The scope of the General Product Safety Regulation
“GPSR is always applicable”
The General Product Safety Regulation (EU) 2023/988 ‘GPSR’ has been in force since 13 December 2024. Some say the GPSR applies to all products, others say it applies only to ‘non-harmonised’ products. Which statement is true, when, and how can you tell if a product is harmonised?
Initial steps
Article 2 sets out the scope of the GPSR. It divides products into 3 groups where safety is concerned.
- Products for which there are no Union laws on their safety.
- Products of which their safety is fully imposed by Union law.
- Products partially subject to Union law, but with some safety risks not covered.
Regardless of the group applicable to the product, the following steps should be taken:
- The first step is always to determine the safety risks, perform a risk assessment.
- The next step is finding for which risks Union law already imposes requirements.
- The final step is to determine to what extend GPSR still applies.
1 - Safety
According to the (shortened) definition, a safe product means a product which does not present any unacceptable risk, consistent with a high level of protection of the health and safety of consumers.
Safety risks should be assessed with a broad view. It includes environmental risks that endanger the health and safety of consumers. It includes mental health and privacy risks posed by internet connected products.
All relevant aspects of the product should be taken into account, and there often are many. The entire lifespan of the product shall be considered, including disposal. And special attention is required for vulnerable users.
Above all safety, security and privacy shall be arranged by design. Warnings and safety instructions are a last resort and not a short-cut to safety.
GPSR Article 6 contains quite a few practical and relevant aspects to be considered, as appropriate.
Details on how to execute a risk assessment are beyond the scope of this article, refer to ProductIPedia for that.
Proportionality
The depth of the risk assessment and the amount of required technical documentation depends on the complexity of the product, and it should be proportionate to the possible risks. One might think a risk assessment for simple products is unnecessary. But even simple products can carry risks such as sharp edges, detaching small parts or the presence of banned heavy metals. The recalls on Safety Gate are certainly not limited to the complex or obviously hazardous ones.
2 - Union law
Specific safety requirements are laid down in Union law, or Union harmonisation legislation.
Sometimes referred to as ‘CE marking’ legislation, but note that by no means all Union laws require CE marking.
Regulation (EU) 2019/1020 lays down the framework for products subject to Union harmonisation legislation. Annex I to the Regulation lists as many as 71 pieces of Union harmonisation legislation, Directives and Regulations. These Directives and Regulations define the specific safety requirements to be met by the related products.
A distinction can be made between horizontal and vertical legislation. Horizontal legislation deals with a particular aspect across many products, such as chemical safety or packaging / waste. Vertical legislation deals with particular product groups such as toys, cosmetics or medical devices. Mixed forms also exist, such as the personal protective equipment regulation, a specific product group with specific safety aspects.
3 - GPSR
The key question of whether there are any aspects besides the 71 pieces of legislation that are not covered, and thus fall under GPSR, is difficult to answer generically. In general, it can be said that legislation lags behind new developments.
For instance, the legislation for machines was recently updated and that for toys will soon be updated to reflect developments around artificial intelligence.
There are also some known gaps, as the following two examples will show.
Children’s products
The risks of toys are covered by the Toy Safety Directive that will soon be replaced by the Toy Safety Regulation.
However, there are many child use and child care products that are not toys, and not subject to the toys legislation.
Yet the risks are similar for products near or in the hands of children. It makes sense to have a close look at the toys legislation and available harmonised standards when assessing the risks of other children’s products.
This applies also to child appealing products, keep in mind that children do not read safety instructions.
Battery-powered products
The risks associated with electrical products have traditionally been dealt with in the Low Voltage Directive 2014/35/EU.
The standards harmonised for this directive are often, but incorrectly, referred to as “LVD standards”.
But the scope of the Low Voltage Directive is limited to products with a power supply above 50 Vac and 75 Vdc, thus excluding an ever-increasingly large group of battery-powered products. Nevertheless, the risks are similar to those of electrical devices “with a plug”. As the recalls of, for instance, power-banks all too often make clear.
Also here, the application of “LVD” standards for “GPSR” battery-powered products makes sense.
‘Fun fact’ - Products with wireless technology are subject to the Radio Equipment Directive (RED) 2014/53/EU. This Directive applies the same safety requirements as the LVD, but with no voltage limit applying.
GPSR Harmonised standards
It might be surprising that there are harmonised standards for ‘non-harmonised’ products covered by GPSR. Harmonised standards are available for certain furniture, child use and care articles, bicycles, and more.
B2C not B2B
Another angle to take into account is the fact that the GPSR is limited to consumer products. GPSR excludes products meant only for person’s trade, business, craft or profession. Please note that even products which are designed exclusively for professional use, but which have migrated to the consumer market, are subject to GPSR because they could pose risks to the health and safety of consumers when used under reasonably foreseeable conditions.
Professional equipment sold via a webshop accessible for private shoppers might be subject to GPSR.
But then, all products
Despite all mentioned previously, the following rules from GPSR apply to all products, harmonised and non-harmonised.
- Chapter I: General provisions (objective, scope, definitions).
- Chapter III, Section 2: Obligations in the case of distance sales and obligations on accident reporting.
- Chapter IV: Specific product safety obligations for online marketplace providers.
- Chapter VI: Safety Gate Rapid Alert System and Safety Business Gateway to report dangerous products and accidents
- Chapter VIII: Obligation to inform consumers about product safety recalls and safety warnings; mandatory remedies in case of a product safety recall, and the mandatory product safety recall notice template.
The GPSR obligation to mention an electronic address does not apply to all products, but it is expected that upcoming Union law will follow this example so it makes sense to update traceability information as a ‘running change’.
Out of scope
Article 2(2) of GPSR lists the products to which the Regulation does not apply: food; feed; medicinal products; living plants and animals; animal by-products; plant protection products; transport (ride and travel) service equipment; aircraft; and antiques. For (most of) these products other legislative systems are in place.
ProductIP
In ProductIP the requirement ‘GPSR (EU) 2023/988 - Risk assessment’ will appear in technical files when there is no Union law, or only for part of the risks. The GPSR requirement may also be added depending on the answer(s) given in the Q&A.
The GPSR requirement is not be listed for products where one or more Union laws, especially product specific ones, are available.
