Commission Regulation (EU) 2016/1120 of 11 July 2016 amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)
Commission Regulation (EU) 2016/1120of 11 July 2016amending Annex IV 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)Carbon Black is authorized as a colorant in cosmetics under entry 126 of Annex IV to Regulation (EC) No 1223/2009. The Scientific Committee on Consumer Safety ("SCCS") carried out a risk assessment of Carbon Black (nano) and adopted an opinion on 12 December 2013SCCS/1515/13 Revision of 15 December 2015, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_144.pdf, in which it concluded that the use of Carbon Black in its nano-structured form (with a primary particle size of 20 nm or larger) at a concentration up to 10 % w/w as a colorant in cosmetic products does not pose any risk of adverse effects in humans after application on healthy, intact skin.(2)Moreover, the SCCS indicated, in a further opinion of 23 September 2014 for clarification of the meaning of the term "sprayable applications/products" for the nano forms of Carbon Black CI 77266, Titanium Dioxide and Zinc OxideSCCS/1539/14 Revision of 25 June 2015, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_163.pdf, that the opinion on Carbon Black (nano) does not apply to applications that might lead to exposure of the consumer's lungs to Carbon Black nanoparticles by inhalation.(3)The SCCS conclusions apply to Carbon Black (nano) with a defined purity and impurity profile. Furthermore, the purity criteria set out for non-nano Carbon Black are no longer up-to-date and should be removed, as Commission Directive 95/45/ECCommission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (OJ L 226, 22.9.1995, p. 1). was repealed by Directive 2008/128/ECCommission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (OJ L 6, 10.1.2009, p. 20).. Those criteria should be replaced by the criteria applicable to Carbon Black (nano).(4)In light of the SCCS opinions mentioned above, the Commission considers that Carbon Black (nano) (according to the SCCS's specifications) should be authorized for use as a colorant in cosmetic products at a maximum concentration of 10 % w/w, except in applications that may lead to exposure of the end user's lungs by inhalation.(5)The Commission considers that Annex IV to Regulation (EC) No 1223/2009 should be amended for the purpose of adapting it to technical and scientific progress.(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 IV 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, 11 July 2016.For the CommissionThe PresidentJean-Claude JunckerANNEXAnnex IV to Regulation (EC) No 1223/2009 is amended as follows:
Reference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical NameColour index Number/Name of Common Ingredients GlossaryCAS numberEC numberColourProduct type, Body partsMaximum concentration in ready for use preparationOther
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"126Carbon black772661333-86-4, 7440-44-0215-609-9, 231-153-3, 931-328-0, 931-334-3BlackPurity > 97 %, with the following impurity profile: Ash content ≤ 0,15 %, total sulphur ≤ 0,65 %, total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, total Hg ≤ 1 ppm.
126aCarbon black77266 (nano)Carbon Black (nano)1333-86-4, 7440-44-0215-609-9, 231-153-3, 931-328-0, 931-334-3Black10 %Not to be used in applications that may lead to exposure of the end user's lungs by inhalation.Only nanomaterials having the following characteristics are allowed:Purity > 97 %, with the following impurity profile: Ash content ≤ 0,15 %, total sulphur ≤ 0,65 %, total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, and total Hg ≤ 1 ppm;Primary particle size ≥ 20 nm."