OECD Template #88: Effectiveness against target organisms and intended uses - general information (Version 2-June 2012)

The following table gives a detailed description of the type of information prompted for by the data entry fields. Elements provided to guide the user include predefined picklist phrases, freetext templates and context-sensitive help texts. In addition, technical elements are provided, i.e. field and data types, explanations for use in Data Element Dictionary (DED) and the xml schema. The conventions used are explained in part 'Introduction and Format of OECD Harmonised Templates'.

Field number

Field description

[Field label]

  1. Field type
  2. Data type
  3. Group ID
  4. Max occ.
  5. Detail level
  6. Picklist code

Remarks, Picklist, Freetext template

Help text

Explanation for use in Data Element Dictionary (DED)

XML Schema

 

ADMINISTRATIVE DATA

 

REMARKS:

Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., 'key study'), the type of result (e.g., 'experimental study'), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and may therefore be displayed on top of each template. For detailed guidance, refer to Administrative data.

 

 

 

SE10.01.00.0215

General information

[General information]

  1. HEAD-1
  2. Heading level 1
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'General information'.

 

SE10.01.00.0220

Background information

[Background information]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

Use this field to include any background information, if required, or any relevant introductory remark. Leave field empty if not applicable. Do not include information for which specific fields are provided.

PURPOSE OF THIS TEMPLATE:

This template can be used for recording general information on the effectiveness of an active substance or a biocidal product, together with its active substances (as required by the relevant legislation).

For products, efficacy studies should be reported using the corresponding template 'Efficacy data'. For active substances, the effectiveness achieved or claimed should be briefly described in this template. If required or sensible such description can be supported by including summary table(s) which give an overview of relevant efficacy studies performed with a product or products.

As appropriate, the general information can be provided in one record or in several individual records. For instance, one record may be sensible if several target organisms, but same function and product type are addressed. Separate records may be sensible for addressing different types of target organisms and functions.

Note that this template focuses primarily on biocides. If used for other than this purpose additional pieces of information may have to be added in several fields. Consult the programme-specific guidance on the details to be included.

Description of any relevant background information or any relevant introductory remarks on the study summary.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:BACKGROUND_INFORMATION>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE10.01.00.0225

Pest / target organisms to be controlled

[Pest / target organisms to be controlled]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Pest / target organisms to be controlled'.

 

SE10.01.00.0229

Target organisms

[Target organisms]

  1. HEAD BLOCK
  2. Block label
  3. g2
  4. 40
  5. 1
  6. [N/A]

 

Specify the target organism(s) to be controlled. Repeat this block of fields as necessary. Due to the great number of possible target organisms this picklist is not exhaustive. If the species name is not listed, choose an appropriate superior term (e.g. 'Acaridae:') and specify by entering free text in the related field. If organism is not listed at all, choose 'other:' and enter the name or several names in a row in the related text field.

Heading of field block 'Test / target organism(s) to be controlled'

 

SE10.01.00.0230

Scientific name of target organism

[Scientific name]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g2
  4. 1
  5. 1
  6. C109

Picklist Values:

