The General Product Safety Regulation replaces the General Product Safety Directive. The regulation sets general safety requirements for consumer products, including software. Other regulations for specific product groups, or certain design aspects of products may also cover your products. However, if your consumer products are not covered by any other EU regulation, they are at least regulated by the GPSR. For this reason, the GPSR is often referred to as a "safety net".
Here is an overview of the main requirements of the GPSR:
1. Product Safety
A product may only be placed on the EU market if it safe and the safety has been assessed and documented. Article 9, paragraph 2 of the GPSR requires that a risk assessment is carried out. In most cases, a safety assessment includes additional testing. For example, typically for all types of products it is necessary to test the materials to ensure they do not contain prohibited substances or persistent organic pollutants.
If your company buys ready-made products or critical parts or components from suppliers, you may rely on them to have already undergone safety assessments. Unfortunately, our experience shows that seldomly the safety assessments and test reports and certificates are complete. It is recommended to conduct or commission the safety assessments yourself. Every time a product is modified, retesting and reassessments may be required.
2. Conformity Marking(s)
The GPSR does not require the affixing of any conformity markings. However, please note other regulations may apply that do require a conformity marking or symbol to be affixed.
3. Traceability - Model Number
The GPSR requires the products to be affixed with a model name or number, a batch or serial number, or another feature that allows the product to be identified. For example, you may use an EAN or UTC number. This requirement helps identify and trace products.
4. Traceability - Name and Address
The GPSR requires the name and postal address of the private labeller/manufacturer and importer to be affixed on the product. Only if this is impossible (e.g., because the product is too small), this information may be included on the packaging or in the manual. We advise that, in addition to placing the name and address on the product, you also place them on the packaging.
See also point 9 below: if your company is located outside the EU and does not have distributors/importers, you will indicate the EU Responsible Person’s name and address instead.
5. Instructions and warnings
The GPSR requires that the product is accompanied by instructions and warnings necessary for the user to safely use/install/maintain the product. If the product is very simple, and use is obvious, no warnings have to be provided.
Warnings and instructions must be provided in the official language(s) of the EU countries where the products are made available. For example, in the Netherlands, the instructions must be in Dutch. In Belgium, the instructions must be in both Dutch and French.
6. Declaration of Conformity
The GPSR does not require an EU Declaration of Conformity.
7. Technical File
The product's safety must be demonstrated with documentation. The complete set of documentation necessary to demonstrate compliance with all requirements and regulations is known as a ‘technical file’ or ‘technical documentation’. The file must be kept for 10 years after the product is marketed. Technologies and safety perceptions are subject to change. Also, products may be modified. Therefore, the technical file will need to be updated regularly. An efficient document management system is essential.
8. Incident Register
The GPSR also requires procedures for recording and reporting complaints and incidents. You are required to keep an internal complaint and incident register.
If you receive information that shows there are safety concerns, you must inform distributors and market surveillance authorities services, and notify them of any corrective measures you have taken. You may be required to withdraw the product from the distribution chain or recall it from the market. It is highly recommended you setup a recall procedure now, and to practice it. Don't wait until a case occurs, because you will have very little time to implement corrective measures.
9. Appoint an EU Responsible Person
Is your company selling in EU countries, but based outside the EU? If so, it is required for your company to appoint an EU Responsible Person. This can be an importer or distributor located in the EU. You may also appoint an EU-based authorised representative.
The EU Responsible Person is the point of contact for the Competent Authorities. The EU Responsible Person also retains your products’ technical files and makes them available to the authorities upon request, and notifies the authorities of non-conformities, and product incidents. The EU Responsible Person is required to verify the product safety and compliance documents and to record the verifications.
Updated: 19 November 2024