Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

ANNEXU.K.

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

(1)

in Annex II, in the table, the following entries are added:

Reference number	Substance identification
^a From 3 September 2021 hair and eyelash dye products containing those substances shall not be placed on the Union market. From 3 June 2022 hair and eyelash dye products containing those substances shall not be made available on the Union market.’;
Reference number	Chemical name/INN	CAS number	EC number
‘1642	1,2,4-Trihydroxybenzene^a when used as a substance in hair and eyelash dye products	533-73-3	208-575-1
1643	4-Amino-3-hydroxytoluene^a when used as a substance in hair and eyelash dye products	2835-98-5	220-620-7
1644	2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid^a when used as a substance in hair and eyelash dye products	117907-43-4	411-260-3

(2)

in Annex III, the table is amended as follows:

(a)

entry 292 is replaced by the following:

Reference number	Substance identification	Restrictions	Wordings 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 use preparation	Other
a	b	c	d	e	f	g	h	i
‘292	1,4-Benzenediamine, 2-(methoxymethyl) 1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate	2-Methoxymethyl-p-Phenylenediamine 2-Methoxymethyl-p-Phenylenediamine Sulfate	337906-36-2 337906-37-3	679-526-3 638-749-6	(a) Hair dye substance in oxidative hair dye products (b) Products intended for colouring eyelashes		(a) (b) After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1,8 % (calculated as free base) (b) Professional use	(a) To be printed on the label: The mixing ratio. ‘ Hair colorants 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.’ (b) To be printed on the label: The mixing ratio. ‘ This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary “black henna” tattoo in the past. For professional use only. Rinse eyes immediately if product comes into contact with them.’

Reference number

Substance identification

Restrictions

Wordings 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 use preparation

Other

‘292

1,4-Benzenediamine, 2-(methoxymethyl)

1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate

2-Methoxymethyl-p-Phenylenediamine

2-Methoxymethyl-p-Phenylenediamine Sulfate

337906-36-2

337906-37-3

679-526-3

638-749-6

(a)

Hair dye substance in oxidative hair dye products

(b)

Products intended for colouring eyelashes

(a) (b)

After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1,8 % (calculated as free base)

(b)

Professional use

(a)

To be printed on the label:

The mixing ratio.
‘ Hair colorants 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.’

(b)

To be printed on the label: The mixing ratio.

‘ This product 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 the risk of allergy.
Eyelashes shall not be coloured if the consumer:
- has a rash on the face or sensitive, irritated and damaged scalp,
- has experienced any reaction after colouring hair or eyelashes,
- has experienced a reaction to a temporary “black henna” tattoo in the past.
For professional use only.
Rinse eyes immediately if product comes into contact with them.’

(b)

the following entries are added:

[X1Reference number	Substance identification				Restrictions			Wordings of conditions of use and warnings
[X1Reference number	Chemical name/INN	Name of Common Ingredients Glossary	CAS number	EC number	Product type, body parts	Maximum concentration in ready use preparation	Other	Wordings of conditions of use and warnings
a	b	c	d	e	f	g	h	i
‘ 315	4-(3-aminopyrazolo[1,5-A]pyridin-2-yl)-1,1-dimethylpiperazin-1-ium chloride hydrochloride	Dimethylpiperazinium Aminopyrazolopyridine HCl	1256553-33-9	813-255-5	Hair dye substance in oxidative hair dye products		As from 3 June 2021 , after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base)	As from 3 December 2021 , to be printed on the label: The mixing ratio. ‘ 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. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary
316	1-(3-((4-Aminophenyl)amino)propyl)-3-methyl-1H-imidazol-3-ium chloride hydrochloride	Methylimidazoliumpropyl p-phenylenediamine HCl	220158-86-1		Hair dye substance in oxidative hair dye products		As from 3 June 2021 , after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base)	As from 3 December 2021 , to be printed on the label: The mixing ratio. 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. Hair colorants can cause severe allergic reactions.
317	Di-[2-[(E)-2-[4-[bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium]-ethyl]disulphide dimethanesulfonate	HC Orange No 6	1449653-83-1		Hair dye substance in non-oxidative hair dye products	As from 3 June 2021 : 0,5 %	Methanesulfonates impurities, in particular ethyl methanesulfonate shall not be present.
318	Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulfonate	Acid Orange 7	633-96-5	211-199-0	Hair dye substance in non-oxidative hair dye products	As from 3 June 2021 : 0,5 %
319	Phenol, 4,4'-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-	Tetrabromophenol Blue	4430-25-5	224-622-9	(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products	(b) As from 3 June 2021 : 0,2 %	(a) As from 3 June 2021 , after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,2 % (calculated as free base)	(a) As from 3 December 2021 , to be printed on the label: The mixing ratio. 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. Hair colorants can cause severe allergic reactions.
320	Indigofera tinctoria , dried and pulverised leaves of Indigofera tinctoria L	Indigofera tinctoria leaf Indigofera tinctoria leaf powder Indigofera tinctoria leaf extract Indigofera tinctoria extract	84775-63-3	283-892-6	Hair dye substance in non-oxidative hair dye products	As from 3 June 2021 : 25 % ’		]

Editorial Information

X1 Substituted by Corrigendum to Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Official Journal of the European Union L 379 of 13 November 2020).

Commission Regulation (EU) 2020/1683Show full title

ANNEXU.K.