EU Cosmetics Regulation Guide (EC 1223/2009)

Regulation (EC) No 1223/2009 is the cornerstone of cosmetics law in the European Union. It applies to any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair, nails, lips, external genital organs) or with the teeth and mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odours.

The regulation entered into force on 11 July 2013, replacing the earlier Cosmetics Directive 76/768/EEC. Unlike a directive, this regulation is directly applicable in all Member States, meaning there is one single set of rules across the entire EU, EEA (Norway, Iceland, Liechtenstein), and -- through bilateral agreements -- Switzerland and the UK (which adopted a near-identical version post-Brexit as the Product Safety and Metrology etc. (Amendment) Regulation 2019).

The Responsible Person

The concept of the Responsible Person (RP) is central to the EU cosmetics framework. Every cosmetic product placed on the EU market must have a designated RP established within the EU (or EEA). The RP bears legal responsibility for the product's compliance with the entire regulation.

Who can be the RP?

• EU manufacturer: If the product is manufactured within the EU and not subsequently exported and reimported, the manufacturer is the RP by default (Article 4(1)).
• Importer: For products manufactured outside the EU, the importer is the RP (Article 4(2)). Each imported product must have one designated EU importer as RP.
• Designated person: The manufacturer or importer may designate a person established within the EU as the RP by written mandate (Article 4(3)). This is common for non-EU brands that use a regulatory consultancy or European distributor as their RP.
• Distributor: A distributor becomes the RP if they place the product on the market under their own name or trademark, or modify a product already on the market in a way that could affect compliance (Article 4(6)).

RP obligations

The Responsible Person must:

1. Ensure the cosmetic product has undergone a safety assessment before being placed on the market (Article 10).
2. Prepare and maintain the Product Information File (PIF) (Article 11).
3. Notify the product on the CPNP before placing it on the market (Article 13).
4. Comply with good manufacturing practice (GMP) per ISO 22716.
5. Ensure labelling complies with Article 19.
6. Report serious undesirable effects (SUEs) to the competent authority without delay (Article 23).
7. Cooperate with competent authorities on market surveillance activities (Article 24).
8. Take corrective action, including product withdrawal or recall, when a product is non-compliant (Article 5).

CPNP notification

The Cosmetic Products Notification Portal (CPNP) is the European Commission's online system for cosmetic product notifications. Under Article 13, the RP must notify each product before it is placed on the EU market.

What the notification includes

• Product category (selected from a predefined list of categories and sub-categories)
• Product name (sufficient to identify the specific product)
• Name and address of the Responsible Person
• Country of origin (for imported products)
• Member State where the product will first be placed on the market
• Contact details of a physical person for rapid contact in case of emergency
• Presence of substances in the form of nanomaterials (with identification and reasonably foreseeable exposure conditions)
• Name and CAS/EC number of CMR (carcinogenic, mutagenic, reprotoxic) substances
• Frame formulation (allowing prompt and appropriate medical treatment in case of poisoning)

The frame formulation is particularly important for poison centres. It provides enough information about ingredient concentrations for medical professionals to determine appropriate treatment, without disclosing the exact proprietary formulation. The RP selects from standardised concentration ranges.

Distributor notifications

Under Article 13(3), distributors who make a product available in a Member State where it has not already been notified must also submit a notification to the CPNP. This distributor notification references the original RP notification and adds the Member State, product name in that market, and the distributor's details.

Safety assessment (CPSR)

Article 10 requires that every cosmetic product placed on the EU market undergo a safety assessment. The outcome is documented in the Cosmetic Product Safety Report (CPSR), which must follow the structure prescribed in Annex I.

Part A: Cosmetic Product Safety Information

This section compiles the factual data underpinning the assessment:

1. Quantitative and qualitative composition: Full formulation with INCI names, CAS numbers, concentrations, and functions.
2. Physical/chemical characteristics: Stability data, pH, viscosity, particle size (where relevant), preservative efficacy testing (PET/challenge test).
3. Microbiological quality: Microbial limits for the finished product (typically: total aerobic mesophilic count ≤ 100 CFU/g or ml for products used around eyes, lips, or mucous membranes; ≤ 1000 CFU/g or ml for other products; absence of Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans in 1 g or 1 ml).
4. Impurities and traces: Purity of raw materials, residual solvents, heavy metal content.
5. Packaging material: Compatibility of packaging with the formulation, migration considerations, barrier properties.
6. Normal and reasonably foreseeable use: Description of how consumers will use the product.
7. Exposure to the cosmetic product: Application site, area of application, amount used per application, frequency, total duration of use, target population (including children), route of exposure.
8. Exposure to substances: Individual substance exposure calculated from formulation concentration and product exposure data.
9. Toxicological profile: For each ingredient -- acute toxicity, irritation, corrosivity, skin sensitisation, dermal/percutaneous absorption, repeated dose toxicity, mutagenicity/genotoxicity, carcinogenicity, reproductive toxicity, photo-induced toxicity. Data must comply with the animal testing ban (Article 18).
10. Undesirable effects and serious undesirable effects: Existing data from complaints, vigilance reports, clinical studies, literature.
11. Information on the cosmetic product: Any other relevant data, including existing studies on the finished product or similar formulations.

