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- Point in Time (31/12/2020)
- Original (As adopted by EU)
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
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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:
permit any residue of concern to be defined;
reliably predict the residues in food and feed, including succeeding crops;
reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing;
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;
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
F1Words in Annex 2 point 3.1 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(g) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
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
F2Words in Annex 2 point 3.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(h) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxicological, ecotoxicological or environmental relevance of metabolites.
Textual Amendments
F3Words in Annex 2 point 3.5.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(h) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F4Words 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)
Textual Amendments
F5Words 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)
F6Words 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)
F7Words 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)
Textual Amendments
F8Words 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)
F9Words 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)
F10Words 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)
Textual Amendments
F11Word 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)
F12Words 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).
F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F13Words 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)
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:
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;
it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
the adverse effect is a consequence of the endocrine mode of action.
Editorial Information
X1Substituted 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
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:
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):
scientific data generated in accordance with internationally agreed study protocols, in particular those listed in [F15guidance issued] in accordance with this Regulation;
other scientific data selected applying a systematic review methodology, in particular following guidance on literature data [F16issued], in accordance with this Regulation;
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:
both positive and negative results;
the relevance of the study designs, for the assessment of adverse effects and of the endocrine mode of action;
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;
the route of exposure, toxicokinetic and metabolism studies;
the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
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;
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
F15Words 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)
F16Words 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)
A substance that fulfils all three of the criteria of the points below is a POP.
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.
An active substance, safener or synergist fulfils the bioaccumulation criterion where there is:
evidence that its bio-concentration factor or bioaccumulation factor in aquatic species is greater than 5 000 or, in the absence of such data, that the partition coefficient n-octanol/water (log Ko/w) is greater than 5, or
evidence that the active substance, safener or synergist present other reasons for concern, such as high bioaccumulation in other non-target species, high toxicity or ecotoxicity.
An active substance, safener or synergist fulfils the potential for long-range environmental transport criterion where:
measured levels of the active substance, safener or synergist in locations distant from the sources of its release are of potential concern,
monitoring data show that long-range environmental transport of the active substance, safener or synergist, with the potential for transfer to a receiving environment, may have occurred via air, water or migratory species, or
environmental fate properties and/or model results demonstrate that the active substance, safener or synergist has a potential for long-range environmental transport through air, water or migratory species, with the potential for transfer to a receiving environment in locations distant from the sources of its release. For an active substance safener or synergist that migrates significantly through the air, its DT50 in air is to be greater than 2 days.
A substance that fulfils all three of the criteria of the points below is a PBT substance.
An active substance, safener or synergist fulfils the persistence criterion where:
the half-life in marine water is higher than 60 days,
the half-life in fresh or estuarine water is higher than 40 days,
the half-life in marine sediment is higher than 180 days,
the half-life in fresh or estuarine water sediment is higher than 120 days, or
the half-life in soil is higher than 120 days.
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.
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.
An active substance, safener or synergist fulfils the toxicity criterion where:
the long-term no-observed effect concentration for marine or freshwater organisms is less than 0,01 mg/l,
the substance is classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) pursuant to Regulation (EC) No 1272/2008, or
there is other evidence of chronic toxicity, as identified by the classifications STOT RE 1 or STOT RE 2 pursuant to Regulation (EC) No 1272/2008.
A substance that fulfils both of the criteria of the points below is a vPvB substance.
An active substance, safener or synergist fulfils the ‘very persistent’ criterion where:
the half-life in marine, fresh- or estuarine water is higher than 60 days,
the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or
the half-life in soil is higher than 180 days.
An active substance, safener or synergist fulfils the ‘very bioaccumulative’ criterion where the bioconcentration factor is greater than 5 000.
Textual Amendments
F17Words in Annex 2 point 3.8.1 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(m) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F18Words in Annex 2 point 3.8.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(n)(i) (with Sch. 1) (as amended by S.I. 2019/1410, regs. 1(2), 6(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)
[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:
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;
it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
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:
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):
scientific data generated in accordance with internationally agreed study protocols, in particular, those listed in [F19guidance issued] in accordance with this Regulation;
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;
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:
both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant;
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;
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;
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;
the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
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;
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
F19Words in Annex 2 point 3.8.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(n)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F20Words in Annex 2 point 3.8.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(n)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
will result in a negligible exposure of honeybees, or
has no unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae and honeybee behaviour.
Textual Amendments
F21Word in Annex 2 point 3.8.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(o) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
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.
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
F22Words in Annex 2 point 3.10 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(p) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
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