On April 25, 2023, the approval process was completed for General Product Safety Regulation (EU) No 2023/998, which repeals and replaces the former General Product Safety Directive (EC) No 2001/95/EC (GPSD). (1)
A quantum leap in the direction of consumer protection on general product safety through a uniform set of rules to be applied throughout the European Union. ABC to follow.
1) General Product Safety Regulation (EU) No 2023/998, Introduction
The objective of the regulation is to ensure a high and uniform level of general safety of all products in the European Union, to protect the health of consumers. With special regard to children, the elderly, the frail and people with disabilities.
The GPSR applies to every ‘product‘, understood as ‘any item, whether or not interconnected with other items, provided or made available for consideration or free of charge, including as part of a service, to consumers or likely, under reasonably foreseeable conditions, to be used by consumers‘ (Article 3.1.a).
‘Products offeredfor sale online or through other distance selling channels are considered to be made available on the market if the offer is intended for consumers in the Union‘ (GPSR, Art. 4). Therefore, regardless of whether operators are located in non-EU countries.
2) Scope of application
The scope of the GPSR is extended to general product safety:
– ‘subject to specific safety requirements prescribed by Union law (…) for those aspects and risks or categories of risks not subject to such requirements‘ (Art. 2.2). Such is the case with materials and articles intended to come into contact with food (MOCA), although subject to the Food Contact Materials Regulation (EC) No 1935/04,
– intended exclusively for professional use, if ‘subsequently placed on the consumer market‘(recital 9),
– ‘second-hand or repaired, reconditioned or recycled, fed back into the supply chain as part of a business‘. Unless the consumer cannot ‘reasonably expect compliance with current safety standards, such as products that are explicitly presented as products to be repaired or reconditioned or that are made available as collectibles of historical interest‘(Recital 16, Art. 2.5),
– provided as part of service provision, outside the case of transportation devices and means (e.g., bikes, electric scooters) operated directly by service providers (GPSR, Art. 2).
2.1) Excluded products
They are excluded from the scope of the General Product Safety Regulation, nonetheless:
– food and feed, the safety of which is ensured through General Food Law (EC) No 178/2002, Hygiene Package (EC Reg. 852, 853/04 et seq.),
– live plants and animals, including GMOs, and reproductive material, also subject toOfficial Controls Regulation (EU) No 2017/625,
– Confined-use genetically modified microorganisms,
– Animal by-products,
– agrochemicals (instead excluded from EU reg. 2017/625), (3)
– medicines,
– aircraft,
– antiques.
3) General product safety, basic requirements
‘Economic operators shall place or make available on the market only safe products’ (GPSR, Article 5. General safety obligation). And the product:
– is considered safe when ‘under normal or reasonably foreseeable conditions of use, including the actual duration of use, it presents no risk or only minimal risks consistent with the use of the product, which are considered acceptable and consistent with a high level of consumer health and safety protection‘ (GPSR, Art. 3.2),
– is presumed safe when it complies with relevant standards at the European level or, failing that, with standards established at the national level (GPSR, Art. 7). However, the possibility of achieving higher levels of safety, as well as the presence of less risky products in the market, is not sufficient reason to consider a product dangerous (GPSR, Art. 6.2).
4) Security assessment
The safety assessment of the product must consider its characteristics, viz:
– design, technical characteristics, composition, (4) category of consumers it is aimed at, packaging,
– presentation and labeling, including any warnings (including in relation to age suitability for children), instructions for safe use and disposal, assembly and/or installation,
– the effects of such use combined with other products, including digital products, with which it is ‘reasonably foreseeable‘ it may be used,
– ‘the categories of consumers who use the product, particularly assessing the risks to vulnerable consumers such as children, the elderly, and people with disabilities, as well as the impact of gender differences on health and safety.’
– appearance, if the non-food product (in appearance, smell or color) may resemble food and be brought to the mouth or ingested by young children. Or otherwise result attractive to children but its use by them is not intended,
– ‘the appropriate cybersecurity features necessary to protect the product from outside influences, including malicious third parties, if such influence could impact the security of the product, including the possible loss of interconnection.’
– ‘if required by the nature of the product, the evolutionary, learning and predictive features of the product‘ (GPSR, Article 6).
4.1) Security assessment, additional elements.
In addition to the industry regulations referred to under reg. EU 1025/2012 and when the presumption of conformity does not apply (see para. 3 above), the safety assessment must also consider:
– regulations and international agreements,
– ‘voluntary certification systems or similar third-party conformity assessment frameworks‘,
– ‘Commission recommendations and guidelines on product safety assessment‘,
– ‘national standards developed in the member state where the product is made available‘,
– ‘state of the art and technology, including the opinion of recognized scientific bodies and expert committees.’
– ‘product safety codes of practice in force in the sector concerned‘,
– ‘the safety that consumers can reasonably expect‘ (GPSR, Article 8).
5) Mandatory information
The product-or, if this is not possible, its packaging or accompanying documents-must contain the following mandatory information:
– Name, trade name or registered trademark, e-mail address of the manufacturer as well as, if different, the postal or electronic address of the single point at which the manufacturer can be contacted, (4)
– ‘type, batch, series number‘ or other easily visible element that enables its identification,
– Clear instructions and information, in a language easily understood by the consumer (as determined by the member state where the product is distributed), where necessary for the safe use of the product.
Manufacturers should specify the communication channels(email, telephone, or a section of the website) that consumers can activate to file complaints and report any incidents that occur with the product.
6) Responsibility
Conditio sine-qua-non
to place goods subject to the General Product Safety Regulation on the EU market is the existence of an economic operator established in the European Union who assumes the responsibilities already defined in reg. EU 2019/1020, Article 4.3(General Product Safety Regulation, Article 16). Namely:
– verification of the existence of an EU declaration of conformity or declaration of performance and related technical documentation, where prescribed,
– retention of the said documents for the period prescribed by any applicable regulations,
– provision to the supervisory authorities, in a language easily understood by them, of all the information and documentation necessary to demonstrate product compliance,
– reporting any security risks to the authority, cooperation in risk management.
6.1) Manufacturer’s responsibility
The manufacturer-that is, the trademark holder, or the importer (5)-ensures that the products it places on the market are safe (GPSR, Article 5). To this end, the responsible operator must:
– perform theanalysis of ‘possiblerisks associated with the product and the solutions adopted to eliminate or mitigate those risks, including the results of any reports concerning tests carried out by the manufacturer or a third party on its behalf.’
– Draw up a data sheet where the product characteristics necessary for safety assessment, potential risks, any warnings, instructions for use are given. With a requirement to update the sheet, including in light of possible emerging risks and solutions adopted to mitigate them, and keep it for a period of 10 years after the product is placed on the market,
– Ensure theidentification and traceability of products by affixing a type, batch, serial or other easily visible number that enables their identification. Also with a view to possible corrective action (e.g., withdrawal, recall. GPSR, Art. 9).
6.2) Responsibility of the distributor
‘Before making a product available on the market, distributors shall ensure that the manufacturer and, where applicable, the importer have complied’ witha number of requirements:
– Identification of the product, by type number, batch, series or other easily visible item,
– Exact references of the manufacturer or importer and point of contact, also in view of possible complaints,
– clear instructions and safety information in an easily understandable language, unless the product can also be used safely in their default (GPSR, Articles 9(5,6,7) and 11(3,4)).
During ‘the period when a product is under their responsibility,’ distributors ensure that:
– ‘the conditions of storage or transportation do not compromise its compliance with the general safety obligation under Article 5.’
– mandatory information identifying the product and the manufacturer or importer is kept clearly visible to the consumer, with a duty to
– refrain from selling products that the distributor himself ‘believes or has reason to believe, based on information in his possession,’ do not comply with the above requirements (GPSR, Art. 12).
6.3) Online marketplaces, the responsibilities of managers
Operators of marketplaces for online sales must register on the Safety Gate portal (see Sec. 9 below), indicating a single point of contact for communications with supervisors and consumers. Member states must give competent authorities the power to order operators of online marketplaces to remove content regarding products deemed dangerous, disable access to them, or post warnings (GPSR, Art. 22).
Operators must:
– To execute the orders of the authorities without delay, within the maximum period of two days from their receipt, and provide feedback through the SG portal.
– follow SG portal updates on hazardous products and take necessary measures within three days to remove or disable access to related content.
It is the responsibility of the operators of online marketplaces to monitor the due inclusion–by sellers using the platform–of the mandatory information referred to in paragraph 5 above, accompanied by an image of the product. With duty to suspend manufacturers, importers and distributors who frequently offer non-compliant products, informing the supervisory authorities (GPSR, Art. 22).
7) Risk management
Where the manufacturer believes or has reason to believe that a product already placed on the market is dangerous:
– takes immediate corrective actions necessary to mitigate the risks, which include commercial recall or public recall,
– immediately inform consumers, including through digital tools,
– notifies the relevant authorities through the Safety Business Gateway. With detailed information on the risk to consumer safety and any corrective measures already taken.
