title: Commission Directive 2013/8/EU of 26 February 2013 amending, for the purpose of adapting its technical provisions, Directive 2009/144/EC of the European Parliament and of the Council on certain components and characteristics of wheeled agricultural or forestry tractors  Text with EEA relevance

text:
               28.2.2013

               EN

               Official Journal of the European Union

               L 56/8

         COMMISSION DIRECTIVE 2013/8/EU
   of 26 February 2013
   amending, for the purpose of adapting its technical provisions, Directive 2009/144/EC of the European Parliament and of the Council on certain components and characteristics of wheeled agricultural or forestry tractors
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (1), and in particular point (b) of Article 19(1) thereof,
   Whereas:

               (1)

               Annex IV to Directive 2009/144/EC of the European Parliament and of the Council (2) sets out general provisions and requirements for mechanical couplings between tractor and towed vehicle and vertical load on the coupling point.

               (2)

               In recent years, new kinds of couplings have been put into use in the Union and are currently nationally approved on the basis of ISO standards. These are namely no-swivel clevis couplings (ISO 6489-5:2011), ball type couplings (ISO 24347:2005) and pin type couplings (ISO 6489-4:2004).

               (3)

               In order to take account of the current market situation, to minimise possible safety and economic impacts and to allow those couplings to be EC type-approved, it is necessary to include the couplings concerned and the relevant ISO standards in Directive 2009/144/EC.

               (4)

               Directive 2009/144/EC should therefore be amended accordingly.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 20(1) of Directive 2003/37/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2009/144/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 1 April 2014 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   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 twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 26 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 171, 9.7.2003, p. 1.

      (2)  OJ L 27, 30.1.2010, p. 33.

      ANNEX
      Annex IV to Directive 2009/144/EC is amended as follows:

                  (1)

                  point 1.1 is replaced by the following:
                   1.1.   Mechanical coupling between tractor and towed vehicle” means the components installed on the tractor and on the towed vehicle in order to provide the mechanical coupling between those vehicles.
                  Only mechanical coupling components for tractors are covered in this Directive.
                  Among the various types of mechanical coupling components for tractors a basic distinction is made between:

                              —

                              clevis type (see Figures 1 and 2 of Appendix 1),

                              —

                              no-swivel clevis couplings (see Figure 1d of Appendix 1),

                              —

                              towing hook (see Figure 1 – “Hitch-hook dimensions” in ISO 6489-1:2001),

                              —

                              tractor drawbar (see Figure 3 of Appendix 1),

                              —

                              ball type (see Figure 4 of Appendix 1),

                              —

                              pin (piton) type (see Figure 5 of Appendix 1).’;

                  (2)

                  point 2.7 is replaced by the following:
                  2.7.   The jaw must permit the drawbar rings to swivel axially at least 90° to the right or left around the longitudinal axis of the coupling with a fixed braking momentum of between 30 and 150 Nm.
                  The towing hook, no-swivel clevis coupling, ball type coupling and pin type coupling must allow the drawbar ring to swivel axially at least 20° to the right or left around the longitudinal axis of the coupling.’;

                  (3)

                  point 3.1 is replaced by the following:
                  ‘3.1.   Dimensions

                  The dimensions of the mechanical coupling components on the tractor must comply with Appendix 1, Figures 1 to 5 and Table 1.’;

                  (4)

                  point 3.3.1 is replaced by the following:

                              ‘3.3.1.

                              The maximum static vertical load is laid down by the manufacturer. However, it must not exceed 3 000 kg, except for the ball type coupling, where the maximum value shall not exceed 4 000 kg.’;

                  (5)

                  in 3.4.1, the following sentence is added:
                  ‘Masses mt, mlt, ma and mla are expressed in kg.’;

                  (6)

                  point 4.2 is replaced by the following:
                  4.2.   For each type of mechanical coupling component the application must be accompanied by the following documents and particulars:

                              —

                              scale drawings of the coupling device (three copies). These drawings must in particular show the required dimensions in detail as well as the measurements for mounting the device,

                              —

                              a short technical description of the coupling device specifying the type of construction and the material used,

                              —

                              a statement of the value of D as referred to in Appendix 2 for the dynamic test or the value of T (towable mass in tonnes), corresponding to 1,5 times the technically permissible maximum laden trailer mass, as referred to in Appendix 3 for the static test, and also the vertical maximum load on the coupling point S (expressed in kg),

                              —

                              one or more sample devices as required by the technical service.’;

                  (7)

                  points 5.1.3 and 5.1.4 are replaced by the following:

                              ‘5.1.3.

                              where the strength is checked in accordance with Appendix 2 (dynamic test):
                              permissible value of D (kN),
                              static vertical load value of S (kg);

                              5.1.4.

                              where the strength is checked in accordance with Appendix 3 (static test):
                              towable mass T (tonnes), and vertical load on the coupling point S (kg).’;

                  (8)

                  point 6 is replaced by the following:
                  ‘6.   INSTRUCTIONS FOR USE
                  All mechanical couplings must be accompanied by the manufacturer’s instructions for use. These instructions must include the EC component type-approved number and also the values of D (kN) or T (tonnes) depending on which test was performed on the coupling.’;

                  (9)

                  Appendix 1 is amended as follows:

                              (a)

                              the following Figure 1d and Table 1 are inserted after Figure 1c:
                              ‘Figure 1d

                                 No-swivel clevis coupling (corresponding to ISO 6489-5:2011)

                                 Table 1

                                 Shapes and dimensions of trailer or implement clevis couplings

                                             Vertical load

                                          S
                                          kg

                                             D value

                                          D
                                          kN

                                             Shape

                                             Dimension

                                          mm

                                          D
                                          ± 0,5

                                          a
                                          min.

