Handmade soaps, natural creams or bespoke make-up…Do you dream of turning your passion for cosmetics into a real business project?
In Brussels, launching your own brand requires careful preparation and compliance: regulation, safety, labelling, testing and EU notification are all essential steps. This guide brings together everything you need to know to make your project a reality in line with legal obligations.
What are cosmetics?
A cosmetic product is “any substance or mixture intended to be applied to the superficial parts of the human body (skin, hair, nails, lips, teeth, oral mucosa) for one or more of the following purposes”:
- to clean (e.g. soap)
- to protect (e.g. sunscreen)
- to care for and keep in good condition (e.g. day cream, toothpaste)
- to remove unpleasant odours (e.g. deodorant)
- to perfume
- to change the appearance (e.g. hair dye, mascara)
What regulations govern cosmetic products?
Cosmetic products are governed by two key legal texts:
- EU Regulation (EC) No 1223/2009, which sets out the rules on composition, labelling, restricted or banned substances, and authorised colourants, preservatives and UV filters;
- the Royal Decree of 17 July 2012, which transposes these rules into Belgian law and defines the legal obligations of operators towards the competent authorities.
In Belgium, the competent authority is the Federal Public Service (FPS) Health, Food Chain Safety and Environment.
What should you consider when manufacturing a cosmetic product in Belgium?
Manufacturing includes all stages needed to obtain the finished or semi-finished product: weighing ingredients, mixing, processing and quality control.
There are three possible channels:
- manufacturing the products yourself,
- outsourcing production to a third party,
- or importing them.
The EU Regulation 1223/2009 provides for:
- a list of banned substances (Annex II);
- a list of restricted substances (Annex III);
- and lists of authorised colourants, preservatives and UV filters (Annexes IV–VI).
Manufacturers based in Belgium must inform the FPS Health of their activities every two years.
⚠️ Note: Home production is not recommended, as it poses sanitary and traceability risks. Most entrepreneurs use an approved laboratory to ensure compliance and product safety.
Whether or not you outsource certain stages, the distribution of responsibilities must be clearly defined in the Product Information File (PIF).
What are the labelling and packaging requirements?
Packaging covers all operations involving the transfer of the product to its final container (pots, bottles, tubes, etc.) and includes labelling.
Mandatory information:
- name and address of the responsible person
- nominal content (quantity)
- minimum durability: “best used before end of…” (for products lasting under 30 months)
- period after opening (in months) for products lasting more than 30 months
- batch number
- product function (unless obvious from presentation)
- precautions for use
- ingredients listed under their INCI names, referenced in the CosIng database
Language requirements:
The label must be written in the language(s) of the region where the product is sold (French, Dutch and/or German).
Claims:
Claims about a product’s properties must be substantiated in line with EU Regulation No 655/2013 and the European Commission’s technical document.
Who can be the “responsible person” for a cosmetic product?
Only cosmetic products for which a natural or legal person established in the EU is designated as the responsible person may be placed on the market.
This person ensures the product’s regulatory compliance and safety, and may be held accountable in the event of non-compliance or adverse effects.
The responsible person may be:
- the manufacturer,
- the importer,
- the distributor,
- or another authorised party.
Whichever way you choose, you must remember that, as a brand owner, you are always responsible for the products. If the products contain prohibited ingredients or if customers complain because of unforeseen, unwanted side effects, you will be held responsible and accountable. Even if a third party was responsible for importing or manufacturing it, you are ultimately responsible. So choose the partners with whom you are going to work wisely (quality, reliability, verifiability, etc.)
What technical file is required for a cosmetic product?
Every cosmetic product must have a technical file in accordance with Articles 10 and 11 of Regulation 1223/2009.
It consists of two parts: a safety report and a Product Information File (PIF).
Safety report
The safety assessment (raw materials, composition, effects, etc.) must be carried out by a qualified person holding a recognised university degree (pharmacology, toxicology, medicine or equivalent).
This person may work in Belgium or any other EU Member State.
By validating the product’s safety, this expert assumes legal responsibility for its reliability.
💡 Regional support available: to help cover the cost of this evaluation, Brussels offers:
- the Start-up grant (for those without a business number);
- the Consultancy grant (for established self-employed entrepreneurs).
Product Information File (PIF)
The PIF must include:
- manufacturing method and declaration of compliance with Good Manufacturing Practices;
- stability, compatibility and microbiological tests (except for pure oils, with justification);
- proof and tests demonstrating product claims (e.g. “moisturising”, “nourishing”).
How to notify your product in the CPNP database
Before placing a product on the market, each cosmetic must be notified in the European database Cosmetic Products Notification Portal (CPNP).
Each formula—even if its ingredients are already authorised—must be registered individually. The final formula is evaluated and recorded.
The FPS Health and the Poison Centre have access to this data at any time.
What to do in case of adverse effects?
Forms and guidance for reporting serious undesirable effects are available on the European Commission’s website.
Where to find help and useful contacts in Brussels?
Support and assistance:
Use the “Who can help me?” wizard to find business support organisations in Brussels (including Local Economy Offices).
The Hub.info service can also guide you.
FPS Health
- Recommendations on cosmetics
- Cosmetics leaflet
- Cosmetics Unit: +32 (0)2 524 97 97 | apf.inspec@sante.belgique.be
Belgian Cosmetics Federation
DETIC
- Guide on ethical advertising in cosmetics
- Overview of sector initiatives.
In summary
Launching a cosmetic brand in Belgium requires you to:
- understand the applicable regulations (Regulation 1223/2009 and Royal Decree 2012);
- ensure safe manufacturing and labelling;
- appoint a responsible person in the EU;
- compile a complete technical file (safety report + PIF);
- notify the product in the CPNP database before marketing.
With the right preparation and professional guidance, you can launch your cosmetic brand in full compliance.