BR-ANAC-R-IFRA flashcards
BR-ANAC-R-IFRA · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- IFRA Standard
- A rule in the IFRA Code of Practice that prohibits, restricts, or sets specifications for a fragrance ingredient, expressed per product category.
- Certificate of Conformity
- A document issued by a fragrance supplier declaring that a fragrance complies with a stated IFRA amendment for specified product categories.
- Restriction limit
- The maximum permitted concentration of an ingredient in the finished product for a given category, normally expressed as a percentage.
- Prohibited material
- A substance that may not be used in fragrance for the stated purpose at any concentration under the applicable standard.
- Dosage conversion
- Ingredient percentage in the finished product equals ingredient percentage in the concentrate multiplied by concentrate dosage percentage, divided by one hundred.
- Purity criterion
- A specification limiting a specific impurity or isomer in a raw material, applied to the material itself rather than the finished product.
- Quantitative risk assessment
- An exposure-based method for sensitisation that compares estimated consumer exposure with an acceptable exposure level derived for that ingredient.
- Margin of safety
- The ratio of a derived safe exposure level to the estimated consumer exposure; it must meet an agreed minimum to support safe use.
- Aggregate exposure
- Total exposure to an ingredient summed across all product types a consumer uses, which may exceed the limit for any single product.
- Safety assessment report
- The documented evaluation of a fragrance's ingredients against intended product categories, signed by a qualified safety assessor.
- Responsible person
- The legal entity accountable for a finished cosmetic product's compliance, documentation, and availability of the product information file.
- Stricter rule principle
- Where industry standards and legislation both apply, the more restrictive requirement governs the formulation and labelling decision.
- Allergen labelling
- The legal obligation to declare specified fragrance allergens on the product label when their concentration exceeds defined thresholds.
- REACH
- The EU regulation on registration, evaluation, authorisation and restriction of chemicals, driving SDS content and exposure scenarios.
- LogP
- The octanol-water partition coefficient; a higher value indicates greater lipophilicity, affecting skin penetration and environmental behaviour.
- Terpene oxidation
- Air exposure converts terpenes such as limonene and linalool into hydroperoxides, which are more potent sensitisers than the parent compounds.
- Structural alert
- A molecular feature associated with a toxicological mode of action, used to flag ingredients for closer safety evaluation.
- Volatility
- A property governed by boiling point and vapour pressure that determines note behaviour and the potential for inhalation exposure.
- IFRA product category
- A grouping of products by application site and use pattern, used to select the applicable restriction limit for an ingredient.
- Leave-on versus rinse-off
- A distinction based on whether a product remains on skin; leave-on products generally permit lower fragrance levels because exposure is longer.
- Inhalation exposure
- Exposure arising from volatile ingredients in aerosols or ambient products, assessed separately from dermal exposure.
- Category misassignment
- Applying a restriction limit from the wrong product category, a frequent cause of non-compliant fragrance formulations.
- Traceability
- The documented ability to link a finished fragrance or product batch back to each raw material batch and its supplier.
- Supplier qualification
- The process of approving a raw material supplier through specification agreement, audit, and verification of regulatory status.
- Change control
- A formal process ensuring that formulation, supplier, or process changes are assessed for safety and compliance before implementation.
- Certificate of analysis
- A supplier document reporting measured identity and purity results for a batch; it supports but does not replace the safety assessment.
- Weighing verification
- A GMP control confirming that dispensed quantities match the formula, typically by double-check or automated system.
- Cross-contamination control
- Prevention of unintended material transfer through cleaning validation, dedicated equipment, and segregation of materials and personnel.
- Out-of-specification result
- A test result outside an established acceptance criterion, requiring documented investigation before any batch release decision.
- Cleaning validation
- Documented evidence that a cleaning procedure reliably reduces residues of previous materials below an established acceptance limit.
- Batch record
- The documented record of materials, quantities, and process steps for a batch, enabling reconstruction of the exact formulation used.
- Specification sheet
- A document defining a raw material's identity, purity, and physical parameters, forming the basis for supplier agreement and testing.