Avis juridique important

|

32002L0015

Directive 2002/15/EC of the European Parliament and of the Council of 11 March 2002 on the organisation of the working time of persons performing mobile road transport activities

Official Journal L 080 , 23/03/2002 P. 0035 - 0039

Directive 2002/15/EC of the European Parliament and of the Councilof 11 March 2002on the organisation of the working time of persons performing mobile road transport activitiesTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 71 and Article 137(2) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Following consultation of the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), and in the light of the joint text approved by the Conciliation Committee on 16 January 2002,Whereas:(1) Council Regulation (EEC) No 3820/85 of 20 December 1985 on the harmonisation of certain social legislation relating to road transport(4) laid down common rules on driving times and rest periods for drivers; that Regulation does not cover other aspects of working time for road transport.(2) Council Directive 93/104/EC of 23 November 1993 concerning certain aspects of the organisation of working time(5) makes it possible to adopt more specific requirements for the organisation of working time. Bearing in mind the sectoral nature of this Directive, the provisions thereof take precedence over Directive 93/104/EC by virtue of Article 14 thereof.(3) Despite intensive negotiations between the social partners, it has not been possible to reach agreement on the subject of mobile workers in road transport.(4) It is therefore necessary to lay down a series of more specific provisions concerning the hours of work in road transport intended to ensure the safety of transport and the health and safety of the persons involved.(5) Since the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the proposed action, be better achieved at Community level, the Community 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.(6) The scope of this Directive covers only mobile workers employed by transport undertakings established in a Member State participating in mobile road transport activities covered by Regulation (EEC) No 3820/85 or, failing that, by the European agreement concerning the work of crews of vehicles engaged in international road transport (AETR).(7) It should be made clear that mobile workers excluded from the scope of this Directive, other than self-employed drivers, benefit from the basic protection provided for in Directive 93/104/EC. That basic protection includes the existing rules on adequate rest, the maximum average working week, annual leave and certain basic provisions for night workers including health assessment.(8) As self-employed drivers are included within the scope of Regulation (EEC) No 3820/85 but excluded from that of Directive 93/104/EC, they should be excluded temporarily from the scope of this Directive in accordance with the provisions of Article 2(1).(9) The definitions used in this Directive are not to constitute a precedent for other Community regulations on working time.(10) In order to improve road safety, prevent the distortion of competition and guarantee the safety and health of the mobile workers covered by this Directive, the latter should know exactly which periods devoted to road transport activities constitute working time and which do not and are thus deemed to be break times, rest times or periods of availability. These workers should be granted minimum daily and weekly periods of rest, and adequate breaks. It is also necessary to place a maximum limit on the number of weekly working hours.(11) Research has shown that the human body is more sensitive at night to environmental disturbances and also to certain burdensome forms of organisation and that long periods of night work can be detrimental to the health of workers and can endanger their safety and also road safety in general.(12) As a consequence, there is a need to limit the duration of periods of night work and to provide that professional drivers who work at night should receive appropriate compensation for their activity and should not be disadvantaged as regards training opportunities.(13) Employers should keep records of instances when the maximum average working week applicable to mobile workers is exceeded.(14) The provisions of Regulation (EEC) No 3820/85 on driving time in international and national passenger transport, other than regular services, should continue to apply.(15) The Commission should monitor the implementation of this Directive and developments in this field in the Member States and submit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions a report on the application of the rules and the consequences of the provisions on night work.(16) It is necessary to provide that certain provisions may be subject to derogations adopted, according to the circumstances, by the Member States or the two sides of industry. As a general rule, in the event of a derogation, the workers concerned must be given compensatory rest periods,HAVE ADOPTED THIS DIRECTIVE:Article 1PurposeThe purpose of this Directive shall be to establish minimum requirements in relation to the organisation of working time in order to improve the health and safety protection of persons performing mobile road transport activities and to improve road safety and align conditions of competition.Article 2Scope1. This Directive shall apply to mobile workers employed by undertakings established in a Member State, participating in road transport activities covered by Regulation (EEC) No 3820/85 or, failing that, by the AETR Agreement.Without prejudice to the provisions of following subparagraph, this Directive shall apply to self-employed drivers from 23 March 2009.At the latest two years before this date, the Commission shall present a report to the European Parliament and the Council. This report shall analyse the consequences of the exclusion of self-employed drivers from the scope of the Directive in respect of road safety, conditions of competition, the structure of the profession as well as social aspects. The circumstances in each Member State relating to the structure of the transport industry and to the working environment of the road transport profession shall be taken into account. On the basis of this report, the Commission shall submit a proposal, the aim of which may be either, as appropriate- to set out the modalities for the inclusion of the self-employed drivers within the scope of the Directive in respect of certain self-employed drivers who are not participating in road transport activities in other Member States and who are subject to local constraints for objective reasons, such as peripheral location, long internal distances and a particular competitive environment, or- not to include self-employed drivers within the scope of the Directive.2. The provisions of Directive 93/104/EC shall apply to mobile workers excluded from the scope of this Directive.3. In so far as this Directive contains more specific provisions as regards mobile workers performing road transport activities it shall, pursuant to Article 14 of Directive 93/104/EC, take precedence over the relevant provisions of that Directive.4. This Directive shall supplement the provisions of Regulation (EEC) No 3820/85 and, where necessary, of the AETR Agreement, which take precedence over the provisions of this Directive.Article 3DefinitionsFor the purposes of this Directive:(a) "working time" shall mean:1. in the case of mobile workers: the time from the beginning to the end of work, during which the mobile worker is at his workstation, at the disposal of the employer and exercising his functions or activities, that is to say:- the time devoted to all road transport activities. These activities are, in particular, the following:(i) driving;(ii) loading and unloading;(iii) assisting passengers boarding and disembarking from the vehicle;(iv) cleaning and technical maintenance;(v) all other work intended to ensure the safety of the vehicle, its cargo and passengers or to fulfil the legal or regulatory obligations directly linked to the specific transport operation under way, including monitoring of loading and unloading, administrative formalities with police, customs, immigration officers etc.,- the times during which he cannot dispose freely of his time and is required to be at his workstation, ready to take up normal work, with certain tasks associated with being on duty, in particular during periods awaiting loading or unloading where their foreseeable duration is not known in advance, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Member States;2. in the case of self-employed drivers, the same definition shall apply to the time from the beginning to the end of work, during which the self employed driver is at his workstation, at the disposal of the client and exercising his functions or activities other than general administrative work that is not directly linked to the specific transport operation under way.The break times referred to in Article 5, the rest times referred to in Article 6 and, without prejudice to the legislation of Member States or agreements between the social partners providing that such periods should be compensated or limited, the periods of availability referred to in (b) of this Article, shall be excluded from working time;(b) "periods of availability" shall mean:- periods other than those relating to break times and rest times during which the mobile worker is not required to remain at his workstation, but must be available to answer any calls to start or resume driving or to carry out other work. In particular such periods of availability shall include periods during which the mobile worker is accompanying a vehicle being transported by ferryboat or by train as well as periods of waiting at frontiers and those due to traffic prohibitions.These periods and their foreseeable duration shall be known in advance by the mobile worker, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Member States,- for mobile workers driving in a team, the time spent sitting next to the driver or on the couchette while the vehicle is in motion;(c) "workstation" shall mean:- the location of the main place of business of the undertaking for which the person performing mobile road transport activities carries out duties, together with its various subsidiary places of business, regardless