Interpretation of criteria for approval of active substances in the proposed EU plant protection regulation

The Swedish Chemicals Agency (KemI) has made a preliminary interpretation of the criteria for approval of active substances in plant protection products, adopted by the European Council in its first reading. These criteria are well in agreement with the initial proposal of the European Commission in 2006. The interpretation is also in line with the criteria earlier applied nationally by Sweden.

The criteria would imply a higher level of protection for the health of human, animal beings and the environment when plant protection products are used. It would also mean a faster handling of the approval procedure of active substances in the EU.

There are currently no clear guidelines for how certain criteria for approval of active substances in plant protection products should be interpreted in the European Commission's proposal for a new plant protection regulation.

The criteria imply that it would not be allowed to approve substances with the following serious, intrinsic properties in plant protection products (Annex II 3.6-3.7):

  1. Substances that could cause cancer, have mutagenic or reproductive effects (so-called CMR Category 1 and 2), except for negligible human exposure under realistic conditions (excluding mutagenic substances).
  2. Substances giving rise to endocrine disruptions, which could cause harmful effects in humans, except for substances where human exposure is negligible under realistic conditions.
  3. Substances fulfilling the criteria of being persistent organic pollutants (POPs).
  4. Substances fulfilling the criteria of being persistent, bioaccumulating and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

KemI's interpretation of the plant protection regulation imply that 23 active substances that are currently approved (or close to be approved) for use in plant protection products may be withdrawn from the European market, due to their particularly serious properties.

The list of 23 active substances is included in the report "Interpretation in Sweden of the impact of the “cut-off” criteria adopted in the common position of the Council concerning the Regulation on placing plant protection products on the market (document 11119/08)" (PDF, 178 kB). The 23 substances that meet the “cut-off” criteria amount to 8 percent of the 271 active substances being assessed in the report.


Luisa Becedas
Tel: +46-8 519 41 101
Mobile: +46-70 429 39 10 

Peter Bergkvist
Tel: +46-8 519 41 209

Vibeke Bernson
Tel: +46-8 519 41 139

Swedish Chemicals Agency, P.O. Box 2, SE-172 13 Sundbyberg, +46 8 519 41 100, kemi@kemi.se