Commission Implementing Decision (EU) 2019/417Show full title

1. Introduction U.K.

Consumer products may cause harm when used, e.g. a hot flat-iron that can cause burns, scissors or knives that can cause cuts, or a household cleaner that can damage the skin. This kind of damage is not a usual occurrence because general knowledge or instructions teach how to use consumer products safely. Nevertheless, the risk of damage remains.

This risk can be assessed in different ways. A range of methods have been used to quantify risk for consumer products, such as a nomograph method(2), a matrix method(3), and the method previously recommended for the EU's RAPEX rapid alert system(4). While the general principles for risk assessment have always been agreed, how to quantify risks has been under permanent development. This has led to diverging results and ensuing discussions, as well as to consideration of what the best possible practice might be.

The purpose of these risk assessment guidelines is therefore to improve the situation and, within the framework of the Directive on General Product Safety(5), to provide a transparent and practicable method for appropriate use by Member States' competent authorities when they assess the risks of non-food consumer products. These guidelines are based on a risk assessment method developed for other purposes, adapted to the specific requirements of non-food consumer products.

A certain amount of training will of course be needed before these guidelines can be put into practice, but expertise in risk assessment will greatly facilitate this task. This will be backed by exchanges of views between risk assessors, since expertise and experience accumulated through the years is invaluable.

In building up a risk assessment method in small, manageable steps, these guidelines help to focus on the relevant issues of a product, its user(s) and its use(s), and to identify possible divergences of views between risk assessors from the onset, thus avoiding time-consuming discussions. They should thus lead to consistent and robust risk assessment results based on evidence and science, and consequently to widely acceptable consensus on the risks that the many non-food consumer products may present.

A quick overview and a flow chart on how to prepare a risk assessment pursuant to these guidelines is provided in section 5 — ‘Consumer products’ mean non-food consumer products throughout these guidelines.

These guidelines do not set out to replace other guidelines that may address very specific products or may be specifically provided for in legislation, such as in the area of chemicals, cosmetics, pharmaceuticals or medical devices. It is highly recommended to use this specific guidance, since it is tailor-made, but it will always be for the risk assessor to decide how best to assess the risks of a product.

Nor are these guidelines to be used by manufacturers ‘just to avoid serious risks’ when designing and manufacturing products. Consumer products have to be safe, and these guidelines aim at helping authorities to identify serious risks when, despite the best efforts of the manufacturer, a product is not safe.

(1)

If you need more information on the Risk Assessment method for harmonised products (both consumer and professional products) in relation to broader categories of public risks protected under EU harmonisation legislation, please refer to Part I, Chapter 5.3.

(2)

Benis HG (1990): A Product Risk Assessment Nomograph, report prepared for the New Zealand Ministry of Consumer Affairs, dated February 1990. Cited in: European Commission (2005) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices. Report prepared by Risk & Policy Analysts (RPA), Loddon, Norfolk, UK.

(3)

Method used by the Belgian authorities. Cited in: European Commission (2005) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices. Report prepared by Risk & Policy Analysts (RPA), Loddon, Norfolk, UK.

(4)

Commission Decision 2004/418/EC of 29 April 2004 laying down guidelines for the management of the EU Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC (OJ L 151, 30.4.2004, p. 83).

(5)

Directive 2001/95/EC.