of whether they are located in the same place as its head office or main place of business,- the vehicle which the person performing mobile road transport activities uses when he carries out duties, and- any other place in which activities connected with transportation are carried out;(d) "mobile worker" shall mean any worker forming part of the travelling staff, including trainees and apprentices, who is in the service of an undertaking which operates transport services for passengers or goods by road for hire or reward or on its own account;(e) "self-employed driver" shall mean anyone whose main occupation is to transport passengers or goods by road for hire or reward within the meaning of Community legislation under cover of a Community licence or any other professional authorisation to carry out the aforementioned transport, who is entitled to work for himself and who is not tied to an employer by an employment contract or by any other type of working hierarchical relationship, who is free to organise the relevant working activities, whose income depends directly on the profits made and who has the freedom to, individually or through a cooperation between self-employed drivers, have commercial relations with several customers.For the purposes of this Directive, those drivers who do not satisfy these criteria shall be subject to the same obligations and benefit from the same rights as those provided for mobile workers by this Directive;(f) "person performing mobile road transport activities" shall mean any mobile worker or self-employed driver who performs such activities;(g) "week" shall mean the period between 00.00 hours on Monday and 24.00 hours on Sunday;(h) "night time" shall mean a period of at least four hours, as defined by national law, between 00.00 hours and 07.00 hours;(i) "night work" shall mean any work performed during night time.Article 4Maximum weekly working timeMember States shall take the measures necessary to ensure that:(a) the average weekly working time may not exceed 48 hours. The maximum weekly working time may be extended to 60 hours only if, over four months, an average of 48 hours a week is not exceeded. The fourth and fifth subparagraphs of Article 6(1) of Regulation (EEC) No 3820/85 or, where necessary, the fourth subparagraph of Article 6(1) of the AETR Agreement shall take precedence over this Directive, in so far as the drivers concerned do not exceed an average working time of 48 hours a week over four months;(b) working time for different employers is the sum of the working hours. The employer shall ask the mobile worker concerned in writing for an account of time worked for another employer. The mobile worker shall provide such information in writing.Article 5Breaks1. Member States shall take the measures necessary to ensure that, without prejudice to the level of protection provided by Regulation (EEC) No 3820/85 or, failing that, by the AETR Agreement, persons performing mobile road transport activities, without prejudice to Article 2(1), in no circumstances work for more than six consecutive hours without a break. Working time shall be interrupted by a break of at least 30 minutes, if working hours total between six and nine hours, and of at least 45 minutes, if working hours total more than nine hours.2. Breaks may be subdivided into periods of at least 15 minutes each.Article 6Rest periodsFor the purposes of this Directive, apprentices and trainees shall be covered by the same provisions on rest time as other mobile workers in pursuance of Regulation (EEC) No 3820/85 or, failing that, of the AETR Agreement.Article 7Night work1. Member States shall take the measures necessary to ensure that:- if night work is performed, the daily working time does not exceed ten hours in each 24 period,- compensation for night work is given in accordance with national legislative measures, collective agreements, agreements between the two sides of industry and/or national practice, on condition that such compensation is not liable to endanger road safety.2. By 23 March 2007, the Commission shall, within the framework of the report which it draws up in accordance with Article 13(2), assess the consequences of the provisions laid down in paragraph 1 above. The Commission shall, if necessary, submit appropriate proposals along with that report.3. The Commission shall present a proposal for a Directive containing provisions relating to the training of professional drivers, including those who perform night work, and laying down the general principles of such training.Article 8Derogations1. Derogations from Articles 4 and 7 may, for objective or technical reasons or reasons concerning the organisation of work, be adopted by means of collective agreements, agreements between the social partners, or if this is not possible, by laws, regulations or administrative provisions provided there is consultation of the representatives of the employers and workers concerned and efforts are made to encourage all relevant forms of social dialogue.2. The option to derogate from Article 4 may not result in the establishment of a reference period exceeding six months, for calculation of the average maximum weekly working time of forty-eight hours.Article 9Information and recordsMember States shall ensure that:(a) mobile workers are informed of the relevant national requirements, the internal rules of the undertaking and agreements between the two sides of industry, in particular collective agreements and any company agreements, reached on the basis of this Directive, without prejudice to Council Directive 91/533/EEC of 14 October 1991 on an employer's obligation to inform employees of the conditions applicable to the contract or employment relationship(6);(b) without prejudice to Article 2(1), the working time of persons performing mobile road transport activities is recorded. Records shall be kept for at least two years after the end of the period covered. Employers shall be responsible for recording the working time of mobile workers. Employers shall upon request provide mobile workers with copies of the records of hours worked.Article 10More favourable provisionsThis Directive shall not affect Member States' right to apply or introduce laws, regulations or administrative provisions more favourable to the protection of the health and safety of persons performing mobile road transport activities, or their right to facilitate or permit the application of collective agreements or other agreements concluded between the two sides of industry which are more favourable to the protection of the health and safety of mobile workers. Implementation of this Directive shall not constitute valid grounds for reducing the general level of protection afforded to workers referred to in Article 2(1).Article 11PenaltiesMember States shall lay down a system of penalties for breaches of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that these penalties are applied. The penalties thus provided for shall be effective, proportional and dissuasive.Article 12Negotiations with third countriesOnce this Directive has entered into force, the Community shall begin negotiations with the relevant third countries with a view to the application of rules equivalent to those laid down in this Directive to mobile workers employed by undertakings established in a third country.Article 13Reports1. Member States shall report to the Commission every two years on the implementation of this Directive, indicating the views of the two sides of industry. The report must reach the Commission no later than 30 September following the date on which the two-year period covered by the report expires. The two-year period shall be the same as that referred to in Article 16(2) of Regulation (EEC) No 3820/85.2. The Commission shall produce a report every two years on the implementation of this Directive by Member States and developments in the field in question. The Commission shall forward this report to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions.Article 14Final provisions1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 23 March 2005 or shall ensure by that date that the two sides of industry have established the necessary measures by agreement, the Member States being obliged to take any steps to allow them to be able at any time to guarantee the results required by this Directive.When Member States adopt the measures referred to in the first subparagraph, 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.2. Member States shall communicate to the Commission the provisions of national law which they have already adopted or which they adopt in the field covered by this Directive.3. Member States shall take care that consignors, freight forwarders, prime contractors, subcontractors and enterprises which employ mobile workers comply with the relevant provisions of this Directive.Article 15Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 16AddresseesThis Directive is addressed to the Member States.Done at Brussels, 11 March 2002.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentJ. Piqué i Camps(1) OJ C 43, 17.2.1999, p. 4.(2) OJ C 138, 18.5.1999, p. 33.(3) Opinion of the European Parliament of 14 April 1999 (OJ C 219, 30.7.1999, p. 235), as confirmed on 6 May 1999 (OJ C 279, 1.10.1999, p. 270), Council Common Position of 23 March 2001 (OJ C 142, 15.5.2001, p. 24) and Decision of the European Parliament of 14 June 2001 (not yet published in the Official Journal). Decision of the European Parliament of 5 February 2002 and Council Decision of 18 February 2002.(4) OJ L 370, 31.12.1985, p. 1.(5) OJ L 307, 13.12.1993, p. 18. Directive as last amended by Directive 2000/34/EC of the European Parliament and of the Council (OJ L 195, 1.8.2000, p. 41).(6) OJ L 288, 18.10.1991, p. 32.


title: Commission Directive 2008/65/EC of 27 June 2008 amending Directive 91/439/EEC on driving licences

text:
               28.6.2008

               EN

               Official Journal of the European Union

               L 168/36

      COMMISSION DIRECTIVE 2008/65/EC
   of 27 June 2008
   amending Directive 91/439/EEC on driving licences
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/439/EEC of 29 July 1991 on driving licences (1), and in particular Article 7a (2) thereof,
   Whereas:

               (1)

               The list of codes as described in Annex I and Ia to Directive 91/439/EEC needs to be adapted.