                                          b
                                          min.

                                          ≤ 1 000

                                          ≤ 35

                                          w

                                          18

                                          50

                                          40

                                          ≤ 2 000

                                          ≤ 90

                                          x

                                          28

                                          70

                                          55

                                          ≤ 3 000

                                          ≤ 120

                                          y

                                          43

                                          100

                                          80

                                          ≤ 3 000

                                          ≤ 120

                                          z

                                          50

                                          110

                                          95’

                              (b)

                              the following Figures 4 and 5 are added:
                              ‘Figure 4

                                 Ball type coupling (corresponding to ISO 24347:2005)

                                 Figure 5

                                 Pin type coupling (corresponding to ISO 6489-4:2004)

                                             ’

                  (10)

                  Appendix 2 is amended as follows:

                              (a)

                              in point 2 the fifth and sixth paragraphs are replaced by the following:
                              ‘The vertical force components at right angles to the track are expressed by the static vertical load S (kg).
                              The technically permissible masses MT and MR are given by the manufacturer in tonnes.’;

                              (b)

                              point 3.2 is replaced by the following:
                              ‘3.2.   Test forces
                              The test force consists in geometrical terms of the horizontal and vertical test components as follows:

                              where:

                                  in the case of alternating force,
                              or

                                  in the case of rising force (traction or pressure),

                                  (value expressed in kN)

                                          S

                                          =

                                          static drawbar load (load on the track, expressed in kg).’;

                  (11)

                  in Appendix 3 point 1.5 is replaced by the following:
                  1.5.   The test referred to in point 1.4.2 must be preceded by a test in which an initial load of three times the maximum permissible vertical force (in daN, equal to g · S/10) recommended by the manufacturer is applied in a gradually increasing manner, starting from an initial load of 500 daN, to the reference centre of the coupling device.
                  During the test, deformation of the coupling device must not exceed 10 % of the maximum elastic deformation occurring.
                  The check is carried out after removing the vertical force (in daN, equal to g · S/10) and returning to the initial load of 500 daN.’;

                  (12)

                  in Appendix 4 the following example is added:
                  ‘Example of an EC type-approval mark

                  The coupling bearing the EC component type-approval mark shown above is a device for which EC component type-approval was granted in Germany (e1) under the number 38-363 and on which a static strength test (S) was performed.’;

                  (13)

                  Appendix 5 is amended as follows:

                              (a)

                              the title is replaced by the following:
                              ‘NOTIFICATION CONCERNING THE GRANTING, REFUSAL, WITHDRAWAL OR EXTENSION OF EC COMPONENT TYPE-APPROVAL WITH REGARD TO THE STRENGTH AND DIMENSIONS AND VERTICAL LOAD ON THE COUPLING POINT OF A TYPE OF COUPLING DEVICE (CLEVIS TYPE, NO-SWIVEL CLEVIS COUPLINGS, TOWING HOOK, TRACTOR DRAWBAR, BALL TYPE AND PIN TYPE.)’;

                              (b)

                              point 2 is replaced by the following:
                              2.   Type of coupling device (clevis type, no-swivel clevis couplings, towing hook, tractor drawbar, ball type, pin type) (2)’;

                              (c)

                              points 5.1 and 5.2 are replaced by the following:
                              ‘5.1.   Dynamic test:

                              value of D:
                              … (kN)
                              vertical load on the coupling point (S):
                              … (kg)
                              5.2.   Static test:

                              towable mass T:
                              … (tonnes)
                              vertical load on the coupling point (S):
                              … (kg)’;

                  (14)

                  in Appendix 7, point 9 is replaced by the following:
                  9.   Permissible static vertical load on the coupling point:
                  … (kg)’


Avis juridique important

|

31997L0054

Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 amending, as regards the maximum design speed of wheeled agricultural or forestry tractors, Council Directives 74/150/EEC, 74/151/EEC, 74/152/EEC, 74/346/EEC, 74/347/EEC, 75/321/EEC, 75/322/EEC, 76/432/EEC, 76/763/EEC, 77/311/EEC, 77/537/EEC, 78/764/EEC, 78/933/EEC, 79/532/EEC, 79/533/EEC, 80/720/EEC, 86/297/EEC, 86/415/EEC and 89/173/EEC

