Avis juridique important

|

31978L0633

Eighth Commission Directive 78/633/EEC of 15 June 1978 establishing Community methods of analysis for the official control of feedingstuffs

Official Journal L 206 , 29/07/1978 P. 0043 - 0055 Finnish special edition: Chapter 3 Volume 10 P. 0071  Greek special edition: Chapter 03 Volume 22 P. 0067  Swedish special edition: Chapter 3 Volume 10 P. 0071  Spanish special edition: Chapter 03 Volume 14 P. 0230  Portuguese special edition Chapter 03 Volume 14 P. 0230

EIGHT COMMISSION DIRECTIVE  of 15 June 1978  establishing Community methods of analysis for the official control of feedingstuffs  (78/633/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Act of Accession, and in particular Article 2 thereof,  Whereas that Directive requires that official control of feedingstuffs be carried out using Community methods of sampling and analysis for the purpose of checking compliance with requirements arising under the provisions laid down by law, regulation or administrative action concerning the quality and composition of feedingstuffs;  Whereas Commission Directives 71/250/EEC of 15 June 1971 (2), 71/393/EEC of 18 November 1971 (3), 72/199/EEC of 27 April 1972 (4), 73/46/EEC of 5 December 1972 (5), 74/203/EEC of 25 March 1974 (6), 75/84/EEC of 20 December 1974 (7) and 76/372/EEC of 1 March 1976 (8) have already established a number of Community methods of analysis ; whereas the progress of work since then makes it advisable to adopt an eighth set of methods;  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 1. Member States shall require that analyses for official controls of feedingstuffs, as regards their content of zinc bacitracin, flavophospholipol, iron, copper, manganese and zinc, be carried out in accordance with the methods described in the Annex to this Directive.  2. The general provisions set out in Part 1 "Introduction" of the Annex to First Directive 71/250/EEC, with the exception of the part dealing with preparation of the sample to be analyzed, shall apply to the methods described in the Annex to this Directive.   Article 2 Member States shall, on 1 January 1979, bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. They shall forthwith notify the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 15 June 1978.  For the Commission  Finn GUNDELACH  Vice-President  (1)OJ No L 170, 3.8.1970, p. 2. (2)OJ No L 155, 12.7.1971, p. 13. (3)OJ No L 279, 20.12.1971, p. 7. (4)OJ No L 123, 29.5.1972, p. 6. (5)OJ No L 83, 30.3.1973, p. 21. (6)OJ No L 108, 22.4.1974, p. 7. (7)OJ No L 32, 5.2.1975, p. 26. (8)OJ No L 102, 15.4.1976, p. 8.      ANNEX  1. DETERMINATION OF ZINC BACITRACIN BY DIFFUSION IN AN AGAR MEDIUM     1. PURPOSE AND SCOPE  The method is for the determination of zinc bacitracin in feedingstuffs, concentrates and premixes. The lower limit of determination is 5 mg/kg (5 ppm) (*). The method is not valid in the presence of interfering substances, particularly large amounts of copper and ascorbic acid.      2. PRINCIPLE  The sample is extracted at pH 2 with a mixture of methanol/water/hydrochloric acid. The extract is brought to pH 6 75, concentrated (where necessary) and diluted. Its antibiotic activity is determined by measuring the diffusion of zinc bacitracin in an agar medium inoculated with Micrococcus luteus (Syn. M. flavus). Diffusion is shown by the formation of zones of inhibition of the micro-organism. The diameter of these zones is taken to be in direct proportion to the logarithm of the antibiotic concentration over the range of antibiotic concentrations employed.      3. MICRO-ORGANISM : MICROCOCCUS LUTEUS ATCC 10240    3.1. Maintenance of stock culture  Inoculate Micrococcus luteus on to agar slopes of culture medium (4.1). Incubate for 24 hours at 30 to 37 ºC, store in a refrigerator at about 4 ºC and reinoculate every two weeks onto agar slopes.         3.2. preparation of the bacterial suspension (a)     >PIC FILE= "T0013288">      4. CULTURE MEDIA AND REAGENTS        4.1 Culture medium (b)    >PIC FILE= "T9001028">       4.2 Assay medium (b)    >PIC FILE= "T9001029">        4.3 Sodium chloride solution 0 78 % (w/v): dissolve 8 g of sodium chloride a.p. in water and dilute to 1 000 ml; sterilize.     4.4 Mixture of methanol, pure/water/hydrochloric acid a.p. (d: 1 718 to 1 719) : 80/17 75/2 75 (v/v/v).   (*)1 mg feedingstuff grade zinc bacitracin is equivalent to 42 international units (i.u.).  (a)Other methods may be used provided that it has been established that they give similar bacterial suspensions.  (b)Any commercial culture medium of similar composition and giving the same results may be used.       4.5. Phosphate buffer, pH 6 75  Potassium hydrogen phosphate K2HPO4 a.p. (22 715 g).  Potassium dihydrogen phosphate KH2PO4 a.p. (27 785 g).  Water to 1 000 ml.      4.6. Hydrochloric acid a.p. (d : 1 718 to 1 719).      4.7. Hydrochloric acid a.p. (0 71 N).      4.8. Sodium hydroxide 1 N solution a.p.      4.9. Bromocresol purple solution 0 704 % (w/v) : dissolve 0 71 g of bromocresol purple in 18 75 ml of 0 701 N sodium hydroxide solution. Make up the volume to 250 ml with water and mix.      4.10. Standard substance : zinc bacitracin of known activity (in i.u.).          5. STANDARD SOLUTIONS  Weigh out a quantity of standard zinc bacitracin (4.10) corresponding to 1 050 i.u. (according to the activity indicated). Add 5 ml of 0 71 N hydrochloric acid (4.7) and leave to stand for 15 minutes. Add 30 ml of water, adjust the pH to 4 75 with phosphate buffer pH 6 75 (4.5) (about 4 ml), make up to a volume of 50 ml with water and mix well (1 ml = 21 i.u.).  From this solution prepare by successive dilution with phosphate buffer pH 6 75 (4.5) the following solutions: >PIC FILE= "T0013289">     6. PREPARATION OF THE EXTRACT      6.1. Extraction        6.1.1. Concentrates, premixes and mineral feeds  Weigh out a quantity of sample of 2 70 to 5 70 g, add 30 ml of the mixture (4.4) and shake briefly. Check that the pH is about 2. Shake for 10 minutes, add 30 ml of phosphate buffer pH 6 75 (4.5) and shake for 15 minutes. Dilute with phosphate buffer (4.5) to obtain an expected zinc bacitracin content of 0 742 i.u./ml) (= U8).               6.1.2. Protein concentrates  Weigh out a quantity of sample of 10 70 g, add 50 ml of the mixture (4.4) and shake briefly. Check that the pH is about 2. Shake for 10 minutes, add 50 ml of phosphate buffer pH 6 75 (4.5) and shake for 15 minutes. Dilute with phosphate buffer (4.5) to obtain an expected zinc bacitracin content of 0 742 i.u./ml (= U8).               6.1.3. Other feeds  Weigh out a quantity of sample of 10 70 g (20 70 g for an expected zinc bacitracin content of 5 mg/kg), add 25 ml of the mixture (4.4) and homogenize for about 10 minutes. Add 25 ml of phosphate buffer pH 6 75 (4.5), shake for 15 minutes and centrifuge. Take 20 ml of the supernatant solution and adjust the pH to 6 75 by means of 1 N sodium hydroxide solution (4.8) with the bromocresol purple solution (4.9) as indicator. Evaporate to about 4 ml in a rotary evaporator at a temperature not exceeding 35 ºC. Dilute the residue with water to obtain an expected zinc bacitracin content of 0 742 i.u./ml (= U8).                          6.2. Assay solutions  From solution U8 prepare solutions U4 (expected content : 0 721 i.u./ml), U2 (expected content : 0 7105 i.u./ml) and U1 (expected content : 0 70525 i.u./ml) by means of successive dilution (1 + 1) with phosphate buffer (4.5).        7. ASSAY PROCEDURE        7.1. Inoculation of the assay medium  Inoculate the assay medium (4.2) with the bacterial suspension (3.2) at about 50 ºC. By preliminary trials on plates with assay medium (4.2) determine the quantity of bacterial suspension required to give the largest and clearest zones of inhibition with the various concentrations of zinc bacitracin.                7.2. Preparation of the plates  Diffusion through agar is carried out in plates with the four concentrations of the standard solution (S8, S4, S2,S1) and the four concentrations of the assay solution (U8, U4,U2, U1). These four concentrations of extract and standard must necessarily be placed in each plate. To this effect, select plates big enough to allow at least eight holes with a diameter of 10 to 13 mm and not less than 30 mm between centres to be made in the agar medium. The test may be carried out on plates consisting of a sheet of glass with a faced aluminium or plastic ring placed on top, 200 mm in diameter and 20 mm high.  