title: Commission Directive 2009/25/EC of 2 April 2009 amending Council Directive 91/414/EEC as regards an extension of the use of the active substance pyraclostrobin (Text with EEA relevance)

text:
               3.4.2009

               EN

               Official Journal of the European Union

               L 91/20

      COMMISSION DIRECTIVE 2009/25/EC
   of 2 April 2009
   amending Council Directive 91/414/EEC as regards an extension of the use of the active substance pyraclostrobin
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               By Commission Directive 2004/30/EC (2) pyraclostrobin was included as active substance in Annex I to Directive 91/414/CEE.

               (2)

               When applying for the inclusion of pyraclostrobin its manufacturer BASF SE (hereinafter the notifier) submitted data on uses to control certain fungi which supported the overall conclusion that it may be expected that plant protection products containing pyraclostrobin will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. Therefore, pyraclostrobin was included in Annex I to that Directive with the specific provision that Member States may only authorise uses as fungicide.

               (3)

               In addition to the control of fungi in certain agricultural uses, the notifier now has applied for an amendment to those specific provisions to allow pyraclostrobin to be used as a plant growth regulator. In order to support such an extension of the use, the notifier submitted additional information.

               (4)

               Germany evaluated the information and data submitted by the notifier. Germany informed the Commission in October 2008 about its conclusion that the requested extension of use does not cause any risks in addition to those already taken into account in the specific provisions for pyraclostrobin in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. In particular, the extension does not involve a modification of the application parameters, as set out in the specific provisions of Annex I to Directive 91/414/EEC.

               (5)

               Therefore it is justified to modify the specific provisions for pyraclostrobin.

               (6)

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

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 3 August 2009 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 4 August 2009.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   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, 2 April 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 77, 13.3.2004, p. 50.

      ANNEX
      In Annex I to Directive 91/414/EEC, row 82 is replaced by the following:

                     ‘82

                     Pyraclostrobin
                     CAS No 175013-18-0
                     CIPAC No 657

                     methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate

                     975 g/kg
                     The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.

                     1 June 2004

                     31 May 2014

                     Only uses as fungicide or plant growth regulator may be authorised.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States

                                 —

                                 should pay particular attention to the protection of aquatic organisms, especially fish,

                                 —

                                 should pay particular attention to the protection of terrestrial arthropods and earthworms,

                           Risk mitigation measures should be applied where appropriate.
                     The Member States shall inform the Commission in accordance with Article 13(5) on the specification of the technical material as commercially manufactured.’


title: Commission Directive 2006/5/EC of  17 January 2006  amending Council Directive 91/414/EEC to include warfarin as active substance   (Text with EEA relevance)

text:
               18.1.2006

               EN

               Official Journal of the European Union

               L 12/17

      COMMISSION DIRECTIVE 2006/5/EC
   of 17 January 2006
   amending Council Directive 91/414/EEC to include warfarin as active substance
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1) and in particular Article 6(1) thereof,
   Whereas:

               (1)

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

               (2)

               For warfarin the effects on human health and the environment has been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92 (3), Ireland was designated as Rapporteur Member State. Ireland submitted the relevant assessment report and recommendations to the Commission on 8 May 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.

               (3)

               The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 23 September 2005 in the format of the Commission review report for warfarin.

               (4)

               The report on warfarin and further information were also submitted to the Scientific Committee for Plants. The Committee was asked to comment on the acceptability of using clinical data generated following repeated warfarin use as an anti-coagulant in human medicine for establishing an acceptable daily intake (ADI) and an acceptable operator exposure level (AOEL). In its opinion (4), the Scientific Committee concluded that it is not necessary to allocate an ADI for warfarin. Furthermore, data available from the extensive clinical use of warfarin as an anticoagulant may confidently be expected to support the establishment of an ADI, should this be considered necessary. An AOEL can likewise be established based on human data, taking into account that in rats about 15 % of the applied dose is absorbed through the skin.

               (5)

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

               (6)

               Warfarin is used as a rodenticide. All other active substances used as rodenticides are covered by Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (5). Furthermore, the substance is currently subject to evaluation in the framework of 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 (6). As with all substances included in Annex I to Directive 91/414/EEC, the status of warfarin could be reviewed under Article 5(5) of that Directive in the light of any new data becoming available, in particular from the assessment of similar substances or from the assessment of warfarin itself under Directive 98/8/EC.

               (7)

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

               (8)

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

               (9)

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

               (10)

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

               (11)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 March 2007, at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 April 2007.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing warfarin as an active substance by 31 March 2007. By that date, they shall in particular verify that the conditions in Annex I to that Directive, relating to warfarin, are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.
   2.   By derogation from paragraph 1, for each authorised plant protection product containing warfarin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning warfarin. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

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

               (b)

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

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

      Done at Brussels, 17 January 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

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

      (2)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

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

      (4)  Opinion of the Scientific Committee on Plants regarding the possible inclusion of warfarin in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market; SCP/WARFAR/002 final, adopted on 6 June 2000.

      (5)  OJ L 168, 27.6.2002, p. 14.

      (6)  OJ L 123, 24.4.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

      ANNEX

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

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘XX

                     Warfarin
                     CAS No 81-81-2
                     CIPAC No 70

                     (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin

                     ≥ 990 g/kg

                     1 October 2006

                     30 September 2013

                     PART A
                     Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals.
                     Risk mitigation measures should be applied where appropriate.’

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


Avis juridique important

|

31975L0084

Sixth Commission Directive 75/84/EEC of 20 December 1974 establishing Community methods of analysis for the official control of feedingstuffs

Official Journal L 032 , 05/02/1975 P. 0026 - 0033 Finnish special edition: Chapter 3 Volume 6 P. 0045  Greek special edition: Chapter 03 Volume 11 P. 0198  Swedish special edition: Chapter 3 Volume 6 P. 0045  Spanish special edition: Chapter 03 Volume 8 P. 0079  Portuguese special edition Chapter 03 Volume 8 P. 0079

