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31984L0004

Commission Directive 84/4/EEC of 20 December 1983 amending Directives 71/393/EEC, 72/199/EEC and 78/633/EEC establishing Community methods of analysis for the official control of feedingstuffs

Official Journal L 015 , 18/01/1984 P. 0028 - 0038 Finnish special edition: Chapter 3 Volume 17 P. 0033  Spanish special edition: Chapter 03 Volume 29 P. 0233  Swedish special edition: Chapter 3 Volume 17 P. 0033  Portuguese special edition Chapter 03 Volume 29 P. 0233

*****COMMISSION  DIRECTIVE  of 20 December 1983  amending Directives 71/393/EEC, 72/199/EEC and 78/633/EEC establishing Community methods of analysis for the official control of feedingstuffs  (84/4/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 of Greece, and in particular Article 2 thereof,  Whereas Commission Directives 71/393/EEC (2), 72/199/EEC (3) and 78/633/EEC (4) set out the methods of analysis for crude oils and fats, virginiamycin and zinc bacitracin; whereas there is a need to replace these methods by methods which reflect advances in scientific and technical knowledge;  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 the Annex to Directive 71/393/EEC, part IV 'Determination of crude oils and fats' is replaced by Annex I to this Directive.  Article 2  In Annex II to Directive 72/199/EEC, part 5 'Determination of virginiamycin by diffusion in an agar medium' is replaced by Annex II to this Directive.  Article 3  In the Annex to Directive 78/633/EEC, part 1 'Determination of zinc bacitracin by diffusion in an agar medium' is replaced by Annex III to this Directive.  Article 4  Member States shall, by 1 June 1984 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof.  Article 5  This Directive is addressed to the Member States.  Done at Brussels, 20 December 1983.  For the Commission  Poul DALSAGER  Member of the Commission  (1) OJ No L 170, 3. 8. 1970, p. 2.  (2) OJ No L 279, 20. 12. 1971, p. 7.  (3) OJ No L 123, 29. 5. 1972, p. 6.  (4) OJ No L 206, 29. 7. 1978, p. 43.  ANNEX I  '4. DETERMINATION OF CRUDE OILS AND FATS  1. Purpose and scope  This method makes it possible to determine the content of crude oils and fats in feedingstuffs. It does not cover the analysis of the oil seeds and oleaginous fruit defined in Council Regulation 136/66/EEC of 22 September 1966.  Depending on the nature of the feedingstuff, either of the two methods described must be used.  1.1. Method A  Applicable to sraight feedingstuffs of plant origin, with the exception of those which are known to contain oils and fats which cannot be totally extracted with light petroleum without prior hydrolysis. Among these are glutens, yeasts, soya and potato proteins. This method is also applicable to compound feedingstuffs, with the exception of those which contain milk powder or from which oils and fats cannot be totally extracted with light petroleum without prior hydrolysis.  1.2. Method B  Applicable to straight feedingstuffs of animal origin as well as to feedingstuffs mentioned under point 1.1 as being exceptions for method A.  2. Principle  2.1. Method A  The sample is extracted with light petroleum. The solvent is distilled off and the residue dried and weighed.  2.2. Method B  The sample is treated under heating with hydrochloric acid. The mixture is cooled and filtered. The residue is washed and dried and submitted to the determination according to method A.  3. Reagents  3.1. Light petroleum, boiling range: 40 to 60 °C. The bromine value must be less than 1 and the residue of evaporation less than 2 mg/100 ml.  3.2. Sodium sulphate, anhydrous.  3.3. Hydrochloric acid 3N.  3.4. Filtration aid, e.g. Kieselgur, Hyflo-supercel.  4. Apparatus  4.1. Extraction apparatus. If fitted with a siphon (Soxhlet apparatus), the reflux rate should be such as to produce about 10 cycles per hour; if of the non-siphoning type, the reflux rate should be about 10 ml per minute.  4.2. Extraction thimbles, free of matter soluble in light petroleum and having a porosity consistent with the requirements of point 4.1.  4.3. Drying oven, either a vacuum oven set at 75 ± 3 °C or an air-oven set at 100 ± 3 °C.  5. Procedure  5.1. Method A (see point 8.1)  Weigh 5 g of the sample to the nearest 1 mg, transfer it to an extraction thimble (4.2) and cover with a fat-free wad of cotton wool.  Place the thimble in an extractor (4.1) and extract for six hours with light petroleum (3.1). Collect the light petroleum extract in a dry, weighed flask containing fragments of pumice stone (1).  Distil off the solvent. Dry the evaporation residue maintaining the flask for one and a half hours in the drying oven (4.3). Leave to cool in a dessiccator and weigh. Dry again for 30 minutes to ensure that the weight of the oils and fats remains constant (loss in weight between two successive weighings must be less than 1 mg).  5.2. Method B  Weigh 2,5 g of the sample to the nearest 1 mg (see point 8.2), place in a 400 ml beaker or a 300 ml conical flask and add 100 ml of hydrochloric acid 3N (3.3) and fragments of pumice stone. Cover the beaker with a watch glass or fit the conical flask with a reflux condenser. Bring the mixture to a gentle boil over a low flame or a hot-plate and keep it there for one hour. Do not allow the product to stick to the sides of the container.  Cool and add a quantity of filtration aid (3.4) sufficient to prevent any loss of oil and fat during filtration. Filter through a moistened, fat-free, double filter paper. Wash the residue in cold water until a neutral filtrate is obtained. Check that the filtrate does not contain any oil or fats. Their presence indicates that the sample must be extracted with light petroleum, using method A, before hydrolysis.  Place the double filter paper containing the residue on a watch glass and dry for one and a half hours in the oven at 100 ± 3 °C.  Place the double filter paper containing the dry residue in an extraction thimble (4.2) and cover with a fat-free wad of cotton wool. Place the thimble in an extractor (4.1) and proceed as indicated in the second and third paragraphs of point 5.1.  6. Expression of result  Express the weight of the residue as a percentage of the sample.  7. Repeatability  The difference between the results of two parallel determinations carried out on the same sample by the same analyst should not exceed:  - 0,2 %, in absolute value, for contents of crude oils and fats lower than 5 %,  - 4,0 % related to the highest result for contents of 5 to 10 %,  - 0,4 % in absolute value, for contents above 10 %.  8. Observations  8.1. For products with a high content of oils and fats, which are difficult to crush or unsuitable for drawing a homogeneous reduced test sample, proceed as follows.  Weigh 20 g of the sample to the nearest 1 mg and mix with 10 g or more of anhydrous sodium sulphate (3.2). Extract with light petroleum (3.1) as indicated in point 5.1. Make up the extract obtained to 500 ml with light petroleum (3.1) and homogenize. Take 50 ml of the solution and place in a small, dry, weighed flask containing fragments of pumice stone (1). Distil off the solvent, dry and proceed as indicated in the last paragraph of point 5.1.  Eliminate the solvent from the extraction residue left in the thimble, crush the residue to a fineness of 1 mm, return it to the extraction thimble (do not add sodium sulphate) and proceed as indicated in the second and third paragraphs of point 5.1.  Calculate the content of oils and fats as a percentage of the sample by using the following formula:  (10 a + b) × 5  where:  a = mass in grams of the residue after the first extraction (aliquot part of the extract),  b = mass in grams of the residue after the second extraction.  8.2. For products low in oils and fats the test sample may be increased to 5 g.'  (1) Where the oil or fat has to undergo subsequent quality tests, replace the fragments of pumice stone by glass beads.  (1) Where the oil or fat has to undergo subsequent quality tests, replace the fragments of pumice stone by glass beads.  ANNEX II  '5. Determination of virginiamycin  - by diffusion in an agar medium -  1. Purpose and scope  The method is for the determination of virginiamycin in feedingstuffs and premixes. The lower limit of determination is 2 mg/kg (2 ppm) (1).  2. Principle  The sample is extracted with a methanolic solution of Tween 80. The extract is decanted or centrifuged and diluted. Its antibiotic activity is determined by measuring the diffusion of virginiamycin in an agar medium inoculated with Micrococcus luteus. 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 9341 (NCTC 8340, NCIB 8553)  3.1. Maintenance of stock culture  Inoculate tubes containing slopes of culture medium (4.1) with Micrococcus luteus and incubate for 24 hours at 30 °C. Store the culture in a refrigerator at about 4 °C. Reinoculate every two weeks.  3.2. Preparation of the bacterial suspension (a)  Harvest the growth from a recently prepared agar slope (3.1) with 2 to 3 ml of sodium cloride solution (4.3). Use this suspension to inoculate 250 ml of culture medium (4.1) contained in a Roux flask and incubate for 18 to 20 hours at 30 °C. Harvest the growth in 25 ml of sodium chloride solution (4.3) and mix. Dilute the suspension to 1/10 with sodium chloride solution (4.3). The light transmission of the suspension must be about 75 %, measured at 650 nm in a 1 cm cell against sodium chloride solution (4.3). This suspension may be kept for one week at about 4 °C.  4. Culture media and reagents  4.1. Culture and assay medium (b)  1.2 // Meat peptone  // 6,0 g  // Tryptone  // 4,0 g  // Yeast extract  // 3,0 g  // Meat extract  // 1,5 g  // Glucose  // 1,0 g  // Agar  // 10,0 to 20,0 g  // Water  // 1 000 ml  // ph 6,5 (after sterilization).  //  4.2. Phosphate buffer, pH 6  1.2 // Potassium hydrogen phosphate, K2HPO4  // 2,0 g  // Potassium dihydrogen phosphate, KH2PO4  // 8,0 g  // Water to  // 1 000 ml  4.3. Sodium chloride solution 0,8 % (w/v): dissolve 8 g sodium chloride in water and dilute to 1 000 ml; sterilize.  4.4. Methanol.  4.5. Mixture of phosphate buffer (4.2)/methanol (4.4): 80/20 (v/v).  4.6. Tween 80 methanolic solution 0,5 % (w/v): dissolve 5 g Tween 80 in methanol (4.4) and dilute with methanol to 1 000 ml.  4.7. Standard substance: virginiamycin of known activity.  5. Standard solutions  Dissolve an accurately weighed quantity of the standard substance (4.7) in methanol (4.4) and dilute with methanol (4.4) to give a stock solution containing 1 000 mg virginiamycin per ml.  Stored in a stoppered flask at 4 °C this solution is stable for up to five days.  From this stock solution prepare by successive dilution with the mixture (4.5) the following solutions:  s8 1 mg/ml  s4 0,5 mg/ml  s2 0,25 mg/ml  s1 0,125 mg/ml  6. Preparation of the extract and assay solutions  6.1. Extraction  6.1.1. Products with a virginiamycin content up to 100 mg/kg  Weigh out a quantity of sample of 50 g, add 200 ml of solution (4.6) and shake for 30 minutes. Leave to settle or centrifuge, take 20 ml of the supernatant solution and evaporate to about 5 ml in a rotary evaporator at a temperature not exceeding 40 °C. Dilute the residue with the mixture (4.5) to obtain an expected virginiamycin content of 1 mg/ml (= u8).  6.1.2. Products with a virginiamycin content greater than 100 mg/kg  Weigh out a quantity of sample not exceeding 10,0 g and containing between 1 and 50 mg virginiamycin, add 100 ml of solution (4.6) and shake for 30 minutes. Leave to settle or centrifuge, then dilute the supernatant solution with the mixture (4.5) to obtain an expected virginiamycin content of 1 m g/ml (= u8).  6.2. Assay solutions  From solution u8 prepare solutions u4 (expected content: 0,5 m g/ml), u2 (expected content: 0,25 mg/ml) and u1 (expected content: 0,125 mg/ml) by means of successive dilution (1 + 1) with the mixture (4.5).  7. Assay procedure  7.1. Inoculation of the assay medium  Inoculate the assay medium (4.1) with the bacterial suspension (3.2) at about 50 °C. By preliminary trials on plates with the medium (4.1) determine the quantity of bacterial suspension required to give the largest and clearest zones of inhibition with the various concentrations of virginiamycin.  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 and s1) and the four concentrations of the assay solution (u8, u4, u2 and 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 (4.1) inoculated as in point 7.1, to give a layer about 2 mm thick (60 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 0,10 and 0,15 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 30 ± 2 °C.  8. Evaluation  Measure the diameter of the zones of inhibition to the nearest 0,1 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:  1.2 // (a) SL =  // 7s1 + 4s2 + s4 - 2s8 10  Determine the ''best fit" point for the standard highest level (SH) using the formula:  1.2 // (b) SH =  // 7s8 + 4s4 + s2 - 2s1 10  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:  1.2.3.4 // (a' ) SL =  // 5s1 + 2s2 - s4 6  // or  // 5s2 + 2s4 - s8 6  // (b' ) SH =  // 5s4 + 2s2 - s1 6  // or  // 5s8 + 2s4 - s2 6  and similarly for UL and UH. The same criteria of parallelism should be satisfied. 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, depending upon whether three or four levels have been used for the assessment of parallelism.  For four levels  1.2 // (c) Log A =  // (u1 + u2 + u4 + u8 - s1 - s2 - s4 - s8) × 0,602 u4 + u8 + s4 + s8 - u1 - u2 - s1 - s2  For three levels  1.2 // (d) Log A =  // (u1 + u2 + u4 - s1 - s2 - s4) × 0,401 u4 + s4 - u1 - s1  // or  //   // (d' ) Log A =  // (u2 + u4 + u8 - s2 - s4 - s8) × 0,401 u8 + s8 - u2 - s2  Activity of sample extract = activity of relevant standard × A  (u8 = s8 × A)  If the relative activity is found to be outside the range of 0,5 to 2,0, then repeat the assay making appropriate adjustments to the extract concentrations or, if this is not possible, to the standard solutions. When the relative activity cannot be brought into the required range, any result obtained must be considered as approximate and this should be noted on the final report.  When the lines are considered as not being parallel, repeat the determination. If parallelism is still not achieved, the determination must be considered as unsatisfactory.  Express the result in milligrams of virginiamycin per kilogram of feedingstuff. 9. Repeatability  The difference between the results of two parallel determinations carried out on the same sample by the same analyst should not exceed:  - 2 mg/kg, in absolute value, for contents of virginiamycin up to 10 mg/kg,  - 20 % related to the highest value for contents of 10 to 25 mg/kg,  - 5 mg/kg, in absolute value, for contents of 25 to 50 mg/kg,  - 10 % related to the highest value for contents above 50 mg/kg.'  (1) 1 mg virginiamycin is equivalent to 1 000 UK units.  (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.  ANNEX III  '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 and premixes. The lower limit of determination is 5 mg/kg (5 ppm) (1).  2. Principle  The sample is extracted at pH 2 with a mixture of methanol/water/hydrochloric acid, and a sodium sulphide solution. The addition of sodium sulphide is to precipitate any soluble copper salts that may interfere with the assay. The extract is brought to pH 6,5, 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 (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 (flavus) ATCC 10240  3.1. Maintenance of stock culture  Inoculate tubes containing slopes of culture medium (4.1) with Micrococcus luteus (flavus) and incubate for 24 hours at 30 °C. Store the culture in a refrigerator at about 4 °C. Reinoculate every two weeks.  3.2. Preparation of the bacterial suspension (a)  Harvest the growth from a recently prepared agar slope (3.1) with 2 to 3 ml of sodium chloride solution (4.3). Use this suspension to inoculate 250 ml of culture medium (4.1) contained in a Roux flask and incubate for 18 to 20 hours at 30 °C. Harvest the growth in 25 ml of sodium chloride solution (4.3) and mix. Dilute the suspension to 1/10 with sodium chloride solution (4.3). The light transmission of the suspension must be about 75 %, measured at 650 nm in a 1 cm cell against sodium chloride solution (4.3). This suspension may be kept for one week at about 4 °C.  4. Culture media and reagents  4.1. Culture medium (b)  1.2 // Meat peptone  // 6,0 g  // Tryptone  // 4,0 g  // Yeast extract  // 3,0 g  // Meat extract  // 1,5 g  // Glucose  // 1,0 g  // Agar  // 10,0 to 20,0 g  // Water  // 1 000 ml  // pH 6,5 to 6,6 (after sterilization).  //  4.2. Assay medium (b)  1.2 // Tryptone  // 10,0 g  // Yeast extract  // 3,0 g  // Meat extract  // 1,5 g  // Glucose  // 1,0 g  // Agar  // 10,0 to 20,0 g  // Tween 80  // 1 ml  // Water  // 1 000 ml  // pH 6,5 (after sterilization).  //  4.3. Sodium chloride solution 0,8 % (w/v): dissolve 8 g sodium chloride in water and dilute to 1 000 ml; sterilize.  4.4. Mixture of methanol/water hydrochloric acid (4.6):  80/17,5/2,5 (v/v/v).  4.5. Phosphate buffer, pH 6,5:  1.2 // Potassium hydrogen phosphate K2HPO4  // 22,15 g.  // Potassium dihydrogen phosphate KH2PO4  // 27,85 g.  // Water to  // 1 000 ml.  4.6. Hydrochloric acid (d: 1,18 to 1,19).  4.7. Hydrochloric acid (0,1 M).  4.8. Sodium hydroxide 1 M solution.  4.9. Sodium sulphide about 0,5 M solution.  4.10. Bromocresol purple solution 0,04 % (w/v): dissolve 0,1 g of bromocresol purple in 18,5 ml of 0,01 M sodium hydroxide solution. Make up the volume to 250 ml with water and mix.  4.11. Standard substance: zinc bacitracin of known activity (in i. u.).  5. Standard solutions  Weigh out a quantity of standard zinc bacitracin (4.11) corresponding to 1 050 i.u. (according to the activity indicated). Add 5 ml of 0,1 M hydrochloric acid (4.7) and leave to stand for 15 minutes. Add 30 ml of water, adjust the pH to 4,5 with phosphate buffer (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 (4.5) the following solutions:  s8 0,42 i.u./ml  s4 0,21 i.u./ml  s2 0,105 i.u./ml  s1 0,0525 i.u./ml  6. Preparation of the extract and assay solutions  6.1. Extraction  6.1.1. Premixes and mineral feeds  Weigh out a quantity of sample of 2,0 to 5,0 g, add 29,0 ml of the mixture (4.4) and 1,0 ml of sodium sulphide solution (4.9) and shake briefly. Check that the pH is about 2. Shake for 10 minutes, add 30 ml of phosphate buffer (4.5), shake for 15 minutes and centrifuge. Take a suitable aliquot of the supernatant solution and adjust the pH to 6,5 by means of 1 M hydroxide solution (4.8) with a pH-meter or with the bromocresol purple solution (4.10) as indicator. Dilute with phosphate buffer (4.5) to obtain an expected zinc bacitracin content of 0,42 i.u./ml (=u8).  