Pour into the plates a quantity of the medium (4.2), inoculated as in point 7.1, to give a layer about 2 mm thick (50 ml for a plate of 200 mm diameter). Allow to set in a level position, bore the holes and place in them exactly measured volumes of assay and standard solutions (between 0 710 and 0 715 ml per hole, according to the diameter).  Apply each concentration at least four times so that each determination is subject to an evaluation of 32 zones of inhibition.               7.3. Incubation  Incubate the plates for 16 to 18 hours at 28 to 30 ºC.     8. EVALUATION  Measure the diameter of the zones of inhibition to the nearest 0 71 mm. Record the mean measurements for each concentration on semi-logarithmic graph paper showing the logarithm of the concentrations in relation to the diameters of the zones of inhibition. Plot the best fit lines of both the standard solution and the extract, for example as below.  Determine the "best fit" point for the standard lowest level (SL) using the formula: >PIC FILE= "T0013290">   Determine the "best fit" point for the standard highest level (SH) using the formula: >PIC FILE= "T0013291">   Similarly calculate the "best fit" points for the extract lowest level (UL) and the extract highest level (UH) by substituting U1, U2, U4 and U8 for S1, S4 and S8 in the above formulae.  Record the calculated SL and SH values on the same graph paper and join them to give the "best fit" line for the standard solution. Similarly record UL and UH and join them to give the "best fit" line for the extract.  In the absence of any interference the lines should be parallel. For practical purposes the lines can be considered parallel if the values (SH-SL) and (UH-UL) do not differ by more than 10 % from their mean value.  If the lines are found to be non-parallel, either U1 and S1 or U8 and S8 may be discarded and SL, SH, UL and UH calculated, using the alternative formulae, to give alternative "best fit" lines: >PIC FILE= "T0013292">   and similarly for UL and UH. The alternative best fit lines should be checked for parallelism as before. The fact that the result has been calculated from three levels should be noted on the final report.  When the lines are considered as being parallel, calculate the logarithm of the relative activity (log. A) by means of one of the following formulae.  For four levels >PIC FILE= "T0013293">    For three levels >PIC FILE= "T0013294">   Real activity = supposed activity × relative activity.  When the lines are considered as not being parallel, repeat the determination. If parallelism is still not achieved, calculate the logarithm of the relative activity (log. A) by means of formula (c). The result obtained must however be considered as approximate and this should be noted in the final report.   9. REPEATABILITY  The difference between the results of two determinations carried out on the same sample by the same analyst should not exceed:  20 % related to the highest value for contents of zinc bacitracin from 5 and up to 25 mg/kg;  5 mg/kg, in absolute value, for contents greater than 25 and up to 50 mg/kg;  10 % related to the highest value for contents above 50 mg/kg.   2. DETERMINATION OF FLAVOPHOSPHOLIPOL BY DIFFUSION IN AN AGAR MEDIUM          1. PURPOSE AND SCOPE  The method is for the determination of flavophospholipol in feedingstuffs, concentrates and premixes. The lower limit of determination is 1 mg/kg (1 ppm).                   2. PRINCIPLE  The sample is extracted with diluted methanol by heating under reflux. After centrifuging, the extract is purified (where necessary) by treatment with ion exchange resins and diluted. Its antibiotic activity is determined by measuring the diffusion of flavophospholipol in an agar medium inoculated with Staphylococcus aureus. Diffusion is shown by the formation of zones of inhibition of the micro-organism. The diameter of these zones is taken to be in direct proportion to the logarithm of the antibiotic concentration over the range of antibiotic concentrations employed.                   3. MICRO-ORGANISM : STAPHYLOCOCCUS AUREUS ATCC 6538 P            3.1. Maintenance of stock culture  Inoculate Staphylococcus aureus onto agar slopes of culture medium (4.1). Incubate for 24 hours at 37 ºC, store in a refrigerator at about 4 ºC arid reinoculate every month onto agar slopes.                       3.2. Preparation of the bacterial suspension (a)  Set aside two tubes containing the stock culture (3.1) and reinoculate them weekly. Incubate for 24 hours at 37 ºC and store in a refrigerator at about 4 ºC.  24 hours before the assay, inoculate with this growth two to four tubes containing slopes of culture medium (4.1). Incubate for 16 to 18 hours at 37 ºC. Make a suspension of the growth in the sodium chloride solution (4.3). The light transmission of the suspension must be about 40 %, measured at 578 nm in a 1 cm cell against sodium chloride solution (4.3).  (a)Other methods may be used provided that it has been established that they give similar bacterial suspensions.      >PIC FILE= "T0013295">      >PIC FILE= "T0013296">     7. PREPARATION OF THE EXTRACT              7.1. Extraction                7.1.1. Concentrates, premixes and mineral feeds  Weigh out a quantity of sample of 2 70 to 5 70 g and add about 150 mg of ascorbic acid (4.13). Homogenize with 150 ml of 50 % methanol (4.5) in a conical flask (5.3) and adjust the pH to 8 71 to 8 72 with about 400 mg of tris(hydroxymethyl)aminomethane (4.7). Check the pH with indicator paper (4.12). Allow to stand for 15 minutes, then readjust the pH to 8 71 to 8 72 with tris(hydroxymethyl)aminomethane (4.7) and boil for 10 minutes under reflux (5.4) with constant stirring. Allow to cool, centrifuge the mixture and decant the extract.                               7.1.2. Other feeds  Weigh out a quantity of samle of 5 70 to 30 70 g containing at least 30 ¶g of flavophospholipol. Homegenize with 150 ml of 50 % methanol (4.5) in a conical flask (5.3) and adjust the pH to 8 71 to 8 72 with about 400 mg of tris(hydroxymethyl)aminomethane (4.7). Check the pH with indicator paper (4.12). Allow to stand for 15 minutes, then readjust the pH to 8 71 to 8 72 with tris(hydroxymethyl)aminomethane (4.7) and boil for 10 minutes under reflux (5.4) with constant stirring. Allow to cool, centrifuge the mixture and decant the extract.                                                          7.2. Purification (this step may be omitted for concentrates, premixes and mineral feeds)  Mix 110 ml of the extract with 11 g of the cation exchanger (4.9), boil for one minute under reflux (5.4) with constant stirring. Separate the cation exchanger by centrifugation or filtration. Mix 100 ml of the extract with 150 ml of methanol (4.4) and store the solution for 12 to 15 hours at 4 ºC. Filter off the flocculent mass while cold.  Insert a glass wool plug (4.11) at the bottom end of a glass tube (5.1), pour into the tube 5 ml of the anion exchanger (4.10) and wash the column with 100 ml of 80 % methanol (4.6). Using the funnel (5.2), transfer to the column a volume of filtrate of at least 100 ml which is expected to contain 16 ¶g of flavophospholipol (200 ml for a 30 g sample of feedingstuff at 1 ppm). Where necessary, before application to the column, dilute the filtrate with 80 % methanol (4.6) to obtain an expected flavophospholipol content of 16 ¶g/100 ml. Adjust the flow rate to about 2 ml/minute. Discard the effluent. Then wash the column with 50 ml of 80 % methanol (4.6) and discard the effluent.  Elute the flavophospholipol with the methanolic solution of potassium chloride (4.8) keeping the flow rate to about 2 ml/minute. Collect 50 ml of the eluate in a graduated flask, add 30 ml of water and mix. This solution should have a flavophospholipol content of 0 72 ¶g/ml (= U8).                           7.3. Assay solutions  Where necessary (i.e. when the purification step has been omitted), dilute the extract obtained in point 7.1.1 with 50 % methanol (4.5) to obtain an expected flavophospholipol content of 0 72 ¶g/ml (= U8).  From solution U8 prepare solutions U4 (expected content : 0 71 ¶g/ml), U2 (expected content : 0 705 ¶g/ml) and U1 (expected content : 0 7025 ¶g/ml) by means of successive dilution (1 + 1) with 50 % methanol (4.5).     