AUTHORIZED REPRESENTATIVE FOR GENERAL PRODUCT SAFETY (GPSR)

Manufacturers placing product on the EU or UK market have specific obligations under the EU Directives and UK Regulations. These include appointing and Authorized(where the manufacturer is not established in the EU or UK)

EU requirements:Directive 2001/95/EC on General Product Safety(the "GPSR") aims to ensure that only safe products are made available to consumers. It defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.

UK requirements: The UK’s General Product Safety Regulations 2005/1803 (the "GPSR") aims to ensure that only safe products are made available to UK consumers. This defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.

Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales) and (2) Northern Ireland.

It is the manufacturer’s responsibility to comply with the GPSR when selling products in the UK, including if you are selling online directly or via through fulfilment centre. (Such as Amazon or Ebay).

WHAT PRODUCTS ARE IN THE SCOPE OF THE GPSR AND GPSD?

Both the GPSD and GSPR apply to any new, used, or reconditioned product that is intended for consumers or those where it is reasonably foreseeable that consumers may use it. This includes products supplied or made available in the course of a commercial activity, including in the context of providing a service.

They also applies to products that come within the scope of sector specific EU legislation (see our other pages on specific product such as Toys, Low Voltage equipment, Cosmetics etc.).

Exceptions to the scope are specific higher risk products ie pharmaceuticals, medical devices, and food as these product types fall under separate legislation. (again see our other pages relative to these products)

Is CE marking necessary for GPSD compliance?

GPSD does not fall under the CE marking directive and therefore does not necessitate CE marking. However, if a product is subject to both GPSD and one or more CE marking directives, like the Low Voltage Directive and the EMC Directive, CE marking becomes obligatory. Any product covered by at least one CE marking directive must bear the CE marking.

General Guidelines

This directive outlines safety standards for consumer goods like bicycles and treadmills. Manufacturers must ensure that their products meet safety requirements outlined in the GPSD.

Compliance with relevant harmonized standards implies adherence to the safety regulations of the directive. The European Commission’s website offers a downloadable list of harmonized standards, while specific standards can be found on CENELEC’s website.

In cases where specific harmonized standards are unavailable for a particular product, alternative references include:

• Voluntary standards
• International standards
• Codes of good practice for product safety

Manufacturers are generally required to conduct tests on their products to demonstrate compliance with relevant standards. They should also maintain records of complaints and promptly inform distributors of these.

Documentation for GPSD Compliance

There are instances where manufacturers may need to furnish documentation such as user manuals and test findings. While not always mandatory under the GPSD, having such documentation can serve to validate a product's compliance and aid consumers in its safe utilization.

User Manuals

Although not explicitly mandated by the directive, providing user manuals to end-users can enhance safety by delineating proper product usage. Here are some details you might consider incorporating into the user manual:

• Assembly guidelines
• Installation procedures
• Maintenance instructions
• Operating guidelines
• Disposal recommendations
• Test Findings

Article 5 of the GPSD, outlining producer obligations, suggests conducting sample testing of products available in the market when deemed necessary. Consequently, it may be requisite to subject your products to tests aligning with pertinent standards and criteria.

Upon successful completion of the tests, the testing laboratory will furnish a test report, serving as substantiation of compliance with applicable requirements.

Product Labelling Requirements

Manufacturers are responsible for appropriately labelling their products, including providing traceability details and warnings.

Traceability Details

As per the directive, producers must include the following traceability information on the product or its packaging:

• Producer’s identification and contact information
• Product reference
• Batch information (if applicable)

Provision of Warnings

Where necessary, manufacturers are obliged to affix pertinent warnings on the product, indicating potential risks. These warnings should meet the following criteria:

• Relevance to the product's risks
• Readability
• Clarity in wording
• Compliance with the official languages of the Member State

PART I - EU REQUIREMENTS

Manufacturers should only provide safe products to consumers. In addition, Manufacturers must provide consumers with all relevant information needed to use the product safely or take necessary precautions to mitigate any risk.

The presence of warnings does not exempt a person from compliance with the requirements of the GPSD.

