All of the world’s cosmetic regulators focus on the safety of cosmetic ingredients, rather than whether they work or not. Where regulators differ is how they treat so-called cosmeceutical and medical beauty ingredients that make scientific-sounding claims, or suggest mild therapeutic benefits.

Sunscreens are also handled differently depending on the regulator. The U.S. for example classifies sun protection products as drugs, whereas the EU treats them as cosmetics with additional requirements.

U.S. Food and Drug Administration (FDA)

In the United States, companies assume responsibility for the safety of their cosmetic products. The United States FDA only requires pre-approval for colour additives used in cosmetics. It tends to intervene reactively when safety or misbranding issues arise, since the U.S. system relies largely on post-market enforcement rather than pre-market authorisation.

There is no FDA requirement to prove that products work, unless a brand makes a claim that might classify it as a drug, which triggers stricter requirements.

EU and UK

Both the EU and UK require businesses to complete and retain a Cosmetic Product Safety Report (CPSR) before marketing a product, which needs to be signed by a qualified safety assessor.

Businesses also need to notify the relevant authority before marketing a product, either to the Office for Product Safety and Standards in the UK, or via the Cosmetic Products Notification Portal in the EU. Every product requires a ‘responsible person’ in the country.

In general, claims made regarding a cosmetic product need to be truthful, evidence-based, and not misleading. However the standard of proof for cosmetic claims is considerably lower than that required of medicines.

China and Japan

Beauty products that make mild therapeutic or preventive claims of efficacy, known as functional claims, require pre-market approval in Japan and China. These so-called quasi-drugs (Japan) or special cosmetics (China), represent a distinct category with their own rules.

Since 2021, under the Cosmetic Supervision and Administration Regulation (CSAR), China labels general care and makeup as ordinary cosmetics. Meanwhile hair growth, whitening, anti-hair loss, Sun Protection Factor (SPF) and anti-wrinkle are considered special cosmetics. Special cosmetics require evidence to support their claims of efficacy, and must await approval before going to market.

Japan’s equivalent to special cosmetics is quasi-drugs, which includes whitening and anti-dandruff products. The Ministry of Health, Labour and Welfare (MHLW) must pre-approve such ingredients that make mild therapeutic or preventive claims, unlike Western markets.

Australia

Australia stands out for its treatment of sunscreens. It requires all sunscreens intended primarily for sun protection, that make claims of SPF 4 or more, to be listed with the Therapeutic Goods Administration (TGA). Products such as moisturisers or lipsticks that are primarily marketed as cosmetics, but also provide SPF of less than 15, are subject to cosmetic regulation.

Recent controversies around SPF mislabelling has led to tighter post-market testing in Australia.

Regulator risk

In all Western countries, a cosmetic product that claims to treat, heal or prevent a skin condition such as acne, triggers extra regulator scrutiny. The product then runs the risk of being classified as a medicinal product, which can lead to lengthy and costly clinical trials, with uncertain outcomes - which most cosmetic companies are keen to avoid.