               (2)

               Community code 78, restricting the right to drive vehicles within a driving licence category to vehicles with automatic transmission only, should be amended in view of scientific and technical progress in the field.

               (3)

               The minimum requirements for driving test vehicles as laid down in Annex II of Directive 91/439/EEC need to be aligned with the change in the definition of Community code 78.

               (4)

               The minimum requirements for theory and practical tests as laid down in Annex II of Directive 91/439/EEC should be reviewed in order to bring the testing requirements into line with the demands of daily traffic with regard to the use of tunnels so as to improve the road safety level of this particular part of the road infrastructure.

               (5)

               The periods laid down in points 5.2 and 6.2.5 of Annex II to Directive 91/439/EEC have proved to be inadequate for the satisfactory implementation of the necessary measures. A supplementary period should be granted.

               (6)

               Directive 91/439/EEC should therefore be amended accordingly.

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 91/439/EEC is amended as follows:

               1.

               in Annex I, point (2), concerning page 4 of the licence and in Annex Ia, point (2), concerning page 2 of the licence, point (a)(12), the wording of Community code 10.02 is replaced by the following:

                           ‘10.02.

                           Vehicles without a clutch pedal (or lever operated manually for categories A or A1)’;

               2.

               in Annex I, point (2), concerning page 4 of the licence and in Annex Ia, point (2), concerning page 2 of the licence, point (a)(12), the wording of Community code 78 is replaced by the following:
               78.   Valid only for vehicles without a clutch pedal (or lever operated manually for categories A or A1)’;

               3.

               Annex II is amended as follows:

                           (a)

                           in point 2.1.3, the following indent is added:

                                       ‘—

                                       safe driving in road tunnels’;

                           (b)

                           in point 5.1, the second and the third paragraphs are replaced by the following:
                           ‘If an applicant takes the test of skills and behaviour on a vehicle without a clutch pedal (or lever operated manually for categories A and A1) this shall be recorded on any licence issued on the basis of such a test. Licences with this indication shall be valid only for driving vehicles without a clutch pedal (or lever operated manually for categories A or A1).
                           “Vehicle with automatic transmission” means a vehicle in which no clutch pedal (or lever operated manually for categories A or A1) is present.’

                           (c)

                           in point 5.2, the final paragraph is replaced by the following:
                           ‘Testing vehicles for categories B+E, C, C+E, C1, C1+E, D, D+E, D1 and D1+E which are not in conformity with the minimum criteria given above but which were in use on or before the date specified in Article 3 of Commission Directive 2008/65/EC (2), may still be used until 30 September 2013. The requirements related to the load to be carried by these vehicles may be implemented by Member States up to 30 September 2013.

                           (d)

                           in the second paragraph of point 6.2.5, ‘five years after entry into force of this Directive’ is replaced by ‘by 30 September 2008’;

                           (e)

                           in points 6.3.8, 7.4.8 and 8.3.8 the word ‘tunnels’ is added to the list of special road features covered.

         Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2008 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.
   2.   Member States shall communicate to the Commission the texts of the essential provisions of national law which they adopt in the field governed 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 Communities.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 27 June 2008.

            For the Commission

         Antonio TAJANI

            Vice-President

      (1)  OJ L 237, 24.8.1991, p. 1. Directive as last amended by Directive 2006/103/EC (OJ L 363, 20.12.2006, p. 344).

      (2)  OJ L 168, 28.6.2008, p. 36.’


Avis juridique important

|

31996L0045

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (Text with EEA relevance)

