Regulatory Scope: Food, Cosmetics, and Consumer Health Products
We cover food and cosmetics regulation through NutraCompliance, our dedicated division for these product categories, while our pharma and device teams handle the borderline and classification questions that arise when products cross regulatory boundaries.
This page covers food supplements, foods for special groups (including food for special medical purposes), novel foods, cosmetic products, and general consumer goods where regulatory compliance intersects with health-related claims or borderline classification. For detailed food and cosmetics regulatory services, visit NutraCompliance. For medical devices and substance-based devices, see Medical Devices. For borderline classification between product categories, see Borderline Products. For herbal medicines regulated as medicinal products, see Pharmaceuticals.
The Regulatory Landscape
Food and cosmetics regulation in the EU is built on product-specific frameworks that differ substantially from pharmaceutical and device law. Each has its own evidence requirements, notification processes, and market-by-market complexity.
Food Supplements
Directive 2002/46/EC Reg. (EC) 1169/2011 Reg. (EC) 1924/2006 Reg. (EU) 2015/2283Food supplements are generally regulated under Directive 2002/46/EC with pre-market notification through national authorities in the majority of EU Member States. Other international markets may have registration procedures similar to medicines. The notification procedures don't always come with a product evaluation pre-marketing, so manufacturers must ensure ingredient compliance (permitted vitamins, minerals, and maximum levels), comply with labelling requirements, and substantiate any health or nutrition claims against the EU Register of authorised claims.
Novel foods (ingredients without a significant history of consumption in the EU before May 1997) require authorisation under Regulation (EU) 2015/2283 before they can be placed on the market, involving an EFSA safety assessment.
Cosmetic Products
Reg. (EC) 1223/2009 ISO 22716 CPNPCosmetic products are regulated under Regulation (EC) No 1223/2009. Cosmetics require a Cosmetic Product Safety Report (CPSR), a Product Information File (PIF), notification via the Cosmetic Products Notification Portal (CPNP), and compliance with positive/negative ingredient lists (Annexes II-VI). There is no pre-market authorisation, but the Responsible Person must ensure the product is safe before placing it on the market.
GMP for cosmetics follows ISO 22716, and all claims made on a cosmetic product must be substantiated.
Food for Special Medical Purposes (FSMP)
Reg. (EU) 609/2013 Del. Reg. (EU) 2016/128FSMP falls under Regulation (EU) No 609/2013 and Delegated Regulation (EU) 2016/128. These products are intended for the dietary management of specific diseases or conditions and must be used under medical supervision. FSMP sits closer to the pharmaceutical world than standard food supplements, and the evidence requirements for claims about disease management are correspondingly higher.
Each of these frameworks has its own notification requirements, which vary by EU Member State and by target market outside the EU. Country-specific rules on permissible ingredients, maximum dosages, labelling language, and claims create significant complexity for multi-market product launches.
Where Food & Cosmetics Meets Pharma and Device Regulation
This is where our broader regulatory expertise matters most. Products that cross the boundary between food/cosmetics and pharma/device face a classification question that determines which regulatory framework applies, and the consequences of getting it wrong are significant.
Food Supplement vs. Medicinal Product
A product containing a pharmacologically active plant extract at a therapeutic dose may be classified as a medicinal product rather than a food supplement, regardless of how the manufacturer positions it. The classification depends on the product's composition, pharmacological properties, and the claims made.
All EU Member States apply a "presentation" criterion (how the product is presented to the consumer) alongside a "function" criterion (what the product actually does), and these assessments can differ between countries.
Cosmetic vs. Medicinal Product / Medical Device
A topical product that claims to treat a skin condition (rather than simply cleaning, perfuming, or maintaining the skin) may be regulated as a medicinal product or a medical device. The distinction is driven by the claims and the mechanism of action.
Dermal fillers, which were previously unregulated or regulated as cosmetics in some markets, now fall under MDR Annex XVI as products without an intended medical purpose, subject to Common Specifications and Notified Body assessment.
Food Supplement vs. Medical Device
Substance-based products that claim a specific physiological effect may be classified as medical devices under MDR Rule 21, particularly if the mechanism of action is physical rather than metabolic. The distinction is often unclear, and competent authorities across Member States do not always agree.
We handle these classification assessments routinely. When a product sits on a borderline, our pharma, device, and Nutra Compliance teams assess the options together and recommend the pathway that fits the product’s evidence base, commercial strategy, and risk profile. See our Borderline Products page for more detail on the classification framework.
Nutra Compliance: Our Dedicated Food and Cosmetics Division
Dedicated food and cosmetics regulatory compliance, from formulation to market.
- Formulation review and ingredient compliance assessment
- Label compliance and translations for EU, UK, and global markets
- Health and nutrition claims assessment and EFSA applications
- Novel food authorisation applications
- Food supplement and fortified foods notifications across the EU
- Cosmetic Product Safety Reports and Product Information Files
- Cosmetic product notifications in the EU and UK
- Food Business Operator (FBO) and Cosmetic Responsible Person (RP) services
- Site inspections, HACCP audits, and GMP audits (ISO 22716)
- Multi-market launch support through regulanet® for country-specific requirements
Nutra Compliance operates from our UK and Germany offices and covers 90+ countries through the regulanet® network. For companies with products that span both food/cosmetics and pharma/device regulation, Nutra Compliance works directly with our pharma and device regulatory teams, providing a single point of coordination across all product categories.
Visit nutracompliance.com for full details on capabilities, sectors, and how to get in touch.
Have a Food, Cosmetic, or Consumer Health Product?
Tell us about your product, your target markets, and where you are in development. We will get back to you shortly to discuss how we can support.
Speak with an ExpertFrequently Asked Questions (FAQ)
Why is food and cosmetics on a pharma/device consultancy's website?
Because a significant number of products sit at the boundary between these categories, and classification determines the entire regulatory pathway. A company developing a substance-based health product needs to know whether it is a food supplement, a cosmetic, a medical device, or a medicinal product before it can plan a regulatory strategy. We cover all of these categories, which means we can assess the full range of options rather than defaulting to a single framework.
Do food supplements need a marketing authorisation like medicines in the EU?
No. Mostly, food supplements do not require pre-market authorisation in the EU, but a pre-market notification. Manufacturers must ensure ingredient compliance, comply with labelling requirements, notify the product in the relevant Member States, and substantiate any health or nutrition claims. Novel food ingredients (those without significant EU consumption history before 1997) do require EFSA assessment and Commission authorisation before market placement. Some international markets like Australia have a more in-depth listing process for food supplement equivalent categories.
What is a Cosmetic Product Safety Report?
The CPSR is a mandatory safety assessment required under Regulation (EC) No 1223/2009 before a cosmetic product can be placed on the EU market. It consists of Part A (product safety information including toxicological profile, stability, microbiological quality, impurities, and packaging) and Part B (the safety assessor's conclusion). The CPSR must be prepared by a qualified safety assessor and included in the Product Information File.
How do I know if my product is a food supplement or a medicinal product?
It depends on the composition, the dose of active ingredients, the pharmacological properties, and the claims. If the product contains ingredients at pharmacologically active doses and claims to treat or prevent a disease, it is likely a medicinal product regardless of how it is marketed. MDCG 2022-5 Rev.1 and national competent authority guidance address the borderline. We assess these questions across both frameworks and recommend the classification that fits.
Can NutraCompliance support markets outside the EU?
Yes. Through the regulanet® network, NutraCompliance covers 90+ countries including the UK, US (FDA), Canada, Middle East, ASEAN, and Australia. Country-specific requirements for ingredients, labelling, and claims are managed through a single point of contact.