EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10716/2021  
[…](2021) XXX  draft  
ANNEX 1  
 
ANNEXES  
to the  
COMMISSION REGULATION (EU)  
amending Regulation (EU) No 546/2011 as regards specific uniform principles for 
evaluation and authorisation of plant protection products containing micro -organisms    
   
   
EN 1  EN  ‘ANNEX  
GENERAL INTRODUCTION  
1. GENERAL PRINCIPLES  
1.1. The objective of the principles developed in this Annex is to ensure a high level of protection of 
human and animal  (species normally fed and kept by humans or food producing animals)  health and 
the environment in  evaluations and decisions by Member States  with regard to authorisation of plant 
protection products, implement ing the requirements of Articl e 29(1)(e) in conjunction with Article 
4(3) and Article 29(1)(f), (g ) and (h) of Regulation (EC) No  1107/2009. For the purpose of this 
Annex, the following definitions apply:  
(1)  ‘efficacy ’ means  a measure concerning the overall effect of the application of a plant protection 
product on the agricultural system in which it is used  (i.e. which includes positive effects of 
treatment in performing the  desired plant protection activity  and negative effects such as 
development of resistance ); 
(2)  ‘relevant impu rity’ means a  chemical impurity  that is of concern for human health, animal 
health or the environment ; 
(3)  ‘storage stability ’ means  the capacity of a plant protection product to maintain the initial 
properties and the specified content during the storage  period under established storage 
conditions . 
1.2. In evaluating applications for granting authorisations Member States shall:  
(a)  
– ensure that dossiers supplied are in accordance with the requirements of the Annex to 
Commission Regulation (EU) No 284/20131, at th e latest at the time of finalisation of the 
evaluation for the purpose of decision -making, without prejudice, where relevant, to 
Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,   
– ensure that the data submitted by the applicant are acceptable in terms of quantity, 
quality, consistency and reliability and sufficient to permit a proper evaluation of the 
dossier,   
– evaluate, where relevant, justifications submitted by the applicant for not supplying 
certain data;  
(b) take into account the data concerning the active substance in the plant protection product of the 
Annex to Commission Regulation (EU) No  283/20132, submitted for the purpose of approval of 
the active substance under Regulation (EC) No 1107/2009, and the results of the evaluation of 
those data,  without prejudice, where relevant, to the provisions of Article 33(3) and of Articles 
34 and 59 of Regulation (EC) No 1107/2009;  
(c) take into consideration other relevant technical or scientific information with regard to the 
efficacy of the plant protection  product or to t he potentially adverse effects of the plant 
protection product its components or its residues, where relevant.  
                                                 
1 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 ). 
2 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).   
EN 2  EN 1.3. Where, in the specific principles on evaluation, reference is made to the data of the Annex to 
Regulation (EU) No 283/2013 this s hall be understood as being the data referred to in point  1.2(b)  of 
this Annex .  
1.4. Where the data and information provided are sufficient to permit completion of the evaluation for one 
of the proposed uses, Member States shall evaluate applications and make a decision for the proposed 
use.  
Taking account of justifications provided and with the benefit of any subsequent clarifications, 
Member States shall reject applications for granting authorisations for which the data gaps are such 
that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the 
proposed uses.  
1.5. During the process of evaluation and decision -making, Member States shall cooperate with the 
applicants in order to resolve any questions on the dossier quick ly or to identify at an early stage any 
additional studies necessary for a technically complete dossier that allows for a proper evaluation, or 
to amend any proposed conditions for the use of the plant protection product or to modify its nature 
or its comp osition in order to ensure full compliance with the requirements of this Annex and more 
generally with the provisions of Regulation (EC) No 1107/2009.  
1.6. During the process of evaluation and decision -making,  Member States shall base  their assessment on 
scient ific principles, preferably recognised at international level, and be made with the benefit of 
expert advice.  
1.7. Member States shall take into account those guidance documents applicable at the date of the 
submission of the application for the authorisation.  
2. EVALUATION , GENERAL PRINCIPLES  
2.1. Having regard to current scientific and technical knowledge, Member States shall evaluate the 
information referred to in point 1.2, and in particular:  
(a) identify the risk arising, assess their significance and the expected expo sure, and make a 
judgement as to the likely risks to humans, animals or the environment;  
(b) assess efficacy in terms of effectiveness (including possible development of resistance or cross -
resistance of the target organism(s)) and adverse effects (including phytotoxicity/pathogenicity) 
on crops (including treated crops, succeeding crops and adjacent crops) of the plant protection 
product for each use for which authorisation is sought.  
2.2. Member States shall evaluate the quality/methodology of tests, especially w here there are no 
standardised test methods, as well as the following characteristics of the methods described, when 
available:  
relevance; representativeness; sensitivity; specificity; reproducibility.   
EN 3  EN 2.3. In interpreting the results of evaluations, Member St ates shall take into consideration and report 
possible elements of uncertainty in the information obtained during the evaluation, in order to ensure 
that the chances of failing to detect adverse effects or of underestimating their importance are 
reduced to  a minimum. The decision -making process shall be examined to identify critical decision 
points or items of data for which uncertainties could lead to a false classification of risk.  
2.4. In accordance with Article 29 of Regulation (EC) No 1107/2009, Member Sta tes shall ensure that 
evaluations carried out have regard to the proposed practical conditions of use and, in particular, to 
the purpose of use, the application dose, the application method, frequency and timing of 
applications, and the nature and composit ion of the plant protection product.  
In accordance with the requirements for proper use as set out in  Article 55 of Regulation (EC) 
No 1107/2009, Member States shall take into account the provisions of Directive 2009/128/EC  of the 
European Parliament and of the Council3 and, in particular, the principles of integrated pest 
management.  
2.5. In the evaluation, Member States shall consider the agricultural, plant health or environmental 
(including climatic) conditions in the areas of use.  
2.6. Where specific principles in Section 1 of Part A or Section 1 of Part B  (as applicable)  provide for the 
use of calculation models in the evaluation of a plant protection product, those models shall:  
(a) make a possible estimation in an appropriate way of all relevant processes involved taking into 
account realistic parameters and assumptions;  
(b) be submitted to an evaluation as referred to in point 2.3;  
(c) be reliably validated with measurements carried out under circumstances relevant for the use of 
the model;   
(d) be relevant to the conditions in the area of use;   
(e) in cases the models have not been validated, be supported with details indicating how the 
model calculates estimates provided, and explanations of all the inputs to the model and details 
of how they have b een derived.  
2.7. Where metabolites  are referred to in the specific principles , only those that are relevant for the 
proposed criterion shall be taken into consideration. For Part A this concerns  also degradation or 
reaction products. For Part B this concerns  what is defined as “metabolites of concern”.  
3. DECISION -MAKING , GENERAL PRINCIPLES  
3.1. Where appropriate, Member States shall impose conditions or restrictions on the authorisations they 
grant. The nature and severity of these conditions or restrictions shall be selected on the basis of, and 
be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.  
3.2. Member States shall ensure that decisions taken to grant authorisations take account of the 
agricultural, plant health or envir onmental (including climatic) conditions in the areas of envisaged 
use. Such considerations may result in specific conditions and restrictions on use, and in 
authorisation being granted for some but not other areas within the Member State in question.  
3.3. Memb er States shall ensure that the authorised application rates and number of applications, are the 
minimum necessary to achieve the desired effect even where higher rates would not result in 
unacceptable risks to human or animal health or to the environment.  The authorised rates shall be 
differentiated in accordance with, and be appropriate to, the agricultural, plant health or 
                                                 
3 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) .  
EN 4  EN environmental (including climatic) conditions in the various areas for which an authorisation is 
granted. However, the application ra tes and the number of applications may not give rise to 
undesirable effects such as the development of resistance in the target organism.  
3.4. Member States shall ensure that decisions taken to grant authorisations consider integrated pest 
management as set out  in Directive 2009/128/EC. In particular, Member States shall ensure that a 
warning phrase is indicated on the label in case negative effects are expected on beneficial organisms 
that are deliberately released as part of integrated pest management strategi es. 
3.5. Since the evaluation is to be based on data concerning a limited number of representative non -target 
species, Member States shall ensure that use of plant protection products does not have any long -term 
repercussions for the abundance and diversity of non-target species.  
3.6. Before issuing an authorisation, Member States shall ensure that the label of the plant protection 
product:  
(a) fulfils the requirements setting out in Regulation (EU) No 547/2011;   
(b) also contains the information on protection of operators,  workers, bystanders and residents 
required by EU legislation on worker protection;  
(c) specifies in particular the conditions or restrictions under which the plant protection product 
may or may not be used as referred to in points 3.1 to 3.5  of this general i ntroduction; and  
(d) The authorisation shall mention the particulars indicated in Regulation (EC) No  1272/2008  of 
the European Parliament and of the Council4. 
3.7. Before issuing authorisations, Member States shall:  
(a) ensure that the proposed packaging is in accordance with the p rovisions of Regulation (EC) 
No 1272/2008;  
(b) ensure that  the following procedures are in accordance with the relevant regulatory provisions :  
– the procedures for destruction of the plant protection product,  
– the procedures for neutralisa tion of any adverse effects of the plant protection product if 
it is accidentally dispersed, and  
– the procedures for the decontamination and destruction of the packaging . 
 
3.8. No authorisation shall be granted unless all the requirements referred to in Section 2 of Part A or 
Section 2  of Part B ( as applicable ) are satisfied. However:  
(a) when one or more of the specific decision -making requirements referred to in point s 2.1, 2.2, 
2.3 or 2.7  of Part A, or point  2.3 of Part B, respectively, are not satisfied, authorisations shall be 
granted only where the advantages of the use of the plant protection product under the proposed 
conditions of use outweigh the possible adverse effects of  its use. Any restrictions on use of the 
plant protection product relating to non -compliance with some of the aforementioned 
requirements must be mentioned on the label, and non -compliance with the requirements 
referred to in point  2.7 of Part A  (if Part A  applies) shall  not compromise proper use of the 
plant protection product. These advantages can be in terms of:   
– advantages for and compatibility with integrated control measures or organic farming,  
                                                 
4 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 ).  
EN 5  EN – facilitating strategies to minimise the risk of development of resistance,  
– the need for a greater diversity of types of active substances or biochemical modes of 
action, e.g. for use in strategies to avoid accelerated breakdown in the soil,  
– reduced risk for operators and consumers,  
– reduced contamination of the environment and reduce d impact on non -target species.  
(b) where the criteria referred to in point  2.6 of Part A or point  2.4 of Part B, respectively, are not 
fully satisfied because of limitations in c urrent analytical science and technology, authorisation 
shall be granted for a limited period if the methods submitted prove adequate for the purposes 
intended. In this case , the applicant shall be required to develop and submit analytical methods 
that are  in accordance with those criteria  by a specific deadline . The authorisation shall be 
reviewed on expiry of th at deadline ;  
(c) where the reproducibility of the submitted analytical methods referred to in point  2.6 of Part A 
or point  2.4 of Part B, respectivel y has only been verified in two laboratories, an authorisation 
shall be granted for 1 year to permit the applicant to demonstrate the reproducibility of those 
methods in accordance with agreed criteria  in at least a third laboratory . 
3.9. Where an authorisation  has been granted in accordance with the requirements provided for in this 
Annex, Member States may, by virtue of Article 44 of Regulation (EC) No 1107/2009:  
(a) define, where possible, preferably in close cooperation with the applicant, measures to improve 
the efficacy of the plant protection product; and/or  
(b) define, where possible, in close cooperation with the applicant, measures to reduce further the 
exposure that could occur during and after use of the plant protection product.  
Member States shall inform applicants of any measures identified under (a) or (b) and shall require 
applicants to provide any supplementary data and information necessary to demonstrate efficacy or 
acceptability of risks arising under the changed conditions.  
3.10. Member States shall ensu re, as far as it is practically possible, that for all active substances contained 
in plant protection products that are considered for an authorisation, the applicant has taken into 
account all available relevant knowledge and information in scientific literature at the time of 
submission of the dossier on the plant protection product.  
   
EN 6  EN PART A 
Uniform principles for evaluation and authorisation of chemical plant protection products  
 
1. Evaluation  
1.1. Efficacy  
1.2. Absence of unacceptable effects on plants or plant products  
1.3. Impact on vertebrates to be controlled  
1.4. I mpact on human or animal health  
1.4.1. Impact on human or animal health arising from the plant protection product  
1.4.2. Impact on human and animal health arising from residues  
1.5. Influence on the environment  
1.5.1. Fate and distribution in the environment  
1.5.2. Impact on non -target species  
1.6. Analytical methods  
1.7. Physical and chemical properties  
2. Decision -making  
2.1. Efficacy  
2.2. Absence of unacceptable effects on plants or plant products  
2.3. Impact on vertebrates to be controlled  
2.4. Impact on human or animal health  
2.4.1. Impact on human or animal health arising from the plant protec tion product  
2.4.2. Impact on human or animal health arising from residues  
2.5. Influence on the environment  
2.5.1. Fate and distribution in the environment  
2.5.2. Impact on non -target species  
2.6. Analytical methods  
2.7. Physical and chemical properties  
   
