Update on (re-)authorisation of cobalt salts and silica

EFSA published on 29 October its opinion on the safety and efficacy of 4 cobalt salts (cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate and cobalt(II) sulphate heptahydrate. EFSA concludes positively on all aspects except for consumer safety. EFSA indeed stressed that "due to the lack of adequate deposition data to assess consumer exposure, the FEEDAP Panel is not in the position to conclude on the safety for the consumer." For the record, an exceptional prolongation of the authorisation of these 4 salts until 14/7/2028 was granted by EU authorities for the sake of animal welfare, following a request from FEFAC, after the applicant missed the deadline for submission of a dossier for renewal of authorisation. The applicant was expected to use this 5-year "grace" period to submit a full application for authorisation, which was done. The situation should be discussed at the SCoPAFF meeting of 1-2 December 2025, with 2 options, i.e. either denying the authorisation or giving a second chance to the applicant to submit missing data. The second option would still require a clear commitment from the applicant to submit the missing data, which is not guaranteed at this stage. In case the authorities would opt for a denial of authorisation, only one cobalt compound would remain authorised, i.e. coated granulated cobalt (II) carbonate, providing that the upcoming opinion of EFSA on the renewal of its authorisation is positive on all aspects. It is useful to remind that, in parallel, the EU Commission issued a proposal for the establishment of maximum Occupational Exposure Levels for cobalt for entry into application in 2028.Concerning silicic acid and colloidal silica (resp. E551a and E551b), which are still at the stage of re-authorisation, the applicant ASASP informed of its decision to perform the tolerance studies on chicken, piglets, dairy cow and Salmonids, as requested by EFSA. Still, ASASP needs to decide on the use levels, bearing in mind that collected data on current practices show inclusion rates around 1%, except for piglets and milk replacers, where levels can reach 3%. The decision could be to perform tolerance studies for two different use levels, which will depend on costs. In this regard, ASASP reiterated its call for financial support from users. Companies willing to express their interest in supporting financially ASASP are welcome to write to Damiano Kiss ([email protected]). FEFAC indicated to ASASP that it has no mandate to participate financially in consortia for feed additives authorisations.