Food additives in foods for particular nutritional uses

Commission Regulation (EU) 2025/2058 of 14 October 2025 amending Annexes II and III and correcting Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards foods intended for particular nutritional uses

Update

The rules on foods intended for particular nutritional uses (infant formula, baby foods, foods for special medical purposes, meal replacements for weight loss) were replaced in 2013 by Regulation 609/2013.

Regulation 1333/2008 on food additives has now been updated to refer to Regulation 609/2013. This alignment requires changes to the names of some categories of foods, but these changes do not have an impact on the additives that may be used in foods for particular nutritional uses.

Impacted Products

Foods for particular nutritional uses

What is changing?

In 2013, Regulation 609/2013 replaced three laws on foods intended for particular nutritional uses (see Background). As a result, Regulation 1333/2008 on food additives – which covers all foods, including those for particular nutritional uses – included references to legislation that was no longer in force.

The European Union (EU) has updated the food additives rules to refer to Regulation 609/2013 and align the food categories for nutritional uses, including the following changes.

• Replace food category 13.1.4 (other foods for young children: milk-based products for young children other than foods mentioned in other subcategories of food category 13) with a new subcategory 01.10, “dairy products and analogues”.
• Remove the reference to “special formulae for infants” from food category 13.1.5 and subcategory 13.1.5.1.
• Create a new subcategory, 18.1, covering processed foods not covered by categories 18.2 and 18.3, excluding foods for infants and young children.
• Rename food category 13.3 (dietary foods for weight control diets intended to replace the total daily food intake or an individual meal) to cover only total diet replacement, and move foods for replacing one or two main meals to a new food subcategory, 18.2.
• Move foods suitable for people intolerant to gluten from food category 13.4 to a new subcategory, 18.3.
• Correct the E code for the food additive advantame (E 969) in food categories 13.2 and 13.3.

The revised tables for the above food categories can be found in Annex I of Regulation 2025/2058.

Timeline

This Regulation enters into force on 4 November 2025.

What are the major implications for exporting countries?

These changes are for legal consistency, and do not have any impact on trade.

Background

Regulation 609/2013 covers the following categories of foods intended for particular nutritional uses:

• infant formula and follow-on formula
• processed cereal-based food and baby food
• food for special medical purposes
• total diet replacement for weight control.

Regulation 609/2013 replaced three laws:

• Directive 2009/39/EC on foodstuffs intended for particular nutritional uses
• Commission Directive 2006/141/EC on infant formulae and follow-on formulae
• Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children.

Resources

Sources