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Are all food ingredients, dietary supplement ingredients and even foods, required to meet the same safety standards? Are they all equally safe? If so, then why do the various categories have different expressions describing their safety, such as "reasonable certainty of no harm" for food ingredients and "reasonable expectation of no harm" for dietary supplement ingredients? The basis for these different expressions is that they are not standards of safety, but standards of proof of safety. Just as in criminal vs. civil courts, the threshold for proving guilt or fault is different, so too are there differences between various categories of consumer products regulated by the US Food and Drug Administration. This manuscript describes the threshold requirements for each standard, as well as to the identity of the decision makers on what is safe, their credentials as decision makers and the databases mandated for their use., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objectives: To determine the compliance of online vendors to the UK Opticians Act 1989 Section 27 requirements and safety regulations for cosmetic contact lens (CCL) sales and the quality of online CCL health information., Methods: The top 50 websites selling CCLs on each three search engines, namely Google, Yahoo, and Bing, were selected. Duplicates were removed, and the remaining websites were systematically analyzed in February 2023. UK legal authorization for CCL sales was assessed using the Opticians Act Section 27 and safety regulations determined by the presence of Conformité Européene (CE) marking. The quality and reliability of online information was graded using the DISCERN (16-80) and JAMA (0-4) scores by two independent reviewers., Results: Forty-seven eligible websites were analyzed. Only six (12.7%) met the UK legal authorization for CCL sales. Forty-nine different brands of CCLs were sold on these websites, of which 13 (26.5%) had no CE marking. The mean DISCERN and JAMA benchmark scores were 26 ± 12.2 and 1.3 ± 0.6, respectively (intraclass correlation scores: 0.99 for both)., Conclusions: A significant number of websites provide consumers with easy, unsafe, and unregulated access to CCLs. Most online stores do not meet the requirements set out in the Opticians Act for CCL sales in the United Kingdom. A significant number of CCLs lack CE marking, while the average quality of information on websites selling CCLs is poor. Together, these pose a risk to consumers purchasing CCLs from unregulated websites, and therefore, further stringent regulations on the online sales of these products are needed., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Contact Lens Association of Ophthalmologists.)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a "safety standard") for cosmetics to the standard of a "reasonable certainty … [of] … safe."a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as "a preponderance of the evidence" or "beyond reasonable doubt." The standards of proof for these product categories are also ranked according to increasing threshold for achievement of "safe" status. Lastly, this manuscript suggests how the requirements for the high standard of a "reasonable certainty of safe" (or "reasonable certainty of no harm") might be met., Competing Interests: Declaration of competing interest The author declares that he has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Botanical dietary supplement use is widespread and growing, therefore, ensuring the safety of botanical products is a public health priority. This commentary describes the mission and objectives of the Botanical Safety Consortium (BSC) - a public-private partnership aimed at enhancing the toolkit for conducting the safety evaluation of botanicals. This partnership is the result of a Memorandum of Understanding between the US FDA, the National Institute of Environmental Health Sciences, and the Health and Environmental Sciences Institute. The BSC serves as a global forum for scientists from government, academia, consumer health groups, industry, and non-profit organizations to work collaboratively on adapting and integrating new approach methodologies (NAMs) into routine botanical safety assessments. The objectives of the BSC are to: 1) engage with a group of global stakeholders to leverage scientific safety approaches; 2) establish appropriate levels of chemical characterization for botanicals as complex mixtures; 3) identify pragmatic, fit-for-purpose NAMs to evaluate botanical safety; 4) evaluate the application of these tools via comparison to the currently available safety information on selected botanicals; 5) and integrate these tools into a framework that can facilitate the evaluation of botanicals. Initially, the BSC is focused on oral exposure from dietary supplements, but this scope could be expanded in future phases of work. This commentary provides an overview of the structure, goals, and strategies of this initiative and insights regarding our first objectives, namely the selection and prioritization of botanicals based on putative toxicological properties., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision" (SCCS/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients for which a concern has been expressed for human health. Indirectly, the Guidance also provides some advice on the safety of finished products. A general aim is to improve harmonised compliance with the current cosmetic EU legislation, Regulation (EC) No 1223/2009, for which animal testing and marketing bans fully apply from 2013 onwards. This means that no in vivo testing of ingredients or finished products is allowed in Europe for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made in regard to the development and validation of alternative replacement methods, also referred to as new approach methodology (NAM). The "SCCS Notes of Guidance" are regularly revised and updated in order to incorporate progress made and experience gained over time, in particular on the use of NAMs, and the new methods and data that became available since previous revision (SCCS/1602/18) formed the basis of the current (11 th) Revision., (Copyright © 2021 Elsevier Inc. All rights reserved.)

We report on manufacturing outcomes for 41 autologous polyclonal regulatory T cell (PolyTreg) products for 7 different Phase 1 clinical trials over a 10-year period (2011-2020). Data on patient characteristics, manufacturing parameters, and manufacturing outcomes were collected from manufacturing batch records and entered into a secure database. Overall, 88% (36/41) of PolyTreg products met release criteria and 83% (34/41) of products were successfully infused into patients. Of the 7 not infused, 5 failed release criteria, and 2 were not infused because the patient became ineligible due to a change in clinical status. The median fold expansion over the 14-day manufacturing process was 434.8 -fold (range 29.8-2,232), resulting in a median post-expansion cell count of 1,841 x 10 6 (range 56.9-16,179 x 10 6 ). The main correlate of post-expansion cell number was starting cell number, which positively correlates with absolute circulating Treg cell count. Other parameters, including date of PolyTreg production, patient sex, and patient age did not significantly correlate with fold expansion of Treg during product manufacturing. In conclusion, PolyTreg manufacturing outcomes are consistent across trials and dates of production., Competing Interests: JAB is a co-founder, CEO and a Board member of Sonoma Biotherapeutics. He is a co-founder of Celsius Therapeutics; a member of the Board of Directors of Gilead and Provention Bio, and a member of the scientific advisory boards of Arcus Biosciences, Solid Biosciences, and Vir Biotechnology. QT is a co-founder of Sonoma Biotherapeutics. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Balcerek, Shy, Putnam, Masiello, Lares, Dekovic, Acevedo, Lee, Nguyen, Liu, Paruthiyil, Xu, Leinbach, Bluestone, Tang and Esensten.)

