CELEX: 32008L0113
Language: en
Date: 2008-12-08 00:00:00
Title: Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several micro-organisms as active substances (Text with EEA relevance)

9.12.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 330/6
            
         
      COMMISSION DIRECTIVE 2008/113/EC
   of 8 December 2008
   amending Council Directive 91/414/EEC to include several micro-organisms as active substances
   (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 Regulations (EC) No 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish 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 the active substances listed in the Annex to this Directive.
            
         
               (2)
            
            
               By Commission Regulation (EC) No 1095/2007 (4) a new Article 24b was inserted into Regulation (EC) No 2229/2004 to allow active substances for which there are clear indications that it may be expected that they do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, to be included in Annex I to Directive 91/414/EEC without detailed scientific advice from the European Food Safety Authority (EFSA) having been sought.
            
         
               (3)
            
            
               For the active substances listed in the Annex to this Directive the Commission examined in accordance with Article 24a of Regulation (EC) No 2229/2004 the effects on human, animal health, groundwater and the environment for a range of uses proposed by the notifiers, with the conclusion that those active substances satisfy the requirements of Article 24b of Regulation (EC) No 2229/2004.
            
         
               (4)
            
            
               In accordance with Article 25(1) of Regulation (EC) No 2229/2004 the Commission has submitted draft review reports for the active substances listed in the Annex to this Directive to the Standing Committee on the Food Chain and Animal Health, for examination. Those reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 July 2008 in the format of the Commission review reports. In accordance with Article 25a of Regulation (EC) No 2229/2004 the Commission is to request the EFSA to deliver its view on the draft review reports by 31 December 2010 at the latest.
            
         
               (5)
            
            
               It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive 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 have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
            
         
               (6)
            
            
               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.
            
         
               (7)
            
            
               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 the active substances listed in the Annex 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.
            
         
               (8)
            
            
               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) 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 that have been adopted until now amending Annex I.
            
         
               (9)
            
            
               It is therefore appropriate to amend Directive 91/414/EEC accordingly.
            
         
               (10)
            
            
               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 October 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 1 November 2009.
   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 the active substances listed in the Annex as active substances by 31 October 2009.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to the active substances listed in the Annex are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holders of the authorisations have, or have access to, dossiers satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing one of the active substances listed in the Annex 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 April 2009 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 the active substances listed in the Annex. 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 one of the active substances listed in the Annex as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2014 at the latest; or
            
         
               (b)
            
            
               in the case of a product containing one of the active substances listed in the Annex as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2014 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 May 2009.
   Article 5
   This Directive is addressed to the Member States.
   
      Done at Brussels, 8 December 2008.
      
         
            For the Commission
         
         Androulla VASSILIOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 230, 19.8.1991, p. 1.
   
      (2)  OJ L 168, 27.6.2002, p. 14.
   
      (3)  OJ L 379, 24.12.2004, p. 13.
   
      (4)  OJ L 246, 21.9.2007, p. 19.
   
      (5)  OJ L 366, 15.12.1992, p. 10.
   
      ANNEX
      The following entry 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
                  
               
                     ‘199
                  
                  
                     
                        Bacillus thuringiensis subsp. aizawai
                     
                     STRAIN: ABTS-1857
                     Culture collection: No SD-1372,
                     STRAIN: GC-91
                     Culture collection: No NCTC 11821
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     200
                  
                  
                     
                        Bacillus thuringiensis subsp. israeliensis (serotype H-14)
                     
                     STRAIN: AM65-52
                     Culture collection: No ATCC-1276
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52 (SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     201
                  
                  
                     
                        Bacillus thuringiensis subsp. kurstaki
                     
                     STRAIN: ABTS 351
                     Culture collection: No ATCC SD-1275
                     STRAIN: PB 54
                     Culture collection: No CECT 7209
                     STRAIN: SA 11
                     Culture collection: No NRRL B-30790
                     STRAIN: SA 12
                     Culture collection: No NRRL B-30791
                     STRAIN: EG 2348
                     Culture collection: No NRRL B-18208
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     202
                  
                  
                     
                        Bacillus thuringiensis subsp. Tenebrionis
                     
                     STRAIN: NB 176 (TM 14 1)
                     Culture collection: No SD-5428
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     203
                  
                  
                     
                        Beauveria bassiana
                     
                     STRAIN: ATCC 74040
                     Culture collection: No ATCC 74040
                     STRAIN: GHA
                     Culture collection: No ATCC 74250
                  
