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31998L0046

Council Directive 98/46/EC of 24 June 1998 amending Annexes A, D (Chapter I) and F to Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine

Official Journal L 198 , 15/07/1998 P. 0022 - 0039

COUNCIL DIRECTIVE 98/46/EC of 24 June 1998 amending Annexes A, D (Chapter I) and F to Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swineTHE COUNCIL OF THE EUROPEAN UNION,Having regard to Council Directive 64/432/EEC of 26 June 1964 on health problems affecting intra-Community trade in bovine animals and swine (1), and in particular Article 16(1)(a) thereof,Having regard to the proposal from the Commission (2),Having regard to the opinion of the European Parliament (3),Whereas in Article 16 of Directive 64/432/EEC the Commission has been requested to make proposals to amend Annexes A, D (Chapter I) and F to the said Directive, in particular with regard to their adaptation to technological developments;Whereas in the same Article it is stipulated that the Council is to decide on these proposals by a qualified majority before 1 January 1998;Whereas in recent times the development of veterinary administrative procedures regarding herd management, animal movement control, animal identification and information handling in relation to disease control requires amendments to be made to certain Annexes to Directive 64/432/EEC,HAS ADOPTED THIS DIRECTIVE:Article 1 Annexes A, D (Chapter I) and F to Directive 64/432/EEC are hereby replaced by the Annexes to this Directive.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1999. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Luxembourg, 24 June 1998.For the CouncilThe PresidentJ. CUNNINGHAM(1) OJ 121, 29. 7. 1964, p. 1977/64. Directive as last amended by Directive 97/12/EC (OJ L 109, 25. 4. 1997, p. 1).(2) OJ C 266, 3. 9. 1997, p. 4, and OJ C 337, 7. 11. 1997, p. 1.(3) OJ C 14, 19. 1. 1998, p. 58.ANNEX I 'ANNEX AI. Officially tuberculosis-free bovine herdFor the purposes of this section 'bovine animals` means all bovine animals with the exception of animals taking part in cultural or sporting events.1. A bovine herd is officially tuberculosis-free if:(a) all the animals are free from clinical signs of tuberculosis;(b) all the bovine 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 six months after the elimination of any infection from the herd and the second six months later or, where the herd has been assembled solely from animals that originate in officially tuberculosis-free herds, the first test shall be carried out at least 60 days after assembly and the second shall not be required;(c) following the completion of the first test referred to in (b), no bovine animal over six weeks old has been introduced into the herd unless it has reacted negatively to an intradermal tuberculin test performed and assessed according to Annex B and carried out either in the 30 days prior to, or the 30 days after the date of its introduction into the herd; in the latter case the animal(s) must be isolated physically from the other animals of the herd in a way to avoid any direct or indirect contact with the other animals until proven negative.However, the competent authority may not require this test to be carried out for movements of animals on its own territory if the animal is from an officially tuberculosis-free herd, except in a Member State where, on 1 January 1998 and until the status of officially tuberculosis-free region is obtained, the competent authority required such tests to be carried out for animals moving between herds participating in a network system as referred to in Article 14.2. A bovine herd will retain officially tuberculosis-free status if:(a) the conditions detailed in 1(a) and (c) continue to apply;(b) all animals entering the holding come from herds of officially tuberculosis-free status;(c) all animals on the holding, with the exception of calves under six weeks old which were born in the holding, are subjected to routine tuberculin testing in accordance with Annex B at yearly intervals.However, the competent authority of a Member State may, for the Member State or part of the Member State where all the bovine herds are subject to an official programme to combat tuberculosis, alter the frequency of the routine tests as follows:- if the average - determined at 31 December of each year - of the annual percentages of bovine herds confirmed as infected with tuberculosis is not more than 1 % of all herds within the defined area during the two most recent annual supervisory periods, the interval between routine herd tests may be increased to two years and male animals for fattening within an isolated epidemiological unit may be exempted from tuberculin testing provided that they come from officially tuberculosis-free herds and that the competent authority guarantees that the males for fattening will not be used for breeding and will go direct for slaughter,- if the average - determined at 31 December of each year - of the annual percentages of bovine herds confirmed as infected with tuberculosis is not more than 0,2 % of all herds within the defined area during the two most recent biennial supervisory periods, the interval between routine tests may be increased to three years and/or the age at which animals have to undergo these tests may be increased to 24 months,- if the average - determined at 31 December of each year - of the annual percentages of bovine herds confirmed as infected with tuberculosis is not more than 0,1 % of all herds within the defined area during the two most recent supervisory triennial periods, the interval between routine tests may be increased to four years, or, providing the following conditions are met, the competent authority may dispense with tuberculin testing of the herds:(1) before the introduction into the herd all the bovine animals are subjected to an intradermal tuberculin test with negative results;(2) all bovine animals slaughtered are examined for lesions of tuberculosis and any such lesions are submitted to a histopathological and bacteriological examination for evidence of tuberculosis.The competent authority may also, in respect of the Member State or a part thereof, increase the frequency of tuberculin testing if the level of the disease has increased.3A. The officially tuberculosis-free status of a herd is to be suspended if:(a) the conditions detailed in paragraph 2 are no longer fulfilled;or(b) one or more animals are deemed to have given a positive reaction to a tuberculin test, or a case of tuberculosis is suspected at post-mortem examination.When an animal is considered to be a positive reactor it will be removed from the herd and slaughtered. Appropriate post-mortem, laboratory and epidemiological examinations shall be carried out on the positive reactor or the carcase of the suspect animal. The status of the herd will remain suspended until such time as all laboratory examinations have been completed. If the presence of tuberculosis is not confirmed, the suspension of the officially tuberculosis-free status may be lifted following a test of all animals over six weeks of age with negative results at least 42 days after the removal of the reactor animal(s);or(c) the herd contains animals of unresolved status as described in Annex B. In this case, the status of the herd is to remain suspended until the animals' status has been clarified. Such animals must be isolated from the other animals of the herd until their status has been clarified, either by a further test after 42 days or by post-mortem and laboratory examination;(d) however, by way of derogation from the requirements of paragraph (c), in a Member State where the competent authority carries out routine herd testing using the comparative tuberculin test described in Annex B, and in the case of a herd where no confirmed reactor animals have been disclosed for at least three years, the competent authority may decide not to restrict the movement of other animals in the herd, provided that the status of any inconclusive reactors is resolved by a further test after 42 days and that no animals from the holding are allowed to enter into intra-Community trade until the status of any inconclusive reactors has been resolved. If at this further test any animal either gives a positive reaction or continues to give an inconclusive reaction, then the conditions of paragraph (b) apply. If the presence of disease is subsequently confirmed, all animals leaving the holding since the time of the last clear herd test must be traced and tested.3B. The officially tuberculosis-free status of the herd is to be withdrawn if the presence of tuberculosis is confirmed by the isolation of M. bovis on laboratory examination.The competent authority may withdraw status if:(a) the conditions detailed in point 2 are no longer fulfilled, or(b) classical lesions of tuberculosis are seen at post-mortem examination, or(c) an epidemiological enquiry establishes the likelihood of infection,(d) or for any other reasons considered necessary for the purpose of controlling bovine tuberculosis.Tracing and checking is to be undertaken by the competent authority of any herd considered to be epidemiologically related. The officially tuberculosis-free status of a herd is to remain withdrawn until cleansing and disinfection of the premises and utensils has been completed and all animals over six weeks of age have reacted negatively to at least two consecutive tuberculin tests, the first no less than 60 days and the second no less than four months and no more than 12 months after the removal of the last positive reactor.4. On the basis of information supplied in accordance with Article 8, a Member State or part of a Member State may be declared officially tuberculosis-free according to the procedure laid down in Article 17 if it meets the following conditions:(a) the percentage of bovine herds confirmed as infected with tuberculosis has not exceeded 0,1 % per year of all herds for six consecutive years and at least 99,9 % of herds have achieved officially tuberculosis-free status each year for six consecutive years, the calculation of this latter percentage to take place on 31 December each calendar year;(b) an identification system making it possible to identify the herds of origin and transit for each bovine animal is in existence in accordance with Regulation (EC) No 820/97 (1)(1) Council Regulation (EC) No 820/97 of 21 April 1997 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products (OJ L 117, 7. 5. 1997, p. 1).;(c) all bovine animals slaughtered are subjected to an official post-mortem examination;(d) the procedures for suspension and withdrawal of officially tuberculosis-free status are complied with.5. The Member State or part of a Member State will retain officially tuberculosis-free status if the conditions 4(a) to (d) continue to be met. However, if there is evidence of a significant change in the situation as regards tuberculosis in a Member State or part of a Member State which has been recognised as officially tuberculosis-free, the Commission may, in accordance with the procedure laid down in Article 17, take a Decision suspending or revoking the status until the requirements of the Decision have been fulfilled.II. Officially brucellosis-free and brucellosis-free bovine herdsFor the purposes of this section 'bovine animals` means all bovine animals with the exception of males for fattening provided that they come from officially brucellosis-free herds and that the competent authority guarantees that the males for fattening will not be used for breeding and will go direct for slaughter.1. A bovine herd is officially brucellosis-free if:(a) it contains no bovine animals which have been vaccinated against brucellosis, except 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 12 months old have been subjected to one of the following test regimes with negative results in accordance with Annex C:(i) two serological tests specified in paragraph 10 at an interval of more than three months and less than 12 months;(ii) three tests on milk samples at three-monthly intervals followed at least six weeks later by a serological test specified in paragraph 10;(d) any bovine animal entering the herd comes from a herd of officially brucellosis-free status and, in the case of bovine animals over 12 months old, has shown a brucella titre of less than 30 IU of agglutination per ml when given a serum agglutination test in accordance with Annex C or has reacted negatively to any other test approved in accordance with the procedure at Article 17 during the 30 days prior to or the 30 days after the date of its introduction into the herd: in the latter case, the animal(s) must be isolated physically from the other animals of the herd in such a way as to avoid direct or indirect contact with the other animals until proven negative.2. A bovine herd will retain officially brucellosis-free status if:(a) one of the following test regimes is carried out annually with negative results in accordance with Annex C:(i) three milk ring tests carried out at intervals of at least three months;(ii) three milk ELISAs carried out at intervals of at least three months;(iii) two milk ring tests carried out at an interval of at least three months followed at least six weeks later by a serological test referred to in paragraph 10;(iv) two milk ELISAs carried out at an interval of at least three months followed at least six weeks later by a serological test referred to in paragraph 10;(v) two serological tests carried out at an interval of at least three months and not more than 12 months.However, the competent authority of a Member State may, for the Member State or part of the Member State which is not officially brucellosis-free but where all the bovine herds are subject to an official programme to combat brucellosis, alter the frequency of the routine tests as follows:- where not more than 1 % of bovine herds are infected, it may be sufficient to carry out each year two milk ring tests or two milk ELISAs at an interval of at least three months, or one serological test,- where at least 99,8 % of bovine herds have been recognised as officially brucellosis-free for at least four years, the interval between checks may be extended to two years if all animals over 12 months of age are tested, or testing may be restricted to animals over 24 months of age if herds continue to be tested each year. The checks must be carried out using one of the serological tests referred to in paragraph 10;(b) all bovine animals entering the herd come from herds of officially brucellosis-free status and, in the case of bovine animals over 12 months old, have shown a brucella