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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.
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
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 upNovember 8, 2023
MoCRA: FDA provides update on upcoming launch of electronic submission portal As previously reported, the submission of information about existing facilities who are marketing cosmetic produscts 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 an electronic portalNovember 3, 2023
MoCRA: Draft Guidance issued by FDA – new submission portal announced for October On 7th August 2023, the US Food and Drug Administration (FDA) issued the draft guidance on cosmetic product facility registrations and products, following the Modernization of Cosmetics Regulation Act (MoCRA) passed by the Congress and signed by the President as part ofAugust 10, 2023
Fragrance allergens for cosmetic products: New EU Regulation provides significant changes in labelling requirements Regulation (EU) 2023/1545 was published on 26th July 2023, regarding labelling of fragrance allergens in cosmetic products. It introduces 56 new fragrance substances to Annex III, plus updates to some already existing entries. The new Regulation follows the SCCS opinion onAugust 9, 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.
- 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.
A broad spectrum of regulatory and industry experience.
Setting your company up for success.