What rules apply to marketing infant formula in the EU?

Placing infant formula and follow-on formula on the European Union market requires meticulous adherence to Commission Delegated Regulation (EU) 2016/127. This regulatory framework establishes exhaustive compositional requirements for energy and nutrients, mandates labeling language that unequivocally prioritizes the superiority of breastfeeding, and severely restricts advertising to scientific or specialized publications. Additionally, food business operators (FBOs) must comply with formal notification protocols to Member State authorities before a product is launched to ensure safety and legal alignment.

Compositional Compliance and Safety Standards

The nutritional integrity and safety of these products are governed by Article 2 and the exhaustive requirements in Annex I (Infant Formula) and Annex II (Follow-on Formula). These annexes define mandatory ranges for energy (60–70 kcal/100 ml), proteins, lipids, and vitamins. As a practitioner, it is imperative to note that all compositional limits and safety thresholds apply to the food ready for use after preparation according to the manufacturer’s instructions (Article 4(5)).

Regulatory Safety Checklist

The following prohibitions and limits represent the absolute safety floor for compliance:

• Prohibited Lipids: The use of sesame seed oil and cotton seed oil is strictly forbidden (Annex I, point 5.1).
• Pesticide Residue Limit: A general limit of 0.01 mg/kg per active substance applies (Article 4(2)).
• Zero-Tolerance Substances: For high-risk active substances listed in Annex V (e.g., Aldrin, Heptachlor, Terbufos), a more stringent detection limit of 0.003 mg/kg is enforced (Article 4(4)).
• Mandatory DHA: Inclusion of Docosahexaenoic acid (DHA) is mandatory per Annex I, point 5.6. However, be advised that the statement “contains Docosahexaenoic acid…” specified in Article 9(3) is a transitional provision and may only be used for products placed on the market before 22 February 2025.

Protein Hydrolysates Updates (M7 & M9)

Requirements for formulas manufactured from protein hydrolysates have been significantly expanded through recent amendments. These are categorized into “Protein-related requirements groups” (A–F):

• Groups A through D: Established under Regulation (EU) 2024/2684 (M7), defining specific protein sources, processing (such as enzymatic precipitation or trypsin preparation), and heat treatments.
• Groups E and F: Introduced by Regulation (EU) 2026/743 (M9), covering specific two-stage hydrolysis processes using serine endopeptidases (Group E) or mixtures of skimmed milk and whey protein concentrates (Group F).

Product Naming and Labeling Requirements

Naming is strictly contingent upon the protein source used (Article 5). To use the names “Infant milk” or “Follow-on milk” (Annex VI, Part B), the product must be manufactured entirely from cows’ or goats’ milk proteins. If other sources like soya protein isolates or protein hydrolysates are used, the product must be named “Infant formula” or “Follow-on formula” (Annex VI, Part A).

Mandatory Information and Prohibitions

Under Article 6, labels must be in a language easily understood by consumers and include:

• An “important notice” regarding the superiority of breastfeeding and a recommendation to use the product only on professional advice.
• Clear instructions for preparation, storage, and disposal, including a health hazard warning for improper use.
• Prohibited Terms: Terms such as “humanised,” “maternalised,” or “adapted” are explicitly banned (Article 6(6)).
• Visual Distinction: Labels must avoid any risk of confusion between infant and follow-on formula through distinct text, images, and colors.

The Nutrition Declaration

The nutrition declaration is mandatory regardless of packaging size (Article 7(4)). Under Article 7(1) and 7(6), practitioners must adhere to the following:

• Mandatory Nutrients: In addition to standard nutrients, infant formula declarations must include choline, inositol, and carnitine.
• Salt Exclusion: By derogation from Regulation (EU) 1169/2011, the amount of salt must not be included.
• Expression: Values must be expressed per 100 ml of the food ready for use.

Commercial and Promotional Restrictions

Marketing practices for infant formula are heavily restricted to protect breastfeeding (Article 10).

• Advertising: Restricted exclusively to publications specializing in baby care or scientific publications. Information must be scientific and factual. Note that Member States may further restrict or prohibit such advertising locally.
• Retail Prohibitions: There is a total ban on point-of-sale advertising, free samples, and promotional devices (coupons, premiums, or tie-in sales) at the retail level.
• Direct Promotion: FBOs are prohibited from providing free or low-priced products or gifts to the general public, pregnant women, or mothers.

Mandatory Notification Process

Compliance involves a mandatory administrative step before market entry (Article 12):

1. Infant Formula: FBOs must notify the competent authority of each Member State where the product is marketed by submitting a model of the label.
2. Follow-on Formula: Notification is only mandatory if the product is manufactured from protein hydrolysates or contains “other substances” not listed in Annex II. Member States may, however, provide exemptions for follow-on formula if an efficient monitoring system is in place.

Utilizing Regulatory Intelligence in AI Assistants

Regulatory affairs practitioners can significantly optimize compliance workflows by utilizing AI assistants. By uploading the consolidated version of Regulation (EU) 2016/127, a user can instantly cross-reference label drafts against the mandatory “important notice” language or verify that formulation values (e.g., Vitamin D or erucic acid levels) align with the precise limits in the Annexes. This ensures that technical updates, such as the new protein groups in M9, are immediately accounted for in product development.

Practitioner FAQ

Can I use photos of infants on my formula packaging?
No. Under Article 11(2), informational and educational materials shall not use pictures which may idealise the use of infant formula. Furthermore, Article 6(6) requires that the presentation avoid any risk of confusion between infant and follow-on formula, which limits the use of infant imagery that might suggest equivalence to breastfeeding.

Is a nutrition declaration mandatory for small packs?
Yes. Per Article 7(4), the nutrition declaration is mandatory for all infant and follow-on formula, regardless of the size of the packaging or container, meaning there is no “small pack” exemption.

Can I make a health claim on infant formula?
No. Article 8 explicitly prohibits the use of any nutrition or health claims on infant formula to ensure that marketing does not undermine breastfeeding.

What is the limit for lactose-free claims?
According to Article 9(2), “lactose free” may be used if the lactose content is not greater than 2.5 mg/100 kJ (10 mg/100 kcal). Unless the product is manufactured from soya protein isolates, this claim must be accompanied by the statement “not suitable for infants with galactosaemia.”

Do I need to notify the authorities for every country?
Yes. Article 12(1) requires that for infant formula, you must notify the competent authority of each individual Member State where the product is being marketed. For follow-on formula, notification is mandatory only for specific formulations (hydrolysates or “other substances”) unless a national exemption applies.