titre of less than 30 IU of agglutination per ml when given a serum agglutination test in accordance with Annex C or have reacted negatively to any other test approved in accordance with the procedure at Article 17 during the 30 days prior to or the 30 days after the date of their introduction into the herd; in the latter case, the animal(s) must be isolated physically from the other animals of the herd in such a way as to avoid direct or indirect contact with the other animals until proven negative.However, the test described in point (b) need not be required in Member States, or regions of Member States, where the percentage of bovine herds infected with brucellosis has not exceeded 0,2 % for at least two years and where the animal comes from an officially brucellosis-free bovine herd within that Member State or region and has not during transportation come into contact with bovine animals of lesser status;(c) notwithstanding point (b), bovine animals from a brucellosis-free bovine herd may be introduced into an officially brucellosis-free herd if they are at least 18 months old and, if vaccinated against brucellosis, the vaccination was carried out more than a year previously.Such animals must have shown, in the 30 days prior to introduction, a brucella titre lower than 30 IU of agglutination per ml and a negative result when given a complement fixation test, or other test approved under the procedure set out in Article 17.If, however, a female bovine animal from a brucellosis-free herd is introduced into an officially brucellosis-free herd, under the provisions of the above paragraph, that herd shall be considered to be brucellosis-free for two years from the date on which the last vaccinated animal was introduced.3A. The officially brucellosis-free status of a herd is to be suspended if:(a) the conditions detailed in paragraphs 1 and 2 are no longer fulfilled; or(b) as a result of laboratory tests or on clinical grounds one or more bovine animals is suspected of having brucellosis and the suspect animals have been slaughtered or isolated in a way to avoid any direct or indirect contact with the other animals.Where the animal has been slaughtered and is no longer available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex C on all bovine animals in the herd over 12 months old, show a titre lower than 30 IU of agglutination per ml. The first test shall be carried out at least 30 days after the removal of the animal and the second at least 60 days later.Where the animal has been isolated from the animals in the herd, it may be reintroduced into the herd and the status of the herd may be restored following:(a) a serum agglutination test which has shown a titre lower than 30 IU of agglutination per ml and has given a negative result to a complement fixation test, or(b) a negative result to any other combination of tests approved for that purpose under the procedure set out in Article 17.3B. The officially brucellosis-free status of the herd is to be withdrawn if, as a result of laboratory tests or epidemiological investigations, brucella infection has been confirmed in the herd.The status of the herd is not to be restored until either all bovine animals present in the herd at the time of the outbreak have been slaughtered, or the herd has been subject to check testing and all animals over 12 months of age have given negative results to two consecutive tests at 60-day intervals, the first being carried out not less than 30 days after removal of the positive animal(s).In the case of bovine animals which were pregnant at the time of the outbreak, the final check must be carried out at least 21 days after the last animal pregnant at the time of the outbreak has calved.4. A bovine herd is brucellosis-free if it complies with the conditions in 1(b) and (c) and when vaccination has been carried out as follows:(i) female bovine animals have been vaccinated:- before the age of six months old with live strain 19 vaccine, or- before the age of 15 months old with killed 45/20 adjuvant vaccine which has been officially inspected and approved, or- with other vaccines approved under the procedure laid down in Article 17;(ii) bovine animals under 30 months old which have been vaccinated with live strain 19 vaccine may give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.5. A bovine herd will retain brucellosis-free status if:(i) it is subject to one of the testing regimes listed in 2(a);(ii) bovine animals entering the herd comply with the requirements of 2(b); or- come from herds of brucellosis-free status, and in the case of bovine animals over 12 months old, have shown, in the 30 days prior to or in isolation after introduction into the herd, less than 30 IU of agglutination per ml when given a serum agglutination test and a negative result to a complement fixation test in accordance with Annex C, or- come from herds of brucellosis-free status, are under 30 months old and have been vaccinated with live strain 19 vaccine if they give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.6A. The brucellosis-free status of a herd is to be suspended if:(a) the conditions detailed in paragraphs 4 and 5 have not been complied with; or(b) as a result of laboratory tests or on clinical grounds one or more bovine animals over 30 months old is suspected of having brucellosis and the animal(s) under suspicion have been slaughtered, or isolated in a way to avoid any direct or indirect contact with other animals.Where the animal has been isolated, it may be reintroduced into the herd and the status of the herd may be restored, if it subsequently shows a serum agglutination titre lower than 30 IU of agglutination per ml and has given a negative result to a complement fixation test, or other test approved under the procedure set out in Article 17.Where the animals have been slaughtered and are no longer available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex C on all bovine animals in the holding over 12 months old, show a titre lower than 30 IU of agglutination per ml. The first test is to be carried out at least 30 days after the removal of the animal and the second at least 60 days later.If the animals to be tested in the previous two subparagraphs are under 30 months old and have been vaccinated with live strain 19 vaccine they may be considered to be negative if they give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.6B. The brucellosis-free status of the herd is to be withdrawn if, as a result of laboratory tests of epidemiological investigations, brucella infection has been confirmed in a herd. The status of the herd is not to be restored until either all the bovine animals present in the herd at the time of the outbreak have been slaughtered or the herd has been subject to check testing and all unvaccinated animals over 12 months of age have given negative results to two consecutive tests at 60 day intervals, the first being carried out not less than 30 days after removal of the positive animal(s).If all the animals to be tested referred to in the preceding paragraph are less than 30 months old and have been vaccinated with live strain 19 vaccine, they may be considered negative if they show a brucella titre of more than 30 IU but less than 80 IU of agglutination per ml, provided that in the complement fixation test they show a titre of less than 30 EEC units in the case of females vaccinated less than 12 months previously or a titre of less than 20 EEC units in all other cases.In the case of bovine animals which were pregnant at the time of the outbreak, the final check must have been carried out at least 21 days after the last animal pregnant at the time of the outbreak has calved.7. A Member State or a region of a Member State may be declared officially brucellosis-free according to the procedure laid down in Article 17 if it meets the following conditions:(a) no case of abortion due to brucella infection and no isolation of B. abortus has been recorded for at least three years and at least 99,8 % of herds have achieved officially brucellosis-free status each year for five consecutive years, the calculation of this percentage to take place on 31 December each calendar year. However, where the competent authority adopts a policy of whole herd slaughter, isolated incidents shown by epidemiological enquiry to be due to the introduction of animals from outside the Member State or part of the Member State and herds whose officially brucellosis-free status has been suspended or withdrawn for reasons other than suspicion of disease, is to be disregarded for the purpose of the above calculation provided that the central competent authority of the Member State concerned by these incidents makes an annual record and forwards them to the Commission in accordance with Article 8(2), and(b) an identification system making it possible to identify the herds of origin and transit for each bovine animal is in existence in accordance with Regulation (EC) No 820/97, and(c) notification of cases of abortion is mandatory and they are investigated by the competent authority.8. Subject to paragraph 9, a Member State or a region of a Member State declared officially brucellosis-free is to retain this status if:(a) the conditions imposed by paragraph 7(a) and (b) are still fulfilled and notification of cases of abortion suspected of being due to brucellosis is mandatory and are investigated by the competent authority;(b) every year for the first five years after attaining status, all bovine animals over 24 months of age in not less than 20 % of herds have been tested and have reacted negatively to a serological test carried out in accordance with Annex C or, in the case of dairy herds, by examination of milk samples in accordance with Annex C;(c) every bovine animal suspected of being infected with brucellosis is notified to the competent authority and undergoes official epidemiological investigation for brucellosis comprising at least two serological blood tests, including the complement fixation test, and a microbiological examination of appropriate samples;(d) during the period of suspicion, which is to continue until negative results have been obtained from the tests provided for in (c), the officially brucellosis-free status of the herd of origin or transit of the suspected bovine animal and of the herds linked epidemiologically to it is to be suspended;(e) in the event of an outbreak of brucellosis that has spread, all bovine animals have been slaughtered. Animals of the remaining susceptible species will undergo appropriate tests and premises and equipment will be cleaned and disinfected.9. A Member State or a region of a Member State declared officially brucellosis-free is to report the occurrence of all cases of brucellosis to the Commission. If there is evidence of a significant change in the situation as regards brucellosis in a Member State or part of a Member State which has been recognised as officially brucellosis-free, the Commission may according to the procedure laid down in Article 17 propose that the status be suspended or revoked until the requirements of the Decision have been fulfilled.10. For the purposes of section II, a serological test means either a serum agglutination test, buffered brucella antigen test, complement fixation test, plasma agglutination test, plasma ring test, micro-agglutination test or individual blood ELISA, as described in Annex C. Any other diagnostic test approved under the procedure laid down in Article 17 and described in Annex C will also be accepted for the purposes of section II. A milk test means a milk ring test or a milk ELISA in accordance with Annex C.ANNEX DCHAPTER IOFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER STATES AND REGIONSA. Officially enzootic-bovine-leukosis-free herd means a herd in which:(i) there is no evidence, either clinical or as a result of a laboratory test, of any case of enzootic bovine leukosis in the herd and no such case has been confirmed in the previous two years; and(ii) all animals over 24 months of age have reacted negatively during the preceding 12 months to two tests carried out in accordance with this Annex, at an interval of at least four months; or(iii) it meets the requirements of (i) above and is situated in an officially enzootic-bovine-leukosis-free Member State or region.B. A herd shall retain officially enzootic-bovine-leukosis-free status provided:(i) the condition in A(i) continues to be fulfilled;(ii) any animals introduced into the herd come from an officially enzootic-bovine-leukosis-free herd;(iii) all animals over 24 months of age continue to react negatively to a test carried out in accordance with Chapter II at intervals of three years;(iv) breeding animals introduced into a herd and originating from a third country have been imported in accordance with Directive 72/462/EEC.C. The officially leukosis-free status of a herd is to be suspended if the conditions detailed in B are not fulfilled, or where as a result of laboratory tests or on clinical grounds one or more bovine animals are suspected of having enzootic bovine leukosis and the suspect animal(s) are immediately slaughtered.D. The status is to remain suspended until the following requirements are complied with:1. If a single animal in an officially enzootic-bovine-leukosis-free herd has reacted positively to one of the tests referred to in Chapter II, or where infection is otherwise suspected in one animal in a herd:(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;(ii) all animals in the herd more than 12 months old have reacted negatively to two serological tests (at least 4 months and less than 12 months apart) carried out in accordance with Chapter II three months at least after removal of the positive animal and any possible progeny thereof;(iii) an epidemiological inquiry has been conducted with negative results and the herds linked epidemiologically to the infected herd have been 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 immediately after calving. In this case, the calf must be made subject to the requirements provided for in 2(iii).2. Where more than one animal from an officially enzootic-bovine-leukosis-free herd has reacted positively to one of the tests referred to in Chapter II, or where infection has otherwise been suspected in more than one animal in a herd:(i) any animals which have reacted positively and, in the case of cows, their calves, must be removed for slaughter under the supervision of the veterinary authorities;(ii) all animals in the herd aged over 12 months must react negatively to two tests carried out in accordance with Chapter II at an interval of at least four months and no more than 12 months;(iii) all