IFRA and allergens

Safety standards, categories and label declaration

Fisfis Academy · 16 min read ·

IFRA and allergens

What you will learn

  • Explain how RIFM, IFRA and legislation complement one another
  • Distinguish between the prohibition, restriction and specification types of IFRA Standards
  • Understand the QRA2 approach and why the 12 product categories carry different limits
  • Work out when fragrance allergens must be declared on the label in the EU and Türkiye
  • Know the expanded allergen list introduced by Regulation (EU) 2023/1545 and its transition dates

A perfumer designs not only a beautiful scent but also a safe one. Every commercial fragrance on the market today has to pass through industry standards built on scientific risk assessment and through each country's cosmetics legislation. In this lesson we will see how that system is set up and how it constrains a formula.

The formula's invisible partner: every raw material goes through a safety assessment and comes out with a limit.
The formula's invisible partner: every raw material goes through a safety assessment and comes out with a limit.

A three-tier safety system

Science: Founded in 1966, RIFM (Research Institute for Fragrance Materials) collects and assesses toxicological data on fragrance materials; its findings are reviewed by an independent expert panel.

Self-regulation: Founded in Geneva in 1973, IFRA (International Fragrance Association) turns these assessments into the IFRA Standards. Member companies commit to complying with the Standards, and brands ask their suppliers for an IFRA certificate as proof of compliance.

Law: In the EU, Regulation (EC) No 1223/2009 sets the binding rules; in Türkiye, it is Cosmetics Law No. 5324 and the Cosmetics Regulation issued under it. The law is sometimes stricter than IFRA, and it always has the final word.

  • 1966 – RIFM founded: The scientific body that collects safety data on fragrance materials.
  • 1973 – IFRA founded: The industry's self-regulatory body was born in Geneva; its Standards are updated over time in packages called Amendments.
  • 2003 – 26 allergens: Directive 2003/15/EC required 26 fragrance allergens to be named on the label above certain thresholds.
  • 2013 – 1223/2009 takes effect: The EU Cosmetics Regulation became fully applicable on July 11, 2013.
  • 2020 – IFRA 49th Amendment: The QRA2 method for skin sensitization, and product categories increased from 11 to 12.
  • 2023 – 51st Amendment and 2023/1545: IFRA notified the 51st Amendment on June 30, 2023; the same year, the EU published the regulation expanding the allergen labeling list.
  • 2026 – New labeling rule: From July 31, 2026, new products placed on the EU market must comply with the expanded list; the deadline for products already on the market is July 31, 2028.
  • 1973 IFRA founded
  • 12 IFRA product categories (with subcategories)
  • 0.001% Allergen declaration threshold in leave-on products
  • 80+ Substances and groups on the declaration list after 2023/1545

How do the IFRA Standards work?

  • Prohibition: The material may not be used in fragrance compositions at all.
  • Restriction: The material may not exceed a maximum level in the finished product, set by category.
  • Specification: The material may be used only if it meets certain purity criteria, for example an upper limit on unwanted constituents in some natural extracts.

For skin sensitization (developing an allergy), IFRA uses the QRA2 (Quantitative Risk Assessment) method. The calculation starts from the dose level not expected to induce sensitization (NESIL) and accounts for safety factors and for how much of a product is applied to the skin, how often and where. The result is a separate maximum level for each category.

Category 1: Lip products

  • Applied near the mouth, frequently
  • Usually the strictest limits
  • Many materials are practically unusable

Category 4: Fine fragrance

  • EDT, EDP, cologne, solid perfume, aftershave
  • The category for alcohol-based perfumes
  • Moderate limits

Category 9: Rinse-off products

  • Soap, shampoo, shower gel
  • Stays on the skin only briefly
  • Relatively generous limits

Category 12: No skin contact

  • Products such as candles and air fresheners
  • Very low transfer to the skin
  • The widest scope of use

Allergens and the label

In the EU, fragrance ingredients appear on the label as a single word, Parfum. However, listed allergens must also be named individually by their INCI names if they exceed 0.001% in leave-on products or 0.01% in rinse-off products in the finished product: Limonene, Linalool, Citral, Coumarin and so on.