Official Journal L 213 , 22/08/1996 P. 0008 - 0015

SEVENTH COMMISSION DIRECTIVE 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (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), as last amended by Commission Directive 95/34/EC (2), and in particular Article 8 (1) thereof,Whereas Directive 76/768/EEC provides for the official testing of cosmetic products with the aim of ensuring that the conditions laid down by Community provisions concerning the composition of cosmetic products are satisfied;Whereas all the necessary methods of analysis should be laid down as quickly as possible; whereas certain methods have already been adopted in Commission Directives 80/1335/EEC (3), as amended by Directive 87/143/EEC (4), 82/434/EEC (5), as amended by Directive 90/207/EEC (6), and by Commission Directives 83/514/EEC (7), 85/490/EEC (8), 93/73/EEC (9) and 95/32/EC (10);Whereas the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in cosmetic products constitute a seventh step;Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation of Directive 76/768/EEC to technical progress,HAS ADOPTED THIS DECISION:Article 1 Member States shall take all the necessary steps to ensure that during official testing of cosmetic products, the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate shall be carried out in accordance with the method described in the Annex.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 30 September 1997. They shall forthwith inform the Commission thereof.2. 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 the Member States.3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 2 July 1996.For the CommissionEmma BONINOMember of the Commission(1) OJ No L 262, 27. 9. 1976, p. 169.(2) OJ No L 167, 18. 7. 1995, p. 19.(3) OJ No L 383, 31. 12. 1980, p. 27.(4) OJ No L 57, 27. 2. 1987, p. 56.(5) OJ No L 185, 30. 6. 1982, p. 1.(6) OJ No L 108, 28. 4. 1990, p. 92.(7) OJ No L 291, 24. 10. 1983, p. 9.(8) OJ No L 295, 7. 11. 1985, p. 30.(9) OJ No L 231, 14. 9. 1993, p. 34.(10) OJ No L 178, 28. 7. 1995, p. 20.ANNEX IDENTIFICATION AND DETERMINATION OF 2-PHENOXYETHANOL, 1-PHENOXYPROPAN-2-OL, METHYL, ETHYL, PROPYL, BUTYL AND BENZYL 4-HYDROXYBENZOATE IN COSMETIC PRODUCTS A. IDENTIFICATION 1. Scope and field of applicationThis method specifies a TLC procedure that, in combination with the determination method described in Section B, allows the identification of 2-phenoxyethanol, 1-phenoxypropan-2-ol, methyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, butyl 4-hydroxybenzoate and benzyl 4-hydroxybenzoate in cosmetic products.2. PrincipleThe preservatives are extracted from the acidified cosmetic sample with acetone. After filtration, the acetone solution is mixed with water, and in an alkaline medium the fatty acids are precipitated as their calcium salts. The alkaline acetone/water mixture is extracted with diethylether to remove lipophilic substances. After acidification the preservatives are extracted with diethylether. An aliquot of the diethylether extract is spotted on a silica-gel coated thin-layer plate. After development of the plate, the chromatogram obtained is observed under UV light and visualized using Millon's reagent.3. Reagents3.1. GeneralAll reagents used shall be of analytical purity. Water shall be distilled water, or water of at least equal purity.3.2. Acetone3.3. Diethylether3.4. n-Pentane3.5. Methanol3.6. Acetic acid, glacial3.7. Hydrochloric acid solution, c(HCl)=4mol/l3.8. Potassium hydroxide solution, c(KOH)=4 mol/l3.9. Calcium chloride dihydrate (CaCl2 72H2O)3.10. Detection reagent: Millon's reagentMillon's reagent (Mercury (II) nitrate) is a ready-made solution which is commercially available (Fluka 69820).3.11. 2-Phenoxyethanol3.12. 1-Phenoxypropan-2-ol3.13. Methyl 4-hydroxybenzoate (methylparaben)3.14. Ethyl 4-hydroxybenzoate (ethylparaben)3.15. n-Propyl 4-hydroxybenzoate (propylparaben)3.16. n-Butyl 4-hydroxybenzoate (butylparaben)3.17. Benzyl 4-hydroxybenzoate (benzylparaben)3.18. Reference solutionsPrepare 0,1 % (m/V) solutions of each of the reference substances 3.11, 3.12, 3.13, 3.14, 3.15, 3.16 and 3.17 in methanol.3.19. Development solventMix 88 volumes of n-pentane (3.4) with 12 volumes of glacial acetic acid (3.6).4. ApparatusNormal laboratory equipment, and:4.1. Waterbath, capable of maintaining a temperature of 60 °C4.2. Developing tank (not lined with filter paper)4.3. Ultraviolet light source, 254 nm4.4. Thin-layer plates, 20 cm × 20 cm, precoated with 0,25 mm silica gel 60F254, with concentrating zone (Merck No 11798, Darmstadt, or equivalent)4.5. Oven, capable of maintaining up to 105 °C4.6. Hot-air hair dryer4.7. Woollen paint roller, length approximately 10 cm, outside diameter approximately 3,5 cm. The thickness of the wool-layer shall be 2 to 3 mm. Trim the wool if necessary.See note under 5.24.8. 50-ml glass tubes with screw cap4.9. Electric heating plate, with thermostatic temperature controller. Temperature setting: about 80 °C. The hot plate shall be covered with an aluminium plate of 20 cm × 20 cm and a thickness of about 6 mm, to obtain a uniform heat distribution.5. Procedure5.1. Sample preparationWeigh approximately 1 g of sample in a 50-ml glass tube with screw cap (4.8). Add four drops of hydrochloric acid solution (3.7) and 40 ml of acetone.For strongly basic cosmetic products, such as toilet-soap, 20 drops of hydrochloric acid solution shall be added. Close the tube, gently heat the mixture to approximately 60 °C to facilitate the extraction of the preservatives into the acetone phase and shake vigourously for one minute.Measure the pH of the solution with pH indicator paper and adjust the pH of the solution ≤ 3 with hydrochloric acid solution. Shake vigorously again for one minute.Cool the solution to room temperature and filter through a filter paper into a conical flask. Transfer 20 ml of the filtrate into a 200-ml conical flask, add 60 ml water and mix. Adjust the pH of the mixture to approximately 10 with potassium hydroxide (3.8), using pH indicator paper.Add 1 g calcium chloride dihydrate (3.9) and shake vigorously. Filter the solution through a filter paper into a 250-ml separating funnel containing 75 ml diethylether and shake vigorously for one minute. Allow the phases to separate and collect the aqueous layer in a 200-ml conical flask. Adjust the pH of the solution to approximately 2 with hydrochloric acid solution, using pH indicator paper. Subsequently, add 10 ml diethylether and shake vigorously for one minute. Allow the phases to separate and transfer approximately 2 ml of the diethylether layer into a 5-ml sample vial.5.2. Thin-layer chromatography (TLC)Place a TLC plate (4.4) on the heated aluminium plate (4.9). Apply 10 ìl of each of the reference solutions (3.18) and 100 ìl of the sample solution(s) (5.1) on a start line in the concentration zone of the TLC plate.If desired, a stream of air can be used to facilitate evaporation of the solvent. Remove the TLC plate from the heating plate and allow to cool to room temperature. Transfer 100 ml of the development solvent (3.19) into a developing tank (4.2).Place the TLC plate immediately in the unsaturated chamber and develop at room temperature until the solvent front has run about 15 cm from the base line. Remove the plate from the development tank and dry in a stream of hot air by means of a hot-air hair dryer.Examine the plate under UV light (4.3) and mark the position of the spots. Heat the plate for 30 minutes in an oven (4.5) at 100 °C to remove excess acetic acid. Visualize the preservatives in the chromatogram with Millon's reagent (3.10), by dipping the paint roller (4.7) into the reagent and rolling over the TLC-plate until evenly wetted.Note: Alternatively, the spots may be visualized by the careful application of a drop of Millon's reagent on each of the spots marked under UV light.Esters of 4-hydroxybenzoic acid appear as red spots, 2-phenoxyethanol and 1-phenoxypropan-2-ol as yellow spots. Note, however, that 4-hydroxybenzoic acid itself, which may be present in the samples as a preservative or decomposition product of the parabens, will also appear as a red spot. See 7.3 and 7.4.6. IdentificationCalculate the Rf-value for each spot. Compare the spots obtained from the sample solution with those of the reference solutions with respect to their Rf-values, their behaviour under UV radiation and the colour after visualization. Draw preliminary conclusions about the identity of the preservatives.If parabens appear to be present, the HPLC procedure described in Section B should be performed. Combine the results from TLC and high-performance liquid chromatography (HPLC) to confirm the presence of the 2-phenoxyethanol, 1-phenoxypropan-2-ol and the parabens.7. Remarks7.1. Because of the toxicity of Millon's reagent this reagent is best applied by one of the procedures described. Spraying is not recommended.7.2. Other compounds containing hydroxyl groups may also give colours with Millon's reagent. A table of colours and Rf-values obtained for a number of preservatives using this TLC procedure may be found in: N. de Kruijf, M. A. H. Rijk, L. A. Pranato-Soetardhi and A. Schouten (1987): Determination of preservatives in cosmetic products I: Thin-layer chromatographic procedure for the identification of preservatives in cosmetic products (J. Chomatography 410, 395-411).7.3. The Rf-values listed in the following table serve as an indication of the values that may be obtained:>TABLE>7.4. No separation is obtained for 4-hydroxybenzoic acid and methylparaben, or for benzylparaben and ethylparaben. Identification of these compounds should be confirmed by performing the HPLC method described under Section B and comparing the retention times obtained from the sample with those of standards.B. DETERMINATION 1. Scope and field of applicationThis method specifies a procedure for the determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, methyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, butyl 4-hydroxybnenzoate and benzyl 4-hydroxybenzoate in cosmetic products.2. DefinitionThe amounts of the preservatives determined by this method are expressed as percentage by mass.3. PrincipleThe sample is acidified by adding sulfuric acid and then suspended in a mixture of ethanol and water. After gently heating the mixture to melt the lipid phase to promote quantitative extraction, the mixture is filtered.The preservatives in the filtrate are determined by reversed phase HPLC using isopropyl 4-hydroxybenzoate as the internal standard.4. Reagents4.1. GeneralAll reagents must be of analytical purity and suitable for HPLC where appropriate. Water shall be distilled water, or water of at least equal purity.4.2. Ethanol, absolute4.3. 