The Union Customs Code

The European Union Customs Union, in place since 1968, is a pillar of the European Union’s single market and is vital to the free flow of goods and services across Member States. In 2013, the European Union adopted the Union Customs Code, the legal framework for ongoing actions to modernize EU customs.  Its substantive provisions went into effect in May 2016. Its goals are to provide a comprehensive framework for customs rules and procedures in the EU customs territory and to create a paperless and fully automated customs union system. A comprehensive framework for customs rules and procedures is needed because while customs rules are the same across the European Union, Member States’ customs authorities have not always applied them in a consistent manner regarding customs duties and clearance, creating fragmentation and additional administrative burdens.  

The Union Customs Code forms the basis for structural and administrative changes to customs policy, procedures, and implementation. The Union Customs Code also mandates a move to an all-electronic customs system. The system consists of seventeen separate but interconnected components.  While some systems are currently in place, a number of components are lagging due to the complexity of the tasks.

The EU is revising its Customs Union framework to modernize customs procedures, enhance digitalization through improved IT systems, and strengthen enforcement against illicit trade. A key change under consideration is the removal of the de minimis threshold, which previously allowed imports valued below €150 euros to enter the EU free of customs duties and VAT.  These revisions introduce a new handling fee to be applied to imports to cover customs clearance costs and enforcement activities.  This fee is intended to fund enhanced customs controls and improve supply chain security but may increase costs for businesses and consumers.  

U.S.-EU Customs Cooperation

Since 1997, the United States and the European Union have a Customs Mutual Assistance Agreement.  In 2012, the United States and the European Union signed a decision recognizing the compatibility of the Authorised Economic Operator (AEO) and Customs-Trade Partnership Against Terrorism (C-TPAT) programs, thereby facilitating faster and more secure trade between transatlantic operators. AEO certification is issued by a national customs authority and is recognized by all Member States’ customs agencies.  An AEO can consist of two different types of authorization: customs simplification or security and safety. The former allows for an AEO to benefit from simplification related to customs legislation, while the latter allows for facilitation through security and safety procedures. Shipping to a trader with AEO status could facilitate an exporter’s trade, with benefits such as expedited processing of shipments, reduced thefts and losses, reduced data requirements, lower inspection costs, and enhanced loyalty and recognition. Under the revised Union Customs Code, in order for an operator to make use of certain customs simplifications, the authorization of AEO becomes mandatory.

Since 2012, the United States and the European Union have recognized each other’s security certified operators and will take the respective membership status of certified trusted traders favorably into account. Therefore, Customers and Border Protection identification numbers for foreign manufacturers are recognized by customs authorities in the European Union.

The Integrated Tariff is also available to help determine if a license is required for a particular product.  The European Commission maintains a link to the Access2Markets portal (which replaces the EU Trade Helpdesk) where information can be found using Harmonized Systems codes to determine, among other information, potential requirements, tariffs, the European Union’s markets import rules, and taxes.  The Access2Markets portal does not provide information for exports from the United States to the European Union, however.  (Using information for a similar North American country, such as exports from Canada, approximates key requirements that may be used as a starting point for your most current Harmonized Systems code.).  For information relevant to Member State import licenses, please consult the relevant Member States’ Country Commercial Guide. 

Economic Operator Registration and Identification

Since July 1, 2009, all companies established outside of the European Union are required to have an Economic Operator Registration and Identification (EORI) number if they wish to lodge a customs declaration or a Summary Declaration. All U.S. companies should use the EORI number for their customs clearances, which must be formally requested from the customs authorities of the specific Member State to which the company first exports.  Member State customs authorities may request additional documents to be submitted alongside a formal request for an EORI number. Once a company has received an EORI number, it can use it for exports to any Member States. There is no single format for the EORI number.  Once an operator holds an EORI number, they can request Authorized Economic Operator (AEO) certification, which can give quicker access to certain simplified customs procedures.

Summary Declaration and the Single Administrative Document

Goods brought into the customs territory of the European Union are, from the time of their entry, subject to customs supervision until customs formalities are completed. Such goods are covered by a Summary Declaration, which is filed once the items have been presented to customs officials. The customs authorities may, however, allow a period for completing the Summary Declaration, which cannot be extended beyond the first working day following the day on which the goods are presented to customs.

