EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12042/2020  
[…](2021) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION REGULATION (EU) .../...  
amending Regulation (EU) No 284/2013 as regards the information to be submitted for 
plant protection products and the specific data requirements for plant protection products 
containing micro -organisms   EN 1  EN ANNEX I 
‘Introduction  
Information to be submitted, its generation and its presentation  
1. For the purpose s of this Annex, the following definitions apply:  
(1) ‘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 ; 
(2) ‘effectiveness ’ means the capacity of the plant protection product to produce a 
positive  effect regarding the desired plant protection activity ; 
(3) ‘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 ); 
(4)  ‘relevant impurity’ means a  chemical impurity that is of concern for human 
health, animal health or the environment ; 
(5) ‘toxicity ’ means  the degree of injury or damage in a n organisms  caused by a 
toxin or a toxic substance ; 
(6)  ‘toxin’ means  a (organic) substance that is  produced in nature and is  able to 
injure or damage a  living  organism . 
The information submitted shall meet the requirements  set out in points 1.1  to 1.15.  
1.1. The information shall be sufficient to evaluate efficacy and the foreseeable risks, 
whether immediate or delayed, which the plant protection product may entail for 
humans, including vulnerable groups, animals and the environment and contain at 
least the in formation and results of the studies referred to in this Annex.  
1.2. Any information including any known data on potentially harmful effects of the plant 
protection product on human and animal health or on groundwater shall be included 
as well as known an d expected cumulative and synergistic effects.  
1.3. Any information  including any known data  on potentially unacceptable effects of the 
plant protection product on the environment, plants and plant products shall be 
included as well as known and expected cumulative and synergistic effects.  
1.4. The information shall include all relevant data fro m the scientific peer reviewed open 
literature on the active substance, relevant metabolites, and where relevant 
breakdown or reaction products, and plant protection products containing the active 
substance and dealing with side -effects on human and animal  health, the 
environment and non -target species. A summary of th at data shall be provided.  
1.5. The information shall include a full and unbiased report of the studies conducted as 
well as a full description of them. Such information shall not be required,  , where a 
justification is provided showing that :  
(a) it is not necessary owing to the nature of the plant protection product or its 
proposed uses, or it is not scientifically necessary; or 
(b) it is technically not possible to supply.  
 EN 2  EN 1.6.  Where relevant, th e information shall be generated using test methods, which are 
included in the list referred to in point 6.  
In the absence of suitable internationally or nationally validated test guidelines, test 
guidelines accepted by the competent authority shall be us ed. Any deviations from 
test guidelines shall be described and justified.  
1.7.  The information shall include a full description of the test methods used.  
1.8. Where relevant, the information shall be generated in accordance with Directive 
2010/63/EU of the European Parliament and of the Council1.  
1.9. The information shall include a list of endpoints for the plant protection product  
where relevant.  
1.10.  The information shall include the proposed classification and labelling of the plant 
protection pr oduct in accordance with Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council2, where relevant.  
1.11.  Information as provided for in Commission Regulation (EU) No 283/20133 may be 
required by the competent authorities on co -formulan ts. Before requiring additional 
studies to be performed, the competent authorities shall assess all available 
information provided in accordance with other Union legislation.  
1.12.  The information provided for the plant protection product and that provide d for the 
active substance, shall be sufficient to:  
(a) decide whether or not the plant protection product is to be authorised;  
(b) specify conditions or restrictions to be associated with any authorisation;  
(c) permit an evaluation of short and long -term risks for non-target species, 
populations, communities and processes;  
(d) identify relevant first aid measures as well as appropriate diagnostic and 
therapeutic measures to be followed in the event of poisoning in humans;  
(e) permit a risk assessment of acute and chronic consumer exposure, including, 
where relevant, a cumulative risk assessment deriving from exposure to more 
than one active substance;  
(f) permit an estimation of acute and chronic exposure to operators, workers, 
residents and bystanders including, where releva nt, the cumulative exposure to 
more than one active substance;  
(g) permit an evaluation to be made as to the nature and extent of the risks for 
humans, animals (species normally fed and kept by humans or food producing 
animals) and of the risks for other non -target vertebrate species;  
(h) predict the distribution, fate and behaviour in the environment, as well as the 
time courses involved;  
                                                 
1 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the 
protection of animals used for scientific purposes ( OJ L 276, 20.10.2010, p. 33 ). 
2 Regulation (EC) No 1 272/2008 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 3 53, 31.12.2008, p. 
1). 
3 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 3  EN (i) identify non -target species and populations for which hazards arise because of 
potential exposure;  
(j) permit an assessment of the impact of the plant protection product on non -
target species;  
(k) identify measures necessary to minimise contamination of the environment and 
impact on non -target species;  
(l) classify the plant protection product as to hazard in accordance with Regulation 
(EC) No 1272/2008;  
(m) specify the pictograms, the signal words, and relevant hazard and precautionary 
statements for the protection  of human  health , non -target species and the 
environment, which are to be used for labelling purposes .  
1.13. Where relevant, te sts shall be designed and data analysed using appropriate statistical 
methods. D etails of the statistical analysis shall be reported  transparently.  
1.14.  Exposure calculations shall refer to scientific methods accepted by the European 
Food Safety Authority , when available. The use of a dditional methods shall be 
justified.  
1.15. For each section of th is Annex , a summary of all data, information and evaluation 
made shall be  submitted. This shall include a detailed and critical assessment in 
accordance with  Article 4 of  Regulation (EC) No  1107/2009.   
2. The requirements set out in this Annex constitute  the minimum set of data to be 
submitted. Member States may set out a dditional requirements at national level to 
address  specific circumstances, specific exposure  scenarios  and patterns of use other 
than those taken into account for approval. The applicant shall pay c areful attention 
to environmental, climatic and agronomic conditions when tests are set up subject to 
the approv al by the Member State where the appli cation has been submitted .  
3.  Good laboratory practice (GLP)  
3.1.  Tests and analyses shall be conducted in accordance with the principles laid down in 
Directive 2004/10/EC of the European Parliament and of the Council4 where testing 
is done to obtain d ata on the properties or safety with respect to human or animal 
health or the environment.  
3.2.  By way of derogation from point 3.1, tests and analyses, required under Section 6 of 
Part A and  Section 6 of Part  B, may be conducted by official or officiall y recognised 
testing facilities or organisations , which satisfy at least the following requirements:  
(a) they have at their disposal sufficient scientific and technical staff having the 
necessary education, training, technical knowledge and experience for the ir 
assigned functions;  
(b) they have at their disposal suitable equipment required for correct performance 
of the tests and measurements which they claim to be competent to carry out; 
that equipment is properly maintained and calibrated, where appropriate, 
before being put into service and thereafter in accordance with  an established 
programme;  
                                                 
4 Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the 
harmonisation of laws, regulations and administrative provisions relating to the application of the 
principles of good laboratory practice and the verification of their applications for tests on chemical 
substances ( OJ L 50, 20.2.2004, p. 44).  EN 4  EN (c) they have at their disposal appropriate experimental fields and, where 
necessary , greenhouses, growth cabinets or storage rooms; the y ensure that  
environment in which the tests are undertaken does not invalidate their results 
or adversely effect the required accuracy of measurement;  
(d) they make available to all relevant personnel operating procedures and 
protocols used for the trials;  
(e) they make available, where requested  by the competent authority, prior to the 
commencement of a test, information on its location and on the tested plant 
protection products;  
(f) they ensure that the quality of the work performed is appropriate to its type, 
range, volume and intended purpose;  
(g) they maintain records of all observations, calculations and derived data and 
calibrations records and final test report as long as the plant protection product 
concerned is authorised in a Member State.  
3.3. Officially recognised testing facilities and organisations, and, where requested by the 
competent authorities, official facilities and organisations shall:  
(a)  report to the relevant national authority all information necessary to 
demonstrate that they can s atisfy the requirements set out  in point  3.2,  
(b)  permit at any time the inspections, which each Member State shall regularly 
organise on its territory in order to verify the compliance with point  3.2.  
3.4.  By way of derogation from point 3.1:  
(a) For active substances that are micro -organisms, tests and analyses performed to 
obtain data on their properties and safety with respect to other aspects than 
human health, may be conducted by official or officially recognised testing 
facilities or organisa tions which satisfy at least the requirements specified in 
points  3.2 and  3.3. 
(b) Studies conducted before the application of this Regulation, although not fully 
compliant with GLP requirements or with current test methods, shall be 
considered for the assessm ent if carried out in accordance with the recognised 
international test guidelines in place at the time of conduction of the studies 
and/or scientifically valid, thereby avoiding  repeating animal tests, especially 
for carcinogenicity and reprotoxicity stud ies. This derogation  shall  apply in 
particular  to studies with vertebrate species.  
4.  Test material   
4.1.  Due to the influence that impurities and other components can have on toxicological 
and ecotoxicological behaviour, a detailed description (specifi cation) of the test 
material used shall be provided for each study submitted. Studies shall be conducted 
using the plant protection product to be authorised or bridging principles may be 
applied, for example , use of a study on a plant protection product wi th a 
comparable/equivalent composition. A detailed description of the composition used 
shall be provided.  
4.2.  Where radio -labelled test material is used, radio -labels shall be positioned at sites 
(one or more as necessary), to facilitate elucidation of metabolic and transformation 
pathways and to facilitate investigation of the distribution of the active substance and 
of its metabolites, breakdown and reaction products.  EN 5  EN 4.3  Whenever a study implies the use of different doses, the relationship between the 
dose and the adverse effect shall be reported . 
5.  Tests on vertebrate animals   
5.1.  Tests on vertebrate animals shall be undertaken only where no other validated 
methods are available. Alternative methods shall include in vitro methods, in-silico  
meth ods. Reduction and refinement methods for in vivo testing shall also be 
encouraged to keep the number of animals used in testing to a minimum.  