2-Phenoxyethanol4.4. 1-Phenoxypropan-2-ol4.5. Methyl 4-hydroxybenzoate (methylparaben)4.6. Ethyl 4-hydroxybenzoate (ethylparaben)4.7. n-Propyl 4-hydroxybenzoate (propylparaben)4.8. Isopropyl 4-hydroxybenzoate (isopropylparaben)4.9. n-Butyl 4-hydroxybenzoate (butylparaben)4.10. Benzyl 4-hydroxybenzoate (benzylparaben)4.11. Tetrahydrofuran4.12. Methanol4.13. Acetonitrile4.14. Sulfuric acid solution c(H2SO4)=2mol/l4.15. Ethanol/water mixtureMix nine volumes of ethanol (4.2) and one volume of water.4.16. Internal standard solutionAccurately weigh approximately 0,25 g isopropylparaben (4.8), transfer to a 500-ml volumetric flask, dissolve and make up to volume with ethanol/water mixture (4.15).4.17. Mobile phase: tetrahydrofuran/water/methanol/acetonitrile mixtureMix 5 volumes of tetrahydrofuran, 60 volumes of water, 10 volumes of methanol and 25 volumes of acetonitrile.4.18. Preservative stock solutionAccurately weigh approximately 0,2 g 2-phenoxyethanol, 0,2 g 1-phenoxypropan-2-ol, 0,05 g methylparaben, 0,05 g ethylparaben, 0,05 g propylparaben, 0,05 g butylparaben and 0,025 g benzylparaben in a 100-ml volumetric flask, dissolve and make up to volume with ethanol/water mixture.Kept in a refrigerator the solution is stable for one week.4.19. Standard preservative solutionsFrom the stock solution (4.18) transfer respectively 20,00 ml, 10,00 ml, 5,00 ml, 2,00 ml and 1,00 ml into 50-ml volumetric flasks. To each flask, add 10,00 ml internal standard solution (4.16) and 1,0 ml sulfuric acid solution (4.14) and make up to volume with ethanol/water mixture. These solutions should be freshly prepared.5. ApparatusNormal laboratory equipment, and:5.1. Waterbath, capable of maintaining a temperature of 60 °C ± 1 °C.5.2. High performance liquid chromatograph with a UV-detector, wavelength 280 nm5.3. Analytical column:Stainless steel, 25 cm × 4,6 mm i.d. (or 12,5 cm × 4,6 mm i.d.) packed with Nucleosil 5C18, or equivalent (see 10.1)5.4. 100-ml glass tubes with screw cap5.5. Boiling chips, carborundum, size 2 to 4 mm, or equivalent6. Procedure6.1. Sample preparation6.1.1. Sample preparation without addition of the internal standardWeigh approximately 1,0 g of sample in a 100-ml glass tube with screw cap. Pipette 1,0 ml sulfuric acid solution (4.14) and 50,0 ml ethanol/water mixture (4.15) into the tubes. Add approximately 1 g of boiling chips (5.5), close the tube and shake vigorously until a homogeneous suspension is obtained. Shake for at least one minute. Place the tube for five minutes in a waterbath (5.1) kept at 60 °C ± 1 °C to facilitate the extraction of the preservatives into the ethanol phase.Immediately cool the tube in a stream of cold water and store the extract in the refrigerator for one hour. Filter the extract using a filter paper. Transfer approximately 2 ml of the filtrate into a 5-ml sample vial. Store the extracts in the refrigerator and perform the HPLC determination within 24 hours.6.1.2. Sample preparation including addition of internal standardWeigh to three decimal places 1,0 g ± 0,1 g of sample in a 100-ml glass tube with screw cap.Pipette 1,0 ml sulfuric acid solution and 40,0 ml ethanol/water mixture into the tube. Add approximately 1 g of boiling chips (5.5) and exactly 10,00 ml internal standard solution. Close the tube and shake vigorously until a homogeneous suspension is obtained. Shake for at least one minute. Place the tube for five 5 minutes in a waterbath kept at 60 °C ± 1 °C to facilitate extraction of the preservatives into the ethanol phase.Immediately cool the tube in a stream of cold tap water and store the extract in the refrigerator for one hour. Filter the extract using a filter paper.Transfer approximately 2 ml of the filtrate into a 5-ml sample vial (test solution). Store the extract in the refrigerator and perform the HPLC determinations within 24 hours.6.2. High-performance liquid chromatography (HPLC)6.2.1. Chromatographic conditions- Mobile phase: tetrahydrofuran/water/methanol/acetonitrile mixture (4.17)- Flow rate: 1,5 ml/minute- Detection wavelength: 280 nm6.2.2. CalibrationInject 10ìl of each of the standard preservative solutions (4.19). From the chromatograms obtained determine the ratios of the peak heights of the standard preservative solutions to the peak height of the internal standard. Plot a curve for each preservative relating these ratios to the concentrations of the standard solutions.6.2.3. DeterminationInject 10 ìl of the sample solution without internal standard (6.1.1) into the chromatograph and record the chromatogram.Inject 10 ìl of one of the standard preservative solutions (4.19) and record the chromatogram. Compare the chromatograms obtained.If, in the chromatogram of the sample extract (6.1.1), no peak is present having approximately the same retention time as isopropylparaben (recommended internal standard), continue by injecting 10 ìl sample solution with internal standard (6.1.2). Record the chromatogram and measure the peak heights.If an interfering peak is observed in the chromatogram of the sample solution having approximately the same retention time as isopropylparaben, another internal standard should be selected.If one of the preservatives under examination is absent in the chromatogram of the sample, this preservative can be used as an alternative internal standard.Calculate the ratios of the peak heights of the investigated preservatives to the peak height of the internal standard.Ascertain that for the standard solutions used in the calibration procedure a linear response is obtained.Ascertain whether the chromatograms obtained for a standard solution and the sample solution meet the following requirements:- the peak separation of the worst separated pair shall be at least 0,90. (For definition of peak separation, see Figure 1).>REFERENCE TO A FILM>peak separation (p)p=f/gFigure 1: Peak separationIf the required separation is not achieved, either a more efficient column should be used, or the mobile phase composition should be adjusted until the requirement is met.- the asymmetry factor As of all peaks obtained shall range between 0,9 to 1,5. (For definition of the peak asymmetry factor, see Figure 2.) To record the chromatogram for the determination of the asymmetry factor a chart speed of at least 2 cm/minute is recommended.>REFERENCE TO A FILM>Asymmetry factor (As)As=b/aFigure 2: Peak asymmetry factor- A steady baseline shall be obtained.7. CalculationUse the calibration curve (6.2.2) and the ratios of the peak heights of the investigated preservatives to the peak height of the internal standard to calculate the concentration of the preservatives in the sample solution. Calculate the 2-phenoxyethanol, 1-phenoxypropan-2-ol, methyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, butyl 4-hydroxybenzoate and benzyl 4-hydroxybenzoate contents, wi, as percentage by weight (% m/m), using the formula:% wi (m/m) = >NUM>bi >DEN>200 × ain which:bi = the concentration (ìg/ml) of preservative i in the test solution as read from the calibration curve; anda = the mass (g) of the test position.8. Repeatability (1)See remarks, 10.5.9. Reproducibility (2)See remarks, 10.5.10. Remarks10.1. Stationary phaseThe retention behaviour of the solutes in HPLC determinations is strongly dependent on the type, the brand and the history of the stationary phase. Whether a column can be used for the separation of the preservatives under examination, can be concluded from the results obtained for standard solutions (see remarks 6.2.3). In addition to the proposed column packing material, Hypersil ODS and Zorbax ODS were also found to be suitable.Alternatively, the recommended mobile phase composition can be optimized in order to obtain the required separation.10.2. Detection wavelengthA ruggedness test on the described method has shown that a slight change in the detection wavelength can have a significant effect on the results of the determination.Therefore, this parameter must be controlled carefully during the analysis.10.3. InterferencesUnder the conditions described in this method many other compounds, such as preservatives and cosmetic additives, are eluted as well. Retention times of a large number of preservatives mentioned in Annex VI to the Council Directive regarding cosmetic products are listed in: N. de Kruijf, M. A. H. Rijk, L. A. Pranato-Soetardhi and A. Schouten, (1989). Determination of preservatives in cosmetic products II. High-performance liquid chromatographic identification (J. Chromatography 469, 317-398).10.4. To project the analytical column an appropriate guard column may be used.10.5. The method has been investigated in a collaborative trial in which nine laboratories participated. Three samples were analyzed. The following table lists, for each of the three samples, the means in % m/m (m), repeatabilities (r), reproducibilities (R) found for the analytes they contained:>TABLE>(1) ISO 5725.


