Co-formulants are substances or preparations, which are used or intended to be used in a plant protection product or adjuvant but are neither active substances nor safeners or synergists (Assimilated Regulation (EC) No. 1107/2009, Article 2(3) point (c)).
Article 27 (1) of the same regulation establishes that:
- Co-formulants are unacceptable in plant protection products if their residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment
- Co-formulants are also unacceptable in plant protection products if their use, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or have an unacceptable effect on plants, plant products or the environment
On this basis unacceptable co-formulants include:
- substances with a harmonised classification as carcinogens, category 1A or 1B, as mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B, in accordance with Annex VI to Assimilated Regulation No. 1272/2008 (‘the GB Classification, Labelling and Packaging (CLP) Regulation’).
- substances identified as persistent organic pollutants (‘POP’) under Assimilated Regulation 2019/1021.
- substances identified as persistent, bioaccumulative and toxic (‘PBT’) or very persistent and very bioaccumulative (‘vpvb’) in accordance with points (d) and (e) of Article 57 of Assimilated Regulation No. 1907/2006 (UK REACH).
- substances of very high concern due to endocrine disrupting properties in accordance with point (f) of Article 57 of Assimilated Regulation No. 1907/2006 (UK REACH).
- substances identified as endocrine disruptors under Assimilated Regulation No 582/2012 (the GB Biocidal Products Regulation; GB BPR)
- substances for which a decision has been made not to approve the co-formulant as an active substance for product-type 6 under Assimilated Regulation No 582/2012 (the GB Biocidal Products Regulation; GB BPR)
- substances approved under Assimilated Regulation No 528/2012 (the GB Biocidal Products Regulation; GB BPR) with restrictions that are relevant for uses as a co-formulant in plant protection products will be considered for inclusion in the GB unacceptable co-formulants register.
- substances restricted for use as co-formulants in plant protection products according to Annex XVII of Assimilated Regulation No. 1907/2006 (UK REACH).
- any other substances which, when considering realistic conditions of use and good plant protection practice, do not fulfil the criteria for approval of an Active Substance (as given in Annex II to Assimilated Regulation No. 1107/2009) when used as a co-formulant in a plant protection product.
Unacceptable co-formulants may be present as unintentional impurities in other co-formulants. In this instance the individual concentration of the unacceptable co-formulant in the finished plant protection product or adjuvant should be less than 0.1 % weight by weight (w/w), or lower if a specific concentration limit has been set based on its carcinogenic, mutagenic and reprotoxic properties. Consideration may also be given to limits for unintentional impurities based on technical limitations of relevant analytical methods.