This paper explored the occurrence of food fraud and adulterations (FFA) in exports from the Association of South- East Asia Nations (ASEAN), with implications on food chain and international trade. Data from European Union Rapid Alert System for Food and Feed (EU RASFF) about FFA notifications on ASEAN exports for a period of 20 years (2000-2020) were extracted and analyzed. Results from this study revealed that of all ten ASEAN member countries, seven had cases of FFA notified in the database with Thailand (n = 47, 32%) and the Philippines (n = 37, 26%) receiving the highest frequency of notifications in the region. There was a statistical significance difference in frequency of notifications received on products from these seven countries with herbs and spices ranking highest (n = 22, 15%). Highest notifications of FFA on ASEAN exports came from the United Kingdom (n = 31, 21%). All the seven countries experienced border rejections and consequent destruction of food products especially on exports from Indonesia where 95% of product with FFA were border rejected. Border rejections on products from these countries were significantly different. Therefore, a thorough implementation system, appropriate testing and constantly updating each country's FFA database could aid actions in curtailing future events., Competing Interests: The authors have declared that no competing interests exist.

The Cosmetic Regulation (EC) No 1223/2009 specifically covers the risk of nanomaterials used in cosmetic products. If there are concerns regarding the safety of a nanomaterial, the European Commission refers it to the SCCS for a scientific opinion. The Commission mandated the SCCS to identify the scientific basis for safety concerns that could be used as a basis for identifying and prioritising nanomaterials for safety assessment, and to revisit previous inconclusive SCCS opinions on nanomaterials to identify any concerns for potential risks to the consumer health. The SCCS Scientific Advice identified the key general aspects of nanomaterials that should raise a safety concern for a safety assessor/manager, so that the nanomaterial(s) in question could be subjected to safety assessment to establish safety to the consumer. The Advice also developed a list of the nanomaterials notified to the Commission for use in cosmetics in an order of priority for safety assessment, and revisited three previous inconclusive opinions on nanomaterials to highlight concerns over consumer safety that merited further safety assessment., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Analysis of spontaneous reports of adverse events is an important source of information that can be used to improve consumer products. Various agencies have adverse event reporting requirements and many companies collect such data directly from consumers. Nonetheless, a universal framework is absent that identifies and evaluates spontaneously reported adverse events, and, most important, assesses the potential association between exposure and adverse events. We are presenting a three-part framework: Phase I - Intake and Documentation of Original Incidents; Phase II - In Depth Review and Follow-up of Phase I Incidents (enhanced, tailored questionnaire); Phase III - Association Assessment. The basis for scoring the strength of association between exposure and adverse events requires assessment of standard factors of association including: temporality; biological, physiological, or pharmacological plausibility; results of de-challenge; results of re-challenge; and consideration of confounding factors. Scores tied to the answers to these questions are totaled for each incident to determine the strength of association between exposure and reported adverse event. We propose that consumer product companies come together to adopt such an association assessment framework to improve adverse event management, obtain maximum value from the data obtained, and use the knowledge derived to improve overall product safety for consumers., (Copyright © 2021 Elsevier Inc. All rights reserved.)

In cosmetic products, the ingredient propylparaben (CAS No 94-13-3, EC No 202-307-7) with the chemical names Propyl 4-hydroxybenzoate and 4-Hydroxybenzoic acid propyl ester is currently regulated as a preservative in a concentration up to 0.14% (as acid) (Annex V/12a). In addition, a safe concentration was established for mixtures of parabens, where the sum of the individual concentrations should not exceed 0.8% (as acid). However, in such mixtures the sum of the individual concentrations of butyl- and propylparaben and their salts should not exceed 0.14%. Propylparaben was subject to different safety evaluations in 2005 (SCCP/0874/05), 2006 (SCCP/1017/06), 2008 (SCCP/1183/08), 2010 (SCCS/1348/10), 2011 (SCCS/1446/11), and in 2013 (SCCS/1514/13). On the basis of the safety assessment of propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14%. The available data on propylparaben provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of propylparaben for the environment. Link to the Opinion (SCCS/1623/20): https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_243.pdf., (Copyright © 2021. Published by Elsevier Inc.)

Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

In 2019, the Dutch Food and Consumer Product Safety Authority performed a market surveillance for toy-slime (23 samples) and putty (16 samples). For 35% of the toy-slimes and 13% of the putties, the migration of boron exceeded the European legal limit of 300 and 1200 mg/kg respectively. In 36% of the toy samples, methylisothiazolinone (MI) and chloromethylisothiazolinone (CMI) were detected in levels up to 25 and 38 mg/kg, respectively, much higher than the European legal limit for aqueous toys intended for children younger than three. 59% of the toys contained other preservatives such as 2-phenoxyethanol, p-hydroxybenzoic acid and parabens. In 2 toy-slimes and 2 putties N-nitrosodiethanolamine (NDELA) was found in amounts up to 2.3 mg/kg. A risk assessment was performed for boron and NDELA. The estimated exposure to boron did not exceed the health based guidance value. The estimated exposure to NDELA from 2 toy-slimes may pose a health risk. For 2 putties the estimated exposure to NDELA was somewhat lower, but health risks could not be excluded. The presence of isothiazolinones may lead to skin sensitisation. It is recommended to extend the legal limit for NDELA, MI and CMI in finger-paint and labelling requirements to other aqueous toys., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Dermal contact is the main route of exposure for most cosmetics; however, inhalation exposure could be significant for some formulations (e.g., aerosols, powders). Current cosmetic regulations do not require specific tests addressing respiratory irritation and sensitisation, and despite the prohibition of animal testing for cosmetics, no alternative methods have been validated to assess these endpoints to date. Inhalation hazard is mainly determined based on existing human and animal evidence, read-across, and extrapolation of data from different target organs or tissues, such as the skin. However, because of mechanistic differences, effects on the skin cannot predict effects on the respiratory tract, which indicates a substantial need for the development of new approach methodologies addressing respiratory endpoints for inhalable chemicals in general. Cosmetics might present a particularly significant need for risk assessments of inhalation exposure to provide a more accurate toxicological evaluation and ensure consumer safety. This review describes the differences in the mechanisms of irritation and sensitisation between the skin and the respiratory tract, the progress that has already been made, and what still needs to be done to fill the gap in the inhalation risk assessment of cosmetic ingredients., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Customized cosmetics immediately made on the spot are now in the market. The present study surveyed 1084 consumers to obtain general insights into their perceptions and perspectives on this novel type of cosmetic. Over half of the total respondents (57.2%) answered they were likely to purchase customized cosmetics; however, a large proportion of consumers also thought microbiological (59.2%)/chemical safety (69.4%) of cosmetics were not good. This reflects consumer anxiety regarding safety issues concerning the customized cosmetics. Even customized cosmetics are regulated by the cosmetic act in each country (i.e., the Cosmetic Act in the Republic of Korea, the Federal Food, Drug, and Cosmetic Act in the USA, and EC Cosmetic Regulation 1123/2009 in Europe), there have been no specific regulations for customized cosmetics made on the spot worldwide so far. To dispel consumer concerns and establish a principled market for the new cosmetics in the field, proper management plans should be established based on consumer surveys. This study indicated that consumers thought it was important to manage the facility/equipment and safety of raw materials (19.7%, each). We believe this study provides a valuable resource for understanding consumers' perceptions and requirements on customized cosmetics, which contributes to establishing future regulations and guidelines., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The Food and Drug Administration (FDA) was required to issue and put into effect a final sunscreen monograph by November 26, 2019. On March 27, 2020, President Donald Trump signed into effect H.R. 748, the "Coronavirus Aid, Relief, and Economic Security Act" (CARES). This bill eliminated the November 2019 requirement. The CARES Act includes legislative reforms that modernize the way over-the-counter (OTC) monograph drugs are regulated in the United States. Under this Act, sunscreens will be considered generally recognized as safe and effective (GRASE), if they meet conditions newly defined by the FDA. In addition, the FDA is required to issue a proposal to revise the sun-screen requirements for GRASE not later than 18 months after enactment and will sunset by the end of the fiscal year 2022. The CARES Act also addresses the requirement for a new drug application (NDA). 1-7 .

In this work, the occurrence of 34 common antibiotic (15 sulfonamides and 19 quinolones) residues were evaluated in 236 ready-to-eat duck eggs (salted and preserved duck eggs) marketed through e-commerce stores by ultra-performance liquid chromatography coupled to tandem mass spectrometry, and subsequent dietary risk assessments for Chinese consumers were conducted. Among violated positives in duck egg samples, 11 analytes were found including sulfamethazine, sulfaquinoxaline, sulfamethoxazole, sulfadiazine, sulfamonomethoxine, ciprofloxacin, enrofloxacin, ofloxacin, flumequine, sarafloxacin, and nalidixic acid. A higher number of antibiotics were detected in salted duck eggs (five sulfonamides and six quinolones) than in preserved duck eggs (one sulfonamide and two quinolones). The maximum contamination of sulfonamides and quniolones was 448.0 µg/kg (sulfaquinoxaline) and 563.7 µg/kg (enrofloxacin) in salted duck eggs, respectively. Dietary exposure was evaluated through the estimated daily intake (EDI) of risky antibiotics (sulfamethazine, ciprofloxacin, and enrofloxacin) and hazard quotients (HQs). The results showed that EDIs and HQs were in the range of 0.0004 to 0.0099 µg/kg bw/day and 0.0009 to 0.1594%, respectively. The risk was low since HQs obtained were less than 100%. However, a special attention should be paid to ready-to-eat duck egg products high percentile consumers with the prosperity of e-commerce market in China. PRACTICAL APPLICATION: The present analytical method could be used for multiresidue determination of antibiotics in ready-to-eat duck eggs, and dietary risk assessments of risky antibiotics provided a support for the work of regulatory bodies to conduct surveillance programs regarding food safety evaluation of ready-to-eat foods., (© 2021 Institute of Food Technologists®.)

