Recall process from
                                  A to Z: 
                                  Guidance for economic 
                                  operators and market 
                                  surveillance authorities
                                  Date 22/07/2021
        Contents
        Why this guide?...................................................................................................................................2
        1. Legal framework on recalls..............................................................................................................3
         What is a recall?...............................................................................................................................3
          Types of recall...............................................................................................................................3
          Recall versus market withdrawal and other corrective actions......................................................3
         Overview of the main EU legal acts relevant to recalls.....................................................................3
         Roles and responsibilities of different actors in the recall process....................................................4
          Economic operators.......................................................................................................................4
          Market surveillance authorities......................................................................................................5
          European Commission...................................................................................................................5
        2. Recall process from the point of view of economic operators...........................................................6
         Schematic overview of the recall process: process flowchart............................................................6
         Detailed overview of the recall process............................................................................................7
          Being ready for a recall.................................................................................................................7
          Performing a recall......................................................................................................................12
        3. Recall process from the point of view of MSAs...............................................................................24
         Schematic overview of the recall process: process flowchart..........................................................24
         Detailed overview of the recall process from the point of view of MSAs..........................................25
          Key steps in the recall process....................................................................................................25
          Supporting economic operators...................................................................................................30
        4. Appendices....................................................................................................................................32
         4.1 List of national MSAs................................................................................................................32
         4.2 Overview of national guidance documents for product recalls..................................................32
         4.3 Overview of recall databases and portals of recalled products.................................................33
         4.4 Interesting links / further reading.............................................................................................34
         4.5 Economic operator checklist for recalls.....................................................................................35
        #EUCASP2020                                       1
                                 EU CASP 2020
                                 Activity: Recall effectiveness
                                 Recall process from A-Z
                                 Date 22/07/2021
                Why this guide?
                Product recalls are important for protecting consumers from dangerous products and may even save
                lives. Recalls are one of the most common measures to mitigate the risks posed by dangerous
                products that have already been supplied to consumers. Among the over 2,000 alerts on dangerous
                products exchanged each year through the EU’s Rapid alert system for dangerous non-food products1
                (Safety Gate / RAPEX), about half concern recalling products from consumers. 
                While response rates vary considerably, depending on factors such as the channel of sale and
                product category, the proportion of products successfully recovered from consumers remains
                generally low. This is because consumers either are not aware that a product they own is being
                recalled, or fail to react when seeing a recall announcement.  
                No company likes to take corrective measures, but when a safety problem makes a product recall
                necessary to prevent injuries and save lives, it benefits both economic operators and consumers to
                move quickly and effectively. Evidence suggests that consumers’ trust in companies can actually
                increase as a result of a well-managed recall.
                The purpose of this document is to provide guidance to both economic operators and market
                surveillance authorities (MSAs) on all aspects of a recall process.
                The recommendations provided in this guide are meant to complement the requirements under EU
                legislation, and do not in themselves constitute legally binding obligations. The guide applies to all
                                                 2                                                                      3
                non-food consumer products , as defined in the General Product Safety Directive (GPSD) , without
                prejudice to any product-specific requirements or guidance. 
                                                                                             4
                This guide has been developed in cooperation with European MSAs  and the European Commission’s
                Directorate-General for Justice and Consumers in the framework of 2020 Coordinated Activities for
                                                   5
                the Safety of Products (CASP) . It is intended as a working document that could be updated in the
                future on the basis of new trends and evidence. 
                The guide covers: 
                        Legal framework on recalls, including definitions, overview of the main legal acts and roles
                         and responsibilities of different actors in the recall process;
                        Recall process from the point of view of economic operators;
                        Recall process from the point of view of MSAs.
                1 https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rape
                    x/index_en.htm 
                2 Sector specific recall requirements or guidance may be developed for harmonised products in the future.
                3 Under Art. 2(a) of the GPSD, consumer products are products intended or likely, under reasonably foreseeable
                conditions, to be used by consumers even if not intended for them and supplied or made available in the course
                of a commercial activity (with the exception of second-hand products supplied as antiques or as products to be
                repaired or reconditioned prior to being used). The definition does not cover food, medical devices and
                pharmaceuticals. https://ec.europa.eu/info/general-product-safety-directive_en
                4 Developed in cooperation with MSAs from Austria, Bulgaria, Croatia, the Czech Republic, France, Germany,
                Iceland, Malta, Spain and Sweden.
                5 https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=casp:2020&lng=en 
                #EUCASP2020                                                                                                    2
                1. Legal framework on recalls
                What is a recall?
                                                                                                         6
                A recall is any measure aimed at achieving the return of a dangerous product  that is already in the
                                                            7
                hands of consumers or other end users . 
                Types of recall 
                Recalls may be undertaken directly by economic operators on a voluntary basis, often as a result of
                guidance and suggestions provided by MSAs. When the MSA orders the economic operator to initiate
                a recall, this is considered to be a ‘mandatory recall’. 
                In exceptional situations where there may be no other workable option to prevent the risks involved
                (e.g., when the economic operator cannot be identified or fails to act), the MSA may need to carry
                out corrective action themselves including recalling the product. 
                Recall versus market withdrawal and other corrective actions
                While a recall aims at achieving the return of a dangerous product from end users, a withdrawal is
                any measure aimed at preventing a product in the supply chain from being made available on the
                        8
                market .
                Besides a recall and a withdrawal, other corrective actions can also be taken by economic operators
                or ordered by authorities. These include among other: 
                        Marking a product that poses risks in certain conditions with suitable warnings;
                        Making the marketing of a product subject to prior conditions in order to make it safe;
                        Completely banning the marketing of a product;
                        Destroying a product;
                        Technically repairing/amending the product.
                Overview of the main EU legal acts relevant to recalls
                General Product Safety Directive (2001/95/EC)
                The key legislation at the EU level is the General Product Safety Directive (GPSD) 2001/95/EC.
                In relation to product recalls, the GPSD sets out the obligations of producers and distributors, the
                obligations and powers of the Member States and the system for rapid exchange of information (see
                section 1.3). These requirements apply to non-harmonised consumer products as well as to products
                                                        9
                covered by harmonised legislation , if this legislation does not already contain provisions with the
                same objective.
                Regulation (EU) 2019/1020 on market surveillance and compliance of products
                This regulation sets out market surveillance rules for harmonised products, i.e., products belonging
                to sectors subject to common rules across the EU, such as toys, electrical appliances or protective
                personal equipment. It provides for the powers of MSAs, which include the power to order that the
                product is withdrawn or recalled, and the power to remove content from an online interface where no
                other effective means are available to eliminate a serious risk.
                E-commerce Directive (2000/31/EC)
                6 A dangerous product refers to any product which, under normal conditions of use including duration, putting
                into service, installation and maintenance requirements, presents a risk for the safety and health of persons. The
                RAPEX guidelines set out the framework for assessing the risk linked to a product. The risk-assessment tool can
                be found via https://ec.europa.eu/consumers/consumer-safety/rag/#/screen/home.
                7 As per Articles 2(g) of the General Product Safety Directive 2001/95/EC (GPSD) and 3(22) of Regulation (EU)
                2019/1020.
                8 As per Articles 2(h) of the General Product Safety Directive 2001/95/EC (GPSD) and 3(23) of Regulation (EU)
                2019/1020.
                9  Harmonised sectors are subject to common rules across the EU (https://ec.europa.eu/growth/single-
                market/goods/free-movement-sectors_en).
                #EUCASP2020                                                                                                    3