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 products1, 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 hydroxide2, 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

ANNEX

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

  1. (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 hydroxide3

    Potassium hydroxide/sodium hydroxide

    1310-58-3/1310-73-2

    215-181-3/215-185-5

    (a)

    Nail cuticle solvent

    (a)

    5 %4

    (a)Contains alkali

    Avoid contact with eyes

    Can cause blindness

    Keep out of reach of children

    (b)

    Hair straightener

    2 %4

    General use

    Contains alkali

    Avoid contact with eyes

    Can cause blindness

    Keep out of reach of children

    4,5 %4

    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

    3

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

    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.’;

  2. (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 hydroxide5

    Potassium hydroxide

    1310-58-3

    215-181-3

    Callosity softener/remover

    1,5 %6

    Contains alkali

    Avoid contact with eyes

    Keep out of reach of children

    Read directions for use carefully

    5

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

    6

    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.’