Avis juridique important

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32002L0069

Commission Directive 2002/69/EC of 26 July 2002 laying down the sampling methods and the methods of analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs (Text with EEA relevance)

Official Journal L 209 , 06/08/2002 P. 0005 - 0014

Commission Directive 2002/69/ECof 26 July 2002laying down the sampling methods and the methods of analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), and in particular Article 1 thereof,Whereas:(1) Commission Regulation (EC) No 466/2001(2), as last amended by Regulation (EC) No 563/2002(3), and amended by Council Regulation (EC) No 2375/2001(4) establishes maximum limits for dioxins and furans in certain foodstuffs.(2) Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs(5) lays down the general principles for the performance of control of foodstuffs. Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(6) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs.(3) Directive 85/591/EEC has fixed general criteria for methods of sampling and analysis. However, in certain cases it is necessary to lay down more specific criteria and or requirements with which the method of analysis should comply in order to ensure that laboratories use methods of analysis with comparable levels of performance.(4) The provisions for sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge.(5) The provisions laid down in this Directive relate only to the sampling and analysis of dioxins and dioxin-like PCBs for the implementation of Regulation (EC) No 466/2001 and do not affect the sampling strategy, sampling levels and frequency as specified in Annexes III and IV to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC(7). They do not affect the targeting criteria for sampling as laid down in Commission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products(8).(6) An active approach should be pursued in order to obtain comprehensive reliable data on the presence of dioxin-like PCBs in foodstuffs. Requirements should therefore be laid down as regards the methods of analysis to be used for the determination of dioxin-like PCBs in foodstuffs.(7) A screening method of analysis with proven, widely acceptable validation and high throughput could be used to select the samples with significant levels of dioxins. The levels of dioxins in these samples need to be determined by a confirmatory method of analysis. It is therefore appropriate to establish strict requirements for the confirmatory methods of analysis and minimum requirements for the screening method.(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1The Member States shall ensure that the sampling for the official control of the levels of dioxins and furans and the determination of the levels of dioxin-like PCBs in foodstuffs is carried out in accordance with the methods described in Annex I.Article 2The Member States shall ensure that sample preparation and methods of analyses used for the official control of the levels of dioxins and furans and the determination of the levels of dioxin-like PCBs in foodstuffs comply with the criteria described in Annex II.Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2003 at the latest. They shall forthwith inform the Commission thereof.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 4This Directive shall enter into force on the 20th 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, 26 July 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 372, 31.12.1985, p. 50.(2) OJ L 77, 16.3.2001, p. 1.(3) OJ L 86, 3.4.2002, p. 5.(4) OJ L 321, 6.12.2001, p. 1.(5) OJ L 186, 30.6.1989, p. 23.(6) OJ L 290, 24.11.1993, p. 14.(7) OJ L 125, 23.5.1996, p. 10.(8) OJ L 65, 5.3.1998, p. 31.ANNEX IMETHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF DIOXINS (PCDD/PCDF) AND THE DETERMINATION OF DIOXIN-LIKE PCBs IN CERTAIN FOODSTUFFS1. Purpose and scopeSamples intended for the official control of the levels of dioxins (PCDD/PCDF) content, as well for the determination of the content of dioxin-like PCBs(1) in foodstuffs shall be taken according to the methods described below. Aggregate samples thus obtained shall be considered as representative of the lots or sublots from which they are taken. Compliance with maximum levels laid down in Commission Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs shall be established on the basis of the levels determined in the laboratory samples.2. DefinitionsLot: an identifiable quantity of food delivered at one time and determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings. In the case of fish and fishery products, also the size of fish shall be comparable.Sublot: designated part of a large lot in order to apply the sampling method on that designated part. Each sublot must be physically separated and identifiable.Incremental sample: a quantity of material taken from a single place in the lot or sublot.Aggregate sample: the combined total of all the incremental samples taken from the lot or sublot.Laboratory sample: a representative part/quantity of the aggregate sample intended for the laboratory3. General provisions3.1. PersonnelSampling shall be performed by an authorised qualified person as specified by the Member States.3.2. Material to be sampledEach lot, which is to be examined, must be sampled separately.3.3. Precautions to be takenIn the course of sampling and preparation of laboratory samples precautions must be taken to avoid any changes, which would affect the content of dioxins and dioxin-like PCBs, adversely affect the analytical determination or make the aggregate samples unrepresentative.3.4. Incremental samplesAs far as practical incremental samples shall be taken at various places distributed throughout the lot or sublot. Departure from this procedure must be recorded in the record provided for under 3.8.3.5. Preparation of the aggregate sampleThe aggregate sample is made up by uniting all incremental samples. It shall be at least 1 kg unless not practical, e.g. when a single package has been sampled.3.6. Subdivision of aggregate sample in laboratory samples for enforcement, defence and referee purposesThe laboratory samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised aggregate sample unless this conflicts with Member States' regulations on sampling. The size of the laboratory samples for enforcement shall be sufficient to allow at least for duplicate analyses.3.7. Packaging and transmission of aggregate and laboratory samplesEach aggregate and laboratory sample shall be placed in a clean, inert container offering adequate protection from contamination, from loss of analytes by adsorption to the internal wall of the container and against damage in transit. All necessary precautions shall be taken to avoid change of composition of the aggregate and laboratory samples, which might arise during transportation or storage.3.8. Sealing and labelling of aggregate and laboratory samplesEach sample taken for official use shall be sealed at the place of sampling and identified following the Member States' regulations. A record must be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.4. Sampling plansThe sampling method applied shall ensure that the aggregate sample is representative for the lot that is to be controlled.Number of incremental samplesIn the case of milk and oils, for which a homogeneous distribution of the contaminants in question can be assumed within a given lot, it is sufficient to take three incremental samples per lot which forms the aggregate sample. Reference to the lot number shall be given. For other products, the minimum number of incremental samples to be taken from the lot shall be as given in Table 1.The aggregate sample uniting all incremental samples shall be at least 1 kg (see point 3.5). The incremental samples shall be of similar weight. The weight of an incremental sample should be at least 100 grams. The weight of the incremental sample is dependent on the size of the particles in the lot. Departure from this procedure must be recorded in the record provided for under 3.8. In accordance with the provisions of Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products(2), the sample size for hen eggs is at least 12 eggs (for bulk lots as well for lots consisting of individual packages, Tables 1 and 2).TABLE 1Minimum number of incremental samples to be taken from the lot>TABLE>If the lot consists of individual packages, then the number of packages, which shall be taken to form the aggregate sample, is given in Table 2.TABLE 2Number of packages (incremental samples) which shall be taken to form the aggregate sample if the lot consists of individual packages>TABLE>5. Compliance of the lot or sublot with the specificationThe control laboratory shall analyse the laboratory sample for enforcement in duplicate analysis in case the obtained result of the first analysis is less than 20 % below or above the maximum level, and calculate the mean of the results. The lot is accepted if the result of the first analysis is more than 20 % below the maximum level or, where duplicate analysis is necessary, if the mean conforms to the respective maximum level as laid down in Regulation (EC) No 466/2001.