Dietary supplements for babies are “neither useful nor recommended” before weaning, and their use is advised against between 1 and 3 years of age outside medical supervision. That is the conclusion of an opinion from Anses (the French food safety agency) dated 31 July 2024, issued at the request of the French Ministry of Agriculture. It forms part of the revision of the decree governing which vitamins and minerals are permitted in these products. The agency bases its view on two findings: dietary intakes that are already high in toddlers, and 165 reports of adverse effects recorded since 2012, including 7 severe cases in children under 3.
Why did Anses issue an opinion on dietary supplements for babies?
In France, the vitamins and minerals that may be used in dietary supplements, and their maximum daily doses, are set by a decree of 9 May 2006. The text had never been revised, apart from the annulment of certain doses by the Conseil d’État (France’s highest administrative court) in 2011. On 25 September 2023, the Direction générale de l’alimentation (the French directorate-general for food) referred a draft update to Anses. The referral raised three questions. Revise the maximum doses. Examine “the relevance of prohibiting the consumption of dietary supplements by children under 3”. Define the warnings to appear on labelling.
The assessment was carried out by the specialised expert committee on “Human Nutrition”, which adopted its conclusions on 5 July 2024. The opinion was signed by the director general on 31 July 2024.
What the opinion says for babies under one year
For breastfed or formula-fed babies who have not yet started weaning, the agency is unequivocal. It points out that European Regulation 2016/127 defines infant formula as a food that “by itself satisfies the nutritional requirements” until complementary feeding is introduced. It concludes that, “outside medical supervision specifically intended for this population, the consumption of dietary supplements is neither useful nor recommended”.
This position does not cover vitamin D prescribed by the doctor, nor vitamin K given at birth: these are medicines with a controlled dosage, not dietary supplements. Anses had in fact warned about poisonings linked to highly concentrated vitamin D supplements, which we cover in detail in our article on vitamin D in infants and the risk of overdose. The distinction between a medicine and a dietary supplement is at the heart of the matter.
What the opinion says for children aged 1 to 3
For young children, from the start of weaning, the regulations are less precise. The agency nevertheless takes a clear stance: “except in specific cases requiring medical care, there is no reason to give dietary supplements to this population on nutritional pretexts”. It supports the wording proposed by the ministry for the future decree. “Vitamin and mineral supplementation of infants (0-1 year) and young children (1-3 years) must be subject to medical supervision.” This restriction will have to appear on the label of any supplement containing nutrients, unless the product clearly excludes this age group.
The opinion goes further on a point of method. The draft decree provided for a category of “children under 10”. The committee considers that it “should de facto exclude 0-3 year-olds”. In other words, doses designed for an 8-year-old should not be used as a reference for an 18-month-old.
Intakes already above safety limits in 1-3 year-olds
The central argument lies in the consumption data. Using the Inca 3 study (France’s national food consumption survey), Anses calculated the proportion of children whose usual dietary intake already exceeds the upper safety limit, before any supplement. In 1-3 year-olds, this proportion is high for several minerals.
- Selenium: exceeded in 44.2% of boys and 24.5% of girls.
- Zinc: 37.2% of boys, 23.6% of girls.
- Iron: 29.7% of boys, 13% of girls.
- Copper: 23.8% of boys, 11.8% of girls.
- Sodium: 63.5% of boys, 50.7% of girls.
- Vitamin A: 4.6% of children aged 1 to 3.
The committee concludes that “the consumption of dietary supplements containing the nutrients mentioned above may pose health risks” and “advises against the use of these products for this target population”. Iron illustrates the reasoning well: iron supplementation is a matter for prescription, because a deficiency can be screened for and treated, and an excess comes at a cost. Our article on iron deficiency in infants covers both sides.
Nutrivigilance reports
Since 2012, the Anses nutrivigilance scheme has recorded 165 cases of adverse effects with “at least possible causality” linked to vitamin and mineral supplements. Of these, 15 were of severity level 3, meaning serious, with or without a threat to life. Seven of those 15 cases involved children under 3. Set against a population that is not supposed to be taking these products at all, this figure is the signal that weighed in the decision.
For context, the opinion also notes that 14% of 3-17 year-olds were taking dietary supplements in the Inca 3 study. It gives no figure for under-3s, whose numbers in the study are too small for an analysis by sex.
Fluoride, boron, silicon: what the agency rules out
Three substances are explicitly excluded. Fluoride “must not be added to dietary supplements”, because exposure is already hard to control given the variability of tap water and mineral waters. Boron and silicon, which are not essential nutrients, “should not be included” as there is no nutritional reference value. For parents, this means that a product marketed for a toddler’s “bones” or “teeth” has no basis in this opinion.
What to do if you are offered a supplement for your child?
The opinion’s answer fits in one line: medical supervision. In practice, this means the question is one for the doctor or the PMI (France’s mother and child health service), with a specific reason, not for the shop shelf. Three situations come up often.
- “He hardly eats any meat.” Iron is something to discuss with the doctor, who can prescribe a blood test before any treatment.
- “He no longer drinks formula.” Switching to cow’s milk or growing-up milk after age 1 has its own guidelines, which we summarise in our article on growing-up milk. A supplement is not one of them.
- “He’s tired and often has colds.” Multivitamins “for immunity” have no place before age 3 according to the opinion. Repeated colds in a child at nursery are to be expected; if in doubt, it calls for an appointment, not a course of supplements.
The same logic applies to supplements sold to breastfeeding mothers, one example of which Anses re-examined in 2025; we discuss it in our article on fenugreek and breastfeeding.
What the opinion does not change
A child’s nutritional needs from 6 months to 3 years are met through food. The weaning guidelines, updated by Anses, remain the reference; our article on weaning according to Anses sums them up. Learning independence at the table, as described in our article on babies feeding themselves with a spoon, does more for a varied plate than a bottle of capsules.
One last safety point. Adult dietary supplements, often colourful and sweet, are among the products toddlers swallow by accident. Data from poison control centres are summarised in our article on accidental poisoning in children. Store them up high, just like medicines.
Where does the decree stand?
The opinion concerns a draft text. At the time of writing, we found no trace of the revised decree being published in the Journal officiel (France’s official gazette). Until it is published, the statement “medical supervision before age 3” is not mandatory on labels. The Anses recommendation, however, already applies today to the thinking of parents and professionals.
Key takeaways
- Before weaning, dietary supplements are “neither useful nor recommended” without medical supervision.
- From 1 to 3 years, Anses advises against them: dietary intakes already exceed safety limits for several minerals in a significant share of children.
- 165 nutrivigilance reports since 2012, including 7 severe cases in under-3s.
- Prescribed vitamin D and vitamin K remain medicines, outside the scope of this opinion.
Sources
- Anses, “Avis relatif à la mise à jour de l'arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires”, referral no. 2023-SA-0165, 31 July 2024. Conclusions of the CES Nutrition humaine (expert committee) adopted on 5 July 2024.
- Commission Delegated Regulation (EU) 2016/127 of 25 September 2015, infant formula and follow-on formula, cited in the opinion.
- Arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires, cited in the opinion.
