Short answer
Since 13 December 2024, the General Product Safety Regulation (EU) 2023/988 requires every consumer product sold in the EU to be safe, to have a risk analysis and technical documentation kept for 10 years, to carry manufacturer and product identification, and to have an economic operator established in the EU. Online listings must show this information too.
The General Product Safety Regulation (EU) 2023/988, known as GPSR, replaced the old General Product Safety Directive on 13 December 2024. For manufacturers outside the EU, it closed a gap: products without CE marking, such as kitchenware, textiles, furniture or decorations, now also need an EU-established responsible operator.
Which products are covered?
GPSR applies to non-food consumer products, new or second-hand, sold online or offline. It covers:
- products with no specific EU harmonisation legislation, the classic GPSR products;
- CE-marked products, for safety risks not covered by their specific legislation.
Medicines, food and some other categories regulated elsewhere are excluded.
The six things a non-EU manufacturer must have
1. A risk analysis and technical documentation
Before placing a product on the market, you must carry out an internal risk analysis and draw up technical documentation: a general description of the product, its essential safety characteristics, and the analysis of possible risks and the solutions adopted. Keep it up to date and available for 10 years.
2. Product identification
The product must carry a type, batch or serial number, or another element allowing identification, visible to consumers. If size or nature does not allow it, put it on the packaging or an accompanying document.
3. Manufacturer details
Your name, registered trade name or trade mark, and postal and electronic address must appear on the product, or on the packaging or accompanying document when that is not possible.
4. An EU responsible operator
Under Article 16 of GPSR, which refers to Article 4 of Regulation (EU) 2019/1020, a product may not be placed on the EU market unless there is an economic operator established in the EU responsible for it: manufacturer, importer, Authorized Representative or fulfilment service provider. Its name and contact details must accompany the product.
5. Instructions and safety information
Instructions and safety warnings must be in a language easily understood by consumers in the member state where the product is sold. For Romania, that means Romanian.
6. Accident and recall procedures
Manufacturers must notify accidents caused by their products through the EU Safety Business Gateway and must be able to organise effective recalls. Your EU operator must be informed and must cooperate.
Online sales: what your listing must show
Article 19 of GPSR requires distance sales offers to display clearly:
- the manufacturer’s name, postal and electronic address;
- where the manufacturer is not in the EU, the name and contact details of the EU responsible person;
- information identifying the product, including a picture, type and any other identifier;
- any warning or safety information to be affixed to the product or included in the manual.
Marketplaces enforce this. Listings without a valid EU responsible person are increasingly blocked or removed.
A practical checklist
- Product list with models and identifiers
- Risk analysis for each product type
- Technical documentation file
- Label with manufacturer details and identification
- Instructions and warnings in the languages of your markets
- Written mandate with an EU responsible operator
- EU operator details added to labels and online listings
- Internal procedure for complaints, accidents and recalls
How ISOCONSULT helps
ISOCONSULT S.R.L. acts as your GPSR responsible person in the EU. We review your risk analysis and documentation, approve your label, archive your file for 10 years and provide the details you need for your listings. Request a quote.
This article is general information about EU product legislation and is not legal advice. Requirements depend on the exact product; contact us for an assessment of your case.