(1) Table WHO TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15-18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106(12), 775).>TABLE>Abbreviations used: T = tetra; Pe = penta; Hx = hexa; Hp = hepta; O = octa; CDD = chlorodibenzodioxin; CDF = chlorodibenzofuran; CB = chlorobiphenyl.(2) OJ L 303, 6.11.1997, p. 12.ANNEX IISAMPLE PREPARATION AND REQUIREMENTS FOR METHODS OF ANALYSIS USED IN OFFICIAL CONTROL OF THE LEVELS OF DIOXINS (PCDD/PCDF) AND THE DETERMINATION OF DIOXIN-LIKE PCBs IN CERTAIN FOODSTUFFS1. Objective and field of applicationThese requirements should be applied where foodstuffs are analysed for the official control of the levels of dioxins (polychlorinated dibenzo-p-dioxins (PCDD) and polychlorinated dibenzofurans (PCDF)) and the determination of dioxin-like PCBs.Monitoring for the presence of dioxins in foodstuffs can be performed by a strategy involving a screening method in order to select those samples with levels of dioxins and dioxin-like PCBs that are less than 30-40 % below or exceed the level of interest. The concentration of dioxins in those samples with significant levels needs to be determined/confirmed by a confirmatory method.Screening methods are methods that are used to detect the presence of dioxins and dioxin-like PCBs at the level of interest. These methods have a capacity for a high sample throughput and are used to sift large numbers of samples for potential positives. They are specifically designed to avoid false negatives.Confirmatory methods are methods that provide full or complementary information enabling the dioxins and dioxin-like PCBs to be identified and quantified unequivocally at the level of interest.2. BackgroundBecause environmental and biological samples (including samples of foodstuffs) in general contain complex mixtures of different dioxin congeners, the concept of Toxic Equivalency Factors (TEFs) has been developed to facilitate risk assessment. These TEFs have been established to express concentrations of mixtures of 2,3,7,8-substituted PCDDs and PCDFs, and more recently, some non-ortho and mono-ortho chlorine substituted PCBs which possesses dioxin-like activity in toxic equivalents (TEQs) of 2,3,7,8-TCDD (see Annex I, footnote 1).The concentrations of the individual substances in a given sample are multiplied by their respective TEF and subsequently summed to give the total concentration of dioxin-like compounds expressed as TEQs.The concept of "upperbound" requires using the limit of quantification for the contribution of each non-quantified congener to the TEQ.The concept of "lowerbound" requires using zero for the contribution of each non-quantified congener to the TEQ.The concept of "mediumbound" requires using half of the limit of quantification calculating the contribution of each non-quantified congener to the TEQ.3. Quality assurance requirements to be complied with for sample preparation- Measures must be taken to avoid cross-contamination at each stage of the sampling and analysis procedure.- The samples must be stored and transported in glass, aluminium, polypropylene or polyethylene containers. Traces of paper dust must be removed from the sample container. Glassware should be rinsed with solvents previously controlled for the presence of dioxins.- The sample storage and transportation has to be performed in a way that maintains the integrity of the foodstuff sample.- Insofar as relevant, finely grind and mix thoroughly each laboratory sample using a process that has been demonstrated to achieve complete homogenisation (e.g. ground to pass a 1 mm sieve); samples have to be dried before grinding if moisture content is too high.- Perform a blank analysis by carrying out the entire analytical procedure omitting only the sample.- Sample weight used for the extraction must be sufficient to fulfil the requirements with respect to sensitivity.- There are many satisfactory specific sample preparation procedures, which may be used for the products under consideration. The procedures have to be validated according to internationally accepted guidelines.4. Requirements for laboratories- Laboratories shall demonstrate the performance of a method in the range of the level of interest, e.g. 0,5 ×, 1 × and 2 × the level of interest with an acceptable coefficient of variation for repeated analysis. For details of acceptance criteria, see point 5.- Limit of quantification for a confirmatory method should be in the range of about one fifth of the level of interest, to make sure that acceptable coefficients of variations are met in the range of the level of interest.- Regular blank controls and spiking experiments or analysis of control samples (preferably, if available, certified reference material) should be performed as internal quality control measures.- Successful participation in interlaboratory studies that assess laboratory proficiency is the best way to prove the competence in specific analyses. However successful participation in interlaboratory studies for, e.g. soil or sewage samples, does not necessarily prove the competence also in the field of food or feedingstuff samples, which present lower contamination levels. Therefore, the continuous participation in interlaboratory studies for the determination of dioxins and dioxin-like PCBs in the relevant feed/food matrices is mandatory.- In accordance with the provisions of Directive 93/99/EEC, laboratories should be accredited by a recognised body operating in accordance with ISO Guide 58 to ensure that they are applying analytical quality assurance. Laboratories should be accredited following the ISO/IEC/17025:1999 standard.5. Requirements to be met by analytical procedure for dioxins and dioxin-like PCBsBasic requirements for acceptance of analytical procedures:- High sensitivity and low limits of detection. For PCDDs and PCDFs, detectable quantities have to be in the picogram TEQ (10-12 g) range because of extreme toxicity of some of these compounds. PCBs are known to occur at higher levels than the PCDDs and PCDFs. For most PCB congeners sensitivity in the nanogram (10-9 g) range is already sufficient. However, for the measurement of the more toxic dioxin-like PCB congeners (in particular non-ortho substituted congeners), the same sensitivity must be reached as for the PCDDs and PCDFs.- High selectivity (specificity). A distinction is required for PCDDs, PCDFs and dioxin-like PCBs from a multitude of other, coextracted and possibly interfering compounds present at concentrations up to several orders of magnitude higher than those of the analytes of interest. For gas chromatography/mass spectrometry (GC/MS) methods a differentiation among various congeners is necessary, such as between toxic (e.g. the seventeen 2,3,7,8-substituted PCDDs and PCDFs and dioxin-like PCBs) and other congeners. Bioassays should be able to determine TEQ values selectively as the sum of PCDDs, PCDFs and dioxin-like PCBs.- High accuracy (trueness and precision). The determination should provide a valid estimate of the true concentration in a sample. High accuracy (accuracy of the measurement: the closeness of the agreement between the result of a measurement with the true or assigned value of the measurement) is necessary to avoid the rejection of a sample analysis result on the basis of poor reliability of the estimate of TEQ. Accuracy is expressed as trueness (difference between the mean value measured for an analyte in a certified material and its certified value, expressed as percentage of this value) and precision (precision is usually calculated as a standard deviation including repeatability and reproducibility, and indicates the closeness of agreement between the results obtained by applying the experimental procedure several times under prescribed conditions).Screening methods can comprise bioassays and GC/MS methods; confirmatory methods are high-resolution gas chromatography/high resolution mass spectrometry (HRGC/HRMS) methods. Following criteria have to be complied with on total TEQ value:>TABLE>6. Specific requirements for GC/MS methods to be complied with for screening or confirmatory purposes- Addition of 13C-labelled 2,3,7,8-chlorine substituted internal PCDD/F standards (and of 13C-labelled internal dioxin-like PCB standards, if dioxin-like PCBs have to be determined) must be carried out at the very beginning or start of the analytical method e.g. prior to extraction in order to validate the analytical procedure. At least one congener for each of the tetra to octa-chlorinated homologous groups for PCDD/F (and at least one congener for each of the homologous groups for dioxin-like PCBs, if dioxin-like PCBs have to be determined) must be added (alternatively, at least one congener for each mass spectrometric selected ion recording function used for monitoring PCDD/F and dioxin-like PCBs). There is a clear preference, certainly in case of confirmatory methods, of using all 17 13C-labelled 2,3,7,8-substituted internal PCDD/F standards and all 12 13C-labelled internal dioxin-like PCB standard (if dioxin-like PCBs have to be determined).Relative response factors should also be determined for those congeners for which no 13C-labelled analogue is added by using appropriate calibration solutions.