Objectives: To evaluate the impact of the ASTM International (formerly American Society of Testing Materials) safety standard and associated product safety changes on accidental exposures to liquid laundry packets (LLPs) in children., Methods: The National Poison Data System was queried for reports of accidental exposures to LLPs in children <6 years old received from 01 July 2012 to 31 December 2018. In 2014, ASTM International began developing a standard specifying voluntary product changes to reduce the risk of LLP exposures in young children. Product changes were made between 2013 and 2016. Exposures were grouped into baseline, transition, and post periods based on the timing of the standard's implementation. Exposure counts and sales adjusted rates were compared between the baseline and post period for all exposures and exposures involving healthcare facility (HCF) evaluation, HCF admission, and major medical outcomes., Results: A total of 73,942 accidental exposures in children <6 years old were reported (baseline: 10,229, 13.8%; transition: 43,507, 58.8%; post: 20,206, 27.3%). The percentage of exposures involving HCF evaluation (41.5% to 33.8%), HCF admission (4.5% to 1.9%), and major medical outcomes (0.6% to 0.1%) decreased from the baseline to post period. Sales adjusted rates of all exposures decreased 57.4% (4.920-2.094 exposures/1 million packets sold). Decreases also occurred in HCF evaluations (65.0% decrease; 2.026-0.708 exposures/1 million packets sold), HCF admissions (81.4% decrease; 0.218-0.041 exposures/1 million packets sold), and major medical outcomes (90.9% decrease; 0.030-0.003 exposures/1 million packets sold)., Conclusions: The morbidity of accidental exposures to LLPs in children decreased substantially following implementation of the ASTM International safety standard. Ongoing monitoring should be performed to determine if additional safety measures are required.

Recent and pending bans in specific jurisdictions of some organic ultraviolet (UV) filters have resulted in significant concern and controversy over the potential impacts of these contaminants in the marine environment. Organic UV filters have been quantified in the aquatic environment as contaminants in water, sediments, and the tissues of aquatic organisms. The limited available laboratory studies on the toxicity of UV filters to keystone marine species such as reef-building corals describe a wide variety of impacts, from significant acute effects to no observed effects. However, interpretation of results is complicated by differences in methodology, and exposures to single agents in vitro may not reflect the effects of longer exposure to finished sunscreens containing UV filters in combination with numerous other chemicals. Relatively short-term observations of laboratory effects thus may not translate to real-life field conditions, where organisms may be subject to the effects of long-term chronic exposure to UV filters as well as other environmental contaminants and stressors. The lack of current understanding of the full impacts of UV filters, both in the laboratory and in the environment, represents a significant challenge in interpreting the environmental risk associated with the widespread use of sunscreens., (© 2021 S. Karger AG, Basel.)

Although skin is a vital barrier to the outside world, it is permeable to certain substances used in topical pharmacotherapy. It is therefore not surprising that other xenobiotics intentionally or accidentally coming in contact with skin can cross the skin barrier. Long before the turn of the millennium, it became clear that sunscreen filters from sunscreen products can be systemically absorbed and detected in urine and plasma. Against this background, we review issues and challenges with safety assessments related to the possible percutaneous absorption of the sunscreen filters. A reference is made to the Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (version 1 August 2018) and the concepts of the Maximal Usage Trial (MUsT) and Generally Recognized As Safe and Effective (GRASE), currently discussed in the United States., (© 2021 S. Karger AG, Basel.)

Objective: Convertible cars have existed since among the first automobiles, and the lack of substantial roof structure creates some safety concerns. Though crash tests have demonstrated that convertibles can resist excessive intrusion in front and side crashes and that strong A-pillars and roll bars can help maintain survival space in rollovers, little work has been done examining the real-world crash experience of these vehicles. The objective of this study was to compare the crash experience of recent convertibles with nonconvertible versions of the same cars using the most recent crash data., Methods: Crash and exposure data were obtained from the U.S. Department of Transportation and IHS Markit, respectively. Rates of driver deaths and police-reported crash involvements were compared for 1- to 5-year-old convertible cars and their nonconvertible versions during 2014-2018. Exposure measures included registered vehicle years (RVY) and vehicle miles traveled (VMT). These rates were compared using the standardized mortality ratio to account for possible differences in exposure distribution. Crash circumstances (e.g., point of impact, rollover, ejection) and behavioral outcomes (e.g., speeding, alcohol impairment, seat belt use) were compared for drivers killed in crashes., Results: Convertibles had lower driver death rates and police-reported crash involvement rates on the basis of both RVY and VMT. However, the differences in driver death rates were not statistically significant. Driver deaths per 10 billion VMT were 11% lower for convertibles, and driver involvement in police-reported crashes per 10 million VMT was 6% lower. On average, convertibles were driven 1,595 fewer miles per year than the nonconvertible versions of these cars. Among fatally injured drivers, convertibles had slightly higher rates of ejection, and behavioral differences were minimal. The number of rollovers was small and their rate did not substantially differ between convertibles and their nonconvertible versions., Conclusions: Safety concerns associated with convertibles' retractable roof structures were not supported by the results of this study.

Organic and inorganic ultraviolet (UV) filters are used in topical sunscreens and other applications to prevent or limit damage following exposure to UV light. Increasing use of UV filters has contributed to a growing number of investigations examining potential effects on human health and the environment. Worldwide environmental monitoring data demonstrate that UV filters reach aquatic environments through two main input sources - direct (i.e., washoff from swimmers/bathers) and indirect (i.e., incomplete wastewater treatment removal) - and can be taken up by various algal, plant, and animal species and sediments. In areas where industrial wastewater sources or significant recreational activities result in a greater input load, levels may be elevated and could impart an increased risk on native species health. In vitro, at higher levels typically not measured in the environment, effects on growth and reproduction are observed in different species, including fish, coral reef, and plants. Despite this, predicted no-effect concentrations for UV filters are generally above measured environmental concentrations. Recent legislative activity banning the use of certain UV filters has heightened awareness of their environmental ubiquity and precipitated a need for a thorough examination of evidence linking their ecological presence with adverse outcomes. In order to gauge the true potential risk to native ecosystems associated with UV filters, future studies should consider factors inherent both to finished sunscreen products (e.g., metabolic fate/transport and effect of inactive ingredients) and to the sampled environment (e.g., species sensitivity, presence of other contaminants, water flow, and photodegradation)., (© 2021 S. Karger AG, Basel.)

