§3.1.1 I am a manufacturer: what are my obligations under the GPSR?

Who is a manufacturer? The GPSR defines a manufacturer as any natural or legal person who manufactures a product or has a product designed or manufactured, and who markets the product under the person’s name or trademark. Firstly, the manufacturer must first have either manufactured the product, or had a product designed or manufactured on its behalf. Secondly, it must market the product under its name or trademark. Natural or legal persons are therefore considered manufacturers if they market the product under their name (even if they did not produce the product themselves); additionally, they are also considered manufacturers if they substantially modify the product manufactured by another person and place it themselves on the market. Example: A company A purchases mugs from another company B that produced them. Company A brands them with its logo and sells to consumers. Company A becomes the manufacturer of these mugs and is subject to the manufacturer’s obligations under the GPSR. As a manufacturer, you play the most important role to play in product safety since you are involved from the design stage of the product onward. Your overall obligation is to ensure that the products you place on the market have been designed and manufactured in such a way that they are safe. How to design safe products? The importance of the internal risk analysis You have an obligation to only place or make available products that are safe by design. For this purpose, you must carry out an internal risk analysis, which means a proper risk assessment of the product. You have to take into account a number of elements when assessing the safety of a product. The GPSR provides a non-exhaustive list of elements that need to be taken into account when analysing the potential risk of a given product. You must first consider the characteristics of the product. These include its design, technical features, composition, packaging and instructions. If your product may be used with other products, you also need to take into account the effect of your product on these other products and the effect that other products might have on your product. For example, a software, or its update, might cause overheating of the device due to prompting the device’s processor to overwork. You will also need to consider how to present your product and which safety information, label, warning and instructions for its safe use and disposal you need to affix on your product or its packaging. For instance, depending on the nature of the product, you may need to label the product regarding its age suitability for children, as well as to add any appropriate warnings and instructions. You also need to bear in mind the categories of consumers using your product. You have to pay particular attention to the potential risks that your products might pose for consumers in situations of vulnerability (e.g., children, older people, persons with disabilities…) and take into account characteristics such as the gender of the user. Example: Depending on the nature of the product, you may need to consider that women are usually smaller than men, so that the product’s potential risks must take into account different possible body sizes. Furthermore, you need to consider the appearance of your product, especially when it is likely to confuse consumers. This mainly concerns: — Food-imitating products: you must assess if your product looks like food and can lead consumers to put it in their mouth. Examples would include decorative articles that look like fruits, or a bar of soap that looks like a cupcake, and from which small pieces could detach if bitten into. — Child-appealing products: you must assess if your product, even if not intended for children, is likely to attract their attention and therefore be used by them. This could be the case for instance with a battery or a detergent decorated with cartoon characters. Depending on the nature of your product, you will also have to take into account the cybersecurity features necessary to protect it against external influences and its evolving, learning and predictive functionalities. As explained in the second section of these guidelines, your product will presume to be safe if it complies with (i) the relevant European standards, the references to which have been published in the Official Journal of the EU, for the risks covered by these standards or in their absence, (ii) with the relevant national requirements of the Member State in which your product will be placed or made available on the market. However, if your product does not benefit from such a presumption of safety, or for the risks not covered by these standards, you should carry out a full assessment of its potential risks and ways to eliminate or mitigate them. In this case, in order to assess the risks of your product, you will need to consider to take into consideration a number of additional elements, if available: a) Other European standards; b) International standards; c) International agreements; d) Voluntary certification schemes or similar third-party conformity assessment frameworks; e) Commission recommendations or guidelines on product safety assessment; f) National standards drawn up in the Member State in which the product is made available; g) The state of the art and technology; h) Product safety codes of good practice in force in the sector concerned; i) Reasonable consumer expectations concerning safety; and j) Safety requirements, adopted by the Commission via implementing acts, which are meant to be covered by European standards to ensure that the product is safe. When do I need to draft the technical documentation? Which information should I include in the technical documentation (16) ? Before placing the product on the market, you have to carry out an internal risk analysis as mentioned above and you must draw up a technical documentation to document