Regulatory FAQ

As explai­ned in the Cos­me­tics Euro­pe’s ​‘Gui­de­li­nes on the ​‘Fra­gran­ce Aller­gens Requi­re­ments’, the new ​‘fra­gran­ce aller­gens’ labe­lling regu­la­tion (Com­mis­sion Regu­la­tion (EU) ²⁰²³⁄₁₅₄₅ of 26 July
2023 amen­ding Regu­la­tion (EC) No ¹²²³⁄₂₀₀₉ of the Euro­pean Par­lia­ment and of the Coun­cil as regards labe­lling of fra­gran­ce aller­gens in cos­me­tic pro­ducts), which expands the list to 80+ aller­gens, aims to pro­tect aller­gic indi­vi­duals through pro­vi­ding them labe­lling infor­ma­tion that allows them to make a pro­per choi­ce when buying products.

This Com­mis­sion Regu­la­tion sets out new obli­ga­tions for the labe­lling of an exten­ded list of so called ​‘fra­gran­ce aller­gens’ in addi­tion to the one set by direc­ti­ve 2003/15/CE.

On the Regu­la­tion imple­men­ta­tion, the Regu­la­tion ente­red into for­ce on 16 August 202. The­re is a transition period for new res­tric­tions foreseen:

• until 31 July 2026 for pla­cing pro­ducts on the market,
• until 31 July 2028 for with­dra­wal of pro­ducts from the market.

Labe­lling is man­da­tory if the subs­tan­ce is pre­sent in the cos­me­tic pro­duct abo­ve spe­ci­fic threshold con­cen­tra­tions, which are dif­fe­rent for lea­ve-on and rin­se-off pro­ducts.

The abo­ve-men­tio­ned Cos­me­tics Euro­pe gui­dan­ce docu­ment aims to help com­pa­nies to unders­tand and correctly inter­pret the ​‘fra­gran­ce aller­gens’ labe­lling requi­re­ments and adapt its prac­ti­ces to ensu­re con­ti­nued compliance.

Labe­ling or finished pro­ducts con­tai­ning fra­gran­ce oil on drums must comply with appli­ca­ble natio­nal and regio­nal regu­la­tions, which may inclu­de ele­ments of the Glo­bally Har­mo­ni­zed Sys­tem of Clas­si­fi­ca­tion and Labe­lling of Che­mi­cals (GHS).

To request a copy of the IFRA-IOFI Labe­lling Manual on GHS, plea­se sub­mit an enquiry via our con­tact form.

Fra­gran­ce manu­fac­tu­rers are requi­red to comply with the regu­la­tions in for­ce within the coun­tries whe­re they ope­ra­te and mar­ket their products.

In addi­tion to legal requi­re­ments, com­pa­nies may also choo­se to follow the IFRA Stan­dards, which form a volun­tary, glo­bally accep­ted and recog­ni­zed risk mana­ge­ment sys­tem for the safe use of fra­gran­ce ingre­dients and are part of the IFRA Code of Practice.

In some ins­tan­ces, safety assess­ments for a fra­gran­ce mate­rial may dif­fer bet­ween natio­nal regu­la­tions and IFRA Stan­dards. For exam­ple, Butylphenyl Methyl­pro­pio­nal (BMH­CA), also known com­mer­cially as Lilial, has been ban­ned in cos­me­tic pro­ducts (both exis­ting and new) in the Euro­pean Union as of March 2022. t is impor­tant to note that this res­tric­tion applies exclu­si­vely within the EU.

The use of BMH­CA remains per­mit­ted in mar­kets outsi­de the EU, sub­ject to local regulations.

With res­pect to the IFRA Stan­dards, the Research Ins­ti­tu­te for Fra­gran­ce Mate­rials (RIFM) has con­duc­ted a com­prehen­si­ve aggre­ga­te expo­su­re risk assess­ment. This assess­ment sup­ports the con­ti­nued safe use of p‑BMHCA in both cos­me­tic and non-cos­me­tic appli­ca­tions at the con­cen­tra­tions currently in use.

Given the near-extin­ction sta­tus of some musk deer popu­la­tions and increa­sing regu­la­tory pro­tec­tion under CITES (the Con­ven­tion on Inter­na­tio­nal Tra­de in Endan­ge­red Spe­cies of Wild Fau­na and Flo­ra), IFRA reques­ted that all fra­gran­ce manu­fac­tu­rers cea­se the use of natu­ral musk sin­ce 31 Octo­ber 2000, as sta­ted in IFRA’s Infor­ma­tion Let­ter nr 608.

Currently, all spe­cies of musk deer are lis­ted in CITES Appen­dix I or Appen­dix II. For tho­se musk deer popu­la­tions lis­ted under in CITES Appen­dix I, the inter­na­tio­nal tra­de in the­se spe­ci­mens is prohi­bi­ted. For all other musk deer popu­la­tions lis­ted under Appen­dix II, the inter­na­tio­nal tra­de of tho­se spe­ci­mens are allo­wed but strictly monitored.

The IFRA Board res­ta­ted its com­mit­ment under the Infor­ma­tion Let­ter 608:
- to the pro­tec­tion of ani­mals and par­ti­cu­larly of endan­ge­red spe­cies;
- to the use of mate­rials, the collec­tion of which does not invol­ve cruelty to ani­mals and does not put at risk endan­ge­red species.

Fra­gran­ce manu­fac­tu­rers are requi­red to comply with legally bin­ding regu­la­tions in for­ce within the coun­tries whe­re they ope­ra­te and mar­ket their products.

The IFRA Stan­dards is a volun­tary risk mana­ge­ment sys­tem for the safe use of fra­gran­ce ingre­dients but man­da­tory for IFRA mem­bers, as part of the IFRA Code of Practice.

In some ins­tan­ces, IFRA Stan­dards may dif­fer from legal regu­la­tory risk mana­ge­ment mea­su­res (i.e. bans or res­tric­tions) .This is the case for Butylphenyl Methyl­pro­pio­nal (BMHCA,CAS n° 80−54−6), also known com­mer­cially as Lilial, which has been ban­ned in cos­me­tic pro­ducts (both exis­ting and new) in the Euro­pean Union as of March 2022.

The use of BMH­CA remains per­mit­ted in mar­kets outsi­de the EU (sub­ject to local regu­la­tions, if any) but IFRA mem­bers must comply with the con­cer­ned Standard.

The Research Ins­ti­tu­te for Fra­gran­ce Mate­rials (RIFM) has con­duc­ted a com­prehen­si­ve aggre­ga­te expo­su­re risk assess­ment. This assess­ment sup­ports the con­ti­nued safe use of p‑BMHCA in both cos­me­tic and non-cos­me­tic appli­ca­tions at the con­cen­tra­tions currently in use