Scientific Opinion on the evaluation of the safety and efficacy of Cecure® for the removal of microbial surface contamination of raw poultry products

Abstract

On request from the European Commission, results of studies submitted with an application for potential approval of Cecure® to be used for the removal of microbial surface contamination of raw poultry products were assessed to evaluate its safety and efficacy. The proposed treatment consisted of an aqueous solution containing cetylpyridinium chloride (CPC) as the active ingredient at a concentration not to exceed 1% and propylene glycol (PG), applied by drenching on whole chicken carcasses and recycled after use. Based on the available evidence, there is no concern for genotoxicity of CPC. Taking into account the estimated margins of safety and the conservative exposure estimates used to assess CPC exposure from consumption of poultry carcasses, there are no safety concerns for humans from the proposed use of Cecure®. Based on the information provided by the applicant, both Cecure® and CPC were found to be efficacious in reducing contamination with pathogenic microorganisms on fresh broiler carcasses. The efficacy of the treatment appeared to be influenced more by the concentration of the active ingredient (within the range of 0.2% to 0.5%), than by the volume of solution applied, flow rate, spraying pressure, rate of carcass processing, and time of exposure. The data about the potential emergence and selection of isolates with reduced susceptibility to biocides and/or resistance to therapeutic antimicrobials linked to the use of CPC under the conditions of application, in the recycled solution and in the wastewater, were not provided or not considered sufficient for the assessment. Based on the available limited data, the intended use of CPC in poultry slaughterhouses would pose risks for the environmental compartments surface water, sediment and soil. No risks for the function of sewage treatment plants are expected and there are no safety concerns regarding secondary poisoning for birds and mammals, and for humans indirectly exposed via the environment. More specifically, the approval was sought for treatments using an aqueous solution of Cecure® consisting of cetylpyridinium chloride (CPC) as the active ingredient and food-grade propylene glycol (PG). Cecure® should be applied by drenching at a concentration of less than 1.0% CPC, at room temperature, and the solution should be recycled for reuse.The Commission asked EFSA to issue a Scientific Opinion on the assessment of the safety and efficacy of Cecure® when used to reduce microbial surface contamination on raw poultry products (defined as skin-on whole chicken carcasses or parts). Specifically, the task was to consider the toxicological safety of the substance, its antimicrobial efficacy, the potential emergence of reduced microbial susceptibility to biocides and/or resistance to therapeutic antimicrobials linked to the use of the substance, and any risk related to the release of effluents containing the substance from the slaughterhouse and/or processing plant into the environment. The assessment was based on the guidance document on the submiss...

Evaluation of the safety and efficacy of lactic acid to reduce microbiological surface contamination on carcases from kangaroos, wild pigs, goats and sheep

“…spraying or dipping) and other conditions of use, see, e.g. EFSA BIOHAZ Panel ( 2011 ), EFSA BIOHAZ Panel and EFSA CEF Panel ( 2012 ) and EFSA CEP Panel ( 2018 ).…”