EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council  
as regards labelling of fragrance allergens in cosmetic products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council  
as regards labelling of fragrance allergens in cosmetic products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the 
Council  of 30 November 2009 on cosmetic products1, and in particular Article 31(1)  thereof,  
Whereas:  
(1) Fragrance substances are organic compounds with characteristic, usually pleasant, 
odours. They are widely used in perfumes and other perfumed cosmetic pr oducts, but 
also in many other products  such as detergents, fabric softeners  and other household 
products.  
(2) Contact allergy is a life -long, altered specific reactivity in the  human  immune system . 
Upon re -exposure to a sufficient amount of an allergen, eczema  (allergic contact 
dermatitis ) may develop . When a person has already been sensitised to an allergen,  a 
much lower concentration of it is sufficient to trigger symptoms of an allergy. The 
percentage of the population allergic to fragrance allergens in the Union can be 
estimated to 1–9 %2.  
(3) Different measures aim to protect the  whole population f rom acquiring fragrance 
allergies (primary prevention ) and to protect sensitised individuals from developing 
allergy symptoms  (secondary prevention ).   
(4) For the purpose s of primary pr evention , a restriction of fragrance allergens may be 
sufficient . However,  sensitised persons may develop symptoms when they are exposed 
to lower concentrations  of an allergen  than the maximum permitted levels . Therefore, 
as a measure of secondary prevention , it is important to provide inform ation  on the 
presence of individual fragrance allergens in  cosmetic products so that sensitised 
persons can avoid contact  with the  substance  to which they are allergic .  
(5) In accord ance with  Article 19(1) , point  (g), of Regulation (EC) No 1223/2009, a 
cosmetic product  is to be made available  on the Union market only where a list of 
ingredients is indicated on its packaging. Furthermore, that Article specifies that 
perfume and aromatic compositions and  their raw material are to be referred to by the 
terms ‘parfum’ or ‘aroma’  in the list of ingredients and complemented by substances 
the mention of which is required under the column ‘Other’ in Annex III to that 
Regulation . Currently,  25 fragrance allergen s listed in entries 67  to 92 of Annex III to 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 Impact assessment study on fragrance labelling on cosmetic products - Publications Office of the EU 
(europa.eu) , p. 64.  EN 2  EN Regulation (EC) No 1223/2009 are to be mentioned in the list of ingredients 
(individually labelled) . 
(6) In response to the request of the Commission  for an update  of the list of individually 
labelled fragrance allergens , the Scientific Commit tee on Consumer Safety (SCCS) 
adopted an opinion at its plenary meeting of 26-27 June 20123. It confirmed that the 
fragrance allergens listed in entries 67 –92 of Annex III to Regulation (EC) No 
1223/2009 are still relevant . Furthermore, it  identified 56 additional  fragrance 
allergens , which have clearly caused allergies in humans and which have currently no 
requirement of individual labelling .   
(7) In light of the SCCS opinion, it can be concluded that there is a potential risk to human 
health arising from the use of the additional fragrance allergens identified by the 
SCCS and that it is necessary to inform consumer s about the presence of those 
fragrance allergens.  Therefore, an obligation  to individual ly label  those fragrance 
allergens should be introduced in Annex III to Regulation (EC) No 1223/2009  when 
their concentration exceeds 0,001 % in leave -on products and 0,01 % in rinse -off 
products . Furthermore, fragrance substances , such as prehaptens  and prohaptens , that 
can be transformed to known contact allergens via  air oxidation or bioactivation 
should be treated as equivalent to fragrance  allergens and be subject to  the same 
restrictions and other regulatory requirements . 
(8) For reasons of consiste ncy and clarity, it is also necessary to update certain existing 
entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 by 
aligning common names of the substances to those  of the latest version of the 
Common Ingredients Glossary  refer red to in Article 33 of that Regulation , and by  
grouping similar substances in one entry . Furthermore, when there are multiple  
common ingredient names for a substance , it should be set out in the individual 
labelling requirement which name is to be used in the list of ingredients referred to in 
Article 19(1), point (g), in order for the labelling to be streamlined and more 
consumer -friendly , as well as to facilitate th e work of economic operators and national 
authorities . 
(9) For reasons of completeness and clarity, it is also necessary to update certain existing 
entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 by 
adding isomers and by complement ing and amending the respective CAS and EC  
numbers, thus facilitat ing the work of economic operators and national authorities.  
(10) As the update d list of fragrance allergens  is likely to  result in entries in Annex III to 
Regulation (EC) 1223/2009 combining exi sting and new restrictions, it is necessary to 
provide  that the  economic operators should , on the one hand,  continue to apply 
existing restrictions, and, on the other hand,  be allowed a reasonable period of time to 
comply with new restrictions . 
(11) With regard  to the new restrictions, e conomic operators  should be allowed a 
reasonable period of time to adapt to the m by making the adjustments to product 
formulations and containers that are necessary to ensure that only cosmetic products 
complying with the new requirements are placed on the market. Economic operators 
should also be allowed a reasonable period of time to  withdraw from the market 
cosmetic products which do not comply with the new requirements and which were 
placed on the market before the new labelling provisions become applicable. 
                                                 
3 SCCS (Scientific Committee on Consumer Safety ), opinion on fragrance allergens in cosmetic 
products, 26 -27 June 2012.  EN 3  EN Considering the relatively low and stable percentage of consumers develop ing allergic 
contact dermatitis, the large  number of new fragrance allergens to be individually 
labelled and the significant number of  cosmetic products concerned , the transition 
period should be 3 and 5 years , respectively .  
(12) The measures provided for in thi s Regulation are in accordance with the opinion of 
the Standing  Committee  on Consumer Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Anne x III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to th is 
Regulation.  
Article 2  
This Regu lation shall enter into force on the twentie th day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen