Europe | Amending Annex II, III and VI of Cosmetics Regulation

Reference number

a

‘313

314

Substance identification

Chemical name/INN

b

2-Hydroxyethyl Methacrylate

11,14-Dioxa-2,9-diazaheptadec-16-enoic Acid, 4,4,6,16-tetramethyl-10,15-dioxo, 2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester

Name of Common Ingredients Glossary

c

HEMA

DI-HEMA TRIMETHYLHEXYL DICARBAMATE

CAS number

d

868-77-9

41137-60-4/72869-86-4

EC number

e

212-782-2

255-239-5/276-957-5

Restrictions

Product type, body parts

f

Nail products

Nail products

Maximum concentration in ready for use preparation

g

Other

h

Professional use only

Professional use only

Wording of conditions of use and warnings

i

For professional use only
Can cause an allergic reaction

For professional use only
Can cause an allergic reaction

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

Reference number

Substance identification

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

a

b

c

d

e

‘292

1,4-Benzenediamine, 2-(methoxymethyl)

2-Methoxymethyl-p-Phenylenediamine

337906-36-2

679-526-3

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

2-Methoxymethyl-p-Phenylenediamine Sulfate

337906-37-3

638-749-6

Reference number

Restrictions

Wordings of conditions of use and warnings

Product type, body parts

Maximum concentration in ready use preparation

Other

a

f

g

h

i

‘292

(a) Hair dye substance in oxidative hair dye products

(b) Products intended for colouring eyelashes

(a) After mixing

(b) 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.’

Ref.

Substance identification

Chemical name/INN

Name of Common Ingredients Glossary

CAS No.

EC No.

a

b

c

d

e

‘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

316

1-(3-((4-Aminophenyl)amino)propyl)-3-methyl-1H-imidazol-3-ium chloride hydrochloride

Methylimidazoliumpropyl p-phenylenediamine HCl

220158-86-1

317

Di-[2-[(E)-2-[4-[bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium]-ethyl]disulphide dimethanesulfonate

HC Orange No 6

1449653-83-1

318

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulfonate

Acid Orange 7

633-96-5

211-199-0

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

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

Ref.

Restrictions

Wordings of conditions of use and warnings

Product type, body parts

Maximum concentration in ready use preparation

Other

a

f

g

h

i

‘315

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

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

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

Hair dye substance in non-oxidative hair dye products

As from 3 June 2021: 0,5%

319

(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

Hair dye substance in non-oxidative hair dye products

As from 3 June 2021: 25%’

Reference number

a

‘32

Substance identification

Chemical name/INN/XAN

b

2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate

Name of Common Ingredients Glossary

c

Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate

CAS number

d

1419401-88-9

EC number

e

700-860-3

Conditions

Product type, Body parts

f

Maximum concentration in ready for use preparation

g

3%

Other

h

• Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation
• Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg
• Keep in nitrite-free containers’

Wording of conditions of use and warnings

Wording of conditions of use and warnings

i