Specialised nutrition products are strictly regulated at EU level in terms of composition, production, labelling and marketing.
General Food Law
As any other food products placed on the EU market, specialised nutrition products must comply with the General Food Law Regulation (Regulation (EC) No 178/2002), Food Information to Consumers Regulation (Regulation (EU) No 1169/2011), Nutrition and Health Claims Regulation (Regulation (EC) 1924/2006) as well as food safety standards (i.e. hygiene, contaminants, pesticide residues, etc.).
EU Framework for Specialised Nutrition Products
Until recently, specialised nutrition products (including foods for infants and young children, foods for special medical purposes, foods intended for weight control, gluten-free foods and foods intended to sportspeople) were regulated under the PARNUTs Directive (Directive 2009/39/EC on foodstuff intended for particular nutritional uses).
In 2016, the PARNUTs Directive was replaced by the Food for Specific Groups (FSG) Regulation (Regulation (EU) No 609/2013). The new EU framework provides a mandate to lay down specific requirements for foods intended for vulnerable groups of consumers, including:
- Infant Formula and Follow-on Formula
- Processed cereal-based food and baby food for infants and young children
- Food for Special Medical Purposes
- Total Diet Replacements for weight control
Specific Category Rules
Under the FSG framework, detailed provisions are laid down for specific compositional and information requirements in the form of Delegated Regulations. The four categories currently regulated include:
- Infant and Follow-On Formula: Delegated Regulation (EU) 2016/127
- Foods for Special Medical Purposes: Delegated Regulation (EU) 2016/128
- Total Diet Replacements for weight control: Delegated Regulation (EU) 2017/1798
- Processed cereal-based foods and baby foods are currently regulated under Directive 2006/125/EC, until the adoption of a Delegated Regulation for this category.
The other specialised food categories are considered under EU legislation as “general foods” but some of their specificities are still recognised:
- Gluten-free foods must comply with:
- Implementing Regulation (EU) No 828/2013 on the requirements for the provisions of information to consumers on the absence or reduced presence of gluten in food.
- Delegated Regulation (EU) No 1155/2013 on the provision of food information to consumers as regards information on the absence or reduced presence of gluten in food.
- Sports foods: Regulation (EU) 432/2012 establishing a list of permitted health claims made on foods currently allows six health claims that target sportspeople or people engaged in physical exercise. Foods intended to sportspeople must also follow specific national requirements established by some Member States;
- Meal replacements for weight control: Regulation (EU) 2016/1413 establishing a list of permitted health claims lay down specific conditions for the use of the two authorised health claims for meal replacements for weight control;
- Young Child Formula: this category’s specificity is recognised via international standards or specific national rules.