Impacto de los filtros ultravioleta en el entorno natural / Environmental Impact of UV Filters

Los filtros ultravioleta (UV) se han convertido en compuestos de uso diario para millones de personas. Sin embargo, algunos de ellos no son biodegradables al 100% y las plantas de tratamiento de aguas residuales muchas veces no son capaces de filtrarlos correctamente. Todo ello está llevando a su diseminación ambiental y a la detección de distintos filtros UV en el suelo, las aguas continentales, los océanos y en múltiples organismos (algas, corales, peces, mamíferos, incluso aves terrestres). Además, algunos filtros UV, especialmente la benzofenona-3 y el octocrileno se han mostrado tóxicos en estos organismos. Entre sus efectos tóxicos destacamos el blanqueamiento de los corales y problemas metabólicos, enzimáticos y de capacidad reproductiva en prácticamente cualquier organismo. Existen datos preliminares sobre la posible bioacumulación de estos filtros UV en humanos, al detectarse en muestras de orina y leche materna. Sin embargo, el estudio del impacto medioambiental de los filtros UV presenta muchas limitaciones (AU)

UV filters are used daily by millions of people. Not all of these filters, however, are 100% biodegradable, and many wastewater treatments plants are ill-equipped to filter them properly. As a result, UV filters are increasingly reaching the environment. Various types have been detected in soil, continental water, oceans, and numerous organisms, including algae, corals, fish, mammals, and even land birds. In addition, some filters, benzophenone-3 and octocrylene in particular, are toxic to these organisms. Toxic effects include coral bleaching and interference with metabolic, enzymatic, and reproductive activities in practically all organisms. Preliminary data suggest that UV filters may be bioaccumulating in humans, as they have been detected in urine and breast milk. It should be noted, however, that research into the environmental impact of UV filters holds challenges and limitations (AU)

[Translated article] Environmental Impact of UV Filters / Impacto de los filtros ultravioleta en el entorno natural

UV filters are used daily by millions of people. Not all of these filters, however, are 100% biodegradable, and many wastewater treatments plants are ill-equipped to filter them properly. As a result, UV filters are increasingly reaching the environment. Various types have been detected in soil, continental water, oceans, and numerous organisms, including algae, corals, fish, mammals, and even land birds. In addition, some filters, benzophenone-3 and octocrylene in particular, are toxic to these organisms. Toxic effects include coral bleaching and interference with metabolic, enzymatic, and reproductive activities in practically all organisms. Preliminary data suggest that UV filters may be bioaccumulating in humans, as they have been detected in urine and breast milk. It should be noted, however, that research into the environmental impact of UV filters holds challenges and limitations (AU)

Los filtros ultravioleta (UV) se han convertido en compuestos de uso diario para millones de personas. Sin embargo, algunos de ellos no son biodegradables al 100% y las plantas de tratamiento de aguas residuales muchas veces no son capaces de filtrarlos correctamente. Todo ello está llevando a su diseminación ambiental y a la detección de distintos filtros UV en el suelo, las aguas continentales, los océanos y en múltiples organismos (algas, corales, peces, mamíferos, incluso aves terrestres). Además, algunos filtros UV, especialmente la benzofenona-3 y el octocrileno se han mostrado tóxicos en estos organismos. Entre sus efectos tóxicos destacamos el blanqueamiento de los corales y problemas metabólicos, enzimáticos y de capacidad reproductiva en prácticamente cualquier organismo. Existen datos preliminares sobre la posible bioacumulación de estos filtros UV en humanos, al detectarse en muestras de orina y leche materna. Sin embargo, el estudio del impacto medioambiental de los filtros UV presenta muchas limitaciones (AU)

Environmental Effects of Ultraviolet (UV) Filters.

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).

Interpreting Risk from Sunscreens in the Marine Environment.

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.

Introducing the Rapid Alert Supply Network Extractor (RASNEX) tool to mine supply chain information from food and feed contamination notifications in Europe.

BACKGROUND: During food or feed contamination events, it is of utmost importance to ensure their rapid resolution to minimize impact on human health, animal health and finances. The existing Rapid Alert System for Food and Feed (RASFF) is used by the European Commission, national competent authorities of member countries and the European Food Safety Authority to report information on any direct or indirect human health risk arising from food or feed, or serious risks to animal health or the environment in relation to feed. Nevertheless, no methods exist to to collectively evaluate this vast source of supply chain information. METHODS: To aid in the extraction, evaluation and visualization of the data in RASFF notifications, we present the Rapid Alert Supply Network Extractor (RASNEX) open-source tool available from https://doi.org/10.5281/zenodo.4322555 freely. Among RASNEX's functions is the graphical mapping of food and feed supply chain operators implicated in contamination events. RASNEX can be used during ongoing events as a support tool for risk analysis using RASFF notifications as input. RESULTS: In a first use case, we showcase the functionality of RASNEX with the RASFF notification on a 2017/2018 contamination event in eggs caused by the illegal use of fipronil. The information in this RASFF notification is used to visualize nine different flows of main and related food products. In a second use case, we combine RASFF notifications from different types of food safety hazards (Salmonella spp., fipronil and others) to obtain wider coverage of the visualized egg supply network compared to the first use case. Actors in the egg supply chain were identified mainly for Italy, Poland and Benelux. Other countries (although involved in the egg supply chain) were underrepresented. CONCLUSIONS: We hypothesize that biases may be caused by inconsistent RASFF reporting behaviors by its members. These inconsistencies may be counteracted by implementing standardized decision-making tools to harmonize decisions whether to launch a RASFF notification, in turn resulting in a more uniform future coverage across European food and feed supply chains with RASNEX.

