Avis juridique important

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31993L0025

Council Directive 93/25/EEC of 1 June 1993 on the statistical surveys to be carried out on sheep and goat stocks

Official Journal L 149 , 21/06/1993 P. 0010 - 0013 Finnish special edition: Chapter 3 Volume 50 P. 0051  Swedish special edition: Chapter 3 Volume 50 P. 0051

COUNCIL DIRECTIVE 93/25/EEC of 1 June 1993 on the statictical surveys to be carried out on sheep and goat stocksTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission(1) ,  Having regard to the opinion of the European Parliament(2) ,  Whereas Council Directive 82/177/EEC of 22 March 1982 on the statistical surveys to be carried out by the Member States on sheep and goat stocks(3)  has been amended several times; whereas further amendments being necessary, the provisions thereof  should, for reasons of clarity, be recast;  Whereas provision should be made for those Member States whose goat population makes up only a small percentage of the overall population of the Community to reduce the number of surveys where appropriate;  Whereas it is important to follow the trend in the structure of the agricultural holdings in the Member States;  Whereas, in order to ensure that the common agricultural policy is properly administered, particularly where the sheepmeat and goatmeat market is concerned, the Commission requires regular data on trends in livestock and in sheepmeat and goatmeat  production;  Whereas the collection and processing of the data as well as the organization of the survey at national level should continue to lie within the competence of the statistical services of the Member States, and the Commission should be responsible for the  coordination and harmonization of statistical information at European level and arrange for the harmonized methodologies necessary to implement Community policies;  Whereas, in order to facilitate implementation of this Directive, close cooperation is necessary between the Member States and the Commission and this should in particular be effected via the Standing Committee on Agricultural Statistics set up by  Decision 72/279/EEC(4) ,  HAS ADOPTED THIS DIRECTIVE:  SECTION I SURVEYS OF THE POPULATION  A. At national level Frequency - Field of survey Article 1  1.  The Member States shall carry out statistical survey of the sheep population on their territory each year with referring to one of the first days in December.  2.  Member States shall also carry out a statistical survey of the goat population, either as a separate survey or as a single survey of both sheep and goat populations:  (a) each year, with reference to one of the first days in December, where the goat population is 500 000 head or more;  (b) at least once every five years where the goat population is less than 500 000 head.  3.  The Member States may, at their request, be authorized to use administrative sources instead of the statistical surveys under paragraphs 1 and 2.  4.  In considering the requests referred to in paragraph 3, the Commission shall decide in accordance with the procedure laid down in Article 20.  Article 2  1.  For the purposes of this Directive, 'sheep' means domestic animals of the species Ovis and 'goats' means domestic animals of the species Capra.  2.  The surveys referred to in Article 1 shall cover all sheep and goats on agricultural holdings as defined by the Commission in accordance with the procedure laid down in Article 20. They shall cover sufficient holdings to account for at least 95 % of  the entire population as determined by the last survey on the structure of agricultural holdings.  3.  As far as possible, Member States shall supplement the results of the surveys referred to in paragraph 2 with an estimate of the goat and sheep population not covered by the surveys.  Breakdown by category Article 3  1.  The surveys refered to in Article 1 shall be conducted in such a way as to provide a breakdown of the sheep and goat populations into at least the following categories:  A. sheep, total:  A.1. ewes and ewe lambs put to the ram:  A.1.1. milk ewes and milk ewe lambs put to the ram;  A.1.2. other ewes and ewe lambs put to the ram;  A.2. other sheep.  B. goats, total:  B.1. goats which have already kidded and goats mated:  B.1.1. goats which have already kidded;  B.1.2. goats mated for the first time;  B.2. other goats.  2.  The categories referred to in paragraph 1 may be modified in accordance with the procedure laid down in Article 20.  3.  The categories shall be defined in accordance with the procedure laid down in Article 20.  Accuracy Article 4  1.  The surveys referred to in Article 1 shall be conducted in the form of exhaustive surveys or by representative sampling.  2.  For each of the Member States, sampling errors for the results of the surveys provided for in Article 2 (2) shall not exceed 2 % (confidence interval of 68 %) of the total number of sheep and of goats, or an absolute number to be set in accordance  with the procedure laid down in Article 20.  3.  In addition to the sampling frame and the supplementary estimates referred to in Article 2 (3), Member States shall take whatever measures they deem appropriate to maintain the quality of the survey results.  Transmission deadline Article 5  1.  Member States shall notify the Commission of the provisional results of the surveys and supplementary estimates before 1 March after the reference month for the data referred to in Article 3 (1).  2.  Member States shall notify the Commission of the results of the surveys and of the supplementary estimates, in compliance with Article 4 (2), before 1 April following the reference month.  Derogations Article 6  1.  By way of derogation from Article 3 (1):  (a) the subdivisions of category A.1 shall be optional for those Member States where the sheep population at the time of the survey is less than 2 500 000 head;  (b) the subdivisions of category B.1 shall be optional for those Member States where the goat population at the time of the survey is less than 500 000 head;  (c) the Member States referred to in Article 1 (2) (b) shall make an estimate of the total numbers referred to in category B, without subdivision, for each of the years not covered by the survey;  (d) the Member States for which the population of category A.1.1 represents less than 1 % of category A.1 shall be authorized to estimate the figure or derive it from other sources.  2.  By way of derogation from Articles 1 and 5, Denmark and the Netherlands shall be authorized to estimate the sheep and goat populations and the United Kingdom the goat population held in December on the basis of the populations recorded during the  annual agricultural census which they carry out in May/June of the same year. They shall forward the provisional results referred to in Article 5 (1) to the Commission before 1 March and the results referred to in Article 5 (2) before 15 September of  the year following the reference year.  B. At regional level Territorial subdivisions Article 7  1.  The final results of the survey shall be compiled for each of the territorial subdivisions as defined in accordance with the procedure laid down in Article 20.  2.  The territorial subdivisions referred to in paragraph 1 may be amended in accordance with the procedure laid down in Article 20.  Transmission deadline Article 8  Member States shall notify the Commission of the data referred to in Article 7 before 15 May of the year following the reference month.  Derogations Article 9  By way of derogation from Article 8:  (a) the Netherlands shall be authorized to notify sheep numbers by 'provincie' in the case of populations covered by the agricultural census conducted in May of the reference year, before 15 September of that year;  (b) the Member States referred to in Article 1 (2) (b) shall be exempt from notifying the regional breakdown of their goat numbers.  C. Breakdown by size of flock herd Size classes Article 10  1.  In odd-numbered years, Member States shall provide a breadown of the final results of the survey at national level by size classes as defined in accordance with the procedure laid down in Article 20.  2.  In accordance with the procedure laid down in Article 20, the Commission may approve an application from a Member State to use the breakdown by size classes referred to in paragraph 1 for the final results of even-numbered years.  3.  The size classes referred to in paragraph 1 may be amended in accordance with the procedure laid down in Article 20.  Transmission deadline Article 11  Member States shall notify the Commission of the data referred to in Article 10 (1) before 15 May of the year following the reference month.  Derogations Article 12  By way of derogation from Article 11, Denmark and the Netherlands shall be authorized to notify the data on the structure of their sheep and goat populations and the United Kingdom those of its goat population covered by the agricultural  census conducted in May/June of the reference year before 15 May of the following year SECTION II SLAUGHTERING STATISTICS   Article 13  1.  Member States shall draw up monthly statistics relating to the number and carcase weight of sheep and goats slaughtered in the slaughterhouses on their territory, the meat of which is deemed fit for human consumption.  If necessary, they shall also supply estimates of slaughterings not included in the returns, so that the statistics include all the sheep and goats slaughtered on their territory.  2.  The statistics referred to in paragraph 1 shall be drawn up for the following categories:  A. sheep, total:  A.1. of which: lambs;  B. goats, total.  3.  The carcase weight referred to in paragraph 1 and the categories referred to in paragraph 2 shall be defined in accordance with the procedure laid down in Article 20.  Transmission deadline Article 14  Member States shall forward the Commission the results of the statistics referred to in Article 13 (1) within the two months following the reference month.  SECTION III PRODUCTION FORECASTS   Article 15  1.  Member States shall use the survey results and other available information to produce forecasts, for each calendar half-year, of their supply of sheep and goats.  This supply shall be expressed as the gross indigenous production which shall include all sheep and goats slaughtered plus the balance of intra-Community and external trade in live sheep and goats.  2.  The definition 'supply' referred to in paragraph 1 may be amended in accordance with the procedure laid down in Article 20.  Transmission deadline Article 16  Member States shall notify the Commission of the forecasts referred to in Article 15 (1) before 1 March following the survey for the two six-month periods of the current year.  SECTION IV GENERAL REMARKS   Article 17  Member States shall forward to the Commission the data referred in Articles 5, 6, 8, 9, 11, 12, 14 and 16 in compliance with Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical  confidentiality to the Statistical Office of the European Communities(5) .  Article 18  The Commission shall examine, in consultation with the Member States:  (a) the results supplied;  (b) the technical problems which arise, in particular in preparing and conducting out the surveys and estimates;  (c) the reliability of the survey results and estimates.  Article 19  Member States shall inform the Commission of any methodological or other change which would considerably influence the statistics. This shall be done within three months after the change in question enters into force. The Commission shall  notify the other Member States of any such communication in the appropriate working parties.  Article 20  1.  Where the procedure laid down in this Article is to be followed, the chairman of the Standing Committee on Agricultural Statistics hereinafter referred to as 'the committee', shall refer the matter of the committee, either on his own  initiative or at the request of the representative of a Member State.  2.  The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter.  The opinion shall be delivered by a majority of 54 votes, the votes of the representatives of the Member States being weighted in the manner set out in Article 148 (2) of the Treaty. The chairman shall not vote.  3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.  (b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a  qualified majority.  If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.  Article 21  1.  Directive 82/177/EEC shall be repealed as from 1 January 1994.  2.  The references to the repealed Directive shall be construed as referring to this Directive.  Article 22  Members States shall bring into force the legal and administrative measures necessary to comply with this Directive not later than 1 January 1994.  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 a reference shall be laid down by the Member  States.  Article 23  1.  This Directive is addressed to the Member States.  Done at Luxembourg, 1 June 1993.  For the Council The President J. ANDERSEN   (1) OJ No C 18, 23. 1. 1993, p. 15.  (2) OJ No C 115, 26. 4. 1993.  (3) OJ No L 81, 27. 3. 1982, p. 35. Directive last amended by Regulation (EEC) No 1057/91 (OJ No L 107, 27. 4. 1991, p. 11).  (4) OJ No L 179, 7. 8. 1972, p. 1.  (5) OJ No L 151, 15. 6. 1990, p. 1.


