GPSR Regulation

The General Product Safety Regulation (GPSR) is an EU regulation aimed at ensuring that all products placed on the EU market are safe for consumers. The GPSR entered into force on December 13, 2024, replacing the previous General Product Safety Directive.

Who does GPSR apply to?

The GPSR Regulation imposes obligations on marketplace platforms, producers, responsible persons, importers, distributors and sellers, including those selling online – both through their own online store and through the marketplace.

GPSR application scope – what products does GPSR apply to?

The GPSR covers all consumer products introduced to the European Union market, regardless of how they are sold – both in-store and online. This is particularly important in the age of rapidly growing e-commerce. The regulations apply to new, used, repaired, and refurbished products, except those that require repair before use and are clearly marked as such.

What products are excluded from GPSR?

The regulation does not cover the following products:

  1. medicinal products – both intended for human use and for
    veterinary medicinal products;
  2. food;
  3. feed;
  4. living plants and animals, genetically modified organisms and plant and animal products directly related to their future reproduction;
  5. animal by-products;
  6. plant protection products;
  7. equipment used in transport services (moving or
    travel);
  8. aircraft;
  9. antiques.

Hierarchy of requirements

When verifying product safety obligations, it is necessary to verify applicable industry or sectoral requirements, which can be found, among other things, in specific regulations or national standards for a specific product. The GPSR regulates obligations to the extent that they are not covered by specialized or more detailed regulations.

Responsibilities and GPSR

Generally speaking, responsibilities include:

  • ensuring that products are safe and preparing technical documentation
    documenting this circumstance,
  • placing information on products identifying the manufacturer and seller
    and, if necessary, the importer,
  • including instructions and warnings in the language of the country where the product is sold,
  • monitoring the safety of products after they are introduced to the market and
    taking action in the event of threats being identified.

The specific scope of responsibilities depends on the role in the supply chain.

Who is the producer in the light of GPSR?

Manufacturer means any natural or legal person who manufactures a product or who has a product designed or manufactured and markets that product under his name or trademark.

According to GPSR, a producer is a natural or legal person who produces a product or who:

  1. commissions:
    1. product design
      or
    2. product manufacturing
  2. and sells this product:
    1. under your own name
      or
    2. under its own trademark.

GPSR Manufacturer Obligations

The manufacturer is obligated to collect and maintain complete documentation regarding the products offered. A key aspect of compliance with the GPSR and other applicable regulations is conducting an internal risk analysis and developing technical documentation. This documentation should include, at a minimum, a general description of the product and its key characteristics that impact safety assessment. All required documents must be made immediately available to regulatory authorities upon request.

What does a manufacturer need to take care of in relation to GPSR?

The manufacturer must take particular care to:

  1. adapting labels/packaging to new requirements – labels require
    verification of all necessary information and the form of its submission
    presentation, including the product series identification number,
  2. attaching instructions to products in the target language,
  3. posting safety information on the website,
    product cards,
  4. preparing a risk analysis,
  5. handling security reports.

Who is an importer under GPSR?

Importer means any natural or legal person established in the EU who places a product from a third country on the EU market.

The importer according to GPSR is:

  1. a natural or legal person who:
    1. has in the European Union:
      1. domicile
        or
      2. headquarters
    2. and places a product from outside the EU on the EU market.

Obligations of the GPSR importer

What must an importer do before placing goods on the market?

Before placing a product on the market, importers must indicate their details on the product label or packaging, ensure that it meets the safety requirements set out in the GPSR and that the manufacturer has fulfilled the following obligations:

  1. conducted a risk analysis and prepared technical documentation containing at least a general description of the product and its key features relevant to the safety assessment,
  2. Mark the product with a type, batch, or serial number, or other legible and visible identification element. If this is not possible due to the size or specific nature of the product, the required information should be included on the packaging or in the accompanying documentation,
  3. included all required information on the label or packaging, in accordance with
    applicable regulations.

Who is a distributor under GPSR? Who is a seller under GPSR?

Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

Distributor/Retailer according to GPSR:

  1. a natural or legal person in the supply chain who
  2. is not a manufacturer or importer
  3. and makes the product available on the EU market.

GPSR Distributor Obligations | GPSR Seller Obligations

Before placing a product on the market, distributors must ensure that the manufacturer has met the requirements for product identification, including labeling it with a batch, type, or serial number, and, if the product is limited by size or nature, including this information on the packaging or in the documentation. Furthermore, they should verify that the manufacturer has provided all necessary labeling information and included instructions for use and safety information in a language understandable to consumers, if these are necessary for the proper and safe use of the product.

Distributors are also required to verify that the importer has provided their information on the product label, such as company name, postal and email addresses, and that this information does not obstruct the reading of other required markings. Additionally, they must verify that the importer has provided appropriate instructions for use and safety information in the official language of the country where the product is made available, provided that these are necessary for its safe use.

Who is the responsible person under GPSR?

Each product must have a designated person or entity responsible for its compliance with regulations, and their contact details must be included on the packaging, product or user manual.

Who must appoint a responsible person?

An entity that places goods on the market (producer) and does not have a place of residence or registered office in the EU.

What must every GPSR product have?

  1. Information about the manufacturer and his contact details.
  2. Information about the importer/seller and their contact details.
  3. Safety information.
  4. Instructions - if the use of the product requires it.
  5. Technical documentation, including risk analysis (further documentation depending on the outcome of the analysis).

Obligation to provide manufacturer's data

What data must the manufacturer indicate on the product/label/packaging?

  1. name and surname or your name,
  2. registered trade name or registered trademark,
  3. company postal address,
  4. e-mail address,
  5. postal or e-mail address of the contact point, if different from the company address,
  6. product code, batch number.

Can the information be placed on the packaging instead of the product?

As a general rule, information should be placed on the product itself. It can only be placed on the packaging or in a document accompanying the product if the size or nature of the product prevents it from being placed directly on the product.

Importantly, aesthetic values ​​are not considered as a factor determining whether information should be placed on the packaging or in an accompanying document instead of on the product.

What should be included on the product card in the online store in connection with
GPSR?

  1. Details of the manufacturer, importer, seller: name and surname or name, registered trade name or registered trademark of the manufacturer and postal address and electronic e-mail address/link to the contact form – this cannot be a link to the website itself.
  2. Details of the responsible person (if the manufacturer is not based in the EU): name and surname or business name and postal address and e-mail address/link to the contact form – this cannot be a link to the website itself.
  3. Product identification information, including product image, type, and other product identifiers.
  4. Any warnings or safety information that should appear on or on the packaging or in an accompanying document in accordance with the GPSR or applicable Union harmonisation legislation, 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.
  5. Assembly, operation and use instructions (if applicable).
  6. Photos of packaging containing information about the manufacturer, importer (if applicable), seller, responsible person (if applicable), warnings and safety information.

Preparing for GPSR implementation

To comply with GPSR requirements, you must:

  • analyze current procedures and ensure that products meet new safety standards;
  • update product documentation, including risk analysis, instructions and warnings;
  • ensure that the manufacturer's or importer's details are visible on the product/packaging, product data sheet and product documentation;
  • monitor changes in regulations and adapt to them on an ongoing basis.

Consequences of not implementing GPSR

Each country was required to define sanctions in its national laws.

Fines vary and depend on the entity's role in the supply chain – they can amount to up to PLN 1,000,000 (one million zlotys) per product.

Contact