All Knowledge & Insights By Date

On June 12, 2024, the U.S. District Court for the Eastern District of California (District Court) issued an Order granting a preliminary injunction brought by the Personal Care Products Council (PCPC), which alleged that the California Office of Environmental Health Hazard Assessment’s (OEHHA) requirement for warnings under Proposition 65 (Prop 65) related to titanium dioxide in cosmetics and personal care products violated the First Amendment. The Personal Care Products Council v. Bonta, No....

The National Institute for Occupational Safety and Health (NIOSH) continues to celebrate the 20th anniversary of its Nanotechnology Research Center (NTRC). NIOSH highlights NTRC activities in the risk assessment of engineered nanomaterials in a June 3, 2024, NIOSH Science blog item entitled “NIOSH Risk Assessment of Engineered Nanomaterials.” The item notes that NTRC risk assessments were used in developing NIOSH recommended exposure limits (REL) for three different classes of nanomaterials...

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on May 27, 2024, on its preliminary opinion on a new coating for titanium dioxide (nano form). According to the preliminary opinion, SCCS concluded that: Comments are due July 22, 2024....

On May 23, 2024, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published a document entitled “Scientific Advice on Titanium dioxide (TiO2).” The document includes the following questions from the EC and SCCS’s conclusions: Q: In light of the European Food Safety Authority’s (EFSA) opinion on genotoxicity concerns for E171, does SCCS consider titanium dioxide safe in oral cosmetic products? A: From the provided information, SCCS notes that the titanium...

On April 29, 2024, the German Environment Agency (UBA) posted an item entitled “ZnO nanoforms – REACH substance evaluation: environmental aspects.” The Federal Office for Chemicals, the Federal Institute for Risk Assessment (BfR), and UBA have been conducting a Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) substance evaluation on the registered nanoforms of zinc oxide since 2017. According to the item, based on the studies submitted by the registrants,...

On December 5, 2023, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on its preliminary opinion on titanium dioxide. Comments on the preliminary opinion are due February 6, 2024. The preliminary opinion includes the following questions from the EC and SCCS’s conclusions: Q: In light of the European Food Safety Authority’s (EFSA) opinion on genotoxicity concerns for E171, does SCCS consider titanium dioxide safe in oral cosmetic...

The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) announced the release of its final opinion on the safety of titanium dioxide in toys on June 27, 2023. Following the mandate from the EC, the scientific opinion evaluates whether the uses of pigmentary titanium dioxide in toys and toy materials can be considered to be safe in light of the exposure identified and in light of the classification of titanium dioxide...

The U.S. Food and Drug Administration (FDA) announced on May 3, 2023, 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). 88 Fed. Reg. 27818. The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 C.F.R....

On February 14, 2023, the European Commission (EC) appealed the November 23, 2022, decision of the European General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court concluded that the EC “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and,...

According to a February 13, 2023, press release issued by France’s Ministry of Ecological Transition and Territorial Cohesion and Ministry of Energy Transition, France is appealing the November 23, 2022, decision of the European General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court concluded that the European...

As reported in our October 19, 2021, blog item, in 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) released a scientific guide to assess the risks posed by nanomaterials in food. On December 16, 2022, ANSES announced that the methodology has been “tested” on the food additive E171, titanium dioxide. ANSES states that the test has “confirmed the relevance of [its] methodology and the need for a nanospecific approach.” According to...

.The Organization for Economic Cooperation and Development (OECD) has published for comment a draft study report entitled “Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nanomaterials.” Switzerland conducted experimental work with selected nanomaterials using OECD Test Guideline (TG) 442D (KeratinoSensTM) and made a basic in vitro to in vivo correlation to outline the potential relevance of the results for prediction of skin sensitisation of...

The National Academies of Sciences, Engineering, and Medicine (NASEM) released on August 9, 2022, a report entitled Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health. NASEM was tasked by Congress and funded by the U.S. Environmental Protection Agency (EPA) to undertake a consensus study of the potential risk of ultraviolet (UV) filters on already threatened aquatic environments and the potential...

On July 29, 2022, the National Institute for Occupational Safety and Health (NIOSH) published a Technical Report: Occupational Exposure Sampling for Engineered Nanomaterials. Since 2010, NIOSH has developed guidance for workplace sampling for three engineered nanomaterials: carbon nanotubes (CNT) and nanofiber (CNF), silver, and titanium dioxide, each of which has an elemental mass-based NIOSH recommended exposure limit (REL). NIOSH has also developed a practical approach to...

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...

The European Commission (EC) announced on January 14, 2022, that it adopted a ban on the use of titanium dioxide (E171) as a food additive. The ban will apply after a six-month transition period, and beginning summer 2022, this additive should no longer be added to food products. According to the EC, titanium dioxide “is used to impart white colour to many foods, from baked goods and sandwich spreads to soups, sauces, salad dressing and food supplements.” The...

On December 17, 2021, Canada published the Chemicals Management Plan implementation table for 2021-2024. Under the Canadian Environmental Protection Act, 1999 (CEPA), Canada plans to take the following actions regarding nanomaterials on the Domestic Substances List (DSL): prioritization of substances in commerce according to responses to the CEPA Section 71 Survey and screening assessment of high-priority nanomaterials on the DSL. The deliverables include: The rationale for action...

