Call for data on ingredients used in cosmetic products
date: 11/06/2019
Policy fields
Internal market and industry, public health
Target
Any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the substances concerned, relevant industry and consumers associations.
Period of consultation
11 June 2019 - 10 November 2019
Request
The Commission would like to invite any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the 14 substances mentioned below and consumers associations, to submit any scientific information relevant to the safety assessment of
1. ‘Gold (nano) and colloidal gold (nano)’ (CAS no. 7440-57-5, EC No. 231-165-9, without or with surface modifications – e.g. CAS no. 1360157-34-1)
2. ‘Platinum (nano) and colloidal platinum (nano)’ (CAS no. 7440-06-4, EC No. 231-116-1, without or with surface modifications)
3. ‘Copper (nano) and colloidal copper (nano)’ (CAS no. 7440-50-8, EC No. 231-159-6)
Action proposed by the Commission
The Commission has concerns about the use of gold, colloidal gold, platinum, colloidal platinum, copper and colloidal copper in the nano form, because of the potential of nanoparticles to enter cells through dermal absorption or across a mucous membrane. In addition, the data submitted by the applicants seem to be insufficient for the scientific committee on consumer safety (SCCS)to carry out a full risk assessment.
We have mandated the SCCS to assess the safety of the above-mentioned nanomaterials. Therefore, interested parties are invited to submit, in accordance with the requirements described below, any relevant scientific information on the safety of
- ‘gold (nano) and colloidal gold (nano)’ (CAS no. 7440-57-5, EC no. 231-165-9, with or without surface modifications, e.g. CAS no. 1360157-34-1)
- ‘platinum (nano) and colloidal platinum (nano)’ (CAS No 7440-06-4, EC No. 231-116-1, with or without surface modifications)
- ‘copper (nano) and colloidal copper (nano)’ (CAS No 7440-50-8, EC no. 231-159-6) used in cosmetic products.
Requirements
If you are interested, we invite you to submit data on all physicochemical properties, toxicokinetics and toxicological end-points, assessment of exposure through consumer products and/or an indication on the suggested safe concentration limits for these ingredients.
Please provide your input with
a) the attached template (template for submitting input – checklists)
b) a table of contents
c) numbered references
Data submitted should be in line with the SCCS ‘notes of guidance’ (testing of cosmetic ingredients and their safety evaluation - 10th revision) and with the SCCS ‘guidance on the safety assessment of nanomaterials in cosmetics’.
How to submit your contribution
Any comments and information should be delivered with the reference: ‘gold, colloidal gold, platinum, colloidal platinum, copper and colloidal copper nanos in cosmetic products’ by post or e-mail by 10 November at the latest to
European Commission
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
Unit D/4, Health Technology and Cosmetics
Avenue d’Auderghem 45, BREY 12/23
1040 Brussels
Belgium
Email: grow-cosmetics-and-medical-devices@ec.europa.eu
Background
Accoriding to article 2(1)(k) of Regulation (EC) No 1223/2009, ‘nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
This definition only covers materials in the nanoscale that are intentionally made, and are insoluble or biopersistent (e.g. metals, metal oxides, carbon materials, etc), and does not cover those that are soluble or degradable/non-persistent in biological systems (e.g. liposomes, emulsions, etc). Article 16 of Regulation (EC) No 1223/2009 (Cosmetics Regulation) requires any cosmetic product other than colourants, preservatives and UV-filters, containing nanomaterials to be notified to the Commission 6 months prior to being placed on the market. If there are concerns over the safety of a nanomaterial, the Commission shall mandate the scientific committee on consumer safety (SCCS) to carry out a full risk assessment.
The Commission has received notifications of several cosmetics products containing the following ingredients: ‘gold (nano) and colloidal gold (nano)’ (CAS No 7440-57-5, EC No. 231-165-9, without or with surface modifications – e.g. CAS No. 1360157-34-1), ‘platinum (nano) and colloidal platinum (nano)’ (CAS No 7440-06-4, EC No. 231-116-1, without or with surface modifications), and ‘copper (nano) and colloidal copper (nano)’ (CAS No 7440-50-8, EC No. 231-159-6).
Gold, without any reference to the nano form, is reported in CosIng database as a colourant (CI 77480) and it is regulated according to entry 133 of annex IV (IV/133) of the Cosmetic Regulation (EC) No 1223/2009. Colloidal gold without any reference to the nano form is reported in CosIng with antimicrobial and skin conditioning functions. According to the available notifications, both ingredients (gold and colloidal gold) are used in nano form in leave-on skin cosmetic products with different concentrations and specifications, mainly with antimicrobial function.
The CosIng database reports platinum with the following functions: antimicrobial, antioxidant and skin conditioning. It reports colloidal platinum with antimicrobial, antioxidant and deodorant function. In both cases, there is no reference to the nanoforms and they are not regulated under the Cosmetic Regulation (EC) No 1223/2009. According to the notifications submitted, both ingredients (platinum and colloidal platinum) are used in nano form in leave-on and rinse-off skin cosmetic products with different concentration and specifications.
The CosIng database reports copper as a colourant (CI 77400) and entry 132 of annex IV (IV/132) of the Cosmetic Regulation (EC) No 1223/2009 regulates it without any reference to the nano form.Colloidal copper is not reported in CosIng. According to the notifications submitted, both ingredients (copper and colloidal copper) are used in nano form in leave-on and rinse-off cosmetic products including skin, nail and cuticle, hair and scalp, as well as oral hygiene products with different concentration and specifications, mainly with antimicrobial function.