Avis juridique important

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31998L0064

Commission Directive 98/64/EC of 3 September 1998 establishing Community methods of analysis for the determination of amino-acids, crude oils and fats, and olaquindox in feedingstuffs and amending Directive 71/393/EEC (Text with EEA relevance)

Official Journal L 257 , 19/09/1998 P. 0014 - 0028

COMMISSION DIRECTIVE 98/64/EC of 3 September 1998 establishing Community methods of analysis for the determination of amino-acids, crude oils and fats, and olaquindox in feedingstuffs and amending Directive 71/393/EEC (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 2 thereof,Whereas Directive 70/373/EEC stipulates that official controls of feedingstuffs for the purpose of checking compliance with the requirements arising under the laws, regulations and administrative provisions governing their quality and composition must be carried out using Community methods of sampling and analysis;Whereas Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (2), as last amended by Commission Directive 97/47/EC (3), and Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (4), as last amended by Directive 96/25/EC (5), stipulate that amino-acids and crude oils and fats are to be set out on the feedingstuffs label;Whereas Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (6), as last amended by Commission Directive 98/19/EC (7), stipulates that the olaquindox content must be indicated on the labelling where this substance is added to compound feedingstuffs;Whereas the second Commission Directive 71/393/EEC of 18 November 1971 establishing Community methods of analysis for the official control of feedingstuffs (8), as last amended by Commission Directive 84/4/EEC (9), sets out methods for analysis for, inter alia, the determination of crude oils and fats; whereas it is appropriate to modify the method described;Whereas Community methods of analysis must be established for checking these substances;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 The Member States shall provide that analyses conducted with a view to official controls of the amino-acid, crude oil and fat, and olaquindox content of feedingstuffs are carried out using the methods set out in the Annex hereto.Article 2 In the Annex to Commission Directive 71/393/EEC, point '4. Determination of crude oils and fats` is replaced by part B of the annex to this Directive.Article 3 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 December 1998. They shall immediately inform the Commission thereof.They shall apply the measures from 1 January 1999.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 5 This Directive is addressed to the Member States.Done at Brussels, 3 September 1998.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 170, 3. 8. 1970, p. 2.(2) OJ L 86, 6. 4. 1979, p. 30.(3) OJ L 211, 5. 8. 1997, p. 45.(4) OJ L 237, 22. 9. 1993, p. 23.(5) OJ L 125, 23. 5. 1996, p. 35.(6) OJ L 270, 14. 12. 1970, p. 1.(7) OJ L 96, 28. 3. 1998, p. 39.(8) OJ L 279, 20. 12. 1971, p. 7.(9) OJ L 15, 18. 1. 1984, p. 28.ANNEX PART A DETERMINATION OF AMINO ACIDS 1. Purpose and scope This method is for the determination of free (synthetic and natural) and total (peptide bound and free) amino acids in feedingstuffs, using an amino acid analyzer. It is applicable to the following amino acids: cyst(e)ine, methionine, lysine, threonine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, phenylalanine, proline, serine, tyrosine and valine.The method does not distinguish between the salts of amino acids and it cannot differentiate between D and L forms of amino acids. It is not valid for the determination of tryptophan or hydroxy analogues of amino acids.2. Principle 2.1. Free amino acids The free amino acids are extracted with diluted hydrochloric acid. Coextracted nitrogenous macromolecules are precipitated with sulfosalicylic acid and removed by filtration. The filtered solution is adjusted to pH 2,20. The amino acids are separated by ion exchange chromatography and determined by reaction with ninhydrin with photometric detection at 570 nm.2.2. Total amino acids The procedure chosen depends on the amino acids under investigation. Cyst(e)ine and methionine must be oxidised to cysteic acid and methionine sulphone respectively prior to hydrolysis. Tyrosine must be determined in hydrolysates of unoxidized samples. All the other amino acids listed in paragraph 1 can be determined in either the oxidised or unoxidised sample.Oxidation is performed at 0 °C with a performic acid/phenol mixture. Excess oxidation reagent is decomposed with sodium disulphite. The oxidised or unoxidised sample is hydrolysed with hydrochloric acid (c = 6 mol/l) for 23 hours. The hydrolysate is adjusted to pH 2,20. The amino acids are separated by ion exchange chromatography and determined by reaction with ninhydrin using photometric detection at 570 nm (440 nm for proline).3. Reagents Double distilled water or water of equivalent quality must be used (conductivity NUM>A × E × MW × F>DEN>B × W × 1 000 = g amino acid per kg sampleIf an internal standard is used multiply by:>NUM>D>DEN>C>TABLE>Cystine and cysteine are both determined as cysteic acid in hydrolysates of oxidized sample, but calculated as cystine (C6H12N2O4S2, MW 240,30 by using MW 120,15 (= 0,5 × 240,30).Methionine is determined as methionine sulphone in hydrolysates of oxidized sample, but calculated as methionine by using MW of methionine: 149,21.Added free methionine is determined after extraction as methionine, for the calculation the same MW is used.6.1. The total dilution volume of extracts (F) for determination of free amino acids (5.2) is calculated as following:F = 100 ml × >NUM>(10 ml + 5ml)>DEN>10 ml × >NUM>Vml>DEN>10 mlV = volume of final extract7. Evaluation of the method The method has been tested in an intercomparison made at international level in 1990 using four different feedingstuffs (mixed pig feed, broiler compound, protein concentrate, premixture). The results, after elimination of outliers, of mean and standard deviation are given in the table below:>TABLE>7.1. Repeatability The repeatability expressed as 'within laboratory standard deviation` of the above mentioned intercomparison is given in the tables below:>TABLE>>TABLE>7.2. Reproducibility The results for between laboratory standard deviation by the above mentioned intercomparison are given in the table below:>TABLE>>TABLE>8. Use of reference materials The correct application of the method shall be verified by making replicate measurements of certified reference materials when available. Calibration with certified amino acid calibration solution is recommended.9. Observations 9.1. Because of differences between amino acid analysers the final concentrations of the calibration solutions of standard amino acids (see 3.27.4 and 3.27.5) and of the hydrolysate (see 5.3.4) should be taken as a guideline.The range of linear response of the apparatus has to be checked for all amino acids.The standard solution is diluted with citrate buffer to give peak areas in the middle of the range.9.2. Where high performance liquid chromatographic equipment is used to analyse the hydrolysates, the experimental conditions must be optimised in accordance with the manufacturer's