There is much talk about the use of nanomaterials and nanoparticles. Are they present in my cosmetic formulation? You may get asked this question by a safety assessor.
The answer is possibly yes, if you measure the particle sizes of colourants. However, is it relevant to the use of colourants within cosmetics? The answer is no.
If you look at the regulations, the one that applies to cosmetics in Europe is EU Regulation 1223/2009.
In the consolidated version of 08/2018 it states:
“The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified.”
Therefore, colourants with nanomaterials are allowed to be used in EU Cosmetics.
Regarding the safety of nanomaterials, ETAD (Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers) have produced a position paper on organic pigments as nanomaterials (updated 2018)
It states on Page 3 on this paper, “The experience and the scientific results over this time have given no indication of any adverse effects that can be attributed solely to their very small size.”
The safety concerns about nanomaterials is the risk of inhalation. When doing a safety assessment of such products, the following have to be taken into account
1) What do the EU Regulations state?
There is only one specific exception on nanomaterials within colourants. Carbon Black. All the other colourants listed within Annex IV are OK to sues subject to any restriction in use. If you are using Carbon Black, you would need to confirm that your product you are using complies with the regulations.
2) What does it say on SDS?
Section 8 of an SDS will have information on exposure controls and personal protection.
For example, on one of our SDS for a cosmetic pigment it says:
“During the risk assessment process, it is essential to take into consideration the ACGIH occupational exposure levels for inert particulate not otherwise classified (PNOC respirable fraction: 3 mg/m3; PNOC inhalable fraction: 10 mg/m3). For values above these limits, use a P type filter, whose class (1, 2 or 3) must be chosen according to the outcome of risk assessment.”
3) How much product is being handled?
You need look at the whole method of how you handle colourants before deciding if you need to implement exposure controls and if personal protection is required.
The risk will vary considerably with the quantity that is being handled. For example, handling 2g compared to 20 Kg of the same product is completely different.
4) How do you handle it?
The risk is completely different if you are using an existing extraction system as compared to handling something roughly.
Hopefully, this some answers to questions about nanomaterials and colourants. If you need any additional help, please contact the company.