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 (Text with EEA relevance)
Date: 2023-07-26
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: allergy, chemical product, consumer information, cosmetic product, health risk, labelling, product safety




L_2023188EN.01000101.xml










27.7.2023   


EN


Official Journal of the European Union


L 188/1








            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
(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 products (1), 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 products, 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 from acquiring fragrance allergies (primary prevention) and to protect sensitised individuals from developing allergy symptoms (secondary prevention).












(4)


For the purposes of primary prevention, 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 information 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 accordance 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, 24 fragrance allergens listed in entries 45 and 67 to 92 of Annex III to 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 Committee on Consumer Safety (SCCS) adopted an opinion at its plenary meeting of 26-27 June 2012 (3). It confirmed that the fragrance allergens listed in entries 45 and 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 consumers about the presence of those fragrance allergens. Therefore, an obligation to individually 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 consistency 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 referred 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 the 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 complementing and amending the respective CAS and EC numbers, thus facilitating the work of economic operators and national authorities.












(10)


As the updated list of fragrance allergens is likely to result in entries in Annex III to Regulation (EC) No 1223/2009 combining existing 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, economic operators should be allowed a reasonable period of time to adapt to them 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. Considering the relatively low and stable percentage of consumers developing 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 this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,





HAS ADOPTED THIS REGULATION:



Article 1
Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth 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, 26 July 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(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.

(3)  SCCS (Scientific Committee on Consumer Safety), opinion on fragrance allergens in cosmetic products (SCCS/1459/11), 26-27 June 2012.




ANNEX
Annex III to Regulation (EC) No 1223/2009 is amended as follows:






(1)


entries 45, 46, 70, 73, 86, 88, 109, 114, 122, 124, 131, 133, 154, 157, 175, 196 and 324 are replaced by the following:













Reference number


Substance identification


Restrictions


Wording of conditions of use and warnings




Chemical name/INN


Name of Common Ingredients Glossary


CAS number


EC number


Product type, body parts


Maximum concentration in ready for use preparation


Other




a


b


c


d


e


f


g


h


i




‘45


Benzyl alcohol(6)
 (*2)



Benzyl Alcohol


100-51-6


202-859-9


 


 


For purposes other than inhibiting the development of microorganisms in the product. This purpose has to be apparent from the presentation of the product.
The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




46


6-Methylcoumarin (*2)



6-Methyl Coumarin


92-48-8


202-158-8


Oral products


0,003 %


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




70


3,7-Dimethyl-2,6-octadienal


Citral


5392-40-5


226-394-6


 


 


The presence of the substance or substances shall be indicated as ‘Citral’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




(E)-3,7-dimethylocta-2,6-dienal (*1)



Geranial


141-27-5


205-476-5




(Z)-3,7-dimethylocta-2,6-dienal (*1)



Neral


106-26-3


203-379-2




73


Phenol, 2-methoxy-4-(1-propenyl)


Isoeugenol


97-54-1


202-590-7








(a)


Oral products










(b)


Other products












(b)


0,02 %






(a) (b)
The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




(E)-2-methoxy-4-(prop-1-enyl)phenol;
(trans-Isoeugenol)


5932-68-3


227-678-2




(Z)-2-methoxy-4-(prop-1-enyl)phenol;
(cis-Isoeugenol)


5912-86-7


227-633-7




86


Citronellol/ (±)
3,7-Dimethyl-6-octen-1-ol


Citronellol


106-22-9/
26489-01-0


203-375-0/
247-737-6


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




(3R)-3,7-dimethyloct-6-en-1-ol


1117-61-9


214-250-5




(3S)-3,7-dimethyloct-6-en-1-ol


7540-51-4


231-415-7




88


1-methyl-4-prop-1-en-2-yl-cyclohexene; dl-limonene (racemic); Dipentene (*1)



Limonene


138-86-3/
7705-14-8


205-341-0/
231-732-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.




The peroxide value for each substance shall be less than 20 mmoles/L(15)



 




(R)-p-mentha-1,8-diene; (d-limonene)


5989-27-5


227-813-5




(S)-p-mentha-1,8-diene; (l-limonene) (*1)



5989-54-8


227-815-6




109



Pinus mugo leaf and twig oil and extract (*2)



Pinus Mugo Leaf Oil; Pinus Mugo Twig Leaf Extract; Pinus Mugo Twig Oil


90082-72-7


290-163-6


 


 


The presence of the substance or substances shall be indicated as ‘Pinus Mugo’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.




The peroxide value shall be less than 10 mmoles/L(15)



 




114



Pinus pumila leaf and twig oil and extract (*2)



Pinus Pumila Needle Extract;
Pinus Pumila Twig Leaf Extract;
Pinus Pumila Twig Leaf Oil


97676-05-6


307-681-6


 


 


The presence of the substance or substances shall be indicated as ‘Pinus Pumila’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.




The peroxide value shall be less than 10 mmoles/L(15)



 




122



Cedrus atlantica oil and extract (*2)



Cedrus Atlantica Bark Extract;
Cedrus Atlantica Bark Oil;
Cedrus Atlantica Bark Water;
Cedrus Atlantica Leaf Extract;
Cedrus Atlantica Wood Extract;
Cedrus Atlantica Wood Oil


92201-55-3/
8023-85-6


295-985-9/
-


 


 


The presence of the substance or substances shall be indicated as ‘Cedrus Atlantica Oil/ Extract’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.




The peroxide value shall be less than 10 mmoles/L(15)



 




124


Turpentine gum (Pinus spp.); Turpentine oil and rectified oil; Turpentine, steam distilled (Pinus spp.) (*2)



Turpentine


9005-90-7;
8006-64-2;
8052-14-0


232-688-5;
232-350-7;
-


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.




The peroxide value for each substance shall be less than 10 mmoles/L(15)



 




131


p-Mentha-1,3-diene (*2)



Alpha-Terpinene


99-86-5


202-795-1


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.




The peroxide value shall be less than 10 mmoles/L(15)



 




133


p-Mentha-1,4(8)-diene (*2)



Terpinolene


586-62-9


209-578-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products




The peroxide value shall be less than 10 mmoles/L(15)



 




154



Myroxylon balsamum var. pereirae; extracts and distillates; Balsam Peru oil, absolute and anhydrol (Balsam Oil Peru) (*2)



Myroxylon Balsamum Pereirae Balsam Extract;
Myroxylon Balsamum Pereirae Balsam Oil; Myroxylon Pereirae Oil;
Myroxylon Pereirae Resin Extract;
Myroxylon Pereirae Resin


8007-00-9


232-352-8


 


0,4 %


The presence of the substance or substances shall be indicated as ‘Myroxylon Pereirae Oil/ Extract’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




157


1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(16)
 (*2)



Alpha-Damascone;
cis-Rose ketone 1


43052-87-5/
23726-94-5


-/
245-845-8








(a)


Oral products










(b)


Other products












(b)


0,02 %






(a) (b)
The presence of the substance or substances shall be indicated as ‘Rose Ketones’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




trans-Rose ketone 1


24720-09-0


246-430-4




1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one(16)
 (*2)



Rose ketone 4 (Damascone)


23696-85-7


245-833-2




1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-1-one(16)
 (*2)



Rose ketone 3 (delta-Damascone)


57378-68-4


260-709-8




trans-Rose ketone 3


71048-82-3


275-156-8




(Z)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (16)
 (*2)



cis-Rose ketone 2
(cis-beta-Damascone)


23726-92-3


245-843-7




(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(16)
 (*2)



trans-Rose ketone 2
(trans-beta-Damascone)


23726-91-2


245-842-1




175


3-Propylidene-1(3H)-isobenzofuranone;
3-Propylidenephthalide (*2)



3-Propylidenephthalide


17369-59-4


241-402-8








(a)


Oral products










(b)


Other products












b)


0,01 %






(a)
The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




196


Verbena absolute (*2)
 (*3)



Lippia citriodora absolute


8024-12-2/
85116-63-8


-
285-515-0


 


0,2 %


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




324


Methyl 2-hydroxybenzoate (*2)



Methyl Salicylate


119-36-8


204-317-7








(a)


Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products)












(a)


0,06 %






Not to be used in preparations for children under 6 years of age, with the exception of (k) “Toothpaste”.
The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 










(b)


Face makeup (except lip products, eye makeup and makeup remover)












(b)


0,05 %














(c)


Eye makeup and makeup remover












(c)


0,002 %














(d)


Leave-on hair products (spray/aerosol)












(d)


0,009 %














(e)


Deodorant spray/aerosol












(e)


0,003 %














(f)


Body lotion spray/aerosol












(f)


0,04 %














(g)


Rinse-off skin products (except hand wash) and rinse-off hair products












(g)


0,06 %














(h)


Hand wash












(h)


0,6 %














(i)


Hydroalcoholic-based fragrances












(i)


0,6 %














(j)


Lip products












(j)


0,03 %














(k)


Toothpaste












(k)


2,52 %














(l)


Mouthwash intended for children aged 6–10 years












(l)


0,1 %














(m)


Mouthwash intended for children above 10 years of age and adults












(m)


0,6 %














(n)


Mouth spray












(n)


0,65 %


















(2)


entries 125, 126, 158, 160-163, 165, 167 and 168 are deleted;










(3)


the following entries are added:













Reference number


Substance identification


Restrictions


Wording of conditions of use and warnings




Chemical name/INN


Name of Common Ingredients Glossary


CAS number


EC number


Product type, body parts


Maximum concentration in ready for use preparation


Other




a


b


c


d


e


f


g


h


i




‘327


[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one (*4)



Acetyl Cedrene


32388-55-9


251-020-3


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




328


Pentyl-2-hydroxy-benzoate (*4)



Amyl Salicylate


2050-08-0


218-080-2


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




329


1-Methoxy-4-(1E)-1-propen-1-yl-benzene (trans-Anethole) (*4)



Anethole


104-46-1/ 4180-23-8


203-205-5/ 224-052-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




330


Benzaldehyde (*4)



Benzaldehyde


100-52-7


202-860-4


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




331


Bornan-2-one; 1,7,7-Trimethylbi-cyclo[2.2.1]-2-heptanone (*4)



Camphor


76-22-2/ 21368-68-3/ 464-49-3/ 464-48-2


200-945-0/ 244-350-4/ 207-355-2/ 207-354-7


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




332


(1R,4E,9S)-4,11,11-Trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene (*4)



Beta-Caryophyllene


87-44-5


201-746-1


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




333


2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one;(5R)-2-Methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one;(5S)-2-Methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one (*4)



Carvone


99-49-0 / 6485-40-1/ 2244-16-8


202-759-5/ 229-352-5/ 218-827-2


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




334


2-Methyl-1-phenyl-2-propyl acetate; Dimethylbenzyl Carbinyl Acetate (*4)



Dimethyl Phenethyl Acetate


151-05-3


205-781-3


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




335


Oxacyclohepta-decan-2-one (*4)



Hexadecanolactone


109-29-5


203-662-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




336


1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-γ-2-benzopyran (*4)



Hexamethylindanopyran


1222-05-5


214-946-9


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




337


3,7-Dimethyl octa-1,6-diene-3-yl acetate (*4)



Linalyl Acetate


115-95-7


204-116-4


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




338


Menthol;
dl-menthol;
l-menthol;
d-menthol (*4)



Menthol


89-78-1 / 1490-04-6 / 2216-51-5 / 15356-60-2


201-939-0/ 216-074-4/ 218-690-9/ 239-387-8


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




339


3-Methyl-5-(2,2,3-Trimethyl-3-Cyclopentenyl)pent-4-en-2-ol (*4)



Trimethylcyclopentenyl Methylisopentenol


67801-20-1


267-140-4


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




340


o-Hydroxy-benzaldehyde (*4)



Salicylaldehyde


90-02-8


201-961-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




341


5-(2,3-Dimethyl-tricyclo[2.2.1.02,6]-hept-3-yl)-2-methylpent-2-en-1-ol (alpha-Santalol);
(1S-(1a,2a(Z),4a))-2-Methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
(beta-Santalol) (*4)



Santalol


11031-45-1/
115-71-9/
77-42-9


234-262-4/
204-102-8/
201-027-2


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




342


[1R-(1alpha)]-alpha-Ethenyldecahydro-2-hydroxy-a,2,5,5,8a-pentamethyl-1-naphthalenepropanol (*4)



Sclareol


515-03-7


208-194-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




343


2-(4-methylcyclohex-3-en-1-yl)propan-2-ol; p-Menth-1-en-8-ol (alpha-Terpineol); 1-methyl-4-(1-methylvinyl)cyclohexan-1-ol (beta-Terpineol); 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol (gamma-Terpineol) (*4)



Terpineol


8000-41-7/
98-55-5/
138-87-4/
586-81-2


232-268-1/
202-680-6/
205-342-6/
209-584-3


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




344


1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthyl)ethan-1-one; 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthyl)ethan-1-one; 1-(1,2,3,5,6,7,8,8a-octahydro-2,3,8,8-tetramethyl-2-naphthyl)ethan-1-one; 1-(1,2,3,4,6,7,8,8a-octahydro-2,3,8,8-tetramethyl-2-naphthyl)ethan-1-one (*4)



Tetramethyl acetyloctahydronaphthalenes


54464-57-2/
54464-59-4/
68155-66-8/
68155-67-9/


259-174-3/ 259-175-9/ 268-978-3/ 268-979-9/


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




345


3-(2,2-Dimethyl-3-hydroxypropyl)toluene (*4)



Trimethylbenzenepropanol


103694-68-4


403-140-4


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




346


4-Hydroxy-3-methoxybenz-aldehyde (*4)



Vanillin


121-33-5


204-465-2


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




347


Cananga odorata flower oil and extract; Ylang Ylang flower oil and extract (*4)



Cananga Odorata Flower Extract; Cananga Odorata Flower Oil


83863-30-3/
8006-81-3/ 68606-83-7/
93686-30-7


281-092-1/ -/
-/
297-681-1


 


 


The presence of the substance or substances shall be indicated as ‘Cananga Odorata Oil/Extract’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration exceeds of the substance or substances:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




348


Cinnamomum cassia leaf Oil (*4)



Cinnamomum Cassia Leaf Oil


8007-80-5/
84961-46-6


-/
284-635-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




349


Cinnamomum zeylanicum bark oil (*4)



Cinnamomum Zeylanicum Bark Oil


8015-91-6/
84649-98-9


-/
283-479-0


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




350


Citrus aurantium amara and dulcis flower oil (*4)



Citrus Aurantium Amara Flower Oil


72968-50-4


277-143-2


 


 


The presence of the substance or substances shall be indicated as ‘Citrus Aurantium Flower Oil’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Citrus Aurantium Dulcis Flower Oil


8028-48-6/ 8016-38-4


232-433-8/
-




351


Citrus aurantium amara and dulcis peel oil (*4)



Citrus Aurantium Amara Peel Oil


68916-04-1/ 72968-50-4


-/
277-143-2


 


 


The presence of the substance or substances shall be indicated as ‘Citrus Aurantium Peel Oil’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Citrus Aurantium Dulcis Peel Oil;
Citrus Sinensis Peel Oil


97766-30-8/ 8028-48-6/
8008-57-9


307-891-8/
232-433-8/
-




352


Citrus aurantium bergamia oil (Bergamot oil) (*4)



Citrus Aurantium Bergamia Peel Oil


8007-75-8
89957-91-5
68648-33-9/
8007-75-8/
85049-52-1


616-915-9
289-612-9
-/
616-915-9/
-


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




353


Citrus limon oil (*4)



Citrus Limon Peel Oil


84929-31-7/
8008-56-8


284-515-8/
-


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




354


Cymbopogon citratus / schoenanthus/flexuosus oils (*4)



Cymbopogon Schoenanthus Oil


8007-02-1/ 89998-16-3


-/
289-754-1


 


 


The presence of the substance or substances shall be indicated as ‘Lemongrass Oil’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Cymbopogon Flexuosus Oil


91844-92-7


295-161-9




Cymbopogon Citratus Leaf Oil


8007-02-1/
91844-92-7


295-161-9/ 295-161-9




355


Eucalyptus globulus oil (*4)



Eucalyptus Globulus Leaf Oil;


97926-40-4/ 8000-48-4/


308-257-3/
616-775-9/


 


 


The presence of the substance or substances shall be indicated as ‘Eucalyptus Globulus Oil’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Eucalyptus Globulus Leaf/Twig Oil


8000-48-4


616-775-9




356


Eugenia caryophyllus oil (*4)



Eugenia Caryophyllus Leaf Oil


8000-34-8 / 8015-97-2/ 84961-50-2


616-772-2/ -/
284-638-7


 


 


The presence of the substance or substances shall be indicated as ‘Eugenia Caryophyllus Oil’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Eugenia Caryophyllus Flower Oil


84961-50-2


284-638-7




Eugenia Caryophyllus Stem oil


84961-50-2


284-638-7




Eugenia Caryophyllus Bud oil


84961-50-2


284-638-7




357


Jasminum grandiflorum / officinale oil and extract (*4)



Jasminum Grandiflorum Flower Extract;
Jasminum Officinale Oil;
Jasminum Officinale Flower Extract


84776-64-7/
90045-94-6/ 8022-96-6/ 8024-43-9
90045-94-6


283-993-5/
289-960-1/ -/
-
289-960-1


 


 


The presence of the substance or substances shall be indicated as ‘Jasmine Oil/Extract’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products






 




358


Juniperus virginiana oil (*4)



Juniperus Virginiana Oil; Juniperus Virginiana Wood Oil


8000-27-9 / 85085-41-2


-/
285-370-3


 


 


The presence of the substance or substances shall be indicated as ‘Juniperus Virginiana Oil’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




359


Laurus nobilis oil (*4)
 (*6)



Laurus Nobilis Leaf Oil


8002-41-3/
8007-48-5/
84603-73-6


-/
-/
283-272-5


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




360


Lavandula hybrida oil/extract;


Lavandula Hybrida Oil;
Lavandula Hybrida Extract;
Lavandula Hybrida Flower Extract;


91722-69-9/
8022-15-9/
93455-96-0/
93455-97-1/
92623-76-2


294-470-6/
-/
-/
-/
296-408-3


 


 


The presence of the substance or substances shall be indicated ‘Lavandula Oil/ Extract’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Lavandula intermedia oil/extract;


Lavandula Intermedia Flower/Leaf/Stem Extract; Lavandula Intermedia Flower/Leaf/Stem Oil; Lavandula Intermedia Oil


84776-65-8/
8000-28-0/
90063-37-9


283-994-0/
-/
289-995-2




Lavandula angustifolia oil/extract (*4)



Lavandula Angustifolia Oil; Lavandula Angustifolia Flower/Leaf/Stem Extract


84776-65-8/
8000-28-0/
90063-37-9


283-994-0/
-/
289-995-2




361


Mentha piperita oil (*4)



Mentha Piperita Oil


8006-90-4/
84082-70-2


-/
282-015-4


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




362


Mentha spicata oil (spearmint oil) (*4)



