The new GPSR for manufacturers and sellers on Amazon (help with Regulation 2023/988/EC – template for safety information)
The new GPSR brings numerous new obligations for Amazon sellers and manufacturers. Below is a rough overview of the new requirements from Regulation 2023/988.
The GPSR will apply directly in all member states from December 13, 2024 for products placed on the market from December 13, 2024. All products placed on the market before this date will still be subject to the previously applicable provisions after December 13, 2024. It would therefore be inadmissible for Amazon to deactivate offers for FBA inventory delivered before December 13, 2024.
Nevertheless, Amazon is already asking all sellers to ensure that all compliance requirements are met.
The GPSR relies on a simple but effective security requirement in Art. 5 GPSR.
Economic operators shall place or make available on the market only safe products.
Art. 5 Regulation 2023/988
Fortunately, the GPSR also contains a small simplification and presumption of safety: If products comply with European standards, it is presumed under Art. 7 of the GPSR that the product is safe. It is therefore advisable to comply with the relevant standards when manufacturing products.
The GPSR replaces Directive 2001/95/EC and also to a large extent the national Product Safety Act. However, the requirements of the GPSR can also lead to additions for CE products, for example.
There are no exceptions for small companies, as the GPSR is about consumer protection through product safety. The GPSR therefore applies to all consumer products within the meaning of Art. 3 No. 1 GPSR. Anything that a consumer could even remotely use is a “consumer product”.
The GPSR only applies subordinately if there are already legal provisions for the harmonization of the products concerned (example: CE products).
Other legal provisions such as the REACH Regulation remain valid even with the GPSR and must be observed in parallel.
Particular problems arise with products that could be used for several purposes. Here, a product dedication and corresponding warnings must ensure that the products are only used by consumers for their intended purpose.
For example, it is advisable to sell a nylon rope not as a nylon rope, but as a laundry rope or household rope (= product dedication) so that it is not mistakenly used by the consumer as a climbing rope.
An additional or new certificate of conformity for the GPSR – such as for CE products – is not required. Nevertheless, a certificate of conformity is still required for CE products.
The new main obligations for manufacturers and sellers on Amazon are
- internal risk analysis
- Electronic address
- Reporting obligations
- Manufacturer marking and EU economic operator marking
- Identification labeling
- Warnings or safety information (see Art. 9 para. 7 GPSR)
- Regulation of safety warnings and product recalls
internal risk analysis
Manufacturers are generally obliged to carry out an internal risk analysis. Although no specific form or template is required, the risk analysis must include at least a general technical description of the product and its properties as well as all safety-relevant properties and risks.
Trivial products are, for example, handkerchiefs. A description as mentioned above is sufficient here.
If risks are present, it must also be described how the identified risks are dealt with or how they can be mitigated. As part of this extended documentation obligation (in the case of risks), all test reports for the product must also be included in the documentation. All European standards and legal regulations to be observed must also be included.
The internal risk analysis must be handed over to the market surveillance authorities on request and does not have to be included in the public manual.
When assessing safety, Art. 6 GPSR must be observed.
Electronic address
The obligations for CE products already included a manufacturer’s label in the past; the GPSR extends this obligation to an electronic address. This electronic address should be affixed to the packaging and also be available before purchase. An electronic address can be an e-mail address, for example, but not an Internet address without a contact form.
The electronic address does not have to be permanently linked to the product (as is the case with trade names for CE products).
Notification obligations
At the same time as Art. 20 GPSR, the GPSR introduces extensive reporting obligations for manufacturers if accidents have occurred during the use of products that have caused death or damage to health.
The notification must include the type of product, the identification number and the circumstances of the accident and must be made immediately. The report is sent to the Safety Business Gateway.
Dealers and importers are obliged to report such accidents to manufacturers. However, the report is made by the manufacturer, unless the manufacturer instructs the dealer to make this report.
Manufacturer labeling and EU economic operator labeling
In online trading, a manufacturer’s label consisting of the name, trade name or registered trademark including a postal address and an electronic address of the manufacturer is also required.
For manufacturers and distributors outside the EU, an EU economic operator mark is also required.
Identification marking
All products must be clearly identifiable. This must be ensured, for example, by means of an article number such as the GTIN and an image of the product. Other product identifiers such as the batch number can and should also be used in individual cases.
Warnings or safety information
The previously conducted risk analysis usually results in automatically determined risks. According to the GPSR, these risks must be mitigated accordingly. This is done by means of warnings and/or safety information in the national language. The information must be easy to understand and should be supported by pictograms.
Important: The information must be made available before purchase. Provision after purchase (e.g. printed on the packaging) is also necessary but not sufficient in online trading/distance selling.
General information on the homepage or in hidden places is also not sufficient. The information must be provided clearly and unambiguously with every offer. However, 10 A4 pages of safety information do not have to be displayed immediately. A clearly visible and clear reference to this information (supported by pictograms), e.g. in a PDF file with all the information, should be sufficient.
Product recall and consumer rights in the event of a recall
The GPSR now stipulates in Art. 36, 37 GPSR how a product recall and safety warnings for products already placed on the market must be carried out.
