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31982L0242

Council Directive 82/242/EEC of 31 March 1982 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of non-ionic surfactants and amending Directive 73/404/EEC

Official Journal L 109 , 22/04/1982 P. 0001 - 0017 Finnish special edition: Chapter 15 Volume 3 P. 0217  Spanish special edition: Chapter 13 Volume 12 P. 0118  Swedish special edition: Chapter 15 Volume 3 P. 0217  Portuguese special edition Chapter 13 Volume 12 P. 0118

COUNCIL DIRECTIVE of 31 March 1982 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of non-ionic surfactants and amending Directive 73/404/EEC (82/242/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the methods of testing in force in the Member States, while pursuing the same objective, differ in certain respects and are thus detrimental to the proper functioning of the common market;  Whereas Council Directive 73/404/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to detergents (4) provides in Article 4 for the adoption of Directives specifying methods of testing as well as relevant tolerances to enable compliance with the requirements of that Directive to be established ; whereas Council Directive 73/405/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactants (5) specified such methods and tolerances for anionic surfactants;  Whereas, to enable Member States to determine the level of biodegradability of non-ionic surfactants, it is advisable to employ methods of testing already in use for this purpose in certain Member States ; whereas, however, in the event of disputes, biodegradability should be tested by a common reference method;  Whereas, in regard to the approximation of the laws of the Member States relating to detergents, suitable tolerances for measuring biodegradability should be laid down, as provided for in Article 4 of Council Directive 73/404/EEC, in order to safeguard against the unreliability of methods of testing which could lead to rejection decisions having considerable economic consequences ; whereas a rejection decision must be taken only if the results obtained by an analytical method mentioned in Article 2 show a level of biodegradability lower than 80 %;  (1) OJ No C 104, 28.4.1980, p. 112. (2) OJ No C 197, 4.8.1980, p. 66. (3) OJ No C 310, 30.11.1981, p. 7. (4) OJ No L 347, 17.12.1973, p. 51. (5) OJ No L 347, 17.12.1973, p. 53.   Whereas for the time being small quantities of certain non-ionic surfactants of low biodegradability must be used for some purposes because of technical problems and in order to prevent other undesirable effects on health and the environment ; whereas it will nevertheless be necessary to have the opportunity of reviewing the use of these surfactants of low biodegradability in the light of technical progress;  Whereas technical progress necessitates a rapid adaptation of the technical requirements specified by the Directives on detergents ; whereas, to facilitate implementation of the necessary measures designed to achieve this, a procedure should be established providing for close collaboration between the Member States and the Commission by means of a Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in detergents,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive concerns the methods of testing the biodegradability of non-ionic surfactants present in the detergents defined in Article 1 of Directive 73/404/EEC.   Article 2 In accordance with the provisions of Article 4 of Directive 73/404/EEC, the Member States shall prohibit the placing on the market and use on their territory of a detergent if the level of biodegradability of the non-ionic surfactants contained in such detergent is less than 80 % determined in accordance with one of the following methods:  - the OECD method, published in the OECD technical report of 11 June 1976 on the "Proposed Method for the Determination of the Biodegradability of Surfactants used in Synthetic Detergents",   - the method in use in Germany, established by the "Verordnung über die Abbaubarkeit anionischer und nichtionischer grenzflächenaktiver Stoffe in Wasch- und Reinigungsmitteln" of 30 January 1977, published in the Bundesgesetzblatt, 1977, Part I, page 244, as set out in the Regulation amending that Regulation of 18 June 1980, published in the Bundesgesetzblatt, 1980, Part I, page 706,   - the method in use in France, approved by Decree of 28 December 1977 published in the Journal officiel de la République française of 18 January 1978, and experimental standard T 73-270 March 1974, published by the Association française de normalisation (AFNOR),   - the method in use in the United Kingdom called the "Porous Pot Test", as described in Technical Report No 70/1978 of the Water Research Centre.      Article 3 Under the procedure laid down in Article 5 (2) of Directive 73/404/EEC, the laboratory opinion on non-ionic surfactants shall be based on the reference method (confirmatory test procedure) described in the Annex to this Directive.   Article 4 The amendments required for adapting the Annex to technical progress shall be adopted in accordance with the procedure laid down in Article 7b of Directive 73/404/EEC.   Article 5 The following Articles shall be inserted in Directive 73/404/EEC:  "Article 2a 1. Until 31 March 1986:  (a) Member States may exempt the following products from the requirements of paragraph 1 of Article 2 : low-foaming alkene oxide additives on such substances as alcohols, alkylphenols, glycols, polyols, fatty acids, amides or amines used in dish-washing products;   (b) the requirements of paragraph 1 of Article 2 shall not apply to alkali-resistant terminally blocked alkyl and alkyl-aryl polyglycol ethers and substances of the type referred to in paragraph (a), used in cleaning agents for the food, beverage and metal-working industries.     2. Paragraph 1 shall apply to the abovementioned non-ionic surfactants which  come on the market after 30 September 1983 only if they have a higher level of biodegradability than existing products for the same application.  3. The use of the non-ionic surfactants benefiting from a temporary derogation mentioned in paragraphs 1 and 2 must not, under normal conditions of use, be harmful to human or animal health.  Article 7a 1. A Committee shall be established for the adaptation to technical progress of Directives for removing technical barriers to trade in the detergents sector, hereinafter called "the Committee", which shall consist of representatives of the Member States under the chairmanship of a representative of the Commission.  2. The Committee shall establish its rules of procedure.  Article 7b 1. Where recourse is had to the procedure defined in this Article, the matter shall be referred to the Committee by its chairman, on his own initiative or at the request of the representative of a Member State.  2. The Commission representative shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a period which may be fixed by the chairman according to the urgency of the matter. A qualified majority of votes as laid down in Article 148 (2) of the Treaty shall be required before the Committee can deliver its opinion.  The chairman shall not vote.  3.  (a) The Commission shall adopt the proposed measures where they are in accordance with the opinion of the Committee.    (b)  Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall submit to the Council without delay a proposal on the measures to be adopted. The Council shall decide by a qualified majority.   (c)  If the Council has not acted within three months of the date on which the proposal was submitted, the proposed measures shall be adopted by the Commission.  Article 7c 1. In accordance with the procedure laid down in Article 7b,  - the references to test methods in the Directives referred to in Article 4 shall, if necessary, be brought up to date or supplemented by other references to test methods established in other Member States,   - the reference methods (confirmatory test) in the Annexes to the Directives referred to in Article 4 shall be modified in order to adapt them to technical progress.     2. These adaptations should not have the effect of modifying in a negative fashion the biodegradability requirements of surfactants, already laid down in accordance with Article 4."   Article 6 1. The Member States shall bring into force the provisions necessary to comply with this Directive within a period of 18 months following its notification. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.   Article 7 This Directive is addressed to the Member States.     Done at Brussels, 31 March 1982.  For the Council  The President  P. de KEERSMAEKER     ANNEX DETERMINATION OF THE BIODEGRADABILITY OF NON-IONIC SURFACTANTS Reference method (confirmatory test)  CHAPTER 1   1.1. Definition  Non-ionic surface active agents in the sense of this Directive are those surface active agents which, after passage through cationic and anionic ion exchangers, are determined as bismuth-active substance (BiAS) according to the analytical procedure described in Chapter 3.   1.2. Equipment needed for measurement  The method of measurement employs the small activated sludge plant shown in Figure 1, and in greater detail in Figure 2. The equipment consists of a storage vessel A for synthetic sewage, dosing pump B, aeration vessel C, settling vessel D, air-lift pump E to recycle the activated sludge, and vessel F for collecting the treated effluent.  Vessels A and F must be of glass or suitable plastic and hold at least 24 litres. Pump B must provide a constant flow of synthetic sewage to the aeration vessel ; this vessel, during normal operation, contains three litres of mixed liquor. A sintered aeration cube G is suspended in the vessel C at the apex of the cone. The quantity of air blown through the aerator should be monitored by means of a flowmeter H.   1.3. Synthetic sewage  A synthetic sewage is employed for the test. Dissolve in each litre of tap water:  160 mg peptone, 110 mg meat extract, 30 mg urea CO(NH2)2, 7 mg sodium chloride NaCl, 4 mg calcium chloride, CaCl2  7 2H2O, 2 mg magnesium sulphate, MgSO4  7 7H2O, 28 mg of dipotassium hydrogen phosphate K2HPO4 and 10 ± 1 mg BiAS.  The BiAS is extracted from the product to be tested by the method given in Chapter 2. The synthetic sewage is freshly prepared daily.   1.4. Preparation of samples  1.4.1. Uncompounded surfactants may be examined in the original state. The BiAS content must be determined in order to prepare the synthetic sewage (1.3).   1.4.2. Formulated products are analyzed for BiAS, MBAS and soap content. They must be subjected to an alcoholic extraction and to a separation of the BiAS (see Chapter 2). The BiAS content of the extract must be known in order to prepare the synthetic sewage.      