Guidance

EU Regulation 2023/988 on General Product Safety: detailed guidance

Published 3 December 2024

Applies to Northern Ireland

Guidance for business placing products on the market in Northern Ireland from December 2024.

1) Introduction

From 13 December 2024, the EU Regulation on General Product Safety 2023/988 (the ‘GPSR’) applies in European Union (EU) Member States. It amends the provisions in EU Regulation No 1025/2012 and Directive 2020/1828, and repeals Directive 2001/95/EC and Directive 87/357/EEC.

For products regulated by GPSR to be placed on the EU market, there must be a responsible economic operator in place to ensure compliance tasks are fulfilled. The obligations of a responsible economic operator are set out in Article 4 of the EU Regulation on Market Surveillance and Compliance (the MS Regulation) and Article 16 of GPSR.

This guidance explains the GPSR requirements in the context of goods placed on the market ^{[footnote 1]} in Northern Ireland (NI). There are various ways to meet the Regulation, and most UK businesses that sell goods in NI will likely have sufficient arrangements in place as the rules in many cases formalise the reality of how businesses are already operating in the UK to be able to sell goods into the EU. If adjustments are needed, this guidance outlines what to do. Note that this guidance is not intended to be exhaustive, but to assist in understanding the GPSR. If you are not clear on your obligations, you should seek independent legal advice.

This guidance is particularly relevant to businesses in Great Britain (GB) selling products to the NI market and which do not have a presence in the EU. These businesses should note that there are private sector services available if an EU or NI-based representative is required; online marketplaces may also provide this service.

Sign up for the Trader Support Service if you have general queries or concerns about the changes that have been made to the way goods move in and out of NI.

We are keen to hear from businesses that have questions and concerns which this and the further guidance does not address. Please contact [email protected] and [email protected] – including where you may have any concerns about compliance or supplying products to NI.

NI-based businesses continue to benefit from unfettered access protections as set out in the UK Internal Market Act 2020. This allows for goods that can be sold in NI (Qualifying NI Goods) to also be sold in the rest of the UK without needing to meet any further regulatory requirements.

Read guidance on moving qualifying goods from NI to the rest of the UK.

Businesses should note section 7 of this guidance, which details the transitional measures in GPSR, including that the Regulation applies only to products placed on the market from 13 December 2024; no action needs to be taken for products that have already been placed on the market in NI before 13 December 2024 and which are in compliance with the 2005 UK GPSR.

UK authorities will continue to take a proportionate, risk-based, and intelligence-led approach to enforcement of the rules, minimising disruption to compliant businesses, including using compliance advice and guidance to assist businesses in addressing actual, suspected or potential non-compliance. See section 6 of this guidance for further information on enforcement.

2) Summary of the Regulation

Scope

This Regulation requires that all consumer products placed on the NI and EU markets are safe and establishes specific obligations for businesses to ensure that safety. The Regulation applies to products placed on, or made available to, the market where there are no sector-specific provisions with the same objective.

The regulation does not apply to:

• medicinal products for human or veterinary use
• food
• feed
• living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products or plants and animals relating directly to their future reproduction
• animal by-products and derived products
• plant protection products
• equipment on which consumers ride or travel where that equipment is directly operated by a service provider within the context of a transport service provided to consumers and is not operated by the consumers themselves
• aircrafts which involve low risks for aviation safety ^{[footnote 2]}
• antiques

The Regulation applies to products placed on, or made available to, the market which are new, used, repaired, or reconditioned. It does not apply to products intended to be repaired or reconditioned prior to being used where those products are clearly marked as such when being placed on or made available to the market, such as items of historical significance. It clarifies that distance sales are in scope where the offer of a product is targeted at consumers in the EU or NI.

This Regulation does not apply to products being placed on, or made available to, the GB market. Those products will continue to be regulated by the General Product Safety Regulations 2005 (UK GPSR). As noted above, NI benefits from unfettered access protections as set out in the UK Internal Market Act 2020 which means that goods that meet the relevant rules in NI can be sold in GB without needing to meet any further regulatory requirements.

General safety requirement

Economic operators ^{[footnote 3]} shall place on or make available to the market only safe products.

When assessing whether a product is a safe product, economic operators should consider the following aspects:

• The characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, if applicable, for installation, use and maintenance.
• The effect that other products might have on the product being assessed, where it is reasonably foreseeable that other products will be used with the product. This includes the effect of non-embedded items that are meant to determine, change or complete the way the product being assessed works, which has to be considered when assessing the safety of the product.
• The effect the product has on other products, where it is reasonably foreseeable that it will be used with other products, including the interconnection of those products.
• The presentation of the product, the labelling, including labelling regarding age suitability for children.
• The categories of consumers using the product, in particular vulnerable consumers such as children, older people and persons with disabilities, as well as any impact gender differences might have on health and safety.

