The transition is a scheduled regulatory change, not a completed enforcement action. It also does not mean that every existing package becomes unlawful on Aug. 12. The European Commission says specified provisions of the older directive will continue to apply until Dec. 31, 2029.

What changes on Aug. 12

Regulation (EU) 2025/40 concerns packaging and packaging waste. Its scope covers products placed or made available on the European Union market, whether they are sold or provided free of charge.

That reach matters for businesses that sell packaged goods across EU markets and for companies outside the bloc that supply products to customers there. Compliance will depend on the products and packaging involved, but the EU framework includes requirements related to packaging size, packaging materials, food-contact materials and single-use plastics.

The regulation replaces the legal framework established by Directive 94/62/EC. Because some provisions of the directive remain applicable through the end of 2029, businesses will face a transition period in which the new regulation and specified older requirements do not disappear from the compliance picture at the same time.

Why companies are watching the transition

Manufacturers, importers and retailers will need to assess how the new framework applies to the packaged products they place or make available in the EU. Packaging design, material choices, product-contact uses and single-use plastic obligations are among the areas identified in the Commission’s summary of the rules.

The practical effect will not be identical for every product category. The Commission’s public information does not establish one universal timetable for all products or a single enforcement approach across every national market. Companies therefore face a regulatory change with details that may vary according to the product, packaging type and applicable transition provision.

The rules also have implications for international supply chains. A company does not avoid the EU framework simply because a packaged product is manufactured elsewhere: the relevant question is whether the product is placed or made available on the EU market. That makes the Aug. 12 date important for businesses serving European customers, even when production and packaging operations occur outside the bloc.

Broader product-information context

The packaging transition comes as the European Commission is also expanding information about product transparency requirements. On July 17, 2026, the Commission launched a web page explaining the Digital Product Passport, an initiative intended to help businesses and consumers follow future product-information and transparency requirements.

The Digital Product Passport page is separate from the scheduled repeal of Directive 94/62/EC, and the public announcement does not establish that every packaging obligation will be handled through that system. It does show the wider direction of EU product policy: companies are being asked to track not only what they sell, but also information connected to products and their characteristics.

For now, the central deadline is Aug. 12, 2026. The older directive is scheduled for repeal on that date, while specified provisions remain in effect until Dec. 31, 2029. Businesses placing packaged goods on the EU market will need to navigate both the new regulation and the remaining transitional requirements during that period.

The proposal, Establishment Registration and Product Listing for Tobacco Products, was announced on June 26, 2026, and published in the Federal Register on June 29, 2026. It is still only a proposed rule, and comments are due by September 14, 2026.

What would change

FDA says current federal law requires U.S. tobacco manufacturers to register and list products, but foreign manufacturers are not subject to the same requirements unless FDA creates them by regulation. The agency says that leaves “significant gaps” in its information.

If finalized, the rule would apply to foreign establishments that manufacture, prepare, compound, or process tobacco products for commercial distribution in the United States. FDA says the rule would also extend inspections to foreign establishments.

Why FDA says it matters

FDA says complete registration and product-listing data would help it identify illegal foreign tobacco products, including youth-appealing e-cigarettes, and act more quickly against unauthorized imports. The agency also says better records would improve its ability to verify compliance at the source.

The preliminary regulatory impact analysis says the proposal would close a current gap by extending registration and listing requirements to foreign owners and operators.

What readers should watch

For importers, manufacturers, and public-health advocates, the next key date is September 14, 2026, when public comments close. FDA will review those comments before deciding whether to issue a final rule.

For now, nothing is banned simply because the proposal exists. But if finalized, it would give FDA more visibility into foreign tobacco supply chains and more tools to target products that may be illegal, mislabeled, or otherwise out of compliance.

Sources

• FDA press release: Proposed rule on foreign tobacco manufacturer accountability
• Federal Register proposed rule published June 29, 2026