COMMISSION  SIXTH COMMISSION DIRECTIVE  of 20 December 1974  establishing Community methods of analysis for the official control of feedingstuffs  (75/84/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community;  Having regard to the Council Directive of 20 July 1970 (1) on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs, as last amended by the Act (2) annexed to the Treaty (3) concerning the accession of new Member States to the European Economic Community and to the European Atomic Energy Community, and in particular Article 2 thereof;  Whereas that Directive requires that official controls of feedingstuffs be carried out using Community methods of sampling and analysis for the purpose of checking compliance with requirements arising under the provisions laid down by law, regulation or administrative action concerning the quality and composition of feedingstuffs;  Whereas Commission Directives No 71/250/EEC of 15 June 1971(4), No 71/393/EEC of 18 November 1971 (5), No 72/199/EEC of 27 April 1972 (6), No 73/46/EEC of 5 December 1972 (7) and No 74/203/EEC of 25 March 1974 (8) have already established a number of Community methods of analysis ; whereas the progress of work since then makes it advisable to adopt a sixth set of methods;  Whereas the measures provided for in this Directive are in accordance with the Opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The Member States shall require that analyses for official controls of feedingstuffs as regards their content of buquinolate, sulphaquinoxaline and furazolidone be carried out in accordance with the methods described in the Annex to this Directive.  The general provisions set out in Part 1 (Introduction) of the Annex to the first Commission Directive No 71/250/EEC of 15 June 1971, with the exception of the part dealing with preparation of the sample to be analysed, shall be applicable to the methods described in the Annex to this Directive.   Article 2 The Member States shall not later than 1 November 1975 bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. They shall forthwith notify the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 20 December 1974.  For the Commission  The President  François-Xavier ORTOLI  (1)OJ No L 170, 3.8.1970, p. 2. (2)OJ No L 73, 27.3.1972, p. 14. (3)OJ No L 73, 27.3.1972, p. 5. (4)OJ No L 155, 12.7.1971, p. 13. (5)OJ No L 279, 20.12.1971, p. 7. (6)OJ No L 123, 29.5.1972, p. 6. (7)OJ No L 83, 30.3.1973, p. 21. (8)OJ No L 108, 22.4.1974, p. 7.     ANNEX 1. DETERMINATION OF BUQUINOLATE (ethyl-4-hydroxy-6,7-diisobutoxy-3-quinoline carboxylate)     1.  Purpose and scope  The method makes it possible to determine the quantity of buquinolate in feedingstuffs, concentrates and premixes. The lower limit of determination is 10 ppm. Decoquinate interferes in the determination.    2.  Principle  The sample is extracted with chloroform : The extract is evaporated to dryness, the residue is dissolved in chloroform and the solution is then subjected to thin-layer chromatography. The buquinolate is eluted with ethanol and determined spectrophotofluoremetrically by comparison with standard solutions.    3.  Reagents    3.1. Chloroform a.p.      3.2.96 % (V/V) ethanol a.p.  3.3. Mixture of chloroform and ethanol : mix 10 volumes of chloroform (3.1) with one volume of ethanol (3.2).  3.4.80 % (V/V) ethanol a.p.  3.5. Silica gel G for thin-layer chromatography.  3.6. Standard substance : pure buquinolate.  3.7. Standard solutions:    3.7.1. Standard solution of 0.2 mg of buquinolate per ml : Weigh out 50 mg, to within 0.1 mg, of standard substance (3.6). Dissolve in chloroform (3.1) in a 250 ml volumetric flask by warming in a water-bath at 50º C. Leave to cool to room temperature, make up the volume with chloroform (3.1) and mix.       3.7.2. Working standard solutions : Transfer 5, 10, 15, 20 and 25 ml aliquots of the solution (3.7.1) into 25 ml volumetric flasks. Make up the volume with chloroform (3.1) and mix. Prepare immediately before use. These solutions contain respectively 0.04, 0.08, 0.12, 0.16 and 0.20 mg of buquinolate per ml.           4.  Apparatus    4.1. 50 and 250 ml conical flasks, with ground-glass stoppers.       4.2. Shaker.       4.3. Centrifuge, with 15 ml tubes with ground-glass stoppers.       4.4. Water bath at 50º C.       4.5. Equipment for thin-layer chromatography.       4.6. Glass-plates for thin-layer chromatography, 200 × 200 mm, treated as follows. Spread on the plates a uniform layer 0.5 mm thick of silica gel G (3.5) and leave to dry in the air for 15 minutes. Keep the plates in the drying oven (4.11) for two hours and transfer into a dessicator containing dehydrating silica gel. Ready-made plates are suitable if they give results similar to those for the plates treated as indicated above.       4.7. 0.50 ml micropipettes.       4.8. Zone collector for thin-layer chromatography.        4.9. Short-wavelength ultraviolet lamp.       4.10. Spectrophotofluorimeter fitted with a xenon lamp, and two monochromators.       4.11. Drying oven equipped with a fan and regulated to 100º C.       4.12. Rotary vacuum evaporator, with 250 ml flask.         5. Procedure    5.1. Preparation of the sample  Grind the sample so that the whole of it will pass through a sieve with a 1 mm mesh (in accordance with recommendation ISO R 565).       5.2. Extraction  Weigh out, to within 1 mg, a quantity of the finely divided and homogeneous sample containing about 1.25 mg of buquinolate. Place the test portion in a 250 ml conical flask (4.1) and add 100 ml of chloroform (3.1). Mix, stopper the flask, and shake for one hour using the shaker (4.2). Decant, filter and discard the first millilitres of the filtrate.  Transfer 80 ml of the clear filtrate into a 150 ml beaker, or into a 250 ml flask fitted to the rotary evaporator (4.12). Evaporate nearly to dryness on a water-bath (4.4), dissolve the oily residue, using repeatedly a few millilitres of chloroform (3.1) and transfer quantitatively the liquids into a 10 ml volumetric flask, using a funnel with a thin stem. Make up the volume with chloroform (3.1) and mix. If the solution is not clear, centrifuge for three minutes at 3 000 rpm using a stoppered tube.       5.3. Thin-layer chromatography  Using a micropipette (4.7), deposit in spots on a plate for thin layer chromatography (4.6), at intervals of 2 cm, volumes of 0.25 ml of the extract obtained in 5.2 and of the five working standard solutions (3.7.2).  Develop the chromatogram with chloroform (3.1) until the solvent front has practically reached the upper edge of the plate, then dry with the aid of a current of air. Develop with the chloroform-ethanol mixture (3.3) until the solvent front has travelled about 12 cm. Let the solvents evaporate. Expose the chromatogram to ultraviolet light (4.9) and using a needle, mark the boundary of the stain of buquinolate spot (Rf-value 0.4 to 0.6).       5.4. Elution  Collect the silica gel from each marked zone, using a zone collector (4.8), and place in centrifuge tubes. Add to each tube 10 ml of ethanol (3.4), shake for 20 minutes, then centrifuge for five minutes at 3 000 rpm. Decant the dear solutions into 50 ml conical flasks (4.1).       