Guidance

Product safety and noncompliance notification guidance

Published 18 March 2025

Guidance on product safety and noncompliance notifications for UK market surveillance authorities and enforcement authorities.

Version 10

1. Introduction

1.1 This guidance is for market surveillance and enforcement authorities in the UK including the Office for Product Safety and Standards (OPSS) and outlines the requirement to notify the Secretary of State if products pose a risk to the health and safety of consumers or users or products are found to be noncompliant with the relevant legislation.

1.2 This guidance applies to authorities operating in respect of both Great Britain (GB) and Northern Ireland (NI) markets, and outlines the notification requirements placed on them through their respective legal obligations in:

• GB: the General Product Safety Regulations 2005 as applicable in GB and the Regulation on Accreditation and Market Surveillance as applicable in GB (‘GB RAMS’) (assimilated and amended in GB) and sector-specific product safety legislation.
• NI: the EU General Product Safety Regulation 2023/988 (EU GPSR) and the Regulation on Market Surveillance and Compliance of Products 2019/1020 as directly applicable in NI (‘MSC’) and sector-specific product safety legislation.

1.3 Notifications must be made using the Product Safety Database (PSD) and this guidance should be read alongside the PSD user guidance.

1.4 This guidance outlines functions and actions OPSS will take following notification on the PSD where required, including:

• validation and publication of Product Safety Reports and Product Recalls
• reporting of information to overseas regulators

1.5 It also outlines OPSS’ international monitoring function and details any referrals authorities may receive from OPSS, in addition to support OPSS may be able to provide in coordination with international partners and overseas regulators

2. Legal requirements to notify product safety risk and noncompliance

2.1 The General Product Safety Regulations 2005 (‘GPSR’), GB RAMS, EU GPSR and MSC establish the notification requirements for products found to pose a risk to the health and safety of consumers or end users and / or products that have been found to be noncompliant with the relevant legislation.

General Product Safety Regulations 2005 (GB)

Products covered

2.2 The GPSR applies to products that are intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them. This includes products supplied or made available in the course of commercial activity, regardless of whether they are new, used or reconditioned. Additionally, products supplied for consumers’ own use within a service context fall under the GPSR.

Exclusions

2.3 The GPSR excludes equipment used by service providers themselves to supply a service to consumers. Specifically, it excludes equipment on which consumers ride or travel, operated by a service provider. This means that equipment used solely by service providers themselves, rather than directly by consumers, is not covered by the GPSR

2.4 It also excludes second hand products supplied as an antique or as a product to be repaired or reconditioned prior to being used, provided the supplier clearly informs the person to whom he supplies the product to that effect.

Notifications

2.5 Regulation 33 (Duty to notify Secretary of State) of GPSR requires that enforcement authorities notify the Secretary of State (DBT) using the PSD in the following circumstances. When an enforcement authority:

• receives a notification from a business involved in the supply chain regarding an unsafe product they have placed on the market or supplied which poses risks to the consumer that are incompatible with the general product safety requirement; or
• takes a measure which restricts the placing on the market of a product, or requires its withdrawal or recall, specifying its reasons for taking the action. It shall also immediately notify the Secretary of State of any modification or lifting of such a measure; or
• adopts or decides to adopt, recommend or agree with producers and distributors, whether on a compulsory or voluntary basis, a measure or action to prevent, restrict or impose specific conditions on the possible marketing or use of a product by reason of a serious risk. It shall also immediately notify the Secretary of State of any modification or withdrawal of any such measure or action.

2.6 MSAs are also required to make information available to the public in accordance with Regulation 39 GPSR, which is fulfilled where products are published on the Product Recalls and Alerts website.

Regulation on Accreditation and Market Surveillance (GB)

2.7 GB RAMS requires market surveillance authorities (MSAs) to:

• Ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Secretary of State is informed without delay (Article 20).
• Ensure that any decision regarding whether a product represents a serious risk is based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence (Article 20).
• Inform the public and Secretary of State where products covered by any relevant enactment which, when used in accordance with their intended purposes or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to the applicable requirements, or are withdrawn or their being made available on the market is prohibited or restricted (Article 16).
• Take appropriate measures to alert users within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage (Article 19).

