REGULATION (EU) 2023/988, also known as the General Product Safety Regulation (GPSR), aims to ensure that products placed on the market are safe for consumers. This regulation applies to all products, including those sold online, and sets out the responsibilities of manufacturers, importers, and distributors to ensure product safety.
A GPSR file is designed to make sure you have a reasonable system for ensuring that your product is generally safe. There is obviously a lot more to it than paperwork, but documenting what you have done is one of the essential points and having a file that details the important parts of the system is clearly needed.
Title and Introduction: Start with a clear and concise title that indicates the purpose of the file. Follow this with an introduction that provides an overview of what the GPSR (General Product Safety Regulation) compliance entails and the importance of adhering to these regulations.
Product Description: Include a detailed description of the product, covering its intended use, target market, and any variations or models. This section should also outline the product’s key features and specifications.
Safety Assessment: Provide a comprehensive safety assessment of the product. This should include potential hazards, risk analysis, and the measures taken to mitigate these risks. Highlight any safety standards or regulations the product complies with.
Compliance Documentation: List and describe all relevant compliance documentation, such as test reports, certifications, and conformity assessments. Ensure that each document is clearly referenced and easily accessible.
Instructions for Use: Include detailed instructions for the safe use of the product. This should cover assembly, operation, maintenance, and disposal. Ensure that these instructions are clear, concise, and easy to follow.
Labelling and Packaging: Describe the labelling and packaging requirements for the product. This should include information on safety warnings, symbols, and any other mandatory information that must be displayed on the product or its packaging.
Incident Reporting: Outline the procedure for reporting any incidents or safety concerns related to the product. Provide contact information for the responsible person or department and explain the steps to be taken in the event of an incident. A system for keeping track of feedback is important for showing due diligence and a concern for safety. It is also a common sense bit of good practice that you should be doing anyway, probably are doing anyway. Most people and companies instinctively understand that listening when someone is telling you what you are doing wrong is a good idea. The system can be as simple as a file where complaints are kept, a simple spreadsheet or even a database created specifically to monitor feedback. However you keep the data, it should be regularly reviewed and action taken to improve things if necessary.
Review and Updates: Explain the process for regularly reviewing and updating the GPSR file. This should include a schedule for periodic reviews and the criteria for making updates based on new information or changes in regulations.
The file should have a section dedicated to the Economic Operator’s information. This includes the name, contact details, and any relevant identification such as company registration number.
Supporting documentation is another important element. This section should include any relevant files, images, or additional information that can help in establishing that the product is safe. Including comprehensive supporting documents can significantly improve the speed you can respond if you get challenged by customers our the authorities. It can include relevant sections of legislation, industry guidelines, scientific papers and even articles from the trade press or the general press. Referring to related product categories is often useful.
These general outlines are a starting point but the exact detail will depend on the nature of the products you are dealing with. New products are often innovative and groundbreaking, and often claim to be even when they aren’t. Safety on the other hand is an area where a more conservative approach is better. So where possible seek out existing models to draw from. If a framework exists in a related category, adapting it is more advisable than working out your own scheme.
