MoCRA and EU 1223/2009: the formulation record behind a cosmetic product safety report
A Cosmetic Product Safety Report or MoCRA safety-substantiation file is only as reliable as the formulation record beneath it. 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 get the answer. MoCRA and EU 1223/2009: The Formulation Record Behind a Cosmetic Product Safety Report is a white paper that specifies, field by field, what that record must contain.
Most of the required evidence begins in R&D, not during the assessment. If composition exists only at trade-name level, teams cannot reliably trace the substances inside a supplier blend or calculate exposure at the level a safety assessment requires. A trade-named raw material can itself be a blend of several substances.
What formulation data does a cosmetic safety assessment need?
A cosmetic safety assessment needs substance-level composition, not trade-name composition. Under EU Cosmetics Regulation 1223/2009, the Cosmetic Product Safety Report covers composition, physical and chemical characteristics, microbiological quality, impurities, packaging, exposure, toxicological profiles, undesirable effects, and related product information. Annex I Part A asks for the chemical identity, CAS number, EC number, and intended function of every substance in the finished product.
The EU and US requirements overlap but are not identical. The EU requires a safety assessment and 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 decide whether evidence can be retrieved, refreshed, and defended. That is why regulatory management works best on the same record R&D uses to build the formula.
Who this white paper is for
Cosmetics regulatory and product-safety leaders working with the 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.
What's inside
Inside this white paper:
- The formulation data required to support a Cosmetic Product Safety Report, covering composition, impurities, fragrance, and exposure
- 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
- Five open US regulatory questions
Download the white paper and build a formulation record that answers a safety question by query, not by investigation. For the reformulation side of the same problem, see the cosmetics and personal care solution brief.
FAQs
A Cosmetic Product Safety Report is the Annex I-structured safety assessment the EU requires under Regulation 1223/2009 before a cosmetic product is placed on the market. MoCRA, the US law, instead requires adequate substantiation of safety, an outcome standard without a prescribed report structure. Both the EU report and the MoCRA substantiation file draw on the same underlying formulation record.
A cosmetic formulation record needs substance-level composition because 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 cannot answer the impurity, exposure, or margin-of-safety questions a safety assessment needs.
A change to active concentration, preservative system, fragrance compound, supplier specification, packaging material, or a label claim can each reopen a cosmetic product's safety assessment, its regulatory notification, or both. Which one depends on what changed and which regime applies. Formula version control and change traceability make it possible to see which assessments a given change affects.
Not yet in full. MoCRA sets an outcome standard rather than a prescribed dossier structure like the EU Cosmetic Product Safety Report. As of the white paper's publication, several MoCRA implementing rules, including fragrance allergen disclosure and cosmetic good manufacturing practice, were still proposed, undated, or withdrawn rather than final.
The MoCRA and EU 1223/2009 white paper is for cosmetics regulatory and product-safety leaders and the R&D teams that own formulation data. The white paper specifies what the formulation record behind a Cosmetic Product Safety Report or MoCRA substantiation file must contain, at what granularity, and which changes should trigger a controlled reassessment.
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