Companies that bring both food products and cosmetics to the EU market often assume that one regulatory representative can cover both categories.
Food and cosmetics fall under two distinct legal frameworks, each with its regulatory requirements, appointee, registration pathways, and compliance obligations.
This article outlines the key differences between the Food Business Operator (FBO) and the Cosmetic Responsible Person (RP), and explains how these roles apply differently to food supplements and cosmetic products entering the European market in 2026.
Food Business Operator vs RP
Under Article 3 of Regulation (EC) No 178/2002 (the General Food Law), a Food Business Operator is the natural or legal person responsible for ensuring that food law requirements are met within the business under their control. Several FBOs can exist along the same supply chain, since the manufacturer, importer, and distributor of a food product may each carry FBO obligations for their own stage of activity.
The Cosmetic Responsible Person, is defined under Article 4 of Regulation (EC) No 1223/2009: only cosmetic products for which a person has been designated as RP within the EU may be placed on the market. Article 5 of the same Regulation lists the RP’s obligations across more than a dozen articles, from safety documentation to labelling and market surveillance, concentrating accountability in a single appointed entity per product.
The practical distinction is structural as FBO status is shared across the food supply chain and registered at national level, while the RP role is centralised. In both cases, a legal or natural person responsible for the product’s compliance must be identified on the label. As with the Responsible Person under cosmetics legislation, the same FBO can generally be identified on the artwork across the EU, with Greece being a notable practical exception.
FBO Registration Requirements in the EU
Article 6 of Regulation (EC) No 852/2004 requires food business operators to notify the competent authority of each establishment under their control, so that it can be entered in a national register. Additionally, a number of Member States require food supplements to undergo a national notification procedure before they can be lawfully placed on their markets.
There is no EU-wide portal comparable to the CPNP, so registration is handled by national authorities and procedures can vary between Member States.
- Notification to the relevant national food safety authority before commercial activity begins (Regulation (EC) No 852/2004, Article 6).
- National notification of the placement on the market of a food supplement, if applicable, under Article 10 of Directive 2002/46/EC
- An EU-established FBO must be identified when a non-EU food brand has no legal presence in the Union, since Article 8 of Regulation (EU) No 1169/2011 assigns responsibility to the operator under whose name the food is marketed, or to the EU importer.
- That operator’s name and address must appear on the label, among the mandatory particulars listed in Article 9 of Regulation (EU) No 1169/2011.
- Traceability records covering both suppliers and customers must be kept and made available to authorities on request (Regulation (EC) No 178/2002, Article 18).
Food Supplements Compliance vs Cosmetic Responsible Person
Food supplements are regulated as food under Directive 2002/46/EC, together with national implementing rules, which means they fall under the FBO regime rather than requiring a Responsible Person. Brands that sell both an oral supplement and a topical cosmetic under the same product line therefore need two separate compliance pathways, even when the products share a brand name or target the same consumer.
The documentation differs accordingly. Cosmetic products require a Product Information File (Article 11 of Regulation (EC) No 1223/2009), a Cosmetic Product Safety Report, and CPNP notification before the product reaches the market.
Food supplements instead follow a more decentralised model: under Article 10 of Directive 2002/46/EC, Member States may, but are not obliged to, require notification of the product label to their own competent authority, so requirements differ from one EU country to another.
Documentation obligations for food supplements are less codified: rather than a single supplement-specific dossier, FBOs must be able to demonstrate the product’s safety and maintain traceability records under the EU’s general food law (Regulation (EC) No 178/2002), identifying suppliers and customers one step back and one step forward.
A single regulatory partner can act as FBO for the supplement and RP for the cosmetic, but the two appointments remain legally distinct and must each be formalised separately.
FBO Legal Responsibilities
Article 17(1) of Regulation (EC) No 178/2002 requires FBOs to verify that the requirements of food law are met at every stage of production, processing, and distribution under their control. Core obligations built on this principle include:
- Ensuring the safety and compliant labelling of the food product.
- Maintaining traceability one step back and one step forward in the supply chain (Article 18).
- Withdrawing or recalling non-compliant products and informing the competent authority without delay where the product may have reached consumers (Article 19).
- Cooperating with inspections and providing documentation on request.
These duties mirror, but do not replace, the RP’s obligations under Regulation (EC) No 1223/2009: taking corrective action, withdrawing, or recalling a non-conforming cosmetic product (Article 5(2)), and reporting serious undesirable effects to the competent authority (Article 23). The two roles are built on similar principles of accountability and traceability, but they sit within entirely separate legal regimes.
Contact Obelis today to ensure your products remain compliant in the EU and global markets!
Frequently Asked Questions
Yes, there is no legal barrier to a single company holding both roles. However, each appointment is governed by its own regulation, so meeting the FBO obligations under Regulation (EC) No 178/2002 does not automatically satisfy the RP requirements under Regulation (EC) No 1223/2009, or vice versa. The two roles must still be fulfilled independently.
The product is non-compliant and cannot legally be sold in the EU. Customs and market surveillance authorities can stop it at the border, order its withdrawal from sale, and the company involved may face fines or other penalties under national enforcement rules.
Under Article 11(1) of Regulation (EC) No 1223/2009, the Responsible Person must keep the Product Information File (PIF) for at least 10 years after the last batch of that product is placed on the EU market, readily accessible to the competent authority.
No, the appointed FBO or RP remains legally responsible regardless of the sales channel. However, since the General Product Safety Regulation (EU) 2023/988 became applicable in December 2024, online marketplaces also carry their own due-diligence obligations, so brands selling via platforms such as Amazon or Allegro should check the platform’s specific compliance requirements in addition to their own statutory ones.
Sources:
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law (consolidated version current as of 1 January 2026). Articles 3, 17, 18, 19. https://eur-lex.europa.eu/eli/reg/2002/178/2026-01-01
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. Article 6.https://eur-lex.europa.eu/eli/reg/2004/852/oj/eng
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. Articles 8, 9.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32011R1169
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Articles 2, 10.https://eur-lex.europa.eu/eli/dir/2002/46/oj/eng
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (consolidated version current as of 1 September 2025). Articles 4, 5, 11, 13, 23. https://eur-lex.europa.eu/eli/reg/2009/1223/oj/eng