Avis juridique important

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31988L0406

Council Directive 88/406/EEC of 14 June 1988 amending Directive 64/432/EEC as regards enzootic bovine leukosis and repealing Directive 80/1102/EEC

Official Journal L 194 , 22/07/1988 P. 0001 - 0009 Finnish special edition: Chapter 3 Volume 27 P. 0006  Swedish special edition: Chapter 3 Volume 27 P. 0006

COUNCIL DIRECTIVE of 14 June 1988 amending Directive 64/432/EEC as regards enzootic bovine leukosis and repealing Directive 80/1102/EEC (88/406/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas one of the tasks of the Community in the veterinary field is to improve the state of health of livestock, and thus to make stock-breeding more profitable;  Whereas there is a need to protect the Community against enzootic bovine leukosis; whereas the Community, by Directives 77/391/EEC (4) and 78/52/EEC (5), and by Decision 87/58/EEC (6) has already taken measures to eradicate this disease;  Whereas such measures must contribute to the abolition of barriers to trade in live animals between Member States, which are due to differences in health situations;  Whereas to that end measures for protection against enzootic bovine leukosis were introduced until 31 December 1987, by Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (7), as last amended by Regulation (EEC) No 3805/87 (8);  Whereas such measures should be extended, whilst recognizing new methods of detection of enzootic bovine leukosis;  Whereas, at the end of a transitional period, special rules laid down by the current arrangements for countries which applied national programmes for the combat of this disease, should be cancelled;  Whereas rules should be laid down for the qualification of herds with regard to enzootic bovine leukosis;  Whereas Member States must, in order to qualify their herd, implement a programme such that their herds undergo one of the tests for detecting leukosis laid down in Annex G to Directive 64/432/EEC;  Whereas, with the exception of animals for slaughter of less than 30 months, animals intended for intra-Community trade must come from a tested herd and have undergone an individual test,  HAS ADOPTED THIS DIRECTIVE:    Article 1 As from 1 July 1988, Directive 64/432/EEC is hereby amended as follows:  1.  the following is added to Article 2:  ´(s)  ´Enzootic bovine leukosis free herd' means: a herd in which:  ii(i)  there is no evidence, either clinical or as a result of tests carried out in accordance with Annex G, of any case of enzootic bovine leukosis nor has any such case been confirmed in the previous two years;  i(ii)  the animals over 24 months of age have, during the previous 12 months reacted negatively to two tests carried out in accordance with Annex G, at intervals of at least four months or, in the case of a herd which has already satisfied that  requirement, have reacted negatively to a single test carried out in accordance with that Annex;  (iii)  from the date of the first inspection, there are only animals born in the herd, or which have come from an enzootic bovine leukosis free herd.';  2.  the following is added to Article 3 (2):  ´(j)  in the case of pure-bred breeding bovine animals, as defined in Article 1 of Directive 77/504/EEC, which are intended solely for reproductive purposes and are highly valuable, come from a herd:  i(i)  in which no facts have been brought to the notice of the official veterinarian which would lead him to conclude that a case of enzootic bovine leukosis has occurred within the preceding two years;  (ii)  the owner of which has declared that he has no knowledge of such facts and has further declared in writing that the animal or animals intended for intra-Community trade have either been born and reared in the said herd or have remained an integral  part of it for the previous 12 months.';  3.  the following is added to Article 3 (3):  ´(d)  come from a herd in which there has been no evidence of enzootic bovine leukosis during the preceding two years and, if they are more than 12 months of age, have reacted negatively to an individual test carried out in accordance with Annex G  during the 30 days before they are loaded.  However, this test will not be required in the case of male bovine animals and bullocks less than 30 months of age intended for meat production, provided that such animals are identified by a special mark when they are loaded and that the Member State  takes all measures to prevent contamination of indigenous herds.';  4.  the following is added to Article 7 (1):  ´G.  Female bovine animals less than 30 months of age intended for meat production which, by way of derogation from Article 3 (3) (d), have not been subjected to an individual test. Such animals must bear a special mark. The Member State of destination  shall take all measures to prevent contamination of indigenous herds.';  5.  the following is added to Article 8 (2):  ´With particular regard to enzootic bovine leukosis and in the case of the animals referred to in Article 3 (2) (j). Member States are authorized to require in addition, subject to compliance with the general provisions of the Treaty, that all members  of the herd from which the animals come and more than 24 months of age at the date of the test have in the previous 12 months reacted negatively to a test carried out in accordance with Annex G. However, such guarantees shall not be required upon the  introduction of animals from a Member State which, in accordance with the procedure laid down in Article 12, is recognized as providing adequate guarantees as regards enzootic bovine leukosis.';  6.  the following Article is inserted:  ´Article 8a 1.  Member States which since 1980 have been applying a compulsory national programme for the eradication of enzootic bovine leukosis may make the introduction into their territory of bovine animals for breeding or production intended for combining with  bovine herds not suspected of having leukosis, conditional upon the production of a certificate issued on the day of loading by a competent official veterinarian and drawn up, as a minimum requirement, in the language or languages of the country of  destination, certifying:  (a)  that the veterinarian has no knowledge of facts which would lead him to conclude that a case of enzootic bovine leukosis has occurred within the three preceding years in the herd from which they come, and that the owner of this herd has declared  that he has no knowledge of such facts and that he has further declared, in writing, that the animal or animals intended for intra-Community trade have been born and reared in the said herd or have remained an integral part of it for the previous 12  months;  (b)  that during the previous 12 months all the bovine animals over 24 months of age on the date of the test and forming part of the herd from which they come have reacted negatively to a test carried out in accordance with Annex G.  2.  In accordance with the procedure laid down in Article 12, Member States other than those referred to in paragraph 1 may be authorized to apply the same requirements for their territory or, in the case of the United Kingdom, for Northern Ireland, if a plan for the eradication of enzootic bovine leukosis is being implemented therein pursuant to Decision  87/58/EEC, or if it can be proved that on the date on which the matter is referred to the Standing Veterinary Committee they have been applying therein for at least two years a minimum eradication programme including the following minimum requirements:  - all tumours in the organs and the lymphatic system of bovines must be notified and must be examined histologically by a veterinary laboratory which is directly supervised by a laboratory mentioned in Annex G,  - all cattle in herds which have had contagious contact with an animal found to be suffering from leukotic tumours shall be subjected to a test for enzootic bovine leukosis carried out in accordance with the requirements of Annex G and in a laboratory  directly supervised by a laboratory mentioned in that Annex,  - in a herd in which an animal is found to be afflicted with a leukotic tumour and the diagnosis of enzootic bovine leukosis has been confirmed, infected animals may be removed only for slaughter under the supervision of the veterinary authorities. The  herd should remain under official supervision until such time as it has shown a negative reaction to at least two tests carried out at at least four-monthly intervals on all the cattle over 24 months of age and in accordance with the requirements of  Annex G in a laboratory directly supervised by a laboratory mentioned in Annex G.  