5.2.  The principles of replacement, reduction and refinement of the use of vertebrate 
animals shall be fully tak en into account in the design of the test methods, in 
particular when appropriate validated methods become available to replace, reduce or 
refine animal testing.  
5.3.  Study designs shall be carefully considered  from an ethical point of view , taking into 
account the scope for reduction, refinement and replacement of animal tests. For 
example, by including one or more additional dose groups or time points for blood 
sampling in one study, it may be possible to avoid the need for another study.  
6.  For purposes of information and harmonisation , the list of test methods and guidance 
documents referred to in this Annex shall be published in the Official Journal of the 
European Union . That list shall be regularly updated. ’ EN 6  EN ANNEX II 
‘PART B  
PLANT PROTECTION PRODUCTS  CONTAINING AN ACTIVE SUBSTANCE THAT IS 
A MICRO -ORGANISM  EN 7  EN TABLE OF CONTENTS  
INTRODUCTION  TO PART B  
1. Identity of the applicant the plant protection product and manufac turing information  
1.1. Applicant  
1.2. Producer of the preparation and the micro -organism(s)   
1.3. Trade name or proposed trade name, and producer ’s development code number of 
the preparation if appropriate  
1.4. Detailed quantitative and qualitative information on the  composition of the 
preparation  
1.5. Physical stat e and nature of the preparation  
1.6. Method of production of the preparation and quality control  
1.7. Packaging and compatibility of the preparation wi th proposed packaging materials  
2. Physical, chemical and technical properties of the plant protection product  
2.1. Appearance (colour and odour)  
2.2. Explosivity  and oxidising properties  
2.3. Flash point and other indications of flamm ability or spontaneous ignition  
2.4. Acidity, alkal inity and if necessary pH value  
2.5. Viscosity and surface t ension  
2.6. Storage stability and shelf  life 
2.6.1.  Use concentration  
2.6.2.  Effec ts of temperature and packaging  
2.6.3.  Other factors affecting stability  
2.7. Technical characteristics of the plant pr otection product  
2.7.1.  Wettability  
2.7.2.  Persistent foaming  
2.7.3.  Suspensibility,  spontaneity of disp ersion and dispersion stability  
2.7.4.  Dry sieve test and wet sieve test  
2.7.5.  Particle size distribution (dustable and wettable powders, granules), co ntent of 
dust/fines (granules), attr ition and friability (granules)  
2.7.6.  Emul sifiability, re -emulsifiability and  emulsion stabili ty 
2.7.7.  Flowability, pourabilit y (rinsability) and dustability  
2.8. Physical and chemical compatibility with other plant pr otection products including 
plant protection products with wh ich its use is to be authorised  
2.8.1.  Physical compatibility  
2.8.2.  Chemical compatibility  
2.9. Adhe rence and distribution to seeds  EN 8  EN 3. Data on application  
3.1. Field of use envisaged  
3.2. Mode of action  on the target organism  
3.3. Function, target organisms, plants or plants products to be protected and po ssible risk 
mitigation measures  
3.4. Application rate  
3.5. Content of micro -organism in material used (e.g. in the dilute d spray, baits or tre ated 
seed)  
3.6. Method of application  
3.7. Number, timing of applications on the same crop, duration of p rotection and waiting 
period(s)  
3.8. Proposed instructions for use  
3.9. Safety intervals and other precautions to protect human  health , animal  health  and the 
environment  
4. Further information on the plant protection product  
4.1. Procedures for cleaning and decontami nating of application equipment  
4.2. Recommended methods and precautions concerning: handling, storage, transport, fire 
or use  
4.3. Measures in case of accident  
4.4. Procedures for destruction or decontamination of the plant prote ction product and its 
packaging  
4.4.1.  Controlled incineration  
4.4.2.  Others  
5. Analytical methods  
5.1. Methods for the analysis of the preparation  
5.2. Metho ds to determine and quantify residues  
6. Efficacy data  
6.1. Preliminary tes ts 
6.2. Minimum effective dose  
6.3. Testing effectiveness  
6.4. Information on possible development of  resistance in target organisms  
6.5. Adverse effects on treated crops  
6.5.1.  Phytotoxicity to target plants (including different cultivar s), or to target plant 
products  
6.5.2.  Effects on the yield of t reated plants or plant products  
6.5.3.  Effects on the qual ity of plants or plant products  
6.5.4.  Effects on transformation processes  EN 9  EN 6.5.5.  Impact on treated plant s or plant propagating material  
6.6. Observations on undesirable or unintended side -effects on su cceeding crops and 
other plants  
6.6.1. Impact on succeeding crop  
6.6.2.  Impact on other p lants, including adjacent crops  
6.7. Com patibility  in plant protection programmes  
7. Effect on human health  
7.1. Medical data  
7.2. Assessment of potential toxicity of the plant protection product  
7.3. Acute toxicity studies  
7.3.1. Acute oral toxicity studies  
7.3.2.  Acute dermal toxicity  
7.3.3. Acute inhalation toxicity  
7.3.4.  Skin irritation  
7.3.5.  Eye irritation  
7.3.6.  Skin sens itisation  
7.4. Additional toxicity information  
7.5. Data on exposure  
7.6. Available toxicological data relating to non -active sub stances  
7.7. Supplementary studies for combinatio ns of plant protection products  
8. Residues in or on treated products, food and feed  
9. Fate a nd behaviour in the environment  
10. Effects on non -target organisms  
10.1.  Effects on terrestrial vertebrates  
10.2. Effects on aquatic organisms  
10.2.1.  Effects on fish  
10.2.2.  Effects on aquatic invertebrates  
10.2.3.  Effects on algae  
10.2.4.  Effects on aquatic macrophytes  
10.3.  Effects on bees  
10.4.  Effects on non -target arthropods other than bees  
10.5.  Effects on non-target meso- and macroorganisms in soil 
10.6. Effects on non-target terrestrial plants  
10.7. Additional toxicity studiesEN 10  EN INTRODUCTION  TO PART B  
(i)  This Introduction to P art B  complements the Introduction to this Annex with points 
which are specific for plant protecti on products  containing an active substance that is 
a micro -organism.  
(ii) For the purpose s of Part B, 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 succession of cultures ultimately derive d from an initial 
single colony;   
(2) ‘colony -forming unit ’ (‘CFU ’) means  a measurement unit used to estimate the 
number of bacter ial or fungal cells in a sample, which have  the ability to 
multiply under controlled growing conditions , with the consequence that one or 
more cells reproduce and multiply to form a single visible colony ; 
(3) ‘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 protection 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 interm ediate ; 
(4)  ‘additive’  means a  component added to the active substance that is a micro -
organism  during its  manufactur ing, to preserve microbial stability and /or 
facilitate handling ; 
(5) ‘purity ’ means  the content of the micro -organism  in relevant unit in the 
MASAM and the maximum c ontent of substances of concern  in case they are 
identified ;  
(6) ‘relevant c ontaminating micro -organism’ means a  pathogenic/infective 
micro -organism  unintentionally present in the MASAM;  
(7) ‘seed stock ’ means a  microbial strain starter culture used to manufacture the 
MASAM or the final plant protection product ; 
(8) ‘spent medium/rest fraction ’ means  the fraction of the MASAM excluding 
the microorganism (s), metabolites of concern , additives, relevant 
contaminatin g micro -organisms, and relevant impurities consisting of 
remaining or  transformed starting materials ; 
(9) ‘starting material ’ means  substance s used in the manufacturing process as 
substrate and/or buffering agent for the production process of the MASAM;  
(10) ‘infectivity ’ means  the ability of a micro -organism  to cause an infection ;  
(11) ‘infection’  means the non -opportunistic introduction or entry of 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 the 
micro -organism causes pathological effects or disease ;  EN 11  EN (12) ‘pathogenicity’  means the non -opportunistic ability of a micro -organism to 
inflict injury and damage to the host upon infection ; 
(13)  ‘non-opportunistic ’ means a condition under which a micro -organism exerts 
an infection or inflicts an injury or damage when the immune system of the 
host is not impaired by an unrelated cause ; 
(14)  ‘metabolite  of concern ’ means  a metabolite produced 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 
adequately justified that in-situ production of the metabolite is not relevant for 
the risk assessment ; 
(15) ‘in-situ production’  means the production of a metabolite by the micro -
organism after application of the plant protection product cont aining that 
micro -organism;  
(16)  ‘relevant antimicrobial activity ’ means the  antimicrobial activity caused by 
relevant antimicrobial agents;  
(17)  ‘antimicrobial agent ’ means a ny antibacterial, antiviral, antifungal, 
anthelmintic or antiprotozoal agents  that is a  substance of natural, semi -
synthetic, or synthetic origin that at in vivo  concentrations kills or inhibits the 
growth of micro -organism s by interacting with a specific target ; 
(18)  ‘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 Regulation (EU) 2021/17605 
in accordance with Article 37(5) of Regulation (E U) No 2019/6 of the 
European Parliament and of the Council6, or 
– by the World Health Organisation7  in the  lists of Critically Important 
Antimicrobials , Highly Important Antimicrobials and Important 
Antimicr obials for Human Med icine . 
(iii)  The information from scientific peer -reviewed literature as mentioned under the 
Introduction to this Annex, point 1.4, shall be provided at the relevant taxonomic 
level . An explanation  on why the chosen taxonomic level is considered relevant  for 
the addressed data requirement  shall be provided .  
(iv)  Other available sources of information, such as medical reports, may also be 
provided and submitted in a summary.  
(v)  Where appropriate or specifically indicated  in the data requirements , test guidelines 
as described in Part A shall be used also for this Part, upon  adapt ation  in such a way 
that they are appropriate for  chemical compounds present in the plant protection 
product containing an active substance that is a micro -organism.  