EN 7  EN 1.  EVALUATION   
Member States shall, for the evaluation of the data and information submitted in support of 
applications, and without prejudice to the general principles of Section 2  of the general introduction , 
implement the following principles.  
1.1.  Efficacy  
1.1.1.  Where the proposed use concerns the control of or protection against an organism, Member States 
shall evaluate the possibility that this organism could be harmful under the agricultural, plant health 
and environmental (including climatic) conditions in th e area of the proposed use.  
1.1.2.  Where the proposed use concerns an effect other than the control of or protection against an 
organism, Member States shall evaluate whether significant damage, loss or inconvenience could 
occur under the agricultural, p lant health and environmental (including climatic) conditions in the 
area of proposed use if the plant protection product were not used.  
1.1.3.  Member States shall evaluate the efficacy data on the plant protection product as provided for in the 
Annex to  Regulation (EU) No 284/2013  having regard to the degree of control or the extent of the 
effect desired and having regard to the relevant experimental conditions such as:  
– the choice of the crop or cultivar,  
– the agricultural and environmental (including c limatic) conditions,  
– the presence and density of the harmful organism,  
– the development stage of crop and organism,  
– the amount of the plant protection product used,  
– if required on the label, the amount of adjuvant added,  
– the frequency and timing of the  applications,  
– the type of application equipment.  
1.1.4.  Member States shall evaluate the performance of the plant protection product in a range of 
agricultural, plant health and environmental (including climatic) conditions likely to be encountered 
in practice in the area of proposed use and in particular:  
(i)  the level, consistency and duration of the effect sought in relation to the dose in comparison 
with a suitable reference product or products and an untreated control;  
(ii)  where relevant, effe ct on yield or reduction of loss in storage, in terms of quantity and/or 
quality, in comparison with a suitable reference product or products and an untreated control.  
Where no suitable reference product exists, Member States shall evaluate the performanc e of the 
plant protection product to determine whether there is a consistent and defined benefit under the 
agricultural, plant health and environmental (including climatic) conditions in the area of proposed 
use.  
1.1.5.  Where the product label includes r equirements for use of the plant protection product with other plant 
protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations 
referred to in point s 1.1.1 to 1.1.4 in relation to the information supplied for the tank  mix.  
Where the product label includes recommendations for use of the plant protection product with other 
plant protection products and/or with adjuvants as a tank mix, Member States shall evaluate the 
appropriateness of the mix and of its conditions of u se.  
EN 8  EN 1.2.  Absence of unacceptable effects on plants or plant products  
1.2.1.  Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant 
protection product in accordance with the proposed conditions of use in com parison, where relevant, 
with a suitable reference product or products, where they exist, and/or an untreated control.  
(a) This evaluation shall take into consideration the following information:   
(i) the efficacy data provided for in the Annex to Regulation (EU) No 284/2013 ;  
(ii) other relevant information on the plant protection product such as nature of the 
preparation, dose, method of application, number and timing of applications;  
(iii) all relevant information on the active substance as provided for in of the Annex to 
Regulation (EU) No 283/2013 , including mode of action, vapour pressure, volatility and 
water solubility.   
(b) This evaluation shall include:   
(i)  the nature, frequency, level and duration of observed phytotoxic effects and the 
agricultural, plant health and environmental (including climatic) conditions that affect 
them;   
(ii)  the differences between main cultivars with regard to their sensitivity to phytotoxic 
effects;   
(iii)  the part of the treated crop or plant products where phytotoxic effects are observed;   
(iv)  the adverse impact on the yield of the treated crop or plant products in terms of quantity 
and/or quality;   
(v)  the adverse impact on treated plants or plant pro ducts to be used for propagation, in terms 
of viability, germination, sprouting, rooting and establishment;   
(vi)  where volatile products are concerned, the adverse impact on adjacent crops.  
1.2.2.  Where the available data indicate that the active substa nce or significant metabolites, degradation and 
reaction products persist in soils and/or in or on plant substances in significant quantities after use of 
the plant protection product in accordance with the proposed conditions of use, Member States shall 
evaluate the degree of adverse effects on subsequent crops. This evaluation shall be carried out as 
specified in point  1.2.1.  
1.2.3.  Where the product label includes requirements for use of the plant protection product with other plant 
protection products  or with adjuvants as a tank mix, the evaluation as specified in point  1.1.1 shall be 
carried out in relation to the information supplied for the tank mix.  
1.3.  Impact on vertebrates to be controlled  
Where the proposed use of the plant protection produc t aims to have an effect on vertebrates, 
Member States shall evaluate the mechanism by which this effect is obtained and the observed effects 
on the behaviour and health of the target animals; when the intended effect is to kill the target animal 
they shal l evaluate the time necessary to obtain the death of the animal and the conditions under 
which death occurs.  
This evaluation shall take into consideration the following information:  
(i)  all relevant information as provided for in the Annex to Regulation  (EU) No 283/2013  and the 
results of the evaluation thereof, including the toxicological and metabolism studies;  
(ii)  all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013 , including toxicological studies and efficacy data.   
EN 9  EN 1.4.  Impact on human or animal health  
1.4.1.  Impact on human or animal health arising from the plant protection product  
1.4.1.1.  Member States shall evaluate operator exposure to the active substanc e and/or to toxicologically 
relevant compounds in the plant protection product likely to occur under the proposed conditions of 
use (including in particular dose, application method and climatic conditions) using by preference 
realistic data on exposure an d, if such data are not available, a suitable, validated calculation model.  
(a) This evaluation shall take into consideration the following information:   
(i) the toxicological and metabolism studies as provided for in the Annex to Regulation (EU) 
No 283/2013  and the results of the evaluation thereof including the acceptable operator 
exposure level (AOEL). The acceptable operator exposure level is the maximum amount 
of active substance to which the operator may be exposed without any adverse health 
effects. The  AOEL is expressed as milligrams of the chemical per kilogram body weight 
of the operator. The AOEL is based on the highest level at which no adverse effect is 
observed in tests in the most sensitive relevant animal species or, if appropriate data are 
available, in humans;  
(ii) other relevant information on the active substances such as physical and chemical 
properties;   
(iii)  the toxicological studies provided for in the Annex to Regulation (EU) No 284/2013 , 
including where appropriate dermal absorption studies;   
(iv)  other relevant information as provided for in the Annex to Regulation (EU) No  284/2013  
such as:   
– composition of the preparation,  
– nature of the preparation,  
– size, design and type of packaging,  
– field of use and nature of crop or target,  
– method of application including handling, loading and mixing of product,  
– exposure reduction measures recommended,  
– protective clothing recommendations,  
– maximum application rate,  
– minimum spray application volume stated on the label,  
– number and timing of applications.  
(b) This evaluation shall be made for each type of application method and application equipment 
proposed for use of the plant protection product as well as for the different types and sizes of 
containers to be used, taking account of mixing, loa ding operations, application of the plant 
protection product and cleaning and routine maintenance of application equipment.   
1.4.1.2.  Member States shall examine information relating to the nature and characteristics of the packaging 
proposed with particu lar reference to the following aspects:  
– the type of packaging,  
– its dimensions and capacity,  
– the size of the opening,  
– the type of closure,   
EN 10  EN – its strength, leakproofness and resistance to normal transport and handling,  
– its resistance to and compatibility with the contents.  
1.4.1.3.  Member States shall examine the nature and characteristics of the protective clothing and equipment 
proposed with particular reference to the following aspects:  
– obtainability and suitability ,  
– ease of wearing taking into account physical stress and climatic conditions.  
1.4.1.4.  Member States shall evaluate the possibility of exposure of other humans (bystanders or workers 
exposed after the application of the plant protection product) or anim als to the active substance 
and/or to other toxicologically relevant compounds in the plant protection product under the proposed 
conditions of use.  
 This evaluation shall take into consideration the following information:  
(i)  the toxicological and metabolism studies on the active substance as provided for in the Annex 
to Regulation (EU) No 283/2013  and the results of the evaluation thereof, including the 
acceptable operator exposure level;  
(ii)  the toxicological studies provi ded for in the Annex to Regulation (EU) No 284/2013 , including 
where appropriate dermal absorption studies;  
(iii)  other relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013  such as:  
– re-entry pe riods, necessary waiting periods or other precautions to protect humans and 
animals,  
– method of application, in particular spraying,  
– maximum application rate,  
– maximum spray application volume,  
– composition of the preparation,  
– excess remaining on plants and plant products after treatment,  
– further activities whereby workers are exposed.  
1.4.2.  Impact on human and animal health arising from residues  
1.4.2.1.  Member States shall evaluate the specific information on toxicology as provided for in the Annex to 
Regulation (EU) No 283/2013  and in particular:  
– the determination of an acceptable daily intake (ADI),  
– the identification of metabolites, degradation and reaction products in treated plants or plant 
products,  
– behaviour of residues of the active substa nce and its metabolites from the time of application 
until harvest, or in the case of postharvest uses, until outloading of stored plant products.  
1.4.2.2.  Prior to evaluating the residue levels in the reported trials or in products of animal origin Membe r 
States shall examine the following information:  
– data on the proposed good agricultural practice, including data on application as provided for in 
the Annex to Regulation (EU) No 284/2013  and proposed pre -harvest intervals for envisaged 
uses, or withhold ing periods or storage periods, in the case of post -harvest uses,  
– nature of the preparation,   
EN 11  EN – analytical methods and the residue definition.  
1.4.2.3.  On the basis of suitable statistical models Member States shall evaluate the residue levels observed in 
the reported trials. This evaluation shall be made for each proposed use and shall take into 
consideration:  
(i) the proposed conditions of use of the p lant protection product;  
(ii)  the specific information on residues in or on treated plants, plant products, food and feed as 
provided for in the Annex to Regulation (EU) No 284/2013  and the distribution of residues 
between edible and non -edible parts;  
(iii)  the specific information on residues in or on treated plants, plant products, food and feed as 
provided for in the Annex to Regulation (EU) No 283/2013  and the results of the evaluation 
thereof;  
(iv)  the realistic possibilities of extrapolating dat a from one crop to another.  
1.4.2.4. Member States shall evaluate the residue levels observed in products of animal origin, taking into 
consideration the information provided for in point  8.4 of Part A of the Annex to Regulation (EU) 
No 284/2013  and residues resulting from other uses.  
1.4.2.5.  Member States shall estimate the potential exposure of consumers through diet and, where relevant, 
other ways of exposure, using a suitable calculation model. This evaluation shall take account, where 
relevant, of other sources of information such as other authorised uses of plant protection products 
containing the same active substance or which give rise to the same residues.  
1.4.2.6.  Member States shall, where relevant, estimate the exposure of animals, taking into account the 
residue levels observed in treated plants or plant products intended to be fed to animals.  
1.5.  Influence on the environment  
1.5.1.  Fate and distribution in the environment  
In the evaluation of the fate and distribution of the plant protection product in the environment, 
Member States shall have regard to all aspects of the environment, including biota, and in particular 
to the following:  
1.5.1.1.  Member States shall evaluate the possibility of the plant protection product reac hing the soil under 
the proposed conditions of use; if this possibility exists they shall estimate the rate and the route of 
degradation in the soil, the mobility in the soil and the change in the total concentration (extractable 
and non -extractable5 of th e active substance and of relevant metabolites, degradation and reaction 
products that could be expected in the soil in the area of envisaged use after use of the plant 
protection product in accordance with the proposed conditions of use.  
This evaluation s hall take into consideration the following information:  
(i)  the specific information on fate and behaviour in soil as provided for in the Annex to 
Regulation (EU) No 283/2013  and the results of the evaluation thereof;  
(ii)  other relevant information on the active substance such as:  
– molecular weight,  
– solubility in water,  
                                                 
