Search results for: titanium dioxide

  • On March 4, 2024, FDA published a webpage discussing the use of titanium dioxide (TiO2) as a color additive in foods. The webpage, which references a color additive petition requesting to revoke the listing for the use of TiO2 in foods, represents a stronger FDA stance regarding the safety of the additive.
  • TiO2, listed at 21 CFR 73.575, is a synthetically prepared white pigment that may be safely used as a color additive in nonstandardized foods at no more than 1 percent by weight of the food. TiO2 may also be used as a colorant in food contact materials, such as packaging materials, under 21 CFR 178.3297.
  • FDA highlighted a recent report from the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives (JECFA) that concluded that TiO2 is safe for use in food and that based on the available data, the total daily intake of the substance does not represent a hazard to health. Although the European Food Safety Authority (EFSA) took the position in a 2021 opinion that it could not rule out genotoxicity from TiO2, other international regulatory bodies have found the substance to be safe. According to the United Kingdom’s Food Standards Agency, Health Canada, and Food Standards Australia and New Zealand, there is no evidence to support that TiO2 presents any safety concerns when used in food. In addition, FDA stated that “some of the genotoxicity tests considered in the EFSA assessment included test materials not representative of the color additive, and some tests included administration routes not relevant to human dietary exposure.” Overall, FDA also did not identify genotoxicity concerns related to TiO2 and noted that the substance did not cause cancer in National Toxicology Program carcinogenicity studies.
  • The Codex Alimentarius Commission Committee on Food Additives will consider the JECFA and EFSA findings at its April meeting in Chengdu, China.
  • TiO2 was originally included in the list of substances California considered prohibiting in 2023; however, it was removed before the state passed the California Food Safety Act, banning four other substances from use in food.
  • Keller and Heckman will continue to monitor and report on any developments regarding TiO2.

  • The California Food Safety Act (AB 418) was amended by the Senate to remove titanium dioxide from its list of prohibited substances. Four substances remain on the list: brominated vegetable oil, potassium bromate, propylparaben, and Red dye 3. The amendment was made just before the Legislature was to cast the final vote on AB 418, but it is now ordered to a third reading.
  • Additionally, in a July amendment, the effectiveness date was amended from January 1, 2025 to January 1, 2027, which would give affected parties two additional years to comply if AB 418 is passed.
  • As we have outlined in two previous posts (available here and here), AB 418 would prohibit manufacturing, selling, delivering, distributing, holding, or offering for sale a food product that contains any of the now four remaining substances. Anyone found to be in violation of the Act would be liable for a civil penalty not to exceed $5,000 for a first violation, and not to exceed $10,000 for each subsequent violation.
  • If passed, AB 418 would be the first law of its kind in the United States. Advocates of the bill, including Consumer Reports and the Environmental Working Group, argue that these substances have not been adequately reviewed by the FDA and view this bill as a necessary step to remove harmful chemicals from the food supply. The European Union has already imposed restrictions or bans on use of these substances in food.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • On May 3, FDA announced that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), the Center for Environmental Health (CEH), the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 CFR 73.575, which permits its use in food products.
  • The petitioners assert that the intended use of this color additive no longer meets the safety standard under 21 CFR 70.3(i), and cite, as evidence, an opinion by the European Food Safety Authority (EFSA) entitled “Safety assessment of titanium dioxide (E171) as a food additive” that was published in May 2021. On January 14, 2022, the European Commission (EC) announced that it adopted a ban on the use of titanium dioxide as a food additive. To read more about EFSA’s 2021 titanium dioxide safety opinion, click here.
  • FDA also submitted notice of the color additive petition to the World Trade Organization’s Committee on Sanitary and Phytosanitary Measures on May 5 to request international input on the proposed titanium dioxide ban.
  • FDA is currently seeking comments, additional scientific data, and other information related to the safety of titanium dioxide in foods until July 3, 2023. Electronic comments can be submitted here.
  • Keller and Heckman would be happy to assist in submitting comments. We will continue to monitor developments regarding the permissive use of titanium dioxide as a color additive in foods.
  • On May 6, 2021, the European Food Safety Authority (EFSA) updated its 2016 safety assessment of the food additive titanium dioxide (TiO2, E 171) and concluded that it can no longer be considered safe as a food additive despite EFSA’s findings in 2016 that E 171 did not raise a genotoxic concern.  Currently, TiO2 is authorized as a food additive in the European Union according to Annex II of Regulation (EC) No 1333/2008.