- For foodstuffs of plant origin and foodstuffs of animal origin containing less than 10 % fat, the addition of the internal standards is mandatory prior to extraction. For foodstuffs of animal origin containing more than 10 % fat, the internal standards can be added either before extraction or after fat extraction. An appropriate validation of the extraction efficiency should be carried out, depending on the stage at which internal standards are introduced and on whether results are reported on product or fat basis.- Prior to GC/MS analysis, 1 or 2 recovery (surrogate) standard(s) must be added.- Control of recovery is necessary. For confirmatory methods, the recoveries of the individual internal standards should be in the range of 60 % to 120 %. Lower or higher recoveries for individual congeners, in particular for some hepta- and octa- chlorinated dibenzodioxins and dibenzofurans, are acceptable on the condition that their contribution to the TEQ value does not exceed 10 % of the total TEQ value (based on PCDD/F only). For screening methods, the recoveries should be in the range of 30 % to 140 %.- Separation of dioxins from interfering chlorinated compounds such as PCBs and chlorinated diphenyl ethers should be carried out by suitable chromatographic techniques (preferably with a florisil, alumina and/or carbon column).- Gaschromatographic separation of isomers should be sufficient (<  25 % peak to peak between 1,2,3,4,7,8-HxCDF and 1,2,3,6,7,8-HxCDF).- Determination should be performed according to EPA Method 1613 revision B: Tetra- through octa-chlorinated dioxins and furans by isotope dilution HRGC/HRMS or another with equivalent performance criteria.- The difference between upperbound level and lower bound level should not exceed 20 % for foodstuffs with a dioxin contamination of about 1 pg WHO-TEQ/g fat (based on PCDD/PCDF only). For foodstuffs with a low fat content, the same requirements for contamination levels of about 1 pg WHO-TEQ/g product have to be applied. For lower contamination levels, for example 0,50 pg WHO-TEQ/g product, the difference between upperbound and lowerbound level may be in the range of 25 to 40 %.7. Screening methods of analysis7.1. IntroductionDifferent analytical approaches can be performed using a screening method: a pure screening approach and a quantitative approach.Screening approachThe response of samples is compared to that of a reference sample at the level of interest. Samples with a response less than the reference are declared negative, those with a higher response are suspected positives. Requirements:- A blank and a reference sample(s) have to be included in each test series, which is extracted and tested at the same time under identical conditions. The reference sample must show a clearly elevated response in comparison to a blank.- Extra reference samples 0,5 × and 2 × the level of interest should be included to demonstrate the proper performance of the test in the range of interest for the control of the level of interest.- When testing other matrices, the suitability of the reference sample(s) has to be demonstrated, preferentially by including samples shown by HRGC/HRMS to contain a TEQ level around that of the reference sample or else a blank spiked at this level.- Since no internal standards can be used in bioassays, tests on repeatability are very important to obtain information on the standard deviation within one test series. The coefficient of variation should be below 30 %.- For bioassays, the target compounds, possible interferences and maximum tolerable blank levels should be defined.Quantitative approachThe quantitative approach requires standard dilution series, duplicate or triplicate clean up and measuring as well as blank and recovery controls. The result may be expressed as TEQ, thereby assuming that the compounds responsible for the signal correspond to the TEQ principle. This can be performed by using TCDD (or a dioxin/furan standard mixture) to produce a calibration curve to calculate the TEQ level in the extract and thus in the sample. This is subsequently corrected for the TEQ level calculated for a blank sample (to account for impurities from solvents and chemicals used), and a recovery (calculated from the TEQ level in a quality control sample around the level of interest). It is essential to note that part of the apparent recovery loss may be due to matrix effects and/or differences between the TEF values in the bioassays and the official TEF values set by WHO.7.2. Requirements for methods of analysis used for screening- GC/MS methods of analysis and bioassays may be used for screening. For GC/MS methods the requirements as laid down in point 6 are to be used. For cell based bioassays specific requirements are laid down in point 7.3 and for kit-based bioassays in point 7.4.- Information on the number of false-positive and false-negative results of a large set of samples below and above the maximum level or action level is necessary, in comparison to the TEQ content as determined by a confirmatory method of analysis. Actual false negative rates should be under 1 %. The rate of false positive samples should be low enough to make the use of a screening tool advantageous.- Positive results have always to be confirmed by a confirmatory method of analysis (HRGC/HRMS). In addition, samples from a wide TEQ-range should be confirmed by HRGC/HRMS (approximately 2 % to 10 % of the negative samples). Information on correspondence between bioassay and HRGC/HRMS results should be made available.7.3. Specific requirements for cell-based bioassays- When performing a bioassay, every test run requires a series of reference concentrations of TCDD or a dioxin/furan mixture (full dose-response curve with a R2  > 0,95). However, for screening purposes an expanded low level curve for analysing low level samples could be used.- A TCDD reference concentration (about 3 × limit of quantification) on a quality control sheet should be used for the outcome of the bioassay over a constant time period. An alternative could be the relative response of a reference sample in comparison to the TCDD calibration line since the response of the cells may depend on many factors.- Quality control (QC) charts for each type of reference material should be recorded and checked to make sure the outcome is in accordance with the stated guidelines.- In particular for quantitative calculations, the induction of the sample dilution used must be within the linear portion of the response curve. Samples above the linear portion of the response curve must be diluted and re-tested. Therefore, at least three or more dilutions at one time are recommended to be tested.- The percent standard deviation should not be above 15 % in a triplicate determination for each sample dilution and not above 30 % between three independent experiments.- The limit of detection may be set as 3 × the standard deviation of the solvent blank or of the background response. Another approach is to apply a response that is above the background (induction factor 5 × the solvent blank) calculated from the calibration curve of the day. The limit of quantification may be set as 5 × to 6 × the standard deviation of the solvent blank or of the background response or to apply a response that is above the background (induction factor 10 × the solvent blank) calculated from the calibration curve of the day.7.4. Specific requirements for kit-based bioassays(1)- Manufacturer's instructions for sample preparation and analyses have to be followed.- Test kits should not be used after the expiration date.- Materials or components designed for use with other kits should not be used.- Test kits should be kept within the specified range of storage temperature and used at the specified operating temperature.- The limit of detection for immunoassays is determined as 3 × the standard deviation, based on 10 replicate analysis of the blank, to be divided by the slope value of the linear regression equation.- Reference standards should be used for tests at the laboratory to make sure that the responsiveness to the standard is within an acceptable range.8. Reporting of the resultInsofar as the used analytical procedure makes it possible, the analytical results should contain the levels of the individual PCDD/F and PCB congeners and be reported as lowerbound, upperbound and mediumbound in order to include a maximum of information in the reporting of the results and thereby enabling the interpretation of the results according to specific requirements.The report should also include the lipid content of the sample as well the method used for lipid extraction.The recoveries of the individual internal standards must be made available in case the recoveries are outside the range mentioned in point 6, in case the maximum level is exceeded and in other cases upon request.(1) No evidence have yet been submitted of commercially available kit-based bioassays having sufficient sensitivity and reliability to be used for screening for the presence of dioxins at the required levels in samples of foodstuffs and feedingstuffs.