recommendations.9.3. By applying the method to feedingstuffs containing more than 1 % chloride (concentrate, mineral feeds, supplementary feeds) underestimation of methionine could occur and special treatment has to be done.PART B DETERMINATION OF CRUDE OILS AND FATS 1. Purpose and scope This method is for the determination of crude oils and fats in feedingstuffs. It does not cover the analysis of oil seeds and oleaginous fruit defined in Council Regulation 136/66/EEC of 22 September 1966.The use of the two procedures described below depends on the nature and composition of the feedingstuff and the reason for carrying out the analysis.1.1. Procedure A - Directly extractable crude oils and fats This method is applicable to feed materials of plant origin, except those included within the scope of Procedure B.1.2. Procedure B - Total crude oils and fats This method is applicable to feed materials of animal origin and to all compound feeds. It is to be used for all materials from which the oils and fats cannot be completely extracted without prior hydrolysis (eg glutens, yeast, potato proteins and products subject to processes such as extrusion, flaking and heating).1.3. Interpretation of results In all cases where a higher result is obtained by using Procedure B than by Procedure A, the result obtained by Procedure B shall be accepted as the true value.2. Principle 2.1. Procedure A The sample is extracted with light petroleum. The solvent is distilled off and the residue dried and weighed.2.2. Procedure B The sample is treated under heating with hydrochloric acid. The mixture is cooled and filtered. The residue is washed and dried and submitted to the determination according to Procedure A.3. Reagents 3.1. Light petroleum, boiling range: 40 to 60 °C. The bromine value must be less than 1 and the residue on evaporation less than 2 mg/100 ml.3.2. Sodium sulfate, anhydrous.3.3. Hydrochloric acid, c = 3 mol HCl/l3.4. Filtration aid, e.g. Kieselguhr, Hyflo-supercel.4. Apparatus 4.1. Extraction apparatus. If fitted with a siphon (Soxhlet apparatus), the reflux rate should be such as to produce about 10 cycles per hour; if of the non-siphoning type, the reflux rate should be about 10 ml per minute.4.2. Extraction thimbles, free of matter soluble in light petroleum and having a porosity consistent with the requirements of point 4.1.4.3. Drying oven, either a vacuum oven set at 75 °C ± 3 °C or an air-oven set at 100 °C ± 3 °C.5. Procedure 5.1. Procedure A (see point 8.1) Weigh 5 g of the sample to the nearest 1 mg, transfer it to an extraction thimble (4.2) and cover with a fat-free wad of cotton wool.Place the thimble in an extractor (4.1) and extract for six hours with light petroleum (3.1). Collect the light petroleum extract in a dry, weighed flask containing fragments of pumice stone (1).Distil off the solvent. Dry the residue maintaining the flask for one and a half hours in the drying oven (4.3). Leave to cool in a desiccator and weigh. Dry again for 30 minutes to ensure that the weight of the oils and fats remains constant (loss in weight between two successive weighings must be less than 1 mg).5.2. Procedure B Weigh 2,5 g of the sample to the nearest 1 mg (see point 8.2), place in a 400 ml beaker or a 300 ml conical flask and add 100 ml of hydrochloric acid (3.3) and fragments of pumice stone. Cover the beaker with a watch glass or fit the conical flask with a reflux condenser. Bring the mixture to a gentle boil over a low flame or a hot-plate and keep it there for one hour. Do not allow the product to stick to the sides of the container.Cool and add a quantity of filtration aid (3.4) sufficient to prevent any loss of oil and fat during filtration. Filter through a moistened, fat-free, double filter paper. Wash the residue in cold water until a neutral filtrate is obtained. Check that the filtrate does not contain any oil or fats. Their presence indicates that the sample must be extracted with light petroleum, using Procedure A, before hydrolysis.Place the double filter paper containing the residue on a watch glass and dry for one and a half hours in the air oven (4.3) 100 °C ± 3 °C.Place the double filter paper containing the dry residue in an extraction thimble (4.2) and cover with a fat-free wad of cotton wool. Place the thimble in an extractor (4.1) and proceed as indicated in the second and third paragraphs of point 5.1.6. Expression of result Express the weight of the residue as a percentage of the sample.7. Repeatability The difference between the results of two parallel determinations carried out on the same sample by the same analyst should not exceed:- 0,2 % in absolute value, for contents of crude oils and fats lower than 5 %,- 4,0 % relative to the highest result for contents of 5 to 10 %,- 0,4 % in absolute value, for contents above 10 %.8. Observations 8.1. For products with a high content of oils and fats, which are difficult to crush or unsuitable for drawing a homogeneous reduced test sample, proceed as follows.Weigh 20 g of the sample to the nearest 1 mg and mix with 10 g or more of anhydrous sodium sulfate (3.2). Extract with light petroleum (3.1) as indicated in point 5.1. Make up the extract obtained to 500 ml with light petroleum (3.1) and mix. Take 50 ml of the solution and place in a small, dry, weighed flask containing fragments of pumice stone (2). Distil off the solvent, dry and proceed as indicated in the last paragraph of point 5.1.Eliminate the solvent from the extraction residue left in the thimble, crush the residue to a fineness of 1 mm, return it to the extraction thimble (do not add sodium sulfate) and proceed as indicated in the second and third paragraphs of point 5.1.Calculate the content of oils and fats as a percentage of the sample by using the following formula:(10 a + b) × 5where:a = mass in grams of the residue after the first extraction (aliquot part of the extract),b = mass in grams of the residue after the second extraction.8.2. For products low in oils and fats the test sample may be increased to 5 g.8.3. Pet foods containing a high content of water may need to be mixed with anhydrous sodium sulfate prior to hydrolysis and extraction as per Procedure B.8.4. In paragraph 5.2 it may be more effective to use hot water in place of cold water to wash the residue after filtration.8.5. The drying time of 1,5 h may need to be extended for some feedingstuffs. Excessive drying should be avoided as this can lead to low results. A microwave oven can also be used.8.6. Pre-extraction by Procedure A prior to hydrolysis and re-extraction by Procedure B is recommended if the crude oil/fat content is greater than 15 %. To some extent this depends on the nature of the feedingstuff and the nature of the oil-fat in the feedingstuff.PART C DETERMINATION OF OLAQUINDOX (2-[N-2'-(hydroxyethyl)carbamoyl]-3-methylquinoxaline-N1,N4-dioxyde) 1. Purpose and scope This method is for the determination of olaquindox in feedingstuffs. The lower limit of determination is 5 mg/kg.2. Principle The sample is extracted by a water-methanol mixture. The content of olaquindox is determined by reversed-phase high-performance liquid chromatography (HPLC) using an UV detector.3. Reagents 3.1. Methanol.3.2. Methanol, HPLC grade3.3. Water, HPLC grade3.4. Mobile phase for HPLC:Water (3.3) -methanol (3.2) mixture, 900 + 100 (V + V).3.5. Standard substance: pure olaquindox 2-[N-2'-(hydroxyethyl)carbamoyl]-3-methylquinoxaline-N1,N4-dioxyde, E 851.3.5.1. Olaquindox stock standard solution, 250 ìg/mlWeigh to the nearest 0,1 mg 50 mg of olaquindox (3.5) in a 200 ml graduated flask and add ca. 190 ml water. Then place the flask for 20 min into an ultrasonic bath (4.1). After ultrasonic treatment bring the solution to room temperature, make up to the mark with water and mix. Wrap the flask with aluminum foil and store in a refrigerator. This solution must be prepared fresh each month.3.5.2. Olaquindox intermediate standard solution, 25 ìg/mlTransfer 10,0 ml of the stock standard solution (3.5.1) into a 100 ml graduated flask, make up to the mark with the mobile phase (3.4) and mix. Wrap the flask with aluminium foil and store in a refrigerator. This solution must be prepared fresh each day.3.5.3. Calibration solutions:Into a series of 50 ml graduated flask transfer 1,0, 2,0, 5,0, 10,0, 15,0 and 20,0 ml of the intermediate standard solution (3.5.2). Make up to the mark with the mobile phase (3.4) and mix. Wrap the flask with aluminium foil. These solutions correspond to 0,5, 1,0, 2,5, 5,0, 7,5 and 10,0 ìg of olaquindox per ml respectively.These solutions must be prepared fresh each day.4. Apparatus 4.1. Ultrasonic bath4.2. Mechanical shaker4.3. HPLC equipment with variable wavelength ultraviolet detector or diode array detector4.3.1. Liquid chromatographic column, 250 mm × 4 mm, C18, 10 ìm packing, or equivalent4.4. Membrane filters, 0,45 ìm5. Procedure Note: Olaquindox is light sensitive. Carry out all procedures under subdued light or use amber glassware.5.1. General 5.1.1. A blank feed should be analysed to check that neither olquindox nor interfering substances are present.5.1.2. A recovery test should be carried out by analysing the blank feed which has been fortified by addition of a quantity of olaquindox, similar to that present in the sample. To fortify at a level of 50 mg/kg, transfer 10,0 ml of the stock standard solution (3.5.1) to a 250 ml conical flask and evaporate the solution to ca. 0,5 ml. Add 50 g of the blank feed, mix thoroughly and leave for 10 min mixing again several times before proceeding with the extraction step (5.2).Note: For the purpose of this method the blank feed should be similar in type to that of the sample and olaquindox should not be detected.5.2. Extraction Weigh to the nearest 0,01 g, approximately 50 g of the sample. Transfer to a 1 000 ml conical flask, add 100 ml of methanol (3.1) and place the flask for 5 minutes in the ultrasonic bath (4.1). Add 410 ml water and leave in the ultrasonic bath for further 15 minutes. Remove the flask from the ultrasonic bath, shake it for 30 minutes on the shaker (4.2) and filter through a folded filter. Transfer 10,0 ml of the filtrate into a 20 ml graduated flask, make up to the mark with water and mix. An aliquot is filtered through a membrane filter (4.4). (see 9. Observation) Proceed to the HPLC determination (5.3).5.3. HPLC determination 5.3.1. Parameters: The following conditions are offered for guidance, other conditions may be used provided that they give equivalent results.>TABLE>Check the stability of the chromatographic system, injecting several times the calibration solution (3.5.3) containing 2,5 ìg/ml, until constant peak heights and retention times are achieved.5.3.2. Calibration graph Inject each calibration solution (3.5.3) several times and determine the mean peak height (areas) for each concentration. Plot a calibration graph using the mean peak heights (areas) of the calibration solutions as the ordinates and the corresponding concentrations in ìg/ml as the abscissae.5.3.3. Sample solution Inject the sample extract (5.2) several times using the same volume as taken for the calibration solutions and determine the mean peak height (area) of the olaquindox peaks.6. Calculation of the results From the mean height (area) of the olaquindox peaks of the sample solution determine the concentration of the sample solution in ìg/ml by reference to the calibration graph (5.3.2).The olaquindox content w in mg/kg of the sample is given by the following formula:w = >NUM>c × 1 000>DEN>min which:c = olaquindox concentration of the sample extract (5.2) in ìg/mlm = mass of the test portion in g (5.2).7. Validation of the results 7.1. Identity The identity of the analyte can be confirmed by co-chromatography, or by using a diode-array detector by which the spectra of the sample extract (5.2) and the calibration solution (3.5.3) containing 5,0 ìg/ml are compared.7.1.1. Co-chromatography A sample extract (5.2) is fortified by addition of an appropriate amount of calibration solution (3.5.3). The amount of added olaquindox should be similar to the amount of olaquindox found in the sample extract.Only the height of the olaquindox peak should be enhanced after taking into account both the amount added and the dilution of the extract. The peak width, at half of its height, must be within ± 10 % of the original width of the olaquindox peak of the unfortified sample extract.7.1.2. Diode array detection The results are evaluated according to the following criteria:(a) The wavelength of maximum absorption of the sample and of the standard spectra, recorded at the peak apex on the chromatogram, must be within a margin determined by the resolving power of the detection system. For diode-array detection this is typically within ± 2 nm.(b) Between 220 and 400 nm, the sample and standard spectra recorded at the peak apex of the chromatogram, must not be different for those parts of the spectrum within the range 10-100 % of relative absorbance. This criterion is met when the same maxima are present and at no observed point the deviation between the two spectra exceeds 15 % of the absorbance of the standard analyte.(c) Between 220 and 400 nm, the spectra of the upslope, apex and downslope of the peak produced by the sample extract must not be different from each other for those parts of the spectrum within the range 10-100 % of relative absorbance. This criterion is met when the same maxima are present and when at all observed points the deviation between the spectra does not exceed 15 % of the absorbance of the spectrum of the peak apex.If one of these criteria is not met the presence of the analyte has not been confirmed.7.2. Repeatability The difference between the results of two parallel determinations carried out on the same sample must not exceed 15 % relative to the higher result for olaquindox contents between 10 and 20 mg/kg.7.3. Recovery For a fortified blank sample the recovery should be at least 90 %.8. Results of a collaborative study An EC collaborative study was arranged in which four piglet feed samples including one blank feed were analysed by up to 13 laboratories. The results are given below:>TABLE>9. Observation Although the method has not been validated for feeds containing more than 100 mg/kg of olaquindox, it may be possible to obtain satisfactory results by taking a smaller sample weight and/or diluting the extract (5.2) to reach a concentration within the range of the calibration graph (5.3.2).(1) Where the oil or fat has to undergo subsequent quality tests, replace the fragments of pumice stone by glass beads.