Phthalates in children toys available in Malaysian market: Quantification and potential human health risk.

In Malaysia, inexpensive toys are sold in various urban and rural shops. Although safety regulations for toys are available in Malaysia there are limited reports about the chemicals in toys. Thus, this study aimed to assess the levels of phthalates (bis-[2-ethylhexyl] phthalate [DEHP], diethyl phthalate [DEP], diisobutyl phthalate [DiBP] and dibutyl phthalate [DBP]) in inexpensive toys sold at local markets in Kuala Lumpur (Malaysia) and its health risks to children. All 30 toys analysed exceeded the European Union limit (0.1 % by mass) indicating that the phthalate used as plasticizers is still prominent in toys. Bis-[2-ethylhexyl] phthalate (DEHP) was the highest detected phthalate in toy sample which was manufactured in Malaysia and sold without Malaysian Conformity Mark. Significant association was found between phthalate levels and country, indicating a need to monitor and raise public awareness about potential toxic chemicals in inexpensive toys and children's products. There are few inexpensive toys that have a hazard index value of more than one, which is associated with developmental toxicity and causes developmental effects in children. Given the severity and complexity of these toys to children health, there is a need for regular monitoring and effective enforcements to develop an acceptable baseline level of children toys products manufactured in or imported to Malaysia. Furthermore, risk management efforts should also include all the stakeholders involved in toy production, policy makers as well as consumers to ensure only toy products with proper labels being sole and purchased.

Glass table injuries: A silent public health problem.

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.

Menthol additives to tobacco products. Reasons for withdrawing mentholated cigarettes in European Union on 20th may 2020 according to tobacco products directive (2014/40/EU).

Menthol, which is a natural cyclic monoterpene alcohol with a minty smell, is one of the main constituents of essential oils that naturally occur in some aromatic plants, such as Mentha × piperita L. This natural compound shows many biological properties, such as anesthetic, analgesic, antibacterial and antifungal, immunomodulating, and skin penetration-enhancing. It is added to a variety of goods, such as food, oral-care products, OTC products, cosmetics, and tobacco products. Menthol is not just a simple flavoring agent, especially when it comes to tobacco products. Its ability to 'mask' the negative effects of nicotine and its additional positive sensory effects makes it the most common additive in such products. For the customers, mentholated tobacco products may be mistakenly perceived as less harmful for health, which may increase their consumption. However, as the evidence shows, menthol cigarettes are no safer than conventional cigarettes and may lead to more frequent disease exacerbation during prolonged exposure to smoke from such products. In addition, because of its complex interactions with nicotine, menthol may affect smoking behavior and may increase addiction to nicotine. For those reasons, the European Union banned flavored cigarettes (whose sale size reached more than 3% of the total tobacco product market) by implementing the Tobacco Products Directive (2014/40/EU) on 20th May 2020. While the menthol ban was based on health concerns, the ultimate effect on consumers, regarding potential quitting, is yet to be determined.

Use of a common European approach for nanomaterials' testing to support regulation: a case study on titanium and silicon dioxide representative nanomaterials.

The European Union (EU) continuously takes ensuring the safe use of manufactured nanomaterials (MNMs) in consumer products into consideration. The application of a common approach for testing MNMs, including the use of optimized protocols and methods' selection, becomes increasingly important to obtain reliable and comparable results supporting the regulatory framework. In the present study, we tested four representative MNMs, two titanium dioxides (NM100 and NM101) and two silicon dioxides (NM200 and NM203), using the EU FP7-NANoREG approach, starting from suspension and dispersion preparations, through to their characterization and final evaluation of biological effects. MNM dispersions were prepared following a refined NANOGENOTOX protocol and characterized by dynamic light scattering (DLS) in water/bovine serum albumin and in media used for in vitro testing. Potential genotoxic effects were evaluated on human bronchial BEAS-2B cells using micronucleus and Comet assays, and pro-inflammatory effects by cytokines release. Murine macrophages RAW 264.7 were used to detect potential innate immune responses using two functional endpoints (pro-inflammatory cytokines and nitric oxide [NO] production). The interaction of MNMs with RAW 264.7 cells was studied by electron microscopy. No chromosomal damage and slight DNA damage and an oxidative effect, depending on MNMs, were observed in bronchial cells. In murine macrophages, the four MNMs directly induced tumor necrosis factor α or interleukin 6 secretion, although at very low levels; lipopolysaccharide-induced NO production was significantly decreased by the titania and one silica MNM. The application of this approach for the evaluation of MNM biological effects could be useful for both regulators and industries.