• The appearance of the product if it is likely to lead consumers to use the product in a way different to what was designed for, and in particular:

  • Food-imitating products: where a product that is not foodstuff but resembles foodstuff and is likely to be confused with foodstuff and might therefore be placed in the mouth, sucked, or ingested by consumers, particularly by children.
  • Use by children: where a product is not designed or intended to be used by children but is likely to be used by children or resembles a commonly recognised object that would appeal to children.
• When required by the nature of the product, the appropriate cybersecurity features needed to protect the product against external influences where such influence might impact the safety of the product.
• When required by the nature of the product, any evolving, learning and predictive functionalities of the product.

Obligations of manufacturers

Manufacturers need to:

• Ensure that a product complies with the general safety requirement outlined in the Regulation before placing it on the market.
• Carry out an internal risk assessment and draw up technical documentation on the product before placing it on the market. Technical documentation should provide a general description of the product and the characteristics relevant for assessing its safety.
• Ensure that the product can be identified by consumers in an easily visible and legible way. This includes a batch or serial number or any other identifying element. If the size and/or nature of the product does not allow this, the information should be provided on the packaging or in a document accompanying the product.
• Indicate their name, registered trade name or registered trademark, postal and electronic address and, if different, the postal or electronic address of the single contact point that consumers can contact them on. This can be a link to a webpage but it must be reasonably straightforward for the consumer to identify from that link where and how to make contact.
• Where a product cannot be safely used as intended without it, ensure that products are accompanied with clear instructions and safety information in language consumers can easily understand.

• Where a manufacturer believes a product it has placed on the market is dangerous, it shall immediately:

  • take necessary corrective measures to bring the product into conformity. This can include withdrawal or recall of the product, if appropriate
  • inform affected consumers of the corrective measures
  • inform the relevant Market Surveillance Authorities (MSAs) through the Safety Business Gateway (see section 5 for further information on cooperation with MSAs)

Obligations of importers

Importers need to:

• Ensure that a product complies with the general safety requirement outlined in this Regulation before placing it on the market.
• Ensure that the manufacturer of a product has complied with its requirements to carry out an internal risk assessment and draw up technical documentation, and to include certain traceability information, before placing it on the market.

• Not place products on the market if they believe a product does not conform to the general safety requirement until it has been brought into conformity. In such situations, importers also need to immediately:

  • inform the manufacturer that they believe the product is dangerous
  • inform the relevant MSAs through the Safety Business Gateway (see section 5)
• Indicate their name, registered trade name or registered trademark, postal and electronic address and, if different, the postal or electronic address of the single contact point that consumers can contact them on. This can be a link to a webpage, but it must be reasonably straightforward for the consumer to identify from that link where and how to make contact.
• Ensure that, where necessary, products are accompanied with clear instructions and safety information in language consumers can easily understand. Where a product is not compliant, as a result of failure by the manufacturer to comply with their requirements, the importer may bring the product into compliance, for example by adding the necessary instructions or information without returning the product to the manufacturer. This information must be accurate and correct, and it is for the importer and the manufacturer to decide who is best placed to take these actions. Also note the transitional arrangements in place in section 7 of this guidance, which mean that no action needs to be taken for products that have already been placed on the market in NI before 13 December 2024.
• Not jeopardise the conformity of a product to the general safety requirement while it is under their responsibility, during storage and transport.

Obligations of distributors

Distributors need to:

• Verify with the manufacturer and, where applicable, with the importer, that they have complied with the requirements placed on them under the Regulation regarding product traceability information, and for products to be accompanied with instructions and safety information (where applicable) before making a product available to the market. Where a product is not compliant as a result of failure by the manufacturer or importer to comply with those requirements, the distributor (with the manufacturer and/or importer as relevant) may bring the product into compliance, for example by adding the necessary labelling or documentation without returning the product to the manufacturer or importer. This information must be accurate and correct, and it is for the distributor and the importer or manufacturer to decide who is best placed to take these actions. Also note the transitional arrangements in place in section 7 of this guidance, which mean that no action needs to be taken for products that have already been placed on the market in NI before 13 December 2024 and which are in compliance with the 2005 UK GPSR.