The additional conditions to which this extension to each Member State or part thereof concerned may be subject may be specified in the decision provided for in the first subparagraph.';  7.  the following is added at the end of (a) of Annex E:  ´- enzootic bovine leukosis.';  8.  Annex F, Model I:  (a)  V:  (aa)  the following is added after (d):  ´(e) -  for the previous 12 months (9) or, if less than 12 months of age, since birth, they have been kept in a herd in which, during the preceding three years (10) to the knowledge of the undersigned and as declared by their owner, no cases of enzootic bovine leukosis have been diagnosed (11) (12),  -  they come from a herd in which there has been no evidence of enzootic bovine leukosis during the preceding three years (13),  -  on the date of their examination,  all the animals more than 24 months old had within the previous 12 months (14) undergone (15) (16) a test (17) the result of which proved negative,  -  within the prescribed 30 days (18),  they have given a negative reaction (19) (20) (21) to an individual test (22) for enzootic bovine leukosis,  -  they are intended for fattening (23) (24);' (bb)  (e) to (i) become (f) to (j) respectively;  (b)  the following are added after footnote (25):  ´(26)  This exception is permitted only in the case of male animals less than 30 months of age intended for fattening and provided that the animals are marked in a different manner and undergo a special check in the country of destination.  ´(27)  This is unnecessary except in the case of pure-bred breeding animals intended solely for reproductive purposes and which are highly valuable.  ´(28)  The individual test was carried out in accordance with Annex G to Directive 64/432/EEC.';  9.  Annex G annexed to this Directive is added.  Article 2 As from 1 July 1990, Directive 64/432/EEC is hereby amended as follows:  1.  Article 3 (2) (j) is deleted;  2.  Article 3 (3) (d) is replaced by the following and (e) to (f) are added:  ´(d) come from an enzootic bovine leukosis free herd within the meaning of Article 2 (s);  ´(e) in addition to the condition under (d) where they are over 12 months of age, have reacted negatively to an individual test carried out in accordance with Annex G during the 30 days before they were loaded;  ´(f) not be subject to the requirements of (d) and (e) if they are under 30 months of age and intended for meat production, if they:  i(i)  come from a herd in which no case of enzootic bovine leukosis has been notified and confirmed within the previous 2 years;  (ii)  they are identified by a special mark when they are loaded and they remain under supervision until they are slaughtered;  provided that the Member State of destination takes all the measures necessary to prevent contamination of indigenous herds.';  3.  Article 7 (1) G is deleted;  4.  Article 8 (2), the last subparagraph is deleted;  5.  Article 8a is deleted;  6.  in Model I of Annex F:  -  V (e) is replaced by the following:  ´(e)  -  the previous 12 months (29) or, if less than 12 months of age (30), since birth, they have been kept in an enzootic bovine leukosis free herd (31) (32),  -  within the prescribed 30 days (33) they have given a negative reaction to an individual test (34) for the detection of enzootic bovine leukosis (35) (36),  -  they are intended for fattening (37).';  -  footnote (38) is replaced by the following:  ´(39)  This exception is permitted only in the case of bovine animals less than 30 months of age intended for fattening, and provided that the animals:  -  come from a herd in which no case of enzootic bovine leukosis has been notified and confirmed during the preceding two years,  -  are marked in a different manner and undergo a special check in the country of destination.';  -  footnote (40) is deleted,  -  footnote (41) becomes footnote (42).  Article 3 1.  In order to qualify their herds as enzootic bovine leukosis free, Member States shall implement a programme, such that their herds undergo one of the tests referred to in Annex G to Directive 64/432/EEC.  2.  Member States shall notify the Commission at least once a year of the progress of their programmes, and the results obtained.  Article 4 The Council, acting on a proposal from the Commission, shall, before 1 January 1990, lay down the criteria permitting a Member State or part of the territory of a Member State to be recognized as being free from enzootic bovine leukosis and the conditions to be implemented to guarantee the maintenance of such status, as well as the rules applicable to trade from enzootic bovine leukosis free regions or Member States.  Article 5 Member States shall bring into force the necessary provision to comply with the requirements of:  - Articles 1 and 3 not later than 1 July 1988,  - Article 2 not later than 1 July 1990.  They shall forthwith inform the Commission thereof.  Article 6 Directive 80/1102/EEC (43) is hereby repealed.  Article 7 This Directive is addressed to the Member States.   Done at Luxembourg, 14 June 1988.  For the Council The President I. KIECHLE EWG:L111UMBE00.95 FF: 1UEN;   SETUP: 01;   Hoehe: 1853 mm;   344 Zeilen;   14206 Zeichen;  Bediener: SUSI   Pr.: C;  Kunde:   (1) OJ No C 5, 9. 1. 1988, p. 5. (2) OJ No C 49, 22. 2. 1988, p. 164. (3) OJ No C 80, 28. 3. 1988, p. 34. (4) OJ No L 145, 13. 6. 1977, p. 44. (5) OJ No L 15, 19. 1. 1978, p. 34. (6) OJ No L 24, 27. 1. 1987, p. 51.(7) OJ No 121, 29. 7. 1964, p. 1977/64. (8) OJ No L 357, 19. 12. 1987, p. 1.(9) OJ No L 325, 1. 12. 1980, p. 18.   ANNEX   ´ANNEX G  TESTS FOR ENZOOTIC BOVINE LEUKOSIS Tests for enzootic bovine leukosis shall be carried out by the immuno-diffusion test under the conditions described in points A and B below or by the enzyme-linked immunosorbent assay (Elisa) under the conditions described in point C below. The  immuno-diffusion method may only be used for individual tests.  If test results are the subject of a duly-substantiated challenge, an additional check shall be carried out by means of the immuno-diffusion test.  A.  Agar gel immuno-diffusion test for enzootic bovine leukosis 1.  The antigen to be used in the test must contain bovine leukosis virus glycoproteins. The antigen must be standardized against a standard serum (El serum) supplied by the State Veterinary Serum Laboratory, Copenhagen.  2.  The official institutes indicated below must be made responsible for calibrating the standard working antigen of the laboratory against the official EEC standard serum (El serum) provided by the State Veterinary Serum Laboratory, Copenhagen.  (a)  Germany:  Bundesforschungsanstalt fuer Viruskrankheiten der Tiere, Tuebingen (b) Belgium:  Institut national de recherches vétérinaires, Bruxelles (c) France:  Laboratoire national de pathologie bovine, Lyon (d) Grand Duchy of Luxembourg:  - (e) Italy:  Istituto Zooprofilattico Sperimentale, Perugia (f) Netherlands:  Centraal Diergeneeskundig Instituut, Afdeling Rotterdam (g) Denmark:  Statens Veterinaere Serum Laboratorium, Copenhagen (h) Ireland:  Veterinary Research Laboratory, Abbotstown, Dublin (i) United Kingdom:  1.  