                                                 
5 Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU)  
2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of 
antimicrobials to be reserved for the treatment of certain infections in humans  (OJ L 353, 6.10.2021, p. 
1). 
6 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). 
7 https://ap ps.who.int/iris/bitstream/handle/10665/312266/9789241515528 -eng.pdf?ua=1 . EN 12  EN (vi)  Where testing is done, a detailed description (specification) of the material used and 
its impurities, in accordance with point  1.4, shall be provided.  
(vii)  In cases where a new plant protection product  containing an active substance  that is a 
micro -organism  is to be dealt with, data extrapolation from Part B of the Annex to 
Regulation (EU) No 283/2013, may be acceptable, provided that all the possible 
effects on toxicity of the co -formulants and other components, are sufficiently 
characterized and eval uated as of no concern.  
(viii)  Alternative methods to test toxicity of plant protection products containing an active 
substance that is a micro -organism on vertebrates , may also be included in a weight 
of evidence approach.  
  EN 13  EN 1. IDENTITY OF THE APPLI CANT THE  PLANT PROTECTION PR ODUCT AND 
MANUFACTURING INFORM ATION  
The information provided, taken together with that provided for the active substance 
that is a micro -organism , shall  be sufficient to precisely identify and define plant 
protection products . The information provided, shall be sufficient to identify if any 
factor could alter the properties of the active substance  that is a  micro -organism  as a 
plant protection product , in comparison to the active substance  as such, which is 
treated in Part B of the Annex to Regulation (EU) No 283/2013. The information and 
data referred to, unless otherwise specified, are required for all plant protection 
products.  
1.1. Applicant  
The name and address of the applicant shall be provided as well as the name, 
address, tel ephone number and e -mail address of the contact point.  
1.2. Producer of the preparation and the micro -organism(s)  
The name and address of the producer of the preparation and of each active 
substance that is  a micro -organism in the preparation shall be provided , as well as the 
name and address of each manufacturing plant in which the preparation and active 
substance  that is  a micro -organism are manufactured. If the producer contracts a third 
party for the manufacturing process, same information shall be provided  for such 
third party.  
A contact point (preferable a central contact point, to include name, telephone 
number, e -mail address and fax number) shall be provided for each producer.  
If the active substance  that is  a micro -organism is manufactured  by a produc er wh ose 
data have not been submitted in accordance with Regulation (EU) No 283/2013, data 
to address th e relevant  requirements laid down in Regulation (EU) No 283/2013 shall 
be provided.  
1.3. Trade name or proposed trade name, and producer ’s development code n umber 
of the preparation if appropriate  
All former and current trade names and proposed trade names and development code 
numbers of the preparation  referred to in the dossier as well as the current names and 
numbers shall  be provided. Full detail of any di fferences shall be provided. The 
proposed trade name shall not give rise to confusion with the trade name of already 
authorised plant protection products.  
1.4. Detailed quantitative and qualitative information on the composition of the 
preparation  
(i) Each micro -organism that is subject to the application shall be identified as 
unequivocally belonging to a certain species, based on the latest scientific 
information, and  named at the strain level, including any other designation 
which may be relevant to the m icro-organism (e.g. isolate level, if relevant for 
viruses), as required by point 1.3 of Part B of the Annex to Regulation (E U) No 
283/2013. The micro -organism shall be deposited at a recognised culture 
collection and given an accession number. The scienti fic name shall be stated, 
as well as the group assignment (bacteria, virus, etc.) and any other 
denomination relevant to the micro -organism (e.g. strain, serotype). In 
addition, the development phase of the micro -organism (e.g. spores, mycelium) 
in the mar keted plant protection product shall be stated.  EN 14  EN (ii)  For preparations , the following information shall be reported:  
– the minimum and maximum content of the active substance that is  a 
micro -organism in the plant protection product, as required in point 1.4.1  
of Part B of the Annex to Regulation (EU) No 283/2013 , 
– the minimum and maximum content of the MASAM in the plant 
protection product , 
– in case of presence of relevant contaminating micro -organism s, the 
identity and the maximum content of relevant contaminating micro -
organism s expressed in appropriate microbial unit , 
– in case of presence of chemical impurities that are relevant for human 
and animal health and/or the environment, including metabolites of 
concern (identified in accord ance with  point  2.8 of Part B of the Annex 
to Regulation (EU) No 283/2013) produced by the micro -organism as 
relevant impurities in the manufacturing batch, the identity and 
maximum content, expressed in appropriate units , shall be provided , 
– the content of co -formulants, safe ners (if present), synergists in the plant 
protection  product.   
(iii) Co-formulants, safeners and synergists shall, where possible, be identified 
either by their International Chemical Identification as given in Annex VI to 
Regulation (EC) No 1272/2008, or , if not included in that Regulation, in 
accordance with both IUPAC and CA nomenclature. Their structure or 
structural formula shall be provided. For each component of the co -formulants 
safeners and synergists the relevant EC (EINECS or ELINCS) number and 
CAS number , where they exist, shall be provided. Where the information 
provided does not lead to an identification, an appropriate specification shall be 
provided. The trade name of co -formulants , safeners (if present) and synergists, 
if present , shall also be provided.  
(iv) For co -formulants , the function shall  be given  as:  
– adhesive (sticker),  
– antifoaming agent,  
– antifreeze,  
– antioxidants , 
– binder,  
– buffer,  
– carrier,  
– deodorant,  
– dispersing agent,  
– dye,  
– emetic,  
– emulsifier,  
– fertilising product,  EN 15  EN – humect ants, 
– odorant,  
– osmotic protectants,  
– perfume,  
– preservative,  
– propellant,  
– repellent,  
– safener,  
– solar protectants,  
– solvent,  
– stabiliser,  
– thickener,  
– wetting agent ,  
– miscellaneous ( shall be specified ).  
(v)  Relevant c ontaminating micro -organisms shall be identified as provided for  
under  point 1.4.2.2 of Part B of the Annex to Regulation (EU) No 283/ 2013.  
Chemicals (inert components, by -products, etc.) shall be identified as provided 
for under  point 1.10 of Part A of the Annex to Regulation (EU) No 283/2013. 
Where the information provided does not fully identify a component  (such as 
condensate, culture medium ), detailed information on the composition shall be 
provided for each such component.  
1.5. Physica l state and nature of the preparation  
The type and code of preparation shall be designated in accordance with the 
‘Catalogue of pesticide formulation types and international coding system (GIFAP 
Technical Monograph No 2)’. Where a particular preparation i s not defined precisely 
in that catalogue, a full description of the physical nature and state of the preparation 
shall be provided, together with a proposal for a suitable description of the type of 
preparation and a proposal for its definition.  
1.6. Method of  production of the preparation and quality control  
Full information on how the plant protection product is produced in bulk shall be 
provided for all the steps of the manufacturing process. The type of manufacturing 
process (e.g. continuous or batch proces s) shall be indicated.  
1.7. Packaging and compatibility of the preparation with proposed packaging 
materials  
(i)  Packaging to be used shall be described and specified in terms of the materials 
used, manner  of construction (e.g. extruded, welded), size and cap acity, size of 
opening, type of c losure and seals.   
(ii)  The suitability of the packaging, including closures, in terms of its strength, 
leakproofness and r esistance to normal transport , storage and handling 
conditions, shall be determined and reported.  
(iii)  The resistance of the packaging material to its content shall be reported.   EN 16  EN 2. PHYSICAL , CHEMICAL AND TECHNI CAL PROPERTIES OF TH E PLANT PROTECTION 
PRODUCT  
2.1. Appearance (colour and odour)  
A description of the colour and the odour, if any, and the physical  state of the 
preparation shall be provided.  
2.2. Explosivity and oxidising properties  
Explosivity and oxidising properties shall be reported as provided for under point 2.2 
of Part A, unless it can be justified that it is technically or scientifically not ne cessary 
to perform such studies.  
2.3. Flash point and other indications of flammability or spontaneous ignition  
Flash point and flammability shall be reported, as provided for under point 2.3 of 
Part A, unless it can be justified that it is technically or scie ntifically not necessary to 
perform such studies.  
2.4. Acidity, alkalinity and if necessary pH value  
Acidity, alkalinity and pH (before and after storage at the recommended conditions)  
shall be reported, as provided for under point 2.4 of Part A, unless it can be justified 
that it is technically or scientifically not necessary to perform such studies.  
2.5. Viscosity and surface tension  
Viscosity and surface tension shall be reported , as provided for under point 2.5 of 
Part A, unless it  can be justified that it is technically or scientifically not necessary to 
perform such studies.  
2.6. Storage stability and shelf  life  
2.6.1.  Use concentration  
The appropriate minimum and maximum use concentrations of the plant protection 
product , justifying the vo lume of the commercial packaging used in line with a 
reasonable storage period, shall be indicate d, as well as the nature of the packaging 
material in line with the recommended storage conditions.  
2.6.2.  Effects of temperature and packaging  
The optimal temperatu re and packaging to ensure the storage  stability of the plant 
protection product in line with the recommended maximal shelf  life shall also be 
stated. Where shelf  life is less than two years, the shelf  life in months, shall be 
reported.  
At these conditions , information shall be provide d on: 
–  the physical stability of the preparation during  and after storage at the 
recommended storage temperature and, in case of liquid preparation , at low 
temperatures , evaluated by performing t ests in the original packaging , 
–  the content of the active substance that is  a micro -organism , which shall be in 
accordance with the minimum and maximum certified content declared by the 
applicant before and after storage at the recommended storage temperature and, 
if applicable, at low  temperatures , 
–  growth of possible relevant contaminating micro -organism s, before and after 
storage at the recommended storage temperature, described in appropriate EN 17  EN terms for micro -organism s (such as number of active units per volume or 
weight, colony form ing units (CFU) or international units per volume or 
weight, or any other manner that is relevant to the micro -organism ),  
– presence of metabolites of concern identified in accordance with  point 2.8 of 
Part B of the Annex to Regulation ( EU) No 283/2013, before and after storage.  
