On 5 March 2024, the Grand Chamber of the Court of Justice of the European Union ruled, notably on the basis of the principle of transparency, that individuals have a right of access to harmonised technical standards (case C-588/21 P | Public.Resource.Org and Right to Know v Commission and others). This judgment sets aside the […]
An ECHA’s ( European Chemicals Agency) investigation has identified several substances used for PVC plastic which may be harmful to humans and the environment. It focused on 63 PVC additives, such as plasticers, flame retardants and heat stabilisers. The investigation concludes recommending greater regulatory action in order to minimise the impacts and risks these new […]
The MDGC (Medical Device Coordination Group) has published guidance in order to ensure timely compliance with MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Regulation). The study calls on manufacturers, and the bodies that help regulate them, to increase transparency in regards to the timeline for conformity assessments and increase their public availability. […]
On 7 November 2023, the European Commission adopted Decision (EU) 2023/2461 implementing harmonised standards for construction products. This Decision entered into force on 9 November 2023. This Decision amends Decision (EU) 2019/451 by adding five new entries (8-12) that deal with residential solid fuel burning appliances. These are: Room heaters. Inset appliances including open fires. […]
On 30 November 2023, the Commission adopted Decision 2023/2683 on the rules regarding recycled plastic content in single use bottles (Recycled Content in Bottles Decision = RCBD). The RCBD implements Directive 2019/904 (Reduction of Impact of Plastic Products Directive = RIPPD). It will enter into force on 4 December 2023. The RCBD lays down the […]
On 18 October 2023, the Medical Device Coordination Group (MDCG), a group composed of representatives of all Member States and chaired by a representative of the European Commission, adopted a Medical Device Software (MDSW) Hardware combinations Guidance. This Guidance is aimed at helping manufacturers of medical software understand how to make products in conformity with […]
On 10 July 2023, the European Commission adopted Regulation (EU) 2023/2197 that modifies Part C of Annex VI to Regulation (EU) 2017/7405 on medical devices by setting new requirements that will equally apply to both (i) standard contact lenses and (ii) made to order contact lenses. These requirements will obligatorily apply as from 9 November 2025, although […]
On 14 September 2023, the European Commission adopted a Decision (2023/6024) which updates the EU’s Ecolabelling Criteria for absorbent hygiene products and menstrual cups. This Decision has been effective since 21 September 2023. It repeals Decision 2014/763 as it introduces new criteria for absorbent hygiene products and reusable menstrual cups, aligning with market trends and […]
On 1 August 2023 the UK Department for Business and Trade announced that the UK government intends to continue to recognise the CE marking across the UK, indefinitely. This means that the UKCA (UK Conformity Assessed) marking on products will not be required from British importers and distributors of EU-made products or of products that bear […]
On 10 October 2022, the European Commission adopted Regulation (EU) 2022/1923, re-authorizing the use of ascorbic acid, sodium ascorbate, and calcium ascorbate—compounds of Vitamin C—as additives for tuna products. An investigation by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated these substances, concluding no safety concerns from their use. […]
