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ANNEX IIU.K.Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II

3.Criteria for the approval of an active substanceU.K.

3.1.DossierU.K.

The dossiers submitted pursuant to [F1Article 7(1D)] shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD).

In the case of an active substance, safener or synergist for which one or more representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to [F1Article 7(1D)] shall contain the information necessary to carry out a risk assessment and for enforcement purposes.

The dossier shall in particular:

(a)

permit any residue of concern to be defined;

(b)

reliably predict the residues in food and feed, including succeeding crops;

(c)

reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing;

(d)

permit a maximum residue level to be defined and to be determined by appropriate methods in general use for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals;

(e)

permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined.

The dossier submitted pursuant to [F1Article 7(1D)] shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species.

Textual Amendments

3.2.EfficacyU.K.

An active substance alone or associated with a safener or synergist shall only be approved where it has been established for one or more representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently effective. This requirement shall be evaluated in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in [F2Article 29(6)(a) in relation to the relevant constituent territory].

Textual Amendments

3.3.Relevance of metabolitesU.K.

Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxicological, ecotoxicological or environmental relevance of metabolites.

3.4.Composition of the active substance, safener or synergistU.K.

3.4.1.The specification shall define the minimum degree of purity, the identity and maximum content of impurities and, where relevant, of isomers/diastereo-isomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.U.K.
3.4.2.The specification shall be in compliance with the relevant Food and Agriculture Organisation specification as appropriate, where such specification exists. However, where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted.U.K.

3.5.Methods of analysisU.K.

3.5.1.The methods of analysis of the active substance, safener or synergist as manufactured and of determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance, safener or synergist as manufactured, shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.U.K.
3.5.2.The methods of residue analysis for the active substance and relevant metabolites in plant, animal and environmental matrices and drinking water, as appropriate, shall have been validated and shown to be sufficiently sensitive with respect to the levels of concern.U.K.
3.5.3.The evaluation has been carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in [F3Article 29(6)(a) in relation to the relevant constituent territory].U.K.

Textual Amendments

3.6.Impact on human healthU.K.

3.6.1.Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population. When the critical effect is judged of particular significance, such as developmental neurotoxic or immunotoxic effects, an increased margin of safety shall be considered, and applied if necessary.U.K.
3.6.2.An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature F4... , it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B.U.K.

Textual Amendments

3.6.3.An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist [F5in relation to the relevant constituent territory] and other available data and information, including a review of the scientific literature F6... , it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with [F7Article 18A of Regulation (EC) No 396/2005 in relation to the relevant constituent territory].U.K.

Textual Amendments

3.6.4.An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists [F8in relation to the relevant constituent territory] and other available data and information, including a review of the scientific literature F9... , it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with [F10Article 18A of Regulation (EC) No 396/2005 in relation to the relevant constituent territory].U.K.

Textual Amendments

3.6.5.An active substance, safener or synergist shall only be approved if, on the basis of the assessment of [F11nationally] or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the [F12competent authority], it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.U.K.

Textual Amendments

By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F14From [X110 November 2018], an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effect in humans if, based on points (1) to (4) of the sixth paragraph, it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans:

(1)

it shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;

(2)

it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;

(3)

the adverse effect is a consequence of the endocrine mode of action.

Editorial Information

Textual Amendments

The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effect in humans in accordance with the fifth paragraph shall be based on all of the following points:

(1)

all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action):

(a)

scientific data generated in accordance with internationally agreed study protocols, in particular those listed in [F15guidance issued] in accordance with this Regulation;

(b)

other scientific data selected applying a systematic review methodology, in particular following guidance on literature data [F16issued], in accordance with this Regulation;

(2)

an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in the fifth paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall, in particular, consider all of the following factors:

(a)

both positive and negative results;

(b)

the relevance of the study designs, for the assessment of adverse effects and of the endocrine mode of action;

(c)

the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different species;

(d)

the route of exposure, toxicokinetic and metabolism studies;

(e)

the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;

(3)

using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;

(4)

adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor.]

Textual Amendments

3.7.Fate and behaviour in the environmentU.K.

3.7.1.An active substance, safener or synergist shall only be approved where it is not considered to be a persistent organic pollutant (POP).U.K.

A substance that fulfils all three of the criteria of the points below is a POP.

