Table 1 Selected data requirements with relevance for existing DNT studies over time for active substance dossiers submitted to EU authorities

Necessary/

sufficient information for evaluating the foreseeable risks to be included in dossier

[The required information shall] include a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below (Annex II paragraph 1.5)

[The information required shall] include a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the active substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below (Annex paragraph 1.1)

The information shall be sufficient to evaluate the foreseeable risks, whether immediate or delayed, which the active substance may entail for humans, including vulnerable groups, animals and the environment and contain at least the information and results of the studies referred to in this Annex. (Annex paragraph 1.1)

All information on potentially harmful effects to be included

There is a need to investigate and report all potentially adverse effects found during routine toxicological investigations (including effects on organs and special systems such as immunotoxicity and neurotoxicity) and to undertake and report such additional studies which may be necessary to investigate the probable mechanism involved, to establish Noaels (no observed adverse effect levels), and to assess the significance of these effects. All available biological data and information which is relevant to the assessment of the toxicological profile of the substance tested, must be reported. (Annex II Part A paragraph 5 point (ii))

There is a need to investigate and report all potentially adverse effects found during routine toxicological investigations (including effects on organs and special systems such as immunotoxicity and neurotoxicity) and to undertake and report such additional studies which may be necessary to investigate the probable mechanism involved, to establish Noaels (no observed adverse effect levels), and to assess the significance of these effects. All available biological data and information which are relevant to the assessment of the toxicological profile of the substance tested, must be reported. (Annex Part A paragraph 5 point (ii))

Any information on potentially harmful effects of the active substance, its metabolites and impurities on human and animal health or on groundwater shall be included. (Annex paragraph 1.2)

Full and unbiased report of all studies conducted to be included

[The information required shall] include a full and unbiased report of the studies conducted as well as full description of them or a justification, which is acceptable to the competent authority where:

— particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided,

or

— it is not scientifically necessary, or technically possible to supply information and data (Annex II paragraph 1.5)

[The information required shall] include a full and unbiased report of the studies conducted as well as full description of them or a justification, which is acceptable to the competent authority where:

— particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or

— it is not scientifically necessary, or technically possible to supply information and data;

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 one of the following conditions is fulfilled:

(a) it is not necessary owing to the nature of the product or its proposed uses, or it is not scientifically necessary;

(b) it is technically not possible to supply.

In such a case a justification shall be provided. (Annex paragraph 1.5)

Need to perform a DNT study

(DNT not explicitly mentioned)

(DNT not explicitly mentioned)

When indicated by observations in other studies or the mode of action of the test substance, supplementary studies or information may be required to provide information on the postnatal manifestation of effects such as developmental neurotoxicity. (Annex paragraph 5.6.2 last subparagraph)