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Version · Cosmetics Regulation

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Made by Regulation (EU) 2019/1966 32019R1966 on EUR-Lex (external, EUR-Lex)

Version 24 of 41 recorded for Cosmetics Regulation.

First seen by emendrix on , when it first read this version; that is not a legal date.

4 changes in this version

  • 1 where sources differ
  • 1 not in every list
  • 1 without an explanation

What these mean

Consolidated versions 02009R1223-20191218 → 02009R1223-20200501. v1 is the previous version, v2 this one.

Everything Regulation (EU) 2019/1966 changed

What changed

Annex I COSMETIC PRODUCT SAFETY REPORT, Modified

+17 −17 characters · Applies from: no date changed

Not in every listWhat this means

Found in the text, but not every source lists it — the text comparison found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. Both are shown; neither is overruled.

Explanation, written by a model and checked against the cited text

The heading of section 2 shows a single character substitution, with the word "chemical" rendered as "chěmical" using an accented letter in place of the plain "e".

No other wording in section 2 or elsewhere in Annex I differs between the two texts.

Cited: Annex I, v2 (external, EUR-Lex) · Annex I, v1 (external, EUR-Lex)

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version, in force 18 December 2019 02009R1223-20191218 → this version, in force 1 May 2020 02009R1223-20200501

ANNEX I COSMETIC PRODUCT SAFETY REPORT The cosmetic product safety report shall, as a minimum, contain the following: PART A – Cosmetic product safety information 1. Quantitative and qualitative composition of the cosmetic product The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier. 2. Physical/chemical Physical/chěmical characteristics and stability of the cosmetic product The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product. The stability of the cosmetics product under reasonably foreseeable storage conditions. 3. Microbiological quality The microbiological specifications of the substance or … 612 unchanged words … be duly justified. Impacts of the stability on the safety of the cosmetic product shall be duly considered. 4. Assessor's credentials and approval of part B Name and address of the safety assessor. Proof of qualification of safety assessor. Date and signature of safety assessor.

Annex II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS, Modified

+1,529 −0 characters · Applies from: no date changed

No explanation shipped — the difference between the two versions lies beyond the characters this stage can show, so no explanation was requested.

Each CAS and EC number in these tables links to its own page, which lists every entry that prints it across the acts this record holds.

12 entries added, 0 amended, 0 removed.

3 rows carry no key and are not compared.

12 entries added

Added entries, Annex II, table 1
IdentifiersReference numberSubstance identification
Chemical name/INNCAS numberEC number
abcd
Reference number 1612CAS 732-11-6EC 211-987-41612Phosmet (ISO); S-[(1,3-dioxo-1,3-dihydro-2H- isoindol-2-yl)methyl]-O,O-dimethyl phosphorodithioate; O,O-dimethyl-S-phthalimidomethyl phosphorodithioate732-11-6211-987-4
Reference number 1613CAS 7722-64-7EC 231-760-31613Potassium permanganate7722-64-7231-760-3
Reference number 1614CAS 119313-12-1EC 404-360-316142-Benzyl-2-dimethylamino-4′- morpholinobutyrophenone119313-12-1404-360-3
Reference number 1615CAS 200509-41-7EC 414-200-41615Quizalofop-p-tefuryl (ISO); (+/–) tetrahydrofurfuryl (R)-2-[4-(6- chloroquinoxalin-2- yloxy)phenyloxy]propionate200509-41-7414-200-4
Reference number 1616CAS 60207-90-1EC 262-104-41616Propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4- dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl}-1H- 1,2,4-triazole60207-90-1262-104-4
Reference number 1617CAS 243973-20-8EC 635-361-91617Pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate243973-20-8635-361-9
Reference number 1618CAS 7696-12-0EC 231-711-61618Tetramethrin (ISO); (1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate7696-12-0231-711-6
Reference number 1619CAS 1166-46-7EC 214-619-01619(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate1166-46-7214-619-0
Reference number 1620CAS 148477-71-8EC 604-636-51620Spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo- 1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate148477-71-8604-636-5
Reference number 1621CAS 897393-42-9EC 447-920-21621Reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but-2-ylamine897393-42-9447-920-2
Reference number 1622CAS 1072-63-5EC 214-012-016221-Vinylimidazole1072-63-5214-012-0
Reference number 1623CAS 348635-87-0EC 672-776-41623Amisulbrom (ISO)3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide348635-87-0672-776-4
Text from EUR-Lex, before and after