5 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 natura l products.   
EN 12  EN – octanol/water partition coefficient,  
– vapour pressure,  
– volatilisation rate,  
– dissociation constant,  
– photodegradation rate and identity of breakdown prod ucts,  
– hydrolysis rate in relation to pH and identity of breakdown products.  
(iii)  all information on the plant protection product as provided for in the Annex to Regulation 
(EU) No  284/2013 , including the information on distribution and dissipation in so il;  
(iv)  where relevant, other authorised uses of plant protection products in the area of proposed use 
containing the same active substance or which give rise to the same residues.  
1.5.1.2.  Member States shall evaluate the possibility of the plant prot ection product reaching the groundwater 
under the proposed conditions of use; if this possibility exists, they shall estimate, using a suitable 
calculation model validated at EU level, the concentration of the active substance and of relevant 
metabolites, degradation and reaction products that could be expected in the groundwater in the area 
of envisaged use after use of the plant protection product in accordance with the proposed conditions 
of use.  
As long as there is no validated EU calculation model, Me mber States shall base their evaluation 
especially on the results of mobility and persistence in soil studies as provided for in the Annex to 
Regulation (EU) No  283/2013  and to Regulation (EU) No 284/2013 .  
This evaluation shall also take into consideratio n the following information:  
(i)  the specific information on fate and behaviour in soil and water as provided for in the Annex to 
Regulation (EU) No 283/2013  and the results of the evaluation thereof;  
(ii)  other relevant information on the active substance such as:  
– molecular weight,  
– solubility in water,  
– octanol/water partition coefficient,  
– vapour pressure,  
– volatilisation rate,  
– hydrolysis rate in relation to pH and identity of breakdown products,  
– disso ciation constant;  
(iii)  all information on the plant protection product as provided for in the Annex to Regulation (EU) 
No 284/2013 , including the information on distribution and dissipation in soil and water;  
(iv)  where relevant, other authorised uses  of plant protection products in the area of envisaged use 
containing the same active substance or which give rise to the same residues;  
(v)  where relevant, data on dissipation including transformation and sorption in the saturated zone;  
(vi)  where relevant, data on the procedures for drinking water abstraction and treatment in the area 
of envisaged use;  
(vii)  where relevant, monitoring data on the presence or absence of the active substance and relevant 
metabolites, degradation or reaction p roducts in groundwater as a result of previous use of plant  
EN 13  EN protection products containing the same active substance or which give rise to the same 
residues; such monitoring data shall be interpreted in a consistent scientific way.  
1.5.1.3.  Member States shall evaluate the possibility of the plant protection product reaching surface water 
under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable 
calculation model validated at EU level, the short -term and long -term predicted concentration of the 
active substance and of metabolites, degradation and reaction products that could be expected in the 
surface water in the area of envisaged use after use of the plant protection product in accordance with 
the proposed cond itions of use.  
If there is no validated EU calculation model, Member States shall base their evaluation especially on 
the results of mobility and persistence in soil studies and the information on run -off and drift as 
provided for in the Annex to Regulati on (EU) No 283/2013  and to Regulation (EU) No 284/2013 .  
This evaluation shall also take into consideration the following information:  
(i)  the specific information on fate and behaviour in soil and water as provided for in the Annex to 
Regulation (EU) No  283/2013  and the results of the evaluation thereof;  
(ii)  other relevant information on the active substance such as:  
– molecular weight,  
– solubility in water,  
– octanol/water partition coefficient,  
– vapour pressure,  
– volatilisation rate,  
– hydrolysis rate in relation to pH and identity of breakdown products,  
– dissociation constant;  
(iii) all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013 , including the information on distribution and dissipa tion in soil 
and water;  
(iv)  possible routes of exposure:  
– drift,  
– run-off,  
– overspray,  
– discharge via drains,  
– leaching,  
– deposit from  the atmosphere;  
(v)  where relevant, other authorised uses of plant protection products in the area of envisaged use 
containing the same active substance or which give rise to the same residues;  
(vi)  where relevant, data on the procedures for drinking water abstraction and t reatment in the area 
of envisaged use.  
1.5.1.4.  Member States shall evaluate the possibility of the plant protection product being dissipated in the air 
under the proposed conditions of use; if this possibility exists they shall make the best possible 
estimation, using where appropriate a suitable, validated calculation model, of the concentration of 
the active substance and of relevant metabolites, degradation and reaction products that could be  
EN 14  EN expected in the air after use of the plant protection produc t in accordance with the proposed 
conditions of use.  
This evaluation shall take into consideration the following information:  
(i) the specific information on fate and behaviour in soil, water and air as provided for in the 
Annex to Regulation (EU) No 283/2013  and the results of the evaluation thereof;  
(ii)  other relevant information on the active substance such as:  
– vapour pressure,  
– solubility in water,  
– hydrolysis rate in relation to pH and identity of breakdown products,  
– photochemical degradation  in water and air and identity of breakdown products,  
– octan ol/water partition coefficient;  
(iii) all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013 , including the information on distributio n and dissipation in air.  
1.5.1.5.  Member States shall evaluate the procedures for destruction or decontamination of the plant 
protection product and its packaging.  
1.5.2.  Impact on non -target species  
When calculating toxicity/exposure ratios Member Sta tes shall take into consideration toxicity to the 
most sensitive relevant organism used in the tests.  
1.5.2.1.  Member States shall evaluate the possibility of exposure of birds and other terrestrial vertebrates to 
the plant protection product under the pr oposed conditions of use; if this possibility exists they shall 
evaluate the extent of the short -term and long -term risk to be expected for these organisms, including 
their reproduction, after use of the plant protection product in accordance with the prop osed 
conditions of use.  
(a) This evaluation shall take into consideration the following information:  
(i) the specific information relating to toxicological studies on mammals and to the effects 
on birds and other non -target terrestrial vertebrates, including effects on reproduction, 
and other relevant information concerning the active substance as provided fo r in the 
Annex to Regulation (EU) No 283/2013  and the results of the evaluation thereof;  
(ii)  all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013 , including the information on effects on bi rds and other 
non-target terrestrial vertebrates;  
(iii)  where relevant, other authorised uses of plant protection products in the area of envisaged 
use containing the same active substance or which give rise to the same residues.  
(b) This evaluation shall i nclude:   
(i)  the fate and distribution, including persistence and bioconcentration, of the active 
substance and of relevant metabolites, breakdown and reaction products in the various 
parts of the environment after application of the plant protection prod uct;  
(ii)  the estimated exposure of the species likely to be exposed at the time of application or 
during the period that residues are present, taking into account all relevant routes of 
exposure such as ingestion of the formulated product or treated foo d, predation on 
invertebrates, feeding on vertebrate prey, contact by overspraying or with treated 
vegetation;   
EN 15  EN (iii)  a calculation of the acute, short -term and, where necessary, long -term toxicity/exposure 
ratio. The toxicity/exposure ratios are defined as respectively the quotient of LD50, LC50 
or non  observable effects of concentration (NOEC) expressed on an active substance 
basis and the estimated exposure expressed in mg/kg body weight.  
1.5.2.2.  Member States shall evaluate the possibility of exposure  of aquatic organisms to the plant protection 
product under the proposed conditions of use; if this possibility exists they shall evaluate the degree 
of short -term and long -term risk to be expected for aquatic organisms after use of the plant protection 
product in accordance with the proposed conditions of use.  
(a) This evaluation shall take into consideration the following information:  
(i)  the specific information relating to the effects on aquatic organisms as provided for in the 
Annex to Regulation (EU) N o 283/2013  and the res ults of the evaluation thereof;  
(ii)  other relevant information on the active substance such as:  
– solubility in water,  
– octanol/water partition coefficient,  
– vapour pressure,  
– volatilisation rate,  
– KOC,  
– biodegradation in aquatic sys tems and in particular the ready biodegradability,  
– photodegradation rate and identity of breakdown products,  
– hydrolysis rate in relation to pH and identity of breakdown products.  
(iii)  all relevant information on the plant protection product as provided  for in the Annex to 
Regulation (EU) No 284/2013  and in particular the effects on aquatic organisms;  
(iv)  where relevant, other authorised uses of plant protection products in the area of envisaged 
use, containing the same active substance or which give rise to the same residues.  
(b) This evaluation shall include:   
(i)  the fate and distribution of residues of the active substance and of relevant metabolites, 
breakdown and reaction products in water, sediment or fish;  
(ii)  a calculation of the acute toxici ty/exposure ratio for fish and Daphnia. This ratio is 
defined as the quotient of respectively acute LC50 or EC50 and the predicted short -term 
environmental concentration;  
(iii)  a calculation of the algal growth inhibition/exposure ratio for algae. This r atio is defined 
as the quotient of the EC50 and the predicted short -term environmental concentration;  
(iv)  a calculation of the long -term toxicity/exposure ratio for fish and Daphnia. The long -term 
toxicity/exposure ratio is defined as the quotient of the NOEC and the predicted long -
term environmental concentration;  
(v)  where relevant, the bioconcentration in  fish and possible exposure of predators of fish, 
including humans;  
(vi)  if the plant protection product is to be applied directly to surface water, the effect on the 
change of surface water quality, such as pH or dissolved oxygen content.  
1.5.2.3.  Memb er States shall evaluate the possibility of exposure of honeybees to the plant protection product 
under the proposed conditions of use; if this possibility exists they shall evaluate the short -term and  
EN 16  EN long-term risk to be expected for honeybees after use of the plant protection product in accordance 
with the proposed conditions of use.  
(a) This evaluation shall take into consideration the following information:   
(i) the specific information on toxicity to honeybees as provided for in the Annex to 
Regulation (EU) No 283/2013  and the results of the evaluation thereof;  
(ii)  other relevant information on the active substance such as:  
– solubility in water,  
– octanol/water  partition coefficient,  
– vapour pressure,  
– photodegradation rate and identity of breakdown products,  
– mode of action (e. g. insect growth regulating activity);  
(iii) all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013 , including the toxicity to honeybees;  
(iv) where relevant, other authorised uses of plant protection products in the area of envisaged 
use, containing the same active substance or which give rise to the same residues.  
(b) This eva luation shall include:  
(i)  the ratio between the maximum application rate expressed in grams of active substance 
per hectare and the contact and oral LD50 expressed in μg of active substance per bee 
(hazard quotients) and where necessary the persistence of residues on or, where relevant, 
in the treated plants;  
(ii)  where relevant, the effects on honeybee larvae, honeybee behaviour, colony survival and 
development after use of the plant protection product in accordance with the proposed 
conditions of use .  
1.5.2.4.  Member States shall evaluate the possibility of exposure of beneficial arthropods other than 
honeybees to the plant protection product under the proposed conditions of use; if this possibility 
exists they shall assess the lethal and sublethal e ffects on these organisms to be expected and the 
reduction in their activity after use of the plant protection product in accordance with the proposed 
conditions of use.  
This evaluation shall take into consideration the following information:  
(i)  the sp ecific information on toxicity to honeybees and other beneficial arthropods as provided 
for in the Annex to Regulation (EU) No 283/2013  and the results of the evaluation thereof;  
(ii)  other relevant information on the active substance such as:  
– solubilit y in water,  
– octanol/water partition coefficient,  
– vapour pressure,  
– photodegradation rate and identity of breakdown products,  
– mode of action (e. g. insect growth regulating activity);  
(iii) all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013  such as:  
– effects on beneficial arthropods other than bees,   
EN 17  EN – toxicity to honeybees,  
– available data from biological primary screening,  
– maximum application rate,  
– maximum number and timetable of applications;  
(iv) where relevant, other authorised uses of plant protection products in the area of envisaged use, 
containing the same active substance or which give rise to the same residues.  
1.5.2.5. Member States shall evaluate the possibility of exposure of earthworms and other non -target soil 
macro -organisms to the plant protection product under the proposed conditions of use; if this 
possibility exists they shall evaluate the degree of short -term and long -term risk to be expected to 
these organisms after use of the plant protection product in accordance with the proposed conditions 
of use.  
(a) This evaluation shall take into consideration the following information:   
(i)  the specific information relating to the toxicity of the active substance to earthworms and 
to other non -target soil macro -organisms as provided for in the Annex to Regul ation (EU) 
No 283/2013  and the results of the evaluation thereof;  
(ii)  other relevant information on the acti ve substance such as:  
– solubility in water,  
– octanol/water partition coefficient,  
– Kd for adsorption,  
– vapour pressure,  
– hydrolysis rate in relation to pH and identity of breakdown products,  
– photodegradation rate and identity of breakdown products,  
– DT50 a nd DT 90 for degradation in the soil.  
(iii) all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013 , including the effects on earthworms and other non -target 
soil macro -organisms;  
(iv) where rele vant, other authorised uses of plant protection products in the area of envisaged 
use, containing the same active substance or which give rise to the same residues.  
(b) This evaluation shall include:   
(i)  the lethal and sublethal effects;  
(ii)  the predicte d initial and long -term environmental concentration;  
(iii)  a calculation of the acute toxicity/exposure ratio (defined as the quotient of LC50 and 
predicted initial environmental concentration) and of the long -term toxicity/exposure 
ratio (defined as the quotient of the NOEC and predicted long -term environmental 
concentration);  
(iv)  where relevant, the bioconcentration and persistence of residues in earthworms.   
EN 18  EN 1.5.2.6.  Member States shall, where the evaluation carried out under point  1.5.1.1 does not exclude the 
possibility of the plant protection product reach ing the soil under the proposed conditions of use, 
evaluate the impact on microbial activity such as the impact on nitrogen and carbon mineralisation 
processes in the soil after use of the plant protection product in accordance with the proposed 
conditions  of use.  
This evaluation shall take into consideration the following information:  
(i)  all relevant information on the active substance, including the specific information relating to 
the effects of non -target soil micro -organisms as provided for in the Annex to Regulation (EU) 
No 283/2013  and the results of the evaluation thereof;  
(ii)  all relevant information on the plant protection product as provided for in the Annex to 
Regulation (EU) No 284/2013 , including the effects on non -target soil micro -organisms;  
(iii)  where relevant, other authorised uses of plant protection products in the area of proposed use, 
containing the same active substance or which give rise to the same residues;  
(iv)  all available information from biological primary screening.  
1.6.  Analytical methods  
Member States shall evaluate the analytical methods proposed for postregistration control and 
monitoring purposes, to determine:  
1.6.1.  for formulation analysis:  
 the nature and quantity of the active substance(s) in the plant protection product and, where 
appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co -
formulants.  
This evaluation shall take into consideration the  following information:  
(i) the data on analytical methods as provided for in the Annex to Regulation (EU) No 283/2013  
and the results of the evaluation thereof;  
(ii) the data on analytical methods as provided for in the Annex to Regulation (EU) No 284/2 013 
and in particular:  
– the specificity and linearity of the proposed methods,  
– the importance of interferences,  
– the precision of the proposed methods (intralaboratory repeatability and interlaboratory 
reproducibility);  
(iii) the limit of detection and d etermination of the proposed methods for impurities.  
1.6.2.  for residue analysis:  
the residues of the active substance, metabolites, breakdown or reaction products resulting from 
authorised uses of the plant protection product and which are of toxicologi cal, ecotoxicological or 
environmental significance.  
This evaluation shall take into consideration the following information:  
(i)  the data on analytical methods as provided for in the Annex to Regulation (EU) No 283/2013  
and the results of the evaluation thereof;  
(ii)  the data on analytical methods as provided for in the Annex to Regulation (EU) No 284/2013  
and in particular:  
– the specificity of the proposed methods,   
EN 19  EN – the precision of the proposed methods (intralaborato ry repeatability and interlaboratory 
reproducibility),  
– the recovery rate of the proposed methods at appropriate concentrations;  
(iii)  the limit of detection of the proposed methods;  
(iv)  the limit of determination of the proposed methods.  
1.7.  Physical and chemical properties  
1.7.1.  Member States shall evaluate the actual active substance content of the plant protection product and 
its stability during storage.  
1.7.2.  Member States shall evaluate the physical and chemical properties of the p lant protection product and 
in particular:  
– where a suitable FAO (Food and Agriculture Organisation of the United Nations) specification 
exists, the physical and chemical properties addressed in that specification,  
– where no suitable FAO specification exis ts, all the relevant physical and chemical properties 
for the formulation as referred to in the ‘Manual on the development and use of FAO and WHO 
specifications for plant protection products’.  
This evaluation shall take into consideration the following in formation:  
(i)  the data on the physical and chemical properties of the active substance as provided for in the 
Annex to Regulation (EU) No 283/2013  and the results of the evaluation thereof;  
(ii)  the data on the physical and chemical properties of the plant protection product as provided for 
in the Annex to Regulation (EU) No 284/2013 .  
1.7.3.  Where proposed label claims include requirements or recommendations for use of the plant 
protection product with other plant protection products or adjuvants as a tank mix, the physical and 
chemical compatibility of the products in the mixture must be evaluated.  
2.  DECISION -MAKING   
These principles shall apply without prejudice to the general principles referred to in Section 3 of the 
general introduction.  
2.1.  Efficacy  
2.1.1.  Where the proposed uses include recommendations for the control of or protection against organisms 
which are not considered to be harmful on the basis of experience acquired or scientific evidence 
under normal agricultural, plant health  and environmental (including climatic) conditions in the areas 
of proposed use or where the other intended effects are not considered to be beneficial under those 
conditions, no authorisation shall be granted for those uses.  
2.1.2.  The level, consistency and duration of control or protection or other intended effects must be similar 
to those resulting from the use of suitable reference products. If no suitable reference product exists, 
the plant protection product must be shown to gi ve a defined benefit in terms of the level, consistency 
and duration of control or protection or other intended effects under the agricultural, plant health and 
environmental (including climatic) conditions in the area of proposed use.  
2.1.3.  Where relev ant, yield response when the product is used and reduction of loss in storage must be 
quantitatively and/or qualitatively similar to those resulting from the use of suitable reference 
products. If no suitable reference product exists, the plant protection product must be shown to give a 
consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction  
EN 20  EN of loss in storage under the agricultural, plant health and environmental (including climatic) 
conditions in the area of  proposed use.  
2.1.4.  Conclusions as to the performance of the preparation must be valid for all areas of the Member State 
in which it is to be authorised, and must hold for all conditions under which its use is proposed, 
except where the proposed label specifies that the preparation is intended for use in certain specified 
circumstances (e.g. light infestations, particular soil types or particular growing conditions).  
2.1.5.  Where proposed label claims include requirements for use of the preparation with other specified 
plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and 
comply with the principles referred to in point s 2.1.1 to  2.1.4.  
Where proposed label claims include recommendations for use of the preparation with specified plant 
protection products or adjuvants as a tank mix, Member States shall not accept the recommendations 
unless they are justified.  
2.2.  Absence of una cceptable effects on plants or plant products  
2.2.1.  There must be no relevant phytotoxic effects on treated plants or plant products except where the 
proposed label indicates appropriate limitations of use.  
2.2.2.  There must be no reduction of yield a t harvest due to phytotoxic effects below that which could be 
obtained without the use of the plant protection product, unless this reduction is compensated for by 
other advantages such as an enhancement of the quality of the treated plants or plant produc ts.  
2.2.3.  There must be no unacceptable adverse effects on the quality of treated plants or plant products, 
except in the case of adverse effects on processing where proposed label claims specify that the 
preparation must not be applied to crops to be u sed for processing purposes.  
2.2.4.  There must be no unacceptable adverse effects on treated plants or plant products used for 
propagation or reproduction, such as effects on viability, germination, sprouting, rooting and 
establishment, except where prop osed label claims specify that the preparation should not be applied 
to plants or plant products to be used for propagation or reproduction.  
2.2.5.  There must be no unacceptable impact on succeeding crops, except where proposed label claims 
specify that particular crops, which would be affected, must not be grown following the treated crop.  
2.2.6.  There must be no unacceptable impact on adjacent crops, except where proposed label claims specify 
that the preparation should not be applied when particular sensitive adjacent crops are present.  
2.2.7.  Where proposed label claims include requirements for use of the preparation with other plant 
protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred 
to in point s 2.2.1 to 2.2.6.  
2.2.8.  The proposed instructions for cleaning the application equipment must be both practical and effective 
so that they can be applied with ease to ensure the removal of residual traces of the plant protection 
product which could subsequ ently cause damage.  
2.3.  Impact on vertebrates to be controlled  
An authorisation for a plant protection product intended to eliminate vertebrates shall be granted only 
when:  
– death is synchronous with the extinction of consciousness, or  
– death occurs im mediately, or  
– vital functions are reduced gradually without signs of obvious suffering.  
For repellent products, the intended effect shall be obtained without unnecessary suffering and pain 
for the target animals.   
EN 21  EN 2.4.  Impact on human or animal health  
2.4.1.  Impact on human or animal health arising from the plant protection product  
2.4.1.1.  No authorisation shall be granted if the extent of operator exposure in handling and using the plant 
protection product under the proposed conditions of use, inclu ding dose and application method, 
exceeds the AOEL.  
Moreover, the conditions of the authorisation shall be in compliance with the limit value established 
for the active substance and/or toxicologically relevant compound(s) of the product in accordance 
with Council Directive 98/24/EC6 and in accordance with Directive 2004/37/EC of the European 
Parliament and of the Council7.  
2.4.1.2.  Where the proposed conditions of use require use of items of protective clothing and equipment, no 
authorisation shall be gr anted unless those items are effective and in accordance with the relevant EU 
provisions and are readily obtainable by the user and unless it is feasible to use them under the 
circumstances of use of the plant protection product, taking into account climat ic conditions in 
particular.  
2.4.1.3.  Plant protection products which because of particular properties or if mishandled or misused could 
lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size 
of packagin g, formulation type, distribution, use or manner of use.  
Moreover, those plant protection products may not be authorised for use by non -professional users 
which are classified as:  
(i)  acute toxicity category 1 and 2 for any route of uptake, provided the  ATE (acute toxicity 
estimate) of the product does not exceed 25 mg/kg bw for the oral route of uptake or 
0,25 mg/l/4h for the inhalation of dust, mist or fume;  
(ii)  STOT (single exposure), category 1 (oral), provided their classification is due to the p resence 
of classified substances showing significant non -lethal toxic effects at guidance values below 
25 mg/kg bw;  
(iii)  STOT (single exposure), category 1 (dermal), provided their classification is due to the 
presence of classified substances showing s ignificant non -lethal toxic effects at guidance values 
below 50  mg/kg bw;  
(iv)  STOT (single exposure), category 1 (inhalation of gas/vapour), provided their classification is 
due to the presence of classified substances showing significant non -lethal tox ic effects at 
guidance values below 0,5  mg/l/4h;  
(v)  STOT (single exposure), category 1 (inhalation of dust/mist/fume), provided their classification 
is due to the presence of classified substances showing significant non -lethal toxic effects at 
guidance  values below 0,25  mg/l/4h.  
                                                 
