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EFSA Publishes Scientific Opinion on Proposed Amendment to EU Specifications for Titanium Dioxide (E 171)

On July 12, 2019, the European Food Safety Authority (EFSA) published in the EFSA Journal its “Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution.”  The opinion addresses the assessment of data provided by interested business operators in support of an amendment of the European Union (EU) specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution.  According to the opinion, titanium dioxide (E 171), which is used as a food additive in food, undergoes no surface treatment and is not coated.  The opinion states that interested business operators have proposed to revise the EU specifications for E 171 to include “a specification of more than 100 nm for median Feret min diameter and less than 50% of the number of constituent particles below 100 nm; measured by EM in both cases.” 

The EFSA Panel on Food Additives and Flavorings, after reviewing the data, “concluded that a specification of more than 100 nm for median minimal external dimension, equivalent to less than 50% of the number of constituent particles with a median minimal external dimension below 100 nm, should be inserted in the current EU specifications.”  According to the opinion, the Panel determined that the conclusions made, and the uncertainties identified, in previous EFSA assessments of E 171 remain valid.  The Panel reiterates the need for further research as recommended in previous opinions to decrease the level of uncertainty and acknowledges that interested business operators are carrying out additional studies with characterized E 171.  More information on EFSA’s 2018 review of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171) is available in our August 6, 2018, blog item.

©2019 Bergeson & Campbell, P.C.

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About this Author

Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

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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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), 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 advocating before Congress, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.

Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

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