New General Product Safety Regulation

New regulation on general product safety

The General Product Safety Regulation (RGSP) was published in the Official Gazette of the European Union on May 23, 2023 and will officially take effect on December 13, 2024. This new regulation will replace the current General Product Safety Directive currently in force. This is a step taken by the EU for the protection of consumer goods and that substantially tightens some of the requirements on products.

This regulation introduces many important changes, such as the application of precautionary principles, increased demand for products, specific strategies for the online market in order to ensure product safety, etc. This regulation requires the economic operator to ensure that imported products comply with European standards, have technical documentation and a declaration of conformity, among other new features.

Whether you are an Amazon seller, of any e-commerce, whether you import products from outside the EU or even manufacture and design your own products, this interests you. The changes introduced are very important and platforms such as Amazon are already starting to request documentation, in order to comply with the obligations imposed on them by the new Regulation as online service providers.

General obligations of manufacturers

The General Product Safety Regulation (RGSP) has established a series of legal obligations to ensure consumer safety and ensure that products entering the European market comply with regulations. Next, we are going to break down one by one, the changes that we consider to be the most important and how to deal with them.

Applicable to products without specific regulations: In Recital 8 of the Regulation, we found the first interesting point that we must take into account and that tells us about the application of this Regulation to products that are not affected by harmonization legislation. This means that the new Regulation will apply in its entirety, to products that do not have specific regulations and in certain parts, to all products

Mandatory nature of the technical file or technical documentation: Here we are faced with one of the key elements of these regulations, which greatly affect any seller, and this is the obligation to prepare the technical documentation for any product, which, until now, was only mandatory for products with specific regulations. Manufacturers are required to prepare technical documentation for the products they place on the market, which must contain the information necessary to demonstrate their safety.

This documentation is based on an internal risk analysis performed by the manufacturer and must be proportional to the complexity of the product and the potential risks identified.

Essentially, it should include an overview of the product and the necessary elements to evaluate its safety. For complex products or those with potential risks, a more detailed description may be required, as well as an analysis of risks and the technical measures taken to mitigate them. In addition, when the product complies with European standards or other requirements to ensure its safety, a list of these standards or applied elements must be included.

If you want to go deeper, we have an article on the blog for a 2-minute read developing everything related to technical documentation.

Manufacturer condition: Faced with the rise of private branding as a business model, we must be very aware of the obligations that this entails and in recital 34 of the new Regulation, he makes this clear. If you make a private label, you have the obligations of the manufacturer and in this case it is worth transcribing this section of the standard literally: “Any natural or legal person who places a product on the market under their own name or brand, or modifies it substantially in a way that may affect its compliance with the requirements of this Regulation, must consider itself its manufacturer and assume the obligations that correspond to it”.

It is important to break down, at least in summary form, the manufacturer's specific obligations that are detailed in Article 9:

Compliance with the safety requirement: Ensure that products are designed and manufactured in accordance with general safety requirements.

Risk analysis and technical documentation: Perform an internal risk analysis and prepare technical documentation describing the product and its essential characteristics to assess its safety. The complexity of the technical documentation will be proportional to the complexity of the product.

Maintenance and availability of technical documentation: Ensure that technical documentation is up to date and available to market surveillance authorities for at least 10 years.

Product identification: Make sure that each product has a model or serial number for identification.

Manufacturer's contact information: Clearly indicate the name, address and contact of the manufacturer on the product or on its packaging.

Clear and safe instructions: Manufacturers must include clear instructions and product safety for consumers, in easily understandable language, as determined by the Member State of marketing. However, this requirement does not apply if the product can be used safely without such instructions.

Responsible person or authorized representative: If you sell in the EU, using as a legal form an LLC or a company incorporated outside the Union, you are probably familiar with this figure. Until now, companies from outside the EU that marketed products with the CE mark or subject to specific regulations, were required to appoint an authorized representative constituted within the EU. This changes radically with the publication of the new Regulation, which will require, as of December 13, 2024, to name this figure for any type of product.
 

Obligations for online sellers: When selling products online or through other means of distance selling, economic operators must provide the following information clearly and visibly in the product offering:

- Name, registered trade name or trademark of the manufacturer, together with your postal and email address for contact.

- If the manufacturer is not in the European Union, the name and the postal and email address of the responsible person must be provided as established in the relevant regulations.

- Information that allows the product to be identified, including an image, model and any other identifier.

- Warnings or safety information required by Union legislation, in a language that is easily understandable to consumers, determined by the Member State where the product is marketed.

Online operators such as Amazon are already enabling zones in their listings where product safety warnings, instructions, etc. appear.

Keep a copy of the technical documentation: Manufacturers must keep a copy of the technical documentation for their products for at least 10 years after the product is introduced to the market. If the documentation is requested by market surveillance authorities, importers must provide a copy of the documentation to the authorities.
 
Investigation of complaints and accidents: Manufacturers must investigate complaints and information about accidents related to the safety of the products they sell. They must submit those complaints, together with information about product recalls and corrective measures taken, in the appropriate register. Importers must report such research and its results to manufacturers, distributors and suppliers.

Amazon and other platform requirements

The new Regulation makes online sales service providers (Amazon-like platforms) responsible for the data that appears on their site. If you sell on Amazon, you have probably received an email, in which they refer the seller to a table with a series of documents that must be uploaded to the platform.

In the very detail offered by Amazon, it gives a list of optional documents to upload, all related to the technical documentation of the product, including safety data sheet (SDS), instruction manual, safety warnings, etc. The platform itself does not specify which are mandatory and which are not, it simply says that you can upload one or all of the documents and this fits perfectly with what the Regulation itself dictates on the complexity of technical documentation.

As we have already seen in Recital 33, the new Regulation establishes that the information contained in the technical documentation must be proportional to the complexity of the product itself. At the moment, we do not know if Amazon-like platforms are going to establish any of these documents as mandatory, since the regulations have not even come into force, but it doesn't hurt to anticipate and prepare this documentation.
 
In conclusion, the General Product Safety Regulation aims to improve product safety by applying strict requirements for manufacturers, importers and service providers.

If you have questions about how to prepare the technical documentation for your product, please contact us and we will be happy to assist you.