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

2.6. Impact on human and animal health U.K.

2.6.1. Effects on human and animal health arising from the plant protection product U.K.

2.6.1.1. No authorisation shall be granted if on the basis of the information provided in the dossier it appears that the micro-organism is pathogenic to humans or non-target animals under the proposed conditions of use. U.K.

2.6.1.2. No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals. U.K.

When making a decision on the authorisation of the microbial plant protection product, [F1 competent authorities] shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment and at work, and animals.

Textual Amendments

F1 Words in Annex Pt. 2.C point 2.6.1.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xviii); 2020 c. 1, Sch. 5 para. 1(1)

2.6.1.3. All micro-organisms shall be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism shall not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment. U.K.

Where the proposed conditions of use require use of items of protective clothing, no authorisation shall be granted unless those items are effective and in accordance with relevant [F2 retained EU law], and are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the plant protection product, taking into account climatic conditions in particular.

Textual Amendments

F2 Words in Annex Pt. 2.C point 2.6.1.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xix); 2020 c. 1, Sch. 5 para. 1(1)

2.6.1.4. No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms may lead to adverse effects on human and animal health, including resistance to known therapeutic substances. U.K.

2.6.1.5. Plant protection products which, because of particular properties, or which, 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. Moreover, plant protection products which are classified as very toxic shall not be authorised for use by non-professional users. U.K.

2.6.1.6. Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on bystanders or workers exposed after application of the plant protection product are expected. U.K.

2.6.1.7. Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on animals are expected. U.K.

2.6.1.8. Waiting and re-entry periods or other precautions to ensure that no colonisation or adverse effects are expected must be realistic; if necessary, special precautionary measures must be prescribed. U.K.

2.6.1.9. The conditions of authorisation shall be in compliance with [F3 the EU-derived domestic legislation which transposed] Directive 98/24/EC and Directive 2000/54/EC of the European Parliament and of the Council(1). The experimental data and information relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and therapeutic measures provided shall be considered. The conditions of authorisation shall also be in compliance with [F3 the EU-derived domestic legislation which transposed] Directive 2004/37/EC. The conditions of authorisation shall also be in compliance with Council Directive 89/656/EEC(2). U.K.

Textual Amendments

F3 Words in Annex Pt. 2.C point 2.6.1.9 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(c)(xx); 2020 c. 1, Sch. 5 para. 1(1)

2.6.2. Effects on human and animal health arising from residues U.K.

2.6.2.1. No authorisation shall be granted unless there is sufficient information for plant protection products containing the micro-organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism, its residual traces and metabolites/toxins remaining in or on plants or plant products. U.K.

2.6.2.2. No authorisation shall be granted unless viable residues and/or non-viable 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 viable residues and/or toxins at harvest, slaughter or after storage are reduced to a minimum. U.K.

(1)

OJ L 262, 17.10.2000, p. 21.

(2)

OJ L 393, 30.12.1989, p. 18.