- Regulatory consulting
- Responsible Person (EU & UK)
- US Agent
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.
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.
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
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From California to New York: State-specific regulations for cosmetics
From California to New York: State-specific regulations for cosmetics in the USA Federal laws such as the Food, Drug, and Cosmetic Act (FD&C Act) and MoCRA regulate the safety and labelling of cosmetics at a national level. However, throughout the years several US states implemented their own regulations to address specific concerns regarding cosmetics. The
May 14, 2024 -
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
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.
MDSS Cosmetics 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
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.