Commission Regulation (EU) No 546/2011Show full title

2. Specific principles U.K.

The specific principles shall apply without prejudice to the general principles referred to in Section 1.

2.1. Efficacy U.K.

2.1.1. Where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions, no authorisation shall be granted for those uses. U.K.

2.1.2. The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. U.K.

2.1.3. Where relevant, yield response when the product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. U.K.

2.1.4. Conclusions as to the performance of the preparation must be valid for all areas of the [F1 constituent territory of the competent authority] in which it is to be authorised, and must hold for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions). U.K.

Textual Amendments

F1 Words in Annex Pt. 1.C point 2.1.4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(viii); 2020 c. 1, Sch. 5 para. 1(1)

2.1.5. Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.1.1 to 2.1.4. U.K.

Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, [F2 competent authorities] shall not accept the recommendations unless they are justified.

Textual Amendments

F2 Words in Annex Pt. 1.C point 2.1.5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(ix); 2020 c. 1, Sch. 5 para. 1(1)

2.2. Absence of unacceptable effects on plants or plant products U.K.

2.2.1. There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appropriate limitations of use. U.K.

2.2.2. There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products. U.K.

2.2.3. There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation must not be applied to crops to be used for processing purposes. U.K.

2.2.4. There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction. U.K.

2.2.5. There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, must not be grown following the treated crop. U.K.

2.2.6. There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present. U.K.

2.2.7. Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.2.1 to 2.2.6. U.K.

2.2.8. The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage. U.K.

2.3. Impact on vertebrates to be controlled U.K.

An authorisation for a plant protection product intended to eliminate vertebrates shall be granted only when:

• death is synchronous with the extinction of consciousness, or

• death occurs immediately, or

• vital functions are reduced gradually without signs of obvious suffering.

For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for the target animals.

2.4. Impact on human or animal health U.K.

2.4.1. Impact on human or animal health arising from the plant protection product U.K.

2.4.1.1. No authorisation shall be granted if the extent of operator exposure in handling and using the plant protection product under the proposed conditions of use, including dose and application method, exceeds the AOEL. U.K.

Moreover, the conditions of the authorisation shall be in compliance with the limit value established for the active substance and/or toxicologically relevant compound(s) of the product in accordance with [F3 the EU-derived domestic legislation which transposed] Council Directive 98/24/EC(1) and in accordance with [F3 the EU-derived domestic legislation which transposed] Directive 2004/37/EC of the European Parliament and of the Council(2).

Textual Amendments

F3 Words in Annex Pt. 1.C point 2.4.1.1 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(x); 2020 c. 1, Sch. 5 para. 1(1)

2.4.1.2. Where the proposed conditions of use require use of items of protective clothing and equipment, no authorisation shall be granted unless those items are effective and in accordance with the relevant [F4 retained EU law] and are readily obtainable by the user and unless it is feasible to use them under the circumstances of use of the plant protection product, taking into account climatic conditions in particular. U.K.

Textual Amendments

F4 Words in Annex Pt. 1.C point 2.4.1.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xi); 2020 c. 1, Sch. 5 para. 1(1)

2.4.1.3. Plant protection products which because of particular properties or if mishandled or misused could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use. U.K.

Moreover, those plant protection products may not be authorised for use by non-professional users which are classified as:

(i)

acute toxicity category 1 and 2 for any route of uptake, provided the ATE (acute toxicity estimate) of the product does not exceed 25 mg/kg bw for the oral route of uptake or 0,25 mg/l/4h for the inhalation of dust, mist or fume;

(ii)

STOT (single exposure), category 1 (oral), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 25 mg/kg bw;

(iii)

STOT (single exposure), category 1 (dermal), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 50 mg/kg bw;

(iv)

STOT (single exposure), category 1 (inhalation of gas/vapour), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 0,5 mg/l/4h;

(v)

STOT (single exposure), category 1 (inhalation of dust/mist/fume), provided their classification is due to the presence of classified substances showing significant non-lethal toxic effects at guidance values below 0,25 mg/l/4h.

2.4.1.4. Waiting and re-entry safety periods or other precautions must be such that the exposure of bystanders or workers exposed after the application of the plant protection product does not exceed the AOEL levels established for the active substance or toxicologically relevant compound(s) in the plant protection product nor any limit values established for those compounds in accordance with the F5 ... provisions referred to in point 2.4.1.1. U.K.

Textual Amendments

F5 Words in Annex Pt. 1.C point 2.4.1.4 omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xii); 2020 c. 1, Sch. 5 para. 1(1)

2.4.1.5. Waiting and re-entry safety periods or other precautions must be established in such a way that no adverse impact on animals occurs. U.K.

