The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles.
The request notes that titanium dioxide is authorized both as a colorant under entry 143 of Annex IV and as an ultraviolet (UV) filter under entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No. 1223/2009 (Cosmetics Regulation). The request states that in light of titanium dioxide’s classification as a Carcinogen Category 2 (i.e., suspected human carcinogen) by inhalation route only and its inclusion in Annex VI to Regulation (EC) No. 1272/2008 (Classification, Labeling, and Packaging (CLP) Regulation), SCCS has reassessed titanium dioxide. Subsequently, entry 321in Annex III was introduced and additional provisions in existing entries 143 of Annex IV and 27 and 27a of Annex VI were added that further restricted the use of titanium dioxide in cosmetic products.
As reported in our May 10, 2021, blog item, on May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive. According to EFSA, “[a] critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles.”
According to the request, in May 2022, the EC received a dossier submission by industry accompanied by a comprehensive, up-to-date review of the genetic toxicity database for titanium dioxide “providing scientific evidence to demonstrate the safety of non-nano (pigmentary) and nano form” of titanium dioxide in cosmetic products.
Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...
Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...
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