Skip to Menu Skip to Search Contact Us Global Websites & Languages Skip to Content

SAFEGUARDS | Cosmetics, Personal Care & Household NO. 110/16

SafeGuardS SPA beauty products

The European Commission has published a Commission Regulation (EU) 2016/622 on 21 April 2016 for amending Annex III of Regulation (EC) No. 1223/2009. An entry of requirement on Potassium Hydroxide is incorporated into Annex III.

Potassium Hydroxide is regulated in current Cosmetics Regulation (EC) 1223/2009 when it falls into the scope of (a) Nail cuticle solvent, (b) Hair straightener, (c) pH adjuster for depilatories, and (d) other uses as pH adjuster. The Scientific Committee on Consumer Safety (SCCS) has studied and concluded that Potassium Hydroxide should be considered as safe for use as a callosity softener/ remover up to a maximum concentration of 1.5% w/w.

European Commission has adopted the opinion from SCCS into Regulation (EC) 1223/2009 with an entry of Potassium Hydroxide incorporated into Annex III as below. The regulation enters into force on 12 May 2016.

Table 1: Entry 15a is replaced by the following entry

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
15a Potassium
or sodium hydroxide (*)
Potassium
hydroxide/sodium hydroxide

1310-58-3/,

1310-73-2

215-181-3/,

215-185-5

(a) Nail
cuticle solvent
(a) 5 % (**)

(a) Contains alkali

Avoid contact with eyes

Can cause blindness
Keep out of reach of children

(b) Hair
straightener
2 % (**) General
use

Contains alkali

Avoid contact with eyes

Can cause blindness
Keep out of reach of children

4,5 % (**) Professional
use

For professional use only

Avoid contact with eyes

Can cause blindness

(c) pH
adjuster for depilatories
(c) pH < 12,7

Keep out of reach of children

Avoid contact with eyes

(d) Other
uses as pH adjuster
(d) pH < 11

 

Table 2:  Entry 15d is inserted:

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
15d Potassium
hydroxide (***)
Potassium
hydroxide
1310-58-3 215-181-3 Callosity
softener/remover
1,5 % (****) Contains alkali, Avoid contact with eyes, Keep out of reach of children, Read directions for use carefully

(*) For other uses of potassium hydroxide, see Annex III, No 15d.

(**) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.’;

(***) For other uses of Potassium hydroxide, see Annex III, No 15a.

(****) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.’

It is crucial for all cosmetic, personal care and household products to be safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognised standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

Reference Sources: Commission Regulation (EU) 2016/622 on 21 April 2016.

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household

t: +852 2765 3672

Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!

© SGS Group Management SA - 2016 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.