Spain Tightens Rules on Infant Formula Advertising

The Ministry of Health and the Ministry of Social Rights, Consumer Affairs, and the 2030 Agenda have submitted a draft Royal Decree for legislative consideration that regulates the promotion, advertising, and information regarding infant formula, follow-on formula, milk-based beverages, and other similar products intended for young children, as well as cereal-based foods and infant and young child foods (hereinafter, the "Draft"). The main purpose of the proposal is to protect breastfeeding and ensure that decisions regarding infant feeding are made based on objective, accurate information grounded in scientific evidence, free from influences stemming from commercial practices.

Background

The Draft is based on the premise that certain marketing practices can influence the decisions of mothers, fathers, and caregivers, especially in healthcare and digital settings. In this context, the regulation is part of the effort to advance compliance with the World Health Organization’s International Code of Marketing of Breast-milk Substitutes (hereinafter, the "Code"), whose implementation in Spain was rated at only 32 out of a possible 100 points in the organization’s 2026 monitoring report[1]. It also responds to a priority recommendation made to Spain in 2026 by the United Nations Committee on the Rights of the Child.

Until now, the relevant national regulation was Royal Decree 867/2008, dated May 23, which approves the specific technical and health regulations for infant formula and follow-on formula, supplemented by Regulation (EU) No. 609/2013 and its Delegated Regulation (EU) 2016/127, which regulate the composition, labeling, and certain aspects of the advertising and marketing of these products at the European level.

However, this framework did not fully incorporate the Code’s recommendations, particularly regarding promotion in healthcare facilities and services and relations with healthcare professionals and institutions, nor did it extend certain restrictions to other related products, such as baby bottles and teats, or to follow-on formulas or “growth milks” intended for children aged one to three years. Nor did it expressly regulate cross-promotion or indirect promotion, nor new forms of digital marketing and promotion, such as baby clubs, social media groups, or mobile apps.

The Draft substantially tightens this previous framework on several fronts: it extends its scope to milk-based beverages and other similar products intended for young children, a category that until now has not been subject to specific advertising restrictions; it introduces, for the first time, explicit prohibitions on cross-promotion, indirect promotion, and promotion in digital environments and baby clubs; it significantly strengthens the restrictions applicable to healthcare facilities and pharmacies; and it incorporates, also for the first time, explicit limits on relationships between manufacturers and distributors and individual healthcare professionals.

Key Measures

The Draft is structured around three main pillars: information, training, and counseling; advertising and promotion; and measures for healthcare facilities and pharmacies. Among the most significant measures are:

• Detailed requirements are imposed on the content of informational and educational materials aimed at both families and healthcare professionals, which must be based on scientific evidence and include, among other things, information on the benefits of breastfeeding, risks associated with the incorrect use of formula, the importance of not introducing complementary feeding before six months of age, and a prohibition on including manufacturers’ brand names or logos in such materials.
• A total ban on the advertising of infant formula in all media and formats, as well as on nutritional claims or health claims regarding such products.
• Specific restrictions on the advertising and promotion of follow-on formulas, which may not be presented as substitutes for general food, nor include images that idealize their use (for example, using terms such as “humanized” or “maternized”), incorporate testimonials from healthcare professionals or scientists, nor refer to their use in healthcare facilities or pharmacies.
• Prohibition on cross-promotion or indirect promotion through colors, designs, slogans, or mascots similar to those of regulated products, as well as their promotion in baby clubs, social media groups, mobile apps, or helplines.
• Restrictions in the healthcare setting: Healthcare facilities and pharmacies may not accept free or nominal-price supplies, sales incentives, or any type of sponsorship or gift from manufacturers and distributors; nor may advertising or promotional displays of these products be conducted in such establishments.
• Brand neutrality in clinical administration: Products used in healthcare facilities must be administered without the brand being visible, and discharge reports to families must refer to the type of formula, avoiding the mention of brand names.
• Restrictions on relationships with healthcare professionals, who may not accept gifts, samples, sponsorships, or benefits of any kind from manufacturers or distributors of these products.

Penalty System

Failure to comply with the established prohibitions and restrictions will be classified as a minor, serious, or very serious violation in accordance with Law 17/2011 of July 5 on food safety and nutrition.

Conclusion

The Draft represents a significant tightening of the framework governing information, advertising, and promotion of breast-milk substitutes and related products, with particular implications for the healthcare setting and for digital marketing and cross-promotion practices. Industry operators will need to review their commercial communication strategies, their policies regarding relationships with healthcare facilities and professionals, and their presence on digital channels, in light of the new prohibitions and restrictions that will ultimately be approved following the public hearing and consultation process.

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