Anses Clarifies Implementation of EU Regulation 2026/1120 on Newly Prohibited Co-formulants in France

On 27 May 2026, the European Commission published Regulation (EU) 2026/1120, amending Annex III of Regulation (EC) No 1107/2009 by adding 12 co-formulants that can no longer be accepted in plant protection products. The regulation entered into force on 16 June 2026, triggering new compliance obligations for both pending applications and already authorized products in the French territory.

To support implementation at the national level, the French Agency for Food, Environmental and Occupational Health & Safety (Anses) issued an updated guidance note on 26 June 2026, detailing how these new restrictions will be handled for plant protection products, adjuvants and mixed products in France.

What Does EU Regulation 2026/1120 Change?

Regulation (EU) 2026/1120 updates Annex III of Regulation (EC) No 1107/2009 by adding twelve co-formulants that are no longer permitted in plant protection products (unless present as unintentional impurities in other co-formulants, i.e. at less than 0,1 % weight by weight (w/w) or less than a specific concentration limit related to CMR properties, which as such are acceptable for use in plant protection products or adjuvants). Member States are required to withdraw authorizations for products containing these substances as quickly as possible and no later than 16 June 2028, unless the prohibited co-formulants are successfully replaced through an approved change of composition. Noting, nonetheless, that requests for composition changes will be accepted by Member States during the freezing period.

The regulation also applies to adjuvants, requiring equivalent action from authorization holders.

Key Requirements for Applications Currently Under Evaluation

For applications for authorization submitted before 16 June 2026 that are still under evaluation and contain one of the newly prohibited co-formulants, Anses will allow applicants to submit a minor (non-significant) change of composition request to replace the affected ingredient.

Important deadline

  • Change of composition requests must be submitted as soon as possible and no later than 16 December 2026.
  • The cover letter should clearly state that the modification aims to substitute a co-formulant prohibited under Regulation (EU) 2026/1120.
  • Failure to submit a compliant change request within this timeframe will result in the rejection of the authorization application.

Requirements for Existing Authorizations

For products already holding an authorization in France, Anses requires authorization holders to identify affected products and communicate their intentions regarding reformulation. This obligation applies to plant protection products, adjuvants and mixed products.

Step 1: Notification to Anses

Authorization holders must notify Anses of affected products by 31 July 2026. The notification should indicate whether the company intends to submit a change of composition request or has already submitted one that is currently under assessment.

Step 2: Submission of Reformulation Application

Where companies intend to replace a prohibited co-formulant, a minor change of composition application must be submitted as soon as possible and no later than 16 June 2027.

If no application is submitted within this period, Anses will proceed with withdrawal of the authorization. The same outcome may occur if the submitted dossier is deemed inadmissible.

What Happens if No Action Is Taken?

Anses has confirmed that products containing prohibited co-formulants for which no acceptable reformulation dossier is submitted will be subject to authorization withdrawal.

The withdrawal process will follow the standard administrative procedure, including an opportunity for authorization holders to provide comments before a final decision is taken. According to the regulation, withdrawals must occur no later than 16 June 2028.

Following withdrawal, grace periods may be granted but will be limited to:

  • A maximum of 3 months for sale and distribution; and
  • A maximum of 12 months for storage and use of existing stocks.

What should companies do?

Companies with products registered or under evaluation in France should immediately review their formulations against the list of co-formulants added to Annex III by Regulation (EU) 2026/1120. Early assessment of reformulation options and preparation of change-of-composition dossiers will be critical to maintaining market access.

 

Key Dates at a Glance

Deadline Requirement
16 June 2026 Regulation (EU) 2026/1120 enters into force
31 July 2026 Notification to Anses for authorized products containing prohibited co-formulants
16 December 2026 Deadline to amend applications under evaluation submitted before 16 June 2026
16 June 2027 Deadline to submit change-of-composition applications for authorized products
16 June 2028 Latest date for withdrawal of affected authorizations

 

How can SynTech Research help?

Our experts can help assess the impact of Regulation (EU) 2026/1120 on your product portfolio, identify reformulation pathways and manage interactions with national authorities such as Anses.

Need support with reformulation or authorization maintenance in France? Contact SynTech Research’s Regulatory Affairs team to ensure compliance with the new co-formulant requirements at info@syntechresearch.com

 

 

 

 

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