§612 Fragrance Allergen Transparency
§612 directs FDA to publish a fragrance allergen list and timeline. Companies must monitor the rule, map affected SKUs, and update labels and consumer communications.
Key obligations
- Monitor FDA updates so you know when the allergen list and compliance date go live.
- Map allergens to formulas and identify the SKUs that will need updated artwork.
- Coordinate with suppliers to receive timely allergen disclosures.
- Train labeling, regulatory, and customer-service teams on the new statements.
Evidence regulators expect to see
- Ingredient-to-artwork matrix showing potential allergen disclosures.
- Supplier attestations or certificates that declare allergen content.
- Change-control entries documenting artwork updates and approvals.
- Training slides or FAQ for customer-facing teams.
Intake sections that populate this section
Relevant SOP templates
Risk of non-compliance
- Misbranding actions if allergens stay off labels past the FDA deadline.
- Retailer compliance holds until updated packaging ships.
- Customer complaints or litigation tied to undisclosed allergen exposure.
Further reading
Use these notes to brief leadership and justify remediation work. As you complete the intake, the Generate Package step merges your answers into each SOP so you can demonstrate compliance with §612 Fragrance Allergen Transparency.