A French agency has made a number of proposals to help improve the control of microbiological hazards in powdered infant formula.
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) was asked by the Directorate General for Food (DGAL) in December 2018 to look at these products after an outbreak of salmonellosis in 2017 traced to their consumption. The agency’s opinion covers the hygiene, surveillance and control measures in the production chain.
ANSES stressed the importance of applying general hygiene measures to prevent product contamination, the need to strengthen environmental monitoring of production sites and recommended development by industry of a guide to good hygiene practices and HACCP principles for the sector.
Two recent outbreaks
Lactalis infant formula was linked to a Salmonella Agona outbreak in 2017 that sickened 38 babies in France, two in Spain and one in Greece. Recalled formula was distributed to more than 80 countries.
Since then, there was a Salmonella Poona outbreak linked to rice-based infant formula between August 2018 and February 2019. A total of 32 confirmed cases were reported: 30 in France and one each in Belgium and Luxembourg in infants aged 2 months to 28 months old. This incident was linked to products made at the Industrias Lacteas Asturianas SA (ILAS) factory in Anleo, a municipality in the Spanish province of Asturias and marketed by Sodilac under the Modilac brand.
The work updates expertise in 2008 and will be used as a basis for instructions on the focus points to be examined during inspections. Slightly more than 500,000 tons of milk powder were produced in France in 2018, including 125,862 tons of powdered infant formula by 40 factories.
ANSES used on scientific literature and analysis of technical documents describing measures taken by professionals to ensure the hygiene and safety of their products. Analysis of the manufacturing process made it possible to identify potential routes of contamination and the main preventive measures.
The agency said the outbreaks have shown microbiological analyzes on finished products are insufficient to control the risk. When microbial contamination is low, an “unrealistic” number of samples must be taken and analyzed to get relevant information.
Salmonella and Cronobacter main microbiological hazards
Salmonella is typically difficult to detect in dried products and requires sampling and testing methods with a high degree of sensitivity, according to EFSA and ECDC. They added sensitivity of the sampling procedures and analytical methods for this food warrant further evaluation.
Infant formula manufacturing steps generally include mixing the ingredients in liquid form, heat treatment such as pasteurization, drying and adding ingredients before final packaging. All these steps mean infant formula may be contaminated at different stages by bacteria in the plant environment.
The opinion advises infant formula producers to reconsider hazards after each formulation or process change and to account for new epidemiological data.
Salmonella spp. and Cronobacter spp. are the two main microbiological hazards. Products may be contaminated after pasteurization by bacteria in the plant or when adding ingredients.
From 2008 to 2019, 13 alerts for biological hazards, five each from Salmonella and Cronobacter and one for Staphylococcus in powdered infant formula were made on the Rapid Alert System for Food and Feed.
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