MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE

Get a Quote from MDSS Your Authorized Representative forMedical Devices and In Vitro Diagnostic Devices

News Updates
    
HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

more...


In-House Workshops
"The NEW CE MARKING"
Book now
to make sure you’re ready to survive and thrive!


Keep up to date!

Cosmetic Products in Europe

Latest News



EVENTS
Join us!

International
MDR Happening

December 11-12, 2018
Hannover, Germany



Meet us!

Arab Health
January 28-31, 2019
Dubai

SE-Asian Healthcare & Pharma Show
April 9-11, 2019
Kuala Lumpur






Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





Titanium dioxide – the next “parabenized” ingredient?



Titanium dioxide is well known as white pigment in various cosmetic products, e.g. creams, pastes and powdery decorative cosmetic products. It is also used as UV filter, either in its conventional or its “nano”-form (1 nm- 100 nm particle size). Furthermore, it is authorized as food additive with the number E 171.

In May 2016, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) proposed to the European Chemicals Agency (ECHA) to classify titanium dioxide as CMR Class 1B (1). In June 2017 ECHA’s Risk Assessment Committee (RAC) concluded that due to the lack of scientific evidence the substance shall be classified as CMR of Category 2 on the inhalation route, which is the less severe category (2).

In April 2017, ANSES also draw the public attention to an animal study that postulates an increased risk associated with daily intake of titanium dioxide in terms of carcinogenesis and chronic inflammation in the intestinal tract of rats. Based on their results, the authors recommend to investigating oral exposure of titanium dioxide also in studies for human beings (3). The results represent contradictions to other studies and in particular to the opinion published by the Scientific Committee on Consumer Safety (SCCS) in 2013 (4) and the re-evaluation by the European Food Safety Agency (EFSA) in 2016 (5). Both institutions have evaluated titanium dioxide, also as nanoparticle, with comprehensive research over years and repeatedly considered it as safe for human use in food as well as in cosmetics.

Notwithstanding the questionable significance of the cited animal study, ANSES concluded that the demonstrated effects for carcinogenesis have not been shown before so further investigation will be required (6).
At this time, it must be hoped that the above conclusion on the evaluation of titanium dioxide does not cause further effects on the public perception of the ingredient. It would not be the first time that insufficient and misleading information lead to a de facto ban of an ingredient by the consumer. The intense public discussion on parabens and their preventive ban by the European Commission in 2014 have been significant warning examples.

MDSS will keep this matter under constant review. If you have any questions, please contact us via cosmetics@mdss.com.


Sources:


2. Titanium dioxide proposed to be classified as suspected of causing cancer when inhaled

3. Bettini et al. – Food-grade TiO2 impairs intestinal and systemic immune homeostasis, initiates preneoplastic lesions and promotes aberrant crypt development in the rat colon, Sci. Rep. 7, 40373 (2017) (http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4545/epdf)

4. SCCS Opinion on Titanium dioxide (nano form) SCCS/1516/13 (22 July 2013)

5. Re-evaluation of titanium dioxide as a food additive (14 September 2016)