Joining other third-country business groups, AmCham EU has co-signed a joint statement outlining concerns about the extraterritorial implications of the Corporate Sustainability Due Diligence Directive (CS3D) and the Corporate Sustainability Reporting Directive (CSRD). The letter highlights concerns regarding legal uncertainty created by certain extraterritoriality requirements in the ongoing Omnibus 1 process and outlines recommendations to ensure a clear, workable framework for all companies operating in or engaging with the EU market.
Addressing extraterritoriality in the EU’s sustainability framework
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Simplification is moving. But EU policy still hasn’t seen the complete mindset shift it needs.
Authored by Malte Lohan, CEO, AmCham EU
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Healthcare, competitiveness, innovation and simplification
Europe’s life sciences sector sits at the heart of the EU’s competitiveness agenda. It supports advanced manufacturing and helps bring new treatments and technologies to patients. Yet companies deciding where to invest need a regulatory environment that is predictable and open to global cooperation.
The European Commission’s work on the Biotech Act and the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) offers an opportunity to improve that environment. Both files can help make Europe a stronger location for life sciences investment.
The EU should use this moment to build a framework that keeps pace with scientific progress. That means faster and clearer procedures. It also means better use of data and intellectual property rules that recognise the realities of global supply chains.
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Delivering simpler, science-based rules for Europe’s agri-food sector
The EU’s agri-food regulatory framework is fragmented and lacks predictability. The Food and Feed Safety Omnibus is a chance to address these shortcomings by reducing delays, improving consistency and easing compliance burdens that limit market access.
Uncertainty discourages investment and slows the uptake of new solutions. A more proportionate approach can improve legal certainty and support more consistent implementation across Member States. At the same time, maintaining a science-based, risk-based approach to trade measures is necessary to safeguard food security and avoid supply disruptions.
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