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1.The Commission shall be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article.
2.Active substances give rise to concern where:
(a)they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:
(a)explosive/highly flammable,
organic peroxide,
acutely toxic of category 1, 2 or 3,
corrosive of category 1A, 1B or 1C,
respiratory sensitiser,
skin sensitiser,
germ cell mutagen of category 1 or 2;
carcinogen of category 1 or 2,
human reproductive toxicant of category 1 or 2 or with effects on or via lactation,
specific target organ toxicant by single or repeated exposure, or
toxic to aquatic life of acute category 1;
(b)they fulfil any of the substitution criteria set out in Article 10(1); or
(c)they have neurotoxic or immunotoxic properties.
Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.
3.The Commission shall also be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to restrict or to remove the entry for an active substance if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25. Where imperative grounds of urgency so require, the procedure provided for in Article 84 shall apply to delegated acts adopted pursuant to this paragraph.
4.The Commission shall apply paragraph 1 or 3 at its own initiative or at the request of an economic operator or a Member State providing the necessary evidence as referred to in those paragraphs.
Whenever the Commission amends Annex I it shall adopt a separate delegated act in respect of each substance.
5.The Commission may adopt implementing acts further specifying the procedures to be followed with respect to an amendment of Annex I. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).