2.6.3.  Other factors affecting stability  
Effect of exposure to air, light etc., on the  plant protection  product ’s stability shall be 
reported.  
The optimal moisture conditions to ensure the storage stability of the plant protection 
product shall be stated. For dry preparations also the effects of contaminating water 
on viability of the mi cro-organism shall be described. This information may be 
provided by direct measurement of moisture content before and after storage or by 
providing inf ormation on packaging integrity and viability of the micro -organism 
before and after storage.  
2.7. Technical characteristics of the plant protection product  
The technical characteristics of plant protection product s shall be determined and 
reported at appropri ate concentrations.  
2.7.1.  Wettability  
The wettability of solid plant protection product s which is diluted for use (e.g. 
wettable powders and water dispersible granules), shall be determined and reported.  
2.7.2.  Persistent foaming  
The persistence of foaming of plant protection product s to be diluted with water shall 
be determined and reported.  
2.7.3.  Suspensibility,  spontaneity of dispersion and dispersion stability  
The suspensibility of water dispersible plant protection product s (e.g. wettable 
powders, water dispersible g ranules, suspension concentrates) shall be determined 
and reported.   
The spontaneity of dispersion of water dispersible plant protection product (e.g. 
suspension concentrates and water dispersible granules) shall be determined and 
reported.  
The dispersion stability of plant protection product such as aqueous suspo -emulsions 
(SE), oil -based suspension concentrate (OD) or emulsifiable granule (EG) shall be 
determined and reported.  
2.7.4.  Dry sieve test and wet sieve test  
In order to ensure that dustable powders hav e a suitable particle size distribution for 
ease of application, a dry sieve test shall be conducted and reported. In the case of 
water dispersible plant protection product s, a wet sieve test shall be conducted and 
reported.  
The nominal size range of granu les shall be determined and reported.  EN 18  EN 2.7.5.  Particle size distribution (dustable and wettable powders, granules), content of 
dust/fines (granules), attrition and friability (granules)  
(i)  The size distribution of particles in the case of powders shall be determ ined 
and reported. The nominal size range of granules for direct application shall be 
determined and reported.  
(ii)  The dust content of granular plant protection product s shall be determined and 
reported. If results show > 1 % w/w dust then the particle s ize of the dust 
generated shall be determined and reported. If relevant for operator exposure 
the particle size of dust shall be determined and reported.  
(iii)  The friability and attrition characteristics of granules and tablets , which are 
loose packed , shall be determined and reported.  
(iv)  The hardness and integrity of tablets shall be determined and reported.  
2.7.6.  Emulsifiability, re -emulsifiability  and emulsion stability  
(i)  The emulsifiability, emulsion stability and re -emulsifiability of plant protect ion 
product s which form emulsions, shall be determined and reported.  
(ii)  The stability of dilute emulsions and of plant protection products which are 
emulsions, shall be determined and reported.  
2.7.7.  Flowability, pourability (rinsability) and dustability  
(i)  The flowability of granular plant protection product s shall  be determined . 
(ii)  The pourability (including rinsed residue) of suspension plant protection 
product s (e.g. suspension concentrates, suspo -emulsions) shall  be determined 
and reported.  
(iii)  The dustability of dustable powder shall  be determined and reported.  
2.8. Physical and chemical compatibility with other plant protection products 
including plant protection products with which its use is to be authorised  
2.8.1.  Physical compatibility  
If in the lab el claim a use in a mixture with other plant protection products or 
adjuvants  is indicated , the physical compatibility of the plant protection product with 
different plant protection products and adjuvants , which are indicated in the label 
claim , to be use d in the same recommended tank mixes shall  be determined and 
reported.  
2.8.2.  Chemical compatibility  
If in the label claim a use in a mixture with other plant protection products or 
adjuvants  is indicated , the chemical compatibility of the plant protection produ ct 
with different plant protection products or adjuvants in the same recommended tank 
mixes shall be determined and reported, except where  after examination of the 
individual properties of the plant protection product it is establish ed that there is no 
possibility of reaction taking place. In such cases , it is sufficient to provide that 
information as justification for not practically determining the chemical 
compatibility.  
2.9. Adherence and distribution to seeds  
In the case of plant protection product s for se ed treatment , distribution and adhesion 
of the plant protection product to the seeds shall be investigated and reported.   EN 19  EN 3. DATA ON APPLICATION  
3.1. Field of use envisaged  
The field(s) of use, existing and proposed, for plant protection product containing the 
micro -organism shall be specified  as:  
– field use, such as agriculture, horticulture, forestry and viticulture,  
– protected crops (e.g. in greenhouses),  
– non-cultivated areas,  
– home gardening,  
– houseplants,  
– stored food/feed items,  
– other ( shall be speci fied) . 
3.2. Mode of action on the target organism  
The information required in accordance with point 2.3 of Part B of the Annex to 
Regulation (EU) No 283/2013 shall be provided for the plant protection product. 
Additional information on the mode of action on the  target organism shall be 
provided in case the chemical component s (e.g. co -formulants) may have a relevant 
effect on efficacy, human and animal health or the environment.  
3.3. Function, target organisms, plants or plants products to be protected and 
possible r isk mitigation measures  
The biological function shall be given as one of the following :  
– control of bacteria,  
– control of fungi,  
– control of insects,  
– control of mites,  
– control of molluscs,  
– control of nematodes,  
– control of plants,  
– other (shall be speci fied).  
Details of the target organisms, plants or plant products to be protected  and risk 
mitigation measure (if relevant) shall be provided.  
3.4. Application rate  
For each method of application and each use, the rate of application per unit treated, 
in terms  of g, kg, ml or l for the plant protection product and in terms of appropriate 
units for the micro -organism (e.g. number of active units, colony forming units 
(CFU) or international units per volume or weight) shall be provided. For protected 
crops and ho me gardening use rates shall be expressed in g o r kg/100 m2, or g or 
kg/m3, ml or l/100 m2, or ml or l/m3. EN 20  EN 3.5. Content of micro -organism in material used (e.g. in the diluted spray, baits or 
treated seed)  
The content of micro -organism shall be reported, as ap propriate, such as number of 
active unit per volume or weight, colony forming units (CFU) or international units 
per volume or weight, or any other manner that is relevant to the micro -organism.  
3.6. Method of application  
The method of application proposed sha ll be described, indicating the type of 
equipment to be used, if any, as well as the type and volume of diluent to be used per 
unit of area of application, or volume of plant protection product.  
3.7. Number, timing of applications on the same crop, duration of  protection and 
waiting period(s)  
The maximum number of applications to be used on the same crop and their timing 
shall be reported.  
Where relevant , the growth stages of the crops to be protected and the development 
stages of the target organisms shall be indicated. Where applicable, the interval 
between applications, in days, shall be stated. The duration of protection afforded 
both by each applicati on and by the maximum number of applications to be used 
shall be indicated.  
3.8. Proposed instructions for use  
The proposed instructions for use of the plant protection product to be printed on 
labels and leaflets shall be provided.  
3.9. Safety intervals and other precautions to protect human health, animal health  
and the environment  
The information provided shall follow from and be supported by the data provided 
for the micro -organism(s) and that provided under Sections 7  to 10. 
(i)  Where relevant , pre-harvest in tervals, re -entry periods or withholding periods 
necessary to minimise the presence of residues in or on crops, plants and plant 
products, or in treated areas or spaces, with a view to protecting human and 
animal health , shall be specified e.g.:  
– pre-harves t interval (in days) for each relevant crop,  
– re-entry period (in days) for livestock, to areas to be grazed,  
– re-entry period (in hours or days) for humans to crops, buildings or 
spaces treated,  
– withholding period (in days) for animal feeding  stuffs and for  post-
harvest uses,  
– waiting period (in days) between application and handling treated 
products.  
(ii)  Where necessary, in the light of the test results, information on any specific 
agricultural, plant health or environmental conditions under which the plan t 
protection product may or may not be used shall be provided.   EN 21  EN 4. FURTHER INFORMATION O N THE PLANT PROTECTI ON PRODUCT  
4.1. Procedures for cleaning and decontaminating of application equipment  
Cleaning and decontaminating procedures for application equipment and p rotective 
clothing shall be described.  
Such procedures shall aim at inactivating or destroying the active substance that is  a 
micro -organism and at removing residues of the plant protection product (including 
metabolites of concern, if any w ere identified  in accordance with point 2.8 of Part B 
of the Annex to Regulation (EU) No 283/2013).  
Sufficient data shall be submitted to demonstrate the effectiveness of the cleaning 
and decontaminating procedure s. 
4.2. Recommended methods and precautions concerning: handli ng, storage, 
transport, fire or use  
The recommended methods and precautions concerning (detailed) handling 
procedures for the storage, at both warehouse and user level of plant protection 
products, for their transport and in the event of fire shall be prov ided. Where 
relevant, information on combustion products shall be provided. The hazards likely 
to arise and the methods and procedures to minimise the risks shall be specified. 
Procedures to preclude or minimize the generation of waste or leftovers shall b e 
provided.  
Where relevant, an assessment of the procedures shall be provided.  
The nature and characteristics of protective clothing and equipment proposed shall be 
provided. The data provided shall be sufficient to evaluate obtainability, suitability 
and effectiveness under realistic conditions of use (e.g. field or greenhouse 
circumstances), resistance and compatibility with the plant protection product.  
4.3. Measures in case of accident  
Whether arising during transport, storage or use, detailed procedures to  be followed 
in the event of an accident shall be provided and include:  
– containment of spillages,  
– decontamination of areas, vehicles and buildings,  
– disposal of damaged packaging, adsorbents and other materials,  
– protection of emergency workers and residents, including bystanders,  
– first-aid measures.  
