Exporting to the EU - A Guide for Canadian Business

Table of Contents

Introduction

The purpose of this guide is to provide Canadian companies, particularly small and medium-sized enterprises (SMEs), with an overview of European Union (EU) legislation affecting their exports to Europe.

This guide complements the information about EU markets and sectors provided by the Canadian Trade Commissioner Service. It is an additional tool offered by the Government of Canada to assist Canadian exporters. The guide covers legislation harmonized by the EU, but does not describe specific rules that exist within EU member states.

Understanding EU regulatory requirements is key to export success in the EU. This guide provides the information needed to access the EU market, and answers the questions most frequently asked by Canadian exporters about topics such as CE marking, customs duties, intellectual property rights, data protection and environmental regulations. The guide also includes essential links to additional information and guidance on how to comply with EU rules.

Disclaimer: All information on EU legislation mentioned in this Guide is publicly available on the EU website and was current at the time of publication. For updated information, please consult the Europa Website.

The information contained in this Guide is intended solely to provide general guidance to readers who accept full responsibility for its use. The information is provided with the understanding that the authors and publishers are not herein engaged in rendering professional legal advice or services. As such, it should not be used as a substitute for professional consultation.

While we have made every attempt to ensure the information contained in this Guide has been obtained from reliable sources, the Government of Canada is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information in this Guide is provided “as is” with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose. Nothing herein shall to any extent substitute for the independent investigations and the sound technical and business judgment of the reader. Laws and regulations are continually changing, and can be interpreted only in light of particular factual situations.

Certain links in this Guide connect to other websites maintained by third parties that may or may not be presented within a frame in this Guide. The Government of Canada has not verified the contents of such third-party sites and does not endorse, warrant, promote or recommend any services or products, that may be provided or accessed through them or any person or body which may provide them. The Government of Canada has not issued or caused to be issued any advertisements which may appear on these websites.

Chapter 1 - The EU and EU markets

The EU is a strong economic and political union of 28 member states and over 500 million people. The EU has built a single market, developed common policies, liberalized inter-country travel and launched a common currency shared by 19 countries.

The EU is the world’s most integrated market.

1.1 EU membership

The European Union currently consists of 28 Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom.

The European Union

The European Union

Croatia, the newest member of the EU, joined on July 1, 2013. Countries seeking to join include Turkey, Iceland, Serbia, Montenegro and Macedonia. However, no firm timelines exist for the accession of these countries to the EU. Albania, Bosnia and Herzegovina, and Kosovo have also expressed interest in joining the EU but do not yet fulfill the political and economic conditions for EU membership.

European Free Trade Association countries (Norway, Iceland, Switzerland, Liechtenstein) participate in the EU’s internal market, and Turkey has a customs union with the EU, making Europe an ever-expanding marketplace.

1.2 The EU Economy in the World

Taken as a single entity, the EU represents the world’s largest economy. The economy of the EU generates a GDP of over €13 trillion (US $16.66 trillion in 2012, source: World Bank). Germany, France, the United Kingdom and Italy are individually among the ten-largest economies in the world. In terms of population, the EU represents also one of the world’s largest markets, with over 500 million consumers.

The EU is the world’s largest exporter and importer, accounting for approximately 16 percent of total world trade. The EU is a highly diverse market and imports primary products, raw materials and energy, along with capital equipment, chemicals and consumer goods (Eurostat, International trade and foreign direct investment, 2013).

1.3 Current Economic Situation in the EU

The recent economic and financial crisis hit the EU hard. In 2009, the EU economy suffered the worst recession since its inception. GDP fell by 4 percent and industrial production dropped by 20 percent to 1990s levels. In 2013, unemployment reached an average of 12 percent across the EU areaFootnote 1.

Some EU member countries, including those of Ireland, Greece, Portugal and Spain, required loans from the International Monetary Fund (IMF) and individual EU member states. These loans came with strict austerity measures and mandated reforms to each country’s public and financial sectors. Because of the depth of the crisis and persistent structural issues in some member states, economic recovery in the EU has been slow and continues to be uneven, with high unemployment rates in the countries most affected by the crisis, such as Greece and Spain.

Today, the EU shows signs of economic recovery. Following real GDP growth of 1.6 percent in the EU and 1.2 percent in the EurozoneFootnote 2 in 2014, activity is expected to grow during 2015 by 2 percent and 1.7 percent, respectively. Though growth differentials are expected to persist, the gap between the best performing countries and those still facing difficulties will narrow. In 2015, all EU economies are expected to experience growth (European Economic Forecast, Spring 2014).

1.4 The EU and Canada

In 2013, the EU was Canada’s second-most important trading partner (after the United States), accounting for 9.8 percent of Canada’s total international trade. Canada’s exports to the 28-member EU were worth a total of nearly $33.2 billion, while the value of merchandise imported from the EU was $53.2 billion. In 2013, Canada’s top merchandise exports to the EU by value were: precious stones and metals ($10 billion), machinery ($3 billion), mineral ores ($2.3 billion), mineral fuels and oils ($2.3 billion), and aircraft and parts ($1.7 billion). Canada’s top merchandise imports from the EU by value were: machinery ($10.4 billion), vehicles and parts ($6.5 billion), pharmaceuticals ($5.6 billion), mineral fuels and oils ($4.6 billion), and electric machinery and equipment ($3.4 billion). Moreover, Canadian agri-food exports to the EU in 2013 were valued at $2.4 billion, while imports of agri-food products were valued at $4.4 billion.

Trade in services is significant, with Canada exporting just under $14.5 billion worth of services to the EU in 2013, while importing $17.6 billion worth from the EU. Canada’s services exports to the EU represent 17 percent of its total services exports by value. In 2011, the latest year for which sector-specific data is available, Canada’s top services export categories to the EU by value included management services ($1.8 billion), research and development (almost $1.3 billion), financial services ($1.3 billion), computer and information services ($1.2 billion), charges for the use of intellectual property ($598 million) and architectural, engineering and other technical services ($675 million).

For additional information on Canada-EU trade, consult the following websites:

On September 26, 2014, Canada and the EU celebrated the historic conclusion of the Comprehensive Economic and Trade Agreement (CETA) (CETA) negotiations. Once implemented, the agreement is expected to remove most tariffs and create new opportunities for businesses, including SMEs. The benefits for Canadian businesses are expected to be significant, especially for small and medium enterprises.

1.5 EU Institutions and Laws

Decision-making in the EU primarily involves three main institutions: the Council of the EU (with representatives of the executive governments of all 28 member states), the European Parliament (with representatives elected directly by EU citizens), and the European Commission (which serves as the executive branch, with a President and 27 Commissioners). The EU also has several specialized agencies tasked with implementing legislation and policy or providing advice to EU institutions, such as the European Food Safety Agency (EFSA) or the European Chemicals Agency (ECHA).

Explaining how EU institutions work to create legislation and regulation goes beyond the scope of this guide. However, this guide will briefly summarize some of the main legislative and regulatory acts that are important for Canadian exporters to the EU. The guide will also mention, to the extent possible, new developments that could affect business in the short term. Some EU laws and regulations are implemented at the member-state level differently than they are at the EU level. As EU law and policy are complex and change regularly; it is the responsibility of each exporter to be informed about relevant legal developments and to obtain appropriate advice.

1.6 European Union Markets

The structure of the EU is unique and its laws and regulations touch on a vast array of matters, including economic, environmental and social policy, foreign and trade affairs, etc. However, from the point of view of Canadian exporters, the role of the EU can be summarized in three points.

One: the EU is a customs union with a common tariff on imports from non-EU countries and a common commercial policy (for an overview of what this means in practical terms, please refer to Chapter 2: Customs).

