News

Green Transition to impose new obligations for manufacturers

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

What is the Common list of COVID-19 rapid antigen tests?

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

Restriction of the use of hazardous substances in electronics: what is next?

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

EU list of recommended antigen COVID-19 test replaces Belgian list

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

Obelis Group acquires SYNC Projects Ltd.

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

New EU Standardisation Strategy: Is the EU a global standard-setter?

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

Lilial and Zinc pyrithione banned in the EU

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

Toys containing aqueous media: New Revision of Protocol on Microbiological Safety

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

EMC ADCO publishes its market surveillance report on microwave ovens

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