18 REGULATION
marketed for exposure to natural/artificial UV light”.7
The EC has notified the WTO that it
proposes to restrict the use of methyl-N- methylanthranilate by adding it to Annex III of Regulation 1223/2009. The substance will be permitted to be used at 0.1% in leave-on products (but not in sunscreen products and products marketed for exposure to natural or artificial UV light, as per the SCCS opinion) and at 0.2% in rinse-off products. As it can form nitrosamines, it should not be used with nitrosating agents. The maximum nitrosamine content has been set at 50 µg/kg and it should be kept in nitrite-free containers.8 Products not complying with the restriction will
be permitted to be placed on the EU market for six months from the date of entry in to force of the change in regulation. All products not complying with the restriction must be off the market within nine months of the date of the change in regulation coming into force.
Nanomaterials Article 16 of Regulation 1223/2009 requires products containing nanomaterials to be notified to the EC six months prior to being placed on the EU market unless they contain nanomaterials that are listed in Annexes III (restricted substances), IV (colorants), V (preservatives) or VI (UV filters). If the EC has any concerns regarding the safety of the nanomaterial, it will ask the SCCS to give an opinion. The SCCS has published opinions for a number of nanomaterials. For bis-(diethylaminohydroxybenzoyl
benzoyl) piperazine, the SCCS concluded that it is safe to be used as a UV filter up to a maximum concentration of 10% in dermal applications.9
If nano and non-nano
formulations are used in the same formulation, the maximum combined concentration must not exceed 10%. This opinion was based on the low
solubility, low dermal and oral absorption and low systemic availability of the nanomaterial. The SCCS had concerns that bis-(diethylaminohydroxybenzoyl benzoyl) piperazine may cause inflammation of the lungs and does not recommend its use in products that may be inhaled into the lungs. On separate occasions, the SCCS
was asked to consider whether platinum (nano), colloidal platinum (nano) and acetyl tetrapeptide-17 colloidal platinum (nano) and gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano) and acetyl heptapeptide-9 colloidal gold (nano) are safe in leave-on cosmetic products. In both cases, it was unable to carry out a safety assessment due to limited or missing essential information and concluded that there is a basis of concern for the use of these nanomaterials in cosmetic products that could pose a risk to the consumer. If further evidence was provided, it will reassess the safety of these nanomaterials.10,11 Similarly, the SCCS was asked to consider
if copper (nano) and colloidal copper (nano) are safe when used in leave-on and rinse-off dermal and oral cosmetic products, including
PERSONAL CARE November 2021
Skin sensitisation is at the heart of many new regulations
skin, nail and cuticle, hair and scalp and oral hygiene products, at a maximum concentration of 1%.12
The committee was unable to carry out a safety
assessment due to limited and missing essential information. Much of the toxicity information was for copper and the committee was unable to relate this to copper in the nano form. The SCCS requires more information to characterise the nanomaterials and carry out a toxicological evaluation. The SCCS had also previously been asked
to consider if hydroxyapatite (nano) was safe to be used at up to 10 % in oral cosmetics products including toothpastes, tooth whiteners and mouth washes and published an opinion13
in October
2015, which was revised in March 2016. This concluded that it was unable to assess the safety of hydroxyapatite (nano) in oral products due to insufficient information. As the information provided could not be
related to the hydroxyapatite materials under evaluation, toxicological data specific to or related to the nanomaterial was required. Following submission of additional information, the SCCS looked at the safety of hydroxyapatite (nano) again.14 Having considered this, the SCCS was of the
opinion that it could not conclude on the safety of hydroxyapatite (nano) as the information provided on genotoxicity was insufficient. Although the particle shape of the hydroxyapatite (nano) considered in the opinion was reported to be rod- shaped the SCCS is aware that it can be in needle- shaped form. Needle-shaped hydroxyapatite (nano) should not be used in cosmetic products due to potential toxicity concerns.
Conclusion This article has looked at how Regulation 1223/2009 has been amended in 2020 and up to August 2021. It has also looked at the notifications that the EC has made to the WTO
for future changes to the regulation. The article finally looks at the opinions of the SCCS on a number of nanomaterials. For the exact wording, it is recommended that the relevant regulation, or opinion is referred to.
References 1. SCCS Opinion on salicylic acid, Corrigendum of 20-21 June 2019, SCCS/1601/18
2. SCCS Opinion on Deoxyarbutin Tetrahydropyranyloxy Phenol, SCCS/1554/15
3.
https://echa.europa.eu/ documents/10162/6405ddd0-2429-9e13- 31bd-4e0752fe7430
4. SCCS Opinion on Zinc Pyrithione (ZPT) – Submission III, SCCS/1614/19, Final Opinion
5. Draft regulation submitted to WTO, 22 January 2021
6. SCCS Opinion on Methyl-N- methylanthranilate (phototoxicity only). SCCS/1455/11
7. Draft regulation submitted to WTO, 15 March 2021
8. SCCS Scientific Advice on the SCCS Opinion on Methyl-N-Methylanthranilate. SCCS/1455/11, Corrigendum of 1 June 2021
9. SCCS Opinion on HAA299 (nano) SCCS/1634/21, Preliminary Opinion
10. SCCS, Opinion on Platinum (nano) Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano), SCCS/1630/21, Final Opinion
11. SCCS Opinion on Gold (nano), Colloidal gold (nano), Gold Thioethylamino Hyaluronic Acid (nano), and Acetyl heptapeptide-9 colloidal gold (nano), SCCS/1629/21, Final Opinion
12. SCCS Opinion on Copper (nano) and Colloidal Copper (nano), SCCS/1621/20, Final Opinion
13. SCCS Opinion on Hydroxyapatite (nano), SCCS/1566/15, Revision of 16 March 2016
14. SCCS Opinion on Hydroxyapatite (nano), SCCS/1624/20, Final Opinion
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