1.5. Operation of equipment  Initially, fill aeration vessel C and settling vessel D with synthetic sewage. The height of the vessel D should be so fixed that the volume contained in the seration vessel C is three  litres. Inoculation is made by introducing 3 ml of a secondary effluent of good quality, freshly collected from a treatment plant dealing with a predominantly domestic sewage. The effluent must be kept under aerobic conditions in the period between sampling and application. Then set the aerator G, air-lift E and dosing device B in operation. The synthetic sewage must pass through the aeration vessel C at a rate of one litre per hour ; this gives a mean retention time of three hours.  The rate of aeration should be so regulated that the contents of vessel C are kept constantly in suspension and the dissolved oxygen content is at least 2 mg/l. Foaming must be prevented by appropriate means. Anti-foaming agents which inhibit the activated sludge or contain BiAS must not be used. The air-lift pump E must be set so that the activated sludge from the settling vessel is continually and regularly recycled to aeration vessel C. Sludge which has accumulated around the top of the aeration vessel C, in the base of the settling vessel D, or in the circulation circuit must be returned to the circulation at least once each day by brushing or some other appropriate means. When the sludge fails to settle, its settlebility may be increased by the addition of 2 ml portions of a 5 % solution of ferric chloride, repeated as necessary.  The effluent from the settling vessel D is accumulated in vessel F for 24 hours, following which a sample is taken after thorough mixing. Vessel F must then be carefully cleaned.   1.6. Checking measuring equipment  The BiAS content (in mg/l) of the synthetic sewage is determined immediately before use.  The BiAS content (in mg/l) of the effluent collected over 24 hours in vessel F should be determined analytically by the same method, immediately after collection : otherwise the samples must be preserved, preferably by freezing. The concentrations must be determined to the nearest 0 71 mg/l BiAS.  As a check on the efficiency of the process, the chemical oxygen demand (COD) or the dissolved organic carbon (DOC) of the glass fibre filtered effluent accumulated in vessel F and of the filtered synthetic sewage in vessel A is measured at least twice per week.  The reduction in COD or DOC should level off when a roughly regular daily BiAS degradation is obtained at the end of the running-in period shown in Figure 3.  The content of dry matter in the activated sludge contained in the aeration vessel should be determined twice a week in g/l. If it is more than 2 75 g/l, the excess activated sludge must be discarded.  The degradation test is performed at room temperature ; this should be steady and kept between 292 and 297 K (19-24 ºC).   1.7. Calculation of biodegradability  The percentage degradation of BiAS must be calculated every day on the basis of the BiAS content in mg/l of the synthetic sewage and of the corresponding effluent accumulated in vessel F.  The degradability figures thus obtained should be presented graphically as in Figure 3.  The degradability of the BiAS should be calculated as the arithmetic mean of the figures obtained over the 21 days which follow the running-in period, during which degradation has been regular and the operation of the plant trouble-free. In any event the duration of the running-in period should not exceed six weeks.  The daily degradation values are calculated to the nearest 0 71 % but the final result is given to the nearest whole number.  In some cases it may be permissible to reduce the frequency of sampling but at least 14 results collected over the 21 days which follow the running-in period should be used in calculating the average.     CHAPTER 2 PRELIMINARY TREATMENT OF PRODUCTS TO BE TESTED   2.1. Preliminary notes  2.1.1. Treatment of samples  The treatment of non-ionic surface active agents and formulated detergents prior to the determination of biodegradability in the confirmatory test is: >PIC FILE= "T0021434">   The purpose of the alcoholic extraction is to eliminate the insoluble and inorganic ingredients of the commercial product, which in some circumstances might upset the biodegradability test.   2.1.2. Ion-exchange procedure  Isolation and separation of non-ionic surface active agents from soap, anionic and cationic surfactants is required for correct biodegradability tests.  This is achieved by an ion-exchange technique using a macro-porous exchange resin and suitable elutants for fractional elution. Thus soap, anionic and non-ionic surfactants may be isolated in one procedure.   2.1.3. Analytical control  After homogenizing, the concentration of anionic and non-ionic surfactants in the detergent is determined according to the MBAS and BiAS analytical procedure. The soap content is determined by a suitable analytical method.  This analysis of the product is necessary to calculate the quantities required to prepare fractions for the biodegradability tests.  Quantitative extraction is not necessary ; however, at least 80 % of the non-ionic surfactants should be extracted. Usually, 90 % or more is obtained.      2.2. Principle  From an homogeneous sample (powders, dried pastes and dried liquids) an ethanol extract is obtained which contains the surfactants, soap and other alcohol-soluble constituents of the detergent sample.  The ethanol extract is evaporated to dryness, dissolved in an isopropanol/water mixture and the solution obtained is passed through a strongly acidic cation exchange/macroporous anion exchange combination heated to 323 K (50 ºC). This high temperature is necessary to prevent the precipitation of any fatty acids, which may be present in acidic media.  The non-ionic surfactants are obtained from the effluent by evaporation.  Cationic surfactants, which might upset the degradation test and the analytical procedure are eliminated by the cation exchanger placed above the anion exchanger.   2.3. Chemicals and equipment  2.3.1. Deionized water   2.3.2. Ethanol, 95 % (v/v) C2H5OH  (permissible denaturant : methyl-ethyl ketone or methanol)   2.3.3.  Isopropanol/water mixture (50/50 v/v):  50 parts by volume isopropanol (CH3CHOH  7 CH3) and 50 parts by volume water (2.3.1)   2.3.4. Ammonium bicarbonate solution (60/40 v/v):  0 73 mol NH4HCO3 in 1 000 ml of an isopropanol/water mixture consisting of 60 parts by volume isopropanol and 40 parts by volume water (2.3.1)   2.3.5. Cation exchanger (KAT), strongly acidic, resistant to alcohol (50-100 mesh)   2.3.6. Anion exchanger (AAT), macro-porous, Merck Lewatit MP 7080 (70-150 mesh) or equivalent   2.3.7. Hydrochloric acid, 10 % HCl w/w   2.3.8. 2 000 ml round-bottomed flask with ground glass stopper and reflux condenser   2.3.9. 90 mm diameter suction filter (heatable) for filter papers   2.3.10. 2 000 ml filter flask   2.3.11. Exchange columns with heating jacket and tap : inner tube 60 mm in diameter and 450 mm in height (Figure 4)   2.3.12. Water-bath   2.3.13. Vacuum drying oven   2.3.14. Thermostat   2.3.15. Rotary evaporator      2.4. Preparation of extract and separation of non-ionic active agents  2.4.1. Preparation of extract  The quantity of surface active agents necessary for the degradation test is about 25 g BiAS.  In preparing extracts for the degradation tests, the quantity of product to be used should be limited to a maximum of 2 000 g. Therefore it may be necessary to carry out the operation two or more times in order to obtain sufficient quantity for the degradation tests. Experience has shown that there are advantages in using a number of small extractions rather than one large extraction.   2.4.2. Isolation of alcohol-soluble constituents  Add 250 g of the synthetic detergent to be analyzed to 1 250 ml ethanol and heat the mixture to boiling point and reflux for one hour with stirring. Pass the hot alcoholic solution through a coarse-pored suction filter heated to 323 K (50 ºC) and filter rapidly. Wash the flask and suction filter with approximately 200 ml hot ethanol. Collect the filtrate and filter washings in a filter flask.  In the case of pastes or liquid products to be analyzed, make sure that not more than 25 g anionic surfactants and 35 g soap are contained in the sample. Evaporate this weighed sample to dryness. Dissolve the residue in 500 ml ethanol and proceed as described above.  In case of powders of low apparent density (Evaporate the ethanolic filtrate to complete dryness, preferably by means of rotary evaporator. Repeat the operation if a greater quantity of extract is required. Dissolve the residue in 5 000 ml isopropanol/water mixture.    2.4.3. Preparation of ion-exchange columns  Cation-exchange column  Place 600 ml cation-exchange resin (2.3.5) in a 3 000 ml beaker and cover by adding 2 000 ml hydrochloric acid (2.3.7). Allow to stand for at least two hours, with occasional stirring. Decant the acid and transfer the resin into the column (2.3.11) by means of deionized water. The column should contain a glass wool plug. Wash the column with deionized water at a rate of 10-30 ml/min until the eluate is free of chloride. Displace the water with 2 000 ml isopropanol/water mixture (2.3.3) at a rate of 10-30 ml/min. The exchange column is now ready for operation.  Anion-exchange column  Place 600 ml anion-exchange resin (2.3.6) in a beaker and cover by adding 2 000 ml deionized water. Allow the resin to swell for at least two hours. Transfer the resin into the column by means of deionized water. The column should contain a glass wool plug.  Wash the column with 0 73 M ammonium bicarbonate solution (2.3.4) until free of chloride. This requires about 5 000 ml solution. Wash again with 2 000 ml deionized water. Displace the water with 2 000 ml isopropanol/water mixture (2.3.3) at a rate of 10-30 ml/min. The exchange column is now in the OH form and ready for operation.   2.4.4. Ion-exchange procedure  Connect the exchange columns so that the cation-exchange column is placed on top of the anion-exchange column. Heat the exchange columns to 323 K (50 ºC) using thermostatic control. Heat 5 000 ml of the solution obtained in item 2.4.2 to 333 K (60 ºC) and pass the solution through the exchanger combination at a rate of 20 ml/min. Wash the columns with 1 000 ml hot isopropanol/water mixture (2.3.3).  To obtain the non-ionic surface active agents, collect the filtrate and filter washings and evaporate to dryness, preferably by means of a rotary evaporator. The residue contains the BiAS. Add deionized water until a defined volume is obtained and determine the BiAS content as in item 3.3 in an aliquot. The solution is used as a standard solution of non-ionic surfactants for the degradation test. The solution should be kept at a temperature below 278 K (5 ºC).   2.4.5. Regeneration of ion-exchange resins  The cation exchanger is rejected after use.  