EU Cosmetics Regulation (EC) No. 1223/2009 — Complete Guide for Perfume Manufacturers

Regulation (EC) No. 1223/2009 on cosmetic products has been fully and directly applicable in all EU Member States since July 11, 2013. It replaces the old Cosmetics Directive 76/768/EEC and creates a harmonized regulatory framework for the entire European Economic Area.

What is a cosmetic product? According to Article 2 of the Regulation, cosmetic products are substances or mixtures intended exclusively or mainly for cleaning, perfuming, changing, protecting or maintaining in good condition external parts of the human body or the teeth. Perfumes, Eau de Toilette and Eau de Cologne clearly fall under this definition.

Territorial scope: The Regulation applies to all cosmetic products placed on the market in the EEA — regardless of where they were manufactured. A perfume produced in the USA is subject to the same requirements as a product manufactured in Germany.

The concept of the Responsible Person is the centerpiece of the EU Cosmetics Regulation. Every cosmetic product requires exactly one Responsible Person established in the EEA who bears full legal liability.

Duties of the Responsible Person:
- Ensuring compliance with the Regulation
- Creating and maintaining the Product Information File (PIF)
- Commissioning and storing the CPSR
- CPNP notification of all products
- Cooperation with authorities during inspections
- Reporting serious undesirable effects to competent authorities

Who can be the Responsible Person? The EU-established manufacturer, the EU importer or an authorized representative with written power of attorney. A company from a third country (e.g. USA, UAE) cannot directly take on this role.

The Product Information File (PIF) is the complete technical documentation of the product. It must be kept for the entire marketing period plus ten years after the last placing on the market.

Contents of a complete PIF:

1. Product description (name, category, intended use)
2. CPSR (complete safety report)
3. Manufacturing method and GMP evidence
4. Evidence of claimed effects (Efficacy Claims)
5. Data on undesirable effects
6. Complete formulation with INCI list
7. Stability data
8. Microbiological data (Challenge Test)
9. CPNP confirmation screenshot
10. Label layout (all language versions)
11. IFRA compliance certificates

The PIF must be electronically accessible to authorities at any time and must be provided within a short period during market inspections.

Article 19 of the Regulation conclusively defines what information must be on the label. For perfumes, the following mandatory information applies:

Essential information on primary labeling carrier (bottle):
- Name or company and address of the Responsible Person
- Nominal content (in grams or milliliters)
- Best before date (if ≤ 30 months) or PAO symbol (if > 30 months)
- Batch designation
- Intended use (if not apparent from the product)

Mandatory information on outer packaging or insert:
- Complete INCI ingredient list
- Special precautions
- Country of origin (for imports from third countries)

Allergen declaration: Above 0.001% concentration in rinse-off products and above 0.0001% in leave-on products, certain IFRA-relevant allergens must be explicitly listed in the INCI list. The list of declarable allergens was expanded by the EU Cosmetics Regulation in Annex III.

The Regulation contains three important annexes on regulated substances:

Annex II — Prohibited substances: Over 1,300 substances that may not be used in cosmetic products. These include certain heavy metals, aromatic amines, CMR substances (carcinogenic, mutagenic, reprotoxic) and many synthetic fragrance ingredients whose safety has not been sufficiently demonstrated.

Annex III — Restricted substances: Substances that may only be used under certain conditions (maximum concentrations, restrictions on use, mandatory warnings). Many fragrance ingredients, preservatives and hair dyes fall under this category.

Annexes IV/V/VI: Permitted colorants, preservatives and UV filters with their conditions of use.

The lists are regularly updated by the European Commission and the Scientific Committee on Consumer Safety (SCCS).

Violations of the EU Cosmetics Regulation are sanctioned differently in EU Member States, as penal provisions are a national matter. In Germany, the Food and Feed Code (LFGB) regulates sanctions:

• Administrative offences — fines for minor violations (e.g. missing mandatory information)
• Criminal offences up to 3 years imprisonment for intentional serious violations (e.g. placing prohibited substances on the market)
• Product recalls for identified safety deficiencies, by order of the authorities
• Sales bans for products that do not meet requirements

In addition to state sanctions, civil law claims from injured consumers under the Product Liability Act are threatened.