5.5. Measurement of fluorescence  Set the scale of the spectrophotofluorimeter (4.10) at 100 with the aid of the eluate from the most concentrated standard solution, using the excitation wavelength between 200 and 280 nm that gives the most intense fluorescence and an emission wavelength of 375 nm.  Under these conditions, measure the fluorescence of the other eluates (5.4). From the values obtained, determine the quantity (A) of buquinolate in mg in the 10 ml of eluate from the sample.    6.  Calculation of results  The buquinolate content in mg per kg of sample is given by the formula >PIC FILE= "T0006679">   in which:  A = quantity in mg of buquinolate determined by spectrofluorometric measurement.  P = weight of test portion in grammes.     7.  Repeatability  The difference between the results of two parallel determinations carried out on the same sample must not exceed:  50 % relative to the higher result for buquinolate contents between 10 and 20 ppm;  10 ppm in absolute value for contents between 20 and 100 ppm;  10 % relative to the higher result for contents between 100 and 5 000 ppm;  500 ppm in absolute value for contents between 5 000 and 10 000 ppm;  5 % relative to the higher result for contents above 10 000 ppm.  2. DETERMINATION OF SULPHAQUINOXALINE [(2-4-aminobenzenesulphonamido) quinoxaline]    1. Purpose and scope  The method makes it possible to determine the quantity of sulphaquinoxaline in feedingstuffs, concentrates and premixes. The lower limit of determination is 20 ppm. Other sulphonamides and arsanilic acid interfere with the determination.       2. Principle  The sample is extracted with dimethylformamide and chloroform. The sulphaquinoxaline is hydrolyzed in alkaline medium. After neutralization, the amino derivative formed is diazotized and coupled with N-2-aminoethyl-1-naphthylamine. The optical density of the solution is measured at 545 nm.       3. Reagents      3.1. N, N-dimethylformamide a.p.           3.2. Chloroform a.p.           3.3. Ethanol absolute.           3.4. Alkaline brine : Dissolve 10 g sodium hydroxide a.p. and 25 g sodium chloride a.p. in water. Make up to 500 ml with water and mix.           3.5. Concentrated hydrochloric acid a.p., d = 1.18.           3.6. 0.1 % (m/V) sodium nitrite solution : Dissolve 100 mg sodium nitrite a.p. in water, make up to 100 ml with water and mix. Prepare immediately before use.           3.7. 0.5 % (m/V) ammonium sulphamate solution : Dissolve 500 mg ammonium sulphamate a.p. in water, make up to 100 ml with water and mix. Prepare immediately before use.           3.8. 0.1 % (m/V) N-2-aminoethyl-1-naphthylamine dihydrochloride solution : Dissolve 100 mg of N-2-aminoethyl-1-naphthylamine dihydrochloride a.p. in 0.1 % (V/V) hydrochloric acid a.p. ; make up to 100 ml with the same acid and mix. Prepare immediately before use.           3.9. Standard substance : pure sulphaquinoxaline.           3.10. Standard solution : Weigh out 250 mg, to within 0.1 mg, of standard substance (3.9). Dissolve in 50 ml sodium hydroxide solution (25 ml 0.1 N sodium hydroxide a.p. solution + 25 ml water), make up to 500 ml with water and mix. Dilute 5 ml to 100 ml with water. 1 ml of this solution contains 25 ¶g of sulphaquinoxaline.                  4. Apparatus      4.1. 250 ml conical flasks, with ground-glass stoppers.           4.2. Shaker.           4.3. Sintered glass funnel, porosity 3,80 mm diameter, with filter flask.           4.4. 250 ml separating funnels.            4.5. 50, 100, 250 and 500 ml volumetric flasks.           4.6. Test tubes, 150 mm × 25 mm.           4.7. Steam bath.           4.8. Spectrophotometer, with 20 mm cells.                  5. Procedure      5.1. Preparation of the sample  Grind the sample so that the whole of it will pass through a sieve with 1 mm mesh (in accordance with recommendation ISO R 565).           5.2. Extraction  Weigh out, to within 1 mg, a quantity of the finely divided and homogeneous sample containing between 0.25 and 1.25 mg of sulphaquinoxaline. Place the test portion in a 250 ml conical flask (4.1) and add 20 ml N, N-dimethylformamide (3.1). Mix and heat the flask on the steam bath (4.7) for 20 minutes. Leave to cool under a stream of cold water. Add 60 ml of chloroform (3.2), stopper the flask and shake for 30 minutes with the aid of a shaker (4.2).  Filter the liquid through a sintered funnel (4.3) under mild suction. Rinse the filter flask with four 5 ml portions of chloroform (3.2) and pass the rinsings through the funnel. Transfer the filtrate to a separating funnel (4.4), rinse the filter flask with about 15 ml chloroform (3.2) and transfer the rinsings to the separating funnel.           5.3. Hydrolysis  Add to the separating funnel 50 ml of alkaline brine (3.4) and 5 ml ethanol (3.3). Thoroughly mix the layers avoiding emulsion formation, either by slow inversion of the funnel about 20 times or by rotating it about the horizontal axis of the stem and the stopper. Allow the layers to separate (separation is usually complete in about 15 minutes).  Transfer the upper layer (aqueous layer) to a 250 ml volumetric flask (4.5). Repeat the extraction of the chloroform layer with three further 50 ml portions of alkaline brine (3.4), adding each aqueous extract to the contents of the volumetric flask. Make up the volume with water and mix.  Transfer 25 ml of the solution to a 50 ml volumetric flask (4.5), add 5 ml hydrochloric acid (3.5), make up the volume with water and mix. Filter if necessary, discarding the first 15 ml of filtrate. Transfer 10 ml aliquots of the solution to two test tubes (4.6), A and B.           5.4. Development of colour, and measurement of the optical density  To each tube add 2 ml of sodium nitrite solution (3.6), mix and leave to stand for three minutes. Add 2 ml of ammonium sulphamate solution (3.7), mix and leave to stand for two minutes. Add 1 ml of N-2-aminoethyl-1-naphthylamine dihydrochloride solution (3.8) to tube A and 1 ml water to tube B. Mix thoroughly the contents of each tube. By means of a water pump apply a slight vacuum to the tubes through rubber connections in order to remove dissolved nitrogen.  After 10 minutes measure the optical densities EA and EB of the solutions with the spectrophotometer (4.8) at 545 nm using water as blank. From the value EA - EB determine the amount (A) of sulphaquinoxaline present in the sample solution by reference to a previously prepared calibration curve (5.5).           5.5. Calibration curve  Transfer into a series of 100 ml volumetric flasks (4.5) volumes of 2, 4, 6, 8 and 10 ml of the standard solution (3.10) corresponding to 50, 100, 150, 200 and 250 micrograms of sulphaquinoxaline. Add 8 ml hydrochloric acid (3.5) to each flask, make up the volume with water and mix.  Pipette 10 ml of each solution (equivalent to 5, 10, 15, 20 and 25 microgrammes sulphaquinoxaline) into test tubes (4.6). Develop the colour reaction as indicated under point 5.4, first paragraph. Measure the optical densities at 545 nm using water as blank. Trace the calibration curve, using the optical density values as ordinates and the corresponding quantities of sulphaquinoxaline in microgrammes as abcissae.        