Fragrance Compliance in cosmetics is a highly specialized area that requires adherence to two distinct, yet interconnected, regulatory frameworks: the legally binding government regulations (like the EU’s Cosmetic Regulation) and the self-regulatory standards set by the fragrance industry itself. The goal is to maximize consumer enjoyment while minimizing the risk of allergic reactions and sensitization.
1. The IFRA Standards (Industry Self-Regulation)
The core of Fragrance Compliance is defined by the IFRA Standards set by the International Fragrance Association (IFRA). Although not legal mandates, these standards are globally recognized as the essential benchmark for safe fragrance use, as their compliance is often required by cosmetic manufacturers.
- Basis: The standards are based on the toxicological research and risk assessments performed by RIFM (Research Institute for Fragrance Materials).
- The Three Categories of Standards:
- Prohibited Substances: Ingredients that pose significant health or environmental risks are completely banned.
- Restricted Substances: Ingredients that can only be used up to a specified maximum concentration limit (e.g., Linalool, Coumarin).
- Specification Standards: Ingredients that must meet specific criteria for purity and composition.
- Product Categories: IFRA Standards divide consumer products into numerous categories (e.g., Category 1: Lip products; Category 5A: Body lotions) to determine the maximum permissible use level for each restricted ingredient, based on the consumer’s exposure duration and area.
- IFRA Certificate: For a final cosmetic product to be considered safe, the fragrance supplier must provide an IFRA Certificate of Conformity, guaranteeing the fragrance mixture complies with the latest IFRA Standards for the product’s specific category.
2. Allergen Labelling (Legal Mandate)
Government regulations focus on consumer protection through transparent Labelling, particularly concerning common allergens. In the European Union (EU), the Cosmetic Regulation (EC) No 1223/2009 contains strict rules for Allergen Labelling.
- The “Parfum” Exception: Generally, manufacturers are allowed to list the complex fragrance mixture simply as “Parfum” or “Aroma” to protect the formula’s intellectual property.
- Mandatory Disclosure: This exception is overridden when a substance is known to cause contact sensitization. Manufacturers must individually list these specific fragrance allergens on the ingredient list when their concentration exceeds:
- $0.001\%$ in leave-on products (e.g., creams, fine perfumes).
- $0.01\%$ in rinse-off products (e.g., shampoos, shower gels).
- Expanded List: Based on scientific advice from the SCCS, the list of mandated individual allergens has been significantly expanded (from the original 26 to over 80 under the latest EU amendments, like Regulation 2023/1545), compelling brands to reformulate and update their Labelling to maintain Fragrance Compliance.
In essence, Fragrance Compliance is a dual-layered requirement: the IFRA Standards control what is put into the bottle (safety limits), and Allergen Labelling controls what must be disclosed on the label (transparency).
