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 EU Trade Helpdesk where information can be found using Harmonized Systems codes to determine, among other information, potential requirements, tariffs, the European Union’s market’s import rules, and taxes. The EU Trade Helpdesk does not provide information for exports from the United States to the European Union. (Using information for a similar North American country, such as exports from Canada, approximates key requirements 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 EU Member States’ Country Commercial Guide.
A key EU priority is to ensure products marketed in the region are safe for the environment and human health. United States manufacturers exporting to the European Union need to ensure their products meet these requirements to enter the market.
European Green Deal, Circular Economy Action Plan II, and the Chemicals Strategy for Sustainability
New legislative initiatives published by the European Commission are regularly made available for public consultation on the EU “Welcome to Have your say” website. U.S. companies, civil society organizations and individuals can all participate in these consultations.
On December 11, 2019, the EU Commission presented the European Green Deal as a flagship policy program to transform Europe into a climate neutral society by 2050. The European Green Deal affects all aspects of the European economy including agriculture, fisheries, construction, finance, and manufacturing. To implement the European Green Deal, the Commission has drafted and updated several high-level policy agendas that identify areas in need of new legislative and other actions to deliver on the European Union’s climate ambitions.
For example, the 2020 Circular Economy Action Plan II (CEAP) is an iteration of the 2014 Action plan, which takes the circular economy concept as its starting point to propose a general shift in the European Union’s product policies. The fundamental idea is that raw materials, products, and services can and should be used several times – not only for the initial intended purpose, but for other purposes through reuse and recycling. This involves placing a larger emphasis on sharing-economy models, leasing, reusing, repairing, refurbishing, and recycling existing materials and products for as long as possible in an effort to extend their life cycle.
The Circular Economy Action Plan sets out a sustainable product policy framework with three main building blocks: actions on product design, on empowering consumers, and on more sustainable production processes. To translate this framework into law, the Commission proposed modifying the scope of the Eco-Design Directive, which establishes a framework for mandatory ecological requirements for energy-related products in the EU; modifying consumer protection laws to give more power and access to information to consumers, including establishing an EU-wide “right to repair” framework; and mainstreaming this circular production concept into the European Union’s industrial policies and industrial emissions legislation.
Further legislative initiatives are expected for products that have a significant impact on EU-wide emissions, including concerning electronics, information and communication technologies, batteries, vehicles, packaging, plastics, textiles, construction and buildings, food waste, and nutrients; for waste reduction goals to meet European Union-wide targets; and for raw materials to prevent the export of waste to countries outside the European Union. Through CEAP, the Commission is positioning the European Union as a global leader on the shift towards a more circular economy, including identifying the advancement of global discussions on plastics and negotiating an international agreement on the management of natural resources as two international priorities.
The EU Battery Directive (2006/66/EC) was adopted in 2006. It applies to all batteries and accumulators placed on the EU market, including automotive, industrial, and portable batteries. The Directive seeks to protect the environment by restricting the sale of batteries and accumulators that contain mercury or cadmium (with an exemption for emergency and alarm systems, medical equipment, and cordless power tools) and by promoting a high level of collection and recycling of those batteries. It places the responsibility on producers to finance the costs associated with the collection, treatment, and recycling of used batteries and accumulators. The Directive includes provisions on the labeling of batteries and their removability from equipment. The European Commission has published a frequently asked questions document to assist interested parties in interpreting its provisions, and an April 2019 report was published to evaluate the Directive.
As a part of CEAP, the Commission published a legislative proposal in December 2020 that would replace the 2006 Directive with a new batteries-related regulation. The new law would dramatically expand the scope of the current legal framework to promote a transition to a more circular economy. The regulation would create carbon footprint performance classes and maximum life-cycle footprint thresholds, introduce minimum recycled content requirements, and create a battery passport to enable economic operators to access information about the batteries to facilitate their repair and reuse. The completion of such a directive is expected to be concluded by early 2022.
Based on the European Green Deal’s objective to reduce pollution and move towards a toxic-free environment, the Communication on the Chemicals Strategy for Sustainability takes stock of the performance of the European Union’s chemicals legislative framework, in place since 2007, which primarily consists of two Regulations: the Registration, Evaluation Authorization and Restriction of Chemicals (REACH) Regulation, and the Classification, Labelling and Packaging of Hazardous Substances (CLP) Regulation. Although the Commission considers these two regulations to be successful in protecting human health and the environment, it has identified several shortcomings that impede the European Union’s chemicals framework from reaching its full potential. In particular, the Commission has acknowledged the need 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., there are currently parallel, and at times, contradictory processes for the same substances), and overall, more predictable for companies.
To achieve these objectives, the Commission is likely to introduce a series of new concepts and procedural changes to REACH and CLP. Most notably, it will move away from its current case-by-case chemicals assessment model in favor of a more generic approach whereby it will group chemicals and apply restrictions to these groups. Determining when the use of otherwise restricted chemicals will be allowed will be based on a new “essential use” concept (based on, but not identical to, the Montreal Protocol’s definition of “essential use”). The Commission is also looking to streamline parallel substance evaluations and possible conflicts arising from uncoordinated actions by the Commission by introducing stronger internal coordination and planning mechanisms under the motto of “one substance, one assessment.” Further actions under the Chemicals Strategy for Sustainability include developing and promoting a “sustainable-by-design approach” to placing chemicals on the market to encourage substitution of certain high-risk chemicals; developing new methodologies to measure the lifecycle impacts of chemicals; taking stronger action against endocrine disrupting substances; introducing a “mixture assessment factor” during the safety assessment of substances; addressing contamination by synthetic per- and polyfluoroalkyl substances; and increasing efforts to ensure compliance.
In addition, the Commission is in the process of conducting a series of studies to weigh options for improving the REACH and CLP Regulations, which will feed into the broader impact assessment process for modifying these regulations, which be made available to the public. The Commission is also set to conduct public consultations for both regulations in late 2021 and early 2022, with final regulatory proposals expected by the end of 2021 for CLP and 2022 for REACH. The regulations will then have to pass through the co-legislative process involving the European Parliament and the Council of the European Union and could take several years.
Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
REACH 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 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.
Public Activities Coordination Tool for Chemicals
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.
Waste Electrical and Electronic Equipment
EU rules on waste electronical and electronic 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.
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.
The most controversial element of EU legislation harmonizing the regulation of cosmetics was the introduction of 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.
- 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, EU 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. Most recently, certificates re being harmonized for a series of highly processed products, including chondroitin sulphate, hyaluronic acid, hydrolyzed cartilage products, chitosan, glucosamine, rennet, isinglass, and amino acids. 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. Information on Harmonized Import Requirements can be found at in the FAIRS Export Certificate Report - United States Mission to the European Union (usda-eu.org).
Sanitary Certificates (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. The European Union and the United States are currently negotiating a veterinary equivalency agreement on shellfish. In the meantime, the European Union has had a ban in place since July 1, 2010, which prohibits the import of U.S. bivalve mollusks, in whatever form, into EU territory. This ban does not apply to wild roe-off scallops.
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.