6 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).  
7 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 mean ing of Article 
16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).   
EN 22  EN 2.4.1.4. Waiting and re -entry safety periods or other precautions must be such that the exposure of bystanders 
or workers exposed after the application of the plant protection product does not exceed the AOEL 
levels established for the active substance or toxicologically relevant compound(s) in the plant 
protection product nor any limit values established for those compounds in accordance with the EU 
provisions referred to in point  2.4.1.1.  
2.4.1.5.  Waiting and re -entry safety p eriods or other precautions must be established in such a way that no 
adverse impact on animals occurs.  
2.4.1.6.  Waiting and re -entry periods or other precautions to ensure that the AOEL levels and limit values are 
respected must be realistic; if necessar y special precautionary measures must be prescribed.  
2.4.2.  Impact on human or animal health arising from residues  
2.4.2.1.  Authorisations must ensure that residues occurring reflect the minimum quantities of the plant 
protection product necessary to achi eve adequate control corresponding to good agricultural practice, 
applied in such a manner (including pre -harvest intervals or withholding periods or storage periods) 
that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum.  
2.4.2.2.  Where the new circumstances under which the plant protection product is to be used do not 
correspond to those under which a MRL (maximum residue limit) was established previously, 
Member States shall not grant an authorisation for the plant protection product unless the applicant 
can provide evidence that its recommended use shall not exceed the MRL established under 
Regulation (EC) No 396/2005 of the European P arliament and of the Council8.  
2.4.2.3.  Where a MRL exists Member States shall not grant an authorisation for the plant protection product 
unless the applicant can provide evidence that its recommended use shall not exceed that MRL, or 
unless a new MRL has been established under Regulation (EC) No 396/2005.  
2.4.2.4.  In the cases referred to in point s 2.4.2.2, each application for an authorisation must be accompanied 
by a risk assessment taking into account worst -case potential exposure of consumers in the Member 
State concerned on the basis of g ood agricultural practice.  
Taking into account all registered uses, the proposed use shall not be authorised if the best possible 
estimate of dietary exposure exceeds the ADI.  
2.4.2.5.  Where the nature of residues is affected during processing, a separat e risk assessment may need to be 
carried out under the conditions provided for in point  2.4.2.4.  
2.4.2.6. Where the treated plants or plant products are intended to be fed to animals, residues occurring shall 
not have an adverse effect on animal health.  
2.5.  Influence on the environment  
2.5.1.  Fate and distribution in the environment  
2.5.1.1.  No authorisation shall be granted if the active substance and, where they are of significance from the 
toxicological, ecotoxicological or environmental point of v iew, metabolites and breakdown or 
reaction products, after use of the plant protection product under the proposed conditions of use:  
– during tests in the field, persist in soil for more than 1 year (i.e. DT90 > 1 year and DT50 > 3 
months), or  
– during labor atory tests, form non -extractable residues in amounts exceeding 70 % of the initial 
dose after 100 days with a mineralisation rate of less than 5 % in 100 days,  
                                                 
8 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).   
EN 23  EN unless it is scientifically demonstrated that under field conditions there is no accumulation in soil at 
such levels that unacceptable residues in succeeding crops occur and/or that unacceptable phytotoxic 
effects on succeeding crops occur and/or that there is an unacceptable impact on the environment, in 
accordance with the relevant requirements p rovided for in point s 2.5.1.2, 2.5.1.3, 2.5.1.4 and 2.5.2.  
2.5.1.2.  No authorisation shall be granted if the concentration of the active substance or of relevant 
metabolites, degradation or reaction products in groundwater, may be expected to exceed, as a  result 
of use of the plant protection product under the proposed conditions of use, the lower of the 
following limit values:  
(i)  the maximum permissible concentration laid down by Council Directive 98/83/EC9; or  
(ii)  the maximum concentration laid dow n when approving the active substance in accordance with 
Regulation (EC) No 1107/2009, on the basis of 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 in accordance with 
Regulation (EC) No 1107/2009,  
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is 
not exceeded.  
2.5.1.3.  No authorisation shall be granted if the concentration of the active substance or of relevant 
metabolites, breakdown or reaction products to be expected after use of the plant protection product 
under the proposed conditions of use in surface water:  
– excee ds, where the surface water in or from the area of envisaged use is intended for the 
abstraction of drinking water, concentrations above which compliance with drinking water 
quality established in accordance with Directive 2000/60/EC of the European Parlia ment and of 
the Council10 is compromised, or  
– has an impact deemed unacceptable on non -target species, including animals, in accordance 
with the relevant requirements provided for in point  2.5.2.  
The proposed instructions for use of the plant protection pr oduct, including procedures for cleaning 
application equipment, must be such that the likelihood of accidental contamination of surface water 
is reduced to a minimum.  
2.5.1.4.  No authorisation shall be granted if the airborne concentration of the active s ubstance under the 
proposed conditions of use is such that either the AOEL or the limit values for operators, bystanders 
or workers as referred to in point  2.4.1 are exceeded.  
2.5.2.  Impact on non -target species  
2.5.2.1.  Where there is a possibility of birds and other non -target terrestrial vertebrates being exposed, no 
authorisation shall be granted if:  
– the acute and short -term toxicity/exposure ratio for birds and other non -target terrestrial 
vertebrates is less than 10  on the basis of LD50 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 after use of the plant protection product in 
accordance with the proposed conditions of use,  
– the bioconcentration factor (BCF, related to fat tissue) is greater than 1, unless it is clearly 
established through an appropriate risk assessment that under field conditions no unacceptable 
                                                 
9 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). 
10 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).   
EN 24  EN effects occur — directly or indirectly — after use of the plant protection product in accordance 
with the proposed conditions of use.  
2.5.2.2.  Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:  
– the toxicity/exposure rat io for fish and Daphnia is less than 100 for acute exposure and less 
than 10 for long -term exposure, or  
– the algal growth inhibition/exposure ratio is less than 10, or  
– the maximum bioconcentration factor (BCF) is greater than 1 000 for plant protection pr oducts 
containing active substances which are readily biodegradable or greater than 100 for those 
which are not readily biodegradable,  
unless it is clearly established through an appropriate risk assessment that under field conditions no 
unacceptable impa ct on the viability of exposed species (predators) occurs — directly or indirectly — 
after use of the plant protection product in accordance with the proposed conditions of use.  
2.5.2.3.  Where there is a possibility of honeybees being exposed, no authoris ation shall be granted if the 
hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly 
established through an appropriate risk assessment that under field conditions there are no 
unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development 
after use of the plant protection product in accordance with the proposed conditions of use.  
2.5.2.4.  Where there is a possibility of beneficial arthropods other than honeybees being exposed, no 
authorisation shall be granted if more than 30 % of the test organisms are affected in lethal or 
sublethal laboratory tests conducted at the maximum proposed application rate, unless it is clearly 
established through an appropriate risk assessment that under field conditions there is no 
unacceptable impact on those organisms 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 sh all be substantiated by appropriate data.  
2.5.2.5.  Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the 
acute toxicity/exposure ratio for earthworms 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 earthworm populations are not at risk after use of the plant protection product in 
accordance with the proposed conditions of use.  
2.5.2.6.  Where there is a possibility of non -target soil micro -organisms being exposed, no authorisation shall 
be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by 
more than 25 % after 100 days, unless it is clearly esta blished through an appropriate risk assessment 
that under field conditions there is no unacceptable impact on microbial activity after use of the plant 
protection product in accordance with the proposed conditions of use, taking account of the ability of 
micro-organisms to multiply.  
2.6.  Analytical methods  
The methods proposed must reflect the state of the article. The following criteria must be met in 
order to permit validation of the analytical methods proposed for post -registration control and 
monitor ing purposes:  
2.6.1.  for formulation analysis:  
the method must be able to determine and to identify the active substance(s) and where appropriate 
any toxicologically, ecotoxicologically or environmentally significant impurities and co -formulants;   
EN 25  EN 2.6.2 . for residue analysis:  
(i)  the method must be able to determine and confirm residues of toxicological, ecotoxicological 
or environmental significance;  
(ii)  the mean recovery rates should be between 70 % and 110 % with a relative standard deviation 
of ≤ 20 %;  
(iii)  the repeatability must be less than the following values for residues in foodstuffs:  
Residue level  
mg/kg  Difference  
mg/kg  Difference  
in %  
0,01 0,005  50 
0,1 0,025  25 
1 0,125  12,5 
>1  12,5 
Intermediate values shall be determined by interpolation from a log -log graph;  
(iv)  the reproducibility must be less than the following values for residues in foodstuffs:  
Residue level  
mg/kg  Difference  
mg/kg  Difference  
in %  
0,01 0,01 100 
0,1 0,05 50 
1 0, 25  25 
>1  25 
Intermediate values are determined by interpolation from a log -log graph;  
(v)  in the case of residue analysis in treated plants, plant products, foodstuffs, feedingstuffs or 
products of animal origin, except where the MRL or the proposed MRL is at the limit of 
determination, the sensitivity of the methods proposed must satisfy the f ollowing criteria:  
Limit of determination in relation to the proposed provisional or EU MRL:  
MRL  
(mg/kg)  limit of determination  
(mg/kg)  
> 0,5  0,1 
0,5 – 0,05 0,1 – 0,02 
< 0,05  LMR × 0,5   
EN 26  EN 2.7.  Physical and chemical properties  
2.7.1  Where an appropriate FAO specification exists, that specification must be met.  
2.7.2.  Where no appropriate FAO specification exists, the physical and chemical properties of the product 
must meet the following requirements  
(a) Chemical properties:   
Throughout the shelf -life period, the difference between the stated and the actual content of the 
active substance in the plant protection product must not exceed the following values:  
Declared content in g/kg or g/l at 
20 °C Tolerance  
up to 25  ± 15 % homogeneous formulation  
± 25 % non -homogeneous formulation  
more than 25 up to 100  ± 10 %  
more than 100 up to 250  ± 6 %  
more than 250 up to 500  ± 5 %  
more than 500  ± 25 g/kg or ± 25 g/l  
(b) Physical properties:   
The plant protection product must fulfil the physical criteria (including storage stability) 
specified for the relevant formulation type in the ‘Manual on the development and use of FAO 
and WHO specifications for plant protection products’.  
2.7.3.  Where the proposed label claims include requirements or recommendations for use of the preparation 
with other plant protection products or adjuvants as a tank mix and/or where the proposed label 
includes indications on the compatibility of the preparation with o ther plant protection products as a 
tank mix, those products or adjuvants must be physically and chemically compatible in the tank mix.   
EN 27  EN PART B 
Uniform principles for evaluation and authorisation of plant protection products 
containing an active substance that is a micro -organism  
 
