Regulation (EC) No 1223/2009 is the primary legislative framework governing cosmetic products placed on the European Union market. The Regulation establishes a harmonized legal system across all EU Member States and aims to ensure a high level of protection for human health while enabling the free movement of cosmetic products within the single market.
As a regulation rather than a directive, its provisions apply directly and uniformly across the EU, leaving no scope for national interpretation or deviation.
Core Objectives and Cosmetic Compliance Requirements
Regulation 1223/2009 requires cosmetic products to meet strict safety standards before entering the EU market. Compliance applies throughout the product lifecycle and includes ensuring product safety, appointing an EU-based Responsible Person, maintaining a complete Product Information File with a Cosmetic Product Safety Report, and submitting product notifications via the Cosmetic Products Notification Portal prior to market placement.
The Role of Annexes in Cosmetic Regulation
The Annexes to Regulation 1223/2009 provide detailed and binding rules on cosmetic ingredients and their permitted use. These Annexes are critical for formulation decisions and regulatory compliance.
Annex II sets out substances that cosmetic products must not contain. Under Annex III, certain ingredients remain permitted only when manufacturers comply with specific conditions, including concentration limits, usage restrictions, or mandatory label warnings. Separate annexes regulate functional ingredients: Annex IV lists authorized colorants, Annex V defines approved preservatives with applicable limits, and Annex VI identifies permitted UV filters used in sun protection products.
These Annexes are dynamic and subject to regular updates following scientific evaluation by the Scientific Committee on Consumer Safety. As a result, companies must continuously monitor regulatory changes to maintain ongoing compliance.
Scientific Oversight and Continuous Monitoring
The Scientific Committee on Consumer Safety plays a central role in assessing ingredient safety and supporting regulatory updates. Its opinions directly influence amendments to the Annexes, making regulatory monitoring an essential compliance activity for cosmetic manufacturers and Responsible Persons.
Failure to adapt formulations or labeling in response to Annex updates can result in non-compliance and enforcement action.
Regulation 1223/2009 as an Industry Guideline
Regulation 1223/2009 functions as the foundational guideline for all stages of the cosmetic supply chain. It governs raw material sourcing, manufacturing in accordance with Good Manufacturing Practices, labeling requirements, and post-market surveillance activities.
The Regulation also establishes strict rules on animal testing, which has been largely prohibited for cosmetic products and ingredients since 2013. Labeling obligations include the mandatory use of INCI ingredient names and the display of safety-related symbols such as the Period After Opening indicator.
By setting uniform standards across the EU, Regulation 1223/2009 ensures consistent cosmetic compliance and consumer protection throughout the European market.
Who the Regulation holds responsible
The Regulation does not regulate products in the abstract — it assigns duties to named economic operators. The central figure is the Responsible Person, a legal or natural person established inside the EU who must be designated for every cosmetic product before it is placed on the market. No Responsible Person means no legal market access, regardless of how compliant the product itself may be.
The Responsible Person guarantees compliance: they hold the Product Information File, ensure the safety assessment has been carried out, submit the CPNP notification, handle communication with competent authorities, and take corrective action — including withdrawal or recall — where a product presents a risk. Their name and address must appear on the label.
For a brand based outside the EU, the Responsible Person is typically the EU importer or a third party appointed under written mandate. Distributors carry lighter but real obligations of their own: they must check that mandatory labelling is present, that language requirements are met, and that durability dates have not passed before making a product available.
The documents the Regulation requires
Three obligations account for most of the compliance workload, and they run in sequence rather than in parallel.
The safety assessment comes first. A qualified safety assessor evaluates the formulation and produces the Cosmetic Product Safety Report, whose required contents are set out in Annex I. The assessor must hold a university-level qualification in pharmacy, toxicology, medicine or a similar discipline — practical experience alone does not satisfy the requirement.
The Product Information File holds that report together with the product description, manufacturing method and GMP statement, proof of claimed effects, and animal-testing data. It must be kept accessible at the Responsible Person’s address for ten years after the last batch was placed on the market.
The CPNP notification comes last, immediately before launch. It is a declaration, not an approval: submitting it does not mean an authority has reviewed or endorsed the product. A single notification covers all Member States, which removes the need for national filings.
How the Regulation is enforced
Because there is no pre-market approval, enforcement happens after the product is already on sale. National competent authorities carry out market surveillance: they inspect products, request the Product Information File, and can require it within a short deadline. An incomplete or unavailable file is itself a breach, independent of whether the product is safe.
Where a product presents a risk, authorities can require withdrawal from the market or recall from consumers, and serious risks are shared across Member States through the EU rapid alert system — so an issue found in one country becomes visible everywhere. Penalties are set nationally and vary considerably, ranging from administrative fines to criminal liability in the most serious cases.
Compliance is also not a one-off exercise. The Annexes are amended regularly as the Scientific Committee on Consumer Safety issues new opinions, and a formulation that was compliant when launched can become non-compliant when a substance is restricted or banned. Monitoring those amendments is part of the Responsible Person’s ongoing duty.
Frequently asked questions
Does Regulation 1223/2009 still apply in the UK?
Not directly. Following Brexit, Great Britain applies its own retained version of the Regulation with a separate UK Responsible Person and its own notification system. Northern Ireland continues to follow the EU rules. Selling in both markets means meeting both sets of requirements.
Do I need a separate CPSR for each product variant?
Not always. Shades within a decorative range can often be covered by a single assessment where the base formula is common and the differences are limited to colorants. Distinct formulations need distinct assessments — the safety assessor decides where the line falls.
Is there a certificate or approval number for a compliant cosmetic?
No. The Regulation operates on self-responsibility. There is no authorisation, no approval number and no certificate issued by an authority. Compliance is demonstrated by the documentation you hold, not by a licence.
How often are the Annexes updated?
Several times a year. Amendments follow scientific opinions and typically restrict or prohibit substances with defined transition periods. Formulations and labels should be reviewed against the current consolidated text rather than the version in force at launch.
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