Product compliance and regulatory wrinkles

By Jason Malcore, AEM Director of Global Standards and Compliance

Over the past five years, the UK (UK) and the European Union (EU) have mostly completed their long and tumultuous divorce process, in what is commonly referred to as Brexit. While the UK officially completed its separation from the EU on December 31, 2020, when it withdrew from the single European market, the European customs union, the common agricultural policy and the common fisheries policy, several lingering issues are waiting to be resolved before the process is completed.

For equipment manufacturers looking to sell their products in both trade areas, it is important to understand the current regulatory environment and the requirements necessary to comply with UK and EU law.

The border of Northern Ireland

The Good Friday Agreement (GFA) marked a major turning point in ending decades of civil and political unrest in Northern Ireland. As part of the GFA, the UK agreed to abolish military and customs checkpoints between Northern Ireland and the Republic of Ireland, an institution known as the ‘hard border’.

Under the aegis of the EU Customs Union, goods could freely cross the border of Northern Ireland and the Republic of Ireland, as both countries operated under EU laws on the EU product and free trade area conformity. After Brexit, the Irish border became the only land border between the EU and the UK. Without checkpoints to enforce regulatory and customs requirements, the open border has threatened the entire negotiating process between the UK government and the EU.

Due to the sensitive nature of Ireland’s ‘hard borders’ and the continued pressure to complete the broader Brexit process, the UK government has offered a supportive deal known as the Northern Ireland Protocol. From an OEM perspective, under the protocol:

  • The Irish border will remain clear, avoiding the establishment of any “hard border” checkpoint.
  • Northern Ireland will remain in British customs territory. The UK will levy customs duties on products deemed “at risk” of being transferred to the EU via the Irish border. If the final destination of the products is in Northern Ireland, companies can claim a discount on goods that are priced below the EU. UK and EU promise increased cooperation to identify risky products to watch.
  • Northern Ireland will continue to comply with EU product compliance regulations. From a product perspective, this means that products placed on the market in Northern Ireland must continue to use the CE mark to show that the products and products comply with EU rules. If a manufacturer uses a UK certification body to perform third-party conformity assessments, they will need to apply a UKNI mark as well as the standard CE mark to prove conformity.
  • Companies operating in Northern Ireland can import goods into the UK with CE and UKNI marks, provided the goods meet certain administrative requirements.

Product safety rules

In the pre-Brexit era, the European Single Market provided manufacturers with a level of certainty about product requirements and certifications. With a set of rules for the entire continent, there was no need to worry about designing products to meet conflicting requirements in France, Germany and Britain. As Brexit threatens the long-term stability of the European regulatory environment, in the short to medium term, Brexit negotiators have put in place administrative relief provisions to ensure manufacturers have an extended transition period necessary to comply with the UK law.

January 1, 2021, products intended for sale in England, Wales or Scotland (Great Britain) must meet the United Kingdom Conformity Assessment Standards (UKCA) for all relevant UK product laws and apply the UKCA mark as defined in UK law. Manufacturers must meet the following requirements:

  1. All goods falling within the scope of applicable UK product regulations must meet self-declaration requirements or the requirements of approved UK certification bodies.
  2. Until December 31, 2022, products correctly marked with the European CE mark may continue to be sold in Great Britain.
  3. On January 1, 2023, the UK government will only accept the UKCA mark to prove compliance with relevant rules and requirements.
  4. Until January 1, 2023, the UKCA mark can be either affixed directly to the product or on an accompanying document. Then the UKCA mark must be affixed directly to the product.
  5. The UKCA mark does not apply to Northern Ireland.

This administrative arrangement assumes that EU and UK laws do not diverge in their compliance standards. If the rules start to diverge, the UK will ban manufacturers from using the CE mark to prove compliance with the law. It will therefore be important to monitor regulatory developments in the UK and the EU to ensure that your businesses can maintain their market access.

Brexit is a complex, politically charged and ever-changing issue. The final chapter probably hasn’t been written yet, but AEM will remain committed to keeping you and your businesses updated. If you would like to learn more about this issue or if you would like to join the AEM Safety and Product Leadership Committees to stay engaged, please contact AEM Global Compliance Director Jason Malcore at [email protected].

AEM Security and Product Leadership

“Do it once, do it right, do it globally” is the long-standing motto of AEM’s product safety and leadership department, and it guides efforts to meet the ever-increasing global demands of manufacturers. equipment to develop safe, productive and compliant machines. . To learn more about AEM’s security and product leadership activities, visit https://www.aem.org/safety-product-leadership.

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