                  
                     Not applicable
                  
                  
                     Max level of beauvericin: 5 mg/kg
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     204
                  
                  
                     
                        Cydia pomonella Granulovirus (CpGV)
                     
                  
                  
                     Not applicable
                  
                  
                     Contaminating micro-organisms (Bacillus cereus) < 1 × 106 CFU/g
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     205
                  
                  
                     
                        Lecanicillium muscarium
                     
                     (formerly Verticilium lecanii)
                     STRAIN: Ve 6
                     Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     206
                  
                  
                     
                        Metarhizium anisopliae var. anisopliae
                     
                     (formerly Metarhizium anisopliae)
                     STRAIN: BIPESCO 5/F52
                     Culture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as insecticide and acaricide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     207
                  
                  
                     
                        Phlebiopsis gigantea
                     
                     STRAIN: VRA 1835
                     Culture collection: No ATCC 90304
                     STRAIN: VRA 1984
                     Culture collection: No DSM16201
                     STRAIN: VRA 1985
                     Culture collection: No DSM 16202
                     STRAIN: VRA 1986
                     Culture collection: No DSM 16203
                     STRAIN: FOC PG B20/5
                     Culture collection: No IMI 390096
                     STRAIN: FOC PG SP log 6
                     Culture collection: No IMI 390097
                     STRAIN: FOC PG SP log 5
                     Culture collection: No IMI390098
                     STRAIN: FOC PG BU 3
                     Culture collection: No IMI 390099
                     STRAIN: FOC PG BU 4
                     Culture collection: No IMI 390100
                     STRAIN: FOC PG 410.3
                     Culture collection: No IMI 390101
                     STRAIN: FOC PG97/1062/116/1.1
                     Culture collection: No IMI 390102
                     STRAIN: FOC PG B22/SP1287/3.1
                     Culture collection: No IMI 390103
                     STRAIN: FOC PG SH 1
                     Culture collection: No IMI 390104
                     STRAIN: FOC PG B22/SP1190/3.2
                     Culture collection: No IMI 390105
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     208
                  
                  
                     
                        Pythium oligandrum
                     
                     STRAINS: M1
                     Culture collection No ATCC 38472
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     209
                  
                  
                     
                        Streptomyces K61 (formerly S. griseoviridis)
                     STRAIN: K61
                     Culture collection: No DSM 7206
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     210
                  
                  
                     
                        Trichoderma atroviride
                     
                     (formerly T. harzianum)
                     STRAIN: IMI 206040
                     Culture collection No IMI 206040, ATCC 20476;
                     STRAIN: T11
                     Culture collection: No
                     Spanish type culture collection CECT 20498, identical with IMI 352941
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     211
                  
                  
                     
                        Trichoderma polysporum
                     
                     STRAIN: Trichoderma polysporum IMI 206039
                     Culture collection No IMI 206039, ATCC 20475
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     212
                  
                  
                     
                        Trichoderma harzianum Rifai
                     STRAIN:
                     
                        Trichoderma harzianum T-22;
                     Culture collection No ATCC 20847
                     STRAIN: Trichoderma harzianum ITEM 908;
                     Culture collection No CBS 118749
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     213
                  
                  
                     
                        Trichoderma asperellum
                     
                     (formerly T. harzianum)
                     STRAIN: ICC012
                     Culture collection No CABI CC IMI 392716
                     STRAIN: Trichoderma asperellum
                     
                     (formerly T. viride T25) T11
                     Culture collection No CECT 20178
                     STRAIN: Trichoderma asperellum
                     
                     (formerly T. viride TV1) TV1
                     Culture collection No MUCL 43093
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T11 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     214
                  
                  
                     
                        Trichoderma gamsii (formerly T. viride)
                     STRAINS:
                     ICC080
                     Culture collection No IMI CC number 392151 CABI
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                  
               
                     215
                  
                  
                     
                        Verticillium albo-atrum
                     
                     (formerly Verticillium dahliae)
                     STRAIN: Verticillium albo-atrum isolate WCS850
                     Culture collection No CBS 276.92
                  
                  
                     Not applicable
                  
                  
                     No relevant impurities
                  
                  
                     1 May 2009
                  
                  
                     30 April 2019
                  
                  
                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Verticillium albo-atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.’
                  
               
      
         (1)  Further details on identity and specification of active substance are provided in the review report.