32019R1966R(01)

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Document 32019R1966R(01)

Corrigendum to Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Official Journal of the European Union L 307 of 28 November 2019)

IO L 324, 13.12.2019, p. 81–89 (ES, EL, HR, IT, HU, NL, PL, SK)
IO L 324, 13.12.2019, p. 80–88 (BG, CS, DA, DE, ET, EN, FR, LV, LT, MT, PT, RO, SL, FI, SV)

ELI: http://data.europa.eu/eli/reg/2019/1966/corrigendum/2019-12-13/oj

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Official Journal

13.12.2019

Official Journal of the European Union

L 324/80

(Official Journal of the European Union L 307 of 28 November 2019)

On page 19, Annex I and Annex II are replaced as follows:

‘ANNEX I

(1)

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

The following entries are added:

Reference number	Substance identification
Reference number	Chemical name/INN	CAS number	EC number
a	b	c	d
“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”

(2)

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

Entry 98 is replaced by the following:

“98

Benzoic acid, 2-hydroxy- (*1)

Salicylic acid

69-72-7

200-712-3

(a)	Rinse-off hair products

(a)

3,0 %

Not to be used in preparations for children under 3 years of age.

Not to be used for children under 3 years of age (*2)

(b)	Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant

(b)

2,0 %

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.

(3)

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

Entry 3 is replaced by the following:

Reference number	Substance Identification				Conditions			Wording of conditions of use and warnings
Reference number	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
“3	Salicylic acid (*3) and its salts	Salicylic 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 (*4)
							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- salicylate	824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5	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.	Not to be used for children under 3 years of age (*5)

‘ANNEX II

(1)

Annex II to Regulation (EC) No 1223/2009 is corrected as follows:

(a)

entry 395 is replaced by the following:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

“395

Hydroxy-8-quinoline and its sulphate bis(8-hydroxyquinolinium) sulphate, except for the uses of the sulphate provided for in entry 51 of Annex III

148-24-3

134-31-6

205-711-1

205-137-1”

(b)

entry 1396 is replaced by the following:

Reference number	Substance identification
Reference number	Chemical name/INN	CAS number	EC number
a	b	c	d
“1396	Borates, tetraborates, octaborates and boric acid salts and esters, including:
	Disodium octaborate anhydrous [1]	12008-41-2 [1]	234-541-0 [1]
	Disodium octaborate tetrahydrate [2]	12280-03-4 [2]	234-541-0 [2]
	2-Aminoethanol, monoester with boric acid [3]	10377-81-8 [3]	233-829-3 [3]
	2-Hydroxypropyl ammonium dihydrogen orthoborate [4]	68003-13-4 [4]	268-109-8 [4]
	Potassium borate, boric acid potassium salt [5]	12712-38-8 [5]	603-184-6 [5]
	Trioctyldodecyl borate [6]	- [6]	- [6]
	Zinc borate [7]	1332-07-6 [7]	215-566-6 [7]
	Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt [8]	1330-43-4 [8]	215-540-4 [8]
	Tetraboron disodium heptaoxide, hydrate [9]	12267-73-1 [9]	235-541-3 [9]
	Orthoboric acid, sodium salt [10]	13840-56-7 [10]	237-560-2 [10]
	Disodium tetraborate decahydrate; borax decahydrate [11]	1303-96-4 [11]	215-540-4 [11]
	Disodium tetraborate pentahydrate; borax pentahydrate [12]	12179-04-3 [12]	215-540-4 [12]”

(c)

entry 1507 is replaced by the following:

Reference number	Substance identification
Reference number	Chemical name/INN	CAS number	EC number
“1507	Diaminotoluene, methyl-phenylenediamine, technical product-reaction mass of [4-methyl-m-phenylenediamine and 2-methyl-m-phenylenediamine]	–	–”

(d)

the following entries are added:

Reference number	Substance identification
Reference number	Chemical name/INN	CAS number	EC number
a	b	c	d
“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”

(2)

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

(a)

entry 9 is replaced by the following:

Ref

No.

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

“9

Methylphenylenediamines, their N- substituted derivatives and their salts (1), with the exception of the substance listed under reference numbers 9 a and 9 b of this Annex and the substances listed under reference numbers 364, 413, 1144, 1310, 1313 and 1507 of Annex II

Hair dye substance in oxidative hair dye products

(a)	General use

(a)

To be printed on the label:

The mixing ratio.

“

Hair colourants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on persons under the age of 16.

Temporary “black henna” tattoos may increase your risk of allergy.

Do not colour your hair if:

—	you have a rash on your face or sensitive, irritated and damaged scalp,

—	you have ever experienced any reaction after colouring your hair,

—	you have experienced a reaction to a temporary “black henna” tattoo in the past.

Contains phenylenediamines (toluenediamines).

Do not use to dye eyelashes or eyebrows.”

(b)	Professional use

(b)	To be printed on the label:

For (a) and (b):

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base

The mixing ratio.

“For professional use only. Hair colourants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on persons under the age of 16.

Temporary “black henna” tattoos may increase your risk of allergy.

Do not colour your hair if:

—	you have a rash on your face or sensitive, irritated and damaged scalp,

—	you have ever experienced any reaction after colouring your hair,

—	you have experienced a reaction to a temporary “black henna” tattoo in the past.

Contains phenylenediamines (toluenediamines).

Wear suitable gloves.””

(b)

the following entry is 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
“51	Bis(8-hydroxyquinolinium) sulphate	Oxyqui-noline sulphate	134-31-6	205-137-1	Stabilizer for hydrogen peroxide in rinse-off hair products	(0,3 % as base)
					Stabilizer for hydrogen peroxide in leave-on hair products	(0,03 % as base)”

’

(*1) For use as a preservative see Annex V, No 3.

(*2) Solely for products which might be used for children under 3 years of age.”

(*3) For uses other than preservative, see Annex III, No 98.

(*4) Solely for products which might be used for children under 3 years of age

(*5) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.”

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