Ixodidae: || Kalotermitidae || Larus argentatus || Larus carnus || Larus fuscus || Larus marinus || Larus ridibundus || Latridiidae: || Lecanora dispersa || Lepidoptera: || Lepismatidae: || Limnoria lignorum || Limnoria spp. || Linognathidae: || Liposcelidae: || Lunularia cruciata || Lyctus brunneus || Macronyssidae: || Mallophaga: || Marchantia polymorpha || Mesostigmata (Gamasida): || Metastigmata (Ixodida): || Microtidae: || Muridae: || Mus macedonius || Mus musculus || Mus musculus domesticus || Mus musculus musculus || Mus spretus || Muscidae: || Myrmicinae: || Nostoc commune || Oniscidae: || Ostomidae: || Passer domesticus || Pediculidae: || Penicillium purpurogenum || Phialophora spp. || Phoma violacea || Phthiraptera: || Phthiridae: || Pica pica || Pleurococcus spp. || Porcellionidae: || Prostigmata: || Pseudomonas aeruginosa || Pseudomonas spp. || Psocoptera: || Psoroptidae: || Psychodidae: || Psyllipsocidae: || Ptinidae: || Pulicidae: || Pyemotidae: || Pyraloidea: || Pyroglyphidae: || Rattus norvegicus || Rattus rattus || Reticulitermes sp. || Rhodotorula rubra || Rhynchostegiella tenella || Rodentia: || Saltatoria: || Sarcophagidae: || Sarcoptidae: || Sciurus carolinensis || Serpula lacrymans || Silvanidae: || Simuliidae: || Siphonaptera: || Sporbolomyces roseus || Stachybotrys atra || Stichococcus bacillaris || Streptopelia decaocto || Sturnus vulgaris || Tabanidae: || Tenebrionidae: || Teredo navalis || Teredo spp. || Tineidae: || Tortula muralis || Trogiidae: || Trombiculidae: || Ulocladium atrum || Xestobium rufovillosum || Zygentoma: || Acaridae: || Actinobacter spp. || Aerobacter spp. || Alternaria spp. || Amphora spp. || Anobiidae: || Anobium punctatum De Geer || Arachnida: Acari: || Argasidae: || Arthropoda: || Aspergillus versicolor || Astigmata: || Aureobasidium pullulans spp. || Bacillus spp. || Barbula cylindrica || Basidiomycetes: || Blattellidae: || Blattidae: || Blattodea: || Bostrichidae: || Branta bernicla || Branta canadensis || Buellia canescens || Calliphoridae: || Caloplaca spp. || Camptothecium sericenum || Candelariella spp. || Ceratocystis spp. || Ceratophyllidae: || Ceratopogonidae: || Cheyletiellidae: || Cimicidae: || Cladosporium caldosporioides || Coleoptera: || Columba livia || Columba palumbus || Corvus corone || Corvus frugilegus || Corvus monedula || Crustacea: || Culicidae: || Curculionidae: || Dermanyssidae: || Dermaptera: || Dermestidae: || Diptera: || Dolichoderinae: || Drosophilidae: || Enteromorpha spp. || Forficulidae: || Formicinae: || Fungi: || Garrulus glandarius || Gelechiidae: || Gloeocapsa alpicola || Glycyphagidae: || Grimmia pulvinata || Gryllidae: || Haematopinidae: || Hemiptera: Heteroptera: || Hesperophanes spp. || Hippoboscidae: || Hylotrupes bajulus L. || Hymenoptera: Formicidae: || Hymenoptera: Vespinae: || Insecta: || Isopoda: || Isoptera: || other: || no data

Select appropriate scientific name from picklist. If not listed, select 'other' and specify. If not given/known, select 'no data'. See also instructions on this block of fields.

Any remarks can be entered in the supplementary remarks field, for instance any code for target organism if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'I.1.1.1 (EU BPD)'.

Scientific name of the test/target organism.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_SCIENTIFIC_NAME>

<i5:SCIENTIFIC_NAME>

SE10.01.00.0231

Scientific name of target organism

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g2
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_SCIENTIFIC_NAME>

<i5:SCIENTIFIC_NAME_TXT>

SE10.01.00.0240

Common name of target organism

[Common name]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g2
  4. 1
  5. 1
  6. C110

Picklist Values:

