Over the last years, the European Union has been putting particular importance on sustainability. The most ambitious goal is to reach climate neutrality by 2050 and an entirely circular economy by 2030. Additionally, at the end of March 2022, the European Commission proposed to update the consumer rules to boost
Rapid antigen tests are widely used in the European Union and are becoming a common tool to strengthen a country’s testing capacity. Even if RT-PCR tests remain the main tests to detect COVID-19, antigen tests are an essential way to control and suppress the spread of the virus. BackgroundAlready
The European Union restricts hazardous substances in electrical and electronic equipment. Hazardous substances represent a risk for human health as well as for the environment. Directive 2012/19/EU on Waste from Electrical and Electronic Equipment (WEEE), together with Directive 2011/65/EU (RoHS Directive), regulate the use and the
Testing is fundamental to face the COVID-19 pandemic. In particular, antigen tests are widely used in the European Union, both among professionals and the general public. Antigen tests are IVDs (In Vitro Diagnostic medical devices) of class D under the IVDR. This means that they will fall under the highest-risk
A circular economy is an economic model based on using products and raw materials as long as possible. The model consists of reusing, recycling, repairing, sharing, leasing, and refurbishing products and their components. The aim is to reduce waste and fight global challenges such as pollution and climate change. The
We are glad to announce that, as of February 20, 2022, SYNC Projects Ltd. - a consultancy company operating in the Israeli regulatory domain of medical devices & cosmetics - has been acquired by Obelis Group. With this addition, Obelis Group expands its operations to the Israeli Market, in addition
In February 2022, the Court Justice of the European Union has published a judgment regarding a case of filter cigarettes. The dispute is related to the use of filter cigarettes for sale in the Netherlands, which complied with the maximum emission levels for tar, nicotine, and carbon monoxide prescribed by
In February 2022, the European Commission rolled out a new Standardisation Strategy. The Strategy delineates the Union’s approach towards harmonised standards, not only within the Single Market but also worldwide. The new Strategy is a key element within the European framework since it aims to strengthen the EU's competitiveness
As of March 1, 2022, two common cosmetic ingredients are banned for use in the EU. They are Butylphenyl Methylpropional (Lilial) and Zinc pyrithione. Omnibus Act IV On November 3, 2021, the European Commission published the Omnibus Act IV (Regulation (EU) 2021/1902) that foresees the prohibition of 23 cosmetic
In January,2022, the European Commission published the fourth Revision of Protocol No2 on Microbiological safety of toys containing aqueous media. This protocol provides a specification of the microbiological requirements on toys covered by its scope and since there are no particular microbiological requirements for toys, the Notified Body toys
The EMC Administrative Co-operation Working Group (EMC ADCO) published its report due to its 13th EMC market surveillance campaign, this time concerning microwave ovens for domestic use and catering. Alongside ten national market surveillance authorities, 62 devices were tested in compliance with the administrative and technical requirements of the EMC
The Treaty of Lisbon was the most ambitious EU project until its date of entry into force in 2009. The main purpose of the new treaty was to further deepen European integration, acquire new conferred powers, reinforce the European Economic Area, and enlarge its legislative scope. Novel policy areas emerged