The anion-exchange resin is regenerated by passing about 5 000-6 000 ml of ammonium bicarbonate solution (2.3.4) down the column at a flow rate of approximately 10 ml/min until the eluate is free from anionic surfactants (methylene blue test). Then pass 2 000 ml isopropanol/water mixture (2.3.3) down the anion exchanger to wash. The anion exchanger is again ready for operation.       CHAPTER 3 DETERMINATION OF NON-IONIC SURFACE ACTIVE AGENT IN BIODEGRADATION TEST LIQUORS   3.1. Principle  Surface active agents are concentrated and isolated by gas stripping. In the sample used, the quantity of non-ionic surfactant should be in the range 250-800 ¶g.  The stripped surfactant is dissolved in ethyl acetate.  After phaser separation and evaporation of the solvent, the non-ionic surfactant is precipitated in aqueous solution with modified Dragendorff reagent (KBiJ4 + BaCl2 + glacial acetic acid).   The precipitate is filtered, washed with glacial acetic acid and dissolved in ammonium tartrate solution. The bismuth in the solution is titrated potentiometrically with pyrrolidinedithiocarbamate solution at pH 4-5 using a bright platinum indicator electrode and a calomel or silver/silver chloride reference electrode.  The method is applicable to non-ionic surfactants containing 6-30 alkylene oxide groups.  The titration result is multiplied by the empirical factor of 54 for conversion to the reference substance nonylphenol condensed with 10 mols ethylene oxide (NP 10).   3.2. Reagents and equipment  Reagents are to be made up in deionized water.  3.2.1. Pure ethyl acetate, freshly distilled.   3.2.2. Sodium bicarbonate (NaHCO3) AR   3.2.3. Dilute hydrochloric acid (20 ml concentrated acid (HCl) diluted to 1 000 ml with water)   3.2.4. Methanol AR, freshly distilled, stored in a glass bottle.   3.2.5. Bromocresol purple, 0 71 g in 100 ml methanol.   3.2.6. Precipitating agent : the precipitating agent is a mixture of two volumes of solution A and one volume of solution B. The mixture is stored in a brown bottle and can be used for up to one week after mixing.  3.2.6.1. Solution A  Dissolve 1 77 g bismuth nitrate AR (BiONO3 7H2O) in 20 ml glacial acetic acid, and make up to 100 ml with water. Then dissolve 65 g potassium iodide AR in 200 ml water. Mix these two solutions in a 1 000 ml measuring flask, add 200 ml glacial acetic acid (3.2.7) and make up to 1 000 ml with water.   3.2.6.2. Solution B  Dissolve 290 g barium chloride (BaCl2  7 2H2O) AR in 1 000 ml of water.      3.2.7. Glacial acetic acid 99-100 % (lower concentrations are unsuitable).   3.2.8. Ammonium tartrate solution : mix 12 74 g tartaric acid AR and 12 74 ml of ammonia solution AR (d = 0 7910 g/ml) and make up to 1 000 ml with water (or use the equivalent amount of ammonium tartrate AR).   3.2.9. Dilute ammonia solution : 40 ml ammonia solution AR (d = 0 7910 g/ml) diluted to 1 000 ml with water.   3.2.10. Standard acetate buffer : dissolve 40 g solid sodium hydroxide AR in 500 ml water in a beaker and allow to cool. Add 120 ml glacial acetic acid (3.2.7). Mix thoroughly, cool and transfer to a 1 000 ml volumetric flask. Make up to the mark with water.   3.2.11. Pyrrolidinedithiocarbamate solution (known as "carbate solution") : dissolve 103 mg sodium pyrrolidinedithiocarbamate (C5H8NNaS2  7 2H2O) in about 500 ml water, add 10 ml of n-amyl alcohol AR and 0 75 g NaHCO3 AR, and make up to 1 000 ml with water.   3.2.12. Copper sulphate solution (for standardization of 3.2.11).  Stock solution  Mix 1 7249 g copper suphate (CuSO4  7 5H2O) AR with 50 ml 0 75 M sulphuric acid and make up to 1 000 ml with water.  Standard solution  Mix 50 ml stock solution with 10 ml 0 75 M H2SO4 and make up to 1 000 ml with water.   3.2.13. Sodium chloride AR   3.2.14. Gas-stripping apparatus (see Figure 5).  The diameter of the sintered disc must be the same as the internal diameter of the cylinder.   3.2.15. Separating funnel, 250 ml.   3.2.16. Magnetic stirrer with magnet 25-30 mm.   3.2.17. Gooch crucible, diameter of the perforated base = 25 mm, Type G 4.   3.2.18. Circular glass-fibre filter papers, 27 mm diameter with fibre diameter 0 75-1 75 ¶m.   3.2.19. Two filter flasks with adaptors and rubber collars, 500 and 250 ml respectively.   3.2.20. Recording potentiometer fitted with a bright platinum indicator electrode and a calomel or silver/silver chloride reference electrode with a 250 mV range, with automatic burette of 20-25 ml capacity, or alternative manual equipment.      3.3. Method  3.3.1. Concentration and separation of the surfactant  Filter the aqueous sample through a qualitative filter paper. Discard the first 100 ml of the filtrate.  Into the stripping apparatus, previously rinsed with ethyl acetate, place a measured quantity of the sample, such that it contains between 250-800 ¶g non-ionic surfactant.  To improve the separation add 100 g sodium chloride and 5 g sodium bicarbonate.  If the volume of the sample exceeds 500 ml, add these salts to the stripping apparatus in solid form, and dissolve by passing nitrogen or air through.  If a smaller-sized sample is used, dissolve the salts in 400 ml water and then add to the stripping apparatus.  Add water to bring the level to the upper stopcock.  Cautiously add 100 ml ethyl acetate on top of the water.  Fill the wash-bottle in the gas-line (nitrogen or air) two-thirds full with ethyl acetate.  Pass a gas stream of 30-60 l/h through the apparatus ; the inclusion of a rotameter is recommended. The rate of aeration must be increased gradually at the beginning. The gas rate must be so adjusted that the phases remain noticeably separate to minimize the mixing of the phases and the solution of the ethyl acetate in the water. Stop the gas flow after five minutes.  If there is a reduction of more than 20 % in the volume of the organic phase through solution in water, the sublation must be repeated paying special attention to the rate of gas flow.  Run off the organic phase into a separating funnel. Return any water in the separating funnel from the aqueous phase - it should only be a few ml - to the stripping apparatus. Filter the ethyl acetate phase through a dry qualitative filter paper into a 250 ml beaker.  Put a further 100 ml ethyl acetate into the stripping apparatus and again pass nitrogen or air through for five minutes. Draw off the organic phase into the separating funnel used for the first separation, reject the aqueous phase and run the organic phase through the same filter as the first ethyl acetate portion. Rinse both the separating funnel and the filter with about 20 ml ethyl acetate.  Evaporate the ethyl acetate extract to dryness on a water-bath (fume cupboard). Direct a gentle stream of air over the surface of the solution to accelerate the evaporation.   3.3.2. Precipitation and filtration  Dissolve the dry residue from 3.3.1 in 5 ml methanol, add 40 ml water and 0 75 ml diluted HCl (3.2.3) and stir the mixture with a magnetic stirrer.   To this solution add 30 ml of precipitating agent (3.2.6) from a measuring cylinder. The precipitate forms after repeated stirring. After stirring for 10 minutes leave the mixture to stand for at least five minutes.  Filter the mixture through a Gooch crucible, the base of which is covered with a glass-fibre filter paper. First wash the filter under suction with about 2 ml glacial acetic acid. Then thoroughly wash the beaker, magnet, and crucible with glacial acetic acid, of which about 40-50 ml is necessary. It is not necessary to quantitatively transfer the precipitate adhering to the sides of the beaker, to the filter, because the solution of the precipitate for the titration is returned to the precipitating beaker, and the remaining precipitate will then be dissolved.   3.3.3. Solution of the precipitate  Dissolve the precipitate in the filter crucible by the addition of hot ammonium tartrate solution (about 80 ºC, 353 K) (3.2.8) in three portions of 10 ml each. Allow each portion to stand in the crucible for some minutes before being sucked through the filter into the flask.  Put the contents of the filter flask into the beaker used for the precipitation. Rinse the sides of the beaker with a further 20 ml of tartrate solution to dissolve the rest of the precipitate.  Carefully wash the crucible, adaptor and filter flask with 150-200 ml water, and return the rinsing water to the beaker used for the precipitation.   3.3.4. The titration  Stir the solution using a magnetic stirrer (3.2.16), add a few drops of bromocresol purple (3.2.5) and add the diluted ammonia solution (3.2.9) until the colour turns violet (the solution is weakly acid from the residue of acetic acid used for rinsing).  Then add 10 ml standard acetate buffer (3.2.10), immerse the electrodes in the solution, and titrate potentiometrically with standard "carbate solution" (3.2.11), the burette tip being immersed in the solution.  The titration rate should not exceed 2 ml/min.  The endpoint is the intersection of the tangents to the two branches of the potential curve. It will be observed occasionally that the inflection in the potential curve becomes flattened this can be eliminated by carefully cleaning the platinum electrode (by polishing with emery paper).   3.3.5. Blank determinations  At the same time run a blank determination through the whole procedure with 5 ml methanol and 40 ml water, according to the instructions in 3.3.2. The blank titration should be below 1 ml, otherwise the purity of the reagents (3.2.3 - 3.2.7 - 3.2.8 - 3.2.9 - 3.2.10) is suspect, especially their content of heavy metals, and they must be replaced. The blank must be taken into account in the calculation of the results.   3.3.6. Control of the factor of the "carbate solution"  Determine the factor for the carbate solution on the day of use. To do this, titrate 10 ml of the copper sulphate solution (3.2.12) with carbate solution after the addition of 100 ml water and 10 ml standard acetate buffer (3.2.10). If the amount used is "a" ml, the factor f is: >PIC FILE= "T0021435">   and all the results of the titrations are multiplied by this factor.      3.4. Calculation of results  Every non-ionic surfactant has its own factor, depending on its composition, particularly on the length of the alkene oxide chain. The concentration of non-ionic surfactant is expressed in relation to a standard substance - a nonyl phenol with 10 ethylene oxide units (NP 10) - for which the conversion factor is 0 7054.   Using this factor the amount of surfactant present in the sample is found expressed as mg of NP 10 equivalent, as follows:  (b-c)  7 f  7 0 7054 = mg non-ionic surfactant as NP 10  where : b = volume of "carbate solution" used by the sample (ml),  c = volume of "carbate solution" used by the blank (ml),  f = factor of the "carbate solution".   3.5. Expression of results  Express the results in mg/l as NP 10 to the nearest 0 71.     Figure 1  >PIC FILE= "T0021436">    >PIC FILE= "T0021437">    >PIC FILE= "T0021438">    Figure 4 Heated exchange column (Dimensions in millimetres)  >PIC FILE= "T0021439">    Figure 5 Gas-stripping apparatus (Dimensions in millimetres)  >PIC FILE= "T0021440">