8. ASSAY PROCEDURE                8.1. Inoculation of the assay medium  Inoculate the assay medium (4.2.2) with the bacterial suspension (3.2) at about 50 ºC. By preliminary trials on plates with assay medium (4.2.2) determine the quantity of bacterial suspension required to give the largest and clearest zones of inhibition with the various concentrations of flavophospholipol (about 30 ml/litre).                               8.2. Preparation of the plates  Diffusion through agar is carried out in plates with the four concentrations of the standard solution (S8, S4, S2, S1) and the four concentrations of the assay solution (U8, U4, U2, U1). These four concentrations of extract and standard must necessarily be placed in each plate. To this  effect, select plates big enough to allow at least eight holes with a diameter of 10 to 13 mm and not less than 30 mm between centres to be made in the agar medium. The test may be carried out on plates consisting of a sheet of glass with a faced aluminium or plastic ring placed on top, 200 mm in diameter and 20 mm high.  Pour into the plates a quantity of the medium (4.2.1) to give a layer about 1 75 mm thick (45 ml for a plate of 200 mm diameter). Allow to set in a level position and then over-layer with a quantity of the medium (4.2.2) inoculated as in point 8.1 to give a layer 1 mm thick (30 ml for a plate of 200 mm diameter). Allow to set again in a level position, bore the holes and place in them exactly measured volumes of assay and standard solutions (between 0 710 and 0 715 ml per hole, according to the diameter).  Apply each concentration at least four times so that each determination is subject to an evaluation of 32 zones of inhibition.                               8.3. Incubation  Icubate the plates for 16 to 18 hours at 28 to 30 ºC.     9. EVALUATION  Measure the diameter of the zones of inhibition to the nearest 0 71 mm. Record the mean measurements for each concentration on semi-logarithmic graph paper showing the logarithm of the concentrations in relation to the diameters of the zones of inhibition. Plot the best fit lines of both the standard solution and the extract, for example as below.  Determine the "best fit" point for the standard lowest level (SL) using the formula: >PIC FILE= "T0013297">   Similarly calculate the "best fit" points for the extract lowest level (UL) and the extract highest level (UH) by substituting U1, U2, U4 and U8 for S1, S2, S4 and S8 in the above formulae.  Record the calculated SL and SH values on the same graph paper and join them to give the "best fit" line for the standard solution. Similarly record UL and UH and join them to give the "best fit" line for the extract.  In the absence of any interference the lines should be parallel. For practical purposes the lines can be considered parallel if the values (SH-SL) and (UH-UL) do not differ by more than 10 % from their mean value.  If the lines are found to be non-parallel, either U1 and S1 or U8 and S8 may be discarded and SL, SH, UL and UH calculated, using the alternative formulae, to give alternative "best fit" lines: >PIC FILE= "T0013298">   and similarly for UL and UH. The alternative best fit lines should be checked for parallelism as before. The fact that the result has been calculated from three levels should be noted on the final report.  When the lines are considered as being parallel, calculate the logarithm of the relative activity (log. A) by means of one of the following formulae.  For four levels >PIC FILE= "T0013299">    For three levels >PIC FILE= "T0013300">   Real activity = supposed activity × relative activity.  When the lines are considered as not being parallel, repeat the determination. If parallelism is still not achieved, calculate the logarithm of the relative activity (log. A) by means of formula (c). The result obtained must however be considered as approximate and this should be noted in the final report.    10. REPEATABILITY  The difference between the results of two determinations carried out on the same sample by the same analyst should not exceed:  0 75 mg/kg, in absolute value, for contents of flavophospholipol from 1 and up to 2 mg/kg;  25 % related to the highest value for contents greater than 2 and up to 10 mg/kg;  20 % related to the highest value for contents greater than 10 and up to 25 mg/kg;  5 mg/kg, in absolute value, for contents greater than 25 and up to 50 mg/kg;  10 % related to the highest value for contents above 50 mg/kg.    3. DETERMINATION OF THE TRACE ELEMENTS IRON, COOPER, MANGANESE AND ZINC                  1. PURPOSE AND SCOPE  The method makes it possible to determine the trace elements iron, copper, manganese and zinc in feedingstuffs. The lower limits of determination are:  iron (Fe) : 20 mg/kg  copper (Cu) : 10 mg/kg  manganese (Mn) : 20 mg/kg  zinc (Zn) : 20 mg/kg                                   2. PRINCIPLE  The sample is brought into solution in hydrochloric acid after destruction of organic matter, if any. The elements iron, copper, manganese and zinc are determined, after appropriate dilution, by atomic absorption spectrometry.                                   3. REAGENTS  Introductory comments  For preparation of the reagents and analytical solutions use water free from the cations to be determined, obtained either by double distilling water in a borosilicate glass or quartz still or by double treatment on ion exchange resin.  The reagents must be of at least analytical grade (a.p.). Freedom from the element to be determined must be checked in a blank experiment. If necessary, the reagents must be further purified.  In place of the standard solutions decribed below, commercial standard solutions may be used provided that they are guaranteed and have been checked before use.                    3.1. Hydrochloric acid a.p. (d : 1 719).                                       3.2. Hydrochloric acid a.p. (6 N).                                       3.3. Hydrochloric acid a.p. (0 75 N).                                        3.4. Hydrofluoric acid 38 to 40 % (v/v) having an iron content of less than 1 mg Fe/litre and a residue after evaporation of less than 10 mg (as sulphate)/litre.                                       3.5. Sulphuric acid a.p. (d : 1 784).                                       3.6. Hydrogen peroxide a.p. (approximately 100 volumes of oxygen (30 % by weight)).                                       3.7. Standard iron solution (1 000 ¶g Fe/ml) prepared as follows : dissolve 1 g of iron wire a.p. in 200 ml of 6 N hydrochloric acid (3.2), add 16 ml of hydrogen peroxide (3.6) and make up to one litre with water.                      3.7.1. Working standard iron solution (100 ¶g Fe/ml) prepared by diluting the standard solution (3.7) 1 + 9 with water.                                                                                3.8. Standard copper solution (1 000 ¶g Cu/ml) prepared as follows : dissolve 1 g of copper in powder form (a.p.) in 25 ml of 6 N hydrochloric acid (3.2), add 5 ml of hydrogen peroxide (3.6) and make up to one litre with water.                      3.8.1. Working standard copper solution (10 ¶g Cu/ml) prepared by diluting the standard solution (3.8) 1 + 9 with water and then diluting the resulting solution 1 + 9 with water.                                                                                3.9. Standard manganese solution (1 000 ¶g Mn/ml) prepared as follows : dissolve 1 g of manganese in powder form (a.p.) in 25 ml of 6 N hydrochloric acid (3.2) and make up to one litre with water.                      3.9.1. Working standard manganese solution (10 ¶g Mn/ml) prepared by diluting the standard solution (3.9) 1+ 9 with water and then diluting the resulting solution 1 + 9 with water.                                                                                3.10. Standard zinc solution (1 000 ¶g Zn/ml) prepared as follows : dissolve 1 g of zinc in strip or leaf form (a.p.) in 25 ml of 6 N hydrochloric acid (3.2) and make up to one litre with water.                      3.10.1. Working standard zinc solution (10 ¶g Zn/ml) prepared by diluting the standard solution (3.10) 1 + 9 with water and then diluting the resulting solution 1 + 9 with water.                                                                                3.11. Lanthanum choride solution prepared as follows : dissolve 12 g of lanthanum oxide in 150 ml of water, add 100 ml of 6 N hydrochloric acid (3.2) and make up to one litre with water.                                                                          4. APPARATUS                    4.1. Muffle furnace with temperature regulation and recorder.                                       