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.

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