Great Britain:  The Central Veterinary Laboratory, Weybridge, England 2.  Northern Ireland:  The Veterinary Research Laboratory, Stormont, Belfast (j) Spain:  Laboratorio de Sanidad y Produccion Animal de Barcelona (k) Portugal:  Laboratório Nácional de Investigaçao Veterinária, Lisboa 3.  The standard antigens used in the laboratory must be submitted at least once a year to the EEC reference laboratories listed in paragraph 2 above for testing against the official EEC standard serum. Apart from this standardization the antigen in use  can be calibrated in accordance with B.  4.  The reagents for the test shall consist of:  (a)  antigen: the antigen must contain specific glycoproteins of enzootic bovine leukosis virus which has been standardized against the official EEC serum;  (b) the test serum;  (c) known positive control serum;  (d) Agar gel,  0,8 % agar,  8,5 % NaCl,  0,05 M Tris-buffer pH 7,2,  15 ml of this agar must be introduced into a petri dish of 85 mm diameter, resulting in a depth of 2,6 mm of agar.  5.  A test pattern of seven moisture-free wells be cut in the agar to the bottom of the plate; the pattern must consist of one central well and six wells in a circle around it.  Diameter of central well: 4 mm Diameter of peripheral wells: 6 mm Distance between central and peripheral wells: 3 mm 6.  The central well must be filled with the standard antigen. The peripheral wells 1 and 4 (see diagram below) are filled with the known positive serum, the wells 2, 3, 5 and 6 with the test sera. The wells must be filled until the meniscus  disappears.  A.  6.  1 k 6 kk 2 k 5 kk 3 k 4 7.  This results in the following quantities being obtained:  antigen:  32 ml;  control serum:  73 ml;  test serum:  73 ml.  8.  Incubation must be for 72 hours at room temperature (20 to 27 °C) in a closed humid chamber.  9.  The test may be read at 24 and 48 hours but a final result may not be obtained before 72 hours:  (a)  a test serum is positive if it forms a specific precipitin line with the BLV antigen and forms a complete line of identity with the control serum;  (b) a test serum is negative if it does not form a specific precipitin line with the BLV antigen and if it does not bend the line of the control serum;  (c) the reaction cannot be considered conclusive if it:  i(i) bends the line of the control serum towards the BLV antigen well without forming a visible precipitin line with the antigen;  or (ii) if it cannot be read either as negative or as positive.  In inconclusive reactions the test may be repeated and concentrated serum utilized.  B.  Method for antigen standardization Solutions and materials required:  1.  40 ml of 1,6 % agarose in 0,05 % M Tris/HCl buffer, pH 7,2 with 8,5 % NaCl.  2.  15 ml of a bovine leukosis serum, having antibody only to bovine leukosis virus glycoproteins, diluted 1:10 in 0,05 M Tris/HCl buffer, pH 7,2 with 8,5 % NaCl.  3.  15 ml of a bovine leukosis serum, having antibody only to bovine leukosis virus glycoproteins, diluted 1:5 in 0,05 M Tris/HCl buffer, pH 7,2 with 8,5 % NaCl.  4.  Four plastic petri dishes with a diameter of 85 mm.  5.  A punch with a diameter of 4 to 6 mm.  6.  A reference antigen.  7.  The antigen which is to be standardized.  8.  A water bath (56 °C).  Procedure:  Dissolve the agarose (1,6 %) in the Tris/HCl buffer by carefully heating to 100 °C. Place in 56 °C water bath for approximately one hour. Also, place the bovine leukosis serum dilutions in 56 °C water bath.  Now, mix 15 ml of the 56 °C agarose solution with the 15 ml bovine leukosis serum (1:10), quickly shake and pour 15 ml into each of two petri dishes.  Repeat this procedure with the bovine leukosis serum diluted 1:5.  When the agarose has hardened, holes are made in it as follows:  Addition of antigen:  II. Petri dishes 1 and 3 well A = undiluted reference antigen,  well B = 1:2 diluted reference antigen,  wells C and E = reference antigen,  well D = undiluted antigen to be tested.  II. Petri dishes 2 and 4 well A = undiluted test antigen,  well B = 1:2 diluted test antigen,  well C = 1:4 diluted test antigen,  well D = 1:8 diluted test antigen.  Additional instructions:  1.  The experiment shall be carried out with two serum dilutions (1:5 and 1:10) in order to achieve optimal precipitation.  2.  If the precipitation diameter is too small with both dilutions, then the serum must be further diluted.  3.  If the precipitation diameter in both dilutions is too large and faint, then a lower serum must be chosen.  4.  The final concentration of the agarose must be 0,8 %; that of the sera 5 % and 10 % respectively.  5.  Plot the measured diameters in the following coordinate system. The dilution of the antigen to be tested with the same diameter as the reference antigen is the working dilution.  C.  Enzyme-linked immunosorbent assay (Elisa) for enzootic bovine leukosis 1.  For the Elisa method, the materials and reagents to be used are as follows:  (a)  solid phase microplates, cuvettes or any other solid phase;  (b) the antigen is fixed to the solid phase with or without the aid of polyclonal or monoclonal catching antibodies. If antigen is coated directly to the solid phase all test samples giving positive reactions have to be retested against control antigen. The  control antigen should be identical to the antigen except for the BLV antigens. If catching antibodies are coated to the solid phase the antibodies must not react to other antigens other than BLV antigens;  (c) the bilogical fluid to be tested (serum or milk);  (d) a positive and negative control;  (e) conjugate - an antibovine immunoglobulin biotinylated or enzyme conjugated or an anti-BLV immunoglobulin biotinylated or enzyme conjugated;  (f) avidin - enzyme for assays using biotynilated immunoglobulin preparations;  (g) a substrate adapted to the enzyme used;  (h) a stopping solution;  (i) buffered solutions for the dilution of the test samples for preparations of the reagents and for washing;  (j) a reading system with appropriate filters corresponding to the substrate used.  2.  Standardization and sensitivity of test The sensitivity of the Elisa assay must be of such a level that E4 serum is scored positive when diluted 10 times (serum samples) or 250 times (milk samples) more than the dilution obtained of individual samples when these are included in pools.  In assays where samples (serum and milk) are tested individually E4 serum diluted 1 to 10 (in negative serum) or 1 to 250 (in negative milk) must be scored positive when tested in the same assay dilution as used for the individual test samples.  The E4 serum will be supplied by the National Veterinary Laboratory, Copenhagen.  3.  Conditions for use of the Elisa test The Elisa method may be used on a sample of milk taken from the milk collected from a farm with at least 30 % of dairy cows in milk on condition that the sample comes from the milk produced by less than 50 cows, and from a whey concentration if  collected from between 20 and 50 cows maximum, and that, if the milk collected comes from more than 50 cows, the number of samples is increased proportionally.  The Elisa method may also be used on a blood sample taken from a maximum of 50 animals.  If use is made of one of these abovementioned possibilities, measures must be taken to ensure that the samples taken can be identified with the animals from which the milk or sera examined were taken.  If one of the samples scores positive, the herd must remain under official supervision until a negative result has been recorded for at least two individual tests carried out, at a minimum interval of four months, on all cattle aged more than six  months, in accordance with the abovementioned provisions and in a laboratory that is directly supervised by a laboratory mentioned in point A.'


