Toxicology risk assessment (TRA)
Full toxicological risk assessments in line with the relevant territorial regulation.
Toxicological Risk Assessment
In today’s dynamic cosmetic and personal care industry, safeguarding consumer health is paramount. With an ever-expanding range of ingredients entering the market, the potential for adverse reactions or health risks underscores the need for robust toxicological risk assessments.
This service provides a structured evaluation of product safety, analysing ingredient profiles, exposure levels, and potential risks to ensure compliance with regulatory standards. Toxicological risk assessments are not limited to cosmetics alone—they are equally essential for products that may fall outside the strict definition of cosmetics but still require safety verification to protect consumers and demonstrate regulatory due diligence.
At ADSL, our experienced safety assessors deliver comprehensive toxicological risk assessments tailored to each product. By combining scientific expertise with a deep understanding of global regulations, we enable brands to confidently place safe, compliant products on the market.
Frequently asked questions about toxicology risk assessments
Why do I need one for my cosmetic or personal care product?
Regulations in the UK, EU, US, and other regions require manufacturers to demonstrate that their products are safe before they are placed on the market. A toxicological risk assessment provides the documented evidence of safety needed for compliance.
Does every cosmetic product require this assessment?
Yes. Under cosmetic regulations, all products must undergo a safety assessment. Even products that do not strictly fall under the cosmetic definition may still benefit from or require a toxicological risk review to demonstrate due diligence and protect consumers.
What information do I need to provide?
You’ll need to supply full details of your formulation (INCI and raw material composition), raw material safety data, manufacturing information, and supporting documents such as stability or microbiology results, if available.
How long does the process take?
The timeline depends on the completeness of the information provided and the complexity of the product, but we aim to work closely within your timeframe and constraints. Our customer service offer is designed to make your life as easy as possible with a dedicated point of contact in most cases and a detailed schedule to keep you up-to-date with the process.
What happens if my product does not pass the risk assessment?
Our assessors will provide clear feedback on the safety concerns identified and suggest practical solutions, such as reformulation, concentration adjustments, or additional supporting data.
What other services does my product require?
In addition to a toxicological risk assessment, cosmetic and personal care products must undergo a range of compliance steps before being placed on the market. These typically include a full Cosmetic Product Safety Report (CPSR), creation of a Product Information File (PIF), labelling and INCI compliance checks, stability and microbiological testing, and notification on the relevant regulatory portals. Depending on the product and its claims, further services such as claims substantiation, Good Manufacturing Practice (GMP) verification, and ongoing post-market surveillance may also be required. ADSL can support with all of these and work with you to create a clear plan to bring your product to market as efficiently as possible.
Why use ADSL?
Formed in 2008, our fully qualified, independent team of Chartered Chemists, Toxicologists, Microbiologists and Regulatory experts specialise in formulation and testing services within the cosmetic, household goods, food and industrial sectors. We are a UKAS accredited testing laboratory offering a range of accredited and non accredited microbiological tests. Our team includes individuals with a host of industry qualifications including Fellows of the Royal Society Of Chemistry and a “Chartered” Chemist and Scientist, Members of The Society Of Cosmetic Scientists, Members of the British Toxicology Society, Members of Society of Dermatology, Members of International Society of Dermoscopy, Members of European Academy of Dermatology & Venereology (EADV) along with Chem CSci, CChem FRSC and PhD attainment. With our exceptional expertise and complementary skills in manufacturing, process controls, industry regulation, health and safety, marketing, and project management we are with you every step of the way to see your product through to successful market launch. Furthermore, our technical consulting helps many businesses by cost effectively filling gaps in their skills and knowledge base and providing a fresh perspective and strategy on the best way forward. Fundamentally we have the the knowledge and know-how to successfully take your cosmetic product to market. Your product inside out.
We are the UK’s leading provider of toxicology risk assessments and supporting services
Concept to shelf
We deliver our extensive range of services from our own leading UK based facilities, meaning better support and service for you. Whether a full “turnkey” product development from concept to shelf is needed or a single regulatory or testing requirement, we can help from under one roof.
Trusted by leading brands
From household names to start-ups, we support brands of all sizes, helping them get their products on to the shelf. We have a wide range of testing & compliance capabilities to assist at every part of the development lifecycle process.
Unrivalled expertise
Experts in our field, we have over 20 years of cosmetic formulation, compliance, testing and safety experience. Through this experience we can help customers to navigate through the increasingly demanding regulatory landscape.
Ready to get started? Complete our enquiry form or get in touch with our team today +44 (0) 1803 520 048
Commission Regulation (EU) 2021/1902 (4th CMR Omnibus)
This regulation prohibits the use of 23 substances in cosmetic products and applies in the EU from 1 March 2022. These substances have been classified as carcinogenic, mutagenic and toxic to reproduction by Delegated Regulation (EU) 2020/1182 (15th ATP to CLP).
13/10/2022
Cosmetic Supervision and Administration Regulations (CSAR)
ADSL has for several years followed with interest the development of the new Cosmetic Supervision and Administration Regulations (CSAR) in China.
06/09/2022
European Commission Inception Impact Assessment on Review of the EU Cosmetics Regulation
The European Commission is reviewing the Cosmetics Regulation (EC) 1223/2009 as part of the EU Chemical Strategy for Sustainability.
13/10/2022