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Eu SCCS issue’s preliminary opinion on titanium Dioxide

2024-02-03 19:56:34


Titanium dioxide is the best white pigment in the world today. Nano titanium dioxide is an inorganic component, with excellent chemical stability, thermal stability, and non-migration and strong achromatosis, hiding power, low corrosion, good easy dispersion, and non-toxic, tasteless, non-irritant, safe to use, but also have the effect of sterilization and deodorization. More importantly, nano-titanium dioxide can not only absorb ultraviolet light, but also emit and scatter ultraviolet light, so it has strong ability to resist ultraviolet light. It is a kind of physical shielding anti-ultraviolet agent with superior performance in today's sunscreen cosmetics.

On October 27, 2017, titanium dioxide was included in the 2B list of carcinogens in the preliminary compilation of the list of carcinogens released by the International Agency for Research on Cancer of the World Health Organization.

On 5 December 2023, the EU Scientific Committee on Consumer Safety (SCCS) published its preliminary opinion on Titanium Dioxide (TiO2) (SCCS/1661/23), with a public comment deadline of 6 February 2024.

The assessment conclusions of SCCS are as follows:

1. Based on the opinion of the European Food Safety Authority (EFSA) on the issue of genotoxicity of E171, does the SCCS consider titanium dioxide (TiO2) to be safe for use in oral cosmetics? SCCS considers that the available evidence is insufficient to rule out the potential genotoxicity of all titanium dioxide grades used in oral cosmetics. Except for two nano-sized titanium dioxides (RM09 and RM11), as the genotoxicity data provided have shown that they do not present genotoxicity problems. However, more relevant information on the potential uptake and cellular effects of nano sized Tio 2 in oral mucosa is needed to consider their safety for use in oral care products.

2. In view of the opinion of the European Food Safety Authority (EFSA), does SCCS consider it necessary to revise its previous opinion on titanium dioxide in terms of inhalation and skin exposure?

The titanium dioxide grades and coatings resulting from the previous SCCS opinions on titanium dioxide in skin cosmetics (SCCS/1516/13, SCCS/1580/16) remain unchanged. New skin absorption data are required for other types of titanium dioxide grades and coatings not covered by EU Regulation 1223/2009 on Cosmetics and not covered by Item 27a of Annex VI.

In accordance with EU Regulation 1223/2009 on Cosmetics, Article 27a of Annex VI already restricts the use of nano-sized titanium dioxide in products that may cause inhalation exposure to the lungs of the end user. The safety conclusions of the previous opinion (and SCCS/1583/17, SCCS/1617/20) regarding the use of titanium dioxide in specific cosmetic products (which may cause inhalation exposure) also remain unchanged.

3. If the estimated exposure to titanium dioxide in cosmetics is found to be of concern, the SCCS is required to recommend safe concentration limits for each product category and type of use.

Since genotoxic hazards cannot be ruled out for almost all grades of titanium dioxide (except RM09 and RM11), SCCS is unable to recommend safe limits for these materials that may result in oral or inhalation exposure when used in cosmetics, In addition to the safety limits already indicated in the previous SCCS opinions (SCCS/1516/13, SCCS/1580/16 and SCCS/1617/20).

With the development of society and human progress, the safety of raw materials has been paid more and more attention. 

As the toping leading manufacturer of carbomers and acrylates copolymer, Anhui Newman Chemicals have been launching NM-Carbomer products for more than 12 years. Our key technology and carbomer products have created a positive global impact on pharmaceuticals and personal care industry.

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Anhui Newman launched carbomer for pharmaceuticals and oral care products below information.

1)    Carbomer homopolymer: carbomer homopolymer type A such as NM-Carbomer 971P, 71G, 981G. And Carbomer Homopolymer Type B such as NM-Carbomer 974P, 934P, and Carbomer Homopolymer type C such as NM-Carbomer 980G.

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