Global Trade Compliance Updates

Steel measure proposed today by the European Commission is a game changer, for both EU and global trade: https://lnkd.in/eYZ_bFhm 1️⃣ Quota for steel imports in the EU cut in almost half (compared to 2024) 2️⃣ Out-of-quota tariff doubled from 25% to 50% WHAT ARE THE EU'S STATED REASONS FOR DOING THIS? 1. WTO rules require that the current EU steel safeguard (already imposing tariff rate quotas since 2018) expires in June 2026 2. To address global overcapacity in steel (the quota takes imports back to their market share in the EU in 2013, before overcapacity kicked in) 3. Steel restrictions imposed in other countries (esp. the US) are causing trade diversion of steel from third markets to the EU 4. To safe a "strategically crucial industry" and bolster EU economic security 5. To support the EU steel industry in its decarbonization efforts 6. To align itself with "like-minded countries" such as the US, Canada and Mexico who have enacted similar measures GAME CHANGER FOR EU TRADE POLICY: ✅ Beyond trade defense instruments, this is the first time the EU is openly coming to the rescue of an EU industry GAME CHANGER FOR GLOBAL TRADE POLICY: ✅ The EU is not invoking national security (as the US and Canada did) but will renegotiate its bound (MFN) tariff on steel (currently zero) into a tariff-rate-quota in line with GATT Art. XXVIII (this may involve compensating some steel exporters to the EU; EEA countries will be exempted, but "an exclusion of FTA partners' imports [representing 2/3 of total imports] is not possible"; the EU may invoke safeguards under FTAs) ✅ Unlike the current EU safeguard on steel (in place since 2018), the new measure (a tariff renegotiation) is "permanent" (it will be reviewed every 5 years) ✅ The measure effectively creates a "steel club" of like-minded countries who are "ring-fencing their economies form global overcapacity while securing supply chains and increasing mutual market access" (the measure may, indeed, lead to more market access for EU steel exports to the US, pursuant to the EU-US trade deal) WHAT'S NEXT? - The Commission's proposal needs to be approved by the Council and European Parliament - Once authorization obtained by the Council, the Commission can start tariff renegotiations at the WTO in Geneva - Only primary steel products would be covered; within 2 years, a possible product scope extension to downstream products will be considered THE BIG QUESTION: Are other sectors of EU industry, where the same concerns are pressing, next? Or is steel truly special?

From my expertise working inside the FDA and alongside CBP, I can tell you this — what just happened isn’t a trade adjustment, it’s a regulatory upheaval. New import taxes are being introduced under the guise of fairness, but they’re about to trigger a domino effect that affects everyone moving products across borders — especially those regulated by federal agencies. Costs won’t just rise. Risk will. Businesses operating in highly controlled industries will now face a triple-threat: 🔸 Unpredictable border interventions 🔸 Shifting agency priorities 🔸 Higher stakes for even minor missteps I’ve seen this kind of pressure play out from the inside. It’s not just about what you bring into the country — it’s about whether your business is built to survive these shifts. If you're responsible for compliance, legal strategy, or product movement — especially in food, supplements, drugs, devices, cosmetics, or even pet goods — now’s the time to act, not react. #TradePolicy #RegulatoryStrategy #FDACompliance #TariffImpact #USImports #GlobalTrade #CBPEnforcement #SupplyChainRisks #ExecutiveLeadership #LegalStrategy #FoodLaw #PharmaCompliance #MedicalDeviceRegulations #PetIndustryRegulations #CrossBorderTrade #ProductSafety #RiskMitigation #ThoughtLeadership #USDA #LinkedInCreators

