| Deadline | Regulation | What It Requires |
|---|---|---|
| May 01, 2026 Passed | Omnibus VIII (EU 2026/78) | CMR substance bans; no transitional period |
| July 30, 2026 | Updated INCI Glossary (EU 2025/1175) | 348 new/revised ingredient nomenclature entries; mandatory CI naming for non-hair-dye colorants |
| July 31, 2026 | Formaldehyde Releasers (EU 2022/1181) | Warning threshold drops from 500 ppm to 10 ppm |
| July 31, 2026 | Fragrance Allergens (EU 2023/1545) | Disclosure list expands from 26 to 81 allergens |
1. Audit Against Omnibus VIII CMR Bans (Regulation EU 2026/78)
Unlike routine regulatory transitions, Omnibus VIII took effect on May 01, 2026, with no transitional sell-through period. It updated the harmonized CMR (carcinogenic, mutagenic, reprotoxic) classification of several substances under CLP, which under Article 15 of the Cosmetics Regulation makes them prohibited in cosmetics by default. If a product contains a newly restricted substance, it cannot remain on the market — there is no grace period to document around.
PIF/CPSR Action Steps for Safety Assessors
- 1 Verify active formulations and raw material documentation. Audit all raw material Safety Data Sheets (SDS) and Certificates of Analysis (CoA) for newly classified CMRs — including specific silver forms, hexyl salicylate restrictions, and newly listed solvents and intermediates.
- 2 Confirm cross-contamination and impurity profiles. Ensure technical dossiers explicitly state that prohibited trace impurities do not exceed technically unavoidable limits (Article 17).
- 3 Update CPSR Part A and Part B. Where reformulation or a concentration adjustment is required, the Safety Assessor must re-evaluate Margin of Safety (MoS) calculations and reissue Part B.
2. Re-Align Ingredient Lists with the Mandatory 2026 INCI Glossary
As of July 30, 2026, Commission Implementing Decision (EU) 2025/1175 is the sole legally compliant reference for ingredient nomenclature across the EU market. The updated glossary adds 348 new ingredient entities, revises existing entries, and mandates Color Index (CI) nomenclature for non-hair-dye colorants. This is a naming-convention change, not a safety reassessment, but it's one of the more common ways a CPSR quietly drifts out of alignment with the physical label.
PIF/CPSR Action Steps for Quality & Regulatory Teams
- 4 Cross-check labeling against the revised glossary. Compare exact packaging text line-by-line against the new glossary designations.
- 5 Correct splitting and nomenclature changes. Ensure complex botanicals, modified polymers, and split designations are correctly reflected.
- 6 Match CPSR Part A to updated packaging. Verify the ingredient breakdown in Section 1 of CPSR Part A uses the exact INCI names reflected on commercial artwork, a mismatch between the CPSR and the physical label violates Article 19.
3. Verify Formaldehyde Releaser Thresholds & Fragrance Allergen Disclosures
Two labeling obligations reach full effect on July 31, 2026: the formaldehyde releaser warning threshold drops from 0.05% (500 ppm) to 0.001% (10 ppm) under Regulation (EU) 2022/1181, and mandatory fragrance allergen disclosure expands to over 80 individual substances under Regulation (EU) 2023/1545.
PIF Management Action Steps
- 7 Request updated supplier breakdown statements. Obtain full quantitative breakdown declarations from fragrance houses and raw material vendors for all 80+ listed allergens and formaldehyde-releasing preservatives (e.g., DMDM Hydantoin, Imidazolidinyl Urea, Sodium Hydroxymethylglycinate).
- 8 Trigger CPSR Section 2 (toxicological profile) updates. Ensure the Safety Assessor incorporates exposure calculations for newly disclosed individual allergens in Part A.
- 9 Update label artwork and CPNP notification. Amend packaging artwork and the Cosmetic Products Notification Portal entry to reflect the expanded INCI declarations.
