Cosmetic Product Safety Reports, ingredient safety assessments and SCCS-style review of finished products — signed off as a qualified Safety Assessor for both EU and UK markets, and structured so your Responsible Person can respond to authority questions with the reasoning already in place.
A safety file the Responsible Person can defend.
The Responsible Person carries the legal liability — not the assessor, not the brand, not the contract manufacturer. We structure every file around the questions a market-surveillance authority opens a CPSR to ask.
From ingredient dossier to Part B sign-off — the same reasoning, applied at every concentration and product format.
From ingredient triage at formulation through to SCCS opinion response — concrete points across the lifecycle where senior cosmetic-safety input shapes the file.
From formulation triage to SCCS opinion response — safety assessments structured to hold up under market-surveillance review.
Brand owners launching a new range who need a Safety Assessor on the file. Contract manufacturers needing CPSRs across a portfolio with consistent reasoning. Indie brands navigating UK SCPN alongside EU CPNP for the first time. We also support clients facing cosmetovigilance signals or market-surveillance correspondence.
A cosmetic ingredient under reformulation had no usable in vivo DART data — and animal testing was not an option under EU Cosmetics Regulation Article 18.
No usable in vivo developmental and reproductive toxicity data, a strict animal-testing prohibition under Article 18, and a regulator-facing safety case that still had to stand on its own.
Outcome. DART data gap addressed without animal testing. Safety margin demonstrated using internal-dose comparison. SCCS submission supported by transparent NAM-based reasoning, with the NAM/PBPK framework reusable for related ingredients.
Most cosmetics conversations start in one of these five places. If yours doesn't fit, send it through anyway — we'd rather hear the question than guess at it.
Yes, for both EU and UK markets. The Article 10(2) competence requirements under EU 1223/2009 and the UK Cosmetics Regulation specify a university qualification in pharmacy, toxicology, medicine or a similar discipline. CPSRs are signed by senior toxicologists at NexGenTox holding qualifying degrees in pharmacology or toxicology, together with European Registered Toxicologist (ERT) credentials and over 20 years of cosmetic safety assessment practice. Sign-off includes MoS modelling, foreseeable use reasoning and assessor signature.
Per IFRA standards and the 26 + 81 SCCS-listed allergens, with concentration-specific MoS and labelling assessment. Where IFRA certificates are missing or insufficient, we work with the supplier to obtain compliant documentation before sign-off.
Through weight-of-evidence assessment of endocrine activity and adversity at realistic cosmetic exposure levels, following SCCS scientific reasoning. We distinguish hazard signals from biologically relevant effects, integrate in vitro mechanistic data with apical evidence where available, and document uncertainty transparently. The aim is a defensible position on whether endocrine activity translates into concern under intended cosmetic use, supported by structured documentation of activity, adversity and uncertainty.
Through structured read-across, weight-of-evidence reasoning and NAM-derived evidence, applied within frameworks recognised by SCCS. Where ingredients lack conventional in vivo data, we build the safety case using analogue data, in silico predictions, in vitro bioactivity and, where useful, PBPK-informed internal exposure modelling — with uncertainty handled transparently rather than hidden in defaults.
Yes. We prepare SCCS-compliant safety dossiers for ingredients under expert review, address Notes of Guidance requirements, and respond to SCCS comments, clarifications or requests for further justification with structured technical responses.
Tell us the product, the market and the launch date. We'll come back with an initial scope and a fit assessment.