4.2. Glassware must be of resistant borosilicate type and it is recommended to use apparatus which is reserved exclusively for trace element determinations.                                       4.3. Platinum crucible and (optional) quartz crucible.                                       4.4. Atomic absorption spectrophotometer meeting the requirements of the method with regard to sensitivity and precision in the required range.                                                                          5. PROCEDURE                    5.1. Samples containing organic matter                      5.1.1. Ashing and preparation of the solution for analysis (*)                        (i) Place 5 to 10 g of sample weighed to the nearest 0 72 mg in a quartz or platinium crucible (4.3) (see Note (b)), dry in an oven at 105 ºC and introduce the crucible into the cold muffle furnace (4.1). Close the furnace (see Note (c)) and gradually raise the temperature to 450 to 475 ºC over about 90 minutes. Maintain this temperature for 4 to 16 hours (e.g. overnight) to remove carbonaceous material and then open the furnace and allow to cool (see Note (d)).  Wash the crucible out with a total of about 5 ml of hydrochloric acid (3.1) and add the latter slowly and carefully to the beaker (there may be a vigorous reaction due to CO2  (*)Green fodder (fresh or dried) is liable to contain large amounts of vegetable silica, which may retain trace elements and must be removed. For samples of these feedingstuffs, therefore, the following modified procedure must be followed. Carry out operation 5.1.1 (i) as far as the filtration. Wash the filter paper containing the insoluble residue twice with boiling water and place it in a platinum crucible (4.3). Ignite in the muffle furnace (4.1) at a temperature below 550 ºC until all carbonaceous material has completely disappeared. Allow to cool, add a few drops of water followed by 10 to 15 ml of hydrofluoric add (3.4) and evaporate to dryness at about 150 ºC. If any silica remains in the residue, redissolve it in a few millilitres of hydrofluoric add (3.4) and evaporate to dryness. Add five drops of sulphuric acid (3.5) and heat until no more white fumes are given off. After the addition of 5 ml of 6 N hydrochloric acid (3.2) and about 30 ml of water, heat, filter the solution into the 250 ml volumetric flask and make up to the mark with water (HCl concentration about 0 75 N). Proceed then with the determination from point 5.1.3.   formation). Add hydrochloric acid (3.1) dropwise with agitation until all effervescence has  stopped. Evaporate to dryness, occasionally stirring with a glass rod.  Next add 15 ml of 6 N hydrochloric acid (3.2) to the residue followed by about 120 ml of water. Stir with the glass rod, which should be left in the beaker, and cover the beaker with a watchglass. Bring gently to the boil and maintain at boiling point until no more ash can be seen to dissolve. Filter on ash-free filter paper and collect the filtrate in a 250 ml volumetric flask. Wash the beaker and filter with 5 ml of hot 6 N hydrochloric acid (3.2) and twice with boiling water. Fill the volumetric flask up to the mark with water (HCl concentration about 0 75 N).           (ii) If the residue in the filter appears black (carbon), put it back in the furnace and ash again at 450 to 475 ºC. This ashing, which only requires a few hours (about three to five hours), is complete when the ash appears white or nearly white. Dissolve the residue with about 2 ml of hydrochloric acid (3.1), evaporate to dryness and add 5 ml of 6 N hydrochloric acid (3.2). Heat, filter the solution into the volumetric flask and make up to the mark with water (HCl concentration about 0 75 N).  Notes:      (a) In determining trace elements it is important to be alert to the risks of contamination, particularly by zinc, copper and iron. For this reason, the equipment used in preparing the samples must be free of these metals.  To reduce the general risk of contamination, work in a dust-free atmosphere with scrupulously clean equipment and carefully washed glassware. The determination of zinc is particularly sensitive to many types of contamination, e.g. from glassware, reagents, dust, etc.             (b) The weight of sample to be ashed is calculated from the approximate trace element content of the feedingstuff in relation to the sensitivity of the spectrophotometer used. For certain feedingstuffs low in trace elements it may be necessary to start with a 10 to 20 g sample and make up the final solution to only 100 ml.                                                   (c) Ashing must be carried out in a closed furnace without injection of air or oxygen.                                                   (d) The temperature indicated by the pyrometer must not exceed 475 ºC.                                                                                5.1.2. Spectrophotometric determination                        5.1.2.1. Preparation of calibration solutions  For each of the elements to be determined, prepare from the working standard solutions given in points 3.7.1, 3.8.1, 3.9.1 and 3.10.1 a range of calibration solutions, each calibration solution having an HCl concentration of about 0 75 N and (in the cases of iron, manganese and zinc) a lanthanum chloride concentration equivalent to 0 71 % La (w/v). The trace element concentrations selected must lie within the range of sensitivity of the spectrophotometer used. The tables below show, by way of example, the compositions of typical ranges of calibration solutions ; depending, however, on the type and sensitivity of spectrophotometer used it may be necessary to select other concentrations. >PIC FILE= "T0013301">    >PIC FILE= "T0013302">                                                5.1.2.2. Preparation of solution for analysis  For the determination of copper, the solution prepared from point 5.1.1 can normally be used directly. If necessary to bring its concentration within the range of the calibration solutions, an aliquot portion may be pipetted into a 100 ml volumetric flask and made up to the mark with 0 75 N hydrochloric acid (3.3).  For the determination of iron, manganese and zinc, pipette an aliquot portion of the solution prepared from point 5.1.1 into a 100 ml volumetric flask, add 10 ml of lanthanum chloride solution (3.11) and make up to the mark with 0 75 N hydrochloric acid (3.3) (see also point 8 "Observation").                                               5.1.2.3. Blank experiment  The blank experiment must include all the prescribed steps of the procedure except that the sample material is omitted.  The calibration solution "0" must not be used as the blank.                                               5.1.2.4. Measurement of the atomic absorption  Measure the atomic absorption of the calibration solutions and of the solution to be analyzed using an oxidizing air-acetylene flame at the following wavelengths: >PIC FILE= "T0013303">   Carry out each measurement four times.                                                                                5.2. Mineral feedingstuffs  If the sample contains no organic matter, prior ashing is unnecessary. Proceed as described in point 5.1.1 (i) starting from the second paragraph. Evaporation with hydrofluoric acid may be omitted.                                                                          6. CALCULATION OF RESULTS  Using a calibration curve, calculate the trace element concentration in the solution to be analyzed and express the result in milligrams of trace element per kilogram of sample (ppm).                                   7. REPEATABILITY  The difference between the results of zwo parallel determinations carried out on the same sample by the same analyst should not exceed:                    - 5 mg/kg, in absolute value, for contents of the trace element concerned up to 50 mg/kg;                                        - 10 % of the higher result for contents of the trace element concerned from 50 and up to 100 mg/kg;                                       - 10 mg/kg, in absolute value, for contents of the trace element concerned from 100 and up to 200 mg/kg;                                       - 5 % of the higher result for contents of the trace element concerned above 200 mg/kg.                                                                          8. OBSERVATION >PIC FILE= "T0013304">


