MEDICAL DEVICES INDUSTRY REPORTS
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Regulatory Framework of Drug-Device Combination

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.

Amendment to the European Standard for Risk Management of Medical Devices

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.

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Risk Management Under EU Medical Device Regulation

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.

Person Responsible for Regulatory Compliance (PPRC) under MDR & IVDR

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).

EUDAMED Status Update 2021

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.

EN ISO 13485:2016 – Amendment 11 has been published!

The European standardisation bodies CEN and CENELEC published EN ISO 13485:2016+A11:2021 featuring new annexes ZA and ZB that link the requirements of the MDR (Regulation EU 2017/745) and the IVDR (Regulation EU 2017/746), respectively, to specific clauses of the standard.

New EU Commission Recommendation for PPE and Medical Devices – COVID-19

PPE and Medical Devices have proven to be essential for healthcare workers in the efforts to contain the COVID-19 outbreak. In March 2020, the EU Commission urged the economic operators to increase rapid supply into the market. Currently, the Commission considers that the conditions for exceptional access to market are no longer met, limiting the placing of PPE and Medical Devices which have not successfully undergone the relevant conformity assessment procedures applicable on the EU market.

EU Medical Devices Trade with Switzerland after the Implementation of the MDR

The new EU regulation on medical devices (EU-MDR) has been enforced since May 26, 2021. However, Switzerland is not an EU Member State, which means it is considered a third country according to the new EU-MDR. This entails consequences for the trade of CE-marked medical devices between Switzerland and the EU.

Harmonized Standards for Medical Devices

In July 2021, the European Commission published an Implementing Decision on the harmonized standards for medical devices. These standards were drafted in support of Regulation (EU) 2017/745, the new EU Medical Devices Regulation.

The CORE-MD Project

The new regulation on medical devices (MDR) has already come into force in the EU. The new rules increase clinical evidence requirements for high-risk medical devices. The main goals of the CORE-MD project are to translate expert knowledge into advice for EU regulatory guidance and to strengthen expertise in regulatory science in the clinical community.

BREXIT – Impact on Medical Devices placed in the UK market

From 31 of December 2020, the UK will be regarded as a third country and not a Member State of the European Union. There will be some changes regarding medical devices placed in the UK. The UK’s MHRA has published guidance regarding the regulation of medical devices from 1 January 2021, where it explains what changes and what there is to know about placing a medical device in the Great Britain, Northern Ireland and EU markets.

Brazil – Class II Medical Devices – New Resolution

A new Resolution of the Collegiate Board of Directors (RDC No. 423/2020) has been published by Brazil’s National Agency of Health Surveillance (ANVISA). This new Resolution announces the elimination of the ‘Cadastro’ pathway regarding the registration of medical devices (Class II) and IVDs, substituting it with a notification registration system.

EU Medical Devices Regulation – Unique Device Identifier (UDI)

In 2017, two Regulations on medical devices (MDR) and in in vitro diagnostic medical devices (IVDR) entered into force in the European Union (EU), establishing a modernized and more robust EU legislative framework and safeguarding a better public health protection and patient safety. According to the these Regulations, the Unique Device Identifier (UDI) will be mandatory for all medical devices and in vitro medical devices.

Swiss Medical Devices Regulation Revision

A revision of the Medical Devices Ordinance (MedDO) has been approved by the Swiss Federal Council. This revision will take effect on 26th May 2021, along with a new Ordinance on Clinical Trials for Medical Devices (ClinO-MED). The aim of this revision is to align and harmonize it with the European Union Medical Devices Regulation (MDR) and consequently simplify market trading and maintain Switzerland’s market participation.

EU MDR – Person Responsible for Regulatory Compliance (PRRC)

The EU Medical Devices Regulation (MDR) lays down the rules regarding the placing on the market, making available on the market or putting into service of medical devices and accessories for such devices. When compared to the prior applicable Directives, the MDR (and also IVDR) makes it mandatory for manufacturers to have within their organizations at least one Person Responsible for Regulatory Compliance.

