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 (c. 1107)

ANNEX II U.K. Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II

[F1 5. Low-risk active substances U.K.

5.1. Active substances other than micro-organisms U.K.

5.1.1. An active substance, other than a micro-organism, shall not be considered as being of low-risk where it corresponds to any of the following: U.K.

(a)

it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as any of the following:

• carcinogenic category 1A, 1B or 2,

• mutagenic category 1A, 1B or 2,

• toxic to reproduction category 1A, 1B or 2,

• skin sensitiser category 1,

• serious damage to eye category 1,

• respiratory sensitiser category 1,

• acute toxicity category 1, 2 or 3,

• specific Target Organ Toxicant, category 1 or 2,

• toxic to aquatic life of acute and chronic category 1 on the basis of appropriate standard tests,

• explosive,

• skin corrosive, category 1A, 1B or 1C;

(b)

it has been identified as priority substance [F2 and is listed in Annex 10 to] Directive 2000/60/EC;

(c)

it is deemed to be an endocrine disruptor;

(d)

it has neurotoxic or immunotoxic effects.

Textual Amendments

F2 Words in Annex 2 point 5.1.1(b) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 14(3)(r) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

5.1.2. An active substance, other than a micro-organism, shall not be considered as being of low-risk where it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100. U.K.

However, a naturally occurring active substance which does not correspond to any of points (a) to (d) of point 5.1.1 may be considered as being of low-risk, even if it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100.

5.1.3. An active substance, other than a micro-organism, emitted and used by plants, animals and other organisms for communication, shall be considered as being of low- risk where it does not correspond to any of points (a) to (d) of point 5.1.1. U.K.

5.2. Micro-organisms U.K.

5.2.1. An active substance which is a micro-organism may be considered as being of low-risk unless at strain level it has demonstrated multiple resistance to anti-microbials used in human or veterinary medicine. U.K.

5.2.2. Baculoviruses shall be considered as being of low-risk unless at strain level they have demonstrated adverse effects on non-target insects.] U.K.

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2017/1432 of 7 August 2017 amending Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the placing of plant protection products on the market as regards the criteria for the approval of low-risk active substances (Text with EEA relevance).