States being weighted as
suspend imports coming from third countries in res             provided for in Article 148(2) of the Treaty . The
pect of which no decision within the meaning of                 Chairman shall not vote .
paragraph 2 has been taken .
                                                                3 . The Commission shall adopt the measures and
6.     For the purposes of application of paragraphs 1          implement them immediately where they are in accor
to 5 , the Commission shall draw up a list of the               dance with the opinion of the Committee. Where they
products authorized by third countries for the thera           are not in accordance with the opinion of the Com
peutic treatments referred to in Article 4 of Directive         mittee or if no opinion is delivered, the Commission
81 /602/ EEC .                                                  shall immediately submit to the Council a
 ---pagebreak--- 31 . 12 . 85                       Official Journal of the European Communities                      No L 382/231
proposal on the measures to be taken . The Council                                   Article 10
shall act by a qualified majority.
                                                              Member States shall bring into force the laws, regula
If within three months of the date on which a matter          tions and administrative provisions necessary to com
was referred to it the Council has not adopted any            ply ;
measures, the Commission shall adopt the proposed            — with Directive 85/358/EEC, by 1 January 1987 at
measures and implement them immediately, save                     the latest ;
where the Council has decided against the measures            — with this Directive, by 1 January 1988 at the latest.
by a simple majority.
                                                              They shall immediately inform the Commission the
                                                              reof.
                                                                                Article 11
                         Article 9
                                                              This Directive is addressed to the Member States .
The measures necessary to ensure the transition to the        Done at Brussels, 31 December 1985 .
final arrangements extending the ban laid down in                                                    For the Council
Article 2 to domestic production may be adopted in
accordance with the procedure laid down in Article . 8                                                The President
during a maximum period af one year.                                                                  R. STEICHEN


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31980L1098

Council Directive 80/1098/EEC of 11 November 1980 amending Directive 64/432/EEC with regard to swine vesicular disease and classical swine fever

Official Journal L 325 , 01/12/1980 P. 0011 - 0013 Finnish special edition: Chapter 3 Volume 12 P. 0207  Greek special edition: Chapter 03 Volume 31 P. 0236  Swedish special edition: Chapter 3 Volume 12 P. 0207  Spanish special edition: Chapter 03 Volume 19 P. 0235  Portuguese special edition Chapter 03 Volume 19 P. 0235