Avis juridique important

|

31990L0035

Commission Directive 90/35/EEC of 19 December 1989 defining in accordance with Article 6 of Directive 88/379/EEC the categories of preparations the packaging of which must be fitted with child-resistant fastenings and/or carry a tactile warning of danger

Official Journal L 019 , 24/01/1990 P. 0014 - 0015 Finnish special edition: Chapter 15 Volume 9 P. 0166  Swedish special edition: Chapter 15 Volume 9 P. 0166

*****COMMISSION  DIRECTIVE  of 19 December 1989  defining in accordance with Article 6 of Directive 88/379/EEC the categories of preparations the packaging of which must be fitted with child-resistant fastenings and/or carry a tactile warning of danger  (90/35/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 88/379/EEC of 7 June 1988 on the approximation of Member States' laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (1), as last amended by Directive 89/178/EEC (2), and in particular Article 6 (3) thereof,  Whereas, under Article 6 (2) of Directive 88/379/EEC, containers containing certain categories of dangerous preparations offered or sold to the general public are to be fitted with child-resistant fastenings and/or carry a tactile warning of danger; whereas under Article 6 (3) the categories of dangerous preparations the packaging of which have to be fitted with the abovementioned devices are defined by the procedure set out in Article 21 of Council Directive 67/548/EEC (3), as last amended by Directive 88/490/EEC (4);  Whereas all forms of sufficiently child-resistant packages, especially those defined by international standards, can be considered as packages fitted with child-resistant fastenings;  Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Dangerous Substances and Preparations;  HAS ADOPTED THIS DIRECTIVE:  Article 1  Containers of whatever the capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic or corrosive in accordance with Article 7 of Directive 88/379/EEC and under the conditions laid down in Article 3 thereof shall be fitted with child-resistant fastenings and carry a tactile warning of danger.  These fastenings and warnings must conform to the specifications in parts A and B of Annex IX to Directive 67/548/EEC.  Article 2  Containers of whatever the capacity, containing preparations offered of sold to the general public and labelled as harmful, extremely flammable or highly flammable in accordance with Article 7 and under the conditions laid down in Article 3 of Directive 88/379/EEC, shall carry a tactile warning of danger.  This warning must conform to the specifications in part B of Annex IX to Directive 67/548/EEC.  Article 3  By 31 December 1990, Member States shall adopt and publish the provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof.  They shall apply these provisions from 10 June 1991 at the latest.  Article 4  This Directive is addressed to the Member States.  Done at Brussels, 19 December 1989.  For the Commission  Martin BANGEMANN  Vice-President  (1) OJ No L 187, 16. 7. 1988, p. 14.  (2) OJ No L 64, 8. 3. 1989, p. 18.  (3) OJ No 196, 16. 8. 1967, p. 1.  (4) OJ No L 259, 19. 9. 1988, p. 1.


Avis juridique important

|

31984L0253

Eighth Council Directive 84/253/EEC of 10 April 1984 based on Article 54 (3) (g) of the Treaty on the approval of persons responsible for carrying out the statutory audits of accounting documents

Official Journal L 126 , 12/05/1984 P. 0020 - 0026 Finnish special edition: Chapter 17 Volume 1 P. 0073  Spanish special edition: Chapter 17 Volume 1 P. 0136  Swedish special edition: Chapter 17 Volume 1 P. 0073  Portuguese special edition Chapter 17 Volume 1 P. 0136