Could antibody serologic tests downplay SARS-CoV-2 virus prevalence?

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.

Medical Devices – Brazil Regulatory Framework

Brazil represents the biggest market for medical devices in South America. Selling and marketing medical devices in Brazil requires several actions and compliance with legislation and standards, which can be a complex process.

Medical Devices – U.S. Regulatory Framework

The Food and Drug Administration (FDA) is the authority regulating Medical Devices in the U.S., to ensure their safety and effectiveness. Medical devices are divided into three classes (I, II and III) and this classification defines the regulatory requirements for each device type.

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COSMETIC INDUSTRY REPORTS

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

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.

Request for SCCS Scientific Opinion on Citral

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.

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

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.

Cosmetic Regulation in the Andean Community

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).

Cosmetic Product Labelling in the European Union

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.

Environmental Claims in the UK

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 in Cosmetic Products

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.

The Product Information File (PIF)

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.

How are Cosmetic Products Regulated in Australia?

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.

Ban of Butylphenyl Methylpropional Postponed in the UK

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

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.

What is a Cosmetic Product Safety Report (CPSR)?

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).

Produção Artesanal de Cosméticos em Portugal

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”).

White Paper on Testing for Asbestos in Cosmetic Products Containing Talc

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.

Will CBD be legalized in Israel?

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 for Aerosol Products in the UK

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.

‘Free From’ Claims in Cosmetic Products

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.

The Use of Preservatives in Cosmetic Products

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.

Cosmetic Claims in the European Union

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.

Restriction on the use of M-N-MA in Cosmetic Products

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.

Global Consumer Trends in 2022

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.

The Responsible Person in the EU

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.

SCCS Preliminary Opinion on Genistein and Daidzein

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.

The Cosmetic Products Notification Portal (CPNP)

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).

French Anti-Waste Law

The Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France in 2020. Since the beginning of this year, some requirements of the law became mandatory, like the Triman logo. The law provides for a ban on all single-use plastics by 2040.

SCCS Preliminary Opinion on 4-MBC

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.

SCCS Revision of the Opinion on Vitamin A

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.

Octocrylene Restriction in Cosmetic Products Placed in the European Union

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.

Health Canada Cosmetics

Canadian Cosmetic Products Regulations

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.

EU Ecolabel Criteria Extended to All Cosmetic Products

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.

China’s First Regulation for Children’s Cosmetics

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.

SCCS Preliminary Opinion on Kojic Acid

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.

SCCS Final Opinion on HAA299 (Nano)

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.

SCCS Final Opinion on Methyl Salicylate

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.

New Formaldehyde Threshold in Cosmetic Products

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.

New Restriction on the Use of Benzophenone-3 in Cosmetics

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.

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European Commission Calls for Data on Ingredients with Potential Endocrine-Disrupting Properties

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.

SCCS Preliminary Opinion on Prostaglandins and Prostaglandin-analogues

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.

SCCS Preliminary Opinion on Butylated Hydroxytoluene (BHT)

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.

EU Prohibition of Zinc Pyrithione in Cosmetic Products

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.

EU Chemicals Strategy for Sustainability

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.

Nanotechnology in Sun Care 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. Currently, there are 4 nano-ingredients approved in the European Union for use as UV filters in cosmetic products.

May Butylphenyl Methylpropional be used 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.

How are Cosmetic Products Regulated in the United Arab Emirates?

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.

European Commission Report on Nanomaterials – 2021

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.

New Labelling Requirements for Cosmetic Products in China

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.

50th Amendment to the IFRA Code of Practice

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.

How are Cosmetic Products Regulated in India?

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.

Is Phenoxyethanol Safe for Use in All Cosmetic Products?

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 in Cosmetic Products

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.

Cosmetic Products Testing in the European Union

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.

Animal Testing Ban in Mexico

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.

