See Full Document Text
27.7.2023 EN Official Journal of the European Union L 188/1
II
(Non-legislative acts)
REGULATIONS
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 2009on
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).
(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.L 188/2 EN Official Journal of the European Union 27.7.2023
(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.
(3) SCCS (Scientific Committee on Consumer Safety), opinion on fragrance allergens in cosmetic products (SCCS/1459/11), 26-27 June
2012.27.7.2023 EN Official Journal of the European Union L 188/3
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 LEYENANNEX
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:
Substance identification Restrictions
Refer- Wording of
ence Maximum conditions of
num- Name of Common Product type, concentration use and
Chemical name/INN CAS number EC number Other
ber Ingredients Glossary body parts in ready for use warnings
preparation
a b c d e f g h i
‘45 Benzyl alcohol(6)(**) 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-Methylcou- 6-Methyl 92-48-8 202-158-8 Oral products 0,003 % The presence of the substance shall be indicated in the
marin(**) Coumarin 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-oc- Citral 5392-40-5 226-394-6 The presence of the substance or substances shall be
tadienal indicated as ‘Citral’ in the list of ingredients referred to in
Article 19(1), point (g), when the concentration of the
(E)-3,7-dimethyloc- Geranial 141-27-5 205-476-5
substance or substances exceeds:
ta-2,6-dienal(*)
— 0,001 % in leave-on products
(Z)-3,7-dimethyloc- Neral 106-26-3 203-379-2 — 0,01 % in rinse-off products.
ta-2,6-dienal(*)
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27.7.202373 Phenol, 2-methoxy- Isoeugenol 97-54-1 202-590-7 (a) Oral pro (b) 0,02 % (a) (b)
4-(1-propenyl) ducts The presence of the substance shall be indicated in the
(b) Other list of ingredients referred to in Article 19(1), point (g),
(E)-2-methoxy- 5932-68-3 227-678-2
products when its concentration exceeds:
4-(prop-1-enyl)
— 0,001 % in leave-on products
phenol;
— 0,01 % in rinse-off products.
(trans-Isoeugenol)
(Z)-2-methoxy- 5912-86-7 227-633-7
4-(prop-1-enyl)
phenol;
(cis-Isoeugenol)
86 Citronellol/ (±) Citronellol 106-22-9/ 203-375-0/ The presence of the substance shall be indicated in the
3,7-Dimethyl- 26489-01-0 247-737-6 list of ingredients referred to in Article 19(1), point (g),
6-octen-1-ol when its concentration exceeds:
— 0,001 % in leave-on products
(3R)-3,7-dimethy- 1117-61-9 214-250-5
— 0,01 % in rinse-off products.
loct-6-en-1-ol
(3S)-3,7-dimethy- 7540-51-4 231-415-7
loct-6-en-1-ol
88 1-methyl-4-prop- Limonene 138-86-3/ 205-341-0/ The presence of the substance shall be indicated in the
1-en-2-yl- 7705-14-8 231-732-0 list of ingredients referred to in Article 19(1), point (g),
cyclohexene; when its concentration exceeds:
dl-limonene — 0,001 % in leave-on products
(racemic); — 0,01 % in rinse-off products.
Dipentene(*)
The peroxide value for each substance shall be less than
(R)-p- 5989-27-5 227-813-5 20 mmoles/L(15)
mentha-1,8-diene;
(d-limonene)
(S)-p- 5989-54-8 227-815-6
mentha-1,8-diene;
(l-limonene)(*)
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188/5109 Pinus mugo leaf and Pinus Mugo Leaf 90082-72-7 290-163-6 The presence of the substance or substances shall be
twig oil and Oil; Pinus Mugo indicated as ‘Pinus Mugo’ in the list of ingredients
extract(**) Twig Leaf Extract; referred to in Article 19(1), point (g), when the
Pinus Mugo Twig concentration of the substance or substances exceeds:
Oil — 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 Pinus Pumila 97676-05-6 307-681-6 The presence of the substance or substances shall be
twig oil and Needle Extract; indicated as ‘Pinus Pumila’ in the list of ingredients
extract(**) Pinus Pumila Twig referred to in Article 19(1), point (g), when the
Leaf Extract; concentration of the substance or substances exceeds:
Pinus Pumila Twig — 0,001 % in leave-on products
Leaf Oil — 0,01 % in rinse-off products.
