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.
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.
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 (Commission Delegated Regulation No. 2020/1182), Butylphenyl Methylpropional is now classified as toxic to reproduction (Repr. 1B – CMR 1B) and it shall be prohibited in cosmetic products from 1st March 2022.
On 16th January 2020, China’s National Development and Reform Commission (NDRC) issued the Notice [2020] No. 80, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. More detailed information was given in the Notice [2020] No. 1146, issued by the NDRC on 10th July 2020.
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.
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.
Every week, the RAPEX system publishes notifications of urgent measures taken by EU Member-States to prevent, restrict or impose conditions on the marketing of products due to the serious and immediate danger they pose to the health and safety of consumers.
Packaging material is defined as the container (or primary packaging) that is in direct contact with the formulation. According to the European Cosmetic Regulation No. 1223/2009, packaging evaluation is mandatory to guarantee cosmetic product safety. To meet this Regulation requirements, the European Commission issued the Decision 2013/674/EU, establishing guidelines on the practical application of such requirements and identifying information that should be collected on the packaging materials and the potential migration of substances from packaging.
Hoy en día, es posible encontrar en el mercado varios productos cosméticos con reivindicaciones como “protección anticontaminación”, “escudo de contaminación”, “contra daños por contaminación” y similares. Pero, ¿cómo puede una empresa probar este tipo de acusaciones?
Hoje em dia, é possível encontrar no mercado diversos produtos cosméticos com alegações de “proteção antipoluição”, “escudo antipoluição”, “contra os danos da poluição” e similares. Mas como pode uma empresa testar e provar estes tipos de alegações?
Nowadays, it is possible to find in the market several cosmetic products with claims like “anti-pollution protection”, “pollution shield”, “against pollution damage” and similar ones. But how can a company test and prove this type of allegations?
