Maximum Residue Limits (MRLs) and Withdrawal Periods

Residues of chemicals in food can be an emotive subject and the regulations in place to safeguard the consumers of food products from animals treated with veterinary medicines sometimes go beyond pure science. Cyton’s safety team understands this context and is intimately familiar with the European Regulations and guidelines for the establishment of MRLs and withdrawal periods. Our experience with the regulators ensures that the data for your product supports the most favourable withdrawal period possible, maximising your competitive edge on the market.

Our specialist services and expertise for MRLs and withdrawal periods

  • Qualified toxicologists with expertise in all core toxicological endpoints
  • Calculation of acceptable daily intake (ADI), based on No Observable Effect Levels (NOELs)
    • Toxicological ADI
    • Pharmacological ADI
    • Microbiological ADI
  • Calculation of MRLs in milk or tissue for inclusion in Table 1 of the annex to Commission Regulation (EU) No 37/2010
  • Preparation of suitable and scientifically justified exemptions from MRL requirements:
    • Proposals for listing as ‘No MRL Required’ in Table 1 of the annex to Commission Regulation (EU) No 37/2010.
    • Proposals for entry in the ‘out of scope’ list (substances considered as not falling within the scope of Regulation (EC) no 470/2009)
  • Preparation of initial MRL dossiers and dossiers for additional target species
  • Calculation of withdrawal periods for milk and tissues
  • Data audits, gap analysis and literature reviews (find out more here)
  • CRO selection, study design and reporting (find out more here)
  • Dossier writing, DACS (Expert Reports) and responses to questions (find out more here)