,The European Commission has adopted Commission Regulation (EU) 2025/2058, bringing important updates to the rules governing the use of food additives in foods intended for particular nutritional uses, such as infant formula, foods for special medical purposes, and meal replacement products.
This new regulation, published on 14 October 2025, amends Regulation (EC) No 1333/2008 on food additives to make it consistent with the current EU legal framework. The amendment replaces outdated references to old, repealed directives—mainly Directive 2009/39/EC, which previously regulated “foods for particular nutritional uses”—with updated references to Regulation (EU) No 609/2013, which is now the core law governing foods for specific groups (FSGs).
Updated Legal References and Terminology
The outdated term “foods for particular nutritional uses” has been replaced with “foods for specific groups” to align with Regulation (EU) No 609/2013.
This ensures consistency across EU food legislation and removes confusion caused by older, repealed directives.
Reorganization of Food Additive Categories
In Annex II, Part E of Regulation 1333/2008,food category 13 has been renamed from “Foods for particular nutritional uses” to “Foods for specific groups”.
Sub-categories have been deleted or restructured to reflect current product definitions under EU law.
For example, category 13.1.4 (“Other foods for young children”) has been removed, and new categories (18.1 to 18.3) have been added to cover:
Processed foods not classified elsewhere (18.1)
Meal replacements for weight control (18.2)
Gluten-reduced or gluten-free foods (18.3).
Revised Conditions of Use for Additives
Updates in Annex III adjust the conditions under which certain additives can be used in nutrient preparations and infant foods.
These corrections ensure that additive authorizations correctly correspond to the new food categories and align with current scientific and regulatory understanding.
Improved Legal Coherence
The amendment eliminates conflicting references and ensures that food additive authorizations apply under the same legal definitions now in force for infant foods, medical foods, and other specialized nutrition products.
Why It Matters:
This update represents a structural modernization of the EU’s food additive framework. It does not introduce new additives or change maximum permitted levels, but rather aligns the existing additive rules with today’s legal and product landscape.
By removing obsolete references and adjusting category definitions, the regulation improves regulatory clarity and consistency—making it easier for food business operators, enforcement authorities, and consumers to understand which additives are authorized for specific types of foods.
This is especially important for:
Manufacturers of infant nutrition, dietary management, and medical foods;
Importers/exporters supplying specialized food products to the EU;
Regulatory teams maintaining compliance under Regulation (EC) 1333/2008 and (EU) 609/2013.
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