COUNCIL DIRECTIVE  of 11 November 1980  amending Directive 64/432/EEC with regard to swine vesicular disease and classical swine fever  (80/1098/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 (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Directive 64/432/EEC (4), as last amended by Directive 80/219/EEC (5), lays down the health requirements which must be fulfilled by live bovine animals and swine intended for intra-Community trade;  Whereas the existence of swine vesicular disease in the Community represents a danger for the Community stock of swine ; whereas, accordingly, steps should be taken to ensure that the disease is not spread;  Whereas the persistence of classical swine fever in certain parts of the Community represents a danger for the stock of swine of those Member States which are free from the disease ; whereas until such time as classical swine fever has been eliminated in the parts where it still exists, the Member States should be authorized to take additional measures with a view to preventing any contamination in the course of trade,  HAS ADOPTED THIS DIRECTIVE:    Article 1 With effect from 1 November 1980, Directive 64/432/EEC is hereby amended as follows:    1. In Article 2 (j) (ii) the words "swine vesicular disease" shall be inserted between the words "swine fever" and "or contagious swine paralysis";       2. In Article 3 (2):      (a) at (b) the words "swine vesicular disease" shall be inserted between the words "foot-and-mouth disease" and "swine fever";           (b) at (b) (i) and (ii), the words "or swine vesicular disease" shall be inserted after the words "foot-and-mouth disease";           (c) at (c) (ii) the words "swine vesicular disease" shall be inserted between the words "foot-and-mouth disease", and "bovine and porcine brucellosis";                  3. In Article 2, the following points shall be added:  "(p) "officially swine fever-free holding" means a holding in which:      - no swine fever has been detected for at least the preceding 12 months,           - there are no pigs which have been vaccinated against swine fever,           - vaccination against swine fever has not been authorized for at least the preceding 12 months,             in addition, no swine fever must have been detected for at least the preceding 12 months within a radius of two kilometres around the holding;  (q) "officially swine fever-free Member State or region" means a Member State or region which:      - no swine fever has been detected for at least the preceding 12 months,           - vaccination against swine fever has not been authorized for at least the preceding 12 months,             and in which the holdings contain no pigs which have been vaccinated against swine fever;  (r) "swine fever-free Member State, region or holding" means a Member State, region or holding in which no swine fever has been detected for at least the preceding 12 months.    ";   4. In Article 3 (4) the following words shall be inserted after "brucellosis-free stock" : "and from an officially  (1)OJ No C 130, 31.5.1980, p. 6. (2)OJ No C 175, 14.7.1980, p. 79. (3)OJ No C 300, 18.11.1980, p. 20. (4)OJ No 121, 29.7.1964, p. 1977/64. (5)OJ No L 47, 21.2.1980, p. 25.  swine fever-free holding or a swine fever-free holding, provided that in the latter case the animals are accompanied by a certificate testifying that they have not been vaccinated.";       5. In Article 4b, the following penultimate paragraph shall be inserted:  "Until 31 December 1982 and subject to compliance with the general provisions of the Treaty, the Member States referred to in the first subparagraph may also make the introduction into their territory of swine for breeding or production conditional upon a negative result when tested for antibodies of swine vesicular disease during the 30 days preceding shipment.";       6. The following Article shall be inserted:  "Article 4c 1. Member States which have availed themselves of the authorization laid down in Directive 80/218/EEC and which are officially swine fever-free may not oppose the introduction into their territories of swine which come from:        (a) either a Member State the territory of which is officially swine fever-free;               (b) or a Member State:          - which has not allowed vaccination against swine since at least 12 months previously,                   - in which during the same period there have not been any cases of swine fever,                   - but which does not allow the introduction of vaccinated pigs into its territory unless they are slaughter pigs or fattening pigs weighing less than 25 kg and destined for fatstock holdings which they may not leave except to go for slaughter,                     provided that the animals intended for the Member States referred to at the beginning of this paragraph have been born and reared on officially swine fever-free holdings and, in the case of animals for breeding or production, they have shown a negative result in the test for the antibody produced by swine fever;               (c) or a part of a territory made up of a region or of several adjacent regions, that part being recognized as officially swine fever-free for the purpose of intra-Community trade by the Council acting unanimously on a proposal from the Commission within three months following the date on which the proposal was referred to it.  This status shall, without prejudice to the possibility of recourse to Article 9 of this Directive, be suspended by the Commission for a period of 15 days upon the occurrence of an outbreak or of several epizootiologically linked outbreaks of swine fever within a geographically limited area.  A decision may be taken within this period in accordance with the procedure provided for in Article 12 either to reconfirm or to withdraw the status of the part of the territory in question.  In the event of withdrawal, that status may be granted afresh to the part of the territory in accordance with the same procedure only after a period of:          - three months, if there has been no vaccination,                   - six months, if there has.                                    2. However, subject to compliance with the general provisions of the Treaty, the Member States which have availed themselves of the authorization laid down in Directive 80/218/EEC shall be authorized to retain their national regulations on protection against swine fever as regards the introduction into their territories of animals for breeding, production or slaughter from the Member States other than those referred to in paragraph 1 (a) and (b) above and, until such time as the decision referred to in the first subparagraph of paragraph 1 (c) has been taken, from the parts of territories concerned.";         7. In Article 7 (1) the following point shall be added:  "F. In the case of swine for breeding or production, by way of derogation from Article 3 (4) and until 31 December 1985, those animals which have been vaccinated against swine fever.";       8. In Annex E paragraph (b), the fifth indent shall be deleted and the following three indents added:  "- swine fever,      - swine vesicular disease,           - African swine fever;           "       9. Annex F, Model III, point V shall be amended as follows:      1. the following point shall be inserted:  "(c) they come from:        - an officially swine fever-free holding (2),               - a swine fever-free holding (2), and          (i) have not been vaccinated against swine fever (2);                    (ii) have been vaccinated against swine fever ; the vaccination has been authorized by the country of destination (2);";                                             2. points (c) to (f) shall become points (d) to (g).           3. in the second paragraph of point (e), the words "swine vesicular disease", shall be inserted between the words "foot-and-mouth disease", and "bovine and swine brucellosis,".                     Article 2 Article 4 c of Directive 64/432/EEC shall apply until 31 December 1985.  Before 1 July 1985, the Commission shall submit to the Council a report on developments in the situation with particular regard to trade, together with appropriate proposals as regards swine fever.  The Council shall take a decision on these proposals not later than 31 December 1985.   Article 3 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1981 and shall forthwith inform the Commission thereof.  Until the date on which the Member States are able to comply, and until 1 July 1981 at the latest, Denmark, Ireland and the United Kingdom are authorized to retain their national rules relating to protection against swine fever upon introduction into their territory of swine for breeding, production and slaughter, subject to compliance with the general provisions of the Treaty.   Article 4 This Directive is addressed to the Member States.     Done at Brussels, 11 November 1980.  For the Council  The President  C. NEY


