Regulatory and scientific consulting for Specific Food Groups
Foods for specific groups (FSG) require careful positioning to ensure compliance with regulations. At Pharmanager Development, we guide you in evaluating and strategically positioning your products to determine if they fall under this category.
We also assist in preparing comprehensive scientific dossiers, which include proof of efficacy and product safety. With our expertise, we ensure your products meet both European and national regulatory standards, ensuring a safe market entry.
Product compliance validation
We analyze your products to ensure they meet the specific regulatory standards for foods for specific groups (FSG), including their composition, formulation, and nutritional characteristics.
Label Verification
We ensure that your labels comply with the applicable regulations, including mandatory and optional statements.
Registration of your products
We manage the declaration process when required, ensuring full compliance with applicable European and national regulations.
Preparation of Scientific Dossiers
We compile comprehensive scientific dossiers based on robust scientific data to justify the consistency of your FSMP with the nutritional needs of the target population, to demonstrate the bioavailability of an ingredient usable in FSG, or to build the foundation of your reimbursement application dossier for the LPPR with social security.
Pharmanager Development assists you in:
We support our clients in identifying the most appropriate regulatory positioning by developing positioning strategies tailored to market needs.
At the same time, we take into account the specific regulatory requirements of each category of Foods for Specific Groups to ensure product compliance from the design stage. We work closely with our clients to guarantee that every step meets the applicable requirements.
From conception to market placement, we assist you in ensuring the compliance of your products. Our services include verifying compatibility with FSG status, checking composition and labeling, and providing support for product registration with the competent authorities. In doing so, we ensure that your products fully comply with all European regulatory requirements.
Discover our case studies
Our answers to your questions
What are the criteria for a product to be classified as a food for specific groups?
A product is classified as FSG if it meets specific nutritional needs or is intended for well-defined uses, such as infant formula or total meal replacements for weight control.
How can I ensure my cosmetic product meets EU and US regulations?
In the EU, cosmetics must comply with Regulation (EC) No 1223/2009, which includes safety assessments, ingredient restrictions, and proper labeling. A Product Information File (PIF) and notification on the Cosmetic Products Notification Portal (CPNP) are mandatory. In the US, the FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act, focusing on safety and labeling but without a pre-market approval system. Ensuring compliance through expert guidance helps avoid regulatory issues.
What are the labeling requirements for animal nutrition products?
Labeling requirements for animal nutrition products differ between markets. In the EU, Regulation (EC) No 767/2009 sets rules on feed labeling, including ingredient declaration, nutritional values, and claims restrictions. In the US, the Association of American Feed Control Officials (AAFCO) provides guidance, with each state having specific regulations. Clear, compliant labeling is crucial for market access and consumer trust.
Can I make health claims on dietary supplements and functional foods?
Health claims on dietary supplements and functional foods are strictly regulated. In the EU, Regulation (EC) No 1924/2006 requires that only approved claims from the EFSA (European Food Safety Authority) list can be used. In the US, structure/function claims must be substantiated, and the FDA requires a disclaimer stating the product is not intended to diagnose, treat, cure, or prevent any disease. Proper scientific substantiation is key to ensuring compliance.