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 are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.

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.

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.

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.

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)".

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.

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."

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)".

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 recommeded 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.

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".

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)".

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).

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

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

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

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.

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.

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.

Enter any conclusions if applicable.

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.

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.