Slide background
Slide background




EU general risk assessment methodology

ID 2359 | | Visite: 11747 | Documenti Marcatura CE UEPermalink: https://www.certifico.com/id/2359



EU general risk assessment methodology

This EU general risk assessment methodology implements Article 20 of Regulation (EC) No 765/2008.

This provision obliges Member States to ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22.

Article 20 specifies that the decision whether or not a product represents a serious risk must ‘be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence’.

Therefore the objective of this methodology is to provide guidance to authorities on when rapid intervention is needed, whether a RAPEX notification should be made and on which measures to take in relation to the non-conformity of a product (proportionality).

The methodology builds on the RAPEX Guidelines, developed within the framework of the Directive on General Product Safety (GPSD) and extends them in two respects:

1) to make sure that the broader categories of public risk protected under EU harmonization legislation can be taken into account (see section 2.2 below);
2) to reflect the specific legal requirements on harmonised products (see sections 3.1 and 3.2).

In particular the risk assessment of a harmonised product does not replace the evaluation of the compliance of the product with the requirements laid down in EU legislation and the relevant harmonised standards. Product compliance or non-compliance remains the basis on which authorities decide whether corrective action is needed.

The risk assessment of a harmonised product complements the product compliance evaluation, as it allows the assessment of how serious the possible consequences of non-compliance could be. It therefore helps to determine the most appropriate type of follow up (rapid intervention, RAPEX notification, proportionate corrective action). More details on possible corrective action depending on the level of risk are given in section 4.

The risk assessment of a harmonised product is inherently linked to the evaluation of its compliance with legal requirements.

The application of this methodology does not entitle risk assessors to make abstraction of or freely interpret the applicable legal requirements and standards, which reflect the choice of the EU legislator as to the acceptable level of product risk. The application of the proposed methodology also adds transparency to the authority’s decisions. An economic operator may be able to better understand an authority’s risk management decision if he is able to understand the risk assessment considerations made by the authority.

This methodology is intended to assist market surveillance authorities when they assess the compliance of products that are subject to Union harmonization legislation.

1. PURPOSE AND SCOPE OF APPLICATION OF THE METHODOLOGY
2. BASIC PRINCIPLES FOR A GENERAL RISK ASSESSMENT METHODOLOGY
2.1. Terminology
2.2. A generalisation of existing methodologies beyond health and safety
2.3. The relevant phases of risk assessment
3. RISK ASSESSMENT PROCESS
3.1. Step 1: Defining the Product
3.2. Step 2: Identifying the hazard(s)
3.3. Step 3: Identifying the subject at risk
3.4. Step 4: Describing how the hazard may harm the subject, i.e. the relevant harm scenario
3.5. Step 5: Determining the potential harm
3.6. Step 6: Determining the severity of harm
3.7. Step 7: Determining the probability of harm
3.8. Step 8: Determining the risk level by combining the severity of harm and the probability of that harm occurring in the scenario described
3.9. Uncertainty concerning risk assessment
4. FROM RISK TO ACTION

European Commission 2016

Regolamento (CE) N. 765/2008

Descrizione Livello Dimensione Downloads
Allegato riservato EU general risk assessment methodology.pdf
European Commission 2016
1011 kB 303

Tags: Marcatura CE Nuovo approccio Abbonati Marcatura CE

Ultimi archiviati Marcatura CE

Feb 29, 2024 135

Regolamento di esecuzione (UE) 2020/1668

Regolamento di esecuzione (UE) 2020/1668 ID 21443 | 29.02.2024 Regolamento di esecuzione (UE) 2020/1668 della Commissione del 10 novembre 2020 che specifica i dettagli e le funzionalità del sistema di informazione e comunicazione da utilizzare ai fini del regolamento (UE) 2019/515 del Parlamento… Leggi tutto
Marking of Cranes  Hooks   Hook Blocks considering European Legislation
Feb 24, 2024 312

Marking of Cranes, Hooks and Hook Blocks considering European Legislation

Marking of Cranes, Hooks and Hook Blocks considering European Legislation / FEM 2022 ID 21424 | 24.02.2024 / Document FEM CLE N 0371 Frankfurt, 24.03.2022 FEM CLE: Marking of Cranes, Hooks and Hook Blocks considering European Legislation This position paper aims to provide guidance on how to… Leggi tutto
Feb 15, 2024 172

Regolamento delegato (UE) 2015/1187

Regolamento delegato (UE) 2015/1187 ID 21364 | 15.02.2024 Regolamento delegato (UE) 2015/1187 della Commissione, del 27 aprile 2015, che integra la direttiva 2010/30/UE per quanto riguarda l'etichettatura energetica delle caldaie a combustibile solido e degli insiemi di caldaia a combustibile… Leggi tutto
Decreto 13 dicembre 2023 n  227
Feb 06, 2024 1015

Decreto 13 dicembre 2023 n. 227

Decreto 13 dicembre 2023 n. 227 ID 21305 | 06.02.2024 Decreto 13 dicembre 2023 n. 227 - Regolamento recante modifica al decreto 10 maggio 2005, n. 121, concernente l'istituzione e la disciplina dei titoli professionali del diporto. (GU n.29 del 05.02.2024) Entrata in vigore del provvedimento:… Leggi tutto

Più letti Marcatura CE

Set 04, 2022 105215

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) (GU L 88/10… Leggi tutto