Nanomaterials may be small in size, but they are big in business. The global market for nanomaterials is estimated at 11 million tonnes with a market value of 20 billion euros. Certain standards have been put in place for their use.
In Regulation (EC) No 1223/2009, Article 2 (1) (k), nanomaterials are defined as insoluble or biopersistent and intentionally manufactured materials with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. Based on this definition, soluble or degradable/non-persistent nanomaterials like liposomes, emulsions, etc. are not considered within this classification.
According to Article 16 of this Regulation, the Commission must be notified six months prior to any cosmetic product containing nanomaterials being placed on the market. Furthermore, Article 19:1 requires the nano-scale ingredients to be labeled (name of the ingredient, followed by ‘nano’ in brackets).
When nanomaterials are approved to be used in cosmetic products, they should be listed in the appropriate annexes. In this case, notification of nonmaterial under article 16 is not required since they have been approved in the positive lists.
Herein is the summary of the latest approved nanomaterials in cosmetic products:
Titanium dioxide is allowed to be used in cosmetic products via Annex IV/143 as a colourant and Annex VI/27 as a UV filter. In July 2016, an additional entry Annex VI/27a authorized the application of titanium dioxide nano by maximum concentration of 25% in cosmetic products.
This conclusion is only valid if there is no possibility of inhalation exposure for the finished products. Hence, Titanium dioxode nano is not safe to be used in sprays, aerosols or any other products that may cause exposure to lungs. Furthermore, Titanium dioxide nano shall have further physiochemical characteristic as:
- purity ≥ 99%, rutile form, or rutile with up to 5% anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes,
- median particle size based on number size distribution ≥ 30 nm,
- aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3,
- coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone;
- photocatalytic activity ≤ 10% compared to corresponding non-coated or non-doped reference, nanoparticles shall be photostable in the final product.
There are still further ongoing discussion regarding Titanium dioxide being used in products with possible oral ingestion, like lipsticks. In case the nanomaterials are coated with manganese dioxide, the potential harmful effects of coating materials should be taken into account. (This Scientific Committee on Consumer Safety (SCCS) opinion is still open for comments by January 2017).
Another new entry in annex VI: Zinc oxide (nano)/30a by maximum concentration of 255 in the finished product. Like the other nanomaterials, in case of inhalation exposure, it is not considered a safe ingredient. In addition, there are certain criteria set in the regulation for Zinc oxide nano as:
- 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, dimethoxydiphenylsilane triethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.
In the positive list of allowed colorants in cosmetic products (Annex IV), Carbon black (nano) is a new approved entry/126a by maximum final concentration of 10%. However, this conclusion is only valid when there is no possibility of inhalation exposure and the product is used on intact and healthy skin.
Carbon black has a long history of use as a cosmetic colorant. Carbon black nanoparticles are non-porous materials engineered to be sorbents; due to their small particle sizes (over 20 nm), they possess a significant surface area for absorption.
Hence, there is certain purity criteria for Carbon black nanomaterials which should be met as:
- Purity > 97%
- 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
In conclusion, it is important to note that risk assessment of nanomaterials is currently evolving. In particular, criteria like long-term stability of coating and possibility of oral ingestions are yet to be investigated. There are certain knowledge gaps in regard to potential penetration of nanoparticles through cuts and bruises, or long term application of nanomaterials. It is also important to state that, in the SCCS opinions for nanomaterials’ safety, environmental impact of nanomaterials have not been investigated and have yet to be considered.
- SCCS “Guidance on the safety assessment of nanomaterials in cosmetics”(SCCS/1484/12)
- ECHA “Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance” (ECHA, 20121).
- European Commission REACH chemical information on
- ADDENDUM to the OPINION SCCS/1489/12 on Zinc oxide (nano form) SCCS/1518/13 Revision of 22 April 2014
- Commission Regulation (EU) 2016/621 of 21 April 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Commission Regulation (EU) 2016/1143 of 13 July 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- SCCS OPINION on Carbon Black (nano-form) SCCS/1515/13 Revision of 15 December 2015
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