Previous version, in force 18 December 2019 02009R1223-20191218 → this version, in force 1 May 2020 02009R1223-20200501

ANNEX II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS OJ L 159, 29.6.1996, p. 1Modified INNM-name.OJ L 273, 10.10.2002, p. 1.for the individual ingredient see reference number 364 in Annex II.for the individual ingredient see reference number 413 in Annex II.From 23 … 16,424 unchanged words … the source, in the mixture as placed on the market is ≥ 0,1 % w/w — — 1608 Methylhydrazine 60-34-4 200-471-4 1609 Triadimenol (ISO); (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol 55219-65-3 259-537-6 1610 Thiacloprid (ISO); (Z)-3-(6-chloro-3-pyridyl-methyl)-1-3-thiazolidin-2-ylidenecyanamide; {(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide 111988-49-9 601-147-9 1611 Carbetamide (ISO); (R)-1-(ethylcarbamoyl) ethyl-carbanilate; (2R)-1-(ethylamino) -1-oxopro-pan-2-yl-phenylcarbamate 16118-49-3 240-286-6 1612 Phosmet (ISO); S-[(1,3-dioxo-1,3-dihydro-2H- isoindol-2-yl)methyl]-O,O-dimethyl phosphorodithioate; O,O-dimethyl-S-phthalimidomethyl phosphorodithioate 732-11-6 211-987-4 1613 Potassium permanganate 7722-64-7 231-760-3 1614 2-Benzyl-2-dimethylamino-4′- morpholinobutyrophenone 119313-12-1 404-360-3 1615 Quizalofop-p-tefuryl (ISO); (+/–) tetrahydrofurfuryl (R)-2-[4-(6- chloroquinoxalin-2- yloxy)phenyloxy]propionate 200509-41-7 414-200-4 1616 Propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4- dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl}-1H- 1,2,4-triazole 60207-90-1 262-104-4 1617 Pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate 243973-20-8 635-361-9 1618 Tetramethrin (ISO); (1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate 7696-12-0 231-711-6 1619 (1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate 1166-46-7 214-619-0 1620 Spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo- 1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate 148477-71-8 604-636-5 1621 Reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but-2-ylamine 897393-42-9 447-920-2 1622 1-Vinylimidazole 1072-63-5 214-012-0 1623 Amisulbrom (ISO)3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide 348635-87-0 672-776-4 1624 Pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate 23103-98-2 245-430-1 1625 1,2-Dichloropropane; propylene dichloride 78-87-5 201-152-2 1626 Phenol, dodecyl-, branched [1] 121158-58-5 [1] 310-154-3 [1] Phenol, 2-dodecyl-, branched [2] 1801269-80-6 [2] - [2] Phenol, 3-dodecyl-, branched [3] 1801269-77-1 [3] - [3] Phenol, 4-dodecyl-, branched [4] 210555-94-5 [4] 640-104-9 [4] Phenol, (tetrapropenyl) derivatives [5] 74499-35-7 [5] 616-100-8 [5] 1627 Coumatetralyl (ISO); 4- hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl) coumarin 5836-29-3 227-424-0 1628 Difenacoum (ISO); 3-(3- biphenyl-4-yl-1,2,3,4- tetrahydro-1-naphthyl)- 4-hydroxycoumarin 56073-07-5 259-978-4 1629 Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin 56073-10-0 259-980-5 1630 Flocoumafen (ISO); reaction mass of: cis-4- hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin 90035-08-8 421-960-0 1631 Acetochlor (ISO); 2- chloro-N-(ethoxymethyl)-N-(2-ethyl-6- methylphenyl)acetamide 34256-82-1 251-899-3 1632 e-Glass microfibres of representative composition - - 1633 Glass microfibres of representative composition - - 1634 Bromadiolone (ISO); 3- [3-(4′-bromobiphenyl- 4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy- 2H-chromen-2-one 28772-56-7 249-205-9 1635 Difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]- 4-hydroxy-2H-1-benzothiopyran-2-one 104653-34-1 600-594-7 1636 Perfluorononan-1-oic acid [1] 375-95-1 [1] 206-801-3 [1] and its sodium [2] 21049-39-8 [2] - [2] and ammonium [3] salts 4149-60-4 [3] - [3] 1637 Dicyclohexyl phthalate 84-61-7 201-545-9 1638 3,7-Dimethylocta-2,6- dienenitrile 5146-66-7 225-918-0 1639 Bupirimate (ISO); 5-butyl-2-ethylamino-6- methylpyrimidin-4-yl dimethylsulfamate 41483-43-6 255-391-2 1640 Triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1- (1H-imidazol-1-yl)-2- propoxyethanimine 68694-11-1 604-708-8 1641 tert-Butyl hydroperoxide 75-91-2 200-915-7