Two: the EU is a single market. This single (or internal) market was created in the 1980s and 1990s through the progressive removal of technical and physical barriers to the movement of people, goods, services and capital. The single market and harmonized rules makes it easier to access 28 national markets and more than 500 million potential customersFootnote 3. A number of EU policies (on competition, science and technology, transport, energy, environment, etc.) help the single market function effectively. Citizens of EU countries can cross international borders within the Schengen areaFootnote 4 without passports and border controls. Chapters 3 to 9 of this guide provide an overview of what this means for Canadian exporters.

Finally, 19 of the 28 EU Member States have taken European integration further and adopted the Euro as their common currency: Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, the Netherlands, Portugal, Slovakia, Slovenia, Spain, Latvia and Lithuania (since 1 January 2015). These 19 countries form the Eurozone. Introduced in 1999, the Euro is the world’s second-most important international currency, after the U.S. dollar. The Euro is the second-most traded currency in foreign-exchange markets worldwide, and is used in more than one-third of all foreign-exchange transactions. The European Central Bank is responsible for monetary policy and maintaining price stability within the Eurozone.

Despite these characteristics, the EU remains a challenging place for businesses. As will be seen throughout this guide, EU regulations and directives can be complex and, in some cases, can create market-access difficulties for Canadian exporters. Furthermore, the EU single market is not complete—national and sub-national rules continue to co-exist with EU-level laws in many areas (e.g. commercial law, labour regulations, and transportation); uneven and delayed implementation of EU rules by member states fragments the internal market. Finally, and perhaps more importantly, the EU remains a union of 28 sovereign countries, with 24 official languages and many diverse cultures, economic profiles and business opportunities. To be successful in the EU, it is important to understand these differences. The Canadian Trade Commissioner Services and other organizations can help you navigate this complex business environment.

1.7 Assistance for Canadian Exporters

The Canadian Trade Commissioner Service (TCS) helps Canadian companies and organizations succeed globally. The TCS is, first and foremost, a network of trade offices in Canada and around the world, including offices in 24 EU member states. This network provides Canadian businesses with on-the-ground intelligence, problem-solving services, qualified contacts, strategic alliances and practical advice on international markets. For assistance, you should first identify the most appropriate trade commissioner in Canada or in Europe.

At a more general level, the TCS has prepared a Step-by-Step Guide to Exporting to help businesses get ready to do business outside of Canada. Finally, the TCS compiles market reports, guides and other sources of information designed for exporters. For the EU, this includes:

Other partners offer services or information useful for preparing or implementing export strategies for European markets. For example, EEN Canada™ (Enterprise Europe Network), officially launched in May 2014, helps Canadian SMEs find new business and technology partners, and provides advice on EU funding opportunities, laws and standards. A European Commission initiative, EEN brings together 600 organizations (e.g. chambers of commerce, development agencies) from more than 50 countries.

The European Commission has published a “Practical guide to doing business in Europe” for European companies doing business in other EU countries. It includes useful links to national legislation and competent authorities in the 28 EU Member States (click “Select a country” on the main page).

Chapter 2 - Customs

The EU is a Customs Union. The 28 EU member states apply the same tariff on goods imported from outside the EU (the Common Customs Tariff). Regardless of where in the EU the goods are declared, the same rules apply, and once the goods have cleared customs, they can circulate freely and be sold anywhere within the EU customs territory. EU member states have abolished customs duties between themselves. The EU is also part of customs unions with Andorra, San Marino and Turkey.

This section covers customs rules and procedures in the EU. For export procedures in Canada, see the Step-by-Step Guide to Exporting Commercial Goods from Canada on the Canada Border Services Agency website.

2.1 Classifying your goods

The Combined Nomenclature (CN) is the EU’s system for classifying goods. It is based on the Harmonized System Nomenclature (HS), the international system for classifying goods run by the World Customs Organisation, and used by Canada and other countries.

Table 1 - Classification Example: Frozen Atlantic Salmon
NomenclatureDigitsCodeProduct description
Section ILive animals; Animal products
HS Chapter - International2 digits03Fish and crustaceans, molluscs and other aquatic invertebrates
HS Heading - International4 digits0303Fish frozen, excluding fish fillets and other fish meat
HS Sub-heading - International6 digits0303 13Atlantic Salmon (Salmo salar) and Danube salmon (Hucho hucho)
CN code - European8 digits0303 13 00Atlantic Salmon (Salmo salar) and Danube salmon (Hucho hucho)
TARIC code - European10 digits0303 13 00 10Atlantic Salmon (Salmo salar)

Knowing the HS code or classification in other countries helps identify how the EU classifies a product. The first six digits of the code are common to all markets; the remaining four digits are unique to the EU.

The code for importing Frozen Atlantic Salmon into the EU is 0303 13 00 10. Note that the classification is different for live, fresh, frozen or smoked Atlantic salmon as well as for prepared Atlantic salmon.

The EU’s Combined Nomenclature (updated every year) is available on the EC website, together with explanatory notes.

You can also use TARIC, the EU’s integrated tariff online database, to find codes. To find a goods code, use either the “Browse” or the “Advanced Search” function. In both cases, you must identify the appropriate section of the Combined Nomenclature, then the appropriate chapter, and lastly the appropriate subheadings for HS, CN and TARIC by choosing the correct goods description (see table 1).

Classification of products is a complex task, given the wide variety of products traded. Correct classification is important, however, as it determines applicable duties and controls. It is also required to complete shipping documents: incorrect classification may result in delays in clearing goods and incur additional duties.

National customs authorities will provide Binding Tariff Information (BTI)—the correct tariff classification for particular goods. BTI is valid throughout the EU. To obtain a BTI, contact one of the customs authorities appointed by member states.

2.2 Calculating Customs Duties

Most customs duties are expressed as a percentage of the import price (ad valorem duty). Some products, however, are subject to a specific duty—a fixed amount per physical unit (e.g. kilogram, litre, percentage of alcohol content, etc.), or a mixed duty—a combination of ad valorem and specific duties.

Variable import duties apply to some imports, such as high-quality wheat, durum wheat, rye, maize and sorghum. The duty applied to cereal imports is fixed on the basis of the difference between the EU intervention price for cereals multiplied by 1.55 and a representative CIF (cost, insurance and freight) import price for these cereals at the port of Rotterdam.

Duty is paid on the declared customs value. This value includes the purchase price, along with shipping and related insurance costs.

The TARIC database lists the duty applicable to any product: from the main screen, enter the product code and the country of origin, and click on “retrieve measures.” You will get the customs duty as well as any EU measures (such as tariff quotas or licences), that apply to the product; provided the product is deemed to originate from Canada under EU rules of origin (other regions may generate different customs duties).

TARIC is regularly updated and will be updated again when CETA, the Canada-EU Free Trade Agreement, enters into force. Additional information on the calculation of customs duties in the EU can be found on the EC website.

2.3 VAT (Value-added Tax)

VAT on imports: Goods imported into the EU are subject to import VAT at their point of entry into EU. When the goods are imported into one EU country but are intended for use in another EU country, however, they are eligible for a VAT suspensive arrangement. Under this arrangement, the VAT will be charged in the destination country rather than at point of entry.

Import VAT is paid by the importer at the rate that applies in the importing country. Each EU country fixes VAT rates within the following limits: standard rates may not be less than 15 percent, and reduced rates may not be less than 5 percent. The VAT rate applied in each EU member state is posted to the European Commission (EC) website.

The following table shows how import charges are calculated on a small shipment of frozen Atlantic salmon (product code: 0303 13 00 10) from Canada to Belgium, after converting Canadian dollars to Euros.

VAT on electronic services: EU rules on e-commerce are changing. As of January 1, 2015, the country of taxation for telecommunications, broadcasting and electronic services (ESS) changed from the supplier’s country to the customer’s country.