2.8 If a product presenting a serious risk has been made available on the GB market, MSAs in GB must notify the Secretary of State of any measures taken and communicated by an economic operator and this obligation is fulfilled by a notification on the PSD.

2.9 Additionally, measures taken against unsafe and noncompliant products at the border, such as those detailed in Article 29 RAMS, should also be notified on the PSD. This does not replace any additional reporting requirements under grant funding arrangements.

2.10 OPSS encourages authorities to make full use of the PSD to fulfil their obligations to inform the Secretary of State under Article 16 of GB RAMS; support information sharing; enable the development of comprehensive datasets for product safety issues; and reduce duplication of effort across authorities.

2.11 OPSS requests that all product recalls are notified and published, to allow greatest access to information on unsafe and recalled products for consumers and users.

2.12 MSAs are required to inform the public of safety risks under Article 16 of GB RAMS, and alert users under Article 19 of GB RAMS, which is fulfilled through publications of Product Safety Reports and Product Recalls on the Product Recalls and Alerts website. This process is further detailed in Section 4.

EU Regulation on Market Surveillance and Compliance (MSC) of Products (NI)

2.13 MSC has been directly applicable in NI since July 2021. This regulation changed the scope of notifications and reporting required by market surveillance authorities, in respect of NI.

2.14 Article 34 states that MSAs must report all relevant information (including results of testing, identification of risks and reports of injuries) and measures taken where an in-depth compliance check has taken place, including where the product is judged to be compliant.

2.15 There are requirements to notify in the case of a serious risk which must be assessed based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence (Article 19). Article 20 requires that MSAs notify if they take or plan to take measures under Article 19 that extend beyond their territory, in addition to any modification or withdrawals of such measures

2.16 This is wider than the previous RAMS requirement to report all information for products presenting a risk. While Articles 28 and 34 MSC relate to ICSMS rather than Safety Gate (formerly known as RAPEX), all information required for reports under MSC should be reported to the PSD and OPSS will make the notification to the appropriate system (Safety Gate or ICSMS).

EU Regulation on General Product Safety (GPSR) (NI)

2.17 The EU GPSR has been directly applicable in NI since December 2024. This regulation provides for the functioning of the EU Safety Gate Rapid Alert System.

2.18 Article 26 requires that Member States shall notify through the Safety Gate Rapid Alert System corrective measures taken by their authorities or by economic operators on the basis of serious risk.

2.19 For further information on notifications and reporting in respect of NI, including associated process, please refer to Annex B.

3. The role of the MSA / enforcement authority

3.1 The PSD is a database that enables MSAs and enforcement authorities to notify and share information relating to unsafe and noncompliant products. The PSD is not an intelligence database; current procedures for the recording and dissemination of intelligence are not impacted by this guidance and continue to be in line with legislative requirements and national guidelines.

3.2 Notifications should be made on the PSD where:

• a notification to the Secretary of State is required in legislation, as outlined in Section 2
• there is an established risk across an entire product line and action is taken to mitigate against that risk
• you are planning to undertake an investigation and/or commission testing, to be able to share your results and prevent duplication of effort. OPSS encourages MSAs to notify early and update as they progress, to ensure other authorities are aware that an issue is being investigated, and / or
• you require the notification to be published on the Product Recalls and Alerts website to fulfil your legal requirements to notify the public and users, as outlined in Section 2

3.3 Sharing of intelligence via an intelligence database such as IDB would be more appropriate where:

• you’ve been made aware of or have identified a potential issue relating to a business, individual or product and need to make the relevant authority aware, or
• you’ve been made aware of an individual consumer incident and need to make the relevant Primary Authority or home authority aware

3.4 OPSS has published guidance for Fire and Rescue Services and fire investigators on notifying product-related fires to businesses and regulators. Notifications concerning individual fires should not be notified on the PSD, unless there has been a subsequent investigation confirming a safety risk, and a corrective action has been decided or undertaken.

