Reviewing fragrance allergens on a cosmetic label

Carry the formulation evidence into the artwork review

An allergen label review needs more than an ingredient line. Give the reviewer the formula revision, supplier evidence, calculation record, intended use and exact artwork panels. Record the market and the supply circumstances being considered. A corrected PDF with no connection to its evidence cannot explain why the wording changed.

The Commission's current overview distinguishes thresholds above 0.001% for leave-on products and above 0.01% for rinse-off products for covered Annex III fragrance allergens. The applicable entry, grouping, required name and conditions still need to be checked. This comparison is not a safety assessment or an assessment of all labelling duties.

Synthetic Product A: the same number, different questions

Use the wholly fictional calculation in I04: candidate Allergen A totals 0.0035% by mass in formula F03. The example deliberately does not identify a real Annex III substance. It therefore cannot produce a final ingredient-list instruction.

If the specialist confirms a matching entry to which those thresholds apply, 0.0035% is numerically above 0.001% and below 0.01%. That arithmetic illustrates why the intended leave-on or rinse-off use matters. It does not establish which category the real product belongs to, validate the inputs or resolve naming and transition conditions.

Record the intended use with its evidence. Do not change a cream's classification in a spreadsheet merely to obtain a different threshold comparison. Ask the reviewer to resolve an uncertain use or presentation before artwork instructions are issued.

Review each packaging component

Give the bottle, carton and any accompanying material separate identifiers. For each proposed correction, record the panel location, current wording, proposed wording, source finding and the formulation revision. Keep the designer's action separate from the specialist's instruction.

The worked file contains an unresolved placeholder for the ingredient-list correction on carton artwork 4. No real INCI wording is supplied for Allergen A. The next task is to obtain the identity and the review decision, not to print the placeholder or copy a name from another brand.

When a correction is agreed, compare the new artwork with the instruction. Record which panels were checked and retain the earlier copy. A designer can verify that instructed wording appears on the panel while the specialist retains responsibility for the scope and interpretation of that instruction.

Record dates through the actual supply question

The expanded requirements have transition conditions under Regulation 2023/1545. Ask which product, batch and placing-on-market evidence the specialist needs. Do not treat the 2028 milestone as a general extension for all newly supplied products, or use the date of an artwork export to establish the product's market history.

Keep the source version and date finding in the review record. GB and NI require their own scope checks; this EU worked comparison does not settle them.

Close the correction with a specific record

The final handover identifies the artwork revision, formula, source records, specialist finding, outstanding questions and correction verification. Keep the decision unresolved until the required evidence is available. Use the sample workspace to practise assigning the missing-information task; use released labelling and ingredient guides for later steps as they become available. The result should be a traceable correction, not a green badge based only on the presence of text.

Sources and legal dates