— Services —

EU Cosmetics

Compliance Services

regulation

EC 1223/2009

notification portal

CPNP

Markets covered

27 EU + EEA

REady in

2–3 weeks
— TRC, your trusted compliance partner

All-in Responsible Person services including Safety Assessments

Benefit from our all-in full-service solutions with our in-house PIF services, Safety Assessment (CPSR), label and claim review, CPNP notification, and including EU Responsible Person services.

A fast track service. We can be ready for notification in the EU in 2-3 weeks after all required input information has been shared. These timelines also apply in case of transfer to TRC as the new Responsible Person (RP).

In-house Compliance and Safety Assessments & RP services in 1

Combine your Safety Assessment and Responsible Person services within one expert team. This reduces duplicated work, as the same team reviews your formulations and compliance documentation, resulting in shorter lead times, lower costs and clear responsibilities. When formulations, labels or other product information change, updates can also be assessed and managed within the same team.

Label Content Briefs

For each product, we share an up to date label content brief for every artwork production to ensure all mandatory content is included on your product labels including the ingredient list, mandatory warnings/instructions and other details. Easy to share in your label design process.

Codified RP details

Our EU RP details are presented in a concise format (“codified”) to minimise the impact on your design, and to avoid confusing or distracting the consumer. For the EU, the required label text is simply “TRC 2514 AA NL”. No additional EU address details are required.

Targeted compliance and safety monitoring

Instead of sending generic regulatory alerts, we notify you only when action is relevant to your portfolio.TRC keeps track of amendments that impact your products and formulations. We tell you exactly which products are impacted, how they are affected and what action is required, so you can manage remaining stock and adapt your products in time to meet new requirements.

CPSR reports, updated on request, included in our services fees

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.

Powered by PRIMS Compliance and Safety Software

Managing change is complex and cannot do without software to manage continued compliance and safety. Changes/adjustments in products, formulations, raw materials, packaging, suppliers, labels, claims and regulatory amendments all happen simultaneously and impact each other.

— The TRC method

Compliant in 5 steps.

Our structured compliance process removes complexity and creates a clear, easy pathway to market – in every jurisdiction, powered by PRIMS Compliance and Safety Software in every step.

The process aligns with the requirements of the regulations and includes all the prerequisite services needed for compliance and safety as needed for your portfolio:

1

Prescan

Initial assessment of your formulations, product label and marketing requirements, discuss your product dossiers.

2

PIF Building

Compilation and structuring of a complete PIF, including all required technical documentation and records.

3

CPSR

Safety Assessment and Cosmetic Product Safety Report (CPSR) by qualified in-house toxicologists and safety assessors.

4

Label & Claim Review

Regulatory review of product labelling, INCI ingredient listings and marketing claims prior to market launch.

5

Notification / Listing

Submission of product notifications and listings through CPNP (EU), SCPN (UK), FDA systems (USA) or Health Canada.

— About the regulations —

What is the EU Cosmetics Regulation?

Cosmetic products placed on the market in the EU, EEA countries (Iceland, Norway, Liechtenstein), and Northern-Ireland are regulated centrally under the EU Cosmetics Regulation (EC) No. 1223/2009, together with its subsequent amendments and guidelines.

Under this framework, EU manufacturers and EU importers of products manufactured outside the EU are by definition considered the Responsible Person (RP) and carry the associated legal responsibilities. Brand owners located outside or inside the EU can appoint a Responsible Person (Article 4 and 5 of the European Cosmetics Regulation). Only a legal or natural person established within the EU can be the Responsible Person. An RP must ensure full product compliance and safety, and be able to demonstrate that in front of the competent authorities at all times.

The Regulatory Company acts as the Responsible Person for many non-EU cosmetics brands and is mandated by many EU importers to assume Responsible Person obligations on their behalf.

Legal basis

Regulation (EC) No 1223/2009

RP requirement

Mandatory — must be established in the EU

Notification

CPNP before first product placement

Geographic scope

EU + EEA + Northern Ireland

— Key requirements

6 key requirements in the EU Cosmetics Regulation

The EU Cosmetics Regulation is complex, and for each individual cosmetic product placed on the market, the Responsible Person (RP) is required to ensure full product compliance and safety, and must be able to demonstrate this at all times. The RP must be an EU-based legal entity (a person/company established in an EU member state).