other animals in the herd must, after identification, remain on the holding until they are aged over 24 months and have been tested in accordance with Chapter II after reaching that age, except that the competent authority may permit such animals to go directly for slaughter under official supervision;(iv) an epidemiological inquiry has been conducted with negative results and any herd linked epidemiologically to the infected herd has been 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 immediately after calving. In this case, the calf must be made subject to the requirements provided for in 2(iii).E. In accordance with the procedure in Article 17 and on the basis of information supplied in accordance with Article 8, a Member State or part of a Member State may be considered officially enzootic-bovine-leukosis-free if:(a) all the conditions of paragraph A are fulfilled and at least 99,8 % of the bovine herds are officially enzootic-bovine-leukosis-free;or(b) no case of enzootic bovine leukosis has been confirmed in the Member State or the part of the Member State for the past three years, and the presence of tumours suspected of being due to EBL is compulsorily notifiable, with investigations of cause being carried out, andin the case of a Member State, all animals aged over 24 months in at least 10 % of the herds, selected randomly, have been tested with negative results in accordance with Chapter II in the previous 24 months, orin the case of a part of a Member State, all animals aged over 24 months have undergone a test provided for in Chapter II with negative results in accordance with Chapter II in the previous 24 months;or(c) any other method which demonstrates to a confidence rating of 99 % that less than 0,2 % of herds were infected.F. A Member State or a region of a Member State is to retain officially enzootic-bovine-leukosis-free status if:(a) all animals slaughtered within the territory of that Member State or region are submitted to official post-mortem examinations at which all tumours which could be due to the EBL virus are sent for laboratory examination,(b) the Member State reports to the Commission all cases of enzootic bovine leukosis that occur in the region,(c) all animals which react positively to any of the tests provided for in Chapter II are slaughtered and their herds remain subject to restrictions until re-establishment of their status in accordance with Section D, and(d) all animals more than two years old have been tested, either once in the first five years after the status is granted under Chapter II or during the first five years after the grant of the status under any other procedure demonstrating with a certainty level of 99 % that less than 0,2 % of herds have been infected. However, where no case of enzootic bovine leukosis has been recorded in a Member State or in a region of a Member State in a proportion of one herd out of 10 000 for at least three years, a decision may be taken in accordance with the procedure laid down in Article 17 that routine serological tests may be reduced provided that all bovine animals more than 12 months old in at least 1 % of herds, selected at random each year, have been subjected to a test carried out in accordance with Chapter II.G. The officially enzootic-bovine-leukosis-free status of a Member State or part of a Member State is to be suspended, in accordance with the procedure in Article 17 if, as a result of investigations carried out in accordance with paragraph F above, there is evidence of a significant change in the situation as regards enzootic bovine leukosis in a Member State or part of a Member State which has been recognised as officially enzootic-bovine-leukosis-free.The officially enzootic-bovine-leukosis-free status may be restored in accordance with the procedure in Article 17 when the criteria laid down by the same procedure are fulfilled.ANNEX FModel 1 >START OF GRAPHIC>HEALTH CERTIFICATE FOR ANIMALS OF THE BOVINE SPECIES FOR SLAUGHTER (1)/BREEDING (1)/PRODUCTION (1)Member State of origin:.............. /Certificate number (7)Region of origin:.................... /Reference number to original certificate (8)SECTION AName and address of consignor:...............................Name and address of holding of origin:....................(2)Dealer's approval number:.................................(3)Address and approval number of assembly centre in the Member State of origin (1) or transit (1):..........................................................(3)..........................................................(3)Health informationI certify that each animal of the consignment described below1. comes from a holding of origin and an area which, in conformity with Community or national legislation, is not subject to any prohibition or restriction for reasons of animal diseases affecting bovine animals;2. comes form a herd of origin situated in a Member State or part of its territory(a) with a surveillance network approved by:Commission Decision . . . /. . . /EC (3)(b) which is recognised as being:- officially tuberculosis-free / Commission Decision . . . /. . . /EC (3)- officially brucellosis-free / Commission Decision . . . /. . . /EC (3)- officially leukosis-free / Commission Decision . . . /. . . /EC (3)3.(3) is an animal for breeding (1) or production (1) that:- has been resident, as far as can be ascertained, on the holding of origin during the past 30 days, or since birth if less than 30 days of age, and no animal imported from a third country was introduced into that holding during this period, unless it was isolated from all other animals on the holding,- comes from a herd which is officially free of tuberculosis, brucellosis and leukosis and had been tested with negative results during the 30 days prior to departure from the holding of origin, in accordance with Article 6(2) of Directive 64/432/EEC, as follows:>TABLE>4.(3) is an animal for slaughter coming from an officially tuberculosis and leukosis-free herd and is- either castrated (3)or- uncastrated and comes from an officially brucellosis-free herd (3);5.(3) is an animal for slaughter originating from a herd which is not officially free of tuberculosis, brucellosis, and leukosis, and is dispatched in accordance with Article 6(3) of Directive 64/432/EEC under licence No . . . . . . . . . . . . . . . .from a holding in Spain, and has been tested with negative results during the 30 days prior to departure from the holding of origin, as follows:>TABLE>6.(11) based on the information provided either in an official document or a certificate in which Sections A and B were completed by the official veterinarian or the approved veterinarian responsible for the holding of origin, fulfils the applicable health requirements of points 1 to 5 of Section A which are therefore not detailed in this certificate.SECTION BDescription of the consignmentDate of departure:................................................Total number of animals:..........................................Identification of animal(s):>TABLE>Approval number of transporter (if different from transporter stated in Section C and/or if distance of transport exceeds 50 km):.............................Means of transport:............ Registration:.....................Section A and B certification>TABLE>SECTION C (9)Name and address of consignee:....................................Name and address of holding of destination (1) or approved assembly centre in the Member State of destination (1)(complete this field in printed characters)Name:.............................................................Street:...........................................................Country/province:.................................................Postal code:.................... Member State:....................Dealer's approval number:......................................(3)Approval number of transporter (if distance of transport exceeds 50 km):..............................................................(10)Means of transport:............. Registration:....................After inspection as required by regulations, I certify that:1. the above described animals had been inspected on (insert date) during the 24 hours before scheduled departure and had not shown clinical signs of infectious or contagious disease;2. the holding of origin and where applicable the approved assembly centre and the area they are situated in are not subject to any prohibitions or restrictions for reasons of animal diseases affecting bovine animals in conformity with Community or national legislation;3. all applicable provisions of Council Directive 64/432/EEC have been fulfilled;4.(3) the above animals meet the additional guarantees for:- Disease:- In accordance with Commission Decision . . . /. . . /EC;5. the animals did not remain more than six days in the approved assembly centre (3).Section C certification>TABLE>Additional information1. The certificate must be stamped and signed in colour different to the printing.2. This certificate remains valid for 10 days following the date of the health inspection carried out in the Member State of origin and referred to in Section C.3. The required details of this certificate have to be entered into the ANIMO system on the day of issuing the certificate and at least within 24 hours thereof.(1) Delete as appropriate.(2) Not applicable where animals are from several holdings.(3) Delete if not applicable.(4) Not required if a system of surveillance networks is approved by Commission Decision ... / .../EC.(5) Not required if the Member State or the part of the Member State where the herd is situated is recognised as being officially free of the diease concerned.(6) Or any other test approved in accordance with Article 17 of Directive 64/432/EEC.(7) To be completed by the official veterinarian of the Member State of origin.(8) To be completed by the official veterinarian at the approved assembly centre of the Member State of transit.(9) Delete if certificate is used for movement of animals within Member State of origin and only Sections A and B are completed and signed.(10) Delete if transporter is not different to transporter identified in Section B.(11) Point 6 of Section A must be signed by the official veterinarian at the approved assemby centre after documentary and identity checks on animals arriving with an official document or Sections A and B completed certificate, otherwise this point must be deleted.Model 2HEALTH CERTIFICATE FOR ANIMALS OF THE PORCINE SPECIES FOR SLAUGHTER (1)/BREEDING (1)/PRODUCTION (1)Member State of origin:................. /Certificate number (4)Region of origin:....................... /Reference number to original certificate (5)SECTION AName and address of consignor:..................................Name and address of holding of origin:.......................(2)Dealer's registration number:................................(3)Address and approval number of assembly centre in the Member State of origin (1) or transit (1)..................................................(3).............................................................(3)Health informationI certify that each animal of the consignment described below1. comes from a holding of origin and an area which, in conformity with Community or national legislation, is not subject to any prohibition or restriction for reasons of animal diseases affecting porcine animals;2. (3) is an animal for breeding (1) or production (1) that has been resident, as far as can be ascertained, on the holding of origin during the past 30 days or since birth if less than 30 days of age, and no animal imported from a third country was introduced into that holding during this period, unless it was isolated from all other animals on the holding.SECTION BDescription of the consignmentDate of departure:..............................................Total number of animals:........................................Identification of animal(s):>TABLE>Approval number of transporter (if different from transporter stated in Section C and/or if distance of transport exceeds 50 km):...........................Means of transport:................ Registration:...............Section A and B certification>TABLE>SECTION C (6)Name and address of consignee:..................................Name and address of holding of destination (complete this field in printed characters):Name:...........................................................Street:.........................................................Country/province:...............................................Postal code:.................. Member State:....................Approval number of transporter (if distance of transport exceeds 50 km):.............................................................(7)Means of transport:........... Registration:....................After inspection as required by regulations, I certify that:1. the above described animals had been inspected on (insert date). . . . . . during the 24 hours before scheduled departure and had not shown clinical signs of infectious or contagious disease;2. the holding of origin and where applicable the approved assembly centre and the area they are situated in are not subject to any prohibitions or restrictions for reasons of animal diseases affecting porcine animals in conformity with Community or national legislation;3. all applicable provisions of Council Directive 64/432/EEC have been fulfilled;4. (3) the above animals meet the additional guarantees for:- disease:..................................................- in accordance with Commission Decision . . . /. . . /EC;5. the animals did not remain more than six days in the approved assembly centre (3).Section C certification>TABLE>Additional information1. The certificate must be stamped and signed in colour different to the printing.2. This certificate remains valid for 10 days following the date of the health inspection carried out in the Member State of origin and referred to in Section C.3. The required details of this certificate have to be entered into the ANIMO system on the day of issuing the certificate and at least within 24 hours thereof.(1) Delete as appropriate.(2) Not applicable where animals are from several holdings.(3) Delete if not applicable.(4) To be completed by the official veterinarian of the Member State of origin.(5) To be completed by the official veterinarian at the assembly centre of the Member State of transit.(6) Delete if certificate is used for movement of animals within Member State of origin and only Sections A and B are completed and signed.(7) Delete if transporter is not different to transporter identified in Section B.'>END OF GRAPHIC>ANNEX II >TABLE>


