Novel Ingredients

An ingredient without an established safety history is the hardest thing to assess, because there is little regulatory precedent to lean on. The work is to build the evidence to the standard a regulator will accept, and to build it under the constraints of cosmetics law, which forbids animal testing for cosmetic purposes and so rules out the routes a toxicologist might otherwise reach for.

What the safety assessment needs

The assessor works to the data requirements of the SCCS Notes of Guidance, currently the 12th revision (SCCS/1647/22). For a substance with the potential to be absorbed, that means a toxicological dossier covering the core endpoints: acute toxicity, skin and eye irritation and corrosion, skin sensitisation, dermal absorption, repeated-dose toxicity, mutagenicity and genotoxicity, carcinogenicity where the profile warrants it, reproductive toxicity and toxicokinetics, with a margin of safety calculated from the no-observed-adverse-effect level against the systemic exposure dose for the intended use. Because in vivo testing for cosmetic purposes is banned, the 12th revision leans on New Approach Methodologies and Next Generation Risk Assessment: defined approaches for skin sensitisation, in vitro genotoxicity methods such as the 3D skin comet and the in vitro micronucleus test, in silico prediction, read-across to related substances, and the threshold of toxicological concern, all anchored to a realistic exposure estimate including aggregate and, where relevant, inhalation exposure.

Nanomaterials and CMR substances

Two categories carry extra obligations. A nanomaterial must be notified to the European Commission under Article 16 of Regulation (EC) No 1223/2009 six months before the product is placed on the market, in addition to the ordinary CPNP notification, with safety data specific to the nano form, since a substance can behave very differently at the nanoscale; the nano form is also declared in the ingredient list with “nano” in brackets. Substances classified as carcinogenic, mutagenic or reprotoxic are governed by Article 15, which prohibits their cosmetic use unless a narrow derogation applies. It is also worth keeping the cosmetic-novel question distinct from the novel-foods regime, which governs ingestible products, not topical ones, and does not apply to cosmetics.

Beyond the EU and UK

Several markets operate their own new-ingredient gateways, and they are not interchangeable. China requires a new cosmetic ingredient, meaning one not on the Inventory of Existing Cosmetic Ingredients in China, to go through the National Medical Products Administration: registration for higher-risk ingredients, such as preservatives, sunscreens, colorants, hair dyes and whitening agents, or notification for lower-risk ones, followed by a three-year safety-monitoring period before the ingredient joins the inventory and can be used freely. The United States has no general premarket approval for cosmetic ingredients, with colour additives the exception, but MoCRA’s safety-substantiation duty still has to be met. Each market sets its own data bar, so the same ingredient can need a different dossier in each.

How we help

We define the data requirements for each market in scope, audit the existing data against them, identify the gaps, and commission the missing non-animal testing through our laboratories and validated partners. We then compile the dossier and assess the ingredient to the SCCS Notes of Guidance for the EU and UK, and to the relevant national requirements elsewhere, so a new ingredient can be carried into several markets from one coordinated body of evidence rather than reassembled for each.