New active substances (NAS) and existing active substances (EAS) under Directive 91/414/EEC and REGULATION (EC) No 1107/2209

Date: 2 April 2020

Under former Directive 91/414/EEC a new active substance (NAS) is defined as a substance with market entry after July 1993, whereas an existing active substance (EAS) defines active substances with market entry before July 1993, i.e. 2 years after publication of Directive 91/414/EEC. In order to bring all existing active substances on the European market to the same standard, the commission initiated a work programme with Directive 91/414/EEC for the gradual examination of all currently approved substances. This programme ran from 1995 until 2012 and included 4 separate lists and stages:
  • List 1: 1st stage REGULATION (EEC) No 3600/92
  • List 2: 2nd stage REGULATION (EC ) No 451/2000
  • List 3: 3rd stage REGULATION (EC ) No 1490/2002
  • List 4: 4th stage REGULATION (EC) No 2229/2004

Main aspects taken into account during the examination include health and environmental concerns, the possibility of residues in treated products, and information on knowledge gaps in documents of existing active substances.

Under the ‘new’ REGULATION (EC) No 1107/2009, new active substances per definition have not yet been approved for use in plant protection products and the applicant can choose the RMS (Rapporteur Member State). In contrast to that, existing active substances have already been approved previously and the RMS/Co-RMS is allocated. The procedure for the renewal of approval of existing active substances is summarized in the AIR (Annex-I-renewal) programmes. If you want to learn more about the AIR programmes, stay tuned for a new contribution to our temporary online academy.

Alexander Rücker