Mentha Viridis Leaf Oil


8008-79-5/
84696-51-5


616-927-4/
283-656-2


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




363


Narcissus poeticus/pseudonarcissus/jonquilla/tazetta extract (*4)



Narcissus Poeticus Extract


90064-26-9/
68917-12-4


290-087-3/
-


 


 


The presence of the substance or substances shall be indicated as ‘Narcissus Extract’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Narcissus Pseudonarcissus Flower Extract


90064-27-0


290-088-9




Narcissus Jonquilla Extract
Narcissus Tazetta Extract


90064-25-8


290-086-8




364


Pelargonium graveolens oil (*4)



Pelargonium Graveolens Flower Oil


90082-51-2/
8000-46-2


290-140-0/ -


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




365


Pogostemon cablin oil (*4)



Pogostemon Cablin Oil


8014-09-3/ 84238-39-1


-/
282-493-4


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




366


Rosa damascena flower oil/extract;


Rosa Damascena Flower Oil; Rosa Damascena Flower Extract


8007-01-0/
90106-38-0/


-/
290-260-3


 


 


The presence of the substance or substances shall be indicated as ‘Rose Flower Oil/Extract’ in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




Rosa alba flower oil/extract;


Rosa Alba Flower Oil; Rosa Alba Flower Extract


93334-48-6


297-122-1




Rosa canina flower oil;


Rosa Canina Flower Oil


84696-47-9


283-652-0




Rosa centifolia oil/extract;


Rosa Centifolia Flower Oil; Rosa Centifolia Flower Extract


84604-12-6


283-289-8




Rosa gallica flower oil;


Rosa Gallica Flower Oil


84604-13-7


283-290-3




Rosa moschata flower oil;


Rosa Moschata Flower Oil


-


-




Rosa rugosa flower oil (*4)



Rosa Rugosa Flower Oil


92347-25-6


296-213-3




367


Santalum album oil (*4)



Santalum Album Oil


8006-87-9/
84787-70-2


-/
284-111-1


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




368


Phenol, 2-methoxy-4-(2-propenyl)-, acetate (*4)



Eugenyl Acetate


93-28-7


202-235-6


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




369


2,6-Octadien-1-ol, 3,7-dimethyl-,1-acetate, (2E)- (*4)



Geranyl Acetate


105-87-3


203-341-5


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




370


2-Methoxy-4-prop-1-enylphenyl acetate (*4)



Isoeugenyl Acetate


93-29-8


202-236-1


 


 


The presence of the substance shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when its concentration exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.






 




371


2,6,6-Trimethylbi-cyclo[3.1.1]hept-2-ene (alpha-Pinene);
6,6-Dimethyl- 2-methylenebicyclo[3.1.1]heptane (beta-Pinene) (*4)
 (*5)



Pinene


80-56-8/
7785-70-8/
127-91-3/
18172-67-3


201-291-9/
232-087-8/
204-872-5/ 242-060-2


 


 


The presence of the substance or the substances shall be indicated in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or the substances exceeds:






—


0,001 % in leave-on products










—


0,01 % in rinse-off products.




The peroxide value shall be less than 10 mmoles/L(15)



 










(*1)  Cosmetic products containing that substance that do not comply with the restrictions may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.

(*2)  Cosmetic products containing that substance that do not comply with the restrictions may, provided that they comply with the restrictions applicable on 15 August 2023, be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.

(*3)  For use as Verbena essential oils (Lippia citriodora Kunth.) and derivatives, see Annex II, No 450.’
         

(*4)  Cosmetic products containing that substance that do not comply with the restriction(s) may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.

(*5)  Since that substance is a monoterpene, it is subject to the restriction on peroxide value set out in entry 130.

(*6)  For use of ‘
            Oil from the seeds of Laurus nobilis L.
            ’, see Annex II, No 359.’