Avis juridique important

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31994L0002

Commission Directive 94/2/EC of 21 January 1994 implementing Council Directive 92/75/EEC with regard to energy labelling of household electric refrigerators, freezers and their combinations

Official Journal L 045 , 17/02/1994 P. 0001 - 0022 Finnish special edition: Chapter 13 Volume 25 P. 0249  Swedish special edition: Chapter 13 Volume 25 P. 0249

COMMISSION DIRECTIVE 94/2/ECof 21 January 1994implementing Council  Directive 92/75/EEC with regard to energy labelling of household electric refrigerators, freezers  and their combinationsTHE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling  and standard product information of the consumption of energy and other resources of household  appliances (1), and in particular Articles 9 and 12 thereof, Whereas under Directive 92/75/EEC the Commission is to adopt an implementing directive in respect  of household appliances including refrigerators, freezers and their combinations; Whereas electricity use by refrigerators and freezers accounts for a significant part of total  Community electricity demand; whereas the scope for reduced energy use by these appliances is  substantial; Whereas CEN (European Committee for Standardization) standard EN 153 provides a method for  measuring the consumption of energy of refrigerators, freezers and their combinations; Whereas the Community, confirming its interest in an international standardization system capable  of producing standards that are actually used by all partners in international trade and of meeting  the requirements of Community policy, invites the European standards organizations to continue  their cooperation with international standards organizations; Whereas the European Committe for Standardization and the European Committee for Electrotechnical  Standardization (Cenelec) are the bodies recognized as competent to adopt harmonized standards in  accordance with the general guidelines for cooperation between the Commission and these two bodies  signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonized standard is  a technical specification (European standard or harmonization document) adopted by CEN or Cenelec  on the basis of a remit (mandate) from the Commission in accordance with the provisions of Council  Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in  the field of technical standards and regulations (2), as last amended by Commission Decision  92/400/EEC (3), and on the basis of those general guidelines; Whereas the measures set out in this Directive are in accordance with the opinion of the committee  set up under Article 10 of Directive 92/75/EEC, HAS ADOPTED THIS DIRECTIVE: Article 11. This Directive shall apply to electric mains operated household  refrigerators, frozen food storage cabinets, food freezers and their combinations. Appliances that  may also use other energy sources, such as batteries, are excluded. 2. The information required by this Directive shall be measured in accordance with EN 153 of May  1990 or with harmonized standards, the reference numbers of which have been published in the  Official Journal of the European Communities and for which Member States have published the  reference numbers of the national standards transposing those harmonized standards. The information  relating to noise, where applicable, shall be measured in accordance with Council Directive  86/594/EEC (4). 3. The harmonized standards referred to in paragraph 2 shall be drawn up under mandate from the  Commission in accordance with Directive 83/189/EEC. 4. 'Dealer', 'supplier', 'information sheet', and 'supplementary information' shall have the  meanings set out in Article 1 (4) of Directive 92/75/EEC. Article 21. The technical documentation referred to in Article 2 (3) of Directive 92/75/EEC  shall include: - the name and address of the supplier, - a general description of the appliance, sufficient for it to be identified, - information, including drawings as relevant, on the main design features of the model and in  particular items which appreciably affect its energy consumption, - reports of relevant measurement tests carried out under the standards referred to in Article 1  (2) of this Directive, - operating instructions, if any. 2. The appliances covered by this Directive shall be divided into the 'categories' set out in Annex  IV. 3. The label referred to in Article 2 (1) of Directive 92/75/EEC shall be as specified in Annex I  to this Directive. It shall be placed on the outside of the front or top of the appliance, in such  a way as to be clearly visible, and not obscured. 4. The content and format of the fiche referred to in the third indent of Article 2 (1) of  Directive 92/75/EEC shall be as specified in Annex II to this Directive. 5. In the circumstances covered by Article 5 of Directive 92/75/EEC, and where the offer for sale,  hire, or hire purchase, is provided by means of a printed communication, such as a mail order  catalogue, then that printed communication shall include all the information specified in Annex III  to this Directive. 6. The energy efficiency class of an appliance shall be as specified in Annex V. Article 3Member States shall take all necessary measures to ensure that all suppliers and  dealers established in their territory fulfil their obligations under this Directive. Article 41. Member States shall adopt and publish the provisions necessary to comply with this  Directive by 31 December 1994. They shall immediately inform the Commission therof. They shall  apply those provisions from 1 January 1995. When Member States adopt these provisions, these shall contain a reference to this Directive or  shall be accompanied by such reference at the time of their official publication. The procedure for  such reference shall be adopted by Member States. 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 5This Directive shall enter into force on the 20th day following its publication in the  Official Journal of the European Communities. Article 6This Directive is adressed to the Member States. Done at Brussels, 21 January 1994. For the CommissionAbel MATUTESMember of the Commission(1) OJ No L 297, 13.  10. 1992, p. 16. (2) OJ No L 109, 26. 4. 1983, p. 8. (3) OJ No L 221, 6. 8. 1992, p. 55. (4) OJ No L 344, 6. 12. 1986, p. 24.  ANNEX I THE LABEL Label design1. The label shall be in accordance with the following  illustrations: >REFERENCE TO A GRAPHIC>>REFERENCE TO A GRAPHIC>>REFERENCE TO A GRAPHIC>>REFERENCE TO A GRAPHIC> >REFERENCE TO A GRAPHIC>>REFERENCE TO A GRAPHIC>>REFERENCE TO A GRAPHIC>>REFERENCE TO A GRAPHIC> >REFERENCE TO A GRAPHIC>Notes on label2. The following notes define the information to be  included: Note: I. Supplier's name or trade mark. II. Suppliers model identifier. III. The energy efficiency class of an appliance shall be determined in accordance with Annex V.  