Avis juridique important

|

31985L0509

Second Commission Directive 85/509/EEC of 6 November 1985 amending the Annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition

Official Journal L 314 , 23/11/1985 P. 0025 - 0026 Finnish special edition: Chapter 3 Volume 19 P. 0207  Spanish special edition: Chapter 03 Volume 39 P. 0025  Swedish special edition: Chapter 3 Volume 19 P. 0207  Portuguese special edition Chapter 03 Volume 39 P. 0025

*****SECOND  COMMISSION DIRECTIVE  of 6 November 1985  amending the Annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition  (85/509/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (1), as last amended by Commission Directive 84/443/EEC (2), and in particular Article 6 thereof,  Whereas Directive 82/471/EEC provides for regular amendment of the content of the Annexes thereto as a result of developments in scientific or technical knowledge;  Whereas it is unnecessary to require on the label or packaging of compound feedingstuffs a declaration stating 'by-products from the production of L-glutamic acid' or 'by-products from the production of L-lysine' as the other labelling requirements in respect of those products are sufficient to identify them;  Whereas studies on certain amino acids have shown that these products fulfil the requirements of Directive 82/471/EEC and that their use in animal nutrition may therefore be permitted under certain conditions;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The Annex to Directive 82/471/EEC is amended as set out in the Annex hereto.  Article 2  The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 not later than 30 June 1986. They shall immediately inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 6 November 1985.  For the Commission  Frans ANDRIESSEN  Vice-President  (1) OJ No L 213, 21. 7. 1982, p. 8.  (2) OJ No L 245, 14. 9. 1984, p. 21.  ANNEX  1. Under group 2.3. 'By-products from the production of amino-acids by fermentation' in column 7 headed 'Special provisions' the first indent under 'Declarations to be made on the label or packaging of compound feedingstuffs' is to be deleted.  2. Under point 3 'Amino acids and their salts' the following products are added:  1.2.3.4.5.6.7 //  //  //  //  //  //  //  // '1   // 2  // 3  // 4   // 5  // 6  // 7  //  //  //  //  //  //  //  // Name of product group   // Name of product  // Designation of nutritive principle or identity of micro-organism   // Culture substrate (specifications, if any)   // Composition characteristics of products  // Animal species  // Special provisions  //  //  //  //  //  //  //  //  // 3.7. L-tryptophan, technically pure   // (C8H5NH)-CH2-CH(NH2)-COOH  // -   // L-tryptophan minimum 98 %   // All animal species  // Declarations to be made on the label or packaging of the product: - the name: 'L-tryptophan', - L-tryptophan and moisture contents   //   // 3.8. DL-tryptophan, technically pure   // (C8H5NH)-CH2-CH(NH2)-COOH   // -   // DL-tryptophan minimum 98 %   // All animal species   // Declarations to be made on the label or packaging of the product: - the name: 'DL-tryptophan', - DL-tryptophan and moisture contents'   //  //   //   //   //   //   //


title: Commission Directive 2007/34/EC of 14 June 2007 amending, for the purposes of its adaptation to technical progress, Council Directive 70/157/EEC concerning the permissible sound level and the exhaust system of motor vehicles (Text with EEA relevance)

text:
               15.6.2007

               EN

               Official Journal of the European Union

               L 155/49

      COMMISSION DIRECTIVE 2007/34/EC
   of 14 June 2007
   amending, for the purposes of its adaptation to technical progress, Council Directive 70/157/EEC concerning the permissible sound level and the exhaust system of motor vehicles
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular the second indent of Article 13(2) thereof,
   Having regard to Council Directive 70/157/EEC relating to the permissible sound level and the exhaust system of motor vehicles (2), and in particular Article 3 thereof,
   Whereas:

               (1)

               Directive 70/157/EEC is one of the separate Directives in the context of the Community type-approval procedure laid down in Directive 70/156/EEC. The provisions of Directive 70/156/EEC relating to systems, components and separate technical units for vehicles therefore apply to Directive 70/157/EEC.

               (2)

               Since the entry into force of Directive 70/157/EEC of 6 February 1970, the noise limits for motor vehicles have been reduced several times, most recently in 1995. The last reduction did not have the expected effects and subsequent studies have shown that the measurement method no longer reflects the real life driving behaviour. It is therefore necessary to introduce a new test cycle and bring the driving conditions for carrying out the noise test closer into line with real life driving operations. The new test cycle is contained in UN/ECE Regulation No 51, 02 series of amendments (3).

               (3)

               During a transitional period, the current test as well as the new test should be carried out for type-approval and the results of both tests should be reported to the Commission. This would enable the Commission to obtain the necessary data for establishing appropriate limit values for the new measurement method which would replace the existing test protocol. The current method should continue to be required in order to receive type-approval and the new method should be used for monitoring purposes. After the transitional period, the test protocol as adapted to the new test should become the only measurement required in order to receive type-approval.

               (4)

               In order to take into account the most recent amendments to UN/ECE Regulations Nos 51 and 59, to which the Community has already acceded, it is appropriate to adapt Directive 70/157/EEC to technical progress by aligning it with the technical requirements of those regulations. This is important, in particular, in order to take over the mandatory monitoring procedure of the motor vehicle noise emissions laid down in the UN/ECE Regulation No 51 for the purposes of EC type-approval. Otherwise, the Directive would fall behind the Regulation with regard to technical advancement.

               (5)

               Pursuant to Article 3 of Directive 70/157/EEC, the measures provided for by this Directive do not modify the requirements set out in points 5.2.2.1 and 5.2.2.5 of Annex I to Directive 70/157/EEC. With regard to the new structure of the Annexes, it is necessary to adapt the numbering and references specified in those points. In order to ensure the link to other provisions of Community legislation, it is also appropriate to provide for a correlation between the current and the new numbering.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   1.   Directive 70/157/EEC is amended as follows:

               (a)

               Annex I is replaced by the text set out in Annex I to this Directive;

               (b)

               Annex II is replaced by the text set out in Annex II to this Directive;

               (c)

               Annex III is replaced by the text set out in Annex III to this Directive;

               (d)

               Annex IV is deleted.

         2.   References to points 5.2.2.1 and 5.2.2.5 of Annex I to Directive 70/157/EEC shall be construed as references to points 2.1 and 2.2 of Annex I, as replaced by this Directive.
   Article 2
   With effect from 6 July 2008 and until 6 July 2010, the vehicle to be type-approved shall be subject to the test laid down in Annex 10 of UN/ECE Regulation No 51 for monitoring purposes only. The results of that test shall be added to the documents set out in Appendices 1 and 2 of Annex I to Directive 70/157/EEC as amended by this Directive, in conformity with Annex 9 of UN/ECE Regulation No 51. The Member State concerned shall send such information documents to the Commission. These obligations do not affect cases of extension of existing approvals according to this Directive. For the purpose of this monitoring procedure a vehicle is not considered to be a new type if the vehicle differs only in respect to paragraphs 2.2.1 and 2.2.2 of UN/ECE Regulation No 51.
   Article 3
   1.   Member States shall adopt and publish, by 5 July 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 6 July 2008.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 14 June 2007.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 42, 23.2.1970, p. 1. Directive as last amended by Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).

      (2)  OJ L 42, 23.2.1970, p. 16. Directive as last amended by Directive 2006/96/EC.

      (3)  OJ L 137, 30.5.2007, p. 68.

      ANNEX I
      ‘
            ANNEX I
            PROVISIONS FOR EC TYPE-APPROVAL IN RESPECT OF THE SOUND LEVEL OF A TYPE OF MOTOR VEHICLE
            1.   APPLICATION FOR EC TYPE-APPROVAL OF A VEHICLE TYPE
            1.1.   The application for EC type-approval pursuant to Article 3(4) of Directive 70/156/EEC of a vehicle type with regard to its sound level shall be submitted by the vehicle manufacturer.
            1.2.   A model for the information document is given in Appendix 1.
            1.3.   A vehicle representative of the type in respect of which type-approval is sought must be submitted to the technical service responsible for the tests by the vehicle manufacturer.
            1.4.   At the request of the technical service, a specimen of the exhaust system and an engine of at least the same cylinder capacity and rated maximum power as that fitted to the vehicle in respect of which type-approval is sought must also be submitted.
            2.   SOUND LEVEL OF MOVING VEHICLES
            2.1.   Limiting values
            The sound level measured in accordance with the provisions of Annex III shall not exceed the following limits:

                        Vehicle categories

                        Values expressed in dB(A)
                        (decibels(A))

                                    2.1.1.

                                    Vehicles intended for the carriage of passengers, and comprising not more than nine seats including the driver's seat

                        74

                  2.1.2.   Vehicles intended for the carriage of passengers and equipped with more than nine seats, including the driver's seat; and having a maximum permissible mass of more than 3,5 tonnes and:

                                    2.1.2.1.

                                    with an engine power of less than 150 kW

                        78

                                    2.1.2.2.

                                    with an engine power of not less than 150 kW

                        80

                  2.1.3.   Vehicles intended for the carriage of passengers and equipped with more than nine seats, including the driver's seat; vehicles intended for the carriage of goods:

                                    2.1.3.1.

                                    with a maximum permissible mass not exceeding 2 tonnes

                        76

                                    2.1.3.2.

                                    with a maximum permissible mass exceeding 2 tonnes but not exceeding 3,5 tonnes

                        77

                  2.1.4.   Vehicles intended for the carriage of goods and having a maximum permissible mass exceeding 3,5 tonnes:

                                    2.1.4.1.

                                    with an engine power of less than 75 kW

                        77

                                    2.1.4.2.

                                    with an engine power of not less than 75 kW but less than 150 kW

                        78

                                    2.1.4.3.

                                    with an engine power of not less than 150 kW

                        80

                  However

                        —

                        for vehicles of categories 2.1.1 and 2.1.3, the limit values are increased by 1 dB(A) if they are equipped with a direct injection diesel engine,

                        —

                        for vehicles with a maximum permissible mass of over two tonnes designed for off-road use, the limit values are increased by 1 dB(A) if their engine power is less than 150 kW and 2 dB(A) if their engine power is 150 kW or more,

                        —

                        for vehicles in category 2.1.1, equipped with a manually operated gear box having more than four forward gears and with an engine developing a maximum power exceeding 140 kW/t and whose maximum power/maximum mass ratio exceeds 75 kW/t, the limit values are increased by 1 dB(A) if the speed at which the rear of the vehicle passes the line BB' in third gear is greater than 61 km/h.

