The Rapex System: a tool serving consumers and EU Member States
Rapex Report: Second Half of 2019– The Rapex system – the Rapid Alert System for Non-Food Consumer Products for EU consumers– is a mechanism of the European Commission that enables national authorities in Member States to share information on the recall of consumer products that do not comply with EU safety regulations.
Each member country notifies the products it has withdrawn, in accordance with EU regulations, including basic information such as the product category, the type of item, its trade name, the brand, the country of manufacture, and the reason for the product recall.
The M. Camps Pharmaceutical Technical Consultancy carried out the following throughout 2019 an infographic every week and a blog post every month, which provide details on the number of products recalled in the EU and those notified by the Spanish authorities. And more details on the cosmetics and tattoo inks featured in the report.
Rapex Report – Second Half of 2019
During the second half of 2019, 25 Rapex System reports were published. One was published every Friday, except on 27 December, when no report was published as it was in the middle of the Christmas holiday period.
In these 25 reports, a total of 1,112 alerts of products that are hazardous to consumers (Table 1). All of them, classified on the basis of the consumer category to which the withdrawn articles belong.
These notices cover toys, chemicals, fireworks, electrical appliances, motor vehicles, clothing and accessories, and all kinds of consumer goods (with the exception of the food sector, which is reported through other channels).
The Spanish authorities have still not notified any products to the Rapex system
Unfortunately, we have to inform you that the Spanish authorities have continued with the approach they adopted at the start of 2019, and They have not notified the Rapex system of a single product in the second half of the year.
Based on what we had been seeing between 2015 and early 2019, the Spanish authorities used to regularly issue alerts about dangerous products detected on their market and through border controls. However, halfway through the first half of 2019 – perhaps due to political instability – they stopped notifying the rest of the EU of these products. And we can at least confirm that they had still not published any such alerts by the end of the year.
Let’s hope that by 2020 our country’s authorities will reverse this trend, resume compliance with their EU partners, and participate in the Rapex notifications to ensure the safety of EU consumers.
Products recalled via the Rapex system in the Cosmetics category (official figures)
At GTF M. Camps, we have been holding a weekly infographic with detailed information on recalled cosmetics and, every month, a blog post featuring all the infographics from that month and other relevant information about the bans. So if you’re interested in finding out what types of products have been withdrawn, or the reasons why these items did not comply with the regulations, You can view them here.
Of the 1,112 alerts published by the Rapex system between July and December 2019, 49 of them (Table 2) fell within the Cosmetics category. In the chart below, you can see, by month, the Trends in alerts issued by the Rapex system for the ‘Cosmetics’ category:
Cosmetics recalled across all categories of the RAPEX system (unofficial data compiled by GTF)
Whilst it is true that, generally speaking, cosmetic products are usually notified under the ‘Cosmetics’ category itself, at GTF M. Camps we have noticed that There are a number of products in this sector that are reported under other categories in the Report. And that, therefore, discontinued cosmetics are not officially being taken into account, but rather as Chemicals, Toys o Clothing and Accessories, which are the usual categories for these articles.
For this reason, in the Rapex Report we have carried out our own parallel analysis (Table 3), as a result of the monitoring of alerts carried out by our office. And we have detected a total of 61 cosmetic products withdrawn in the second half of 2019.
Where do all these figures come from in the cosmetics tally?
There are various circumstances that justify the Pharmaceutical Technical Office publishing figures that differ from the official figures for the Rapex Cosmetics Category (which are published by the AEMPS in its cosmetics bulletins).
The most common cases we have encountered are:
- The children's make-up sets, which are often withdrawn in accordance with Regulation 1223/2009 on cosmetic products. It is also common to find toys in this category that use soap, and which are withdrawn because the soap is contaminated with bacteria. However, in this case, they are not classified as cosmetics, as they are not intended for cosmetic use.
- The glue for false nails, which we have seen published over the course of this semester in the cosmetics, chemicals and clothing and accessories categories. There does not appear to be a consensus regarding these products amongst the national authorities in the eurozone.
- The notification of more than one cosmetic product in a single alert. Although, generally speaking, each alert is linked to a specific product, sometimes a recall affects an entire product range, involving the ban not of just one, but of three, five or even eight items (as far as we have seen). And this is not reflected in the official statistics.
However, there is consensus on the reason for the withdrawal:
All cosmetic products withdrawn from the EU market via Rapex alerts were in breach of some provision of Regulation 1223/2009 on cosmetic products.
What are the most common reasons for the recall of a cosmetic product in the RAPEX system?
Alerts regarding cosmetics are always based on non-compliance with the Cosmetic Products Regulation 1223/2009. Each product is usually notified individually, so there is a wide range of reasons for the withdrawal of a cosmetic product.
