Commission Regulation (EU) 2016/622 of 21 April 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)
Date: 2016-04-21
Institutions: European Commission
Subjects: chemical compound, consumer information, cosmetic product, health control, health risk, product safety




L_2016106EN.01000701.xml










22.4.2016   


EN


Official Journal of the European Union


L 106/7








            COMMISSION REGULATION (EU) 2016/622
of 21 April 2016
         
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 31(2) thereof,

Whereas:







(1)


On 27 March 2014, the Scientific Committee on Consumer Safety (‘SCCS’) issued a scientific opinion on potassium hydroxide (2), which concluded that potassium hydroxide is safe for use as a callosity softener/remover up to a maximum concentration of 1,5 % w/w.












(2)


The SCCS also concluded that the safe use of cosmetic products containing free potassium hydroxide in concentrations from 0,5 % w/w depends on responsible risk management, through warnings and extensive guidance for use.












(3)


Following the scientific opinion of the SCCS, the Commission considers that potassium hydroxide should be considered safe for use as a callosity softener/remover up to a maximum use concentration of 1,5 % w/w.












(4)


In light of the conclusion of the SCCS regarding responsible risk management with respect to products containing free potassium hydroxide in concentrations from 0,5 % w/w, the Commission considers that cosmetic products containing potassium hydroxide for use as a callosity softener/remover should bear a warning referring to the directions for use.












(5)


Regulation (EC) No 1223/2009 should therefore be amended accordingly.












(6)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,





HAS ADOPTED THIS REGULATION:



Article 1
Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 April 2016.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 342, 22.12.2009, p. 59.

(2)  SCCS/1527/14, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_154.pdf




ANNEX
Annex III to Regulation (EC) No 1223/2009 is amended as follows:






(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 (*1)



Potassium hydroxide/sodium hydroxide


1310-58-3/1310-73-2


215-181-3/215-185-5








(a)


Nail cuticle solvent












(a)


5 % (*2)







 








(a)


Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children














(b)


Hair straightener






2 % (*2)



General use


Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach of children




4,5 % (*2)



Professional use


For professional use only
Avoid contact with eyes
Can cause blindness










(c)


pH adjuster for depilatories






 








(c)


pH < 12,7












(c)


Keep out of reach of children
Avoid contact with eyes














(d)


Other uses as pH adjuster






 








(d)


pH < 11






 














(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 (*3)



Potassium hydroxide


1310-58-3


215-181-3


Callosity softener/remover


1,5 % (*4)



 


Contains alkali
Avoid contact with eyes
Keep out of reach of children
Read directions for use carefully










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

(*2)  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.’;

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

(*4)  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.’