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31972L0097

Council Directive 72/97/EEC of 7 February 1972 extending the period set in Article 7 (1) (C) of the Council Directive of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine

Official Journal L 038 , 12/02/1972 P. 0095 - 0095 Danish special edition: Series I Chapter 1972(I) P. 0088  English special edition: Series I Chapter 1972(I) P. 0094  Greek special edition: Chapter 03 Volume 7 P. 0152  Spanish special edition: Chapter 03 Volume 5 P. 0165  Portuguese special edition Chapter 03 Volume 5 P. 0165

COUNCIL DIRECTIVE  of 7 February 1972  extending the period set in Article 7 (1) (C) of the Council Directive of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine  (72/97/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 1964 1 on animal health problems affecting intra-Community trade in bovine animals and swine, as last amended by the Council Directive of 19 July 1971 2, makes provision in Article 7 (1), as amended by the Council Directive of 13 July 1970 3, for countries of destination to grant general or restricted authorizations for the introduction of certain animals into their territory;  Whereas in respect of bovine animals for production under thirty months old, it follows from (C) of the abovementioned provision that such authorizations may only be granted during a limited period ending on 31 December 1971;  Whereas that period should be extended until 31 December 1975;  HAS ADOPTED THIS DIRECTIVE:    Article 1 The following shall be substituted for the second subparagraph of Article 7 (1) (C) of the Council Directive of 26 June 1964, as amended by the Directive of 13 July 1970:  "This provision shall apply until 31 December 1975 unless otherwise decided by the Council acting by a qualified majority on a proposal from the Commission."   Article 2 The Member States shall bring into force with effect from 1 January 1972 the laws, regulations or administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 7 February 1972.  For the Council  The President  J.P. BUCHLER  1OJ No 121, 29.7.1964, p. 1977/64. 2OJ No L 179, 9.8.1971, p. 1. 3OJ No L 157, 18.7.1970, p. 40.


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31990L0677

Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products

Official Journal L 373 , 31/12/1990 P. 0026 - 0028 Finnish special edition: P. 0034  Swedish special edition: P. 0004