4.4. Procedures for destruction or decontamination of the plant protection product 
and its packaging  
Procedures for destruction and decontamination shall be developed and described for 
both small quantities (e.g. user level) and large quantities (e.g. warehouse level). The 
procedures shall be consistent with provisions in place relating to the disposal of 
waste and of toxic waste. The means of disposal proposed shall be without 
unacceptable effects on the env ironment and be the most cost effective and practical 
means of disposal feasible.  EN 22  EN 4.4.1.  Controlled incineration  
The applicant shall provide detailed instructions for safe disposal , taking into 
consideration that,  in many cases , the preferred or sole means to saf ely dispose of 
plant protection products and in particular the co -formulants contained in it, 
contaminated materials, or contaminated packaging, is through controlled 
incineration in a licensed incinerator.  
4.4.2.  Others  
Other methods for destruction or decontami nation of plant protection products, 
packaging and contaminated materials, where proposed, shall be described. Data 
shall be provided for such methods.  
  EN 23  EN 5. ANALYTICAL METHODS  
Introduction  
This section only cover s analytical methods required for post - author isation  control 
and monitoring purposes.  
Both production and the resulting plant protection product shall be subject to a 
continuous quality control by the applicant. The quality criteria for the plant 
protection product shall be submitted.  
For analytical  methods used for generation of data as required by this Annex or for 
other purposes, a justification for the method used  shall be provide d.  
Descriptions of methods shall be provided and include details of equipment, 
materials and conditions used. The app licability of existing CIPAC methods shall be 
reported. These methods shall employ the simplest approach, involve the minimum 
cost and require commonly available equipment.  
On request of competent authorities, the following samples shall be provided:  
(i)  samples of the preparation;  
(ii)  samples of the MASAM;  
(iii)  sample of microbiological strain starter culture from seed stock used to 
manufacture the MASAM;  
(iv)  if technically possible, analytical standards of metabolites of concern (see point 
2.8 of Part B of the Annex to Regulation ( EU) No 283/2013) and all other 
components included in the residue definition;  
(v)  analytical standards of relevant impurities, where relevant  and available . 
5.1. Methods for the analysis of the preparation  
The following methods  shall be describe d: 
– for identification and quantification of each micro -organism in the plant 
protection product , of which the active substance consists, including methods 
on how to distinguish between different micro -organisms, when the plant 
protection product includes more than one , and the most appropriate molecular 
analytical and phenotypic methods as described in point 4.1 of Part B of the 
Annex to Regulation (EC) No 283/2013 , 
– to establish microbiological purity of the plant protection product , 
– to detect and enumerate relevant contaminating micro -organisms in the plant 
protection product ,  
– used to determine the storage stability and shelf life of the plant protection 
product.  
5.2. Methods to determine and quantify residues  
Analytical methods for the  determination of residues, as provided for in point 4.2 of 
Part B of the Annex to Regulation (EU) No 283/2013 , shall be submitted, unless the 
information already submitted in accordance with the requirements of point 4.2 of 
Part B of the Annex to Regulati on (EU) No 283/2013 is sufficient .  EN 24  EN 6. EFFICACY DATA  
Introduction  
The data supplied shall be sufficient to permit an evaluation of the plant protection 
product to be made. In particular , it shall be possible to evaluate the nature and extent 
of benefits that accrue following use of the plant protection product, in comparison to 
suitable reference products and damage thresholds, and to define its conditions of 
use.  
The design, analysis, conduct and reporting of trials shall be in accordance with the 
relevant s tandards, where available. Deviations from available relevant standards 
may only be acceptable if the trials design meets the minimum requirements of the 
relevant standards and it is described and justified. The report shall include a detailed 
and critical  assessment of the data.  
The number of trials to be conducted and reported shall depend on factors such as the 
extent to which the properties of the active substance that is a  micro -organism in the 
plant protection product  are known. This number may depend  also on the variability 
of conditions that arise in the trials (e.g. variability of plant health or climatic 
conditions), on the range of agricultural practices, the uniformity of the crops, the 
mode of application, the type of target organism, the climat ic region and the type of 
plant protection product.  
Data submitted shall be sufficient to be representative for the regions and the range 
of conditions of use encountered in practice concerning the uses of the plant 
protection product. If properly justifi ed and relevant  based on case -by-case approach 
and expert judgement , the applicant may read -across data to support the application , 
including data generated on other relevant uses, crops, European environments or 
other relevant conditions .  
If read -across cannot be applied in order to assess seasonal differences, if any, 
sufficient data shall be generated and submitted to confirm the efficacy of the plant 
protection product in each agronomically and climatically different region for each 
particular crop (or  commodity)/target organism combination. Trials on efficacy or 
phytotoxicity, where relevant, in at least two growing seasons shall be reported.  
Any effects, positive or negative, on any non -target organism, which is observed in 
the tests performed in acc ordance with the requirements of this Section, shall be 
reported.  
6.1. Preliminary tests  
When requested by the competent authority, summary reports of preliminary tests  
shall be submit ted, including laboratory, greenhouse and field studies, used to assess 
the biological activity, mode of action and dose -range finding of the plant protection 
product and the active substance(s) it contains. This information shall  provide 
justification on the combination of several active substances, safeners and/or 
synergists, if  applicable , and it shall  provide additional information for the competent 
authority when it evaluates the plant protection product. Where this information is 
not submitted , a justification , which is acceptable to the competent authority , shall be 
provided .  
6.2. Minimum effective dose  
The minimum effective dose  shall be reported , or a range of minimum doses, 
necessary to achieve with sufﬁcient efﬁcacy the claimed plant protection action, EN 25  EN across the broad range of situations in which that plant protection produ ct is to be 
applied.  
6.3. Testing effectiveness  
The tests shall provide sufficient data to permit an evaluation of the level, duration 
and consistency of intended effects of the plant protection product. Also , possible 
beneficial effects on treated crops shall  be reported. In case of availability of suitable 
reference plant protection products, a comparison shall  be performed between the 
plant protection product subject of the application and the reference  plant protection  
product. Trials shall be designed to investigate specified issues, to minimise the 
effects of random variation between different parts of each testing site and to enable 
statistical analysis to be applied to results amenable to such analysis. The design, 
analysis and reporting of trials shall be in accordance with relevant standards or with 
guidelines satisfying at least the requirements of the corresponding relevant 
standards. The report shall include a detailed and critical assessment of the data. A 
statistical analysis of results amenable to such analysis shall be carried out . Where 
necessary , the test guideline used shall be adapted to enable such analysis.  
6.4. Information on possible development of resistance in target organisms  
Data on the occurrence and development of resistance or cross -resistance in 
populations of target organisms to the active substance that is a  micro -organism shall 
be provided. Such data may be generated in experimental studies (either in 
laboratories or under field condition) or ret rieve d from available scientific literature.  
If such information is available for uses not directly relevant to the uses for which 
authorisation is sought or to be renewed , including information on different species 
of target organism or different crops, this information  shall  also be provided. Where 
there is evidence or information to suggest that, in commercial use, the development 
of resistance is likely, evidence shall be generated and submitted as to the sensitivity 
of the population of the target orga nism concerned to the plant protection product. In 
such cases , a management strategy designed to minimise the likelihood of resistance 
or cross -resistance developing in target species shall be provided.  
6.5. Adverse effects on treated crops  
6.5.1.  Phytotoxicity to t arget plants (including different cultivars) or to target plant 
products  
For herbicides and for other plant protection products for which adverse effects, 
however transitory, are seen during the trials, the margins of selectivity on target 
crops shall be established, using twice the recommended rate of application. In this 
case, test shall be performed to provide sufficient data to permit an evaluation of the 
possible occurrence of phytotoxicity after treatment with the plant protection 
product. Where seri ous phytotoxic effects are seen, an intermediate application rate 
shall also be investigated. Where adverse effects occur, but are claimed to be 
unimportant in comparison with the benefits of use or transient, evidence to support 
that claim is required. If  necessary, yield measurement shall be submitted.  
If testing is required, the safety of the plant protection product to the main cultivars 
of the main crops for which it is recommended shall be demonstrated, including 
effects of crop growth stage, vigour and other factors , which may influence 
susceptibility to damage or injury.  EN 26  EN The extent of investigation necessary on other crops shall  depend on their degree of 
similarity to the main crops already tested, the quantity and quality of data available 
on those  main crops and how far the manner of use of the plant protection product, if 
relevant, is similar. The test may be  perform ed with the main preparation type to be 
authorised.  
Where proposed label claims include recommendations for the use of the plant 
protection product with other plant protection product(s), the provisions laid down in 
this point shall  apply for the mixture.  
Where phytotoxic effects are seen, they shall be accurately assessed and recorded in 
accordance with the relevant EPPO standards or , when a Member State requires so 
and when the test is carried out on the territory of th at Member State, with guidelines 
satisfying at least the requirements of the relevant EPPO guideline.  
6.5.2.  Effects on the yield of treated plants or plant products  
Tests shall be performed to provide sufficient data to permit an evaluation of the 
efficacy of the plant protection product and of possible occurrence of yield reduction 
or loss in storage of treated plants or plant products.  
The effects of plant protection prod ucts on the yield or yield components of treated 
plant products shall be determined, unless the applicant can properly justify that such 
data is not relevant. When treated plants or plant products are likely to be stored, 
possible effects on the yield afte r storage, including data on storage life, shall be 
reported.  
6.5.3.  Effects on the quality of plants or plant products  
Appropriate observations of quality parameters may be required for individual crops 
(for example , cereal grain quality  and sugar content). Suc h information may be 
gathered from appropriate assessments in trials described under points 6.3 and 6.5.1.  
Where relevant, taint testing shall be conducted.  
