Commission Regulation (EU) No 284/2013Dangos y teitl llawn

1. The information submitted shall meet the following requirements. U.K.

1.1. The information shall be sufficient to evaluate efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product may entail for humans, including vulnerable groups, animals and the environment and contain at least the information and results of the studies referred to in this Annex. U.K.

1.2. Any information on potentially harmful effects of the plant protection product on human and animal health or on groundwater shall be included as well as known and expected cumulative and synergistic effects. U.K.

1.3. Any information on potentially unacceptable effects of the plant protection product on the environment, on plants and plant products shall be included as well as known and expected cumulative and synergistic effects. U.K.

1.4. The information shall include all relevant data from the scientific peer reviewed open literature on the active substance, metabolites and breakdown or reaction products and plant protection products containing the active substance and dealing with side-effects on health, the environment and non-target species. A summary of this data shall be provided. U.K.

1.5. The information shall include a full and unbiased report of the studies conducted as well as a full description of them. Such information shall not be required, where one of the following conditions is fulfilled: U.K.

(a)

it is not necessary owing to the nature of the product or its proposed uses, or it is not scientifically necessary;

(b)

it is technically not possible to supply.

In such a case a justification shall be provided.

1.6. Where relevant, the information shall be generated using test methods, which are included in the list referred to in point 6. In the absence of suitable internationally or nationally validated test guidelines, test guidelines accepted by the F1 ... competent authority shall be used. Any deviations shall be described and justified. U.K.

Textual Amendments

F1 Word in Annex Introduction point 1.6 omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

1.7. The information shall include a full description of the test methods used. U.K.

1.8. Where relevant, the information shall be generated in accordance with [F2 the Animals (Scientific Procedures) Act 1986]. U.K.

Textual Amendments

F2 Words in Annex Introduction point 1.8 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

1.9. The information shall include a list of endpoints for the plant protection product. U.K.

1.10. The information shall include the proposed classification and labelling of the plant protection product in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council(1), where relevant. U.K.

1.11. Information as provided for in Commission Regulation (EU) No 283/2013(2) may be required by the competent authorities on co-formulants. Before requiring additional studies to be performed, the competent authorities shall assess all available information provided in accordance with other [F3 retained EU law]. U.K.

Textual Amendments

F3 Words in Annex Introduction point 1.11 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

1.12. The information provided for the plant protection product and that provided for the active substance, shall be sufficient to: U.K.

(a)

decide whether, or not, the plant protection product is to be authorised;

(b)

specify conditions or restrictions to be associated with any authorisation;

(c)

permit an evaluation of short and long-term risks for non-target species, populations, communities and processes;

(d)

identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in humans;

(e)

permit a risk assessment of acute and chronic consumer exposure, including, where relevant, a cumulative risk assessment deriving from exposure to more than one active substance;

(f)

permit an estimation of acute and chronic exposure to operators, workers, residents and bystanders including, where relevant, the cumulative exposure to more than one active substance;

(g)

permit an evaluation to be made as to the nature and extent of the risks for humans, animals (species normally fed and kept by humans or food producing animals) and of the risks for other non-target vertebrate species;

(h)

predict the distribution, fate, and behaviour in the environment, as well as the time courses involved;

(i)

identify non-target species and populations for which hazards arise because of potential exposure;

(j)

permit an assessment of the impact of the plant protection product on non target species;

(k)

identify measures necessary to minimise contamination of the environment and impact on non-target species;

(l)

classify the plant protection product as to hazard in accordance with Regulation (EC) No 1272/2008.

1.13. Where relevant, tests shall be designed and data analysed using appropriate statistical methods. U.K.

1.14. Exposure calculations shall refer to scientific methods [F4 set out in guidance issued in accordance with Article 77 of Regulation (EC) No 1107/2009], when available. Additional methods, when used, shall be justified. U.K.

Textual Amendments

F4 Words in Annex Introduction point 1.14 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ L 353, 31.12.2008, p. 1.

(2)

See page 1 of this Official Journal.