3 letters can block your device from global markets.   UDI isn't just another compliance checkbox.   It's your passport to selling medical devices worldwide.   Get it wrong and you lose access to entire regions. Get it right and doors open across continents.   Here's what matters for global UDI success:   EU UDI Requirements ↳ Basic UDI-DI structure is non-negotiable ↳ Data for new UDI-DIs entered at market placement; updates within 30 days ↳ UDI active; carrier deadlines — labels 2025, direct marking 2027 ↳ Grace periods vary by device class and carrier type   US UDI Requirements ↳ FDA system tracks devices through distribution ↳ Direct marking for reusables due ~2 years after label compliance ↳ GUDID submission before US distribution ↳ All classes now in effect   UK UDI Requirements ↳ UKCA marking required by June 2028 ↳ CE marks accepted in GB until 2030; legacy devices until 2028 or expiry ↳ Future database system in development ↳ Northern Ireland follows different rules   Common mistakes that cost companies millions:   ❌ Confusing Basic UDI-DI with UDI-DI ❌ Assuming EUDAMED is fully ready ❌ Missing FDA listing requirements ❌ Wrong device classification ❌ Incomplete GUDID submissions ❌ Ignoring UKCA/CE mark differences   The strategic approach that works:   ✅ Start with Basic UDI-DI structure ✅ Plan for all three regions simultaneously ✅ Validate data in sandbox environments ✅ Maintain dual CE/UKCA strategy ✅ Keep production records current ✅ Register UK Responsible Person early   Here's the truth:   UDI compliance isn't about meeting minimum requirements.   It's about: → Enabling global traceability → Protecting patient safety → Streamlining recalls if needed → Building regulatory trust   The timeline is tightening: • EUDAMED delays won't last forever • UK requirements are non-negotiable • FDA enforcement is increasing   Smart MedTech leaders treat UDI as infrastructure. Not overhead.   Because every device needs identity. Every market has rules. Every delay costs opportunity.   Which market challenges you most? ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let's connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

🚨 BREAKING: The EU Commission has just published the Digital Omnibus [HINT: Yes, the Washington Effect is here]. These are some of the changes being proposed to the EU AI Act: 1. Linking the implementation timeline of high-risk rules to the availability of standards or other support tools; 2. Extending regulatory simplifications granted to small and medium-sized enterprises to small mid-caps, including simplified technical documentation requirements and special consideration in the application of penalties; 3. Requiring the Commission and the Member States to foster AI literacy instead of enforcing this obligation on providers and deployers of AI systems; 4. Removing the prescription of a harmonized post-market monitoring plan; 5. Removing the registration obligation for providers of AI systems that are used in high-risk areas, but for which the provider has concluded that they are not high-risk; 6. Centralizing oversight over a large number of AI systems built on general-purpose AI models or embedded in very large online platforms and very large search engines with the AI Office; 7. Allowing providers and deployers of all AI systems and models to process special categories of personal data for ensuring bias detection and correction, with the appropriate safeguards; 8. A broader use of AI regulatory sandboxes and real-world testing; 9. Targeted changes clarifying the interplay between the AI Act and other EU legislation and adjusting the AI Act’s procedures to improve its overall implementation and operation. - These changes reflect the EU's narrative shift, which we have been observing since the Draghi report on European Competitiveness, published in September 2024. Over the past 11 months, especially after Trump's election, the EU has been scrambling to appear more "business-friendly" and deregulatory to Washington (watch videos of the AI Summit in February, especially JD Vance's speech). Its recent publications seem to highlight its new focus on innovation and an "AI-first" mentality - even when it does not make sense, as a recently posted video of Ursula von der Leyen made clear. The digital omnibus seems to be the coronation of this new European mentality, but it's still unclear to me how these changes will foster innovation or improve European competitiveness. Lastly, negotiations will now begin, and it's unclear when they will finish. At the same time, there is an upcoming EU AI Act milestone on August 2nd, 2026. Perhaps unsurprisingly, this might lead to MUCH MORE legal uncertainty than before. Europe is changing, and Europeans who care about protecting fundamental rights in the digital sphere should share their thoughts loudly and clearly, and act before it's too late. 👉 Read my full analysis of the proposed changes to the AI Act and join my newsletter's 86,300 subscribers below.