6.5.4.  Effects on transformation processes  
The tests shall provide sufficient data to permit an evaluatio n of the possible 
occurrence of adverse effects after treatment with the plant protection product on 
transformation processes or on the quality of their products, and it is required when 
all of the following circumstances apply:  
– the treated plants or plant  products are normally intended for use in 
transformation process (e.g. wine making, brewing or bread making ), 
– at harvest, significant residues are present (see Section 8) , and 
– at least one of the following two also apply:  
– there are indications that the use of the plant protection product could 
have an influence on the processes involved (for example , in the case of 
yeast or active substance that is  a micro -organism with fungicidal 
function, when used close to the harvest ), or  
– other plant protection products based on the same or a closely similar 
active ingredient have been shown to have an adverse influence on these 
processes or its products.  
When the test is required, it may be perform ed with the main preparation type to be 
authorized. The possibility of the occurrence of adverse effects on transformation EN 27  EN processes shall be investigated and reported. The tests shall provide sufficient data to 
permit an evaluation of the possible occurrence of adverse effects after treatment 
with the plant protection pro duct on transformation processes or on the quality of 
their products.  
6.5.5.  Impact on treated plants or plant propagating material   
Sufficient data shall be reported to permit an evaluation of possible adverse effects of 
a treatment with the plant protection pr oduct on plants or plant products to be used 
for propagation, except where the proposed uses preclude use on crops intended for 
production of seeds, cuttings, runners or tubers for planting, as appropriate.  
Observations shall be submitted  for: 
(i)  seeds — viability, germination and vigour;  
(ii)  cuttings — rooting and growth rates;  
(iii)  runners — establishment and growth rates;  
(iv)  tubers — sprouting and normal growth.  
Seeds testing shall be done in accordance with the relevant standards or with 
guidelines satisfying at least their requirements.  
6.6. Observations on undesirable or unintended side -effects on succeeding crops and 
other plants  
6.6.1.  Impact on succeeding crops  
The pr ovision laid down in this point shall apply only for :  
– plant -pathogenic micro -organisms, or  
– metabolites of concern for which a hazard to plants was identified, and for 
which data provided in accordance with Section 9 shows that significant 
amounts of thes e metabolites of concern remain in soil or in plant materials, 
such as straw or organics material up to sowing or planting time of possible 
succeeding crops.  
Sufficient data shall be reported to permit an evaluation of possible adverse effects of 
a treatme nt with the plant protection product on succeeding crops. Minimum waiting 
periods between the last application and sowing or planting of succeeding crops shall 
be stated. Limitations on choice of succeeding crops, if any, shall be stated. The 
duration of p rotection brought both by each application and by the maximum number 
of applications to be used shall be indicated.  
6.6.2.  Impact on other plants, including adjacent crops  
Sufficient data shall be reported to permit an evaluation of possible adverse effects of 
a treatment with the plant protection product on other plants, including adjacent 
crops.  
Observations shall be submitted on adverse effects on other plants, including the 
normal range of adjacent crops, when there are indications that the plant protection 
product could affect these plants via drift.  
6.7. Compatibility in plant protection programmes  
Where the proposed label claim includes requirements for the use conditions with 
other plant protection products in tank mix, spray sequences or other relevant types  EN 28  EN of applications, potential effects (e.g. antagonism, fungicidal effects) on the activity 
of the micro -organism after mixing, spraying in sequence, or employing other 
relevant types of applications with other plant protection products shall be 
investigated . Appropriate information shall be provided.  
A general precautionary statement shall be propose d on the label, alerting the user 
about possible loss of efficacy of the micro -organism due to interaction in tank mix, 
spray sequences or other relevant types o f applications with plant protection products 
other than those indicated in the label. Known biological incompatibilities with other 
plant protection products shall be reported  on the label . 
Appropriate recommendations (e.g. intervals between application o f the plant 
protection product and other products) shall be specified, where necessary to avoid 
potential negative effects on the activity of the micro -organism. Appropriate 
information supporting the recommendations shall be provided.  
If relevant, potent ial adverse effects of the plant protection product with natural 
enemies (e.g. released biological control agents) or other practices (e.g. conservation 
biological control ) under the expected condition of use of the plant protection 
product shall be report ed. The assessment of those potential adverse effects  shall be 
based on information provided on  one or more of the following :  
– host range of the micro -organism ( point 2.3 of Part B of the Annex to 
Regulation (EU) No 283/2013),  
– effects on bees ( point 8.3 of Part B of the Annex to Regulation (EU) No 
283/2013 and point 10.3 of Part B of the Annex to Regulation (EU) No 
284/2013 ),  
– effects on non -target arthropods other than bees ( point 8.4 of Part B of the 
Annex to Regulation (EU) No 283/2013 and point 10.4 of Part B of the Annex 
to Regulation (EU) No 28 4/2013 ) or  
– any other relevant information.  
  EN 29  EN 7. EFFECT ON HUMAN HEALT H 
Introduction  
For proper evaluation of risks for human and animal (i.e. species normally fed and 
kept by humans or food -producing animals ) health linked to the use of a plant 
protection product containing an active substance that is  a micro -organism, the 
infectivity and pathogenicity of the micro -organism have been already assessed in 
accordance with Section 5 of Part B of the Annex to Regu lation ( EU) No 283/2013. 
This assessment includes the micro -organism and any metabolite(s) of concern for 
human and animal health identified in accordance with point 2.8 of Part B of the 
Annex to that Regulation.  
This Section identif ies the relevant additional tests to be carried out to determine the 
classification and labelling of the plant protection product and the acceptability of the 
risks related to its use . In some cases, already existing information on toxicity of co -
formulants an d other non -active ingredients of the plant protection product may be 
sufficient to conclude on the toxicity of the plant protection product.  
In view of determining the classification and labelling of the plant protection 
product, as well as the risks asso ciated with its use, information on intrinsic 
toxicological properties of the co -formulants, safeners and synergists (if present), 
shall be provided. Possible adverse synergistic effects and/or interaction among 
chemical substances present in the plant pro tection product (e.g. co -formulants, other 
active substance(s) and its/their impurities present in the same plant protection 
product) shall also be investigated. Available data concerning any possible adverse 
effect on human health  shall be reported.  
The information provided shall be sufficient to allow an evaluation of the risks to 
human health  associated with the use of the plant protection products (e.g. operators, 
workers, bystanders, residents and consumers), the risk for human  health  handling 
treated crops, as well as the risk for human  health  and animals arising from residual 
traces remaining in food, feed and water. In addition, the information provided shall 
be sufficient to:  
– permit a decision to be made as to whether, or not, the plant protect ion product 
may be authorized , 
– specify appropriate conditions or restrictions to be associated with any 
authorization , 
– specify hazard and precautionary statements for the protection of human  
health , animal  health  and the environment to be included on packa ging 
(containers ), 
– identify relevant first aid measures as well as appropriate diagnostic and 
therapeutic measures to be followed in the event of infection or another adverse 
effect in humans.  
In the context of the possible contribution that relevant impu rities and other 
components can have on the toxicological profile of the plant protection product, for 
each study submitted, a detailed description of the material used shall be provided. 
Tests shall be conducted using the plant protection product to be au thorised. In 
particular, the information provided shall demonstrate  that the micro -organism used 
in the plant protection product and the conditions of culturing it are the same for 
which information and data are submitted in accordance with Part B of the A nnex to EN 30  EN Regulation (EU) No 283/2013. While performing toxicology studies, all signs of 
adverse effects shall be reported.  
Based on the information submitted, proposals for the classification and labelling of 
the plant protection product, using CLP calculat ion rules in accordance with 
Regulation (EC) No 1272/2008, where applicable, shall be submitted and justified, 
including:  
– pictograms,  
– signal words,  
– hazard statements, and  
– precautionary statements.  
Where the information available is considered not to be  robust enough to exclude 
possible adverse synergistic effects of substances present in the plant protection 
product (e.g. co -formulants, other active substance(s) and its/their impurities present 
in the same plant protection product), toxicological studie s on possible adverse 
synergistic effects shall be required by the competent authority, as described under  
points 7.4 and 7.7.  
7.1. Medical data  
Any available information on possible adverse effect on human  health  shall be 
reported, including sensitisation and allergenic response of humans exposed to the 
plant protection product. In the case of adverse effects, special attention shall  be paid 
to whether the individual’s susceptibility may have been affected by e.g.  pre-existing 
disease, medication, compromised immunity, pregnancy or breast -feeding. The 
information provided shall include details of level and duration of exposure, 
symptoms observed and other relevant clinical observation.  
7.2. Assessment of potential toxic ity of the plant protection product  
Possible human health hazards related to pathogenic events linked to the use of the 
plant protection product are addressed through data on infectiveness, pathogenicity, 
and clearance of the active substance that is  a mic ro-organism in accordance with 
Section  5 of Part B of the Annex to Regulation ( EU) No 283/2013.  