Annex III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN, Modified

+636 −500 characters · Applies from: no date changed

Explanation, written by a model and checked against the cited text

One footnote changes wording slightly, replacing "For use as a preservative, see Annex V, No. 3" with "For use as a preservative see Annex V, No 3", a minor punctuation adjustment.

Another footnote is shortened by removing the clause about remaining in prolonged contact with the skin, so it now reads only that it is solely for products which might be used for children under 3 years of age.

The remainder of the visible text, including the numbered substance entries, appears unchanged between the two versions, though both texts were truncated before the full annex could be compared.

Cited: Annex III, v1 (external, EUR-Lex) · Annex III, v2 (external, EUR-Lex)

v1 is the previous version, v2 this one.

0 entries added, 1 amended, 0 removed.

4 rows carry no key and are not compared.

1 entry amended

Amended entries, Annex III, table 1
IdentifiersVersionReference numberSubstance identificationRestrictionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOther
abcdefghi
Reference number 98CAS 69-72-7EC 200-712-3Before98Benzoic acid, 2-hydroxy- Salicylic acid69-72-7200-712-3(a) Rinse-off hair products (b) Other products(a) 3,0 % (b) 2,0 %Not to be used in preparations for children under 3 years of age, except for shampoos For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the productNot to be used for children under 3 years of age
After98Benzoic acid, 2-hydroxy- Salicylic acid69-72-7200-712-3(a) Rinse-off hair products (b) Other productsexcept body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant(a) 3,0 % (b) 2,0 %Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.Not to be used for children under 3 years of age
Text from EUR-Lex, before and after

Previous version, in force 18 December 2019 02009R1223-20191218 → this version, in force 1 May 2020 02009R1223-20200501

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1. For use as a preservative, see Annex V, No. 5. Only if the concentration exceeds 0,05 %. These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 2. The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g. The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g. For use as a preservative, see Annex V, No. 34. For use as a preservative, see Annex V, No 43. For use as a preservative, see Annex V, No. 54. For use as a preservative, see Annex V, No 3. Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin. For use as a preservative see Annex V, No 3. Solely for products which might be used for children under 3 years of age. For use as a preservative, see Annex V, No 9. For use as a preservative, see AnnexV, No 23. For use as a preservative, see Annex V, No 8. … 537 unchanged lines … (b) 0,56 % in eau de toilette (c) 0,042 % in other products 98 Benzoic acid, 2-hydroxy- Salicylic acid 69-72-7 200-712-3 (a) Rinse-off hair products (b) Other products (a) 3,0 % (b) 2,0 % Not to be used in preparations for children under 3 years of age, except for shampoos For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product Not to be used for children under 3 years of age (b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant (a) 3,0 % (b) 2,0 % Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. Not to be used for children under 3 years of age 99 Inorganic sulfites and bisulfites (a) Oxidative hair dye products (a) 0,67 % (as free SO2) For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product (b) Hair straightening products (b) 6,7 % (as free SO2) (c) Self-tanning products for the face (c) 0,45 % (as free SO2) … 1,325 unchanged lines … Avoid skin contact Read directions for use carefully 312 2-Furaldehyde Furfural 98-01-1 202-627-7 0,001 %

Annex V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS, Modified

+341 −90 characters · Applies from: no date changed

Explanation, written by a model and checked against the cited text

Entry 3, covering salicylic acid and its salts, is restructured so that salicylic acid itself is now listed on its own line with its own CAS and EC numbers, separated from the other salicylate salts, which are grouped on a second line with their own identifiers.