Definitions  
1. Evaluation  
1.1. Identity and manufacturing information  
1.1.1. Identity of the micro -organism contained in the plant protection product  
1.1.2. Quality control of the producti on of the micro -organism contained in the plant 
protection product  
1.1.3. Identity of the plant protection product  
1.1.4. Quality control of the plant protection product  
1.2. Biological, physical, chemical  and technical properties  
1.2.1. Biological properties of the micro -organism in the plant protection product  
1.2.2. Physical, chemical and technical properties of the plant protection product  
1.3. Efficacy  
1.4. Identification/detection and quantification methods  
1.4.1. Analytical methods for the pl ant protection product  
1.4.1.1. Analytical methods for micro -organisms  
1.4.1.2. Analytical methods for metabolites of concern, relevant impurities, additives, co -
formulants, safeners and syner gist 
1.4.2. Analytical methods fo r the determination of residues  and density of the micro -organism  
1.4.2.1. Density of the micro -organism  
1.4.2.2. Residues of m etabolites of concern  
1.5. Impact on human and animal health  
1.5.1. Effects on human or animal health arising from the plant protection product  
1.5.2. Effects o n human or animal health arising from residues of metabolites of concern  
1.6. Environmental occurrence of the micro -organism, including fate and behaviour of 
metabolites of concern  
1.6.1. Environmental occurrence of the micro -organism  
1.6.2 Environmental fate and behaviour of the metabolite s of concern  
1.7. Effects on non -target organisms  
1.8. Conclusions and proposals  
2. Decision -making  
2.1. Identity   
EN 28  EN 2.2. Biological and technical properties  
2.3. Efficacy and absence of  unacceptable effects on plants and plant products  
2.3.1. Efficacy  
2.3.2. Absence of unacceptable effects on plants and plant products  
2.4 Identification/detect ion and quantification methods  
2.5. Impact on human and animal health  
2.5.1. Effects on human and animal health arising from the plant protection product  
2.5.2.  Effects on human and animal health arising from residues  
2.6. Fate and behaviour in the environment  
2.7. Effects on non -target organisms  
   
EN 29  EN Definitions  
For the purpose s of Part B , in addition to general introduction, the following definitions 
apply:  
(1) ‘strain ’ means  a genetic variant of an organism in its taxonomic rank (species) that 
is made up of the descendants of a single isolation in pure culture and usually is 
made up of a s uccession of cultures ultimately derived from an initial single colony ; 
(2)  ‘Microbial Active Substance As Manufactured ’ (‘MASAM ’) means the  outcome 
of the manufacturing process of the micro -organism (s) intended to be used as active 
substance in plant pro tection products, consist ing of the micro -organism(s) and any 
additives, metabolites (including metabolites of concern ), chemical impurities  
(including relevant impurities) , contaminating micro -organisms (including relevant 
contaminating micro -organisms) and the spent medium/rest fraction  resulting from 
the production process or, i n case of a continuous  manufacturing  process es a strict 
separation between the manufacturing of the micro -organism (s) and the production 
process of the plant protection product  is not possible,  a non -isolated intermediate ; 
(3) ‘relevant contaminating micro -organism ’ means  a pathogenic/infective micro -
organism unintentionally present in the MASAM ; 
(4)  ‘spent medium/rest fraction ’ means  the fraction of the MASAM excluding the 
micro -organism (s), metabolites of concern , additives, relevant contaminating micro -
organisms,  and relevant impurities consisting of remaining or transformed starting 
materials ; 
(5)  ‘starting material ’ means  substances used in the manufacturing process as substrate 
and/or buffering agent for the production  process  of the MASAM;  
(6)  ‘ecological niche ’ means  an ecological function and actual physical spaces occupied 
by a particular species within the community  or ecosystem ;  
(7)  ‘host range ’ means  the range of different biological host -species that can be infected 
by a microbial species or strain ;  
(8)  ‘infectivity ’ means  the ability of a micro -organism to cause an infection ;  
(9)  ‘infection ’ means  the non-opportunistic introduction or entry of a micro -organism 
into a susceptible host, where the micro -organism is able  to reproduce to form new 
infective units  and persist in the host, whether or not it causes pathological effects or 
disease ;  
(10)  ‘pathogenicity ’ means  the non-opportunistic ability of a micro -organism  to inflict 
injury and damage to the host upon  infection ; 
(11)  ‘non-opportunistic’ means a condition under which a micro -organism exert s an 
infection or inflict s injury or damage when the immune system of the host is not 
impaired by an unrelated cause ;  
(12)  ‘virulence ’ means  the degree of pathogenicity that a pathogenic micro -organism is 
able exert in the host ;  
(13)  ‘metabolite of concern ’ means  a metabolite pr oduced by the micro -organism under 
assessment, with known toxicity or known relevant antimicrobial activity , which  is 
present in the MASAM at levels that may present a risk to human  health , animal  
health  or the environment , and/or for which it cannot be ad equately justified that in-
situ production of the metabolite is not relevant for the risk assessment ;  
EN 30  EN (14) ‘in-situ production’  means the production of a metabolite by the micro -organism 
after application of the plant protection product containing that micro -organism;  
(15)  ‘antibiosis ’ means  a relationship between two or more species in which one species 
is actively harmed (as by  the production of toxins by the harming species);  
(16)  ‘antimicrobial resistance ’ (‘AMR ’) means  the intrinsic or acquired  ability of a 
micro -organism to multiply in the presence of an antimicrobial agent  at 
concentrations which are relevant for therapeutic measures in human or veterinary 
medicine, making that substance therapeutically ineffective ;  
(17)  ‘antimicrobial agent ’ means  any antibacterial, antiviral, antifungal, anthelmintic or 
antiprotozoal ag ents that is a  substance of natural, semi -synthetic, or synthetic origin 
that at in vivo  concentrations kills or inhibits the growth of micro -organisms by 
interacting with a specific target;  
(18)  ‘acquired antimicrobial resistance ’ means a  non-intrinsic and acqui red novel 
resistance enabl ing a micro -organism  to survive or multiply in the presence of an 
antimicrobial agent at concentrations higher than that which inhibits wild type strains 
of the same species ; 
(19)  ‘intrinsic antimicrobial resistance ’ means all inherent properties of a microbial 
species that limit the action of antimicrobial  agent s thereby allowing them to survive 
and multiply at relevant therapeutic concentrations of an antimicrobial agent . 
Inherent properties of micro -organisms are consi dered not transferable and can 
include structural characteristics such as  lack of drug targets, the impermeability of 
cellular envelopes, activity of multidrug efflux pumps, or metabolic enzymes. An 
antimicrobial resistance gene is considered intrinsic if it is located on a chromosome 
in the absence of mobile genetic element and shared by the majority of wild type 
strains of the same species ;  
(20)  ‘relevant antimicrobial activity ’ means the  antimicrobial activity caused by 
relevant antimicrobial agents;  
(21)  ‘relevant antimicrobial  agent s’ means  all antimicrobial agents important for 
therapeutic use in humans or animals , as described in the  latest  available  version s at 
the time of submission of the dossier :  
– in a list adopted by means of Commission Regula tion (EU) 2021/176011 in 
accordance with Article 37(5) of Regulation (E U) No 2019/6 of the European 
Parliament and of the Council12, or 
– by the World Health Organisation13 in the lists of Critically Important 
Antimicrobials, Highly Important Antimicrobials and Important Antimicrobials 
for Human Medicine . 
1.  EVALUATION  
Member States shall consider during the evaluations that : 
                                                 
