SAFEGUARDS | Cosmetics, Personal Care & Household NO. 091/16

SafeGuardS cosmetics

The European Commission has published a Commission Regulation (EU) 2016/621 on 21 April 2016 for amending Annex VI of Regulation (EC) No. 1223/2009. An entry of requirement on Zinc Oxide and its nano form are incorporated into Annex VI. 

The European Commission has published a Commission Regulation (EU) 2016/621 on 21 April 2016 for amending Annex VI of Regulation (EC) No. 1223/2009. An entry of requirement on Zinc Oxide and its nano form are incorporated into Annex VI. 

The Scientific Committee on Consumer Safety (SCCS) has studied and concluded that Non-Nano Zinc Oxide and Nano Zinc Oxide with specific characteristics do not pose a risk of adverse effect in humans at a concentration up to 25% as a UV filter after dermal application. However, it does not include Nano Zinc Oxide in spray products.

The European Commission has adopted the opinion from SCCS into Regulation (EC) 1223/2009 with two entries incorporated into Annex VI as below. In order to be used as a UV filter, Nano Zinc Oxide is required to fulfil a list of criteria including particle size, purity, solubility etc; and the use of both Non-Nano Zinc Oxide and Nano Zinc Oxide is excluded in the application that may lead to exposure of the end user’s lungs by inhalation.

The regulation enters into force on 12 May 2016. 

The following entries are added to Annex VI to Regulation (EC) No 1223/2009 as reference numbers 30 and 30a:

table 1

Reference number Substance identification
Chemical name/INN Name of Common Ingredients Glossary CAS number EC number
a b c d e
‘30 Zinc oxide Zinc Oxide 1314-13-2 215-222-5
30a Zinc oxide Zinc Oxide (nano) 1314-13-2 215-222-5

continue

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
‘30 25 %(*) Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
30a 25 % (*)

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 ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total
  • median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm
  • water solubility < 50 mg/L
  • uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.

[1] (*) In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.’

SGS solution:

It is crucial for all cosmetic, personal care and household products to be 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 recognised 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: Commission Regulation (EU) 2016/621 on 21 April 2016

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household
t: +852 2765 3672

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