Avis juridique important

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31996L0010

Directive 96/10/EC of the European Parliament and of the Council of 21 March 1996 amending Directive 89/647/EEC as regards recognition of contractual netting by the competent authorities

Official Journal L 085 , 03/04/1996 P. 0017 - 0021

DIRECTIVE 96/10/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 March 1996 amending Directive 89/647/EEC as regards recognition of contractual netting by the competent authoritiesTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 57 (2) thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Having regard to the opinion of the European Monetary Institute (3),Acting in accordance with the procedure laid down in Article 189b of the Treaty (4),Whereas Annex II to Council Directive 89/647/EEC of 18 December 1989 on a solvency ratio for credit institutions (5) lays down the treatment of off-balance-sheet items concerning interest and foreign-exchange rates in the context of the calculation of credit institutions' capital requirements;Whereas with a view to the smooth functioning of the internal market and in particular with a view to ensuring a level playing field Member States are obliged to strive for uniform assessment of contractual netting agreements by their competent authorities;Whereas this Directive is in accordance with the work of an international forum of banking supervisors on the supervisory recognition of bilateral netting, in particular the possibility of calculating the own-funds requirements for certain transactions on the basis of a net rather than a gross amount provided that there are legally binding agreements which ensure that the credit risk is confined to the net amount;Whereas the rules contemplated for the supervisory recognition of netting at the wider international level will lead to the possibility of reducing the capital requirements for internationally active credit institutions and groups of credit institutions in a wide range of non-member countries credit institutions which compete with Community credit institutions;Whereas for credit institutions incorporated in the Member States, only an amendment of Directive 89/647/EEC can create a similar possibility for the recognition of bilateral netting by the competent authorities and thereby offer them equal conditions of competition; whereas the rules are both well balanced and appropriate for the further reinforcement of the application of prudential supervisory measures to credit institutions;Whereas the competent authorities in the Member States should ensure that the calculation of add-ons is based on effective rather than apparent notional amounts;Whereas, having regard to this situation, this Directive complies with the principle of subsidiarity, since the aim of this Directive can be achieved only by means of the harmonized amendment of existing Community legislation,HAVE ADOPTED THIS DIRECTIVE:Article 1Annex II to Directive 89/647/EEC shall be replaced by the Annex hereto.Article 2Article 1 shall be without prejudice to the competent authorities' recognition of bilateral contracts for novation concluded before the entry into force of the laws, regulations and administrative provisions necessary for the implementation of this Directive.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive after its entry into force and no later than 30 June 1996. They shall forthwith inform the Commission thereof.When the Member States adopt those measures they shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such references shall be laid down by the Member States.2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.Article 4This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 21 March 1996.For the European ParliamentThe PresidentK. HÄNSCHFor the CouncilThe PresidentA. GAMBINO(1) OJ No C 142, 25. 5. 1994, p. 8, and OJ No C 165, 1. 7. 1995, p. 6.(2) OJ No C 393, 31. 12. 1994, p. 30.(3) Opinion delivered on 16 January 1995 (not yet published in the Official Journal).(4) Opinion of the European Parliament of 16 February 1995 (OJ No C 56, 6. 3. 1995, p. 79), Council common position of 5 September 1995 (OJ No C 288, 30. 10. 1995, p. 30) and Decision of the European Parliament of 14 December 1995 (OJ No C 17, 22. 1. 1996). Council Decision of 26 February 1996.(5) OJ No L 386, 30. 12. 1989, p. 14. Directive as last amended by Commission Directive 95/15/EC (OJ No L 125, 8. 6. 1995, p. 23).ANNEX 'ANNEX IITHE TREATMENT OF OFF-BALANCE-SHEET ITEMS CONCERNING INTEREST AND FOREIGN-EXCHANGE RATES1. SCOPE AND CHOICE OF METHODSubject to the consent of their competent authorities, credit institutions may choose one of the methods set out below to measure the risks associated with the transactions listed in Annex III. Interest-rate and foreign-exchange contracts traded on recognized exchanges where they are subject to daily margin requirements and foreign-exchange contracts with an original maturity of fourteen calendar days or less are excluded.2. METHODSMethod 1: the "mark-to-market" approachStep (a): by attaching current market values to contracts (mark to market) the current replacement cost of all contracts with positive values is obtained.Step (b): to obtain a figure for the potential future credit exposure (1), the notional principal amounts or underlying values are multiplied by the following percentages:>TABLE>Step (c): the sum of the current replacement cost and the potential future credit exposure is multiplied by the risk weightings allocated to the relevant counterparties in Article 6.Method 2: the "original exposure" approachStep (a): the notional principal amount of each instrument is multiplied by the percentages given below:>TABLE>Step (b): the original exposure thus obtained is multiplied by the risk weightings allocated to the relevant counterparties in Article 6.(1) Except in the case of single-currency "floating/floating" interest-rate swaps in which only the current replacement cost will be calculated.3. CONTRACTUAL NETTING (CONTRACTS FOR NOVATION AND OTHER NETTING AGREEMENTS)(a) Types of netting that the competent authorities may recognizeFor the purposes of this point 3 "counterparty" means any entity (including natural persons) that has the power to conclude a contractual netting agreement.The competent authorities may recognize as risk-reducing the following types of contractual netting:(i) bilateral contracts for novation between a credit institution and its counterparty under which mutual claims and obligations are automatically amalgamated in such a way that this novation fixes one single net amount each time novation applies and thus creates a legally binding, single new contract extinguishing former contracts;(ii) other bilateral netting agreements between a credit institution and its counterparty.(b) Conditions for recognitionThe competent authorities may recognize contractual netting as risk-reducing only under the following conditions:(i) a credit institution must have a contractual netting agreement with its counterparty which creates a single legal obligation, covering all included transactions, such that, in the event of a counterparty's failure to perform owing to default, bankruptcy, liquidation or any other similar circumstance, the credit institution would have a claim to receive or an obligation to pay only the net sum of the positive and negative mark-to-market values of included individual transactions;(ii) a credit institution must have made available to the competent authorities written and reasoned legal opinions to the effect that, in the event of a legal challenge, the relevant courts and administrative authorities would, in the cases described under (i), find that the credit institution's claims and obligations would be limited to the net sum, as described in (i), under:- the law of the jurisdiction in which the counterparty is incorporated and, if a foreign branch of an undertaking is involved, also under the law of the jurisdiction in which the branch is located,- the law that governs the individual transactions included, and- the law that governs any contract or agreement necessary to effect the contractual netting;(iii) a credit institution must have procedures in place to ensure that the legal validity of its contractual netting is kept under review in the light of possible changes in the relevant laws.The competent authorities must be satisfied, if necessary after consulting the other competent authorities concerned, that the contractual netting is legally valid under the law of each of the relevant jurisdictions. If any of the competent authorities is not satisfied in that respect, the contractual netting agreement will not be recognized as risk-reducing for either of the counterparties.The competent authorities may accept reasoned legal opinions drawn up by types of contractual netting.No contract containing a provision which permits a non-defaulting counterparty to make limited payments only, or no payments at all, to the estate of the defaulter, even if the defaulter is a net creditor (a "walkaway" clause), may be recognized as risk-reducing.(c) Effects of recognition(i) Contracts for novationThe single net amounts fixed by contracts for novation, rather than the gross amounts involved, may be weighted. Thus, in the application of Method 1, in- Step (a): the current replacement cost, and in- Step (b): the notional principal amounts or underlying valuesmay be obtained taking account of the contract for novation. In the application of Method 2, in Step (a) the notional principal amount may be calculated taking account of the contract for novation; the percentages of Table 2 must apply.(ii) Other netting agreementsIn the application of Method 1, in Step (a) the current replacement cost for the contracts included in a netting agreement may be obtained by taking account of the current hypothetical net replacement cost which results from the agreement. In Step (b) the single net amounts may be taken into account only for forward foreign-exchange contracts and other similar contracts, in which notional principal is equivalent to cash flows, in cases where the amounts to be claimed or delivered fall due on the same value date and in the same currency.In the application of Method 2, in Step (a)- for forward foreign-exchange contracts and other similar contracts, in which notional principal is equivalent to cash flows, in cases where the amounts to be claimed or delivered fall due on the same value date and in the same currency, the notional principal amount may be calculated taking account of the netting agreement; to all these contracts Table 2 must apply,- for all other contracts included in a netting agreement, the percentages applicable may be reduced as indicated in Table 3:>TABLE>`


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31967L0227

First Council Directive 67/227/EEC of 11 April 1967 on the harmonisation of legislation of Member States concerning turnover taxes

Official Journal 071 , 14/04/1967 P. 1301 - 1303 Finnish special edition: Chapter 9 Volume 1 P. 0003  Danish special edition: Series I Chapter 1967 P. 0012  Swedish special edition: Chapter 9 Volume 1 P. 0003  English special edition: Series I Chapter 1967 P. 0014  Greek special edition: Chapter 09 Volume 1 P. 0003  Spanish special edition: Chapter 09 Volume 1 P. 0003  Portuguese special edition Chapter 09 Volume 1 P. 0003