                  2.2.   Interpretation of results
            2.2.1.   To take account of inaccuracies in the measuring instruments, the result obtained from each measurement is determined by deducting 1 dB(A) from the meter reading.
            2.2.2.   The measurements are considered valid if the difference between two consecutive measurements on the same side of the vehicle does not exceed 2 dB(A).
            2.2.3.   The highest sound level measured shall constitute the test result. Should the result exceed the maximum permissible sound level for the category of vehicle tested by 1 dB(A), two further measurements shall be made at the corresponding microphone position. Three of the four measurements thus obtained at that microphone position must fall within the prescribed limits.
            3.   MARKINGS
            3.1.   The exhaust and intake system components, excluding fixing hardware and pipes, must bear:
            3.1.1.   the trade mark or name of the manufacturer of the systems and their components;
            3.1.2.   the manufacturer's trade description.
            3.2.   These markings must be clearly legible and indelible, even when the system is fitted to the vehicle.
            4.   GRANTING OF EC TYPE-APPROVAL OF A VEHICLE TYPE
            4.1.   If the relevant requirements are satisfied, EC type-approval pursuant to Article 4(3) and, if applicable, 4(4) of Directive 70/156/EEC shall be granted.
            4.2.   A model for the EC type-approval certificate is given in Appendix 2.
            4.3.   An approval number in accordance with Annex VII to Directive 70/156/EEC shall be assigned to each vehicle type approved. The same Member State shall not assign the same number to another vehicle type.
            5.   MODIFICATIONS OF THE TYPE AND AMENDMENTS TO APPROVALS
            5.1.   In the case of modifications of the type approved pursuant to this Directive, the provisions of Article 5 of Directive 70/156/EEC shall apply.
            6.   CONFORMITY OF PRODUCTION
            6.1.   Measures to ensure the conformity of production shall be taken in accordance with the requirements laid down in Article 10 of Directive 70/156/EEC.
            6.2.   Special provisions:
            6.2.1.   The tests referred to in item 2.3.5 of Annex X to Directive 70/156/EEC are those laid down in Annex 7 of UN/ECE Regulation No 51 as referred to in Annex III of this Directive.
            6.2.2.   The frequency of inspections referred to in item 3 of Annex X to Directive 70/156/EEC is normally one every two years.

            Appendix 1
            Information document No … pursuant to Annex I of Council Directive 70/156/EEC (1) relating to EC type-approval of a vehicle with respect to the permissible sound level and the exhaust system (Directive 70/157/EEC, as last amended by Directive …/…/EC)
            The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 or on a folder of A4 format. Photographs, if any, must show sufficient detail.
            If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied.
            0.   General
            0.1.   Make (trade name of manufacturer):
            0.2.   Type and general commercial description(s):
            0.3.   Means of identification of type, if marked on the vehicle (b):
            0.3.1.   Location of that marking.
            0.4.   Category of vehicle (c):
            0.5.   Name and address of manufacturer:
            0.8.   Address(es) of assembly plant(s):
            1.   General construction characteristics of the vehicle
            1.1.   Photographs and/or drawings of a representative vehicle:
            1.3.3.   Powered axles (number, position, interconnection):
            1.6.   Position and arrangement of the engine:
            2.   Masses and dimensions (e) (in kg and mm) (Refer to drawing where applicable)
            2.4.   Range of vehicle dimensions (overall)
            2.4.1.   For chassis without bodywork
            2.4.1.1.   Length (j):
            2.4.1.2.   Width (k):
            2.4.2.   For chassis with bodywork
            2.4.2.1.   Length (j):
            2.4.2.2.   Width (k):
            2.6.   Mass of the vehicle with bodywork in running order, or mass of the chassis with cab if the manufacturer does not fit the bodywork (with standard equipment, including coolant, oils, fuel, tools, spare wheel and driver) (o) (maximum and minimum):
            3.   Power plant (q)
            3.1.   Manufacturer:
            3.1.1.   Manufacturer's engine code: (As marked on the engine, or other means of identification)
            3.2.   Internal combustion engine
            3.2.1.1.   Working principle: positive ignition/compression ignition, four stroke/two stroke (2)

            3.2.1.2.   Number and arrangement of cylinders:
            3.2.1.2.3.   Firing order:
            3.2.1.3.   Engine capacity (s): cm3

            3.2.1.8.   Maximum net power (t): kW at min–1 (manufacturer's declared value)
            3.2.4.   Fuel feed
            3.2.4.1.   By carburettor(s): yes/no (2)

            3.2.4.1.2.   Type(s):
            3.2.4.1.3.   Number fitted:
            3.2.4.2.   By fuel injection (compression ignition only): yes/no (2)

            3.2.4.2.2.   Working principle: Direct injection/pre-chamber/swirl chamber (2)

            3.2.4.2.4.   Governor
            3.2.4.2.4.1.   Type:
            3.2.4.2.4.2.1.   Cut-off point under load: min–1

            3.2.4.3.   By fuel injection (positive ignition only): yes/no (2)

            3.2.4.3.1.   Working principle: Intake manifold (single-/multi-point (2))/direct injection/other (specify) (2)

            3.2.8.   Intake system
            3.2.8.4.2.   Air filter, drawings; or
            3.2.8.4.2.1.   Make(s):
            3.2.8.4.2.2.   Type(s):
            3.2.8.4.3.   Intake silencer, drawings; or
            3.2.8.4.3.1.   Make(s):
            3.2.8.4.3.2.   Type(s):
            3.2.9.   Exhaust system
            3.2.9.2.   Description and/or drawing of the exhaust system:
            3.2.9.4.   Exhaust silencer(s):
            For front, centre, rear silencer: construction, type, marking, where relevant for exterior noise: reducing measures in the engine compartment and on the engine:
            3.2.9.5.   Location of the exhaust outlet:
            3.2.9.6.   Exhaust silencer containing fibrous materials:
            3.2.12.2.1.   Catalytic convertor: yes/no (3)

            3.2.12.2.1.1.   Number of catalytic convertors and elements:
            3.3.   Electric motor
            3.3.1.   Type (winding, excitation):
            3.3.1.1.   Maximum hourly output: kW
            3.3.1.2.   Operating voltage: V
            3.4.   Other engines or motors or combinations thereof (particulars regarding the parts of such engines or motors):
            4.   Transmission (v)
            4.2.   Type (mechanical, hydraulic, electric, etc.):
            4.6.   Gear ratios

                        Gear

                        Internal gearbox ratios
                        (ratios of engine to gearbox output shaft revolutions)

                        Final drive ratio(s)
                        (ratio of gearbox output shaft to driven wheel revolutions)

                        Total gear ratios

                        Maximum for CVT (4)

                        1
                        2
                        3
                        …
                        Minimum for CVT (4)

                        Reverse

                  4.7.   Maximum vehicle speed (and gear in which this is achieved) (in km/h) (w):
            6.   Suspension
            6.6.   Tyres and wheels
            6.6.2.   Upper and lower limits of rolling radii
            6.6.2.1.   Axle 1:
            6.6.2.2.   Axle 2:
            6.6.2.3.   Axle 3:
            6.6.2.4.   Axle 4:
            etc.
            9.   Bodywork (not applicable for vehicles of category M1)
            9.1.   Type of bodywork:
            9.2.   Materials used and method of construction
            12.   Miscellaneous
            12.5.   Details of any non-engine devices designed to reduce noise (if not covered by other items):
            Additional information in the case of off-road vehicles:
            1.3.   Number of axles and wheels:
            2.4.1.   For chassis without bodywork
            2.4.1.4.1.   Approach angle (na): … degrees
            2.4.1.5.1.   Departure angle (nb): … degrees
            2.4.1.6.   Ground clearance (as defined in point 4.5 of section A of Annex II to Directive 70/156/EEC)
            2.4.1.6.1.   Between the axles:
            2.4.1.6.2.   Under the front axle(s):
            2.4.1.6.3.   Under the rear axle(s):
            2.4.1.7.   Ramp angle (nc): … degrees
            2.4.2.   For chassis with bodywork
            2.4.2.4.1.   Approach angle (na): … degrees
            2.4.2.5.1.   Departure angle (nb): … degrees
            2.4.2.6.   Ground clearance (as defined in point 4.5 of section A of Annex II to Directive 70/156/EEC)
            2.4.2.6.1.   Between the axles:
            2.4.2.6.2.   Under the front axle(s):
            2.4.2.6.3.   Under the rear axle(s):
            2.4.2.7.   Ramp angle (nc): … degrees
            2.15.   Hill-starting ability (solo vehicle): … percent
            4.9.   Differential lock: yes/no/optional (5)

            Date, File

            Appendix 2
            MODEL
            EC TYPE-APPROVAL CERTIFICATE
            (Maximum Format: A4 (210 × 297 mm))

               Stamp of administration

            Communication concerning the

                        —

                        type-approval (6)

                        —

                        extension of type-approval (6)

                        —

                        refusal of type-approval (6)

                        —

                        withdrawal of type-approval (6)

                  of a type of a vehicle/component/separate technical unit (6) with regard to Directive …/…/EEC, as last amended by Directive …/…/EC.
            Type-approval number:
            Reason for extension:
            SECTION I
            0.1.   Make (trade name of manufacturer):
            0.2.   Type and general commercial description(s):
            0.3.   Means of identification of type if marked on the vehicle/component/separate technical unit (6)
                (7)

            0.3.1.   Location of that marking.
            0.4.   Category of vehicle (8):
            0.5.   Name and address of manufacturer:
            0.7.   In the case of components and separate technical units, location and method of affixing of the EC approval mark:
            0.8.   Address(es) of assembly plant(s)
            SECTION II
            1.   Additional information (where applicable): See Addendum
            2.   Technical service responsible for carrying out the tests:
            3.   Date of test report:
            4.   Number of test report:
            5.   Remarks (if any): See Addendum
            6.   Place:
            7.   Date:
            8.   Signature:
            9.   The index to the information package lodged with the approval authority, which may be obtained on request, is attached.

