HomeSafetyGeneral Product Safety Regulation, at the starting line in the European Union. The ABC

General Product Safety Regulation, at the starting line in the European Union. The ABC

On April 25, 2023, the approval process was concluded General Product Safety Regulation (EU) No 2023/998, which repeals and replaces the previous one General Product Safety Directive (EC) No 2001/95/EC (GPSD). (1)

A quantum leap in the direction of consumer protection on the general safety of products, thanks to a set of uniform rules to be applied throughout the European Union. The ABC's to follow.

1) General Product Safety Regulation (EU) No 2023/998, introduction

Target of the regulation is to guarantee a high and homogeneous level of general safety of all products in the European Union, to protect the health of consumers. With particular regard to children, the elderly, frail and disabled people.

The GPSR applies to every 'product', understood as'any item, whether or not interconnected with other items, supplied or made available for consideration or free of charge, including as part of a supply of services, to consumers or capable, under reasonably foreseeable conditions, of being used by consumers' (article 3.1.a).

'The products put in online selling or via other distance selling channels are considered to be made available on the market if the offer is aimed at consumers in the Union' (GPSR, art. 4). Therefore regardless of the location of the operators in non-EU countries.

2) Field of application

The field of application of the GPSR is extended to the general safety of products:

- 'subject to specific security requirements prescribed by Union law (…) for the aspects and risks or risk categories not subject to these requirements' (Article 2.2). As is the case with materials and objects intended to come into contact with foodstuffs (MOCA), although subject to the Food Contact Materials Regulation (EC) No 1935/04,

– intended for professional use only, if 'subsequently placed on the consumer market'(considering 9)

- 'second-hand or repaired, refurbished or recycled, put back into the supply chain as part of a business'. Unless the consumer can'reasonably expect compliance with current safety standards, such as products that are explicitly presented as products for repair or refurbishment or that are made available as collectibles of historical interest'(considering 16, art. 2.5),

– provided in the context of the provision of services, with the exception of devices and means of transport (e.g. bicycles, electric scooters) managed directly by the service providers (GPSR, art. 2).

2.1) Excluded products

Are excluded from the scope of the General Product Safety Regulation, nevertheless:

– food and feed, the safety of which is guaranteed through General Food Law (EC) No 178/2002, Hygiene package (EC Reg. 852, 853/04 and following),

– live plants and animals, including GMOs, and reproductive material, also subject to theOfficial Controls Regulation (EU) No 2017/625,

– genetically modified microorganisms for contained use,

– by-products of animal origin,

– agrochemical products (instead excluded from EU regulation 2017/625), (3)

– medicines,

– aircraft,

– antiques.

3) General product safety, basic requirements

'Economic operators only place or make available on the market safe products' (GPSR, article 5. General safety obligation). And the product:

- means safe when 'under normal or reasonably foreseeable conditions of use, including actual duration of use, presents no or only minimal risks compatible with the use of the product, considered acceptable and consistent with a high level of protection of health and consumer safety' (GPSR, art. 3.2),

- it's supposed safe when it complies with the relevant standards at European level or, in the absence of these, with the standards established at national level (GPSR, art. 7). The possibility of reaching higher levels of safety, as well as the presence of less risky products on the market, are not however sufficient reasons to consider a product dangerous (GPSR, art. 6.2).

4) Safety assessment

The safety assessment of the product must consider its characteristics, namely:

– design, technical characteristics, composition, (4) category of consumers to whom it is addressed, packaging,

– presentation and labelling, including any warnings (including in relation to the age of suitability for children), instructions for safe use and disposal, assembly and/or installation,

– the effects of such combined use with other products, including digital ones, with which it is 'reasonably foreseeable' can be used,

- 'the categories of consumers who use the product, in particular by assessing the risks for vulnerable consumers such as children, the elderly and people with disabilities, as well as the impact of gender differences on health and safety’,

– the appearance, if the non-food product (in terms of appearance, smell or colour) may resemble food and be placed in the mouth or ingested by young children. Or in any case it is attractive to children but its use by them is not intended,