Where PIF and CPSR Governance Tends to Break Down
These three deadlines share a common thread: none of them require a reformulation to trigger non-compliance. The gap is almost always in document governance, not chemistry. The following are the failure points we see most often when regulatory-triggered updates hit a PIF.
CPSR-to-Label Drift
The INCI glossary update makes this the highest-probability gap of the three. A CPSR that was accurate in June can be out of alignment with its own product label by August if the ingredient list wasn't re-checked against the new nomenclature — even though nothing about the formula changed.
Document Version Control
A CPSR is a living document, but many organizations still treat each revision as a one-off edit rather than a tracked change. Without a clear version history tied to the regulatory trigger that caused the update, it's difficult to demonstrate to an inspector why a revision happened and when.
CPNP Portal Lag
Label artwork and CPSR updates are often completed before the corresponding CPNP notification is amended — or vice versa. Any mismatch between what's declared in the portal and what's on the physical product is a visible, easily-flagged inconsistency during market surveillance.
Cross-File Consistency Across the PIF
A PIF has multiple internal sections — CPSR Part A and B, labeling, manufacturing method, product function — that all need to reference the same ingredient nomenclature and safety data. Updating the CPSR without propagating the same change through the rest of the PIF leaves an internally inconsistent file.
Responsible Person Sign-Off Traceability
Every CPSR revision requires re-approval through the Responsible Person. When updates are handled informally — a quick edit rather than a documented review and re-approval — that traceability gap is exactly what surfaces first in an audit.
The Audit Checklist: A Quick Action Summary for RPs
To ensure your PIFs are fully defensible during a competent authority inspection, follow this structural audit checklist:
| Document Section | Audit Action | Target Deadline |
|---|---|---|
| CPSR Part A | Audit SDS/CoAs for Omnibus VIII CMR substances and trace impurities | Immediate / Priority |
| CPSR Part A, Section 1 | Re-align all ingredient list references with the updated 2026 INCI Glossary | July 30, 2026 |
| CPSR Part A, Sections 2 & 8 | Incorporate exposure data for 80+ expanded fragrance allergens; recalculate MoS | July 31, 2026 |
| PIF Section 2 | Verify label warning text for formaldehyde releasers (>10 ppm threshold) | July 31, 2026 |
| CPNP Portal | Update active product notifications with revised INCI and allergen disclosures | Concurrent with label updates |
PIF Gap Analyses, CPSR Re-Evaluations, and Label Verification Services
Navigating shifting EU cosmetics regulations requires dedicated regulatory and toxicological expertise. Contact AVS Life Sciences today to speak with our compliance specialists about PIF gap analyses, CPSR re-evaluations, and label verification services.
Frequently Asked Questions
No. Regulation (EU) 2026/78 applied from May 1, 2026 with no adaptation period. Products containing newly prohibited substances must already have been withdrawn from the EU market.
Commission Implementing Decision (EU) 2025/1175 is the updated, mandatory reference for cosmetic ingredient nomenclature in the EU, effective July 30, 2026. It adds 348 new ingredient entities, revises existing entries, and mandates Color Index (CI) nomenclature for non-hair-dye colorants.
The CPSR must reflect the exact ingredient nomenclature used on commercial packaging. If the INCI glossary changes an ingredient's approved name and the CPSR isn't updated to match, the CPSR and the physical label are no longer aligned — a violation of Article 19 of Regulation (EC) No 1223/2009.
From July 31, 2026, the threshold requiring the "releases formaldehyde" warning statement drops from 0.05% (500 ppm) to 0.001% (10 ppm) of total released formaldehyde — a 50-fold reduction.
Regulation (EU) 2023/1545 expands mandatory fragrance allergen disclosure from 26 to over 80 individual substances, required in the INCI breakdown above 0.001% in leave-on products or 0.01% in rinse-off products.
AVS provides regulatory affairs support for PIF gap analyses, CPSR re-evaluations, label verification, and CPNP coordination — helping Responsible Persons and Quality teams stay audit-ready across converging deadlines.