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)
Commission Regulation (EU) 2016/622of 21 April 2016amending 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 productsOJ L 342, 22.12.2009, p. 59., 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 hydroxideSCCS/1527/14, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_154.pdf, 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 1Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
Article 2This 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 CommissionThe PresidentJean-Claude JunckerANNEXAnnex III to Regulation (EC) No 1223/2009 is amended as follows:(1)entry 15a is replaced by the following entry:
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.";
Ref No.Substance identificationRestrictionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOther
abcdefghi
"15aPotassium or sodium hydroxidePotassium hydroxide/sodium hydroxide1310-58-3/1310-73-2215-181-3/215-185-5(a)Nail cuticle solvent(a)5 %(a)Contains alkaliAvoid contact with eyesCan cause blindnessKeep out of reach of children
(b)Hair straightener2 %General useContains alkaliAvoid contact with eyesCan cause blindnessKeep out of reach of children
4,5 %Professional useFor professional use onlyAvoid contact with eyesCan cause blindness
(c)pH adjuster for depilatories(c)pH < 12,7(c)Keep out of reach of childrenAvoid contact with eyes
(d)Other uses as pH adjuster(d)pH < 11
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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.";(2)entry 15d is inserted:
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."
Ref No.Substance identificationRestrictionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOther
abcdefghi
"15dPotassium hydroxidePotassium hydroxide1310-58-3215-181-3Callosity softener/remover1,5 %Contains alkaliAvoid contact with eyesKeep out of reach of childrenRead directions for use carefully
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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."