it. (17) The technical documentation is to be prepared with respect to each product (product model), not individual units thereof. However, if the individual units of a product (product model) are produced with different features that may impact their safety (e.g., different colour, different composition, different functionalities), that makes them specific products and specific technical documentation is required for each of them (18). The technical documentation should contain the risk analysis of the product and highlight all the identified possible risks of the product, irrespective of their risk level. The amount of information and the level of details to be provided in the technical documentation should be proportionate to the complexity of the product and the possible risks identified by the manufacturer. The technical documentation should include: — A general description of the product; — The essential characteristics of the product that are relevant for assessing its safety (e.g., its chemical components, etc.); and — Where appropriate with regard to possible risks related to the product: — An analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks (this might include the outcome of test reports); — A list of relevant European standards applied (if these are only partly applied, specify the parts which have been applied); — In the absence of relevant European standards, a list of national requirements related to the safety of the product, where available; or — Other elements/methods used to assess the safety/mitigate the risks of the products. The technical documentation can be in electronic format and also in form of a file composed by different documents. You should keep the technical documentation up to date and for 10 years after the product has been placed on the market. Below you can find a model template that may help you in the drafting and organisation of your technical documentation. This model template is not compulsory. Technical documentation – model template 1. Product identification: Brand: Name of product: Model type/ batch / serial number or other identification element: Product description: Picture of product: Packaging description: Picture of packaging: 2. Characteristics and composition of product: Characteristics: Material: Composition: 3. Risk analysis and risk mitigation measures You have to describe separately every potential risk identified and the measures that you have taken to mitigate or eliminate this risk or the presumption of conformity provisions (e.g., use of EU standards). Potential risk 1: Description of potential risk: Measures to address this potential risk: — E.g., All substances used in the product and packaging comply with […] — The […] complies with European standard […]- — Warnings and instructions for use provided with the product comply with European standard […] Potential risk 2: Description of potential risk: Measures to address this potential risk: [...] Which information should I provide on/with the product when placing a product on the market? Information you must provide: A) A type, batch or serial number or other element enabling its identification (e.g., barcode) B) Your name as manufacturer C) Your registered trade name or registered trademark D) Your postal and electronic address and, if different, the postal address or electronic address of the single contact point through which consumers can contact you E) Name or registered trademark, and contact details, including the postal and electronic address of the responsible person in the EU for this product How should information listed in points A to E be displayed? You have to ensure that consumers can easily see and read this information. It should be placed on the product or, if that is not possible, on its packaging or in a document accompanying the product. The decision where to display this information is up to you within the framework provided. You should therefore also be able to justify your choice in case of dispute. In principle, only the size of the product (and therefore not, for example, aesthetic or similar reasons) could justify moving some required information from the product to its packaging or other accompanying documents. (19) What does “electronic address” mean? An electronic address can be an e-mail address or dedicated section of your website that enables consumers to contact you directly and easily. A website is not in itself sufficient if it does not allow direct communication with you. F) Clear instructions for safe use G) Clear safety information In which language do I have to provide the information listed in points F and G? You must make sure that these instructions and the safety information are in a language easily understood by consumers. This is determined by the Member State on whose market you place the product. Is this information mandatory in all cases? No, if the product can be used safely and as you intended without such instructions and safety information, then they are not mandatory. This is the case, for instance, for products that pose risks that are well known to consumers (e.g., knives). What are my obligations if I am located outside the EU? It is important to underline the point that for products covered by the GPSR, you can only place a product on the EU market if there is a responsible person for it established in the EU. The responsible person of the product can be the importer, the authorised representative mandated by you or a fulfilment service provider. The identification and contact details of the responsible person must also be indicated on the product (or on its packaging, the parcel or an accompanying document). This can be done directly by you or another operator, but you must ensure that your product is not placed on the EU market unless the contact details of the responsible person in the EU are provided. See more information in point 3.2. What are my obligations if I offer a product via distance sales? If