The EU has the most stringent regulation globally, never more so than when it covers safety. Most global markets choose to either adopt EU regulation and standards, or develop their own variants that are very closely aligned. Therefore, adopting EU regulation in any domain usually stands a company in good stead for being able to comply with global regulation.
Within the EU, safety regulation falls within the Harmonised Product Safety Regulation – Framework governed by the New Legislative Framework (NLF), which includes Regulation (EC) No 765/2008 (accreditation and market surveillance) and Decision No 768/2008/EC (provides a template for harmonised legislation). Essentially these ensure that products placed on the EU market meet uniform safety standards, enabling free movement while protecting consumers and workers.
Products complying with EU harmonised standards benefit from a presumption of conformity with essential safety requirements. CE Marking is also mandatory for most regulated products (e.g. toys, machinery, electrical equipment) as this indicates conformity with applicable EU legislation.
Each sectoral directive or regulation (e.g. Low Voltage Directive, Toy Safety Directive) defines safety, health, and environmental protection criteria. Manufacturers must ensure compliance, maintain technical documentation, and affix CE marking. National authorities monitor compliance and can restrict or recall unsafe products. Below is an illustration of all products governed by harmonised safety regulation.
Following the UK’s decision to leave the EU, companies in Great Britain (GB) exporting products governed by EU harmonised regulation (medical devices, toys, machinery, etc.) have had to appoint a Responsible Person in the EU to comply with local regulation. EU regulation dictates that a Responsible Person can be an individual residing in, or a company established in the EU, often referred to as ‘natural’ and ‘legal persons’ respectively.
The Northern Ireland Protocol negotiated as part of the UK Withdrawal Agreement, and more recently the Windsor Framework, suspends Northern Ireland (NI) in a kind of hybrid situation. For the purpose of goods, NI remains closely aligned to the EU Single Market and therefore must comply with all product regulation, despite being part of the UK Customs Territory.
What does this mean? Essentially this means that product regulation applicable to GB exports to the EU, also applies to GB goods going into NI (as well as the three EEA markets (Norway, Iceland and Liechtenstein).
GTD provides technical consulting around all harmonised regulation ensuring companies understand exactly what they must do to be fully compliant before placing their product on the EU market; we also provide a Responsible Person / Authorised Representative service for companies based outside of the 27 member states, the 3 EEA markets, and Northern Ireland.
EU General Product Safety Regulation (EU GPSR) which repeals the longstanding General Product Safety Directive (GPSD), extends the requirement for an EU Responsible Person to non-harmonised goods when they are sold to consumers via distance sales and online marketplaces.
What does this mean? Essentially, it means that tens of thousands of GB micro businesses and SMEs exporting furniture, clothing and footwear, baby products, pet products, home decor, sports equipment, and many more products to consumers, now find themselves in the position of having to appoint a Responsible Person (often cost-prohibitive) or cease trading with the EU.
The box to the left highlights the products falling under the new EU GPSR.
More hands-on regulation support
GTD provides technical consulting around all harmonised regulation ensuring companies understand exactly what they must do to be fully compliant before placing their product on the EU market; we also provide a Responsible Person / Authorised Representative service for companies based outside of the 27 member states, the 3 EEA markets, and Northern Ireland.
GTD provides extensive, practical support around sustainability regulation, including but not limited to EU CBAM, Extended Producer Responsibility (EPR), Corporate Sustainability Reporting, Digital Product Passport (DPP), EU PPWR, EU ESPR, and much more.
GTD is increasingly removing the burden of Extended Producer Responsibility (EPR) compliance from small businesses by determining whether their goods and packaging are with in scope and then undertaking the registration and reporting requirements on their behalf.
GTD has now assisted tens of UK SMEs to establish an overseas office, be they separate legal entities or extensions of their UK operation. If an overseas office is key to your expansion plans, and you would benefit from practical advice or support in making it a reality, get in touch to learn how we can help.
Obtain an impartial, outside-in assessment of your current global trading processes and practices, with practical recommendations of how you can incorporate sustainability values and targets to meet future EU and global regulatory requirements and drive long-term growth.
Great Britain: Global Trade Department Ltd, Kingston House, Great Western Way, Swindon, Wilshire, SN5 8UB, Great Britain.
Global Trade Department Ltd is a company registered in England and Wales, Company no: 07000152. VAT no: GB994 7629 49
EU/Northern Ireland: Global Trade Department (NI) Ltd, Office 834, 92 Castle Street, Belfast, BT1 1HE, Northern Ireland.
Global Trade Department (NI) Ltd is a company registered in Northern Ireland, Company no: NI724330
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