EIGHTH COUNCIL DIRECTIVE of 10 April 1984 based on Article 54 (3) (g) of the Treaty on the approval of persons responsible for carrying out the statutory audits of accounting documents (84/253/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 (3) (g) thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas, under Directive 78/660/EEC (4), the annual accounts of certain types of company must be audited by one or more persons entitled to carry out such audits from which only the companies mentioned in Article 11 of that Directive may be exempted;  Whereas the aforementioned Directive has been supplemented by Directive 83/349/EEC (5) on consolidated accounts;  Whereas the qualifications of persons entitled to carry out the statutory audits of accounting documents should be harmonized ; whereas it should be ensured that such persons are independent and of good repute;  Whereas the high level of theoretical knowledge required for the statutory auditing of accounting documents and the ability to apply that knowledge in practice must be ensured by means of an examination of professional competence;  Whereas the Member States should be given the power to approve persons who, while not fulfilling all the conditions imposed concerning theoretical training, nevertheless have engaged in professional activities for a long time, affording them sufficient experience in the fields of finance, law and accountancy and have passed the examination of professional competence;  Whereas the Member States should also be authorized to adopt transitional provisions for the benefit of professional persons;  (1) OJ No C 112, 13.5.1978, p. 6 ; OJ No C 317, 18.12.1975, p. 6. (2) OJ No C 140, 5.6.1979, p. 154. (3) OJ No C 171, 9.7.1979, p. 30. (4) OJ No L 222, 14.8.1978, p. 11. (5) OJ No L 193, 18.7.1983, p. 1.   Whereas the Member States will be able to approve both natural persons and firms of auditors which may be legal persons or other types of company, firms or partnership;  Whereas natural persons who carry out the statutory audits of accounting documents on behalf of such firms of auditors must fulfill the conditions of this Directive;  Whereas a Member State will be able to approve persons who have obtained qualifications outside that State which are equivalent to those required by this Directive;  Whereas a Member State which, when this Directive is adopted, recognizes categories of natural persons who fulfil the conditions imposed in this Directive, but whose level of examination of professional competence is below university, final examination level, should be allowed to continue, under certain conditions and until subsequent coordination, to grant such persons special approval for the purpose of carrying out the statutory audits of the accounting documents of companies and bodies of undertakings, of limited size, when such Member State has not made use of the possibilities for exemption afforded by Community Directives in respect of the preparation of consolidated accounts;  Whereas this Directive does not cover either the right of establishment or the freedom to provide services with regard to persons responsible for carrying out the statutory audits of accounting documents;  Whereas recognition of the approval given to nationals of other Member States for the purpose of carrying out such audits will be specifically regulated by Directives on the taking up and pursuit of activities in the fields of finance, economics and accountancy, as well as on the freedom to provide services in those fields,  HAS ADOPTED THIS DIRECTIVE:    SECTION I  Scope  Article 1 1. The coordination measures prescribed in this Directive shall apply to the laws, regulations and administrative provisions of the Member States concerning persons responsible for:    (a) carrying out statutory audits of the annual accounts of companies and firms and verifying that the annual reports are consistent with those annual accounts in so far as such audits and such verification are required by Community law;       (b) carrying out statutory audits of the consolidated accounts of bodies of undertakings and verifying that the consolidated annual reports are consistent with those consolidated accounts in so far as such audits and such verification are required by Community law.         2. The persons referred to in paragraph 1 may, depending on the legislation of each Member State, be natural or legal persons or other types of company, firm or partnership (firms of auditors as defined in this Directive).  SECTION II  Rules on approval   Article 2 1. Statutory audits of the documents referred to in Article 1 (1) shall be carried out only by approved persons. The authorities of the Member States may approve only:    (a) natural persons who satisfy at least the conditions laid down in Articles 3 to 19;       (b) firms of auditors which satisfy at least the following conditions:      (i) the natural persons who carry out statutory audits of the documents referred to in Article 1 on behalf of firms of auditors must satisfy at least the conditions imposed in Articles 3 to 19 ; the Member States may provide that such natural persons must also be approved;           (ii) a majority of the voting rights must be held by natural persons or firms of auditors who satisfy at least the conditions imposed in Articles 3 to 19 with the exception of Article 11 (1) (b) ; the Member States may provide that such natural persons or firms of auditors must also be approved. However, those Member States which do not impose such majority at the time of the adoption of this Directive need not impose it provided that all the shares in a firm of auditors are registered and can be transferred only with the agreement of the firm  of auditors and/or, where the Member State so provides, with the approval of the competent authority;           (iii) a majority of the members of the administrative or management body of a firm of auditors must be natural persons or firms of auditors who satisfy at least the conditions imposed in Articles 3 to 19 ; the Member States may provide that such natural persons or firms of auditors must also be approved. Where such body has no more than two members, one of those members must satisfy at least those conditions.                    Without prejudice to Article 14 (2), the approval of a firm of auditors must be withdrawn when any of the conditions imposed in (b) is no longer fulfilled. The Member States may, however, provide for a period of grace of not more than two years for the purpose of meeting the requirements imposed in (b) (ii) and (iii).  2. For the purposes of this Directive, the authorities of the Member States may be professional associations provided that they are authorized by national law to grant approval as defined in this Directive.   Article 3 The authorities of a Member State shall grant approval only to persons of good repute who are not carrying on any activity which is incompatible, under the law of that Member State, with the statutory auditing of the documents referred to in Article 1 (1).   Article 4 A natural person may be approved to carry out statutory audits of the documents referred to in Article 1 (1) only after having attained university entrance level, then completed a course of theoretical instruction, undergone practical training and passed an examination of professional competence of university, final examination level organized or recognized by the State.   Article 5 The examination of professional competence referred to in Article 4 must guarantee the necessary level of theoretical knowledge of subjects relevant to the statutory auditing of the documents referred to in Article 1 (1) and the ability to apply such knowledge in practice.  Part at least of that examination must be written.    Article 6  The text of theoretical knowledge included in the examination must cover the following subjects in particular:  (a)   - auditing,    - analysis and critical assessment of annual accounts,       - general accounting,       - consolidated accounts,       - cost and management accounting,       - internal audit,       - standards relating to the preparation of annual and consolidated accounts and to methods of valuing balance sheet items and of computing profits and losses,       - legal and professional standards relating to the statutory auditing of accounting documents and to those carrying out such audits;         (b) in so far as they are relevant to auditing:    - company law,       - the law of insolvency and similar procedures,       - tax law,       - civil and commercial law,       - social-security law and law of employment,       - information and computer systems,       - business, general and financial economics,       - mathematics and statistics,       - basic principles of the financial management of undertakings.         Article 7 1. By way of derogation from Articles 5 and 6, a Member State may provide that a person who has passed a university or equivalent examination or holds a university degree or equivalent qualification in one or more of the subjects referred to in Article 6 may be exempted from the test of theoretical knowledge in the subjects covered by that examination or degree.  2. By way of derogation from Article 5, a Member State may provide that a holder of a university degree or equivalent qualification in one or more of the subjects referred to in Article 6 may be exempted from the test of  the ability to apply in practice his theoretical knowledge of such subjects when he has received practical training in them attested by an examination or diploma recognized by the State.   Article 8 1. In order to ensure the ability to apply theoretical knowledge in practice, a test of which is included in the examination, a trainee must complete a minimum of three years' practical training in inter alia the auditing of annual accounts, consolidated accounts or similar financial statements. At least two-thirds of such practical training must be completed under a person approved under the law of the Member State in accordance with this Directive ; the Member State may, however, permit practical training to be carried out under a person approved by the law of another Member State in accordance with this Directive.  2. Member States shall ensure that all training is carried out under persons providing adequate guarantees regarding training.   Article 9 Member States may approve persons to carry out statutory audits of the documents referred to in Article 1 (1) even if they do not fulfil the conditions imposed in Article 4, if they can show either:    (a) that they have, for 15 years, engaged in professional activities which have enabled them to acquire sufficient experience in the fields of finance, law and accountancy and have passed the examination of professional competence referred to in Article 4, or       (b) that they have, for seven years, engaged in professional activities in those fields and have, in addition, undergone the practical training referred to in Article 8 and passed the examination of professional competence referred to in Article 4.          Article 10 1. Member States may deduct periods of theoretical instruction in the fields referred to in Article 6 from the years of professional activity referred to in Article 9, provided that such instruction is attested by an examination recognized by the State. Such instruction must last not less than one year, nor may it reduce the period of professional activity by more than four years.  