 COUNCIL DIRECTIVE    of 13 December 1990    extending the scope of Directive 81/851/EEC on the   approximation of the laws of the Member States   relating to veterinary medicinal products and laving   down additional provisions for immunological   veterinary medicinal products     ( 90/677/EEC )    THE COUNCIL OF THE EUROPEAN COMMUNITIES ,    Having regard to the Treaty establishing the European   Economic Community , and in particular Article 100a   thereof ,    Having regard to the proposal from the Commission (1) ,    In cooperation with the European Parliament (2) ,    Having * opinion of the Economic and Social   Committee (3) ,    Whereas disparities in the provisions laid down by law ,   regulation or administrative action by Member States may   hinder trade in immunological veterinary medicinal products   within the Community ;    Whereas the essential aim of any rules governing the   production , distribution or use of veterinary medicinal   products must be to ensure a high level of protection of   public health ;    Whereas the provisions of Directive 81/851/EEC (4) as last   amended by Directive 90/676/EEC (5) , although   appropriate , are not adequate for veterinary medicinal   products used in order to produce active immunity , to   diagnose the state of immunity or to produce passive   immunity ( immunological veterinary medicinal   products ) ;    Whereas in accordance with Article 5 of Council Directive   87/22/EEC of 22 December 1986 on the approximation of   national provisions relating to the placing on the market of   high-technology medicinal products , particularly those   derived from biotechnology (6) , the Commission is required   to submit proposals to harmonize the conditions for   authorizing the manufacture and placing on the market of   immunological veterinary medicinal products ;    Whereas , before an authorization to market an   immunological veterinary medicinal product can be granted ,   the manufacturer must demonstrate his ability to attain   batch-to-batch consistency ;    Whereas the competent authorities should also be   empowered to prohibit the use of an immunological   veterinary medicinal product when the immunological   responses of the treated animal will interfere with a   national or Community programme for the diagnosis ,   eradication or control of animal disease ;    Whereas changes will be required to the requirements for   the testing of veterinary medicinal products laid down   in Annex I to Council Directive 81/852/EEC of   28 September 1981 on the approximation of the laws   of the Member States relating to analytical ,   pharmaco-toxicological and clinical standards   and protocols in respect of the testing of veterinary   medicinal products (7) , as amended by   Directive 87/20/EEC (8) , to take account of the   special nature of immunological veterinary   medicinal products ; whereas the Commission   should be empowered to adopt the necessary   changes in close cooperation with the Committee for the   Adaptation to Technical Progress of the Directives on the   Removal of Technical Barriers to Trade in the Veterinary   Medicinal Products Sector , thus ensuring greater quality ,   safety and effectiveness ,    HAS ADOPTED THIS DIRECTIVE :    Article 1    1 . Subject to the provisions of this Directive ,   Directive 81/851/EEC shall apply to immunological   veterinary medicinal products .    2 . For the purposes of this Directive   " immunological veterinary medicinal product " means a   veterinary medicinal product administered to animals   in order to produce active or passive immunity or to   diagnose the state of immunity .    3 . This Directive and Directive 81/851/EEC shall not   apply to inactivated immunological veterinary medicinal   products which are manufactured from pathogens and   antigens obtained from an animal or animals from a holding   and used for the treatment of that animal or the animals of   that holding in the same locality .    4 . Member States may provide that this Directive does   not apply to non-activated immunological veterinary   medicinal products of the type referred to in   paragraph 3 .    Article 2    1 . The quantitative particulars of an immunological   veterinary medicinal product shall be expressed by mass or   by international units or by units of biological activity   or by the number of germs or by specific protein content   where possible , as appropriate to the product   concerned .    2 . In respect of immunological veterinary medicinal   products , in Directive 81/851/EEC the expression   " qualitative and quantitative composition of the   constituents " shall include particulars relating to   biological activity or to protein content and the   expression " qualitative and quantitative composition "   shall include the composition of the product expressed   in terms of the biological activity or of protein   content .    3 . In any document established in accordance with   Directive 81/851/EEC in which the name of an   immunological veterinary medicinal product is expressed ,   the full common or scientific name of the active   constituents shall also be included at least once .    