6.1.2. Protein concentrates  Weigh out a quantity of sample of 10,0 g, add 49,0 ml of the mixture (4.4) and 1,0 ml of sodium sulphide solution (4.9) and shake briefly. Check that the pH is about 2. Shake for 10 minutes. Add 50 ml of phosphate buffer (4.5), shake for 15 minutes and centrifuge. Take a suitable volume of the supernatant solution and adjust the pH to 6,5 by means of 1 M sodium hydroxide solution (4.8) with a pH-meter or with the bromocresol purple solution (4.10) as indicator. Evaporate to approximately half volume in a rotary evaporator at a temperature not exceeding 35 °C.  Dilute with phosphate buffer (4.5) to obtain an expected zinc bacitracin content of 0,42 i.u./ml (= u8).  6.1.3. Other feeds  Weigh out a quantity of sample of 10,0 g (20,0 g for an expected zinc bacitracin content of 5 mg/kg). Add a mixture of 24,0 ml of the mixture (4.4) and 1,0 ml of sodium sulphide solution (4.9) and homogenize for 10 minutes. Add 25 ml of phosphate buffer (4,5), shake for 15 minutes and centrifuge. Take 20 ml of the supernatant solution and adjust the pH to 6.5 by means of 1 M sodium hydroxide solution (4.8) with a pH-meter or with the bromocresol purple solution (4.10) as indicator. Evaporate to about 4 ml in a rotary evaporator at a temperature not exceeding 35 °C. Dilute the residue with phosphate buffer (4.5) to obtain an expected zinc bacitracin content of 0,42 i.u./ml (= u8).  6.2. Assay solutions  From solution u8 prepare solutions u4 (expected content: 0,21 i.u./ml), u2 (expected content: 0,105 i.u./ml) and u1 (expected content: 0,0525 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 °C. 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 and s1) and the four concentrations of the assay solution (u8, u4, u2 and 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 (60 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 0,10 and 0,15 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 30 ± 2 °C.  8. Evaluation  Measure the diameter of the zones of inhibition to the nearest 0,1 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:  1.2 // (a) SL =  // 7s1 + 4s2 + s4 - 2s8 10  Determine the ''best fit" point for the standard highest level (SH) using the formula:  1.2 // (b) SH =  // 7s8 + 4s4 + s2 - 2s1 10  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:  1.2.3.4 // (a' ) SL =  // 5s1 + 2s2 - s4 6  // or  // 5s2 + 2s4 - s8 6  // (b' ) SH =  // 5s4 + 2s2 - s1 6  // or  // 5s8 + 2s4 - s2 6  and similarly for UL and UH. The same criteria of parallelism should be satisfied. 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 (log A) of the relative activity (A) by means of one of the following formulae, depending upon whether three or four levels have been used for the assessment of parallelism.  For four levels  1.2 // (c) log A =  // (u1 + u2 + u4 + u8 - s1 - s2 - s4 - s8) × 0,602 u4 + u8 + s4 + s8 - u1 - u2 - s1 - s2  For three levels  1.2 // (d) log A =  // (u1 + u2 + u4 - s1 - s2 - s4) × 0,401 u4 + s4 - u1 - s1  // or  //   // (d' ) log A =  // (u2 + u4 + u8 - s2 - s4 - s8) × 0,401 u8 + s8 - u2 - s2  Activity of sample extract = activity of relevant standard × A  (u8 = s8 × A)  If the relative activity is found to be outside the range of 0,5 to 2,0, then repeat the assay making appropriate adjustments to the extract concentrations or, if this is not possible, to the standard solutions. When the relative activity cannot be brought into the required range, any result obtained must be considered as approximate and this should be noted on the final report.  When the lines are considered as not being parallel, repeat the determination. If parallelism is still not achieved, a satisfactory determination has not been obtained.  Express the result in milligrams of zinc bacitracin per kilogram of feedingstuff.  9. Repeatability  The difference between the results of two determinations carried out on the same sample by the same analyst should not exceed:  - 2 mg/kg, in absolute value, for contents of zinc bacitracin up to 10 mg/kg,  - 20 % related to the highest value for contents from 10 to 25 mg/kg,  - 5 mg/kg, in absolute value, for contents of 25 to 50 mg/kg,  - 10 % related to the highest value for contents above 50 mg/kg.'  (1) 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.4.11 . STANDARD SUBSTANCE : ZINC BACITRACIN OF KNOWN ACTIVITY ( IN I . U .).  5 . STANDARD SOLUTIONS  WEIGH OUT A QUANTITY OF STANDARD ZINC BACITRACIN ( 4.11 ) CORRESPONDING TO 1 050 I.U . ( ACCORDING TO THE ACTIVITY INDICATED ). ADD 5 ML OF 0,1 M HYDROCHLORIC ACID ( 4.7 ) AND LEAVE TO STAND FOR 15 MINUTES . ADD 30 ML OF WATER, ADJUST THE PH TO 4,5 WITH PHOSPHATE BUFFER ( 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 ( 4.5 ) THE FOLLOWING SOLUTIONS :  S8 0,42 I.U./ML  S4 0,21 I.U./ML  S2 0,105 I.U./ML  S1 0,0525 I.U./ML  6 . PREPARATION OF THE EXTRACT AND ASSAY SOLUTIONS  6.1 . EXTRACTION  6.1.1 . PREMIXES AND MINERAL FEEDS  WEIGH OUT A QUANTITY OF SAMPLE OF 2,0 TO 5,0 G, ADD 29,0 ML OF THE MIXTURE ( 4.4 ) AND 1,0 ML OF SODIUM SULPHIDE SOLUTION ( 4.9 ) AND SHAKE BRIEFLY . CHECK THAT THE PH IS ABOUT 2 . SHAKE FOR 10 MINUTES, ADD 30 ML OF PHOSPHATE BUFFER ( 4.5 ), SHAKE FOR 15 MINUTES AND CENTRIFUGE . TAKE A SUITABLE ALIQUOT OF THE SUPERNATANT SOLUTION AND ADJUST THE PH TO 6,5 BY MEANS OF 1 M HYDROXIDE SOLUTION ( 4.8 ) WITH A PH-METER OR WITH THE BROMOCRESOL PURPLE SOLUTION ( 4.10 ) AS INDICATOR . DILUTE WITH PHOSPHATE BUFFER ( 4.5 ) TO OBTAIN AN EXPECTED ZINC BACITRACIN CONTENT OF 0,42 I.U./ML (= U8 ).  6.1.2 . PROTEIN CONCENTRATES  WEIGH OUT A QUANTITY OF SAMPLE OF 10,0 G, ADD 49,0 ML OF THE MIXTURE ( 4.4 ) AND 1,0 ML OF SODIUM SULPHIDE SOLUTION ( 4.9 ) AND SHAKE BRIEFLY . CHECK THAT THE PH IS ABOUT 2 . SHAKE FOR 10 MINUTES . ADD 50 ML OF PHOSPHATE BUFFER ( 4.5 ), SHAKE FOR 15 MINUTES AND CENTRIFUGE . TAKE A SUITABLE VOLUME OF THE SUPERNATANT SOLUTION AND ADJUST THE PH TO 6,5 BY MEANS OF 1 M SODIUM HYDROXIDE SOLUTION ( 4.8 ) WITH A PH-METER OR WITH THE BROMOCRESOL PURPLE SOLUTION ( 4.10 ) AS INDICATOR . EVAPORATE TO APPROXIMATELY HALF VOLUME IN A ROTARY EVAPORATOR AT A TEMPERATURE NOT EXCEEDING 35 C .  DILUTE WITH PHOSPHATE BUFFER ( 4.5 ) TO OBTAIN AN EXPECTED ZINC BACITRACIN CONTENT OF 0,42 I.U./ML (= U8 ).  6.1.3 . OTHER FEEDS  WEIGH OUT A QUANTITY OF SAMPLE OF 10,0 G ( 20,0 G FOR AN EXPECTED ZINC BACITRACIN CONTENT OF 5 MG/KG ). ADD A MIXTURE OF 24,0 ML OF THE MIXTURE ( 4.4 ) AND 1,0 ML OF SODIUM SULPHIDE SOLUTION ( 4.9 ) AND HOMOGENIZE FOR 10 MINUTES . ADD 25 ML OF PHOSPHATE BUFFER ( 4,5 ), SHAKE FOR 15 MINUTES AND CENTRIFUGE . TAKE 20 ML OF THE SUPERNATANT SOLUTION AND ADJUST THE PH TO 6.5 BY MEANS OF 1 M SODIUM HYDROXIDE SOLUTION ( 4.8 ) WITH A PH-METER OR WITH THE BROMOCRESOL PURPLE SOLUTION ( 4.10 ) AS INDICATOR . EVAPORATE TO ABOUT 4 ML IN A ROTARY EVAPORATOR AT A TEMPERATURE NOT EXCEEDING 35 C . DILUTE THE RESIDUE WITH PHOSPHATE BUFFER ( 4.5 ) TO OBTAIN AN EXPECTED ZINC BACITRACIN CONTENT OF 0,42 I.U./ML (= U8 ).  6.2 . ASSAY SOLUTIONS  FROM SOLUTION U8 PREPARE SOLUTIONS U4 ( EXPECTED CONTENT : 0,21 I.U./ML ), U2 ( EXPECTED CONTENT : 0,105 I.U./ML ) AND U1 ( EXPECTED CONTENT : 0,0525 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 C . 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 AND S1 ) AND THE FOUR CONCENTRATIONS OF THE ASSAY SOLUTION ( U8, U4, U2 AND 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 ( 60 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 0,10 AND 0,15 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 30  2 C .  8 . EVALUATION  MEASURE THE DIAMETER OF THE ZONES OF INHIBITION TO THE NEAREST 0,1 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 :  1.2(A ) SL =  7S1 + 4S2 + S4 - 2S8 10  DETERMINE THE BEST FIT" POINT FOR THE STANDARD HIGHEST LEVEL ( SH ) USING THE FORMULA :  1.2(B ) SH =  7S8 + 4S4 + S2 - 2S1 10  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 :  1.2.3.4(A' ) SL =  5S1 + 2S2 - S4 6  OR  5S2 + 2S4 - S8 6  ( B' ) SH =  5S4 + 2S2 - S1 6  OR  5S8 + 2S4 - S2 6  AND SIMILARLY FOR UL AND UH . THE SAME CRITERIA OF PARALLELISM SHOULD BE SATISFIED . 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 ( LOG A ) OF THE RELATIVE ACTIVITY ( A ) BY MEANS OF ONE OF THE FOLLOWING FORMULAE, DEPENDING UPON WHETHER THREE OR FOUR LEVELS HAVE BEEN USED FOR THE ASSESSMENT OF PARALLELISM .  FOR FOUR LEVELS  1.2(C ) LOG A =  ( U1 + U2 + U4 + U8 - S1 - S2 - S4 - S8 )  0,602 U4 + U8 + S4 + S8 - U1 - U2 - S1 - S2  FOR THREE LEVELS  1.2(D ) LOG A =  ( U1 + U2 + U4 - S1 - S2 - S4 )  0,401 U4 + S4 - U1 - S1  OR  //  ( D' ) LOG A =  ( U2 + U4 + U8 - S2 - S4 - S8 )  0,401 U8 + S8 - U2 - S2  ACTIVITY OF SAMPLE EXTRACT = ACTIVITY OF RELEVANT STANDARD  A  ( U8 = S8  A )  IF THE RELATIVE ACTIVITY IS FOUND TO BE OUTSIDE THE RANGE OF 0,5 TO 2,0, THEN REPEAT THE ASSAY MAKING APPROPRIATE ADJUSTMENTS TO THE EXTRACT CONCENTRATIONS OR, IF THIS IS NOT POSSIBLE, TO THE STANDARD SOLUTIONS . WHEN THE RELATIVE ACTIVITY CANNOT BE BROUGHT INTO THE REQUIRED RANGE, ANY RESULT OBTAINED MUST BE CONSIDERED AS APPROXIMATE AND THIS SHOULD BE NOTED ON THE FINAL REPORT .  WHEN THE LINES ARE CONSIDERED AS NOT BEING PARALLEL, REPEAT THE DETERMINATION . IF PARALLELISM IS STILL NOT ACHIEVED, A SATISFACTORY DETERMINATION HAS NOT BEEN OBTAINED .  EXPRESS THE RESULT IN MILLIGRAMS OF ZINC BACITRACIN PER KILOGRAM OF FEEDINGSTUFF .  9 . REPEATABILITY  THE DIFFERENCE BETWEEN THE RESULTS OF TWO DETERMINATIONS CARRIED OUT ON THE SAME SAMPLE BY THE SAME ANALYST SHOULD NOT EXCEED :  - 2 MG/KG, IN ABSOLUTE VALUE, FOR CONTENTS OF ZINC BACITRACIN UP TO 10 MG/KG,  - 20 % RELATED TO THE HIGHEST VALUE FOR CONTENTS FROM 10 TO 25 MG/KG,  - 5 MG/KG, IN ABSOLUTE VALUE, FOR CONTENTS OF 25 TO 50 MG/KG,  - 10 % RELATED TO THE HIGHEST VALUE FOR CONTENTS ABOVE 50 MG/KG .'  ( 1 ) 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 .