Preparations containing pigments have been used since ancient times to protect against negative effects of solar radiation. Since the 1950s, sunscreen products containing micronized TiO2 and ZnO have been marketed. These products were soon regarded as cosmetically unattrac-tive due to their property of remaining as a white paste on the skin, a result of particle sizes. In order to eliminate these unfavourable properties, particle size distribution was lowered into a range below 100 nm, a size threshold for decreasing the particle's optical property to reflect visible light. After 2000, new nanoparticulate organic filters were developed. Effects of both the inorganic and organic nanoparticulate substances - alone or in combination - with non-particulate UV filters were well documented and had shown great effectiveness. At the time, nanotechnology fuelled great hope in the progress of science and technology, including the health sector and cosmetics industry. Instead, influenced by images from the science fiction literature of self-replicating nanorobots destroying all living matter or health and environmental disasters caused by asbestos, fear of this new unknown amongst the general population has hindered acceptance and progress of nano-enabled products. Consumers have started to suspect that the particles permeate through skin, are absorbed by the blood and are distributed throughout the body, causing disease. Not least because of public pressure, cosmetics - which include sunscreen products - became the first product segment in which appropriately manufactured substances were subject to stringent rules. Despite advanced regulation and rigorous approval procedures for nanoparticulate UV filters, widespread reservations remain. Possible reasons could be a lack of knowledge of current legislation and unclear ideas about nature and behaviour of nanoparticles. Against this background, we discuss the nature and behaviour of nanoparticulate UV filters within finished products, on the skin and potentially in the skin, and the regulatory framework that ensures that nanoparticulate UV filters and the sunscreen products containing them are safe to use., (© 2021 S. Karger AG, Basel.)

Background: Glass tables can break and cause traumatic injury. This public health issue is avoidable by adequate regulatory measures. We describe the burden and characteristics of these injuries using the National Electronic Injury Surveillance System (NEISS) database and data from a level 1 trauma center., Methods: NEISS data was extracted from 2009 to 2015. Injuries were classified by type, severity, and involvement of faulty glass using predetermined criteria. A retrospective chart review of a level 1 trauma center data was performed. Epidemiologic and outcomes data are reported., Results: 3241 cases were reviewed from NEISS. 56% of injuries were attributable to faulty tables. 15% were severe. A bimodal age distribution of age under 7 and early 20s was observed. Commonly injured areas were the upper extremity and forehead. 24 trauma center cases were reviewed. 21% presented with hemodynamic instability, 34% had major organ, body cavity or joint space injuries, and 58% required surgical intervention. 30-day mortality rate was 8%. More than 54% required inpatient care., Conclusion: Glass table injuries are common, estimated at over 2.5 million per year. Regulation of glass quality may prevent injury., Summary: Glass table injuries are more common than may be recognized and represent a public health problem that can be mitigated through proper regulatory measures., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest related to this work., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Despite widespread and prolonged use of adult novelties, their health safety is not regularly tested or legally regulated. In the EU, adult novelties are subjected to the General Product Safety Directive, placing the burden of proof regarding safe products onto the manufacturers. The aim of our pilot study was to expand knowledge on potential application of in vitro methods for hazard prediction of extracts from final products. We subjected extracts of 20 adult novelties, purchased on the Czech market to toxicological tests including NRU cytotoxicity assay, sensitization tests DPRA and LuSens and the YES/YAS endocrine assay. Four samples produced cytotoxicity. Sensitization potential was recorded by DPRA (three samples) while the LuSens reported ten samples. Regarding endocrine disruption, three samples produced antiestrogen and antiandrogen effects. Six samples exhibited androgenic potential and one sample showed estrogenic potential. Positive results with possible health effects were recorded repeatedly for samples made of ABS, PVC and latex. The study has confirmed promising usefulness of our test methods combination with regard to safety testing of this type of consumer products. The results should be evaluated with care, however, the data bring added-value to the limited knowledge of mixture toxicology and are indicative for further testing., (Copyright © 2020. Published by Elsevier Inc.)

The Medicines Evaluation Board (MEB) grants market authorisation for medicinal products in the Netherlands. The European Medicines Agency (EMA) coordinates the evaluation and safeguarding of medicinal products in the European Union. The core task of the MEB is to evaluate the quality of every medicinal product for which marketing authorisation is applied for by the manufacturer, and to assess the risk - efficacy balance of the product concerned. There are three different procedures that a manufacturer can follow: (a) the national procedure; (b) the decentralised procedure or mutual recognition procedure; (c) the centralised procedure. After marketing authorisation has been granted, the MEB ensures pharmacovigilance in cooperation with partners such as the Netherlands Pharmacovigilance Centre (Lareb). The MEB determines the text of the package leaflet, the packaging and the Summary of Product Characteristics (SmPC). The MEB checks the warnings that are sent out by manufacturers if important new information about a medicinal product becomes available.

The labeling of all ingredients contained in consumer products has been requested by consumers concerned regarding their safety. Consequently, regulatory agencies have set guidelines for industries on how to provide safety information regarding the ingredients in their products. However, discordant opinions were raised from stakeholders, resulting in the formation of a risk communication forum among industries, regulatory agencies, consumer groups, and academia. There are several methods that might be utilized to provide ingredient information to consumers: (1) listing all ingredients on the label of products, (2) providing major ingredients on the label of products, (3) presenting all ingredients on the websites of each manufacturer, and (4) listing major ingredients on the label of products and the remainder of ingredients (not on the label) on the websites. Each method might have its own advantages and disadvantages with respect to providing the information regarding the names of the ingredients used in consumer products to the consumers. A continuous risk communication forum might be an effective tool to facilitate an improved understanding of chemical information, toxicological science, regulatory guidelines, labeling methods, and consumers' concern. This study suggests that risk communication efforts may be helpful and a good opportunity for stakeholders to exchange opinions and reach a harmonious conclusion on labeling of consumer products ingredients.