Part B: Cosmetic Product Safety Assessment

Part B is the expert evaluation performed by a qualified safety assessor. Under Article 10(2), the safety assessor must hold a diploma or equivalent qualification in pharmacy, toxicology, medicine, or a similar discipline as recognised by a Member State. Part B includes:

• Assessment conclusion: a clear statement on whether the product is safe for human health under normal or reasonably foreseeable conditions of use.
• Labelled warnings and conditions of use: any specific warnings to include on the label.
• Reasoning: the scientific rationale underpinning the conclusions, including the margin of safety (MoS) calculations for each relevant substance. The SCCS (Scientific Committee on Consumer Safety) recommends a MoS of at least 100 for systemic exposure calculations.

Product Information File (PIF)

Under Article 11, the RP must maintain a Product Information File for each cosmetic product. The PIF must be kept for 10 years after the date on which the last batch was placed on the market. It must be made available to the competent authority at the address indicated on the label.

PIF contents

1. A description of the cosmetic product enabling clear attribution of the PIF to the product.
2. The Cosmetic Product Safety Report (CPSR) as described above.
3. A description of the method of manufacturing and a statement of compliance with GMP (ISO 22716).
4. Where justified by the nature or effect of the product, proof of the claimed effect (e.g., clinical study reports for efficacy claims, SPF test reports for sunscreens, in-vitro or in-vivo anti-ageing evidence).
5. Data on any animal testing performed by or on behalf of the manufacturer, his agents, or suppliers, relating to the development or safety evaluation of the product or its ingredients (for transparency and compliance with Article 18).

Ingredient annexes

Regulation 1223/2009 contains six ingredient annexes that form the positive and negative lists for cosmetic formulations. These annexes are regularly updated by Commission regulations.

Important: ingredients not listed on Annex II (prohibited) or Annex III (restricted) are not automatically permitted. They must still be safe under the conditions of use as demonstrated through the safety assessment. The positive-list approach (Annexes IV, V, VI) means that only listed colourants, preservatives, and UV filters may be used for those specific functions.

INCI labelling rules

Article 19 sets out the labelling requirements for cosmetic products. The list of ingredients must use INCI (International Nomenclature of Cosmetic Ingredients) names as maintained by the Personal Care Products Council (formerly CTFA). The European Commission publishes the official glossary of common ingredient names for cosmetic ingredients, known as the CosIng database.

Ingredient listing order

• Ingredients listed in descending order of weight at the time of incorporation into the formulation.
• Ingredients present at concentrations below 1% may be listed in any order after all ingredients at 1% or above.
• Colourants may be listed in any order after the other ingredients, using their CI numbers. Where the same product is manufactured in several shades, all colourants may be listed after "may contain" or the "+/-" symbol.

Fragrance allergens

Twenty-six allergenic fragrance substances must be individually declared on the label when present above specific thresholds:

• Leave-on products: 0.001% (10 ppm)
• Rinse-off products: 0.01% (100 ppm)

These substances include: amyl cinnamal, benzyl alcohol, cinnamyl alcohol, citral, eugenol, hydroxycitronellal, isoeugenol, amylcinnamyl alcohol, benzyl salicylate, cinnamal, coumarin, geraniol, hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC/Lyral), anise alcohol, benzyl cinnamate, farnesol, butylphenyl methylpropional (Lilial), linalool, benzyl benzoate, citronellol, hexyl cinnamal, limonene, methyl 2-octynoate, alpha-isomethyl ionone, evernia prunastri extract (oak moss), and evernia furfuracea extract (tree moss). Note that HICC/Lyral and butylphenyl methylpropional/Lilial have been restricted under updated Annex III entries, with Lilial banned from cosmetic products placed on the EU market from 1 March 2022.

Other labelling requirements

Beyond the ingredients list, Article 19(1) requires the following to appear on the container and packaging:

1. Name and address of the Responsible Person.
2. Nominal content at time of packaging (weight or volume).
3. Date of minimum durability: indicated by the egg-timer symbol or "Best before end" followed by the date (month/year or day/month/year). Not required if minimum durability exceeds 30 months.
4. Period after opening (PAO): for products with a minimum durability exceeding 30 months, the open-jar symbol with the number of months (e.g., "12M") indicates how long the product remains safe after first opening.
5. Particular precautions for use (including those mandated by Annexes III-VI).
6. Batch number or reference for identification of the product.
7. Product function (unless evident from the product's presentation).
8. Country of origin for products imported from outside the EU.

Claims regulation (655/2013)

Commission Regulation (EU) No 655/2013 establishes six common criteria that all cosmetic product claims must meet. These apply to all claims, whether made on the packaging, in advertising, or in any other commercial communication.

