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Artigos do nosso site anterior, mantidos para que as ligações existentes continuem a funcionar. Não são atualizados, e alguns descrevem regras ou serviços que entretanto mudaram. Para informação atual, use os Briefings.

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UK Product Safety and Metrology EU Exit Regulations

The fact that the United Kingdom (UK) has left the European Union (EU) is not news for anyone. This means that the UK will no longer be considered a Member-State of the EU and will be considered a third country, implying that all the EU rules and regulations will no longer apply. On July 3rd, the UK government has released the last version of the Product Safety and Metrology EU Exit Regulations, which includes the UK Cosmetic Regulation within Schedule 34.

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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.

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Acetylated Vetiver Oil as a perfuming agent

Acetylated Vetiver Oil, also called Vetiveryl acetate or Vetiveria Zizanioides Root Extract Acetylated, is a natural complex substance derived from Vetiver Oil. In 2019, the European Commission’s Scientific Committee on Consumer Safety (SCCS) issued an opinion on the safety of Acetylated Vetiver Oil in cosmetic products and considered it safe under specific conditions.

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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.

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Cosmetics Regulation in Australia

Cosmetics and personal care products are regulated in different ways according to the country they are manufactured and made available. Regulatory compliance with international regulations is a critical factor for the internationalization of a cosmetic product. Since 1st July 2020, the Australian Industrial Chemicals Introduction Scheme (AICIS) is the entity responsible for controlling cosmetics. Cosmetic products must be used, advertised and presented in a specific way to be considered cosmetics rather than therapeutic goods.

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Ban of animal testing in Australia

Australia’s legislation regarding industrial chemicals has changed. Since July 1st 2020, animal testing information can no longer be used to prove safety of new cosmetic ingredients manufactured in or imported into Australia.

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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.

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Butylphenyl Methylpropional – is the aggregate exposure safe?

Butylphenyl Methylpropional is an aromatic aldehyde used as a fragrance compound in cosmetic and non-cosmetic products. New opinions regarding the safety of this fragrance ingredient have been recently published.

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OECD Updated and Corrected Testing Guidelines

The Organisation for Economic Co-operation and Development (OECD) is an international organisation that works on “establishing evidence-based international standards and finding solutions to a range of social, economic and environmental challenges”. The OECD has updated and corrected eight OECD Test Guidelines, in order to continue ensuring chemicals safety and keep up with scientific progress for OECD members and Mutual Acceptance of Data (MAD) adhering countries.

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What is Cosmetovigilance?

Essentially, Cosmetovigilance is the continuous compilation, evaluation and monitoring of cosmetic products’ safety, concerning human health. Manufacturers have the responsibility to determine that cosmetic products and their ingredients are safe before they enter the market, as well as to gather reports of adverse reactions.

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