Official Journal L 277 , 10/10/1997 P. 0024 - 0025

DIRECTIVE 97/54/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 September 1997 amending, as regards the maximum design speed of wheeled agricultural or forestry tractors, Council Directives 74/150/EEC, 74/151/EEC, 74/152/EEC, 74/346/EEC, 74/347/EEC, 75/321/EEC, 75/322/EEC, 76/432/EEC, 76/763/EEC, 77/311/EEC, 77/537/EEC, 78/764/EEC, 78/933/EEC, 79/532/EEC, 79/533/EEC, 80/720/EEC, 86/297/EEC, 86/415/EEC and 89/173/EECTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),Whereas the scope of Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (4), is currently limited to tractors which have a maximum design speed of between 6 and 30 km/h;Whereas the maximum design speed of a large number of tractors today exceeds 30 km/h; whereas it has therefore become necessary to amend Directive 74/150/EEC and the separate directives forming part of the European whole-vehicle type-approval system applying to these vehicles, so as to avoid having the procedure apply to fewer and fewer vehicles;Whereas separate Directives 74/151/EEC (5), 74/152/EEC (6), 74/346/EEC (7), 74/347/EEC (8), 75/321/EEC (9), 75/322/EEC (10), 76/432/EEC (11), 76/763/EEC (12), 77/311/EEC (13), 77/537/EEC (14), 78/764/EEC (15), 78/933/EEC (16), 79/532/EEC (17), 79/533/EEC (18), 80/720/EEC (19), 86/297/EEC (20), 86/415/EEC (21) and 89/173/EEC (22), contain a specific definition of their scope in relation to maximum design speed; whereas these Directives also need to be amended under the procedure laid down in Article 12 of Directive 74/150/EEC, so as to avoid having them apply to fewer and fewer vehicles;Whereas an appropriate increase in the design speed is from 30 to 40 km/h;Whereas an increase in the maximum design speed used to define the scope of Directive 74/150/EEC and certain individual directives requires also a change to Council Directive 76/432/EEC of 6 April 1976 on the approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors (23); whereas this change, which is made in a separate act, must enter into force no later than this Directive;Whereas it is necessary to improve and harmonize all safety aspects such as the installation of safety belts;Whereas pollution from tractors should be the subject of future Community legislation,HAVE ADOPTED THIS DIRECTIVE:Article 1 The words '30 km/h` shall be replaced by '40 km/h`:- in Article 1 (2) of Directives 74/150/EEC, 74/151/EEC, 74/152/EEC, 74/346/EEC, 74/347/EEC, 75/321/EEC, 75/322/EEC, 76/432/EEC, 76/763/EEC, 77/311/EEC, 77/537/EEC, 78/933/EEC, 79/532/EEC, 79/533/EEC, 80/720/EEC, 86/297/EEC, 86/415/EEC and 89/173/EEC,- in Article 9 (2) of Directive 78/764/EEC, and- point 1.5 in the Annex to Directive 74/152/EEC.Article 2 Member States shall adopt and publish the measures necessary to comply with this Directive before 23 September 1998. They shall forthwith inform the Commission thereof. They shall apply the measures from 23 September 1998.When Member States adopt these measures, they shall contain a reference to this Directive, or be accompanied by such a reference when they are officially published. The form of the reference shall be decided by the Member States.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, 23 September 1997.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentF. BODEN(1) OJ C 186, 26. 6. 1996, p. 11.(2) OJ C 56, 24. 2. 1997, p. 74.(3) Opinion of the European Parliament of 10 December 1996 (OJ C 20, 20. 1. 1997, p. 25), Council common position of 13 March 1997 (OJ C 157, 24. 5. 1997, p. 1) and Decision of the European Parliament of 16 July 1997 (OJ C 286, 22. 9. 1997). Council Decision of 29 July 1997.(4) OJ L 84, 28. 3. 1974, p. 10. Directive as last amended by the 1994 Act of Accession.(5) OJ L 84, 28. 3. 1974, p. 25.(6) OJ L 84, 28. 3. 1974, p. 33.(7) OJ L 191, 15. 7. 1974, p. 1.(8) OJ L 191, 15. 7. 1974, p. 5.(9) OJ L 147, 9. 6. 1975, p. 24.(10) OJ L 147, 9. 6. 1975, p. 28.(11) OJ L 122, 8. 5. 1976, p. 1.(12) OJ L 262, 27. 9. 1976, p. 135.(13) OJ L 105, 28. 4. 1977, p. 1.(14) OJ L 220, 29. 8. 1977, p. 38.(15) OJ L 255, 18. 9. 1978, p. 1.(16) OJ L 325, 20. 11. 1978, p. 16.(17) OJ L 145, 13. 6. 1979, p. 16.(18) OJ L 145, 13. 6. 1979, p. 20.(19) OJ L 194, 28. 7. 1980, p. 1.(20) OJ L 186, 8. 7. 1986, p. 19.(21) OJ L 240, 26. 8. 1986, p. 1.(22) OJ L 67, 10. 3. 1989, p. 1.(23) OJ L 122, 8. 5. 1976, p. 1. Directive as last amended by Directive 96/63/EC (OJ L 253, 10. 5. 1996, p. 13).


title: Commission Directive 2012/2/EU of 9 February 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include copper (II) oxide, copper (II) hydroxide and basic copper carbonate as active substances in Annex I thereto  Text with EEA relevance

text:
               10.2.2012

               EN

               Official Journal of the European Union

               L 37/60

         COMMISSION DIRECTIVE 2012/2/EU
   of 9 February 2012
   amending Directive 98/8/EC of the European Parliament and of the Council to include copper (II) oxide, copper (II) hydroxide and basic copper carbonate as active substances in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes copper (II) oxide, copper (II) hydroxide and basic copper carbonate for use in product type 8, wood preservatives, as defined in Annex V to that Directive.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, copper (II) oxide, copper (II) hydroxide and basic copper carbonate have been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 8.

               (3)

               France was designated as rapporteur Member State and submitted the competent authority reports, together with recommendations, to the Commission in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007 on 10 May 2007 for copper (II) oxide, on 19 February 2008 for copper (II) hydroxide, and on 10 May 2007 and 19 February 2008 for basic copper carbonate.

               (4)

               The competent authority reports were reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the reviews were incorporated, within the Standing Committee on Biocidal Products on 22 September 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as wood preservatives and containing copper (II) oxide, copper (II) hydroxide or basic copper carbonate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include copper (II) oxide, copper (II) hydroxide and basic copper carbonate in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated at Union level. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established for products containing copper (II) oxide, copper (II) hydroxide or basic copper carbonate and authorised for industrial use, and that those products are used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial users can be reduced to an acceptable level by other means.

               (8)

               Copper (II) hydroxide and basic copper carbonate were also evaluated for application by dipping, and should, in view of the risks identified for human health, not be authorised for that use, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures. For copper (II) oxide, application by dipping was not assessed, and it follows from the requirement referred to in recital 6 that products cannot be authorised for such application unless the authorising Member State assesses it.

               (9)

               Unacceptable risks for the environment were identified in the case of wood treated with copper (II) oxide, copper (II) hydroxide or basic copper carbonate and used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD (3)). For basic copper carbonate and copper (II) oxide, unacceptable risks were also found for in-service use of treated wood in contact with fresh water (use class 4b as defined by OECD). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures. For copper (II) hydroxide, wood in contact with fresh water was not assessed, and it follows from the requirement referred to in recital 6 above that products cannot be authorised for that use unless the authorising Member State assesses it.

               (10)

               In view of the risks identified for the aquatic and soil compartments, it is appropriate to require that freshly treated timber is stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing copper (II) oxide, copper (II) hydroxide or basic copper carbonate are collected for reuse or disposal.

               (11)

               The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substances copper (II) oxide, copper (II) hydroxide and basic copper carbonate, and also to facilitate the proper operation of the biocidal products market in general.

               (12)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (13)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (14)

               Directive 98/8/EC should therefore be amended accordingly.

               (15)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 January 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2014.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 9 February 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      (3)  OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, part 2, p. 64.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entries are added:

                     No

                     Common name

                     IUPAC name, identification numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘50

                     Copper hydroxide

                     Copper (II) hydroxide
                     EC No: 243-815-9
                     CAS No: 20427-59-2

                     965 g/kg

                     1 February 2014

                     31 January 2016

                     31 January 2024

                     8

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 Products shall not be authorised for application by dipping, unless data have been submitted in the application for product authorisation demonstrating that that application meets the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

                                 (2)

                                 For products authorised for industrial use, safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial users can be reduced to an acceptable level by other means.

                                 (3)

                                 Labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.

                                 (4)

                                 Products shall not be authorised for treatment of wood that will be used in outdoor constructions near or above water, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.

                     51

                     Copper (II) oxide

                     Copper (II) oxide
                     EC No: 215-269-1
                     CAS No: 1317-38-0

                     976 g/kg

                     1 February 2014

                     31 January 2016

                     31 January 2024

                     8

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 For products authorised for industrial use, safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial users can be reduced to an acceptable level by other means.

                                 (2)

                                 Labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.

                                 (3)

                                 Products shall not be authorised for treatment of wood that will be used in outdoor constructions near or above water or for the treatment of wood in contact with fresh water, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.

                     52

                     Basic copper carbonate

                     Copper(II) carbonate-copper(II) hydroxide (1:1)
                     EC No: 235-113-6
                     CAS No: 12069-69-1

                     957 g/kg

                     1 February 2014

                     31 January 2016

                     31 January 2024

                     8

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 Products shall not be authorised for application by dipping, unless data have been submitted in the application for product authorisation demonstrating that that application meets the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

                                 (2)

                                 For products authorised for industrial use, safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial users can be reduced to an acceptable level by other means.

                                 (3)

                                 Labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.

                                 (4)

                                 Products shall not be authorised for treatment of wood that will be used in outdoor constructions near or above water, or for the treatment of wood in direct contact with fresh water, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm


Avis juridique important

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31975L0379

Council Directive 75/379/EEC of 24 June 1975 amending Directives No 64/432/EEC, No 64/433/EEC, No 71/118/EEC, No 72/461/EEC and No 72/462/EEC as regards the validity of the procedures of the Standing Veterinary Committee

Official Journal L 172 , 03/07/1975 P. 0017 - 0017 Finnish special edition: Chapter 3 Volume 6 P. 0090  Greek special edition: Chapter 03 Volume 13 P. 0032  Swedish special edition: Chapter 3 Volume 6 P. 0090