The Summary Declaration is completed by the person who brought the goods into the customs territory of the European Union, by any person who assumes responsibility for carriage of the goods following such entry, or the person in whose name the person referred to above acted. The Summary Declaration can be made on a form provided by the customs authorities. However, customs authorities may also allow the use of any commercial or official document that contains the specific information required to identify the goods.  The Single Administrative Document serves as the European Union importer’s declaration.  This form describes goods and their movement around the world and is essential for trade outside the European Union or trade of non-EU goods. It encompasses both customs duties and VAT and is valid in all Member States. The declaration is made by whoever is clearing the goods, normally the importer of record or an agent on behalf of the importer.

European Free Trade Association countries, including Norway, Iceland, Switzerland, and Liechtenstein also use the Single Administrative Document.  Information on import and export forms is contained in Commission Delegated Regulation (EU) No 2015/2446.

 efforts, simplifying the EU regulatory environment and reducing the administrative burden on companies have emerged as a top priority.  A series of simplification packages – referred to as simplification omnibus proposals – are being introduced by the European Commission to streamline and simplify EU regulations in areas such as sustainability, due diligence, defense, chemicals, digital, and the environment.  According to the European Commission, such simplification will result in reduced compliance costs for companies operating on the EU market.    

Despite these different legislative goals, a key EU priority is to ensure products marketed in the region are safe for the environment and human health.  U.S. manufacturers exporting to the European Union must ensure their products meet these requirements to enter the market.  New legislative initiatives published by the European Commission are regularly made available for public consultation on the EU “Have your say” website. U.S. companies, civil society organizations, and individuals can all participate in these consultations.

Batteries 

In August 2023, the EU Batteries Regulation (EU 2023/1542) entered into force, replacing the EU Battery Directive (2006/66/EC).  The EU Batteries Regulation applies to all categories of batteries placed on the EU market or otherwise put into service, such as batteries that are incorporated into a product.  The Regulation introduces a harmonized legal framework for batteries, covering their entire lifecycle, from sourcing to recycling. With the aim to promote a transition to a more circular economy for batteries, the Regulation broadens the scope of the 2006 EU Batteries Directive by setting sustainability, durability, and performance requirements. The Regulation also lays down safety, marking, labelling and information requirements, including the introduction of a battery passport to enable economic operators to access information about the batteries to facilitate their repair and reuse and enhance transparency along the supply chain.  Furthermore, the Regulation requires companies with a turnover over a certain threshold to implement due diligence policies concerning the environmental and social risks associated with specific raw materials contained in their batteries.  Companies must also have their due diligence policies verified by a notified body (third-party verification).

The new requirements under the EU Batteries Regulation will start applying gradually.  On May 21, 2025, as part of the fourth simplification omnibus proposal to simplify EU rules, the European Commission proposed postponing the application of due diligence obligations under the EU Batteries Regulation from 2025 to 2027, thereby giving companies more time to prepare for the new rules.  

Biotech Act

In December 2025, the European Commission published an expansive health-related legislative proposal.  Central to the proposal is the Biotech Act, intended to support a €40 ($46.97) billion health sector in the EU.  If enacted, the Act will facilitate access to capital in the biotechnology industry, in part through a €10 ($11.7) billion investment scheme operated through the European Investment Bank Group.  It would fast track new therapies using AI, data, and regulatory sandboxes, and simplify EU regulations concerning life sciences to expedite regulatory approvals for new treatments.  Through amendments to the EU Clinical Trials Regulation, it would accelerate clinical trials in Europe.  The legislation would extend patent rights for certain treatments with year-long supplementary protection certifications when production takes place in the EU.  It would also include provisions to ensure that biotechnology production is not misused (e.g., the introduction of dangerous pathogens) and early detection of novel biological threats.  The proposed legislation must go through the regular EU legislative process to become law, a process which could take years.

