May 28, 2021 – Nanomaterials are a hot topic within the EU cosmetics industry. In this respect, the Scientific Committee on Consumer Safety (SCCS) published a corrigendum on March 8, 2021 to the scientific advice on the safety of nanomaterials in cosmetics adopted on January 8, 2021 and on March 30-31, 2021, as well as releasing a preliminary opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino 17 Hyaluronic Acid (nano) and Acetyl heptapeptide-9 18 Colloidal gold (nano).
Nanomaterials are insoluble particles smaller than 100nm in one or more dimensions. Article 16 of the EU Cosmetics Regulation provides that “In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission […] six months prior to being placed on the market”. Hence, in case of concerns about the safety of nanomaterials, the European Commission has to ask the opinion of the SCCS. Based on the information uploaded on the CPNP, the EU Commission publishes a catalogue of nanomaterials used in cosmetic products and it updates it every year.
Moreover, according to the EU Cosmetics Regulation, article 16(10a): “Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the Commission may amend Annexes II and III.”.
SCCS’s scientific advice on the safety of nanomaterials in cosmetics
In the scientific advice on the safety of nanomaterials in cosmetics previously mentioned, the SCCS developed a scoring system in order to evaluate the overall concern for consumer safety associated to all nanomaterials listed on the EU catalogue of nanomaterials of 2019. Thanks to this system, the SCCS has realised a priority list of nanomaterials that has to undergo a safety assessment based on scientific data and literature.
To elaborate the scoring system, the SCCS considered several possible risks inherent to the nature of nanomaterials. In fact, materials’ properties may change when they are manufactured at very small size dimensions and this can lead to different side effects from those found in the normal version of the same material.
Among the aspects to evaluate the concern regarding to a nanomaterial, there are:
- Dimension of particles – the smaller they are, the higher it is the possible harm to human’s safety and/or environment,
- Certain features, such as needle shape and rigid long fibres, indicate potential harmful effects,
- Different biokinetic behaviour from the bulk version may lead to adverse effects on other parts of the body,
- Evidence of accumulation of nanoparticles in the body,
- When a nanomaterial is in an inhalable product and the particles are respirable, the concern is higher because they can reach the respiratory epithelium.
For a complete list of factors, please consult pages 16 and 17 of the SCCS/1618/20, Scientific Advice – Corrigendum of March 8, 2021. To sum up, the scoring system developed by the SCCS on the model of Brand, takes into account four categories: physico-chemical properties, hazard, kinetics and exposure.
SCCS’s opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino 17 Hyaluronic Acid (nano) and Acetyl heptapeptide-9 18 Colloidal gold (nano)
In the conclusion of its preliminary opinion dated March 30-31, 2021, the SCCS declared that it was not possible to carry out a conclusive safety assessment for the following nanomaterials: Gold, Colloidal Gold and Surface Modified Gold due to the lack of information. In fact, most of the data provided were not related to the nano version of materials, but to the bulk ones.
Nevertheless, the available scientific literature suggests that human body organs (particularly, liver and spleen) may absorb and accumulate gold nanoparticles, which have potential mutagenic effects. On this basis, the SCCS concluded that the concern on the use of these nanomaterials in cosmetic products is justified and further analyses are necessary.
At the moment, 68 cosmetics containing Gold (nano), 169 containing Colloidal Gold (nano), 11 containing Gold Thioethylamino 17 Hyaluronic Acid (nano) and 18 containing Acetyl heptapeptide-9 18 Colloidal gold (nano) were notified on the EU Cosmetic Products Notification Portal (CPNP).
All the notifications related to Acetyl heptapeptide-9 Colloidal 18 gold (nano) were withdrawn by the notifiers and therefore the nanomaterial is not included in the SCCS’s opinion.
The nanomaterials topic is constantly evolving, and new updates are expected in the near future – follow Obelis Newsletter and COSlaw to be immediately informed!
- European Commission. (2021). Scientific Committee on Consumer Safety – Scientific Advice on the safety of nanomaterials in cosmetics. Retrieved on 27/05/2021
- European Commission. (2021). Scientific Committee on Consumer Safety – Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino 17 Hyaluronic Acid (nano) and Acetyl heptapeptide-9 18 Colloidal gold (nano). Retrieved on 27/05/2021
- National Institute for Public Health and Environment. (2019). Potential health risks of nanomaterials in food: a methodology to identify signals and prioritise risks. Retrieved on 27/05/2021