Commission Directive 68/156/EEC of 12 March 1968 setting the timetable for the phasing-out of the tax imposed by the Federal Republic of Germany on imports of certain cereal - based manufactured products and certain animal feedingstuffs from the other Member States


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31996L0065

Commission Directive 96/65/EC of 11 October 1996 adapting to technical progress for the fourth time Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and modifying Directive 91/442/EEC on dangerous preparations the packaging of which must be fitted with child-resistant fastenings (Text with EEA relevance)

Official Journal L 265 , 18/10/1996 P. 0015 - 0017

COMMISSION DIRECTIVE 96/65/EC of 11 October 1996 adapting to technical progress for the fourth time Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and modifying Directive 91/442/EEC on dangerous preparations the packaging of which must be fitted with child-resistant fastenings (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1), as last amended by Commission Directive 93/18/EEC (2), and in particular Articles 6 and 15 thereof,Whereas Annex VI to Council Directive 67/548/EEC (3), as last amended by Commission Directive 96/54/EC (4), provides for new criteria and a new R phrase for 'Aspiration hazard` under the category of danger 'harmful`, and in particular R phrase 65;Whereas the provisions set out in Annex I to Directive 88/379/EEC, should therefore be supplemented;Whereas the Annex to Commission Directive 91/442/EEC (5) defines, in accordance with Article 6 of Directive 88/379/EEC, the characteristics of certain preparations which shall be fitted with child resistant fastenings; whereas these characteristics should be revised to correspond to the criteria for 'Aspiration hazard` of Annex VI to Directive 67/548/EEC.Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Dangerous Substances and Preparations,HAS ADOPTED THIS DIRECTIVE:Article 1 Annex I to Directive 88/379/EEC is completed by a new paragraph 1.3. as in Annex I of this Directive.Article 2 Directive 91/442/EEC is modified as follows:- Article 2 of Directive 91/442/EEC is replaced by the following Article:'Article 2The provisions of Articles 1 and 2 of Directive 90/35/EEC and those of Article 1 of this Directive, with the exception of the preparations characterized in point (a) of the Annex, shall also apply to preparations offered or sold to the general public in the form of aerosols or in containers fitted with a sealed spray attachment.`,- the Annex is replaced by Annex II to this Directive.Article 3 1. The Member States shall bring into force the provisions necessary to comply with this Directive no later than 31 May 1998 and shall forthwith inform the Commission thereof.2. This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.3. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 4 This Directive is addressed to the Member States.Done at Brussels, 11 October 1996.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ No L 187, 16. 7. 1988, p. 14.(2) OJ No L 104, 29. 4. 1993, p. 46.(3) OJ No 196, 16. 8. 1967, p. 1.(4) OJ No L 248, 30. 9. 1996, p. 1.(5) OJ No L 238, 27. 8. 1991, p. 25.ANNEX I The following paragraph 1.3. is added to Annex I to Directive 88/379/EEC:'1.3. Preparations presenting an aspiration hazardPreparations presenting an aspiration hazard (R 65) shall be classified and labelled according to criteria of paragraph 3.2.3 of Annex VI to Directive 67/548/EEC.In applying the conventional method according to Article 3 (5) (c) (i) and (ii) of Directive 88/379/EEC, no account shall be taken of the classification of a substance as R 65.`ANNEX II 'ANNEXCharacteristics referred to in Article 1:(a) Preparations presenting an aspiration hazard (R 65) and classified and labelled according to paragraph 3.2.3. of Annex VI to Directive 67/548/EEC.(b) At least one of the substances mentioned below is present in a concentration equal to or greater than the maximum individual concentration specified.>TABLE>


