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SAFEGUARDS | Cosmetics, Personal Care & Household NO. 151/16

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The European Commission published Commission Regulation (EU) 2016/1120 on July 11, 2016 amending Annex IV of Regulation (EC) No. 1223/2009. The entry for Carbon Black (CI 77266) as a colorant is updated.

Following opinions SCCS/1515/13 and SCCS/1539/14 from the Scientific Committee on Consumer Safety (SCCS), Carbon Black (nano) is authorized at a maximum concentration of 10% by weight. However, its use in applications that may lead to exposure of the end-user's lungs by inhalation is not allowed.

The new entry becomes effective July 31, 2016.

Table 1: Annex IV of Regulation (EC) No. 1223/2009 is amended as follows:

Reference number Substance identification
Chemical name/INN Name of Common Ingredients Glossary CAS number EC number
a b c d e
‘126 Carbon black 77266 1333-86-4, 7440-44-0 215-609-9, 231-153-3, 931-328-0, 931-334-3
126a Carbon black 77266 (nano), Carbon Black (nano) 1333-86-4, 7440-44-0 215-609-9, 231-153-3, 931-328-0, 931-334-3

Continued:

Reference number Conditions Wording of conditions of use and warnings
Product type, body parts Maximum concentration in ready for use preparation Other
a f g h i
‘126 Black Purity >97 %, with the following impurity profile: Ash content
≤ 0.15 %, total sulfur ≤ 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.
126a Black 10%

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 sulfur ≤ 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

It is crucial that all cosmetic, personal care and household products are 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 recognized 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:

[1] Commission Regulation (EU) 2016/1120 on 11 July 2016

[2] Scientific Opinion SCCS/1515/13 on Carbon Black (nano-form)

[3] Scientific Opinion SCCS/1539/14 for clarification of the meaning of the term “sprayable applications/ products” for the nano forms of Carbon Black CI 77266, Titanium Dioxide and Zinc Oxide

For enquiries, please contact:

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

t: +852 2765 3672

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