title: Commission Directive 2010/59/EU of 26 August 2010 amending Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients  Text with EEA relevance

text:
               27.8.2010

               EN

               Official Journal of the European Union

               L 225/10

         COMMISSION DIRECTIVE 2010/59/EU
   of 26 August 2010
   amending Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (1) and in particular Article 4 thereof,
   Whereas:

               (1)

               Directive 2009/32/EC applies to extraction solvents used or intended for use in the production of foodstuffs or food ingredients. That Directive does not apply to extraction solvents used in the production of food additives, vitamins and other nutritional additives, unless such food additives, vitamins or nutritional additives are listed in its Annex I. The European Food Safety Authority (the Authority) evaluated the safety of dimethyl ether as an extraction solvent to remove fat from animal protein raw materials and expressed its opinion of 29 January 2009 (2). The Authority concluded that there is no safety concern provided that the maximum residual limit of dimethyl ether is 9 μg/kg of extracted animal proteins. Therefore the use of dimethyl ether as an extraction solvent to remove fat from animal protein raw materials should be authorised under the condition of a maximum residual limit of dimethyl ether of 9 μg/kg in the defatted protein product.

               (2)

               Part III of Annex I to Directive 2009/32/EC does not establish specific residue limits in foodstuffs for methanol and propan-2-ol resulting from the preparation of flavourings. Member States and the Commission pointed out that the general residue limit of 10 mg/kg for methanol and propane-2-ol, as set out in Part II of Annex I to Directive 2009/32/EC, is too strict if applied directly to flavourings.

               (3)

               Therefore specific limits should be set in foodstuffs for methanol and propan-2-ol resulting from their use for the preparation of flavourings from natural flavouring materials. Those limits should be lower than the limit of 10 mg/kg assessed as safe by the Scientific Committee for Food (3), in order to be considered as safe.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 2009/32/EC is amended in accordance with 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 15 September 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 26 August 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 141, 6.6.2009, p. 3.

      (2)  Scientific opinion of the panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF) on request from European Commission on the safety in use of dimethyl ether as an extraction solvent. The EFSA Journal (2009) 983, 1-13.

      (3)  Scientific Committee for Food. Second opinion on extraction solvents expressed on 21 June 1991. Food Science and Techniques Reports of the Scientific Committee for Food (29th series), p. 1-11.

      ANNEX
      Annex I to Directive 2009/32/EC is amended as follows:

                  1.

                  in Part II the following row is added:

                              ‘Dimethyl ether

                              Preparation of defatted animal protein products

                              0,009 mg/kg in the defatted protein product’

                  2.

                  in Part III the following rows are added:

                              ‘Methanol

                              1,5 mg/kg

                              Propan-2-ol

                              1 mg/kg’


Avis juridique important

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31990L0018

Commission Directive 90/18/EEC of 18 December 1989 adapting to technical progress the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP)

Official Journal L 011 , 13/01/1990 P. 0037 - 0050 Finnish special edition: Chapter 15 Volume 9 P. 0152  Swedish special edition: Chapter 15 Volume 9 P. 0152