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31982L0148

Council Directive 82/148/EEC of 3 March 1982 amending Directive 79/279/EEC coordinating the conditions for the admission of securities to official stock exchange listing and Directive 80/390/EEC coordinating the requirements for the drawing up, scrutiny and distribution of the listing particulars to be published for the admission of securities to official stock exchange listing

Official Journal L 062 , 05/03/1982 P. 0022 - 0023 Finnish special edition: Chapter 6 Volume 2 P. 0086  Spanish special edition: Chapter 06 Volume 2 P. 0137  Swedish special edition: Chapter 6 Volume 2 P. 0086  Portuguese special edition Chapter 06 Volume 2 P. 0137

*****COUNCIL  DIRECTIVE  of 3 March 1982  amending Directive 79/279/EEC coordinating the conditions for the admission of securities to official stock exchange listing and Directive 80/390/EEC coordinating the requirements for the drawing up, scrutiny and distribution of the listing particulars to be published for the admission of securities to official stock exchange listing  (82/148/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 54 (3) (g) and 100 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 Economic and Social Committee (2),  Whereas Member States must comply with Directive 79/279/EEC (3) within two years of its notification; whereas such notification took place on 8 March 1979; whereas the period therefore expired on 8 March 1981; whereas, however, the period was extended by one year in the case of Member States simultaneously introducing Directives 79/279/EEC and 80/390/EEC (4); whereas such period expires, in these circumstances, on 8 March 1982;  Whereas Member States must comply with Directive 80/390/EEC within 30 months of its notification; whereas such notification took place on 19 March 1980; whereas the period therefore expires on 19 September 1982; whereas, however, the period will expire on the earlier date of 8 March 1982 in the case of Member States simultaneously introducing Directives 79/279/EEC and 80/390/EEC;  Whereas Member States must comply by 30 June 1983 at the latest with Council Directive 82/121/EEC of 15 February 1982 on information to be published on a regular basis by companies the shares of which have been admitted to official stock-exchange listing (5);  Whereas there is a close link between these three Directives, not only because the purpose of all three is to coordinate a number of rules relating to securities which have been admitted to official stock exchange listing or whose admission to such official listing is requested, but above all because the three Directives aim to establish at Community level a coordinated information policy on the securities in question;  Whereas Member States should therefore be given the possibility of implementing the three Directives simultaneously so that they do not have to initiate several legislative or rule-making procedures in one and the same area at very short intervals, which might constitute an unacceptable extra burden for national parliaments or national stock exchange authorities;  Whereas Directives 79/279/EEC and 80/390/EEC should therefore be amended to allow Member States to implement them on the same date as Directive 82/121/EEC, namely by 30 June 1983 at the latest,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The following subparagraph shall be added to Article 22 (1) of Directive 79/279/EEC:  'However, this period shall be extended to 30 June 1983 in the case of Member States simultaneously introducing this Directive and Directives 80/390/EEC and 82/121/EEC.'  Article 2  The following subparagraph shall be added to Article 27 (1) of Directive 80/390/EEC:  'This period shall be extended to 30 June 1983 in the case of Member States simultaneously introducing this Directive and Directives 79/279/EEC and 82/121/EEC'.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 3 March 1982.  For the Council  The President  L. TINDEMANS  (1) Opinion delivered on 19 February 1982 (not yet published in the Official Journal).  (2) Opinion delivered on 25 February 1982 (not yet published in the Official Journal).  (3) OJ No L 66, 16. 3. 1979, p. 21.  (4) OJ No L 100, 17. 4. 1980, p. 1.  (5) OJ No L 48, 20. 2. 1982, p. 26.


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31992L0115

Council Directive 92/115/EEC of 17 December 1992 amending for the first time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients

Official Journal L 409 , 31/12/1992 P. 0031 - 0032

COUNCIL DIRECTIVE 92/115/EEC of 17  December 1992 amending for the first time Directive 88/344/EEC on the approximation of the laws of  the Member States on extraction solvents used in the production of foodstuffs and food ingredientsTHE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  100a thereof, Having regard to the proposal from the Commission  (1), In cooperation with the European Parliament  (2), Having regard to the opinion of the Economic and Social Committee  (3), Whereas Article 2 (5) of Directive 88/344/EEC  (4) provides that within two years of the adoption  of that Directive the Commission shall, after consulting the Scientific Committee for Food,  re-examine the provisions relating to the solvents in the Annex and to Methyl-propan-2-ol and  propose any necessary amendments; Whereas as part of this amendment the Council should decide whether the residues of the extraction  solvents in Part III of the Annex should refer to flavourings rather than foodstuffs; Whereas, three years after the adoption of Directive 88/344/EEC, the Commission should submit any  appropriate proposal to the Council for some of the solvents in Article 2 (6), regulated so far  only by national legislations; Whereas the Scientific Committee for Food reconsidered all the extraction solvents mentioned in  that Directive in 1990 and in 1991 with the aim of replacing the temporary acceptable daily intakes  (ADIs) established in 1981 with permanent assessments; whereas this has not always been possible,  as appropriate information, although requested, has not been provided; whereas on the basis of the  information received, the Scientific Committee for Food decided to confirm its acceptance or to  retain the temporary status or to withdraw its previous temporary approval, depending on the  substance concerned, HAS ADOPTED THIS DIRECTIVE:Article 1Directive 88/344/EEC is hereby amended as  follows: 1.   in Article 1: (a)   the following subparagraph shall be added to paragraph 1: 'This Directive shall apply without prejudice to the provisions adopted under more specific  Community rules.`;  (b) Paragraph 2 shall be deleted; 2. in Article 2, paragraphs 5 and 6 shall be deleted; 3. the Annex shall be amended as follows: (a) IN PART I: -   the following footnote 2 shall be added to Acetone: '(2)  The use of Acetone in the refining of olive-pomace oil is forbidden.`;  (b) IN PART II: - the solvents methanol and Propan-2-ol shall be added for all uses with a maximum residue content  of 10 mg/kg,  - footnote 1 shall be completed with the following sentence: 'The combined use of Hexane and Ethylmethylketone is forbidden.`,  - footnote 2 shall be deleted. In the third column, the presence of 10 mg/kg in respect of  Dichlormethane in roasted coffee, shall be replaced by the presence of '2 mg/kg`,  - the following footnote 2 shall be added to Ethylmethylketone: '(2)  The presence of n-Hexane in this solvent should not exceed 50 mg/kg. This solvent may not be  used in combination with Hexane.`;  (c) IN PART III: - Cyclohexane, Isobutane, and the footnote shall be deleted,  - the presence of 0,1 mg/kg in respect of Dichloromethane shall be replaced by the presence of  0,02 mg/kg,  - Propan-1-ol shall be added, with a maximum residue limit of 1 mg/kg,  - a footnote shall be added to Hexane and Ethylmethylketone on the following page: '(1)The combined use of these two solvents is forbidden.`Article 21.    Member States shall  amend their laws, regulations and administrative provisions in such a way as to: -   permit trade in products complying with this Directive at the latest by 1 July 1993, - prohibit trade in products not complying with this Directive with effect from 1 January 1994. They shall forthwith inform the Commission thereof. 2.    When Member States adopt the measures referred to in paragraph 1, they shall contain a  reference to this Directive or shall be accompanied by such reference on the occasion of their  official publication. The methods of making such a reference shall be laid down by the Member  States.Article 3This Directive is addressed to the Member States. Done at Brussels, 17 December 1992, For the CouncilThe PresidentR. NEEDHAM   (1)  OJ No C 11, 17. 1. 1992, p.  5.  (2)  OJ No C 94, 13. 4. 1992, p. 158, andOJ No C 337, 21. 12. 1992.  (3)  OJ No C 223, 31. 8. 1992, p. 23.  (4)  OJ No L 157, 24. 6. 1988, p. 28.