These changes affect Canadians who sell services supplied electronically to private consumers in the EU (business to consumer or B2C). Canadian sellers must, like their EU counterparts, charge and account for VAT. Canadian companies must register for VAT in the EU member state where their non-business customer resides. A one-stop-shop procedure enables businesses to complete a single registration valid throughout the EU.

The rules for non-EU companies supplying EES to business customers in the EU (business to business, or B2B) remain unchanged. These companies do not need to charge VAT; EU business customers pay the VAT under a reverse-charge mechanism.

The European Commission DG Taxation web page provides additional information.

VAT
GoodsInvoice PriceShipping and insuranceCustoms valueCustoms dutyValue for VATVAT (Belgium)Total duties and VAT
Frozen Atlantic Salmon€ 600€ 200€ 8002% = € 16€ 8162% = € 48.96€ 64.96

2.4 Excise Duties

Certain goods, such as alcohol, tobacco and energy products, are subject to excise duty.

A product becomes subject to excise duty when it is produced in, or imported into, the EU. The duty, however, is due only once the product is released for consumption. An excise duty is paid in the country where the goods are consumed or used, rather than at the point of entry into the EU.

EU rules set minimum excise duty rates; member states can, however, set higher rates.

The European Commission website publishes a general overview of excise duties, along with additional details on excise duties for alcohol, tobacco and energy.

2.5 Other Import Measures

Tariff rate quotas: Under tariff rate quotas (TRQs), specified quantities of goods can be imported into the EU at reduced or zero-duty rates. Canadian agricultural exporters should note that the EU applies tariff rate quotas to imports of beef, bison and pork products, dairy products and some cereals. Once a quota is reached, a much higher rate applies to additional imports in that category. Exporters must understand how each TRQ is administered to take advantage of it. The Government of Canada publishes factsheets about exporting certain agri-food products to the EU.

Import licences: Imports of some agricultural products (such as cereals, milk products, beef, wine, etc.), textiles, and iron and steel products must be accompanied by import licences issued by EU national authorities. The licences are generally issued automatically on request, except when tariff rate quotas apply. For information about licensing requirements, consult the TARIC database. The EC has also published a document about import licenses for agricultural products.

2.6 Documentation and Customs Clearance

All goods imported into the EU must be declared to the customs authorities of the appropriate country using the Single Administrative Document (SAD). The SAD is the common import declaration form for all EU countries and is usually completed by the importer or their agent.

Depending on the type of goods, additional documents must also be presented to customs authorities. These may include commercial invoices, transport documents (bills of lading), certificates of origin, import licences, and inspection certificates (such as health, veterinary or plant-health certificates). Information concerning these certificates is provided in Chapter 3: EU Sanitary and Phytosanitary Requirements.

Additional information may be found on the European Commission DG Trade website concerning EU import procedures and documents for customs clearance.

2.7 Making Export Easier

You will need to deal with a lot of documents when exporting goods to the EU market. To make exporting easier, you may wish to use freight forwarders and customs brokers. For assistance, please contact our network of trade commissioners in Canada and in Europe, and consult our Step-by-Step Guide to Exporting. Additional information may also be found on the Canada Border Services Agency website.

EU information is also available online through sites such as the Taxation and Customs Union the EU Member States customs authorities, the EU export helpdesk, and the EU Customs Code.

Chapter 3 - EU Sanitary and Phytosanitary Requirements

Goods imported into the EU must meet sanitary and phytosanitary requirements that protect human, animal and plant health. This chapter is an introduction to EU regulations related to food safety, and animal and plant health.

3.1 Food Safety

EU legislation on food safety governs production, labelling and tracking through the supply chain. The EU also regulates the safety of imported food. The European Food Safety Agency (EFSA) provides scientific advice on food-safety issues. EFSA is independent from the European Commission’s DG Health and Food Safety (DG SANCO), which regulates imports. EU food legislation and import requirements are constantly evolving. It is essential to check the food-safety section of the European Commission website for the most recent requirements.

3.1.1 Food laws

Food legislation includes rules that are common to all foodstuffs (such as rules on hygiene) and legislation on specific products (e.g. fruit juices). They include:

EU legislation establishes official controls along the food chain, namely Regulation N. 854/2004 (products derived from animals) and Regulation N. 882/2004 (verification of compliance with laws on feed and food, and animal health and welfare).

Additional information on food safety can be found on the European Commission (DG SANCO) website.

3.1.2 Food labelling and packaging

3.1.2.1 Food labelling

New food information to consumers regulation (1169/2011) replaces current labelling rules and applies as of December 13, 2014.

EU rules after December 13, 2014:

On 13 December 2014, EU rules on food labelling changed. Regulation 1169/2011 on food information to consumers replaced directives 2000/13/EC (labelling) and 90/496/ EEC (nutrition).

Under the new regulation, labels must include information about nutrition, list all potential allergens (such as nuts, cow’s milk, shellfish) and meet new standards for legibility. Some products will also be subject to new labelling standards for listing product origin; the labels of unprocessed frozen meat and fishery products must indicate date of freezing.

For more information:

European Commission:

In addition to general rules on food labelling, specific labeling rules apply to:

For more information, see the European Commission (DG SANCO) labelling webpage.

3.1.2.2 Food packaging

If you export foodstuffs to the EU, you have to make sure that the packaging complies with the EU requirements for food contact materials.

Regulation (EC) N. 1935/2004 requires that materials and articles intended to come into contact with foodstuffs (e.g. packaging materials, cutlery, dishes, etc.) must be safe. They must be manufactured in line with good manufacturing practices (regulation N. 2023/2006). They must not transfer their constituents to the food in quantities that could endanger human health, change the composition of the food or change the odour or taste of the food.

Food packaging

The regulation establishes a list of materials and articles (such as plastics, ceramics, glass, etc.) which may be covered by specific measures. The list includes authorized substances, purity standards, special conditions of use, provisions for ensuring traceability, rules for the authorization of substances, etc.

The labels of materials and articles that come in contact with food must include the text for “food contact” or the wine glass and fork symbol (shown below), unless it is obvious that the article is for food contact. The symbol identifies that the material used in the product is safe for food contact.

For more information:

See the European Commission, DG Health and Food Safety (DG SANCO) website.

3.2 Animal Health

EU health rules on animals and products of animal origin are designed to protect the health of animals and to ensure the safety of food produced for human consumption (Directive 2002/99/EC laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption).

Principles for veterinary checks on products entering the EU from third countries are laid down in Directive 97/78/EC, Regulations 854/2004 and 882/2004 on official controls.

Animals and animal products can only be imported into the EU if:

  • They come from countries approved by the EU for those categories of products.
  • They come from approved processing establishments: See the list of establishments in Canada approved to export to the EU.
  • They are accompanied by a health certificate (signed by the Canadian Food Inspection Agency).
  • They have passed health controls (veterinary checks) carried out at the border inspection post (BIP) in the EU country of arrival. At the border inspection post, each consignment is subject to documentation check, identity check and, as appropriate, physical checks. If products fail any of these checks, they are not allowed into the EU and may be destroyed or returned to the country of origin. If they are compliant, they get a CVED (Common Veterinary Entry Document) and can be marketed freely within the EU.
  • In addition to the above requirements, fishery products entering the EU need a catch certificate to demonstrate that the product has been caught legally. In Canada, Department of Fisheries and Oceans (DFO) Catch Certification Office (CCO) is the authority that issues Catch Certificates.

A practical way to start exporting products of animal origin to the EU is to contact the Canadian Food Inspection Agency.