11 Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 
2019/6 o f 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). 
12 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 ). 
13 https://ap ps.who.int/iris/bitstream/handle/10665/312266/9789241515528 -eng.pdf?ua=1 .  
EN 31  EN – micro -organisms are living organisms capable of  replication  that may be 
naturally present in high numbers in the environment, and that the specific 
micro -organism under assessment may already be occurring in relevant 
European environments at a relevant taxonomic level ,  
– the biological properties and th e mode of action of a micro -organism are the 
first and crucial step in the evaluation process, because they define which are 
the relevant aspects and elements on which the evaluation should focus, and 
also which aspects are not relevant for a robust inform ed decision making , 
– extensive information on the micro -organism under assessment (at the relevant 
taxonomic level) may be available in the public domain (e.g. history of use, 
peer-reviewed scientific literature). Best use of this information should be 
made . Where applicable, regulatory experimental studies may be needed to 
determine the specific properties of the micro -organism under evaluation.  
Metabolism is inherent of all living organisms. If secondary metabolites that are 
known to be hazardous to humans  or other non -target organisms have been identified 
during the assessment of the micro -organism , the evaluation of a plant protection 
product containing this micro -organism  shall include an assessment of the risk due to 
exposures to such metabolites expect ed from the intended use.  
Member States shall implement the following principles in the evaluation of the data 
and information submitted in support of applications, without prejudice to the 
general principles prescribed in Section 2 of the general introduc tion. 
1.1.  Identity and manufacturing information  
An overall assessment is necessary  for those data on the identity and manufacturing 
information required according to Section  1 of Part B of the Annex to Regulation  
(EU) No 283/2013 and Section  1 of P art B of the Annex to Regulation  (EU) 
No 284/2013 . 
1.1.1.  Identity of the micro -organism contained in the plant protection product  
Member States shall verify t he identity of the micro -organism that is the active 
substance based on information provided under point  1.3 of Part B of the Annex to 
Regulation  (EU) No 283/2013.  
Furthermore, Member States shall evaluate if the MASAM used for manufacturing 
of the plant protection product complies with specification of the MASAM 
characteri sed and quantified as required in point  1.4 of Part B of the Annex to 
Regulation  (EU) No 283/2013 (e.g. in terms of content and identity of the micro -
organism (s), metabolites of concerns, additives, relevant contaminating micro -
organisms, and releva nt impurities) . 
1.1.2.  Quality control of the production of the micro -organism contained in the plant 
protection product  
Member States shall evaluate t he quality assurance criteria proposed for the 
production of the active substance. Process control, good  manufacturing practice, 
operational practices, process flows, cleaning practices, microbial monitoring and 
hygiene conditions sh all be present and ensure stable  quality of the MASAM.  
1.1.3.  Identity of the plant protection product  
Member States shall ev aluate the detailed quantitative and qualitative information 
provided on the composition of the plant protection product as required in point  1.4,  
EN 32  EN e.g. micro -organism (active substance), metabolites of concern, relevant impurities, 
relevant contaminating m icro-organisms, co -formulants, safeners and synergists.  
1.1.4.  Quality control of the plant protection product  
Member States shall evaluate t he quality assurance criteria proposed , in particular 
whether strict maintenance of environmental conditions and quality control analysis 
during the manufacturing process have been assured by the producer, in order to 
ensure compliance with  the limits for relevant contaminating micro -organisms,  
relevant impurities and metabolites of concern.   
1.2.  Biological, physical, chemical and technical properties   
Member States shall carry out a n overall assessment of the information  on biological, 
physical, chemical, and technical properties of the plant  protection product provided 
under Section  2 of Part B of the Annex to Regulation  (EU) No 283/2013 and Section  
2 of Part B of the Annex to Regulation  (EU) No  284/2013 . 
1.2.1.  Biological properties of the micro -organism in the plant protection product  
1.2.1.1. Member States shall evaluate i nformation on the origin, occurrence and history of 
use of the micro -organism contained the plant protection product, giving particular 
relevance to both the location from which the strain was isolated, and the 
geographic al distribution of the micro -organism at the relevant  highest  taxonomic 
level in relevant E uropean  environments.  
1.2.1.2.  Member States shall evaluate i nformation on the ecology and the life cycle of the 
micro -organism , taking also into consideration the  population densities  of the micro -
organism in relation to host densities  as provided for  in point  2.3 of Part B of the 
Annex to Regulation  (EU) No 283/2013. In particular, for bacteriophages, the 
lysogenic and lytic properties of the virus shall be evaluat ed.  
1.2.1.3.  Member States shall evaluate information on the mode of action on the target 
organisms for the plant protection product to identify potential risks and function  of 
the active substance  that is a micro -organism  according to  the proposed condit ions of 
use. In particular, Member States shall evaluate the role of possible infectiv ity, 
pathogenicity, toxicity and relevant antimicrobial activity in the mode of action 
against the target organism. If applicable, factors that enhance the 
pathogenicity/ virulence of  a micro -organism  and environmental factors affecting a 
pathogenic mode of action shall be described.  
Information on the mode of action can be a very valuable tool in identifying potential 
risks and purpose of the micro -organism in the plant pr otection product.  
Aspects to be considered in the evaluation are, for instance:  
(a)  invertebrate pathogenicity ;  
(b)  parasitisation ; 
(c)  competition f or the  ecological niche (e.g. nutrients, habitats);   
(d)  endophytic growth ; 
(e)  interference with the virulence of a pathogenic target organism;   
(f)  induction of plant defen ce;  
(g) antibiosis .  
EN 33  EN 1.2.1.4.  Member States shall evaluate d ata provided on the host range of the micro -organism, 
taking into account any available information on the relationship of the micro -
organism to known pathogens to humans, animals, plants and other non -target 
species, at the most appropriate taxonomic level.  
1.2.1.5.  Member States shall evaluate i nformation on growth requirements , by defining 
limiting factors e.g. UV light, humidity, pH , temperatur es and other relevant agro -
environmental conditions influencing the growth of the micro -organism.  
1.2.1.6.  Member States shall evaluate t he genetic stability of a micro -organism that is a non-
virulent variant of a plant pathogen virus , taking into consider ation the likelihood of 
the micro -organisms to regain virulence, and the risk eventually caused by this 
occurrence.  
1.2.1.7.  In order to determine whether the micro -organism produces metabolites of concern, 
Member States shall take into account the informa tion on production and/or 
relevance of metabolites as provided for in point s 2.8, 6.1, 6.2, 5.5, 7.4 and 8.8 of 
Part B of the Annex to Regulation (EU) No 283/2013.  
1.2.1.8.  For bacteria, Member States shall evaluate information on phenotypical resistance t o 
relevant  antimicrobial  agent s. Member States shall evaluate, t aking into 
consideration that resistance genes in bacteria can be horizontally transmitted, and 
that this may potentially interfere with the effectiveness of relevant antimicrobial 
agents , information on the presence and transferability of genes coding for resistance 
to such antimicrobial  agent s. 
1.2.2. Physical, chemical and technical properties of the plant protection product  
1.2.2.1.  Member States shall evaluate s helf-life and storage stability of the plant protection 
product, taking into account the packaging, optimal (recommended) storage 
temperature,  and light conditions. Possible changes in composition due to growth or 
decline of the micro -organism or of relevant contaminating micro -organisms, or the 
production of metabolites of concern during storage, etc., shall be considered.  
1.2.2.2.  Member States shall evaluate the physical and chemical properties of the plant 
protection product and the retention of these characteristics after s torage and take 
into consideration, unless a suitable FAO specification exists, all relevant physical 
and chemical properties o f the plant protection product.  
1.2.2.3.  Where the proposed label include s requirements or recommendations for use of the 
plant p rotection product in combination with other plant protection products or 
adjuvants as a tank mix,  Member states shall evaluate whether  the plant protection 
product is physically and chemically compatible with those other plant protection 
products  or adjuva nts in the tank mix . 
1.3.  Efficacy  
Member States shall evaluate  the efficacy  of the plant protection product based on  
those data submitted in accordance with Section  6 of P art B of the Annex to 
Regulation (EU) No  284/2013 .  
EN 34  EN 1.3.1.  Where the proposed use c oncerns the control of or protection against an organism, 
Member States shall evaluate if the target organism could be a danger to plant health 
under the agricultural and environmental (including climatic) conditions in the area 
of the proposed use.  
1.3.2.  Member States shall evaluate whether significant damage  to plants or plant products  
or loss in yields  could occur under the agricultural and environmental (including 
climatic) conditions in the area of proposed use, if the plant protection product was 
not used.  
1.3.3.  Member States shall evaluate the efficacy data provided for in Part B of the Annex to 
Regulation (EU) No 284/2013 for the plant protection product , having regard to the 
degree of control or the extent of the effect desired and to rele vant experimental 
conditions such as:  
(a)  the choice of the crop or cultivar;   
(b)  the agricultural and environmental (including climatic) conditions (if necessary 
for a specific use such data/information should also be given for the time 
before and after applic ation);   
(c)  the presence and density of the target organism;   
(d)  the development stage of crop and target organism;   
(e) the application rate of the plant protection product;   
(f) if required on the label, the application rate of adjuvant to be added;   
(g)  the frequency and timing of the applications;   
(h) the type of application equipment to be used;   
(i) the need for any special cleaning measures for the application equipment 
before and after use.  
1.3.4. Member States shall evaluate the efficacy of the plant protection product under the 
range of agricultural, plant health and environmental (including climatic) conditions 
likely to be encountered in practice in the area of proposed use. The evaluation shall 
include the c ompatibility with integrated pest management. In particular,  
consideration shall be paid to:  
(a) the level, consistency and duration of the effect sought in relation to the 
proposed dose;  
(b) the comparison of the proposed dose with a suitable reference product or 
products, where they exist, and an untreated control;   
(c) where relevant, the effect on yield or reduction of loss in storage, in terms of 
quantity and/or quality, in comparison with a suitable reference product or 
products, where they exist, and an untreated control;  
(d) the risk of occurrence and development of res istance or cross -resistance in 
populations of target organism.  
Where no suitable reference product exists, Member States shall evaluate the 
efficacy of the plant protection product to determine whether there is a consistent and 
defined benefit under the ag ricultural, plant health and environmental (including 
climatic) conditions likely to be encountered in practice in the area of proposed use.   
EN 35  EN 1.3.5.  Member States shall evaluate possible occurrence of adverse effects and their degree, 
on the treated crop a fter use of the plant protection product in accordance with the 
proposed conditions of use in comparison, where relevant, with a suitable reference 
product or products, where they exist, and/or an untreated control.  
(a) This evaluation shall take into consideration the following information:   
(i) efficacy data;  
(ii) other relevant information on the plant protection product such as nature of 
the plant protection product, dose, method of application, number and 
timing of applications, incompatibility wi th other crop treatments;  
(iii) all relevant information on the micro -organism, including biological 
properties e.g. mode of action, survival, specificity of the host range .  
(b) This evaluation shall include:   
(i) the nature, frequency, level and duration of  observed 
phytotoxic/phytopathogenic effects and the agricultural, plant health and 
environmental (including climatic) conditions that affect them;  
(ii) differences between main cultivars with regard to their sensitivity to 
phytotoxic/phytopathogenic effe cts;  
(iii)  the part of the treated crop or plant products where 
phytotoxic/phytopathogenic effects are observed;  
(iv)  adverse impact on the yield of the treated crop or plant products in terms 
of quantity and/or quality, and on transformation (processi ng);  
(v)  adverse impact on treated plants or plant products to be used for 
propagation, in terms of viability, germination, sprouting, rooting and 
establishment;  
(vi)  where micro -organisms are disseminated,  in particular for weed control,  
any adverse i mpact on adjacent crops.  
1.3.6.  Where the proposed label of the plant protection product includes recommendations 
or requirements for the use of the plant protection product with other plant protection 
products and/or adjuvants as a tank mix, Member State s shall make the evaluations 
referred to in point s 1.3.3 to 1.3.5 with regard to  the information supplied for the tank 
mix, and shall evaluate the appropriateness of the mix and of its conditions of use.  
1.3.7.  Member States shall evaluate potential effec ts (e.g. antagonism, fungicidal effects) 
on the activity of the micro -organism after mixing or spraying in sequence (or 
employing other relevant types of applications) with other plant protection products 
in accordance with the instructions proposed by the  applicant on the label.  
1.3.8.  Where the available data indicate that the micro -organism has adverse effects on 
plants, or that metabolites of concern that have adverse effects on plants can persist 
in soil, and/or persist in/on plants in significant qu antities after use of the plant 
protection product in accordance with the proposed conditions of use, Member States 
shall evaluate the degree of adverse effects on succeeding crops, taking into 
consideration the relevant information provided for under point 6.6 of Part B of the 
Annex to Regulation (EU) No  284/2013.  
1.3.9.  Member States shall evaluate potential negative effects of the micro -organism on 
beneficial organisms, either deliberately released, or as part of other practices (e.g.  
EN 36  EN conservation biolo gical control), taking into consideration the relevant information 
provided for under point  6.7 of Part B of the Annex to Regulation (EU) 
No 284/2013.  
1.3.10.  Where the proposed use of a plant protection product is intended to have an effect on 
vertebrate s, Member States shall evaluate the mechanism by which this effect is 
obtained and the observed effects on the behaviour and health of the target animals. 
When the intended effect is to kill the target animal they shall evaluate the time 
necessary to obtai n the death of the animal and the conditions under which death 
occurs.  
This evaluation shall take into consideration the following information:  
(a) all relevant information as provided for under Part B of the Annex to 
Regulation (EU) No  283/2013 and the results of the evaluation thereof, 
including the toxicological studies;  
(b) all relevant information on the plant protection product as provided for under 
Part B of the Annex to Regulation (EU) No 284/2013, including toxicological 
studies and  efficacy data.  
1.3.11.  If there is evidence of development of resistance of the target organism towards the 
plant protection product requiring a resistance management strategy, the Member 
State shall evaluate if the submitted resistance management strate gy, required 
according to point  6.4 of Part B of the Annex to Regulation (EU) No 284/2013, 
addresses this adequately and sufficiently.  
1.4.  Identification/detection and quantification methods  
Member States shall assess data on the i dentification/detection  and quantification 
methods submitted in accordance with  Section  4 of P art B of the Annex to 
Regulation  (EU) No  283/2013 and Section  5 of Part B of the Annex to Regulation  
(EU) No  284/2013 . 
Member States shall evaluate the analytical methods proposed for c ontrol and 
monitoring purposes, of the micro -organism both in the plant protection product and, 
where relevant, in or on edible parts of treated crops. In addition, where relevant, the 
analytical methods relating to metabolites of concern and relevant impu rities present 
in the plant protection product shall also  be evaluated. Appropriate validation data 
shall be provided by the applicant as regards the pre -authorisation analytical methods 
and post -authorisation monitoring methods. Methods that are considere d suitably 
validated for post -authorisation monitoring shall be clearly identified.  
1.4.1.  Analytical methods for the plant protection product  
The evaluation concerning analytical methods for the plant protection product shall 
take into consideration the relevant information provided for under  point  4.1 of Part 
B of the Annex to Regulation (EU) No 283/2013 and under  point  5.1 of Part B of the 
Annex to Regulation (EU) No  284/2013.  
1.4.1.1.  Analytical methods for micro -organisms  
Member States shall evaluate the methods proposed to identify and quantify the 
micro -organism, and especially methods that discriminate that micro -organism from 
closely re lated strains. These methods shall include the most appropriate molecular 
analytical and phenotypic methods, to allow unequivocal distinction between the 
micro -organism under assessment, and other strains belonging to the same species.  
EN 37  EN Member States shall also evaluate the methods proposed to identify and quantify 
relevant contaminating micro -organisms.  
1.4.1.2.  Analytical methods for metabolites of concern, relevant impurities, additives, co -
formulants, safeners and synergist  
Where applicable, Member Sta tes shall evaluate the analytical methods proposed to 
identify and quantify metabolites of concern identified according to point  2.8 of Part 
B of the Annex to Regulation  (EU) 283/2013, relevant impurities, co -formulants, 
safeners and synergists.  
1.4.2.   Analytical methods for the determination of residues  and density of the micro -
organism  
Member States shall take into consideration the relevant information provided for 
under  point  4.2 of Part B of the Annex  to Regulation (EU) No  283/2013 and under  
point  5.2 of Part B of the Annex to Regulation (EU) No  284/2013.  
1.4.2.1. Density  of the micro -organism  
Member States shall evaluate the methods pr oposed to identify and quantify  the 
density  of the micro -organis m, where relevant, on and/or in crop s, in foodstuff s and 
feeding  stuffs, in animal and human body tissues and fluids, in relevant 
environmental compartment .  
1.4.2.2. Residues of metabolites of concern  
Member States shall evaluate the analytical methods proposed to identify and 
quantify  residues  of metabol ites of concern  and relevant impurities and additives , 
where relevant, on and/or in crop s, in foodstuffs and feeding  stuffs, in animal and 
human body tissues and fluids, in relevant environmental compartment.  
1.5.  Impact on human and animal health  
Member States shall evaluate data on human and animal (i.e. species normally fed 
and kept by humans or food -producing animals)  health submitted in accordance with  
Sections 5 and 6 of Part B of the Annex to Regulation  (EU) No  283/2013 and 
Section s 7 and 8  of Part B of the Annex to Regulation  (EU) No  284/2013 . 
The most important aspects that shall be assessed are:  
– infectivity and pathogen icity;  
– toxicity of metabolites of concern, safeners, syne rgists, and relevant impurities;  
– relevant antimicrobial activity of metabolites present in the plant protection 
product;  
– susceptibility to relevant  antimicrobial  agent s to ensure the availability of 
sufficient treatment options in case of an opportunistic infection . 
These aspects comprise  a complex set of interactions between micro -organisms and 
the hosts, and need to be assessed in an integrated way and applying a weight of 
evidence approach.  
An assessment of infectiv ity and pathogenicity is always necessary.   
EN 38  EN 1.5.1. Effects on human or a nimal health arising from the plant protection product  
1.5.1.1.  Availability of sufficient treatment options against the micro -organism contained in 
the plant protection product shall be evaluated.   
1.5.1.2.  For micro -organisms, infectivity and pathogeni city tests on animals may not always 
be suitable for extrapolation to humans due to differences between humans and test 
animals (e.g. immune system, microbiome). Micro -organisms might have  a narrow 
host range, hence it cannot always be assumed that a micro -organism that does cause 
disease in the animals tested has the same re sult in humans, and vice -versa.  
Information available and provided by the applicant, as required in point s 2.1, 2.3, 
2.4, 2.6 and 5.1 of Part B of the Annex to Reg ulation  (EU) No 283/2013, and/or 
retrieved from any other reliable sources (e.g. Qualified Presumption of Safety, peer -
reviewed literature) may provide robust and reliable  scientific  indication on 
infectivity and  pathogenicity of the micro -organism. Where an applicant provides a 
summary of information already available on infectivity and  pathogenicity of the 
micro -organism, as described in point  5.2 of Part B of the Annex to Reg ulation  (EU) 
No 283/2013, Member Sta tes shall assess such scientific evidence provided by the 
applicant using  a weight of evidence approach, in order to evaluate whether the 
possible non -submission of certain studies required in point s 5.3.1 and 5.4 of Part B 
of the Annex to Reg ulation  (EU) No 283/2013 is justified.  
1.5.1.3.  Information available on toxicity, such as  from  published literature, medical 
information, Integrated Approach to Testing and Assessment (IATA), results of CLP 
calculation rules in accordance with Regulation (EC) No 1272 /2008, or bridging data 
from similar plant protection products, may provide robust and reliable  scientific 
indication on the toxicity of relevant chemical substances contained in the plant 
protection product , and be used for classification and labelling. W here an applicant 
provides information available on human and animal toxicity of (chemical 
substances  present in) the plant protection product (including in-vitro  and ex-vivo 
data), Member States shall assess such scientific evidence provided by the applicant 
using  a weight of evidence approach, in order to evaluate whether non -submission of 
certain studies required in point s 7.3.1 to 7.3.6 of Part B of the Annex to Reg ulation  
(EU) No 284/2013 is justified.  
1.5.1.4.  Member States shall evaluate non -dietary exposure of operators, workers, bystanders 
and residents to the micro -organism which is contained in the plant protection 
product, and the components which may be toxicologically relevant (e.g. metabolites 
of concern, relevant impurities), and which  are likely to occur under the proposed 
conditions of use (including , in particular , dose, application method and climatic 
conditions). Realistic data on exposure levels to the plant protection product shall be 
used. If such data is not available, a suitab le, and if possible validated, calculation 
model for plant protection products containing a micro -organism  shall be employed.  
(a) The infectivity and pathogenicity evaluation of the micro -organism and the 
toxicological evaluation of metabolites of concern and relevant impurities shall 
take into consideration the following information:   
(i)  the available information on infectivity and pathogenicity (e.g. based on 
biological properties, peer -reviewed literature, animal studies performed 
by the applicant) as prov ided for in Part B of the Annex to Regulation 
(EU) No  283/2013. The evaluation shall take into consideration the 
following principles:   
EN 39  EN – to avoid unnecessary animal testing , in a first instance infectivity 
and pathogenicity shall be assessed on the bas is of existing 
information as provided for under  point  5.2 of Part B of the Annex 
to Regulation (EU) No 283/2013 ;  
– infectivity and pathogenicity studies described in point  5.3.1 of Part 
B of the Annex to Regulation (EU) No 283/2013 may be necessary, 
as described in point  1.5.1.2 ;  
– further specific studies may be required, as indicated in point  5.4 of 
Part B of the Annex to Regulation  (EU) No 283/2013. For instance, 
if there are indica tions of colonisation in the host , infectivity , or 
any adverse effects, further testing shall be conducted , taking into 
account the exposure scenario and an observation period suitable 
for the micro -organisms, to allow observing a complete clearance 
in the  host. The choice of appropriate timing may be based on 
available information such as biological properties of the micro -
organism or other relevant available information.  
The evaluation of available information and possible animal studies 
performed by the  applicant, shall take into consideration the ability of the 
micro -organism to infect, persist or grow in the mammalian host, and its 
ability to cause effects  or reactions in the host. Parameters that indicate 
the absence of ability to persist and multiply  in the host, and the absence 
of ability to produce adverse effects in a host, include clearance from the 
body, if relevant. Replication temperatures may be different from 
mammalian body temperature, possibly indicating low likelihood of 
persistence and mu ltiplication in the host. However, temperature 
adaptation may occur, and this parameter alone shall not be considered 
sufficient to conclude on persistence and multiplication of the micro -
organism in the host. Evaluation based on relevant parameters of stu dy 
results and available information shall lead to an assessment of the 
possible effects of occupational exposure.  
(ii)  the available information on toxicity (e.g.  based on  biological properties , 
peer-reviewed literature , animal studies performed by the applicant)  as 
described in point s 2.8 and 5.5 of Part B of the Annex to Regulation  (EU) 
No 283/2013, and Section  7 of Part B of the Annex to Regulation  (EU) 
No 284/2013.  The evaluation shall take into consideration the following 
principles :  
– to avoid unnec essary animal testing , in a first instance toxicity shall 
be assessed on the bas is of existing information as provided for in 
point  7.2 of Part B of the Annex to Regulation (EU) No 284/2013 ;  
– toxicity studies may be necessary, as described in point  1.5.1.3 ; 
– further specific studies may be required taking into consideration 
the intended use, according to the provisions of point s 2.8 and 5.5 
of Part B of the Annex to Regulation (EU) No 283/2013, and of 
point s 7.4 and 7.7 of Part B of the Annex to Regulation ( EU) 
No 284/2013.  
The evaluation of available information and possible animal studies 
performed by the applicant, shall take into consideration the ability of  
EN 40  EN metabolites of concern, safeners, synergists, and relevant impurities to 
cause adverse effects on  humans or animals.  The exposure to metabolites 
of concern , safeners, synergists, and relevant impurities shall be assessed 
if a hazard has been identified.  Evaluation based on relevant parameters 
of the tests shall lead to an assessment of the possible e ffects of non -
dietary exposure, taking into account the intensity and duration of 
exposure under the proposed conditions of  use.  
(iii)  other relevant information provided for under  Part B of the Annex to 
Regulation (EU) No 284/2013 , such as:  
– composition  of the plant protection product,  
– nature of the plant protection product,  
– size, design and type of packaging,  
– field of use and nature of the crop or target,  
– method of application including handling, mixing  and loading of 
the plant protection product,  
– exposure reduction measures recommended,  
– protective clothing recommendations,  
– maximum application rate,  
– cleaning and routine maintenance of application equipment , , 
taking into account  also seed treatment and good occupational 
practice,  
– recommendation t o be followed after application, such as re -entry 
period and working duration,  
– minimum (spray) application volume stated on the label,  
– number and timing of applications , including intervals between 
applications,  
– re-entry periods, necessary waiting periods  or other precautions to 
protect humans and animals,  
– dried residues of the plant protection products on plants and plant 
products after treatment, taking into account the capacity of the 
micro -organism to grow in situ , and the influence of factors such as 
temperature, UV light, pH and the presence of certain substances,  
– further information on exposure (e.g. 
operator/worker/bystander/resident exposure study, further 
activities whereby workers are exposed).  
(b) On the basis of the information referred to in (a) t he following overall end -
points should be established for single or repeated operator, worker, bystanders 
and residents exposure following the intended use, as regards:  
– observed or expected infectivity and  pathogenicity of the micro -
organism (s) in the pla nt protection product,   
EN 41  EN – observed or expected adverse toxicological effects of the plant protection 
product due to metabolites of concern safeners, synergists, and/or 
relevant impurities.  
(c) The evaluation of the exposure of the operator shall be made for each type of 
application method and application equipment proposed for  the use of the plant 
protection product as well as for the different types and sizes of packaging 
containers to be used, taking into account mixing, loading operations, 
application of t he plant protection product and cleaning and routine 
maintenance of application equipment. Where relevant, other authorised uses 
of the plant protection product in the area of envisaged use , containing the 
same active substance or which give rise to the sa me residues , shall  also be 
taken into account.   
(d) The possibility of adverse effects in humans shall be assessed with regard to 
measured or estimated levels of human exposure as compared to the tested 
dose levels , as provided for under  Section 7 of Part B of  the Annex to 
Regulation (EU) No  284/2013. This risk assessment shall include consideration 
of e.g. mode of action, physical and chemical properties of the micro -organism 
and other components in the plant protection product , such as  metabolites of 
concern,  safeners, synergists and relevant impurities.  
1.5.1.5.  Member States shall evaluate  information relating to the nature and characteristics of 
the packaging proposed , in particular the following aspects:  
(a) the type of packaging;   
(b) its dimensions and capacit y;  
(c) the size of the opening;  
(d) the type of closure;   
(e) its strength, leak  proofness and resistance to normal transport and handling;   
(f) its resistance to and compatibility with the contents.  
1.5.1.6.  Member States shall evaluate the nature and characteristics of the protective clothing 
and equipment proposed , in particular the following aspects:  
(a) obtainability and suitability;   
(b) effectiveness;  
(c) ease of wearing taking into account physical stress and climatic conditions;   
(d) resistance to and compatibility with the plant protection product.  
1.5.1.7.  Micro -organisms approved as active substances of plant protection product are not 
expected to be infective for humans. However, in order to ensure the availability of 
sufficient therapeutic measures in the event of opport unistic infection s, Member 
States shall , where relevant based on biological properties of the micro -organism,  
evaluate the susceptibility of the micro -organism (except viruses) to antimicrobial  
agent s. 
1.5.2.  Effects on human or animal health arising from  residues of metabolites of concern  
The evaluation of consumer exposure  to residues of metabolites , for which a hazard 
to human and animal health was identified , is based either on the applicant’s 
substantiated estimation or, in case where the substantiate d estimation does not  
EN 42  EN demonstrate an acceptable risk to consumers, on residue trials for metabolites of 
concern.  
In cases provided for in point  6.1 of Part B of the Annex to Regulation (EU) 
No 283/2013, also information on viable micro -organisms may be req uired and 
assessed with the information on residues of metabolites of concern.   
1.5.2.1.  Member States shall evaluate  the potential residue levels of metabolites of concern 
for which a hazard was identified to human or animal health in point s 2.8 and 5.5 of 
Part B of Annex to Regulation  (EU) No 283/2013. This evaluation  shall be 
performed for each proposed use and shall take into account the following 
information:  
– the intended use , including data on application and proposed pre -harvest 
intervals for envisa ged uses or withholding periods or storage periods in the 
case of post -harvest uses;  
– analytical methods  as provided for under  point  5.2 of Part B of the Annex to 
Regulation  (EU) No 284/2013;  
– the specific information on residues in/on treated plants, plant products, food 
and feed as provided for in Section  8 of Part B of the Annex to Regulation  
(EU) No 284/2013;  
– realistic possibilities f or extrapolating data from one crop to another.  
Member Sta tes shall evaluate  the potential exposure of consumers to metabolites of 
concern through diet using a suitable calculation model. This evaluation shall take 
into account, where relevant, other sources of the same metabolite of concern for 
which either maxi mum residue levels ha ve been set in accordance with Regulation 
(EC) No 396/2005, or maximum tolerances ha ve been set in accordance with Council 
Regulation (EEC) No  315/9314 on contaminants in food . 
In cases where the estimation of residue levels does not de monstrate acceptable risk 
to consumers, Member States shall refine the evaluation, either based on data 
generated  through residues trials, or on toxicity of metabolites of concern through 
determination of a toxicological endpoint , such as the acceptable da ily intake (ADI), 
or, where appropriate , the Threshold of Toxicological Concern (TTC) value having 
regard to the specific information provided in accordance with point  6.2 of Part B of 
the Annex to Regulation (EU) No  283/2013.  
1.5.2.2.  Member States shall , where relevant, estimate the exposure of animals to residues of 
metabolites of concern, taking into account the residue levels estimated or measured  
in treated plants or plant products intended to be fed to animals.  
1.5.2.3.  Member States shall, where re levant, evaluate the residues of metabolites of concern 
estimated or measured  in products of animal origin and their toxicity, taking into 
consideration the information provided for under  point s 2.8, 5.5 and 6 of Part B of 
the Annex to Regulation (EU) No 2 83/2013.  
1.5.2.4.  Member States shall, where relevant, estimate the potential exposure of consumers to 
metabolites of concern through diet via the products of animal origin mentioned in 
point  1.5.2.3, using a suitable calculation model. This evaluation shall take account, 
where relevant, of other sources of the same metabolite of concern for which either 
                                                 
