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Before introducing products on the market, a product notification in the EU/UK or a product listing in the USA must be done. A last short step towards market readiness by your dedicated TRC expert. We will notify your products as your Responsible Person (EU/UK), list your products with the FDA (USA), or assist you to do so under your own company name. EU product notifications are valid for all EU and EEA countries. US product notifications are performed at federal level with the FDA.
CPNP (EU) and SCPN (UK) are free of charge online notification systems created to facilitate the implementation of the EU and UK Cosmetics Regulations. Information in CPNP and SCPN serves (national) authorities for the purpose of market surveillance, analysis, evaluation and consumer information. It may also be used by Poison Centers or similar bodies for the purpose of medical treatment in case of serious adverse events and poisoning.
FDA Direct (previously CDER Direct) now includes both CDER Direct and Cosmetics Direct and is a free of charge online registration system. Cosmetic Direct is used for the registration of cosmetic product manufacturing facilities, and for listing cosmetic products. CDER Direct is the used for OTC and prescription drugs. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens, while classified as cosmetics in the EU/UK, are all classified as OTC drugs and must be listed in CDER Direct.
Our experts will ensure that all mandatory notification data is correctly and timely submitted for your products, is maintained and timely adjusted (e.g. in case of product updates such as reformulation or label updates).
Your Responsible Person (EU /UK) safeguards and manages the compliance and safety of each cosmetic product on the market, and notifies products under its responsibility with the authorities (CPNP/SCPN). Your US Agent registers cosmetic product manufacturing facility and represents you towards the US FDA. Your US compliance partner will list your products in FDA Direct.
We strongly advise you to appoint one single service provider: to perform the safety assessment and all other regulatory steps towards EU, UK and/or US market readiness; to mandate the same service provider as your Responsible Person for your portfolio in the EU/UK; to serve as your US Agent/compliance partner; and to manage REACH compliance.
Clear processes, shorter timelines, higher efficiency, better quality, lower costs, having the “truth in one place”, and better protection of your confidential information are clear benefits.
TRC provides all product compliance and safety assessment services you need for the EU, the UK and the USA.
As your Responsible Person for the EU/UK, TRC notifies your products, performs updates in the notifications and serves as your central contact point for the UK and all EU member state authorities for as long as your products are available on the EU/UK market. The final digital labels and images of your products are needed for notification. The product labels need to include the codified TRC Responsible Person details for the EU/UK.
To perform a US product listing for a product, information is needed about your product, your organisation as the responsible person (manufacturer, packer, distributor whose details are included on the product label), and the manufacturing facility information. It is optional to include the product label in the product listing in Cosmetics Direct.
To perform a US product listing for a product, information is needed about your product, your organisation as the responsible person (manufacturer, packer, distributor whose details are included on the product label), and the manufacturing facility information. It is optional to include the product label in the product listing in Cosmetics Direct.
Once the product is notified or listed, we will also process all required updates, resulting from changes in formulation, packaging, labelling, images, pack sizes, suppliers, etc.
