Update on the Situation

In late November 2017, the National Reference Center (CNR) for Salmonella (Institut Pasteur, Paris) identified an unusual number of young children with salmonellosis caused by Salmonella serotype Agona. The identification of 8 cases in 8 days triggered an alert, and epidemiological investigations began on December 1 among the parents of the affected infants.

The epidemiological investigation is being conducted by Santé publique France in collaboration with the NRC, the Directorate General for Competition, Consumer Affairs, and Fraud Control, and the Directorate General for Health. To date, the investigation has identified 27 infants (13 boys and 14 girls) with Salmonella Agona serotype salmonellosis, which occurred between mid-August and December 2. These infants reside in 10 different regions (8 in Auvergne-Rhône-Alpes, 6 in Île-de-France, 3 in Burgundy, 2 in Pays de la Loire, 2 in Provence-Alpes-Côte d’Azur, 2 in Nouvelle-Aquitaine, 1 in Lower Normandy, 1 in the Centre region, 1 in Hauts-de-France, and 1 in Occitanie). Their median age is 3 months.

The families of 24 infants were interviewed. Among them, 12 were hospitalized due to salmonellosis; all have been discharged from the hospital and are doing well now.

Of these 24 infants, 23 had consumed, within the 3 days prior to the onset of their symptoms, the following brands of infant formula: Pepti Junior by Picot (19 infants), Picot SL (1 infant), Picot Riz (1 infant), or Milumel Bio 1 without palm oil (2 infants); these four formulas are manufactured at the same production site. One mother reported exclusive breastfeeding.

Geographic distribution of the 27 infants with Salmonella Agona serotype salmonellosis, August–December 2017

Preliminary results of the investigation strongly suggested that Picot’s Pepti Junior, Picot SL, and Milumel Bio 1 palm oil-free formulas, all produced at the same site, were the source of these Salmonella Agona infections.

On December 2, 2017, the manufacturing facility, in coordination with the DGCCRF and the DGS, proceeded with the withdrawal and recall of the affected products (12 batches).

On December 8, a case of Salmonella Agona infection was identified in an infant who had consumed milk produced at the same site but not included in the December 2 withdrawal and recall.

On December 10, 2017, the Minister of the Economy and Finance decided to extend the suspension of sales and exports to more than 600 batches of infant formula produced at this site. The list of affected product codes is available on the website of the Ministry of Solidarity and Health: http://solidarites-sante.gouv.fr/IMG/pdf/liste_des_references_lns_concernees_par_le_retrait-rappel.pdf

The DGS has set up a toll-free number—0800 636 636 (open from 9:00 AM to 8:00 PM). This call center is designed to answer parents’ questions and provide appropriate health recommendations.

The manufacturer has also made a toll-free number available to parents—0 800 120 120 (open from 9:00 AM to 8:00 PM). This hotline is designed to answer parents’ questions about the recalled products.

Parents currently using a box of infant formula affected by this recall must switch to a different formula immediately. The French Society of Pediatrics has issued recommendations for possible substitutes, available on the website of the Ministry of Solidarity and Health. These recommendations have also been shared with general practitioners, pediatricians, midwives, and pharmacists.

Hygiene measures to follow

Santé publique France reiterates the hygiene guidelines to follow when preparing baby bottles:

• Hands must be washed thoroughly with soap and water before handling the formula;

• bottles should not be prepared in advance;

• bottles must be cleaned immediately after use.

Reminders about the disease

Salmonella infections occur within 3 days of ingestion and cause symptoms of gastroenteritis, including vomiting, diarrhea (which may be bloody), and fever in most cases. If these symptoms appear in an infant, families should consult a doctor.

Salmonella Agona is one of approximately 2,000 Salmonella serotypes that are pathogenic to humans. From 2012 to 2016, the CNR for Salmonella identified approximately 65 strains of Salmonella Agona per year. Like most other Salmonella serotypes, Salmonella Agona is found in France in various animal reservoirs, including poultry, cattle, pigs, and animal feed.

Several outbreaks of Salmonella Agona-associated salmonellosis have been reported in the past, notably an outbreak attributed to the consumption of powdered milk by infants in France in 2005, an outbreak among infants in Germany attributed to the consumption of fennel and anise herbal teas², and outbreaks attributed to the consumption of peanut snacks³ or oat-based cereals⁴.

^References1Brouard C, Espie E, Weill FX, Brisabois A, Kerouanton A, Michard J, Hulaud D, Forgues AM, Vaillant V, de Valk H. Outbreak of Salmonella enterica serotype Agona salmonellosis linked to the consumption of infant formula, France, January–May 2005. Bull Epidemiol Hebd 2006;(33):248-50. ²Koch J, Schrauder A, Werber D, Alpers K, Rabsch W, Prager R, Broll S, Frank C, Roggentin P, Tschäpe H, Ammon A, and Stark K. A nationwide outbreak of Salmonella Agona in infants due to aniseed in herbal tea, Germany, October 2002–July 2003. 5th World Congress, Foodborne Infections and Intoxications, June 7–11, 2004, Berlin, Germany.³Killalea D, Ward LR, Roberts D, et al. International epidemiological and microbiological study of an outbreak of Salmonella Agona infection from a ready-to-eat savory snack—I: England and Wales and the United States. BMJ 1996;311-13.⁴From the Centers for Disease Control and Prevention. Multistate outbreak of Salmonella serotype Agona infections linked to toasted oats cereal—United States, April–May, 1998. JAMA. 1998 Aug 5;280(5):411