FIRST COUNCIL DIRECTIVE  of 11 April 1967  on the harmonisation of legislation of Member States concerning turnover taxes  (67/227/EEC)  THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European Parliament; Having regard to the Opinion of the Economic and Social Committee; Whereas the main objective of the Treaty is to establish, within the framework of an economic union, a common market within which there is healthy competition and whose characteristics are similar to those of a domestic market; Whereas the attainment of this objective presupposes the prior application in Member States of legislation concerning turnover taxes such as will not distort conditions of competition or hinder the free movement of goods and services within the common market; Whereas the legislation at present in force does not meet these requirements ; whereas it is therefore in the interest of the commom market to achieve such harmonisation of legislation concerning turnover taxes as will eliminate, as far as possible, factors which may distort conditions of competition, whether at national or Community level, and make it possible subsequently to achieve the aim of abolishing the imposition of tax on importation and the remission of tax on exportation in trade between Member States; Whereas, in the light of the studies made, it has become clear that such harmonisation must result in the abolition of cumulative multi-stage taxes and in the adoption by all Member States of a common system of value added tax; Whereas a system of value added tax achieves the highest degree of simplicity and of neutrality when the tax is levied in as general a manner as possible and when its scope covers all stages of production and distribution and the provision of services ; whereas it is therefore in the interest of the common market and of Member States to adopt a common system which shall also apply to the retail trade; Whereas, however, the application of that tax to retail trade might in some Member States meet with practical and political difficulties ; whereas, therefore, Member States should be permitted, subject to prior consultation, to apply the commom system only up to and including the wholesale trade stage, and to apply, as appropriate, a separate complementary tax at the retail trade stage, or at the preceding stage; Whereas it is necessary to proceed by stages, since the harmonisation of turnover taxes will lead in Member States to substantial alterations in tax structure and will have appreciable consequences in the budgetary, economic and social fields; Whereas the replacement of the cumulative multistage tax systems in force in the majority of Member States by the common system of value added tax is bound, even if the rates and exemptions are not harmonised at the same time, to result in neutrality in competition, in that within each country similar goods bear the same tax burden, whatever the length of the production and distribution chain, and that in international trade the amount of the tax burden borne by goods is known so that an exact equalisation of that amount may be ensured ; whereas therefore, provision should be made, in the first stage, for adoption by all Member States of the common system of value added tax, without an  accompanying harmonisation of rates and exemptions; Whereas it is not possible to foresee at present how and within what period the harmonisation of turnover taxes can achieve the aim of abolishing the imposition of tax on importation and the remission of tax on exportation in trade between Member States ; whereas it is therefore preferable that the second stage and the measures to be taken in respect of that stage should be determined later on the basis of proposals made by the Commission to the Council; HAS ADOPTED THIS DIRECTIVE:   Article 1 Member States shall replace their present system of turnover taxes by the common system of value added tax defined in Article 2. In each Member State the legislation to effect this replacement shall be enacted as rapidly as possible, so that it can enter into force on a date to be fixed by the Member State in the light of the conjunctural situation ; this date shall not be later than 1 January 1970. From the entry into force of such legislation, the Member State shall not maintain or introduce any measure providing for flat-rate equalisation of turnover taxes on importation or exportation in trade between Member States.   Article 2 The principle of the common system of value added tax involves the application to goods and services of a general tax on consumption exactly proportional to the price of the goods and services, whatever the number of transactions which take place in the production and distribution process before the stage at which tax is charged. On each transaction, value added tax, calculated on the price of the goods or services at the rate applicable to such goods or services, shall be chargeable after deduction of the amount of value added tax borne directly by the various cost components. The commom system of value added tax shall be applied up to and including the retail trade stage. However, until the abolition of the imposition of tax on importation and the remission of tax on exportation in trade between Member States, Member States may, subject to the consultation provided for in Article 5, apply this system only up to and including the wholesale trade stage, and may apply, as appropriate, a separate complementary tax at the retail trade stage or at the preceding stage.   Article 3 The Council shall issue, on a proposal from the Commission, a second Directive concerning the structure of, and the procedure for applying, the common system of value added tax.   Article 4 In order to enable the Council to discuss this, and if possible to take decisions before the end of the transitional period, the Commission shall submit to the Council, before the end of 1968, proposals as to how and within what period the harmonisation of turnover taxes can achieve the aim of abolishing the imposition of tax on importation and the remission of tax on exportation in trade between Member States, while ensuring the neutrality of those taxes as regards the origin of the goods or services. In this connection, particular account shall be taken of the relationship between direct and indirect taxes, which differs in the various Member States ; of the effects of an alteration in tax systems on the tax and budget policy of Member States ; and of the influence which tax systems have on conditions of competition and on social conditions in the Community.   Article 5 Should a Member State intend to exercise the power provided for in the last paragraph of Article 2, it shall so inform the Commission in good time, having regard to Article 102 of the Treaty.   Article 6 This Directive is addressed to the Member States.  Done at Brussels, 11 April 1967. For the Council The President R. VAN ELSLANDE


title: Commission Directive 2005/9/EC of 28 January 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annex VII thereto to technical progressText with EEA relevance

text:
               29.1.2005

               EN

               Official Journal of the European Union

               L 27/46

         COMMISSION DIRECTIVE 2005/9/EC
   of 28 January 2005
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annex VII thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers,
   Whereas:

               (1)

               Part 1 of Annex VII to Directive 76/768/EEC establishes a list of UV filters which cosmetic products may contain.

               (2)

               The Scientific Committee on Cosmetic Products and Non-food Products intended for consumers is of the opinion that the use of benzoic acid, 2-[4-(diethylamino) -2-hydroxybenzoyl]-, hexylester up to 10 % in sunscreen products, alone or in combination with other UV absorbers, is safe. Consequently, benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester should be included in Part 1 of Annex VII to Directive 76/768/EEC as reference number 28.

               (3)

               Directive 76/768/EEC should therefore be amended accordingly.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex VII to Directive 76/768/EEC 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 28 July 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, 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 the 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 that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 28 January 2005.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2004/93/EC (OJ L 300, 25.9.2004, p. 13).
   ANNEX
   In Part 1 of Annex VII to Directive 76/768/EEC, the following reference number 28 is added:

                  Reference No

                  Substances

                  Maximum authorised concentration

                  Other limitations and requirements

                  Conditions of use and warnings which must be printed on the label

                  a

                  b

                  c

                  d

                  e

                  ‘28

                  Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-, hexylester
                  (INCI name: Diethylamino Hydroxybenzoyl Hexyl Benzoate;
                  CAS No 302776-68-7)

                  10 % in sunscreen products’


title: Directive 2008/13/EC of the European Parliament and of the Council of 11 March 2008 repealing Council Directive 84/539/EEC on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine (Text with EEA relevance)

text:
               19.3.2008

               EN

               Official Journal of the European Union

               L 76/41

      DIRECTIVE 2008/13/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 11 March 2008
   repealing Council Directive 84/539/EEC on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Community policies on better regulation stress the importance of simplification of national and Community legislation as a crucial element in improving the competitiveness of enterprises and achieving the objectives of the Lisbon Agenda.

               (2)

               The method of conformity assessment provided for by Council Directive 84/539/EEC (3) is no longer necessary for the purposes of the internal market and trade with third countries.

               (3)

               The functioning of the internal market and the protection of users and animals can be better ensured by other Community legislation.

               (4)

               Directive 84/539/EEC should therefore be repealed.

               (5)

               The repeal of Directive 84/539/EEC entails that after 31 December 2008 the specimen mark of conformity of Annex III to that Directive will no longer be used and that the corresponding national implementing measures have to be repealed accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 84/539/EEC is hereby repealed with effect from 31 December 2008.
   Article 2
   Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2008. They shall forthwith communicate to the Commission the text of those measures and a correlation table between them and this Directive.
   When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

      Done at Strasbourg, 11 March 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. LENARČIČ

      (1)  Opinion of 16 January 2008 (not yet published in the Official Journal).

      (2)  Opinion of the European Parliament of 29 November 2007 (not yet published in the Official Journal) and Council Decision of 14 February 2008.

      (3)  OJ L 300, 19.11.1984, p. 179. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).


title: Council Directive 2010/45/EU of 13 July 2010 amending Directive 2006/112/EC on the common system of value added tax as regards the rules on invoicing

text:
               22.7.2010

               EN

               Official Journal of the European Union

               L 189/1

         COUNCIL DIRECTIVE 2010/45/EU
   of 13 July 2010
   amending Directive 2006/112/EC on the common system of value added tax as regards the rules on invoicing
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 113 thereof,
   Having regard to the proposal from the European Commission,
   Having regard to the opinion of the European Parliament,
   Having regard to the opinion of the European Economic and Social Committee,
   Acting in accordance with a special legislative procedure,
   Whereas:

               (1)

               Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (1) lays down conditions and rules concerning value added tax (hereinafter ‘VAT’) with respect to invoices, in order to ensure the proper functioning of the internal market. In accordance with Article 237 of that Directive, the Commission has presented a report which identifies, in the light of technological developments, certain difficulties with regard to electronic invoicing and which, in addition, identifies certain other areas in which the VAT rules should be simplified with a view to improving the functioning of the internal market.

               (2)

               Since record keeping needs to be sufficient to allow Member States to control goods moving temporarily from one Member State to another, it should be made clear that record keeping is to include details of valuations on goods moving temporarily between Member States. Also, transfers of goods for valuation purposes to another Member State should not be regarded as a supply of goods for VAT purposes.