The peroxide value shall be less than 10 mmoles/L(15)
122 Cedrus atlantica oil and Cedrus Atlantica 92201-55-3/ 295-985-9/ The presence of the substance or substances shall be
extract(**) Bark Extract; 8023-85-6 - indicated as ‘Cedrus Atlantica Oil/ Extract’ in the list of
Cedrus Atlantica ingredients referred to in Article 19(1), point (g), when
Bark Oil; the concentration of the substance or substances
Cedrus Atlantica exceeds:
Bark Water; — 0,001 % in leave-on products
Cedrus Atlantica — 0,01 % in rinse-off products.
Leaf Extract;
Cedrus Atlantica The peroxide value shall be less than 10 mmoles/L(15)
Wood Extract;
Cedrus Atlantica
Wood Oil
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27.7.2023124 Turpentine gum Turpentine 9005-90-7; 232-688-5; The presence of the substance shall be indicated in the
(Pinus spp.); 8006-64-2; 232-350-7; list of ingredients referred to in Article 19(1), point (g),
Turpentine oil and 8052-14-0 - when its concentration exceeds:
rectified oil; — 0,001 % in leave-on products
Turpentine, steam — 0,01 % in rinse-off products.
distilled (Pinus
spp.)(**) The peroxide value for each substance shall be less than
10 mmoles/L(15)
131 p-Men- Alpha-Terpinene 99-86-5 202-795-1 The presence of the substance shall be indicated in the
tha-1,3-diene(**) 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)- Terpinolene 586-62-9 209-578-0 The presence of the substance shall be indicated in the
diene(**) 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 Myroxylon 8007-00-9 232-352-8 0,4 % The presence of the substance or substances shall be
var. pereirae; extracts Balsamum Pereirae indicated as ‘Myroxylon Pereirae Oil/ Extract’ in the list
and distillates; Balsam Balsam Extract; of ingredients referred to in Article 19(1), point (g),
Peru oil, absolute and Myroxylon when the concentration of the substance or substances
anhydrol (Balsam Oil Balsamum Pereirae exceeds:
Peru)(**) Balsam Oil; — 0,001 % in leave-on products
Myroxylon Pereirae — 0,01 % in rinse-off products.
Oil;
Myroxylon Pereirae
Resin Extract;
Myroxylon Pereirae
Resin
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188/7157 1-(2,6,6-trimethyl- Alpha-Damascone; 43052-87-5/ -/ (a) Oral pro (b) 0,02 % (a) (b)
2-cyclohexen-1-yl)- cis-Rose ketone 1 23726-94-5 245-845-8 ducts The presence of the substance or substances shall be
2-buten-1-one(16)(**) (b) Other indicated as ‘Rose Ketones’ in the list of ingredients
trans-Rose ketone 1 24720-09-0 246-430-4
products referred to in Article 19(1), point (g), when the
1-(2,6,6-Trimethylcy- Rose ketone 4 23696-85-7 245-833-2 concentration of the substance or substances exceeds:
clohexa-1,3-dien- (Damascone) — 0,001 % in leave-on products
1-yl)-2-buten- — 0,01 % in rinse-off products.
1-one(16)(**)
1-(2,6,6-Trimethyl- Rose ketone 3 57378-68-4 260-709-8
3-cyclohexen-1-yl)- (delta-Damascone)
2-buten-1-one(16)(**)
trans-Rose ketone 3 71048-82-3 275-156-8
(Z)- cis-Rose ketone 2 23726-92-3 245-843-7
1-(2,6,6-trimethyl- (cis-beta-
1-cyclohexen-1-yl)- Damascone)
2-buten-1-one (16)(**)
(E)- trans-Rose ketone 2 23726-91-2 245-842-1
1-(2,6,6-Trimethyl- (trans-beta-
1-cyclohexen-1-yl)- Damascone)
2-buten-1-one(16)(**)
175 3-Propylidene-1(3H)- 3-Propylideneph- 17369-59-4 241-402-8 (a) Oral pro b) 0,01 % (a)
isobenzofuranone; thalide ducts The presence of the substance shall be indicated in the
3-Propylidenephtha- (b) Other list of ingredients referred to in Article 19(1), point (g),
lide(**) products when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
196 Verbena Lippia citriodora 8024-12-2/ - 0,2 % The presence of the substance shall be indicated in the
absolute(**)(***) absolute 85116-63-8 285-515-0 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.
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27.7.2023324 Methyl Methyl Salicylate 119-36-8 204-317-7 (a) Leave-on (a) 0,06 % Not to be used in preparations for children under 6
2-hydroxybenzo- skin pro years of age, with the exception of (k) “Toothpaste”.
ate(**) ducts (ex The presence of the substance shall be indicated in the
cept face list of ingredients referred to in Article 19(1), point (g),
makeup, when its concentration exceeds:
spray/ae — 0,001 % in leave-on products
rosol — 0,01 % in rinse-off products.
body lo
tion,
spray/ae
rosol
deodor
ant and
hydroal
coholic-
based fra
grances)
and leave
on hair
products
(except
spray/ae
rosol pro
ducts)
(b) Face ma (b) 0,05 %
keup (ex
cept lip
products,
eye ma
keup and
makeup
remover)
(c) Eye ma (c) 0,002 %
keup and
makeup
remover
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188/9(d) Leave-on (d) 0,009 %
hair pro
ducts
(spray/a
erosol)
(e) Deodor (e) 0,003 %
ant
spray/ae
rosol
(f) Body lo (f) 0,04 %
tion
spray/aer
osol
(g) Rinse-off (g) 0,06 %
skin pro
ducts (ex
cept hand
wash)
and
rinse-off
hair pro
ducts
(h) Hand (h) 0,6 %
wash
(i) Hydroal (i) 0,6 %
coholic-
based fra
grances
(j) Lip pro (j) 0,03 %
ducts
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27.7.2023(k) Tooth (k) 2,52 %
paste
(l) Mouthw (l) 0,1 %
ash in
tended
for chil
dren aged
6–10
years
(m) Mouth (m) 0,6 %
wash in
tended
for chil
dren
above
10 years
of age
and
adults
(n) Mouth (n) 0,65 %
spray
(*) Cosmetic products containing that substance that do not comply with the restrictions may be placed on the Union market until 31 July 2026and made available on the Union market until 31 July
2028.
(**) 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 2026and made available on the Union market until 31 July 2028.
(***) For use as Verbena essential oils (Lippia citriodora Kunth.) and derivatives, see Annex II, No 450.’
(2) entries 125, 126, 158, 160-163, 165, 167 and 168 are deleted;
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188/11(3) the following entries are added:
Substance identification Restrictions
Wording of
Reference Maximum conditions of
number Name of Common Product type, concentration use and
Chemical name/INN CAS number EC number Other
Ingredients Glossary body parts in ready for use warnings
preparation
a b c d e f g h i
‘327 [3R-(3α,3aβ,7β,8aα)]- Acetyl Cedrene 32388-55-9 251-020-3 The presence of the substance shall be indicated in the
1-(2,3,4,7,8,8a- list of ingredients referred to in Article 19(1), point
hexahy- (g), when its concentration exceeds:
dro-3,6,8,8-tetrame- — 0,001 % in leave-on products
thyl- — 0,01 % in rinse-off products.
1H-3a,7-methanoa-
zulen-5-yl)ethan-
1-one(*)
328 Pentyl-2-hydroxy- Amyl Salicylate 2050-08-0 218-080-2 The presence of the substance shall be indicated in the
benzoate(*) 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)- Anethole 104-46-1/ 203-205-5/ The presence of the substance shall be indicated in the
1-propen-1-yl- 4180-23-8 224-052-0 list of ingredients referred to in Article 19(1), point
benzene (trans- (g), when its concentration exceeds:
Anethole)(*) — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
330 Benzaldehyde(*) 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.
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27.7.2023331 Bornan-2-one; Camphor 76-22-2/ 200-945-0/ The presence of the substance shall be indicated in the
1,7,7-Trimethylbi- 21368-68-3/ 244-350-4/ list of ingredients referred to in Article 19(1), point
cyclo[2.2.1]- 464-49-3/ 207-355-2/ (g), when its concentration exceeds:
2-heptanone(*) 464-48-2 207-354-7 — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
332 (1R,4E,9S)-4,11,11-- Beta- 87-44-5 201-746-1 The presence of the substance shall be indicated in the
Trimethyl- Caryophyllene list of ingredients referred to in Article 19(1), point
8-methylenebicyclo (g), when its concentration exceeds:
[7.2.0]undec- — 0,001 % in leave-on products
4-ene(*) — 0,01 % in rinse-off products.
333 2-methyl-5-(prop- Carvone 99-49-0 / 202-759-5/ The presence of the substance shall be indicated in the
1-en-2-yl)cyclohex- 6485-40-1/ 229-352-5/ list of ingredients referred to in Article 19(1), point
2-en-1-one;(5R)- 2244-16-8 218-827-2 (g), when its concentration exceeds:
2-Methyl-5-prop- — 0,001 % in leave-on products
1-en-2-ylcyclohex- — 0,01 % in rinse-off products.
2-en-1-one;(5S)-
2-Methyl-5-prop-
1-en-2-ylcyclohex-
2-en-1-one(*)
334 2-Methyl-1-phenyl- Dimethyl 151-05-3 205-781-3 The presence of the substance shall be indicated in the
2-propyl acetate; Phenethyl Acetate list of ingredients referred to in Article 19(1), point
Dimethylbenzyl (g), when its concentration exceeds:
Carbinyl Acetate(*) — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
335 Oxacyclohepta- Hexadecanolac- 109-29-5 203-662-0 The presence of the substance shall be indicated in the
decan-2-one(*) tone 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.
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188/13336 1,3,4,6,7,8-Hexahy- Hexamethylinda- 1222-05-5 214-946-9 The presence of the substance shall be indicated in the
dro-4,6,6,7,8,8-hexa- nopyran list of ingredients referred to in Article 19(1), point
methylcyclopenta-γ- (g), when its concentration exceeds:
2-benzopyran(*) — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
337 3,7-Dimethyl Linalyl Acetate 115-95-7 204-116-4 The presence of the substance shall be indicated in the
octa-1,6-diene-3-yl list of ingredients referred to in Article 19(1), point
acetate(*) (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
338 Menthol; Menthol 89-78-1 / 201-939-0/ The presence of the substance shall be indicated in the
dl-menthol; 1490-04-6 / 216-074-4/ list of ingredients referred to in Article 19(1), point
l-menthol; 2216-51-5 / 218-690-9/ (g), when its concentration exceeds:
d-menthol(*) 15356-60-2 239-387-8 — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
339 3-Methyl- Trimethylcyclo- 67801-20-1 267-140-4 The presence of the substance shall be indicated in the
5-(2,2,3-Trimethyl- pentenyl list of ingredients referred to in Article 19(1), point
3-Cyclopentenyl) Methylisopentenol (g), when its concentration exceeds:
pent-4-en-2-ol(*) — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
340 o-Hydroxy- Salicylaldehyde 90-02-8 201-961-0 The presence of the substance shall be indicated in the
benzaldehyde(*) 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.
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27.7.2023341 5-(2,3-Dimethyl- Santalol 11031-45-1/ 234-262-4/ The presence of the substance shall be indicated in the
tricyclo[2.2.1.02,6]- 115-71-9/ 204-102-8/ list of ingredients referred to in Article 19(1), point
hept-3-yl)- 77-42-9 201-027-2 (g), when its concentration exceeds:
2-methylpent-2-en- — 0,001 % in leave-on products
1-ol (alpha-Santalol); — 0,01 % in rinse-off products.
(1S-(1a,2a(Z),4a))-
2-Methyl-
5-(2-methyl-
3-methylenebicyclo
[2.2.1]hept-2-yl)-
2-penten-1-ol
(beta-Santalol)(*)
342 [1R-(1alpha)]-alpha- Sclareol 515-03-7 208-194-0 The presence of the substance shall be indicated in the
Ethenyldecahydro- list of ingredients referred to in Article 19(1), point
2-hydro- (g), when its concentration exceeds:
xy-a,2,5,5,8a- — 0,001 % in leave-on products
pentamethyl- — 0,01 % in rinse-off products.
1-naphthalenepropa-
nol(*)
343 2-(4-methylcyclohex- Terpineol 8000-41-7/ 232-268-1/ The presence of the substance shall be indicated in the
3-en-1-yl)propan- 98-55-5/ 202-680-6/ list of ingredients referred to in Article 19(1), point
2-ol; p-Menth-1-en- 138-87-4/ 205-342-6/ (g), when its concentration exceeds:
8-ol (alpha- 586-81-2 209-584-3 — 0,001 % in leave-on products
Terpineol); 1-methyl- — 0,01 % in rinse-off products.
4-(1-methylvinyl)
cyclohexan-1-ol
(beta-Terpineol);
1-methyl-
4-(1-methylethyli-
dene)cyclohexan-1-ol
(gamma-Terpineol)(*)
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188/15344 1-(1,2,3,4,5,6,7,8-o- Tetramethyl 54464-57-2/ 259-174-3/ The presence of the substance shall be indicated in the
ctahydro-2,3,8,8-te- acetyloctahydro- 54464-59-4/ 259-175-9/ list of ingredients referred to in Article 19(1), point
tramethyl- naphthalenes 68155-66-8/ 268-978-3/ (g), when its concentration exceeds:
2-naphthyl)ethan- 68155-67-9/ 268-979-9/ — 0,001 % in leave-on products
1-one; — 0,01 % in rinse-off products.
1-(1,2,3,4,5,6,7,8-o-
ctahydro-2,3,5,5-te-
tramethyl-
2-naphthyl)ethan-
1-one;
1-(1,2,3,5,6,7,8,8a-
octahydro-2,3,8,8-te-
tramethyl-
2-naphthyl)ethan-
1-one;
1-(1,2,3,4,6,7,8,8a-
octahydro-2,3,8,8-te-
tramethyl-
2-naphthyl)ethan-
1-one(*)
345 3-(2,2-Dimethyl- Trimethylbenzene- 103694-68-- 403-140-4 The presence of the substance shall be indicated in the
3-hydroxypropyl) propanol 4 list of ingredients referred to in Article 19(1), point
toluene(*) (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
346 4-Hydroxy- Vanillin 121-33-5 204-465-2 The presence of the substance shall be indicated in the
3-methoxybenz- list of ingredients referred to in Article 19(1), point
aldehyde(*) (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
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27.7.2023347 Cananga odorata Cananga Odorata 83863-30-3/ 281-092-1/ The presence of the substance or substances shall be
flower oil and extract; Flower Extract; 8006-81-3/ -/ indicated as ‘Cananga Odorata Oil/Extract’ in the list
Ylang Ylang flower oil Cananga Odorata 68606-83-7/ -/ of ingredients referred to in Article 19(1), point (g),
and extract(*) Flower Oil 93686-30-7 297-681-1 when the concentration exceeds of the substance or
substances:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
348 Cinnamomum cassia Cinnamomum 8007-80-5/ -/ The presence of the substance shall be indicated in the
leaf Oil(*) Cassia Leaf Oil 84961-46-6 284-635-0 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 Cinnamomum 8015-91-6/ -/ The presence of the substance shall be indicated in the
zeylanicum bark Zeylanicum Bark 84649-98-9 283-479-0 list of ingredients referred to in Article 19(1), point
oil(*) Oil (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
350 Citrus aurantium Citrus Aurantium 72968-50-4 277-143-2 The presence of the substance or substances shall be
amara and dulcis Amara Flower Oil indicated as ‘Citrus Aurantium Flower Oil’ in the list
flower oil(*) of ingredients referred to in Article 19(1), point (g),
Citrus Aurantium 8028-48-6/ 232-433-8/
when the concentration of the substance or
Dulcis Flower Oil 8016-38-4 -
substances exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
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188/17351 Citrus aurantium Citrus Aurantium 68916-04-1/ -/ The presence of the substance or substances shall be
amara and dulcis peel Amara Peel Oil 72968-50-4 277-143-2 indicated as ‘Citrus Aurantium Peel Oil’ in the list of
oil(*) ingredients referred to in Article 19(1), point (g),
when the concentration of the substance or
Citrus Aurantium 97766-30-8/ 307-891-8/ substances exceeds:
Dulcis Peel Oil; 8028-48-6/ 232-433-8/ — 0,001 % in leave-on products
Citrus Sinensis Peel 8008-57-9 - — 0,01 % in rinse-off products.
Oil
352 Citrus aurantium Citrus Aurantium 8007-75-8 616-915-9 The presence of the substance shall be indicated in the
bergamia oil Bergamia Peel Oil 89957-91-5 289-612-9 list of ingredients referred to in Article 19(1), point
(Bergamot oil)(*) 68648-33-9/ -/ (g), when its concentration exceeds:
8007-75-8/ 616-915-9/ — 0,001 % in leave-on products
85049-52-1 - — 0,01 % in rinse-off products.
353 Citrus limon oil(*) Citrus Limon Peel 84929-31-7/ 284-515-8/ The presence of the substance shall be indicated in the
Oil 8008-56-8 - 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 Cymbopogon 8007-02-1/ -/ The presence of the substance or substances shall be
/ schoenanthus/ Schoenanthus Oil 89998-16-3 289-754-1 indicated as ‘Lemongrass Oil’ in the list of ingredients
flexuosus oils(*) referred to in Article 19(1), point (g), when the
concentration of the substance or substances
Cymbopogon 91844-92-7 295-161-9 exceeds:
Flexuosus Oil — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
Cymbopogon 8007-02-1/ 295-161-9/
Citratus Leaf Oil 91844-92-7 295-161-9
355 Eucalyptus globulus Eucalyptus 97926-40-4/ 308-257-3/ The presence of the substance or substances shall be
oil(*) Globulus Leaf Oil; 8000-48-4/ 616-775-9/ 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
Eucalyptus 8000-48-4 616-775-9 substances exceeds:
Globulus Leaf/Twig — 0,001 % in leave-on products
Oil — 0,01 % in rinse-off products.
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27.7.2023356 Eugenia caryophyllus Eugenia 8000-34-8 / 616-772-2/ The presence of the substance or substances shall be
oil(*) Caryophyllus Leaf 8015-97-2/ -/ indicated as ‘Eugenia Caryophyllus Oil’ in the list of
Oil 84961-50-2 284-638-7 ingredients referred to in Article 19(1), point (g),
when the concentration of the substance or
substances exceeds:
Eugenia 84961-50-2 284-638-7 — 0,001 % in leave-on products
Caryophyllus — 0,01 % in rinse-off products.
Flower Oil
Eugenia 84961-50-2 284-638-7
Caryophyllus Stem
oil
Eugenia 84961-50-2 284-638-7
Caryophyllus Bud
oil
357 Jasminum Jasminum 84776-64-7/ 283-993-5/ The presence of the substance or substances shall be
grandiflorum / Grandiflorum 90045-94-6/ 289-960-1/ indicated as ‘Jasmine Oil/Extract’ in the list of
officinale oil and Flower Extract; 8022-96-6/ -/ ingredients referred to in Article 19(1), point (g),
extract(*) Jasminum 8024-43-9 - when the concentration of the substance or
Officinale Oil; 90045-94-6 289-960-1 substances exceeds:
Jasminum — 0,001 % in leave-on products
Officinale Flower — 0,01 % in rinse-off products
Extract
358 Juniperus virginiana Juniperus 8000-27-9 / -/ The presence of the substance or substances shall be
oil(*) Virginiana Oil; 85085-41-2 285-370-3 indicated as ‘Juniperus Virginiana Oil’ in the list of
Juniperus ingredients referred to in Article 19(1), point (g),
Virginiana Wood when the concentration of the substance or
Oil substances exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
359 Laurus nobilis Laurus Nobilis Leaf 8002-41-3/ -/ The presence of the substance shall be indicated in the
oil(*)(***) Oil 8007-48-5/ -/ list of ingredients referred to in Article 19(1), point
84603-73-6 283-272-5 (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
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188/19360 Lavandula hybrida Lavandula Hybrida 91722-69-9/ 294-470-6/ The presence of the substance or substances shall be
oil/extract; Oil; 8022-15-9/ -/ indicated ‘Lavandula Oil/ Extract’ in the list of
Lavandula Hybrida 93455-96-0/ -/ ingredients referred to in Article 19(1), point (g),
Extract; 93455-97-1/ -/ when the concentration of the substance or
Lavandula Hybrida 92623-76-2 296-408-3 substances exceeds:
Flower Extract; — 0,001 % in leave-on products
— 0,01 % in rinse-off products.
Lavandula intermedia Lavandula 84776-65-8/ 283-994-0/
oil/extract; Intermedia 8000-28-0/ -/
Flower/Leaf/Stem 90063-37-9 289-995-2
Extract; Lavandula
Intermedia
Flower/Leaf/Stem
Oil; Lavandula
Intermedia Oil
Lavandula Lavandula 84776-65-8/ 283-994-0/
angustifolia Angustifolia Oil; 8000-28-0/ -/
oil/extract(*) Lavandula 90063-37-9 289-995-2
Angustifolia
Flower/Leaf/Stem
Extract
361 Mentha piperita oil(*) Mentha Piperita Oil 8006-90-4/ -/ The presence of the substance shall be indicated in the
84082-70-2 282-015-4 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 Mentha Viridis Leaf 8008-79-5/ 616-927-4/ The presence of the substance shall be indicated in the
(spearmint oil)(*) Oil 84696-51-5 283-656-2 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.