In cases of accidents, the operator must make immediate notification on the Safety Gate platform. Specifying the type of product, its serial number and circumstances, if known. In case of serious injury or death of the consumer, the causes of the event must be notified to the competent authorities (GPSR, Art. 9).
The manufacturer’s responsibilities for safety and traceability of products placed on the market also fall on importers, authorized representatives, distributors and operators of marketplaces for online product sales (GPSR, Art. 10,11,12,13). The latter in turn must allow identification of the products for sale by publishing at least one picture of them (GPSR, Art. 19).
8) Safety Gate, the early warning system.
The RAPEX early warning system, renamed Safety Gate, connects the European Commission with national authorities. Operators of online marketplaces are also registered there to ensure the effectiveness of market supervision. The Safety Gate includes three elements:
– rapid alert system on dangerous non-food products, for the exchange of information between national authorities and between them and the Commission can exchange on such products. To this end, each member state designates a national point of contact responsible for notifications and communications with the Commission,
– Web portal intended to inform the public and allow complaints to be filed ( Safety Gate portal area),
– web portal where companies can fulfill their obligation to alert authorities and consumers about dangerous products and accidents (Safety Business Gateway)(General Product Safety Regulation, recital 68).
9) Consumer protections
In the event of a product recall, the trader must offer the consumer an ‘effective, cost-free and timely‘ remedy. Making available to consumers a choice of at least two of the following remedies:
– ‘the repair of the recalled product,
– The replacement of the recalled product with a safe one of the same type and at least the same value and quality, or
– an adequate refund of the value of the recalled product, provided that the amount of the refund is at least equal to the price paid by the consumer’ (GPSR, Art. 37).
In the only case of impossible or exaggeratedly burdensome remedies, the operator may offer only one remedy to the consumer. The consumer is in any case entitled to a refund if the trader has not completed the replacement or repair within a reasonable time and without significant inconvenience to the consumer. If, on the other hand, the repair can be carried out easily and safely by the consumer, this should be specified in the recall notice.
10) Supervision and Sanctions
Member states must:
– To organize a system of supervision and control of products on the market, in line with the provisions of reg. EU 2019/1020, (6)
– Introduce appropriate penalty regimes to punish all violations of the obligations under the General Product Safety Regulation.
The sanctions established for this purpose must be ‘effective, proportionate and dissuasive‘ and the relevant measures must be notified to the European Commission within 18 months of the entry into force of the regulation (GPSR, Art. 44).
12) Entry into force and implementation measures.
The General Product Safety Regulation, after being signed by the European Parliament, will be sent to the offices of the Official Journal of the European Union and will enter into force within 15 days after its publication.
The European Commission is delegated to adopt ‘implementing acts determining the specific safety requirements to be covered by European standards in order to ensure that products complying with these European standards meet the general safety requirement‘ (GPSR, Article 7.2).
Our FARE team is available to operators who wish to organize procedures to ensure product safety and labeling, as well as risk prevention and management.
Dario Dongo and Alessandra Mei
Notes
(1) Regulation of the European Parliament and the Council on product safety https://data.consilium.europa.eu/doc/document/PE-79-2022-INIT/it/pdf
(2) Dario Dongo. General product safety, proposed EU regulation. THE ABC’S. GIFT (Great Italian Food Trade). 14.8.21
(3) NB: The exclusion of agrochemicals (e.g., pesticides, herbicides, fungicides) from the scope of the General Product Safety Regulation is a serious impairment to the health and protection of consumers and the environment. All the more so where one considers the real risk of illegal sale of dangerous chemicals, already reported on this site. V. Dario Dongo. Ecommerce, pesticide smuggling. GIFT (Great Italian Food Trade). 19.10.18
(4) Dario Dongo, Luca Foltran. Toxic chemicals in everyday objects, the English report. GIFT (Great Italian Food Trade). 20.7.19
(5) The manufacturer is ‘The natural or legal person who manufactures a product, or has it designed or manufactured, and markets it bearing that person’s name or trademark‘ (GPSR, Article 3.8). ‘A natural or legal person who places a product on the market under his or her own name or trademark or substantially modifies a product in such a way that compliance with the requirements of this Regulation could be affected should be considered the manufacturer and assume the obligations of the manufacturer‘ (considering 34, Article 13). The responsibilities of importers, authorized representatives, distributors are stated in Articles 10,11,12.
(6) Regulation (EU) 2019/1020 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 https://bit.ly/450AsIF
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Law from the University of Bologna, she attended the Master in Food Law at the same University. You participate in the WIISE srl benefit team by dedicating yourself to European and international research and innovation projects.
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