COUNCIL DIRECTIVE  of 24 June 1975  amending Directives No 64/432/EEC, No 64/433/EEC, No 71/118/EEC, No 72/461/EEC and No 72/462/EEC as regards the validity of the procedures of the Standing Veterinary Committee  (75/379/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament (1);  Whereas the Standing Veterinary Committee, established by Decision No 68/361/EEC (2), expresses its Opinion in accordance with procedures, the validity of which was limited to a period of 30 months from the date on which a request for an Opinion is first referred to the said Committee;  Whereas a matter was first referred to the Committee on 22 December 1972 ; whereas the period which has elapsed is insufficient to enable a final decision to be reached, and whereas the validity of the aforementioned procedures should only be extended temporarily;  HAS ADOPTED THIS DIRECTIVE:    Article 1 In the following Articles, the term "30 months" is replaced by "102 months":    - Article 14 of Council Directive No 64/432/EEC (3) of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine, as last amended by Council Directive No 74/387/EEC (4);       - Article 9b of Council Directive No 64/433/EEC (5) of 26 June 1964 on health problems affecting intra-Community trade in fresh meat, as last amended by Directive No 74/387/EEC;       - Article 13 of Council Directive No 71/118/EEC (6) of 15 February 1971 on health problems affecting trade in fresh poultry-meat, as last amended by Directive No 74/387/EEC;       - Article 10 of Council Directive No 72/461/EEC (7) of 12 December 1972 on health problems affecting intra-Community trade in fresh meat, as last amended by Directive No 74/387/EEC;       - Article 31 of Council Directive No 72/462/EEC (8) of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries, as last amended by Directive No 74/387/EEC.          Article 2 This Decision is addressed to the Member States.     Done at Luxembourg, 24 June 1975.  For the Council  The President  M.A. CLINTON  (1)OJ No C 111, 20.5.1975, p. 26. (2)OJ No L 255, 18.10.1968, p. 23. (3)OJ No 121, 29.7.1964, p. 1977/64. (4)OJ No L 202, 24.7.1974, p. 36. (5)OJ No 121, 29.7.1964, p. 2012/64. (6)OJ No L 55, 8.3.1971, p. 23. (7)OJ No L 302, 31.12.1972, p. 24. (8)OJ No L 302, 31.12.1972, p. 28.


title: Commission Directive 2012/24/EU of 8 October 2012 amending, for the purpose of adapting its technical provisions, Council Directive 86/297/EEC on the approximation of the laws of the Member States relating to the power take-offs of tractors and their protection  Text with EEA relevance

text:
               9.10.2012

               EN

               Official Journal of the European Union

               L 274/24

         COMMISSION DIRECTIVE 2012/24/EU
   of 8 October 2012
   amending, for the purpose of adapting its technical provisions, Council Directive 86/297/EEC on the approximation of the laws of the Member States relating to the power take-offs of tractors and their protection
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (1), and in particular point (b) of Article 19(1) thereof,
   Whereas:

               (1)

               Section 4.2 of Annex I to Council Directive 86/297/EEC (2) sets out general provisions for front power take-off (PTO). Table 2 of that Annex provides for the application of standard ISO 8759-1:1998 to categories of tractors equipped with front power take-off which also sets dimensions for the front PTO location. However, these location requirements are not compatible with a large number of agricultural and forestry tractors due to new design requirements.

               (2)

               The requirements for front power take-off set out in Directive 86/297/EEC only concern safety issues, that is, the PTO location, the requirements of shielding and the clearance zone. The PTO location imposed by Directive 86/297/EEC is not compatible with several tractor categories currently on the market and their mounted implements. Table 2 of Annex I to Directive 86/297/EEC already excludes tractor categories T4.1 and T4.3 from the location requirements.

               (3)

               Tractors of categories T1, T2, T3, T4.2 and T5, in addition to those of categories T4.1 and T4.3 currently exempted from the requirements of clause 4.2 of standard ISO 8759-1:1998, cannot comply with such requirements.

               (4)

               Several tractors can be equipped with special power take-off types, to which standard ISO 8759-1:1998 does not apply.

               (5)

               In the case of tractors of category T3, the standard only applies when the tractor is equipped with a power take-off specified in that standard. However, other vehicle categories, such as T2 and certain smaller T1 tractors, could be equipped with special power take-off types, which are not covered by the standard. Consequently, exemption from the requirements of standard ISO 8759-1:1998 should also be extended to tractor categories T1 and T2.

               (6)

               Difficulties of the same kind are encountered in the corresponding C categories.

               (7)

               As the specifications of standard ISO 8759-1:1998 with the exception of clause 4.2, are to apply to tractors of all T and C categories which are equipped with front power take-offs, Table 2 becomes redundant and should therefore be deleted.

               (8)

               Directive 86/297/EEC should therefore be amended accordingly.

               (9)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 20(1) of Directive 2003/37/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 86/297/EEC is amended as follows:

               (1)

               point 4.2 is replaced by the following:
               ‘4.2.   Provisions for front power take-offs
               The specifications of ISO 8759-1:1998, with the exception of its clause 4.2, apply to tractors of all T and C categories which are equipped with front power take-offs as specified in this standard.’;

               (2)

               Table 2 is deleted.

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

      Done at Brussels, 8 October 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 171, 9.7.2003, p. 1.