2.4.1.6. Waiting and re-entry periods or other precautions to ensure that the AOEL levels and limit values are respected must be realistic; if necessary special precautionary measures must be prescribed. U.K.

2.4.2. Impact on human or animal health arising from residues U.K.

2.4.2.1. Authorisations must ensure that residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum. U.K.

2.4.2.2. Where the new circumstances under which the plant protection product is to be used do not correspond to those under which a MRL (maximum residue limit) was established previously, [F6 competent authorities] shall not grant an authorisation for the plant protection product unless the applicant can provide evidence that its recommended use shall not exceed the MRL established under Regulation (EC) No 396/2005 of the European Parliament and of the Council(3). U.K.

Textual Amendments

F6 Words in Annex Pt. 1.C points 2.4.2.2, 2.4.2.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xiii); 2020 c. 1, Sch. 5 para. 1(1)

2.4.2.3. Where a MRL exists [F6 competent authorities] shall not grant an authorisation for the plant protection product unless the applicant can provide evidence that its recommended use shall not exceed that MRL, or unless a new MRL has been established under Regulation (EC) No 396/2005. U.K.

2.4.2.4. In the cases referred to in points 2.4.2.2, each application for an authorisation must be accompanied by a risk assessment taking into account worst-case potential exposure of consumers in the [F7 constituent territory of the competent authority] concerned on the basis of good agricultural practice. U.K.

Textual Amendments

F7 Words in Annex Pt. 1.C point 2.4.2.4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xiv); 2020 c. 1, Sch. 5 para. 1(1)

Taking into account all registered uses, the proposed use shall not be authorised if the best possible estimate of dietary exposure exceeds the ADI.

2.4.2.5. Where the nature of residues is affected during processing, a separate risk assessment may need to be carried out under the conditions provided for in point 2.4.2.4. U.K.

2.4.2.6. Where the treated plants or plant products are intended to be fed to animals, residues occurring shall not have an adverse effect on animal health. U.K.

2.5. Influence on the environment U.K.

2.5.1. Fate and distribution in the environment U.K.

2.5.1.1. No authorisation shall be granted if the active substance and, where they are of significance from the toxicological, ecotoxicological or environmental point of view, metabolites and breakdown or reaction products, after use of the plant protection product under the proposed conditions of use: U.K.

• during tests in the field, persist in soil for more than 1 year (i.e. DT90 > 1 year and DT50 > 3 months), or

• during laboratory tests, form non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralisation rate of less than 5 % in 100 days,

unless it is scientifically demonstrated that under field conditions there is no accumulation in soil at such levels that unacceptable residues in succeeding crops occur and/or that unacceptable phytotoxic effects on succeeding crops occur and/or that there is an unacceptable impact on the environment, in accordance with the relevant requirements provided for in points 2.5.1.2, 2.5.1.3, 2.5.1.4 and 2.5.2.

2.5.1.2. No authorisation shall be granted if the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed, as a result of use of the plant protection product under the proposed conditions of use, the lower of the following limit values: U.K.

(i)

[F8 the maximum permissible concentration laid down by [F9 the EU-derived domestic legislation which transposed] Council Directive 98/83/EC(4); or]

(ii)

the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, on the basis of appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/2009,

Textual Amendments

F8 Substituted by Commission Regulation (EU) 2018/676 of 3 May 2018 correcting Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance).

F9 Words in Annex Pt. 1.C point 2.5.1.2(i) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xv); 2020 c. 1, Sch. 5 para. 1(1)

unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.

2.5.1.3. No authorisation shall be granted if the concentration of the active substance or of relevant metabolites, breakdown or reaction products to be expected after use of the plant protection product under the proposed conditions of use in surface water: U.K.

• exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with [F10 the EU-derived domestic legislation which transposed] Directive 2000/60/EC of the European Parliament and of the Council(5) is compromised, or

• has an impact deemed unacceptable on non-target species, including animals, in accordance with the relevant requirements provided for in point 2.5.2.

Textual Amendments

F10 Words in Annex Pt. 1.C point 2.5.1.3 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(xvi); 2020 c. 1, Sch. 5 para. 1(1)

The proposed instructions for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum.

2.5.1.4. No authorisation shall be granted if the airborne concentration of the active substance under the proposed conditions of use is such that either the AOEL or the limit values for operators, bystanders or workers as referred to in point 2.4.1 are exceeded. U.K.

2.5.2. Impact on non-target species U.K.

2.5.2.1. Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if: U.K.