14 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. 13 ).  
EN 43  EN maximum residue levels had been set in accordance with Regulation (EC) 
No 396/2005 (in case of authorised uses of the micro -organism producing it in 
biocidal or veterinary products), or maximum tolerances ha ve been set in accordance 
with Regulation (EEC) No 315/93, where relevant.  
1.5.2.5.  Member States  shall assess d ata on density of micro -organisms  on edible parts of 
treated crops, if those are provided  to support the estimation of residues of 
metabolites of concern produced in-situ. Data on density of micro -organisms  on 
edible parts of treated crops  is required only in few circumstances , as provided for  in 
point  6.1 of Part B of Annex to Reg ulation  (EU)  No 28 3/2013 , since micro -
organisms which are infective or pathogenic to humans or other vertebrate animals 
will not be eligible for approval, and non -pathogenic micro -organisms are not 
expected to cause adverse effects to consumers , apart from possible pr oduction of 
metabolites of concern to be assessed in accordance with the point s 1.5.2.1 to 1.5.2.4. 
Absence of viable micro -organisms on edible parts exclude s the  risk of in-situ 
production of metabolites of concern.  
1.6.  Environmental occurrence of the micro -organism, including fate and behaviour 
of metabolites  of concern  
Member States shall assess data on the e nvironmental occurrence of the micro -
organism , including fate and behaviour of metabolites of concern , submitted in 
accordance with  Section  7 of Part B of the Annex to Regulation  (EU) No  283/2013 
and Section  9 of Part B of the Annex to Regulation  (EU) No  284/2013 . 
The evaluation of the environmental occurrence  of an active substance that is a 
micro -organism needs  to take into account that m icro-organisms may be already 
occurring in relevant European  environments, have the ability to replicate and  have 
the ability to become dormant allowing for the formation of seed banks of micro -
organisms.  
The evaluation of the environmental exposure to the releva nt components of the 
plant protection product , i.e. the micro -organism  and metabolites of concern , shall be 
considered in order to conduct risk assessments as regards:  
– non-target organisms (concerning the exposure to the micro -organism and to 
the metabolites of concern);  
– humans via the environment (concerning the exposure to the metabolites of 
concern).  
The evaluation of environmental exposure shall  be based either on a substantiated 
estimation or, in case where this substantiated estimation does not demonstrate an 
acceptable risk, on experimental data. This experimental data may include 
measurements concerning the population dynamics of the micro -organism in specific 
environmental compartments upon use of the plant protection product, and the fate 
and behaviour of metabolites of concern.  
1.6.1.  Environmental occurrence of the micro -organism  
Member States shall evaluate the possibility of exposure of soil and/or surface water 
to the micro -organism based on the intended use and the biological properties of the 
micro -organism. If th e possibility of exposure cannot be excluded, Member States 
shall  evaluate the estimated exposure of soil and/or surface water after the use of the 
plant protection product in accordance with the intended conditions of use.   
EN 44  EN For non -target organisms for which a hazard is identified, for instance based on the 
calculation of the pre dicted environmental density as provided for under  point  7.1 of 
Part B of the Annex to Regulation  (EU) No 283/2013, Member States shall evaluate 
the estimation of the exposure of the relevant non -target organisms to the micro -
organism. This estimation shal l be performed for each intended  use and shall take 
into account the following information:  
– the data on the proposed good agricultural practice, including data on 
application;  
– nature of the plant protection product;  
– analytical methods , as provided for unde r point  4.2 of Part B of the Annex to 
Regulation  (EU) No 283/2013 ,  and under  point  5.2 of Part B of the Annex to 
Regulation  (EU) No  284/2013;  
– the specific information on occurrence of the micro -organism , e.g. possible 
increase of microbial density in the relevant environmental compartment 
compared to the occurrence at the relevant highest taxonomic level in 
European  environments , as provided for under  point s 7.1, 7.2 and 7.3 of Part B 
of the Annex to Regulation  (EU) No 283/2013, and, where  relevant, Sectio n 9 
of Part B of the Annex to Regulation  (EU) No  284/2013;  
– data extrapolated from one crop to another, if considered realistic by Member 
States ; 
– in addition, for micro -organisms not occurring in the relevant E uropean  
environments at the relevant highest taxonomic level, and which are known to 
be pathogenic either for plants or for other organisms, the exposure of non -
target organisms through colonized host organisms shall be evaluated taking 
into account also the  information on the population density of the micro -
organism in host organisms , and the exposure of non -target organisms to 
coloni sed host organisms.  
1.6.2  Environmental fate and behaviour of the metabolite s of concern  
In case a hazard has been identified for humans and/or non -target organisms due to a 
metabolite of concern, as provided for under  point s 2.8, 5.5 and 8.8 of Part B of the 
Annex to Regulation  (EU) No 283/2013, and Section s 7 and 10 of Part B of the 
Annex to Regulation  (EU) No 284/2013, Member Stat es shall estimate the 
concentrations in the relevant environmental compartments that lead to exposure of 
humans and non -target organism for which the hazard has been identified. This 
estimation shall be performed for each  intended  use and shall take into a ccount the 
following information:  
– the data on the proposed good agricultural practice, including data on 
application;  
– nature of the plant protection product;  
– analytical methods , as provided for under  point  4.2 of Part B of the Annex to 
Regulation  (EU) No 2 83/2013 ,  and under  point  5.2 of Part B of the Annex to 
Regulation  (EU) No 28 4/2013;  
– the specific information on environmental fate and behaviour of the metabolite 
of concern present in the plant protection product, as provided for under   
EN 45  EN point  7.4 of Part B of the Annex to Regulation  No 283/2013, and, if relevant, 
Section  9 of Part B of the Annex to Regulation  (EU) No 284/2013;  
– realistic possibilities of extrapolating data from one crop to another.  
1.7.  Effects on non -target organisms  
Member States sh all assess data on  the risks to non -target organisms that the plant 
protection product may cause submitted in accordance with Section  8 Part B of the 
Annex to Regulation  (EU) No 283/2013 and Section  10 Part B of the Annex to 
Regulation  (EU) No  284/2013 .  
This assessment shall take into consideration the biology of the micro -organism, the 
exposure of non -target organisms under field condition according to the proposed 
conditions of use, and shall  take into consideration possible increase of microbial 
density  in the relevant environmental compartment compared to the occurrence of 
the micro -organism in EU environments at the relevant  highest  taxonomic level.  
To assess the possibility of exposure the following information shall be taken into 
consideration:  
(a) cond itions of use ; 
(b) information on fate and behavio ur as provided in Section  7 of Part B of the 
Annex to Regulation  (EU) No 284/2013.  
Where an applicant  does not perform certain studies required in Section 8 of Part B 
of the Annex to Reg ulation  (EU) No 283/2013  and Section 10 of Part B of the Annex 
to Reg ulation  (EU) No 284/2013 , Member States shall assess if the scientific 
evidence provided by the applicant using  a weight of evidence approach  justifies the 
non-submission of these data . 
1.7.1.  Member States shall evaluate  the risks to terrestrial vertebrates after the use of the 
plant protection product in accordance with the proposed conditions of use and 
taking into account the evaluation criteria provided  for in point  1.6. 
(a) Member States shall  evaluate the risks to terrestrial vertebrates due to the 
micro -organism and its potential to infect and multiply in the host, taking into 
account the following information on the micro -organism:  
– mode of action;  
– other biological properties;  
– studies on m ammalian infectivity and  pathogenicity ;  
– studies on avian infectivity and  pathogenicity ; 
– other relevant information on terrestrial vertebrate infectivity and  
pathogenicity . 
(b) Member States shall evaluate the risk to terrestrial vertebrates due to toxic 
effects of the plant protection product  in accordance with point  1.5.2.1 of 
Part A.  
EN 46  EN 1.7.2.  Member States shall evaluate  the risks to aquatic organisms after the use of the plant 
protection product in accordance with the proposed conditions of use and taki ng into 
account the evaluation criteria provided for in point  1.6. 
(a) Member States shall evaluate the risks to aquatic organisms due to the micro -
organism and its potential to infect and multiply the host, taking into account 
the following information on the  micro -organism:   
– its mode of action;  
– other biological properties;  
– studies on infectivity and  pathogenicity to aquatic organisms and/or other 
existing relevant information . 
(b) Member States shall evaluate the risk to aquatic organisms due to toxic effects 
of the plant protection product in accordance with point  1.5.2.2 of Part  A. 
1.7.3.  Member States shall evaluate  the risks to bees after the use of the plant protection 
product in accordance with the proposed conditio ns of use and taking into account 
the evaluation criteria provided for in point  1.6. 
(a) Member States shall evaluate the risks to bees due to the micro -organism and 
its potential to infect and multiply the host, taking into account the following 
information o n the micro -organism:  
– its mode of action;  
– other biological properties;  
– studies on infectivity and pathogenicity to bees  and/or other existing 
relevant information . 
(b) Member States shall evaluate the risk to bees due to toxic effects of the plant 
protection product, in accordance with point  1.5.2.3 of Part A.  
1.7.4.  Member States shall evaluate  the risks to non-target  arthropods other than bees after 
the use of the plant protection product in accordance with the proposed conditions of 
use and taking into account the evaluation criteria provided for in point  1.6. Member 
States shall pay particular attention to the risks to beneficial organisms deliberately 
released for biocontrol purposes.  
(a) Member States shall evaluate the risks to arthropods other than bees due to the 
micro -organism and its potential to infect and multiply the host, taking into 
account the following information on the micro -organism:   
– its mo de of action;  
– other biological properties;  
– studies on infectivity and  pathogenicity to honeybees and other 
arthropods  and/or other existing relevant information . 
(b) Member States shall evaluate the risk to arthropods other than bees due to toxic 
effects of the plant protection product in accordance with point  1.5.2.4 of 
Part A.  
EN 47  EN 1.7.5.  Member States shall evaluate  the risks to non-target  meso - and macro -organisms in 
soil after the use of the plant protection  product in accordance with the proposed 
conditions of use and taking into account the evaluation criteria provided for in point  
1.6. 
(a) Member States shall evaluate the risks to meso - and macroorganisms in soil 
due to the micro -organism and its potential to infect and multiply the host, 
taking into account the following information on the micro -organism:  
– its mode of action;  
– other biological properties;  
– studies on infectivity and pathogenicity to meso - and macro -organisms 
and/or other existing relevant information . 
(b)  Member States shall evaluate the risk to meso - and macro -organisms in soil 
due to toxic effects of the plant protection product in accordance with 
point  1.5.2.5 of part  A.  
1.7.6.  Member States shall evaluate  the risks to non-target  terrestr ial plants after the use of 
the plant protection product in accordance with the proposed conditions of use and 
taking into account the evaluation criteria provided for in point  1.6. 
(a) Member States shall evaluate the risks to terrestrial plants due to the micro -
organism and its potential to infect and multiply the host, taking into account 
the following information on the micro -organism:  
– its mode of action;  
– other biological properties;  
– studies on infectivity and pathogenicity to terrestrial plants;  
– relatedness to known plant -pathogens.  
(b) Member States shall evaluate the risk to terrestrial plants due to toxic effects of 
the plant protection product.  
1.8.  CONCLUSIONS AND PROPO SALS  
Member States shall draw conclusions on the need for further information and /or 
testing and the need for measures to limit the risks arising. Member States shall 
justify proposals for the classification and labelling of plant protection products.  
2.  Decision -making  
The following  principles shall apply without prejudice to the general principles 
referred to in Section 3 of the general introduction . 
2.1.  Identity  
2.1.1.  For each authorisation granted the Member States shall ensure that the active 
substance concerned has been app roved in acc ordance with Regulation (EC) 
No 1107/2009.  
2.1.2.   For each authorisation granted the Member States shall set the specification as 
regards the composition of the plant protection product. The minimum and maximum 
content of the micro -organism that is the active substance contained in the plant 
protection product shall be defined. The content of metabolites of concern, relevant  
EN 48  EN impurities, co -formulants, safeners and synergists in the plant protection product, and 
relevant contaminating micro -organisms derived from the production process shall to 
the extent possible be defined. Member States shall verify, based on the information 
provided in the dossier, that quality assurance on the manufacturing process allows 
levels of metabolites of concern, relevant impurities, and relevant contaminating 
micro -organisms to be controlled to an acceptable level.  
2.1.3.  No authorisation shall be granted unless the manufacturing processes of the MASAM 
and the plant protection product ensure that the production o f MASAM and plant 
protection product is of consistent quality, as set out in the specification set out in 
point  2.1.2.  
2.1.4.  In accordance with Article 48 of Regulation (EC) No 1107/2009 and Directive 
2001/18/EC  of the European Parliament and of the Cou ncil15, where the micro -
organism has been genetically modified no authorisation shall be granted unless:  
– the evaluation conducted in accordance with Directive 2001/18/EC as well as 
the relevant decision taken by the Member States has been provided  by the 
applicant in the dossier , and  
– an authorisation is granted in accordance with Part C of Directive 2001/18/EC 
under which that organism can be released into the environment , or placed on 
the market in a plant protection product . 
2.1.5.  Member States shall ensure that adequate quality control measures are applied to 
ensure the identity of the micro -organism and contents of the plant protection 
product.   
2.2.  Biological and technical properties  
2.2.1.  No authori sation shall be granted for a plant protection product containing a micro -
organism, if the micro -organism that is the active substance is a non -virulent variant 
of a plant pathogen virus, and the likelihood of regaining virulence  and causing 
adverse effects  in target and non -target plants through mutation , after application 
under the proposed conditions of use (including possible risk mitigation measures) , is 
not negligible.  
2.3.  Efficacy and absence of unacceptable effects  on plants and plant products  
2.3.1.  Efficacy  
2.3.1.1.  No authorisation shall be granted where, on the basis of experience acquired or 
scientific evidence under normal agricultural, plant health and environmental 
(including climatic) conditions, the proposed uses include:  
– recommendations for the control of or  protection against target organisms, or 
any other effects, which are not considered to cause adverse effects on crops, 
plants, or plant products; or,  
– effects which are not considered to be beneficial under those conditions.  
2.3.1.2.  No authorisation sha ll be granted when the proposed minimum dose, or a range of 
minimum doses, necessary to achieve sufﬁcient efﬁcacy against a target pest or any 
                                                 
