Cosmetics
Cosmetic products — good manufacturing practice, safety substantiation, and the new MoCRA accountability regime.
What this page does not claim
SPEQ decodes published standards and does not determine which apply to your product. An industry’s counts measure SPEQ’s coverage, not the size of its rulebook.
WHAT THIS INDUSTRY COVERS
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.
REGULATORY LANDSCAPE
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.
WHY THIS PRODUCT IS HARD TO CONTROL
There is no approval step, which changes everything upstream of the market. In the European Union a cosmetic is placed on the market on the responsibility of a named person, backed by a safety assessment signed by someone holding a qualification the regulation itself specifies — nobody reviews it first. In the United States, MoCRA introduced facility registration, product listing and safety substantiation, but again no pre-market approval. So the control is entirely anticipatory: exposure has to be estimated for the realistic and the foreseeable use, for populations including children, before anything ships, because there is no gate later at which someone else will check.
WHAT QUALITY MEANS HERE
Cosmetics GMP (ISO 22716)
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.
Safety substantiation
Documented evidence that each product is safe — the EU Cosmetic Product Safety Report and MoCRA’s safety-substantiation records.
Registration & accountability
Facility registration, product listing, and a designated Responsible Person — the accountability layer MoCRA and the EU regulation both require.
Adverse-event & cosmetovigilance
Serious-adverse-event reporting (MoCRA) and cosmetovigilance (EU) — the post-market safety loop new to much of the industry.
STANDARDS SPEQ DECODES · 6
Open the full library →WHERE QUALITY FAILS
- 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
GXP DISCIPLINES IN THIS INDUSTRY
Cosmetics: frequently asked questions
Quick answers to common questions about GxP in Cosmetics.
What regulations govern cosmetics manufacturing?
The EU Cosmetic Products Regulation (1223/2009) is the global reference, with its Responsible Person, Product Information File, and safety report. In the US, the Modernization of Cosmetics Regulation Act (MoCRA, 2022) and the 21 CFR 700-series apply. ISO 22716 is the international GMP baseline both regimes lean on.
What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 — the most significant expansion of US cosmetics oversight in decades. It introduces facility registration, product listing, safety substantiation, and serious-adverse-event reporting, moving the category toward a registration-and-accountability model.
What GMP standard applies to cosmetics?
ISO 22716 — a right-sized good-manufacturing-practice standard for production, control, storage, and shipment. It is the international baseline that both the EU Cosmetic Products Regulation and the incoming US GMP requirements draw on.