For more information from:

EU:

Canada:

3.3 Plant Health

Plant health control:

The EU Plant Health Directive (2000/29/EC) lays down phytosanitary requirements designed to prevent the introduction and spread of organisms harmful to plants and plant products in the EU.

Imports into the EU of specified plants and plant products (listed in Annex V Part B of the directive) must:

  • Be accompanied by a plant-health certificate. In Canada, the CFIA is the authority that issues Phytosanitary certificates;
  • Pass customs and phytosanitary inspections at the point of entry into the EU;
  • Be imported into the EU by an importer registered by an EU country;
  • Be announced to the customs office before arrival at the point of entry.

For more information, please see the EU factsheet on plant health control.

EU phytosanitary requirements also apply to wood used as packaging. Under EU rules, wood packaging materials (cases, boxes, crates, pallets, etc.) must be either heat treated or fumigated.

Related legislation:

For more information:

EU:

The European Commission’s plant health web page (DG SANCO).

Canada:

Canadian Food Inspection Agency – Phytosanitary certificates

Chapter 4 - Product Safety

The single market for products is achieved through EU-wide harmonized rules that ensure product safety and allow goods to be sold anywhere in the EU. For most products, the legislation is limited to essential safety and health requirements, and leaves the technical details to voluntary European harmonized standards. Under these regulations, the CE mark indicates a product’s compliance with EU legislation and is mandatory for products such as medical devices and electronics.

The CE mark does not apply to foodstuffs, motor vehicles, chemicals, cosmetics, pharmaceuticals and biocides, which all have their own specific rules.

This chapter provides information on EU environmental, health and safety regulations.

4.1 General Product Safety Directive

Products sold to EU consumers must comply with the requirements of the General Product Safety Directive (GPSD) 2001/95/EC. The directive requires manufacturers to place only safe products on the market.

Market-surveillance activities are carried out by member states. Through the Rapid Alert System for non-food dangerous products (RAPEX), member states immediately share information about dangerous products throughout the EU. For any given product, this can result in marketing restrictions, withdrawals or recalls.

For more information see the EC (DG SANCO) Safety of Products and Services web page.

4.2 CE Marking

What is CE Marking?

The CE mark certifies that a product has been assessed and meets all EU requirements for safety, health and environmental protection before being put on the market.

A product with the CE mark can be sold anywhere in the European Economic Area, a market of some 500 million consumers made up of the 28 EU countries, Iceland, Norway and Liechtenstein, plus Switzerland and Turkey.

Manufacturers are responsible for ensuring product compliance and affixing the CE mark.

Which products require CE Marking?

The CE mark is mandatory for certain product groups such as electronics, medical devices and construction products. The European Commission website currently lists 25 categories of products requiring the CE mark:

  • Active implantable medical devices
  • Appliances burning gaseous fuels
  • Cableway installations designed to carry persons
  • Construction products
  • Eco-design of energy related products
  • Electromagnetic compatibility
  • Equipment and protective systems intended for use in potentially explosive atmospheres
  • Explosives for civil uses
  • Hot-water boilers
  • In-vitro diagnostic medical devices
  • Lifts
  • Low-voltage devices
  • Machinery
  • Measuring instruments
  • Medical devices
  • Noise emission in the environment
  • Non-automatic weighing instruments
  • Personal protective equipment
  • Pressure equipment
  • Pyrotechnics
  • Radio and telecommunications terminal equipment
  • Recreational craft
  • Restriction of hazardous substances in electrical and electronic equipment
  • Safety of toys
  • Simple pressure vessels

In some cases, more than one category can apply to a single product. Furthermore, it should be noted that it is illegal to use the CE mark on a product that does not fall into one of these categories.

For an updated list of product categories requiring the CE mark, please visit the European Commission DG Enterprise website.

How does a product get the CE mark?

The European Commission identifies six steps for your product:

  • Step 1: Identify the directives and harmonized standards applicable to your product.
  • Step 2: Verify the product-specific requirements.
  • Step 3: Check if your product must be tested by an independent third-party.
  • Step 4: Test the product and check its conformity.
  • Step 5: Draw up and keep available the required technical documentation.
  • Step 6: Sign the Declaration of Conformity and affix the CE mark.

If you are a manufacturer established in Canada, you have the same obligations as EU manufacturers: to ensure that your product conforms with all relevant EU directives and regulations.

Your importer will have to verify that you have undertaken the necessary steps and that the documentation is available upon request. You may appoint an authorized representative established in the EU to carry out certain administrative tasks on your behalf. It is mandatory to appoint an authorized representative only for medical devices. You are advised to define clearly in writing the tasks delegated to your representative.

Directives: It is the manufacturer’s responsibility to identify the directives that apply to a product. On the European Commission website, you will find a search tool that will help you find the directive(s) applicable to your product, as well as the guidance documents for each product type.

Esssential Requirements: Your product must comply with the relevant essential requirements of the applicable directives. Essential requirements are mandatory health, safety, and environmental protection requirements that products must meet to be placed on the EU market.

European Harmonized Standards are issued with reference to the applied directives, and express in detailed technical terms the essential requirements. Full compliance with harmonized standards gives a product the presumption of conformity with the relevant essential requirements. The use of harmonized standards is voluntary. You are free to choose other ways to fulfill the essential requirements. However, European standards are a reliable way to ensure compliance. Whenever possible, Canadian exporters are advised to follow harmonized standards.

If you use Harmonized Standards, you can get the CE mark for your product and sell it in the EU.

References for European Harmonized Standards are listed on the EC website. You can buy copies of the harmonized standards documents from national members of the European Standards Organisations: CEN (general standards), CENELEC (electrotechnical standards), and ETSI (telecommunications standards).

Copies of certain European Standards documentation may also be purchased from the Standards Council of Canada / Conseil canadien des normes and by private standards vendors operating in North America.

Notified Bodies are authorized third-party conformity-assessment bodies. For some products, a notified body must be involved in testing and certification. This is clearly indicated in the directives. To find a notified body, such as certified labs in North America, see the NANDO database.

Conformity assessment is the process, carried out by the manufacturer, to demonstrate whether a product fulfills its specified requirements.

Conformity assessment involves various checks on the design and manufacture of products. Full details about conformity-assessment procedures (referred to as modules) are included in the annexes of the directives.

Conformity assessment is the responsibility of the manufacturer, regardless of whether the manufacturer self-assesses (possible for most products) or involves a notified body.

For detailed guidance on conformity assessment, see the 2014 Blue Guide on the implementation of EU product rules.

Technical Documentation: Information obtained during the conformity-assessment procedure must be documented in the product’s technical file. The technical file must be kept for ten years and made available to European authorities for control purposes.

Declaration of Conformity: Is a formal declaration, signed by the manufacturer or an authorized representative, that the product meets all requirements of applicable directive(s). The Declaration of Conformity (DoC) must be kept with the technical file. Some directives require products to be accompanied by the DoC. A DoC must be in the official language of the country of import into the EU.

CE mark

Affixing the CE Mark: The CE mark must be affixed by the manufacturer or authorised representative. See EU guidance on how to reproduce the CE mark.

For more information:

The Canadian Trade Commissioner Service produced a brochure on the CE mark available at Six Steps to CE Marking.

European Commission:

CE marking web page and CE marking Brochure.

4.3 Chemicals - REACH

REACH, (Regulation EC 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals), is the EU regulation on chemicals and their safe use. REACH makes industry responsible for managing risks that chemicals may pose to health and the environment, and for providing relevant information to users along the supply chain. The REACH system is run by the European Chemicals Agency (ECHA), which manages the registration, evaluation, authorization and restriction processes that apply to chemical substances throughout the EU.

Who does REACH impact?

