Manufacturers and distributors can gain a valuable insight into the current landscape of unsafe product regulation in the EU from the European Commission’s recent publication: “Keeping European Consumers Safe – Rapid Alert System for Dangerous non-food products - 2014."
The European Commission (“the Commission”) has used data from its RAPEX system to build up a picture of current trends. It is via the RAPEX system that the Commission receives notification of unsafe products on the market in the EU. The statistics collated do not cover food, pharmaceuticals or medical devices which are covered by other regulatory regimes.
Several key themes can be drawn from the statistics:
- More unsafe products are being identified in the EU. Unsafe product notifications continue to rise across the EU with Hungary, Germany, Spain, France and Cyprus submitting half of the total notifications. Overall, there was a 3 percent rise in notifications of unsafe products in 2014, up to a total of 2,435. The increase in notifications is not necessarily indicative of there being a continued influx of unsafe products on to the European market, rather it is more likely to be a result of more rigorous quality assurance and post marketing surveillance by manufacturers and distributors and increased activity by regulators and customs authorities. The majority of consumer and professional products (i.e. those not intended to be used by consumers) notified in 2014 were assessed to represent a serious risk (88 percent). The top 5 dangers reported were injuries, chemical risk, choking, electric shock and strangulation.
- Businesses and regulators are becoming more “safety vigilant.” All 31 EU/EFTA countries made notifications of unsafe products to the European Commission in 2014. This suggests that manufacturers and others in the supply chain are becoming ever more aware of—and responsive to—their regulatory obligations. Despite pressure on budgets, regulators also appear to be stepping up efforts to identify unsafe products and ensure appropriate corrective action is taken. The new proposed Consumer Product Safety Regulation may well prompt a rise in the number of unsafe products notified as vigilance levels increase throughout the supply chain.
- Compulsory measures were taken in most cases. Regulatory authorities commonly advocate a voluntary approach in respect of corrective action (e.g. a recall from consumers by the manufacturer). Such an approach often ensures the most effective results. However, in 59 percent of cases in 2014, compulsory measures were taken in respect of unsafe products (such as a ban on sales or withdrawal from the market by the regulators or rejection of an import). Such a high level of compulsory action is surprising given that most responsible manufacturers will prefer to work hand in hand with regulatory authorities in taking corrective action. Interestingly, the country making the most notifications, Hungary, took compulsory action in all but one of the 291 instances that a notification was made. Similarly, Spain and Cyprus, who were also in the top five countries making notifications, predominately took compulsory measures. This suggests that businesses failed to co-operate with the authorities or failed to take measures which the authorities considered appropriate.
- China remains the country of origin of most unsafe products. 64 percent of unsafe products notified to the Commission in 2014 originated from China. This number is steadily increasing (up from 38 percent in 2004). The continued increase in unsafe products of Chinese origin demonstrates that, in addition to current initiatives (such as “RAPEX China”), more work needs to be undertaken with the Chinese product safety regulator, AQSIQ, to prevent unsafe products being designed, manufactured and exported for sale in the EU. Conversely, the number of unsafe products of EU/EFTA origin has continued to decrease over the past decade, from 27 percent in 2004 to 14 percent in 2014. This suggests that good manufacturing processes, including quality control and post market vigilance, are being increasingly adhered to across the EU.
- Toys are the most commonly notified unsafe consumer product. Toys represented the most commonly notified unsafe product in 2014 (28 percent of notifications), followed by clothing, textiles and fashion items (23 percent), electrical appliances and equipment (9 percent), motor vehicles (8 percent) and childcare articles and children’s equipment (3 percent). It is not surprising that toys and children’s equipment are in the highest categories of notified products, not least due to the vulnerability of the intended user group and the potential for extreme damage to a manufacturer’s brand reputation should an unsafe product cause injury. Clothing, textiles and fashion items continue to attract a high number of notifications. This is primarily as a result of the joint market surveillance action on drawstrings and cords in children’s clothing and the continuing impact of the ban on using DMF (an anti-mould chemical) on clothing and textiles.
- Motor vehicles are the most commonly notified unsafe professional product. Motor vehicles represented the largest category of notified professional products, followed by machinery, chemical products and electrical appliances. Germany made the most notifications, which is expected due to the concentration of the motor industry in the region.
- Traceability remains a challenge. There continue to be instances in which unsafe products fail to bear the details of their brand and/or the model (despite mandatory requirements to do so). In 2014, there were 2,341 instances in which the brand and/or model were unknown. In 90 cases, neither the brand nor model could be identified. This causes problems for consumers, regulators and even the manufacturers themselves. In circumstances where the brand and model are unknown, consumers cannot identify the manufacturer quickly and easily, regulators cannot ensure that the appropriate corrective action is taken or that no further unsafe products are placed on the market and manufacturers find it difficult to trace end-users or to properly publicise corrective action. Furthermore, even if a product’s brand is known, failure by a manufacturer to include model, serial or batch number on the product makes it difficult for them to later identify which cohort of products may be affected or where they have been distributed. The proposals in the new Product Safety and Market Surveillance Package may go some way to address these continued shortcomings, albeit that traceability is likely to remain a continuing challenge.
The 2014 RAPEX statistics demonstrate that an increasing number of unsafe products are being identified across the EU and that regulators are not shying away from taking compulsory measures to ensure that appropriate corrective action is taken. Challenges with products of Chinese origin are ongoing and likely to continue given the volume and breadth of exports to the EU. Continued work with the Chinese authorities and the implementation of the proposed Product Safety and Market Surveillance Package are likely to have a positive impact on the overall number of incidents involving unsafe products, albeit that a wholesale reversal of the current trends is unlikely to be witnessed in the short term.