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Navigating the EU & GB Cosmetics Regulations

Stay Compliant with EU and GB Cosmetics Regulations: Responsible Person, Data, Formulations, Labels, and Notifications
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EU & GB Cosmetic Support

Manage your Regulatory Changes with Confidence with our Customized Cosmetic Solutions

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    Regulatory
    Expertise

    Assistance with compliance to EU and GB regulations, including the Responsible Person requirement and product notifications.
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    Comprehensive
    Support

    Support in preparing the Product Information File (PIF) and Cosmetics Safety Report (CSR).
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    Compliance
    Software

    Access to bespoke software for compiling PIF and CSR, featuring a library of toxicological profiles for cosmetic ingredients.
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Cosmetic Regulation Support

Master the intricacies of cosmetic regulations to guarantee compliance with their diverse requirements

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    EU & GB Cosmetic Regulations

    • The EU Cosmetics Regulation ((EC) No. 1223/2009) and GB Product Safety and Metrology (EU Exit) Regulations 2019 govern the placing of cosmetics in the EU and GB markets.
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    Scope

    • The EU Cosmetics Regulation (EC) No 1223/2009 establishes strict safety, labelling, and marketing requirements for cosmetic products sold within the European Union.
    • It ensures consumer protection by prohibiting harmful substances, mandating safety assessments, and requiring manufacturers to register products in the Cosmetic Products Notification Portal (CPNP). The regulation also enforces Good Manufacturing Practices (GMP) and bans animal testing for cosmetics.
    • It applies to all cosmetic products, including skincare, makeup, fragrances, and personal care items, ensuring they are safe for human use before reaching the market.
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    Requirements

    • The EU Cosmetics Regulation (EC) No 1223/2009 requires that all cosmetic products sold in the EU be safe for human use and properly labelled.
    • Manufacturers must appoint a Responsible Person (RP) within the EU to ensure compliance.
    • Each product must undergo a safety assessment conducted by a qualified expert and be registered in the Cosmetic Products Notification Portal (CPNP) before being placed on the market.
    • Clear labelling, including ingredient lists and usage instructions, is mandatory to ensure consumer safety and transparency.
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Our Tailored Cosmetic Solutions

Customized Assessment

We evaluate whether your product is subject to EU cosmetic regulation 1223 2009 and/or GB Product Safety and Metrology (EU Exit) Regulations 2019.

Personalized Guidance

Our team provides guidance on achieving compliance with the EU & GB cosmetic regulations and preparing the required documentation.

Continual Support

We offer continued support with your cosmetic obligations and are closely monitoring the Modernization of Cosmetics Regulation Act, (MoCRA) developments in the US as well.

Meet Our Cosmetic Expert

Dedicated professionals guiding your compliance journey.

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Mary Kerley |B.SC, CAPM|

Consultant II
Dublin, Ireland
Contact Team Member

Frequently Asked Questions

Tea Tree Oil was provisionally listed under the 23rd ATP to the CLP Regulation, but the decision has been postponed due to ongoing in vitro mechanistic studies funded by industry.

It contains up to 8% p-cymene, which Sweden has proposed classifying as a Category 1B reproductive toxicant based on studies in male rats. The RAC opinion on p-cymene was adopted on 9 January 2025.

Under the EU Cosmetics regulation, a cosmetic is defined as any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”

The Responsible Person (RP) ensures compliance with all regulatory requirements and must be located in the EU. The RP can be the manufacturer, importer, or a designated third party.

Before placing a product on the market, it must be notified to the Cosmetic Products Notification Portal (CPNP).

A PIF is a technical dossier which contains the following information required to demonstrate the safety of a cosmetic product:

    • Cosmetic Product Safety Report (CPSR)
    • Product description
    • Manufacturing method & GMP compliance
    • Labelling & claims evidence
    • Data on any animal testing

Yes, Annex II of the Cosmetics Regulation lists over 1,300 prohibited substances and Annex III lists restricted substances, specifying concentration limits and conditions of use.

Yes, there are comprehensive labelling requirements for cosmetic products in the EU. Each label must provide the following information

  • Product name and function
  • Responsible Person’s name and address
  • Country of origin (for imports)
  • Ingredients list (INCI format)
  • Batch number
  • PAO (Period After Opening) or expiry date
  • Warnings or precautions for use

Yes, but they must appoint an EU-based Responsible Person (RP).