New regulation on general product safety
The Regulation on the General Safety of the Product (RGSP) is published in the Official journal of the European Union on may 23, 2023 and enter officially into force on December 13, 2024. This new regulation will replace the current Directive on general product safety currently in force. It is a step taken by the EU to the protection of the consumer goods and hardens substantially some of the requirements on products.
This regulation introduces many important changesas the application of the principles of precaution, the increased demand for products, strategies specific to the market in line with the order to ensure the safety of products, etc. This regulation requires that the economic operator to ensure that imported products meet the european standards and have technical documentation and declaration of conformity, among other innovations.
Whether you are a Amazon seller, from any and commerceamounts of products from outside the EU or even manufacture and designing your own products, this interests you. The changes are very important and platforms such as Amazon are already starting to ask for documentation, in order to comply with their obligations under the new Regulation as the providers of online services.
General obligations of manufacturers
The General Safety Regulation of Product (RGSP) has established a series of legal obligations to ensure the safety of consumers and to ensure that the products that fall in the european market comply with the regulations. Below, we're going to reel off one by one, the changes that we consider most important and the ways of dealing with them.
Applicable to the products without specific regulations: In Recital 8 of the Regulation, we find the first interesting point that we must take into account and which tells us about the implementation of this Regulation to products that are not affected by harmonisation legislation. This means that to apply the new Rules in their entirety, to the products that lack of specific regulations, and in certain parts, to all products
Obligation of the technical file or technical documentation: Here we run into one of the key elements of these regulations and which affect in a big way, any seller, and this is the task of preparing the technical documentation of any product, which, until now, it was only mandatory for products with specific regulations. Manufacturers are required to prepare technical documentation for products placed on the market, which should contain the necessary information to demonstrate its safety.
This documentation is based on an internal analysis of risks carried out by the manufacturer, and should be proportional to the complexity of the product and the potential risks identified.
Essentially, you must include a general description of the product and the items needed to evaluate its safety. For complex products or those with potential risk, it may require a more detailed description, as well as an analysis of risks and the technical measures taken to mitigate them. In addition, when the product complies with the european standards or other requirements to ensure your safety, you must include a list of these standards or elements to be applied.
If you want to delve deeper, we have a blog article on a reading of 2 minutes to develop everything related to the technical documentation.
Condition of manufacturer: Before the boom of the private brand as a business model, you have to be very aware of the obligations that this entails and in recital 34 of the new Regulation makes it clear. If you do private label, you have the manufacturer's obligations, and in this case it is worth to transcribe literally this section of the standard: “Any natural or legal person to enter a product on the market under his own name or trademark, or substantially modified in a manner that may affect its compliance with the requirements of this Regulation, should be considered as your manufacturer and to assume the obligations and, as such, are appropriate”.
It is important to break down, at least in summary form, the specific obligations of the manufacturer which are detailed in article 9:
Compliance with the safety requirement: Ensure that products are designed and manufactured in accordance with the general safety requirements.
Risk analysis and technical documentation: Perform an internal analysis of risks and develop technical documentation that describes the product and its features essential to assess their safety. The complexity of the technical documentation will be proportional to the complexity of the product.
Maintenance and availability of the technical documentation: Make sure that the technical documentation is updated and available to the market surveillance authorities for at least 10 years.
Product id: Make sure that each product will have a model number or serial number for identification.
Manufacturer contact information: Indicate clearly the name, address and contact number of the manufacturer on the product or on its packaging.
Clear instructions and safe: Manufacturers must include clear instructions and product safety for consumers, in a language easily understandable, as determined by the member State of marketing. However, this requirement is not applicable if the product can be used safely without any 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're probably familiar with this figure. Until now, companies outside the EU that commercially available products with the CE marking or subject to specific regulations, they were required to appoint an authorized representative formed within the EU. This changed radically with the publication of the new Regulation, which will force from 13 December 2024 to name this figure for any type of product.
Obligations for online retailers: When products are sold online or through other means of distance selling, the economic operators must provide the following information in a clear and visible on the product offer:
– Name, registered trade name or trademark of the manufacturer, along with your mailing address and email for contact.
– In case the manufacturer is not in the European Union, you must provide the name and mailing address, and email of the responsible person according to what is established in the relevant regulations.
– Information to identify the product, including an image, model, and any other identifier.
– Warnings and safety information required by the legislation of the Union, in a language easily understandable to the consumer, as determined by the member State where the product is marketed.
Operators on-line such as Amazon, are already enabling areas in their listings where are the safety warnings on the products, instructions, etc
Save a copy of the technical documentation: Manufacturers must maintain a copy of the technical documentation for their products for at least 10 years from the introduction of the product in the market. If the documentation is requested by the market surveillance authorities, importers must provide a copy of the documentation to the authorities.
Investigation of complaints and accidents: Manufacturers are required to investigate complaints and information on accidents related to the security of the products that they market. You will have to submit these complaints, along with the information on product recalls and the corrective actions taken, in the corresponding register. Importers must report on such an investigation and its results to manufacturers, distributors, and suppliers.
Requirements of Amazon and other platforms
The new Regulation, are responsible for the providers of services of online sales platforms (Amazon), of the data contained in your site. If you sell on Amazon, you've probably received an email, in which they refer to the seller at a table with a series of documents that must be uploaded to the platform.
In the own detail that Amazon provides, it gives a list of documents optional to upload, all related to the technical documentation of the product, including safety data sheet (SDS), instruction manual, security warnings, etc., The platform itself does not specify which are mandatory and which are not, it just says that you can upload one or all of the documents and this fits in perfectly with the dictates of the Regulation on the complexity of the technical documentation.
As we have already seen in Recital 33, the new Regulation establishes that the information contained in the technical documentation should be proportionate to the complexity of the product itself. At the moment we do not know if the platforms Amazon, they're going to set any of these documents as required, since the legislation has not even entered into force, but it is not going to anticipating and preparing is documentation.
In conclusion, the General Regulation of Product Safety and aims to improve the safety of products through the application of stringent requirements for manufacturers, importers, and service providers.
If you have doubts on how to compile the technical documentation for your product, please contact with us and we will be happy to assist you.
