The US tightens its regulatory framework: the keys for Spanish companies to maintain their competitiveness in 2026

 

The new competitive landscape in the United States

 

The review of trade policy, the tariff increase that puts rates at levels close to 15%, and tighter control by US authorities are transforming the rules of the game for Spanish companies. This morning, at the Cámara de Comercio de Madrid, it has become clear that market access for Estados Unidos It no longer allows for improvisation. The event included institutional participation from John Coronado, Economic and Commercial Advisor of the Embajada de Estados Unidos en España, who has outlined the roadmap for investment and export.

 

According to Tania MartínezCEO Demos Global GroupThe key lies in understanding that regulations do not represent an arbitrary barrier, but an indispensable requirement to operate in a serious environment. "Regulatory compliance is more important than tariffs, because tariffs are negotiable and there are hundreds of measures you can use to minimize their impact. Regulatory compliance, however, is not negotiable. The law is there."the expert emphasized during her speech.

 

Main changes and requirements for 2026

 

The US market is raising the bar, particularly in the traceability and the effective product controlCompanies must prepare for an environment where documentary errors can lead to border detentions, warnings, or even blacklisting. The sectors most exposed to these changes are... agrifood, the industrial machinery, the sector pharmacist and the cosmetology.

 

The following is a summary of the critical points that are impacting current export operations:

 

• New tariff framework: Evolution of tariffs and application of the Trade Act.
• Reinforcement of the FDA y CBP: Increased surveillance by the U.S. Customs and Border Protectio and Food and Drug Administratio.
• Food safety: Obligation of the FSMA 204 and compliance with the Foreign Supplier Verification Program.
• Machinery and Technical Standards: Compliance with standards of organizations such as OSHA, CPSC, EPA and standards UL/ANSI, NFPA y ASTM.

 

Impact Area	Requirement / Key Change	observation
Duty	Evolution 10% to 15%	Legal context under Trade Act
Identification	FPN, FEI, DUNS	New mandatory documentary requirements
Traceability	FSMA 204 (KDE/CTE)	Strict application of food safety standards
Cosmetics	Act MoCRA	New obligations for exporters

 

Commercial and operational strategy

 

Regarding the cost structure, Tania Martínez He pointed out that, although it depends on factors such as the product or the cost of production, the usual trend in private negotiations is to divide the adaptation costs 50/50 between the importer and the foreign manufacturerThe expert emphasized that the United States is a stable and attractive market, but that it requires acting with professionalism and deep legal knowledge, avoiding the temptation to ignore regulations that are considered non-negotiable.

 

Key points and frequently asked questions about accessing the US market.

 

Are the new tariffs the biggest barrier to exporting to the US?

Not necessarily. Although the tariff increase impacts margins, the real challenge for exporters is the regulatory complianceWhile the tariff impact can be negotiated or mitigated, the regulations of the FDA and other authorities are mandatory and do not admit exceptions.

 

What impact does the MoCRA Act have on cosmetics exporters?

La Modernization of Cosmetics Regulation Act It has entered a critical phase, imposing new registration and compliance obligations for cosmetics exporters. Understanding the regulatory differences compared to European regulations is essential to avoid the risk of non-compliance.

 

How should Spanish companies manage traceability control?

They must be fully integrated into the mandatory traceability system established by the FSMA 204which is already in effect. This implies managing the KDE (Key Data Elements) and the CTE (Critical Tracking Events), in addition to complying with new identifiers such as FPN (Foreign Producer Number).