Read the product-related fire notification guidance.

3.5 Notifications should also be added to the PSD to share details of inspections, testing and/or investigations of a product that has not identified noncompliance.

3.6 Notifications should provide all available details, and at least the following information, as specified in Article 22 RAMS and Regulation 33(1) and 34 GPSR in GB, or in NI Article 20 MSC, once the corrective measure has been decided or undertaken:

• information enabling the product to be identified, including images of the product, labelling and/or packaging where available
• a description of the risk involved, including a summary of the risk assessment, and the supporting evidence, such as results of any test or analysis and of their conclusions which are relevant to assessing the level of risk
• the nature and duration of the measures or action taken or decided on
• information on supply chains and distribution of the product

3.7 For notifications relating to consumer product safety, the Product Safety Risk Assessment Methodology (PRISM) should be used by MSAs in GB with responsibility for consumer product safety. ^{[footnote 1]}

Read further information on PRISM, including a list of products and hazards deemed serious risk and example risk assessments.

3.8 OPSS can provide support with product safety risk assessment in the form of a ‘critical challenge’ of MSAs’ draft assessments. Please contact lau.opss@businessandtrade.gov.uk with details of your request and any applicable PSD/IDB reference numbers and the relevant officer will get back to you. There may be instances in which not all requests can be fulfilled, and in these circumstances, support will be prioritised for the most complex/urgent cases.

3.9 OPSS will automatically be added to notifications for products presenting a serious or high risk, and for products which have been recalled or subject to a modification programme, if the minimum information set has been added. OPSS will proceed to validate the notification and publish a Product Safety Report or Product Recall entry on the Product Recalls and Alerts pages, as set out in Section 4.

3.10 MSAs can request that a Product Safety Report is published for corrective actions presenting a less than high risk, where this will assist in achieving regulatory outcomes and support public protection. To request that a Product Safety Report is published, OPSS Incident Management should be added to the PSD notification and the request specified in the message box provided.

3.11 The UK Product Safety Contact Point (UKCP) within the OPSS Incident Management Team monitors all new notifications added to the PSD. If a notification is identified where a Product Safety Report is recommended, or a product presents a serious or high risk or has been recalled or subject to a modification programme and the OPSS Incident Management Team have not been added to this (for example, where all the required information has not yet been added), they may contact the MSA to make follow up enquiries.

3.12 Read further guidance on use of the PSD.

3.13 For questions relating to the PSD, notification requirements and the publication of Product Safety Reports or Product Recalls, please contact: ukproductsafetycp@businessandtrade.gov.uk.

4. The role of OPSS and the UK Product Safety Contact Point

4.1 OPSS has taken responsibility for a number of functions and responsibilities following EU Exit to ensure MSAs are able to fulfil their legal obligations to:

• Make information relating to unsafe and recalled products available to the public through the publication of notifications on the Product Recalls and Alerts website.
• Report unsafe and noncompliant products with a cross-border supply chain to other countries where required in international law, including the EU-UK Trade and Cooperation Agreement, Windsor Framework, Withdrawal Agreement and free trade and mutual recognition agreements with market surveillance information sharing provisions.

4.2 The UKCP, part of the OPSS Incident Management Team, is responsible for monitoring the PSD and undertaking any actions required, as set out in the remainder of this section. The UKCP can also provide advice on reporting requirements, use of the PSD, and liaison with overseas regulators.

4.3 OPSS may also use information notified on the PSD for monitoring and horizon scanning purposes.

Validation of product safety notifications

4.4 OPSS has implemented a validation function which must be completed before Product Safety Reports and Product Recalls are published on the Product Recalls and Alerts website. The validation function consists of three elements, and primarily acts as a check to ensure notifications have been fully completed; sufficient evidence is available to support the product’s notification; and that no commercially sensitive or otherwise sensitive information is disclosed when the notification is published.