*****COMMISSION  DIRECTIVE  of 18 December 1989  adapting to technical progress the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP)  (90/18/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of good laboratory practice (GLP) (1), and in particular Article 7 (2) thereof,  Whereas it is necessary to adapt the Annex to Directive 88/320/EEC in order to facilitate uniform interpretation throughout the Community by replacing the reference to the OECD guidance documents by the full text of the documents concerned,  HAS DECIDED AS FOLLOWS:  Article 1  The Annex to Directive 88/320/EEC is hereby replaced by the Annex hereto.  Article 2  1. The Member States shall adopt the laws, regulations and administrative provisions needed in order to comply with this Directive not later than 1 July 1990 and in conjunction with Council Directive 88/320/EEC. They shall fort with inform the Commission thereof.  2. Member States shall ensure that the text of the provisions of internal law which they adopt in the field of the Directive is communicated to the Commission.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 18 December 1989.  For the Commission  Martin BANGEMANN  Vice-President  (1) OJ No L 145, 11. 6. 1988, p. 35.  ANNEX  'ANNEX  The provisions for the inspection and verification of GLP which are contained in Annexes A and B to this Directive are those contained in Annexes 1 (guides for compliance monitoring procedures for good laboratory practice) and 2 (guidance for the conduct of laboratory inspections and study audits) respectively to the draft Council recommendation on compliance with principles of good laboratory practice (OECD ENV/CHEM/CM/88/15 (first revision).'  ANNEX A  GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GOOD LABORATORY PRACTICE (GLP)  To facilitate the mutual acceptance of test data generated for submission to regulatory authorities of OECD member countries, harmonization of the procedures adopted to monitor good laboratory practice compliance, as well as comparability of their quality and rigour, are essential.  The aim of this Annex is to provide detailed practical guidance to OECD member countries on the structure, mechanisms and procedures they should adopt when establishing national good laboratory practice compliance monitoring programmes so that these programmes may be internationally acceptable.  It is recognized that member countries will adopt GLP principles and establish compliance monitoring procedures according to national legal and administrative practices, and according to priorities they give to, e.g. the scope of initial and subsequent coverage concerning categories of chemicals and types of testing.  Since member countries may establish more than one good laboratory practice monitoring authority due to their legal framework for chemicals control, more than one good laboratory practice compliance programme may be established. The guidance set forth in the following paragraphs concern each of these authorities and compliance programmes, as appropriate.  DEFINITIONS OF TERMS  The definitions of terms in the 'OECD principles of good laboratory practice', adopted in Article 1 of Council Directive 87/18/EEC (1) are applicable to this document. In addition, the following definitions apply:  GLP principles: Principles of good laboratory practice, that are consistent with the OECD principles of good laboratory practice as adopted in Article 1 of Directive 87/18/EEC.  GLP compliance monitoring: The periodic inspection of laboratories and/or auditing of studies for the purpose of verifying adherence to GLP principles.  (National) GLP compliance programme: The particular scheme established by a member country to monitor good laboratory practice compliance by laboratories within its territories, by means of inspections and study audits.  (National) GLP monitoring authority: A management body established within a member country with responsibility for monitoring the good laboratory practice compliance of laboratories within its territories and for discharging other such functions related to good laboratory practice as may be nationally determined. It is understood that more than one such body may be established in a member country.  Laboratory inspection: An on-site examination of the test facility's procedures and practices to assess the degree of compliance with GLP principles. During inspections, the management structures and operational procedures of the laboratory are examined, key technical personnel are interviewed, and the quality and integrity of data generated by the facility are assessed and reported.  Study audit: A comparison of raw data and associated records with the interim or final report in order to determine whether the raw data have been accurately reported, to determine whether testing was carried out in accordance with the study plan and standard operating procedures, to obtain additional information not provided in the report, and to establish whether practices were employed in the development of data that would impair their validity.  Inspector: A person who performs the laboratory inspections on behalf of the (national) GLP monitoring authority.  GLP compliance status: The level of adherence of a laboratory to the GLP principles as assessed by the (National) GLP monitoring authority.  Regulatory authority: A national body with legal responsibility for aspects of the control of chemicals.  COMPONENTS OF GOOD LABORATORY PRACTICE COMPLIANCE MONITORING PROCEDURES  Administration  A (national) GLP compliance programme should be the responsibility of a properly constituted, legally identifiable management body adequately staffed and working within a defined administrative framework.  Member countries should:  - ensure that the (national) GLP monitoring authority is directly responsible for an adequate 'team' of inspectors having the necessary technical/scientific expertise or is ultimately responsible for such a 'team',  - publish documents relating to the adoption of GLP principles within their territories,  - publish documents providing details of the (national) GLP compliance programme, including information on the legal or administrative framework within which the programme operates and references to published acts, normative documents (e.g. regulations, codes of practice), inspection manuals, guidance notes, etc.,  - maintain records of laboratories inspected (and their GLP compliance status) and of studies audited.  To foster international understanding and liaison, member countries should inform the OECD and other member countries (e.g. through the OECD complementary information exchange procedure) of the nature and availability of the documentation on GLP which has been produced, together with the addresses and telephone numbers of the (national) GLP monitoring authorities.  Confidentiality  (National) GLP monitoring authorities will have access to commercially valuable information and, on occasion, may even need to remove commercially sensitive documents from a laboratory or refer to them in detail in their reports.  Member countries should:  - make provision for the maintenance of confidentiality, not only by Inspectors but also by any other persons who gain access to confidential information as a result of GLP compliance monitoring activities,  - ensure that, unless all commercially sensitive and confidential information has been excised, reports of laboratory inspections and study audits are made available only to regulatory authorities and, where appropriate, to the laboratories inspected or concerned with study audits and/or to study sponsors.  The names of laboratories subject to laboratory inspections within a (national) GLP compliance programme, their levels of compliance with the national GLP principles and the date(s) the inspections were conducted should be made available to national) GLP monitoring authorities in other member countries upon request.  Personnel and training  (National) GLP monitoring authorities should:  - ensure that an adequate number of Inspectors is available  The number of inspectors required will depend upon:  (a) the number of laboratories involved in the (national) GLP compliance programme;  (b) the frequency with which the GLP compliance status of the laboratories is to be assessed;  (c) the number and complexity of the studies undertaken by those laboratories;  (d) the number of special inspections or audits requested by regulatory authorities,  - ensure that inspectors are adequately qualified and trained  Inspectors should have qualifications and practical experience in the range of scientific disciplines relevant to the testing of chemicals. (National) GLP monitoring authorities should:  (a) ensure that arrangements are made for the appropriate training of Inspectors, having regard to their individual qualifications and experience,  (b) encourage consultations, including joint training activities where necessary, with the staff of (national) GLP monitoring authorities in other member countries in order to promote international harmonization in the interpretation and application of GLP principles, and in the monitoring of compliance with such principles,  - ensure that inspectorate personnel have no financial or other interests in the laboratories inspected, the studies audited or the firms sponsoring such studies,  - provide inspectors with a suitable means of identification (e.g. an identity card). Inspectors may be:  - on the permanent staff of the (national) GLP monitoring authority,  - on the permanent staff of a body separate from the (national) GLP monitoring authority, or  - employed on contract, or by another way, by the (national) GLP monitoring authority to perform laboratory inspections or study audits.  In the latter two cases, the (national) GLP monitoring authority should have ultimate responsibility for determining the GLP compliance status of laboratories and the quality/acceptability of a study audit, and for taking any action based on the results of laboratory inspections or study audits which may be necessary.  (National) GLP compliance programmes  GLP compliance monitoring is intended to ascertain whether laboratories have implemented GLP principles for the conduct of studies and are capable of assuring that the resulting data are of adequate quality. As indicated above, member countries should publish the details of their (national) GLP compliance programmes. Such information should inter alia:  - define the scope and extent of the programme  A (national) GLP compliance programme may cover only a limited range of chemicals, e.g. industrial chemicals, pesticides, pharmaceuticals, etc., or may include all chemicals. The scope of the monitoring for compliance should be defined, both with respect to the categories of chemicals and to the types of tests subject to it, e.g. physical, chemical, toxicological and/or ecotoxicological,  - provide an indication as to the mechanism whereby laboratories enter the programme  The application of GLP principles to health and environmental safety data generated for regulatory purposes may be mandatory. A mechanism should be available whereby laboratories may have their compliance with GLP principles monitored by the appropriate (national) GLP monitoring authority,  - provide information on categories of laboratory inspections/study audits  A (national) GLP compliance programme should include:  (a) routine laboratory inspections - i.e. the regular monitoring of laboratories, in principle on a two-year cycle. These inspections include both a general inspection of the laboratory and a (limited) study audit of an on-going or completed study;  (b) special laboratory inspections/study audits at the request of a regulatory authority - e.g. prompted by a query arising from the submission of data to a regulatory authority,  - define the powers of inspectors for entry into laboratories and their access to data held by laboratories  While inspectors will not normally wish to enter laboratories against the will of the laboratory management, circumstances may arise where entry and access to data are essential to protect public health or the environment. The powers available to the (national) GLP monitoring authority in such cases should be defined,  - describe the laboratory inspection and study audit procedures for verification of GLP compliance  The documentation should indicate the procedures which will be used to examine both the organizational processes and the conditions under which laboratory studies are planned, performed, monitored and recorded. Guidance for such procedures is available in Annex B to this Directive,  - describe actions that may be taken as follow-up to laboratory inspections and study audits  Follow-up to laboratory inspections and study audits  When a laboratory inspection or study audit has been completed, the inspector should prepare a written report of the findings.  Member countries should take action where deviations from GLP principles are found during or after a laboratory inspection or study audit. The appropriate actions should be described in documents from the (national) GLP monitoring authority.  If a laboratory inspection or study audit reveals only minor deviations from GLP principles, the laboratory should be required to correct such minor deviations. The inspector may need, at an appropriate time, to return to the facility to verify that corrections have been introduced. Where no or where only minor deviations have been found, the (national) GLP monitoring authority may:  - issue a statement that the laboratory has been inspected and found to be operating in compliance with GLP principles. The date of inspection and, if appropriate, the categories of tests inspected in the laboratory at that time should be included. Such statements may be used to provide information to (national) GLP monitoring authorites in other Member countries,  and/or  - provide the regulatory authority which requested a study audit with a detailed report of the findings.  