Guidance

EU Regulation on General Product Safety (2023/988)

Published 3 December 2024

Applies to Northern Ireland

Guidance for Market Surveillance Authorities which applies in respect of Northern Ireland from 13 December 2024.

1) Introduction

This guidance relates to the European Union (EU) Regulation on General Product Safety 2023/988 (the ‘GPSR’). This Regulation applies directly in respect of Northern Ireland (NI) from 13 December 2024.

The Regulation amends the product safety provisions in EU Regulation No 1025/2012 and Directive 2020/1828 and repeals the General Product Safety Directive 2001/95/EC (GPSD) and Directive 87/357/EEC. ^{[footnote 1]} It sets out the requirement that consumer products must be safe, the responsibilities of relevant Market Surveillance Authorities (MSAs), and requirements for the sharing of product safety information. This guidance provides an overview of the Regulation primarily for MSAs operating in NI. ^{[footnote 2]} This guidance and the corresponding guidance for businesses are not intended to be comprehensive or a definitive guide on the obligations in the GPSR. Where an individual or business is unclear of their legal obligations, they should seek independent legal advice.

Legislative framework

The legislative framework in NI consists of ‘general’ requirements that apply to all harmonised goods, and ‘specific requirements’ that apply to a number of individual product categories – for example, electrical goods and toys. If they are more detailed and specific, these may supersede the general requirements.

Read guidance for businesses on placing manufactured goods on the GB and NI markets.

This Regulation extends the market surveillance provisions introduced by EU Regulation 2019/1020 on Market Surveillance and Compliance of Products, ^{[footnote 3]} bringing products regulated under the Regulation in scope of the Regulation on Market Surveillance.

Read guidance for MSAs on how the Regulation on Market Surveillance applies in NI.

NI continues to be a key part of the UK product safety system. The Office for Product Safety and Standards (OPSS) continues to coordinate the application of legislation that applies in NI and provide support to Authorities and their sponsoring Government Departments across the UK.

Overall approach to market surveillance in NI

The same MSAs retain responsibility for regulating the NI market. This includes any Authorities whose responsibility covers the whole UK market, including NI, even if they are based in Great Britain (GB). OPSS will continue to have the power to also take enforcement action in cases that are nationally significant, novel or contentious and will continue to work with local authorities, other MSAs and border control authorities, where needed.

The majority of market surveillance activities will continue to take place after goods have been made available on the NI market. Authorities will continue to take a proportionate, risk-based, and intelligence-led approach to regulating the NI market, prioritising unsafe products. In line with the Regulators’ Code, Authorities are encouraged to provide advice, support and reassurance to help businesses understand any new obligations, and to avoid non-compliance.

Authorities acting in respect of NI should continue to refer to the most recent version of the European Commission Blue Guide for guidance on the application of relevant goods legislation.

2) Key provisions

Definitions and scope

The GPSR applies to all products subject to harmonised legislation, insofar as there are no specific provisions with the same objective in sector or product specific legislation in relation to product safety.

Notable definitions which were not in the GPSD include:

• ‘Manufacturer’ (Article 3.8) means any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under the person’s name or trademark.
• ‘Authorised representative’ (Article 3.9) means any natural or legal person established within the [European] Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation.
• ‘Importer’ (Article 3.10) means any natural or legal person established within the [European] Union who places a product from a third country on the [European] Union market.
• ‘Distributor’ (Article 3.11) means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available to the market.
• ‘Fulfilment service provider’ (Article 3.12) means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching without having ownership of the products involved, excluding postal services, ^{[footnote 4]} parcel delivery services, ^{[footnote 5]} and any other postal or freight transport services.
• ‘Economic operator’ (Article 3.13) 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 this Regulation.
• ‘Provider of an online marketplace’ (Article 3.14) means a provider of an intermediary service using an online interface which allows consumers to conclude distance contracts with traders for the sale of products.
• ‘Online interface’ (Article 3.15) means any software, including a website, part of a website or an application, including mobile applications.
• ‘Distance contract’ (Article 3.16) means any contract concluded between the trader and the consumer under an organised distance sales or service-provision scheme without the simultaneous physical presence of the trader and the consumer, with the exclusive use of one or more means of distance communication up to and including the time at which the contract is concluded. ^{[footnote 6]}

Business requirements

There are some new requirements for businesses to better enable traceability of products placed on the EU and NI markets, particularly those sold online.

