Plant Protection Products Regulation

02009R1107-20140630 → 02009R1107-20170828

ANNEX II Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II 1. Evaluation 1.1. During the process of evaluation and decision-making provided for in Articles 4 to 21, the rapporteur Member State and the Authority shall … 2,832 unchanged words … information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria laid down in point 3.6.5. 5. Low-risk active substances 5.1. Active substances other than micro-organisms 5.1.1. An active substance substance, other than a micro-organism, shall not be considered as being of low risk low-risk where it corresponds to any of the following: (a) it is or has to be classified in accordance with Regulation (EC) No 1272/2008 as at least one any of the following: carcinogenic, mutagenic, carcinogenic category 1A, 1B or 2, mutagenic category 1A, 1B or 2, toxic to reproduction, sensitising chemicals, very 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 toxic, explosive, corrosive. It 1C; (b) it has been identified as priority substance under Directive 2000/60/EC; (c) it is deemed to be an endocrine disruptor; (d) it has neurotoxic or immunotoxic effects. 5.1.2. An active substance, other than a micro-organism, shall also not be considered as being of low risk if: low-risk where it is persistent (half-life in soil is more than 60 days), bioconcentration days) or its bio-concentration factor is higher than 100, 100. 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 deemed 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. 5.2. Micro-organisms 5.2.1. An active substance which is a micro-organism may be an endocrine disrupter, or considered as being of low-risk unless at strain level it has neurotoxic demonstrated multiple resistance to anti-microbials used in human or immunotoxic effects. veterinary medicine. 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.