6. Calculation of results  The sulphaquinoxaline content in mg per kg of sample is given by the formula >PIC FILE= "T0006680">   in which:  A = quantity of sulphaquinoxaline in microgrammes as determined by photometric measurement.  P = weight of test portion in grammes.       7. Repeatability  The difference between the results of two parallel determinations carried out on the same sample must not exceed:  10 ppm in absolute value for sulphaquinoxaline contents between 20 and 100 ppm;  10 % relative to the higher result for contents between 100 and 5 000 ppm;  500 ppm in absolute value for contents between 5 000 and 10 000 ppm;  5 % relative to the higher result for contents above 10 000 ppm.  3. DETERMINATION OF FURAZOLIDONE [(3-(5-nitrofurfurylideneamino)-oxazolidin-2-one)]    1. Purpose and scope  The method makes it possible to determine the quantity of furazolidone in feedingstuffs, concentrates and premixes. The lower limit of determination is 10 ppm.       2. Principle  The furazolidone is extracted with acetone, after a preliminary extraction of the sample with light petroleum to remove fat. The extract is purified by chromatography on a column of aluminium oxide and the furazolidone is eluted with acetone. The acetone eluate is evaporated to dryness and the residue dissolved in pentanol. Furazolidone is then extracted from the pentanol with aqueous urea solution and the optical density of the extract is measured at 375 nm.       3. Reagents      3.1. Acetone a.p.           3.2. Aluminium oxide for chromatography, neutral, 100 to 240 mesh, prepared as follows : stir 500 g of the aluminium oxide with one litre of hot distilled water and decant the supernatant liquid. Repeat this procedure twice, and finally filter using a Buchner funnel. Dry the aluminium oxide at 105º C to constant weight.           3.3. Pentyl acetate a.p.           3.4. Pentanol a.p. (material containing mixed isomers is acceptable).           3.5. Light petroleum, boiling range 40 to 60º C.           3.6. Urea solution. Mix 90 g of urea a.p. with 100 ml of water, warm gently to ensure complete solution.           3.7. Standard substance : pure furazolidone.           3.8. Standard solution : Weigh out to within 0.1 mg, 25 mg of standard substance (3.7), dissolve in acetone (3.1) in a 250 ml volumetric flask (4.1), make up to the volume with acetone (3.1) and mix. 1 ml of this solution contains 100 ¶g of furazolidone.                  4. Apparatus      4.1. Amberglass 100 and 250 ml volumetric flasks.           4.2. Amberglass 100 ml separating funnels.            4.3. Suitable extraction apparatus, e.g. Soxhlet or Twisselmann.           4.4. Extraction thimbles, 25 × 80 mm or 28 × 100 mm.           4.5. Glass tubes for chromatography, internal diameter : 10 mm, length 300 mm.           4.6. Steam bath.           4.7. Spectrophotometer with 10 mm cells.                  5. Procedure  N.B. All procedures should be carried out in subdued light.      5.1. Preparation of the sample  Grind the sample so that the whole of it will pass through a sieve with a 1 mm mesh (in accordance with recommendation ISO R 565).           5.2. Extraction  Weigh out to within 1 mg, 5 to 20 g of the finely divided and homogeneous sample (containing not more than 1 mg of furazolidone) into an extraction thimble (4.4) and transfer it to the extraction apparatus (4.3). Extract with light petroleum (3.5), ensuring, in the case of a Soxhlet apparatus, 13 to 17 cycles of solvent ; if other extractors are used, allow not less than 30 minutes for this stage. Remove the thimble from the apparatus, drain off the residual solvent and dry the thimble and the extracted feed in a current of warm air.  Place the dried thimble and contents in a clean extraction apparatus and extract with acetone (3.1), allowing at least 25 cycles of solvent when using a Soxhlet apparatus. The exact conditions for achieving complete extraction with any particular apparatus should be predetermined. Evaporate the acetone extract to a volume of 5 to 10 ml on the steam bath (4.6), and cool to room temperature.           5.3. Chromatography  Insert a plug of glass wool into the lower end of a chromatography tube (4.5) and poke it down with a suitable rod to a thickness of 2 to 3 mm. Prepare a slurry of aluminium oxide (3.2) with acetone (3.1), pour into the tube and allow to settle. The prepared column should be about 200 mm in height. Allow the acetone layer to drain down to the top of the column.  Transfer the acetone extract obtained in 5.2 from the flask to the column, rinse the flask several times with acetone (3.1) and transfer the liquid onto the column. Place a suitable flask under the column and elute the furazolidone with acetone (3.1) ; the total volume of acetone used, including that used for rinsing, should be about 150 ml.           5.4. Extraction and measurement of the optical density  Evaporate the acetone eluate (5.3) just to dryness on a steam bath (4.6). (On occasions a small quantity of diacetone alcohol, produced by condensation of acetone on the aluminium oxide may be left but this will not interfere with the subsequent extractions.) Dissolve the residue in 10 ml pentanol (3.4) and transfer the solution to a separating funnel (4.2). Repeat the process using 10 ml pentyl acetate (3.3) as a rinse liquid. Finally rinse the vessel which contained the extract residue with 10 ml of urea solution (3.6), add this to the separating funnel and shake fairly vigorously for two minutes.  Allow the phases to separate for a period of three to four minutes before transferring the aqueous extract to a 100 ml volumetric flask (4.1). Repeat the rinsing and extraction stages with four further 10 ml aliquots of urea solution (3.6) and transfer the aqueous extracts to the volumetric flask. Dilute the contents of the volumetric flask to 100 ml with urea solution (3.6) and mix. Measure the optical density of the solution in the spectrophotometer (4.7) at 375 nm against urea solution (3.6) in the reference cell. Determine the quantity of furazolidone by referring to the calibration curve (5.5).           5.5. Calibration curve  Prepare four chromatographic columns as described in 5.3, first paragraph. Pipette into separate columns volumes of 2.5, 5, 7.5 and 10 ml respectively of the standard solution (3.8). Wash each of the four columns with 150 ml acetone (3.1) and  continue as in paragraph 5.4. Plot the calibration curve, using the optical density values as ordinates and the corresponding quantities of furazolidone in ¶g as abscissae.       6. Calculation of results  The furazolidone content in mg per kg is given by the formula >PIC FILE= "T0006681">   in which:  A = quantity of furazolidone in microgrammes as determined by photometric measurement.  P = weight of test portion in grammes.       7. Repeatability   The difference between the results of two parallel determinations carried out on the same sample must not exceed:  50 % relative to the higher result for furazolidone contents between 10 and 20 ppm;  10 ppm in absolute value for contents between 20 and 100 ppm;  10 % relative to the higher result for contents between 100 and 5 000 ppm;  500 ppm in absolute value for contents between 5 000 and 10 000 ppm;  5 % relative to the higher result for contents above 10 000 ppm.