Carbon Border Adjustment Mechanism 

Beginning in 2026, the EU’s Carbon Border Adjustment Mechanism (CBAM) will impose a fee on embedded emissions of imports.  The fee will be linked to the carbon price under the EU Emissions Trading System (ETS).  The sectors that will be initially affected are cement, iron and steel, aluminum, fertilizers, electricity, and hydrogen, although CBAM may eventually extend to other sectors covered under the EU ETS.  The Commission announced a review of the CBAM legislation in 2026 that would extend the scope of CBAM to additional downstream products and would contain measures to prevent circumvention of CBAM rules.  

Some stakeholders have raised concerns.  CBAM adds a direct financial cost to exporting companies, particularly those in countries without their own carbon price.  It also involves onerous reporting requirements and the disclosure of sensitive and confidential business information.  Declarants will only be obliged to acquire CBAM certificates for emissions resulting from goods imported into the EU in 2026 from 2027 onwards.  The price of CBAM certificates purchased in 2027 to cover emissions from goods imported in 2026 will reflect the price of EU ETS certificates in 2026.  While CBAM will credit imports for explicit carbon prices paid by foreign producers in their home market, U.S. exports may not be eligible for such credits since CBAM does not offer credits for regulatory and other non-price mechanisms for reducing carbon emissions. 

Following a simplification measure published in October 2025, importers importing less than 50 tons of goods subject to CBAM annually will be exempt from CBAM obligations.  The single mass-based threshold does not apply to imports of electricity or hydrogen due to sector-specific implementation challenges.  If an importer exceeds the single mass-based threshold without authorized CBAM declarant status, penalties apply, amounting to three to five times the standard penalty of €100 per ton of embedded emissions.  Such a penalty may be reduced where an importer exceeded the single mass-based threshold by no more than 10% of that threshold.  The simplification also allows importers to report default values instead of real embedded emissions.  Using default values set by the European Commission may be higher than real emissions and may result in higher CBAM fees.  

Chemicals

The European Union’s chemicals legislative framework primarily consists of two regulations: the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation, and the Classification, Labelling and Packaging of substances and mixtures (CLP) Regulation.  

Based on the European Green Deal’s objective to reduce pollution and move towards a toxic-free environment, in 2020, the European Commission published the Chemicals Strategy for Sustainability (CSS) as a flagship initiative to guide EU chemicals policy.  The CSS set out a number of actions to make the chemicals framework more efficient (e.g., faster procedures covering more chemicals), effective (e.g., reducing discrepancies in applying the rules between Member States), coherent (e.g., eliminating parallel, and at times, contradictory processes for the same substances), and overall, more predictable for companies.  With the CSS, the Commission launched revisions to the REACH and CLP Regulations to introduce a series of new concepts and procedural changes.  While the CLP Regulation was revised, the REACH revision was ultimately postponed to the new Commission’s mandate (2024-2029).  

In July 2025, the European Commission published the European Chemicals Industry Action Plan, which sets out measures the Commission intends to take to support the competitiveness and clean transition of the EU chemical sector.  Under the Plan, revisions to the REACH Regulation are expected by the end of 2025.

The REACH Regulation (EC 1907/2006) – as is in force today – applies to all chemicals manufactured or imported into the European Union in quantities exceeding one metric ton.  The regulation entered into force in 2007 and touches virtually every industrial sector, from automobiles to textiles.  REACH imposes a registration obligation on all entities over the one metric ton threshold.  The European Chemicals Agency (ECHA) is responsible for receiving and ensuring the completeness of such registrations.  U.S. companies without a presence in Europe need to rely on a European Union-based partner, typically either an importer or a specialized “Only Representative.”  ECHA will then issue a registration number to the company that submits a complete registration dossier.  

In addition to the registration requirement, REACH allows the European Commission to monitor, restrict, or prohibit the use of hazardous substances and products containing such substances.  The Authorization List identifies substances that require a company to obtain permission from the European Commission to import into the European Union.  In addition, the Restriction List contains a list of substances that are subject to specific controls within the European Union.  The Candidate List of Substances of Very High Concern (SVHCs) identifies substances that the European Commission intends to restrict or prohibit.  Since January 2021, companies supplying items containing SVHC on the candidate list in a concentration above 0.1% weight by weight to the European Union are required to submit information on these items to ECHA through the Substances of Concern in Products (SCIP) Database.   