            Addendum to EC type-approval certificate No …
            concerning the type-approval of a vehicle with regard to Directive 70/157/EEC as last amended by Directive …/…/EC
            1.   Additional information:
            1.1.   If necessary, list of vehicles covered by item 3.1.2.3.2.3. of Annex III of UN/ECE Regulation No 51:
            1.2.   Engine
            1.2.1.   Manufacturer:
            1.2.2.   Type:
            1.2.3.   Model:
            1.2.4.   Rated maximum power … kW at … min–1

            1.3.   Transmission: non-automatic gearbox/automatic gearbox (9)

            1.3.1   Number of gears:
            1.4.   Equipment
            1.4.1.   Exhaust silencer
            1.4.1.1.   Manufacturer:
            1.4.1.2.   Model:
            1.4.1.3.   Type: … in accordance with drawing No:
            1.4.2.   Intake silencer
            1.4.2.1.   Manufacturer:
            1.4.2.2.   Model:
            1.4.2.3.   Type: … in accordance with drawing No:
            1.5.   Tyre size:
            1.5.1.   Description of tyre type used for type-approval testing:
            1.6.   Measurements
            1.6.1.   Sound level of moving vehicle:

                        Measurement results

                        Left-hand side
                        dB(A) (10)

                        Right-hand side
                        dB(A) (10)

                        Position of gear lever

                        first measurement

                        second measurement

                        third measurement

                        fourth measurement

                        Test result: … dB(A)/E (11)

                  1.6.2.   Sound level of stationary vehicle:

                        Measurement results

                        dB(A)

                        Engine

                        first measurement

                        second measurement

                        third measurement

                        Test result: … dB(A)/E (12)

                  1.6.3.   Sound level of compressed air noise:

                        Measurement results

                        Left-hand side
                        dB(A) (13)

                        Right-hand side
                        dB(A) (13)

                        first measurement

                        second measurement

                        third measurement

                        fourth measurement

                        Test result: … dB(A)

                  5.   Remarks:
         ’

         (1)  The item numbers and footnotes used in this information document correspond to those set out in Annex I to Directive 70/156/EEC. Items not relevant for the purpose of this Directive are omitted.

         (2)  Delete as applicable.

         (3)  Delete as applicable.

         (4)  Continuously variable transmission

         (5)  Delete as applicable.

         (6)  Delete as applicable.

         (7)  If the means of identification of type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by the type-approval certificate such characters shall be represented in the documentation by the symbol: “?” (e.g. ABC??123??).

         (8)  As defined in Annex IIA to Directive 70/156/EEC.

         (9)  Delete as applicable.

         (10)  The measurement values are given with the 1 dB(A) deduction in accordance with provisions of item 2.2.1 of Annex I.

         (11)  “E” indicates that the measurements in question were conducted in accordance with this Directive.

         (12)  “E” indicates that the measurements in question were conducted in accordance with this Directive.

         (13)  The measurement values are given with the 1 dB(A) deduction in accordance with provision of item 2.2.1 of Annex I.

      ANNEX II
      ‘
            ANNEX II
            ADMINISTRATIVE PROVISIONS FOR EC TYPE-APPROVAL OF EXHAUST SYSTEMS AS SEPARATE TECHNICAL UNITS (REPLACEMENT EXHAUST SYSTEMS)
            1.   APPLICATION FOR EC TYPE-APPROVAL
            1.1.   The application of EC type-approval pursuant to Article 3(4) of Directive 70/156/EEC in respect of a replacement exhaust system or component thereof as a separate technical unit shall be submitted by the vehicle manufacturer or the manufacturer of the separate technical unit in question.
            1.2.   A model for the information document is given in Appendix 1.
            1.3.   At the request of the technical service concerned, the applicant must submit:
            1.3.1.   two examples of the system in respect of which application for EC type-approval has been made,
            1.3.2.   an exhaust system of the type originally fitted to the vehicle when EC type-approval was granted,
            1.3.3.   a vehicle representative of the type to which the system is to be fitted, which meets the requirements of item 4.1 of Annex 7 of UN/ECE Regulation No 51 as referred to in Annex III of this Directive.
            1.3.4.   a separate engine corresponding to the type of vehicle described above.
            2.   MARKINGS
            2.4.1.   The replacement exhaust system or its components, excluding fixing hardware and pipes must bear:
            2.4.1.1.   the trademark or trade name of the manufacturer of the replacement system and its components,
            2.4.1.2.   the manufacturer's trade description,
            2.4.2.   These marks must be clearly legible and indelible, even when the system is fitted to the vehicle.
            3.   GRANTING OF EC TYPE-APPROVAL
            3.1.   If the relevant requirements are satisfied, EC type-approval pursuant to Article 4(3) and, if applicable, Article 4(4) of Directive 70/156/EEC shall be granted.
            3.2.   A model for the EC type-approval certificate is given in Appendix 2.
            3.3.   A type-approval number in accordance with Annex VII to Directive 70/156/EEC shall be assigned to each type of replacement exhaust system or component thereof approved as a separate technical unit; section 3 of the type-approval number shall indicate the number of the amending Directive which was applicable at the time of the vehicle type-approval. The same Member State shall not assign the same number to another type of replacement exhaust system or component thereof.
            4.   EC TYPE-APPROVAL MARK
            4.1.   Every replacement exhaust system or component thereof, excluding fixing hardware and pipes, conforming to a type approved under this Directive shall bear an EC type-approval mark.
            4.2.   The EC type-approval mark shall consist of a rectangle surrounding the lower case letter “e” followed by the distinguishing letter(s) or number of the Member State which has granted the approval:

                        “1” for Germany

                        “2” for France

                        “3” for Italy

                        “4” for the Netherlands

                        “5” for Sweden

                        “6” for Belgium

                        “7” for Hungary

                        “8” for the Czech Republic

                        “9” for Spain

                        “11” for the United Kingdom

                        “12” for Austria

                        “13” for Luxembourg

                        “17” for Finland

                        “18” for Denmark

                        “19” for Romania

                        “20” for Poland

                        “21” for Portugal

                        “23” for Greece

                        “24” for Ireland

                        “26” for Slovenia

                        “27” for Slovakia

                        “29” for Estonia

                        “32” for Latvia

                        “34” for Bulgaria

                        “36” for Lithuania

                        “49” for Cyprus

                        “50” for Malta

                  It must also include in the vicinity of the rectangle the “base approval number” contained in section 4 of the type-approval number referred to in Annex VII to Directive 70/156/EEC, preceded by the two figures indicating the sequence number assigned to the most recent major technical amendment to Council Directive 70/157/EEC which was applicable at the time of the vehicle type-approval. For Directive 70/157/ EEC, the sequence number is 00; for Directive 77/212/EEC the sequence number is 01; for Directive 84/424/EEC the sequence number is 02; for Directive 92/97/EEC and this Directive the sequence number is 03. Sequence number 03 reflects as well the technical requirements of the 00 series of amendments of UN/ECE Regulation No 59.
            4.3.   The mark must be clearly legible and indelible even when the replacement exhaust system or component thereof is fitted to the vehicle.
            4.4.   An example of the EC type-approval mark is shown in Appendix 3.
            5.   MODIFICATION OF THE TYPE AND AMENDMENTS TO APPROVALS
            5.1.   In the case of modifications of the type approved pursuant to this Directive, the provisions of Article 5 of Directive 70/156/EEC shall apply.
            6.   CONFORMITY OF PRODUCTION
            6.1.   Measures to ensure the conformity of production shall be taken in accordance with the requirements laid down in Article 10 to Directive 70/156/EEC.
            6.2.   Special provisions:
            6.2.1.   The tests referred to item 2.3.5 of Annex X to Directive 70/156/EEC are those prescribed in Annex 5 of UN/ECE Regulation No 59 as referred to in Annex III of this Directive.
            6.2.2.   The frequency of inspections referred to in item 3 of Annex X to Directive 70/156/EEC is normally one every two years.