• Not make products available to the market if they believe the product to be dangerous. In such situations, distributors also need to immediately:

  • inform the manufacturer or importer, where applicable, that they believe the product is dangerous
  • ensure necessary corrective measures to bring the product into conformity, which can include withdrawal or recall as appropriate, are taken
  • ensure the relevant MSAs are informed of the product through the Safety Business Gateway (see section 5)
• Not jeopardise the conformity of a product to the general safety requirement while it is under their responsibility, during storage and transport.

Obligations of providers of online marketplaces ^{[footnote 4]}

Providers of online marketplaces need to:

• Designate a single point of contact allowing direct communication by electronic means with relevant MSAs in relation to product safety issues.
• Designate a single point of contact for consumers to communicate directly with them in relation to product safety issues. This can be a link to a webpage, but it must be reasonably straightforward for the consumer to identify from that link where and how to make contact.
• Register with the Safety Gate Portal (see section 5), indicating their single point of contact on the platform.
• Have in place internal processes for product safety to comply with the relevant requirements of the Regulation.
• Register their contact details with the EU Commission and provide a single point of contact to facilitate communication on product safety issues.

• Cooperate with relevant MSAs. This includes:

  • ensuring consumers affected by a product recall are notified and provided with information relating to the recall in a timely and appropriate manner
  • publish information relating to a product safety recall on its online platform
• Where providers of an online marketplace has actual knowledge that a product made available on its online interface ^{[footnote 5]} is dangerous, it must immediately inform the relevant MSAs through the Safety Business Gateway.

It should be noted that, depending on the services, the same entity can fall within different categories of supply chain actor, including different categories of economic operator, and therefore have to comply with all the obligations applicable to the relevant category. For instance, if a provider of an online marketplace sells its own branded products, it would be considered to be a manufacturer and need to comply with the applicable requirements for manufacturers as regards those products.

It is likely that most of the UK businesses that these obligations apply to already have sufficient arrangements for compliance in place or will be able to implement the relevant arrangements without significant difficulty.

For clarity, the GPSR does not create a new obligation for online marketplaces to pre-emptively identify and remove non-compliant products from their platforms which were placed on the market before 13 December 2024.

Neither is the GPSR intended to amount to a general obligation on online marketplaces to monitor the information which they transmit or store, nor is it intended to require online marketplaces to actively seek facts or circumstances indicating illegal activity.

Nothing above affects any obligations the provider of an online marketplace has to cooperate with MSAs or the obligations it has where, due to its role and dependent on its activities, it is also an economic operator.

Obligations of authorised representatives

What is an authorised representative?

Authorised representatives are a natural or legal person that a manufacturer appoints to represent them and carry out certain duties on their behalf.

To comply with this Regulation, manufacturers can appoint an authorised representative. Authorised representatives must perform at least the following tasks:

• Providing MSAs with necessary information and documentation to demonstrate the safety of a product, when requested to do so by the MSA.
• Inform the manufacturer it represents of relevant products being dangerous, where it considers or has reason to believe so.
• Inform national authorities of actions taken to eliminate risks posed by products if the manufacturer has not already provided that information.
• Cooperate with national authorities on any action taken to effectively eliminate the risks posed by relevant products.

If a manufacturer appoints an authorised representative, there must be a written mandate in place specifying the tasks that the authorised representative agrees to and is authorised to carry out on the manufacturer’s behalf. ^{[footnote 6]} The authorised representative must be based in the EU or NI.

Appointing an authorised representative to carry out the compliance tasks outlined in Article 4 of the MS Regulation and Article 16 of the GPSR is one option traders can use to meet the requirements of Article 4 and Article 16. If traders already have a presence in the EU or NI, they will be considered to be in compliance with the requirements of GPSR relating to the MS Regulation.

The name, registered trade name or registered trademark, and contact details (including postal address) of the responsible economic operator must be indicated on the product or on its packaging, the parcel, or an accompanying document. Accompanying documentation may include, though is not limited to, a store receipt or other despatch or shipping documentation that is provided alongside a product and does not need to be within the same packaging as the product itself as long as it accompanies the product.

3) What businesses need to do

What is a ‘responsible economic operator’ and what are the obligations that come with it?

Article 16 of the GPSR sets out that products can only be placed on, or made available to, the NI market if there is a responsible economic operator established in either NI or the EU to fulfil certain compliance tasks.

There are various ways to meet the requirements of Article 16 of the GPSR, and most UK businesses will likely have sufficient arrangements in place, especially if they already trade with the EU. However, businesses should review this guidance to make certain their arrangements are sufficient or to make necessary changes.

What does the responsible economic operator need to do?