The aims of this study were to establish a relationship between consumers' socioeconomic aspects, key meat attributes, and consumer perception and conduct toward traced beef in Brazil. The authors applied a structured form in 52 supermarkets in eight Brazilian cities, through interviews with 2.949 consumers, in 2012. Federal or state inspection stamp was the attribute that most influenced the consumers' purchase decision (14.1%). Most of the interviewees (57.3%) had never heard about bovine traceability. Among those who had heard about bovine traceability, 63.2% would be willing to pay more for beef with certified origin. Consumers with higher education and income had a better knowledge about this type of certification, as well as older consumers, and therefore they would be willing to pay more for certified beef. This research suggests that educational level was the reason that most influenced Brazilian consumers during beef purchase., (© 2020 Institute of Food Technologists®.)

Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called 'stem cell' preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers. Cite this article: Bone Joint J 2020;102-B(2):148-154.

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard- setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary., (Copyright © 2019 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery, and the European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

The control of Salmonella in low water activity foods poses a challenge for the food industry because of its thermal resistance. The use of surrogate bacteria in a food plant is considered a critical component to validate processing steps. The objective of this study was to evaluate the use of Pediococcus acidilactici ATCC 8042, a generally recognized as safe bacterium (GRAS), as potential surrogate for Salmonella in commercial toasted oats cereal (TOC) and peanut butter. P. acidilactici was compared to a five-serovar cocktail of Salmonella and Enterococcus faecium NRRL-B2354, separately. Cultures were inoculated into TOC and thermal kinetic parameters (δ, β) were determined at 80, 85, 90, and 95 °C using the Weibull model. In peanut butter, δ and β parameters were obtained at 63, 68, 73, and 77 °C. In TOC, the δ values (initial decimal reduction time) of P. acidilactici were 63 and 7 min at 80 and 95 °C, respectively, and at all four temperatures they were not significantly different from δ values of E. faecium. The δ value of Salmonella at 80 °C (139 min) was two-fold greater than the other two bacteria's values (p < 0.05). In peanut butter, δ values of P. acidilactici ranged from 31 min at 63 °C to 2.6 min at 77 °C, and at all temperatures they were not significantly different from E. faecium's δ values. In peanut butter, all Salmonella cocktail's δ values were significantly smaller than P. acidilactici's with values of 2 min at 63 °C and 0.4 min at 77 °C. These results indicated that P. acidilactici was as heat tolerant as E. faecium in these food matrices. However, the thermal inactivation kinetic parameters suggested that P. acidilactici can only be considered a Salmonella surrogate in TOC at temperatures above 85 °C. Because of its greater thermal tolerance in peanut butter, P. acidilactici may be used as Salmonella surrogate if an additional safety factor is recommended., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Seafood has become one of the most heavily traded food commodities in the era of globalization. International seafood supply chains are complex and contend with many difficulties in bringing an enormous variety of products to market. A major challenge involves accurately labelling products such that they comply with a diverse set of regulatory frameworks, ranging from country-of-origin through to the final point of consumer sale. Thanks to DNA barcoding, seafood mislabelling is now recognized as a global problem, with potentially negative impacts on human health, economy and the environment. Mislabelling can result from species misidentification, use of inappropriate common names, incomplete and/or out-dated regulatory frameworks, or through market substitution. While prior studies have focused primarily on retail and food service establishments, this study used barcoding to assess rates of finfish mislabelling at multiple points in the supply chain within Ontario, Canada. A total of 203 specimens from 12 key targeted species were collected from varied importers, registered processing plants and retailers in Southern Ontario and identified using DNA barcoding. Species identity of samples was used to assess conformity of labelling against the Canadian Food Inspection Agency's (CFIA) Fish List, which revealed an overall mislabelling rate of 32.3% among targeted species. The mislabelling rate was significantly different between samples collected from importers and retailers. Among the mislabelled samples were seven samples that originated from US and were properly labelled according to US Food and Drug Administration (FDA) Seafood List. This study evaluated the integrity of chain of custody documents and identified discrepancies in 43 samples (21.4%). Implementing seafood traceability throughout the supply chain and harmonizing labelling regulations between countries can help to ensure industry compliance in a globalized market, while sampling at multiple points in the supply chain can help to reveal causes., (Copyright © 2018. Published by Elsevier Ltd.)

Nanotoxicology and nanosafety has been a topic of intensive research for about more than 20 years. Nearly 10 000 research papers have been published on the topic, yet there exists a gap in terms of understanding and ways to harmonize nanorisk assessment. In this review, we revisit critically ignored parameters of nanoscale materials (e.g. band gap factor, phase instability and silver leaching problem, defect and instability plasmonic versus inorganic particles) versus their biological counterparts (cell batch-to-batch heterogeneity, biological barrier model design, cellular functional characteristics) which yield variability and nonuniformity in results. We also emphasize system biology approaches to integrate the high throughput screening methods coupled with in vivo and in silico modeling to ensure quality in nanosafety research. We emphasize and highlight the recommendation regarding bridging the mechanistic gaps in fundamental research and predictive biological response in nanotoxicology. The research community has to develop visions to predict the unforeseen problems that do not exist yet in context with nanotoxicity and public health hazards due to the burgeoning use of nanomaterial in consumer's product.

