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Assessment of the application for renewal of authorisation of Lantharenol (lanthanum carbonate octahydrate) for cats

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The European Food Safety Authority panel on feed additives reviewed the renewal of Lantharenol, a lanthanum carbonate octahydrate additive used in cat food to lower urinary phosphorus excretion. Based on post-market monitoring and a literature search supplied by the applicant, the panel confirmed safety for cats at up to 7.5 g/kg of complete feed. Because the additive is only for cats, consumer and environmental safety were outside the scope of the opinion.

Key numbers

  • Authorized use in cat feed: 1.5 to 7.5 g/kg of complete feed; recommended inclusion in moist feed (20% to 25% dry matter) 340 to 2,100 mg/kg (Section 3.1.3, p. 6). Section 3 also states a maximum of 7,000 mg/kg complete feed (p. 5), which differs from the 7.5 g/kg used elsewhere.
  • Additive specification: lanthanum 43% to 49%; three analyzed lots contained 45% lanthanum (Section 3.1.1, p. 5).
  • Impurities in the same lots (mg/kg): fluoride 22.6; arsenic below 2; cadmium below 1; chromium below 2; lead below 1; mercury below 0.2; the panel noted uncertainty about the limits of detection and quantification (p. 5).
  • Post-market monitoring: 29 non-serious and 9 serious adverse events reported in cats since authorization; incidence 0.0003% in each of two reporting periods; 8 deaths or euthanasias assessed as unclassifiable or unlikely to be product related (p. 7).

Methods (brief)

Renewal assessment of an applicant dossier under Regulation (EC) No 1831/2003, covering additive characterization, post-market monitoring and pharmacovigilance reports for 2008 to 2016, and an applicant literature search (444 records, four judged relevant). Efficacy was not reassessed.

Evidence fitness

Supports the authorized feed inclusion range for lanthanum carbonate in cat food in the EU and the panel’s target-animal safety conclusion. It explicitly does not assess consumer or environmental safety and provides no human exposure values.

Limitations

Relies on applicant-supplied data; composition analyses were older than one year because the additive was not being manufactured at the time; the literature search used only trade names, which the panel criticized; some content was redacted for confidentiality.

Update history

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