title: Commission Directive 2011/71/EU of 26 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include creosote as an active substance in Annex I thereto  Text with EEA relevance

text:
               27.7.2011

               EN

               Official Journal of the European Union

               L 195/46

         COMMISSION DIRECTIVE 2011/71/EU
   of 26 July 2011
   amending Directive 98/8/EC of the European Parliament and of the Council to include creosote as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes creosote.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, creosote has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive.

               (3)

               Sweden was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 31 October 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. It follows from the report that the evaluation only covers Grade B and Grade C creosote as specified in European Standard EN 13991:2003.

               (4)

               A stakeholder consultation was launched on 30 April 2008. The outcome of the consultation was made public and discussed in the 30th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market.

               (5)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 17 December 2010 in an assessment report.

               (6)

               It appears from the assessment report that wood preservatives containing creosote may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, when applied on wood in some of the scenarios evaluated. Furthermore, there were strong indications in the abovementioned stakeholder consultation that there are considerable socioeconomic benefits of using creosote in certain applications. Life cycle analyses submitted and published in the context of the consultation have suggested that, in certain cases, no appropriate alternatives to creosote exist, which are less damaging to the environment. It is therefore appropriate to include creosote in Annex I.

               (7)

               However, for certain wood use scenarios presented in the assessment report, unacceptable risks for the environment were identified in the risk assessment.

               (8)

               Furthermore, creosote is considered to be a non-threshold carcinogen and is classified as carcinogen category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (3).

               (9)

               Creosote, which is a mixture of hundreds of compounds, contains mainly polycyclic aromatic hydrocarbons (‘PAHs’). Some of these have been considered by the Committee for Risk Assessment of the European Chemicals Agency as persistent, bioaccumulative and toxic (‘PBT’; anthracene (4)) or very persistent and very bioaccumulative (‘vPvB’; fluoranthene, phenanthrene and pyrene (5)) in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (6).

               (10)

               PAHs are listed as substances subject to release reduction provisions in Annex III to the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (‘POPs’) and in Annex III to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (7).

               (11)

               A guidance document adopted by Decision 2009/4 of the Executive Body to the 1979 Convention on Long-Range Transboundary Air Pollution lists best available techniques to control emissions of POPs from major stationary sources. Part E of Section V of that guidance document specifically addresses emissions of PAHs associated with the preservation of wood using coal tar derived products containing PAHs, such as creosote. The techniques relate to impregnation, storage, handling and use of the wood, and include using alternatives that minimise reliance on PAH-based products. It also recommends best available techniques to be applied if treated wood is burned.

               (12)

               According to the second subparagraph of Article 6(2) of Regulation (EC) No 850/2004 read in conjunction with Annex III to that Regulation, Member States are required to adopt action plans including measures to promote the development and, where they deem appropriate, require the use of substitute or modified materials, products and processes to prevent the formation and release of PAHs. Pursuant to Article 3(3) of Regulation (EC) No 850/2004, Member States and the Commission shall, within the assessment and authorisation schemes for existing chemicals and pesticides under the relevant Union legislation, take appropriate measures to control existing chemicals and pesticides which exhibit characteristics of POPs.

               (13)

               Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (8) identifies PAHs as priority hazardous substances, from which pollution of surface waters through discharge, emission or loss must cease or be phased out.

               (14)

               It is therefore appropriate to limit the inclusion to 5 years only and to make it subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.

               (15)

               Furthermore, biocidal products containing creosote should be authorised only for applications where, all local and other circumstances taken into account, no appropriate alternatives are available. When an application is made for product authorisation or mutual recognition, the Member State receiving the application should therefore ask the applicant for an analysis regarding the technical and economic feasibility of substitution. Based on this analysis and any other information available to it, an authorising Member State should justify their conclusion that there are no appropriate alternatives and report the justification to the Commission at a stage when product authorisations can be expected to have been granted. In this context, to increase transparency, it is appropriate to require Member States to include in the report their information on how the development of alternatives is promoted in accordance with Article 6(2) of Regulation (EC) No 850/2004, either directly or by reference to a published action plan. To further increase transparency, it is appropriate to ensure that this information is made public.

               (16)

               Not all potential uses of wood treated with creosote have been evaluated at the Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (17)

               Entry number 31 in Annex XVII to Regulation (EC) No 1907/2006 regulates the conditions for the use of creosote in wood treatment and for the placing on the market of wood treated with creosote. It is appropriate to require that product authorisations for biocidal products containing creosote are subject to compliance with those restrictions. Through Commission Decisions 1999/832/EC of 26 October 1999 concerning the national provisions notified by the Kingdom of the Netherlands concerning the limitations of the marketing and use of creosote (9), 2002/59/EC of 23 January 2002 concerning draft national provisions notified by the Kingdom of the Netherlands under Article 95(5) of the EC Treaty on limitations on the marketing and use of creosote-treated wood (10), and 2002/884/EC of 31 October 2002 concerning national provisions on restrictions on the marketing and use of creosote-treated wood notified by the Netherlands under Article 95(4) and (5) of the EC Treaty (11), the Commission has authorised the Netherlands to maintain existing and more stringent national provisions notified under the EC Treaty. By virtue of Article 67(3) of Regulation (EC) No 1907/2006, and as stated in the Communication from the Commission pursuant to Article 67(3) of Regulation (EC) No 1907/2006 (12), these restrictions may be maintained until 1 June 2013. They include a prohibition of the use of creosote-treated wood for applications involving contact with surface water or groundwater.

               (18)

               In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level to products containing creosote and used as wood preservatives. Due to the carcinogenic properties of creosote, it is appropriate to require that product authorisations for biocidal products containing the substance are subject to the requirement that all possible measures in accordance with Regulation (EC) No 1907/2006 and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (13) be applied to protect workers, including down-stream users, from exposure during treatment and handling of treated wood. In the view of the risks identified for the soil and aquatic compartments, appropriate measures should be taken to protect those compartments. Instructions should therefore be provided to indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing, or both, and that any losses must be collected for reuse or disposal.

               (19)

               It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance creosote and also to facilitate the proper operation of the biocidal products market in general.

               (20)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (21)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (22)

               Directive 98/8/EC should therefore be amended accordingly.

               (23)

               The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an opinion on the measures provided for in this Directive and the Commission therefore submitted to the Council a proposal relating to the measures and forwarded it to the European Parliament. The Council did not act within the 2-month period provided for by Article 5a of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (14), and the Commission therefore submitted the proposal to the European Parliament without delay. The European Parliament did not oppose the measure within 4 months from the abovementioned forwarding,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   Transposition
   1.   Member States shall adopt and publish, by 30 April 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 May 2013.
   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 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 26 July 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      (3)  OJ L 353, 31.12.2008, p. 1.

      (4)  Member State Committee support document for identification of anthracene as a substance of very high concern, adopted on 8 October 2008.

      (5)  Member State Committee support document for identification of anthracene oil, anthracene low as a substance of very high concern because of its CMR, PBT and vPvB properties, adopted on 4 December 2009.

      (6)  OJ L 396, 30.12.2006, p. 1.

      (7)  OJ L 158, 30.4.2004, p. 7.

      (8)  OJ L 327, 22.12.2000, p. 1.

      (9)  OJ L 329, 22.12.1999, p. 25.

      (10)  OJ L 23, 25.1.2002, p. 37.

      (11)  OJ L 308, 9.11.2002, p. 30.