• the acute and short-term toxicity/exposure ratio for birds and other non-target terrestrial vertebrates is less than 10 on the basis of LD₅₀ or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact occurs after use of the plant protection product in accordance with the proposed conditions of use,

• the bioconcentration factor (BCF, related to fat tissue) is greater than 1, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.

2.5.2.2. Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if: U.K.

• the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or

• the algal growth inhibition/exposure ratio is less than 10, or

• the maximum bioconcentration factor (BCF) is greater than 1 000 for plant protection products containing active substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable,

unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species (predators) occurs — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.

2.5.2.3. Where there is a possibility of honeybees being exposed, no authorisation shall be granted if the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product in accordance with the proposed conditions of use. U.K.

2.5.2.4. Where there is a possibility of beneficial arthropods other than honeybees being exposed, no authorisation shall be granted if more than 30 % of the test organisms are affected in lethal or sublethal laboratory tests conducted at the maximum proposed application rate, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product in accordance with the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data. U.K.

2.5.2.5. Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the acute toxicity/exposure ratio for earthworms is less than 10 or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product in accordance with the proposed conditions of use. U.K.

2.5.2.6. Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on microbial activity after use of the plant protection product in accordance with the proposed conditions of use, taking account of the ability of micro-organisms to multiply. U.K.

2.6. Analytical methods U.K.

The methods proposed must reflect the state of the article. The following criteria must be met in order to permit validation of the analytical methods proposed for post-registration control and monitoring purposes:

2.6.1.

for formulation analysis:

the method must be able to determine and to identify the active substance(s) and where appropriate any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants;

2.6.2.

for residue analysis:

(i)

the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental significance;

(ii)

the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of ≤ 20 %;

(iii)

the repeatability must be less than the following values for residues in foodstuffs:

Residue levelmg/kg	Differencemg/kg	Differencein %
0,01	0,005	50
0,1	0,025	25
1	0,125	12,5
> 1		12,5

Intermediate values shall be determined by interpolation from a log-log graph;

(iv)

the reproducibility must be less than the following values for residues in foodstuffs:

Residue levelmg/kg	Differencemg/kg	Differencein %
0,01	0,01	100
0,1	0,05	50
1	0,25	25
> 1		25

Intermediate values are determined by interpolation from a log-log graph;

(v)

in the case of residue analysis in treated plants, plant products, foodstuffs, feedingstuffs or products of animal origin, except where the MRL or the proposed MRL is at the limit of determination, the sensitivity of the methods proposed must satisfy the following criteria:

Limit of determination in relation to the proposed provisional [F11 MRL or] MRL:

MRL(mg/kg)	limit of determination(mg/kg)
> 0,5	0,1
0,5 – 0,05	0,1 – 0,02
< 0,05	LMR × 0,5

Textual Amendments

F11 Words in Annex Pt. 1.C point 2.6.2(v) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 10; 2020 c. 1, Sch. 5 para. 1(1)

2.7. Physical and chemical properties U.K.

2.7.1. Where an appropriate FAO specification exists, that specification must be met. U.K.

2.7.2. Where no appropriate FAO specification exists, the physical and chemical properties of the product must meet the following requirements U.K.

(a)

Chemical properties:

Throughout the shelf-life period, the difference between the stated and the actual content of the active substance in the plant protection product must not exceed the following values:

Declared content in g/kg or g/l at 20 °C	Tolerance
up to 25	± 15 % homogeneous formulation
	± 25 % non-homogeneous formulation
more than 25 up to 100	± 10 %
more than 100 up to 250	± 6 %
more than 250 up to 500	± 5 %
more than 500	± 25 g/kg or ± 25 g/l

(b)

Physical properties:

The plant protection product must fulfil the physical criteria (including storage stability) specified for the relevant formulation type in the ‘Manual on the development and use of FAO and WHO specifications for plant protection products’.

2.7.3. Where the proposed label claims include requirements or recommendations for use of the preparation with other plant protection products or adjuvants as a tank mix and/or where the proposed label includes indications on the compatibility of the preparation with other plant protection products as a tank mix, those products or adjuvants must be physically and chemically compatible in the tank mix. U.K.

(1)

OJ L 131, 5.5.1998, p. 11.

(2)

OJ L 158, 30.4.2004, p. 50.

(3)

OJ L 70, 16.3.2005, p. 1.

(4)

[F8 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption ( OJ L 330, 5.12.1998, p. 32 ).]

(5)

OJ L 327, 22.12.2000, p. 1.

Textual Amendments

F8 Substituted by Commission Regulation (EU) 2018/676 of 3 May 2018 correcting Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance).