EU Amended the ANNEX II, III and V of Cosmetics Regulation on CMR Substances
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23 May 2019, the Official Journal of European Union released the directive (EU) 2019/831, amending the Annex II, III and V to Regulation (EC) No 1223/2009 on cosmetic products. The directive shall enter into force on 11 June 2019. This Regulation shall be binding in its entirety and directly applicable in all Member States.

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226 entries are added to Annex II and the entry 395 is replaced as follows:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

395

Hydroxy-8-quinoline and its sulphate

148-24-2

134-31-6

205-711-1

205-137-1

Entries 1a, 1b, 7, 13 and 51 to Annex III are deleted, and entries 311 and 312 are added as follows:

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

a

b

c

d

e

f

g

h

i

311

Diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide

Trimethyl-benzoyl diphenylphos-phine oxide

75980-60-8

278-355-8

Artificial nail systems

5.0 %

Professional use

For professional use only

Avoid skin contact

Read directions for use carefully

312

2-Furaldehyde

Furfural

98-01-1

202-627-7

0.001 %

Point 2 of the preamble in Annex V is amended: 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 %. Entries 5, 31, 40 and 41 are deleted. Entry 28 is replaced by the following:

Reference number

Substance Identification

Conditions

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

Product type, Body parts

Maximum concentration in ready for use preparation

Other

a

b

c

e

f

g

h

i

28

Polyhexa-methylene biguanide hydrochloride

Polyamino-propyl biguanide

608-723-9

608-042-7

0.1 %

Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation

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