      (12)  OJ C 130, 9.6.2009, p. 3.

      (13)  OJ L 158, 30.4.2004, p. 50.

      (14)  OJ L 184, 17.7.1999, p. 23.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     ‘45

                     Creosote

                     Creosote
                     EC No: 232-287-5
                     CAS No: 8001-58-9

                     Grade B or Grade C creosote as specified in European Standard EN 13991:2003

                     1 May 2013

                     30 April 2015

                     30 April 2018

                     8

                     Biocidal products containing creosote may only be authorised for uses where the authorising Member State, based on an analysis regarding the technical and economic feasibility of substitution which it shall request from the applicant, as well as on any other information available to it, concludes that no appropriate alternatives are available. Those Member States authorising such products in their territory shall no later than 31 July 2016 submit a report to the Commission justifying their conclusion that there are no appropriate alternatives and indicating how the development of alternatives is promoted. The Commission will make these reports publicly available.
                     The active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) before its inclusion in this Annex is renewed.
                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed at the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 Creosote may only be used under the conditions mentioned in point 2 of the second column of entry No 31 in Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1).

                                 (2)

                                 Creosote shall not be used for the treatment of wood intended for those uses referred to in point 3 of the second column of entry No 31 in Annex XVII to Regulation (EC) No 1907/2006.

                                 (3)

                                 Appropriate risk mitigation measures shall be taken to protect workers, including down-stream users, from exposure during treatment and handling of treated wood in compliance with Regulation (EC) No 1907/2006 and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (2).

                                 (4)

                                 Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

         (1)  OJ L 396, 30.12.2006, p. 1.

         (2)  OJ L 158, 30.4.2004, p. 50.’


title: Council Directive 2005/93/EC of  21 December 2005  amending Directive 69/169/EEC as regards the temporary quantitative restriction on beer imports into Finland

text:
               29.12.2005

               EN

               Official Journal of the European Union

               L 346/16

      COUNCIL DIRECTIVE 2005/93/EC
   of 21 December 2005
   amending Directive 69/169/EEC as regards the temporary quantitative restriction on beer imports into Finland
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 93 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Parliament (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Whereas:

               (1)

               Articles 4 and 5 of Council Directive 69/169/EEC of 28 May 1969 on the harmonisation of provisions laid down by law, regulation or administrative action relating to exemption from turnover tax and excise duty on imports in international travel (3) provide for allowances in respect of excisable goods contained in the luggage of travellers coming from third countries on condition that such imports have no commercial character.

               (2)

               Directive 69/169/EEC allows Finland until 31 December 2005 to restrict the import of beer by individuals to not less than 6 litres per person due to serious economic difficulties of Finnish retail traders in the border region as well as a considerable loss of revenue caused by the increased import of beer from third countries. Finland has applied the allowance only to a limited extent and restricted the import of beer to a maximum 16 litres per person.

               (3)

               The accession of new Member States has provided new opportunities for people travelling from one of the Member States, especially from Estonia, who wish to bring beer into Finland. Finland reacted to this situation by reducing tax rates on alcoholic beverages across the board by, on average, 33 %, which is by far the most significant change for 40 years.

               (4)

               The reduction in alcohol tax rates has led not only to significant losses of excise duty revenue but also to increased problems in relation to alcohol policy and to social and health policy. Furthermore, problems in public order and an increase in alcohol-related crime have arisen.

               (5)

               Finland has requested a derogation from Article 4(1) of Directive 69/169/EEC to apply a maximum limit for beer imports by travellers from third countries of not less than 16 litres per person.

               (6)

               Account should be taken of the geographical situation of Finland, the economic difficulties of the Finnish retail traders located in the border regions and the considerable loss of revenue caused by the increased imports of beer from third countries.

               (7)

               For those reasons and in the light of the current reflections on a general revision of the values and quantities of goods set out in Directive 69/169/EEC, it is appropriate to authorise Finland to apply the requested derogation for a further period until 31 December 2007,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Article 5(9) of Directive 69/169/EEC shall be replaced by the following:

      ‘9.   By way of derogation from Article 4(1), Finland shall be authorised, until 31 December 2007, to apply a maximum quantitative limit of not less than 16 litres for the importation of beer from third countries.’

   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2005. They shall forthwith communicate to the Commission the text of such laws, regulations or administrative provisions, together with a table showing the correlation between them and this Directive.
   When they are adopted by Member States, those measures shall contain a reference to this Directive or shall be accompanied by such a 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 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 day of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 21 December 2005.

            For the Council

            The President

         B. BRADSHAW

      (1)  Opinion delivered on 13 December 2005 (not yet published in the Official Journal).

      (2)  Opinion delivered on 14 December 2005 (not yet published in the Official Journal).

      (3)  OJ L 133, 4.6.1969, p. 6. Directive as last amended by Directive 2000/47/EC (OJ L 193, 29.7.2000, p. 73).


Avis juridique important

|

31998L0041

Council Directive 98/41/EC of 18 June 1998 on the registration of persons sailing on board passenger ships operating to or from ports of the Member States of the Community

