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 Text with EEA relevance

The methods proposed shall reflect the most appropriate techniques. The following conditions shall be met in order to permit validation of the pre-authorisation analytical methods and, where relevant, the analytical methods proposed for post-authorisation control and monitoring purposes.

• 2.4.1.No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and quantify the micro-organism in appropriate microbial unit, and any other components of the plant protection product, such as metabolites of concern, relevant impurities and co-formulants, which are relevant for human and animal health and/or the environment. For a plant protection product containing more than one micro-organism as active substance, the recommended methods should be capable of identifying and determining the content of each micro-organism independently of the others.

• 2.4.2.No authorisation shall be granted unless there is an adequate method for control and monitoring to identify and quantify residues of metabolites of concern for which MRL have been set. These methods shall involve the use of commonly available reagents and equipment. Methods shall be available for analysis of:

- (a) plants, plant products, foodstuffs of plant and animal origin and feeding stuffs if relevant residues occur. Residues are considered relevant if a MRL or a waiting or re-entry safety period or other such precaution is required;

• (b) soil, water, air and/or body fluids and tissues, in those compartments where toxicologically, ecotoxicologically or environmentally relevant residues occur.

2.5.   Impact on human and animal health

• 2.5.1.Effects on human and animal health arising from the plant protection product

• When making a decision on the authorisation of the plant protection product containing (a) micro-organism(s), Member States shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the diet or the environment, and on animals.

• 2.5.1.1.No authorisation shall be granted if it is concluded that the micro-organism is infective or causes unacceptable adverse health effects in humans or animals under the recommended conditions of use, including in a realistic worst case exposure scenario.

• 2.5.1.2.No authorisation shall be granted if, where relevant based on biological properties of the micro-organism, there are no sufficient treatment options which are effective against the micro-organism.

• 2.5.1.3.No authorisation shall be granted if the plant protection product has unacceptable toxic effects on humans or animals under the proposed conditions of use, including in a realistic worst-case exposure scenario.

• 2.5.1.4.All micro-organisms shall be regarded as potential sensitisers until a test method is validated and unless it is established by means of relevant information that there is no risk of sensitisation. Authorisations granted shall therefore specify, as a non-specific risk mitigation measure, that personal protective equipment (e.g. masks) shall be worn, taking into account the conditions of use, and that the exposure via inhalation to the plant protection product containing a micro-organism shall be minimised. In addition, the proposed conditions of use may require that specific risk mitigation measures are applied as envisaged by Article 6 of Regulation (EC) No 1107/2009.

• Where the proposed conditions of use require personal protective equipment, no authorisation shall be granted unless those are:

• — effective and in accordance with Regulation (EU) 2016/425 of the European Parliament and of the Council ([^E0016]),

• — readily obtainable by the user,

• — feasibly usable under the claimed conditions of use of the plant protection product, taking into account climatic conditions in particular.

• 2.5.1.5.Plant protection products which, because of particular properties, or which, if mishandled or misused, could lead to unacceptable risk, shall be subject to particular restrictions such as restrictions on the size of packaging, preparation type, distribution, use or manner of use. In addition, plant protection products, which are classified as very toxic, shall not be authorised for use by non-professional users.

• 2.5.1.6.Waiting and re-entry safety periods or other precautions shall be established in such a way that no infection of or other adverse effects on bystanders, workers, or residents or animals exposed after application of the plant protection product are expected.

• 2.5.1.7.Waiting and re-entry periods or other precautions to ensure that no infection or adverse effects are expected shall be realistic; if necessary, special precautionary measures shall be prescribed.

• 2.5.1.8.The conditions of authorisation shall be in compliance with Council Directives 98/24/EC ([^E0017]) and 89/656/EEC ([^E0018]), and Directives 2000/54/EC ([^E0019]) and 2004/37/EC of the European Parliament and of the Council. The experimental data and information relevant to the recognition of the symptoms of infection and on the effectiveness of first aid and therapeutic measures provided shall be considered.

• 2.5.2.Effects on human and animal health arising from residues

- 2.5.2.1.No authorisation shall be granted unless there is sufficient information for plant protection products containing an active substance that is a micro-organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism and metabolites of concern remaining in or on plants or plant products.

• 2.5.2.2.No authorisation shall be granted where the treated plants or plant products are intended to be fed to animals and residues occurring have adverse effect on animal health.

2.6.   Fate and behaviour in the environment

• 2.6.1.No authorisation shall be granted if, as a result of the use of the plant protection product under the proposed conditions, a contamination of surface water is expected by metabolites of concern, and:

• — the surface water in or from the area of envisaged use is intended for the abstraction of drinking water; and

• — this contamination exceeds the parameters or values established in accordance with Directive 2000/60/EC.

• 2.6.2No authorisation shall be granted unless the proposed instruction for use of the plant protection product, including procedures for cleaning application equipment, are clearly described, and reduce to the minimum the likelihood of accidental contamination of surface water.