title: Directive 2014/57/EU of the European Parliament and of the Council of 16 April 2014 on criminal sanctions for market abuse (market abuse directive)

text:
               12.6.2014

               EN

               Official Journal of the European Union

               L 173/179

         DIRECTIVE 2014/57/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 16 April 2014
   on criminal sanctions for market abuse (market abuse directive)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 83(2) thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   Having regard to the opinion of the European Central Bank (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Acting in accordance with the ordinary legislative procedure (3),
   Whereas:

               (1)

               An integrated and efficient financial market and stronger investor confidence requires market integrity. The smooth functioning of securities markets and public confidence in markets are prerequisites for economic growth and wealth. Market abuse harms the integrity of financial markets and public confidence in securities, derivatives and benchmarks.

               (2)

               Directive 2003/6/EC of the European Parliament and the Council (4) completed and updated the Union’s legal framework to protect market integrity. It also required Member States to ensure that competent authorities have the power to detect and investigate market abuse. Without prejudice to the right of Member States to impose criminal sanctions, Directive 2003/6/EC also required Member States to ensure that the appropriate administrative measures can be taken or administrative sanctions can be imposed against the persons responsible for violations of the national rules implementing that Directive.

               (3)

               The report of 25 February 2009 by the High-Level Group on Financial Supervision in the EU, chaired by Jacques de Larosière (the ‘de Larosière Group’), recommended that a sound prudential and conduct of business framework for the financial sector must rest on strong supervisory and sanctioning regimes. To that end, the de Larosière Group considered that supervisory authorities must be equipped with sufficient powers to act and that there should also be equal, strong and deterrent sanctions regimes against all financial crimes, sanctions which should be enforced effectively, in order to preserve market integrity. The de Larosière Group concluded that Member States’ sanctioning regimes are in general weak and heterogeneous.

               (4)

               A well-functioning legislative framework in relation to market abuse requires effective enforcement. An evaluation of the national regimes for administrative sanctions under Directive 2003/6/EC showed that not all national competent authorities had a full set of powers at their disposal to ensure that they could respond to market abuse with the appropriate sanction. In particular, not all Member States provided for pecuniary administrative sanctions for insider dealing and market manipulation, and the level of sanctions varied widely among Member States. A new legislative act is therefore needed to ensure common minimum rules across the Union.

               (5)

               The adoption of administrative sanctions by Member States has, to date, proven to be insufficient to ensure compliance with the rules on preventing and fighting market abuse.

               (6)

               It is essential that compliance with the rules on market abuse be strengthened by the availability of criminal sanctions which demonstrate a stronger form of social disapproval compared to administrative penalties. Establishing criminal offences for at least serious forms of market abuse sets clear boundaries for types of behaviour that are considered to be particularly unacceptable and sends a message to the public and to potential offenders that competent authorities take such behaviour very seriously.

               (7)

               Not all Member States have provided for criminal sanctions for some forms of serious breaches of national law implementing Directive 2003/6/EC. Different approaches by Member States undermine the uniformity of conditions of operation in the internal market and may provide an incentive for persons to carry out market abuse in Member States which do not provide for criminal sanctions for those offences. In addition, there has, to date, been no Union-wide understanding of conduct that is considered to constitute a serious breach of the rules on market abuse. Therefore, minimum rules should be established with regard to the definition of criminal offences committed by natural persons, liability of legal persons and the relevant sanctions. Common minimum rules would also make it possible to use more effective methods of investigation and enable more effective cooperation within and between Member States. In the light of the financial crisis, it is evident that market manipulation has a potential for widespread damage on the lives of millions of people. The Libor scandal, which concerned a serious case of benchmark manipulation, demonstrated that relevant problems and loopholes impact gravely on market confidence and may result in significant losses to investors and distortions of the real economy. The absence of common criminal sanction regimes across the Union creates opportunities for perpetrators of market abuse to take advantage of lighter regimes in some Member States. The imposition of criminal sanctions for market abuse will have an increased deterrent effect on potential offenders.

               (8)

               The introduction by all Member States of criminal sanctions for at least serious market abuse offences is therefore essential to ensure the effective implementation of Union policy on fighting market abuse.

               (9)

               In order for the scope of this Directive to be aligned with that of Regulation (EU) No 596/2014 of the European Parliament and of the Council (5), trading in own shares in buy-back programmes and trading in securities or associated instruments for the stabilisation of securities; transactions, orders or behaviour in pursuit of monetary, exchange-rate or public debt management policy; activities concerning emission allowances undertaken in pursuit of the Union’s climate policy; and activities undertaken in pursuit of the Union’s Common Agricultural Policy and the Union’s Common Fisheries Policy, should be exempt from this Directive.

               (10)

               Member States should be required to provide at least for serious cases of insider dealing, market manipulation and unlawful disclosure of inside information to constitute criminal offences when committed with intent.

               (11)

               For the purposes of this Directive, insider dealing and unlawful disclosure of inside information should be deemed to be serious in cases such as those where the impact on the integrity of the market, the actual or potential profit derived or loss avoided, the level of damage caused to the market, or the overall value of the financial instruments traded is high. Other circumstances that might be taken into account are, for instance, where an offence has been committed within the framework of a criminal organisation or where the person has committed such an offence before.

               (12)

               For the purposes of this Directive, market manipulation should be deemed to be serious in cases such as those where the impact on the integrity of the market, the actual or potential profit derived or loss avoided, the level of damage caused to the market, the level of alteration of the value of the financial instrument or spot commodity contract, or the amount of funds originally used is high or where the manipulation is committed by a person employed or working in the financial sector or in a supervisory or regulatory authority.

               (13)

               Due to the adverse effects of attempted insider dealing and attempted market manipulation on the integrity of the financial markets and on investor confidence in those markets, those forms of behaviour should also be punishable as a criminal offence.

               (14)

               This Directive should oblige Member States to provide in their national law for criminal penalties in respect of insider dealing, market manipulation and unlawful disclosure of inside information to which this Directive applies. This Directive should not create obligations regarding the application of such penalties or any other available system of law enforcement, to individual cases.

               (15)

               This Directive should also require Member States to ensure that inciting, aiding and abetting the criminal offences are also punishable.