Official Journal L 188 , 02/07/1998 P. 0035 - 0039

COUNCIL DIRECTIVE 98/41/EC of 18 June 1998 on the registration of persons sailing on board passenger ships operating to or from ports of the Member States of the Community THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 84(2) 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 laid down in Article 189c of the Treaty (3),(1) Whereas within the framework of the common transport policy further measures must be taken to enhance safety in maritime transport;(2) Whereas the Community is seriously concerned by shipping accidents involving passenger ships which have resulted in massive loss of life, particularly those involving the Herald of Free Enterprise and the Estonia; whereas persons using passenger ships and high-speed passenger craft throughout the Community have the right to expect and to be able to rely on an appropriate level of safety and upon an adequate information system which will facilitate search and rescue and the efficient handling of the aftermath of any accident that might occur;(3) Whereas it is necessary to ensure that the number of passengers on board a passenger ship does not exceed the number for which the ship and its safety equipment have been certified; whereas companies should be able to inform the search and rescue services of the number of persons involved in an accident;(4) Whereas information must be compiled on passengers and crew in order to facilitate search and rescue and the efficient handling of the aftermath of an accident, i.e. identifying the persons involved, providing clearer information on related legal issues and contributing to more appropriate medical care for rescued persons; whereas such information would prevent unnecessary anxiety on the part of relatives and other persons concerned regarding persons on board passenger ships involved in marine accidents in waters for which Member States bear responsibility under the 1979 International Convention on Maritime Search and Rescue (SAR);(5) Whereas passengers should therefore be counted and registered before any ship departs;(6) Whereas Chapter III of the International Convention on the Safety of Life at Sea (the SOLAS Convention) provides for the counting and registration of all persons on board all passenger ships sailing on international voyages, from 1 July 1997 and 1 January 1999 respectively, while permitting Administrations to exempt passenger ships sailing in sheltered waters from those requirements and from the requirement to register if the scheduled voyages of such ships render it impracticable for them to prepare such records; whereas that Chapter of the SOLAS Convention does not apply to domestic voyages and leaves important points of interpretation to the discretion of individual Member States;(7) Whereas this Directive is in accordance with the right of Member States to impose on passenger ships sailing to or from their ports certain requirements more stringent than those laid down in the SOLAS Convention;(8) Whereas in view, in particular, of the internal-market dimension of maritime passenger transport, action at Community level is the most effective way of establishing a common minimum level of safety for ships throughout the Community;(9) Whereas, in view of the principle of proportionality a Council Directive is the appropriate legal instrument as it provides a framework for the Member States' uniform and compulsory application of safety standards while leaving each Member State the right to decide which implementation tools best fit its internal system;(10) Whereas a Member State can ensure compliance with the safety rules applicable on the part of passenger ships flying its flag and the companies that operate them; whereas those rules should not be imposed upon ships operating between ports in third countries; whereas the provisions of the SOLAS Convention apply to those voyages;(11) Whereas the only way of ensuring the safe and efficient handling of the aftermath of accidents for all passenger ships, irrespective of their flags, operating or wishing to operate from their ports, is for the Member States to require effective compliance with the relevant rules as a condition of operating from their ports; whereas the granting of exemptions from those rules cannot be left solely to the flag State since only the port State is in a position to determine the requirements for the best possible search and rescue operations for passenger ships sailing to and from a port;(12) Whereas in order to harmonise safety protection and avoid distortions of competition, Member States should not, for reasons other than those mentioned in this Directive, grant exemptions or derogations from the relevant SOLAS provisions on 'information on passengers` for voyages starting from or arriving at Community ports;(13) Whereas for reasons of practicability and to avoid distortion of competition, a uniform approach must be established to determine the voyages for which the registration of all persons on board should be mandatory; whereas the twenty-mile threshold is the result of taking into consideration general principles and specific points of concern endorsed by all Member States;(14) Whereas, for specific operational reasons, the counting of persons on board passenger ships crossing the Strait of Messina might, for a limited period of time, be done in a simpler way than individual counting; whereas Member States should enjoy the possibility of granting some relaxation from the obligation to communicate to the shore the number of persons in the case of passenger ships operating on regular services of short duration carried out exclusively in protected sea areas, as defined in this Directive; whereas passenger ships operating exclusively in protected sea areas constitute a more limited risk and should, therefore, enjoy the possibility of exemption; whereas in certain specific circumstances it may be impracticable for shipping companies to register persons on board and therefore a derogation from the obligation to register could be permitted under specific circumstances and well defined conditions;(15) Whereas the collection and processing of data concerning named individuals must be carried out in accordance with the principles of data protection laid down in Directive 95/46/EC (4); whereas, in particular, individuals should be fully informed at the time of collection of the purposes for which the data are required, and the data should be retained only for a very short period which should not in any case be any longer than necessary for the purposes of this Directive;(16) Whereas it is necessary that a committee consisting of representatives of the Member States assist the Commission in the effective application of this Directive; whereas the committee set up by Article 12 of Directive 93/75/EEC (5) can assume that function;(17) Whereas certain provisions of this Directive may be adapted by that Committee to take into account future amendments to the SOLAS Convention that have entered into force,HAS ADOPTED THIS DIRECTIVE:Article 1 The purpose of this Directive shall be to enhance the safety and possibilities of rescue of passengers and crew on board passenger ships operating to or from ports in Member States of the Community and to ensure that search and rescue and the aftermath of any accident which may occur can be dealt with more effectively.Article 2 For the purposes of this Directive:- 'persons` shall mean all people on board irrespective of age,- 'passenger ship` shall mean a sea-going ship or a sea-going high-speed craft which carries more than twelve passengers,- 'high-speed craft` shall mean a high-speed craft as defined in Regulation 1 of Chapter X of the 1974 SOLAS Convention, as in force at the time of the adoption of this Directive,- 'company` shall mean the owner of a passenger ship or any other organisation or person such as the manager or the bareboat charterer, who has assumed responsibility for operating the passenger ship from the owner,- 'ISM Code` shall mean the International Management Code for the Safe Operation of Ships and for Pollution Prevention adopted by the International Maritime Organization (IMO) through Assembly Resolution A.741(18) of 4 November 1993,- 'passenger registrar` shall mean the responsible shore-based person designated by a company to fulfil the ISM Code obligations or a shore-based person designated by a company as responsible for the keeping of information on persons who have embarked on a company passenger ship,- 'designated authority` shall mean the competent authority of the Member State responsible for search and rescue or concerned with the aftermath of an accident,- 'a mile` is 1 852 metres,- 'protected sea area` shall mean a sea area sheltered from open sea effects where a ship is at no time more than six miles from a place of refuge where shipwrecked persons can land and in which the proximity of search and rescue facilities is ensured,- 'regular service` shall mean a series of ship crossings operated so as to serve traffic between the same two or more ports, either:(a) according to a published timetable, or(b) with crossings so regular or frequent that they constitute a recognizable systematic series,- 'third country` shall mean any country which is not a Member State.Article 3 This Directive shall apply to passenger ships with the exception of:- ships of war and troop ships, and- pleasure yachts unless they are or will be crewed and carry more than twelve passengers for commercial purposes.Article 4 1. All persons on board any passenger ship which departs from a port located in a Member State shall be counted before that passenger ship departs.2. Before the passenger ship departs the number of persons on board shall be communicated to the master of the passenger ship and to the company's passenger registrar or to a shore-based company system that performs the same function.Article 5 1. The following information shall be recorded regarding every passenger ship that departs from a port located in a Member State to undertake a voyage of more than twenty miles from the point of departure:- the family names of the persons on board,- their forenames or initials,- their sex,- an indication of the category of age (adult, child or infant) to which each person belongs, or the age, or the year of birth,- when volunteered by a passenger, information concerning the need for special care or assistance in emergency situations.2. That information shall be collected before departure and communicated not later than thirty minutes after the passenger ship's departure to the company's passenger registrar or to a shore-based company system that performs the same function.Article 6 1. Each Member State shall, as regards every passenger ship that flies its flag and departs from a port located outwith the Community and is bound for a port located within the Community, require the company to ensure that the information specified in Articles 4(1) and 5(1) is provided as laid down in Articles 4(2) and 5(2).2. Each Member State shall, as regards every passenger ship that flies the flag of a third country and departs from a port located outwith the Community and is bound for a port located within the Community, require the company to ensure that the information specified in Articles 4(1) and 5(1) is collected and maintained so that it is available to the designated authority when needed for purposes of search and rescue and in the aftermath of an accident.3. Where under the relevant SOLAS provisions a Member State grants an exemption or derogation relating to the information concerning passengers to a ship flying its flag arriving at a port located within the Community from a port located outwith the Community, it may do so only under the conditions laid down for exemptions or derogations in this Directive.Article 7 Before a passenger ship departs from a port located in a Member State its master shall ensure that the number of persons on board does not exceed the number the passenger ship is permitted to carry.Article 8 Each company assuming responsibility for operating a passenger ship shall, where required under Articles 4 and 5:- set up a system for the registration of passenger information. The system shall meet the criteria laid down in Article 11,- appoint a passenger registrar responsible for the keeping and the transmission of that information should an emergency occur or in the aftermath of an accident.The company shall ensure that the information required by this Directive is at all times readily available for transmission to the designated authority for search and rescue purposes in the event of an emergency or in the aftermath of an accident.Personal data collected in accordance with Article 5 shall not be kept longer than necessary for the purposes of this Directive.The company shall ensure that information concerning persons who have declared a need for special care or assistance in emergency situations is properly recorded and communicated to the master before the passenger ship departs.Article 9 1. A Member State from a port in which a passenger ship departs may lower the twenty-mile threshold laid down in Article 5.Any decision lowering that threshold for journeys between two ports in different Member States shall be taken jointly by those two Member States.2. (a) When implementing Article 4(1) the Italian Republic may, for regular services crossing the Strait of Messina, adopt provisions for counting the maximum number of persons permitted to be carried on board a passenger ship carrying passenger-train carriages and road vehicles on the basis of the maximum number of passengers authorised to be carried by train carriages and all other vehicles on board, if the persons cannot be counted individually for operational reasons. The application of this provision shall be limited to a period of four years. Any extension shall be decided, in accordance with paragraph 3, in the light of the experience gained.(b) A Member State from a port in which a ship departs may exempt passenger ships operating, exclusively in protected sea areas, regular services of less than one hour between port calls from the obligation laid down in Article 4(2) to communicate the number of persons on board to the passenger registrar or to a shore-based company system that performs the same function.(c) A Member State may exempt passenger ships sailing, exclusively in protected sea areas, between two ports or from and to the same port without intermediate calls from the obligations laid down in Article 5.3. In the circumstances set out in paragraph 2, the following procedure shall apply:(a) the Member State shall without delay inform the Commission of its decision to grant an exemption or a derogation from the relevant provisions of Articles 4 and 5 giving substantive reasons therefor;(b) if within six months of such notification the Commission considers that that decision is not justified or could have adverse effects on competition, it may, acting in accordance with the procedure laid down in Article 13, require the Member State to amend or withdraw its decision.4. For regular services in an area where the annual probability of the significant wave height's exceeding two metres is less than 10%, and- if the voyage does not exceed about thirty miles from the point of departure or- where the primary purpose of the service is to provide regular links to outlying communities for customary purposes,a Member State from a port in which passenger ships sail on domestic voyages or two Member States between ports in which passenger ships sail may request the Commission, if they consider it impracticable for companies to record the information specified in Article 5(1) to derogate, wholly or partly, from this requirement.To this end, evidence of such impracticability shall be provided. In addition, it shall be demonstrated that in the area where such ships operate, shore-based navigational guidance and reliable weather forecasts are provided and that adequate and sufficient search and rescue facilities are available. Derogations granted under this paragraph may not have any adverse effect on competition.A decision shall be taken in accordance with the procedure laid down in Article 13.5. A Member State shall not, under the provisions of this Directive, exempt or grant derogations to any passenger ship sailing from its ports and flying the flag of a third country that is a contracting party to the SOLAS Convention which under the relevant SOLAS provisions does not agree to the application of such exemptions.Article 10 The registration systems set up in accordance with Article 8 shall be approved by the Member States.Member States shall at least carry out random checks on the proper functioning of the registration systems set up pursuant to this Directive within their territories.Each Member State shall designate the authority to which the companies covered by Article 8 shall communicate the information required by this Directive.Article 11 1. For the purposes of this Directive registration systems shall meet the following functional criteria:(i) readability:the required data must be in a format that is easy to read,(ii) availability:the required data must be easily available to the designated authorities for which the information contained in the system is relevant,(iii) facilitation:the system must be designed in such a way that no undue delay is caused for passengers embarking and/or disembarking the vessel;(iv) security:the data must be appropriately protected against accidental or unlawful destruction or loss and unauthorised alteration, disclosure or access.2. A multiplicity of systems on the same or similar routes is to be avoided.Article 12 Without prejudice to the procedures for amending the SOLAS Convention, this Directive may be amended in accordance with the procedure laid down in Article 13, in order to ensure the application, for the purposes of this Directive and without broadening its scope, of subsequent amendments to the SOLAS Convention relating to the registration systems which have entered into force after the adoption of this Directive.Article 13 The Commission shall be assisted by the committee set up pursuant to Article 12(1) of Directive 93/75/EEC. The committee shall operate in accordance with the procedure laid down in paragraphs 2 and 3 of that Article.Article 14 Member States shall lay down systems of penalties for breaching the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that those penalties are applied. The penalties thus provided for shall be effective, proportionate and dissuasive.Article 15 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1999. They shall forthwith inform the Commission thereof. Article 5 shall be applied no later than 1 January 2000.2. When the Member States adopt those measures, they shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such references shall be laid down by the Member States.3. The Member States shall immediately communicate to the Commission the texts of all provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.Article 16 This Directive shall enter into force on the twentieth day after its publication.Article 17 This Directive is addressed to the Member States.Done at Luxembourg, 18 June 1998.For the CouncilThe PresidentG. STRANG(1) OJ C 31, 31. 1. 1997, p. 5 and OJ C 275, 11. 9. 1997, p. 7.(2) OJ C 206, 7. 7. 1997, p. 111.(3) Opinion of the European Parliament of 29 May 1997 (OJ C 138, 16. 6. 1998, p. 31), Council common position of 11 December 1997 (OJ C 23, 23. 1. 1998, p. 17), and Decision of the European Parliament of 11 March 1998 (OJ C 104, 6. 4. 1998).(4) OJ L 281, 23. 11. 1995, p. 31.(5) OJ L 247, 5. 10. 1993, p. 19.