The six common criteria

1. Legal compliance: Claims must comply with Regulation 1223/2009 and other applicable legislation. Claims must not attribute to cosmetics characteristics or functions they do not possess. A cosmetic product must not claim to prevent, treat, or cure disease (that would make it a medicinal product under Directive 2001/83/EC).
2. Truthfulness: Claims must be supported by adequate and verifiable evidence, regardless of the type of evidential support. If the claim quotes a study, the study must be relevant and the claim must accurately represent the findings.
3. Evidential support: The evidence supporting the claim must be appropriate to the nature of the claim. An anti-wrinkle claim requires objective instrumental measurements or clinical assessment. A moisturisation claim can be supported by corneometry data. A "dermatologically tested" claim requires documentation of a dermatological study.
4. Honesty: Claims must not go beyond the available evidence. Limitations of the evidence must not be masked. Performance claims based on in-vitro data must not be presented as if they were in-vivo results.
5. Fairness: Claims must not denigrate competitors or legally used ingredients. Comparative claims must compare like with like. "Free from" claims must not imply that other products containing the referenced substance are unsafe or inferior (unless the substance is genuinely prohibited).
6. Informed decision-making: Claims must be clear, understandable, and must not mislead the average consumer. Marketing language must enable reasonable purchase decisions. Exaggeration that the average consumer would recognise as such is acceptable if the overall message is not misleading.

Common claim types and evidence requirements

Nanomaterials (Article 16)

The regulation introduced specific provisions for nanomaterials used in cosmetics. Under Article 2(1)(k), a "nanomaterial" means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale of 1 to 100 nm.

Notification obligation

Under Article 16, the RP must notify the Commission via the CPNP at least 6 months before placing a cosmetic product containing nanomaterials (other than colourants, UV filters, and preservatives already covered under Annexes IV-VI) on the market. The notification includes: identification of the nanomaterial (IUPAC name, CAS/EC numbers), specification (particle size, physical and chemical properties), estimated quantity placed on the EU market per year, toxicological profile, safety data, and reasonably foreseeable exposure conditions.

Labelling of nanomaterials

All ingredients present in the form of nanomaterials must be indicated in the list of ingredients with the word "nano" in brackets after the ingredient name. For example: Titanium Dioxide (nano), Zinc Oxide (nano).

Common nanomaterials in cosmetics

• Titanium dioxide (nano): Used as a UV filter in sunscreens. The SCCS has issued specific opinions on its safety in nano form, concluding it is safe when used as a UV filter up to 25% concentration in formulations that do not lead to inhalation exposure.
• Zinc oxide (nano): Also used as a UV filter. Considered safe up to 25% in sunscreens, with restrictions on spray products due to inhalation concerns.
• Carbon black (nano): Used as a colourant (CI 77266). Safe for use in cosmetics applied to skin, but not for use in lip products, products applied to mucous membranes, or products used around the eyes.
• Silica (nano), Hydroxyapatite (nano): Various cosmetic applications. Subject to individual SCCS safety opinions.

Good Manufacturing Practice (ISO 22716)

Article 8 of Regulation 1223/2009 requires that the manufacturing of cosmetic products comply with Good Manufacturing Practice (GMP). The harmonised standard is EN ISO 22716:2007 -- Cosmetics -- Good Manufacturing Practices (GMP) -- Guidelines on Good Manufacturing Practices.

Key GMP areas covered by ISO 22716

• Personnel: Training, hygiene, designated responsibilities.
• Premises: Design, construction, maintenance to prevent contamination and mix-ups.
• Equipment: Design, installation, cleaning, calibration, and maintenance.
• Raw materials and packaging materials: Purchasing, receipt, identification, storage, release, and rejection.
• Production: Documented procedures for all manufacturing steps, in-process controls, bulk and finished product handling.
• Finished products: Storage, release criteria, dispatch, and returns.
• Quality control laboratory: Sampling, testing methods, reagents, results evaluation, out-of-specification handling.
• Treatment of product that is out of specification: Rework, rejection, and recall procedures.
• Waste: Proper handling and disposal to prevent contamination.
• Deviations and complaints: Documentation, investigation, corrective and preventive actions (CAPA).
• Change control: Controlled changes to processes, materials, equipment, and premises.
• Internal audit: Regular self-inspection programme.
• Documentation: Master documents, batch records, SOPs, specifications, protocols.

Compliance with ISO 22716 creates a presumption of conformity with the GMP requirement of Article 8. While third-party GMP certification is not mandatory, it is strongly recommended and increasingly required by retailers, particularly for contract manufacturers.

Market surveillance and enforcement

Member State competent authorities conduct market surveillance to verify compliance. Non-compliance can result in product withdrawal or recall, fines (varying by Member State -- typically EUR 5,000 to EUR 300,000+), prohibition of market placement, and publication of non-compliance findings. The RAPEX/Safety Gate system facilitates rapid alert notifications across Member States for products posing a serious risk.

Summary

The EU Cosmetics Regulation 1223/2009 establishes one of the world's most comprehensive regulatory frameworks for cosmetic products. Brands entering or operating in the EU market need to ensure they have a properly designated Responsible Person, a thorough Cosmetic Product Safety Report, CPNP notifications for every product, compliant INCI labelling, substantiated claims, and manufacturing aligned with ISO 22716 GMP. Investing in these fundamentals upfront avoids costly enforcement actions and protects consumer trust in your brand.

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