# 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 (Text with EEA relevance), Part D: Low-risk active substances'

Extent: E+W+S+N.I.

General provisions applying to all substances listed in this Part: the Commission shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make them available to them on specific request.
Further details on identity and specification of active substance are provided in the review report.
https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf
Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127).
Common Name, Identification Numbers
IUPAC Name
Purity
Date of approval
Expiration of approval
Specific provisions
1
Isaria fumosorosea strain Apopka 97
Deposited in the American Type Culture Collection (ATCC) under the name Paecilomyces fumosoroseus Apopka ATCC 20874
Not applicable
Minimum concentration: 1,0 × 10 8 CFU/ml
Maximum concentration: 2,5 × 10 9 CFU/ml
1 January 2016
31 December 2030
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Isaria fumosorosea strain Apopka 97, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Isaria fumosorosea strain Apopka 97 is to be considered as a potential sensitiser.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
2
COS-OGA
CAS No: not allocated
CIPAC No: 979
Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues).
≥ 915 g/kg
OGA/COS ratio comprised between 1 and 1,6
Degree of polymerisation of COS comprised between 5 and 10
Degree of polymerisation of OGA comprised between 9 and 20
Degree of methylation of OGA < 10 %
Degree of acetylation of COS < 50 %
22 April 2015
22 April 2030
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on COS-OGA, and in particular Appendices I and II thereof, shall be taken into account.
3
Cerevisane (no ISO name adopted)
CAS No: not allocated
CIPAC No: 980
Not relevant
≥ 924 g/kg
23 April 2015
23 April 2030
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cerevisane, and in particular Appendices I and II thereof, shall be taken into account.
4
Pepino mosaic virus strain CH2 isolate 1906
GenBank, accession number JN835466
CIPAC No: not allocated
Not applicable
minimum concentration 5 × 10 5 viral genome copies per μL
7 August 2015
7 August 2030
Only the use in greenhouses may be authorised.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pepino mosaic virus strain CH2 isolate 1906, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pepino mosaic virus strain CH2 isolate 1906 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
5
Ferric phosphate
CAS No: 10045-86-0
CIPAC No: 629
Ferric phosphate
Ferric phosphate 703 g/kg equivalent to 260 g/kg iron and 144 g/kg phosphorus
1 January 2016
31 December 2030
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ferric phosphate, and in particular Appendices I and II thereof, shall be taken into account.
6
Saccharomyces cerevisae strain LAS02
Accession number in the collection of the ‘Collection Nationale de Cultures de Microorganismes’ (CNCM) of the Pasteur Institute: CNCM I-3936
Not applicable
Minimum concentration: 1 × 10 13 CFU/kg
6 July 2016
6 July 2031
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Saccharomyces cerevisiae strain LAS02, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Saccharomyces cerevisiae strain LAS02 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
7
Trichoderma atroviride strain SC1
Accession number CBS 122089 in the collection of the Centraalbureau voor Schimmelcultures (CBS) in Utrecht, The Netherland
CIPAC No: 988
Not applicable
minimum concentration 1 × 10 10 CFU/g
6 July 2016
6 July 2031
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride strain SC1, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
8
Mild Pepino Mosaic Virus isolate VC1
Reference number DSM 26973 in the German Collection of Micro-organisms and Cell Cultures (DSMZ)
Not applicable
Nicotine < 0,1 mg/L
29 March 2017
29 March 2032
Only the use in greenhouses may be authorised.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Mild Pepino Mosaic Virus isolate VC1, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Mild Pepino Mosaic Virus isolate VC1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
9
Mild Pepino Mosaic Virus isolate VX1
Reference number DSM 26974 in the German Collection of Micro-organisms and Cell Cultures (DSMZ)
Not applicable
Nicotine < 0,1 mg/L
29 March 2017
29 March 2032
Only the use in greenhouses may be authorised.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Mild Pepino Mosaic Virus isolate VX1, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Mild Pepino Mosaic Virus isolate VX1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
10
Bacillus amyloliquefaciens strain FZB24.
Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: 10271
Accession number at the Agricultural Research Service Culture Collection (NRRL), USA: B-50304
Not applicable
Minimum concentration:
2 × 10 14 CFU/kg
1 June 2017
1 June 2032
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus amyloliquefaciens strain FZB24, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;
the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
Conditions of use shall include risk mitigation measures, where appropriate.
11
Coniothyrium minitans strain CON/M/91-08
Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: DSM 9660
CIPAC No 614
Not applicable
Minimum content of viable spores:
1,17 × 10 12 CFU/kg
1 August 2017
31 July 2032
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Coniothyrium minitans strain CON/M/91-08, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
Conditions of use shall include risk mitigation measures, where appropriate.
12
Laminarin
CAS No 9008-22-4
CIPAC No 671
(1→3)-β-D-glucan
(according to IUPAC-IUB Joint Commission on Biochemical Nomenclature)
≥ 860 g/kg on dry matter (TC)
1 March 2018
28 February 2033
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on laminarin, and in particular Appendices I and II thereto, shall be taken into account.
