The MDCG 2022-19 was published on December 2022. This document indicates a series of templates that should be used for performance study applications under the IVDR, while the respective EUDAMED module is not fully functional.
Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.
If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.
ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?
The Commission published the Implementing Regulation (EU) 2022/2347, laying down rules for the reclassification of several active products without an intended medical purpose mentioned in MDR annex XVI.
The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.
The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.
EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.
Implementation of the MDR is a top priority for the medical devices industry, which has committed significant resources to comply with the new requirements. Despite its efforts, the sector remains seriously held back by the slow and piecemeal implementation of the new regulatory framework.
On 5 of July of 2022, the European Commission published the implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746.
EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?
EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.
Desde o dia 26 de maio de 2022, são aplicáveis as novas regras do RDIV. Em consequência, alguns requisitos nacionais sofrerão alterações ou serão substituídos por regras europeias.
26 May 2022 marks the date of application of the new EU In Vitro Diagnostics Regulation (EU) 2017/746 and with it the most transformative regulatory framework impacting in vitro diagnostics in Europe.
The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.
An European amendment to EN ISO 14971 – Medical devices – Application of risk management to medical devices, designated A11:2021, was published in December 2021, paving the way to the standard being listed in the Official Journal of the European Union (OJEU) as providing a presumption of conformity with the relevant requirements of the European Medical Device and In Vitro Diagnostics Regulations.
Risk management is a continuous iterative process throughout the entire lifecycle of a medical device, and it requires regular systematic updating. According to EU Medical Device Regulation (EU MDR) Article 10(2), all Manufacturers are obligated to establish, document, implement and maintain a risk management system.
The EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Device Regulation (EU IVDR) require all Manufacturers and Authorized Representatives to have a designated employee in their company who is responsible for regulatory compliance with the applicable MDR or IVDR requirements, the Person Responsible for Regulatory Compliance (PRRC).
The development and deployment of EUDAMED is progressing. Following the implementation plan and getting familiar with the information stored in the database’s modules is crucial for economic operators compliance in the EU market.
The European Commission has issued a proposal for extending the transitional arrangements for the new In Vitro Diagnostic Medical Devices Regulation (IVDR) to prevent disruption in the supply chain.
Ingredients: BHT, ACID YELLOW 3, HOMOSALATE, HAA299 and RESORCINOL
Date of publication: 11/11/2022
Date of application: 01/07/2023
Commission Regulation (EU) 2022/2195 of November 2022 amends Regulation (EC) No 1223/2009, restricting the use of BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol, in cosmetic products.
World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.
The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.
On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties.
The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Changes in Annexes III and VI to Regulation are expected, regarding the ingredients: BHT; Acid Yellow 3; Resorcinol; HAA299; and Homosalate.
The European Commission has published the Commission Implementing Decision (EU) 2022/677, which updates the Glossary of common ingredient names for use in the labelling of cosmetic products.
Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.
On July 8th, the European Commission published the Commission Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009. This amendment lowers the current threshold for labelling formaldehyde from 500 ppm to 10 ppm.
Ingredients: BENZOPHENONE-3 and OCTOCRYLENE
Date of publication: 07/07/2022
Date of application: 27/07/2022
On July 7th, the European Commission published the Regulation (EU) 2022/1176, amending the EU Cosmetics Regulation as regards the use of certain UV filter in cosmetic products. The use of Octocrylene and Benzophenone-3 will be restricted, following the opinions published by the SCCS.
The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.
Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.
The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.
The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.
In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).
The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.
Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.
Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.
A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.
The Australian Industrial Chemicals Introduction Scheme (AICIS) is the entity responsible for controlling cosmetics and soaps. Cosmetic ingredients are regulated as industrial chemicals under the Industrial Chemicals Act 2019, which is administered by AICIS.
Due to its classification as toxic to reproduction (Repr.1B – CMR 1B), Butylphenyl Methylpropional is now prohibited in cosmetic products in the European Union. Currently, this ingredient can still be used (subject to restrictons) in cosmetics marketed in Great Britain. However, a ban on Butylphenyl Methylpropional is expected in the near future in GB.
The EcoBeautyScore Consortium aims to enable consumers to make sustainable choices through an environmental impact assessment and scoring system. By now, there are 36 members of the Consortium, but it remains open for other companies and associations to join.
A cosmetic product needs to be safe for human health when used under normal and reasonably foreseeable conditions of use. All cosmetic products placed on the EU market must be subject to a safety assessment conducted by a qualified person. A Cosmetic Product Safety Report (CPSR) shall be done and included in the Product Information File (PIF).
The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex II of the Regulation will be revised and 12 nanomaterials will be included in the list of substances prohibited in cosmetic products.
A produção artesanal de produtos cosméticos é uma tendência crescente no mercado nacional. Os produtos cosméticos destinados a ser comercializados em Portugal devem cumprir com o Regulamento Europeu de Produtos Cosméticos da União Europeia e com a legislação nacional. Isto é válido para todos os produtos, sejam eles fabricados a uma escala industrial ou em pequena escala (“produção artesanal”).
Talc is used in a variety of consumer products, including cosmetics. Some talc deposits may contain Asbestos, a known human carcinogen. The FDA has published a white paper describing the IWGACP scientific opinions on testing methods for asbestos in cosmetic products containing talc.
Cannabis-derived ingredients, particularly CBD, are trendy compounds in the cosmetic industry. Overall, countries are adapting their legislations and allowing the use of CBD products. The Health Ministry of Israel has set up a Committee to look into legalizing CBD.
UKCA marking will be mandatory for aerosol products placed in the UK, as the ‘inverted epsilon symbol’ will no longer be recognized. This applies to all kinds of aerosol products, including cosmetics. Companies will have until the end of the year to make their products compliant.
Consumers are increasingly demand simple, ‘clean’, sustainable cosmetics and their interest on the composition of products is growing. ‘Free from’ or similar claims are usually appreciated and are currently a trend in the market. Nevertheless, not all ‘free from’ claims should be used or are allowed in cosmetic products placed in the European Union market.
Preservatives are essential ingredients in cosmetic products. These ingredients prevent microbiological contamination of products and ensure that they remain safe during their use by consumers.
Claims are an important part of a cosmetic and represent a powerful and essential tool of marketing. It is important to know which claims are allowed in cosmetic products in the European Union and how they must be properly substantiated.
The European Commission has published the Commission Regulation (EU) 2022/135. This regulation amends the European Cosmetic Regulation, adding a new entry to Annex III. The use of Methyl-N-methylanthranilate (M-N-MA) in cosmetic products will be subject to restrictions.
The “Top 10 Global Consumer Trends 2022” report was published by Euromonitor International, a global market research company. It is crucial for companies from all sectors to know and understand market trends and consequently adapt their businesses.
Only cosmetic products for which a Responsible Person is designated in the European Union can be placed on the EU market. The Responsible Person must ensure full compliance with the European Cosmetic Regulation.
The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary opinion on the use of Genistein and Daidzein in cosmetic products. The deadline for comments was set at 14 March 2022.
Only cosmetic products for which a legal or natural person is designated within the EU as a “Responsible Person” can be placed on the European Union (EU) market. Before placing a cosmetic product on the EU market, the RP must notify it in the Cosmetic Products Notification Portal (CPNP).
ECHA has updated its Candidate List of SVHCs with 4 new substances. 4-MBC, which is used in cosmetic products as an UV-filter is one of the new entries.
South Korea has open for comments its draft of the Regulation on Safety Standards, etc. for Cosmetics. This draft proposes new prohibited ingredients, new restrictions on other ingredients and the management of unintentionally added ingredients.
In 2019, the European Commission set out two lists of ingredients suspected of having endocrine disrupting properties. As 4-MBC (UV-filter) was included in the higher priority group, the European Commission asked the SCCS to carry out a safety assessment on this ingredient. The preliminary version of the requested opinion was published.
NMPA has officially launched the platform for the submission of cosmetic ingredients safety information. On this platform, Chinese manufacturers or authorized companies log in and submit information on ingredient safety.
The UK and Australia have signed a free trade agreement. It is the first free trade agreement from scratch since the UK left the European Union.