Article 3    1 . Member States shall take all appropriate measures to   ensure that the manufacturing processes used in the   manufacture of immunological veterinary medicinal   products are completely validated and batch-to-batch   consistency is ensured , in accordance with Article 34 of   Directive 81/851/EEC .    2 . For the purpose of implementing Article 35 of   Directive 81/851/EEC , Member States may require persons   responsible for placing immunological veterinary medicinal   products on the market to submit to the competent   authorities copies of all the control reports signed by the   qualified person in accordance with Article 30 of   Directive 81/851/EEC .    The person responsible for placing immunological   veterinary medicinal products on the market shall ensure   that an adequate number of representative samples of   each batch of finished products is held in stock at   least up to the expiry date , and provide samples   promptly to the competent authorities on request .    3 . Where it considers it necessary , a Member State may   require persons responsible for placing immunological   veterinary medicinal products on the market to submit   samples from the batches of the bulk and/or finished product   for examination by a State laboratory or an approved   laboratory before entry in free circulation . In the case   of a batch manufactured in another Member State ,   examined by the competent authority of another   Member State and declared to be in conformity with   national specifications , such a control may be carried   out only after the control reports of the batch in   question have been examined , after the Commission   has been informed , and where the difference in   veterinary conditions between the two Member States   concerned justifies it . Except where the Commission has   been informed that a longer period is necessary to complete   the analyses , Member States shall ensure that any such   examination is completed within 60 days of receipt of the   samples . The person responsible for placing the product   on the market shall be notified of the results of the   examination within the same time limit . Before   1 January 1992 , the Member States shall notify the   Commission of the immunological veterinary medicinal   products subject to compulsory official control before   being placed on the market .    Article 4    In the absence of specific Community legislation   concerning the use of immunological veterinary medicinal   products for the eradication or control of animal   disease , a Member State may , in accordance with its   national legislation , prohibit the manufacture ,   import , possession , sale , supply and/or use of   immunological veterinary medicinal products on the whole   or part of its territory if it is established that :     ( a ) the administration of the product to animals will   interfere with the implementation of a national   programme for the diagnosis , control or eradication of   animal disease , or will cause difficulties in   certifying the absence of contamination in live animals   or in foodstuffs or other products obtained from   treated animals ;     ( b ) the disease to which the product is intended to   conter immunity is largely absent from the territory in   question .    The competent authorities of the Member States shall   inform the Commission of all instances in which the   provisions of this Article are applied .    Article 5    The amendments which need to be made to the testing   requirements for veterinary medicinal products set out in   the Annex to Directive 81/852/EEC to take account of the   extension of the scope of Directive 81/851/EEC to cover   immunological veterinary medicinal products shall be   adopted in accordance with the procedure laid down in   Article 2c of Directive 81/852/EEC .    Article 6    1 . Member States shall take the necessary measures to   comply with this Directive not later than 1 January 1992 .   They shall forthwith inform the Commission thereof .    In the event of the amendments referred to in Article 5   not being adopted by 1 January 1991 , the date indicated   in the first subparagraph shall be put back to one year   after the date of adoption of those amendments .    2 . When Member States adopt the measures referred to in   paragraph 1 , 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 such a reference shall be laid down by the   Member States .    3 . Requests for marketing authorization for products   covered by this Directive lodged after the date indicated in   paragraph 1 must comply with the provisions of this   Directive .    4 . Within five years of the date indicated in the first   subparagraph of paragraph 1 , this Directive shall apply to   existing immunological veterinary medicinal products .    Article 7    This Directive is addressed to the Member States .    Done at Brussels , 13 December 1990 .    For the Council    The President    P. ROMITA    (1) OJ No C 61 , 10 . 3 . 1989 , p. 20 and   OJ No C 131 , 30 . 5 . 1990 , p. 20 .    (2) OJ No C 96 , 17 . 4 . 1990 , p. 111 and   Decision of 21 November 1990 ( not yet published in the   Official Journal ) .    (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 .    (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 .    (5) See page 15 of this Official Journal .    (6) OJ No L 15 , 17 . 1 . 1987 , p. 38 .    (7) OJ No L 317 , 6 . 11 . 1981 , p. 16 .    (8) OJ No L 15 , 17 . 1 . 1987 , p. 34 .