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188/20
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27.7.2023363 Narcissus poeticus/ Narcissus Poeticus 90064-26-9/ 290-087-3/ The presence of the substance or substances shall be
pseudonarcissus/ Extract 68917-12-4 - indicated as ‘Narcissus Extract’ in the list of
jonquilla/tazetta ingredients referred to in Article 19(1), point (g),
extract(*) when the concentration of the substance or
Narcissus 90064-27-0 290-088-9 substances exceeds:
Pseudonarcissus — 0,001 % in leave-on products
Flower Extract — 0,01 % in rinse-off products.
Narcissus Jonquilla 90064-25-8 290-086-8
Extract
Narcissus Tazetta
Extract
364 Pelargonium Pelargonium 90082-51-2/ 290-140-0/ - The presence of the substance shall be indicated in the
graveolens oil(*) Graveolens Flower 8000-46-2 list of ingredients referred to in Article 19(1), point
Oil (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
365 Pogostemon cablin Pogostemon Cablin 8014-09-3/ -/ The presence of the substance shall be indicated in the
oil(*) Oil 84238-39-1 282-493-4 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 Rosa Damascena 8007-01-0/ -/ The presence of the substance or substances shall be
flower oil/extract; Flower Oil; Rosa 90106-38-0/ 290-260-3 indicated as ‘Rose Flower Oil/Extract’ in the list of
Damascena Flower ingredients referred to in Article 19(1), point (g),
Extract when the concentration of the substance or
substances exceeds:
— 0,001 % in leave-on products
Rosa alba flower Rosa Alba Flower 93334-48-6 297-122-1 — 0,01 % in rinse-off products.
oil/extract; Oil; Rosa Alba
Flower Extract
Rosa canina flower Rosa Canina Flower 84696-47-9 283-652-0
oil; Oil
Rosa centifolia Rosa Centifolia 84604-12-6 283-289-8
oil/extract; Flower Oil; Rosa
Centifolia Flower
Extract
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188/21Rosa gallica flower Rosa Gallica Flower 84604-13-7 283-290-3
oil; Oil
Rosa moschata flower Rosa Moschata - -
oil; Flower Oil
Rosa rugosa flower Rosa Rugosa 92347-25-6 296-213-3
oil(*) Flower Oil
367 Santalum album oil(*) Santalum Album 8006-87-9/ -/ The presence of the substance shall be indicated in the
Oil 84787-70-2 284-111-1 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- Eugenyl Acetate 93-28-7 202-235-6 The presence of the substance shall be indicated in the
4-(2-propenyl)-, list of ingredients referred to in Article 19(1), point
acetate(*) (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
369 2,6-Octadien-1-ol, Geranyl Acetate 105-87-3 203-341-5 The presence of the substance shall be indicated in the
3,7-dimethyl- list of ingredients referred to in Article 19(1), point
,1-acetate, (2E)-(*) (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
370 2-Methoxy-4-prop- Isoeugenyl Acetate 93-29-8 202-236-1 The presence of the substance shall be indicated in the
1-enylphenyl list of ingredients referred to in Article 19(1), point
acetate(*) (g), when its concentration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products.
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27.7.2023371 2,6,6-Trimethylbi- Pinene 80-56-8/ 201-291-9/ The presence of the substance or the substances shall
cyclo[3.1.1]hept- 7785-70-8/ 232-087-8/ be indicated in the list of ingredients referred to in
2-ene (alpha-Pinene); 127-91-3/ 204-872-5/ Article 19(1), point (g), when the concentration of the
6,6-Dimethyl- 18172-67-3 242-060-2 substance or the substances exceeds:
2-methylenebicyclo — 0,001 % in leave-on products
[3.1.1]heptane (beta- — 0,01 % in rinse-off products.
Pinene)(*)(**) The peroxide value shall be less than 10 mmoles/L(15)
(*) Cosmetic products containing that substance that do not comply with the restriction(s) may be placed on the Union market until 31 July 2026and made available on the Union market until 31 July
2028.
(**) Since that substance is a monoterpene, it is subject to the restriction on peroxide value set out in entry 130.
(***) For use of ‘Oil from the seeds of Laurus nobilis L.’, see Annex II, No 359.’
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188/23