The appropriate letter shall be placed at the same level as the relevant arrow. IV. Without prejudice to any requirements under the Community Eco-label award scheme, where an  appliance has been granted a 'Community Eco-label award' pursuant to Council Regulation (EEC) No  880/92 (1) a copy of the Eco-award mark (the flower) may be added here. The 'refrigerator/freezer  label design guide' referred to below, explains how the Eco-award mark, may be included in the  label. V. Energy consumption in accordance with standards referred to in Article 1 (2) but expressed in  kWh per year (i.e. per 24 hours × 365). VI. Sum of net storage volume of all compartments that do not merit a star rating (i.e. operating  temperature > - 6 °C). VII. Sum of net storage volume of all frozen food storage compartments which merit a star rating  (i.e. operating temperature ≤ - 6 °C). VIII. Star rating of frozen food storage compartment, in accordance with standards referred to in  Article 1 (2). Where this compartment does not merit any stars, this position shall be left blank. IX. Where applicable noise measured in accordance with Directive 86/594/EEC. NB: The equivalent terms in other languages to those described above are given in Annex VI. Printing3. The following defines certain aspects of the label: >REFERENCE TO A GRAPHIC>Colours used: CMYK: cyan, magenta, yellow, black. Example: 07X0: 0 % cyan, 70 % magenta, 100 % yellow, 0 % black. Arrows: - A: X0X0, - B: 70X0, - C: 30X0, - D: 00X0, - E: 03X0, - F: 07X0, - G: 0XX0. Outline colour X070. All text is in black. The background is white. Complete printing information is contained in a 'refrigerator/freezer label design guide'  obtainable from: The Secretary of the Committee on Energy Labelling and Standard Product Information for Household  AppliancesDirectorate-General for Energy DG XVII, Commission of the European Communities, 200 Rue de la Loi, B-1049 Brussels. (1) OJ No L 99, 11. 4. 1992, p. 1.  ANNEX II THE FICHE The fiche shall contain the following information. The information  may be given in the form of a table covering a number of appliances supplied by the same supplier,  in which case it shall be given in the order specified, or given in the description of the  appliance: 1. Supplier's name or trade mark. 2. Supplier's model identifier. 3. Type of appliance as follows: >TABLE>4. The energy efficiency class of the model as defined in Annex V, expressed as  'Energy efficiency class . . . on a scale of A (most efficient) to G (least efficient)'. Where this  information is provided in a table this may be expressed by other means provided it is clear that  the scale is from A (most efficient) to G (least efficient). 5. Where the information is provided in a table, and where some of the appliances listed in the  table have been granted a 'Community Eco-label award' under Regulation (EEC) No 880/92, this  information may be included here. In this case the row heading shall state 'Community Eco-label  award', and the entry shall consist of a copy of the Eco-award mark (the flower). This provision is  without prejudice to any requirements under the Community Eco-label award scheme. 6. Energy consumption in accordance with standards referred to in Article 1 (2) but expressed in  kWh per year (i.e. per 24 hours × 365), described as: 'energy consumption XYZ kWh per year, based  on standard test results for 24 h. Actual energy consumption will depend on how the appliance is  used and where it is located.'7. Net storage volume of fresh food storage compartment (5 °C) in  accordance with standards referred to in Article 1 (2) - omit for classes 8 and 9. 8. Net storage volume of frozen food storage compartment, in accordance with standards referred to  in Article 1 (2) - omit for classes 1, 2 and 3. For class 3 appliances the net volume of the 'ice  box'. 7 and 8. For classes 2 and 10 the net volume of each compartment should be listed, in accordance  with standards referred to in Article 1 (2). 9. Star rating of frozen food storage compartment, if any, in accordance with standards referred to  in Article 1 (2). 10. The mention 'no frost' may be included here when in accordance with the definitions given in  the standards referred to in Article 1 (2). 11. 'Power cut safe Z h' defined as 'temperature rise time' in accordance with standards referred  to in Article 1 (2). 12. 'Freezing capacity' in kg/24 h in accordance with standards referred to in Article 1 (2). 13. 'Climate class' in accordance with the standards referred to in Article 1 (2). Where appliance  is of 'temperate' climate class this may be omitted. 14. 'Noise', where applicable, measured in accordance with Directive 86/594/EEC. Where an appliance contains compartments other than a single fresh food compartment and a single  frozen food compartment, extra lines may be added at 7, 8, 9, 10, 11, 12 and 13 to include the  information in respect of these compartments. In this case the naming and order of listing of the  compartments shall be consistent. Where the design temperature of a compartment does not conform to  the star rating system, or the standard fresh food compartment temperature (5 °C), this design  temperature shall be given. The information contained in the label may be given in the form of a copy of the label, either in  colour or in black and white. In this case the further information given only in the fiche must  still be included. Note: The equivalent terms in other languages to those described above are given in Annex VI.  ANNEX III MAIL ORDER AND OTHER DISTANCE SELLING Mail order catalogues and other printed  communications referred to by Article 2 (5) of this Directive shall contain the following  information, given in the order specified: 1. Energy efficiency class (Annex II, point 4)2. Energy consumption (Annex II, point 6)3. Net  volume of fresh food compartment (Annex II, point 7)4. Net volume of frozen food compartment  (Annex II, point 8)5. Star rating (Annex II, point 9)6. Noise (Annex II, point 14)Where other  information contained in the product information fiche is provided, it shall be in the form defined  in Annex II and shall be included in the above list in the order specified for the fiche. The size and font, in which all the information referred to above is printed, shall be legible. Note: The equivalent terms in other languages to those described above are given in Annex VI.  ANNEX IV CATEGORIES The appliances covered by this Directive shall be divided into the  following 'categories': 1. Household refrigerators, without low temperature compartments. 2. Household refrigerator/chillers, with compartments at 5 °C and/or 10 °C. 3. Household refrigerators, with no-star low temperature compartments. 4. Household refrigerators, with low temperature compartments *. 5. Household refrigerators, with low temperature compartments **. 6. Household refrigerators, with low temperature compartments ***. 7. Household refrigerator/freezers, with low temperature compartments *(***). 8. Household food freezers, upright. 9. Household food freezers, chest. 10. Household refrigerators and freezers with more than two doors, or other appliances not covered  above.  ANNEX V ENERGY EFFICIENCY CLASS The energy efficiency class of an appliance shall be  determined in accordance with the following Table 1: >TABLE>Where: 'energy efficiency index' (expressed as a percentage) = annual energy consumption of appliance (1)  / standard annual energy consumption of appliance'standard annual energy consumption of appliance'  (expressed in kWh/year) = M × adjusted net volume + Nandadjusted net volume (expressed in litres)  = net volume of fresh food compartment +  ` × net volume of frozen food compartment. The values of M, N and  ` are taken from Table 2. >TABLE>(1) In accordance with Annex I, note V.  ANNEX VI >TABLE>


title: Commission Directive 2009/113/EC of 25 August 2009 amending Directive 2006/126/EC of the European Parliament and of the Council on driving licences

text:
               26.8.2009

               EN

               Official Journal of the European Union

               L 223/31

      COMMISSION DIRECTIVE 2009/113/EC
   of 25 August 2009
   amending Directive 2006/126/EC of the European Parliament and of the Council on driving licences
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2006/126/EC of the European Parliament and of the Council of 20 December 2006 on driving licences (1), and in particular Article 8 thereof,
   Whereas:

               (1)

               The minimum requirements for fitness to drive are not harmonised to the full extent. Member States are allowed to impose standards that are stricter than the minimum European requirements, as laid down in Annex III point 5 to Directive 2006/126/EC.

               (2)

               Since the existence of different requirements in different Member States may affect the principle of free movement the Council specifically asked for a review of the medical standards for driver licensing in its resolution of 26 June 2000.

               (3)

               In line with this Council resolution, the Commission advised that medium- and long-term work should be undertaken in order to adapt Annex III to scientific and technical progress as laid down in Article 8 of Directive 2006/126/EC.

               (4)

               Eyesight, diabetes and epilepsy were identified as being medical conditions affecting fitness to drive which needed to be considered; to that end working groups comprised of specialists appointed by Member States were set up.

               (5)

               These working groups produced reports with a view to updating the relevant points of Annex III to Directive 2006/126/EC.

               (6)

               Directive 2006/126/EC should therefore be amended accordingly.

