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)
Modified by
  • Regulation (EC) No 1107/2009 of the European Parliament and of the Councilof 21 October 2009concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, 32009R1107, November 24, 2009
Corrected by
  • Corrigendum to Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several micro-organisms as active substances, 32008L0113R(02), May 5, 2009
Commission Directive 2008/113/ECof 8 December 2008amending Council Directive 91/414/EEC to include several micro-organisms as active substances(Text with EEA relevance)
Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2Member 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 31.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 4This Directive shall enter into force on 1 May 2009.
Article 5This Directive is addressed to the Member States.
nullANNEXThe following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
Further details on identity and specification of active substance are provided in the review report.
NoCommon name, identification numbersIUPAC namePurityEntry into forceExpiration of inclusionSpecific provisions
"199Bacillus thuringiensis subsp. aizawaiSTRAIN: ABTS-1857Culture collection: No SD-1372,STRAIN: GC-91Culture collection: No NCTC 11821Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
200Bacillus thuringiensis subsp. israeliensis (serotype H-14)STRAIN: AM65-52Culture collection: No ATCC-1276Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
201Bacillus thuringiensis subsp. kurstakiSTRAIN: ABTS 351Culture collection: No ATCC SD-1275STRAIN: PB 54Culture collection: No CECT 7209STRAIN: SA 11Culture collection: No NRRL B-30790STRAIN: SA 12Culture collection: No NRRL B-30791STRAIN: EG 2348Culture collection: No NRRL B-18208Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
202Bacillus thuringiensis subsp. TenebrionisSTRAIN: NB 176 (TM 14 1)Culture collection: No SD-5428Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
203Beauveria bassianaSTRAIN: ATCC 74040Culture collection: No ATCC 74040STRAIN: GHACulture collection: No ATCC 74250Not applicableMax level of beauvericin: 5 mg/kg1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
204Cydia pomonella Granulovirus (CpGV)Not applicableContaminating micro-organisms (Bacillus cereus) < 1 × 106 CFU/g1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
205Lecanicillium muscarium(formerly Verticilium lecanii)STRAIN: Ve 6Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as insecticide may be authorised.PART BFor 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.
206Metarhizium anisopliae var. anisopliae(formerly Metarhizium anisopliae)STRAIN: BIPESCO 5/F52Culture 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 1095Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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.
207Phlebiopsis giganteaSTRAIN: VRA 1835Culture collection: No ATCC 90304STRAIN: VRA 1984Culture collection: No DSM16201STRAIN: VRA 1985Culture collection: No DSM 16202STRAIN: VRA 1986Culture collection: No DSM 16203STRAIN: FOC PG B20/5Culture collection: No IMI 390096STRAIN: FOC PG SP log 6Culture collection: No IMI 390097STRAIN: FOC PG SP log 5Culture collection: No IMI390098STRAIN: FOC PG BU 3Culture collection: No IMI 390099STRAIN: FOC PG BU 4Culture collection: No IMI 390100STRAIN: FOC PG 410.3Culture collection: No IMI 390101STRAIN: FOC PG97/1062/116/1.1Culture collection: No IMI 390102STRAIN: FOC PG B22/SP1287/3.1Culture collection: No IMI 390103STRAIN: FOC PG SH 1Culture collection: No IMI 390104STRAIN: FOC PG B22/SP1190/3.2Culture collection: No IMI 390105Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
208Pythium oligandrumSTRAINS: M1Culture collection No ATCC 38472Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorisedPART BFor 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.
209Streptomyces K61 (formerly S. griseoviridis)STRAIN: K61Culture collection: No DSM 7206Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
210Trichoderma atroviride(formerly T. harzianum)STRAIN: IMI 206040Culture collection No IMI 206040, ATCC 20476;STRAIN: T11Culture collection: NoSpanish type culture collection CECT 20498, identical with IMI 352941Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
211Trichoderma polysporumSTRAIN: Trichoderma polysporum IMI 206039Culture collection No IMI 206039, ATCC 20475Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
212Trichoderma harzianum RifaiSTRAIN:Trichoderma harzianum T-22;Culture collection No ATCC 20847STRAIN: Trichoderma harzianum ITEM 908;Culture collection No CBS 118749Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
213Trichoderma asperellum(formerly T. harzianum)STRAIN: ICC012Culture collection No CABI CC IMI 392716STRAIN: Trichoderma asperellum(formerly T. viride T25) T25Culture collection No CECT 20178STRAIN: Trichoderma asperellum(formerly T. viride TV1) TV1Culture collection No MUCL 43093Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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) T25 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.
214Trichoderma gamsii (formerly T. viride)STRAINS:ICC080Culture collection No IMI CC number 392151 CABINot applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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.
215Verticillium albo-atrum(formerly Verticillium dahliae)STRAIN: Verticillium albo-atrum isolate WCS850Culture collection No CBS 276.92Not applicableNo relevant impurities1 May 200930 April 2019PART AOnly uses as fungicide may be authorised.PART BFor 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."
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Further details on identity and specification of active substance are provided in the review report.
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