• 2.6.3.No authorisation shall be granted if, as a result of the use of the plant protection product under the proposed conditions, contamination of groundwater is expected by metabolites of concern, and this contamination exceeds the lower of the following limit values:

• (i) the maximum permissible concentration laid down by Council Directive 98/83/EC ([^E0020]); or

- (ii) the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, based on appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved ([^E0021]) in accordance with Regulation (EC) No 1107/2009,

• unless a consumer risk assessment demonstrates no unacceptable risk or it is scientifically demonstrated that under relevant field conditions the parameters or maximum concentrations is not contravened or exceeded.

2.7.   Effects on non-target organisms

Member States shall ensure that the available information is sufficient to permit a decision to be taken as to whether there may be unacceptable effects on non-target organism groups indicated in Section 10 of Part B to the Annex of Regulation (EU) No 284/2013, due to exposure to the plant protection product containing a micro-organism following its intended use.

• 2.7.1.Where there is a possibility of terrestrial vertebrates being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

• (a) if the micro-organism is pathogenic to terrestrial vertebrates,

• (b) in case of toxic effects of the plant protection product, if the acute and short-term toxicity/exposure ratio for terrestrial vertebrates is less than 10 on the basis of LD50 (acute dietary risk assessment) or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact occurs, directly or indirectly, after use of the plant protection product in accordance with the proposed conditions of use.

• 2.7.2.Where there is a possibility of aquatic organisms being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

• (a) if the micro-organism is pathogenic to aquatic organisms, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on aquatic organism populations would occur after use of the plant protection product in accordance with the proposed conditions of use; or

• (b) in case of toxic effects of the plant protection product if the:
• — toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or
• — algal growth inhibition/exposure ratio is less than 10, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on exposed species occurs, directly or indirectly, after use of the plant protection product in accordance with the proposed conditions of use.

• 2.7.3.Where the possibility of bees to be exposed cannot be excluded according to the consideration done under point 1.6, no authorisation shall be granted:

• (a) if the micro-organism is pathogenic to bees under the proposed conditions of use, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact is expected to occur to the populations of bees after use of the plant protection product in accordance with the proposed conditions of use; or

• (b) in case of toxic effects of the plant protection product, as defined in the decision-making principles of point 2.5.2.3 of Part A.

• 2.7.4.Where there is a possibility of arthropods other than bees being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

• (a) if the micro-organism is pathogenic to arthropods other than bees, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact is expected to occur to the populations of arthropods other than bees after use of the plant protection product in accordance with the proposed conditions of use; or

• (b) in case of toxic effects of the plant protection product, as defined in the decision-making principles of point 2.5.2.4 of Part A, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on arthropods other than bees after use of the plant protection product in accordance with the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data.

• 2.7.5.Where the micro-organism was not isolated from the soil and there is a possibility of meso- and macro-organisms in soil being exposed according to the consideration done under point 1.6, no authorisation shall be granted:

• (a) if the micro-organism is pathogenic to meso- and macro-organisms in soil, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on soil meso- and macro-organism populations occurs after use of the plant protection product in accordance with the proposed conditions of use; or

• (b) in the case of toxic effects of the plant protection product, if the acute toxicity/exposure ratio for meso- and macro-organisms in soil is less than 10 or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on soil meso- and macro-organism populations occur after use of the plant protection product in accordance with the proposed conditions of use.

• 2.7.6.If the micro-organism has an herbicidal mode of action or it is closely related to a known plant pathogen, and there is a possibility of terrestrial plants being exposed to the micro-organism according to the consideration done under point 1.6, no authorisation shall be granted if the micro-organism is pathogenic to, or the plant protection product has toxic effects on, terrestrial plants. This criterion applies unless it is clearly established through an appropriate risk assessment that, under field conditions, no unacceptable impact on non-target terrestrial plant populations occurs after use of the plant protection product in accordance with the proposed conditions of use.

[^E0001]: Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 85).

[^E0002]: Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1).

[^E0003]: 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).

[^E0004]: Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

[^E0005]: Non-extractable residues (sometimes referred to as ‘bound’ or ‘non-extracted’ residues) in plants and soils are defined as chemical species originating from pesticides used in accordance with good agricultural practice that cannot be extracted by methods which do not significantly change the chemical nature of these residues. These non-extractable residues are not considered to include fragments through metabolic pathways leading to natural products.

[^E0006]: Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

[^E0007]: Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

[^E0008]: Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

[^E0009]: Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).

[^E0010]: Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

[^E0011]: Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans (OJ L 353, 6.10.2021, p. 1).

[^E0012]: Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7. 1.2019, p.43).

[^E0014]: Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1).

[^E0015]: Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

[^E0016]: Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).

[^E0017]: Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

[^E0018]: Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 393, 30.12.1989, p. 18).

[^E0019]: Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 262, 17.10.2000, p. 21).

[^E0020]: Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).

[^E0021]: Where the ADI is not available for a metabolite of concern, the default value of 0.1 μg/l applies.