The General Product Safety Regulation (GPSR) 

The General Product Safety Regulation (GPSR) 

The General Product Safety Regulation (GPSR) came into force on December 13, 2024, replacing the previous General Product Safety Directive (GPSD). 

The aim is to ensure that all non-food consumer products sold in the EU and Northern Ireland comply with safety standards, regardless of their place of origin, whether they are sold in physical outlets or on e-commerce platforms, or have the CE marking, and that manufacturers, importers, distributors, fulfilment centers, agents, and e-commerce platforms are subject to the regulation. 

Key changes to GPSR： 

• Product Traceability Requirements: Products must be clearly labeled with the manufacturer’s or importer’s contact information, as well as the model number, batch number, or serial number, to ensure product traceability through the supply chain. 

• Instructions for use and safety information: Instructions for use and safety information must be presented in a way that is easily understood by consumers to ensure that they are able to use the product correctly and understand the relevant safety information. 

• Appointment of an EU Authorized Representative: All non-EU manufactured products destined for the EU market must have an Authorized Representative (AR) based in the EU who is responsible for ensuring compliance with the GPSR. 

• Product Recalls: Manufacturers are required to have a detailed product recall process in place to ensure that if a product is deemed unsafe, it can be removed from the market quickly and efficiently, and that full refunds or free replacements are offered to consumers. 

• Supply Chain Quality Control: All segments of the supply chain are required to establish a complete product safety control system and keep records of quality inspections, sampling tests, customer complaints, etc., so as to facilitate the quick recall of problematic products when necessary. 

• Responsibility of e-commerce platforms: E-commerce platforms are required to designate a centralized contact window responsible for communicating with national product safety authorities and ensuring that the products they sell comply with GPSR regulations. 

The individual responsibilities and obligations of manufacturers, importers, distributors, distribution centers, and EU authorized representatives can be found on the official business portal of the Dutch government: 

Product safety | Business.gov.nl 

Non-GPSR regulated products:  

．Pharmaceuticals for human or veterinary use  

．Foodstuffs  

．Feed  

．Live animals and plants (including genetically modified organisms (GMOs) and GM microorganisms in captivity, as well as plant and animal products directly related to their future reproduction)  

．Animal by-products and derivatives  

．Plant protection products (pesticides)  

．Vehicle equipment (buses) used by consumers when they are riding or traveling in a vehicle that is operated by a transportation service provider in the context of a transportation service and not by the consumer himself/herself. 

．Aircraft  

．Antiques  

．products that cannot reasonably be expected by the consumer to meet state-of-the-art safety standards, such as products labeled as needing repair or refurbishment (second-hand items), or collectibles of historical value. 

* Authorized Representative (AR) in the European Union (EU) 

* EU Authorized Representative (EC REP) appointed by a non-EU manufacturer. 

Difference: EC REP mainly applies to Medical Devices to ensure that medical devices comply with MDR or IVDR requirements. AR mainly applies to general consumer products to ensure compliance with GPSR or specific product safety regulations. 

Resource:https://eecloud.sgs.com/Region_TW/Article.aspx?n=476 

               http://www.e-glory.com.tw/other/gpsr.htm 

https://www.taitra.org.tw/News_Content.aspx?n=104&s=106074

Becoming an Authorized Representative (AR) in Europe under the GPSR (General Product Safety Regulation) is one of the core requirements of the European Union (EU) for monitoring the safety of imported products. If a Taiwanese manufacturer does not have an entity in the EU, it must appoint an Authorized Representative (AR) in the EU to ensure that its products can legally enter the European market. 

Below are the details: 

1. Who can become a GPSR “European Authorized Representative (AR)”? 

According to GPSR (Regulation (EU) 2023/988), an Authorized Representative (AR) for Europe must meet the following conditions: 

1. The entity is established in the EU 

• The Authorized Representative must be a natural or legal person (e.g. a company) within the EU, i.e. have a valid EU business address. 

2. Duly appointed in writing by a non-EU manufacturer 

• The manufacturer must provide a formal Mandate authorizing the representative to perform its regulatory duties in the EU. 

3. Ability to fulfill GPSR obligations 

• The ability to fulfill the GPSR’s responsibilities includes maintaining and providing product compliance information, communicating with EU regulatory authorities, and assisting with product recalls. 

2. What are the responsibilities of an AR?  

Being an AR under GPSR is more than just a name, it is also about taking responsibility for product compliance risks and liabilities. Specific responsibilities are listed below: 

Responsibilities	Description
📁 Maintain technical documentation and compliance information	Maintain technical documentation and compliance information, including risk assessments, safety instructions, CE marking declarations of conformity. (where applicable)
📞 Communication window with EU competent authorities	Responsible for assisting with clarification and response in the event of product risk or spot checks.
📦 Assistance with product recalls or corrective actions	Assist in notifying consumers and authorities when products do not meet safety requirements.
🏷️ Labeling of information and disclosure of responsible person’s identity.	GPSR requires AR name, address, and contact information to be labeled on product packaging.

3. How to find AR for Taiwan enterprises, can I set up my own? 

Option 1: Appoint a third-party AR service company (most common) 

• There are a lot of AR service providers in Taiwan, such as Obelis Group (Belgium): 

• Obelis Group (Belgium) 

• ProductIP (Netherlands) 

• EMERGO / Qserve / SGS and other international regulatory consultants. 

• These services usually include address listing, document management and compliance counseling. 

Option 2: Partnering with a European importer as an AR 

• If the Taiwanese company already has a long-standing European agent or distributor, they can act as the AR. 

Option 3: Set up your own European branch (high cost) 

• If there is a demand for stable exports, you can consider setting up a European branch to act as an AR. 

4. Do I need to be registered or accredited to become an AR? 

According to GPSR, the AR itself does not need to be officially registered, however: 

• The AR must be able to prove that he/she is duly appointed (Letter of Appointment) 

• GPSR requires that information about the AR is displayed on the product packaging or labeling. 

• Some European countries or importers may require a letter of appointment or proof of liability insurance. 

5. Note: AR Role for GPSR vs CE Certified Products 

Item	GPSR Authorized Representative	CE Mark Product Authorized Representative
Applicable Products	General non-food consumer products	Machinery, electronics, toys, etc. with CE marking.
Compulsory	Yes(if no EU entity)	Yes (depending on product regulations)
Scope of Responsibilities	General safety responsibilities, information retention, communication	Includes Declaration of Conformity technical documentation retention, risk notification, etc.

Summary: How do Taiwanese companies designate GPSR AR? 

• Confirm whether the product is regulated by GPSR 

• Discuss AR designation with a compliance consultant or importer 

• Sign a formal authorization document (Mandate) 

• Ensure that AR information is displayed on the product packaging/description. 

• Communicate regularly with AR to update product compliance and market response. 

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