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31967L0428

Council Directive 67/428/EEC of 27 June 1967 amending the Council Directive of 26 January 1965 laying down specific criteria of purity for preservatives authorized for use in foodstuffs intended for human consumption

Official Journal 148 , 11/07/1967 P. 0010 - 0011 Finnish special edition: Chapter 13 Volume 1 P. 0099  Danish special edition: Series I Chapter 1967 P. 0161  Swedish special edition: Chapter 13 Volume 1 P. 0099  English special edition: Series I Chapter 1967 P. 0178  Greek special edition: Chapter 03 Volume 2 P. 0129  Spanish special edition: Chapter 13 Volume 1 P. 0048  Portuguese special edition Chapter 13 Volume 1 P. 0048

COUNCIL DIRECTIVE  of 27 June 1967  amending the Council Directive of 26 January 1965 laying down specific criteria of purity for preservatives authorised for use in foodstuffs intended for human consumption  (67/428/EEC) THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY, Having regard to the Treaty establishing the European Economic Community; Having regard to the Council Directive of 5 November 1963 (1) on the approximation of the laws of the Member States concerning preservatives authorised for use in foodstuffs intended for human consumption, as last amended by the Council Directive of 27 June 1967 (2) on the use of certain preservatives for the surface treatment of citrus fruit and on the control measures to be used for the qualitative and quantitative analysis of preservatives in and on citrus fruit, and in particular Article 8 (1) thereof; Having regard to the Council Directive of 26 January 1965 (3) laying down specific criteria of purity for preservatives authorised for use in foodstuffs intended for human consumption; Having regard to the proposal from the Commission; Whereas the Council Directive of 26 January 1965 laid down specific criteria of purity for the preservatives listed in the Annex to the Council Directive of 5 November 1963 ; whereas that Annex was supplemented by the Council Directive of 27 June 1967 which added biphenyl, orthophenylphenol and sodium orthophenylphenate to the list of authorised preservatives; Whereas it is necessary to lay down specific criteria of purity for the three preservatives mentioned above; Whereas the Council Directive of 26 January 1965 fixes for potassium metabisulphite (E 224) a certain minimum content of pure substance ; whereas that content, easily obtained when potassium metabisulphite is produced, cannot be maintained during marketing because of the natural degeneration of this product ; whereas consequently the fixed minimum content should be corrected; HAS ADOPTED THIS DIRECTIVE: Article 1The Annex to the Council Directive of 26 January 1965 shall be amended as follows: 1. Under No E 224, potassium metabisulphite, for the content specifications laid down there shall be substituted the following: "Not less than 90 % of K2S2O5 and not less than 51.8 % of SO2, the remainder being composed almost entirely of potassium sulphate." 2. The following specifications should he inserted between Nos E 225 and E 250: "E 230 Biphenyl >PIC FILE= "T9000039">   (1) OJ No 12, 27.1.1964, p. 161/64. (2) OJ No 148, 11.7.1967, p. 148/1. (3) OJ No 22, 9.2.1965, p. 373/65.   >PIC FILE= "T9000040">  "E 231 Orthophenylphenol >PIC FILE= "T9000041">  "E 232 Sodium orthophenylphenate >PIC FILE= "T9000042">  >PIC FILE= "T9000043">     Article 2 Member States shall, not later than 1 July 1968, bring into force the measures necessary to comply with this Directive and shall forthwith inform the Commission thereof.  Article 3This Directive is addressed to the Member States. Done at Brussels, 27 June 1967. For the Council The President R. VAN ELSLANDE


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31989L0682

Council Directive 89/682/EEC of 21 December 1989 amending directive 86/298/EEC on rear-mounted roll-over protection structures of narrow-track wheeled agricultural and forestry tractors

Official Journal L 398 , 30/12/1989 P. 0029 - 0030 Finnish special edition: Chapter 13 Volume 19 P. 0127  Swedish special edition: Chapter 13 Volume 19 P. 0127