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31973L0238

Council Directive 73/238/EEC of 24 July 1973 on measures to mitigate the effects of difficulties in the supply of crude oil and petroleum products

Official Journal L 228 , 16/08/1973 P. 0001 - 0002 Finnish special edition: Chapter 12 Volume 1 P. 0061  Greek special edition: Chapter 10 Volume 1 P. 0053  Swedish special edition: Chapter 12 Volume 1 P. 0061  Spanish special edition: Chapter 12 Volume 1 P. 0180  Portuguese special edition Chapter 12 Volume 1 P. 0180

COUNCIL DIRECTIVE  of 24 July 1973  on measures to mitigate the effects of difficulties in the supply of crude oil and petroleum products  (73/238/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 103 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament;  Having regard to the Opinion of the Economic and Social Committee;  Whereas the establishment of a common energy policy is one of the objectives the Communities have set themselves;  Whereas crude oil and petroleum products are of increasing importance in providing the Community with supplies of energy ; whereas any difficulty, even temporary, having the effect of considerably reducing supplies of such products could cause serious disturbances in the economic activity of the Community ; whereas the Community must, therefore, be in a position to offset or at least to diminish any harmful effects in such a case;  Whereas procedures and appropriate instruments should be provided in advance to ensure the speedy implementation of measures to mitigate the effects of difficulties in the supply of petroleum and petroleum products;  Whereas all Member States should, therefore, possess the necessary powers to take appropriate action, should the need arise, without delay and in accordance with the Treaty, and in particular Article 103 thereof;  Whereas it is necessary for these powers to be harmonized to a certain extent in order to facilitate the coordination of national measures within the framework of consultations at Community level;  Whereas it is also desirable that a consultative body be set up immediately to facilitate the coordination of practical measures taken or proposed by the Member States in this field;  Whereas it is necessary that each Member State draw up a plan which may be used in the event of difficulties arising in the supply of crude oil and petroleum products;  HAS ADOPTED THIS DIRECTIVE:    Article 1 The Member States shall take all necessary measures to provide the competent authorities with the necessary powers in the event of difficulties arising in the supply of crude oil and petroleum products which might appreciably reduce the supply of these products and cause severe disruption. Those powers should enable the authorities:    - to draw on emergency stocks in accordance with the Council Directive of 20 December 1968 (1)  (1)OJ No L 308, 23.12.1968, p. 14.   imposing an obligation on Member States of the EEC to maintain minimum stocks of crude oil and/or petroleum products and distribute these stocks to users,    - to impose specific or broad restrictions on consumption, depending on the estimated shortages, and to give priority to supplies of petroleum products to certain groups of users,       - to regulate prices in order to prevent abnormal price rises.          Article 2 1. The Member States shall appoint the bodies to be responsible for implementing the measures to be taken in execution of the powers provided for in Article 1.  2. The Member States shall draw up intervention plans for use in the event of difficulties arising with regard to the supply of crude oil and petroleum products.   Article 3 1. If difficulties arise with regard to the supply of crude oil and petroleum products in the Community or one of the Member States, the Commission shall convene as soon as possible, at the request of one of the Member States or on its own initiative, a group of delegates from the Member States whose names shall be made known beforehand, under the chairmanship of the Commission.  2. This group shall carry out the necessary consultations in order to ensure coordination of the measures taken or proposed under the powers provided for in Article 1 above.   Article 4 1. The Member States shall inform the Commission of the provisions which meet the obligations arising from the application of Article 1 of this Directive.  2. The Member States shall notify the Commission of the composition and the mandate of the national bodies set up in accordance with Article 2 (1) in order to implement the measures to be taken.   Article 5 The Member States shall bring into force not later than 30 June 1974 the provisions laid down by law, regulation or administrative action necessary to comply with this Directive.   Article 6 This Directive is addressed to the Member States.     Done at Brussels, 24 July 1973.  For the Council  The President  I. NØRGAARD