               (7)

               The measures provided for in this Directive are in accordance with the opinion of the Committee on driving licences,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III to Directive 2006/126/EC is amended as set out in the Annex.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than one year after entry into force of this Directive. They shall forthwith inform the Commission thereof.
   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 texts of the main provisions of national law which they adopt in the field governed by this Directive.
   Article 3
   This Directive is addressed to the Member States.

      Done at Brussels, 25 August 2009.

            For the Commission

         Antonio TAJANI

            Vice-President

      (1)  OJ L 403, 30.12.2006, p. 18.

      ANNEX
      Annex III to Directive 2006/126/EC is amended as follows:

                  1.

                  point 6 is replaced by the following:
                  ‘EYESIGHT

                              6.

                              All applicants for a driving licence shall undergo an appropriate investigation to ensure that they have adequate visual acuity for driving power-driven vehicles. Where there is reason to doubt that the applicant’s vision is adequate, he/she shall be examined by a competent medical authority. At this examination attention shall be paid, in particular, to the following: visual acuity, field of vision, twilight vision, glare and contrast sensitivity, diplopia and other visual functions that can compromise safe driving.
                              For group 1 drivers, licensing may be considered in “exceptional cases” where the visual field standard or visual acuity standard cannot be met; in such cases the driver should undergo examination by a competent medical authority to demonstrate that there is no other impairment of visual function, including glare, contrast sensitivity and twilight vision. The driver or applicant should also be subject to a positive practical test conducted by a competent authority.

                     Group 1:

                              6.1.

                              Applicants for a driving licence or for the renewal of such a licence shall have a binocular visual acuity, with corrective lenses if necessary, of at least 0,5 when using both eyes together.
                              Moreover, the horizontal visual field should be at least 120 degrees, the extension should be at least 50 degrees left and right and 20 degrees up and down. No defects should be present within a radius of the central 20 degrees.
                              When a progressive eye disease is detected or declared, driving licences may be issued or renewed subject to the applicant undergoing regular examination by a competent medical authority.

                              6.2.

                              Applicants for a driving licence, or for the renewal of such a licence, who have total functional loss of vision in one eye or who use only one eye (e.g. in the case of diplopia) must have a visual acuity of at least 0,5, with corrective lenses if necessary. The competent medical authority must certify that this condition of monocular vision has existed for a sufficiently long time to allow adaptation and that the field of vision in this eye meets the requirement laid down in paragraph 6.1.

                              6.3.

                              After any recently developed diplopia or after the loss of vision in one eye, there should be an appropriate adaptation period (for example, six months), during which driving is not allowed. After this period, driving is only allowed following a favourable opinion from vision and driving experts.

                     Group 2:

                              6.4.

                              Applicants for a driving licence or for the renewal of such a licence shall have a visual acuity, with corrective lenses if necessary, of at least 0,8 in the better eye and at least 0,1 in the worse eye. If corrective lenses are used to attain the values of 0,8 and 0,1, the minimum acuity (0,8 and 0,1) must be achieved either by correction by means of glasses with a power not exceeding plus eight dioptres, or with the aid of contact lenses. The correction must be well tolerated.
                              Moreover, the horizontal visual field with both eyes should be at least 160 degrees, the extension should be at least 70 degrees left and right and 30 degrees up and down. No defects should be present within a radius of the central 30 degrees.
                              Driving licences shall not be issued to or renewed for applicants or drivers suffering from impaired contrast sensitivity or from diplopia.
                              After a substantial loss of vision in one eye, there should be an appropriate adaptation period (for example six months) during which the subject is not allowed to drive. After this period, driving is only allowed after a favourable opinion from vision and driving experts.’;

                  2.

                  point 10 is replaced by the following:
                  ‘DIABETES MELLITUS

                              10.

                              In the following paragraphs, a severe hypoglycaemia means that the assistance of another person is needed and a recurrent hypoglycaemia is defined as a second severe hypoglycaemia during a period of 12 months.

                     Group 1:

                              10.1.

                              Driving licences may be issued to, or renewed for, applicants or drivers who have diabetes mellitus. When treated with medication, they should be subject to authorised medical opinion and regular medical review, appropriate to each case, but the interval should not exceed five years.

                              10.2.

                              Driving licences shall not be issued to, nor renewed for, applicants or drivers who have recurrent severe hypoglycaemia or/and impaired awareness of hypoglycaemia. A driver with diabetes should demonstrate an understanding of the risk of hypoglycaemia and adequate control of the condition.

                     Group 2:

                              10.3.

                              Consideration may be given to the issuing/renewal of group 2 licences to drivers with diabetes mellitus. When treated with medication which carries a risk of inducing hypoglycaemia (that is, with insulin, and some tablets), the following criteria should apply:

                                          —

                                          no severe hypoglycaemic events have occurred in the previous 12 months,

                                          —

                                          the driver has full hypoglycaemic awareness,

                                          —

                                          the driver must show adequate control of the condition by regular blood glucose monitoring, at least twice daily and at times relevant to driving,

                                          —

                                          the driver must demonstrate an understanding of the risks of hypoglycaemia,

                                          —

                                          there are no other debarring complications of diabetes.

                                    Moreover, in these cases, such licences should be issued subject to the opinion of a competent medical authority and to regular medical review, undertaken at intervals of not more than three years.

                              10.4.

                              A severe hypoglycaemic event during waking hours, even unrelated to driving, should be reported and should give rise to a reassessment of the licensing status.’;

                  3.

                  point 12 is replaced by the following:
                  ‘EPILEPSY

                              12.

                              Epileptic seizures or other sudden disturbances of the state of consciousness constitute a serious danger to road safety if they occur in a person driving a power-driven vehicle.
                              Epilepsy is defined as having had two or more epileptic seizures, less than five years apart. A provoked epileptic seizure is defined as a seizure which has a recognisable causative factor that is avoidable.
                              A person who has an initial or isolated seizure or loss of consciousness should be advised not to drive. A specialist report is required, stating the period of driving prohibition and the requested follow-up.
                              It is extremely important that the person’s specific epilepsy syndrome and seizure type are identified so that a proper evaluation of the person’s driving safety can be undertaken (including the risk of further seizures) and the appropriate therapy instituted. This should be done by a neurologist.