Practical consequences for Amazon sellers/manufacturers
If products with their own brand are sold on Amazon, the seller is a so-called “quasi-manufacturer” and is treated as a manufacturer (as before).
In practice, an internal risk analysis with comprehensive technical documentation must now be carried out for all products. A product manual with safety instructions can then be created for the public from the knowledge gained here.
The document must be written in the respective national language or multilingual and should also contain a description of the product, the intended use (not mandatory), instructions for use, risks, warnings and manufacturer and contact information. It should – even if not explicitly required – indicate where future updates of the document will be available.
Stating the intended use is my personal recommendation. This creates additional clarity for products that could be used for different purposes or simply misused.
It is advisable to create a template for a user manual with safety information. This could be done in several languages, e.g. with the help of a glossary. Such an approach is common for European civil status documents and multilingual EU forms (translation aids), for example.
Aspects for assessing the safety of products
Art. 6 of the GPSR stipulates which aspects are generally required when assessing product safety.
the characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance;
Art. 6 para. 1 lit. a) GPSR
In principle, all characteristics and features of a product, including its packaging, must be carefully considered in a risk analysis.
It can be seen here that the design of the user manuals and safety instructions themselves can have an influence on the safety of the product. Therefore, an unsafe product can be made safe again by providing correct safety instructions.
the effect on other products, where it is reasonably foreseeable that the product will be used with other products, including the interconnection of those products;
Art. 6 para. 1 lit. b) GPSR
It is reasonably foreseeable, for example, that the nylon rope described above could be used for other purposes such as climbing or securing loads. Connecting numerous extension cords would also be reasonably foreseeable and could pose a safety risk.
the effect that other products might have on the product to be assessed, where it is reasonably foreseeable that other products will be used with that product, including the effect of non-embedded items that are meant to determine, change or complete the way the product to be assessed works, which has to be taken into consideration when assessing the safety of the product to be assessed;
Art. 6 para. 1 lit. c) GPSR
The use of a multiple socket outlet in combination with a washing machine could be such a possible effect on the product “multiple socket outlet”, as the permissible load could easily be exceeded here.
the presentation of the product, the labelling, including the labelling regarding age suitability for children, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product;
Art. 6 para. 1 lit. d) GPSR
It is clear from this provision that the GPSR extends the obligations arising from the Toys Directive 2009/48/EC. It is also clear that the disposal of the products may also pose a safety risk that needs to be assessed.
the categories of consumers using the product, in particular by assessing the risk for vulnerable consumers such as children, older people and persons with disabilities, as well as the impact of gender differences on health and safety;
Art. 6 para. 1 lit. e) GPSR
Different categories of consumers or groups of people who are likely to use the product have different levels of education and other different characteristics. For example, children are often at risk of putting the products in their mouths. There is not only a risk from swallowing, but also from the chemicals used. A commercially available button cell, for example, can cause severe internal burns.
the appearance of the product where it is likely to lead consumers to use the product in a way different to what it was designed for, and in particular:
Art. 6 para. 1 lit. f) GPSR
It should be noted here that the legislator could have included this sub-item in one point but preferred to split it into three sub-items in order to emphasize the special risks within the GPSR once again. There is always a risk that consumers will use products for a different purpose. This is all the more the case if, for example, images or advertising texts are used that suggest a different intended use.
where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics and might therefore be placed in the mouth, sucked or ingested by consumers, especially by children;
Art. 6 para. 1 lit. i) GPSR
This refers in particular to risks where children could confuse products such as red decorative glass stones with foods such as sweets.
where a product, although neither designed nor intended for use by children, is likely to be used by children or resembles an object commonly recognised as appealing to or intended for use by children because of its design, packaging or characteristics;
Art. 6 para. 1 lit. ii) GPSR
Decorative material for an aquarium, for example, could also fall under this regulation
when required by the nature of the product, the appropriate cybersecurity features necessary to protect the product against external influences, including malicious third parties, where such an influence might have an impact on the safety of the product, including the possible loss of interconnection;
Art. 6 para. 1 lit. g) GPSR
This is particularly the case for smart products with control units (e.g. for heaters) or products with cameras/microphones. Pure software products are not covered by the GPSR.
when required by the nature of the product, the evolving, learning and predictive functionalities of the product.
Art. 6 para. 1 lit. h) GPSR
This could include, for example, a heat detector which, unlike a smoke detector, would not detect a smouldering fire.
The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be a dangerous product.
Art. 6 para. 2 GPSR
A product that involves risks is not automatically a dangerous product. With reference to Art. 6 Para. 1 lit. a) GPSR in particular, an appropriate level of safety can be achieved through appropriate instructions for use and safety instructions.
Concluding remarks
I have personally worked with CE directives and the Product Safety Act and other product safety regulations such as the REACH Regulation in the past and have ensured the conformity of products with the regulations of the internal market. It is simply not possible to create a universal formula or template. Each product and its risks must be considered individually.
I expressly do not consent to the editing, processing or modification of my content with or without computer-aided processes such as ChatGPT. In simple language: If you copywrite this text or have it rewritten by ChatGPT, this still constitutes copyright infringement in most cases.