The Manufacturer should also adopt measures to be kept informed of risks that their product may pose and take appropriate action to avoid these risks (including withdrawal or recall or warning consumers). Taking appropriate action (including withdrawal or recall) is to be done on a voluntary basis or on the request of a competent authority. However, if Manufacturers become aware or know that a product is not safe, they must immediately inform the competent authorities of the Member States and cooperate with them.

The precise requirements of Manufacturer obligations may vary between Member States. Examples of other measures that Manufacturers may be required to do to ensure the safety and compliance of their products include:

• Including information on the product or its packaging for consumers, such as the identity and details of the Manufacturer and the product reference or, where applicable, the batch of products to which it belongs; and
• In all cases where it is appropriate, carrying out sample testing of your products, investigations and, if necessary, keeping a register of complaints and keeping distributors informed of such monitoring.

PART 2 - UK REQUIREMENTS

The GPSR apply to all products sold in the UK, but the provisions apply differently to Great Britain (England, Scotland and Wales, “GB”) and Northern Ireland. You can read more about the position in Northern Ireland (“NI”) below.

Manufacturers should only provide safe products to consumers. In addition, Manufacturers must provide consumers with all relevant information needed to use the product safely or take necessary precautions to mitigate any risk.

The presence of warnings does not exempt a person from compliance with the requirements of the GPSR.

The Manufacturer should also adopt measures to be kept informed of risks that their product may pose and take appropriate action to avoid these risks (including withdrawal or recall or warning consumers). Taking appropriate action (including withdrawal or recall) is to be done on a voluntary basis or at the request of Trading Standards. However, if Manufacturers become aware or know that a product is not safe, they must immediately inform Trading Standards and cooperate with them.

Measures that Manufacturers will usually be required to take to ensure the safety and compliance of their products include:

• Indicating on the product or its packaging for consumers the name and address of the Manufacturer and the product reference or, where applicable, the batch of products to which it belongs; and
• Where and to the extent it is reasonable to do so, carrying out of sample testing of your products, investigations and, if necessary, keep a register of complaints and keep distributors informed of such monitoring.

The UK Government has released guidance on alternative means of providing GB importer traceability information until December 31, 2022. See the BREXIT: UK Government Guidance section below for links to this guidance.

PART 3 - NORTHERN IRELAND

Please note that different rules apply in NI from January 1, 2021 as a result of the Northern Ireland Protocol. In particular:

• You should ensure that products meet EU requirements.
• You are an importer if you are established in the EU or NI and you sell products from a country outside of the EU and Northern Ireland (including from GB) into NI. Products sold in NI should be marked with details of any EU / NI based importer.
• Authorised representatives can be based in NI or the EU.
• “Qualifying Northern Ireland goods” will be able to be sold in GB with the CE mark. The UK Government is issuing guidance on how this will work.

PART 4 - BREXIT: UK GOVERNMENT GUIDANCE

The UK Government has released guidance on selling products in GB and NI from January 1, 2021. This guidance provides information for Manufacturers and distributors regarding compliance requirements from January 1, 2021, including on:

• Whether your legal responsibilities will change;
• Whether you need to provide GB importer information, and methods for doing this (including transitional arrangements until the end of 2022);
• How to deal with existing stock;
• What documentary evidence is required to show that products have been placed in the UK or EU before January 1, 2021; and
• Specific rules for selling products in NI.

PART 5 - FURTHER GUIDANCE

Additional information EU

Further information is available at the European Commission’s website on the GPSD:

General product safety directive

Additional information GB

We recommend that you review guidance provided by the UK Government Office for Product Safety and Standards, see here:

We also encourage you to review this guidance (linked below), alongside any other specific UK Government guidance that applies to your product.

GB:

Product Safety and Metrology in GB from 1 January 2021

General Product Safety Regulations - GB

NI:

Product Safety and Metrology – NI

General Product Safety Regulations - NI

CHANGING YOUR AUTHORIZED REPRESENTATIVE.

Changing your Authorized Representative is a fairly straightforward process. First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).

To be compliant, the manufacturer should address the following aspects:

• The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
• The date until which the manufacturer can show the outgoing AR on the information or promotional material.
• The transfer of documents, including confidentiality aspects and property rights
• The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.