Regulatory Expertise
Novel Ingredients
Bringing a new or little-used ingredient to market: the toxicological dossier the safety assessment needs, nanomaterial and CMR rules, and the new-ingredient registration regimes in markets such as China.
An ingredient without an established safety history is the hardest thing to assess, because there is no body of regulatory precedent to lean on. The work is to build that evidence to the standard a regulator will accept.
What a new ingredient needs
The safety assessor works to the data requirements in the SCCS Notes of Guidance, currently the 12th revision (SCCS/1647/22), which means a toxicological dossier covering the relevant endpoints, including genotoxicity, sensitisation and systemic effects, with exposure modelled for the intended use. Nanomaterials carry a separate notification obligation under Article 16 of Regulation (EC) No 1223/2009, and substances classified as carcinogenic, mutagenic or reprotoxic are governed by Article 15. It is worth keeping the cosmetic-novel line distinct from the novel-foods regime, which applies to ingestible products, not topical ones.
Beyond the EU and UK
Several markets operate their own new-ingredient gateways. China requires registration or notification of a new cosmetic ingredient through the NMPA, with a three-year monitoring period before it joins the existing-ingredient inventory. We compile the dossier, commission the testing where it is missing, and assess the ingredient for each market in scope.
Relevant services
CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →Testing
From £75
Stability, microbiology, photoprotection and analytical testing carried out in our three in-house laboratories. Analytical work is not contracted out; results pass directly to the assessor preparing your CPSR.
Learn more →Frequently asked questions
What is a CPSR?
A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.
What testing does Oxford Biosciences provide?
Oxford Biosciences operates three in-house laboratories supporting Annex I, sections 3 to 5 of Regulation (EC) No 1223/2009. Services include microbiology (Preservative Efficacy Test to ISO 11930, Microbial Content Test to ISO 17516:2014), real-time and accelerated stability and packaging compatibility, photoprotection testing (in vitro and in vivo SPF and UVA-PF under the current ISO series), and analytical work including heavy metals by ICP-MS, antioxidant capacity by the DPPH assay, and GC/MS constituent analysis of essential oils, hydrolats and perfumes. Analytical work is not contracted out.
Who is qualified to sign a CPSR?
Article 10(2) of Regulation (EC) No 1223/2009 requires that the Part B safety assessment be carried out by a person holding a diploma in pharmacy, toxicology, medicine or a similar discipline. At Oxford Biosciences every assessment is conducted and signed by a Clinical Pharmacologist who holds an MSc from the University of Oxford. The assessor's credentials and approval form part of Part B and are the basis on which a competent authority evaluates the report.