Generally speaking, the European authorities tend to notify the following types of cosmetic products:
- Soaps and toiletries that could be mistaken for food. The regulations are clear on this point: the Regulation prohibits the manufacture of cosmetics that could be mistaken for foodstuffs. This includes, for example, cupcake-shaped bath bombs, bars of soap modelled on the shape of fruit, or a shower gel which, due to its labelling, a child might mistake for a dairy product.
- Use of MI and MCI preservatives. Preservatives Methylisothiazolinone (MI) y Methylchloroisothiazolinone (MCI) They can cause allergic reactions and skin sensitisation, which is why they are no longer permitted in the manufacture of cosmetics. When the authorities detect the presence of these ingredients on a product’s label, they proceed to withdraw the product from the market and report it to the Rapex system.
- Bacterial contamination. Although manufacturers endeavour to adhere strictly to hygiene measures during the manufacture, packaging and transport of cosmetic products, from time to time a product becomes contaminated with microorganisms and must be withdrawn from the market. In the cosmetics sector, warnings regarding contamination with mesophilic aerobic bacteria are relatively common.
- Declaration of fragrances in the list of ingredients for perfumery products. Perfume products usually contain a type of ingredient known as fragrances. There is an annex on fragrances in Regulation 1223/2009, which specifies which ones are permitted. In this regard, companies appear to be complying with the regulations; no use of unauthorised fragrances has been reported. However, it is also mandatory to list all fragrances in the ingredients list, as some people have allergies or intolerances to certain fragrances, and this information must be available to consumers at all times. And in this regard, the health authorities have indeed detected errors.
- Ingredients that are regarded as medicines. From time to time, reports emerge of cosmetic products being withdrawn from the market because they contain ingredients used in medicine (particularly in the field of ophthalmology), which should only be used under the supervision of a healthcare professional and which therefore do not comply with the Regulation.
Tattoo inks recalled under the Rapex system
Rapex alerts led to a total of 13 tattoo inks being withdrawn from the market in the eurozone during the second half of 2020. Interestingly, all the bans took place in the last two months of the year and during very specific weeks.
Some interesting facts:
- Tattoo inks are regulated by the Resolution ResAP(2008)1 on safety requirements and criteria for tattoos and permanent make-up. It is therefore these regulations that will be used when specifying the grounds for any withdrawal of the product.
- Tattoo inks are listed in the Rapex Report under the section on Chemicals.
- Most of the items withdrawn each year in this category are manufactured by two US companies: Eternal Ink and Intenze. Both manufacturers tend to use aromatic amines in their inks; these are carcinogenic substances and are not permitted by the ResAP(2008)1.
- Of the 1,112 alerts published by the Rapex system between July and December 2019, only 13 of them (Table 4) concerned tattoo inks. Given these figures, it can be said that This type of item has a fairly low incidence.
The impact of cosmetics and tattoo inks on Rapex alerts as a whole
According to official figures from the Rapex system, a total of 1,112 alerts were reported in the second half of 2019. If we break down the alerts by product category, we find the following official data (Table 5):
- 49 product notifications within the Cosmetics category, which represents 4.4% of the total number of items withdrawn.
- 13 notifications concerning tattoo inks, within the chemicals category, which accounts for 0.2% of the total number of items withdrawn.
These percentages are slightly better than those recorded in previous Rapex reports, in which cosmetics accounted for around 5–6% of the total number of alerts.
Rapex Report – Second Half of 2019)
Conclusions
Judging by the data published in this Rapex Report – Second Half of 2019, one can easily draw the conclusion that, for the most part, Cosmetics are very safe products. And not just because we say so, but because the figures back us up.
In the Cosmetics category, only the following have been reported: 5 out of every 100 items withdrawn by the European authorities through the Rapex system. And the percentage is falling. For this reason, we would like to congratulate, firstly, the national authorities, who are responsible for ensuring consumer safety by monitoring compliance with the Cosmetic Products Regulation 1223/2009. And, on the other hand, to the companies in the sector, which make a great effort every day to comply with the regulations.
With regard to the Spanish authorities, we would like to point out that, at some point, they stopped notifying the Rapex system of products. Whilst we understand that the country has faced its own internal challenges – including a change of government and two elections – we believe that National authorities must resume their work on notifying products to the Rapex system, in order to fulfil its responsibilities both towards its own citizens and those of its EU partners.
Finally, we would like to reaffirm the commitment of the Gabinete Técnico Farmacéutico M. Camps with the monitoring and dissemination of data relating to cosmetic products, tattoo inks and, more generally, personal care products. And our commitment to keeping you informed, from 2020 onwards via a monthly article on our blog, regarding the alerts published weekly via the Rapex system.
Choose us for our experience.
M. Camps Pharmaceutical Technical Office, 2020.
Other news about the Rapex System
We hope you enjoyed our Rapex Report – Second Half of 2019.
Would you like to find out more about the Rapex System’s weekly alerts? Have a look! A new report is published every Friday on its website.
Would you prefer to read other articles by GTF M. Camps, featuring summaries of Rapex alerts, on our blog? Here it is!