Article 4 of the Market Surveillance Regulation requires that for consumer products to be placed on the EU or NI market, an economic operator responsible for compliance must be established in the EU or NI. That obligation is expanded by Article 16 of the GPSR, which includes further obligations on responsible economic operators and widens the scope of products to which that obligation applies. The responsible economic operator can be the manufacturer, importer, authorised representative, or a fulfilment service provider but in all cases must be established in the EU or NI.

Read guidance for MSAs on how Article 4 of the Regulation on Market Surveillance applies in NI.

The economic operator responsible for compliance must:

• 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
  • the list of any European standards that apply to the product, including any Declaration of Conformity, or, in the absence of any relevant European Standards for such product, evidence that the product conforms to UK standards 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:

  • 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, immediately inform the relevant MSA.
• Cooperate: Cooperate with MSAs, including requests to take appropriate corrective action. If that is not possible, the responsible economic operator must mitigate the risks presented by the product where they believe the product presents a risk or are requested to do so by the MSAs.
• Data sharing: Notify the relevant EU MSAs of dangerous products on the market through the Safety Business Gateway.

Providers of online marketplaces

Providers of online marketplaces are not in scope of the Market Surveillance Regulation. However, new obligations, relating to market surveillance, apply to them under the GPSR. Online marketplaces need to:

• designate a single point of contact for direct communication with relevant MSAs in relation to product safety issues
• register and engage with the Safety Gate Portal. This includes taking corrective action when notified via the Safety Gate Portal of instances of non-compliant products being sold or made available through its online interface
• designate a single point of contact to enable consumers to communicate directly and rapidly with them in relation to product safety issues
• cooperate with MSAs to facilitate any action taken to eliminate or mitigate risks presented by a product offered online through its services. This includes abstaining from obstructing product recalls
• comply with Orders / Notices issued by MSAs, within 3 working days from receipt, in relation to product safety issues
• allow MSAs access to their online interface to identify dangerous products
• allow MSAs, upon receiving a reasoned request, to scrape data from its online interface only for product safety purposes
• immediately inform the relevant MSAs, through the Safety Business Gateway, of non-compliant products that have been made available through its online interface
• have in place internal processes for product safety to comply with the relevant requirements of the Regulation

Enforcement

As the GPSR includes obligations on businesses, there will be a proportionate, risk-based and intelligence-led enforcement regime in place, implemented through secondary legislation. See section 3 for further details.

Market surveillance

The market surveillance provisions contained within the GPSR extend most of the provisions found in the Market Surveillance Regulation.

Read guidance for MSAs on how the Regulation on Market Surveillance applies in NI.

The specific provisions of the Market Surveillance Regulation that apply to products covered by the GPSR are:

• Article 10 – Single liaison office: A single liaison office must be established to represent a coordinated position for MSAs and other relevant authorities. For the single liaison office for GB and NI, contact: OPSS-SLO@businessandtrade.gov.uk.

• Article 11(1-7) – Activities of MSAs: MSAs shall ensure that:

  • market surveillance in their territories for products made available to the market online or offline is effective
  • economic operators take appropriate and proportionate corrective action to comply with this Regulation
  • appropriate and proportionate measures are applied when economic operators fail to take corrective action
  • market surveillance powers are exercised independently, impartially, and without bias
  • appropriate checks on the characteristics of products are performed on an adequate scale, through documentary checks and, where appropriate, physical and laboratory checks based on adequate samples
  • procedures are established for following up on complaints or reports on issues or non-compliant products, and justifying corrective actions that have been taken
• Article 12 – Peer reviews: MSAs are to cooperate with EU peer reviews to aid the improved consistency of market surveillance activities with respect to this Regulation.
• Article 13 – National market surveillance strategies: Nations in which this Regulation applies will form an overarching national market surveillance strategy to promote a consistent, comprehensive and integrated approach to market surveillance.
• Article 14 – Powers of MSAs: MSAs have the powers of market surveillance, investigation, and enforcement that are deemed necessary to ensure the safety of products covered by this Regulation. These powers can include requiring economic operators to provide relevant documents, technical specifications, data or information on the compliance and technical aspects of a product.
• Article 15 – Recovery of costs by MSAs: MSAs can be authorised to reclaim the costs of their activities from the relevant economic operator in instances of non-compliance. To do so, contact: OPSS-SLO@businessandtrade.gov.uk.
• Article 16(1-5) – Market surveillance measures: MSAs are to take appropriate measures in ensuring products that fall under this Regulation are compliant and do not present a risk to consumer or wider public safety. This can include the withdrawal or recall of products.
• Article 18 – Procedural rights of economic operators: Actions taken by MSAs must be communicated without delay to the relevant economic operator. Economic operators should also be provided opportunity to discuss potential action before it is taken, within an appropriate period of no less than 10 working days. In instances of urgency on the grounds of public safety and/or interests, MSAs can provide economic operators with fewer than 10 days.
• Article 19 – Products presenting a serious risk: Ensure that products presenting a serious risk are withdrawn or recalled from the market where there is no other effective means to eliminate the serious risk.
• Article 21 – Union testing facilities: The European Commission may designate a public testing facility to test specific categories of products or for specific risks. These testing facilities are to carry out tests at the request of MSAs and provide independent advice.
• Article 22-24: MSAs can use procedures (mutual assistance requests, request for enforcement measures) to help support market surveillance activities. Authorities responsible in NI with access to the Safety Gate should use that to contact authorities in EU Member States. Where this is not possible, OPSS (as the SLO) is available to facilitate communication and cooperation between MSAs to support efficient and effective market surveillance.

MSA powers in relation to providers of online marketplaces

MSAs have the powers, through the Market Surveillance (Northern Ireland) Regulations 2021, to order providers of online marketplaces to remove content relating to dangerous products from their online interface, disable access to that content, or to display an explicit warning.

In addition to this, MSAs can, specifically in relation to providers of online marketplaces:

• request access to its online interface to identify dangerous products
• request access to extract data from its online interface for the purposes of identification. Note: such a request would only be considered reasonable if the administrator of the online interface has put in place technical obstacles to data extraction.

3) Enforcement

As the national regulator for product safety, OPSS has the ability to take enforcement action in cases that are nationally significant, novel or contentious, and will continue to work with local authorities, other MSAs and border control authorities, where necessary. MSAs should continue to take a proportionate, risk-based and intelligence-led approach to regulating the NI market. In line with the Regulators’ Code, Authorities should have an initial focus on providing effective advice and support for UK businesses, helping them to understand any new obligations they may have, and apply their discretion as businesses adapt. The prevention and identification of dangerous products being made available on the market should remain the priority.

A range of enforcement measures are available to MSAs responsible for regulating the compliance of consumer products in NI to exercise proportionately.

In line with the approach to enforcing existing legislation, MSAs must require corrective action to address non-compliance or risks to health and safety, for example, through compliance, withdrawal, or recall notices. A breach of the GPSR is an offence and may lead to a conviction; for example, when an offence is not addressed through the use of notices or there is a deliberate and persistent breach. ^{[footnote 7]} Where there are specific provisions with the same objective in relevant product-specific legislation, the provisions and offences in that product-specific legislation will apply and take precedence over the provisions outlined in this Regulation.

4) 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 that 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. MSAs therefore cannot impede supply of these products if they continue to comply with the 2005 UK GPSR unless they are dangerous products.

MSAs should take into account that businesses may require additional support to ensure compliance with the new requirements in this Regulation.

5) Further information

Authorities with queries on the application of the GPSR or related legislation can contact OPSS using the following contact details: OPSS-SLO@businessandtrade.gov.uk.

6) Footnotes

1. EU Directive 2001/95/EC will be referred to as the ‘GPSD’ for the purposes of this guidance. ↩

2. ‘Market Surveillance Authorities’ include those Authorities designated in legislation as Market Surveillance Authorities, whose responsibility includes the NI market. It also includes Authorities designated as ‘enforcers’ in respect of NI that are otherwise expected to dispense a market surveillance function. ↩

3. For the purposes of this guidance, EU Regulation 2019/1020 on Market Surveillance and Compliance of Products will be referred to as the ‘Market Surveillance Regulation’. ↩

4. As defined in Article 2, point (1) of Directive 97/67/EC of the European Parliament and of the Council. ↩

5. As defined in Article 2, point (2) of Regulation (EU) 2018/644 of the European Parliament and of the Council. ↩

6. As defined in Article 2, point (7) of Directive 2011/83/EU. ↩

7. A conviction may give rise to a fine up to a maximum of £5,000. ↩