Towards an adequate level of personal data protection – Adequacy decisions adopted by the European CommissionOn February 19, 2021, the European Commission published two draft adequacy decisions for the United Kingdom (UK) and initiated their adoption procedure. Following the approval of the EU Member States’ representatives in the commonly named comitology
Smartphones can play an essential role in emergency situations, where accurate caller location enables a swift response from emergency services. For this purpose, the Commission Delegated Regulation (EU) 2019/320 supplements the Radio Equipment Directive regarding caller location technologies in emergency communications from mobile devices to include “technical solutions for
Classification, Labelling and Packaging (CLP) RegulationClassification and labelling of substances and mixtures is covered by the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008). Since June 1, 2015, the CLP is the only legislation in force in the EU for classification and labelling of substances and mixtures (ECHA,
The Machinery Directive 2006/42/EC is a key piece of EU legislation that follows the ‘New approach‘ principles. For this reason, it represents a valued pillar to ensure that safety requirements for machinery products are met before they can enter the European market. On April 21, 2021, the European
Regulation (EU) 2019/1148 on the marketing and use of explosives precursors entered into force on February 1, 2021, amending Regulation (EC) No. 1907/2006 and repealing Regulation (EU) No. 98/2013.The newly applicable Regulation sets out harmonized rules regarding the making available, introduction, possession, and use of substances
On May 20, 2021, the European Commission published the first Report on the Tobacco Products Directive 2014/40EU (TPD), as per the requirement of Article 28 (1) of the TPD. The application of the TPD has resulted in a steady decrease of people smoking, as well as of the use
CORE-MD (Coordinating Research and Evidence for Medical Devices) is a Horizon 2020, EU-funded project with the aim of enriching the EU regulatory guidance documents with expert knowledge on medical devices and building expertise in the field of regulatory science. The project is led by the European Society of Cardiology (ESC)
The publication of the Annual Report of FAMHP (Federal Agency for medicines and health products) has been significantly delayed due to the COVID-19 pandemic, top priority of the Agency, and the impact of Brexit on the Agency's Divisions. The digital Annual Report 2019 contains interesting figures concerning medicines and medical
On May 26, 2021, the Swiss Federal Council announced that Switzerland would not sign the Institutional Framework Agreement (InstA), due to substantial differences with the EU on key aspects, such as freedom of movement of persons, state aid and protection of Swiss wages. The Institutional Agreement was supposed to regulate
The purpose of the Toys Safety Directive is twofold: ensuring that proper rules are in place to make toys safe when they are exposed to children and making sure that the internal market for toys functions successfully. Since its adoption, the Toys Safety Directive has been adapted 12 times, usually
The European Commission and its Scientific Committee on Consumer Safety (SCCS) published on May 14, 2021 its final opinion on the presence of Bisphenol A (BPA) in clothing articles. This document comes after a request by the European Commission to verify the presence and activity of BPA in clothing articles,
Formaldehyde is an ingredient usually used in nail hardeners that can potentially cause allergic skin reactions, and that has also been listed as a Carcinogen substance by the European Commission (EC). Timeline of events Initially, in November 2014, the Scientific Committee on Consumer Safety (SCCS) released the opinion that formaldehyde