you decide to make products available on the market online or through other means of distance sales, the offer of those products (e.g., a product offer on your e-shop) must clearly and visibly indicate at least the following information: (a) Name, registered trade name or registered trademark of the manufacturer, as well as the postal and electronic address at which they can be contacted; (b) Where the manufacturer is not established in the EU, the name, postal and electronic address of the responsible person within the meaning of Article 16(1) of this Regulation or Article 4(1) of Regulation (EU) 2019/1020; (c) Information allowing the identification of the product, including a picture of it, its type and any other product identifier; and (d) Any warning or safety information to be affixed to the product or to the packaging or included in an accompanying document in accordance with this Regulation or the applicable EU harmonisation legislation in a language which consumers can easily understand, as determined by the Member State in which the product is made available on the market. What are my obligations if I have a registration scheme in place or a customer loyalty programme? The GPSR sets out new obligations if you have (or plan to have): — a registration scheme, through which consumers can, after purchasing a product, voluntarily communicate to the manufacturer some information such as their name, contact information, the product model or serial number, and might derive some benefit from this. — a customer loyalty programme that makes it possible to identify products bought by consumers (e.g., customers have a loyalty card that is scanned when they purchase products, and the history of their purchases is available to the business that has set up the loyalty programme). This excludes customer loyalty programmes that do not enable the identification of products bought by consumers, for instance loyalty cards through which customers can receive some benefits for a certain amount purchased, but for which no data on which products have been bought by the customer are registered. Both systems are efficient ways to identify customers affected by a product safety recall or a safety warning. However, customers might choose not to use them because they are not interested in the other benefits offered by the registration scheme or the customer loyalty programme. They might in particular not want to be contacted for marketing purposes. Under the GPSR, if you have a registration scheme or a customer loyalty programme in place, you must allow consumers to choose to join the registration scheme or the customer loyalty programme for safety-related purposes only. Customers should therefore have the possibility to provide their contact details only to receive safety information (e.g., product safety recalls or safety warnings). In this case, their data should only be used to contact them in the event of a recall or safety warning and should not be processed for any other purpose (such as marketing). After placing the product on the market: — Technical documentation: — You should keep the technical documentation up to date. For instance, a change in the composition of the product should be reflected in the technical documentation. — You should keep that documentation for 10 years after the product has been placed on the market. You must be able to provide that documentation to authorities upon request. — Internal processes: you should have procedures in place to ensure that products produced in series remain safe as well as internal processes for product safety in place that allow you to comply with your obligations under the GPSR (e.g., quality controls, staff trained on product safety issues and knowledgeable on EU product safety legislation, introduction of product safety learning paths, procedures to follow when information on accidents or complaint is received, etc.). What should I do if a safety issue arises? If you consider or have reason to believe that a product you placed on the market is dangerous (for instance because of an accident reported by a consumer or by an actor in the supply chain), you must immediately take the following steps: 1) Take the corrective measures necessary to effectively manage a safety risk and bring the product into conformity Examples of corrective measures you can take: — Recall of the product from end-users (see the provisions related to information on recalls, recall notices and remedies in the case of a recall in point 3.4.1); — Withdrawal of the product from the market; — Destruction of the product; — Stop of sales; — Marking the product with appropriate warnings on the risks; Warning consumers of the risks. You should monitor the effectiveness of the measure you adopted and adapt it if necessary. You may have to take several different measures simultaneously. 2) Inform consumers about the dangerous product(s) You have to inform consumers in the event of a product safety recall or a safety warning (information that has to be brought to the attention of consumers to ensure the safe use of a product. See point 3.4.1 for details). You can use the Safety Business Gateway (20) to alert consumers and authorities at the same time (the information provided can be different in terms of details and technicality). Information submitted via the Safety Business Gateway and intended for the public will be made available to consumers on the Safety Gate Portal. 3) Inform the market surveillance authorities of the Member States in which the product has been made available on the market How should I inform the market surveillance authorities? You have to use the Safety Business Gateway (see point 3.4.3). This tool enables you to select all the Member States in which the dangerous product has been made available and to inform authorities immediately and simultaneously. What type of information do I have to communicate to consumers and to authorities? You must give details of: — the risk to the health and safety of consumers: describe in a clear and understandable way what can happen if using the product; — any corrective measure already taken; and — if available, the quantity, by Member State, of products still circulating on the market. 