This information is made available to waste operators and consumers.  The SCIP notification requirements impose a legal obligation on those placing items on the EU market, including importers of U.S. products.  In most cases, European importers will ask their U.S. partners to verify SVHC content and, if applicable, may ask for additional information necessary to comply with SCIP requirements.  There is also an option for U.S. companies to submit notifications in the SCIP database as a foreign user, but this requires reaching an agreement with the European importer. 

Classification, Labelling, and Packaging of Hazardous Substances

The CLP Regulation (EC 1272/2008) implements the UN Global Harmonized System of classification, labelling, and packaging of all hazardous substances.  U.S. exporters must classify, label, and package (including products containing such substances) hazardous substances according to the regulation’s requirements.  For certain hazardous substances, the European Commission will impose a common classification, which may affect demand in the European Union for these substances.  It may also trigger controls on product specific legislation.  

A 2023 amendment to the CLP Regulation introduced new hazard classes and criteria for the classification, labelling, and packaging of substances and mixtures that are placed on the EU market (Commission Delegated Regulation 2023/707), particularly Endocrine Disruptors (ED) for human health or the environment; Persistent, Bioaccumulative and Toxic (PBT); and Very Persistent and Very Bioaccumulative (vPvB).  The new hazard classes will apply following transitional periods, after which suppliers are required to classify (and label) their substances or mixtures according to the new criteria.  In 2024, a broader revision to the CLP Regulation introduced several changes, including new rules on the classification of complex substances, labelling (e.g., mandatory formatting requirements and digital labels), advertising, and online offers.  Revisions to the CLP Regulation (EU 2024/2865) entered into force on December 10, 2024, and it will start applying gradually.  Most industry obligations will become applicable from July 1, 2026.  

On July 8, 2025, as part of the “simplification omnibus proposal on chemical products” aimed at reducing the regulatory burden on companies, the European Commission put forward a legislative proposal to simplify the rules on labelling, advertisement, and distance offers that were recently incorporated into the CLP Regulation.  The Commission also proposed postponing the application of those new requirements.  In line with the EU legislative process, the European Commission’s omnibus simplification proposal will need to be assessed, negotiated, and agreed upon by both the European Parliament and the Council of the EU before it can become law.

The Public Activities Coordination Tool for Chemicals is a free-to-use tool maintained by ECHA, which provides an overview of activities conducted by European public authorities with respect to chemicals, including data generation and assessment, regulatory management option analysis, and regulatory risk management. 

Cosmetic Products

The Cosmetic Products Regulation (EC 1223/2009) governs the placing of cosmetic products on the market in the EU.  The Regulation introduced an EU-wide system for the notification of cosmetic products to the European Commission prior to their placement on the EU market.  Only a European Union-established entity may submit such a notification.  U.S. exporters must therefore retain a Responsible Person to act on their behalf, rely on the entity responsible for the import of their product into the European Union, or establish a presence in a Member State.

In 2025, the European Commission launched an evaluation of the Regulation to assess its functioning and whether a revision is warranted.  Based also on stakeholder feedback, the European Commission will evaluate, among other things, if the scope of the Regulation should be broadened to cover sustainability considerations and the environmental effects of chemicals in cosmetics, as well as whether the Regulation is still ‘fit for purpose’ in light of recent developments such as online or bulk sales.  The Commission will also examine the application of the so-called “generic risk approach” to high-risk substances, labelling provisions, and international convergence with other jurisdictions.  The evaluation of the Cosmetic Products Regulation is expected to be concluded in the second half of 2026.

On July 8, 2025, as part of the simplification omnibus proposal on chemical products, the European Commission put forward an amendment to the Cosmetic Products Regulation.  Proposed changes aim to clarify requirements and procedures, as well as to reduce unnecessary and duplicative reporting obligations.  With the simplification omnibus proposal, the European Commission proposes to remove the pre-notification obligation for cosmetic products containing nanomaterials.  Regarding bans on substances that are classified as carcinogenic, mutagenic, or toxic for reproduction under the CLP Regulation, the European Commission recommends introducing specific timelines for derogation requests and transitional periods to ease industry’s adjustment to restrictions.  The European Commission also proposes streamlining the derogation criteria for such bans.

