Characteristics

Adjuvants are substances or preparations to be mixed with a plant protection product by the user. They enhance the effectiveness or other pesticidal properties of a plant protection product.  An adjuvant has to have an authorisation before it shall be placed on the market or used.

Adjuvants consist of or contain one or more co-formulants. Co-formulants are substances or preparations which are meant  to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists.

Some categories of adjuvants are: Wetting agent, these are products aiming at improving the efficacy of plant protection products by improval of spreading and adherence to crops; Stickers, these are products aiming at enabling better adherence of products for seed treatment and at preventing important dust formation during sowing; Anti-foaming agents, these are products aiming to prevent excessive foam formation, e.g. when several formulations are used together.

Criteria

This application has to be used for all preparations that answer to the definition of adjuvant. Note: the legal basis of the assessment has not been finalised on EU level.

The legal basis

According to Article 58 of the PPPR 1107/2009, an adjuvant must be authorised in the Member State concerned before it can be placed on the market. The rules for such an authorisation have not yet been established as part of a European procedure.

This legal basis is set out in PPPR 1107/2009 article 81(3) where it’s indicated that Member States may apply national provisions for authorization of adjuvants until the adoption of detailed rules at EU level as foreseen in art. 58(2) of the Regulation.

The national provisions on the authorisation of adjuvants in the Netherlands are regulated in the RGB, Article 11.10b, Authorisation of adjuvants:

1.The Ctgb Board grants an authorisation for an adjuvant, as referred to in Article 2, paragraph 3, part d, of Regulation (EC) 1107/2009, if the applicant demonstrates that the adjuvant does not contain any co-formulants included in Annex III of Regulation (EC) 1107/2009.

Annex III of the Regulation on plant protection products is a list of co-formulants which, as referred to in Article 27 of the PPPR 1107/2009 (unacceptable co-formulants), will not be accepted as ingredients in plant protection products.

Because the rules for the assessment of adjuvants must still be established in European legislative framework, the Ctgb only determines if the adjuvant does not contain any co-formulant that is included in Annex III of Regulation (EC) 1107/2009. Consequently, no risk assessment takes place.

The decision and the legal conditions for use report that the legal conditions for use, the instructions for use and the labelling have not been assessed by the Ctgb and that possible risks fall under the responsibility of the authorisation holder.

Authorisation period

Adjuvant authorisations are granted for an indefinite period.

Application costs

Application costs for application for authoration of adjuvants are taken up in the tariff decree.

Registration process

The Ctgb aims to provide the information requested within 12 weeks, provided that the request is complete. You will receive a response from Ctgb by regular mail. This will be in the form of a decision.

Instruction for submission

Use Form Adjuvant authorisation and for the legal instructions for use the 'WG template professional use'.

Check for completeness application

The application for a adjuvant authorisation requires submission of:

  • a completed Form Adjuvant authorisation PPP, including:
    • Labelling data;
    • Proposed Legal conditions for use.

Documentation

Regulation (EC) no 1107/2009, article 58