MoCRA and EU 1223/2009: The Formulation Record Behind a Cosmetic Product Safety Report
A safety assessor asking how much of an impurity is in a finished product should not need nine working days and three supplier emails to answer it. A Cosmetic Product Safety Report or MoCRA safety-substantiation file is only as reliable as the formulation record beneath it.
Most of the required evidence begins in R&D, not during the assessment. Under EU Cosmetics Regulation 1223/2009, the Cosmetic Product Safety Report must cover composition, physical and chemical characteristics, microbiological quality, impurities, packaging, exposure, toxicological profiles, undesirable effects, and related product information. If composition exists only at trade-name level, however, teams cannot reliably trace the substances inside a supplier blend or calculate exposure at the level a safety assessment requires.
The EU and US requirements overlap, but they are not identical. EU rules require a safety assessment and Cosmetic Product Safety Report before a product is placed on the market, while MoCRA requires the responsible person to maintain adequate safety substantiation supporting a reasonable certainty of safety. In both cases, formula version control and change traceability determine whether evidence can be retrieved, refreshed, and defended.
This white paper is for cosmetics regulatory and product-safety leaders working with R&D teams that own the underlying formulation data. It explains what the formulation record needs to contain, at what level of granularity, and how changes should trigger a controlled reassessment.
Inside this white paper:
- The formulation data required to support a Cosmetic Product Safety Report
- Why trade-name-level composition creates gaps in impurity and exposure analysis
- How margin-of-safety calculations depend on product category and use conditions
- Where EU 1223/2009 and MoCRA requirements align and differ
- Which formulation, supplier, fragrance, and packaging changes reopen a safety assessment
Build a formulation record that answers a safety question by query, not by investigation.
FAQs
A Cosmetic Product Safety Report is the specific, Annex I-structured safety assessment the EU requires before a cosmetic product is placed on the market. MoCRA, the US law, requires "adequate substantiation of safety" instead, an outcome standard without a prescribed report structure. Both draw on the same underlying formulation record.
EU Annex I Part A requires the chemical identity, CAS number, EC number, and intended function of every substance in a finished product. A trade-named raw material can itself be a blend of several substances, so a record that stops at the trade name can't answer impurity, exposure, or margin-of-safety questions the assessment needs.
A change to active concentration, preservative system, fragrance compound, supplier specification, packaging material, or a label claim can each reopen the safety assessment, the regulatory notification, or both, depending on what changed and which regime applies.
Not yet in full. MoCRA sets an outcome standard rather than a prescribed dossier structure, and as of this paper's publication several implementing rules, including fragrance allergen disclosure and cosmetic good manufacturing practice, are still proposed, undated, or withdrawn rather than final.
See the Platform Behind the Guide
