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)

Commission Regulation (EU) 2020/1683of 12 November 2020amending 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)

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

Article 2This 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.ANNEXRegulation (EC) No 1223/2009 is amended as follows:(1)in Annex II, in the table, the following entries are added:

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	Substance identification
	Chemical name/INN	CAS number	EC number
"1642	1,2,4-Trihydroxybenzene when used as a substance in hair and eyelash dye products	533-73-3	208-575-1
1643	4-Amino-3-hydroxytoluene 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 when used as a substance in hair and eyelash dye products	117907-43-4	411-260-3

----------------------

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.";(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-Phenylenediamine2-Methoxymethyl-p-Phenylenediamine Sulfate	337906-36-2337906-37-3	679-526-3638-749-6	(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:

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
"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."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."
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."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."
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."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."
320	Indigofera tinctoria, dried and pulverised leaves of Indigofera tinctoria L	Indigofera tinctoria leaf Indigofera tinctoria leaf powderIndigofera tinctoria leaf extractIndigofera tinctoria extract	84775-63-3	283-892-6	Hair dye substance in non-oxidative hair dye products	As from 3 June 2021: 25 %"

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

Article 2This 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.ANNEXRegulation (EC) No 1223/2009 is amended as follows:(1)in Annex II, in the table, the following entries are added:

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	Substance identification
	Chemical name/INN	CAS number	EC number
"1642	1,2,4-Trihydroxybenzene when used as a substance in hair and eyelash dye products	533-73-3	208-575-1
1643	4-Amino-3-hydroxytoluene 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 when used as a substance in hair and eyelash dye products	117907-43-4	411-260-3

----------------------

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.";(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-Phenylenediamine2-Methoxymethyl-p-Phenylenediamine Sulfate	337906-36-2337906-37-3	679-526-3638-749-6	(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:

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
"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."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."
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."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."
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."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."
320	Indigofera tinctoria, dried and pulverised leaves of Indigofera tinctoria L	Indigofera tinctoria leaf Indigofera tinctoria leaf powderIndigofera tinctoria leaf extractIndigofera tinctoria extract	84775-63-3	283-892-6	Hair dye substance in non-oxidative hair dye products	As from 3 June 2021: 25 %"