               (3)

               The rules concerning the chargeability of VAT on intra-Community supplies of goods and on intra-Community acquisitions of goods should be clarified in order to ensure the uniformity of the information submitted in recapitulative statements and the timeliness of the exchange of information by means of those statements. It is furthermore appropriate that the continuous supply of goods from one Member State to another over a period of more than one calendar month should be regarded as being completed at the end of each calendar month.

               (4)

               To help small and medium-sized enterprises that encounter difficulties in paying VAT to the competent authority before they have received payment from their customers, Member States should have the option of allowing VAT to be accounted using a cash accounting scheme which allows the supplier to pay VAT to the competent authority when he receives payment for a supply and which establishes his right of deduction when he pays for a supply. This should allow Member States to introduce an optional cash accounting scheme that does not have a negative effect on cash flow relating to their VAT receipts.

               (5)

               To provide legal certainty for businesses regarding their invoicing obligations, it should be clearly stated which Member State’s invoicing rules apply.

               (6)

               With a view to improving the functioning of the internal market, it is necessary to impose a harmonised time limit for the issue of an invoice with respect to certain cross-border supplies.

               (7)

               Certain requirements concerning the information to be provided on invoices should be amended to allow better control of the tax, to create a more uniform treatment between cross-border and domestic supplies and to help promote electronic invoicing.

               (8)

               Since the use of electronic invoicing can help businesses to reduce costs and be more competitive, current VAT requirements on electronic invoicing should be revised to remove existing burdens and barriers to uptake. Paper invoices and electronic invoices should be treated equally and the administrative burden on paper invoicing should not increase.

               (9)

               Equal treatment should also apply as regards the competences of tax authorities. Their control competences and the rights and obligations of taxable persons should apply equally whether a taxable person chooses to issue paper invoices or electronic invoices.

               (10)

               Invoices must reflect actual supplies and their authenticity, integrity and legibility should therefore be ensured. Business controls can be used to establish reliable audit trails linking invoices and supplies, thereby ensuring that any invoice (whether on paper or in electronic form) complies with those requirements.

               (11)

               The authenticity and integrity of electronic invoices can also be ensured by using certain existing technologies, such as Electronic Data Interchange (EDI) and advanced electronic signatures. However, since other technologies exist, taxable persons should not be required to use any particular electronic-invoicing technology.

               (12)

               It should be clarified that, where a taxable person stores online invoices which he has issued or received, the Member State in which the tax is due, in addition to the Member State in which the taxable person is established, should have the right to access those invoices for control purposes.

               (13)

               Since the objectives of this Directive regarding the simplification, modernisation and harmonisation of the VAT invoicing rules cannot be sufficiently achieved by the Member States and can therefore be better achieved at the level of the Union, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

               (14)

               In accordance with point 34 of the Interinstitutional Agreement on better lawmaking (2), Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (15)

               Directive 2006/112/EC should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 2006/112/EC
   Directive 2006/112/EC is amended as follows:

               1.

               in Article 17(2), point (f) is replaced by the following:

                           ‘(f)

                           the supply of a service performed for the taxable person and consisting in valuations of, or work on, the goods in question physically carried out within the territory of the Member State in which dispatch or transport of the goods ends, provided that the goods, after being valued or worked upon, are returned to that taxable person in the Member State from which they were initially dispatched or transported;’;

               2.

               in Article 64, paragraph 2 is replaced by the following:
               ‘2.   Continuous supplies of goods over a period of more than one calendar month which are dispatched or transported to a Member State other than that in which the dispatch or transport of those goods begins and which are supplied VAT-exempt or which are transferred VAT-exempt to another Member State by a taxable person for the purposes of his business, in accordance with the conditions laid down in Article 138, shall be regarded as being completed on expiry of each calendar month until such time as the supply comes to an end.
               Supplies of services for which VAT is payable by the customer pursuant to Article 196, which are supplied continuously over a period of more than one year and which do not give rise to statements of account or payments during that period, shall be regarded as being completed on expiry of each calendar year until such time as the supply of services comes to an end.
               Member States may provide that, in certain cases other than those referred to in the first and second subparagraphs, the continuous supply of goods or services over a period of time is to be regarded as being completed at least at intervals of one year.’;

               3.

               in Article 66, first paragraph, point (c), and the second paragraph are replaced by the following:

                           ‘(c)

                           where an invoice is not issued, or is issued late, within a specified time no later than on expiry of the time-limit for issue of invoices imposed by Member States pursuant to the second paragraph of Article 222 or where no such time-limit has been imposed by the Member State, within a specified period from the date of the chargeable event.
                           The derogation provided for in the first paragraph shall not, however, apply to supplies of services in respect of which VAT is payable by the customer pursuant to Article 196 and to supplies or transfers of goods referred to in Article 67.’;

               4.

               Article 67 is replaced by the following:
               ‘Article 67
               Where, in accordance with the conditions laid down in Article 138, goods dispatched or transported to a Member State other than that in which dispatch or transport of the goods begins are supplied VAT-exempt or where goods are transferred VAT-exempt to another Member State by a taxable person for the purposes of his business, VAT shall become chargeable on issue of the invoice, or on expiry of the time limit referred to in the first paragraph of Article 222 if no invoice has been issued by that time.
               Article 64(1), the third subparagraph of Article 64(2) and Article 65 shall not apply with respect to the supplies and transfers of goods referred to in the first paragraph.’;

               5.

               Article 69 is replaced by the following:
               ‘Article 69
               In the case of the intra-Community acquisition of goods, VAT shall become chargeable on issue of the invoice, or on expiry of the time limit referred to in the first paragraph of Article 222 if no invoice has been issued by that time.’;

               6.

               in Article 91(2), the second subparagraph is replaced by the following:
               ‘Member States shall accept instead the use of the latest exchange rate published by the European Central Bank at the time the tax becomes chargeable. Conversion between currencies other than the euro shall be made by using the euro exchange rate of each currency. Member States may require that they be notified of the exercise of this option by the taxable person.
               However, for some of the transactions referred to in the first subparagraph or for certain categories of taxable persons, Member States may use the exchange rate determined in accordance with the Community provisions in force governing the calculation of the value for customs purposes.’;

               7.

               the following Article is inserted:
               ‘Article 167a
               Member States may provide within an optional scheme that the right of deduction of a taxable person whose VAT solely becomes chargeable in accordance with Article 66(b) be postponed until the VAT on the goods or services supplied to him has been paid to his supplier.
               Member States which apply the optional scheme referred to in the first paragraph shall set a threshold for taxable persons using the scheme within their territory, based on the annual turnover of the taxable person calculated in accordance with Article 288. That threshold may not be higher than EUR 500 000 or the equivalent in national currency. Member States may increase that threshold up to EUR 2 000 000 or the equivalent in national currency after consulting the VAT Committee. However, such consultation of the VAT Committee shall not be required for Member States which applied a threshold higher than EUR 500 000 or the equivalent in national currency on 31 December 2012.
               Member States shall inform the VAT Committee of national legislative measures adopted pursuant to the first paragraph.’;

               8.

               Article 178 is amended as follows:

                           (a)

                           point (a) is replaced by the following:

                                       ‘(a)

                                       for the purposes of deductions pursuant to Article 168(a), in respect of the supply of goods or services, he must hold an invoice drawn up in accordance with Sections 3 to 6 of Chapter 3 of Title XI;’;

                           (b)

                           point (c) is replaced by the following:

                                       ‘(c)

                                       for the purposes of deductions pursuant to Article 168(c), in respect of the intra-Community acquisition of goods, he must set out in the VAT return provided for in Article 250 all the information needed for the amount of VAT due on his intra-Community acquisitions of goods to be calculated and he must hold an invoice drawn up in accordance with Sections 3 to 5 of Chapter 3 of Title XI;’;

               9.

