Tank mixtures

Date:  8 June 2020

The German authority (Federal Office of Consumer Protection and Food Safety) published an online document about “Tank mixes in the authorisation procedure for plant protection products”. It is mentioned that under good agricultural practice (GAP) in crop protection, tank mixes (TM) can be used on one hand to reduce the application rate, the total effort and the frequency of intervention or and even more important to avoid the development of resistance.

The regulation and the assessment of TM are described in Regulation (EC) No 1107/2009 and Regulation (EU) No 546/2011 on the uniform principles, considering the interaction between active substance, safener, synergist and co-formulants when a plant protection product (PPP) is evaluated. In this context, the interaction between one PPP and another PPP has to be considered in the same way during the authorisation process.

It is differentiated between recommended tank mixes and required tank mixes. When placing an application for authorization at zonal level the applicant decides whether the TM have to be tested as recommended TM or required TM and which mixing partner (e.g. another PPP or an adjuvant) is intended. If a PPP has to be mixed with a mixing partner to fulfil the purpose of its use, it is a required TM and has to be clearly distinguished as such. During authorization TM are described at the use level. As results of the assessment some uses of authorised PPP can serve as TMs and others not or one use can be authorised as recommended TM and the other as required TM. Nevertheless, when a TM is identified as required TM, the authorised TM is binding for the practical use of the PPP and must be labelled as such.

Since no specific data requirements for TM have been laid down, the data requirements for plant protection products according to Part A (chemical PPP) and Part B (preparations of micro-organisms) of the Annex to Regulation (EU) No 284/2013 apply. In accordance with this regulation explicit test requirements for TM are listed, with regard to their

  • Physical, chemical and biological compatibility with other products (Part A point 2.9 and Part B point 2.8 of the Annex)
  • Efficacy (Part A point 6.2, Part B point 6.4.1 and point 6.5 of the Annex) and
  • Toxicological evaluation and operator safety (Part A point 7.1.8 and point 7.2, Part B point 7.5 of the Annex)

All other data and test requirements do not emanate explicitly from the Regulation (EU) No 284/2013 but will be assessed in the same way by the Member states in accordance with the uniform principles. Therefore, additional data in relation to “Fate and behaviour in the environment” (section 9) and “Ecotoxicological studies” (section 10) described in Part A and Part B of the Annex to Regulation (EU) No 284/2013 may be necessary to allow exposure estimation and reliable risk assessment for non-target organisms.

Sandra Rollar