Background: An essential step in ensuring the toxicological safety of cosmetic or personal care products is the evaluation of the skin sensitizing potential of product ingredients., Objective: We used a standardized protocol from cosmetic trade industry and consumer safety groups to evaluate the sensitization potential of ingredients in 3 commercially available cleansing conditioners., Methods: A total of 33 ingredients were evaluated. Each ingredient underwent (1) dermatological evaluation, (2) in silico analysis for irritation and sensitization potential, and (3) a literature evaluation to determine risk of sensitization. Consumer exposure level was compared with the weight-of-evidence no-expected sensitization induction level for the constituent. If a no-expected sensitization induction level for a specific ingredient was not available, the dermal sensitization threshold approach was used. A margin of safety was calculated for each constituent., Results: The margins of safety for all evaluated ingredients in the cleansing conditioners were greater than 1., Conclusions: This analysis indicates that exposure to the individual ingredients present in these cleansing conditioners would not be expected to induce dermal sensitization in a consumer under the examined exposure scenario.

Undercooked poultry is a potential source of foodborne pathogens, such as Salmonella and Campylobacter. The best way to avoid eating undercooked poultry is to use a food thermometer during cooking. However, consumers who cook poultry often use visual appearance for determining doneness, which relies on extrinsic factors, including lighting conditions. Because the United States recently mandated changes in lighting to promote energy conservation, this study evaluated the effect of lighting sources on consumer perceptions of doneness and willingness to eat cooked poultry patties. Consumers ( n = 104) evaluated validated photographs of turkey patties cooked to different end point temperatures (57 to 79°C) and rated the level of perceived doneness and willingness to eat each sample. Evaluations were conducted under different lighting sources: incandescent (60 W, soft white), halogen (43 W, soft white), compact fluorescent lamp (13 W, soft white), light-emitting diode (LED; 10.5 W, soft white), and daylight LED (14 W). Lighting changed perception of doneness and willingness to eat the patties, with some of the energy-efficient options, such as LED and halogen making samples appear more done than they actually were, increasing the willingness to eat undercooked samples. This poses a risk of consuming meat that could contain bacteria not killed by heat treatment. Recent changes in lighting regulations can affect lighting in homes that affects perceptions of poultry doneness, requiring that educators place extra emphasis on the message that properly using a meat thermometer is the only way to ensure meat is cooked to a safe end point temperature.

Safety issues regarding consumer products contaminated with trace amounts of chemicals are of great concern to consumers, with the degree of concern occasionally escalating to the psychological syndrome, chemophobia (i.e., the fear of chemicals). Hazardous substances frequently implicated in safety concerns include heavy metals (arsenic, mercury, cadmium, and lead), volatile organic compounds (VOC) such as benzene and o-toluidine, pesticides, carcinogens, radioactive substances, and endocrine disrupting chemicals (EDC) such as bisphenol A and phthalates. To improve communication of risk to society, members of academia, government, consumer organizations, and industry participated in this workshop to discuss and exchange perspectives on trace chemical safety. From the perspective of academia, integrated risk assessments need to be implemented to encompass various exposure sources and routes. The identification and investigation of new exposure-related biomarkers are also recommended to verify direct causal relationships between specific chemical exposure and effects on human health. As for regulation, governments need to establish and maintain acceptable limits for trace chemicals in products. In addition, harmonized efforts need to be undertaken among government agencies to share regulatory limits and effectively control trace chemicals in consumer products. Manufacturers need to faithfully abide by Good Manufacturing Practice (GMP) guidelines, monitor sources of contamination, and minimize these for consumer safety. To effectively resolve safety issues arising from trace chemicals exposure, collaborative efforts are needed involving academia, government, consumer organizations, and industry. Further, scientific evidence-based risk assessment is a critical approach to effectively manage trace chemical safety issues.

Safety issues regarding consumer products contaminated with trace amounts of chemicals are of great concern to consumers, with the degree of concern occasionally escalating to the psychological syndrome, chemophobia, i.e., the fear of chemicals. Hazardous substances frequently implicated in safety concerns include heavy metals (arsenic, mercury, cadmium, and lead), volatile organic compounds (VOC) such as benzene and o-toluidine, pesticides, carcinogens, radioactive substances, and endocrine disrupting chemicals (EDC) such as bisphenol A and phthalates. To improve communication of risk to society, members of academia, government, consumer organizations, and industry participated in this workshop to discuss and exchange perspectives on trace chemical safety. From the perspective of academia, integrated risk assessments need to be implemented to encompass various exposure sources and routes. The identification and investigation of new exposure-related biomarkers are also recommended to verify direct causal relationships between specific chemical exposure and effects on human health. As for regulation, governments need to establish and maintain acceptable limits for trace chemicals in products. In addition, harmonized efforts need to be undertaken among government agencies to share regulatory limits and effectively control trace chemicals in consumer products. Manufacturers need to faithfully abide by Good Manufacturing Practice (GMP) guidelines, monitor sources of contamination, and minimize these for consumer safety. To effectively resolve safety issues arising from trace chemicals exposure, collaborative efforts are needed involving academia, government, consumer organizations, and industry. Further, scientific evidence-based risk assessment is a critical approach to effectively manage trace chemical safety issues.