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32001L0045

Directive 2001/45/EC of the European Parliament and of the Council of 27 June 2001 amending Council Directive 89/655/EEC concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (Text with EEA relevance)

Official Journal L 195 , 19/07/2001 P. 0046 - 0049

Directive 2001/45/EC of the European Parliament and of the Councilof 27 June 2001amending Council Directive 89/655/EEC concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(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 137(2) thereof,Having regard to the proposal from the Commission, submitted after consulting the Advisory Committee on Safety, Hygiene and Health Protection at Work(1),Having regard to the opinion of the Economic and Social Committee(2),After consulting the Committee of the Regions,Acting in accordance with the procedure referred to in Article 251 of the Treaty(3),Whereas:(1) Article 137(2) of the Treaty provides that the Council may adopt, by means of Directives, minimum requirements for encouraging improvements, especially in the working environment, to ensure a better level of protection of the safety and health of workers.(2) Pursuant to the said Article, such Directives must avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized enterprises.(3) The improvement of occupational safety, hygiene and health is an objective which may not be subordinated to purely economic considerations.(4) Compliance with the minimum requirements designed to ensure a better standard of health and safety in the use of work equipment provided for temporary work at a height is essential to ensure the health and safety of workers.(5) The provisions adopted pursuant to Article 137(2) of the Treaty do not prevent any Member State from maintaining or introducing such more stringent measures for the protection of working conditions as are compatible with the Treaty.(6) Work at a height may expose workers to particularly severe risks to their health and safety, notably to the risks of falls from a height and other serious occupational accidents, which account for a large proportion of all accidents, especially of fatal accidents.(7) Self-employed persons and employers, where they themselves pursue an occupational activity and personally use work equipment intended for carrying out temporary work at a height, may affect employees' health and safety.(8) Council Directive 92/57/EEC of 24 June 1992 on the implementation of minimum safety and health requirements at temporary or mobile construction sites (eighth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(4), imposes on these categories of persons the obligation to respect inter alia Article 4 and Annex I of Directive 89/655/EEC(5).(9) Any employer who intends to have temporary work carried out at a height must select equipment affording adequate protection against the risks of falls from a height.(10) In general collective protection measures to prevent falls offer better protection than personal protection measures. The selection and use of equipment appropriate to each specific site for preventing and eliminating risks should be accompanied by specific training and supplementary investigations where appropriate.(11) Ladders, scaffolding and ropes are the equipment most commonly used in performing temporary work at a height and the safety and health of workers engaged in this type of work therefore depend to a significant extent on their correct use; the manner in which such equipment can most safely be used by workers must therefore be specified; adequate specific training of the workers is therefore required.(12) This Directive is the most appropriate means of achieving the desired objectives and does not go beyond what is necessary for that purpose.(13) This Directive is a practical contribution towards creating the social dimension of the internal market.(14) Member States should be given the opportunity to make use of a transitional period to take account of the particular problems which SMEs have to face,HAVE ADOPTED THIS DIRECTIVE:Article 1The text annexed to this Directive shall be added to Annex II to Directive 89/655/EEC.Article 21. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 19 July 2004. They shall forthwith inform the Commission thereof.Member States shall have the right, as regards the implementation of section 4 of the Annex, to make use of a transitional period of not more than two years from the date mentioned in the first subparagraph, in order to take account of the various situations which might arise from the practical implementation of this Directive in particular by small and medium-sized enterprises.2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.3. Member States shall notify the Commission of the provisions of national law which they have already adopted or adopt in the field covered by this Directive.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Luxembourg, 27 June 2001.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentA. Bourgeois(1) OJ C 247 E, 31.8.1999, p. 23 andOJ C 62 E, 27.2.2001, p. 113.(2) OJ C 138, 18.5.1999, p. 30.(3) Opinion of the European Parliament of 21 September 2000 (OJ C 146, 17.5.2001, p. 78), Council Common Position of 23 March 2001 (OJ C 142, 15.5.2001, p. 16) and Decision of the European Parliament of 14 June 2001.(4) OJ L 245, 26.8.1992, p. 6.(5) OJ L 393, 30.12.1989, p. 1.ANNEX"4. Provisions concerning the use of work equipment provided for temporary work at a height.4.1. General provisions4.1.1. If, pursuant to Article 6 of Directive 89/391/EEC and Article 3 of this Directive, temporary work at a height cannot be carried out safely and under appropriate ergonomic conditions from a suitable surface, the work equipment most suitable to ensure and maintain safe working conditions must be selected. Collective protection measures must be given priority over personal protection measures. The dimensions of the work equipment must be appropriate to the nature of the work to be performed and to the foreseeable stresses and allow passage without danger.The most appropriate means of access to temporary workplaces at a height must be selected according to the frequency of passage, the height to be negotiated and the duration of use. The choice made must permit evacuation in the event of imminent danger. Passage in either direction between a means of access and platforms, decks or gangways must not give rise to any additional risks of falling.4.1.2. Ladders may be used as work stations for work at a height only under circumstances in which, given point 4.1.1, the use of other, safer work equipment is not justified because of the low level of risk and either the short duration of use or existing features on site that the employer cannot alter.4.1.3. Rope access and positioning techniques may be used only under circumstances where the risk assessment indicates that the work can be performed safely and where the use of other, safer work equipment is not justified.Taking the risk assessment into account and depending in particular on the duration of the job and the ergonomic constraints, provision must be made for a seat with appropriate accessories.4.1.4. Depending on the type of work equipment selected on the basis of the foregoing, the appropriate measures for minimising the risks to workers inherent in this type of equipment must be determined. If necessary, provision must be made for the installation of safeguards to prevent falls. These must be of suitable configuration and sufficient strength to prevent or arrest falls from a height and, as far as possible, to preclude injury to workers. Collective safeguards to prevent falls may be interrupted only at points of ladder or stairway access.4.1.5. When the performance of a particular task requires a collective safeguard to prevent falls to be temporarily removed, effective compensatory safety measures must be taken. The task may not be performed until such measures have been taken. Once the particular task has been finished, either definitively or temporarily, the collective safeguards to prevent falls must be reinstalled.4.1.6. Temporary work at a height may be carried out only when the weather conditions do not jeopardise the safety and health of workers.4.2. Specific provisions regarding the use of ladders.4.2.1. Ladders must be so positioned as to ensure their stability during use. Portable ladders must rest on a stable, strong, suitably-sized, immobile footing so that the rungs remain horizontal. Suspended ladders must be attached in a secure manner and, with the exception of rope ladders, so that they cannot be displaced and so that swinging is prevented.4.2.2. The feet of portable ladders must be prevented from slipping during use by securing the stiles at or near their upper or lower ends, by any anti-slip device or by any other arrangement of equivalent effectiveness. Ladders used for access must be long enough to protrude sufficiently beyond the access platform, unless other measures have been taken to ensure a firm handhold. Interlocking ladders and extension ladders must be used so that the different sections are prevented from moving relative to one another. Mobile ladders must be prevented from moving before they are stepped on.4.2.3. Ladders must be used in such a way that a secure handhold and secure support are available to workers at all times. In particular, if a load has to be carried by hand on a ladder, it must not preclude the maintenance of a safe handhold.4.3. Specific provisions regarding the use of scaffolding4.3.1. When a note of the calculations for the scaffolding selected is not available or the note does not cover the structural arrangements contemplated, strength and stability calculations must be carried out unless the scaffolding is assembled in conformity with a generally recognised standard configuration.4.3.2. Depending on the complexity of the scaffolding chosen, an assembly, use and dismantling plan must be drawn up by a competent person. This may be in the form of a standard plan, supplemented by items relating to specific details of the scaffolding in question.4.3.3. The bearing components of scaffolding must be prevented from slipping, whether by attachment to the bearing surface, provision of an anti-slip device or any other means of equivalent effectiveness, and the load-bearing surface must have a sufficient capacity. It must be ensured that the scaffolding is stable. Wheeled scaffolding must be prevented by appropriate devices from moving accidentally during work at a height.4.3.4. The dimensions, form and layout of scaffolding decks must be appropriate to the nature of the work to be performed and suitable for the loads to be carried and permit work and passage in safety. Scaffolding decks must be assembled in such a way that their components cannot move in normal use. There must be no dangerous gap between the deck components and the vertical collective safeguards to prevent falls.4.3.5. When parts of a scaffolding are not ready for use, for example during assembly, dismantling or alteration, they must be marked with general warning signs in accordance with the national provisions transposing Directive 92/58/EEC and be suitably delimited by physical means preventing access to the danger zone.4.3.6. Scaffolding may be assembled, dismantled or significantly altered only under the supervision of a competent person and by workers who must have received appropriate and specific training in the operations envisaged, addressing specific risks in accordance with Article 7, and more particularly in:(a) understanding of the plan for the assembly, dismantling or alteration of the scaffolding concerned;(b) safety during the assembly, dismantling or alteration of the scaffolding concerned;(c) measures to prevent the risk of persons or objects falling;(d) safety measures in the event of changing weather conditions which could adversely affect the safety of the scaffolding concerned;(e) permissible loads;(f) any other risks which the abovementioned assembly, dismantling or alteration operations may entail.The person supervising and the workers concerned must have available the assembly and dismantling plan referred to in 4.3.2., including any instructions it may contain.4.4. Specific provisions regarding the use of rope access and positioning techniquesThe use of rope access and positioning techniques must comply with the following conditions:(a) the system must comprise at least two separately anchored ropes, one as a means of access, descent and support (work rope) and the other as backup (security rope);(b) workers must be provided with and use an appropriate harness and be connected by it to the security rope;(c) the work rope must be equipped with safe means of ascent and descent and have a self-locking system to prevent the user falling should he lose control of his movements. The security rope must be equipped with a mobile fall prevention system which follows the movements of the worker;(d) the tools and other accessories to be used by a worker must be secured to the worker's harness or seat or by some other appropriate means;(e) the work must be properly planned and supervised, so that a worker can be rescued immediately in an emergency;(f) in accordance with Article 7, the workers concerned must receive adequate training specific to the operations envisaged, in particular rescue procedures.In exceptional circumstances where, in view of the assessment of risks, the use of a second rope would make the work more dangerous, the use of a single rope may be permitted, provided that appropriate measures have been taken to ensure safety in accordance with national legislation and/or practice."


title: Directive 2011/87/EU of the European Parliament and of the Council of 16 November 2011 amending Directive 2000/25/EC as regards the application of emission stages for narrow-track tractors Text with EEA relevance

text:
               18.11.2011

               EN

               Official Journal of the European Union

               L 301/1

         DIRECTIVE 2011/87/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 16 November 2011
   amending Directive 2000/25/EC as regards the application of emission stages for narrow-track tractors
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on Functioning of European Union, and in particular Article 114 thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the ordinary legislative procedure (2),
   Whereas:

               (1)

               Directive 2000/25/EC of the European Parliament and of the Council of 22 May 2000 on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors (3) regulates exhaust emissions from engines installed in agricultural and forestry tractors with a view to further safeguarding human health and the environment. Directive 2000/25/EC provided that the emission limits applicable in 2010 for type-approval of the majority of compression ignition engines, referred to as Stage III A, were to be replaced by the more stringent Stage III B limits, entering into force progressively as from 1 January 2010 as regards the type-approval, and from 1 January 2011 with regard to the placing on the market, for those engines. Stage IV, providing for emission limits more stringent than Stage III B, will enter into force progressively as from 1 January 2013 as regards the type-approval for those engines and from 1 January 2014 with regard to the placing on the market.