                     Group 1:

                              12.1.

                              Drivers assessed under group 1 with epilepsy should be under licence review until they have been seizure-free for at least five years.
                              If the person has epilepsy, the criteria for an unconditional licence are not met. Notification should be given to the licensing authority.

                              12.2.

                              Provoked epileptic seizure: the applicant who has had a provoked epileptic seizure because of a recognisable provoking factor that is unlikely to recur at the wheel can be declared able to drive on an individual basis, subject to neurological opinion (the assessment should be, if appropriate, in accordance with other relevant sections of Annex III (e.g. in the case of alcohol or other co-morbidity).

                              12.3.

                              First or single unprovoked seizure: the applicant who has had a first unprovoked epileptic seizure can be declared able to drive after a period of six months without seizures, if there has been an appropriate medical assessment. National authorities may allow drivers with recognised good prognostic indicators to drive sooner.

                              12.4.

                              Other loss of consciousness: the loss of consciousness should be assessed according to the risk of recurrence while driving.

                              12.5.

                              Epilepsy: drivers or applicants can be declared fit to drive after a one-year period free of further seizures.

                              12.6.

                              Seizures exclusively in sleep: the applicant or driver who has never had any seizures other than seizures during sleep can be declared fit to drive so long as this pattern has been established for a period which must not be less than the seizure-free period required for epilepsy. If there is an occurrence of attacks/seizure arising while awake, a one-year period free of further event before licensing is required (see “Epilepsy”).

                              12.7.

                              Seizures without influence on consciousness or the ability to act: the applicant or driver who has never had any seizures other than seizures which have been demonstrated exclusively to affect neither consciousness nor cause any functional impairment can be declared fit to drive so long as this pattern has been established for a period which must not be less than the seizure-free period required for epilepsy. If there is an occurrence of any other kind of attacks/seizures a one-year period free of further event before licensing is required (see “Epilepsy”).

                              12.8.

                              Seizures because of a physician-directed change or reduction of anti-epileptic therapy: the patient may be advised not to drive from the commencement of the period of withdrawal and thereafter for a period of six months after cessation of treatment. Seizures occurring during physician-advised change or withdrawal of medication require three months off driving if the previously effective treatment is reinstated.

                              12.9.

                              After curative epilepsy surgery: see “Epilepsy”.

                     Group 2:

                              12.10.

                              The applicant should be without anti-epileptic medication for the required period of seizure freedom. An appropriate medical follow-up has been done. On extensive neurological investigation, no relevant cerebral pathology was established and there is no epileptiform activity on the electroencephalogram (EEG). An EEG and an appropriate neurological assessment should be performed after the acute episode.

                              12.11.

                              Provoked epileptic seizure: the applicant who has had a provoked epileptic seizure because of a recognisable provoking factor that is unlikely to recur at the wheel can be declared able to drive on an individual basis, subject to neurological opinion. An EEG and an appropriate neurological assessment should be performed after the acute episode.
                              A person with a structural intra-cerebral lesion who has increased risk of seizures should not be able to drive vehicles of group 2 until the epilepsy risk has fallen to at least 2 % per annum. The assessment should be, if appropriate, in accordance with other relevant sections of Annex III (e.g. in the case of alcohol).

                              12.12.

                              First or single unprovoked seizure: the applicant who has had a first unprovoked epileptic seizure can be declared able to drive once five years’ freedom from further seizures has been achieved without the aid of anti-epileptic drugs, if there has been an appropriate neurological assessment. National authorities may allow drivers with recognised good prognostic indicators to drive sooner.

                              12.13.

                              Other loss of consciousness: the loss of consciousness should be assessed according to the risk of recurrence while driving. The risk of recurrence should be 2 % per annum or less.

                              12.14.

                              Epilepsy: 10 years freedom from further seizures shall have been achieved without the aid of anti-epileptic drugs. National authorities may allow drivers with recognised good prognostic indicators to drive sooner. This also applies in case of “juvenile epilepsy”.
                              Certain disorders (e.g. arterio-venous malformation or intra-cerebral haemorrhage) entail an increased risk of seizures, even if seizures have not yet occurred. In such a situation an assessment should be carried out by a competent medical authority; the risk of having a seizure should be 2 % per annum or less to allow licensing.’


title: Commission Directive 2004/110/EC of 9 December 2004 adapting for the sixth time to technical progress Council Directive 96/49/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by railText with EEA relevance

text:
               10.12.2004

               EN

               Official Journal of the European Union

               L 365/24

      COMMISSION DIRECTIVE 2004/110/EC
   of 9 December 2004
   adapting for the sixth time to technical progress Council Directive 96/49/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (1), and in particular Article 8 thereof,
   Whereas:

               (1)

               The Annex to Directive 96/49/EC refers to the Regulation concerning the international carriage of dangerous goods by rail (RID), as applicable from 1 July 2003.

               (2)

               The RID is updated every two years. Consequently, the next amended version shall be applicable as from 1 January 2005, with a transitional period up to 30 June 2005.

               (3)

               It is therefore necessary to amend the Annex to Directive 96/49/EC.

               (4)

               The measures provided for in this Directive are in conformity with the opinion of the Committee on the transport of dangerous goods referred to in Article 9 of Directive 96/49/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The Annex to Directive 96/49/EC is replaced by the following:

      ‘Regulation concerning the international carriage of dangerous goods by rail (RID) appearing in Annex I to Appendix B to the Convention concerning international carriage by rail (COTIF), as applicable with effect from 1 January 2005, it being understood that the terms contracting party and the States or the railways will be replaced by the term Member State.
      The text of the amendments of the 2005 version of the RID will be published as soon as it is available in all official languages of the Community.’

   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 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 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, 9 December 2004.

            For the Commission

         Jacques BARROT

            Member of the Commission

      (1)  OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2004/89/EC (OJ L 293, 16.9.2004, p. 14).