Where serious deviations are found, the action taken by (national) GLP monitoring authorities will depend upon the particular circumstances of each case and the legal or administrative provisions under which GLP compliance monitoring has been established within their countries. Actions which may be taken include, but are not limited to, the following:  - issuance of a statement, giving details of the inadequacies or faults found which might affect the validity of studies conducted in the laboratory,  - suspension of laboratory inspections or study audits of a laboratory and, for example and where administratively possible, removal of the laboratory from the (national) GLP compliance programme or from any existing list or register of laboratories subject to GLP laboratory inspections,  - the requirement that a statement detailing the deviations be attached to specific study reports,  - action through the courts, where warranted by circumstances and where legal/administrative procedures so permit.  Where serious deviations are found which may have affected specific studies, the (national) GLP monitoring authority should consider the need to inform relevant regulatory authorities or (national) GLP monitoring authorities in other member countries of their findings.  Appeals procedures  Problems, or differences of opinion, between inspectors and laboratory management will normally be resolved during the course of an laboratory inspection or study audit. However, it may not always be possible for agreement to be reached. A procedure should exist whereby a laboratory may make representations relating to the outcome of a laboratory inspection or study audit for GLP compliance monitoring and/or relating to the action the GLP monitoring authority proposes to take thereon should exist.  (1) OJ No L 15, 17. 1. 1987, p. 29.  ANNEX B  GUIDANCE FOR THE CONDUCT OF LABORATORY INSPECTIONS AND STUDY AUDITS  INTRODUCTION  The purpose of this Annex is to provide guidance for the conduct of laboratory inspections and study audits which would be mutually acceptable to the OECD member countries. It is principally concerned with laboratory inspections, an activity which occupies much of the time of GLP inspectors. A laboratory inspection will usually include a limited study audit or 'review' as a part of the inspection, but study audits will also have to be conducted from time to time at the request, for example, of a regulatory authority. General guidance for the conduct of study audits will be found at the end of this Annex.  Laboratory inspections are conducted to determine the degree of conformity of test facilities and laboratory studies with GLP principles and to determine the integrity of data to assure that resulting data are of adequate quality for assessment and decision-making by national regulatory authorities. Laboratory inspections result in reports which describe the degree of adherence of a test facility of the GLP principles. Laboratory inspections should be conducted on a regular, routine basis to establish and maintain a record of the GLP compliance status of a test facility.  DEFINITIONS OF TERMS  The definitions of terms in the 'OECD principles of good laboratory practice', adopted in Article 1 of Directive 87/18/EEC and in the Annex A to this Directive, are applicable to this Annex.  LABORATORY INSPECTIONS  Inspections for compliance with GLP principles may take place in any test facility generating health or environmental safety data for regulatory purposes. Inspectors may be required to audit data relating to the physical, chemical, toxicological or ecotoxicological properties of a substance or preparation. In some cases, Inspectors may need assistance from experts in particular disciplines.  The wide diversity of facilities (in terms both of physical layout and management structure), together with the variety of types of studies encountered by inspectors, means that inspectors must use their own judgement to assess the degree and extent of compliance with GLP principles. Nevertheless, inspectors should strive for a consistent approach in evaluating whether, in the case of a particular laboratory or study, an adequate level of compliance with each GLP principle has been achieved.  In the following sections, guidance is provided on the various aspects of the testing facility, including its personnel and procedures, which are likely to be examined by Inspectors. In each section, there is a statement of purpose, as well as an illustrative list of specific items which could be considered during the course of a laboratory inspection. These lists are not meant to be comprehensive and should not be taken as such.  Inspectors should not concern themselves with the need for, or objectives of, the study or the interpretation of the findings of studies with respect to risks for human health or the environment. These aspects are the responsibility of those regulatory authorities to which the data are submitted for regulatory purposes.  Laboratory inspections and study audits inevitably disturb the normal work in a laboratory. Inspectors should therefore carry out their work in a carefully planned way and, so far as practicable, respect the wishes of the management of the laboratory as to the timing of visits to certain sections of the facility.  Inspectors will, while conducting laboratory inspections and study audits, have access to confidential, commercially valuable information. It is essential that they ensure that such information is seen by authorized personnel only. Their responsibilities in this respect will have been established within their (national) GLP compliance monitoring programme. INSPECTION PROCEDURES  Pre-inspection  Purpose: To familiarize the inspector with the facility which is about to be inspected in respect of management structure, physical layout of buildings and range of studies.  Prior to conducting a laboratory inspection or study audit, Inspectors should familiarize themselves with the facility which is to be visited. Any existing information on the facility should be reviewed. This may include previous inspection reports, the layout of the facility, organization charts, study reports, protocols and curricula vitae (CVs) of key personnel. Such documents would provide information on:  - the type, size and layout of the facility,  - the range of studies likely to be encountered during the inspection,  - the management structure of the facility.  Inspectors should note, in particular, any deficiencies from previous laboratory inspections. Where no previous laboratory inspections have been conducted, a pre-inspection visit can be made to obtain relevant information.  Laboratories should be informed of the date and time of inspectors' arrival, the objective of their visit and the length of time they expect to be on the premises. This will allow the laboratory to ensure that the appropriate personnel and documentation are available. In cases where particular documents or records are to be examined, it may be useful to identify these to the laboratory in advance of the visit so that they will be immediately available during the laboratory inspection.  Starting conference  Purpose: To inform the management and staff of the facility of the reason for the laboratory inspection or study audit that is about to take place, and to identify the laboratory areas, study(ies) selected for audit, documents and personnel likely to be involved.  The administrative and practical details of a laboratory inspection or study audit should be discussed with the management of the facility at the start of the visit. At the starting conference, inspectors should:  - outline the purpose and scope of the visit,  - describe the documentation which will be required for the laboratory inspection, such as lists of on-going and completed studies, study plans, standard operating procedures, study reports, etc. Access to and, if necessary, arrangements for the copying of relevant documents should be agreed upon at this time,  - clarify or request information as to the management structure (organization) and personnel of the facility,  - request information as to the conduct, side-by-side, of studies subject to GLP principles with others for which they are not applied,  - make an initial determination as to the parts of the facility to be covered during the laboratory inspection,  - describe the documents and specimens that will be needed for on-going or completed study(ies) selected for study audit.  Before proceeding further with a laboratory inspection, it is advisable for the inspector to establish contact with the laboratory's quality assurance (QA) unit.  As a general rule, when inspecting a facility, Inspectors will find it helpful to be accompanied by a member of the QA unit.  Inspectors may wish to request that a room be set aside for examination of documents and other activities.  Organization and personnel  Purpose: To determine whether: the test facility has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken; the organizational structure is appropriate; and management has established a policy regarding training and staff health surveillance appropriate to the studies undertaken in the facility.  The management should be asked to produce certain documents, for example:  - floor plans,  - facility management and scientific organisation charts,  - CVs of key personnel involved in the type(s) of studies selected for the study audit,  - list(s) of on-going and completed studies with information on the type of study, initiation/completion dates, test system, route of administration and name of study director, - staff training and health surveillance policies, where such policies have been established,  - staff training records where available,  - an index to the facility's standard operating procedures (SOPs),  - specific SOPs as related to the studies or procedures being inspected or audited,  - list(s) of the study directors associated with the study(ies) being audited.  The inspector should check, in particular:  - lists of on-going and completed studies to ascertain the level of work being undertaken by the laboratory,  - the identity and qualifications of the study directors, the head of the quality assurance unit and other key personnel,  - existence of SOPs for all relevant areas of testing.  Quality assurance programme  Purpose: To determine whether the mechanisms used to assure management that laboratory studies are conducted in accordance with GLP principles are adequate.  The head of the quality assurance (QA) unit should be asked to demonstrate the systems and methods for QA inspection and monitoring of studies, and the system for recording observations made during QA monitoring. Inspectors should check:  - the qualifications of the head of QA, and of all QA staff,  - that the QA unit functions independently from the staff involved in the studies,  - how the QA unit schedules and conducts inspections, how it monitors identified critical phases in a study, and what resources are available for QA inspections and monitoring activities,  - that where studies are of such short duration that monitoring of each study is impracticable, arrangements exist for monitoring on a sample basis,  - the extent and depth of QA monitoring during the practical phases of the study,  - the QA procedures for checking the final report to ensure its agreement with the raw data,  - that management receives reports from QA concerning problems likely to affect the quality or integrity of a study,  - the actions taken by QA when deviations are found,  - the QA role, if any, if studies or parts of studies are done in contract laboratories,  - the part played, if any, by QA in the review, revision and up-dating of SOPs.  Facilities  Purpose: To determine whether the test facility is of suitable size, construction, design and location to meet the demands of the studies being undertaken.  The Inspector should check that:  - the design enables an adequate degree of separation so that, e.g. test substances, animals, diets, pathological specimens, etc. of one study cannot be confused with those of another,  - environmental control and monitoring procedures exist and function adequately in critical areas, e.g. animal and other biological test systems rooms, test substance storage areas, laboratory areas,  - the general housekeeping is adequate for the various facilities and that there are, if necessary, pest control procedures.  Care, housing and containment of biological test systems  Purpose: To determine whether the test facility, if engaged in studies using animals or other biological test systems, has support facilities and conditions for their care, housing and containment, adequate to prevent stress and other problems which could affect the test system and hence the quality of data.  A test facility may be carrying out studies which require a diversity of animal or plant species as well as microbial or other cellular or sub-cellular systems. The type of test systems being used will determine the aspects relating to care, housing or containment that the Inspector will monitor. Using his judgement, the inspector will check, according to the test systems, that: - there are facilities adequate for the test systems used and for testing needs,  - there are arrangements to quarantine animals and plants being introduced into the facility and that these arrangements are working satisfactorily,  - there are arrangements to isolate animals (or other elements of a test system, if necessary) known to be, or suspected of being, diseased or carriers of disease,  - there is adequate monitoring and record-keeping of health, behaviour or other aspects, as appropriate to the test system,  - the equipment for maintaining the environmental conditions required for each test system is adequate, well maintained, and effective,  - animal cages, racks, tanks and other containers, as well as accessory equipment, are kept sufficiently clean,  - analyses to check environmental conditions and support systems are carried out as required,  - facilities exist for removal and disposal of animal waste and refuse from the test systems and that these are operated so as to minimise vermin infestation, odours, disease hazards and environmental contamination,  - storage areas are provided for animal feed or equivalent materials for all test systems; that these areas are not used for the storage of other materials such as test substances, pest control chemicals or disinfectants, and that they are separate from areas in which animals are housed or other biological test systems are kept,  - stored feed and bedding are protected from deterioration by adverse environmental conditions, infestation or contamination.  