Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 10 Active substances which are candidates for substitution

1. An active substance shall be considered a candidate for substitution if any of the following conditions are met:

(a) it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2);

(b) it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;

(c) its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario;

(d) it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006;

(e) there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;

(f) it contains a significant proportion of non-active isomers or impurities.

2. When preparing its opinion on the approval or renewal of the approval of an active substance, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion.

3. Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the Commission, the Agency shall make publicly available, without prejudice to Articles 66 and 67, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. The Agency shall take due account of the information received when finalising its opinion.

4. By way of derogation from Article 4(1) and Article 12(3), the approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.

5. Active substances that are considered as candidates for substitution in accordance with paragraph 1 shall be identified as such in the relevant Regulation adopted in accordance with Article 9.