Commission notice concerning a list of potentially low-risk active substances approved for use in plant protection
Date: 2018-07-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: dangerous substance, environmental protection, health risk, market approval, marketing standard, plant health legislation, plant health product








C_2018265EN.01000801.xml










27.7.2018   


EN


Official Journal of the European Union


C 265/8






COMMISSION NOTICE
concerning a list of potentially low-risk active substances approved for use in plant protection
(2018/C 265/02)
1.   INTRODUCTION

As reflected in recital 17 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (1) (hereinafter ‘the Regulation’), low-risk substances should be identified and the placing on the market of plant protection products containing those substances should be facilitated. Moreover, in line with the objectives of Directive 2009/128/EC of the European Parliament and of the Council (2) on the sustainable use of pesticides the use of plant protection products having the least negative effects on human and animal health and on the environment should be promoted.
Active substances that satisfy the criteria for approval in Article 4 and the low-risk criteria in Article 22 of the Regulation are approved as low-risk substances. They are included in Part D of the list of approved active substances in the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). Information about low-risk substances is available in the European pesticides database available at: http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN
Plant protection products containing low-risk substances that meet the requirements of Article 47 of the Regulation shall be authorised by Member States as low-risk plant protection products.
Council Directive 91/414/EEC (4), which was replaced by the Regulation, did not provide for the approval of active substances as low-risk. However, several substances previously approved under this Directive, in particular those substances which were subject to Commission Regulation (EC) No 2229/2004 (5) concerning the fourth stage of the review programme, may potentially be identified as of low-risk.
This Notice is intended to assist Member States in achieving the objectives of Directive 2009/128/EC and specifically the implementation of the provisions of Article 12 and 14 of that Directive as well as the application of the general principles of integrated pest management. For this purpose it provides a list of active substances approved under Directive 91/414/EEC that are expected to meet the low-risk criteria of Article 22 of the Regulation.
The list is established for informative purposes on the basis of information available in the dossiers and assessment reports that substantiated the approval of the substances under Directive 91/414/EEC. Based on this information the active substances approved under this Directive were screened for their compliance with the requirements of Article 22 and specifically the criteria of Annex II point 5 to the Regulation (‘low-risk criteria’). The screening was performed by the Commission with the assistance of the Working Group on Low-risk substances and products.
The list is without prejudice to the outcome of any forthcoming evaluations performed in accordance with the provisions of Regulation (EC) No 1107/2009 for the purpose of the renewal, amendment or review of the approval of an active substance. The inclusion in the list does not formally grant the low-risk status to an active substance and does not result in its listing amongst low-risk active substances in Part D of the Annex to Commission Implementing Regulation (EU) No 540/2011 which can only follow a complete evaluation and decision under the Regulation.
Hence, plant protection products containing the substances on the list cannot be authorised as low-risk products and the specific legal provisions for low-risk products do not apply to them. However, Member States may use the list as considered appropriate to inform users and other stakeholders and to promote more effectively the use of plant protection products with substances of lower risk to contribute to the objectives of Directive 2009/128/EC.
This Notice is intended to assist national authorities in the application of Directive 2009/128/EC. Only the Court of Justice of the European Union is competent to authoritatively interpret Union law.
2.   LIST OF ACTIVE SUBSTANCES EXPECTED TO MEET THE REQUIREMENTS OF ARTICLE 22 OF THE REGULATION

2.1   Micro-organisms







Substance Name


Pesticide Category




Adoxophyes orana GV strain BV-0001


Insecticide




Ampelomyces quisqualis strain AQ10


Fungicide




Bacillus amyloliquefaciens subsp. plantarum D747


Fungicide




Bacillus firmus I-1582


Nematicide




Bacillus pumilus QST 2808


Fungicide




Bacillus subtilis str. QST 713


Bactericide, fungicide




Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91


Insecticide




Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52


Insecticide




Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348


Insecticide




Beauveria bassiana strains ATCC 74040 and GHA


Insecticide




Candida oleophila strain O


Fungicide




Cydia pomonella Granulovirus (CpGV)


Insecticide




Gliocladium catenulatum strain J1446


Fungicide




Helicoverpa armigera nucleopolyhedrovirus (HearNPV)


Insecticide




Lecanicillium muscarium (formerly Verticillium lecanii) strain Ve6


Insecticide




Metarhizium anisopliae var. anisopliae strain BIPESCO 5/F52


Insecticide




Phlebiopsis gigantea (several strains)


Fungicide




Pythium oligandrum M1


Fungicide




Spodoptera exigua nuclear polyhedrosis virus


Insecticide




Spodoptera littoralis nucleopolyhedrovirus


Insecticide




Streptomyces K61 (formerly S. griseoviridis)


Fungicide




Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1


Fungicide




Trichoderma asperellum (strain T34)


Fungicide




Trichoderma atroviride (formerly T. harzianum) strains IMI 206040 and T11


Fungicide




Trichoderma atroviride strain I-1237


Fungicide




Trichoderma gamsii (formerly T. viride) strain ICC080


Fungicide




Trichoderma harzianum strains T-22 and ITEM 908


Fungicide




Trichoderma polysporum strain IMI 206039


Fungicide




Verticillium albo-atrum (formerly Verticillium dahliae) strain WCS850


Fungicide




Zucchini Yellow Mosaik Virus, weak strain


Elicitor




2.2   Other substances








Substance Name


Pesticide Category


Comment




Aluminium ammonium sulphate


Repellent


 




Ammonium acetate


Attractant


 




Ascorbic acid


Fungicide


 




Blood meal


Repellent


 




Calcium carbonate


Repellent


 




Fat distillation residues


Repellent


 




Fatty acids C7 to C20


Insecticide, acaricide, herbicide, plant growth regulator


This does not include free fatty acids with a carbon chain length shorter than C9 (i.e. enanthic acid, caprylic acid).




FEN 560 (Fenugreek seed powder)


Insecticide


 




Garlic extract


Repellent


 




Gibberellic acid


Plant growth regulator


 




Gibberellin


Plant growth regulator


 




Heptamaloxyloglucan


Elicitor


 




Hydrolysed proteins


Insecticide


 




Limestone


Repellent


 




Maltodextrin


Insecticide


 




Pepper dust extraction residue (PDER)


Repellent


 




Plant oils/Rape seed oil


Insecticide, acaricide


 




Potassium hydrogen carbonate


Fungicide


 




Prohexadione


Plant growth regulator


 




Quartz sand


Repellent


 




Repellents by smell of animal or plant origin/fish oil


Repellent


 




Repellents by smell of animal or plant origin/sheep fat


Repellent


 




Sea-algae extract (formerly sea-algae extract and seaweeds)


Plant growth regulator


 




Sodium aluminium silicate


Repellent


 




Straight Chain Lepidopteran Pheromones


Attractant


Applied by dispensers.




Sulphur


Fungicide, acaricide, repellent


 




Urea


Insecticide


 






(1)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 304, 24.11.2009, p. 1).

(2)  Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(4)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(5)  Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further 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 (OJ L 379, 24.12.2004, p. 13).