               Article 181 is replaced by the following:
               ‘Article 181
               Member States may authorise a taxable person who does not hold an invoice drawn up in accordance with Sections 3 to 5 of Chapter 3 of Title XI to make the deduction referred to in Article 168(c) in respect of his intra-Community acquisitions of goods.’;

               10.

               in Article 197(1), point (c) is replaced by the following:

                           ‘(c)

                           the invoice issued by the taxable person not established in the Member State of the person to whom the goods are supplied is drawn up in accordance with Sections 3 to 5 of Chapter 3.’;

               11.

               Article 217 is replaced by the following:
               ‘Article 217
               For the purposes of this Directive, “electronic invoice” means an invoice that contains the information required in this Directive, and which has been issued and received in any electronic format.’;

               12.

               in Section 3 of Chapter 3 of Title XI, the following Article is inserted:
               ‘Article 219a
               Without prejudice to Articles 244 to 248, the following shall apply:

                           (1)

                           Invoicing shall be subject to the rules applying in the Member State in which the supply of goods or services is deemed to be made, in accordance with the provisions of Title V.

                           (2)

                           By way of derogation from point (1), invoicing shall be subject to the rules applying in the Member State in which the supplier has established his business or has a fixed establishment from which the supply is made or, in the absence of such place of establishment or fixed establishment, the Member State where the supplier has his permanent address or usually resides, where:

                                       (a)

                                       the supplier is not established in the Member State in which the supply of goods or services is deemed to be made, in accordance with the provisions of Title V, or his establishment in that Member State does not intervene in the supply within the meaning of Article 192a, and the person liable for the payment of the VAT is the person to whom the goods or services are supplied.
                                       However where the customer issues the invoice (self-billing), point (1) shall apply.

                                       (b)

                                       the supply of goods or services is deemed not to be made within the Community, in accordance with the provisions of Title V.’;

               13.

               Article 220 is replaced by the following:
               ‘Article 220
               1.   Every taxable person shall ensure that, in respect of the following, an invoice is issued, either by himself or by his customer or, in his name and on his behalf, by a third party:

                           (1)

                           supplies of goods or services which he has made to another taxable person or to a non-taxable legal person;

                           (2)

                           supplies of goods as referred to in Article 33;

                           (3)

                           supplies of goods carried out in accordance with the conditions specified in Article 138;

                           (4)

                           any payment on account made to him before one of the supplies of goods referred to in points (1) and (2) was carried out;

                           (5)

                           any payment on account made to him by another taxable person or non-taxable legal person before the provision of services was completed.

                     2.   By way of derogation from paragraph 1, and without prejudice to Article 221(2), the issue of an invoice shall not be required in respect of supplies of services exempted under points (a) to (g) of Article 135(1).’;

               14.

               the following Article is inserted:
               ‘Article 220a
               1.   Member States shall allow taxable persons to issue a simplified invoice in any of the following cases:

                           (a)

                           where the amount of the invoice is not higher than EUR 100 or the equivalent in national currency;

                           (b)

                           where the invoice issued is a document or message treated as an invoice pursuant to Article 219.

                     2.   Member States shall not allow taxable persons to issue a simplified invoice where invoices are required to be issued pursuant to points (2) and (3) of Article 220(1) or where the taxable supply of goods or services is carried out by a taxable person who is not established in the Member State in which the VAT is due, or whose establishment in that Member State does not intervene in the supply within the meaning of Article 192a, and the person liable for the payment of VAT is the person to whom the goods or services are supplied.’;

               15.

               Articles 221, 222, 223, 224 and 225 are replaced by the following:
               ‘Article 221
               1.   Member States may impose on taxable persons an obligation to issue an invoice in accordance with the details required under Article 226 or 226b in respect of supplies of goods or services other than those referred to in Article 220(1).
               2.   Member States may impose on taxable persons who have established their business in their territory or who have a fixed establishment in their territory from which the supply is made, an obligation to issue an invoice in accordance with the details required in Article 226 or 226b in respect of supplies of services exempted under points (a) to (g) of Article 135(1) which those taxable persons have made in their territory or outside the Community.
               3.   Member States may release taxable persons from the obligation laid down in Article 220(1) or in Article 220a to issue an invoice in respect of supplies of goods or services which they have made in their territory and which are exempt, with or without deductibility of the VAT paid in the preceding stage, pursuant to Articles 110 and 111, Article 125(1), Article 127, Article 128(1), Article 132, points (h) to (l) of Article 135(1), Articles 136, 371, 375, 376 and 377, Articles 378(2) and 379(2) and Articles 380 to 390b.
               Article 222
               For supplies of goods carried out in accordance with the conditions specified in Article 138 or for supplies of services for which VAT is payable by the customer pursuant to Article 196, an invoice shall be issued no later than on the fifteenth day of the month following that in which the chargeable event occurs.
               For other supplies of goods or services Member States may impose time limits on taxable persons for the issue of invoices.
               Article 223
               Member States shall allow taxable persons to issue summary invoices which detail several separate supplies of goods or services provided that VAT on the supplies mentioned in the summary invoice becomes chargeable during the same calendar month.
               Without prejudice to Article 222, Member States may allow summary invoices to include supplies for which VAT has become chargeable during a period of time longer than one calendar month.
               Article 224
               Invoices may be drawn up by the customer in respect of the supply to him, by a taxable person, of goods or services, where there is a prior agreement between the two parties and provided that a procedure exists for the acceptance of each invoice by the taxable person supplying the goods or services. Member State may require that such invoices be issued in the name and on behalf of the taxable person.
               Article 225
               Member States may impose specific conditions on taxable persons in cases where the third party, or the customer, who issues invoices is established in a country with which no legal instrument exists relating to mutual assistance similar in scope to that provided for in Directive 2010/24/EU (3) and Regulation (EC) No 1798/2003 (4).

               16.

               Article 226 is amended as follows:

                           (a)

                           the following point is inserted:

                                       ‘(7a)

                                       where the VAT becomes chargeable at the time when the payment is received in accordance with Article 66(b) and the right of deduction arises at the time the deductible tax becomes chargeable, the mention “Cash accounting”;’;

                           (b)

                           the following point is inserted:

                                       ‘(10a)

                                       where the customer receiving a supply issues the invoice instead of the supplier, the mention “Self-billing”;’;

                           (c)

                           point (11) is replaced by the following:

                                       ‘(11)

                                       in the case of an exemption, reference to the applicable provision of this Directive, or to the corresponding national provision, or any other reference indicating that the supply of goods or services is exempt;’;

                           (d)

                           the following point is inserted:

                                       ‘(11a)

                                       where the customer is liable for the payment of the VAT, the mention “Reverse charge”;’;

                           (e)

                           points (13) and (14) are replaced by the following:

                                       ‘(13)

                                       where the margin scheme for travel agents is applied, the mention “Margin scheme — Travel agents”;

                                       (14)

                                       where one of the special arrangements applicable to second-hand goods, works of art, collectors’ items and antiques is applied, the mention “Margin scheme — Second-hand goods”; “Margin scheme — Works of art” or “Margin scheme — Collector’s items and antiques” respectively;’;

               17.

               the following Articles are inserted:
               ‘Article 226a
               Where the invoice is issued by a taxable person, who is not established in the Member State where the tax is due or whose establishment in that Member State does not intervene in the supply within the meaning of Article 192a, and who is making a supply of goods or services to a customer who is liable for payment of VAT, the taxable person may omit the details referred to in points (8), (9) and (10) of Article 226 and instead indicate, by reference to the quantity or extent of the goods or services supplied and their nature, the taxable amount of those goods or services.
               Article 226b
               As regards simplified invoices issued pursuant to Article 220a and Article 221(1) and (2), Member States shall require at least the following details:

                           (a)

                           the date of issue;

                           (b)

                           identification of the taxable person supplying the goods or services;

                           (c)

                           identification of the type of goods or services supplied;

                           (d)

                           the VAT amount payable or the information needed to calculate it;

                           (e)

                           where the invoice issued is a document or message treated as an invoice pursuant to Article 219, specific and unambiguous reference to that initial invoice and the specific details which are being amended.