Europe’s steel industry may be at a turning point.      As DER SPIEGEL’s latest article reports, the EU proposes to almost halve steel import quotas as of July 2026 and apply a 50 percent tariff on out of quota imports. This could lift plant utilization to profitable levels, according to BCG analysis.      The conditions that led to the introduction of EU steel safeguards have not improved. Global overcapacity continues to fuel export pressure and unsustainably low prices, while US trade restrictions keep redirecting steel flows toward Europe. On top of that, weak demand, high energy prices, and rising decarbonization costs persist.      Against this backdrop, the EU decided to tighten and make the trade defense instrument permanent. The aim is to ensure that the EU steel industry can compete on a level playing field and continue to support a strong industrial base in Europe.      It is no accident that the new 50 percent out of quota tariff matches that now imposed by the United States on steel imports. The EU will also introduce a new “melt and pour” requirement, preventing circumvention by ensuring that only steel actually produced in a given country can benefit from its import quota.      Like the existing steel safeguards, quotas will be divided among 30 product families, based on 2022 to 2024 import shares.      The goal is to ensure a more balanced market that keeps EU steel production viable and competitive, creating conditions for continued investment, including in low carbon technologies.      But the move could also raise input costs for Europe’s steel intensive industries. Those competing globally may see margins tighten. However, the medium-term price effect for steel users is unclear. The decline in imports may be offset by higher capacity utilization, a reduction in exports, and the reopening of idled plants.      In reality, both effects are likely: stronger protection for EU steel producers and rising challenges for steel using industries. The key question is how Europe manages this trade off while staying competitive and moving toward decarbonization.      Check the full Der Spiegel article “Hoffnung für Deutschlands Stahlwerke” here (German only): https://lnkd.in/e5fAcMdf       #SteelIndustry #EUTradePolicy #IndustrialStrategy #BCG 

Yesterday, the European Commission released two proposals that will materially affect how HR and TA teams use AI and manage people data: The Digital Omnibus Regulation and the AI Act Simplification Amendment. 1. High-Risk AI Timeline Adjustments The fixed August 2026 enforcement date for high-risk AI no longer applies. Obligations will now begin once the Commission confirms supporting tools (standards, guidance) are available, followed by a six-month transition for HR-related high-risk systems. A new final deadline requires compliance no later than December 2027. This creates a more realistic adoption window for HR technology and recruitment AI. 2. Key GDPR Changes for HR The Digital Omnibus updates GDPR to support modern people analytics and AI use: • Clearer definition of personal data, reducing uncertainty when using aggregated or pseudonymised data. • Permission for residual special-category data in AI training under strict safeguards. • Confirmed allowance for biometric verification when controlled by the employee. • Harmonised DPIA requirements across the EU. • Data breach reporting extended to 96 hours, with a unified EU reporting portal. 3. Streamlined Data and AI Governance Several data laws are consolidated into a clearer Data Act, simplifying vendor oversight and data portability. The AI Act amendment also introduces more practical obligations, expanded simplifications for SMEs and small mid-caps, stronger EU-level oversight, and support for using sensitive data to detect or correct bias in hiring and workforce systems. What This Means for HR and TA: The proposals provide clearer rules, reduced administrative burden, a more achievable timeline for high-risk AI, and better support for fair and compliant AI in recruitment and workforce management. Both the Digital Omnibus and the AI Act amendment are Commission proposals and are not yet law. They now enter the EU’s Ordinary Legislative Procedure, where the European Parliament and the Council will review, amend and negotiate the texts before jointly adopting them. Once approved and published in the Official Journal, each Regulation will enter into force and begin applying on the dates specified in the final legislation. If you’d like a tailored breakdown for your organisation or HR tech stack, feel free to get in touch.

April 2025 has ushered in a fresh test for India’s yarn industry: a 26% US tariff on our imports. Having spent decades scaling businesses and navigating market shifts, here’s my take on what this means and how we can turn it to our advantage. India is in a stronger position than its rivals. With China facing 34%, Bangladesh at 37%, and Vietnam hit with a steep 46%, our 26% tariff offers a competitive edge in the US market. American buyers might shift toward Indian yarn, boosting demand and potentially growing our share—if we act strategically. That said, challenges loom. The 26% tariff still raises costs, and US consumers may not absorb the hike. Our edge could erode unless we streamline logistics and boost operational efficiency. Rerouted trade flows might also strain infrastructure. And if the US market contracts, we’ll need other global buyers—fast. So, what’s the play? •First, India should negotiate smarter US trade terms, perhaps securing zero-duty cotton imports. •Second, diversify markets; over-reliance on one is risky. •Finally, double down on efficiency—cut costs, maintain quality, and stay agile. This tariff isn’t just a barrier—it’s a wake-up call. India’s yarn sector has the talent and grit to make this a win. What’s your view—where should we focus to adapt and thrive? #ustariffs #textile #textileindustry #leadwithrajeev #leadership #globalmarket