Vitamin A is not currently included in the Annexes of the European Cosmetics Regulation (Regulation (EC) No 1223/2009). The SCCS published the preliminary version of its revision of the scientific opinion on Vitamin A (retinol, retinyl palmitate and retinyl acetate). The deadline for comments was set at 7 February.
In 2019, the European Commission established a priority list of potential endocrine disruptors. Octocrylene was one of the ingredients on that list and the SCCS was asked to assess its safety. The European Cosmetics Regulation will be amended in accordance with the SCCS conclusions in such assessment.
Cosmetic Products made available in the Canadian market are regulated by Health Canada and need to comply with the Food and Drugs Act, the Cosmetic Regulation and the Consumer Packaging and Labelling Act. All cosmetic products must not pose a risk to consumers. Therefore, they need to be manufactured, prepared, preserved, packed and stored under rigorous sanitary conditions.
The EU Ecolabel is awarded to products and services that meet high environmental standards throughout their lifecycle. The European Commission published the Commission Decision (EU) 2021/1870, revising the EU Ecolabel criteria for rinse-off cosmetics and expanding its scope to other cosmetic products.
The NMPA has published several Regulations on cosmetic products made available on the Chinese market. Recently, the Regulation on Supervision of Children’s Cosmetics has been published. It is a breakthrough, as it was the first time it was introduced the legal definition of children’s cosmetics and its requirements in the country.
In 2019, the European Commission set out two lists of ingredients suspected of having endocrine disrupting properties. Kojic Acid was included in group A (higher priority) and the European Commission asked the SCCS to carry out a safety assessment on this ingredient. The SCCS has published its preliminary opinion on Kojic Acid and the deadline for comments was set at 14 January 2022.
HAA299 (non-nano) has been used in cosmetic products as a UV filter. In 2014, the SCCS considered that this ingredient in its non-nano form was safe for use as a UV-filter in cosmetics, at a maximum concentration of 10%. The SCCS released its final opinion regarding the use of HAA299 in its nano form.
Methyl Salicylate is used in several fragrance formulation and as a flavouring and soothing agent in oral hygiene products. A classification as “Toxic for Reproduction Category 2” and “Skin sensitizer Category 1B” was recommended in a RAC opinion (2019) and the European Commission asked the SCCS to carry out a safety assessment on Methyl Salicylate. The SCCS’ final opinion on the ingredient was recently released.
The European Commission has issued a draft regulation to amend the preamble of Annex V regarding the threshold for labelling formaldehyde releasers. This amendment results from a scientific advice published by the SCCS concluding that the current threshold does not sufficiently protect consumers sensitized to formaldehyde.
Benzophenone-3 was part of a priority list of potential endocrine disruptors established by the European Commission in 2019. The SCCS was asked to assess the safety of this ingredient and the European Cosmetics Regulation will be amended in accordance with the SCCS assessment conclusions.
Substances classified as endocrine disruptors are compounds that can alter the functioning of the endocrine system and negatively affect the health of humans and animals. In 2019, the European Commission set out two lists of ingredients suspected of having endocrine disrupting properties. More recently, the Commission has published a call for data for 10 ingredients that were included in the low priority group (Group B) for the SCCS to be able to assess their safety.
Following the mandate from the European Commission, the Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on Prostaglandins and Prostaglandin-analogues used in cosmetic products. This preliminary opinion is open for comments and the deadline was set for 23 november 2021.
Following the mandate from the European Commission, the Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on Butylated Hydroxytoluene (BHT). This preliminary opinion is open for comments and the deadline was set for 23 november 2021.
Zinc Pyrithione has been used for more than 60 years as an anti-dandruff agent in cosmetic products. Last month, the European Commission published the Commission Regulation (EU) 2021/1092, which includes this ingredient in Annex II. From March 2022 onwards, Zinc Pyrithione will be prohibited in cosmetic products.
The Chemicals Strategy for Sustainability (CSS) was recently published by the European Union. The CSS is part of the European Green Deal which aims for a toxic-free environment leading to zero pollution. The initiative proposes a new legislative amend to the EU Cosmetic Products Regulation. Simplification and digitalization of labelling requirements plus review of the definition of nanomaterial are two of the main objectives of the CSS.
Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. Currently, there are 4 nano-ingredients approved in the European Union for use as UV filters in cosmetic products.
Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. According to an amendment to the CLP Regulation, the use of Butylphenyl Methylpropional will be prohibited in cosmetic products from 1st March 2022.
The United Arab Emirates (UAE) are an emerging market for the beauty industry. Cosmetics and personal care products supplied or sold in the UAE must comply with the health and safety requirements set out in UAE legislation. Overall, the process for importing a cosmetic product into the UAE market from the European Union can be quite straightforward since the UAE has aligned several of its requirements with the European Cosmetic Regulation.
The European Commission is required to submit to the European Parliament and the Council an annual status report on the use of nanomaterials in cosmetic products and to review the provisions concerning nanomaterials in the European Regulation (EC) No 1223/2009 on cosmetic products. In July 2021, the Commission has issued its latest annual report on this subject.
The new Cosmetics Supervision and Administration Regulation (CSAR) was enacted in China. The National Medical Products Administration (NMPA) has released standards for the testing of cosmetic products’ safety profile and efficacy claims. The NMPA has also published the Administrative Measures on Cosmetics Labelling, an updated set of requirements for the label of cosmetic products made available in the Chinese market.
On June 30, IFRA announced the notification of the 50th Amendment to the IFRA Standards. The Standards form the basis for the globally accepted and recognized risk management system for the safe use of fragrance ingredients and are part of the IFRA Code of Practice. The amendment introduced one update to the Standards and one new prohibited substance – Mintlacton.
The different expectations and needs of consumers are continually changing and therefore the cosmetic industry needs to be gradually evolve to meet the new consumer’s demand. In this regard, India has recently introduced some regulatory updates to ensure that cosmetics placed on the market are safer for all consumers.
Phenoxyethanol is a common preservative used in cosmetic and personal care products worldwide. It has been subject to various safety assessments and most concluded about its safety under the current most frequent uses. Nevertheless, some concerns were raised by the French Agency ANSM, particularly regarding its use in products intended for the nappy area in children up to 3 years old.
Cannabis-derived ingredients are popular compounds with interesting properties. There is specific EU and national legislation regarding cannabis-derived ingredients, identifying which extracts and derivatives may be used in cosmetic products. There are several aspects to consider to ensure compliance when adding these compounds to cosmetics and personal care products.
A cosmetic product which is made available on the European Union market needs to prove that it is safe for consumers. Apart from the mandatory testing, depending on the claims to be used or the type of cosmetic product to be placed on the market, additional tests may be required.
Mexico has become the first country in North America to ban animal testing in cosmetic products. There are now 41 nations in the world that do not allow cosmetics to be tested on animals.
Fullerenes and Hydroxylated Fullerenes have shown interesting biological activity and have been gaining interest from several fields, including the cosmetic industry. These substances are not regulated under the Cosmetic Regulation (EC) No. 1223/2009. However, there are concerns of potential absorption of nanoparticles with their use in cosmetic products. As such, the SCCS is mandated by the European Commission to assess the safety of Fullerenes and Hydroxylated Fullerenes until the end of 2021.
Korean cosmetic products are among the most popular products in the beauty industry, representing one of the leading global markets for cosmetic products. With consumers’ increased concern with the environment and demand for recycled and recyclable materials, South Korea is adapting its regulations to become more ‘eco-friendly’ and empower brands and consumers alike using innovative waste management processes.
South Korean cosmetic products are among the most popular products in the beauty industry. But how are these products regulated? Safety is one of the major goals of South Korean cosmetics regulations and the country has been aligning its regulations with the European Union.
The Cosmetic Hygiene and Safety Act was enacted in Taiwan in 2019. Several dates were set and since July 2021 three new requirements have been enacted. General cosmetics notification is now mandatory and there are new requirements regarding the cosmetic products’ labelling.
Benzene is a chemical that is widely used in some industries. However, benzene is a known human carcinogen and therefore its use or trace presence in cosmetics and personal care products is not allowed. In the U.S., a recent report has identified 78 sun care products contaminated with benzene, requiring their recall by the FDA in order to protect consumers.
Nanotechnology is a growing business worldwide. Nanomaterials are increasingly used in cosmetics and personal care products. Nanomaterials are similar to other chemicals/substances, but there are risks associated to specific nanomaterials and their use. In the EU, cosmetic products containing nanomaterials may have to be notified by the Responsible Person six months before being placed on the market.
Panthenol is used in cosmetics and other consumer products such as pharmaceuticals and biocides. Its wide variety of applications is explained by its properties, most notably the ability to attract and hold moisture and the capacity to enhance skin repair.
Innovation on cosmetics and the higher demand for natural and vegan products may represent a risk, particularly when it comes to cosmetics microbiological contamination or the induction of sensitization. he microbiological testing and control constitutes a major part of quality control of a cosmetic product. It is essential to ensure the product’s safety during normal and foreseeable conditions of use and its shelf life.
In Japan, cosmetic products are regulated by the Pharmaceutical and Medical Device Act, which stipulates compliance requirements and defines two categories of products: cosmetics and quasi-drugs. Quasi-drugs are in between pharmaceuticals and cosmetics, having officially recognized active ingredients. At the end of 2020, the MHLW proposed amendments for the marketing approval standards of medicated oral-care products, hair dyes and permanent wave agents, which were approved and just became effective. The GMP Ministerial Ordinance and the new JSQI were also approved by the MHLW in 2021.
Consumers are increasingly looking for transparency and authenticity in cosmetic products brands. Choosing sustainable ingredients, environmentally friendly packaging and truthful labelling claims are important steps to achieve the “sustainable brand” status. Three essential pillars should be considered in this process: environmental protection, corporate social responsibility and ethical governance.
Sun care products play an important role in our daily life, protecting us from the UV rays and their consequences. As a cosmetic product, sunscreens must be safe for humans and need to have the SPF factor they claim. In December 2019, the Spanish AEMPS started a campaign with the aim of guaranteeing that the claimed FPS of sunscreens available in the market are indeed correct and in accordance with testing results.
Microbiome claims such as probiotic, prebiotic, postbiotic and other related terms are becoming more and more popular in the beauty industry. But what does it really mean? How can a cosmetic company justify such claims? How are these products regulated in terms of their safety and quality standards?
The new Cosmetics Supervision and Administration Regulation (CSAR) has come into force in China. The prohibition of animal testing in certain cosmetics and the publication of guidelines for the safety assessment and efficacy claims testing are two of the main changes included in this new Chinese legislation affecting cosmetic products.
Charcoal and charcoal-containing products, such as toothpastes, are popular among the public. Nevertheless, its safety and efficacy has not yet been proven and the long-term effects are not completely known.
The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.
The new coronavirus SARS-CoV-2 has led to an increasing demand of hand sanitizers. Nevertheless, not all hand sanitizers made available in the market are safe. The U.S. Food and Drug Administration (FDA) has issued a public warning to consumers and health care providers for possible contamination of hand sanitizers with methanol. The FDA advises the public not to use such hand sanitizers, because methanol is a dangerous and toxic substance.
In March 2020, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone (a steroid treatment).
Transmission pathways of coronavirus disease 2019 (COVID-19) were studied by analyzing the trend and mitigation measures in the three epicenters. Results show that the airborne transmission route is highly virulent and dominant for the spread of COVID-19. The difference with and without mandated face covering represents the determinant in shaping the trends of the pandemic. Mitigation measures, such as social distancing implemented in the United States, are insufficient by themselves in protecting the public.
Lockdowns and other distancing measures have had resounding success at thwarting the new coronavirus, according to two independently conducted studies that examined different countries and measures of effectiveness.
20 EU countries have reported to the European Chemicals Agency (ECHA) and the European Commission (EC) that the COVID-19 pandemic has led to an increased number of non-compliant hand disinfectants on their markets since March 2020.
Antibody studies might underestimate the share of a population that has been infected with SARS-CoV-2. Most antibody tests have been validated using blood samples from people hospitalized with severe disease. But these individuals, who make up only a small fraction of infected people, might have higher levels of antibodies circulating in their body than have people with mild or no symptoms.