Conditions of use shall include risk mitigation measures, where appropriate.
13
Pasteuria nishizawae Pn1
Culture collection: ATCC Safe Deposit (SD-5833)
CIPAC No
Not allocated
Not applicable
minimum concentration 1 × 10 11 spores/g
14 October 2018
14 October 2033
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pasteuria nishizawae Pn1, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pasteuria nishizawae Pn 1 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
14
Ampelomyces quisqualis strain AQ10
Not applicable
Minimum content of viable spores:
3,0 × 10 12 CFU/kg
1 August 2018
1 August 2033
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Ampelomyces quisqualis strain AQ10, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers and ensuring that adequate personal protective equipment is included as a condition of use.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
Conditions of use shall include risk mitigation measures, where appropriate.
15
Clonostachys rosea strain J1446
Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212
Not applicable
Not applicable
Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.
1 April 2019
31 March 2034
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Clonostachys rosea strain J1446, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
the specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;
the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;
the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012.
Conditions of use shall include risk mitigation measures, where appropriate.
16
ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)
Not Applicable
1 000 g/kg (active substance)
20 May 2019
20 May 2034
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) and in particular Appendices I and II thereof, shall be taken into account.
17
Bacillus subtilis strain IAB/BS03
Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254
Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682
Not applicable
Minimum concentration:
1 × 10 13 CFU/kg
Maximum concentration:
5 × 10 13 CFU/kg
20 October 2019
20 October 2034
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus subtilis strain IAB/BS03, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
a))the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites;
b))the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers, and ensuring that adequate personal protective equipment is included as a condition of use.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Working Document SANCO/12116/2012.
Conditions of use shall include risk mitigation measures, where appropriate.
18
Verticillium albo-atrum strain WCS850 (culture collection No CBS 276.92)
Not applicable
Minimum concentration:
0,7 × 10 7 CFU/ml distilled water
Maximum concentration:
1,5 × 10 7 CFU/ml distilled water
No relevant impurity
1 November 2019
31 October 2034
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Verticillium albo-atrum strain WCS850, and in particular Appendices I and II thereto, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Verticillium albo-atrum strain WCS850 is to be considered as a potential sensitiser.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012.
19
Lavandulyl senecioate
CAS No: 23960-07-8
CIPAC No: n.a.
(RS)-5-methyl-2-(prop-1-en-2-yl)hex-4-en-1-yl 3-methylbut-2-enoate
≥ 894 g/kg
3 June 2020
3 June 2035
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Lavandulyl senecioate, and in particular Appendices I and II thereto, shall be taken into account.
Member State shall assess any extension of the use pattern beyond passive dispensers, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Commission Regulation (EU) No 546/2011.
20
Ferric pyrophosphate
CAS No: 10058-44-3
CIPAC No: —
iron(3+) diphosphate
≥ 802 g/kg
The following impurities are of toxicological and enviromental concern and must not exceed the following levels in the technical material:
Lead: 3 mg/kg
Mercury: 0,1 mg/kg
Cadmium: 1 mg/kg
3.8.2020
3.8.2035
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ferric pyrophosphate, and in particular Appendices I and II thereto, shall be taken into account.
21
Phlebiopsis gigantea strain VRA 1835
Not applicable
No relevant impurities
1 September 2020
31 August 2035
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain VRA 1835, and in particular Appendices I and II thereto, shall be taken into account.
Member States shall pay particular attention to the protection of operators and workers.
Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.
22
Phlebiopsis gigantea strain VRA 1984
Not applicable
No relevant impurities
1 September 2020
31 August 2035
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain VRA 1984, and in particular Appendices I and II thereto, shall be taken into account.
Member States shall pay particular attention to the protection of operators and workers.
Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.
23
Phlebiopsis gigantea strain FOC PG 410.3
Not applicable
No relevant impurities
1 September 2020
31 August 2035
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Phlebiopsis gigantea strain FOC PG 410.3, and in particular Appendices I and II thereto, shall be taken into account.
Member States shall pay particular attention to the protection of operators and workers.
Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination.
24
Sodium hydrogen carbonate
CAS No: 144-55-8
Sodium hydrogen carbonate
≥ 990 g/kg
Arsenic ≤ 3 mg/kg
Lead ≤ 2 mg/kg
Mercury ≤ 1 mg/kg
1 October 2020
1 October 2035
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium hydrogen carbonate, and in particular Appendices I and II thereof, shall be taken into account.

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Source: https://www.legislation.gov.uk/eur/2011/540/annex/1/part/D (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-540/annex-1/part-D
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.