The role of a responsible economic operator is to cooperate with relevant MSAs and ensure reports of product safety incidents where required by Article 20 of the GPSR. Under Article 16(2) of the GPSR the responsible economic operator has responsibility for the following compliance tasks:

• Verify documentation: Verify that the technical documentation has been drawn up and contains, as applicable:

  • an analysis of possible risks related to the product and solutions to eliminate or mitigate risks (as per Articles 6, 7 and 8 of the GPSR)
  • the list of any relevant standards that apply to the product, including any Declaration of Conformity, in order to meet the general safety requirement of Article 5 of the GPSR

• Verify that the product itself has the following information on it, or in an accompanying document. As explained above, accompanying documentation may include, though is not limited to, a store receipt or other despatch or shipping documentation that is provided alongside a product and does not need to be within the same packaging as the product itself as long as it accompanies the product.

  • a type, batch or serial number or other element enabling the identification of the product
  • the manufacturer’s name, registered trade name or registered trademark, its postal and electronic address and, if different, the postal or electronic address of the single contact point by which it can be contacted
  • clear instructions and safety information, unless such instructions and safety information are not required where the product can be used safely and as intended by the manufacturer without such documentation
• Keep documentation: To keep the technical documentation at the disposal of MSAs for a period of 10 years from the date the product is placed on the market, and ensure that the technical documentation can be made available to those authorities upon request.
• Provide documentation: If a reasoned request is made by an MSA, provide all information and documentation necessary to demonstrate the conformity of the product.
• Notify risk: If there is reason to believe a product presents a risk, inform the MSA.
• Cooperate and take necessary action: Cooperate with MSAs, including requests to take appropriate corrective action to remedy non-compliance. If it is not possible, and the economic operator has reason to believe the product presents a risk, take corrective action to mitigate the risks presented by the product, at their own initiative or at the request of MSAs.

‘Established’ means having a presence in NI or the EU – it cannot simply be, for example, a PO Box address. For a business, this can be a registered office, headquarters, or your permanent place of business (for example, a retail outlet, distribution centre, or other functions) in that country. For an individual, this can be the place where you are resident.

The responsible economic operator can be any one of:

• The manufacturer: A natural or legal person who manufactures a product or has a product designed or manufactured and markets the product under its name or trademark, or any other natural or legal person who can be considered a manufacturer in accordance with Article 13 of the GPSR.
• The importer, when the manufacturer is not established in NI or the EU: A natural or legal person established in NI or the EU who first places a product from outside the EU on the NI or EU market.
• An authorised representative: A natural or legal person established in NI or the EU who is appointed by the manufacturer to act on their behalf to fulfil certain legal duties. A written mandate must be in place, and duties are limited to certain administrative tasks outlined in the mandate.
• A fulfilment service provider: A natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing; packaging; or addressing and dispatching, without having ownership of the products involved. This does not include postal, parcel or freight services.

For a product to be placed on the NI or EU market, one of the economic operators listed above must be in place in the supply chain and they must fulfil the compliance duties outlined in section 5.

Where there is no responsible economic operator established in NI or the EU already, the manufacturer placing the product on the market should take steps to ensure someone is in place to undertake those compliance tasks or the product cannot be placed on the market. Businesses should note that there are private sector services available if an EU or NI-based representative is required. Online marketplaces may also provide this service. Where a manufacturer has not arranged an authorised representative within the EU or NI, an importer (e.g., a retailer) seeking to sell those products in NI, or a fulfilment service provider (where no other economic operator is established in the EU or NI) will act as the responsible economic operator.

The name, registered trade name or registered trademark, and contact details (including the postal address) of the responsible economic operator must be indicated on the product, or on its packaging, the parcel or an accompanying document. This may include (but is not limited to) a receipt, despatch document or other shipping document and does not need to be within the same packaging as the product itself as long as it accompanies the product.

4) Movement of goods

Movement of goods from GB to NI

The GPSR applies in NI. For a GB-based business wanting to place a product on, or make a product available to, the NI market, it will have to comply with the requirements of the Regulation – this includes the responsible economic operator requirement outlined in section 3. If a GB-based business has already taken steps to trade in the EU, it will not have to make any additional changes in order to operate in NI, as it will already be meeting the requirements of the Regulation. Most UK businesses that sell goods in NI will likely have sufficient arrangements in place already in order to sell into the EU.

Movement of goods from NI to GB

NI businesses who are in compliance with the GPSR do not need to make any additional changes to place products on the GB market. As noted above, NI businesses will continue to benefit from unfettered access to the GB market, in line with the rules for qualifying NI goods as set out in the UK Internal Market Act 2020.