REACH affects virtually every industrial sector from automotive, aerospace, plastics and cosmetics to aluminum, household cleaners, computers and textiles. REACH applies to all categories of chemical substances manufactured, imported or used in the EU, with only a few limited exemptions. REACH also applies to chemicals contained in preparations and in finished products (articles).

REACH affects almost all products manufactured in Canada and exported to the EU.

REACH has an impact on you, whether or not you are directly subject to REACH obligations. If you are a Canadian business with a presence in Europe, you have the same obligations as an EU business. If you are a Canadian exporter without a presence in Europe, your EU importer must comply with REACH and will turn to you for information needed to achieve compliance. To protect confidential business information, you may choose to appoint an Only Representative established in the EU to fulfill the obligations of importers under REACH. The Mission of Canada to the EU provides a list of Only Representatives and REACH business service providers.

Complying with REACH

REACH is one of the EU’s most complex pieces of legislation. REACH obligations vary based on the substance, its properties and tonnage, and on the role of the company in the supply chain. To ensure compliance with REACH, secure expert advice. This introduction describes the main obligations and provides links to more information.

REACH Registration: For substances produced or imported in quantities of one ton or more per year per company (legal entity), EU manufacturers and importers must submit a registration dossier to the European Chemicals Agency (ECHA) with information on the properties, uses and classification of the substance, as well as guidance on safe handling. For quantities of ten tons and more, companies must also submit a safety assessment. See the ECHA website for more information on the content of the registration dossier.

The registration process for chemicals already placed on the market before the entry into force of REACH started in 2008, with various registration deadlines imposed on businesses. The next deadline is May 31, 2018 for the registration of substances manufactured or imported in quantities between 1 and 100 tons per year.

Chemical quantities greater than one ton per year per company must be registered with the European Chemicals Agency (ECHA).

REACH requires that manufacturers and importers of identical substances cooperate by sharing data and submitting joint registrations, although companies must still register some information separately. Industry groups have set up consortia to generate the necessary data for joint registration. For more information on joint submission, see REACH guidance on data sharing and registration.

REACH Evaluation enables authorities to determine whether further testing is needed and whether registration dossiers comply with requirements.

REACH Authorization: Under REACH, substances that can be harmful to health or the environment are considered substances of very high concern (SVHCs). These include carcinogens and substances that persist in the environment, and are listed on the REACH Candidate List of substances of very high concern. Once a substance is listed in the Candidate List, it can be subsequently included in REACH Annex XIV as a substance that requires authorization.

Substances on REACH Annex XIV cannot be placed on the EU market or used after a given date, unless an authorization is granted for their specific use, or the use is exempted from authorization. EU manufacturers, importers and downstream users of chemicals can apply for authorization. An Only Representative of a non-EU manufacturer can also apply for authorization to sell or use Annex XIV substances. Authorization is a complex process; companies must show that the risks to health and the environment are adequately controlled or that the socio-economic benefits outweigh the risks and there are no suitable substitutes.

It is important to identify any substance likely to be considered an SVHC, as they may be withdrawn from the market or banned. The Candidate List of SVHCs and Annex XIV are regularly updated on the ECHA website.

REACH Restrictions are imposed on high-risk chemicals. Chemicals restricted or banned in the EU are listed in REACH Annex XVII.

It is important that Canadian exporters maintain an up-to-date understanding of how REACH impacts their products.

Lists of substances affected by REACH change regularly.

Supply chain communication:

Suppliers of chemicals and chemical preparations must communicate information about hazards, use and risks to downstream users, distributors and consumers. REACH has introduced a new format for Safety Data Sheets. These must be prepared by manufacturers or importers for all dangerous substances or mixtures in accordance with REACH Annex II (Guidance on the compilation of safety data sheets) and passed down the supply chain.

Information about hazardous chemicals in finished products must be communicated through the supply chain under certain conditions. If an article contains a substance on the Candidate List of SVHCs in a concentration above 0.1 percent by weight, the EU manufacturer or importer must inform users on safe usage. The European Chemicals Agency must also be notified if an article contains a substance on the Candidate List. For more information on communication and notification requirements for substances in articles, see ECHA’s guidance on Substances in Articles.

REACH requirements
Chemical substancesChemical preparationsChemicals in products
Registration of substances > 1 ton
Authorization (for substances on REACH Annex XIV)
Restrictions (for substances on REACH Annex XVII)
Registration (of substances > 1 ton in preparations)
Authorization (for substances on REACH Annex XIV)
Restrictions (for substances on REACH Annex XVII)
Registration (of substances > 1 ton in the article and intentionally released under normal conditions of use)
Authorization (if the substance is listed on Annex XIV, for articles produced in the EU, not for imported articles)
Restrictions (for substances on Annex XVII)
Notification to ECHA (if the substance is on the Candidate List, > 1 ton, > 0.1%)
Communication to the supply chain (if the substances is on the Candidate List, > 0.1%)

Classification and labelling requirements:

REACH requires that EU manufacturers and importers classify and label all substances subject to registration and authorization, and submit this information to the EU Classification and Labelling Inventory, a database managed by the European Chemicals Agency.

Classification and labeling rules are governed by the CLP regulation on the classification, labeling and packaging of substances and mixtures (see Chapter 5).

For more information, see the CLP pages of the European Chemicals Agency’s website and the guidance on labelling and packaging.

For more information, please see:

Legislative reference:

Registration, Evaluation, Authorisation of Chemicals (REACH) Legislation.

4.4 Biocides

A new regulation on the use and placing on the market of biocidal products (BPR, Regulation (EU) N. 528/2012) came into effect September 1, 2013, replacing directive 98/8/CE.

Biocidal products contain active substances and are used against harmful organisms such as pests and bacteria. They include disinfectants, repellents, insecticides, wood and material preservatives, and anti-fouling paints.

The authorization of biocidal products for the EU market involves two steps: approval of the active substance at the EU level; and product authorization at the national level. The regulation introduces new procedures for the approval of biocidal products at the EU level, along with mandatory data-sharing provisions and new requirements for treated articles (e.g. textiles or furniture treated with or incorporating a biocidal product). This has important implications for exporters to the EU; articles can be treated only with active substances approved in the EU. There are also labelling requirements for some treated articles.

For more information:

Please see the European Chemicals Agency (ECHA) web page on the Biocidal Products Regulation.

Legislative reference:

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

4.5 Cosmetics

In July 2013, a new EU cosmetics regulation (Regulation No 1223/2009/ CE) came into force. The most important changes include:

  • Strengthened safety requirements—manufacturers must prepare and submit product-safety reports (safety assessment).
  • To be placed on the EU market, a cosmetic product must have a designated Responsible Person (e.g. EU manufacturer, importer or a third party) who ensures compliance with the cosmetics regulation and can make technical documentation, including the results of safety assessments, accessible to authorities.
  • Before placing a cosmetic product on the EU market, the Responsible Person must notify the European Commission via the Cosmetic Products Notification Portal (CPNP).
  • The Responsible Person must inform national authorities of any serious undesirable effects attributable to the use of the product.
  • New rules are now in effect on the labelling and safety assessment of nanomaterials used in cosmetics.

Other safety elements of the new regulation relate to the composition and labelling (see Chapter 5) of cosmetic products. The regulation contains lists of banned and restricted substances. Colorants, preservatives and UV filters, including nanomaterials, must be explicitly authorized. Restrictions on ingredients are also listed on the EU cosmetics CosIng database.

Ban on animal testing: Since March 11, 2013, new cosmetic products and ingredients sold in the EU must not have been tested on animals, even if the testing takes place outside the EU. See the European Commission website for more information on alternative methods to animal testing.

For more information:

Commission DG Health and Consumers Cosmetics web page.

Legislative reference:

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.

