What is the GPSR?
As of the 13th of December 2024, Regulation (EU) 2023/988 General Product Safety Regulation (GPSR) , has officially replaced Directive 2001/95/EC General Product Safety Directive (GPSD), bringing forth a more comprehensive approach to consumer safety across the EU. The new regulation:
- Holds online marketplace platforms accountable for product safety, ensuring they monitor and remove unsafe products.
- Improves product traceability by requiring better documentation to trace products along the supply chain.
- Creates a new, user-friendly Safety Gate (formerly RAPEX) to strengthen the EU’s rapid alert system for dangerous non-food products.
- Addresses risks from emerging technologies, including connected and digital products.
- Assesses risk based on the age of the user. Particularly for people with specific needs and vulnerabilities, people with disabilities and the impact of gender differences. Even if the product (or its packaging) is not intended for use by children, considerations should be made if the product seems appealing or intended for use by children.
- Improves market surveillance authorities’ ability to enforce safety rules and recall unsafe products.
This webpage only serves as a guideline on the implementation of GPSR and by no means does it bear any legal weight. Reading this guideline shall not serve as a substitute to one’s familiarisation with the law Regulation (EU) 2023/988 published in the Official Journal of the European Union.
What Qualifies as a “General Product”?
Article 2 of Regulation (EU) 2023/988 lays out the scope of said regulation. The following guide shall help in determining whether certain risks a product may pose, fall within the scope of GPSR.
Check for Specific EU Safety Laws
A product may already have some of its safety risks covered by an existing Union law. GPSR only applies to risks not covered by any Union law.
Identify Excluded Products
GPSR does not apply to the following.
- Medicinal products for human or veterinary use.
- Food or feed.
- Living plants or animals.
- Genetically modified organisms (GMOs)or microorganisms.
- Products related to the reproduction of plants or animals (e.g., seeds or breeding animals).
- Animal by-products or derived products.
- Plant protection products (e.g., pesticides).
- Equipment consumers ride or travel on that is operated by a service provider (e.g., public transport equipment).
- Aircraft as defined in EU Regulation 2018/1139.
- Antiques
Determine Market Status
GPSR applies to new, used, repaired, or reconditioned products placed on the market. If a product is sold with the intent of repair or reconditioning and is clearly marketed as such, GPSR does not apply.
Guidance for Businesses
The EU Commission has issued guidelines aimed to help businesses and particularly small and medium sized enterprises (SMEs), including micro-enterprises, to better understand and fulfil their obligations under GPSR. These guidelines explain the scope of the GPSR in simple terms and provide checklists for every type of economic operator including providers of online marketplaces. The Commission also included a model template that businesses can use to prepare their product’s technical documentation.
For further clarification, the EU Commission has also released an FAQ document that answers common questions from businesses.
Should my Product be CE Marked?
Products that fall exclusively under the scope of GPSR are not to be CE marked and therefore do not require a Declaration of Conformity (DoC). A CE marking shall only be applied to products that fall under the scope of the directives and regulations listed in the New Legislative Framework. A product may fall under the scope of one or more of these regulations/directives, while also having certain risks covered by GPSR. In such cases, the CE mark, and the accompanying DoC only cover aspects not covered by GPSR.
Traceability Requirements
To ensure a rapid response in case of a potential product safety recall, the following information shall be affixed to the product itself. If no sufficient space is available to do so, the information should be placed on the packaging and if this still poses challenges, then on an accompanying document. Each addition of information shall not obscure the manufacturer’s label.
- Product Identification:(1) Type, (2) Identification Element (Type/Batch/Serial Number)
- Manufacturer:(1) Name, (2) Registered Trade Name/Mark, (3) Postal and Electronic Address of the Manufacturer and a Contact Point.
- Importer:(1) Name, (2) Registered Trade Name/Mark, (3) Postal and Electronic Address of the Manufacturer and a Contact Point.
- Responsible Person:(1) Name/Registered Trade Name/Mark, (2) Postal and Electronic Contact Details.
Remedy Entitlement
As per the provisions laid out in Article 37 in the event of a product safety recall, the economic operator responsible for the recall shall provide the consumer at least two out of three possible remedies.
- Repair of the recalled product.
- Replacement of the recalled product with one of the same type, value, and quality.
- An adequate refund amounting to at least the price paid by the consumer for the recalled product.
Banned Products
As per the 18,776th issue of the Government Gazette, Item 634, the use of Sky Lanterns, Chinese Lanterns, Wish Lanterns or similar products are banned in Malta. Such products, involve the ignition of a fuel under a fabric or paper dome-shaped bag which inflates by the action of hot gases.
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