{"id":22968,"date":"2026-03-02T12:54:10","date_gmt":"2026-03-02T12:54:10","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/22968\/"},"modified":"2026-03-02T12:54:10","modified_gmt":"2026-03-02T12:54:10","slug":"another-major-infant-formula-recall-reignites-concerns","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/22968\/","title":{"rendered":"Another major infant-formula recall reignites concerns"},"content":{"rendered":"

\"\"\/<\/p>\n

Credit: Olha Romaniuk\/iStock\/Getty Images Plus via Getty Images<\/p>\n

Following product recalls that started in Europe in December and then spread to more than 60 countries, the infant-formula industry is again under scrutiny \u2013 and the sector insists it is increasing its safety efforts.<\/p>\n

\u201cThe health of infants and food safety and quality of products remain our sector\u2019s highest priorities,\u201d Beat Sp\u00e4th, the secretary general of Brussels-based trade association Specialised Nutrition Europe (SNE), tells Just Food.<\/p>\n

\"\"\/ Discover B2B Marketing That Performs <\/p>\n

\n\t\t\t\t\t\tCombine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.\n\t\t\t\t\t<\/p>\n


\n\t\t\t\t\t\t\tFind out more <\/a><\/p>\n

An initial European recall was kicked off in December by Nestl\u00e9 following the detection of the cereulide toxin in batches of its infant formula. The recall was then expanded globally by the Swiss group in January, when French peers Lactalis and Danone also pulled products, along with some smaller manufacturers.<\/p>\n

Sp\u00e4th underlines what the manufacturers have said was the root cause of the recall \u2013 a contaminated ingredient. He says arachidonic acid (ARA) from a supplier in China caused the contamination, as\u202fcereulide, a heat-resistant toxin produced by bacillus cereus strains, was detected in batches of ARA oil used by infant-formula manufacturers.<\/p>\n

Six EU countries \u2013 Austria, Belgium, Denmark, France, Luxembourg\u202fand Spain \u2013 and the UK have reported infants with gastrointestinal symptoms after consuming infant formula.<\/p>\n

Sp\u00e4th says\u202fcereulide\u202fis \u201cvery uncommon\u201d in ARA oil. \u201cThe only effective way to eliminate the risk is to prevent its formation in the first place,\u201d he says.<\/p>\n

\"InfantInfant formula brands on display in Paris, France, on 10 February 2026 next to a product recall notice for batches of Guigoz products. Guigoz is a Nestl\u00e9 brand. Credit: Riccardo Milani\/Hans Lucas\/AFP via Getty Images<\/p>\n

Consumer confidence dented \u2013 again<\/p>\n

The affair has again hit confidence in infant-formula and its supply chains. The industry has been rocked a number of times in the last decade or more, from the melamine scandal in China of the late 2000s to the 2022 product recall in the US that caused nationwide shortages of formula.<\/p>\n

In recent months in the US, the country\u2019s Food and Drug Administration has suggested a multi-state outbreak of infant botulism\u00a0could be linked to a supplier to formula business ByHeart<\/a>. In November, ByHeart recalled all\u202f<\/a> its infant formula products, including all cans and single-serve \u201canywhere pack\u201d sticks, nationwide.<\/p>\n

As recently as last month, the FDA stressed it continued to receive reports that the recalled\u202fformula was\u202fbeing found on shelves, although it said no new cases of botulism had been added to the investigation since 10 December. The regulator declared the outbreak over on 26 February but its probe continues<\/a>.<\/p>\n

The spotlight, then, is firmly on the infant-formula sector once more on both sides of the Atlantic. However, the recall sparked by\u00a0Nestl\u00e9 has grabbed mainstream headlines and put the world\u2019s largest food manufacturer firmly in the spotlight.<\/p>\n

At the end of January, Nestl\u00e9\u202facknowledged it had detected \u201cvery low levels\u201d of cereulide in formula samples at the end of November \u2013 ten days before informing local authorities. The company confirmed it found the toxin in samples at its Dutch factory \u201cat the end of November\u201d.<\/p>\n

Nestl\u00e9 said at the end of November it had sent the contaminated samples for \u201cfurther, in-depth laboratory analysis\u201d.<\/p>\n

The results, which \u201cconfirmed the presence of trace amounts of cereulide\u201d, were received by Nestl\u00e9 \u201cat the beginning of December\u201d and the company \u201cdecided to recall all products manufactured since the new equipment installation in our factory in the Netherlands\u201d.<\/p>\n

Nestl\u00e9 said it informed the Dutch authorities and \u201call potentially impacted countries\u201d, as well as the European Commission, on 10 December to share its analysis.<\/p>\n

On the same day, the company said it started a \u201ca voluntary and precautionary public recall\u201d of all 25 batches that had been produced across 16 countries in Europe.<\/p>\n

The discovery of cereulide in an oil-based ingredient was unprecedented<\/p>\n

A Nestl\u00e9 spokesperson<\/p>\n

By Christmas Eve, the group said it had confirmation the contamination came from \u201can oil blend used to produce infant formula in several of our factories\u201d.<\/p>\n

Nestl\u00e9 said it stopped using the blend immediately and told its supplier \u2013 which the company has not publicly named \u2013 on 29 December once it had laboratory confirmation the oil was contaminated. Trade associations were informed a day later. The wider voluntary recall started on 5 January.<\/p>\n

\u201cThe discovery of\u202fcereulide\u202fin an oil-based ingredient was unprecedented,\u201d a Nestl\u00e9 spokesperson says, as, while the toxin bacillus cereus is known, it is typically associated with rice and cereals, with scientific literature containing no record of\u202fcereulide\u202fin oils, making it \u201ca blind spot\u201d for the industry.<\/p>\n

Nonetheless, the spokesperson says Nestl\u00e9\u2019s food safety control systems \u201cdetected the toxin, halted production, notified authorities and initiated product recalls\u201d.\u202fThere are lessons to be learned \u201cabout new and unknown risks\u201d, the spokesperson\u202fadds, which could\u202femerge\u202ffrom environmental change,\u202fnew technologies, \u201cor in the case of\u202fcereulide, from risks associated with a fermentation process that ended up being imperfectly understood\u201d.<\/p>\n

Nestl\u00e9 says it is using\u202fmodern technologies and AI to stay alert to new and emerging hazards, while reviewing risks. Auditors are being trained, experts brought in and checklists created for new manufacturing processes such as the extraction of fermented oils, the spokesperson explains.\u202f<\/p>\n

They add: \u201cBecause the company quickly shared its findings with industry and the authorities, Europe now has established regulations for\u202fcereulide.\u201d<\/p>\n

\"ACredit: Richard Juilliart\/Shutterstock.com<\/p>\n

Following a \u201crapid risk assessment\u201d after a request from the European Commission, on 2 February the European Food Safety Authority set a threshold for cereulide at the same level laid down by France a week earlier of 0.014 micrograms per kg of body mass.<\/p>\n

EFSA also provided guidance on consumption levels that could risk the exceedance of the newly defined\u00a0\u2018acute reference dose\u2019\u00a0based on reconstituted infant formula. It said 0.054 micrograms per litre or infant formula and 0.1 micrograms per litre for follow-on formula \u201cmay lead to safe levels being exceeded\u201d.<\/p>\n

While the levels are not legally binding, they support risk management decisions across the EU, notably to see when products should be withdrawn from the market, Sp\u00e4th says.<\/p>\n

A spokesperson for the European Commission says Brussels has\u202fadvised\u202fnational regulators on new threshold concentrations based on EFSA\u2019s assessment.<\/p>\n

\u201cWe have been coordinating member states\u2019 work to recall contaminated products since mid-December 2025. Our Rapid Alert System for Food and Feed has played\u202fan important role\u202fin sharing information swiftly between member states so that they could take the\u202fappropriate action,\u201d the spokesperson says, stressing the \u201cresponsibility of the food operators, as well as member states, in making sure that safe products are put on the shelves and to swiftly remove potentially contaminated products\u201d.\u202f<\/p>\n

A Commission official says \u201ca vast array of contaminants can potentially (and unintentionally) enter the food chain\u201d, adding: \u201cFor this reason, it is not possible for the Commission to set safety levels for\u202feach and every\u202fcontaminant that exists. By default, the contaminant should not be in the food and this includes the case of the infant formula.\u201d<\/p>\n

On 19 February, in a joint statement with the European Centre for Disease Prevention and Control (ECDC), EFSA said they had determined the likelihood of exposure to baby formula contaminated with the cereulide toxin to be \u201clow\u201d given the recalls conducted across the bloc. A day later, EU member states endorsed emergency controls on imports from China of ARA<\/a>.<\/p>\n

\u201cThe contamination was unforeseeable and the distress caused to families and caregivers deeply regrettable. But\u202fimportant changes\u202fhave been and are being made and infant formula is now safer as a result,\u201d the Nestl\u00e9 spokesperson says.<\/p>\n

\u201cThe crisis drove home the need for more robust systems to detect new unknown threats. Nestle\u2019s R&D teams \u2026 understand too that unknown risks need more explicit, structured attention and better horizon scanning and AI tools may help in this regard.\u201d<\/p>\n

Nestl\u00e9, which said last month the impact from the recalls on its first-quarter sales will be around SFr200m (US$258.1m), is mapping all oil ingredients derived from fermentation and other non-traditional methods, reassessing the production and other risks for each ingredient, with priority given\u202fto\u202finfant-food inputs.\u202f<\/p>\n

The company is rethinking how it audits suppliers, is sourcing ARA oil from alternative sources \u2013 cutting ties with the Chinese business at the centre of the recall \u2013 and continuing to test all oil ingredient batches for\u202fcereulide.<\/p>\n

Danone, meanwhile, has increased testing, including adding ingredient controls and checking ARA oil for\u202fcereulide. To\u202fcomply with\u202fthe latest EFSA guidance, Danone has added to its recalls with the withdrawal of \u201ca very limited number of specific batches of infant formula products\u201d, including Aptamil\u202f in Europe and the Middle East.<\/p>\n

\u201cWe are confident in the safety and quality of our products, which are supported by extensive scientific evidence and rigorous testing. In the light of recent events, we went back to review the level of consumer complaints over the period in question and we didn\u2019t find any cause for concern,\u201d Danone CEO Antoine de Saint-Affrique told analysts last month.<\/p>\n

\u201cHowever, in the context of the ongoing evolution of authorities\u2019 requirements, we are working closely with those national food safety authorities and are taking action to comply with their new requirements. We have been recalling from relevant markets, essentially in Europe and now in the Middle East, batches of infant formula products. While doing this, our focus is on supporting parents and healthcare professionals, providing clear information, and helping to restore trust, as their trust makes all the difference.\u201d<\/p>\n

The company estimates the supply disruption will have a one-off impact worth 0.5-1% of its net sales in the first quarter. Taking Danone\u2019s sales of \u20ac6.84bn ($8.06bn) in the first quarter of 2025 as a yardstick, that would equate to around \u20ac68.4m. Danone\u2019s specialised nutrition division, which houses the infant-formula business, generated \u20ac2.31bn in those three months.<\/p>\n

\"DanoneDanone headquarters building in Rueil-Malmaison, France, 13 August 2023. Credit: HJBC\/Shutterstock.com<\/p>\n

At SNE, Sp\u00e4th says some elements of infant-formula manufacturers\u2019 supply chains may appear similar but each operates its own independent sourcing and quality control systems.<\/p>\n

Moreover, only a few suppliers, he adds, can provide ingredients \u201cwhich fulfil the very stringent safety requirements for food for infant and young children\u201d.<\/p>\n

Sp\u00e4th\u202finsists food safety is the industry\u2019s \u201cnon-negotiable top priority\u201d and it supports \u201ccontinued scientific clarification and regulatory consistency, including greater\u202fharmonisation\u202fof analytical methods for substances like\u202fcereulide\u201d.<\/p>\n

He adds: \u201cA clear, science-based and\u202fharmonised\u202fEU approach will help ensure consistent risk assessment, effective enforcement and continued high levels of consumer protection, particularly for vulnerable groups such as infants.\u201d<\/p>\n

Canadian food policy professor\u202fDr Sylvain Charlebois, scientific director of the Agri-Food Analytics Lab at Dalhousie University says infant formula is one of the most tightly regulated food categories, especially in the EU.<\/p>\n

The challenge is enforcement consistency and operational discipline, not necessarily a lack of rules<\/p>\n

Dr Sylvain Charlebois, Dalhousie University<\/p>\n

\u201cCompanies like Nestl\u00e9\u202fand Danone\u202foperate\u202funder strict microbiological standards. However, zero risk does not exist. Detection systems are now extremely sensitive and because infant formula has near-zero tolerance for pathogens, even small deviations trigger recalls. Most incidents are linked to process or environmental control issues rather than competitive pressure or innovation,\u201d he says.<\/p>\n

To reduce scares, Charlebois says \u201cthe priority should be rigorous plant-level monitoring, especially in dry facilities, combined with a strong compliance culture. Transparent and proportionate\u202fcommunication is also essential, as many \u2018health scares\u2019 are precautionary recalls functioning as intended. Better communication can prevent unnecessary public panic\u201d.<\/p>\n

According to Charlebois, adding more laws is not the answer. \u201cIn most advanced markets, the legal framework is already robust. The challenge is enforcement consistency and operational discipline, not necessarily a lack of rules. Strengthening oversight and coordination is likely to be more effective than simply adding more legislation.\u201d<\/p>\n

\"Email<\/p>\n

\n Sign up for our daily news round-up!
\n Give your business an edge with our leading industry insights.\n <\/p>\n","protected":false},"excerpt":{"rendered":"Credit: Olha Romaniuk\/iStock\/Getty Images Plus via Getty Images Following product recalls that started in Europe in December and…\n","protected":false},"author":2,"featured_media":22969,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[586,588,199],"class_list":{"0":"post-22968","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-nestle","8":"tag-danone","9":"tag-lactalis","10":"tag-nestle"},"share_on_mastodon":{"url":"","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/22968","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=22968"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/22968\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/22969"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=22968"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=22968"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=22968"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}