4.6 Pharmaceuticals

Marketing authorization:

To enter the EU, medicinal products for human use must be authorized at either the member state or EU level. Authorizations are granted only to applicants established in the EU. A Canadian company without a presence in the EU must use an EU-based importer or representative to market any pharmaceutical product in the EU.

Under the centralized authorization procedure, companies may submit a single application to the European Medicines Agency (EMA). After scientific evaluation by the EMA, the European Commission authorizes the marketing of medicines, in all member states. The procedure is mandatory for certain types of medicines (such as those used to treat AIDS, cancer or diabetes), and optional for others (Annex I of Regulation (EC) No 726/2004 on the authorization of medicinal products).

At the member-state level, companies have the choice between the decentralized procedure (companies apply for a marketing authorization of a medicinal product simultaneously in several countries with one member state being the reference country), and the mutual-recognition procedure (companies that have a medicine authorized in only one country can then apply for that specific authorization to be recognized in other member states).

Simplified authorization procedures exist for homeopathic medicinal products and traditional herbal medicinal products.

Good Manufacturing Practice:

Medicinal products from outside the EU must conform to Good Manufacturing Practices (GMP) that are at least equivalent to EU standards.

Canada and the EU have concluded Mutual Recognition Agreements (MRAs) covering GMP. Canada and the EU mutually accept results of inspections of manufacturers. Canadian companies exporting drugs and medicinal products to the EU that fall within the scope of the MRA and that are manufactured within Canada may benefit from specified GMP exemptions provided by the MRA. See Health Canada’s webpage for more information on the Canada-EU MRA.

Related topics:

For more information:

European Commission (DG SANCO) medicinal products web page.

Legislative reference:

See Directive 2001/83/EC of the European Parliamant and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

Chapter 5 - Packaging and Labelling

A multitude of product labels exist in the EU: EU and national labels, mandatory and voluntary labels, environmental, energy, food, cosmetic labels, etc.

This section is a general introduction to the most common labels. Country-specific labelling and packaging requirements should be checked for each market.

See Chapter 4 for information about the CE mark and Chapter 3 for information about food labelling.

As a general rule, labels must be in the official language(s) of the country where the product is sold. Multi-language labelling is allowed throughout the EU.

5.1 Mandatory Labels

5.1.1 Classification, labelling and packaging

The CLP Regulation (1272/2008) for the classification, labelling and packaging of substances and mixtures has introduced new hazard pictograms.

Any package containing substances or mixtures classified as hazardous must be clearly labelled with the following information (CLP Article 17):

  • The name of the substance or mixture;
  • The name, address and telephone number of the supplier;
  • The nominal quantity, and where applicable;

Substances or mixtures classified as hazardous must also include, where applicable:

  • The word “danger” or “warning ;”
  • Hazard pictograms (see symbols below);
  • Hazard statement (such as “fatal if swallowed”);
  • Appropriate precautionary statements (such as “keep out of the reach of children”); and
  • Supplemental information.

The CLP regulation follows the United Nations GHS system (Globally Harmonized System of the Classification and Labelling of Chemicals) and classifies chemicals according to their hazardous properties (explosive, flammable, toxic, etc).

The new hazard pictograms (on a white background) replace the previous ones. Substances have been subject to the new provisions since 2010. Mixtures, which represent the vast majority of products on the market, will be subject to the new provisions as of June 1, 2015. Products may have to be re-labelled to comply with the new regulation.

The symbols, from left to right, refer to: corrosive, health hazard, explosive, flammable, oxidising, acute toxicity, serious health hazard, gas under pressure, hazardous to the environment.

The CLP legislation covers chemical substances and mixtures composed of two or more chemical substances, including consumer items such as paints and detergents. Note that the CLP regulation does not apply to medicinal and cosmetic products, medical devices, waste and foodstuffs.

Packaging containing hazardous substances and mixtures must:

  • Prevent any loss of the contents;
  • Be made of resistant materials if they come into contact with the contents;
  • Be strong, solid and have sealable fastenings.

In some cases, child-resistant fastenings and tactile warnings are required.

Hazard pictograms

For more information:

The new pictograms are explained in some detail on the European Chemicals Agency (ECHA) website.

The European Chemicals Agency (ECHA) has also published an introductory guidance and Q&As on the CLP regulation.

Legislative reference:

See Regulation 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.

5.1.2 Energy labelling

The EU energy label (Directive 2010/30/EU) provides the consumer with information concerning the eco-design and energy efficiency of products.

Energy labels are mandatory for all appliances sold in the EU. The directive, initially established for household appliances, has since been extended to include energy-related products in the commercial and industrial sectors.

The Energy Labelling Directive 2010/30/EU sets a framework for the adoption of product-specific directives, including those applying to televisions, washing machines, dishwashers, etc.

Along with information about noise emissions, and consumption of water and energy, the labels must also include the product’s energy-efficiency ranking. The EU added added A+++, A++ and A+ to the traditional A to G scale (which now ends at D). The A class (green) is the most efficient.

  • Projected annual energy consumption;
  • Information related to the use of other resources (e.g. water consumption) and noise emissions, etc.

Example of energy label for washing machines:

Energy label for washing machines

For more information:

Energy labelling, consult the European Commission DG Energy web page.

Legislative reference:

See Directive 2010/30/EU of 19 May 2010 on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products.

5.1.3 Electrical and electronic equipment (WEEE and ROHS)

Waste electrical and electronic equipment

The WEEE Directive (Directive 2012/19/EU on waste electrical and electronic equipment) uses the crossed-out wheeled-bin symbol to show that equipment should not be placed in the normal waste stream.

The directive applies to a wide range of electrical and electronic consumer appliances as well as certain professional equipment:

  • Large and small household appliances;
  • IT and telecommunications equipment;
  • Consumer equipment and photovoltaic panels;
  • Lighting equipment;
  • Electrical and electronic tools (with the exception of large-scale industrial tools);
  • Toys, and leisure and sports equipment;
  • Medical devices (with the exception of all implanted and infected products, which have to be disposed as hazardous waste);
  • Monitoring and controlling instruments; and
  • Automatic dispensers.

After a transitional period (ending in 2019), the legislation will apply to all electrical and electronic equipment (EEE).

Under the WEEE Directive, EU manufacturers and importers of EEE must finance the collection and treatment, recycling or reuse of e-waste. To comply, companies must either join a Producer Compliance Scheme or operate a waste-management plan.

While the WEEE Directive aims to divert e-waste from landflills, its sister directive, the ROHS Directive aims to reduce the hazardous content of Electrical and Electronic Equipment (Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment – named ROHS 2).

ROHS restricts the use of six hazardous substances (lead, cadmium, mercury, hexavalent chromium, and the brominated flame retardants PBB and PBDE) in EEE. New substances will be restricted in line with REACH.

ROHS 2 is a CE Mark Directive: manufacturers must produce technical documentation demonstrating compliance, provide a Declaration of Conformity and affix the CE mark to their products (see Chapter 4 on CE marking).

For more information:

European Commission DG Environment website.

Legislative reference:

See Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment;

Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment.

5.1.4 Cosmetics labels

The Cosmetics Regulation (EC 1223/2009) sets out labelling requirements. Both containers and packaging must be clearly marked with the following information:

  • Name and address of a responsible person in the EU;
  • Nominal content at time of packaging given by weight or volume;
  • Particular precautions for use;
  • Product function;
  • Batch number;
  • List of ingredients;
  • Nanomaterials (indicated in the list of ingredients with the word nano in brackets following the name of the substances, e.g; titanium dioxide [nano]);
  • Country of origin;
  • Date of minimum durability or period when the product is safe after opening (for products lasting more than 30 months) with the following symbols.