4.5 The three elements of the validation are:

• Data validation: a quality assurance of information and data provided to ensure all notification components are present, as outlined in Section 3.6.
• Risk validation: a review of the risk assessment or risk model and the supporting information provided (test reports or visual inspection statements). This element aims to ensure risk is being considered and applied consistently by MSAs and does not constitute an endorsement of the risk assessment.
• Incident validation: a consideration of whether the safety issues identified may fall under nationally significant, novel or contentious criteria, as outlined in the OPSS Incident Management Plan.

4.6 Once a product safety notification has been validated by OPSS Incident Management, this will be reflected on the PSD notification and the notifying authority will receive an auto-generated email notification. The UKCP may make contact with you to clarify details prior to validating a notification.

Publication of information

Product Recalls and Alerts site – GOV.UK

4.7 OPSS publishes information on unsafe products notified on the PSD where they meet certain criteria and where the notifications have been validated.

4.8 Products that should be published by routine include products which have been assessed as presenting a serious or high risk, and products which have been recalled or subject to a modification programme. ^{[footnote 2]} Where these criteria are met and all required information is available, the UKCP will automatically be added to the notification to commence the validation stage.

4.9 Publication of notifications outside of the criteria specified in 4.8 is encouraged where this will assist in public protection. Circumstances in which this may be appropriate can include where product identification information is detailed; where large unit numbers are affected by the safety risk; or where the corrective measure has been applied to a known brand. MSAs can request the publication of a Product Safety Report by following the steps set out in section 3.10.

4.10 A template outlining the PSD fields and equivalent fields on the Product Recalls and Alerts website, and therefore those that are publishable, can be found in Annex A. ^{[footnote 3]}

4.11 OPSS may edit the content of certain fields for clarity and accessibility to ensure greatest benefit to the public, but encourage MSAs to notify clear, concise and publication-ready content on the PSD notification. If MSAs would prefer to review publishable content for a specified notification in advance, they should contact ukproductsafetycp@businessandtrade.gov.uk promptly after notification.

4.12 OPSS owns and facilitates the Product Recalls and Alerts website to enable a single, national product safety and recalls website for UK MSAs. Where requests are made by businesses or external stakeholders to update ore remove published content, requests should be made to the original notifying authority. OPSS is able to consider updates to or removal of published content upon the request of the notifying authority.

4.13 The GOV.UK Product Recalls and Alerts website includes a subscription service. You can receive email notifications for product safety alerts, reports or recalls by clicking the ‘subscribe to feed’ button on the right of the home page.

OECD Global Recall Portal

4.14 The OECD Global Recall Portal brings together information on product recalls issued around the world in this one OECD-held platform. The portal includes information on consumer product recalls issued by a governmental body and made publicly available.

4.15 The portal is used by regulators in taking corrective actions; consumers in checking for safety concerns around products they are intending to purchase; and businesses to track emerging hazards and risks around the world.

4.16 OPSS manages the UK’s input into this resource, adding recalled products which have been published on the Product Recalls and Alerts website.

International reporting and market surveillance data exchange

4.17 Since EU Exit, requirements and procedures for the reporting of unsafe and noncompliant products to overseas regulators and bodies, have changed.

4.18 In multiple pieces of international law, UK MSAs are required to report information relating to unsafe and noncompliant products to other countries, including the EU, on a reciprocal basis.

4.19 To operationalise these requirements in a consistent, streamlined and central format, and as reports relate to the same safety issues and market surveillance outcomes that should already be notified by MSAs on the PSD, OPSS fulfils these reporting requirements through ongoing monitoring of new PSD notifications. MSAs need take no action to ensure these requirements are met.

EU information exchange

4.20 There are multiple routes and mechanisms by which UK MSAs can, and in some cases must, share information relating to unsafe and noncompliant products with the European Commission and EU Member States.

4.21 Article 43.1 of the Withdrawal Agreement commits the UK and the EU to exchanging relevant information on unsafe and noncompliant products where the product was placed on the market before 1 January 2021, was subject to a mandatory measure, and there is an EU-based economic operator in the supply chain (UK-based for EU reports). OPSS exchanges information on the UK’s behalf through the monitoring of new PSD notifications and collation of reports which are exchanged on a weekly basis.

