Before cosmetic products can be placed on the market, they must be notified in the EU/UK, listed with the FDA in the USA or notified to Health Canada as applicable. This is one of the final steps before market launch. Your dedicated TRC expert will manage the entire process on your behalf. We will notify your products as your Responsible Person (EU/UK), complete FDA product listing in the USA, submit Cosmetic Notification Forms to Health Canada, or assist you to do so under your own company name. EU product notifications are valid for all EU and EEA countries. US product listings are performed at federal level with the FDA.

Product notification or listing does not constitute approval by the competent authority. The product must meet all applicable compliance and safety requirements before submission.

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 supports market surveillance by the competent authorities, 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.

The FDA (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, listing and registration data is submitted correctly and timely. We also maintain these records and update them timely (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 Cosmetics Direct. The portal is accessed through the FDA Direct login.

We strongly advise you to appoint one single service provider to perform the safety assessment and all other regulatory steps towards EU, UK US and/or Canada 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; support your Health Canada notifications, and to manage REACH compliance.

Clear processes, shorter timelines, higher efficiency, consistent quality, lower costs, having the “single source of truth”, and better protection of your confidential information are key benefits.

TRC provides all product compliance and safety assessment services you need for the EU, the UK the USA and Canadian markets.
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.

Before submitting a notification or listing, we verify that the required product, formulation, label, safety and company information is complete and consistent.

Once the product is notified or listed, we continue to manage all required updates, resulting from changes in formulation, packaging, labelling, images, pack sizes, suppliers, etc.

Because TRC manages the underlying product data, safety assessments, label content and notifications within one connected compliance environment, submissions remain consistent with the latest approved product information.

We also support the transfer of existing notifications and listings when TRC is appointed as the new Responsible Person, US Agent or compliance partner.

What TRC manages (can also be box)

• CPNP notifications for the EU
• SCPN notifications for Great Britain
• FDA cosmetic product listings and facility registrations
• Health Canada Cosmetic Notification Forms
• Updates following product or company changes
• Transfer of existing notifications and listings
• Communication with the relevant authorities

Discuss with an expert to know more about compliance in the UK and to get started. Schedule a free discovery call.