European Commission proposes new PPP labelling requirements
Introduction
On 6 January 2025, the European Commission published a draft proposal aimed at further harmonising labelling requirements for plant protection products (PPPs) in the European Union (EU). The proposal intends to repeal the existing labelling rules and introduce certain new requirements, including mandatory digital labelling. Since the draft proposal has not yet been formally adopted, some changes to the final version remain possible.
Transitioning towards new PPP labelling rules
The labelling of PPPs in the EU is currently governed by Commission Regulation (EU) No 547/2011. This Regulation imposes labelling requirements such as standard phrases for special risks to human or animal health and safety precautions for the protection of human or animal health or of the environment. Due to the relatively high number of proposed amendments, the Commission intends to replace Commission Regulation (EU) No 547/2011 altogether.
The Commission aims for the new Regulation to take effect on 1 January 2026. Transitional measures will also be implemented once the new rules are adopted. PPPs that are authorised or have a parallel trade permit granted by 1 January 2026 will only need to comply with Regulation (EU) 547/2011. Companies submitting a national marketing authorisation application before this date can either follow the labelling requirements of the new Regulation or those of Regulation (EU) 547/2011. This choice is significant, as the new Regulation would introduce notable changes compared to the current framework.
The most significant changes at a glance
A series of updated/new labelling requirements are included in the current Commission draft. Notable changes include:
- A specific phrase and pictogram to enhance communication to users about PPPs that might pose potential hazards to bees.
- A specific precautionary sentence to warn against the potential sensitisation effects of micro-organisms.
- Users of seeds treated with PPPs should be informed about the risks associated with sowing and the PPP used for coating. Since end-users might not have access to the product label, relevant risk mitigation phrases shall be included on both the product label and the label or documents accompanying the treated seeds.
- The systemic inclusion of a specific standard phrase on the labels of PPPs authorised for professional users to remind them of the obligation to apply the principles of integrated pest management.
- Professional users must be informed via the product label about the possibility of reducing the applied product volume when using precision application techniques.
- A colour-coded scheme on PPP labels to help users identify low-risk products, products containing candidates for substitution, and those with low-risk active substances.
- To help Member States combat illegal trade in PPPs, specific labelling requirements should be established for parallel trade products. In line with the EU Court of Justice’s Syngenta Agro case (see our blog here), the label and/or packaging of parallel trade PPPs must include the batch number and manufacture date from the original manufacturer, the permit number, and the permit holder’s name and address.
- The introduction of a digital labelling requirement. The new Regulation mandates that a PPP label be accessible in two formats, a physical label affixed to the packaging and a digital label. The digital label may not be an exact copy of every character written on the physical label but it shall reflect the content of the marketing authorisation or parallel trade permit. It must be accessible via a link or other machine-readable format, free of charge, and without requiring an account.
ALTIUS’s Life Sciences & EU Regulatory team is available to assist and guide companies in complying with the various regulatory requirements applicable to plant protection products, including their labelling. If you would like further information regarding this topic, then please contact Philippe de Jong (Philippe.deJong@altius.com) or Bart Junior Bollen (Bart.Bollen@altius.com).
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