On October 11, 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced the release of a scientific guide to assess the risks posed by nanomaterials in food. According to ANSES, engineered nanomaterials are used in the food sector as: The guide provides a risk assessment methodology for engineered nanomaterials used as food additives and ingredients with a nutritional function. ANSES notes that the European Food Safety Authority...

The European Commission (EC) announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The EC states that its proposal “is based on a scientific opinion by the European Food Safety Authority, which concluded that E171 could no longer be considered as safe when used as a food additive, in particular due to the fact that concerns regarding...

On June 3, 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published an interview with Aurélie Niaudet, who is in charge of assessing the risks associated with physical agents. Niaudet states that nanomaterials have novel properties that “are highly sought after and increasingly exploited, but can also induce specific types of behaviour when interacting with humans or the environment.” After the human body is exposed, “there is then the question...

On May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive.  The European Commission (EC) asked EFSA to update its safety assessment of the food additive titanium dioxide (E171).  EFSA states:  “Taking into account all available scientific studies and data, the Panel [on Food Additives and Flavorings] concluded that titanium dioxide can no longer be considered safe as a food additive. ...

The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition.  The Toy Safety Directive 2009/48/EC prohibits the use of substances in toys if those substances are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR).  The use of such substances may be permitted under certain...

On March 4, 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced that it is recommending an eight-hour occupational exposure limit (OEL) of 0.80 micrograms per cubic meter (µg/m3) for titanium dioxide nanoparticles.  According to ANSES, compliance with this value “should help prevent lung inflammation, an effect that occurs at the lowest exposure concentrations.”  Due to the lack of available data on the immediate or...

The European Parliament (EP) announced on October 8, 2020, that it objected to a European Commission (EC) proposal to amend the specification for the use of titanium dioxide (E171) in food products.  The EP rejected the EC’s proposal to reduce the amount of titanium dioxide (E171), instead calling on the EC “to apply the precautionary principle and to remove E171 from the EU list of permitted food additives that are currently used mainly to colour confectionery, bakery...

The Developmental and Reproductive Toxicant Identification Committee (DARTIC) of California’s Office of Environmental Health Hazard Assessment (OEHHA) will meet on December 10, 2020, to discuss the prioritization of 22 chemicals or chemical groups, including titanium dioxide nanoparticles.  DARTIC will provide OEHHA with advice on the prioritization of these chemicals for listing consideration at future meetings.  No listing decisions will be made at the meeting. ...

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)...

An Advisory Group of 29 scientists from 18 countries met on March 25-27, 2019, to recommend priorities for the International Agency for Research on Cancer (IARC) Monographs program during 2020-2024.  The Advisory Group assessed the response to a public call for nominations and considered more than 170 unique candidate agents, including the recommended priorities remaining from a similar Advisory Group meeting convened in 2014.  The Advisory Group deliberated on all nominated agents both by...

On April 17, 2019, the Ministry of Ecological and Solidarity Transition issued a press release announcing that France will prohibit foods containing food additive E171 (titanium dioxide) from being placed on the market beginning January 1, 2020.  The press release cites the April 15, 2019, opinion from the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES).  The expert group established by ANSES conducted a literature review on the...

The California Division of Occupational Safety and Health’s (Cal/OSHA) Health Effects Advisory Committee (HEAC) for the Development of Permissible Exposure Limits (PEL) will meet on June 4, 2019.  According to the meeting agenda, HEAC will discuss the selection of Priority 1 substances for HEAC review.  HEAC has posted a draft 2019 Priority 1 List consisting of ten chemical substances.  The draft List includes titanium dioxide, ultrafine (<100 nanometers...

The European Chemicals Agency (ECHA) announced on September 27, 2017, that the Committee for Risk Assessment (RAC) concluded on ten opinions for harmonized classification and labeling (CLH), including titanium dioxide.  In May 2016, France submitted a CLH proposal for titanium dioxide, stating that titanium dioxide should be considered as being potentially carcinogenic to humans when inhaled and thus be classified as category 1B-H350i.  France proposed that the classification...

An August 15, 2016, U.S. Environmental Protection Agency (EPA) blog item describes EPA’s research on sunscreens containing engineered nanomaterials and how they might change when exposed to chemicals in pool water.  According to EPA, many sunscreens contain titanium dioxide engineered nanomaterials, which are often coated with other materials such as aluminum hydroxide to shield skin from reactive oxygen species.  EPA researchers are testing to see whether swimming pool water degrades the...

Inhalation Toxicology has published an article entitled “Exposure assessment of workplace manufacturing nanosized TiO2 and silver,” which monitored the possible exposure to nanoparticles at workplaces that manufacture nano-titanium dioxide (TiO2) and nano-silver.  The abstract states: To estimate the potential exposure of workers, personal sampling, area monitoring, and real-time monitoring using a scanning mobility particle sizer (SMPS) and dust monitor were conducted at...