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Toy safety regulation

Briefing 09-12-2024

On 28 July 2023, the European Commission adopted a proposal to revise EU toy safety legislation, by introducing a new regulation and repealing Directive 2009/48/EC. The proposal pursues two main objectives: a higher level of child protection, including from the most harmful substances; and fewer non-compliant and unsafe toys on the EU market. In relation to the first objective, the proposal extends the definition of health to children's psychological and mental health and to their wellbeing and cognitive ...

On 13 June 2024, as part of efforts to build a strong European health union, the EU adopted a regulation that updates and expands EU legislation on blood, tissues and cells. The new rules establish high standards of quality and safety for substances of human origin (SoHOs) intended for human application, improve the protection of donors, recipients, and offspring born from medically assisted reproduction, reinforce the principle of voluntary and unpaid donation in the EU, and strengthen the national ...

The current Machinery Directive (Directive 2006/42/EC) was designed to allow the free movement of machinery within the internal market, while ensuring a high level of user health and safety. To reduce the occurrence of accidents, it promotes the inherently safe design and construction of machinery, and proper installation and maintenance. On 21 April 2021, the Commission put forward a proposal for a regulation on machinery products, as part of a wider 'artificial intelligence package'. The need for ...

General product safety regulation

Briefing 08-02-2023

On 28 November 2022, the European Ϸվ and the Council reached a political agreement on the proposal for a general product safety regulation. The co-legislators are now expected to adopt the agreed text formally, to allow the new regulation to come into force. The proposed regulation would replace the current General Product Safety Directive. It seeks to address the product safety challenges of emerging technologies, including use of artificial intelligence (AI) and connected devices, and to ...

Since its adoption, EU legislation on blood, tissues and cells has ensured an upward convergence in the quality and safety of these substances from donation to human application. Following an evaluation of the legislation, shortcomings have become apparent, primarily in light of scientific and technical developments in this area. Socio-demographic trends and new epidemiological risks have further consolidated the view that certain provisions of this legislation need to better reflect the current ...

È in corso il quarto aggiornamento della direttiva sugli agenti cancerogeni e mutageni, che si iscrive nell'ambito della lotta contro il cancro e della tutela della salute dei lavoratori in diversi settori. Un accordo a livello di trilogo sulla proposta stabilisce nuovi limiti di esposizione per una serie di sostanze pericolose. Il Parlamento europeo dovrebbe votare l'accordo provvisorio durante la tornata di febbraio.

La direttiva sulla sicurezza dei giocattoli del 2009 protegge i bambini nell'UE da oltre 10 anni, stabilendo dei criteri tra i più severi al mondo per la conformità dei giocattoli, in particolare per quanto riguarda le sostanze chimiche pericolose. Mentre la Commissione europea si prepara ad aggiornare la direttiva, la commissione per il mercato interno e la protezione dei consumatori del Parlamento europeo ha esaminato l'attuazione della direttiva e proposto modi per modificarla. Il Parlamento prevede ...

This briefing provides an initial analysis of the strengths and weaknesses of the impact assessment (IA) accompanying the Commission proposal for a regulation on general product safety aimed at ensuring that EU consumers are protected from dangerous non-food products. The IA defines clearly the problems to be addressed and their analysis appears to be satisfactory but the description of how they would evolve without any EU intervention is limited. The IA does not compare the retained options in terms ...

The Machinery Directive establishes a regulatory framework for mechanical engineering industry products. It regulates the harmonisation of essential health and safety requirements for machinery in order to ensure the free movement of machinery products within the internal market on the one hand, and a high level of protection for machinery users on the other. The European Commission's Regulatory Fitness and Performance Programme (REFIT) evaluation of 2018 concluded that the directive has generally ...

Revising the Machinery Directive

Briefing 02-07-2021

This briefing checks the quality of the Commission impact assessment (IA) accompanying the regulation proposal on machinery products. It finds that the assessment, which is based on various data sources, is mostly qualitative, and explains openly the analytical methods and data limitations. Furthermore, the scale of all problems and the efficiency aspect in the comparison of the options could have been further explained. The briefing also stresses that the IA could have been more informative in terms ...