Difficulty to find out applicable Directives/Regulations/Standards to access the EU market?
Don´t know what to do to comply?
Here you have a summary video:
Starting from 13th December 2024 is in force:
General Product Safety Regulation (GPSR) EU/2023/988, Replacing the
General Product Safety Directive (GPSD) 2001/95/EC
Find the EU Regulation HERE
Let’s clarify some of your doubts about this significant change for retailers, importers, online marketplaces, and manufacturers whose products are placed or made available in the EU market
On May 23, 2023, the European Commission published Regulation (EU) 2023/988 on general product safety, also known as the General Product Safety Regulation (GPSR).
The new regulation will replace the General Product Safety Directive (GPSD) 2001/95/EC after a transitional period that will end in December 2024.
As this is having a big impact for retailers,importers, manufacturers and online marketplaces, Certiverse experts reply to the most frequently asked questions and remain at your disposal for other clarifications and to provide technical support to help you bring compliant products on the European market.
Under Regulation (EU) 2019/1020, manufacturers not established in the EU must appoint an authorised representative to act as an intermediary with the regulatory authorities and ensure the safety of products on the European market.
Article 10
Obligations of authorised representatives
- A manufacturer may, by means of a written mandate, appoint an authorised representative.
- An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorised representative shall provide the market surveillance authorities with a copy of that mandate upon request. The mandate shall allow the authorised representative to perform at least the following tasks:
Providing a market surveillance authority, upon that authority’s reasoned request, with all information and documentation necessary to demonstrate the safety of the product in an official language which can be understood by that authority;
Where the authorised representative considers or has reason to believe that a product in question is a dangerous product, informing the manufacturer thereof;
Informing the competent national authorities about any action taken to eliminate the risks posed by products covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer;
Cooperating with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by products covered by their mandate.
How can CERTIVERSO help brands?
With deep expertise in the safety of consumer products and certification, CERTIVERSE offers a comprehensive portfolio of services for retailers, private labels, importers, Amazon sellers and manufacturers who need to evaluate their products for compliance with safety requirements and how the new regulation will impact their processes in implementing compliance.
We can offer:
EC REP (European Representative) contracts for full representation and consulting services
Our Legal Representation Services
Our firm offers a comprehensive European Authorised Representative service, assuming the following key responsibilities:.
- Liaising with European Authorities: We represent your company before market surveillance bodies, providing the required documentation in an official EU language.
- Product Safety Monitoring: In case of identifying potential hazards in products, we notify the manufacturer and offer advice for their correction.
- Incident Management and Official Notifications: We inform the authorities through the Safety Business Gateway in case of potentially hazardous products, ensuring a timely and effective response.
- Collaboration with Regulatory Bodies: We act in coordination with national authorities to implement measures to minimise the risks associated with the products we represent.
FAQ
The new regulation applies to products placed or made available on the European market, whether new, used, repaired, or reconditioned, and it covers every type of product, whether or not it is interconnected to other items, supplied, or made available, which is intended for consumers or is likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them.
The new Regulation will replace the General Product Safety Directive (GPSD) 2001/95/EC after a transitional period that will end on December 13, 2024.
Yes. The EU GPSR does not apply to: Medicinal products for human or veterinary use Food Feed Living plants and animals, genetically modified organisms, and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction Animal by-products and derived products Plant protection products Equipment on which consumers ride or travel where that equipment is directly operated by a service provider within the context of a transport service provided to consumers and is not operated by the consumers themselves Aircraft and their parts, including remote control, used in military, customs, police, search & rescue, firefighting, border control, coast guard and similar activities Antiques
The term ‘electronic address’ means any electronic address (such as an email address) or website that provides direct communication, e.g., by contact template. A static website would not suffice.
The physical labelling obligations of manufacturers / importers under section 1 of Chapter 3 of the EU GPSR would not apply for products subject to Union harmonisation legislation (Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies) e.g., toys, aerosols, batteries, cosmetics, electrical equipment etc.
The physical labelling requirements of products should follow the same practice as the Blue Guide on the implementation of the product rules Publications Office (europa.eu). Thus, the information should be on the product or, if this is not feasible, on its packaging. Aesthetic reasons do not constitute a justification for not placing the information on the product.
The product can include a label via digital means, but this is strictly in addition to the physical labelling requirements and cannot be used as a substitute.
Where a product is offered via distance sales under Article 19 or via online marketplaces under Article 22, the labelling requirement under section 1 of Chapter 3 of EU GPSR (including electronic address) will need to be provided in the product offers, as this section applies to ALL products, including products subject to Union harmonisation legislation.
Article 9 of the EU GPSR requires that manufacturers conduct an internal risk analysis – effectively a risk assessment. A Declaration does not meet this requirement. The actual risk analysis will always be the responsibility of the manufacturer or their authorised representative.
The EU GPSR requirement for technical documentation commences for products first made available on the Union market after the 13th of December 2024.