4.22 MSAs operating in respect of NI are also required to continue reporting to the European Commission on Safety Gate and ICSMS under the Windsor Framework. As agreed with the EU, OPSS completes this on behalf of MSAs operating in respect of NI by monitoring the PSD and adding the relevant notifications to Safety Gate or ICSMS. From December 2024, it was agreed with the EU that the UK would notify on Safety Gate if a product is likely to have been made available on the NI market, for instance via distance sales. Further details on NI and EU reporting can be found in Annex B.

4.23 In circumstances where there are cross-border product safety issues out of scope of the above arrangements, or there is a more holistic concern that would benefit from bilateral engagement, authorities may exchange or request information from individual Member States through the national contact point network. If you would like support in sharing information internationally, please contact ukproductsafetycp@businessandtrade.gov.uk.

4.24 The EU-UK Trade and Cooperation Agreement made provision for a Safety Gate-PSD data sharing agreement. This guidance will be updated with information relating to the operationalisation of this agreement once it has been finalised and implemented.

Non-EU information exchange

4.25 The requirement exists in some of the UK’s trade agreements for the Government to report when market surveillance authorities take enforcement action against goods originating from the territory of specific trade partners. To fulfil these obligations to the extent required by the agreement, it is necessary that all enforcement actions taken by UK market surveillance authorities are notified on the PSD, including detailed business and supply chain information where available.

4.26 OPSS fulfils these legal obligations on behalf of UK market surveillance authorities through the monitoring of PSD notifications. MSAs do not need to undertake any action to fulfil these requirements but must ensure all relevant information is added to the PSD, as outlined in Section 2.

5. Additional UK Product Safety Contact Point functions

5.1 The UKCP also undertakes a number of additional functions to support UK market surveillance authorities. This includes receiving statutory notifications for unsafe products from other countries and triaging for UK impact; operating an international monitoring function for product safety and recall activity overseas; and facilitating engagement with overseas regulators on specific cases and issues.

5.2 Through these functions it may become apparent that there are risks associated with products identified on the UK market. In this instance, the matter will be referred to lead market surveillance authorities.

5.3 Market surveillance authorities should anticipate referrals from OPSS (and other MSAs) via email.

Overseas liaison and engagement

5.4 Where OPSS receives reports on unsafe and noncompliant products with a cross-border effect from other countries through arrangements outlined in Section 4, the UKCP will triage all reports to assess relevance to the UK market.

5.5 Where a UK-based producer, importer or distributor is identified in the product’s supply chain, or if the product is identified as on sale in the UK via online international monitoring, the notification will be referred to the relevant authority for follow up as they deem appropriate via email. The Primary Authority Register will be consulted to identify preferred method of contact for primary authorities.

International monitoring

5.6 OPSS operates an international monitoring function, identifying and triaging product safety alerts and reports published by overseas counterparts.

5.7 Where the product is identified as available on the UK market or otherwise presents a risk to UK consumers and is believed on initial triage with available information to also be noncompliant with UK safety regulations, the UKCP will ensure the relevant MSA is made aware and, if appropriate, make a referral via email.

5.8 If a UK-based economic operator is identified in the product’s supply chain or the product is identified as on sale in the UK via online monitoring, the notification will be referred to the relevant authority for follow up as they deem appropriate, in order to ascertain whether the safety risk extends to the UK product. The Primary Authority Register will be consulted to identify preferred method of contact for primary authorities.

5.9 If the product is available on the UK market but there is no UK-based economic operator in the supply chain, OPSS will provide national capacity to follow up on the issue through direct liaison with overseas economic operators and liaison with national product safety regulators in other countries, as required.

5.10 Should the relevant authority follow up with the economic operator following a formal report from another country or international monitoring, the triggers for a PSD notification being required may be met, as set out in Section 2.

5.11 This function acts as a national resource and service and any follow up investigation or enforcement activity undertaken after an international monitoring referral is at an MSA’s own discretion. A referral made to an MSA does not indicate that it has been formally ascertained that a product does not comply with UK regulations, as this is for the MSA to confirm with the economic operator post-referral.

