ISEA EU Regulatory Report

Stay informed and updated about evolving policy and regulatory environments in the European Union and other global markets. 

Curated by ISEA Senior Directory of Policy Dan Glucksman

with intel from FiscalNote.

EU: We Want Digital, Green, Resilient Single Market

What We’re Following European regulators and standards writers are advancing the digital and green transition of EU industries. A new standardization strategy introduced this year includes a proposal for an amendment to the Regulation on standardization, a report on its implementation, and the 2022 annual EU work program for European standardization.


What it Means As the EU seeks a climate neutral, resilient, and circular economy, it needs standards, testing methods, management systems and the like to achieve this year. European standards (EN) could be updated along these lines.


What to Watch Similar to past European global standards efforts, EU leaders are well aware of the global race for digital leadership, and they are actively seeking to shape international standards for digital products. 

US, EU Hold 2nd Trade & Technology Council

The US-EU Trade and Technology Council recently concluded a meeting in May to reaffirm their relationship as the Russian economy is pushed further off.


Standards are the focus. The trade negotiators inked a Strategic Standardization Information (“SSI”) working group on international standards development that will look for new standards opportunities. The working group will also explore taking coordinated action if standardization activities (from Russia or China) pose a challenge to US-EU strategic interests and values.


Reducing trade barriers. Both parties will “seek to strengthen bilateral trade and reduce …unnecessary trade barriers for products …derived from new and emerging technologies through enhanced information exchange and concrete trade facilitating initiatives.” (See Working Group 10, pages 43-46 in the joint statement).  

General Safety Directive Regulation to be Updated. 

PPE Directive Not Impacted

What to know: The EU Parliament and Commission are updating the General Product Safety Regulation. ISEA members should be aware this does not impact PPE.

 

The PPE Regulation (Regulation (EU) 2016/425), which has been in place since 2018, is not impacted by the General Safety Directive Regulation (GSDR).

 

Do You Sell Non-PPE Products? The GPSR seeks to improve the safety of non-food consumer products on the internal market and address product safety challenges of emerging technologies, including the use of artificial intelligence (AI), and establish clear obligations for online marketplaces. The aim of General Safety regulation is to ensure harmonized standards in all EU member states. 

Dual-Use Export Controls

eu-dual-use-regulation-export-controls-78026d85ef4a10dg8d1838bf027a0e06 image

Who’s your buyer? US-EU trade of Dual-Use goods (which can be used for both civil and military purposes) includes a number of types of PPE, such as respiratory protection, protective garments and gas detection, to name a few. Sales of these products are reviewed and approved by a range of bureaucrats before a company can finalize a sale.


Software and technology of Dual-Use goods are to be controlled under Regulation (EU) 2021/821, in addition to the products themselves. This move updates the European Union regime for dual-use export controls.

AI-Enabled Products Included in European Products Liability Laws

New liability rules released TODAY. The EU laws cover products in the “circular economy” and those products enabled by AI, such as drones, etc.  The new laws apply to EU manufacturers and companies that import such products from non-EU manufacturers.


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