Acarid mites || Aedes mosquitoes || common furniture beetle || algae || American Cockroach || Anopheles mosquitoes || ants || Arachnids: ticks and mites || astigmatid mites || Australian cockroach || autumn fly || bacon beetle || bacteria, aerobic Gram-negative || bacteria, aerobic Gram-positive || barklice || bed bug || beetles || biting lice || biting midges || black headed gull || blackflies || blattellid cockroaches || Blattid cockroaches || blow flies || blue stain fungi || blue-green algae || book louse || Brent goose || brown ear tick || brown rat || brown rot fungi || brown-banded cockroach || bugs || Canada goose || cat flea || cattle louse || cheese mite || chicken mite || chigger mites || cloth moth || cmmon silverfish || cockroaches || collared dove || common cockroach || common earwig || common gull || common rough woodlouse || common shiny woodlouse || common wasp || confused flour beetle || corn moth || crickets || crickets and grasshoppers || crow || crustaceans || death-watch beetle || Dermanyssid mites || dog flea || dog louse || dry fruit moth || dry rot fungus || dry wood termites || earwigs || Eastern European house mouse || Eastern Mediterranean short-tailed mouse || European earwig || Feral pigeon || firebrat || fleas || flesh flies || flour moth || fodder mite || forficulid earwigs || four mite || fruit fly || fungi || fungi/yeasts || fur mites || gain itch mite || gain weevil || Gamasid mites || garden ant || German cockroach || German wasp || golden spider beetle || great black-backed gull || green algae || grey squirrel || gribble || hard ticks || herring gull || horn flies || house cricket || house dust mites || house fly || house longhorn beetle || house mites || house mosquitoe || house mouse || house rat || house sparrow || human body louse || human flea || human head louse || humpbacked spider beetle || huse itch mites || insects || isopods || jackdaw || jay || Lataste's mouse || Lepismatid silverfishes || lesser black-backed gull || lesser grain borer || lesser house fly || lesser mealworm || lesser rice weevil || lichens || liverworts || lizard mites || long-cheeked Norvegian wasp || long-cheeked Saxon wasp || long-cheeked tree wasp || longhorned wood borer || louse flies || Macronyssid mites || magpie || mange mite || mange mites || marines borers (genus claimed) || median wasp || Mesostigmatid mites || micro-organisms || microtids || mill moth || mosquitoes || mosses || mould fungi || mould mite || murids || mussels || Northern fowl mite || oriental rat flea || other arthropods || other murids: || Pharaoh ant || pig louse || pigeon tick || plaster beetle || poultry mite || poultry red mite || powder post beetles || Prostigmatid mites || pubic louse || rabbit ear mite || red wasp || reptile mites || rodents || roof rat || rook || rusty grain beetle || sandflies || sapstain fungi || sawtoothed grain beetle || scabies mites || sheep scab mite || sheep tick || shipworm || silverfishes || skin moth || snake mite || soft rot fungi || soft ticks || spider beetle || stable flies || starling || straw itch mites || subterranean termites || Sucking lice: pediculid lice || tapestry moth || Tapinoma ant || termites || ticks || tree termites || Trombiculid mites || tropical bedbug || tropical rat mite || wasps || weat or cadelle beetle || Western European house mouse || white rot fungi || white shouldered moth || wood boring beetles || wood destroying insects || wood destroying marine organisms... || wood pigeo...

Select appropriate common name from picklist. If not listed, select 'other' and specify. If not given/known, select 'no data'. See also instructions on this block of fields.

Any remarks can be entered in the supplementary remarks field.

Common name of the test/target organism.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_COMMON_NAME>

<i5:COMMON_NAME>

SE10.01.00.0241

Common name of target organism

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g2
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_COMMON_NAME>

<i5:COMMON_NAME_TXT>

SE10.01.00.0250

Developmental stage of target organism

[Developm. stage]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g2
  4. 1
  5. 1
  6. C116

Picklist Values:

hyphae || pupae || adults || eggs || spores and spore producing structures || juveniles || larvae || nymphs || other: || no data

Indicate the developmental stage of the target organism. If not listed, select 'other' and specify. If not given/known, select 'no data'. If not applicable, leave field empty.

Any remarks can be entered in the supplementary remarks field, for instance any code for the developmental stage if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'I.1.1.1 (EU BPD)'.

Developmental stage of target organism.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_DEVELSTAGE>

<i5:DEVELSTAGE>

SE10.01.00.0251

Developmental stage of target organism

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g2
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_DEVELSTAGE>

<i5:DEVELSTAGE_TXT>

SE10.01.00.0255

Products (materials), organisms or objects to be protected / under study

[Products, organisms or objects to be protected / under study]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Products (materials), organisms or objects to be protected / under study'.

 

SE10.01.00.0260

Organisms (to be protected) or treated materials

[Organisms (to be protected) or treated materials]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

Describe and specify the organism(s) or materials(s) / object(s) to be protected, e.g. human, pets, farm animals, fur- and wool-bearing animals, drinking water, hard surface material , porous surface.

Description of organisms (to be protected) or treated materials.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:OBJECTS_PROTECTED>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE10.01.00.0265

Information on intended use

[Information on intended use and application]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Information on intended use'.

 

SE10.01.00.0269

Function addressed

[Function addressed]

  1. HEAD BLOCK
  2. Block label
  3. g3
  4. 10
  5. 1
  6. [N/A]

 

Indicate the function of the substance. You can copy this field for indicating additional functions provided they relate to the same product type indicated in the next field. However, it may be sensible or required according to legislation-specific guidance to use separate records for each function.

Any remarks can be entered in the supplementary remarks field, for instance any code for the function if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'III.1.1 (EU BPD)'.

Indicator specifying the envisaged function of the substance with respect to controlling pest organisms (e.g. 'fungicide').

