Adjuvants

Regulatory Support for Adjuvants Across European Markets

Adjuvants play an important role in optimising the performance and application of plant protection products. From a regulatory perspective, however, bringing an adjuvant to market across several European countries can be far from straightforward.

Adjuvants fall within the scope of Regulation (EC) No. 1107/2009. While the Regulation provides for detailed rules for the authorisation of adjuvants to be established at EU level, such harmonised authorisation rules have not yet been adopted.

Under the transitional provisions of Regulation (EC) No. 1107/2009, Member States may continue to apply their national provisions for the authorisation of adjuvants. As a result, regulatory requirements and procedures can differ significantly between countries. One product may therefore face different regulatory pathways, documentation requirements and procedures depending on the target market.

At Artemisa, we help companies understand these country-specific requirements and develop practical regulatory strategies for placing adjuvants on the market across the countries we cover. Our combination of local regulatory expertise and central project coordination enables clients to navigate different national procedures through one experienced regulatory partner.

FAQ

Frequently Asked Questions

No. Regulation (EC) No. 1107/2009 provides for detailed EU rules for the authorisation of adjuvants to be established. As these harmonised rules have not yet been adopted, Member States may continue to apply national provisions under the transitional arrangements of Regulation (EC) No. 1107/2009.

This means that regulatory procedures and requirements can differ between countries.

This depends on the individual market. National requirements should therefore be assessed separately for each country where the product is intended to be placed on the market.

Depending on the country, registration, notification or other national requirements may apply.

Not necessarily. Because national provisions continue to apply, an authorisation or regulatory status in one country does not automatically provide market access in another. The requirements of each target country should be assessed individually.

Yes. National authorisation procedures do not mean that EU-level requirements are irrelevant.

For example, EU rules concerning unacceptable co-formulants also affect adjuvants. Commission Regulation (EU) 2026/1120 amended Annex III to Regulation (EC) No. 1107/2009 by adding further unacceptable co-formulants and includes specific requirements concerning adjuvants containing such substances.

This illustrates why both EU-level developments and national authorisation requirements need to be considered when managing adjuvant compliance.

The assessment typically starts with:

  • Product composition
  • Intended use
  • Available technical and regulatory documentation
  • Existing registrations or authorisations
  • Proposed label
  • Safety Data Sheet (SDS)
  • Target countries

Based on this information, we can identify the applicable national procedures and potential additional requirements.

Yes. We can assess the requirements across several target markets and provide a coordinated overview of the applicable procedures, documentation requirements and recommended next steps. This is particularly useful for adjuvants because national requirements may differ considerably.

Yes. Depending on the country and applicable procedure, our local experts can support preparation and review of national regulatory documentation, application forms, labels and other supporting documents.

Where applicable, our local regulatory experts can support communication with competent authorities, follow up on applications and coordinate responses throughout the regulatory process.

Planning To Place An Adjuvant On A New Market?

Different countries may require different regulatory approaches. Tell us about your product and the markets you are considering, and our local experts can help you identify the applicable national requirements and develop an efficient market access strategy.