Nutraceuticals: A Comparative Analysis of Regulatory Framework in Different Countries of the World.

BACKGROUND: Nutraceutical is a term that is a combination of nutrition and pharmaceutical. They are believed to improve physical and mental health and provide therapeutic benefit in disease conditions. Nutraceuticals are claimed to be beneficial in several disease conditions which include cardiovascular disorder, neurodegenerative disorders, metabolic disorders and cancer prevention. OBJECTIVE: In the current review, we will study the current regulatory framework in some of the major countries of the world by comparing different parameters of these regulations. FINDINGS: Global nutraceutical market is currently expanding at a rapid pace but there are some restraints to the market growth which include poor quality manufacturing and unharmonized regulations leading to trade barriers across the globe. Although there are laws and regulations in place which govern nutraceutical products in different countries, these regulations lack harmonization and differ from country to country. Some of the countries follow stringent regulations, whereas, in some of the countries, well-structured and stern regulations for nutraceuticals are lacking. CONCLUSION: The development of a well regulated, harmonized and research-driven approach can help boost the confidence of consumers in nutraceutical products in the world thereby driving the nutraceutical market.

Assessing the Thin Regulation of Consumer-Facing Health Technologies.

This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. and suggests a framework for prioritizing ameliorative regulation. To better understand existing regulatory models, their deficiencies, and how they should be reformed, the article employs an analytical model describing these regulatory systems across two axes. The vertical axis describes the quantity or depth of regulation, such as, for example, the strictness of the rules imposed by the regulatory model. The horizontal axis describes the reach of the regulation, the behaviors, products, or industries to which the regulation applies.

Impact of Health Care Reform on Technology and Innovation.

The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.

Nuevo marco legal para la erradicación de los medicamentos falsificados: los nuevos dispositivos de seguridad / New legal framework for the eradication of falsified medicines: the new safety devices

INTRODUCCIÓN: Los medicamentos falsificados son un problema emergente en la sociedad actual. Una de las principales estrategias para poder combatirlos es el empleo del Derecho. Por ello se promulgó, por parte de las instituciones europeas legalmente competentes para ello, el Reglamento Delegado de la Unión Europea 2016/161 de la Comisión de 2 de octubre de 2015, que completa la Directiva 2001/83/CE del Parlamento Europeo y del Consejo estableciendo disposiciones detalladas relativas a los dispositivos de seguridad que figuran en el envase de los medicamentos de uso humano (de fabricación industrial). MÉTODO: Se realizó una revisión bibliográfica de esta nueva normativa, promulgada por diversas instituciones comunitarias, con el objetivo de analizar las novedades existentes en el ámbito del medicamento. RESULTADOS: La norma comunitaria, objeto de nuestro estudio, establece las directrices para verificar aquellos medicamentos con mayor riesgo de falsificación, mediante unos dispositivos de seguridad compuestos de dos partes. Un dispositivo anti-manipulación que permite visualizar que el envase no ha sido alterado y un código identificador único, que será reconocido en todos los países comunitarios y que posee información sobre el medicamento. Desde las oficinas de farmacia se autentifica cada medicamento mediante la verificación y desactivación del código identificador en el momento de la dispensación del mismo. CONCLUSIONES: Esta nueva normativa pretende evitar la posible entrada de medicamentos falsificados en la cadena de suministro legal de medicamentos. Sus principales ventajas son, garantizar al paciente la veracidad del medicamento dispensado en las oficinas de farmacia y mejorar la trazabilidad de los mismos

INTRODUCTION: Falsified medicines are an emerging problem in today's society. One of the main strategies to combat them is the use of law. That is why the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 was enacted by the relevant European institutions, which supplements Directive 2001/83/ EC of the European Parliament and of the Council by laying down detailed provisions relating to safety features appearing on the external packaging of medicinal products for human use (industrial manufacturing). METHOD: A literature review of this new legislation enacted by various Community institutions has been carried out with the aim of analyzing developments in the scope of the medicinal product. RESULTS: The Community regulation sets out the guidelines for verifying those medicinal products which have an increased risk of been falsified, using safety features consist of two parts: an anti-tampering device that allows to view that the packaging has not been altered, and a unique identifier code, which will be recognized in all Community countries and it has information on the medicinal product. Each drug is authenticated from the Pharmacies by verifying and deactivating the identifier code at the time of dispensing it. CONCLUSIONS: This new regulation aims to avoid the possible entry of falsified medicines into the legal supply chain of medicinal products. Its main advantages are ensuring to the patient the veracity of the drugs dispensed in the Pharmacy and improving the traceability of them

Rogue stem cell clinics.

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.