EU machinery directive/AI proposal - opportunity for comment

As you may have heard, the EU has proposed new regulations for machinery to address emerging technologies, including artificial intelligence, titled Proposal for a Regulation of the European Parliament and of the Council on machinery products. The proposal draws links between the new EU AI regulation and the Machinery Directive and has the potential to impact U.S. companies exporting to the EU and/or operating in the EU.

The U.S. International Trade Administration has been contacted by several U.S. industry stakeholders who have expressed their concerns with the proposed changes to the directive. We are therefore reaching out to companies like you that may be affected by the proposed changes to share information about the regulation proposal and to provide instructions on how to provide feedback and voice any concerns directly to the European Commission (EC) before the August 16, 2021deadline.

A copy of the new proposed regulation and the impact analysis may be found here.

The proposal seeks to accomplish two goals: 1) to “ensure the free movement of machinery within the internal market” and 2) “ensure a high level of protection for users and other exposed persons.” According to the proposal (page 5):

“This proposal is coherent with the Union policy on artificial intelligence (AI) and the upcoming Regulation on artificial intelligence, which will address the risks having an impact on safety for high-risk AI systems embedded in a machinery or that are safety components under the future regulation on machinery products.”

The International Trade Administration has noted that the proposal updates the list of “high-risk machinery products” (Annex 1) to include:

- Software ensuring safety functions, including AI systems, and
- Machinery embedding AI systems ensuring safety functions

Designation as high-risk machinery will mean these products will likely require third-party certification. The proposal also changes the directive to a regulation which will affect implementation.

Comments can be submitted to the European Commission here by August 16, 2021.