               (2)

               Article 2(b) of Directive 2004/26/EC of the European Parliament and of the Council of 21 April 2004 amending Directive 97/68/EC on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (4), provides that the Commission is to consider the available technology, including the cost/benefits, with a view to confirming Stage III B and IV limit values and evaluating the possible need for additional flexibilities, exemptions or later introduction dates for certain types of equipment or engines and taking into account engines installed in non-road mobile machinery used in seasonal applications. Moreover, Article 4(8) of Directive 2000/25/EC provides for a review clause in order to take into account the specificities of tractors of categories T2, T4.1 and C2.

               (3)

               Directive 97/68/EC of the European Parliament and of the Council (5) was the subject of several technical studies. As a result of those technical studies carried out in 2007, 2009 and 2010 and confirmed by the impact assessment carried out by the Commission, it was established that it is not technically feasible for tractors of categories T2, T4.1 and C2 to meet the requirements of Stages III B and IV by the dates set out in that Directive.

               (4)

               In order to prevent Union legislation from prescribing technical requirements which cannot be met yet and in order to prevent a situation in which tractors of categories T2, T4.1 and C2 can no longer be type-approved and placed on the market or put into service, it is necessary to provide for a transitional period of 3 years, during which tractors of categories T2, T4.1 and C2 may still be type-approved and placed on the market or put into service.

               (5)

               The Commission should report annually to the European Parliament and the Council on progress in the development of technical solutions for Stage IV-compliant technology.

               (6)

               Directive 2000/25/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 2000/25/EC
   In Article 4 of Directive 2000/25/EC, the following paragraph is added:

      ‘9.   By way of derogation, the dates set out in points (d) and (e) of paragraph 2 and in paragraph 3 shall, for tractors of categories T2, T4.1 and C2, as defined respectively in the second indent of point A.1 of Chapter A, in point 1.1 of Part I of Appendix 1 of Chapter B, and in point A.2 of Chapter A of Annex II to Directive 2003/37/EC, and equipped with engines of categories L to R, be postponed for 3 years. Until such dates, the requirements of Stage III A in this Directive shall continue to apply.’.

   Article 2
   Availability of compatible technology
   The Commission shall, by 31 December 2014, consider what technology is available that is capable of meeting Stage IV requirements and that is compatible with the needs of categories T2, T4.1 and C2, and submit, where appropriate, proposals to the European Parliament and the Council.
   Article 3
   Transposition
   1.   Member States shall adopt and publish, by 9 December 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those measures.
   When Member States adopt those measures, 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 forthwith communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 16 November 2011.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         W. SZCZUKA

      (1)  OJ C 132, 3.5.2011, p. 53.

      (2)  Position of the European Parliament of 25 October 2011 (not yet published in the Official Journal) and decision of the Council of 8 November 2011.

      (3)  OJ L 173, 12.7.2000, p. 1.

      (4)  OJ L 146, 30.4.2004, p. 1.

      (5)  OJ L 59, 27.2.1998, p. 1.


title: Commission Directive (EU) 2017/845 of 17 May 2017 amending Directive 2008/56/EC of the European Parliament and of the Council as regards the indicative lists of elements to be taken into account for the preparation of marine strategies (Text with EEA relevance. )

text:
               18.5.2017

               EN

               Official Journal of the European Union

               L 125/27

         COMMISSION DIRECTIVE (EU) 2017/845
   of 17 May 2017
   amending Directive 2008/56/EC of the European Parliament and of the Council as regards the indicative lists of elements to be taken into account for the preparation of marine strategies
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for Community action in the field of marine environmental policy (Marine Strategy Framework Directive) (1), and in particular Article 24(1) thereof,
   Whereas:

               (1)

               Annex III to Directive 2008/56/EC lays down the indicative lists of characteristics, pressures and impacts which are referred to in Articles 8(1), 9(1), 9(3), 10(1), 11(1) and 24 of that Directive.

               (2)

               In 2012, on the basis of the initial assessment of their marine waters made pursuant to Article 8(1) of Directive 2008/56/EC and as part of the first cycle of implementation of their marine strategies, Member States notified to the Commission a set of characteristics for good environmental status and their environmental targets, in accordance with Articles 9(2) and 10(2) of Directive 2008/56/EC, respectively. The Commission's assessment (2) of those Member State's reports, undertaken in accordance with Article 12 of that Directive, highlighted that more efforts were urgently needed if Member States and the Union are to reach good environmental status by 2020.

               (3)

               To ensure that the second cycle of implementation of the marine strategies of the Member States further contributes to the achievement of the objectives of Directive 2008/56/EC and yields more consistent determinations of good environmental status, the Commission recommended in its report on the first phase of implementation that, at Union level, the Commission services and Member States collaborate to revise, strengthen and improve Commission Decision 2010/477/EU (3) by 2015, aiming at a clearer, simpler, more concise, more coherent and comparable set of good environmental status criteria and methodological standards and, at the same time, review Annex III of the Marine Strategy Framework Directive, and if necessary revise it, and develop specific guidance to ensure a more coherent and consistent approach for assessments in the next implementation cycle.

               (4)

               The review of Annex III to Directive 2008/56/EC is needed to complement the review of Decision 2010/477/EU. Furthermore, the relationship between Annex III to Directive 2008/56/EC and the qualitative descriptors for determining good environmental status listed in Annex I to that Directive is only implicit in that Directive and, therefore, not sufficiently clear. The Commission, in a staff working paper from 2011 (4), explained relationships between the qualitative descriptors listed in Annex I to Directive 2008/56/EC, the elements set out in Annex III to that Directive, and the criteria and indicators set out in Decision 2010/477/EU, but could provide only a partial answer due to their inherent content. A revision of Annex III to Directive 2008/56/EC is needed in order to further clarify those relationships and facilitate implementation, better linking ecosystem elements, and anthropogenic pressures and impacts on the marine environment with the descriptors in Annex I to Directive 2008/56/EC and the outcome of the review of Decision 2010/477/EU.

               (5)

               Annex III to Directive 2008/56/EC should provide elements for assessment (Article 8(1) of that Directive) with regard to good environmental status (Article 9(1) of that Directive), provide elements for monitoring (Article 11(1) of that Directive), which are complementary to assessment (e.g. temperature, salinity), and provide elements for consideration when setting targets (Article 10(1) of the Directive). The relevance of these elements will vary by region and Member State due to differing regional characteristics. This means that elements need to be addressed only if they are considered ‘essential features and characteristics’ or ‘predominant pressures and impacts’ as referred to in points (a) and (b) of Article 8(1) of Directive 2008/56/EC, respectively, and if they occur in the relevant Member State's waters.

               (6)

               It is important to ensure that the elements set out in Annex III to Directive 2008/56/EC are clearly related to the qualitative descriptors of Annex I to that Directive and to the criteria and methodological standards on good environmental status of marine waters laid down by the Commission on the basis of Article 9(3) of Directive 2008/56/EC, as well as to their application in relation to Articles 8, 9, 10 and 11 of Directive 2008/56/EC. In this context, those elements need to be generic and generally applicable across the Union, considering that more specific elements can be laid down by the Commission on the basis of Article 9(3) of Directive 2008/56/EC or in the context of determining sets of characteristics for good environmental status under Article 9(1) of that Directive.

               (7)

               Tables 1 and 2 of Annex III to Directive 2008/56/EC should be clarified to more clearly relate to state elements (Table 1) and to pressure elements and their impacts (Table 2), and to directly link the elements listed in them with the qualitative descriptors laid down in Annex I of that Directive and through this with the criteria laid down by the Commission on the basis of Article 9(3) of Directive 2008/56/EC.