Ecodesign for Sustainable Products 

In July 2024, the Ecodesign for Sustainable Products Regulation (ESPR) (2024/1781) entered into force, replacing the Ecodesign Directive (2009/125/EC).  This new regulation was adopted to enhance the sustainability of products placed on the EU market.  While previous ecodesign rules focused on energy-related products and their energy efficiency, the ESPR establishes a framework for the EU to progressively set performance and information requirements (i.e., ecodesign requirements) for almost all physical goods placed on the EU market except for medicinal products, food, and feed.  Performance requirements will go beyond energy efficiency and cover product characteristics such as durability, reusability, upgradability, reparability, recycled content, carbon, and environmental footprint.  Additionally, the ESPR introduces the Digital Product Passport (DPP), a data carrier where information on the sustainability characteristics of products will be made available.  The DPP is meant to help consumers and businesses to make informed choices when purchasing products, as well as to support EU authorities in performing checks and controls.  The ESPR also includes provisions on the destruction of unsold consumer products, which will be prohibited for textiles and footwear from July 2026, as well as requirements on so-called substances of concern, which could potentially lead to restrictions on the use of certain chemical substances for sustainability reasons.  The ESPR is therefore expected to impact product design and manufacturing processes.

The ESPR is a framework legislation, meaning that the actual ecodesign requirements to be applied to products are not yet in place.  These requirements will be rolled out gradually by the European Commission based on working plans that identify priority products to be covered first by product-specific measures.  In April 2025, the Commission published the first Ecodesign for Sustainable Products and Energy Labelling Working Plan 2025-2030, and the following products have been identified as priorities: iron and steel; aluminum; textiles; furniture; tires; and mattresses.  Additionally, from 2025 to 2030, the European Commission will focus on the introduction of broader horizontal measures on repairability (including scoring) and recycled content and recyclability of electrical and electronic equipment.  The adoption of the first ESPR measures is expected in 2026.

General Pharmaceutical Legislation

The EU has been revising its General Pharmaceutical Legislation to modernize the regulatory framework with the goal of better supporting innovation, improving access to medicines, and enhancing the sustainability of the pharmaceutical sector.

Key changes under consideration include revising intellectual property incentives for innovative pharmaceuticals, strengthening incentives for the development of medicines targeting unmet medical needs, particularly in areas such as rare diseases and antimicrobial resistance.  The revision also seeks to streamline authorization procedures, improve transparency around medicine pricing and availability, and reinforce supply chain resilience to prevent shortages.  In addition, the legislation proposes enhanced pharmacovigilance requirements (i.e., the evaluation of potential side effects of pharmaceutical products) and measures to encourage greener and more sustainable pharmaceutical production.  The goal is to balance patient safety, industry competitiveness, and public health objectives within a harmonized EU framework.  The revised legislation is expected to provide a more flexible and future-proof system for medicines regulation in Europe.  The General Pharmaceutical Legislation is expected to be adopted in early 2026, with implementation likely to take place by 2028.

Machinery Regulation

The Machinery Regulation (EU 2023/1230) entered into force in July 2023 and will start applying in January 2027.  The Regulation replaces the current Machine Safety Directive (2006/42/EC).  Machinery in the European Union is broadly defined as consisting of an assembly of components, at least one of which moves, for a specific application.  The drive system of machinery is powered by energy other than human or animal effort.   The regulation provides a new framework for machinery and equipment industry, including requirements around cyber security and AI.  