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31980L0131

Thirtieth Commission Directive 80/131/EEC of 9 January 1980 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 030 , 07/02/1980 P. 0021 - 0021 Greek special edition: Chapter 03 Volume 27 P. 0213

****( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .  ( 2 ) OJ NO L 310 , 6 . 12 . 1979 , P . 24 .    THIRTIETH COMMISSION DIRECTIVE   OF 9 JANUARY 1980   AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS  ( 80/131/EEC )   THE COMMISSION OF THE EUROPEAN   COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,   HAVING REGARD TO COUNCIL DIRECTIVE 70/524/EEC OF 23 NOVEMBER 1970 CONCERNING ADDITIVES IN FEEDINGSTUFFS ( 1 ), AS LAST AMENDED BY TWENTY-NINTH COMMISSION DIRECTIVE 79/1011/EEC ( 2 ), AND IN PARTICULAR ARTICLE 6 THEREOF ,   WHEREAS DIRECTIVE 70/524/EEC PROVIDES THAT THE ANNEXES MUST BE CONSTANTLY ADAPTED TO SCIENTIFIC AND TECHNICAL PROGRESS ;   WHEREAS IT IS DESIRABLE TO EXTEND THE PERIOD OF AUTHORIZATION OF CITRANAXANTHINE USED FOR COLOURING EGG YOLKS IN LAYING-HEN FEEDS UNTIL A FINAL DECISION CAN BE TAKEN AS REGARDS THIS ADDITIVE ;   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   IN ANNEX II TO DIRECTIVE 70/524/EEC , PART E ' COLOURING MATTERS INCLUDING PIGMENTS ' , AT POINT 1 ' CITRANAXANTHINE ' ,  ' 31 DECEMBER 1979 '  IS REPLACED BY ' 30 JUNE 1980 ' .   ARTICLE 2   THIS DIRECTIVE SHALL APPLY WITH EFFECT FROM 1 JANUARY 1980 .   ARTICLE 3   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT BRUSSELS , 9 JANUARY 1980 .   FOR THE COMMISSION   FINN GUNDELACH   VICE-PRESIDENT


title: Directive 2008/37/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2005/68/EC on reinsurance, as regards the implementing powers conferred on the Commission (Text with EEA relevance)

text:
               20.3.2008

               EN

               Official Journal of the European Union

               L 81/71

      DIRECTIVE 2008/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 11 March 2008
   amending Directive 2005/68/EC on reinsurance, as regards the implementing powers conferred on the Commission
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 47(2) and 55 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Directive 2005/68/EC of the European Parliament and of the Council (3) provides that certain measures are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4).

               (2)

               Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia, by deleting some of those elements or by supplementing the instrument with new non-essential elements.

               (3)

               In accordance with the statement by the European Parliament, the Council and the Commission (5) concerning Decision 2006/512/EC, for the regulatory procedure with scrutiny to be applicable to instruments adopted in accordance with the procedure referred to in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.

               (4)

               The Commission should be empowered to adopt the measures necessary for the implementation of Directive 2005/68/EC in order to take account of technical developments in the insurance sector or financial markets and to ensure the uniform application of that Directive. More particularly, those measures are designed to extend the list of legal forms, clarify or adjust the items constituting the solvency margin, increase the premiums or claims amounts used for the calculation of the solvency margin for certain reinsurance activities or contract types, alter the minimum guarantee fund, and clarify definitions. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2005/68/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (5)

               Directive 2005/68/EC should therefore be amended accordingly.

               (6)

               Since the amendments made to Directive 2005/68/EC by this Directive are technical in nature and concern committee procedure only, they do not need to be transposed by the Member States. It is therefore not necessary to lay down provisions to that effect,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments
   Directive 2005/68/EC is hereby amended as follows:

               1.

               Article 55 shall be amended as follows:

                           (a)

                           paragraph 2 shall be replaced by the following:
                           ‘2.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

                           (b)

                           paragraph 3 shall be deleted;

               2.

               in Article 56, the introductory phrase shall be replaced by the following:
               ‘The following implementing measures designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 55(2):’.

         Article 2
   Entry into force
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 3
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 11 March 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. LENARČIČ

      (1)  OJ C 161, 13.7.2007, p. 45.

      (2)  Opinion of the European Parliament of 10 July 2007 (not yet published in the Official Journal) and Council Decision of 3 March 2008.

      (3)  OJ L 323, 9.12.2005, p. 1. Directive as amended by Directive 2007/44/EC (OJ L 247, 21.9.2007, p. 1).

      (4)  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

      (5)  OJ C 255, 21.10.2006, p. 1.


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32004L0016

Commission Directive 2004/16/EC of 12 February 2004 laying down the sampling methods and the methods of analysis for the official control of the levels of tin in canned foods (Text with EEA relevance)

