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).