  • EFSA’s expert panel on Food Additives and Flavourings (Panel) stated that it reached this conclusion because of the food additive’s genotoxicity concerns when it is absorbed by the body.  The Panel concluded that, although the absorption of TiO2 particles is low, it has the potential to accumulate in the body, as the food additive contains at most 50% of particles in the nano range (i.e., less than 100 nanometers) to which consumers may be exposed.  EFSA noted that although the evidence for general toxic effects was not conclusive, the new data and strengthened methods did not allow the Agency to rule out a concern for genotoxicity.  By way of background, French authorities suspended the marketing of foods containing TiO2 in 2019, as there were gaps and uncertainties in the food additive’s safety data.
  • Based on EFSA’s opinion, the European Commission and the EU member states will meet to consider phasing out TiO2 from the EU legislation on food.  If the EU takes action in response to EFSA’s opinion, the decision would be notified to the World Trade Organization and would subsequently be considered by the Codex Alimentarius Commission.  It remains to be seen whether there will be ripple effects in other countries or on other products.
  • On April 25, France adopted an executive order banning the placement of foods containing titanium dioxide on the market for one year beginning January 1, 2020.  See our blog on the topic here.
  • On May 13, the European Food Safety Authority (EFSA), published a statement on the risk review performed by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES).  EFSA concluded, in part, that the ANSES evaluation did not identify any new information that would overturn EFSA’s previous scientific assessments of titanium dioxide, the most recent of which was published in 2018.  For more, see the blog post in the Tomorrow’s Food and Feed blog.
  • France’s executive order was the topic of the European Commission Standing Committee on Plants, Animals, Food and Feed Section Novel Food and Toxicological Safety of the Food Chain’s May 13 meeting.    One major topic of concern is that a member state unilaterally reversed course on a safety determination made by Europe as a whole less than a year after the determination had been made – raising concerns about Europe’s ability to maintain a uniform regulatory landscape.
  • The French Authorities will suspend the marketing of foods containing (titanium dioxide – TiO2, E 171) as of January 2020. Links below, except the last one, are to the French documents.
  • On April 25, the French government adopted an executive order, implementing the recent Agriculture and Food Law (No. 2018-938). It contains the conclusion from the French Food Safety Agency’s (ANSES) opinion issued on April 15, 2019 showing data gaps and uncertainties regarding the safety of this food additive.
  • The placing on the French market of foods containing titanium dioxide will be suspended for 1 year, as from January 1st, 2020. Manufacturers will not be able to sell or import foods containing TiO2 on the French market, even when they are legally manufactured in another Member State. The EU market rules (i.e. the mutual recognition principle) should not apply and those products will not be permitted  in France.
  • The cost of this suspension will be supported by the entity responsible for marketing the food product in France. The Order – in its current wording – would appear to also cover stocks and products placed on the market before 2020.
  • Titanium remains authorized in other Member States of the EU. But the French “emergency measure” conflicts with the authorization. The issue should be discussed at EU level within the next few weeks. The European Commission should discuss whether the suspension of TiO2 complies with EU Food Legislation and decide eventually whether it should be extended at EU level or not.
  • The Wisconsin State Assembly introduced Wisconsin Assembly Bill 550 (AB 550) on October 15, 2025. The bill proposes a mandate that manufacturers of packaged food products intended for human consumption must include prominent warning labels if the product contains any of the fifty-one ingredients listed in the bill.
  • Ingredients that would require a warning label include certain artificial colors, sweeteners, preservatives, and other additives, including the FD&C certified colors, titanium dioxide, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), acesulfame potassium, and more. Foods containing these ingredients would be required to bear the label “WARNING: This product contains an artificial color, chemical, or food additive that is banned in Australia, Canada, the European Union, or the United Kingdom.”
  • The bill follows similar laws that were recently enacted in Texas and Louisiana, as we previously blogged. Unlike the Texas law, there is no preemption provision in AB 550.
  • Keller and Heckman will continue to monitor this and other bills related to food labeling.
  • The Texas Department of State Health Services (DSHS) has published its proposed rule (see p. 29, 50 TexReg 6301) implementing The “Make Texas Healthy Again” law (SB25) that was signed in June 2025, as we previously blogged. The law includes a provision requiring on-pack warning labels for food and beverage products that contain any of 44 listed substances, including certified food colors and titanium dioxide.
  • The proposed rule would add sections 229.1001-1005 to the Texas Health and Safety Code and would require the statement “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom” on the label of any food containing one of the listed ingredients unless an exemption applies. The proposed rule also outlines formatting and placement requirements for the warning statement.