                     They may not require details on invoices other than those referred to in Articles 226, 227 and 230.’;

               18.

               Article 228 is deleted;

               19.

               Article 230 is replaced by the following:
               ‘Article 230
               The amounts which appear on the invoice may be expressed in any currency, provided that the amount of VAT payable or to be adjusted is expressed in the national currency of the Member State, using the conversion rate mechanism provided for in Article 91.’;

               20.

               Article 231 is deleted;

               21.

               the heading of Section 5 of Chapter 3 of Title XI is replaced by the following:

               22.

               Articles 232 and 233 are replaced by the following:
               ‘Article 232
               The use of an electronic invoice shall be subject to acceptance by the recipient.
               Article 233
               1.   The authenticity of the origin, the integrity of the content and the legibility of an invoice, whether on paper or in electronic form, shall be ensured from the point in time of issue until the end of the period for storage of the invoice.
               Each taxable person shall determine the way to ensure the authenticity of the origin, the integrity of the content and the legibility of the invoice. This may be achieved by any business controls which create a reliable audit trail between an invoice and a supply of goods or services.
               “Authenticity of the origin” means the assurance of the identity of the supplier or the issuer of the invoice.
               “Integrity of the content” means that the content required according to this Directive has not been altered.
               2.   Other than by way of the type of business controls described in paragraph 1, the following are examples of technologies that ensure the authenticity of the origin and the integrity of the content of an electronic invoice:

                           (a)

                           an advanced electronic signature within the meaning of point (2) of Article 2 of Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (5), based on a qualified certificate and created by a secure signature creation device, within the meaning of points (6) and (10) of Article 2 of Directive 1999/93/EC;

                           (b)

                           electronic data interchange (EDI), as defined in Article 2 of Annex 1 to Commission Recommendation 1994/820/EC of 19 October 1994 relating to the legal aspects of electronic data interchange (6), where the agreement relating to the exchange provides for the use of procedures guaranteeing the authenticity of the origin and integrity of the data.

               23.

               Article 234 is deleted;

               24.

               Articles 235, 236 and 237 are replaced by the following:
               ‘Article 235
               Member States may lay down specific conditions for electronic invoices issued in respect of goods or services supplied in their territory from a country with which no legal instrument exists relating to mutual assistance similar in scope to that provided for in Directive 2010/24/EU and Regulation (EC) No 1798/2003.
               Article 236
               Where batches containing several electronic invoices are sent or made available to the same recipient, the details common to the individual invoices may be mentioned only once where, for each invoice, all the information is accessible.
               Article 237
               By 31 December 2016 at the latest, the Commission shall present to the European Parliament and the Council an overall assessment report, based on an independent economic study, on the impact of the invoicing rules applicable from 1 January 2013 and notably on the extent to which they have effectively led to a decrease in administrative burdens for businesses, accompanied where necessary by an appropriate proposal to amend the relevant rules.’;

               25.

               Article 238 is amended as follows:

                           (a)

                           paragraph 1 is replaced by the following:
                           ‘1.   After consulting the VAT Committee, Member States may, in accordance with conditions which they may lay down, provide that in the following cases only the information required pursuant to Article 226b shall be entered on invoices in respect of supplies of goods or services:

                                       (a)

                                       where the amount of the invoice is higher than EUR 100 but not higher than EUR 400, or the equivalent in national currency;

                                       (b)

                                       where commercial or administrative practice in the business sector concerned or the technical conditions under which the invoices are issued make it particularly difficult to comply with all the obligations referred to in Article 226 or 230.’;

                           (b)

                           paragraph 2 is deleted;

                           (c)

                           paragraph 3 is replaced by the following:
                           ‘3.   The simplified arrangements provided for in paragraph 1 shall not be applied where invoices are required to be issued pursuant to points (2) and (3) of Article 220(1) or where the taxable supply of goods or services is carried out by a taxable person who is not established in the Member State in which the VAT is due or whose establishment in that Member State does not intervene in the supply within the meaning of Article 192a and the person liable for the payment of VAT is the person to whom the goods or services are supplied.’;

               26.

               Article 243 is replaced by the following:
               ‘Article 243
               1.   Every taxable person shall keep a register of the goods dispatched or transported by him, or on his behalf, to a destination outside the territory of the Member State of departure but within the Community for the purposes of transactions consisting in valuations of those goods or work on them or their temporary use as referred to in points (f), (g) and (h) of Article 17(2).
               2.   Every taxable person shall keep accounts in sufficient detail to enable the identification of goods dispatched to him from another Member State, by or on behalf of a taxable person identified for VAT purposes in that other Member State, and used for services consisting in valuations of those goods or work on those goods.’;

               27.

               Article 246 is deleted;

               28.

               in Article 247, paragraphs 2 and 3 are replaced by the following:
               ‘2.   In order to ensure that the requirements laid down in Article 233 are met, the Member State referred to in paragraph 1 may require that invoices be stored in the original form in which they were sent or made available, whether paper or electronic. Additionally, in the case of invoices stored by electronic means, the Member State may require that the data guaranteeing the authenticity of the origin of the invoices and the integrity of their content, as provided for in Article 233, also be stored by electronic means.
               3.   The Member State referred to in paragraph 1 may lay down specific conditions prohibiting or restricting the storage of invoices in a country with which no legal instrument exists relating to mutual assistance similar in scope to that provided for in Directive 2010/24/EU and Regulation (EC) No 1798/2003 or to the right referred to in Article 249 to access by electronic means, to download and to use.’;

               29.

               in Section 3 of Chapter 4 of Title XI, the following Article is inserted:
               ‘Article 248a
               For control purposes, and as regards invoices in respect of supplies of goods or services supplied in their territory and invoices received by taxable persons established in their territory, Member States may, for certain taxable persons or certain cases, require translation into their official languages. Member States may, however, not impose a general requirement that invoices be translated.’;

               30.

               Article 249 is replaced by the following:
               ‘Article 249
               For control purposes, where a taxable person stores, by electronic means guaranteeing online access to the data concerned, invoices which he issues or receives, the competent authorities of the Member State in which he is established and, where the VAT is due in another Member State, the competent authorities of that Member State, shall have the right to access, download and use those invoices.’;

               31.

               in Article 272(1), the second subparagraph is replaced by the following:
               ‘Member States may not release the taxable persons referred to in point (b) of the first subparagraph from the invoicing obligations laid down in Sections 3 to 6 of Chapter 3 and Section 3 of Chapter 4.’.

         Article 2
   Transposition
   1.   Member States shall adopt and publish, by 31 December 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from 1 January 2013.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   Entry into Force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 13 July 2010.

            For the Council

            The President

         D. REYNDERS

      (1)  OJ L 347, 11.12.2006, p. 1.

      (2)  OJ C 321, 31.12.2003, p. 1.

      (3)  Council Directive 2010/24/EU of 16 March 2010 concerning mutual assistance for the recovery of claims relating to taxes, duties and other measures (OJ L 84, 31.3.2010, p. 1).

      (4)  Council Regulation (EC) No 1798/2003 of 7 October 2003 on administrative cooperation in the field of value added tax (OJ L 264, 15.10.2003, p. 1).’;

      (5)  OJ L 13, 19.1.2000, p. 12.

      (6)  OJ L 338, 28.12.1994, p. 98.’;