Annex A – Publication template

The below template outlines the format of Product Safety Reports and Product Recalls that are publishable on the Product Recalls and Alerts site. The italicised text in the body of the alert outlines the PSD fields that are extracted to produce the reports.

The content may be supplemented and/or summarised for consistency and clarity, but it is requested that authorities provide information to a publishable standard to reduce intervention.

Should an authority wish to provide a completed template or review a drafted Product Safety Report or Product Recall prior to publication, please contact ukproductsafetycp@businessandtrade.gov.uk.

OPSS will ensure that all Product Safety Reports and Product Recalls are consistent and no information that is sensitive and protected under GDPR will be disclosed.

Annex B – NI MSAs and notifications

The above notification requirements, processes and procedures apply to all UK market surveillance authorities, including those acting in respect of the NI market.

MSAs with responsibility for the NI market are also subject to additional requirements, primarily those relating to the scope of product safety and compliance notifications that must be reported, and use of EU market surveillance IT systems, which are outlined in this section.

Scope of required notifications

The EU Regulation on Market Surveillance and Compliance of Products (2019/1020) came into effect in the EU on 16 July 2021.

The Regulation has expanded the scope of product safety and compliance matters that must be reported. In addition to the requirements outlined in Section 2, it also requires under Article 34 that MSAs must report all relevant information (including results of testing, identification of risks) and measures taken where an in-depth compliance check has taken place, including where the product is judged to be compliant. This is wider than the previous RAMS requirement to report all information for products presenting a risk. While Article 34 relates to ICSMS rather than Safety Gate, all information required for reports under the new Regulation should be reported to the PSD.

Procedure for notifications

To avoid the need for NI MSAs to notify on multiple systems, OPSS has agreed with the European Commission that NI MSAs will notify products to OPSS on the PSD, with OPSS undertaking any subsequent required notification to the EU.

OPSS regularly monitors the PSD to capture the relevant notifications and report them as required.

OPSS notifies on the EU Safety Gate system where at least one of the following criteria have been met:

• The MSA enforcing the measure or undertaking the market surveillance project is located in NI.
• An economic operator listed on the notification is geographically based within NI.
• The product is likely to have been made available on the NI market (e.g. via distance sales.

OPSS notifies on ICSMS for notifications outside of the above criteria, where the MSA is located in NI and/or an economic operator in the supply chain is geographically based within NI.

Access to EU information

OPSS and NI MSAs do not have access to Safety Gate notifications by default, but non-public information relating to a Safety Gate notification can be requested from the European Commission by exception.

Should a MSA require non-public information relating to a Safety Gate notification to support the discharge of their responsibilities, the request should be sent to ukproductsafetycp@businessandtrade.gov.uk. The UKCP will request this information through the agreed mechanism from the European Commission in their capacity as UK Safety Gate Contact Point.

OPSS, NI MSAs and certain officers in national regulators with responsibility for the NI market have been provided with partial access to ICSMS. Authorities can access ICSMS to search for information relating to notified products and communicate with EU / EEA MSAs.

Cooperation with EU Member States and their MSAs

MSC also outlines the way in which the European Commission, EU Member States and their authorities should communicate, collaborate and exchange information with each other in relation to market surveillance. NI MSAs should anticipate requests for information, mutual assistance or enforcement by EU MSAs through automated ICSMS alerts for ‘baton passes’.

If you require any support or advice relating to liaison with EU MSAs and reporting in respect of NI, please contact the UKCP at ukproductsafetycp@businessandtrade.gov.uk.

Footnotes

1. Authorities operating in Northern Ireland are required to continue to use the Safety Gate Risk Assessment Methodology as set out in Commission Delegated Regulation (EU) 2024/3173. ↩

2. Or other corrective actions requiring engagement with and action from consumers and other end users. ↩

3. The Product Recalls and Alerts website, which is part of GOV.UK, adheres to its content retention and withdrawal archiving policy. ↩