The revamped §232 steel and aluminum tariffs, especially the tariffs on derivative products, are likely to significantly shift effective tariff rates upwards for many products especially those produced in Canada and Mexico. The reason is that the revised §232 tariffs apply to the entire value of the product, as opposed to just the steel or aluminum content. Mexico and Canada are especially impacted because the prior approach tariffed the steel or aluminum content at 50%, but the remainder of the value was duty free if it came in under USMCA. Below is one example of an import category that, from everything I can see in the data, is set for a major increase in effective tariff rates: truck trailers (HTS 8716.39.00). One chart showing the effective tariff rate for imports from Mexico (by far the largest source). Thoughts: •The effective tariff rate for truck trailers was just 2.1% as of February 2026. $2,221,318 in duties we calculated for $108,018,857 of imports. •Why is this figure so low? My educated guess: the steel and aluminum derivatives originally applied only to the value of the steel or aluminum itself, which didn't include processing, machining, milling, heat treating & annealing. These value adding steps constitute much more of the value. •Canada and Mexico are much more affected than the EU because for something like EU construction equipment, the remainder of the value not in steel or aluminum was tariffed at 15%. The USMCA exemption made this figure 0%. •This issue applies beyond just capital goods and also affects intermediate inputs like Canadian steel doors and Mexican air conditioner parts. Implication: Mexico and Canada are the most negatively affected countries by the revamped §232 steel and aluminum derivative tariffs that apply tariff rates to the entire value of the good, not just the value of the steel and aluminum. Will this shift production to the USA? I doubt, since the tariffs on raw steel and aluminum have so inflated the domestic price in the USA that you are better off paying a 25% tariff on an imported aluminum air conditioner part from Mexico than making it in the USA where aluminum is 50% more expensive than in Mexico. #supplychain #freight #trucking #logistics #transportation

Sanctions Alert 🔔 The EU just adopted the Directive (EU) 2024/1226 on the definition of criminal offenses and penalties for the violation of Union restrictive measures and amending Directive (EU) 2018/1673 (“Directive”). In order to ensure the effective application of Union restrictive measures and the integrity of the internal market within the Union, the Directive defines criminal offenses and penalties and establishes minimum rules concerning the prosecution of violations or circumvention of EU sanctions in Member States and directs Member States to ensure that conduct is considered a criminal offense when it is intentional and in violation of a prohibition or an obligation under EU sanctions. In future, at least from a qualification as a criminal offense perspective, there will be a more aligned level-playing field in the EU. For example, the Directive provides that the following conduct (including inciting, aiding, abetting and, in most cases attempt, cf. Article 4 of the Directive) are criminal offenses: Breach and circumvention of asset freeze and/or economic resources measures related to a “designated person, entity or body” where the conduct involves funds or economic resources with value exceeding EUR 10,000. Breach and circumvention of trade control measures, even if only the result of serious negligence, where the conduct involves goods, services, transactions or activities with a value exceeding EUR 10,000. Such conduct includes: the trade, export, import, sale, purchase, transfer, transit, transport, brokering, insurance, technical assistance or any other service related to sanctioned goods; the provision of financial services or the performance of financial activities such as financing and financial assistance, providing investment and investment services, issuing transferable securities and money market instruments, accepting deposits, dealing with in banknotes, providing credit rating services and providing crypto-assets and wallets. Breach of, or failure to comply with, the conditions of authorizations granted by the competent authorities where such conduct involves goods, services, transactions or activities with a value exceeding EUR 10,000. Member States will have until April 30, 2025 to transpose this into national legislation. Our trade compliance and #investigations team regularly publishes updates. If you are interested, feel free to send an email and we will put you on our mailing list.