Medical Device Regulations

The EU’s Medical Device Regulation (MDR) took effect in May 2021, followed by the In Vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022.  Both frameworks were introduced to strengthen patient safety, improve product traceability, and increase oversight across the EU’s medical technology sector.  However, implementation has faced significant delays due to limited notified body capacity and the ongoing effects of the COVID-19 pandemic.  In response, the European Commission adopted Regulation (EU) 2024/1860, introducing extended transition timelines for in vitro diagnostic devices.  Under the revised IVDR schedule, legacy devices may remain on the market if certain conditions are met, including implementation of an IVDR-compliant quality management system by May 2025 and no substantial changes to the device’s design or intended use.  The updated deadlines allow Class D devices, such as HIV and hepatitis tests, to stay on the market until the end of 2027; Class C devices, such as certain influenza and fertility tests, until the end of 2028; and Class B and Class A sterile devices, including pregnancy or glucose tests, until the end of 2029.  The previously required sell-off period was also removed, allowing continued availability of devices that were legally placed on the market before these deadlines.  

Similar extensions have been granted under Regulation (EU) 2023/607 for legacy medical devices governed by the MDR, with higher-risk devices permitted to remain on the market until 2027 and lower-risk ones until 2028.  In addition to these deadline adjustments, both MDR and IVDR now require manufacturers to notify national authorities at least six months in advance of any potential device shortages.  The Commission also continues to roll out the European Database on Medical Devices (EUDAMED), the EU-wide database intended to centralize information on medical devices for better transparency and coordination.  Device classification under IVDR and MDR ranges from Class A (low risk, such as laboratory equipment or specimen containers), to Class B (moderate risk, such as pregnancy or blood glucose tests), to Class C (higher risk, such as cancer screening tests), and Class D (highest risk, including infectious disease and blood-grouping tests).  The higher the classification, the stricter the requirements for certification and oversight.  These regulatory updates aim to provide manufacturers with more time to comply, while still advancing the EU’s commitment to high standards in medical device safety and public health protection.

In December 2025, the European Commission announced proposed revisions to the Medical Device Regulation as part of a broader EU health package.   These revisions, which will require EU legislative approval, are intended to simplify EU rules for medical devices, speed up their access through improvements to the conformity assessment process, and incorporate AI applications in medical devices through new rules.  The revisions envision a stronger role for the European Medicines Agency, including through monitoring shortages of medical devices and creating a list of critical devices.

Packaging 

In February 2025, the Packaging and Packaging Waste Regulation (PPWR) (EU 2025/40) entered into force, replacing the Packaging and Packaging Waste Directive (94/62/EC).  The Regulation substantially redefines the regulatory landscape for all packaging placed on the EU market, setting out requirements that cover the entire life cycle of packaging materials.  The Regulation establishes that, with few exceptions, all packaging placed on the EU market must be recyclable by 2030.  Design for recycling criteria will be developed by the European Commission by 2028.  Packaging recyclability will be expressed using recyclability performance grades, and packaging that falls below certain thresholds will not be allowed to be placed on the market.  

The PPWR introduces new requirements on minimum recycled content in plastic packaging, packaging minimization, and the presence of certain chemical substances.  The latter includes a ban on food contact packaging containing per- and polyfluoroalkyl substances (known as PFAS) if above certain thresholds.  Packaging minimization requirements may also interfere with the intellectual property integrated into the packaging.  Importantly, the PPWR introduces EU-wide harmonized labelling, requiring that, from 2028, all packaging placed on the EU market be marked with a harmonized label containing information on its material composition.  Starting in 2029, reusable packaging will also be required to bear a label informing users that the packaging is reusable.   Other requirements under the PPWR include re-use targets and bans on certain single-use packaging formats.

Compliance with the new requirements under the PPWR will need to be demonstrated through a conformity assessment procedure as set out in the Regulation, and an EU declaration of conformity must be drawn up before placing that packaging on the EU market.  Note that the new requirements will start applying gradually, and they will be further developed via subsequent legislation.

Renewable Energy Directive 

The EU Renewable Energy Directive (RED) ((EC) 2009/28) requires that biofuels and biofuel feedstocks obtain a Proof of Sustainability certification to qualify for tax incentives and national use targets.  RED establishes a methodology and accounting system by which Member States may record and calculate required greenhouse gas emission savings as compared to a baseline for fossil fuels.