5) Market surveillance

Where a dangerous product has been identified, MSAs may request from the manufacturer information on other products produced in the same way or with similar characteristics which are affected by the same risk.

Safety Gate system

The Safety Gate is a rebrand of the Rapid Exchange of Information System (RAPEX), the EU’s rapid alert system for unsafe consumer products and consumer protection. The Safety Gate consists of three elements:

• Safety Gate Rapid Alert System – a rapid alert system between national authorities and the European Commission on dangerous non-food products.
• Safety Gate Portal – a web portal to inform consumers of product-safety related matters and allow consumers to submit product-safety complaints and concerns.
• Safety Business Gateway – a web portal for businesses to comply with their obligations to inform authorities and consumers of dangerous products and product safety incidents.

6) Enforcement

The UK approach to enforcement of goods placed on the NI market is unchanged and in line with the Regulators’ Code. Enforcement continues to be proportionate, risk-based and intelligence-led, minimising disruption to compliant UK businesses. Authorities continue to have an initial focus on providing effective advice and support for UK businesses, helping them to understand and meet any new obligations they may have, and applying their discretion as businesses adapt. Businesses are obliged to cooperate with MSAs and comply with any actions taken by an MSA.

Read guidance for MSAs on the GPSR, which you may find useful.

7) Transitional arrangements

The GPSR includes transitional arrangements for products that are already on the market. Article 51 of the GPSR ensures that products already on the market in the EU or NI and which are compliant with the 2005 UK GPSR, as it applies or applied before 13 December 2024, shall continue to be made available. This includes existing stock of product lines that are already on the market. No action needs to be taken for products that have already been placed on the market in NI before 13 December 2024.

8) Further support and advice

This guidance will be reviewed and updated as necessary.

• Read guidance on placing manufactured goods on the market in NI.
• Read guidance on the MS Regulation on placing certain products on the NI market.
• Read guidance on moving qualifying goods from NI to the rest of the UK.
• Sign up for the Trader Support Service if you have general queries about the changes that have been made to the way goods move in and out of NI.

For queries about the new GPSR, please contact:

• [email protected].

For general queries about compliance or supply products to NI, please contact:

• [email protected], and
• [email protected].

We are keen to hear from businesses if the guidance available does not address their concerns.

9) Examples of how this applies to businesses in different parts of the supply chain

GB-based manufacturer placing products on the NI and EU markets

Questions	Applies	Information
Are you a manufacturer established in NI or the EU?	Yes	In almost all cases, your existing obligations as a manufacturer meet the requirements of A.16 of the GPSR. If so, and the product complies with the general safety requirement outlined in the GPSR, you will be considered to be compliant with the GPSR. Your details need to be on or accompany the product.
No	-	-
Do you have an importer based in NI or the EU?	Yes	In almost all cases, existing importer obligations meet the requirements of A.16 of the GPSR.
No	-	-
Do you have an authorised representative established in NI or the EU?	Yes	You can amend their mandate to include the compliance tasks of A.16 of the GPSR. You must make sure they understand their duties and have appropriate means and any documentation they may need to fulfil their compliance tasks.
No	-	-
Do you use a fulfilment service provider established in NI or the EU?	Yes	They can be the responsible economic operator. You need to ensure you agree with them that they will take on the role, that they understand their responsibilities, and that you provide them with the documentation necessary for them to fulfil the compliance tasks in A.16 of the GPSR.
No	-	-

If you do not have an authorised representative, importer, or fulfilment service provider in NI or the EU already, you must ensure one is in place if you place products on the NI or EU market. They need to understand their obligations and have the required product documentation necessary to fulfil them.

The responsible economic operator can be established in NI and this will be sufficient to meet obligations to place products for sale on the EU market too.

Once agreed, the contact details of the responsible economic operator must be provided on the product or on its packaging, the parcel, or an accompanying document.

10) Footnotes

1. Refer to Sections 2.3 and 2.4 of the most recent version of the Blue Guide for guidance on interpretation of ‘placing on the market’. ↩

2. Definition provided in Article 2(3), point d of EU Regulation 2018/1139 on Common Rules in the Field of Civil Aviation. ↩

3. Article 3 of the GPSR sets out that ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with the GPSR. ↩

4. Under this Regulation, a provider of an online marketplace is “a provider of an intermediary service using an online interface which allows consumers to conclude distance contracts with traders for the sale of products”. ↩

5. Under this Regulation, an online interface is any software, including a website, part of a website or an application, including mobile applications. ↩

6. Note: MSAs can request to see the written mandate and authorised representatives are required to comply with such a request. ↩