Official Journal L 042 , 13/02/2004 P. 0016 - 0022

Commission Directive 2004/16/ECof 12 February 2004laying down the sampling methods and the methods of analysis for the official control of the levels of tin in canned foods(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council(2), and in particular Article 1 thereof,Whereas:(1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs(3), as last amended by Regulation (EC) No 242/2004(4) fixes maximum limits for inorganic tin in canned foodstuffs and makes reference to measures laying down the sampling and analysis methods to be used.(2) Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(5), as amended by Regulation (EC) No 1882/2003, introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs.(3) It seems necessary to fix general criteria, which the method of analysis has to comply with in order to ensure that laboratories, in charge of the control, use methods of analysis with comparable levels of performance. It is also of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the European Union. These interpretation rules are of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply.(4) The provisions for the sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge. Methods to analyse for total tin are appropriate for controls on inorganic tin. The possible presence of organic forms of tin are considered to be negligible in relation to the maximum levels set for inorganic tin.(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1The Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of tin in foodstuffs is carried out in accordance with the methods described in Annex I to this Directive.Article 2The Member States shall take all measures necessary to ensure that sample preparation and methods of analyses used for the official control of the levels of tin in foodstuffs comply with the criteria described in Annex II to this Directive.Article 3The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive by 31 December 2004. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.When Member States adopt those provisions, their provisions shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 4This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.This Directive is addressed to the Member States.Done at Brussels, 12 February 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 372, 31.12.1985, p. 50.(2) OJ L 284, 31.10.2003, p. 1.(3) OJ L 77, 16.3.2001, p. 1.(4) See page 3 of this Official Journal.(5) OJ L 290, 24.11.1993, p. 14.ANNEX IMETHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF TIN IN CANNED FOODSTUFFS1. Purpose and scopeSamples intended for official checking of the levels of tin in canned foodstuffs shall be taken according to the methods described below. Aggregate samples thus obtained shall be considered as representative of the lots. Compliance with maximum levels laid down in Commission Regulation (EC) No 466/2001 shall be established on the basis of the levels determined in the laboratory samples.2. DefinitionsLot: an identifiable quantity of a food commodity delivered at one time and having been determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings.Sublot: designated part of a lot in order to apply the sampling method on that designated part. Each sublot must be physically separate and identifiable.Incremental sample: a quantity of material taken from a single place in the lot or sublot.Aggregate sample: the combined total of all the incremental samples taken from the lot or sublot.Laboratory sample: sample intended for the laboratory.3. General provisions3.1. PersonnelSampling shall be performed by an authorised person as specified by the Member States.3.2. Material to be sampledEach lot which is to be examined must be sampled separately.3.3. Precautions to be takenIn the course of sampling and preparation of the samples precautions must be taken to avoid any changes, which would affect the tin content, adversely affect the analytical determination or make the aggregate samples unrepresentative.3.4. Incremental samplesAs far as possible incremental samples should be taken at various places distributed throughout the lot or sublot. Departure from this procedure must be recorded in the record.3.5. Preparation of the aggregate sampleThe aggregate sample is made up by uniting all incremental samples. This aggregate sample is homogenised in the laboratory.3.6. Replicate laboratory samplesReplicate laboratory samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised aggregate sample unless this conflicts with Member States' rules on sampling.3.7. Packaging and transmission of samplesEach sample shall be placed in a clean, inert container offering adequate protection from contamination and against damage in transit. All necessary precautions shall be taken to avoid any change in composition of the sample, which might arise during transportation or storage.3.8. Sealing and labelling of samplesEach sample taken for official use shall be sealed at the place of sampling and identified following the Member State's regulations.A record must be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.4. Sampling plansThe sampling method applied shall ensure that the aggregate sample is representative for the lot that is to be controlled.4.1. Number of incremental samplesThe minimum number of incremental samples to be taken from cans within a lot shall be as given in Table 1. The incremental samples taken from each can shall be of similar weight, resulting in an aggregate sample (see point 3.5).Table 1 Number of cans (incremental samples) which shall be taken to form the aggregate sample>TABLE>Note that the maximum levels apply to the contents of each can, but for feasibility of testing it is necessary to use an aggregate sampling approach. If the test result for the aggregate sample is less than but close to the maximum level and if it is suspected that individual cans might exceed the maximum level then it might be necessary to conduct further investigations.4.2. Sampling at retail stageSampling of foodstuffs at the retail stage should be done where possible in accordance with the above sampling provisions. Where this is not possible, other effective sampling procedures at retail stage can be used provided that they ensure sufficient representativeness for the sampled lot.5. Compliance of the lot or sublot with the specificationThe control laboratory shall analyse the laboratory sample for enforcement in at least two independent analyses, and calculate the mean of the results.The lot is accepted if the mean does not exceed the respective maximum level (as laid down in Regulation (EC) No 466/2001) taking into account the measurement uncertainty and correction for recovery.The lot is non-compliant with the maximum level (as laid down in Regulation (EC) 466/2001) if the mean exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty and correction for recovery.ANNEX IISAMPLE PREPARATION AND CRITERIA FOR METHODS OF ANALYSIS USED IN OFFICIAL CHECKING OF THE LEVELS OF TIN IN CANNED FOODSTUFFS1. Precautions and general considerations for tinThe basic requirement is to obtain a representative and homogeneous laboratory sample without introducing secondary contamination.The analyst should ensure that samples do not become contaminated during sample preparation. Wherever possible, apparatus coming into contact with the sample should be made of inert materials e.g. plastics such as polypropylene, PTFE etc., and these should be acid cleaned to minimise the risk of contamination. High quality stainless steel can be used for cutting edges.All of the sample material received by the laboratory is to be used for the preparation of test material. Only very finely homogenised samples give reproducible results.There are many satisfactory specific sample preparation procedures which may be used. Those described in the CEN Standard on the "Determination of trace elements - Performance criteria and general consideration" have been found to be satisfactory (1) but others may be equally valid.2. Treatment of the sample as received in the laboratoryFinely grind (where relevant) and mix thoroughly the complete aggregate sample using a process that has been demonstrated to achieve complete homogenisation.3. Subdivision of samples for enforcement and defence purposesThe replicate samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised material unless this conflicts with Member States' rules on sampling.4. Method of analysis to be used by the laboratory and laboratory control requirements4.1. DefinitionsA number of the most commonly used definitions that the laboratory will be required to use are given below:r= Repeatability, the value below which the absolute difference between 2 single test results obtained under repeatability conditions (i.e., same sample, same operator, same apparatus, same laboratory, and short interval of time) may be expected to lie within a specific probability (typically 95 %) and hence r = 2,8 × sr.sr= Standard deviation, calculated from results generated under repeatability conditions.RSDr= Relative standard deviation, calculated from results generated under repeatability conditions [(sr/>PIC FILE= "L_2004042EN.002002.TIF">) × 100], where>PIC FILE= "L_2004042EN.002003.TIF">is the average of results over all laboratories and samples.R= Reproducibility, the value below which the absolute difference between single test results obtained under reproducibility conditions (i.e., on identical material obtained by operators in different laboratories, using the standardised test method), may be expected to lie within a certain probability (typically 95 %); R = 2,8 × sR.sR= Standard deviation, calculated from results under reproducibility conditions.RSDR= Relative standard deviation calculated from results generated under reproducibility conditions [(sR/>PIC FILE= "L_2004042EN.002004.TIF">) × 100].HORRATr= the observed RSDr divided by the RSDr value estimated from the Horwitz equation using the assumption r = 0,66R.HORRATR= the observed RSDR value divided by the RSDR value calculated from the Horwitz equation (2).U= the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.4.2. General requirementsMethods of analysis used for food control purposes must comply with the provisions of items 1 and 2 of the Annex to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption.4.3. Specific requirementsWhere no specific methods for the determination of tin in canned foodstuffs are prescribed at Community level, laboratories may select any validated method provided the selected method meets the performance criteria indicated in Table 2. The validation should ideally include a certified reference material.Table 2 Performance criteria for methods of analysis for tin>TABLE>4.3.1. Performance Criteria - Uncertainty Function ApproachHowever, an uncertainty approach may also be used to assess the suitability of the method of analysis to be used by the laboratory. The laboratory may use a method which will produce results within a maximum standard uncertainty. The maximum standard uncertainty can be calculated using the following formula:>REFERENCE TO A GRAPHIC>where:Uf is the maximum standard uncertaintyLOD is the limit of detection of the methodC is the concentration of interestIf an analytical method provides results with uncertainty measurements less than the maximum standard uncertainty, the method will be equally suitable to one which meets the performance characteristics given in Table 2.4.4. Recovery calculation and reporting of resultsThe analytical result is to be reported corrected or uncorrected for recovery. The manner of reporting and the level of recovery must be reported. The analytical result corrected for recovery is used for checking compliance (see Annex I, point 5).The analyst should note the "Harmonised Guidelines for the Use of Recovery Information in Analytical Measurement" (3) developed under IUPAC/ISO/AOAC. These Guidelines assist when determining recovery factors.The analytical result has to be reported as x +/- U whereby x is the analytical result and U is the measurement uncertainty.4.5. Laboratory quality standardsLaboratories must comply with Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs.4.6. Other considerations for the analysisProficiency testingParticipation in appropriate proficiency testing schemes which comply with the "International Harmonised Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories" (4) developed under the auspices of IUPAC/ISO/AOAC.Some of these schemes specifically include the determination of tin in foods, and participation in such a scheme is recommended rather than a general scheme for the determination of metals in foods.Internal quality controlLaboratories should be able to demonstrate that they have internal quality control procedures in place. Examples of these are the "ISO/AOAC/IUPAC Guidelines on Internal Quality Control in Analytical Chemistry Laboratories" (5).Sample preparationCare must be taken to ensure that all the tin in the sample is taken into solution for analysis. In particular it is recognised that the sample dissolution procedure must be such that no hydrolysed SnIV species is precipitated (i.e. species such as stannic oxide SnO2, Sn(OH)4, SnO2.H2O).Keep prepared samples in 5 mol/l HCl. However, SnCl4 is easily volatilised and so solutions should not be boiled.REFERENCES1. BS EN 13804:2002: Foodstuffs - Determination of trace elements - Performance criteria, general considerations and sample preparation, CEN, Rue de Stassart 36, B-1050 Brussels.2. W Horwitz, "Evaluation of Analytical Methods for Regulation of Foods and Drugs", Anal. Chem., 1982, 54, 67A - 76A.3. ISO/AOAC/IUPAC Harmonised Guidelines for the Use of Recovery Information in Analytical Measurement. Edited Michael Thompson, Steven L R Ellison, Ales Fajgelj, Paul Willetts and Roger Wood, Pure Appl. Chem., 1999, 71, 337 - 348.4. ISO/AOAC/IUPAC International Harmonised Protocol for Proficiency Testing of (Chemical) Analytical Laboratories, Edited by M Thompson and R Wood, Pure Appl. Chem., 1993, 65, 2123 - 2144 (Also published in J. AOAC International, 1993, 76, 926).5. ISO/AOAC/IUPAC International Harmonised Guidelines for Internal Quality Control in Analytical Chemistry Laboratories, Edited by M Thompson and R Wood, Pure Appl. Chem., 1995, 67, 649 - 666.


