The annexes to Regulation (EC) No 1223/2009 are amended as follows:
in Annex II the following entries 1374 to 1378 are added:
| Reference Number | Substance Identification |
|---|
| Chemical Name/INN | CAS number | EC number |
|---|
| a | b | c | d |
|---|
| ‘1374 |
Isopropyl 4-hydroxybenzoate (INCI: Isopropylparaben)
Sodium salt or Salts of Isopropylparaben
| 4191-73-5 | 224-069-3 |
| 1375 | Isobutyl 4-hydroxybenzoate (INCI: Isobutylparaben) | 4247-02-3 | 224-208-8 |
| Sodium salt or Salts of Isobutylparaben | 84930-15-4 | 284-595-4 |
| 1376 | Phenyl 4-hydroxybenzoate (INCI: Phenylparaben) | 17696-62-7 | 241-698-9 |
| 1377 | Benzyl 4-hydroxybenzoate (INCI: Benzylparaben) | 94-18-8 | |
| 1378 | Pentyl 4-hydroxybenzoate (INCI: Pentylparaben) | 6521-29-5 | 229-408-9’ |
Annex V is amended as follows:
entry 12 is replaced by the following:
| Substance Identification | Conditions | |
|---|
| 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 | Wording of conditions of use and warnings |
|---|
| a | b | c | d | e | f | g | h | i |
|---|
| ‘12 | 4-Hydroxybenzoic acid and its salts and esters, other than the esters of isopropyl, isobutyl, phenyl, benzyl and pentyl | 4-Hydroxybenzoic acid | 99-96-7 | 202-804-9 | |
0,4 % (as acid) for single ester,
0,8 % (as acid) for mixtures of esters’
| | |
| methylparaben | 99-76-3 | 202-785-7 |
| butylparaben | 94-26-8 | 202-318-7 |
| potassium ethylparaben | 36457-19-9 | 253-048-1 |
| potassium paraben | 16782-08-4 | 240-830-2 |
| propylparaben | 94-13-3 | 202-307-7 |
| sodium methylparaben | 5026-62-0 | 225-714-1 |
| sodium ethylparaben | 35285-68-8 | 252-487-6 |
| sodium propylparaben | 35285-69-9 | 252-488-1 |
| sodium butylparaben | 36457-20-2 | 253-049-7 |
| ethylparaben | 120-47-8 | 204-399-4 |
| sodium paraben | 114-63-6 | 204-051-1 |
| potassium methylparaben | 26112-07-2 | 247-464-2 |
| potassium butylparaben | 38566-94-8 | 254-009-1 |
| potassium propylparaben | 84930-16-5 | 284-597-5 |
| calcium paraben | 69959-44-0 | 274-235-4 |
entry 25 is replaced by the following:
| Substance Identification | Conditions | |
|---|
| 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 | Wording of conditions of use and warnings |
|---|
| a | b | c | d | e | f | g | h | i |
|---|
| ‘25 | 5-Chloro-2- (2,4- dichlorophenoxy) phenol | Triclosan | 3380-34-5 | 222-182-2 |
(a)
Toothpastes
Hand soaps
Body soaps/Shower gels
Deodorants (non-spray)
Face powders and blemish concealers
Nail products for cleaning the fingernails and toenails before the application of artificial nail systems
|
(a)
0,3 %
| | |
|
(b)
Mouthwashes
|
(b)
0,2 %’
| | |