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

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 [F1 the EU-derived domestic legislation which transposed] Council Directive 98/24/EC(1) and in accordance with [F1 the EU-derived domestic legislation which transposed] Directive 2004/37/EC of the European Parliament and of the Council(2).

Textual Amendments

F1 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 [F2 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

F2 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 F3 ... provisions referred to in point 2.4.1.1. U.K.

Textual Amendments

F3 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, [F4 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

F4 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 [F4 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 [F5 constituent territory of the competent authority] concerned on the basis of good agricultural practice. U.K.

Textual Amendments

F5 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.

(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.