Navigating ingredient regulation: Key insights for maternal and infant health

Mothers and infants have unique nutritional needs and are more susceptible to potential health risks. The European Food Safety Authority (EFSA) therefore uses specific scientific criteria to address the requirements of these vulnerable groups, Luca Bucchini, Managing Director at Hylobates Consulting Srl told NutraIngredients. 

Health claim applications must clearly refer to these groups to establish efficacy. Yet, when applicants seek approval for novel foods, they often leave infants and pregnant women out of their applications. 

An additional complication is that ingredient regulations vary widely across EU Member States, which leads to differences in availability and safety for infants and pregnant women.

“Most ingredients in food supplements have been on the market since before 1997, so they do not undergo EFSA assessment - instead, they are regulated at the national level unless an EU procedure is initiated,” said Bucchini.

“As a result, melatonin is banned in food supplements in some Member States, especially for infants, while it is available for infants in countries like Italy.”

While EFSA scrutinizes health claims and applications, some claims meant for the general population are also applied to supplements for mothers and infants. 

While this may seem compliant, only health claims that specifically mention infants or mothers have been evaluated for these groups, explained Bucchini.

Labeling regulations for maternal and infant food supplements​

The main issue is about safety and appropriate label warnings on supplements for mothers, said Bucchini. 

“While a few label warnings like "should not be consumed by pregnant or lactating women” are set in EU law - for example, green tea catechins, monacolins, caffeine, and sterols - most warnings for mothers are set at the national level, or based on a company's risk assessment.”

He pointed out that this can cause problems, especially regarding claims. Some authorities believe that all food supplements should carry a warning against use by mothers unless the product is specifically designed for them.

And supplements for infants are even more complicated, according to Bucchini. 

“Member States such as France have indicated that they should not even exist, and any supplementation need of infants should be medicines, not supplements.”

However other EU Member States disagree about the rules on food additives in infant food supplements, as the regulation indicates that these additives are generally not allowed, but interpretations differ. 

A shared complexity between maternal and infant supplements is that the recommended intake of vitamins and minerals for infants and mothers differs from those of healthy adults. 

“However, EU law does not provide specific Nutrient Reference Values (NRVs) for these groups, making it challenging for companies to convey information and for consumers to grasp whether, for example, 15% NRV is a significant amount for an infant,” said Bucchini. 

Social media marketing challenges​

The rapid evolution of social media marketing is presenting significant challenges that require a more proactive and collaborative approach to enforcement, Bucchini said.

And while authorities are making efforts to pay more attention to claims in this category, their enforcement capabilities remain low, despite the increasing deployment of AI to monitor the internet. 

While enforcement largely falls to these authorities, some trade groups and consumer organizations also play crucial roles in reporting non-compliant advertising.

Collective efforts not only help to identify and report non-compliant advertising but also promote a culture of integrity and accountability in the advertising landscape.

To effectively navigate the challenges posed by social media marketing, enforcement agencies will need to adopt a more proactive approach, Bucchini noted.

What claims are allowed for maternal and infant food supplements?​

In the EU, claims regarding diseases are prohibited on food supplements, and health claims must receive prior approval.

Several specific health claims are authorized for food supplements aimed at maternal and infant health: 

• α-linolenic acid (ALA) & linoleic acid (LA): Essential fatty acids are needed for normal growth and development of children. 

• Calcium: Needed for normal growth and development of bone in children. 

• Calcium and vitamin D: Needed for normal growth and development of bone in children. 

• Iodine: Contributes to the normal growth of children.

• Iron: Contributes to the normal cognitive development of children. 

• Phosphorus: Needed for the normal growth and development of bone in children. 

• Protein: Needed for normal growth and development of bone in children. 

• Vitamin D: Needed for normal growth and development of bone in children.

• Vitamin D: Contributes to the normal function of the immune system in children.

• Docosahexaenoic acid (DHA): Contributes to the normal visual development of infants up to 12 months of age.

• Docosahexaenoic acid (DHA): Maternal intake contributes to the normal development of the eye of the fetus and breastfed infants. 

• Docosahexaenoic acid (DHA): Maternal intake contributes to the normal brain development of the fetus and breastfed infants.

• Folate: Contributes to maternal tissue growth during pregnancy. 

• Folic Acid: Supplemental folic acid intake increases maternal folate status. Low maternal folate status is a risk factor in the development of neural tube defects in the developing fetus.