      (2)  OJ L 186, 8.7.1986, p. 19.


title: Commission Directive 2006/120/EC of 27 November 2006 correcting and amending Directive 2005/30/EC amending, for the purposes of their adaptation to technical progress, Directives 97/24/EC and 2002/24/EC of the European Parliament and of the Council, relating to the type-approval of two or three-wheel motor vehicles   (Text with EEA relevance)

text:
               28.11.2006

               EN

               Official Journal of the European Union

               L 330/16

      COMMISSION DIRECTIVE 2006/120/EC
   of 27 November 2006
   correcting and amending Directive 2005/30/EC amending, for the purposes of their adaptation to technical progress, Directives 97/24/EC and 2002/24/EC of the European Parliament and of the Council, relating to the type-approval of two or three-wheel motor vehicles
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 97/24/EC of the European Parliament and of the Council of 17 June 1997 on certain components and characteristics of two- or three-wheel motor vehicles (1), and in particular Article 7 thereof,
   Having regard to Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two- and three-wheel motor vehicles and repealing Council Directive 92/61/EEC (2), and in particular Article 17 thereof,
   Whereas:

               (1)

               Commission Directive 2005/30/EC contains some errors which must be corrected.

               (2)

               It is necessary to clarify with the retroactive effect that Article 3(1) of Directive 2005/30/EC concerns new replacement catalytic converters, which comply with Directive 97/24/EC as amended by Directive 2005/30/EC.

               (3)

               Editorial corrections should also be made in Annex I to Directive 2005/30/EC.

               (4)

               Furthermore, it is necessary to make clear, by way of a new provision, that the sale or installation on a vehicle of replacement catalytic converters which are not of a type in respect of which a type-approval has been granted in compliance with Directive 97/24/EC, as amended by 2005/30/EC, is forbidden after a certain transitional period.

               (5)

               Directive 2005/30/EC should therefore be corrected and amended accordingly.

               (6)

               The measures provided for this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2005/30/EC is corrected as follows:

               1.

               Article 3(1) is replaced by the following:
               ‘1.   With effect from 18 May 2006 Member States shall not, in respect of new replacement catalytic converters complying with the requirements of Directive 97/24/EC as amended by this Directive and which are intended to be fitted on vehicles that have been type-approved in accordance with Directive 97/24/EC:

                           (a)

                           refuse to grant EC type-approval pursuant to Article 4(1) of Directive 2002/24/EC;

                           (b)

                           prohibit the sale or installation on a vehicle.’

               2.

               In Annex I, ‘section 5 of Annex VI’ is replaced by ‘section 4a of Annex VI’ throughout the text.

         Article 2
   The following paragraph 3 is added to Article 3 of Directive 2005/30/EC:

      ‘3.   With effect from 1 January 2009, Member States shall refuse the sale or installation on a vehicle of replacement catalytic converters which are not of a type in respect of which a type-approval has been granted in compliance with Directive 97/24/EC, as amended by this Directive.’

   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2007 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 4
   This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 27 November 2006.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 226, 18.8.1997, p. 1. Directive as last amended by Commission Directive 2006/27/EC (OJ L 66, 8.3.2006, p. 7).

      (2)  OJ L 124, 9.5.2002, p. 1. Directive as last amended by Commission Directive 2005/30/EC (OJ L 106, 27.4.2005, p. 17).


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31988L0228

Commission Directive 88/228/EEC of 8 April 1988 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 101 , 20/04/1988 P. 0030 - 0032 Finnish special edition: Chapter 3 Volume 26 P. 0134  Swedish special edition: Chapter 3 Volume 26 P. 0134

*****COMMISSION  DIRECTIVE  of 8 April 1988  amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs  (88/228/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 87/552/EEC (2), and in particular Article 7 thereof,  Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes were consolidated by Commision Directive 85/429/EEC (3);  Whereas canthaxanthin used as a colouring matter in feedingstuffs for trout and salmon complies under the conditions of use prescribed with the principles governing the admission of additives; whereas it is desirable therefore to authorize this use of canthaxanthin throughout the Community;  Whereas the Vitamin A content of certain feedingstuffs should in certain cases be limited to avoid the possible unfavourable effects that excessive ingestion of this additive could have on health;  Whereas new uses of the antibiotics avoparcin and virginiamycin have been successfully investigated in certain Member States; whereas it is desirable to authorize these new uses provisionally at national level, pending their authorization at Community level;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto.  Article 2  Member States shall, by 16 May 1988 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall immediately inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 8 April 1988.  For the Commission  Frans ANDRIESSEN  Vice-President  (1) OJ No L 270, 14. 12. 1970, p. 1.  (2) OJ No L 336, 26. 11. 1987, p. 34.  (3) OJ No L 245, 12. 9. 1985, p. 1.  ANNEX  1. In Annex I:  (a) under part F 'Colouring matters including pigments', item 1 'Carotenoids and xanthophylls' the wording of EEC No E 161 g 'Canthaxanthin' is completed as follows:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content  // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuffs  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 //  //  //  / / '(c)   Salmon, Trout   // -   // -   // 80   // Use permitted from the age of 6 months onwards'   //    //   //   //   //  //   //   //  (b) under part H 'Vitamins, provitamins and and chemically well-defined substances having a similar effect':  (aa) the following item 1 is hereby added:  1.2.3.4.5.6.7 //  //  //  //  //  //  //  // EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Maximum content iu/kg of complete feedingstuff or of the daily ration   // Other provisions  //  //  //  //  //  //  //  // 'E 672   // 1. Vitamin A   // -   // Chickens for fattening   // -   // 20 000   //   //   //   //   // Other species or categories of animals   // -   // -   // All feedingstuffs'   //    //   //   //  //   //   //  (bb) the present item 1 'Vitamin D' is renumbered item 2.  (cc) the present item 2 is replaced by the following:  1.2.3.4.5.6.7 //  //  //  //  //  //  //  // EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Maximum content iu/kg of complete feedingstuff or of the daily ration   // Other provisions  //  //  //  //  //  //  //  //  // '3. All substances in the group except vitamins A and D   // -   // All species or categories of animals   // -   // -   // All feedingstuffs'   //    //   //   //   //   //   //  2. In Annex II, part A 'Antibiotics':  (a) the item No 21 'Virginiamycin' is completed as follows:  1.2.3.4.5.6.7.8.9 //  //  //  //  //  //  //  //  //  // EEC No   // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content  // Other provisions  // Period of authorization 1.2.3.4.5.6,7.8.9 //  //  //  //  //  //  //  //  //  //  //  // //  // mg/kg  of complete feedingstuffs  //  //  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8.9 // //  //  // 'Cattle  for fattening   // -   // 15   // 40  // Indicate in the instructions for use: 'For supplementary feedingstuffs, the maximum dose in the daily ration must not exceed: - for 100 kg bodyweight: 140 mg - above 100 kg: add 6 mg for each additional 10 kg bodyweight'   // 30. 11. 1989"  //    //   //   //   //   //   //   //   //  (b) the item No 22 'Avoparcin' is completed as follows:  1.2.3.4.5.6.7.8.9 //  //  //  //  //  //  //  //  //  // EEC No   // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content  // Other provisions  // Period of authorization 1.2.3.4.5.6,7.8.9 //  //  //  //  //  //  //  //  //  //  //  // //  // mg/kg  of complete feedingstuffs  //  //  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8.9 // //  //  // 'Lambs  from the beginning of rumination with the exception of pasture-grazed lambs   // 16 weeks   // 10   // 20   // -  // 30. 11. 1989'   //    //   //   //   //   //   //  //   //


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32003L0124

Commission Directive 2003/124/EC of 22 December 2003 implementing Directive 2003/6/EC of the European Parliament and of the Council as regards the definition and public disclosure of inside information and the definition of market manipulation (Text with EEA relevance)

Official Journal L 339 , 24/12/2003 P. 0070 - 0072

Commission Directive 2003/124/ECof 22 December 2003implementing Directive 2003/6/EC of the European Parliament and of the Council as regards the definition and public disclosure of inside information and the definition of market manipulation(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse)(1), and in particular the second paragraph of Article 1 and the first, second and third indents of Article 6(10) thereof,After consulting the Committee of European Securities Regulators (CESR)(2) for technical advice,Whereas:(1) Reasonable investors base their investment decisions on information already available to them, that is to say, on ex ante available information. Therefore, the question whether, in making an investment decision, a reasonable investor would be likely to take into account a particular piece of information should be appraised on the basis of the ex ante available information. Such an assessment has to take into consideration the anticipated impact of the information in light of the totality of the related issuer's activity, the reliability of the source of information and any other market variables likely to affect the related financial instrument or derivative financial instrument related thereto in the given circumstances.(2) Ex post information may be used to check the presumption that the ex ante information was price sensitive, but should not be used to take action against someone who drew reasonable conclusions from ex ante information available to him.(3) Legal certainty for market participants should be enhanced through a closer definition of two of the elements essential to the definition of inside information, namely the precise nature of that information and the significance of its potential effect on the prices of financial instruments or related derivative financial instruments.(4) Not only does the protection of investors require timely public disclosure of inside information by issuers, it also requires such disclosure to be as fast and as synchronised as possible between all categories of investors in all Member States in which the issuer has requested or approved admission of its financial instruments to trading on a regulated market, in order to guarantee at Community level equal access of investors to such information and to prevent insider dealing. To this end Member States may officially appoint mechanisms to be used for such disclosure.(5) In order to protect the legitimate interests of issuers, it should be permissible, in closely defined specific circumstances, to delay public disclosure of inside information. However, the protection of investors requires that in such cases the information be kept confidential in order to prevent insider dealing.(6) In order to guide both market participants and competent authorities, signals have to be taken into account when examining possibly manipulative behaviours.(7) The measures provided for in this Directive are in accordance with the opinion of the European Securities Committee,HAS ADOPTED THIS DIRECTIVE:Article 1Inside information1. For the purposes of applying point 1 of Article 1 of Directive 2003/6/EC, information shall be deemed to be of a precise nature if it indicates a set of circumstances which exists or may reasonably be expected to come into existence or an event which has occurred or may reasonably be expected to do so and if it is specific enough to enable a conclusion to be drawn as to the possible effect of that set of circumstances or event on the prices of financial instruments or related derivative financial instruments.2. For the purposes of applying point 1 of Article 1 of Directive 2003/6/EC, "information which, if it were made public, would be likely to have a significant effect on the prices of financial instruments or related derivative financial instruments" shall mean information a reasonable investor would be likely to use as part of the basis of his investment decisions.Article 2Means and time-limits for public disclosure of inside information1. For the purposes of applying Article 6(1) of Directive 2003/6/EC, Articles 102(1) and Article 103 of Directive 2001/34/EC of the European Parliament and of the Council(3) shall apply.Furthermore, Member States shall ensure that the inside information is made public by the issuer in a manner which enables fast access and complete, correct and timely assessment of the information by the public.In addition, Member States shall ensure that the issuer does not combine, in a manner likely to be misleading, the provision of inside information to the public with the marketing of its activities.2. Member States shall ensure that issuers are deemed to have complied with the first subparagraph of Article 6(1) of Directive 2003/6/EC where, upon the coming into existence of a set of circumstances or the occurrence of an event, albeit not yet formalised, the issuers have promptly informed the public thereof.3. Any significant changes concerning already publicly disclosed inside information shall be publicly disclosed promptly after these changes occur, through the same channel as the one used for public disclosure of the original information.4. Member States shall require issuers to take reasonable care to ensure that the disclosure of inside information to the public is synchronised as closely as possible between all categories of investors in all Member States in which those issuers have requested or approved the admission to trading of their financial instruments on a regulated market.Article 3Legitimate interests for delaying public disclosure and confidentiality1. For the purposes of applying Article 6(2) of Directive 2003/6/EC, legitimate interests may, in particular, relate to the following non-exhaustive