ANNEX
- (1)
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 Methyl- and Ethyl- esters, and their salts
4-Hydroxybenzoic acid
methylparaben
potassium ethylparaben
potassium paraben
sodium methylparaben
sodium ethylparaben
ethylparaben
sodium paraben
potassium methylparaben
calcium paraben
99-96-7
99-76-3
36457-19-9
16782-08-4
5026-62-0
35285-68-8
120-47-8
114-63-6
26112-07-2
69959-44-0
202-804-9
202-785-7
253-048-1
240-830-2
225-714-1
252-487-6
204-399-4
204-051-1
247-464-2
274-235-4
0,4 % (as acid) for single ester
0,8 % (as acid) for mixtures of esters’
- (2)
entry 12a is inserted:
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
‘12a
Butyl 4-hydroxybenzoate and its salts
Propyl 4-hydroxybenzoate and its salts
Butylparaben
propylparaben
sodium propylparaben
sodium butylparaben
potassium butylparaben
potassium propylparaben
94-26-8
94-13-3
35285-69-9
36457-20-2
38566-94-8
84930-16-5
202-318-7
202-307-7
252-488-1
253-049-7
254-009-1
284-597-5
0,14 % (as acid) for the sum of the individual concentrations
0,8 % (as acid) for mixtures of substances mentioned in entry 12 and 12a, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 %
Not to be used in leave-on products designed for application on the nappy area of children under three years of age.
For leave-on products designed for children under three years of age:
“Do not use on the nappy area”’