In 2018, the European Commission adopted a new Renewable Energy Directive (RED II) for the period of 2021 to 2030.  It entered into force on January 1, 2021, and introduced sustainability requirements for forestry biomass (e.g., wood pellets).  The European Commission began revisions to RED II in 2022, and the final revisions were published on October 31, 2023 (RED III).  RED III increased the EU’s binding renewable target for 2030 to a minimum of 42.5%, up from the prior target of 32%.  However, the sustainability criteria for biofuels and biomass were not fundamentally changed, which may limit U.S. exports of biofuels and biomass that would otherwise provide viable renewable sources for the EU’s renewable energy targets.  (The United States exported approximately $272 million in wood pellets and $440 million in bioethanol to the EU in 2024.)

The Commission launched the Union Database (UDB) in January 2025 to prevent fraud and double counting of emissions reductions achieved by substituting liquid and gaseous biofuels for fossil fuels.  Currently, no country outside of the EU’s gas grid can use the UDB to certify biogas and biogas derived fuels.  The Commission has pledged to accommodate third countries, but no timeline is available.
Restriction on Hazardous Substances in Electrical and Electronic Equipment
The Restriction on Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive imposes restrictions on the use of certain chemicals in electrical and electronic equipment and applies to nearly all products that require power unless a specific exclusion or exemption applies.  U.S. exporters certify a product meets the requirements of this legislation by affixing a CE Mark to their product.  The U.S. exporter must retain a product file to support the CE Mark in the event of a control.

In December 2023, as part of the “One substance, One Assessment” package the European Commission proposed a targeted amendment of the RoHS Directive, in which ECHA will assume responsibilities for restrictions and exemptions assessment.  

Waste Electrical and Electronic Equipment

EU rules on electronic waste and equipment, while not requiring specific customs or import paperwork, may entail a financial obligation for U.S. exporters.  The Waste Electrical and Electronic Equipment (WEEE) Directive requires U.S. exporters to register relevant products with a national authority or arrange for this registration to be done by a local partner.  It also requires manufacturers to inform the consumer that their product should be recycled by including the “crossed out wheelie-bin” symbol on the product or packaging.

Agricultural Documentation 

Phytosanitary Certificates 

Phytosanitary certificates are required for most fresh fruits, vegetables, and other plant materials. 

Sanitary Certificates

For commodities composed of animal products or by-products, Member States require that shipments be accompanied by a certificate issued by the competent authority of the exporting country.  This applies regardless of whether the product is for human consumption, for pharmaceutical use, or strictly for non-human use (e.g., veterinary biologicals, animal feeds, fertilizers, and research).  The majority of these certificates are uniform throughout the European Union, but the harmonization process is still ongoing.  Until harmonization is finalized, Member State import requirements continue to apply.  In addition to the legally required EU health certificates, a number of other certificates are used in international trade.  These certificates, which may also be harmonized in EU legislation, certify origin for customs purposes and certain quality attributes.  

Sanitary Certificates for U.S. Fisheries

In April 2006, the European Union declared the U.S. seafood inspection system to be equivalent to the European system.  Consequently, a specific public health certificate must accompany U.S. seafood shipments.  The U.S. fishery product sanitary certificate is a combination of Commission Decision 2006/199/EC for the public health attestation and Regulation 1012/2012 for the general template and animal health attestation.  Unlike for fishery products, the U.S. shellfish sanitation system is not equivalent to that of the European Union’s system.  In 2022, the European Union and the United States concluded an agreement that permits the resumption of live, raw, and processed bivalve molluscan shellfish, which will allow producers in certain U.S. States (Massachusetts and Washington) to send mollusks to the European Union, and producers in certain Member States (Spain and the Netherlands) to send products to the United States.

The U.S. competent authority for issuing sanitary certificates for fishery and aquaculture products is the U.S. Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), National Marine Fisheries Service.

In addition to sanitary certificates, all third countries wishing to export fishery products to the European Union are requested to provide a catch certificate.  This catch certificate certifies that the products in question have been caught legally.

For detailed information on import documentation for seafood, please contact the NOAA Fisheries Office at the U.S. Mission to the European Union or visit the NOAA website.