 

SE10.01.00.0270

Function addressed

[Function addressed]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g3
  4. 1
  5. 1
  6. C70

Picklist Values:

algicide || termiticide || attractant || avicide || bactericide || fungicide || insecticide || molluscicide || pheromone || piscicide || repellent || rodenticide || acaricide || herbicide || insect attractant || insect repellent || other:

Indicate the function of the substance. You can copy this field for indicating additional functions provided they relate to the same product type indicated in the next field. However, it may be sensible or required according to legislation-specific guidance to use separate records for each function.

Any remarks can be entered in the supplementary remarks field, for instance any code for the function if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'III.1.1 (EU BPD)'.

Indicator specifying the envisaged function of the substance with respect to controlling pest organisms (e.g. 'fungicide').

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:FUNCTION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE10.01.00.0271

Function addressed

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g3
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:FUNCTION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE10.01.00.0280

Product type

[Product type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. C111

Picklist Values:

EU BPD Product type 1: Human hygiene biocidal products || EU BPD Product type 2: Private area and health area disinfectants || EU BPD Product type 3: Veterinary hygiene biocidal products || EU BPD Product type 4: Food and feed area disinfectants || EU BPD Product type 5: Drinking water disinfectants || EU BPD Product type 6: In-can preservatives || EU BPD Product type 7: Film preservatives || EU BPD Product type 8: Wood preservatives || EU BPD Product type 9: Preservatives for fibres, leather, rubber and polymerised material || EU BPD Product type 10: Masonry preservatives || EU BPD Product type 11: Preservatives for liquid-cooling and processing systems || EU BPD Product type 12: Slimicides || EU BPD Product type 13: Metalworking fluid preservatives || EU BPD Product type 14: Rodenticides || EU BPD Product type 15: Avicides || EU BPD Product type 16: Molluscicides || EU BPD Product type 17: Piscicides || EU BPD Product type 18: Insecticides, acaricides and products to control other arthropods || EU BPD Product type 19: Repellents and attractants || EU BPD Product type 20: Preservatives for food and feedstock || EU BPD Product type 21: Antifouling products || EU BPD Product type 22: Embalming and taxidermist fluids || EU BPD Product type 23: Products for the control of other vertebrates || other:

Indicate the product type in which the active substance is intended to be included or which is envisaged for the product. In case of multiple product types use separate records for each of them.

Note that only product types related to EU BPD are listed. For other legislations, choose 'other:' and specify in the related text field.

Indicator specifying the product type(s) addressed by the information entered in this study summary.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:PRODUCT_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL>

SE10.01.00.0281

Product type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:PRODUCT_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL_TXT>

SE10.01.00.0290

Field of use envisaged

[Field of use envisaged / User]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

In addition to the product type indicated, further information on the envisaged use may be required according to the relevant guidance document (e.g. EU BPD TNsG). This can include a detailed description of the overall use pattern, indication of any relations which give case to exposure, hazard classes, or specific environments in which the product will be used.

Note: If the information or part of the information required by the legislation is included in another chapter, it is sufficient to include a cross-reference to that chapter / record. For instance, state 'Overall use pattern described in chapter 2.5.'

Description of the field of use envisaged and the type of user.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:USE_ENVISAGED>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.01.00.0295

Information on application of biocidal product

[Information on application of biocidal product]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Information on application of biocidal product'.

 

SE10.01.00.0299

Method of application

[Method of application]

  1. HEAD BLOCK
  2. Block label
  3. g4
  4. 10
  5. 1
  6. [N/A]

 

For the product, indicate the method of application. You can copy this field as appropriate for indicating more than one method. If not listed, select 'other' and specify.

Any remarks can be entered in the supplementary remarks field, for instance any code for the method of application if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'VII.1 (EU BPD)'.

Indicator specifying the method of application used.

 

SE10.01.00.0300

Method of application

[Method of application]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g4
  4. 1
  5. 1
  6. C118

Picklist Values:

open || spraying || bait application || closed system || closed system: pressure process || closed system: vacuum impregnation || foam application || fogging || fumigation || fumigation || health protection || in bait boxes || material protection || mixing with glue and mortar || stored product protection / food protection || open system || open system: brush treatment || open system: deluging || open system: diffusion || open system: dip treatment || open system: foam application || open system: immersion || open system: injection || open system: spray treatment || open system: wrapping || painting || pouring || other: || no data

For the product, indicate the method of application. You can copy this field as appropriate for indicating more than one method. If not listed, select 'other' and specify.

Any remarks can be entered in the supplementary remarks field, for instance any code for the method of application if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'VII.1 (EU BPD)'.

Indicator specifying the method of application used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:APPLICATION_METHOD>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE10.01.00.0301

Method of application

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g4
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:APPLICATION_METHOD>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE10.01.00.0310

Details on application

[Details on application]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

REMARKS:

Available predefined table(s) are displayed below, after this template. See also List of Predefined Tables in Annex 2.

Freetext Templates:

DESCRIPTION OF APPLICATION SYSTEM USED

....

APPLICATION RATE

....

LIKELY / FINAL CONCENTRATION AT WHICH ACTIVE SUBSTANCE OR PRODUCT WILL BE USED

....

NUMBER AND TIMING OF APPLICATIONS

....

GEOGRAPHICAL VARIATIONS (where relevant)

....

CLIMATIC VARIATIONS (where relevant)

....

WAITING PERIODS TO PROTECT MAN AND ANIMALS (where relevant)

....

For the product, provide further details on the method of application if required so according to the instructions given in the relevant guidance documents (e.g. EU BPD TNsG). Outline the descriptions using the freetext template as appropriate (delete/add elements). You may summarise data on application and geographical or climatic variations in tabular form. Upload predefined table(s) in the rich text field 'Overall remarks'. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1').

Note: If the information or part of the information required by the legislation is provided in another section, it is sufficient to include a cross-reference to that section / record.

Explanations:

- DESCRIPTION OF APPLICATION SYSTEM USED: Give name of substances used for dilution including their concentration in the biocidal product. State any other substance(s) added including purpose and concentration in the product. Describe the application technique(s). Particularly if more than one product type or application method is applicable, you may summarize these data in tabular form.

- APPLICATION RATE: For each product type and application technique give the recommended dose of the biocidal product and the active substance per object (e.g. per surface area of the material to be protected or as a concentration in a water system). Refer to the instructions given in the relevant guidance documents (e.g. EU BPD TNsG).

- LIKELY / FINAL CONCENTRATION AT WHICH ACTIVE SUBSTANCE OR PRODUCT WILL BE USED: self-explanatory

- NUMBER AND TIMING OF APPLICATIONS: Indicate the recommended number and timing, i.e. duration of application and possible reapplications as well as waiting periods considered necessary. Particularly if more than one product type or application method is applicable, you may summarize these data in tabular form.

- GEOGRAPHICAL VARIATIONS: Where relevant, describe how the application should be varied in different parts of the Community.

- CLIMATIC VARIATIONS: Where relevant, describe how the application should be varied at different climatic conditions.

- WAITING PERIODS TO PROTECT MAN AND ANIMALS: Where relevant, specify any waiting periods.

Description of the application.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:APPLICATION_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.01.00.0315

General information on effectiveness

[General information on effectiveness]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'General information on effectiveness'.

 

SE10.01.00.0320

Effects on target organisms

[Effects on target organisms]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

REMARKS:

Available predefined table(s) are displayed below, after this template. See also List of Predefined Tables in Annex 2.

The effects on the target organisms required for the claimed efficacy should be described and specified if possible for each use and method of application if these have different effects, including any effect-concentration dependences or the possible existence of a threshold concentration of the active substance. Refer to the instructions given in the relevant guidance documents (e.g. EU BPD TNsG).

In case of a submission of an active substance the effectiveness achieved or claimed should be briefly described. If required or sensible such description can be supported by including summary table(s) which give an overview of relevant efficacy studies performed with a product or products. Upload predefined table(s) in the rich text field 'Overall remarks'. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1'). To show possible differences, the use, i.e. product type and method of application of the biocidal product(s) envisaged should also be given.

For products, efficacy studies should be reported using the corresponding template 'Efficacy data'.

Description of effects on the target organisms required for the claimed efficacy for each use and method of application.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:EFFECTS_TARGETORGANISMS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.01.00.0330

Mode of action

[Mode of action]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. C119

Picklist Values:

acute toxin: with lethal effect || synergist: bactericide (to vitamin K-producing bacteria) || attractant || pheromone || repellent || acute toxin || acute toxin: contact toxin || acute toxin: flushing effect || acute toxin: ingestion toxin || acute toxin: inhalation asphyxiant || acute toxin: inhalation toxin || acute toxin: knock-down effect || acute toxin: residual activity (specify duration) || synergist: hypervitaminosis developing substances || insect growth regulator || insect growth regulator: chitin synthesis inhibitor || insect growth regulator: juvenile hormone analog || membrane toxin || metabolism inhibitor || slow acting toxin || slow acting toxin: anticoagulant || slow acting toxin: contact toxin || slow acting toxin: ingestion toxin || slow acting toxin: inhalation toxin || steriliser || synergist || other: || no data

Indicate the principles of the mode of action for the function indicated in above field, e.g. 'acute toxin: contact poison'. If not listed, select 'other' and specify.

