Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilShow full title

3.6. Impact on human health U.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 F1 ... , 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

F1 Words in Annex 2 point 3.6.2 omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

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 [F2 in relation to the relevant constituent territory] and other available data and information, including a review of the scientific literature F3 ... , 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 [F4 Article 18A of Regulation (EC) No 396/2005 in relation to the relevant constituent territory]. U.K.

Textual Amendments

F2 Words in Annex 2 point 3.6.3 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(j)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Annex 2 point 3.6.3 omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(j)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Annex 2 point 3.6.3 substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 13(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

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 [F5 in 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 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 [F7 Article 18A of Regulation (EC) No 396/2005 in relation to the relevant constituent territory]. U.K.

Textual Amendments

F5 Words in Annex 2 point 3.6.4 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(k)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Annex 2 point 3.6.4 omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(k)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Annex 2 point 3.6.4 substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 13(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of [F8 nationally] or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the [F9 competent 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

F8 Word in Annex 2 point 3.6.5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(l)(i)(aa) (with Sch. 1) (as amended by S.I. 2019/1410, regs. 1(2), 6(4)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Annex 2 point 3.6.5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(l)(i)(bb) (with Sch. 1) (as amended by S.I. 2019/1410, regs. 1(2), 6(4)(a)); 2020 c. 1, Sch. 5 para. 1(1)

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).

F10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F10 Words in Annex 2 point 3.6.5 omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(l)(ia) (with Sch. 1) (as amended by S.I. 2019/1410, regs. 1(2), 6(4)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F11 From [X1 10 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

X1 Substituted by Corrigendum to Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (Official Journal of the European Union L 101 of 20 April 2018).

Textual Amendments

F11 Inserted by Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (Text with EEA relevance).

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 [F12 guidance issued] in accordance with this Regulation;

(b)

other scientific data selected applying a systematic review methodology, in particular following guidance on literature data [F13 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 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

F12 Words in Annex 2 point 3.6.5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(l)(ii)(aa) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Annex 2 point 3.6.5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(l)(ii)(bb) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)