Chapter 1: Cosmetics Regulation (EC) No 1223/2009
Scope and Application
The Cosmetics Regulation (EC) No 1223/2009 is the primary EU legislation governing cosmetic products. It applies directly in all Member States without the need for national transposition. The Regulation covers any substance or mixture intended to be placed in contact with external parts of the human body (skin, hair, nails, lips, external genital organs) or with the teeth and mucous membranes of the oral cavity, with a view to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odour.
For salon operators, the Cosmetics Regulation is relevant in two principal ways: first, all professional cosmetic products used in the salon must comply with the Regulation; and second, any cosmetic products manufactured or mixed on the salon premises (such as custom-blended treatments or in-house formulations) must meet all regulatory requirements.
Safety Assessment and Product Information File
Every cosmetic product placed on the EU market must undergo a safety assessment conducted by a qualified assessor. The Responsible Person -- the manufacturer, importer, or a designated entity within the EU -- must maintain a Product Information File (PIF) for each product. The PIF includes the product description, the cosmetic product safety report, the manufacturing method, evidence of claimed effects, and data on animal testing.
Salon operators are not required to prepare PIFs for products they purchase from compliant manufacturers, but they should verify that products sourced from outside the EU have been placed on the market by a Responsible Person established within the EU, and that these products are properly registered in the Cosmetic Products Notification Portal (CPNP).
Prohibited and Restricted Substances
The Cosmetics Regulation maintains extensive lists of substances that are prohibited (Annex II), restricted (Annex III), permitted as colorants (Annex IV), permitted as preservatives (Annex V), and permitted as UV filters (Annex VI). Salon operators should be aware of key restrictions affecting professional products:
- Formaldehyde: Restricted as a preservative to a maximum concentration of 0.1% (measured as free formaldehyde) in cosmetic products generally, and 0.2% in nail hardeners. Products containing formaldehyde-releasing preservatives above 0.05% must carry the warning "contains formaldehyde." Keratin smoothing treatments with formaldehyde concentrations exceeding these limits are non-compliant.
- Hair dye substances: Annex III lists permitted hair dye substances with maximum concentrations and conditions of use, including required warnings and patch test recommendations.
- Hydrogen peroxide: Permitted in hair products at concentrations up to 12% (40 volume) for professional use, with mandatory warnings.
Labelling Requirements
Professional cosmetic products used in salons must carry labels that include the name and address of the Responsible Person, the nominal content, the date of minimum durability or period after opening (PAO), particular precautions for use, the batch number, the function of the product, and the list of ingredients. Products used exclusively by professionals may have reduced labelling if the information is provided through other means (such as technical data sheets), but the INCI ingredient list must always be available.
Adverse Event Reporting
Responsible Persons and distributors must report serious undesirable effects (SUEs) to the competent authority of the Member State where the effect occurred. Salon operators who observe or are informed of serious adverse reactions to cosmetic products should report these to the product manufacturer or distributor and to the national competent authority. An SUE is defined as an undesirable effect that results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, an immediate risk to life, or death.
Professional-Use Products
Certain cosmetic products are intended for professional use only and may contain higher concentrations of active ingredients than consumer versions. The Cosmetics Regulation permits higher concentrations of some substances in professional products, subject to additional conditions such as mandatory use of protective gloves, adequate ventilation, and display of specific warnings. Salon operators must ensure that professional-use products are used only by trained practitioners under appropriate conditions and are not sold directly to consumers unless the consumer version labelling requirements are met.
Member States may impose additional national restrictions on professional products. For example, some Member States require that certain chemical treatments (such as Brazilian blowouts or keratin treatments with elevated formaldehyde content) are performed only by practitioners with specific training, and may set lower concentration limits than the EU Regulation permits.
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Quick Decision Matrix
Find your salon compliance priority in 5 seconds.
| Your Situation | Priority Action | Go To |
|---|---|---|
| Opening a new salon | Licensing + registration before opening day | Chapter 2 |
| Chemical products and colour treatments | Chemical safety and ventilation requirements | Chapter 3 |
| Staff hygiene and infection control | Sanitation protocols and training | Chapter 4 |
| Preparing for health inspection | Inspection readiness review | Chapter 5 |
| Insurance and liability questions | Public liability and professional indemnity | Chapter 4 |
| Hiring stylists (employee vs booth rental) | Employment classification obligations | Chapter 6 |
5-second answer: Every salon needs a valid licence, chemical safety protocols, and infection control procedures. If you don't have all three, start with Chapter 2.