Slide background
Slide background




EU general risk assessment methodology

ID 2359 | | Visite: 11096 | 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risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22.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

Decisione di esecuzione UE 2023 1096
Giu 06, 2023 47

Decisione di esecuzione (UE) 2023/1096

Decisione di esecuzione (UE) 2023/1096 / Incidenti connessi all'uso di articoli pirotecnici ID 19749 | 06.06.2023 Decisione di esecuzione (UE) 2023/1096 della Commissione del 2 giugno 2023 recante modalità di applicazione della direttiva 2013/29/UE del Parlamento europeo e del Consiglio per quanto… Leggi tutto
Mag 24, 2023 100

Regolamento delegato (UE) 2023/807

Regolamento delegato (UE) 2023/807 ID 19674 | 24.05.2023 Regolamento delegato (UE) 2023/807 della Commissione del 15 dicembre 2022 che rivede il fattore di energia primaria per l’energia elettrica in applicazione della direttiva 2012/27/UE del Parlamento europeo e del Consiglio GU L 101/16 del… Leggi tutto
Decisione di esecuzione  UE  2023 975
Mag 17, 2023 140

Decisione di esecuzione (UE) 2023/975

in RAPEX
Decisione di esecuzione (UE) 2023/975 / Modifiche Linee guida RAPEX ID 19640 | 17.05.2023 Decisione di esecuzione (UE) 2023/975 della Commissione del 15 maggio 2023 che modifica la decisione di esecuzione (UE) 2019/417 della Commissione recante linee guida per la gestione del sistema d’informazione… Leggi tutto

Più letti Marcatura CE