COUNCIL DIRECTIVEof 21 December 1989amending Directive  86/298/EEC on rear-mounted roll-over protection structures ofnarrow-track wheeled agricultural and  forestry tractors(89/682/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas it is necessary to adopt measures with the aim of progressively establishing the internal  market over a period expiring on 31 December 1992; whereas the internal market comprises an area  without internal frontiers in which thefree movement of goods, persons, services and capital is  ensured; Whereas Article 13 of Directive 86/298/EEC (4) lays down that the provisions at present in force  shall be supplemented by provisions introducing additional impact tests into the dynamic test  procedure; Whereas, since provision is already made for an additional test in the case of the static test  procedure, it is necessary also in that of the dynamic test procedure to provide for an additional  test which more accurately reflects the situation in the event of tractor roll-over in order that  these two test procedures may be rendered equivalent and the present imbalance between them  eliminated; Whereas the purely theoretical parameters and calculations on which the additional dynamic impact  test was initially based have been the subject of practical experiments that leave no doubt as to  their reliability; Whereas it is also necessary to amend the scope of Directive 86/298/EEC so as to clarify the  wording of the second indent of Article 1 concerning the tyres fitted to the front and rear axles,  and thus eliminate any possibility of differing interpretations, OJ N° C 256, 9. 10. 1989, p. 77. HAS ADOPTED THIS DIRECTIVE: Article 1Directive 86/298/EEC is hereby amended as follows: 1. the second indent of Article 1 is replaced by the following: '- fixed or adjustable minimum track width of less than 1 150 mm for the axles fitted with the  widest tyres; since the axle fitted with the widest tyres is assumed to be adjusted to a maximum  track width of 1 150 mm, the other axle must be capable of being adjusted in such a way that the  outer edges of the narrowest tyres do not project beyond the outer edges of the tyres on the axle  with the widest tyres. Where both axles are equipped with wheels and tyres of the same size, the  fixed or adjustable track width of both axles must be less than 1 150 mm;'2. in Annex II, point 3.1.1 is replaced by the following: '3.1.1. After each partial test in the dynamic test procedure, it shall be free from tears or cracks as  described in point 3.1 of Annex III (A). If, during the dynamic test, significant tears or cracks appear, an additional impact test or  crushing test as defined in point 1.6 of Annex III (A) must be performed immediately after the test  which caused these tears or cracks to appear.'; 3. in Annex III (A), point 1.6 is replaced by the following: '1.6. Additional tests'1.6.1. If cracks or tears which cannot be considered negligible appear during an impact test, a second,  similar test, but with a height of fall of:  Hm =  10  × 12 + 4a  Hm =H10×12 + 4a1 + 2ashall be performed immediately after the impact  test causing these tears or cracks to appear, ''a'' being the ratio of the permanent deformationto  the elastic deformation (a = Dp/De) as measured at the point of impact. The additional permanent deformation due to the second impact must not exceed 30 % of the permanent  deformation due to the first impact. In order to be able to carry out the additional test, it is necessary to measure the elastic  deformation during all of the impact tests. ,1.6.2. If, during a crushing test, significant tears or cracks appear, a second, similar crushing test,  but with a force equal to 1,2 Fv, shall be performed immediately after the crushing test which  caused these tears and cracks to appear.'; 4. in Annex VI, the following point is inserted: '7.3. Indication and results of any additional dynamic test.'Article 2Member States shall bring into  force the laws, regulations and administrative provisions necessary to comply with this Directive  not later than 12 months from 3 January 1990. They shall forthwith inform the Commission thereof. Article 3This Directive is addressed to the Member States. Done at Brussels, 21 December 1989. For the CouncilThe PresidentE. CRESSON(1) OJ N° C 311, 6. 12. 1988, p. 9. (2) OJ N° C 120, 16. 5. 1989, p. 70, and (3) OJ N° C 102, 24. 4. 1989, p. 5. (4) OJ N° L 186, 8. 7. 1986, p. 26.