Date of minimum durability:

Minimum durability

Period after opening:

Period after opening

Special provisions apply to small products that are difficult to label. The symbol showing a hand pointing at a book indicates that a leaflet accompanying the product lists relevant information.

Leaflet accompanying the product lists relevant information

Chapter 4: Product Safety covers EU requirements for the composition and marketing of cosmetic products.

For addition information:

See the European Commission DG Health and Consumers Cosmetics webpage.

Legislative reference:

Council Regulation 1223/2009 on cosmetic products.

5.2 Voluntary Labels

5.2.1 Ecolabel

Ecolabel

The Ecolabel (Regulation (EC) No 66/2010) is a voluntary environmental-labelling system that promotes and identifies “green” products.

The Ecolabel is awarded to products with reduced environmental impacts throughout their lifecycles. The products must comply with criteria related to energy consumption and pollution. Criteria exist for more than 20 product types including detergents, shampoos, footwear, textiles, paints, paper, computers and wooden furniture. Ecolabel product groups and criteria are posted to the Commission DG Environment website.

To apply for the EU Ecolabel, see the step-by-step guide provided by the European Commission.

For additonal information:

Please see the Commission DG Environment Ecolabel web page and the EU brochure on the Ecolabel.

Legislative reference:

Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU ecolabel.

5.2.2 Energy Star

Energy Star

Energy Star is a voluntary energy-efficiency labelling programme run by the U.S. Environmental Protection Agency (EPA).

Through an agreement with the United States, the EU participates in the Energy Star programme for office equipment. Energy Star labels are not as widely used in Europe as they are in North America. Qualified products are, so far, limited to computers, displays and imaging equipment.

For more information:

Energy Star EU and Energy Star Canada.

Legislative reference:

See Regulation (EC) No 106/2008 on a Community energy-efficiency labelling programme for office equipment.

5.2.3 Organic products

Organic products

To be marketed in the EU as “organic,” a product must comply with food-import requirements (see Chapter 3) and organic-product legislation (EC Regulation N. 834/2007 on organic production and the labelling of organic products).

Labels must be clearly visible on product packaging and reference the certification control body. The use of the EU organic production logo is mandatory for organic pre-packaged foods produced in the EU; it is voluntary for any organic products imported into the EU.

Canada and the EU recognize each other’s rules and control systems for organic production. Organic products exported from Canada to the EU under the Canada-EU Organic Equivalency Arrangement can bear the EU logo, although they must be accompanied by a certificate of inspection that is checked upon entry into the EU (Directive (EC) N. 1235/2008 on imports of organic products from third countries).

For more information:

EU:

A user manual and FAQs about the EU organic logo are available on the Commision DG Agriculture Organic Farming web page.

Canada:

Canadian Food Inspection Agency – Organic products.

Legislative reference:

See Regulation (EC) N. 834/2007 on organic production and labeling of organic products;

Directive (EC) N. 1235/2008 on imports of organic products from third countries.

5.2.4 Prepackaged products

Prepackaged products

The e-mark on prepackaged goods indicates that the packaging is filled according to Directive 76/211/EC on pack sizes. The directive applies to packages within the five gram to ten kilogram range (or five millilitres to ten litres). Containers with the e-mark must also indicate the quantity (weight or volume) of the product. The e-mark is not mandatory, but it is recognized througout the EU as a measurement “passport.” Responsibility for the accuracy of all measurements rests with the packer (or the importer).

For more information:

European Commission, DG Enterprise

Legislative reference:

See Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products.

5.2.5 Green Dot

Green Dot

The EU Packaging and Packaging Waste Directive (94/62/EC) covers all packaging and packaging waste for industrial, commercial and household products sold in the EU. The directive sets environmental requirements for the design and manufacture of packaging, including restrictions on certain heavy metals.

The directive makes industry responsible for the collection and recycling of packaging waste. The Green Dot on packaging indicates that the company has joined a packaging-recycling scheme in accordance with the directive.

For more information about the Green Dot fee and application process, consult the Pro Europe website. Pro Europe is the umbrella organization for European packaging, and packaging waste-recovery and recycling schemes.

For more information:

Please see the European Commission DG Environment web page.

Legislative reference:

See Directive 94/62 of the European Parliament and Council of 20 December 1994 on packaging and packaging waste.

Chapter 6 - EU Consumer Rights

EU legislation protects consumers buying goods and services. This section covers EU requirements related to consumer contracts and data protection.

6.1 New Consumer Rights Directive

The New Consumer Rights Directive (2011/83/EC) protects consumers shopping online (distance selling) or away from a retailer’s premises (doorstep sales). Since June 13, 2014, the new directive gives consumers the right to change their minds within two weeks of receiving goods purchased online, and requires online traders to provide clear information to consumers. The changes introduced include:

  • A 14-day EU-wide withdrawal right for consumers.. The purchase price must be refunded to the consumer with 14 days of the withdrawal.
  • The seller has a maximum of 30 calendar days from contract signing to deliver the goods to the consumer otherwise the consumer has the right to cancel the purchase.
  • Prior to the conclusion of the contract, the seller must provide the consumer with clear information including the characteristics of the product, the name and address of the seller, the price inclusive of all taxes, payment and delivery methods, contract duration and return policy. Information on digital content, and compatibility with hardware and software, must also be clear.
  • Pre-ticked boxes on websites for charging extra payments are not allowed.
  • Surcharges for the use of credit cards and telephone hotlines are not permitted.

For more information:

European Commission DG Justice web page on consumer rights.

Legislative reference:

See Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights.

6.2 Guarantees

Under the Product warranty Directive (Directive 99/44/EC) a two-year guarantee applies to the sale of all consumer goods. Consumers have two years to request repair or replacement if the goods are not in conformity with the sales contract (i.e. if they are defective or are not as advertised). The seller must repair or replace faulty goods free of charge. If repair or replacement is not possible or impractical, consumers may request a refund or price reduction. The two-year legal guarantee applies from the date of delivery.

Additional commercial guarantees must be clearly drafted and indicate any additional rights. Note that legislation in some countries provides guarantees longer than the one specified in the European Product warranty directive.

For more information:

European Commission DG Justice web page on sales and guarantees.

Legislative reference:

See Directive 99/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees.

Related information:

6.3 Data Protection

Directive 95/46/EC on data protection regulates the processing of personal data in the EU. It requires member states to allow the transfer of personal data (such as name, e-mail address, bank details, etc.) only to countries that provide “adequate levels of protection.”

In 2002, the EU recognized that the Canadian Personal Information Protection and Electronic Documentation Act (PIPEDA) provides adequate protection. This allows the transfer of personal data subject to PIPEDA from the EU to Canada without additional safeguards.

For more information, please see the Office of the Privacy Commissioner of Canada web page.

In January 2012, the EC proposed a reform of EU data protection rules to strengthen online privacy rights and further develop Europe’s digital economy. Endorsed by the European Parliament in March 2014, the reform is expected to be fully approved by the end of 2015.

For more information:

European Commission DG Justice webpage.

Legislative reference:

See Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

Chapter 7 - Intellectual Property

Intellectual Property (IP) consists of industrial property (patents, trade marks, designs) and literary and artistic property (copyrights). Intellectual property rights (IPR) enable inventors, designers and authors to decide how their inventions and creations are used.

The EU and its member states adhere to all major intellectual-property agreements implemented by the World Intellectual Property Organization (WIPO), and to the WTO TRIPS agreement. The EU has two intellectual-property bodies: the European Patent Office (EPO) and the Office of Harmonization in the Internal Market (OHIM), the agency responsible for the registration of trademarks and designs. The EU protects intellectual property rights against piracy, illegal trade and counterfeiting. The EU is currently preparing rules for the protection of trade secrets.

7.1 Your IP Strategy for Europe

Intellectual property rights are territorial; registration of intellectual property in Canada provides no protection in Europe.