               (16)

               In order for the sanctions for the offences referred to in this Directive to be effective and dissuasive, a minimum level for the maximum term of imprisonment should be set in this Directive.

               (17)

               This Directive should be applied taking into account the legal framework established by Regulation (EU) No 596/2014 and its implementing measures.

               (18)

               In order to ensure effective implementation of the European policy for ensuring the integrity of the financial markets set out in Regulation (EU) No 596/2014, Member States should extend liability for the offences provided for in this Directive to legal persons through the imposition of criminal or non-criminal sanctions or other measures which are effective, proportionate and dissuasive, for example those provided for in Regulation (EU) No 596/2014. Such sanctions or other measures may include the publication of a final decision on a sanction, including the identity of the liable legal person, taking into account fundamental rights, the principle of proportionality and the risks to the stability of financial markets and ongoing investigations. Member States should, where appropriate and where national law provides for criminal liability of legal persons, extend such criminal liability, in accordance with national law, to the offences provided for in this Directive. This Directive should not prevent Member States from publishing final decisions on liability or sanctions.

               (19)

               Member States should take necessary measures to ensure that law enforcement, judicial authorities and other competent authorities responsible for investigating or prosecuting the offences provided for in this Directive have the ability to use effective investigative tools. Taking into account, inter alia, the principle of proportionality, the use of such tools in accordance with national law should be commensurate with the nature and seriousness of the offences under investigation.

               (20)

               As this Directive provides for minimum rules, Member States are free to adopt or maintain more stringent criminal law rules for market abuse.

               (21)

               Member States may, for example, provide that market manipulation committed recklessly or by serious negligence constitutes a criminal offence.

               (22)

               The obligations in this Directive to provide for penalties on natural persons and sanctions on legal persons in their national law do not exempt Member States from the obligation to provide in national law for administrative sanctions and other measures for breaches provided for in Regulation (EU) No 596/2014 unless Member States have decided, in accordance with Regulation (EU) No 596/2014, to provide only for criminal sanctions for such breaches in their national law.

               (23)

               The scope of this Directive is determined in such a way as to complement, and ensure the effective implementation of, Regulation (EU) No 596/2014. Whereas offences should be punishable under this Directive when committed intentionally and at least in serious cases, sanctions for breaches of Regulation (EU) No 596/2014 do not require that intent is proven or that they are qualified as serious. In the application of national law transposing this Directive, Member States should ensure that the imposition of criminal sanctions for offences in accordance with this Directive and of administrative sanctions in accordance with the Regulation (EU) No 596/2014 does not lead to a breach of the principle of ne bis in idem.

               (24)

               Without prejudice to the general rules of national criminal law on the application and execution of sentences in accordance with the concrete circumstances in each individual case, the imposition of sanctions should be proportionate, taking into account the profits made or losses avoided by the persons held liable as well as the damage resulting from the offence to other persons and, where applicable, to the functioning of markets or the wider economy.

               (25)

               Since the objective of this Directive, namely to ensure the availability of criminal sanctions for at least serious market abuse across the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of this Directive, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective.

               (26)

               Increasing cross-border activities require efficient and effective cooperation between national authorities which are competent for the investigation and prosecution of market abuse offences. The organisation and competences of those national authorities in the different Member States should not hinder their cooperation.

               (27)

               This Directive respects the fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union (the Charter) as recognised in the TEU. Specifically, it should be applied with due respect for the right to protection of personal data (Article 8), the freedom of expression and information (Article 11), the freedom to conduct a business (Article 16), the right to an effective remedy and to a fair trial (Article 47), the presumption of innocence and right of defence (Article 48), the principles of legality and proportionality of criminal offences and penalties (Article 49), and the right not to be tried or punished twice in criminal proceedings for the same offence (Article 50).

               (28)

               In implementing this Directive, Member States should ensure procedural rights of suspected or accused persons in criminal proceedings. Their obligations under this Directive are without prejudice to their obligations under Union law on procedural rights in criminal proceedings. Nothing in this Directive is intended to restrict the freedom of press or the freedom of expression in the media in so far as they are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter and other relevant provisions. This should be emphasised in particular as regards disclosure of inside information in accordance with the provisions on such disclosure in this Directive.

               (29)

               Without prejudice to Article 4 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the Treaty on the Functioning of the European Union (TFEU), the United Kingdom will not participate in the adoption of this Directive and is therefore not bound by or be subject to its application.

               (30)

               In accordance with Articles 1, 2, 3 and 4 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, Ireland has notified its wish to take part in the adoption and application of this Directive.

               (31)

               In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Directive and is therefore not bound by it or subject to its application.

               (32)

               The European Data Protection Supervisor delivered an opinion on 10 February 2012 (6),

         HAVE ADOPTED THIS DIRECTIVE;
   Article 1
   Subject matter and scope
   1.   This Directive establishes minimum rules for criminal sanctions for insider dealing, for unlawful disclosure of inside information and for market manipulation to ensure the integrity of financial markets in the Union and to enhance investor protection and confidence in those markets.
   2.   This Directive applies to the following:

               (a)

               financial instruments admitted to trading on a regulated market or for which a request for admission to trading on a regulated market has been made;

               (b)

               financial instruments traded on a multilateral trading facility (MTF), admitted to trading on an MTF or for which a request for admission to trading on an MTF has been made;

               (c)

               financial instruments traded on an organised trading facility (OTF);

               (d)

               financial instruments not covered by point (a), (b) or (c), the price or value of which depends on, or has an effect on, the price or value of a financial instrument referred to in those points, including, but not limited to, credit default swaps and contracts for difference.

         This Directive also applies to behaviour or transactions, including bids, relating to the auctioning on an auction platform authorised as a regulated market of emission allowances or other auctioned products based thereon, including when auctioned products are not financial instruments, pursuant to Commission Regulation (EU) No 1031/2010 (7). Without prejudice to any specific provisions referring to bids submitted in the context of an auction, any provisions in this Directive referring to orders to trade shall apply to such bids.
   3.   This Directive does not apply to:

               (a)

               trading in own shares in buy-back programmes, where such trading is carried out in accordance with Article 5(1), (2) and (3) of Regulation (EU) No 596/2014;

               (b)

               trading in securities or associated instruments as referred to in points (a) and (b) of Article 3(2) of Regulation (EU) No 596/2014 for the stabilisation of securities, where such trading is carried out in accordance with Article 5(4) and (5) of that Regulation;

               (c)

               transactions, orders or behaviours carried out in pursuit of monetary, exchange rate or public debt management policy in accordance with Article 6(1) of Regulation (EU) No 596/2014, transactions order or behaviours carried out in accordance with Article 6(2) thereof, activities in pursuit of the Union’s climate policy in accordance with Article 6(3) thereof, or activities in pursuit of the Union’s Common Agricultural Policy or of the Union’s Common Fisheries Policy in accordance with Article 6(4) thereof;

         4.   Article 5 also applies to:

               (a)

               spot commodity contracts that are not wholesale energy products, where the transaction, order or behaviour has an effect on the price or value of a financial instrument referred to in paragraph 2 of this Article;

               (b)

               types of financial instruments, including derivative contracts or derivative instruments for the transfer of credit risk, where the transaction, order, bid or behaviour has an effect on the price or value of a spot commodity contract where the price or value depends on the price or value of those financial instruments;

               (c)

               behaviour in relation to benchmarks.