Objective: Previous studies have revealed vulnerability of school-age children and older adults in rear seats in motor vehicle crashes. Detailed information about crashes in which these fatalities occur could help improve vehicle and restraint design. Methods: Police accident reports were obtained for crashes from the Fatality Analysis Reporting System data set. Inclusion criteria were crashes in which there was at least one fatally injured restrained rear seat occupant between the ages of 6 and 12 or 55 and older in a passenger vehicle no older than 10 years at the time of the crash. Reports were reviewed for key crash data. Side impacts were selected for analysis. Results: Thirty-nine side impact crashes met the inclusion criteria, resulting in 46 fatalities of interest. Far-side or nondirect impact cases outnumbered near-side cases by 15-11 for juvenile occupants. Sixty-one percent of occupants were in vehicles with side airbags (SABs), all of which deployed for their position, although torso SABs were only present in 3 cases. Head injuries were present in all juvenile cases with injury data available and older occupants suffered equally from head and torso injuries. Impacts with pickup trucks and heavy trucks made up 31 and 22% of all cases, respectively. Three-quarters of cases were judged as survivable for the fatally injured occupant(s), and 5 of 7 cases deemed unsurvivable involved juvenile decedents. Further, of those deemed survivable, two-thirds had damage comparable in magnitude with the same vehicles in consumer information crash tests, evaluated by photo comparison. Conclusions: Older adults suffered thoracic injuries at a higher rate than older children-who suffered predominately head injuries-and most vehicles did not have torso SABs installed, which could have mitigated thoracic injuries. Side impacts in which younger occupants were killed were more severe than impacts that resulted in the death of an older occupant; however, vehicle damage and intrusion in many fatal impacts for both age cohorts appeared similar to that of consumer information testing. Large pickups and heavy vehicles were the striking vehicle in over half of all fatalities; vehicle designs and crash tests should continue to take this into consideration. This research highlights the need for continued work as the automotive safety community seeks to eliminate fatalities in motor vehicle crashes.

The NanoAptamer assay is a bisphenol A (BPA) quantification method that uses magnetic beads, quantum dot nanoparticles, and a BPA-specific aptamer. In this study, screening of various consumer and household products for BPA was demonstrated utilizing the NanoAptamer assay. First, the experimental conditions suitable for BPA detection using the NanoAptamer assay were examined in terms of incubation time, temperature, and buffer composition. The range of BPA quantification via the NanoAptamer assay was determined to be 0.005-1000 ng/mL of BPA. The selectivity was confirmed by detecting BPA in an analog mixture containing bisphenol S and bisphenol F. Finally, a leaching experiment using 20 consumer and household products classified into 4 categories was performed to demonstrate the capability of the NanoAptamer assay for BPA detection. The experiment was validated by high-performance liquid chromatography analysis (correlation coefficient, r = 0.99)., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Introduction: With the increasing use of recreational trampolines, more injuries are seen in emergency depart-ments (ED). Little is known about the relationship between adherence to safety precautions and injuries. This retro-spective study aims to describe the types of injuries and the precautions taken when using trampolines, and to investigate the relationship between injuries and safety precautions., Methods: We reviewed patient lists and the medical records of children younger than 18 years who were treated between 1 April and 30 September 2014 at the ED of Hospital Unit West, Denmark. Demographic data and type of injury were recorded. Patients or guardians were contacted for a structured telephone interview to describe the safety precautions they had taken before the injury occurred. A total of 113 patients were identified, and 100 patients were included in the phone interviews. A total of 13 patients were excluded due to incorrect/missing phone numbers or lack of a Danish home address., Results: 6% of all children treated in the ED had trampoline-related injuries. A total of 58 (51.3%) patients had fracture injuries, and 55 (48.7%) patients had non-fracture injuries. 4% had complied with all five recommended safety precautions., Conclusions: This study describes types of injuries and safety precautions related to trampoline use. 6% of all children in the ED had an injury related to trampoline use. 4% complied with all five recommended safety precautions., Funding: none., Trial Registration: not relevant., (Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.)

Purpose of Review: The purpose of this article is to review clinical manifestations and management of common pediatric foreign body ingestions, with a particular focus on some of the current trends., Recent Findings: Foreign body ingestion (FBI) is a problem that is frequently encountered by pediatric providers. As new toys and products enter the marketplace, there may also be new dangers from those objects not initially recognized. Some of the recent trends and findings in pediatric FBI include an increase in adolescent injury from ingestion of laundry detergent pods because of a popular game where participants are encouraged to bite or swallow the pods, and injuries associated with ingesting parts of a popular toy known as a 'Fidget Spinner'., Summary: Adverse events resulting from FBI range the entire gamut from nonexistent or minor symptoms to moderate injury and rarely may be fatal. Factors such as age, type of object ingested, anatomic location of the foreign body, and timing from ingestion to receipt of medical attention all determine the risk posed to the child and guide management decisions. Because of the constant development of products, and the potential for the emergence of new and dangerous trends among children, continued surveillance by the medical community is important in monitoring and managing injuries associated with FBI.

The concept of "dietary supplements" is either a blessing for those focused on healthy lifestyles and personal management thereof or a crisis fraught with snake oil and drug analogs that are insidiously poisoning the gullible. Lost in this chatter is the role the ethical, and customer-focused industry takes to drive self-directing/self-governing initiatives to demonstrate unequivocally their position as responsible corporate citizens, meeting the needs of the ever-growing body of wellness-seekers., (© 2018 American Society for Clinical Pharmacology and Therapeutics.)

The United States Pharmacopeia (USP) is an independent, nonprofit, science-based organization whose mission is to improve global health through public quality standards for dietary supplements, medicines, and food ingredients. 1 Before developing standards for dietary supplement ingredients, the USP performs an "Admission Evaluation" (Figure 1), which includes an assessment to ascertain that an ingredient does not present a serious health risk. 2 This article discusses the challenges encountered during the evaluation of botanicals and proposes possible solutions., (© 2018 American Society for Clinical Pharmacology and Therapeutics.)