  1. Find the level in the concentrate From the supplier's allergen declaration or your own formula, find out, for example, that linalool makes up 2% of the concentrate. Linalool contained in essential oils counts toward this figure too.
  2. Multiply by the dosage If the concentrate is used at 15% in the perfume: 2% × 0.15 = 0.3% linalool in the finished product.
  3. Compare with the threshold Perfume is a leave-on product; 0.3% is far above the 0.001% threshold. Linalool must appear on the label.
  4. Check the whole list Repeat the same calculation for every substance on the list. In alcohol-based perfumes, declaring a few allergens is almost unavoidable.

Regulation (EU) 2023/1545 expanded the old 26-item list to more than 80 substances and groups of substances; it updated some names to match the current INCI glossary and combined similar substances into single entries. The thresholds did not change; what changed is the number of substances that have to be tracked.

Some substances were banned outright. Under Regulation (EU) 2017/1410, HICC (Lyral) and the oakmoss-derived atranol and chloroatranol can no longer be used in EU cosmetics, and since March 1, 2022, neither can butylphenyl methylpropional (Lilial), because of its classification for reproductive toxicity. This is one reason classic chypre formulas are being rewritten today.

The situation in Türkiye

In Türkiye, cosmetic products are supervised by TİTCK (Turkish Medicines and Medical Devices Agency) under Cosmetics Law No. 5324 and the Cosmetics Regulation. The annexes of the Regulation are updated to align with EU legislation, and TİTCK's guideline on labeling fragrance allergens uses the same 0.001% and 0.01% thresholds. A manufacturer exporting to the EU must comply with EU rules in any case.

IFRA
International Fragrance Association. The self-regulatory body of the fragrance industry; it publishes the IFRA Standards.
RIFM
Research Institute for Fragrance Materials. The scientific body that generates and assesses safety data on fragrance materials.
QRA2
The second generation of quantitative risk assessment for skin sensitization; used to calculate category-based limits.
Leave-on / rinse-off
Products that stay on the skin (perfume, lotion) and products that are rinsed off (shampoo, soap). Allergen thresholds are set separately for each.
INCI
The international naming system for cosmetic ingredients; the ingredient list on the label is written using these names.
IFRA certificate
The supplier's document stating in which categories, and up to what maximum dosage, a fragrance concentrate complies with the Standards.
Safety report
The report prepared for every cosmetic product in the EU that assesses the product's safety (Cosmetic Product Safety Report, CPSR).

Key points

  • RIFM produces the science, IFRA turns it into standards, and the law makes it binding.
  • IFRA Standards come in three types, prohibition, restriction and specification; limits vary across 12 product categories.
  • QRA2 calculates the skin sensitization risk of a material according to how the product is used.
  • In the EU and Türkiye, allergens must be declared on the label above 0.001% in leave-on and 0.01% in rinse-off products.
  • Regulation (EU) 2023/1545 expanded the list to more than 80 entries: July 31, 2026 for new products, July 31, 2028 for existing ones.

Sources

  • IFRA (International Fragrance Association). IFRA Standards, 49th Amendment (2020) and 51st Amendment (2023); IFRA Standards Library.
  • Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, Annex III.
  • Commission Regulation (EU) 2023/1545 amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in cosmetic products.
  • Commission Regulation (EU) 2017/1410 (HICC, atranol, chloroatranol) and Commission Regulation (EU) 2021/1902 (butylphenyl methylpropional).
  • SCCS (Scientific Committee on Consumer Safety). Opinion on fragrance allergens in cosmetic products, SCCS/1459/11 (2012).
  • TİTCK. Kozmetik Ürünlerde Kullanılan Parfüm Alerjenlerinin Etiketlenmesine İlişkin Kılavuz; Cosmetics Law No. 5324 and the Cosmetics Regulation.