New Amendments to the European Cosmetic Regulation

Commission Regulation (EU) 2021/1099 of 5 July 2021 sets out that Deoxyarbutin should be prohibited in cosmetic products and that the use of Dihydroxyacetone should be restricted in non-oxidative hair dye products and in self-tanning products. This results in one new entry to Annex II and one new entry to Annex III of the European Cosmetic Regulation, respectively.

Fullerenes and Hydroxylated Fullerenes

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.

New Packaging Material and Labelling Requirements in South Korea

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.

Regulatory Framework for Cosmetic Products in South Korea

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.

Cosmetic Products Regulation in Taiwan

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 Contamination in Sunscreen Products in the US

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 in Cosmetics

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 Properties and Uses

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.

Microbiological Testing of Vegan and Natural Cosmetic Products

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.

Quasi-Drugs in Japan

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.

Sustainable Cosmetic Products

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.

In-Market Control of Sun Care Products in Spain

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.

Probiotic, Prebiotic and Postbiotic Claims in Cosmetic Products

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?

Standards for Cosmetic Safety Assessment and Efficacy Claims in China

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-based Toothpastes

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.

Single-use Plastic and Microplastics Regulations

The cosmetics and personal care products industry is growing, but with this growth comes a major concern: plastics pollution. The European Commission has published the Directive (EU) 2019/904, known as Single-Use Plastic Directive, which addresses the reduction of the impact of certain plastic products on the environment. In line with what is happening in the EU, different countries around the globe are following the same path.

Creating a “Zero Waste” Cosmetic Industry. Is it possible?

Climate change, pollution, waste management and recycling. These are some of the terms we see frequently on the news and tabloids. Consumers are concerned with the planet and are demanding more innovative,sustainable and eco-friendly solutions. Cosmetic and personal care products have been the target of some criticism by its users. New ingredient and packaging alternatives are being developed and more sustainable products are starting to appear on the market. But how far are we from a “zero waste” cosmetic industry?

United States (U.S.) Cosmetics Regulation

Cosmetics and personal care products were regarded as poorly regulated in the United States (U.S). But in 2019, the new federal bill HR 4296 (Safe Cosmetics and Personal Care Products Act) was introduced in order to replace HR 2359, envisioning a more progressive and robust regulatory framework for cosmetics and personal care products. What are the main challenges that authorities are currently facing in light of this proposed legislation?

Natural and Organic Cosmetic Products

Demand for natural and organic products is increasing, particularly in the cosmetic and personal care products markets. Brands and manufacturers are closely monitoring and creating products to answer this frenzy behaviour. The ISO – International Organization for Standardization has already set guidelines for technical definition and criteria applicable to natural and organic cosmetics. But do you know how to properly substantiate these claims? Here is a quick overview of the requirements to follow.

2021 Updates on the EU Cosmetics Regulation

Substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) are, by default, not allowed in cosmetic products. Some substances have been recently classified as CMR according to the CLP Regulation, so the Commission decided to correct and amend the Annexes of the EU Cosmetics Regulation. There are 12 new ingredients prohibited in cosmetic product and new restrictions on the use of Titanium Dioxide and Salicylic Acid.

New EFSA’s Opinion on Titanium Dioxide

Titanium Dioxide is an ingredient used widely in cosmetic and personal care products. It is also used in medicines and an authorized food additive in the EU and the US. Following a request by the European Commission, new available data on this ingredient was reviewed by the EFSA Panel on Food Additives and Flavourings (FAF), which published an updated evaluation on Titanium Dioxide as a food additive.

PUBLIC HEALTH REPORTS

FDA updates on hand sanitizers safety for use

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.

Hand sanitizers contaminated with methanol

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.

Airborne transmission is the dominant route for the spread of COVID-19

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.

Illegal and Ineffective Disinfectants in the EU Market

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.

Could antibody serologic tests downplay SARS-CoV-2 virus prevalence?

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.

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