Candidates for substitution

Date: 20 April 2020

In its endeavor to push industry towards “safer” active substances (a.s.) and products in plant protection, the authorities introduced in Article 24 of Regulation (EU) 1107/2009 the concept of Candidate for Substitution (CfS), meaning that “less safe” a.s. are substituted by “safer” ones. One consequence already felt at a.s. level, is the limitation of the approval period for a.s. classified as CfS to no longer than seven years.
The criteria for candidates of substitution are laid down in Annex II of Regulation (EU) 1007/2009 under point 4 and are – briefly summarized – as follows:

• ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances
• Two of the criteria to be considered as a PBT (persistent / bioaccumulating / toxic) substance are met
• There are reasons for concern linked to the nature of the critical effects which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures
• Significant proportion of non-active isomers
• Classification as carcinogen category 1A or 1B according to Regulation (EC) No 1272/2008
• Classification as toxic for reproduction category 1A or 1B, according to Regulation (EC) No 1272/2008
• The active substance is considered to have endocrine disrupting properties that may cause adverse effects in humans.

This concept is strictly limited to a.s., but the consequences are to be borne by the respective products containing a CfS a.s.

Dörte Goertz