               (8)

               To guide the assessments on uses of marine waters under point (c) of Article 8(1) of Directive 2008/56/EC, and on human activities under point (b) of Article 8(1), and associated monitoring provided under Article 11 of that Directive, Table 2 should be extended to contain an indicative list of uses and human activities in order to ensure consistency in their assessment across the marine regions and subregions.

               (9)

               Annex III to Directive 2008/56/EC should therefore be amended accordingly.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the regulatory committee established under Article 25(1) of Directive 2008/56/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III to Directive 2008/56/EC is replaced by the text set out in the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 7 December 2018 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.
   3.   The obligation to transpose this Directive shall not apply to Member States without marine waters.
   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 May 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 164, 25.6.2008, p. 19.

      (2)  Report from the Commission to the Council and the European Parliament — The first phase of implementation of the Marine Strategy Framework Directive (2008/56/EC) — The European Commission's assessment and guidance (COM(2014) 97 final, 20.2.2014).

      (3)  Commission Decision 2010/477/EU of 1 September 2010 on criteria and methodological standards on good environmental status of marine waters (OJ L 232, 2.9.2010, p. 14).

      (4)  Commission Staff Working Paper SEC(2011) 1255.

      ANNEX
      ‘
            ANNEX III

               Indicative lists of ecosystem elements, anthropogenic pressures and human activities relevant to the marine waters

            (referred to in Articles 8(1), 9(1), 9(3), 10(1), 11(1) and 24)

               Table 1

               Structure, functions and processes of marine ecosystems

            with particular relevance for point (a) of Article 8(1), and Articles 9 and 11

                        Theme

                        Ecosystem elements

                        Possible parameters and characteristics (Note 1)

                        Relevant qualitative descriptors laid down in Annex I (Notes 2 and 3)

                        Species

                        Species groups (Note 4) of marine birds, mammals, reptiles, fish and cephalopods of the marine region or subregion

                        Spatial and temporal variation per species or population:

                                    —

                                    distribution, abundance and/or biomass

                                    —

                                    size, age and sex structure

                                    —

                                    fecundity, survival and mortality/injury rates

                                    —

                                    behaviour including movement and migration

                                    —

                                    habitat for the species (extent, suitability)

                              Species composition of the group

                        (1); (3)

                        Habitats

                        Broad habitat types of the water column (pelagic) and seabed (benthic) (Note 5), or other habitat types, including their associated biological communities throughout the marine region or subregion

                        Per habitat type:

                                    —

                                    habitat distribution and extent (and volume, if appropriate)

                                    —

                                    species composition, abundance and/or biomass (spatial and temporal variation)

                                    —

                                    size and age structure of species (if appropriate)

                                    —

                                    physical, hydrological and chemical characteristics

                              Additionally for pelagic habitats:

                                    —

                                    chlorophyll a concentration

                                    —

                                    plankton bloom frequencies and spatial extent

                        (1); (6)

                        Ecosystems, including food webs

                        Ecosystem structure, functions and processes, comprising:

                                    —

                                    physical and hydrological characteristics

                                    —

                                    chemical characteristics

                                    —

                                    biological characteristics

                                    —

                                    functions and processes

                        Spatial and temporal variation in:

                                    —

                                    temperature and ice

                                    —

                                    hydrology (wave and current regimes; upwelling, mixing, residence time, freshwater input; sea level)

                                    —

                                    bathymetry

                                    —

                                    turbidity (silt/sediment loads), transparency, sound

                                    —

                                    seabed substrate and morphology

                                    —

                                    salinity, nutrients (N, P), organic carbon, dissolved gases (pCO2, O2) and pH

                                    —

                                    links between habitats and species of marine birds, mammals, reptiles, fish and cephalopods

                                    —

                                    pelagic-benthic community structure

                                    —

                                    productivity

                        (1); (4)

               Notes related to Table 1

                        Note 1:

                        An indicative list of relevant parameters and characteristics for species, habitats and ecosystems is given, reflecting parameters affected by the pressures of Table 2 of this Annex and of relevance to criteria laid down in accordance with Article 9(3). The particular parameters and characteristics to be used for monitoring and assessment should be determined in accordance with the requirements of this Directive, including those of its Articles 8 to 11.

                        Note 2:

                        The numbers in this column refer to the respective numbered points in Annex I.

                        Note 3:

                        Only the state-based qualitative descriptors (1), (3), (4) and (6) which have criteria laid down in accordance with Article 9(3) are listed in Table 1. All other, pressure-based, qualitative descriptors under Annex I may be relevant for each theme.

                        Note 4:

                        These species groups are further specified in Part II of the Annex to Commission Decision (EU) 2017/848 of 17 May 2017 laying down criteria and methodological standards on good environmental status of marine waters and specifications and standardised methods for monitoring and assessment, and repealing Decision 2010/477/EU (see page 43 of this Official Journal).

                        Note 5:

                        These broad habitat types are further specified in Part II of the Annex to Decision (EU) 2017/848.

               Table 2

               Anthropogenic pressures, uses and human activities in or affecting the marine environment

                                    2a.

                                    Anthropogenic pressures on the marine environment
                                    with particular relevance for points (a) and (b) of Article 8(1), and Articles 9, 10 and 11

                        Theme

                        Pressure (Note 1)

                        Possible parameters

                        Relevant qualitative descriptors laid down in Annex I (Notes 2 and 3)

                        Biological

                        Input or spread of non-indigenous species

                        Intensity of, and spatial and temporal variation in, the pressure in the marine environment and, where relevant, at source
                        For assessment of environmental impacts of the pressure, select relevant ecosystem elements and parameters from Table 1

                        (2)

                        Input of microbial pathogens

                        Input of genetically modified species and translocation of native species

                        Loss of, or change to, natural biological communities due to cultivation of animal or plant species

                        Disturbance of species (e.g. where they breed, rest and feed) due to human presence

                        Extraction of, or mortality/injury to, wild species (by commercial and recreational fishing and other activities)

                        (3)

                        Physical

                        Physical disturbance to seabed (temporary or reversible)

                        (6); (7)

                        Physical loss (due to permanent change of seabed substrate or morphology and to extraction of seabed substrate)

                        Changes to hydrological conditions

                        Substances, litter and energy

                        Input of nutrients — diffuse sources, point sources, atmospheric deposition

                        (5)

                        Input of organic matter — diffuse sources and point sources

                        Input of other substances (e.g. synthetic substances, non-synthetic substances, radionuclides) — diffuse sources, point sources, atmospheric deposition, acute events

                        (8); (9)

                        Input of litter (solid waste matter, including micro-sized litter)

                        (10)

                        Input of anthropogenic sound (impulsive, continuous)

                        (11)

                        Input of other forms of energy (including electromagnetic fields, light and heat)

                        Input of water — point sources (e.g. brine)

                                    2b.

                                    Uses and human activities in or affecting the marine environment
                                    with particular relevance for points (b) and (c) of Article 8(1) (only activities marked * are relevant for point (c) of Article 8(1)), and Articles 10 and 13

                        Theme

                        Activity

                        Physical restructuring of rivers, coastline or seabed (water management)

                        Land claim

                        Canalisation and other watercourse modifications

                        Coastal defence and flood protection*

                        Offshore structures (other than for oil/gas/renewables)*

                        Restructuring of seabed morphology, including dredging and depositing of materials*

                        Extraction of non-living resources

                        Extraction of minerals (rock, metal ores, gravel, sand, shell)*

                        Extraction of oil and gas, including infrastructure*

                        Extraction of salt*

                        Extraction of water*

                        Production of energy

                        Renewable energy generation (wind, wave and tidal power), including infrastructure*

                        Non-renewable energy generation

                        Transmission of electricity and communications (cables)*

                        Extraction of living resources

                        Fish and shellfish harvesting (professional, recreational)*

                        Fish and shellfish processing*

                        Marine plant harvesting*

                        Hunting and collecting for other purposes*

                        Cultivation of living resources

                        Aquaculture — marine, including infrastructure*

                        Aquaculture — freshwater

                        Agriculture

                        Forestry

                        Transport

                        Transport infrastructure*

                        Transport — shipping*

                        Transport — air

                        Transport — land

                        Urban and industrial uses

                        Urban uses

                        Industrial uses

                        Waste treatment and disposal*

                        Tourism and leisure

                        Tourism and leisure infrastructure*

                        Tourism and leisure activities*

                        Security/defence

                        Military operations (subject to Article 2(2))

                        Education and research

                        Research, survey and educational activities*

               Notes related to Table 2

                        Note 1:

                        Assessments of pressures should address their levels in the marine environment and, if appropriate, the rates of input (from land-based or atmospheric sources) to the marine environment.

                        Note 2:

                        The numbers in this column refer to the respective numbered points in Annex I.

                        Note 3:

                        Only pressure-based qualitative descriptors (2), (3), (5), (6), (7), (8), (9), (10) and (11), which have criteria laid down in accordance with Article 9(3), are listed in Table 2a. All other, state-based, qualitative descriptors under Annex I may be relevant for each theme.’