            Appendix 1
            Information Document No … relating to EC type-approval as separate technical unit of exhaust systems for motor vehicles (Directive 70/157/EEC, as last amended by Directive …/…/EC)
            The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 or on a folder of A4 format. Photographs, if any, must show sufficient detail.
            If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied.
            0.   General
            0.1.   Make (trade name of manufacturer):
            0.2.   Type and general commercial description(s):
            0.5.   Name and address of manufacturer:
            0.7.   In the case of components and separate technical units, location and method of affixing of the EC approval mark:
            0.8.   Address(es) of assembly plant(s):
            1.   Description of the vehicle for which the device is intended (if the device is intended to be fitted to more than one vehicle type the information requested under this point shall be supplied for each type concerned)
            1.1.   Make (trade name of manufacturer):
            1.2.   Type and general commercial description(s):
            1.3.   Means of identification of type, if marked on the vehicle:
            1.4.   Category of vehicle:
            1.5.   EC type-approval number with regard to sound level:
            1.6.   All the information mentioned in items 1.1 to 1.5 of the type-approval certificate concerning the vehicle (Annex I, Appendix 2 to this Directive):
            2.   Description of the device
            2.1.   A description of the replacement exhaust system indicating the relative position of each system component, together with mounting instructions:
            2.2.   Detailed drawings of each component, so that they can be easily located and identified, and reference to the materials used. These drawings must indicate the place provided for the compulsory affixing of the EC type-approval mark:
            Date, File

            Appendix 2
            MODEL
            EC TYPE-APPROVAL CERTIFICATE
            (Maximum Format: A4 (210 × 297 mm))

               Stamp of administration

            Communication concerning the

                        —

                        type-approval (1)

                        —

                        extension of type-approval (1)

                        —

                        refusal of type-approval (1)

                        —

                        withdrawal of type-approval (1)

                  of a type of a vehicle/component/separate technical unit (1) with regard to Directive …/…/EEC, as last amended by Directive …/…/EC.
            Type-approval number:
            Reason for extension:
            SECTION I
            0.1.   Make (trade name of manufacturer):
            0.2.   Type and general commercial description(s):
            0.3.   Means of identification of type if marked on the vehicle/component/separate technical unit (1)
                (2):
            0.3.1.   Location of that marking:
            0.4.   Category of vehicle (3):
            0.5.   Name and address of manufacturer:
            0.7.   In the case of components and separate technical units, location and method of affixing of the EC approval mark:
            0.8.   Address(es) of assembly plant(s):
            SECTION II
            1.   Additional information (where applicable): See Addendum
            2.   Technical service responsible for carrying out the tests:
            3.   Date of test report:
            4.   Number of test report:
            5.   Remarks (if any): See Addendum
            6.   Place:
            7.   Date:
            8.   Signature:
            9.   The index to the information package lodged with the approval authority, which may be obtained on request, is attached.

            Addendum to EC type-approval certificate No …
            concerning the separate technical unit type-approval of exhaust systems for motor vehicles with regard to Directive 70/157/EEC as last amended by Directive …/…/EC
            1.   Additional information
            1.1.   Composition of the separate technical unit:
            1.2.   Trademark or trade name of the type(s) of motor vehicle to which the silencer is to be fitted (4)

            1.3.   Type(s) of vehicle and its/their type-approval number(s):
            1.4.   Engine
            1.4.1.   Type (positive ignition, diesel):
            1.4.2.   Cycles: two-stroke, four-stroke:
            1.4.3.   Total cylinder capacity:
            1.4.4.   Rated maximum engine power … kW at … min–1

            1.5.   Number of gear ratios:
            1.6.   Gear ratios employed:
            1.7.   Drive-axle ratios(s):
            1.8.   Sound-level values:

                        moving vehicle: … dB(A), speed stabilised before acceleration at … km/h;

                        stationary vehicle dB(A), at … min–1

                  1.9.   Value of the back pressure:
            1.10.   Any restrictions in respect of use and mounting requirements:
            2.   Remarks:

            Appendix 3
            Model for the EC type-approval mark

            The exhaust system or component thereof bearing the above EC type-approval mark is a device which has been approved in Spain (e 9) pursuant to Directive 92/97/EEC (03) under the base approval number 0148.
            The figures used are only indicative.
         ’

         (1)  Delete as applicable.

         (2)  If the means of identification of type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by the type-approval certificate such characters shall be represented in the documentation by the symbol: “?” (e.g. ABC??123??).

         (3)  As defined in Annex IIA to Directive 70/156/EEC.

         (4)  If several types are indicated, items 1.3 to 1.10 inclusive must be completed in respect of each type.

      ANNEX III

            ‘ANNEX III

                        1.

                        The technical requirements are those set out in:

                                    (a)

                                    points 2, 6.1, 6.2.1 and 6.3 of UN/ECE Regulation No 51 (1) and Annexes 3 to 10 thereto;

                                    (b)

                                    points 2 and 6 of UN/ECE Regulation No 59 (2) and Annexes 3 to 5 thereto.

                        2.

                        For the purposes of the application of the provisions referred to in point 1, the following shall apply:

                                    (a)

                                    “Unladen vehicle” means a vehicle the mass of which is described in point 2.6 of Appendix 1 of Annex I to this Directive, without driver;

                                    (b)

                                    “Communication form” shall be understood as type-approval-certificate set out in Appendix 2 of Annexes I and II;

                                    (c)

                                    “Contracting Parties to the respective regulations” shall be understood as Member States;

                                    (d)

                                    references to Regulation No 51 and Regulation No 59 shall be construed as references to Directive 70/157/EEC;

                                    (e)

                                    footnote 1 in point 2.2.6 shall be understood as follows: “For definitions of the categories, see Annex II A to Directive 70/156/EEC”.

         (1)  OJ L 137, 30.5.2007, p. 68.

         (2)  OJ L 326, 24.11.2006, p. 43.’


Avis juridique important

|

31994L0034

European Parliament and Council Directive 94/34/EC of 30 June 1994 amending Directive 89/107/EEC on the approximation of the laws of Member States concerning food additives authorized for use in foodstuffs intended for human consumption

Official Journal L 237 , 10/09/1994 P. 0001 - 0002 Finnish special edition: Chapter 13 Volume 27 P. 0003  Swedish special edition: Chapter 13 Volume 27 P. 0003

EUROPEAN PARLIAMENT AND  COUNCIL DIRECTIVE 94/34/ECof 30 June 1994amending Directive 89/107/EEC on the approximation of  the laws of Member States concerning food additives authorized for use in foodstuffs intended for  human consumptionTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a  thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Whereas rules for harmonization in the field of additives should not affect the application of  provisions of Member States existing on 1 January 1992, which prohibit the use of certain additives  in certain specific foodstuffs which are considered as traditional and are produced on their  territory, provided that those provisions do not cover a whole series of foodstuffs including  foodstuffs which do not come under this Directive but regarding which Community provisions provide  for authorization of additives; Whereas these products could be distinguished by an appropriate labelling; Whereas the free circulation of foodstuffs conforming with directives concerning additives should  not be affected; Whereas the freedom of establishment, the production and sale on the territory of each Member State  of foodstuffs conforming with Directives concerning additives should not be affected, HAVE ADOPTED THIS DIRECTIVE: Article 1The following Article 3a shall be inserted in Directive 89/107/EEC  (4): 'Article 3a1. By way of derogation from Article 3 (2) (a) and (b), the Council shall, acting on a  proposal from the Commission pursuant to the procedure laid down in Article 100a of the Treaty,  authorize the Member States to maintain the prohibition on the use of certain additives in the  production of certain foodstuffs considered as traditional provided that: - this prohibition existed on 1 January 1992, - the Member States concerned authorize on their territory the production and sale of all  foodstuffs not considered as traditional which conform to the rules provided for in Article 3. 2. Without prejudice to Regulations (EEC) No 2081/92 (1) and (EEC) No 2082/92 (2), before 1 July  1994, Member States shall communicate to the list of foodstuffs which they consider as traditional,  giving their reasons in detail, together with the relevant legislative provisions prohibiting the  use of certain additives in such foodstuffs. Before 1 April 1995, the Commission shall submit a proposal to the Council on the criteria to be  applied for deciding whether or not a product is traditional and on the national prohibitions which  may be maintained in conformity with these criteria. The Council shall act on the proposal before 1 April 1996. 3. Until such time as the Council has ruled on paragraph 2, Member States may maintain any  prohibitions which have been communicated to the Commission pursuant to the first subparagraph of  paragraph 2, provided that they comply with the general conditions laid down in paragraph 1. (1) Council Regulation (EEC) No 2081/92 of 14 July 1992 on the protection of geographical  indications and designations of origin for agricultural products and foodstuffs (OJ No L 208, 24.  7. 1992, p. 1). (2) Council Regulation (EEC) No 2082/92 of 14 July 1992 on certificates of specific character for  agricultural products and foodstuffs (OJ No L 208, 24. 7. 1992, p. 9).'Article 2Member States  shall bring into force the laws, regulations and administrative provisions necessary to comply with  this Directive. They shall inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall  be accompanied by such reference when they are officially published. The methods of making such  reference shall be laid down by the Member States. Article 3This Directive shall enter into force on the day of its publication in the Official  Journal of the European Communities. Article 4This Directive is addressed to the Member States. Done at Brussels, 30 June 1994. For the European ParliamentThe PresidentE. KLEPSCHFor the CouncilThe PresidentA.  BALTAS(1) OJ No C 206, 13. 8. 1992, p. 1. (2) OJ No C 73, 15. 3. 1993, p. 4. (3) Opinion of the European Parliament of 26 May 1993 (OJ No C 176, 28. 6. 1993, p. 117), confirmed  on 2 December 1993 (OJ No C 342, 20. 12. 1993), Council common position of 9 March 1994 (not yet  published in the Official Journal) and Decision of the European Parliament of 9 March 1994 (OJ No C  91, 28. 3. 1994, p. 75). (4) OJ No L 40, 11. 2. 1989, p. 27.