Product safety: Changes as of December 2024
The EU’s General Product Safety Regulation will start to apply in Poland on 13 December 2024. The GPSR will replace the product safety regulations now in force, and apply to many types of non-food consumer products. It sets general safety standards for all categories of consumer products for which more specific standards are not provided in other laws. Adapting to the changes will require relabelling of consumer products, among other efforts. But inspections and sanctions will have to wait for legislation by the Polish parliament.
What products will be subject to the new provisions?
The GPSR (Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety) will cover all products whose safety aspects are not specifically regulated by separate laws. Given the breadth of these provisions, there is no specific list of products subject to the GPSR. However, the GPSR will only apply to products for consumers.
Some product categories extensively covered by their own industry regulations, such as medicinal products and foods, are expressly excluded from the GPSR.
For certain other product categories, the GPSR will apply only to a limited extent—this will be the case for such items as cosmetics, medical devices, toys, tobacco products, and biocides.
There are also product categories where, in the absence of specific regulations, the GPSR will apply in full—for example, household goods and furniture.
The scope of application of the GPSR should be determined individually for each type of product.
When will products need to be reconfigured to comply with the new rules?
The GPSR will begin to apply throughout the European Union, including Poland, from 13 December 2024. Products introduced from that date onward must already comply with the new provisions.
The good news for manufacturers is that products placed on the market before 13 December 2024 and complying with the old provisions can still be offered without any adjustments. This principle is enshrined in the GPSR and is carried over to the Polish proposal as well.
What areas are affected by the changes?
One of the key changes is the need to prepare a risk assessment and technical documentation for each product. For manufacturers producing many different types of products subject to the GPSR, this can pose a major organisational challenge.
The GPSR introduces new rules for recalling products for safety reasons. In principle, in the case of a product recall, it will be necessary to directly contact the consumer who bought the product. If this is not possible, the business will have to publish a notice complying with strict rules. Consumers will also have to be offered at least two forms of compensation in relation to a recalled product, out of three options: repair, replacement, or refund.
Changes will also affect labelling. One new aspect is the requirement to list the electronic address of the manufacturer (and the importer in the case of imports). This should facilitate communications on issues of product safety.
For imports from outside the EU, complete data on both the manufacturer and the importer will have to be provided. And in the case of a non-EU manufacturer, it will be necessary to designate a responsible entity from the EU (such as the importer), whose details should also to be indicated on the product.
The Polish act and European Commission guidance
Although the obligations under the GPSR will apply directly, a Polish act must be adopted anyway, to establish a control system and introduce a system of sanctions for GPSR violations.
A bill to this end is currently being processed within the government, after which it will submitted to the parliament. Thus it will be some time before businesses face sanctions. They can use this time to ensure that they have brought their operations into full compliance with the GPSR requirements.
In December 2024, the European Commission released FAQs on the practical aspects of applying the GPSR, explaining for example that:
- The GPSR will also apply digital products such as software
- The necessary “electronic address” to be provided by the manufacturer could be an email address or a web page with an electronic contact form
- The information required on a physical label cannot be replaced by a digital label (e.g. linked from a QR code).
What are the fines for failure to adjust?
The released proposal for the Polish act lays out a set of sanctions for violation of the GPSR. Fines may range up to PLN 1,000,000 (for placing a dangerous product on the market). A fine of up to PLN 100,000 is to be imposed for omissions regarding the manufacturer’s contact information. However, the amount of these fines may still change during the legislative process.
Joanna Krakowiak, attorney-at-law, Marcin Rytel, adwokat, Life Sciences & Healthcare practice, Wardyński & Partners
