ANNEX IISupplementary provisions
ANNEX II Amendments to the Annexes to Regulation (EC) No 2229/2004 After Annex V to Regulation (EC) No 2229/2004 the following Annexes are added as Annexes VI and VII: ‘ANNEX VI Criteria for clear indications of no harmful effects An active substance shall be considered as fulfilling the requirement, as referred to in Article 24b, of there being clear indications that it may be expected that it does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met. 1. The active substance satisfies the following criteria: (a) it is not classified or proposed for classification as C (carcinogenic effects) M (mutagenic effects) R (toxic to reproduction) in categories 1, 2 or 3 in accordance with Directive 67/548/EEC; (b) either not requested or, if required, an ADI (Acceptable Daily Intake), AOEL (Acceptable Operator Exposure Level) and ARfD (Acute Reference Dose) can be established on the basis of the standard assessment factor of 100; (c) it is not considered to have the potential to meet the criteria of a persistent organic pollutant set out in Regulation (EC) No 850/2004 of the European Parliament and of the Council ( *1 ) ; (d) it is not considered to have the potential to meet the criteria set out in Annex XIII to the Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( *2 ) . 2. At least one supported representative use of the active substance satisfies all of the following criteria: (a) operator exposure is less than or equal to 75 % of the AOEL in modelled scenarios, considered relevant for the intended use and where the use of such modelling is appropriate to the supported use and at maximum using gloves as personal protective equipment (PPE); (b) bystander exposure and worker exposure is less than or equal to 75 % AOEL in modelled scenarios, considered relevant for the intended use and where the use of such modelling is appropriate to the supported use and without the use of PPE; (c) consumer exposure is less than or equal to 75 % of the ADI or ARfD (where such a value is necessarily established) in all available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active substance (without special refinements); (d) leaching to groundwater is below 0,1 μg/l in at least half of the scenarios considered relevant for the intended use, or in relevant lysimeter/field studies, for both the parent substance and relevant metabolites; (e) Buffer zones for the protection of the environment do not exceed 30m without any further risk mitigation measures (e.g. drift reducing nozzles); (f) the risk to non-target organisms is acceptable based on standard refinements. ‘ANNEX VII Criteria for clear indications of harmful effects An active substance shall be considered as fulfilling the requirement, as referred to in Article 24f, of there being clear indications that on the basis on the available data, and which have been evaluated in accordance with the provisions of Article 24d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in point 1 or one of the criteria in point 2 is met. 1. As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or an AOEL and such values are necessary to conduct a consumer and operator risk assessment. 2. As regards each supported representative use, at least one of the following criteria is met: (a) operator exposure is greater than 100 % AOEL in all modelled scenarios with the use of PPE/RPE (Personal Protective Equipment/Respiratory Protective Equipment), where the use of such modelling is appropriate to the supported use, and where actual exposure data, if available, also indicate that the AOEL will be exceeded under normal conditions of use; (b) bystander exposure and worker exposure is greater than 100 % AOEL in modelled scenarios, where the use of such modelling is appropriate to the supported use, and where actual exposure data, if available, indicate that the AOEL will be exceeded for these groups under normal conditions of use; (c) consumer exposure is greater than 100 % of the ADI or ARfD (where such a value is required) in at least one of the available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active substance; (d) leaching to groundwater is equal to or above 0,1 μg/l in all modelled scenarios either for the parent substance or for relevant metabolites. ’ ( *1 ) OJ L 158, 30.4.2004, p. 7 ; corrected by OJ L 229, 29.6.2004, p. 5 . ( *2 ) OJ L 396, 30.12.2006, p. 1 ; corrected by OJ L 136, 29.5.2007, p. 3 .