circumstances:(a) negotiations in course, or related elements, where the outcome or normal pattern of those negotiations would be likely to be affected by public disclosure. In particular, in the event that the financial viability of the issuer is in grave and imminent danger, although not within the scope of the applicable insolvency law, public disclosure of information may be delayed for a limited period where such a public disclosure would seriously jeopardise the interest of existing and potential shareholders by undermining the conclusion of specific negotiations designed to ensure the long-term financial recovery of the issuer;(b) decisions taken or contracts made by the management body of an issuer which need the approval of another body of the issuer in order to become effective, where the organisation of such an issuer requires the separation between these bodies, provided that a public disclosure of the information before such approval together with the simultaneous announcement that this approval is still pending would jeopardise the correct assessment of the information by the public.2. For the purposes of applying Article 6(2) of Directive 2003/6/EC, Member States shall require that, in order to be able to ensure the confidentiality of inside information, an issuer controls access to such information and, in particular, that:(a) the issuer has established effective arrangements to deny access to such information to persons other than those who require it for the exercise of their functions within the issuer;(b) the issuer has taken the necessary measures to ensure that any person with access to such information acknowledges the legal and regulatory duties entailed and is aware of the sanctions attaching to the misuse or improper circulation of such information;(c) the issuer has in place measures which allow immediate public disclosure in case the issuer was not able to ensure the confidentiality of the relevant inside information, without prejudice to the second subparagraph of Article 6 (3) of Directive 2003/6/EC.Article 4Manipulative behaviour related to false or misleading signals and to price securingFor the purposes of applying point 2(a) of Article 1 of Directive 2003/6/EC, and without prejudice to the examples set out in the second paragraph of point 2 thereof, Member States shall ensure that the following non-exhaustive signals, which should not necessarily be deemed in themselves to constitute market manipulation, are taken into account when transactions or orders to trade are examined by market participants and competent authorities:(a) the extent to which orders to trade given or transactions undertaken represent a significant proportion of the daily volume of transactions in the relevant financial instrument on the regulated market concerned, in particular when these activities lead to a significant change in the price of the financial instrument;(b) the extent to which orders to trade given or transactions undertaken by persons with a significant buying or selling position in a financial instrument lead to significant changes in the price of the financial instrument or related derivative or underlying asset admitted to trading on a regulated market;(c) whether transactions undertaken lead to no change in beneficial ownership of a financial instrument admitted to trading on a regulated market;(d) the extent to which orders to trade given or transactions undertaken include position reversals in a short period and represent a significant proportion of the daily volume of transactions in the relevant financial instrument on the regulated market concerned, and might be associated with significant changes in the price of a financial instrument admitted to trading on a regulated market;(e) the extent to which orders to trade given or transactions undertaken are concentrated within a short time span in the trading session and lead to a price change which is subsequently reversed;(f) the extent to which orders to trade given change the representation of the best bid or offer prices in a financial instrument admitted to trading on a regulated market, or more generally the representation of the order book available to market participants, and are removed before they are executed;(g) the extent to which orders to trade are given or transactions are undertaken at or around a specific time when reference prices, settlement prices and valuations are calculated and lead to price changes which have an effect on such prices and valuations.Article 5Manipulative behaviours related to the employment of fictitious devices or any other form of deception or contrivanceFor the purposes of applying point 2(b) of Article 1 of Directive 2003/6/EC, and without prejudice to the examples set out in the second paragraph of point 2 thereof, Member States shall ensure that the following non-exhaustive signals, which should not necessarily be deemed in themselves to constitute market manipulation, are taken into account when transactions or orders to trade are examined by market participants and competent authorities:(a) whether orders to trade given or transactions undertaken by persons are preceded or followed by dissemination of false or misleading information by the same persons or persons linked to them;(b) whether orders to trade are given or transactions are undertaken by persons before or after the same persons or persons linked to them produce or disseminate research or investment recommendations which are erroneous or biased or demonstrably influenced by material interest.Article 6Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 12 October 2004 at the latest. They shall forthwith communicate to the Commission the text of the 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 7Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 8AddresseesThis Directive is addressed to the Member States.Done at Brussels, 22 December 2003.For the CommissionFrederik BolkesteinMember of the Commission(1) OJ L 96, 12.4.2003, p. 16.(2) CESR was established by Commission Decision 2001/527/EC (OJ L 191,13.7.2001, p. 43).(3) OJ L 184, 6.7.2001, p. 1.