title: Commission Directive 2014/110/EU of 17 December 2014 amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations  Text with EEA relevance

text:
               20.12.2014

               EN

               Official Journal of the European Union

               L 366/81

         COMMISSION DIRECTIVE 2014/110/EU
   of 17 December 2014
   amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (1), and in particular point (d) of the second paragraph of Article 29 thereof,
   Whereas:

               (1)

               Point 2.2 of Annex III to Commission Directive 2004/33/EC (2) lays down temporary deferral criteria for donors with an infectious illness or donors leaving an area where an infectious illness is present.

               (2)

               Point 2.2.1 of Annex III to Directive 2004/33/EC establishes a deferral period for prospective donors of 28 days after leaving an area with ongoing transmission of West Nile Virus (WNV) to humans.

               (3)

               Recent scientific evidence has demonstrated that a temporary deferral of such prospective donors is not required if a Nucleic Acid Test (NAT) was carried out and the test was negative.

               (4)

               Therefore, the Member States should be given the option to apply such a test, if they want to replace the temporary deferral criteria.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The deferral criterion for West Nile Virus set out in the table (second column, last row) of point 2.2.1 of Annex III to Directive 2004/33/EC is replaced by the following:

      ‘28 days after leaving a risk area of locally acquired West Nile Virus unless an individual Nucleic Acid Test (NAT) is negative’

   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2015 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   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 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 17 December 2014.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 33, 8.2.2003, p. 30.

      (2)  Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (OJ L 91, 30.3.2004, p. 25).


title: Council Directive 2013/12/EU of 13 May 2013 adapting Directive 2012/27/EU of the European Parliament and of the Council on energy efficiency, by reason of the accession of the Republic of Croatia

text:
               28.5.2013

               EN

               Official Journal of the European Union

               L 141/28

         COUNCIL DIRECTIVE 2013/12/EU
   of 13 May 2013
   adapting Directive 2012/27/EU of the European Parliament and of the Council on energy efficiency, by reason of the accession of the Republic of Croatia
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to the Treaty of Accession of Croatia, and in particular Article 3(4) thereof,
   Having regard to the Act of Accession of Croatia, and in particular Article 50 thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               Pursuant to Article 50 of the Act of Accession of Croatia, where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in that Act of Accession or in the Annexes thereto, the Council, acting by qualified majority on a proposal from the Commission, shall, to this end, adopt the necessary acts, if the original act was not adopted by the Commission.

               (2)

               The Final Act of the Conference which drew up and adopted the Treaty of Accession of Croatia indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt those adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

               (3)

               Directive 2012/27/EU of the European Parliament and of the Council (1) requires Member States to set indicative national energy efficiency targets, and in so doing the Member States should take into account the Union’s 2020 energy consumption.

               (4)

               Due to the accession of Croatia it is necessary to adapt technically the projected energy consumption figures for the Union in 2020 to reflect the consumption in 28 Member States. Projections made in 2007 showed a primary energy consumption in 2020 of 1 842 Mtoe for the 27 Member States. The same projections show a primary energy consumption in 2020 of 1 853 Mtoe for the 28 Member States including Croatia. A 20 % reduction results in 1 483 Mtoe in 2020, i.e. a reduction of 370 Mtoe as compared to projections. This technical adaptation is necessary to allow Directive 2012/27/EU to be applicable in Croatia.

               (5)

               Directive 2012/27/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2012/27/EU is amended as set out in the Annex to this Directive.
   Article 2
   The amendments set out in the Annex to this Directive shall be without prejudice to the time limit provided for in the first subparagraph of Article 28(1) of Directive 2012/27/EU.
   Article 3
   This Directive shall enter into force subject to and as from the date of the entry into force of the Treaty of Accession of Croatia.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 13 May 2013.

            For the Council

            The President

         S. COVENEY

      (1)  OJ L 315, 14.11.2012, p. 1.

      ANNEX
      Article 3 of Directive 2012/27/EU is amended as follows:

                  (a)

                  point (a) of the second subparagraph of paragraph 1 is replaced by the following:

                              ‘(a)

                              that the Union’s 2020 energy consumption has to be no more than 1 483 Mtoe of primary energy or no more than 1 086 Mtoe of final energy;’;

                  (b)

                  paragraph 2 is replaced by the following:
                  ‘2.   By 30 June 2014, the Commission shall assess progress achieved and whether the Union is likely to achieve energy consumption of no more than 1 483 Mtoe of primary energy and/or no more than 1 086 Mtoe of final energy in 2020.’;

                  (c)

                  point (d) of paragraph 3 is replaced by the following:

                              ‘(d)

                              compare the results under points (a) to (c) with the quantity of energy consumption that would be needed to achieve energy consumption of no more than 1 483 Mtoe of primary energy and/or no more than 1 086 Mtoe of final energy in 2020.’.