Simplifying Food Safety Rules

Based on this document

What’s the problem that is being addressed

• Farmers and companies face long, confusing, and costly approval processes for plant‑protection products, especially biocontrol substances (natural pest‑control agents).
• Member States lack the expertise and resources to assess new substances quickly, causing delays that keep farmers from using safer, more sustainable products.
• The current rules create uneven rules across the EU, duplicate data‑protection regimes, and require record‑keeping that is not useful for biocontrol products.
• The overall regulatory package is too complex, with many overlapping requirements that increase administrative costs for both industry and authorities.

How that problem is being solved here

• The proposal amends 10 EU regulations (e.g., Regulation (EC) No 1107/2009 on plant‑protection products, Regulation (EU) No 528/2012 on biocidal products, Regulation (EC) No 396/2005 on maximum residue levels, etc.) to simplify procedures and clarify definitions.
• New, clear definitions for biocontrol substances, basic substances, and plant biostimulants are introduced, removing ambiguity.
• Approval periods for active substances are made unlimited (except for those that are candidates for substitution or have safety concerns), freeing up resources that were previously tied to renewal deadlines.
• The European Food Safety Authority (EFSA) is empowered to act as a rapporteur Member State for biocontrol substances, speeding up risk assessments.
• Mutual recognition of authorisations is streamlined: if a product is authorised in one Member State, it is automatically recognised in others after 120 days, unless the product is not placed on the market.
• Record‑keeping for professional users of biocontrol products is removed, reducing paperwork for farmers.
• Data‑protection rules are harmonised across the Union, giving a single, transparent period for all test and study reports.
• The maximum grace period for withdrawing authorisations is increased to 3 years (instead of 18 months), giving farmers time to find alternatives.
• The proposal introduces a digital labelling option for feed additives, reducing printing costs while keeping safety information on physical labels.
• The budget for the new measures is set at €15,073 million for 2028‑2034, with expected annual cost savings of €335.6 million (increasing to €428.6 million by 2029) and a total projected savings of €1 billion (2027‑2029) and €2.1 billion (2029‑2034).
• Administrative costs for authorities are projected to fall by €661 million annually, totaling €4.6 billion over 2027‑2034.

What changes as a result of this document

• Definitions: Biocontrol substances, basic substances, and plant biostimulants are clearly defined.
• Approval periods: Unlimited for most active substances; only limited for substitution candidates or those with safety concerns.
• EFSA role: Can act as rapporteur Member State for biocontrol substances, providing technical support to Member States.
• Mutual recognition: Simplified, with tacit approval after 120 days and automatic recognition if the product is on the market.
• Record‑keeping: Removed for biocontrol products.
• Data protection: Single Union‑wide period for all test and study reports.
• Grace periods: Extended to 3 years for withdrawal of authorisations.
• Digital labelling: Allowed for non‑safety information on feed additives.
• Budget: €15,073 million allocated for 2028‑2034, with significant cost savings for industry and authorities.
• Administrative simplification: Reduced reporting requirements for depopulation operations, BSE monitoring, and laboratory accreditation.

These changes aim to make the EU food and feed safety framework more efficient, reduce unnecessary burdens, and keep high protection standards for human, animal, and environmental health.