Studies to determine the potential toxicity of the plant protection product shall be 
performed as required in point 7.3, unless the applicant demonstrate by fo llowing a 
weight of evidence approach, based on the information provided under Sections 2, 3, 
4 and point 7.1 or retrieved from any other reliable sources (e.g. Integrated Approach 
to Testing and Assessment – IATA, or CLP calculation rules in accordance wi th 
Regulation (EC) No 1272/2008, read -across data from similar preparations) that no 
such effects are to  be expected. An assessment of the potential toxicity of the plant 
protection product shall be submitted, taking into consideration information on the 
intrinsic properties of co -formulants, metabolites of concern identified in accordance  
with point 2.8 of Part B of the Annex to Regulation (E U) No 283/2013, relevant 
impurities, with consideration for possible adverse synergistic effects and/or 
interaction between them and with the proposal for classification and labelling. With 
this assessment, the applicant shall demonstrate whether or not sufficient information 
is available to classify the plant protection product in accordance with Regulation 
(EC) No 1272/2008 with regard to toxicity to humans and whether or not acute 
toxicity studies on animal s as described in points 7.3.1 to 7.3.6 are needed.  EN 31  EN 7.3. Acute toxicity studies  
Unless information can be provide d to allow an assessment to be conducted on the 
possible human toxicity of the plant protection product as set out in point 7.2, the 
applicant shall define which of the tests described in points 7.3.1 to 7.3.6 is relevant 
for the plant protection product and  perform the test(s) identified in accordance with 
the instruction provided in each respective relevant  point . The studies indicated in 
points 7.3.1 and 7.3.6, data and information to be provided and evaluated shall be 
sufficient to permit the identificati on of effects following a single exposure to the 
plant protection product and in particular to establish or indicate:  
– the acute toxicity of the plant protection product ,  
– the time course and characteristics of the adverse effect with full details of 
behavi oural changes and possible gross toxicological findings at post -mortem 
in animal studies ,  
– where possible , the mode of toxic action , and  
– the relative hazard associated with the different routes of exposure.  
The information generated shall also permit the  plant protection product to be 
classified in accordance with Regulation (EC) No 1272/2008.  
7.3.1.  Acute oral toxicity studies  
Unless information can be provide d to allow an assessment to be conducted on the 
possible acute oral toxicity of the plant protection product as set out in point 7.2, a 
test for acute oral toxicity shall be carried out in accordance with  the most 
appropriate guidelines.  
7.3.2.  Acute dermal toxicity  
Unless information can be provide d to allow an assessment to be conducted on the 
possible dermal toxicity of the plant protection product as set out in point 7.2, a test 
for dermal toxicity shall be carried out in accordance with  the most appropriate 
guidelines.  
7.3.3.  Acute inhalation toxicity  
Unless information can be provided to allow an assessment to be conducted on the 
possible inhalation toxicity of the plant protection product as set out in point  7.2, a 
test for acute inhalation toxicity shall be carried out  if the plant protection product:  
– is used with fogging equipment,  
– is used as a smoke generating formulation,  
– is used as a vapour releasing preparation,  
– is to be applied from aircraft in cases where inhalation exposure is relevant 
(broadcast air -assisted sprayer),  
– is an aerosol,  
– is a powder containing a significant proportio n of particles of diameter 
< 50 micrometre (>  1 % on a weight basis),  
– is to be applied in a manner which generates a significant proportion of 
particles or droplets of diameter <  50 micrometre (>  1 % on a weight ba sis), or  
– contains a volatile component at greater than 10  %.  EN 32  EN  
7.3.4.  Skin irritation  
Unless information can be provide d to allow an assessment to be conducted on the 
skin irritating potential of the plant protection product from the available information 
regard ing its components, including the active substance, co -formulants, safeners, 
synergists, and relevant impurities as set out in point 7.2, a test for skin irritation 
shall be carried out in accordance with  the most appropriate guidelines.  
The test shall  provide the potential of skin irritancy of the plant protection product 
including the potential reversibility of the effects observed.  
7.3.5.  Eye irritation  
A test for eye irritation shall be carried out in accordance with  the most appropriate 
guidelines, unless : 
– information can be provide d to allow an assessment to be conducted on the eye 
irritating potential of the plant protection product as set out in point 7.2, or  
– the micro -organism is an already known eye irritant or it is likely, as indicated 
in the test guideline, that severe effects on the eyes may be produced.  
The test shall provide the potential for eye irritation of the plant protection product, 
including the potential reversibility of the effects observed.  
7.3.6.  Skin sensitisation  
Unless information can be provide d to allow an assessment to be conducted on the 
skin sensitization properties of the plant protection product as set out in point 7.2, 
when available, a test for skin sensitization shall be carried out in accordance with  
the most appropriate guide lines.  
7.4. Additional toxicity information  
If, based on results of the studies required in point 7.3, one or more substances of 
concern is present in the plant protection product (e.g. metabolites of concern and/or 
co-formulants) for which the risk is for huma n and animal  health  is considered not 
acceptable based on those studies already performed, relevant additional information 
on toxicity may be necessary for the plant protection product. The need to perform 
supplementary studies on the plant protection prod uct shall be based on expert 
judgement case-by-case, in the light of the particular parameters to be investigated 
and the objectives to be achieved, for example , if concern on the toxicity of the plant 
protection products has arisen from studies described in points 7.3.1 to 7.3.6 or a 
conclusion on toxicity could not be reached.  
7.5. Data on exposure  
If, based on data provided in Section 5 of Part B of the Annex to Regulation (EU) No 
283/2013 and this Section, effects on human health cannot be excluded , sufficient 
information and data shall be generated and reported to permit an assessment of the 
extent of exposure to the plant protection product likely to occur under the proposed 
conditions of use. Study design shall take into account biological, physical , chemical 
and toxicological properties of the plant protection product as well as the type of the 
product (undiluted/diluted), preparation type, and on the route, the degree and 
duration of exposure . EN 33  EN In the case where there is a particular concern for a p ossibility of dermal absorption 
of a toxic component of the plant protection product based on information provided 
in this Section , dermal absorption data shall be provided as provided for under  point 
7.3 of Part A.  
Results from exposure monitoring during  production and use of the plant protection 
product shall be submitted.  
The information and data referred to in this point  shall provide the basis for the 
selection of appropriate protective measures including personal protective equipment 
(see point 4.2) to be used by operators and workers and other appropriate risk 
mitigation measures (e.g. for bystanders and residents) and to be specified on the 
label.  
7.6. Available toxicological data relating to non -active substances  
Where relevant, the following informati on shall be submitted for each co -formulant, 
safeners (if present) and synergists:  
(a) the registration number as referred to in Arti cle 20(3) of Regulation (EC) 
No 1907/2006  of the European Parliament and of the Council8;  
(b) the study summaries included in the  technical dossier ; and  
(c) the safety data sheet as referred to in A rticle 31 of Regulation (EC) 
No 1907/2006.  
All other available information shall be submitted.  
7.7. Supplementary studies for combinations of plant protection products  
Where the plant protectio n product label indicates the  use of the plant protection 
product with other plant protection products and/or with adjuvants as a tank mix , the 
studies as referred to under points 7.3.1 to 7.3.6 shall be carried out for the relevant 
combination of plant pr otection products. Decisions as to the need for supplementary 
studies shall be made on a case -by-case basis, taking into account the results of the 
acute toxicity studies of the individual plant protection products, the possibility for 
exposure to the comb ination of the plant protection products concerned and available 
information or practical experience with the plant protection products concerned or 
similar plant protection products.  
The need to perform supplementary studies on the plant protection produc t shall be 
based on expert judgement case-by-case, in the light of the particular parameters to 
be investigated and the objectives to be achieved (for example , for plant protection 
products containing active substances or other components suspected to have  
synergistic or additive toxicological effects ). 
  
                                                 
8 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals ( REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/E EC, 93/105/EC and 
2000/21/EC ( OJ L 396, 30.12.2006 , p. 1 ). EN 34  EN 8. RESIDUES IN OR ON TRE ATED PRODUCTS , FOOD AND FEED  
Data and information on residues in or on treated products, food and feed in 
accordance with Section 6 of Part B of the Annex to Regulation (EU) No  283/201 3 
shall be submitted, unless the applicant shows that the data and information already 
submitted for the active substance are s ufficient to permit a  risk assessment  to be 
performed on the plant protection product . 
  EN 35  EN 9. FATE AND BEHAVIOUR IN  THE ENVIRONMENT  
Data and information in accordanc e with Section 7 of Part  B of the Annex to 
Regulation (EU) No 283/2013  shall be submitted  on the fate and behaviour of the 
plant protection product in the environment , unless the applicant shows  that the data 
and informatio n already submitted for the active substance are sufficient to permit a 
risk assessment  to be performed on the plant protection product.  
  EN 36  EN 10. EFFECTS ON NON -TARGET ORGANISMS  
Introduction  
(i)  The information provided, taken together with that for the active substance that 
is a micro -organism provided in accordance with  Part B of the Annex to 
Regulation (EU) No 283/2013 (including possible metabolite(s) of concern as 
identified in accordance with point 2.8 of Part B of the Annex to Regulation 
(EU) No 283/2013)  shall be sufficient to permit an assessment of the  potential  
impact on non -target species of the plant protection product, when used as 
proposed. This information shall be sufficient to assess p otential  impact s 
result ed from single, prolonged or repeated exposure and which are  reversible 
or irreversible.  
(ii)  Where exposure data are necessary to decide whether a study shall be 
performed, the data obtained in accordance with Section 9 shall be used. For 
the estimation of exposure of organisms all relevant information on the plant 
protection product and on the mi cro-organism shall be taken into account. 
Where relevant, the data provided for under  this Section shall be used. Where it 
appears from available data that the plant protection product has a stronger 
effect than the active substance that is  a micro -organis m, the data on effects on 
non-target organisms of the plant protection product shall be used for the 
calculation of relevant effect/exposure ratios.  
(iii)  Unless it can be justified that an assessment of effects on non -target organisms 
can be performed wi th the information already available,  experimental data 
may be required. The duration of experimental studies shall be long enough to 
permit time for incubation, infection and manifestation of adverse effects in 
non-target organisms , but in line with the e xpected exposure under the 
proposed use . In order to distinguish between pathogenic and toxic effects, 
appropriate controls shall be used in addition to the no -dosed control group, 
such as inactivated controls, supernatant and/or sterile filtrate controls.  Special 
attention shall be  required when the plant protection product contains a micro -
organism which is pathogenic to non -target organisms other than mammals and 
that was/were not isolated from a relevant European  environment. The 
information provided sh all be sufficient to assess environmental impacts.  
