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Cosmetic products in the EU, the EEA countries (Iceland, Norway, Liechtenstein), and including Northern-Ireland are regulated centrally through the EU regulation 1223/2009, subsequent amendments and guidelines.
EU manufacturers and EU importers (for products manufactured outside the EU) are by definition considered to be the Responsible Person (RP) including legal liability. RPs are required to ensure full product compliance and safety, and to demonstrate that at all times.
The Regulatory Company is contracted by many non-EU brand-owners, and mandated by many EU-importers to take over as the Responsible Person.
With the introduction of the EU regulation 1223/2009 full harmonisation of the regulations that applied to cosmetics in the individual member states within Europe was created.
The EU regulation 1223/2009, subsequent amendments and guidelines, in short the EU Cosmetics Regulation, equally applies in all EU member states. Products that comply with the requirements can be made available on the market in all EU member states without limitations.
However, product labels have to be adequately translated into the local language of the EU member state, additional individual member state requirements that are out of scope of the EU Cosmetics Regulation may apply such as related to packaging waste, and other over-arching regulations that apply to multiple product categories will have to be taken into account such as the EU REACH Regulation.
For each individual product that is available in the EU, the Responsible Person (RP) is required to ensure full product compliance and safety and be able to demonstrate at all times. The RP must be an EU legal entity (a person/company established in a EU member state).
The key requirements are:
The Responsible Person (RP) must be in possession of the full dossier for each cosmetic product on the EU market. The dossier contains essential information regarding the composition, raw materials, purity, safety (toxicology), stability, claim support, etc. The dossier can be regarded as a products “passport” for the EU market. Product dossiers must at all times be available to the competent authorities for inspection at the premises of the RP within 72 hours following on the request
The Responsible Person must ensure that each product has been assessed and has proven to be compliant safe for consumer use before it is introduced on the market. This assessment must be performed by a qualified “Competent Person” according to the set of rules provided in the Annex of the regulation. The Competent Person must hold a degree in toxicology or equivalent qualification in related health sciences.
Cosmetic products on the EU market must be labelled according to strictly defined requirements. The label content depends on the product characteristics, individual raw materials and substances, the product dossier and the related Safety Assessment.
The name and the address of the RP must be displayed on the product label. For TRC the minimum RP details to be displayed on the label are “TRC 2514 AA NL” for the EU (and “TRC UK EC2V 6AA UK” for the UK).
Product marketing claims communicated to the consumer must be in line with EU requirements and guidelines, must be supported with scientific evidence, and cannot claim any pharmacological (medical) effect.
Special attention must be paid to the language requirements, formats and font sizes in which the information is presented.
Cosmetic products must be notified to the competent authorities by electronic means. These notifications (often called registrations) must be submitted centrally by or on behalf of the RP in the EU Cosmetic Product Notification Portal (CPNP) before the products are introduced on the EU market. The notification is valid for marketing in all individual EU member states and EEA countries.
The Responsible Person must ensure to continuously monitor, record and evaluate (post-marketing surveillance) all potential health-related undesirable effects (consumer complaints) resulting from the use of the cosmetic product. This is referred to as "Cosmetovigilance".
The cosmetovigilance records must be regularly evaluated and re-assessed with respect to product safety. If the RP considers or has reason to believe that the product is not safe for use, he should take appropriate further steps (e.g. product adjustment, EU warning system, market withdrawal and/or product recalls) to ensure adequate protection of consumer health and safety.
Any changes/adjustments to the product and/or relevant legislation must be assessed and be accommodated for, e.g. updates of the PIF, the Regulatory Compliance and Safety Assessment, labels and claims, and the CPNP notification.
We focus on the interests of our clients while supporting on a daily basis with comprehensive in-house services including compliance safety assessment and serving as the RP.
We can be ready for notification in the EU in 2-3 weeks after all required input information has been shared, provided that you share an updated label with us including our EU/UK RP details. These timelines also apply in case of transfer to TRC as the new Responsible Person.
Some key and unique features of our services are:
Having the safety assessments performed in-house by your Responsible Person has clear advantages in terms of efficiency, lead-times, and costs. In the case of 2 separate entities, both will have split interdependent tasks and responsibilities and for example will both have to analyse and evaluate your formulations. And in the case of adjustments and updates both entities would have to be involved.
Cosmetic products must be labelled according to strictly defined labelling requirements. For each product we will share a label content brief to ensure all mandatory content is included on your product labels. The brief is shared in pdf format so that it can easily be shared in the artwork design process.
Our RP details are very much “codified” to avoid confusing/distracting the consumer. For the EU these are "TRC 2514 AA NL”. No other EU address is needed on your product labels.
TRC keeps track of regulatory changes in all applicable elements of EU regulations, will inform you timely about the impact on your product portfolio, and will advise on alternatives and how to stay compliant in the ever changing field of regulations.
CPSR are required to be updated in case of relevant changes, such as changes in ingredients and their suppliers, and changes in formulations. Also in case authority requests and inspections it is very valuable to pull together the latest real-time details, and make an up-to-date CPSR and PIF available.
Contact us for a free (video) call. Our first step is always to understand where you stand, and as a next step we will discuss more detailed information needed to perform a free Prescan of your products.
Important input for the free Prescan is information about your product positioning, marketing claims, the exact qualitative and quantitative composition of your formulations, and the availability of substantiation for the shelf-life and period after opening (PAO) of the portfolio.
We are flexible to set-up an introductory (video) call at a day and time that is convenient to you.
All-in full-service solutions through a clear and easy process towards safety and compliance of your cosmetics.
The solutions include our in-house Prescan, PIF services, Safety Assessment, label and claim review, and product notifications (EU/UK)/FDA product listings (USA).
Responsible Person services (EU/UK)/US Agent services are included as needed for your portfolio.
The comprehensive compliance and safety management software for Responsible Persons, (3rd party) manufacturers, importers, and large brand owners.
A robust cloud-based software to fully digitally and easily manage PIF's, product safety and compliance, and REACH obligations.
A 24/7 accessible eco-system with real-time insights in full portfolio safety and compliance against the latest included regulatory and toxicology data.