25 countries issue alerts and withdrawals of contaminated rice-based formulas and baby foods

Powdered infant formulas are NOT sterile products

Risks for infants and young children: 32 babies in France, Belgium and Luxembourg fell ill with Salmonellosis, a serious infection caused by harmful bacteria. The infants, aged between 2 and 18 months, were all fed specialty formulas in powder form made with rice protein; among them were products contaminated by Salmonella enterica serotype Poona. Food Safety News summarised the stage the outbreak had reached by 21st February 2019.

Rise in number of babies affected: Seven babies from five different regions of France were hospitalized between the end of August 2018 and 10th January 2019. All presented symptoms of the same type of food poisoning, causing fever and bloody diarrhoea. All had consumed the Modilac Expert Riz range of rice-based products for children diagnosed with allergy to milk protein. There were five further confirmed cases in France plus one in Belgium and one in Luxembourg. By 12th March 2019, the total had risen to a total of 32 confirmed cases in France in infants and young children aged up to 2 years, as reported in the 12th March Salmonella Poona multi-country outbreak media release by EFSA.

Products implicated: These rice-based formulas and desserts were manufactured in Spain by a Spanish company owned by Laboratorios Ordesa S.A. for the French companies called Sodilac and Lactalis. Lactalis withdrew, as a precaution, 16,300 boxes of their Picot Riz brand, while Sodilac marketed 400,000 boxes of their Modilac Expert brand. These potentially contaminated products were sold in France, Belgium and Luxembourg.  The same products were distributed in 22 more countries by the French company Sodilac and via E-commerce (Amazon.) In the Arab World the products were marketed under the brand names Blemil 1 and Blemil 2.

Cross-border health risk: The sale and distribution of incriminated products created a cross-border health risk in the European Union and European Free Trade countries – as well as world-wide.  An INFOSAN alert was issued in non-European countries to which incriminated products were exported via e-commerce.  All the 25 countries are listed in the EU Commission Rapid Alert System Food Portal : Andorra, Denmark, Ecuador, Germany, Italy, Libya, Mexico, Monaco, Morocco, The Netherlands, Norway, Peru, Portugal, Romania, Saudi Arabia, Spain, Switzerland, Syria, Tunisia, United Arab Emirates, United Kingdom, Vietnam, plus Belgium, France and Luxembourg.

In Italy, the Ministry of Health  issued an alert on 4th February and confirmed that the e-commerce is Amazon, which had asked buyers to return the products. The Ministry of Health in France issued an official government alert on 24th January 2019 and listed the full range of products. This range includes Modilac Expert Rice, premier âge (infant formula) and deuxième âge (6-12 months), both in versions Anti-reflux (AR), Hypoallergenic (HA), Prema, Transit+, Sans Lactose (SL), plus Pre modilac Expert. Products for older babies include ‘My first milk-free dessert’ in 4 flavours cocoa, caramel, banana and vanilla and Modilac Expert Growing-up Rice. The fact that the brand is named ‘Modilac Expert’ is surely ironical.

Risk for charitable organizations: Modilac infant formulas and follow-up formulas are manufactured for distribution by charitable organizations. There is no information about these recipient organizations.

Questions of utmost concern :

Why did it take so long – almost 6 months to make the connection between the contaminated rice-based products and the cases of Salmonellosis food poisoning in infants and young children? The above-cited EFSA media release explains “Salmonella is typically difficult to detect in dried products and requires sampling and testing methods with a high degree of sensitivity.”

Why is Salmonella contamination such a risk for young children?

In the above-cited Food Safety News article, Dr. Peter ben Embarek, INFOSAN Manager in WHO’s Department of Food Safety, explains : “Babies are more susceptible and they only consume this (product), it is 100 percent of their diets so they get continuous exposure to it several times a day and that has a much stronger effect then if they were just eating one contaminated apple or whatever an adult would do as part of their diverse diets.”

“There could be more cases as it is a product with a long shelf life and there might still be cans in people’s homes but the recall should have a positive effect by making sure we don’t have a sharp rise in the number of cases.”

How do these products become contaminated by harmful strains of Salmonella bacteria?

Powdered infant and young child formulas, whether based on cow’s milk or rice protein, are highly processed products which go through many production steps in machinery that can become contaminated by bacteria which can multiply in the hot and wet factory environment. Powdered formulas do not undergo a final sterilisation step; they are thus not sterile products and can become contaminated. As Dr. Ben Embarek explains in Food Safety News “A strain is establishing itself in a factory and it stays there for a long time, in that case several years, and creates different outbreaks over time and probably also some sporadic cases in between, as was the case with Lactalis last year.”  In 2018, 12 million boxes of Lactalis formulas were withdrawn in 83 countries worldwide. The Italian Ministry of Health cited above reports that the drying tower number 2 in the Spanish factory which processed the incriminated rice-based products was closed on January 21st 2019. This is similar to the Lactalis scandal of contaminated milk formula which affected 83 countries worldwide in 2018. In the Lactalis factory it was the drying tower number two which was identified as the source of the contamination.

Why do so many babies require rice infant feeding products?

All the incriminated products are intended for allergic infants and use rice-based protein. In its December 2018 issue, the British Medical Journal links the increase in allergies to milk proteins with over-prescribing by doctors and intensive promotion by the industry  “Overdiagnosis and industry influence :  How cow’s milk protein allergy is extending the reach of infant formula manufacturers”  . “Allergy to cow’s milk protein may be acting as Trojan horse for the $50 billion global formula industry to forge relationships with healthcare professionals in the UK and around the world … Between 2006 and 2016, prescriptions of specialist formula milks for infants with cow’s milk protein allergy increased by nearly 500% … to over 600,000 a year. “

Why does Modilac continue to advertise online?

Modilac laboratories still has adverts on its website for allergic infants. The 22nd March European Union RASSF Consumers Notification Portal cited the Modilac contamination on the very last page – and sent the reader straight to the Modilac website for images of products.  This was a commercial opportunity for the manfacturer to present their products, which are an increasing and lucrative source of revenue for the baby milk companies that manufacture and distribute them. One example is Picot Riz, an expensive formula costing Euros 29,50 for one tin of 800 g.

What is the role of e-commerce?

The Amazon website continues to advertise the range of Modilac products but this does not appear to include rice-based ones. There is no warning on the Amazon site about the risks of using the Modilac Expert Rice range.

Steps of utmost importance for infant health and safety

All labels of powdered formulas must include texts to warn that these are not sterile products. Whether they are milk-based, rice-based or soy-based, these formulas for infants and young children can become contaminated in the factory environment by harmful bacteria. These bacteria can thrive and multiply to levels that harm infant health when warm water is added to the powder. Powdered follow-up formula and cereals for infants and young children may also be contaminated, as shown by the Lactalis and Modilac withdrawals.

In 2007, the World Health Organization issued new safety advice “Powdered infant formula is not sterile. It may contain bacteria that can cause serious illness in infants. By preparing and storing powdered infant formula correctly, you can reduce the risk of illness.”  The decontamination step advised by WHO to prepare formula correctly aims to inactive harmful bacteria by first boiling the water, then cooling it to no less than 70°C before mixing the powder. The prepared formula should be consumed rapidly and any unfinished formula must be discarded.

To date, very few manufacturers include the warning or labels or instructions for preparation to reduce the risk to infant health. The manufacturers and distributors must be held accountable for their failure to inform product users, parents, care-givers and health professionals.

[The most updated recall list (from 2014 to 2019) is available here]

References:

Food Safety News 21st February: https://www.foodsafetynews.com/2019/02/salmonella-infant-formula-illnesses-increase-strain-related-to-past-outbreak/

European Food Safety Authority, EFSA, media release 12th March 2019:  https://www.efsa.europa.eu/en/press/news/190312

European Union Rapid Alert System, RASSF, Consumers Portal:  https://webgate.ec.europa.eu/rasff-window/consumers/?event=notificationDetail&NOTIF_REFERENCE=2019.0224&country=FR

Italy: Ministry of Health ‘Avviso di sicurezza’, 25th January, updated 1st March 2019: http://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=3612

France : Ministry of Health, Direction générale de la santé, Rappel de produits : https://www.economie.gouv.fr/files/files/directions_services/dgccrf/presse/communique/2019/cp-rappel-produits-nutrition-infantile-modilac.pdf

IBFAN ICDC Baby Food Product Recall List and article on Lactalis: https://www.ibfan-icdc.org/ibfan-baby-food-product-recall-list-last-updated-in-april-2018/

IBFAN ICDC 2019 Baby Food Product Recall List including Modilac: https://www.ibfan-icdc.org/wp-content/uploads/Product-Recall-List-2014-2019.pdf

British Medical Journal, December 2018 “Overdiagnosis and industry influence: How cow’s milk protein allergy is extending the reach of infant formula manufacturers” : https://www.bmj.com/content/363/bmj.k5056

And full article available at : http://www.babymilkaction.org/wp-content/uploads/2018/12/bmj.k5056.full_.pdf

European Union RASSF Consumers Notification Portal for March 22nd, now updated for April 2019 and with notification of ‘foodborne outbreak suspected (Salmonella Poona) to be caused by rice milk formula from Spain’ no longer included: https://webgate.ec.europa.eu/rasff-window/consumers/?event=getListByCountry&country=FR

World Health Organization: How to Prepare Formula for Bottle-feeding at Home, 2007: https://www.who.int/foodsafety/document_centre/PIF_Bottle_en.pdf

Full technical Report by the European Food Safety Authority, EFSA, and the European Centre for Disease Control and Prevention, ECDC, of 12 March 2019:  Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula.

The article above is written by Alison Linnecar, Convenor, IBFAN global working group on chemical and microbiological contamination of infant feeding products.