- 'the appropriate cybersecurity features necessary to protect the product from external influences, including malicious third parties, if such influence could have an impact on the security of the product, including 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) Safety assessment, further elements

In addition sector regulations referred to in accordance with reg. EU 1025/2012 and when the presumption of conformity does not apply (see above, par. 3), the safety assessment must also consider:

– international regulations and agreements,

- 'voluntary certification schemes or similar third-party conformity assessment frameworks’,

- 'Commission recommendations and guidelines on product safety assessment’,

- 'national rules 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’,

- 'codes of good practice on product safety 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 bear the following mandatory information:

– name, trade name or registered trademark, email address of the manufacturer and, where different, the postal or email address of the single point at which to contact the manufacturer, (4)

- 'type, lot, series number' or other easily visible element that allows 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 use of the product in safe conditions.

Manufacturers must specify the communication channels (Email, telephone, or a section of the site websites) that consumers can activate to file complaints and report any incidents that have occurred 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 the reg. EU 2019/1020, article 4.3 (General Product Safety Regulation, article 16). That means:

– verification of the existence of an EU declaration of conformity or declaration of performance and related technical documentation, where required,

– conservation of the aforementioned documents for the period prescribed by applicable regulations,

– provision to the supervisory authorities, in a language they can easily understand, of all the information and documentation necessary to demonstrate the conformity of the product,

– reporting any security risks to the authority, cooperation in risk management.

6.1) Responsibility of the manufacturer

The manufacturer – or the owner of the trademark, or the importer (5) – guarantees that the products he places on the market are safe (GPSR, article 5). To this end, the responsible operator must:

– run theanalysis of 'risks related to the product and of the solutions adopted to eliminate or mitigate these risks, including the results of any reports concerning tests carried out by the manufacturer or by a third party on his behalf’,

– draw up a technical where the characteristics of the product necessary for the safety assessment, the potential risks, any warnings and instructions for use are reported. With the obligation to update the card, also in the light of possible emerging risks and solutions adopted to mitigate them, and keep it for a period of 10 years from placing the product on the market,

– ensure theidentification and traceability of the products, by affixing a type, lot, series number or other easily visible element that allows their identification. Also in view of any corrective actions (e.g. withdrawal, recall. GPSR, art. 9).

6.2) Responsibility of the distributor

'First to place a product available on the market, distributors ensure that the manufacturer and, where applicable, the importer have complied' a series of requirements:

– identification of the product, by type, lot, series number or other easily visible element,

– exact references of the manufacturer or importer and contact point, also in view of possible complaints,

– instructions and clear safety information, in an easily understandable language, unless the product can be used safely even in their default (GPSR, articles 9, paragraphs 5,6,7 and 11, par. 3,4) .

During 'the period in which a product is under their responsibility', the distributors guarantee that:

- 'the conditions of storage or transport do not compromise compliance with the general safety obligation set out in Article 5’,

– the mandatory information aimed at identifying the product and the manufacturer or importer are kept clearly visible to the consumer, with the duty to

– refrain from selling products that the distributor himself 'believes or has reason to believe, based on the information in its possession', do not comply with the aforementioned requirements (GPSR, art. 12).

6.3) Online marketplacesthe responsibilities of managers

The managers of marketplace for sales online must register on the portal safety gate (see paragraph 9 below), indicating a single point of contact for communications with the supervisory authorities and with consumers. Member States must give competent authorities the power to order online operators marketplaces the elimination of contents concerning products deemed dangerous, disabling access to them or publishing warnings (GPSR, art. 22).

The operators must:

– carry out the orders of the authorities without delay, within a maximum period of two days of their receipt, and provide the related feedback through the SG portal.

– follow the updates of the SG portal on dangerous products and take the necessary measures within three days to remove or disable access to the related contents.