Product Information File (PIF)

‍‍The RP must hold a full dossier for every cosmetic product placed on the EU market. The PIF dossier contains essential information regarding the composition, raw materials, purity, safety (toxicology), stability, claim support, etc. The dossier can be regarded as a product’s “passport” for the EU market. Product dossiers must always be available to the competent authorities for inspection at the premises of the RP within 72 hours following the request.

Regulatory Compliance & Safety Assessment (products & raw materials)

The RP must ensure that each product has been assessed and proven to be safe for consumer use before it is placed on the EU market. This assessment must be performed by a qualified “Competent Person” (Safety Assessor) 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.

Correct labeling and consumer information (including product claims)

The mandatory label content depends on the product characteristics, individual raw materials and substances, the product dossier and the related Safety Assessment (CPSR). The name and the address of the RP must be displayed on the product label. The claims must be in line with EU requirements and guidelines, must be supported with scientific evidence. Special attention must be paid to the language requirements, formats, presentation and font sizes in which the information is presented.

Product notification

‍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.

Cosmetovigilance

‍The RP must continuously monitor, record and evaluate (post-marketing surveillance) all potential health-related undesirable effects (consumer complaints) resulting from the use of the cosmetic products. The cosmetovigilance records must be regularly evaluated and re-assessed with respect to product safety.

Continuous updates and monitoring

Any changes/adjustments to the product and/or relevant legislation must be assessed and reflected in the PIF, the Regulatory Compliance and Safety Assessment, labels and claims, and the CPNP notification, to ensure continued compliance.

digital first

powered by PRIMS software

experience

15+ years

Responsible Person

5000+ products

portfolio

all product types
—all-in services —

4 key markets, 30+ countries

European Union

Cosmetics Regulation EC 1223/2009

United Kingdom

UK Cosmetics Regulation 2019

United States

MoCRA (federal) & state level Regs.

Canada

Canada Cosmetics Regulation

individual services
Safety & Compliance Assessment (CPSR)

Full cosmetic compliance and safety assessments and reports (CPSR part A and part B) by qualified in-house toxicologists, continuously updated.

Training, Consulting & Outsourcing

Regulatory training, strategic consultancy and outsourced regulatory affairs support for your team.

REACH / CLP (EU, UK)

REACH and CLP compliance reviews, supplier verification and substance assessments on product or portfolio level.

PPWR (EU)

Integrated centralised product and packaging compliance service powered by PRIMS Compliance Software

Common questions about EU compliance

One EU Responsible Person covers all 27 EU member states, plus the EEA countries — Iceland, Norway and Liechtenstein. Northern Ireland is also covered under the EU Cosmetics Regulation as part of the Windsor Framework. A single TRC RP appointment gives you access to this entire market.

When TRC acts as your EU Responsible Person, the codified address on your label is: TRC 2514 AA NL. This concise format satisfies the EC 1223/2009 label requirement while keeping label space clean. For UK products, the equivalent is: TRC UK EC2V 6AA UK.

Once TRC has received all required information and documentation from you, we can typically have your product ready for CPNP notification within 2–3 weeks. The timeline for building the PIF and producing the CPSR varies by product complexity and the availability of safety data.

Since Brexit, the UK and EU are separate regulatory regimes requiring separate notifications and separate Responsible Persons. However, TRC can manage both markets in a coordinated way from a single process, reducing duplication of effort.

Yes. When TRC is your ongoing Responsible Person, updates to your CPSR required by regulatory changes — such as new Annex restrictions or updated SCCS opinions — are covered within your service fee. You will not be invoiced separately for routine compliance maintenance.

TRC monitors regulatory amendments as part of our ongoing RP service. When changes affect your products — for example new restrictions in the Annexes — we notify you proactively and manage any required updates to your PIF and CPNP notifications.
— Get in touch —

Take your next step towards EU compliance

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