GPSR Overview

Manufacturers shall ensure that the technical documentation referred to in paragraph 2 is up to date. They shall keep that documentation at the disposal of the market surveillance authorities for a period of 10 years after the product has been placed on the market and make that documentation available to those authorities upon request.

Manufacturers shall ensure that procedures are in place for products produced in series to remain in conformity with the general safety requirement laid down in Article 5

Manufacturers shall ensure that their products bear a type, batch or serial number or other element enabling the identification of the product and which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.

 Manufacturers shall indicate their name, their registered trade name or registered trade mark, their postal and electronic address and, where different, the postal or electronic address of the single contact point at which they can be contacted. That information shall be placed on the product or, where that is not possible, on its packaging or in a document accompanying the product.

Manufacturers shall ensure that their product is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market. That requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.

Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for persons with disabilities, enabling consumers to submit complaints and to inform manufacturers of any accident or safety issue they have experienced with a product.

Manufacturers shall investigate complaints submitted, and information received on accidents, that concern the safety of products they made available on the market and which have been alleged to be dangerous by the complainant, and shall keep an internal register of those complaints as well as of product recalls and any corrective measures taken to bring the product into conformity.

The internal register of complaints shall only store those personal data that are necessary for the manufacturer to investigate the complaint about an alleged dangerous product. Such data shall only be kept as long as is necessary for the purposes of the investigation and in any event no longer than five years after the data have been entered.

1. A manufacturer may, by means of a written mandate, appoint an authorised representative.
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorized representative shall provide the market surveillance authorities with a copy of that mandate upon request. The mandate shall allow the authorised representative to perform at least the following tasks:

(a) providing a market surveillance authority, upon that authority’s reasoned request, with all information and documentation necessary to demonstrate the safety of the product in an official language which can be understood by that authority;

(b) where the authorised representative considers or has reason to believe that a product in question is a dangerous product, informing the manufacturer thereof;

(c) informing the competent national authorities about any action taken to eliminate the risks posed by products covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer;

(d) cooperating with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by products covered by their mandate.

A technical file gathers all relevant information relating to product safety. It will include test reports, risk assessments (that are the responsibility of the manufacturer), information on traceability, etc.

What is contained within the risk assessment will depend on the complexity of the product and the potential hazard levels. If relevant, it must address, inter alia, physical, mechanical, flammability and chemical hazards. For example, there are no physical or mechanical hazards associated with a plain t-shirt, but chemical safety must be assessed to ensure harmful substances have not been used during manufacturing.

Various sources are available to help manufacturers develop a relevant risk assessment, but there is no official single template. Depending on the product category, information can be found through the European Safety Gate or in Technical Reports published by the European Committee for Standardization (CEN).

Article 18 of the General Data Protection Regulation (GDPR) has a reminder that the Commission shall indicate in relevant delegated acts whether it has used the risk analysis methodology defined in Commission Implementing Decision (EU) 2019/417 or, if this methodology is not appropriate for the product concerned, provide a detailed description of the methodology used.

There are several questions regarding the meaning of ‘electronic address,’ the contact point in the EU and which address should be indicated in instances where the product is manufactured outside the EU.

The term ‘electronic address’ is used in the regulation to denote progression and technological neutrality. It represents any direct electronic means of communication and could be, for example, an email address or a website that includes a means of communication (contact form, direct chat, etc.) Therefore, the translation of ‘electronic address’ as ‘email address’ in some countries is questionable.

In cases where the manufacturer is located outside the EU, but there is a contact point that is an economic operator other than the manufacturer, information concerning both the manufacturer and point of contact must be affixed to the product or its packaging (Article 9 (6)).

It is also important to remember that a product covered by the GPSR can only be placed onto the European market if there is an economic operator established in the Union responsible for the tasks referred to in Article 4 (3) of Regulation (EU) 2019/1020. Information on this responsible actor must also be displayed on the product or its packaging (Article 16 (3)).

According to the regulation, contact information and a means of identification must be affixed to the product, unless this is impossible. However, it is not completely clear what are the acceptable conditions for determining that a product cannot be marked. Size and technical impossibility are potential reasons, but there are instances where labeling may technically be possible, even if it is very complicated.

Since there are no detailed instructions to follow, this will certainly be determined case by case. However, we think aesthetic reasons will not be valid.

The GPSR does not require the CE mark to be affixed to products. However, if any function of the product is covered by a directive or a regulation, for example, Directive 2009/48/EC, the Toy Safety Directive (TSD), then CE marking requirements will still be applicable.

Instructions for use must be provided with the product as soon as they are necessary to enable safe use. It should always be remembered not everyone has access to the internet and so there should always be the facility for them to receive instructions in paper format.