Many of the products people use every day are made in foreign countries - from coffee makers produced in China to cars built in Germany to cell phones manufactured in India. While many of these products fulfill their purpose without any complications, there are others that cause problems for their users. A coffee maker might spill boiling water or a car’s airbag might not open properly. These problems can be caused by manufacturing errors or flaws in product design.
To remove deficient products from the Internal Market (1) as quickly as possible, or to prevent them from entering the market in the first place, the European Union (EU) established the Rapid Exchange of Information System (RAPEX) in 2004 as its official rapid alert system for unsafe consumer products and consumer protection. RAPEX allows for the quick exchange of information among member states and the European Commission on measures such as product recalls and other corrective actions.
The number of RAPEX notifications related to dangerous products steadily increased for several years. Between 2004 and 2010, the total number of notifications validated by the commission rose more than fourfold from 468 to 2,244. However, in 2011 the number of notifications declined for the first time to 1,083. John Dalli, European Commissioner for Health and Consumer Policy, explained the possible reasons for the decrease in the 2011 report on the operation of RAPEX for non-food dangerous products:
- This decrease, which occurred mainly in the first quarter of the year, may be due, partly, to budget cuts and subsequent resource constraints in the national administrations. The decrease in the number of notifications could also indicate that the RAPEX system has reached a certain level of stability and maturity, and that the more active use of the risk assessment guidelines has led to the streamlining of notifications, with improvements in their quality (2).
Product Safety Guidance
The majority of businesses wish to carry out their activities in a responsible manner, and a number of guides have been developed to support these efforts. One of the most established guides in recent years has been Product Safety in Europe: A Guide to Corrective Action Including Recalls. Published by PROSAFE, a non-profit professional organization, the guide is targeted to market surveillance authorities and officers from across the European Economic Area (EEA), and its primary objective is to improve the safety of products and services for consumers in Europe.
The pace of regulatory developments in Europe requires that this kind of guidance be revised periodically to keep it up to date. PROSAFE has reviewed its guide in the framework of the Enhancing Market Surveillance Through Best Practice (EMARS) II project, which aims to improve market surveillance of non-food consumer products in Europe and to achieve this through the practical application and further fine-tuning of the best practices originally developed by the EMARS I project. One of the project goals is to help market surveillance organizations in EEA member states achieve a basic level of expertise and practical experience.
In November 2011, the Commission published the new Corrective Action Guide: Guidelines for Businesses to Manage Product Recalls & Other Corrective Actions (3). As noted previously, the guide’s purpose is to support businesses when they are facing challenges such as the possibility of a product recall and/or the necessity of other corrective actions. The new guide is aimed particularly at managers with responsibilities for product safety compliance, quality control, legal affairs and public corporate relations.
The primary intent of the guide is to cover corrective actions for consumer products other than food, pharmaceuticals and medical devices. These corrective actions are designed to remove safety risks posed by consumer products and may include:
- Changing the design of products; changing the manufacturing process; changing quality control procedures; withdrawing products from the distribution chain; sending information and warnings about correct use of consumer products; modifying or repairing products at the consumer’s premises or elsewhere; and recalling products from consumers for repair, replacement or refund (4).
Unlike the previous guide, the new version is directly connected to Directive 2001/95/EC of the European Parliament and of the Council of December 3, 2001, on General Product Safety, as well as to the Commission Decision 2010/15/EU that lays down guidelines for managing RAPEX, established under Article 12, and the notification procedure established under Article II of Directive 2001/95/EC (the General Product Safety Directive). This system of cross references not only facilitates the understanding of the guidelines but also strengthens legal certainty.
Furthermore, and maybe most importantly, a new risk assessment method in the guide is directly based on Commission Decision 2010/15/EU. This decision provides guidance for RAPEX procedures that are followed by member states in identifying dangerous products and notifying the European Commission of them as well as instructions on how to undertake a risk assessment. The new method certainly leads to a more accurate result when assessing the risk of products, but at the same time the assessment has become much more challenging.
According to the guide, a risk assessment usually consists of several phases incorporating these principles: identifying the hazard (what is the nature of the hazard, who is affected, which factors could affect the severity and probability of injury) and estimating the level of risk (the severity of possible injury to a person who uses or comes into contact with the product in question and the probability of possible injury). The overall risk may be at one of the following levels: serious risk (requiring immediate action), high risk (requiring rapid action), medium risk (requiring some action) and low risk (not requiring any action).
Whether or not the new guidelines will help with product recalls and other corrective actions will be determined in the future. We already know the guidelines cannot replace companies’ individual action plans because even the most practically oriented and sophisticated guidelines cannot foresee all possible combinations of risks that may occur in reality. However, the revised guide is a real improvement when it comes to accurate risk assessment and legal certainty regarding questions of product recalls and other corrective actions.
1. “Internal Market” refers to the common market of all EU member states.
2. Keeping European Consumers Safe: 2011 Annual Report on the Operation of the Rapid Alert System for Non-Food Dangerous Products (RAPEX).
3. This revision of the original guide published in 2004 was not done by the Commission itself. However, the project received significant financial support from the Commission.
4. Corrective Action Guide: Guidelines for Businesses to Manage Product Recalls & Other Corrective Actions.