Avis juridique important

|

32003L0039

Commission Directive 2003/39/EC of 15 May 2003 amending Council Directive 91/414/EEC to include propineb and propyzamide as active substances (Text with EEA relevance)

Official Journal L 124 , 20/05/2003 P. 0030 - 0032

Commission Directive 2003/39/ECof 15 May 2003amending Council Directive 91/414/EEC to include propineb and propyzamide as active substances(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant-protection products on the market(1), as last amended by Commission Directive 2003/31/EC(2), and in particular Article 6(1) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant-protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes propineb and propyzamide.(2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. In accordance with Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant-protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92: for propineb: rapporteur Member State Italy, all relevant information was submitted on 17 July 1996; for propyzamide: rapporteur Member State Sweden, all relevant information was submitted on 19 May 1998.(3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.(4) In accordance with Article 6(4) of Directive 91/414/EEC and in view of a possible unfavourable decision for propineb, the Commission organised a tripartite meeting with the main data submitter and the rapporteur Member State on 4 December 1997. The main data submitter provided further data in order to meet the initial concerns.(5) The reviews of all active substances were finalised on 26 February 2003 in the format of the Commission review reports for propineb and propyzamide.(6) The review of propyzamide did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.(7) The report on propineb and further information were also submitted to the Scientific Committee for Plants for separate consultation. The Scientific Committee was asked to comment on the long-term exposure assessment for birds and on the appropriate animal model to be used for derivation of the acceptable daily intake (ADI) and the acceptable operator exposure level (AOEL). In its opinion(7) the Committee identified a number of respects in which the risks from propineb to birds and from propineb and the metabolite PTU to wild mammals have not been adequately addressed and also indicated ways to improve the risk assessment. Additionally, the Committee emphasised the necessity of a clear expression and justification of all end points, data, assumptions and rationales used for risk assessment. The Committee considered that the rat is the appropriate species for the derivation of ADI and AOEL. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the review report. After the missing information was subsequently delivered by the main notifier and evaluated by the rapporteur Member State, the Member States within the Standing Committee concluded that the risk for birds and wild mammals would be acceptable if appropriate risk-mitigation measures are applied.(8) It has appeared from the various examinations made that plant-protection products containing propineb or propyzamide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant-protection products containing this active substance can be granted in accordance with the provisions of that Directive.(9) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties.(10) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will resulting from the inclusion.(11) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant-protection products containing propineb or propyzamide, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant-protection product in accordance with the uniform principles laid down in Directive 91/414/EEC.(12) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(13) 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 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 30 September 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 October 2004.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.Article 31. Member States shall review the authorisation for each plant-protection product containing propineb or propyzamide to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 September 2004 at the latest, they shall amend or withdraw the authorisation.2. Member States shall, for each authorised plant-protection product containing propineb or propyzamide as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 March 2004 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 March 2008 at the latest, they shall amend or withdraw the authorisation.Article 4This Directive shall enter into force on 1 April 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 15 May 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 101, 23.4.2003, p. 3.(3) OJ L 366, 15.12.1992, p. 10.(4) OJ L 259, 13.10.2000, p. 27.(5) OJ L 107, 28.4.1994, p. 8.(6) OJ L 225, 22.9.1995, p. 1.(7) Opinion of the Scientific Committee on Plants on specific questions from the Commission regarding the evaluation of propineb in the context of Council Directive 91/414/EEC (SCP/PROPINEB/002 final adopted 8 November 2001).ANNEXThe following entries shall be added at the end of the table in Annex I to Directive 91/414/EC">TABLE>"