EU Product Safety Regulation 2023 – Dear and Expensive
2023/06/27 Product safety does not come for free. The EU Product Safety Regulation 2023 sets out essential rules for consumer product safety – which can also be costly for economic operators. From this perspective, some parts of the work are particularly interesting.
Risk analysis for everything and always
Reads like effort: in its wording, the EU Product Safety Regulation requires a risk analysis for all products covered by the regulation. Before manufacturers place their products on the market, they must conduct an internal risk analysis and prepare technical documentation. Without exception.
The technical documentation contains a general description of the product and relevant essential characteristics for the safety assessment. In case of possible risks, further documentation is required, such as results of tests, list of standards, etc. (cf. Art. 9).
All for one: internal procedures for product safety
No economic operator can avoid internal procedures. All means: manufacturers, authorized representatives, importers, distributors, fulfilment service providers and other natural or legal persons who manufacture or provide products in accordance with the Regulation. The internal procedures should make it possible to meet the product safety requirements (see Art. 14).
The new stars
In addition to online marketplace providers, fulfillment service providers have been added to the illustrious circle of economic actors. For fulfilment service providers, obligations are not explicitly mentioned, as in the case of the manufacturer, authorized representative, importer, trader.
However, as an economic operator, they are always included. Fulfilment service providers are all those who offer at least two services in their business: Warehousing, packaging, addressing and shipping of products. Certain postal services are excluded (cf. Art. 3).
Better know the normal use
It is good if you, as an economic operator, think carefully about how your product can be used normally. Reason: You may only place safe products on the market or make them available on the market. And according to the regulation, a product is safe if it offers a high level of protection during normal or reasonably foreseeable use.
Normal use certainly leaves room for interpretation. The same applies to serious risk. In the definition, the risk assessment and the normal and foreseeable use of the product should be taken into account for the assessment of the serious risk (cf. Art. 3, 5).
Suddenly Manufacturer: Criteria for Substantial Modification
You quickly become a manufacturer when you substantially modify products. With all the obligations. The ordinance defines which physical or digital modification affect you.
Accordingly, a substantial modification is when it affects the safety of the product and the modification changes the product in a manner which was not foreseen in the initial risk assessment of the product. And if, in addition, the nature of the hazard has changed, a new hazard has been created or the level of risk has increased because of the modification. And last but not least: if the modifications have not been made by the consumers themselves or on their behalf for their own use.
So you are also quickly subject to the manufacturer’s obligations: if you place a product on the market under your name or trademark (cf. Art. 13).
Full force for warnings about dangerous products
It must be safe: Economic operators must directly and immediately inform all affected consumers in the event of a product safety recall or safety warning. At least those they can identify. It is precisely specified how product safety recalls or safety warnings must be carried out. For example, using customer data, product registration systems, customer loyalty programs, via the company’s website, social media channels, newsletters, points of sale, etc. (see Art. 35).
The form of the recall notice is also specified. Easy to understand, in local language and it must contain certain elements such as headline “Product Safety Recall”, clear description of the recalled product with picture, name, brand, production code numbers and information on when, where and by whom the product was sold as well as description of the hazard. Each element is explained in more detail. This may make the process easier: The EU Commission is to provide economic operators with a template for a simple recall notice (cf. Art. 36).
All requirements also apply to providers of online marketplaces in accordance with their obligations.
Recalls can be expensive
If you are the economic operator responsible for a product safety recall, you must offer the consumer an effective, free and timely remedy. In any case, you must offer the consumer a choice of at least two of the following remedies: Repair of the recalled product, replacement with a safe product of the same type of at least the same value and quality, or reasonable refund of the value, at least at the original price.
The individual measures are further detailed in the regulation. What is essential is that the remedy does not cause significant inconvenience to the consumer – including the cost of shipping or otherwise returning the product, including pickup, if products are not transportable (see Art. 37).
No product without EU domicile
Products may only be placed on the market in the EU if there is a responsible economic operator established in the EU. In addition to his defined obligations, the economic operator must also regularly check whether the requirements for the technical documentation and with regard to manufacturer obligations are fulfilled (cf. Art. 16).
EU Product Safety Regulation 2023 applies from …
The regulation applies from 13 December 2024. It is binding in its entirety and directly applicable in all Member States. Its full name is REGULATION (EU) 2023/988 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and of the Council and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (Text with EEA relevance).
Plan in good time
Ask us if you want to clarify safety aspects of your products with certainty – ideally before the new EU product safety regulation comes into force. Our experts will provide you with reliable advice.
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