Source record
- Jurisdiction
- European Union
- Issuing authority
- European Commission
- Document status
- Implementation guidance on enacted legislation
- Regulation adopted
- Source checked
- Placing-on-the-market transition deadline (passed)
- Making-available transition deadline
Original documents
The practical priority is to connect each fragrance-allergen assessment to the formula, supplier information, approved label and stock it covers. A completed artwork project is only one part of that chain. Teams should also be able to explain which assessment informed the label and which products may still rely on a transition provision.
Jurisdiction: European Union. Status: implementation guidance for the existing changes introduced by Regulation (EU) 2023/1545. Checked: 17 October 2026. The relevant placing-on-the-market transition date has passed.1
Read the deadlines against the products being supplied
The relevant transition provisions allowed products that did not meet the new restrictions to be placed on the EU market until 31 July 2026, and made available until 31 July 2028. Conditions vary with the applicable entry; some expressly require compliance with the restrictions applicable on 15 August 2023.1
These are different supply-chain events. The Cosmetics Regulation defines placing on the market as the first making available; making available covers supply for distribution, consumption or use during a commercial activity.2 The Commission’s Blue Guide explains that placing concerns individual products, including units manufactured in a series, rather than the launch date of a product type.3
Build the transition review around identifiable stock. Record the product and label versions, quantities, relevant transactions and the evidence supporting the conclusion about placing. A familiar product name or an old launch announcement cannot, by itself, establish the position of units supplied later.
Where the supply history is unclear, assign a person to resolve it. Avoid allowing an uncertain classification to become a routine shipping assumption.
Assemble the ingredient information behind the assessment
Start with the exact formula version under review. Then gather the supplier declarations and composition information needed to assess its materials against the applicable Annex III entries.
For each document, record the supplier, material identity, issue date, revision and scope. Check whether it covers the specific material being purchased. A declaration associated with a similarly named fragrance deserves clarification before it is used in a calculation.
Ask suppliers to explain the basis of reported concentrations, the treatment of ranges and the meaning of any reporting limits. An empty cell needs an explanation. It should not silently become a numerical zero.
Review all relevant formula inputs when building the calculation. The administrative category assigned to a raw material should not determine whether its composition is considered. Keep a record of the assumptions used when information is incomplete, and obtain the clarification needed for a justified decision.
Calculate at the finished-product concentration
The expanded individual-labelling provisions use thresholds of more than 0.001% in leave-on products and more than 0.01% in rinse-off products. Apply the actual entry, including its required declaration name and any grouping or additional restrictions.1
Consider an illustrative calculation using mass percentages. A formula contains 0.50% of a fragrance mixture, and a supplier declaration reports 1.00% of a listed substance in that mixture. Its contribution to the finished product is:
0.50 × 1.00 ÷ 100 = 0.0050%.
For an entry using those thresholds, that contribution exceeds the leave-on declaration threshold. If another material contributes the same substance, include its contribution in the total. Preserve the calculation before rounding so the reviewer can follow the decision.
This example demonstrates dilution arithmetic. It does not establish the safety or overall compliance of a real formula. The person reviewing a real product needs to address the full applicable conditions and the quality of the input data.
Connect the assessment to the label actually used
Give the assessment a stable reference and identify the resulting ingredient-list version. The artwork review should then confirm that the intended text reached the packaging file supplied for production.
Use the current Annex III and applicable corrections during the assessment. EUR-Lex lists corrigenda associated with Regulation (EU) 2023/1545, so an unchanged copy of the original table should not be the team’s only reference.4
For a practical approval record, capture who checked the calculation, who reviewed the declaration wording, which artwork was approved and when it became available for use. Make superseded artwork recognisable wherever packaging is selected or ordered.
Also define what happens when a supplier issues revised information after approval. Assign the comparison, record which products are affected and document whether a new calculation or label review is required.
Plan the remaining stock work
For stock assessed as eligible for the transition, create a review list that purchasing, quality and distribution can use together. Suggested fields include batch or stock identifier, label version, quantity, location, relevant placing evidence and the next action.
Set internal checkpoints before the remaining deadline so there is time to reconcile quantities and resolve discrepancies. Ask distribution partners for the information needed to understand stock that has already left your own warehouse.
Keep the transition decision separate from other product checks. A conclusion about an allergen-labelling transition should not be used as evidence that every other requirement has been reviewed. Where a discrepancy is found, record the decision, responsible person, supporting evidence and completion date.
Make the review repeatable
If using software to screen formulas, check how it handles concentration calculations, labelling flags and scheduled rechecks. Use the results to prioritise documented review.
For any software-supported process, agree who maintains the input data, who investigates flags and who records the final decision. A useful demonstration is to change a supplier declaration in a test case and follow the work needed to reassess the formula and its label.
Before closing a product review, confirm that:
The assessment identifies the formula and supplier-document versions used.
Relevant contributions and assumptions are visible in the calculation.
The reviewer checked the applicable entry and declaration wording.
The approved artwork can be connected to the relevant stock.
Any reliance on a transition has supporting supply-history evidence.
Open questions have named owners and follow-up dates.
The outcome should be a record another colleague can follow from the source information to the product being supplied. That makes the next supplier change, artwork revision or regulatory review easier to manage.
Sources
European Commission / EUR-Lex. Commission Regulation (EU) 2023/1545: fragrance allergen labelling. ↩︎ ↩︎ ↩︎
European Parliament and Council / EUR-Lex. Regulation (EC) No 1223/2009 on cosmetic products: Article 2 definitions. ↩︎
European Commission. The Blue Guide on the implementation of EU product rules 2022, sections 2.2 and 2.3. Commission Notice 2022/C 247/01, sections 2.2 and 2.3; Official Journal PDF mirror. ↩︎
EUR-Lex. Regulation (EU) 2023/1545: document information and corrigenda. ↩︎