2. The period of professional activity as well as the practical training must not be shorter than the programme of theoretical instruction and the practical training required by Article 4.   Article 11 1. The authorities of a Member State may approve persons who have obtained all or part of their qualifications in another State provided they fulfil the following two conditions:    (a) the competent authorities must consider their qualifications equivalent to those required under the law of that Member State in accordance with this Directive ; and       (b) they must have furnished proof of the legal knowledge required in that Member State for purposes of the statutory auditing of the documents referred to in Article 1 (1). The authorities of that Member State need not, however, require such proof where they consider legal knowledge obtained in another State sufficient.         2. Article 3 shall apply.   Article 12 1. A Member State may consider to be approved, in accordance with this Directive, those professional persons who were approved by individual acts of that Member State's competent authorities before the application of the provisions referred to in Article 30 (2).  2. The admission of a natural person to a professional association recognized by the State where, according to the law of that State, such admission confers on the members of that association the right to carry out statutory audits of the documents referred to in Article 1 (1), may be considered as approval by individual act for the purposes of paragraph 1 of this Article.   Article 13 Until the application of the provisions referred to in Article 30 (2), a Member State may consider approved, in accordance with this Directive, those professional persons who have not been approved by individual acts of the competent authorities but who have nevertheless the same qualifications in that Member State as persons  approved by individual acts who on the date of approval are carrying out statutory audits of the documents referred to in Article 1 (1) on behalf of such approved persons.   Article 14 1. A Member State may consider to be approved in accordance with this Directive those firms of auditors which have been approved by individual acts of that Member State's competent authorities before the application of the provisions referred to in Article 30 (2).  2. The conditions imposed in Article 2 (1) (b) (ii) and (iii) must be complied with no later than the end of a period which may not be fixed at more than five years from the date of application of the provisions referred to in Article 30 (2).  3. Those natural persons who, until the application of the provisions referred to in Article 30 (2), carried out statutory audits of the documents referred to in Article 1 (1) in the name of a firm of auditors may, after that date, be authorized to continue to do so even if they do not fulfil all the conditions imposed by this Directive.   Article 15 Until one year after the application of the provisions referred to in Article 30 (2), those professional persons who have not been approved by individual acts of the competent authorities but who are nevertheless qualified in a Member State to carry out statutory audits of the documents referred to in Article 1 (1) and have in fact carried on such activities until that date may be approved by that Member State in accordance with this Directive.   Article 16 For one year after the application of the provisions referred to in Article 30 (2), Member States may apply transitional measures in respect of professional persons who, after that date, maintain the right to audit the annual accounting documents of certain types of company or firm not subject to statutory audit but who will no longer be able to carry out such audits upon the introduction of new statutory audits unless special measures are enacted for their benefit.   Article 17 Article 3 shall apply to Articles 15 and 16.   Article 18 1. For six years after the application of the provisions referred to in Article 30 (2), Member States may apply transitional measures in respect of persons already undergoing professional or practical training when those provisions are applied who, on completion of their training, would not fulfil the conditions imposed by this Directive and would therefore be unable to carry out statutory audits of the documents referred to in Article 1 (1) for which they had been trained.  2. Article 3 shall apply.   Article 19 None of the professional persons referred to in Articles 15 and 16 or of those persons referred to in Article 18 may be approved by way of derogation from Article 4 unless the competent authorities consider that they are fit to carry out statutory audits of the documents referred to in Article 1 (1) and have qualifications equivalent to those of persons approved under Article 4.   Article 20 A Member State which does not make use of the possibility provided for in Article 51 (2) of Directive 78/660/EEC and in which, at the time of the adoption of this Directive, several categories of natural persons may, under national legislation, carry out statutory audits of the documents referred to in Article 1 (1) (a) of this Directive, may, until subsequent coordination of the statutory auditing of accounting documents, specially approve, for the purpose of carrying out statutory audits of the documents referred to in Article 1 (1) (a) in the case of a company which does not exceed the limits of two of the three criteria established in Article 27 of Directive 78/660/EEC, natural persons acting in their own names who:  (a) fulfil the conditions imposed in Articles 3 to 19 of this Directive save that the level of the examination of professional competence may be lower than that required in Article 4 of this Directive ; and   (b) have already carried out the statutory audit of the company in question before it exceeded the limits of two of the three criteria established in Article 11 of Directive 78/660/EEC.  However, if a company forms part of a body of undertakings to be consolidated which exceeds the limits of two of the three criteria established in Article 27 of Directive 78/660/EEC, such persons may not carry out the statutory audit of the documents referred to in Article 1 (1) (a) of this Directive in the case of that company.   Article 21 A Member State which does not make use of the possibility provided for in Article 6 (1) of Directive 83/349/EEC and in which, when this Directive is adopted, several categories of natural persons may, under national legislation, carry out statutory audits of the documents referred to in Article 1 (1) (b) of this Directive may, until subsequent coordination of the statutory auditing of accounting documents, specially approve, for the purpose of carrying out statutory audits of the documents referred to in Article 1 (1) (b), a person approved pursuant to Article 20 of this Directive if on the parent undertaking's balance sheet date, the body of undertakings to be consolidated does not, on the basis of those undertakings' latest annual accounts, exceed the limits of two of the three criteria established in Article 27 of Directive 78/660/EEC, provided that he is empowered to carry out the statutory audit, of the documents referred to in Article 1 (1) (a) of this Directive, of all the undertakings included in the consolidation.   Article 22 A Member State which makes use of Article 20 may allow the practical training of the persons concerned as referred to in Article 8 to be completed under a person who has been approved under the law of that Member State to carry out the statutory audits referred to in Article 20.  SECTION III  Professional integrity and independence   Article 23 Member States shall prescribe that persons approved for the statutory auditing of the documents referred to in Article 1 (1) shall carry out such audits with professional integrity.   Article 24 Member States shall prescribe that such persons shall not carry out statutory audits which they have required if such persons are not independent in accordance with the law of the Member State which requires the audit.   Article 25 Articles 23 and 24 shall also apply to natural persons who satisfy the conditions imposed in Articles 3 to 19 and carry out the statutory audit of the documents referred to in Article 1 (1) on behalf of a firm of auditors.   Article 26 Member States shall ensure that approved persons are liable to appropriate sanctions when they do not carry out audits in accordance with Articles 23, 24 and 25.   Article 27 Member States shall ensure at least that the members and shareholders of approved firms of auditors and the members of the administrative, management and supervisory bodies of such firms who do not personally satisfy the conditions laid down in Articles 3 to 19 in a particular Member State do not intervene in the execution of audits in any way which jeopardizes the independence of the natural persons auditing the documents referred to in Article 1 (1) on behalf of such firms of auditors.  SECTION IV  Publicity   Article 28 1. Member States shall ensure that the names and addresses of all natural persons and firms of auditors approved by them to carry out statutory audits of the documents referred to in Article 1 (1) are made available to the public.  2. In addition, the following must be made available to the public in respect of each approved firm of auditors:  (a) the names and addresses of the natural persons referred to in Article 2 (1) (b) (i) ; and   (b) the names and addresses of the members or shareholders of the firm of auditors;  (c) the names and addresses of the members of the administrative or management body of the firm of auditors.  3. Where a natural person is permitted to carry out statutory audits of the documents referred to in Article 1 (1) in the case of a company according to the conditions referred to in Articles 20, 21 and 22, paragraph 1 of this Article shall apply. The category of company or firm or the bodies of undertakings in respect of which such an audit is permitted must, however, be indicated.  SECTION V  Final provisions   Article 29 The Contact Committee set up by Article 52 of Directive 78/660/EEC shall also:    (a) facilitate, without prejudice to Articles 169 and 170 of the Treaty, harmonized application of this Directive through regular meetings dealing, in particular, with practical problems arising in connection with its application;       (b) advise the Commission, if necessary, on additions or amendments to this Directive.          Article 30 1. Member States shall bring into force before 1 January 1988 the laws, regulations and administrative provisions necessary for them to comply with this Directive. They shall forthwith inform the Commission thereof.  2. Member States may provide that the provisions referred to in paragraph 1 shall not apply until 1 January 1990.  3. Member States shall ensure that they communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.  4. Member States shall also ensure that they communicate, to the Commission, lists of the examinations organized or recognized pursuant to Article 4.   Article 31 This Directive is addressed to the Member States.     Done at Brussels, 10 April 1984.  For the Council  The President  C. CHEYSSON