The conditions and wording column for entry 3 now adds statements that salicylic acid is not to be used in products for children under 3 years of age, not to be used in oral products, and not to be used in applications that may lead to exposure of the end-user's lungs by inhalation, alongside the restriction that the other salicylate salts are not to be used in products for children under 3 years of age except for shampoos.

A minor wording change also occurs in the preamble note that previously read "For use other than as a preservative, see Annex III, No. 98," which now reads "For uses other than preservative, see Annex III, No 98."

Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)

v1 is the previous version, v2 this one.

0 entries added, 1 amended, 0 removed.

1 entry amended

Amended entries, Annex V, table 1
IdentifiersVersionReference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOther
abcdefghi
Reference number 3CAS 18917-89-0CAS 2174-16-5CAS 54-21-7CAS 578-36-9CAS 59866-70-5CAS 69-72-7CAS 824-35-1EC 200-198-0EC 200-712-3EC 209-421-6EC 212-525-4EC 218-531-3EC 242-669-3EC 261-963-2Before3Salicylic acid and its saltsSalicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-30,5 % (acid)Not to be used in products for children under 3 years of age, except for shampoosNot to be used for children under 3 years of age
After3Salicylic acid and its saltsSalicylic acid69-72-7200-712-30,5 % (acid)Not to be used in products for children under 3 years of age.Not to be used for children under 3 years of age
Not to be used in oral products.
Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
Calcium salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA- salicylate824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-30,5 % (acid)Not to be used in products for children under 3 years of age, except for shampoos.Not to be used for children under 3 years of age
Text from EUR-Lex, before and after

Previous version, in force 18 December 2019 02009R1223-20191218 → this version, in force 1 May 2020 02009R1223-20200501

ANNEX V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS Preamble 1. For the purposes of this list: Salts is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate. Esters is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl. 2. All finished products containing substances in this Annex and which release formaldehyde must be labelled with the warning contains formaldehyde where the concentration of formaldehyde in the finished product exceeds 0,05 % For use uses other than as a preservative, see Annex III, No. No 98. Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin. For use other than as a preservative, see Annex III, No. 13. For use other than as a preservative, … 450 unchanged words … (acid) 2 Propionic acid and its salts Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate 79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6 201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4 2 % (acid) 3 Salicylic acid and its salts Salicylic acid, calcium acid 69-72-7 200-712-3 0,5 % (acid) Not to be used in products for children under 3 years of age. Not to be used for children under 3 years of age Not to be used in oral products. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Calcium salicylate, magnesium salicylate, MEA-salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA-salicylate 69-72-7, TEA- salicylate 824-35-1, 18917-89-0, 59866-70-5, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5 200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3 0,5 % (acid) Not to be used in products for children under 3 years of age, except for shampoos shampoos. Not to be used for children under 3 years of age 4 Hexa-2,4-dienoic acid and its salts Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate 110-44-1, 7492-55-9, 7757-81-5, 24634-61-5 203-768-7, 231-321-6, 231-819-3, 246-376-1 0,6 % (acid) 5 Formal-dehyde, paraformaldehyde Formaldehyde Paraformaldehyde 50-00-0, 30525-89-4 … 1,169 unchanged words … and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate Citric acid (and) Silver citrate — 460-890-5 0,2 %, corresponding to 0,0024 % of silver Not to be used in oral products and eye products 60 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone 569646-79-3 933-435-8 0,7 %

The full entry is committed at eu/32009R1223/CHANGELOG.md.