Any remarks can be entered in the supplementary remarks field, for instance any code for the mode of action if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'III.1.2 (EU BPD)'.

Indicator specifying the mode of action used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:MODE_ACTION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE10.01.00.0331

Mode of action

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:MODE_ACTION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE10.01.00.0340

Details on mode of action

[Details on mode of action]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

BIOCHEMICAL AND PHYSIOLOGICAL MECHANISMS

...

BIOCHEMICAL PATHWAY

...

TIME DELAY

...

OTHER

...

For the function indicated in above field, indicate the principles of the mode of action; e.g. 'contact poison' or 'stomach poison'. Briefly describe the biochemical and physiological mechanisms, e.g. 'cholinesterase inhibition' and the biochemical pathway and specify any time delay between application and effect. Use the freetext template as appropriate (delete/add elements). For further instructions refer to the relevant guidance documents (e.g. EU BPD TNsG).

Details of the mode of action.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:MODE_ACTION_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.01.00.0350

(Possible) Occurrence of resistance

[(Possible) Occurrence of resistance]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

Indicate whether resistance can possibly develop including cross-resistance. As appropriate include an appraisal of the information gained from the efficacy studies.

Information on the (possible) occurrence of resistance.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:RESISTANCE_OCCURRENCE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.01.00.0360

Management strategies to avoid resistance

[Management strategies to avoid resistance]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

Describe any appropriate management strategies towards the minimization of the development of resistance.

Description of any appropriate management strategies towards the minimization of the development of resistance.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:RESISTANCE_STRATEGIES>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.01.00.0370

Any other known limitations and management strategies

[Any other known limitations and management strategies]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

As applicable describe any other known limitations and relevant management strategies towards them.

Description of any other known limitations and management strategies.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:OTHER_LIMITATIONS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.01.00.0375

OVERALL REMARKS, ATTACHMENTS

[Overall remarks, attachments]

  1. HEAD-1
  2. Heading level 1
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Main heading under which 'Overall remarks, attachments' fields are subsumed.

 

SE10.01.00.0380

Remarks on results including tables and figures

[Remarks on results including tables and figures]

  1. RICHTEXT
  2. STRING/256000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields 'Overall remarks' and 'Executive summary' allow rich text entry.

Rich text editor field for creating formatted text and tables or inserting and editing any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE10.01.00.0389

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g5
  4. 10
  5. 1
  6. [N/A]

 

Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).

Copy this block of fields for attaching more than one file.

Heading of field block 'Attached document'.

 

SE10.01.00.0390

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g5
  4. 1
  5. 1
  6. [N/A]

 

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

File name of document uploaded, i.e. attached. No restriction as to file type.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE10.01.00.0400

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g5
  4. 1
  5. 1
  6. [N/A]

 

As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory.

Remarks on attached document.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE10.01.00.0409

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g6
  4. 10
  5. 1
  6. [N/A]

 

If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached files should be included in the data export or not.

Attached full study report

 

SE10.01.00.0410

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g6
  4. 1
  5. 1
  6. [N/A]

 

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Attached full study report

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE10.01.00.0412

Illustration (picture/graph)

[Illustration (picture/graph)]

  1. PICTURE
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Illustration (picture/graph)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE10.01.00.0415

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's summary and conclusion]

  1. HEAD-1
  2. Heading level 1
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Main heading under which generic 'Applicant's summary and conclusion' fields are subsumed.

 

SE10.01.00.0420

Conclusions

[Conclusions]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

Enter any conclusions if applicable.

Any conclusions either as adapted from the study report / publication or indicated by the submitter.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.01.00.0430

Executive summary

[Executive summary]

  1. RICHTEXT
  2. STRING/256000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.

Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Executive summary in which the relevant aspects of the study including the conclusions reached are briefly summarised.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE10.01.00.0440

Cross-reference to other study

[Cross-reference to other study]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.

Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

A cross-reference to another study or other studies including explanatory text on why other results are relevant in the interpretation of the results of a given study, e.g. for supporting any conclusions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFECTIVENESS>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>