Cosmetics

Cosmetics covers products applied to the body to cleanse, beautify, or alter appearance — from formulation and manufacture through safety substantiation and labelling. Long the lightest-regulated consumer category, it is now moving toward a registration-and-accountability model, especially in the US under MoCRA.

Governed by the EU Cosmetic Products Regulation (1223/2009) — the global reference, with its Responsible Person, Product Information File, and safety report — and, in the US, the Modernization of Cosmetics Regulation Act (MoCRA, 2022) plus 21 CFR 700-series rules. ISO 22716 is the international GMP baseline both regimes lean on.

A right-sized good-manufacturing-practice system for production, control, storage, and shipment — the baseline both the EU and (incoming) US GMP requirements draw on.

Documented evidence that each product is safe — the EU Cosmetic Product Safety Report and MoCRA’s safety-substantiation records.

Facility registration, product listing, and a designated Responsible Person — the accountability layer MoCRA and the EU regulation both require.

Serious-adverse-event reporting (MoCRA) and cosmetovigilance (EU) — the post-market safety loop new to much of the industry.

• ›Microbial contamination of water-based or preservative-light products
• ›Prohibited or restricted ingredients in the formulation
• ›Missing or inadequate product safety substantiation
• ›Undeclared or mislabelled ingredients and misbranding

Derived from the 4 standards SPEQ decodes for this industry.