         5.   This Directive applies to any transaction, order or behaviour concerning any financial instrument as referred to in paragraphs 2 and 4, irrespective of whether or not such transaction, order or behaviour takes place on a trading venue.
   Article 2
   Definitions
   For the purposes of this Directive, the following definitions apply:

               (1)

               ‘financial instrument’ means a financial instrument as defined in point (15) of Article 4(1) of Directive 2014/65/EU of the European Parliament and of the Council (8);

               (2)

               ‘spot commodity contract’ means a spot commodity contract as defined in point (15) of Article 3(1) of Regulation (EU) No 596/2014;

               (3)

               ‘buy-back programme’ means trading in own shares in accordance with Articles 21 to 27 of Directive 2012/30/EU of the European Parliament and of the Council (9);

               (4)

               ‘inside information’ means information within the meaning of Article 7(1) to (4) of Regulation (EU) No 596/2014;

               (5)

               ‘emission allowance’ means an emission allowance as described in point (11) of Section C of Annex I of Directive 2014/65/EU;

               (6)

               ‘benchmark’ means a benchmark as defined in point (29) of Article 3(1) of Regulation (EU) No 596/2014;

               (7)

               ‘accepted market practice’ means a specific market practice that is accepted by the competent authority of a Member State in accordance with Article 13 of Regulation (EU) No 596/2014;

               (8)

               ‘stabilisation’ means stabilisation as defined in Article 3(2)(d) of Regulation (EU) No 596/2014;

               (9)

               ‘regulated market’ means a regulated market as defined in point (21) of Article 4(1) of Directive 2014/65/EU;

               (10)

               ‘multilateral trading facility’ or ‘MTF’ means a multilateral trading facility as defined in point (22) of Article 4(1) of Directive 2014/65/EU;

               (11)

               ‘organised trading facility’ or ‘OTF’ means an organised trading facility as defined in point (23) of Article 4(1) of Directive 2014/65/EU;

               (12)

               ‘trading venue’ means a trading venue as defined in point (24) of Article 4(1) of Directive 2014/65/EU;

               (13)

               ‘wholesale energy product’ means a wholesale energy product as defined in point (4) of Article 2 of Regulation (EU) No 1227/2011 of the European Parliament and of the Council (10);

               (14)

               ‘issuer’ means an issuer as defined in point (21) of Article 3(1) of Regulation (EU) No 596/2014.

         Article 3
   Insider dealing, recommending or inducing another person to engage in insider dealing
   1.   Member States shall take the necessary measures to ensure that insider dealing, recommending or inducing another person to engage in insider dealing as referred to in paragraphs 2 to 8, constitute criminal offences at least in serious cases and when committed intentionally.
   2.   For the purposes of this Directive, insider dealing arises where a person possesses inside information and uses that information by acquiring or disposing of, for its own account or for the account of a third party, directly or indirectly, financial instruments to which that information relates.
   3.   This Article applies to any person who possesses inside information as a result of:

               (a)

               being a member of the administrative, management or supervisory bodies of the issuer or emission allowance market participant;

               (b)

               having a holding in the capital of the issuer or emission allowance market participant;

               (c)

               having access to the information through the exercise of an employment, profession or duties; or

               (d)

               being involved in criminal activities.

         This Article also applies to any person who has obtained inside information under circumstances other than those referred to in the first subparagraph where that person knows that it is inside information.
   4.   The use of inside information by cancelling or amending an order concerning a financial instrument to which the information relates where the order was placed before the person concerned possessed the inside information shall also be considered to be insider dealing.
   5.   In relation to auctions of emission allowances or other auctioned products based thereon that are held pursuant to Regulation (EU) No 1031/2010, the use of inside information referred to in paragraph 4 of this Article shall also comprise submitting, modifying or withdrawing a bid by a person for its own account or for the account of a third party.
   6.   For the purposes of this Directive, recommending that another person engage in insider dealing, or inducing another person to engage in insider dealing, arises where the person possesses inside information and:

               (a)

               recommends, on the basis of that information, that another person acquire or dispose of financial instruments to which that information relates, or induces that person to make such an acquisition or disposal; or

               (b)

               recommends, on the basis of that information, that another person cancel or amend an order concerning a financial instrument to which that information relates, or induces that person to make such a cancellation or amendment.

         7.   The use of the recommendations or inducements referred to in paragraph 6 amounts to insider dealing where the person using the recommendation or inducement knows that it is based upon inside information.
   8.   For the purposes of this Article, it shall not be deemed from the mere fact that a person is or has been in possession of inside information that that person has used that information and has thus engaged in insider dealing on the basis of an acquisition or disposal, where its behaviour qualifies as legitimate behaviour under Article 9 of Regulation (EU) No 596/2014.
   Article 4
   Unlawful disclosure of inside information
   1.   Member States shall take the necessary measures to ensure that unlawful disclosure of inside information as referred to in paragraphs 2 to 5 constitutes a criminal offence at least in serious cases and when committed intentionally.
   2.   For the purposes of this Directive, unlawful disclosure of inside information arises where a person possesses inside information and discloses that information to any other person, except where the disclosure is made in the normal exercise of an employment, a profession or duties, including where the disclosure qualifies as a market sounding made in compliance with Article 11(1) to (8) of Regulation (EU) No 596/2014.
   3.   This Article applies to any person in the situations or circumstances referred to in Article 3(3).
   4.   For the purposes of this Directive, the onward disclosure of recommendations or inducements referred to in Article 3(6) amounts to unlawful disclosure of inside information under this Article where the person disclosing the recommendation or inducement knows that it was based on inside information.
   5.   This Article shall be applied in accordance with the need to protect the freedom of the press and the freedom of expression.
   Article 5
   Market manipulation
   1.   Member States shall take the necessary measures to ensure that market manipulation as referred to in paragraph 2 constitutes a criminal offence at least in serious cases and when committed intentionally.
   2.   For the purposes of this Directive, market manipulation shall comprise the following activities:

               (a)

               entering into a transaction, placing an order to trade or any other behaviour which:

                           (i)

                           gives false or misleading signals as to the supply of, demand for, or price of, a financial instrument or a related spot commodity contract; or

                           (ii)

                           secures the price of one or several financial instruments or a related spot commodity contract at an abnormal or artificial level;

                     unless the reasons for so doing of the person who entered into the transactions or issued the orders to trade are legitimate, and those transactions or orders to trade are in conformity with accepted market practices on the trading venue concerned;

               (b)

               entering into a transaction, placing an order to trade or any other activity or behaviour which affects the price of one or several financial instruments or a related spot commodity contract, which employs a fictitious device or any other form of deception or contrivance;

               (c)

               disseminating information through the media, including the internet, or by any other means, which gives false or misleading signals as to the supply of, demand for, or price of a financial instrument, or a related spot commodity contract, or secures the price of one or several financial instruments or a related spot commodity contract at an abnormal or artificial level, where the persons who made the dissemination derive for themselves or for another person an advantage or profit from the dissemination of the information in question; or

               (d)

               transmitting false or misleading information or providing false or misleading inputs or any other behaviour which manipulates the calculation of a benchmark.

         Article 6
   Inciting, aiding and abetting, and attempt
   1.   Member States shall take the necessary measures to ensure that inciting, aiding and abetting the offences referred to in Article 3(2) to (5) and Articles 4 and 5 is punishable as a criminal offence.
   2.   Member States shall take the necessary measures to ensure that the attempt to commit any of the offences referred to in Article 3(2) to (5) and (7) and Article 5 is punishable as a criminal offence.
   3.   Article 3(8) applies mutatis mutandis.
   Article 7
   Criminal penalties for natural persons
   1.   Member States shall take the necessary measures to ensure that the offences referred to in Articles 3 to 6 are punishable by effective, proportionate and dissuasive criminal penalties.
   2.   Member States shall take the necessary measures to ensure that the offences referred to in Articles 3 and 5 are punishable by a maximum term of imprisonment of at least four years.
   3.   Member States shall take the necessary measures to ensure that the offence referred to in Article 4 is punishable by a maximum term of imprisonment of at least two years.
   Article 8
   Liability of legal persons
   1.   Member States shall take the necessary measures to ensure that legal persons can be held liable for offences referred to in Articles 3 to 6 committed for their benefit by any person, acting either individually or as part of an organ of the legal person, and having a leading position within the legal person based on:

               (a)

               a power of representation of the legal person;

               (b)

               an authority to take decisions on behalf of the legal person; or

               (c)

               an authority to exercise control within the legal person.

         2.   Member States shall also take the necessary measures to ensure that legal persons can be held liable where the lack of supervision or control, by a person referred to in paragraph 1, has made possible the commission of an offence referred to in Articles 3 to 6 for the benefit of the legal person by a person under its authority.
   3.   Liability of legal persons under paragraphs 1 and 2 shall not exclude criminal proceedings against natural persons who are involved as perpetrators, inciters or accessories in the offences referred to in Articles 3 to 6.
   Article 9
   Sanctions for legal persons
   Member States shall take the necessary measures to ensure that a legal person held liable pursuant to Article 8 is subject to effective, proportionate and dissuasive sanctions, which shall include criminal or non-criminal fines and may include other sanctions, such as:

               (a)

               exclusion from entitlement to public benefits or aid;

               (b)

               temporary or permanent disqualification from the practice of commercial activities;

               (c)

               placing under judicial supervision;

               (d)

               judicial winding-up;

               (e)

               temporary or permanent closure of establishments which have been used for committing the offence.

         Article 10
   Jurisdiction
   1.   Member States shall take the necessary measures to establish their jurisdiction over the offences referred to in Articles 3 to 6 where the offence has been committed:

               (a)

               in whole or in part within their territory; or

               (b)

               by one of their nationals, at least in cases where the act is an offence where it was committed.

         2.   A Member State shall inform the Commission where it decides to establish further jurisdiction over the offences referred to in Articles 3 to 6 committed outside its territory where:

               (a)

               the offender is an habitual resident in its territory; or

               (b)

               the offence is committed for the benefit of a legal person established in its territory.

         Article 11
   Training
   Without prejudice to judicial independence and differences in the organisation of the judiciary across the Union, Member States shall request those responsible for the training of judges, prosecutors, police, judicial and those competent authorities’ staff involved in criminal proceedings and investigations to provide appropriate training with respect to the objectives of this Directive.
   Article 12
   Report
   By 4 July 2018, the Commission shall report to the European Parliament and to the Council on the functioning of this Directive and, if necessary, on the need to amend it, including with regard to the interpretation of serious cases as referred to in Article 3(1), Article 4(1) and Article 5(1), the level of sanctions provided for by Member States and the extent to which the optional elements referred to in this Directive have been adopted.
   The Commission’s report shall, if appropriate, be accompanied by a legislative proposal.
   Article 13
   Transposition
   1.   Member States shall adopt and publish, by 3 July 2016, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those measures.
   They shall apply those measures from 3 July 2016 subject to the entry into force of Regulation (EU) No 596/2014.
   When Member States adopt those measures, 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 14
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 15
   Addressees
   This Directive is addressed to the Member States in accordance with the Treaties.

      Done at Strasbourg, 16 April 2014.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         D. KOURKOULAS

      (1)  OJ C 161, 7.6.2012, p. 3.

      (2)  OJ C 181, 21.6.2012, p. 64.

      (3)  Position of the European Parliament of 4 February 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014.

      (4)  Directive 2003/6/EC of the European Parliament and the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) (OJ L 96, 12.4.2003, p. 16).

      (5)  Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (see page 1 of this Official Journal).

      (6)  OJ C 177, 20.6.2012, p. 1.

      (7)  Commission Regulation (EU) No 1031/2010 of 12 November 2010 on the timing, administration and other aspects of auctioning of greenhouse gas emission allowances pursuant to Directive 2003/87/EC of the European Parliament and of the Council establishing a scheme for greenhouse gas emission allowances trading within the Community (OJ L 302, 18.11.2010, p. 1).

      (8)  Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2011/61/EU and Directive 2002/92/EC (see page 349 of this Official Journal).

      (9)  Directive 2012/30/EU of the European Parliament and of the Council of 25 October 2012 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 54 of the Treaty on the Functioning of the European Union, in respect of the formation of public limited liability companies and the maintenance and alteration of their capital, with a view to making such safeguards equivalent (OJ L 315, 14.11.2012, p. 74).

      (10)  Regulation (EU) No 1227/2011 of the European Parliament and of the Council of 25 October 2011 on wholesale energy market integrity and transparency (OJ L 326, 8.12.2011, p. 1).