General Product Safety Regulations

What is the General Product Safety Regulation?

The General Product Safety Regulation (GPSR) text was published on 23rd May 2023. It is set to replace both the General Product Safety Directive (GPSD) and Food Imitating Product Directive from the 13th December 2024. This regulation is an updated version of the EU's product safety standards, addressing the new emerging challenges that are arising from the digital transformation of our economy.

The GPSR serves as a safety measure for products or risks that are not covered by other EU regulations. This safety measure ensures that EU consumers are safeguarded from dangerous products, be it now or in the future. It requires for all consumer products, including non-food product items, sold in the EU market via any distribution channel to be safe and meet standards. Additionally, it specifies the obligations that business must adhere to in order to ensure product safety.

Which products fall under the scope of GPSR?

The GPSR applies to products that:

• Are intended for consumer use

• May be utilised by consumers even if they weren’t originally intended to be used by them

• Are new, used, repaired, or reconditioned

The regulation applies to products placed on the market, so long as there aren’t any regulations that have the same objective as the GPSR to regulate the safety of those products. For instance, electrical safety of electronic devices (with a minimum of 50 V) are covered by the Low Voltage Directive and will not be covered under the GPSR. However, devices operating at low voltage (below 50 V) are not subject to the Low Voltage Directive and will full under the jurisdiction of the GPSR.

Products that are exempt from the regulation include:

• Medicinal products (for human or veterinary usage)

• Food and feed

• Living animals and plants

• Genetically-modified organisms and microorganisms

• Plant and animal products related to reproduction

• Animal by-products

• Products for plant protection

• Travel equipment used by service providers for consumer riding purposes

• Aircraft

• Antiques

Who's Responsibility is it to comply with GPSR?

The GPSR defines the various natural or legal entities responsible for carrying out activities related to the manufacturing and placing of a product on the market.

Manufacturer

The term “manufacturer” is defined as an individual who:

a. Produces a product

b. Has a product designed or produced under their name or trademark

c. Promotes their designed or produced product under their name or trademark

Importer

An “importer” is defined as an established individual in the EU who places a product on the EU market.

Distributor

A “distributor” is defined as an individual in the supply chain (excluding importers and manufacturers) who makes a product available on the market.

Authorised Representative

An 'authorised representative' is defined as a designated individual in the EU who receives instructions from a manufacturer and acts on behalf of the manufacturer to fulfil specific tasks related to the requirements of the GPSR. The GPSR mandates that products cannot be placed on the market without a designated economic operator in the EU. This economic operator is responsible for various tasks, including those stipulated by the Market Surveillance Regulation. This includes, for instance, cooperating with relevant authorities when require. In practical terms, this means that if your business sells products to EU consumers but lack a physical presence in the EU, you must engage the services of an authorised representative.

Fulfilment Service Provider

A “fulfilment service provider” is defined as an individual who offers at least two of the following commercial services without owning the products involved:

• Warehousing

• Packaging

• Addressing

• Dispatching

These services do not include the following:

• Postal services

• Parcel delivery services

• Other postal services

• Freight transport services
  

Provider on an Online Marketplace

A “provider of an online marketplace” is defined as a service provider that acts as an intermediary that uses an online platform to enable consumers to engage in remote sales transactions. As per the GPSR, products falling under the regulation must not be marketed or sold unless there is a responsible economic operator within the EU who is capable of fulfilling the product-related duties outlined in the the Market Surveillance Regulation. InIessence, this means that non-EU companies sellling products in the EU must appoint an authorised representative and affix information about this representative on their labels. Additional requirements stipulated in the Market Surveillance Regulation may also be applicable.

Safety Requirements

The GPSR stipulates that “only” safe products are permitted for sale on the market. It addresses various factors that are relevant for evaluating a product's safety. These aspects including:

a. The characteristics of a product – Such as, composition, design, packaging, technical specifications, and instructions for assembly, installation, use, and maintenance.

b. The potential impact of the product on other products, especially when its use with other products is reasonably foreseeable.

c. How other products may impact the product in question, particularly when the use of those other products is reasonably expected.

d. The product's labelling, information regarding age suitability for children, warnings, and instructions.

e. Risk assessment regarding how the product may affect different consumer groups based on age, disability, or gender.

f. The product’s appearance, which could lead to unintended use – For instance, a non-food product being mistaken for food and may result in ingestion by children.

g. If necessary, the inclusion of relevant cybersecurity features to safeguard the product against malicious third-party activities that could compromise its safety.

h. The product’s evolving, learning, and predictive performance, where such characteristics are essential to the nature of the product.

It is important to note that the potential for achieving higher levels of safety, or the exisence of other products with lower risk levels should not be the grounds for deeming a product unsafe.

GPSR Harmonised standards

The GPSR includes an extensive range of harmonised standards that set safety requirements for specific products. Compliance with these harmonised standards implies products are considered safe. However, the lack of harmonised product standards under the GPSR does not exempt you from the safety requirements of this regulation. Instead, you need to seek compliance with non-harmonised European standards as the next best alternative.

If there are no EN standards available for your products, you should consider looking for standards in other countries or markets or establish your own safety criteria. It is common practice to follow standards that are relevant to similar products. Ultimately, the primary goal of the GPSR is to ensure safety no matter what. While standards are typically in place for most products, in cases where they are absent, it is your responsibility to define safety measures.

Documentation

Under the GPSR, manufacturers are required to provide technical documentation and test reports to demonstrate evidence of product safety prior to placing on the market. In addition to this, they are also responsible for ensuring consumers have user friendly/ easy to understand instructions.

Technical documentation

Manufacturers should prepare a comprehensive set of technical documents that contain the following:

a. A general product description.

b. Key features essential for evaluating product safety.

c. Product-specific risk assessment and strategies for risk reduction

d. List of relevant European standards and/ or other alternative measures (e.g., national standards, guidelines).

e. The results from relevant tests (e.g., test reports).

Instructions

Manufacturers are required to include with their product, easy to understand instructions and safety information using an easily understandable language specified by the Member State where the product is sold.

Test reports

Manufacturers are required to incorporate in their documentation the results of product tests conducted either by themselves or by a third party acting on their behalf.

Labelling

Manufacturers are obliged by the GPSR to include labelling details on their products and packaging, including information related to warnings and traceability. They must also comply with the regulations regarding the placement of such information.

Traceability information

Manufacturers are required under the GPSR to ensure that they can track their products by including product identification details such as a batch code, serial number etc. Additionally they are also required to include their name (or registered trade name or mark) and contact information including postal and email address.

Warnings and instructions

Manufactures are required to include appropriate warnings and guidance on the safe use and disposal of their products, including details on the product's suitability for children of different ages.

Placement

Manufactures are obliged by the GPSR to include labelling details on their products. They may also provide information digitally on an electronic screen if their product has one. In cases where the product's size or characteristics make it impractical to display the information directly, manufacturers should include it on the packaging or in an accompanying document.

Dangerous products

In the event that a manufacturer has a believes, according to their information, that the product they have introduced to the EU market is dangerous, they must immediately:

a. Implement corrective measures to guarantee proper product compliance, which may involve product recall or withdrawal

b. Notify consumers via a product safety recall announcement

c. Utilize the Safety Business Gateway to notify market surveillance authorities regarding the specific product