3.7.1.1.PersistenceU.K.

An active substance, safener or synergist fulfils the persistence criterion where there is evidence that the time it takes for a degradation of 50 % (DT50) in water is greater than 2 months, or that its DT50 in soil is greater than 6 months, or that its DT50 in sediment is greater than 6 months.

3.7.1.2.BioaccumulationU.K.

An active substance, safener or synergist fulfils the bioaccumulation criterion where there is:

3.7.1.3.Potential for long-range environmental transport:U.K.

An active substance, safener or synergist fulfils the potential for long-range environmental transport criterion where:

3.7.2.An active substance, safener or synergist shall only be approved if it is not considered to be a persistent, bioaccumulative and toxic (PBT) substance.U.K.

A substance that fulfils all three of the criteria of the points below is a PBT substance.

3.7.2.1.PersistenceU.K.

An active substance, safener or synergist fulfils the persistence criterion where:

Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant.

3.7.2.2.BioaccumulationU.K.

An active substance, safener or synergist fulfils the bioaccumulation criterion where the bioconcentration factor is higher than 2 000.

Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used.

3.7.2.3.ToxicityU.K.

An active substance, safener or synergist fulfils the toxicity criterion where:

3.7.3.An active substance, safener or synergist shall only be approved if it is not considered to be a very persistent and very bioaccumulative substance (vPvB).U.K.

A substance that fulfils both of the criteria of the points below is a vPvB substance.

3.7.3.1.PersistenceU.K.

An active substance, safener or synergist fulfils the ‘very persistent’ criterion where:

3.7.3.2.BioaccumulationU.K.

An active substance, safener or synergist fulfils the ‘very bioaccumulative’ criterion where the bioconcentration factor is greater than 5 000.

3.8.EcotoxicologyU.K.

3.8.1.An active substance, safener or synergist shall only be approved if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in [F17Article 29(6)(a) in relation to the relevant constituent territory] under realistic proposed conditions of use of a plant protection product containing the active substance, safener or synergist. The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance, safener or synergist is expected to affect adversely by the intended use.U.K.

Textual Amendments

3.8.2.An active substance, safener or synergist shall only be approved if, on the basis of the assessment of [F18nationally] or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible.U.K.

Textual Amendments

[F14From [X110 November 2018], an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effects on non-target organisms if, based on points (1) to (4) of the third paragraph, it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant at the (sub)population level for non-target organisms:

(1)

it shows an adverse effect in non-target organisms, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;

(2)

it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;

(3)

the adverse effect is a consequence of the endocrine mode of action.

The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effects on non-target organisms in accordance with the second paragraph shall be based on all of the following points:

(1)

all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action):

(a)

scientific data generated in accordance with internationally agreed study protocols, in particular, those listed in [F19guidance issued] in accordance with this Regulation;

(b)

other scientific data selected applying a systematic review methodology, in particular following guidance on literature data listed in [F20guidance issued] in accordance with this Regulation;

(2)

an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in the second paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall consider all of the following factors:

(a)

both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant;

(b)

the relevance of the study design for the assessment of the adverse effects and its relevance at the (sub)population level, and for the assessment of the endocrine mode of action;

(c)

the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on (sub)populations. Adequate, reliable and representative field or monitoring data and/or results from population models shall as well be considered where available;

(d)

the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different taxonomic groups;

(e)

the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;

(3)

using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;

(4)

Adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor with respect to non-target organisms.]

Textual Amendments

3.8.3.An active substance, safener or synergist shall be approved only if it is established following an appropriate risk assessment on the basis of [F21nationally] or internationally agreed test guidelines, that the use under the proposed conditions of use of plant protection products containing this active substance, safener or synergist:U.K.

Textual Amendments

3.9.Residue definitionU.K.

An active substance, safener or synergist shall only be approved if, where relevant, a residue definition can be established for the purposes of risk assessment and for enforcement purposes.

3.10.Fate and behaviour concerning groundwaterU.K.

An active substance shall only be approved where it has been established for one or more representative uses, that consequently after application of the plant protection product consistent with realistic conditions on use, the predicted concentration of the active substance or of metabolites, degradation or reaction products in groundwater complies with the respective criteria of the uniform principles for evaluation and authorisation of plant protection products referred to in [F22Article 29(6)(a) in relation to the relevant constituent territory].

Textual Amendments