Apparatus, materials, reagents and specimens  Purpose: To determine whether the laboratory has suitably located, operational apparatus in sufficient quantity and of adequate capacity to meet the requirements of the tests being conducted in the facility and that the materials, reagents and specimens are properly labelled, used and stored.  The inspector should check that:  - apparatus are clean and in good working order,  - records have been kept of apparatus operation, maintenance, standardization and calibration,  - materials and chemical reagents are properly labelled and stored at appropriate temperatures and that expiry dates are not being ignored. Labels for reagents should indicate their source, identity and concentration and/or other pertinent information,  - specimens are well identified by test system, study, nature and date of collection,  - apparatus and materials used do not interfere with the test systems.  Test systems  Purpose: To determine whether adequate procedures exist for the handling and control of the variety of test systems required by the studies undertaken in the facility. e.g. chemical and physical systems, cellular and microbic systems, plants or animals.  Physical and chemical systems  The inspector should check that:  - where required by study plans, the stability of test and reference substances were determined and that the reference substances specified in test plans were used,  - SOPs exist to cover laboratory activities and that their provisions are observed,  - in automated systems, data generated as graphs, recorder traces or computer print-outs are documented as raw data and archived.  Biological test systems  Taking account of the relevant aspects referred to above relating to care, housing or containment of biological test systems, the inspector should check that:  - test systems are as specified in study plans,  - test systems are adequately identified,  - animals are adequately and, if necessary and appropriate, uniquely identified throughout the study, - housing or containers of test systems are properly identified with all the necessary information,  - there is an adequate separation of studies being conducted on the same animal species (or the same biological test systems) but with different substances,  - there is an adequate separation of animal species (and other biological test systems) either in space or in time,  - the biological test system environment is as specified in the study plan or in SOPs for aspects such as temperature, or light/dark cycles,  - the recording of the receipt, handling, housing or containment, care and health evaluation is appropriate to the test systems,  - written records are kept of examination, quarantine, morbidity, mortality, behaviour, diagnosis and treatment of animal and plant test systems or other similar aspects as appropriate to each biological test system,  - there are provisions for the appropriate disposal of test systems at the end of tests.  Test and reference substances  Purpose: To determine whether the laboratory has procedures designed (i) to ensure that the identity, potency, quantity and composition of test and reference substances are in accordance with their specifications, and (ii) to properly receive and store test and reference substances.  The inspector should check that:  - there are SOPs for recording the receipt, and for the handling, sampling, usage and storage of test and reference substances,  - test and reference substances containers are properly labelled,  - storage conditions are appropriate to preserve the concentration, purity and stability of the test and reference substances,  - there are SOPs for the determination of identity, purity, composition, stability, and for the prevention of contamination of test and reference substances, where applicable,  - records are kept of the composition, characterisation, concentration, and stability of test and reference substances, where applicable,  - there are procedures for the determination of the homogeneity and stability of mixtures containing test and reference substances, where applicable,  - containers holding mixtures (or dilutions) of the test and reference substances are labelled and that records are kept of the homogeneity and stability of their contents, where applicable,  - when the test is of longer than four weeks' duration, samples from each batch of test and reference substances have been taken for analytical purposes and that they have been retained for an appropriate time,  - procedures for mixing substances are designed to prevent errors in identification or cross-contamination.  Standard operating procedures  Purpose: To determine whether the laboratory has written standard operating procedures (SOPs) relating to all the important aspects of the laboratory's operations, considering that one of the most important management techniques for controlling laboratory operations is the use of written SOPs. These relate directly to the routine elements of tests conducted by the laboratory.  The inspector should check that:  - each laboratory area has immediately available relevant, authorized copies of SOPs,  - procedures exist for revision and updating of SOPs,  - any amendments or changes to SOPs have been authorized and dated,  - historical files of SOPs are maintained,  - SOPs are available for, but not necessarily limited to, the following activities:  1.2 // (i)   // receipt, identification, labelling, handling, sampling, usage and storage of test and reference substances;  // (ii)   // maintenance, cleaning and calibration of measuring apparatus and environmental control equipment;  // (iii)   // preparation of reagents and dosing formulations;   // (iv)   // record-keeping, reporting, storage and retrieval of records and reports;  // (v)   // preparation and environmental control of areas containing the test systems;   // (vi)   // receipt, transfer, location, characterization, identification and care of test systems;   // (vii)   // handling of the test systems before, during and at the termination of the study;   // (viii)  // disposal of test systems;   // (ix)   // use of pest control and cleaning agents;   // (x)   // quality assurance programme operations.  Performance of the study  Purpose: To verify that written study plans exist and that the plans and the conduct of the study are in accordance with GLP principles.  The inspector should check that:  - the study plan was signed by the study director,  - any amendments to the study plan were signed and dated,  - the date of the agreement to the study plan by the sponsor was recorded, (where applicable),  - measurements, observations, and examinations were in accordance with the study plan and relevant SOPs,  - the results of these measurements, observations and examinations were recorded directly, promptly, accurately and legibly and were signed (or initialled) and dated,  - any changes in the raw data, including data stored in computers, did not obscure previous entries, included the reason for the change and were signed and dated,  - computer-generated or stored data have been identified and that the procedures to protect them against unauthorized amendments or loss are adequate,  - the computer software used within the study is reliable, accurate, and can be validated,  - any unforeseen events recorded in the raw data have been investigated and evaluated,  - the results presented in the reports of the study (interim or final) are consistent and complete and that they correctly reflect the raw data.  Reporting of study results  Purpose: To determine whether final reports are prepared in accordance with GLP Principles.  When a final report is available, the inspector should check that:  - it is signed and dated by the study director and by other principal scientists,  - the study director has signed a statement indicating acceptance of responsibility for the validity of the study and confirming that the study was conducted in accordance with GLP principles,  - a quality assurance statement is included in the report and that it is signed and dated,- any amendments were made by the responsible personnel,  - it lists the archive location of all samples, specimens and raw data.  Storage and retention of records  Purpose: To determine whether the facility has generated adequate records and reports and whether adequate provision has been made for the safe storage and retention of records and materials.  The inspector should check:  - the archive facilities for the storage of study plans, raw data, final reports, samples and specimens,  - the procedures for retrieval or archived materials,  - the procedures whereby access to the archives is limited to authorized personnel and records are kept of personnel given access to raw data, slides, etc.,  - that an inventory is maintained of materials removed from, and returned to, the archives,  - that records and materials are retained for the required or appropriate period of time and are protected from loss or damage by fire, adverse environmental conditions, etc. STUDY AUDITS  Laboratory inspections will generally include inter alia (limited) study audits. These may be brief reviews of on-going or completed studies. When specific study audits are requested by regulatory authorities, the conduct and reporting of the study should be subjected to a detailed examination. Because of the wide variation in the types of studies which might be audited, only general guidance is appropriate, and inspectors and others taking part in study audits will always need to exercise judgement as to the nature and extent of their examinations. The objective should be to reconstruct the study from the study plan using relevant SOPs, raw data and other archived material.  In some cases, inspectors may need assistance from other experts in order to conduct an effective study audit, e.g. where there is a need to examine tissue sections under the microscope.  When conducting a study audit, the inspector should:  - obtain names, job descriptions and summaries of training and experience for selected personnel engaged in the study(ies) such as the study director and principal scientists,  - check that there is sufficient staff trained in relevant areas for the study(ies) undertaken,  - identify individual items of apparatus or special equipment used in the study and examine the calibration, maintenance and service records for the equipment,  - review the records relating to the stability of the test substances, analyses of test substance and formulations, analyses of feed, etc.,  - attempt to determine, through the interview process if possible, the work assignments of selected individuals participating in the study to ascertain if these individuals had the time to accomplish the tasks specified in the study plan or report,  - obtain copies of all documentation concerning control procedures or forming integral parts of the study, including:  (i) the study plan;  (ii) SOPs in use at the time the study was done;  (iii) log books, laboratory notebooks, files, worksheets, print-outs of computer-stored data, etc.;  (iv) the final report.  In studies in which animals (i.e. rodents and other mammals) are used, the inspectors should follow a certain percentage of individual animals from their arrival at the laboratory to autopsy. They should pay particular attention to the records relating to:  - animal body weight, food/water intake, dose formulation and administration, etc.,  - clinical observations and autopsy findings,  - clinical chemistry,  - pathology.  COMPLETION OF INSPECTION OR STUDY AUDIT  When a laboratory inspection or study audit has been completed, the inspector should be prepared to discuss his findings with representatives of the test facility and should prepare a written report, i.e. the inspection report.  A laboratory inspection of any large laboratory is likely to reveal a number of minor deviations from GLP principles but, normally, these will not be sufficiently serious to affect the validity of studies emanating from that laboratory. In such cases, it is reasonable for an inspector to report that the laboratory is operating in compliance with GLP principles according to the criteria established by the (national) GLP monitoring authority. Nevertheless, details of the inadequacies or faults detected should be provided to the laboratory and assurances sought from its senior management that action will be taken to remedy them. The inspector may need to revisit the laboratory after a period of time to verify that necessary action has been taken. If a serious deviation from the GLP principles is identified during a laboratory inspection or study audit which, in the opinion of the inspector, may have affected the validity of that study, or of other studies performed at the facility, the inspector should report back to the (national) GLP monitoring authority. The action taken by that authority will depend upon the nature and extent of the non-compliance and the legal and/or administrative provisions within the GP compliance programme.  Where a study audit has been conducted at the request of a regulatory authority, a full report of the findings should be prepared and sent via the relevant (national) GLP monitoring authority to the regulatory authority concerned.


