New dashboard in the US: tariffs, FDA and market access in 2026

 

La Cámara de Comercio de Madrid y Demos Global Group They will analyze the new access barriers on May 19th. Estados Unidos by 2026. The conference will address the tariff increase to 15% and the strict requirements of the FDA in traceability and food safety for exporters.

 

The new trade and tariff scenario in 2026

 

Market access Estados Unidos Spain is undergoing a phase of accelerated transformation. In a context of profound review of trade policies, Spanish companies are facing increased regulatory pressure and stricter enforcement of regulations by the authorities. FDA (Food and Drug Administration) and the customs authorities of U.S. Customs and Border Protection.

 

One of the most significant changes for fiscal year 2026 is the impact of the new framework under the Trade Actwhich contemplates an increase in tariffs from 10% to 15%. This increase directly affects the profit margins of strategic sectors such as agrifood, the industrial machinery, the pharmacy and cosmetology.

 

To analyze these challenges, the day will include presentations by Ms. Tania MartínezCEO Demos Global Group and expert of the Alianza de Controles Preventivos para la Seguridad Alimentaria FSMA/FDADuring the session, the risks of border blockages and the critical errors that are causing operational cost overruns in exports to the US market will be detailed.

 

Change Factor	Details and Requirement 2026
Tariff Evolution	Increase from 10% to 15% under the Trade Act.
Mandatory Identifiers	Mandatory use of FPN, FEI y DUNS.
Food Traceability	Entry into force of the FSMA 204 (records KDE y CTE).
Cosmetic Regulation	Critical phase of the law MoCRA (Modernization of Cosmetics Regulation Act).

 

FDA and Food Safety: From Formal Compliance to Real Control

 

In the area of ​​food safety, the effective application of the Food Safety Modernization Act (FSMA) imposes new responsibilities on foreign exporters. The regulations FSMA 204 It is already in force, requiring mandatory traceability through the so-called Key Data Elements (KDE) and Critical Tracking Events (CTE).

 

This strengthening of control extends to Foreign Supplier Verification Programwhich grants the importer a greater supervisory role and involves the allocation of a new Foreign Producer Number (FPN) for exporters. Furthermore, the requirements for food contact equipment under the standards of the FDA y NSF They have been strengthened, raising the technical requirements for the capital goods industry.

 

• Cosmetics: The law MoCRA It enters a critical phase with new obligations and key differences compared to European regulations.
• Supplements and OTC: Strict monitoring of mandatory records, Good Manufacturing Practices and labeling according to the DSHEA.
• Machinery: Need to comply with technical standards such as UL/ANSI, NFPA and standards of OSHA.

 

Date: May 19

Hour. 9:30 p.m. to 12:00 p.m.

Place: Plaza/Independencia n 1
28001 Madrid, Madrid 

 

Key points and frequently asked questions about the US market 2026

 

What impact does the new tariff have on Spanish companies?

An increase of 10% to 15% in general tariffs under the Trade ActThis forces companies to review their margins and documentation to avoid additional customs holds.

 

What is FSMA 204 and who does it affect?

It is the new traceability standard of the FDA which requires food exporters to maintain detailed records of critical monitoring events (CTE) and key data elements (KDE).

 

What are the essential document identifiers for 2026?

To avoid border blockages, companies must have the Foreign Producer Number (FPN), the FEI (FDA Establishment Identifier) and the number DUNS duly updated.

 

Registration: