# C_2018265EN.01000801.xml

| 27.7.2018 | EN | Official Journal of the European Union | C 265/8 |
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27.7.2018

EN

Official Journal of the European Union

C 265/8

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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 |

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 | |

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

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(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).

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