Unacceptable co-formulants

Date: 28 May 2020

Co-formulants are substances or preparations used in plant protection products which are neither active substances nor safeners or synergists. According to Article 27 of Regulation (EC) No 1107/2009, it is intended to include a list of co-formulants which should not be permitted in plant protection products as an Annex to the Regulation (Annex III). For a long time this annex did not contain any entries which is why national lists were published by several countries. Early in 2020 a draft list of unacceptable co-formulants was published by the European Comission which includes 90 entries.

According to the corresponding draft regulation amending Annex III, co-formulants are considered unacceptable if they have harmful effects on human or animal health or on groundwater or an unacceptable effect on the environment. Therefore, co-formulants with the following properties are undesirable:

  • Classification as carcinogens, category 1A or 1B, as cell mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008
  • persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with Regulation (EC) No 1907/2006
  • endocrine disrupting properties in accordance with Regulation (EC) No 1907/2006 or substances identified as endocrine disruptors under Regulation (EC) No 528/2012
  • restricted use as co-formulant in plant protection products according to Annex XVII of Regulation (EC) No 1907/2006

For plant protection products containing an unacceptable co-formulant, their registration is intended to be withdrawn no later than 2 years after entry into force of the respective Regulation. The grace period for sale and distribution is foreseen to be 3 months, and additional 9 months for storage, use and disposal after withdrawal of the products.

While unacceptable co-formulants may not be added to plant protection products, it is recognized that traces of unacceptable co-formulants might be present as unintentional impurities in other co-formulants. Therefore, the individual concentration in the finished plant protection product is generally limited to 0.01% w/w (unless otherwise stated).

The draft regulation amending Annex III had been open for commenting until 13 February 2020. A date for adoption has not yet been provided.

Alexander Feyrer