Amending certain Regulations as regards the simplification and strengthening of food and feed safety requirements (Omnibus X)

It affects farmers, food and feed businesses, pesticide and biocide producers, importers, laboratories, and operators handling plants, animals or animal products. Consumers are affected through residue and safety rules.

• Speeds authorisation and mutual recognition for biocontrol and low-risk plant protection products.
• Makes many active-substance, biocide and feed-additive approvals unlimited, with targeted reassessment safeguards.
• Allows stricter pesticide residue limits for hazardous non-EU-approved substances in imported food.
• Simplifies official controls, hygiene notifications, depopulation reporting, laboratory accreditation and GMO-fermentation product classification.

Transitional law

Pending pesticide and feed-additive authorisation or renewal procedures continue under existing rules, with new duration or data-protection rules applied as specified.

• Regulation (EC) No 1107/2009 (32009R1107)
  • art. 2: amends scope and plant-growth-regulator wording
  • art. 3: amends zone and plant biostimulant definitions; adds biocontrol and basic substance definitions
  • art. 4(7): replaces derogation for serious plant health dangers
  • art. 5: replaces first approval duration rules
  • art. 7(1): amends application rules; allows EFSA role for biocontrol substances
  • art. 11: prioritises biocontrol assessments and allows EFSA support
  • art. 13(4): replaces listing rule for approved active substances
  • art. 14: replaces renewal of approval rules
  • art. 18: replaces work programme for renewal of unlimited approvals
  • art. 18a: inserts work programme for targeted reassessment
  • art. 19: replaces implementing measures for renewal and targeted reassessment
  • art. 20(2): replaces grace-period rules after non-renewal or withdrawal
  • art. 22: replaces low-risk active substance criteria references
  • art. 23: replaces basic substance approval criteria
  • art. 23a: inserts basic substance approval procedure and labelling rules
  • art. 27a: inserts rules deeming existing approvals unlimited, with exceptions
  • art. 28(2): amends authorisation exemptions for basic substances and treated reproductive material
  • art. 30: replaces provisional authorisations for biocontrol products
  • art. 32: replaces duration rules for product authorisations
  • art. 33(2): amends proposed evaluating Member State and one-zone cases
  • art. 36(1): amends assessment basis for current scientific and technical knowledge
  • art. 37: adds tacit authorisation, prioritisation and faster decisions
  • art. 40: replaces mutual recognition application rules
  • art. 42: replaces mutual recognition procedure
  • art. 43: amends renewal application timing and information requirements
  • art. 44: inserts check of compliance with confirmed approval conditions
  • art. 46: replaces grace-period rules for withdrawn, amended or non-renewed authorisations
  • art. 49: replaces treated seeds and plant reproductive material rules
  • art. 51: amends minor-use authorisation extensions and mutual recognition
  • art. 59: replaces data protection rules
  • art. 67(1): amends record-keeping obligations, exempting biocontrol-only product use records
  • art. 68: deletes reporting obligation on official controls
• Regulation (EC) No 396/2005 (32005R0396)
  • art. 3(2): amends GAP and LOQ definitions; deletes import tolerance definition
  • art. 6(4): replaces import tolerance applications with third-country GAP MRL applications
  • art. 10(1): replaces LOD reference with LOQ
  • art. 14: adds hazardous-substance MRL rule and transitional measures
  • art. 15(1): deletes point concerning temporary MRLs
  • art. 16: replaces procedure for setting MRLs in certain circumstances
  • art. 18: inserts transitional measures for products compliant when marketed or stored
  • art. 31(1): replaces LOD reference with LOQ
  • art. 43: replaces EFSA scientific opinion and MRL review rules
• Regulation (EU) No 528/2012 (32012R0528)
  • art. 4(1): replaces active substance approval duration rules
  • art. 4(3): amends approval condition on approval and expiry dates
  • art. 9(1): amends implementing regulation content for active substance approval
  • art. 10(4): replaces approval period for candidates for substitution
  • art. 12(3): replaces renewal duration rule
  • art. 13(1): amends timing for renewal applications with specified expiry dates
  • art. 14a: inserts renewal procedure for active substances with unlimited approval
  • art. 15a: inserts rules deeming existing approvals unlimited, with exceptions
  • art. 44(5): replaces Union authorisation decision and publication rules
  • art. 46(4): amends renewal or refusal of Union authorisation decisions
• Regulation (EC) No 1829/2003 (32003R1829)
  • art. 2(10): clarifies food and feed obtained using GMM production strains
• Regulation (EC) No 1831/2003 (32003R1831)
  • art. 2(2): adds label, labelling and holder of authorisation definitions
  • art. 3(3): replaces rule on placing holder-specific additives on market
  • art. 9: amends authorisation content, unlimited validity and Register rules
  • art. 13: amends modification, suspension or revocation procedures
  • art. 14: narrows renewal rules to coccidiostats and histomonostats
  • art. 14a: inserts transitional rules for pending renewal applications
  • art. 16: amends labelling rules and enables digital labelling for some particulars
  • art. 21a: amends exercise of delegation for digital labelling powers