Food supplements (or dietary supplements) are concentrated sources of nutrients, such as minerals and vitamins. They may also contain other substances with a nutritional or physiological effect. These products are marketed in “dose” form. They are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or support specific physiological functions.
Dietary supplements do not have healing properties. However, they can support human health by optimizing nutritional status. They contribute to well-being by supplying nutrients and substances with physiological activity.
Many types of products exist on the market to meet varying needs. The main substances used include milk enzymes, vitamins, fatty acids, proteins, plant extracts, and dietary fiber.
Food Supplements: Regulatory Framework
In the EU, food supplements are regulated as food. The harmonized rules under Directive 2002/46/EC aim to protect consumers against potential health risks. They also ensure that consumers are not provided with misleading information.
Current Regulation
Regulation (EU) No 1169/2011 on the provision of food information to consumers.
Royal Decree 1487/2009 on food supplements (Directive 2002/46/EC).
- Vitamins/Minerals: Commission Regulation (EC) No 1170/2009.
- Additives: Regulation (EC) No 1333/2008 (azo dyes).
- Flavorings: Regulation (EC) No 1334/2008.
- Claims: Regulation (EC) No 1924/2006, Commission Regulation (EU) No 432/2012, and Commission Implementing Decision 2013/63/EU.
- GMOs: Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003.
- Novel Foods: Commission Implementing Regulation (EU) 2017/2470.
- Marking: Regulation (EC) No 853/2004.
- Gluten-Free: Commission Implementing Regulation (EU) No 828/2014.
Mérieux NutriSciences provides specialized regulatory and labeling support across 70 countries. Partner with us to streamline your global commercialization strategy.
Mérieux NutriSciences’ Comprehensive Solutions
Mérieux NutriSciences provides tailor-made projects, expedited timelines, and a single point of contact throughout the entire product lifecycle.
From test plan definition to reporting, we offer a comprehensive pathway. This includes assays, stability and shelf-life studies, performance evaluation, and safety assessments. We also ensure regulatory compliance for target markets. Where required, we have the capability to operate under GMP conditions. Additionally, our experts deliver regulatory consulting, label and registration reviews, sensory studies, and packaging evaluations.
Quality Controls
- Microbiological analysis, including Pharmacopeia test methods and predictive microbiology (challenge test).
- Microorganism identification
- Allergens, using ELISA for protein detection and PCR for DNA detection.
- Nutrients & Botanicals:
- Multi-platform assays: HPLC/LC-MS for active compounds, GC for volatile and lipid fractions, and ICP for elemental analysis.
- Demonstrated batch-to-label compliance.
- Probiotics: probiotic counts on raw materials and finished products for quality control, R&D, and stability protocols. Analyses are performed on both single-strain and multi-strain products.
- Other substances than vitamins: We test substances other than vitamins according to Regulation (EC) 1925/2006. This ensures added amounts are respected for amino acids, organic acids, and enzymes (e.g., coenzyme Q10, bromelain, Lactoferrin).
Our labs support the determination of qualitative and quantitative composition. We also establish the tolerance range for each active substance. This is achieved through an innovative approach using validated methods and feasibility studies.
Stability & Shelf-Life Studies
We conduct ICH long-term and accelerated studies. These establish shelf-life, optimize storage conditions, and validate packaging. Our experts define study protocols tailored to the specific characteristics of your product. We analyze organoleptic, microbiological, physical, and chemical parameters susceptible to degradation (evaluated at appropriate intervals).
Safety & Efficacy Studies
We assess bioaccessibility and bioavailability through exclusive oral and gastrointestinal in vitro models. We also perform adsorption evaluations of compounds and their metabolites.
Safety tests for active ingredients include:
- UNI EN ISO 10993-5
- Bacterial reverse mutation (Ames test – OECD 471)
- Mammalian cell micronucleus test (OECD 487)
- Mammalian cell gene mutation test (OECD 490)
Packaging Safety & Suitability
We use materials compliance and safety studies to test packaging in contact with food supplements. This helps avoid the migration of unwanted contaminants into the product.
- Assessment of Declaration of Compliance.
- Global and specific migration tests based on material type.
- Set-off analysis on printed materials to prevent constituent transfer.
- Risk assessment through screening approaches.
- Emerging contaminants: MOSH/MOAH, PFASs, Bisphenols, etc.
Our Packaging Service
Sensory Science & Consumer Research
The market is shifting from tablets and capsules toward gummies, drinks, and chewing gum. This presents a new challenge: focusing on the sensory attributes of dietary supplements.
Through consumer testing, we identify the aspects that make new supplements appealing and preferred. Any sensory factor crucial to success is a candidate for testing.
Our Sensory & Consumer Research Services
Labeling & Regulatory Compliance
To market a food supplement in the EU, the product must comply with European legislation. It must also meet specific rules in the destination country regarding composition and labeling. Our consultants solve every aspect of compliance for your product.
Our Labeling & Regulatory Services
Research & Development for Cutting-Edge Dietary Supplements
We support the development of industry-leading products. We provide implementation, optimization, and validation of customer-specific methods. Rely on our global research centers and accredited labs for:
- Method development and validation.
- Lab-to-lab transfer.
- Contract research projects.
Our Research & Development Services
Phytochemicals in Food & Food Supplements