(iv)  The relevance of non -target organism species used for testing environmental 
effects shall be based on a weight of evidence approach, taking into 
consideration, for instance:  
– information on the micro -organism (particularly on biological properties) 
as required in Part B of the Annex to Regulation (EU) No  283/2013 ,  
– information concerning the co -formulants, safeners and synergists (if 
present), as required in Sections 1 to 9 , and 
– proposed use patterns of the plant protection product (e.g. foliar or soil 
application).  
In order to facilitate the assessment of the significance of test results obtained, 
where possible, the same strain of each relevant species of non -target 
organisms shall be used in the va rious specified tests for effects on non -target 
organisms.  EN 37  EN (v)  All the adverse effects observed in tests and trials performed with the plant 
protection product  shall be reported , and additional studies , which may be 
necessary to investigate the mechanisms involved and assess the significance 
of these effects , shall be undertake n and report ed.   
(vi)  Where adverse toxic effects are indicated in the studies considered for the risk 
assessment and risk iden tified may be considered not acceptable, additional 
toxicity studies under field conditions and in accordance with the proposed 
recommendations for use shall be conducted, if applicable.  
The type of study to be performed depends on the effects and the aff ected non -
target organism(s) observed in the studies required in points 10.1 to 10.7 and 
during efficacy testing and may have to include also further studies on 
additional non -target species  (i.e. different than those initially tested) . Special 
attention s hall be given to possible effects on non -target organisms occurring in 
the relevant E uropean  environment and deliberately released organisms for 
biological control purposes.  
(vii)  The information provided for the plant protection product, together with ot her 
relevant information, and that provided for the micro -organism (including 
possible metabolites of concern as id entified in point 2.8 of Part  B of the 
Annex to Regulation (EU) No 283/2013) shall be sufficient to:  
– specify the hazard symbols, the indicati ons of danger and relevant risk 
and safety phrases or the pictograms, signal words, relevant hazard and 
precautionary statements for the protection of the environment to be 
mentioned on packaging (containers),  
– permit an evaluation of the short - and long -term risks for non -target 
species — populations, communities, and processes as appropriate,  
– permit an evaluation whether special precautions are necessary for the 
protection of non -target species.  
10.1. Effects on terrestrial vertebrates  
The same information su bmitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use), as 
detailed in points 8.1, 8.7 and 8.8 of Part B of the Annex to Regulation (EU) No 
283/2013 shall be provided for t he plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organism approval (and/or on a plant protection product containing that active 
substance with  respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and quantitative composition), 
as well as for the micro -organism and possible metabolites of concern (based 
on data submitted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the micro -organism(s) in the 
plant protection product), or  
– prove  that the non -target terrestrial vertebrates (e.g. mamma ls, birds, reptiles, 
and amphibians)  will not be exposed to the plant protection product (based on 
data submitted in accordance with  Section  9). EN 38  EN If generation of data is required, the studies shall provide LD 50 values and include 
gross pathological findings. The studies may be conducted on the species used in the 
studies referred to in point 8.1 of Part B of the Annex to Regulation (EU) No 
283/2013. Relevant studies as provided for under  point 10.1 of Part A sha ll be 
performed.  
10.2. Effects on aquatic organisms  
10.2.1.  Effects on fish  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use) as 
detailed in points 8.2.1, 8. 7 and 8.8 of Part B of the Annex to Regulation (EU) No 
283/2013 shall be provided for the plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organi sm approval (and/or on a plant protection product containing that active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and qu antitative composition), 
as well as for the micro -organism and possible metabolites of concern (based 
on data submitted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the active substance(s) in the 
plant protection product), or  
– prove  that fish will not be exposed to the components of the plant protection 
product (based on data submitted in accordance with Section  9). 
If generation of data is required, the studies shall provide LD 50 values, and shall 
include gross pathological findings. The study may be conducted on the species used 
in the studies referred to in point 8.2.1 of Part B of the Annex to Regulation (EU) No 
283/2013. Relevant studies as provided  for under  point 10.2 of Par t A shall be 
performed.  
10.2.2.  Effects on aquatic invertebrates  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use)as 
detailed in points 8.2.2, 8.7 and 8 .8 of Part B of the Annex to Regulation (EU) No 
283/2013 shall be provided for the plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organism appr oval (and/or on a plant protection product containing that active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and quantitat ive composition), 
as well as for the micro -organism and possible metabolites of concern (based 
on data submitted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the active substance(s) in the 
plant pro tection product), or  EN 39  EN – prove  that the aquatic invertebrates will not be exposed to the components of 
the plant protection product (based on data submitted in accordance with  
Section  9). 
If generation of data is required, relevant studies as provided for unde r point 10.2 of 
Part A shall be performed.  
10.2.3.  Effects on algae  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use) as 
detailed in points 8.2.3, 8.7 and 8.8 of Part B of the Annex to Regulation (EU) 
No 283/2013 shall be provided for the plant protection product subject of the 
application, unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the mi cro-
organism approval (and/or on a plant protection product containing that active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitat ive and quantitative composition), 
as well as for the micro -organism and possible metabolites of concern (based 
on data submitted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the micro -organism(s) i n the 
plant protection product), or  
– prove  that algae will not be exposed to the components of the plant protection 
product (based on data submitted in accordance with  Section  9). 
If generation of data is required, relevant studies as provided for under  point 10.2 of 
Part A shall be performed.  
10.2.4.  Effects on aquatic macrophytes  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use) as 
detailed in points 8.2.4, 8.7 and 8.8 of Part B of the Annex to Regulation (EU) No 
283/2013 shall be provided for the plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organism approval (and/or on a plant protection product containing that active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and quantitative composition), 
as well as for the micro -organism and possible metabolites of concern (based 
on data submitted in Section  8 of Part  B of the Annex to Regulation (EU) No 
283/2013 for the approval of the micro -organism(s) in the plant protection 
product), or  
– prove  that aquatic macrophytes will not be exposed to the components of the 
plant protection product (based on data submitted in accordance with  
Section  9). 
If generation of data is required, relevant studies as provided for under  point 10.2 of 
Part A shall be performed.  EN 40  EN 10.3. Effects on bees  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use) as 
detailed in points 8.3, 8.7 and 8. 8 of Part B of the Annex to Regulation (EU) No 
283/2013 shall be provided for the plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organism appro val (and/or on a plant protection product containing that active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and quantitati ve composition), 
as well as for the micro -organism and possible metabolites of concern (based 
on data submi tted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the micro -organism(s) in the 
plant protec tion product),  or 
– prove  that bees will not be exposed to the components of the plant protection 
product (based on data submitted in accordance with  Section  9). 
If generation of data is required, relevant studies as provided  for under  point 10.3.1 
of Part A shall be performed.  
10.4. Effects on non-target arthropods other than  bees  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use) as 
detailed in points 8.4, 8.7 and 8.8 of Part B of the Annex to Regulation (EU) No 
283/2013 s hall be provided for the plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organism approval (and/or on a plant protection product containing that  active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and quantitative composition), 
as well as for the micro -organism and po ssible metabolites of concern (based 
on data submitted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the micro -organism(s) in the 
plant protection product), or  
– prove  that the non -target arthropods ot her than bees will not be exposed to the 
components of the plant protection product (based on data submitted in 
accordance with  Section  9). 
If generation of data is required, relevant studies as provided  for under  point 10.3.2 
of Part A shall be performed. Analyses might include further studies on additional 
species, or higher tier studies such as studies on selected non -target organisms using 
the formulated plant protection product. The choice of non -target arthropods t est 
species playing an important role in integrated pest management may be based on 
several factors, such as biological properties of the micro -organism and the intended 
use (e.g. crop type).  EN 41  EN 10.5. Effects on non-target meso - and macroorganisms in soil  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use) as 
detailed in points 8.5, 8.7 and 8.8 of Part B of the Annex to Regulation (EU) No 
283/2013 shall be r eported for the plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organism approval (and/or on a plant protection product containing that active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and quantitative composition), 
as well as for the micro -organism and possible me tabolites of concern (based 
on data submitted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the micro -organism(s) in the 
plant protection product), or  
– prove  that the non -target meso - and macroorganis ms in soil will not be exposed 
to the components of the plant protection product (based on data submitted in 
accordance with  Section  9). 
If generation of data is required, relevant studies as provided for under  point 10.4 of 
Part A shall be performed.  
10.6. Effects on non-target terrestrial plants  
The same information submitted on the micro -organism (and/or on a plant protection 
product containing that active substance with respect to a representative use) as 
detailed in points 8.6, 8.7 and 8.8 of Part B of the Annex  to Regulation (EU) No 
283/2013 shall be provided for the plant protection product subject of the application, 
unless the applicant can:  
– justify the applicability and relevance of the same data submitted for the micro -
organism approval (and/or on a plant protection product containing that active 
substance with respect to a representative use),  
– predict the effects of the plant protection product on the basis of the data 
available for the co -formulants (e.g. qualitative and quantitative composition) , 
as well as for the micro -organism and possible metabolites of concern (based 
on data submitted in accordance with Section  8 of Part  B of the Annex to 
Regulation (EU) No 283/2013 for the approval of the micro -organism(s) in the 
plant protection product), or 
– prove that the non -target terrestrial plants will not be exposed to the 
components of the plant protection product (based on data submitted in 
accordance with  Section  9). 
If generation of data is required, relevant studies as provided  for under  point 10.6 of 
Part A shall be performed.  
10.7. Additional toxicity studies  
Further data may be submitted or a dditional toxicity studies performed, if tests 
required in points 10.1 to 10.6 have shown adverse effects in one or more non -target 
organisms and the risk is co nsidered not acceptable. The type of study to be 
performed shall be chosen  based on the effects and  the affected non -target EN 42  EN organism(s) observed in the studies required in points 10.1 to 10.6 and during 
efficacy testing, and may have to include also further studies on additional non -target 
species. ’