It is responsibility of the managers of the online marketplaces check the dutiful insertion - by sellers who use the platform - of the mandatory information referred to in paragraph 5 above, accompanied by an image of the product. With the duty to suspend manufacturers, importers and distributors who frequently offer non-compliant products, informing the supervisory authorities (GPSR, art. 22).

7) Risk management

In the case of the manufacturer believes or has reason to believe that a product already on sale is dangerous:

– immediately take the necessary corrective actions to mitigate the risks, which include commercial withdrawal or public recall,

– immediately informs consumers, also through digital tools,

– notify the case to the competent authorities through the Safety Business Gateway. With detailed information on the risk to consumer safety and any corrective measures already taken.

In case of accidents, the operator must perform immediate notification on the platform safety gate. Specifying the type of product, its serial number and the circumstances, if known. In the event of serious injury or death of the consumer, the causes of the event must be notified to the competent authorities (GPSR, art. 9).

Responsibilities of the manufacturer, as regards the safety and traceability of the products placed on the market, also fall on importers, authorized representatives, distributors and managers of the marketplace for the online sale of products (GPSR, art. 10,11,12,13). The latter must in turn allow the identification of the products on sale, by publishing at least one image of them (GPSR, art. 19).

8) safety gate, the early warning system

The alert system rapid RAPEX, renamed safety gate, connects the European Commission with national authorities. The managers of the online ones also register there marketplace to ensure the effectiveness of market surveillance. The safety gate comprises 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 shall designate a national contact point responsible for notifications and communications with the Commission,

– portal websites intended to inform the public and allow the submission of complaints (area of ​​the portal safety gate),

– portal websites where businesses can fulfill their obligation to warn authorities and consumers about dangerous products and accidents (Safety Business Gateway) (General Product Safety Regulation, considering 68).

9) Protection for consumers

In case of recall of a product, the economic operator must offer the consumer a remedy 'effective, cost-free and timely'. By making available to consumers the choice between at least two of the following remedies:

- 'la riparazione of the recalled product,

- There replacement of the recalled product with a safe one of the same type and at least of the same value and quality, or

- A adequate refund of the value of the recalled product, provided that the refund amount is at least equal to the price paid by the consumer' (GPSR, art. 37).

Just in case of impossible or disproportionately expensive remedies, the trader can only offer a remedy to the consumer. In any case, the consumer has the right to a refund if the economic operator has not completed the replacement or repair within a reasonable time and without significant inconvenience for the consumer. If, on the other hand, the repair can be carried out easily and safely by the consumer, this circumstance must be specified in the recall notice.

10) Supervision and sanctions

Member States must:

– organize a system of supervision and controls of products on the market, in line with the provisions of reg. EU 2019/1020, (6)

– introduce special sanctioning regimes to punish all violations of the obligations set out in the general product safety regulation.

The penalties established for this purpose must be 'effective, proportionate and dissuasive' and the related 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

Il General Product Safety Regulation, after being signed by the European Parliament, will be forwarded to the offices of the Official Journal of the European Union and will enter into force within 15 days of 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 obligation' (GPSR, article 7.2).

Our team di FARE it is available to operators who intend to organize procedures to guarantee product safety and labelling, as well as risk prevention and management.

Dario Dongo and Alessandra Mei


(1) Regulation of the European Parliament and of the Council on product safety

(2) Dario Dongo. General product safety, proposed EU regulation. The ABC. GIFT (Great Italian Food Trade). 14.8.21

(3) NB: the exclusion of agrochemical products (eg. pesticides, herbicides, fungicides) from the scope of the regulation on general product safety constitutes a serious disadvantage for the health and protection of consumers and the environment. Even more so when one considers the real risk of illegal sale of dangerous chemicals, already denounced on this site. See 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 under that person's name or trademark' (GPSR, article 3.8). 'Any natural or legal person who places a product on the market under his own name or trade mark or substantially modifies a product in such a way that compliance with the requirements of this Regulation could be impaired should be regarded as the manufacturer and assume the related obligations'(considering 34, article 13). The responsibilities of importers, authorized representatives, distributors are indicated 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

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

Alessandra Mei
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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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