  • The proposed rule includes exemptions for products not intended for human consumption; food labeled, prepared, served, or sold in a restaurant or retail food establishment; products regulated by USDA; products bearing a governmental warning from the surgeon general of the United States Public Health Service; drugs and dietary supplements; and pesticide chemicals, soil or plant nutrients, or other agricultural chemicals used on raw agricultural commodities.
  • Notably, the proposed rule includes the federal preemption provision found in the statute. Section 229.1003(b) of the proposed rule states that it does “not apply to an ingredient, including a food additive and color additive, if a federal law or regulation issued by [FDA] or USDA: (1) prohibits the use of the ingredient; (2) sets conditions for using the ingredient, such as needing a warning or disclosure statement; (3) says an ingredient or group of ingredients is safe for people to eat; or (4) requires a labeling statement for foods that are ultra-processed or processed.” This regulatory language mirrors the statutory language without elaborating on its impact.  In our view, the statute and this regulatory language should significantly limit the impact of the proposed rule because it would mean a warning label will not be required if FDA has issued a regulation authorizing the use of an ingredient. Many of the ingredients listed in the proposed rule are subject to an FDA food additive or generally recognized as safe (GRAS) regulation.  We note, however, that Texas’s proposed regulatory language (an FDA regulation “says an ingredient . . . is safe for people to eat”) differs slightly from the corresponding statutory language (an FDA regulation “determines an ingredient . . . is safe for human consumption”) and would ideally refer in a more straightforward way to the existence of an FDA food additive or GRAS regulation reflecting FDA’s determination that the ingredient is safe.
  • In addition to the exemptions listed above, the Fiscal Note accompanying the proposed rule clarifies that the requirement will only apply to labels that are developed or copyrighted on or after January 1, 2027, and “[i]f labels are never changed, businesses are not required to comply.”
  • DSHS is accepting comments on the proposed rule until October 27, 2025 (31 days after the proposed rule was published in the Texas Register). Keller and Heckman will continue to monitor this proposed rule.
  • On August 26, 2025, The New York City Health Department and the Mayor’s Office of Food Policy announced the release of its updated NYC Food Standards. The updated standards are a part of NYC’s broader Chronic Disease Strategy which targets conditions like diabetes and cardiovascular disease through dietary improvements. The updates standards will take effect on July 1, 2026.
  • The updated standards include:
    • Expanded restrictions on low-and no calorie sweeteners, now applying to all age groups whereas previously it was limited to children under 18;
    • New bans on artificial colors, flour additives, and preservatives; 
    • Elimination of processed meats from all meals served;
    • Increased requirements for whole and minimally processed plant proteins; and
    • Stricter snack guidelines to improve nutritional quality.
  • Specifically, the prohibition applies to aspartame, stevia, sorbitol, FD&C Blue No.1, FD&C Blue No.2, Caramel Color, Citrus Red, Titanium Dioxide, Potassium Bromate, Butylated hydroxyanisole (BHA), and Propylparaben, among others.
  • NYC’s Food Standards were first introduced in 2008 and are now mandated to be updated every three years. The standards apply to meals served by agencies such as the Department of Education, Health and Hospitals, Department of Correction, and Human Resources Administration among others.
  • Keller and Heckman will continue to monitor developments related to municipal nutrition standards and changes to public health policy.
  • On August 19, FDA announced updates to its List of Select Chemicals in the Food Supply Under FDA Review. The list is part of FDA’s plan to conduct post-market reviews of chemicals in food. Note that the excel spreadsheet on the list includes additional information that is not available on the main page such as the date the review was initiated. (see “Export Excel” button on linked page)
  • The new chemicals officially added to the list are:
    • The antioxidants butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT)
    • Azodicarbonamide (ADA), approved as a bleaching agent in cereal flour and as a dough conditioner in bread baking
    • Synthetic color additives FD&C Blue No.1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6.
    • Opiate alkaloids on poppy seeds. Earlier this year, FDA requested information on agricultural, production, and supply chain practices which may contribute to the presence of these opiate alkaloids.
  • FDA’s announcement also notes that (1) it will seek data on BHA, BHT, and ADA to facilitate its post-market assessments, (2) it has separated lead as an impurity in food contact substances from lead as an environmental contaminant, and (3) that it is taking steps to expedite its review of chemicals included in previous updates, including phthalates, propylparaben, and titanium dioxide.