— Services —
CCosmCCosmetic Product Safety and Compliance Assessment (CPSR)
Our cosmetic product safety and regulatory compliance assessments cover the EU, UK, US and Canada. All our assessments and reports meet the EU and UK CPSR requirements, the US MoCRA guidelines for safety substantiation, and Canadian requirements on product safety assessment. The assessments are performed by in-house toxicologists and chemists, all highly qualified and experienced safety assessors.
regulation
Food and Drugs Act + Cosmetics Regulations
assessment by
In-house qualified Safety Assessors
EU Markets covered
EU, UK, US, Canada
REady in
2–3 weeks
— services —
A safety assessment that evolves with your product.
The requirement for safety assessment based on robust toxicology data and accepted exposure calculation standards is consistent across markets, but the regulatory requirements and needed output documentation differ. TRC applies a rigorous safety assessment process to your product and delivers the right documentation for each market, from CPSRs for the EU and UK, to safety substantiation under MoCRA for the US, and product safety documentation for Canada.
We combine the regulatory compliance review of your formulation with an in-depth high quality safety assessment, bringing both compliance and safety perspectives together in one process. Our experts assess the formulation, raw materials, individual substances and relevant product data against the applicable regulatory and toxicological requirements. The outcome is documented in a concise easy to read Cosmetic Product Safety Report (CPSR), signed of with safety assessor details and credentials, and accompanied with a complete product information file (PIF) organised into specification specific folders for easy reference and limited disclosure.
We perform 1-off assessments as a standalone service. At the same time, we advise a continuous service to not stop when the safety report is issued. For most of the products that we assess, we continue to monitor regulatory amendments and toxicological developments that may affect product status. And we process updates in your suppliers, ingredients, formulations and products to ensure compliance and safety today and tomorrow.
— CPSR services for EU/ UK
What is a Cosmetic Product Safety Report?
The Cosmetic Product Safety Report, or CPSR, documents the compliance and safety assessment of a cosmetic product and forms an essential part of the Product Information File (PIF).
Under EU Cosmetics Regulation (EC) No 1223/2009, the Responsible Person must ensure that a cosmetic product has undergone a safety assessment before it is placed on the market and that a CPSR is prepared in accordance with Annex I. The safety assessment must be performed by a suitably qualified safety assessor. The UK has corresponding requirements for cosmetic products placed on the Great Britain market. The USA and Canada regulations include a hard requirement on product safety substantiation, and accept the EU/UK safety assessment standard.
The EU/UK CPSR consists of two parts
— United states
What is safety substantiation under MoCRA?
In the US, the Responsible Person (the manufacturer, packer or distributor whose name appears on the cosmetic product label) must ensure and maintain records supporting adequate substantiation of safety for each cosmetic product under MoCRA. Unlike the EU and UK, there is no prescribed CPSR format.
TRC builds and documents the scientific basis for your product’s safety substantiation, assessing the formulation, toxicological data, exposure, intended use and available safety evidence. We identify any gaps and define the additional data or testing required to complete the assessment.
Already have an EU or UK CPSR? We build on the safety assessment and data you already have to address the US-specific requirements to establish your MoCRA compliance and safety substantiation. We also include individual state-level compliance in our analyses.
— Canada
Cosmetic Safety Assessment for the Canadian market
Canada allows manufacturers and importers flexibility in how product safety is established, but the duty and responsibility for ensuring safety remains clear.
We assess your formulation, ingredients, toxicological data, exposure and product-specific information against Canadian requirements, including the Cosmetic Ingredient Hotlist. We bring the scientific evidence together, document the safety rationale and identify any gaps that need to be addressed.
If an EU/UK CPSR or US safety report is already in place, we build on the relevant existing data, making the Canadian assessment process shorter and more efficient.
— our approach —
Regulatory compliance and safety assessed together
Safety and regulatory compliance are closely connected, but they are not the same assessment.
Our experts first establish whether the formulation complies with the applicable cosmetics legislation. This includes checking prohibited and restricted substances and verifying the permitted use and concentrations of regulated colourants, preservatives and UV filters, where applicable.
We then assess the safety of the product based on its composition, intended use, exposure and the available toxicological data.
This integrated approach means that regulatory restrictions, toxicological endpoints and actual product use are considered together before the final safety conclusion is made.
— CPSR documentation —
What input information is needed for a CPSR?
A reliable safety assessment starts with reliable product and supplier data. Depending on the product, the following input information and supporting documentation is required, covering:
We review the available input documentation and identify missing information that must be addressed before the safety assessment can be completed.
Building the full PIF to include all relevant input information is closely interconnected with the completion of the assessment and the creation of the CPSR report.
The CPSR is not a stand-alone document, but becomes part of the full PIF file together with all input, product artworks, confirmations of product notifications/listings, adverse event records, and all other information that is relevant to be kept on file.
— 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:
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.
— TRC & PRIMS
Safety assessment powered by PRIMS Software
TRC assesses and manages product compliance and safety powered by PRIMS (Product Regulatory Information Management & Safety) Software.
Developed in-house by experts for experts. Initially for internal purposes only, to offer a high-quality standardised and scaleable service, but now also available to brands, manufacturers, consultants as a stand-alone licensed tool or to combine with TRC services.
Product, formula and raw material data and documentation is structured and managed down to substance level with embedded versioning and traceability functionality. Regulatory, toxicology and exposure scenario databases are included and kept up to date and expanded continuously by the TRC team to be applied consistently across the product portfolio.
To assess and monitor compliance (current and future) and safety in real-time for individual products and full portfolios, PRIMS brings together the product composition, cumulative substance concentrations, exposure parameters, regulatory information, toxicological data and relevant supporting documentation.
— all-in services —
4 key markets, 30+ countries
