BR-ANAC-R-IFRA cheat sheet

The IFRA Code of Practice is the governing document; the Standards (prohibition, restriction, specification, purity criteria) are its operative annexes.

A restriction sets a maximum concentration of the fragrance ingredient in the finished product, expressed as a percentage of the product formulation, per product category.

The IFRA Standards are periodically amended; a certificate of conformity is valid only against the amendment in force at the date of issue.

Restriction limits are derived from a safe exposure level (e.g. a No-Observed-Adverse-Effect Level divided by assessment factors) divided by the estimated product-exposure amount.

Where an ingredient has no IFRA restriction, it may still be limited by other instruments (e.g. EU cosmetics rules, REACH).

Compliance is demonstrated per ingredient per product category; a single fragrance concentrate can be compliant in one category and non-compliant in another.

The Certificate of Conformity must identify the fragrance, the IFRA amendment, and the product categories covered.

The Code distinguishes the roles of the fragrance house (formulation and documentation) and the finished-product manufacturer (final compliance).

Specifications (identity/purity) apply to defined materials and are separate from restriction limits.

Prohibited materials may not be used at any level for the stated purpose; restricted materials have a numeric ceiling per category.

When multiple restricted materials share a common mode of action or metabolite, limits may need to be considered in aggregate rather than independently.

Purity criteria (e.g. limits on specific impurities in a material) apply to the raw material, not the finished fragrance.

Restriction percentages refer to the ingredient in the finished product, so concentrate-level limits must be converted using the dosage.

Conversion: ingredient % in product = (ingredient % in concentrate) x (concentrate dosage % in product) / 100.

A material can be banned in one product category (e.g. oral care) while restricted and permitted in others.

Restriction tables are category-specific; using the wrong category is the most common source of non-compliance.

Substances formed in the finished product (e.g. by oxidation or reaction) can fall under restriction even if not added directly.

The safety assessment is performed by a qualified assessor and covers the fragrance mixture, its ingredients, and the intended product types.

Exposure-based assessment compares the estimated consumer exposure (per unit body weight per day) with the derived safe level.

The dermal sensitisation assessment uses quantitative risk assessment (QRA) or an equivalent exposure-based method.

Documentation set typically includes the safety assessment, IFRA certificate, specification sheets, and SDS.

The safety assessor must consider aggregate exposure from multiple product types used by the same consumer.

Phototoxicity and photoallergy must be assessed for ingredients applied to sun-exposed skin.

Systemic toxicity assessment uses a margin-of-safety approach: safe level divided by estimated exposure, compared to an agreed minimum.

Documentation must be retained and traceable to the specific formulation version and the assessment date.

IFRA Standards are industry self-regulation; they operate alongside binding legislation such as the EU Cosmetics Regulation.

Where a legal requirement and an IFRA Standard conflict, the stricter requirement governs compliance.

The EU Cosmetics Regulation requires allergen labelling above defined thresholds and prohibits specified substances.

REACH governs chemical substances in the EU; SDS and exposure scenarios flow from it.

Other jurisdictions (e.g. US, Japan, China) have their own rules; a product compliant in one market is not automatically compliant elsewhere.

The responsible person (or equivalent) bears legal responsibility for the finished product's compliance and documentation.

Good Manufacturing Practice obligations cover premises, personnel, documentation, and quality control.

Product information files must be available to authorities on request and kept for the required retention period.

Fragrance ingredients are classified by functional group (aldehydes, ketones, alcohols, esters, lactones, etc.), which drives reactivity and stability.

Volatility (boiling point/vapour pressure) determines the top/middle/base note behaviour and influences exposure via inhalation.

LogP (octanol-water partition coefficient) indicates lipophilicity and affects skin penetration and environmental fate.

Chemical instability (oxidation, hydrolysis, polymerisation) can generate new substances and alter the safety profile.

Terpenes such as limonene and linalool oxidise on air exposure to hydroperoxides, which are stronger sensitisers than the parent.

Structural alerts (e.g. certain aldehydes, alpha-beta unsaturated carbonyls) inform the toxicological assessment.

Natural and synthetic materials are assessed by the same criteria; 'natural' does not imply lower risk.

Purity and isomer profile of a raw material affect both odour and the safety assessment.

IFRA categories group products by application site and use pattern (e.g. leave-on skin, rinse-off, oral, aerosol).

The same fragrance concentrate has different allowable dosages per category because exposure differs.

Exposure depends on the amount applied, frequency of use, retention on skin, and body surface area.

Aerosol and inhaled products require additional consideration of inhalation exposure.

Oral care and lip products have low acceptable exposure levels because of mucosal contact and ingestion.

Baby products and products for sensitive skin areas are assessed with additional conservatism.

Category assignment must reflect actual consumer use, not marketing description.

Aggregate exposure across product types can make an otherwise compliant fragrance non-compliant.

Traceability requires a documented link from finished fragrance to each raw material batch and supplier.

Supplier qualification includes specification agreement, audit, and verification of IFRA/regulatory status.

A change in raw material source or specification requires re-evaluation of the safety assessment and compliance status.

Batch records must allow reconstruction of the exact formulation used for a given product batch.

Certificates of analysis verify identity and purity; they do not replace the safety assessment.

Change control ensures formulation or supplier changes are assessed before release.

Complaint and recall systems must be able to trace affected batches rapidly.

Documentation retention periods must satisfy both customer and regulatory requirements.

GMP requires defined procedures for receiving, storage, weighing, mixing, filling, and release.

Weighing and dispensing must be verified (e.g. double-check or automated verification) to prevent formulation error.

Cross-contamination is controlled by cleaning validation, dedicated equipment, and segregation of materials.

Laboratory work must follow documented methods, calibration, and control of reference standards.

Out-of-specification results trigger investigation before release; retesting without investigation is not acceptable.

Environmental and storage conditions (temperature, light, humidity) must be controlled to prevent degradation.

Personnel must be trained and training records retained.

Deviations, complaints, and recalls must be documented, investigated, and linked to corrective actions.