title: Commission Directive 2005/57/EC of 21 September 2005 amending Council Directive 91/414/EEC to include MCPA and MCPB as active substances   (Text with EEA relevance)

text:
               22.9.2005

               EN

               Official Journal of the European Union

               L 246/14

      COMMISSION DIRECTIVE 2005/57/EC
   of 21 September 2005
   amending Council Directive 91/414/EEC to include MCPA and MCPB as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes MCPA and MCPB.

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92 (3), Italy was designated as rapporteur Member State. On 5 April 2001 and 19 December 2001 Italy submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.

               (3)

               The assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The reviews were finalised on 15 April 2005 in the format of the Commission review reports for MCPA and MCPB.

               (4)

               The reviews of MCPA and MCPB did not reveal any open question to be addressed by the Scientific Committee on Plants or the European Food Safety Authority (EFSA) which has taken over the role of the latter.

               (5)

               It has appeared from the various examinations made that plant protection products containing MCPA or MCPB may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

               (6)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (7)

               Without prejudice to the obligations defined by Directive 91/414 as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing MCPA or MCPB to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (9)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 October 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 November 2006.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing MCPA or MCPB as active substances by 31 October 2006. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to MCPA and MCPB respectively are met, with the exception of those identified in part B of the entry concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.
   2.   By derogation from paragraph 1, for each authorised plant protection product containing MCPA or MCPB as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning MCPA and MCPB respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing MCPA or MCPB as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2010 at the latest; or

               (b)

               in the case of a product containing MCPA or MCPB as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 May 2006.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 21 September 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1).

      (2)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).

      (3)  OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regulation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘108

                     MCPA
                     CAS No 94-74-6
                     CIPAC No 2

                     4-chloro-o-tolyloxyacetic acid

                     ≥ 930 g/kg

                     1 May 2006

                     30 April 2016

                     PART A
                     Only uses as herbicide may be authorised
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account
                     Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate
                     Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones

                     109

                     MCPB
                     CAS No 94-81-5
                     CIPAC No 50

                     4-(4-chloro-o-tolyloxy)butyric acid

                     ≥ 920 g/kg

                     1 May 2006

                     30 April 2016

                     PART A
                     Only uses as herbicide may be authorised
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account
                     Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate
                     Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones’

         (1)  Further details on identity and specification of active substance are provided in the review report.


Avis juridique important

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31985L0347

Council Directive 85/347/EEC of 8 July 1985 amending Directive 68/297/EEC on the standardization of provisions regarding the duty-free admission of fuel contained in the fuel tanks of commercial motor vehicles

Official Journal L 183 , 16/07/1985 P. 0022 - 0023 Finnish special edition: Chapter 9 Volume 1 P. 0124  Spanish special edition: Chapter 07 Volume 4 P. 0003  Swedish special edition: Chapter 9 Volume 1 P. 0124  Portuguese special edition Chapter 07 Volume 4 P. 0003

*****COUNCIL  DIRECTIVE  of 8 July 1985  amending Directive 68/297/EEC on the standardization of provisions regarding the duty-free admission of fuel contained in the fuel tanks of commercial motor vehicles  (85/347/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 75 and 99 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Directive 68/297/EEC (4), as amended by Directive 83/127/EEC (5), laid down the minimum quantity of fuel contained in the fuel tanks of commercial motor vehicles which must be admitted duty-free at the internal frontiers of the Community;  Whereas, with a view to facilitating the crossing of these frontiers, in an initial stage the said quantity should be increased for vehicles which are designed for, and capable of, the transport of passengers; whereas the Council is to decide at a later date on the increase applicable to vehicles which are designed for, and capable of, the transport of goods;  Whereas the term 'standard fuel tank' should be defined,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 68/297/EEC is hereby amended as follows:  1. Article 1 is replaced by the following:  'Article 1  Member States shall, in accordance with this Directive, standardize provisions regarding the duty-free admission of fuel contained in the standard fuel tanks of commercial motor vehicles travelling across common frontiers between Member States.'  2. Article 2 is replaced by the following:  'Article 2  For the purposes of this Regulation:  - "commercial motor vehicle" means any motorized road vehicle which by its type of construction and equipment is designed for, and capable of, transporting, whether for payment or not:  (a) more than nine persons, including the driver;  (b) goods;  - "standard fuel tanks" means the tanks permanently fixed by the manufacturer to all motor vehicles of the same type as the vehicle in question and whose permanent fitting enables fuel to be used directly, both for the purpose of propulsion and, where appropriate, for the operation of a refrigeration system.  Gas tanks fitted to motor vehicles designed for the direct use of gas as a fuel shall also be considered to be standard fuel tanks.'  3. Paragraph 1 of Article 3 is replaced by the following:  '1. Member States shall admit duty-free the following quantities of fuel contained in standard fuel tanks of commercial motor vehicles:  (a) 200 litres per vehicle and per journey in the case of vehicles designed for, and capable of, transporting goods, with or without payment;  (b) 600 litres per vehicle and per journey in the case of vehicles designed for, and capable of, transporting more than nine persons including the driver.  Acting in accordance with the procedures provided for by the Treaty on this point, the Council shall decide, on a proposal from the Commission, before 1 July 1986, on the increase of the quantity of fuel admitted duty-free and contained in the standard fuel tanks of the vehicles referred to in (a) of the first subparagraph.'  4. Article 5 is deleted.  Article 2  Member States shall take the measures necessary to comply with this Directive not later than 1 October 1985. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 8 July 1985.  For the Council  The President  J. SANTER  (1) OJ No C 95, 6. 4. 1984, p. 4.  (2) OJ No C 172, 2. 7. 1984, p. 15.  (3) OJ No C 248, 17. 9. 1984, p. 13.  (4) OJ No L 175, 23. 7. 1968, p. 15.  (5) OJ No L 91, 9. 4. 1983, p. 28.