In November, 388 dangerous products were reported in the EU’s Safety Gate. This information portal, formerly known as the RAPEX system, is used by market surveillance authorities in the Member States to exchange information on dangerous products.
As soon as a country recognises and reports dangerous products, the authorities of other countries often react with similar measures, such as sales bans or product recalls for the affected articles.
With 157 dangerous products, more than 40% came from the cosmetics sector, followed by toys, baby products, electronic products and jewellery. The European market surveillance authorities issued a product recall for almost one in three of the products that were the subject of a complaint, and for baby products the figure was as high as 44%.
123 hazardous products originated from the People’s Republic of China, 89 products were sold online. Due to the high proportion of dangerous cosmetics, most reports once again came from Italy (120 reports). Many products were also reported by France (45 reports), Germany (41), Hungary (40) and Sweden (38).
According to an Allianz study, recall costs for electrical appliances or toys can amount to between 650,000 and 1,000,000 euros. These considerable financial burdens are often supplemented by additional costs for product changes, adjustments to packaging design or contractual penalties to customers.
Even for medium-sized deliveries, sales bans, import bans or import delays can quickly cause sales losses totalling several hundred thousand euros. In addition, there is a risk of lasting damage to the reputation of manufacturers, importers or retailers, which can have a long-term negative impact on business and market position.
Professional compliance management creates trust with customers and partners and strengthens a company’s market position. We recommend investing in compliance strategies at an early stage in order to protect yourself from legal consequences, financial losses and reputational damage in the long term.
A risk analysis of the products and comprehensive documentation are essential. They not only serve as proof of compliance with legal requirements, but are also mandatory for almost all products under the new Product Safety Regulation from 13 December 2024.
As in many previous months, cosmetics again had by far the highest proportion of hazardous products. A total of 157 products had to be withdrawn from the market by manufacturers, importers or retailers, and 32 even had to be recalled by end consumers. According to the list of ingredients, 140 cosmetic products contained 2-(4-tert-butylbenzyl)propionaldehyde (BMHCA), which is banned in cosmetic products. BMHCA can damage the reproductive system, harm the health of the unborn child and cause skin sensitisation.
Three other products contained hydroxyisohexyl-3-cyclohexene carboxaldehyde (HICC), which is also banned in cosmetic products. HICC can cause an allergic skin reaction. Four other products were microbiologically contaminated with Pseudomonas aeruginosa. If the products are used on damaged skin or if they come into contact with the eyes, infections or irritations can be caused.
For three bath milk products from the UK, there was a risk that they could be mistaken for food due to their characteristic appearance, shape, colour and size. Ingestion could lead to aspiration pneumonia. The products did not comply with the Cosmetics Regulation and the requirements of the Food Counterfeiting Directive and were banned from sale by the Estonian authorities
Fig. 1: Bath milk with risk of confusion
Source: European Commission, https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10092255, date: 14.12.2024, language: German
With 34 products reported, a relatively large number of baby articles and children’s products were affected in November. 25 products harboured the risk of suffocation or strangulation, 9 harboured other risks of injury. 15 products had to be recalled by end consumers.
Most of the dangerous products came from China (9 products), Lithuania (5 products) and Poland (5 products), and were mainly reported by the Finnish (10 reports), Bulgarian (8 reports), Slovakian (7 reports) and Estonian market surveillance authorities (5 reports)
The category of dummies and dummy holders was one of the most frequently reported. A total of 12 products from 9 different countries were criticised here. In almost all products, small parts could come loose or the product could break, which could also lead to small parts. Small children can put them in their mouths and choke. In addition, the chain between the dummy and the dummy holder was too long on some products, which could lead to strangulation.
The products violated the requirements of the General Product Safety Directive and the European standards EN 12586, EN 1400 or EN71-1. Six products must be recalled by end consumers.
Fig. 2: Dangerous dummy holder
Source: European Commission, https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10092091, Date: 4.12.2024, Language: German
he Slovakian market supervisory authority reported 7 out of 8 dangerous children’s beds, most of which posed a risk of entrapment, suffocation or strangulation. In one bed from Poland, the strength of the locking system of the movable side panel was insufficient. In addition, the distance between the attachment points and the top of the cot was insufficient. The child could easily climb out of the bed, which led to falls and injuries.
The pillars on the side of the bed could also easily break, resulting in larger gaps in which the child’s limbs or head could become trapped, leading to injury or strangulation.
The product did not meet the requirements of the General Product Safety Directive or the European standard EN 716-1 and must be recalled by end users.
Fig. 3: Baby cot with various injury risks
Source: European Commission, https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10092051, date: 4.12.2024, language: German
In a bed from Latvia, the attachment points of the cot protruded. Cords (from clothing or a dummy holder) could wrap around the attachment point and lead to strangulation. This bed was also not in compliance with the requirements of the General Product Safety Directive and the European standard EN 716-1. The bed must be recalled by end users and customers must be warned.
Fig. 4: Baby cot with risk of strangulation
Source: European Commission, https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10092025, date: 4.12.2024, language: German
Bulgaria and Lithuania reported a total of 4 highchairs that were also categorised as dangerous. The products, all from China, lacked active restraint systems and/or were not sufficiently stable. Children could fall and suffer injuries.
The products violated the requirements of the General Product Safety Directive and the European standard EN 14988 and must be withdrawn from the market by the importer, distributor or retailer.
Fig. 5: Unstable high chair for children
Source: European Commission, https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10092146?lang=de, Date: 4.12.2024, Language: German
The French market surveillance authorities found in 5 different necklaces for children that in some products the necklace did not open. The necklace could therefore wrap around the child’s neck, which could lead to strangulation. In addition, the products could break easily, resulting in small pieces (the beads). A small child could put them in the mouth and choke.
The products from Lithuania, which were mainly sold on Ebay and AliExpress, did not meet the requirements of the General Product Safety Directive or the European standard EN 71-1. The listing must be terminated and consumers warned.
Fig. 6: Necklaces sold online
Source: European Commission, https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10084613?lang=de, date: 4.12.2024, language: German
Do you sell baby products or children’s products?
How sure are you that all the risks of your products are fully considered?
How do you ensure that you know and comply with current standards?
Have you prepared a risk analysis for all your products that you could make available to authorities on request?
Are all your suppliers familiar with the requirements of the REACH or POP Regulation and the relevant harmonised European standards?
Do you have complete technical documentation for all your products, as required by the new Product Safety Regulation?
Do you have meaningful tests and documents from your suppliers regarding the chemical and electrical components of your products?
How well are you prepared for a product recall and do you have a product recall management system in place?
If you see a need for action here, we will be happy to assist you in identifying potential risks and avoiding additional costs due to dangerous products.
We support you in setting up a suitable risk management system and guide you through the conformity assessment process, including the preparation of technical documentation, risk analyses and EU declarations of conformity.