4) Inform in a timely manner other economic operators, responsible persons, and providers of online marketplaces in the supply chain concerned of any safety issue that you have identified This transmission of information is key to addressing the safety issue quickly. Complaints and accidents You have the following obligations regarding consumer complaints and accidents: 1) Have a channel for consumer complaints You must have a communication channel such as a telephone number, electronic address or dedicated section of your website that enables consumers to submit complaints and inform you of any accident or safety issue they have experienced with a product. This communication channel might be the same as the single contact point you need to display on the product (the postal or electronic address of the single contact point at which you can be contacted). This should take into account the accessibility needs of persons with disabilities. For instance, not all information should be in a picture that cannot be read by a text-to-audio software. (21) 2) Investigate complaints You must investigate all complaints received from a consumer or information about an accident concerning the safety of a product. If it appears justified, you should take a corrective measure. If the consumer has reported an accident concerning the safety of a product, you must report it to the authorities using the Safety Business Gateway. You must keep an internal register of: — consumer complaints and information on accidents; — product recalls; and — any corrective measures taken to bring the product into conformity. You should only store in this internal register of complaints the personal data that you need in order to investigate the complaint. Such data should only be kept for as long as they are necessary for the purposes of the investigation. In any case, you should delete personal data (e.g., the name and address of the consumer) from the register five years after the data have been entered into it. 3) Report accidents related to the safety of products When you are informed or obtain knowledge about an accident caused by a product you placed or made available on the market, you must notify the accident to the competent authorities of the Member State where the accident has occurred, as soon as possible via the Safety Business Gateway. When you are informed by importers or distributors that such accidents have occurred, you must notify these accidents to the competent authorities yourself or instruct the importer, or one of the distributors, to make the notification. What constitutes an accident related to the safety of products? Accidents that must be notified are occurrences associated with the use of a product that resulted in an individual’s death or in serious adverse effects on that individual’s health and safety. These effects can be permanent or temporary. They can include injuries, other damage to the body, illnesses and chronic health effects. Which tool do I have to use to notify the accident? You must use the Safety Business Gateway (see point 3.4.3). What type of information do I have to include in the notification? You must specify: — the type and identification number of the product; and — the circumstances of the accident, if known (for instance, the age of the victim of the accident if relevant, as well as how the product was being used when the accident happened). Check list for the manufacturer ✓ Safety by design: make a proper risk assessment of the product when designing it and eliminate or mitigate all possible safety risks. ✓ Think about using European standards, the references to which have been published in the Official Journal of the EU, where they exist. They facilitate your compliance. ✓ Draw up technical documentation for your product to keep track of your internal risk assessment and keep it for 10 years. ✓ Make sure you affix the necessary information to your product or its packaging: indicate product identification details, your identification and contact details, instructions and safety information if needed. ✓ Ensure that there is a responsible person for your product in the EU and that its contact details and other required information are indicated on the product or on its packaging, the parcel or an accompanying document. ✓ Display the required product information in distance sales offers: — product identification details and its picture, — your identification and contact details, — identification and contact details of the responsible person for the product if you as manufacturer are not established in the EU, — instructions and safety information if needed. ✓ If you have a registration scheme or a customer loyalty programme in place, you must offer the possibility for consumers to subscribe for safety-related purposes only. ✓ Set up internal processes for product safety. ✓ If product safety issue arises: — Take corrective measures (for recalls use the template recall notice and provide remedies) — Inform consumers — Inform national authorities via the Safety Business Gateway — Inform other businesses in the supply chain ✓ Have a direct channel for consumer complaints about product safety and investigate these complaints: this can bring you precious information about safety of your product. Think about accessible formats. ✓ Keep an internal register of consumer complaints, product recalls and corrective measures taken. ✓ Report product-related accidents you become aware of via the Safety Business Gateway. ✓ Cooperate with market surveillance authorities when requested. For more details, refer to the section 3.1.1. on manufacturer’s obligations.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07