15 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).   
EN 49  EN other relevant benefit across the proposed use , i.e. the minimum effective dose , is not 
justified  based on available information or efficacy trials.  
2.3.1.3.  The level, consistency and duration of control or protection or other intended effects 
shall be at least higher than those observed in the untreated control, and if possible 
similar to a suitable reference  product. Where relevant, yield response when the plant 
protection product is used, or reduction of loss in storage, shall be quantitatively 
and/or qualitatively at least higher than those observed for the untreated control, and 
if possible similar to a su itable reference product. The plant protection product shall 
be shown to give a defined benefit under the agricultural, plant health and 
environmental (including climatic) conditions in the area of proposed use.  
2.3.1.4.  Conclusions as to the efficacy of t he plant protection product shall be valid for all 
areas  and conditions  in which it is to be authorised.  
2.3.1. 5.  Where the proposed label include s recommendations or requirements for use of the 
plant protection product with  other  specified plant protecti on products in a tank mix, 
spray sequences, or employing other relevant types of applications, or any other 
recommendations (e.g. weather conditions, soil conditions, irrigation application), 
Member States shall not accept the recommendations or requiremen ts unless they are 
justified, if applicable , by supporting information  and comply with the principles 
referred to in point s 2.3.1.1 to 2.3.1.4 .  
2.3.1. 6. Where negative interactions are expected between the plant protection product 
containing the  micro -organism (s) and other plant protection products , which the label 
requires to use in tank mix, spray sequences, or employing other relevant types of 
applications , or other common practices  (e.g. conservation biological control) , 
affecting the efficacy of one o r the others, Member States shall set appropriate 
conditions in  the authorisation of the  plant protection  product containing the micro -
organism (s), and they shall ensure that a warning labelling phrase  is indicating  such 
negative interaction.  
2.3.2.  Absence of unacceptable effects on plants and plant products  
2.3.2.1.  There shall be no relevant phytotoxic or pathogenic effects on treated plants or plant 
products, except where the proposed label indicates appropriate limitations of use.  
2.3.2.2.  There  shall be no reduction of yield at harvest below that which could be obtained 
without the use of the plant protection product, unless this reduction is compensated 
for by other advantages beside the plant protection action, such as an enhancement of 
the qu ality of the treated plants or plant products.  
2.3.2.3.  There shall be no unacceptable adverse effects on the quality of treated plants or 
plant products, except in the case of adverse effects on food and feed transformation 
processes (e.g. wine making, brewing, bread making, or silage productions as feed) 
where proposed label specif ies that the plant protection product shall  not be applied 
to crops to be used in transformation processes.  
2.3.2.4.  There shall be no unacceptable adverse effects on treate d plants or plant products 
used for propagation or reproduction, such as effects on viability, germination, 
sprouting, rooting and establishment, except where proposed label specif ies that the 
plant protection product sh all not be applied to plants or plan t products to be used for 
propagation or reproduction.   
EN 50  EN 2.3.2.5.  There shall be no unacceptable impact on succeeding crops, except where proposed 
label specif ies that particular crops, which would be affected, shall  not be grown 
following the treated crop .  
2.3.2.6.  There shall be no unacceptable impact on adjacent crops, except where proposed 
label specifies that the plant protection product should not be applied when particular 
sensitive adjacent crops are present.  
2.3.2.7.  Where the proposed label of the plant protection product includes recommendations 
or requirements for the use with other plant protection products and/or adjuvants as  a 
tank mix, the same criteria referred to in point s 2.3.2.1 to 3.4.2.6 apply in relation to 
the information supplied for the tank mix.  
2.3.2.8.  The proposed instructions for cleaning the application equipment shall be both 
practical and effective so that they can be applied with ease so as to ensure the 
removal of residual traces of the plant protection product which cou ld subsequently 
cause damage.  
2.4  Identification/detection and quantification methods  
The methods proposed shall reflect the most appropriate techniques. The following 
conditions shall be met in order to permit validation of the pre -authorisation 
analyti cal methods, where relevant, and 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 prote ction 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 other.  
2.4.2.  No authorisation shall be granted unless there is an adequate method for pre -
authorisation, where relevant, and for post -authorisation control and monitoring of 
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 ani mal 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.   
EN 51  EN 2.5.1.1.  No authorisation shall be granted if it is concluded that the micro -organism is 
infective  or cause s 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 biologica l 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 und er 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. gloves, 
masks) shall be worn , taking into account the conditions of use, and that t he 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)  No 2016/425  of the 
European Parliament and of the Council 16,  
– 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 whic h, 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, worker s, 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, spe cial precautionary 
measures shall be prescribed.  
2.5.1.8.  The conditions of authorisation shall be in compliance with Council Directives 
98/24/EC17 and 89/656/EEC18, and Directives 2000/54/EC19 and 2004/37/EC of the 
                                                 
16 Regulation (EU) 2016/425 of the European Parliament an d 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 ). 
17 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 ).  
EN 52  EN European Parliament and of the Council. Th e 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 effec t 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.  
2.6.2  No authorisatio n 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 wate r. 
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 follo wing 
limit values:  
(i)  the maximum permissible concentration laid down by Council Directive 
98/83/EC20; or  
(ii)  the maximum concentration laid down when approving the active substance in 
accordance with Regulation (EC) No 1107/2009, bas ed 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 approved21 in acc ordance with Regulation (EC) 
No 1107/2 009,  
                                                                                                                                                         
18 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).  
19 Directive 2000/54/EC of the European Parliament and of the Co uncil 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).  
20 Council Directiv e 98/83/EC of 3 November 1998 on the quality of water intended for human 
consumption (OJ L 330, 5.12.1998, p. 32).  
21 Where the ADI is not available for a metabolite of concern, the default value of 0.1 μg/l applies.   
EN 53  EN 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 organi sms  
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 
organisms groups indicated in Section 10 of Part B to the Annex of Regulation (EU) 
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 authoris ation 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 LD 50 (acute, dietary) 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 pl ant 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, directly 
or indirectly, after use of the plant prot ection product in accordance with the 
proposed conditions of use; or  
(b) in case of toxic effects of the plant protection product:  
– the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute 
exposure and less than 10 for long -term exposure, or   
– the 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 pl ant 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 are 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.  
EN 54  EN 2.7.4.  Where there is a possibility of arthropods o ther 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 are 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 -organis m 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 criteria 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. ’