In the European Union, food supplements are classified as foods. They are designed to complement nutritional intake where deficiencies or increased nutritional needs may exist.

Food supplements are typically marketed in dose forms such as:

• Capsules

• Tablets

• Softgels

• Powders

• Sachets

•  ...

The safety and scientific assessment of food supplements within the European Union is primarily supported by the European Food Safety Authority (EFSA).

Key EU Regulations

Contaminants, Pesticide Residues & Microbiological Safety

Food supplements placed on the EU market must comply with strict safety requirements, including:

• Regulation (EC) No 1881/2006 ( for contaminants )

• Regulation (EC) No 396/2005 ( for pesticides )

• Regulation (EC) No 2073/2005 (for Microbiological criteria)

  
  

Labeling and Claims

Regulation (EU) No 1169/2011 establishes mandatory labeling requirements, including:

• Product name

• Ingredient list

• Allergen declaration

• Nutrition information

• Net quantity

• Best-before or expiry date

• Food business operator details

• Country of origin (where applicable)

• Minimum font size requirements

Regulation (EC) No 1924/2006 for Nutrition and Health Claims covers:

• Permitted nutrition claims

• Authorized health claims

• Conditions of use for claims

• Scientific substantiation requirements

Only authorized nutrition and health claims may be used on product packaging and marketing materials.

Formulation & Dosage

The formulation of food supplements must be based on both scientific evidence and regulatory compliance.

Only vitamins, minerals, and their chemical forms listed in the applicable EU legislation may be used in food supplements.

Other ingredients such as:

• Botanical extracts

• Probiotics supplement

• Amino acids

• Functional compounds

• Mushroom extracts

  
  

Recommended daily intake levels should be determined based on:

• Scientific evidence

• Safety evaluations

• Consumer needs

• Market practices in the target country

Labeling & Claims Compliance

Food supplement labels must fully comply with Regulation (EU) No 1169/2011 and include all mandatory information.

Additionally, food supplement packaging must contain specific mandatory statements such as:

• Recommended daily intake

• Warning not to exceed the recommended daily dose

• Statement that food supplements should not be used as a substitute for a varied and balanced diet

• Statement to keep the product out of reach of young children

All packaging, product information, and promotional materials should remain consistent and only use authorized nutrition and health claims.

Novel Food Updates

The EU Novel Food framework continues to evolve as new ingredients are evaluated by EFSA.

In December 2025, EFSA published several scientific opinions relating to novel food applications, including:

1. Galacto-Oligosaccharides (GOS)

(https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9797)

2. Egg Membrane Collagen Peptides

(https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9709)

3. Algal meal from Haematococcus pluvialis containing astaxanthin 

(https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9736)

How OriginBio Supports EU Compliance

OriginBio assists customers throughout the entire product development process, including:

• Formula design and regulatory review

• Ingredient compliance assessment

• Label review and optimization

• Stability studies

• Documentation preparation

• OEM/ODM manufacturing

• Quality assurance and testing support

Our goal is to help brands develop food supplements that are scientifically sound, commercially successful, and compliant with European regulatory requirements.