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EU Responsible Person Service – Cosmetics

As your European Union Cosmetics Responsible Person (EU-RP), MDSS supports your company to market your cosmetic products safe and compliant with EU requirements, and acts as your legal representative in the EU, and first point of contact for the European Union authorities.

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UK Responsible Person Service – Cosmetics

As your United Kingdom Cosmetics Responsible Person (UK-RP), MDSS supports your company to market your cosmetic products safe and compliant with UK requirements, and acts as your legal representative in the United Kingdom, and first point of contact for the UK authorities.

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US Agent Service – Cosmetics

As your US Agent, MDSS supports your company to market your cosmetic products safe and compliant with US requirements, and acts as your first point of contact for the US authorities – Food and Drug Administration Agency (FDA).

✗  Product Notification
✗  Product Information File (PIF)

✗  Handling of third party inquiries
✗  Safety Assessment

✗  Ingredients Review
✗  Labeling Review

Latest News

  • Labelling requirements for cosmetic prodcts in the US: Before and after MoCRA

    Labelling requirements for cosmetic prodcts in the US: Before and after MoCRA Cosmetic products marketed in the USA, whether domestically manufactured or imported, must comply with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FP&L Act). The label elements required under the FD&C Act must

    March 1, 2024
  • Cosmetics in the EU, UK and USA: Legal background and definitions

    Cosmetics in the EU, UK and USA: Legal background and definitions The legal definitions of “cosmetic product” in the European Union (EU), United Kingdom (UK) and the United States of America (USA) show notable differences reflecting distinct regulatory approaches. For the EU and UK, the legal definition of a cosmetic product are outlined in Article

    January 25, 2024
  • MoCRA Update: FDA launches Cosmetics Direct portal and issues Final Guidance document

    MoCRA Update: FDA opens Cosmetics Direct portal and issues Final Guidance document On December 18, 2023, FDA finally opened the Cosmetics Direct electronic submission portal for facility registration and cosmetic product listing, as required according to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) . The Cosmetics Direct portal shall be used exclusively for

    December 19, 2023
  • MoCRA Update: Enforcement of facility registration and product listing pushed back until July 2024

    MoCRA Update: Enforcement of facility registration and product listing pushed back until July 2024 As previously reported, the submission of information about existing facilities who are marketing cosmetic products in the US, and listing of their cosmetic products according to MoCRA will be required from 29th December 2023. The FDA is about to set up

    November 8, 2023

MDSS supports your company to market your cosmetic products safe and compliant in the EU and UK.

As the Responsible Person (“RP”) for your company’s products, MDSS acts as the legal representative within the European Union (EU) and/or the United Kingdom (UK) as the first point of contact for the competent authorities.

Our services include the comprehensive support on the implementation of the European Cosmetics Regulation 1223/2009 and the UK Cosmetics Regulation (orig. “The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34”). This includes the support on establishing the legally required document dossier, the Product Information File (PIF).

Of particular importance for the PIF is the preparation of the safety assessment. This is a written evaluation of the available documentation (e.g. quantitative composition of the final product, data on raw materials, etc.) and must be prepared individually for each product, or for each formulation.

Please contact us for more information.

Our Mission

  • Navigate your company through the legal requirements of the EU and UK
  • Contribute on your product’s legal compliance and safety
  • Support your company in successfully establishing your products on the market

About Us

25 years In Business

Since 1994 we face the challenge of regulatory services with broad knowledge and expertise.

Our Offer

A broad spectrum of regulatory and industry experience.

Our Goal

Setting your company up for success.

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