If you are considering exporting to the EU, it is recommended that you secure professional advice to protect intellectual-property rights. See the guide on Intellectual Property for Exporting Businesses on the website of the Canadian Intellectual Property Office (CIPO).

CIPO manages a list of registered IP agents for patents and trademarks in Canada. Many of them have associate firms in Europe.

The Canadian Trade Commissioner Service can also provide a list of qualified IP professionals.

Ensure you protect your intellectual property before entering the EU market. Get professional advice.

This chapter does not constitute legal advice. It is an introduction to steps you can take to register your IPR in Europe.

7.2 Patents

A patent is a legal title that can be granted for any invention having a technical character provided that it is new, involves an inventive step and can be used in industrial application. Patents offer protection for 20 years. Patent law protects new inventions.

Inventions can be protected in Europe either by:

  • National patents, granted by National Patent Offices;
  • European patents granted centrally by the European Patent Office (EPO). A European patent, obtained by filing a single application for all EPO member countries where protection is sought, has the effect of a national patent in each designated country.

It will soon be possible to obtain a European Patent, effective in all EU member states with the exception of Italy and Spain. The European Patent (sometimes referred to as a “Unitary Patent”) will ensure uniform protection for an invention across the EU and is expected to reduce costs and administrative burden.

A single patent court, the Unified Patent Court, will be created for participating EU member states. The aim is to create more legal certainty by avoiding parallel litigation before multiple national courts, which could result in divergent interpretations and rulings.

The Unitary Patent and the Unified Patent Court are expected to be operational in 2016.

For more information on patents:

The European Patent Office:

Innovaccess, the European Network of National Intellectual Property Offices, provides information on IP issues, including patents, for each EU member state.

7.3 Trademarks

Trademarks are the indications, such as words, phrases, logos and sounds, used by companies to identify and distinguish their products or services from those of their competitors. Trademarks are protected for renewable terms of 10 years (Directive 2008/95/EC on the harmonization of trade mark law in the EU).

Businesses apply for a National Trademark at a national IPR office. It is also possible to apply for a Community Trademark (CTM) with the Office for Harmonization in the Internal Market (OHIM). With a single registration, the Community Trademark offers protection in all 28 EU countries.

The EU is currently revising its trademark system to make it cheaper for businesses and to provide better protection against counterfeiting. More information on the revision of the trademark system is available on the EC website.

The EU also maintains a database of geographical indications (typically place names) that may conflict with trademarks. Geographical indications often identify products that originate in, and have the characteristics associated with, particular places, such as Parma Ham or Champagne.

For more information on trademarks:

OHIM (Office for Harmonization in the Internal Market):

7.4 Designs

Design refers to the “appearance of the whole or part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation” (Regulation 6/2002 on Community designs).

Applications for a National Design registration should be filed before the National Intellectual Property Office. Applications for a Registered Community Design are submitted to the Office for Harmonization of the Internal Market (OHIM). A single application to OHIM enables protection throughout the EU.

A Registered Community Design is valid for five years and can be renewed up four times (a total of 25 years).

For more information:

OHIM (Office for Harmonization in the Internal Market):

7.5 Copyright

Copyright protects original creative material such as music, and theatre or literary works.

Copyright is automatic and requires no formal registration process; copyright protection begins upon creation of the work.

In the EU, copyright protection lasts for 70 years after the death of the creator. If the work originates outside the EU and the author is not an EU national, the protection granted in the EU must not exceed the term set in the EU (Directive 2011/77/EU on the term of protection of copyright and certain related rights).

The inclusion of a copyright notice and symbol © stating copyright owner and creation date is not mandatory, although it is useful in the event of a dispute. Some member states have national copyright-registration systems. While not mandatory, these systems are helpful in the event of disputes.

The latest developments in copyright protection include discussions about simplifying the EU’s regulatory framework to adapt to the digital environment (Review of EU copyright rules).

For more information on copyright:

See Innovaccess.

For additional information:

EU:

Canada:

Canadian Intellectual Property Office.

Chapter 8 - Government (Public) Procurement

European public authorities spend around 16 percent of the EU’s GDPFootnote 5 on the purchase of goods and services, generating significant business opportunities.

Through the WTO Agreement on Government Procurement (GPA) and bilateral or regional free trade agreements, companies based outside the EU can access this public-procurement market. When the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) agreement comes into force, Canadian businesses will have greater access to public-procurement opportunities with EU institutions and the national, regional and local governments of all 28 member states.

8.1 Finding Tender Opportunities

If you are interested in selling your goods or services to EU governments and institutions, consult the TED database. TED (Tenders Electronic Daily), the online version of the supplement to the Official Journal of the European Union, lists up to 1,000 new contract notices published daily. Free of charge, TED provides access to:

  • Tender notices from all EU member states (public contract notices for works, supplies and services as well as utilities—water, energy, transport—and postal services);
  • Tender notices from European institutions (public works, supplies and services, and external aid);
  • Tender notices from Switzerland, Norway, Lichtenstein and Iceland (European Economic Area);
  • Projects funded by the European Investment Bank, the European Central Bank and the EBRD (European Bank for Reconstruction and Development);
  • Prior information notices of forthcoming contracts;
  • Awarded contracts.

TED uses CPV codes (Common Procurement Vocabulary) to identify goods to be procured and NUTS codes (Nomenclature of Territorial Units for Statitics), which enable searching by EU member state.

SIMAP, the European government (public) procurement portal, provides access to all national-procurement databases.

8.2 Access to the EU Government (Public) Procurement Market from Canada

The EU procurement system is generally quite open and suppliers from outside the EU can bid on opportunities.

Suppliers from EU countries, as well as those from countries with which the EU has international procurement obligations, enjoy “preferential access,” including the right to seek recourse if they feel that a process is inconsistent with EU directives or international agreements. Canadian suppliers enjoy “preferential access” to a range of procurement opportunities in the EU under the GPA (WTO Agreement on Government Procurement).

Contracts covered by the GPA:

Notices listed the TED database should specify whether the procurement opportunity is subject to the GPA. This information typically appears in notices under section II. 1.7: “Information about the Government Procurement Agreement (GPA).” If this information is missing, it might be possible to contact the procuring entity to find out whether all bidders receive similar consideration.

Restrictions for Canadian suppliers:

As noted earlier, Canadian suppliers enjoy preferential access to a wide range of procurement opportunities in the EU under the GPA. There are, however, limitations (on the basis of reciprocity). These include:

  • Procurement by sub-central procuring entities of certain communications, protection and coherent-radiation equipment classified under Federal Supply Category 58;
  • Procurement by NUTS 1 and NUTS 2 cities-regions, local procuring entities and bodies governed by public law (NUTS is the EU nomenclature of territorial units used for statistical purposes);
  • Opportunities worth between 200,000 SDRFootnote 6 ($315,538) and 355,000 SDR ($560,300) posted by sub-central procurement entities;
  • Procurement related to urban transit including railway, tramway, trolley bus or bus services; and
  • Procurement by entities in the field of intercity railways.

In addition, Canadian providers are not eligible for procurement opportunities posted by covered entities as per the table below.

Although a tender notice may indicate that the GPA applies to an opportunity, Canadian suppliers may not necessarily enjoy preferential access. As some limitations are quite technical, Canadian suppliers should seek specialized legal advice.

The Canadian Trade Commissioner Service can help identify legal experts in international government (public) procurement.

Access to the EU Government (Public) Procurement Market from Canada
SubjectCPC Reference No.
Maintenance and repair services6112, 6122
Land-transport services, including armoured-car services, and courier services, except transport of mail712, 87304
Air-transport services of passengers and freight, except transport of mail73
Transport of mail by land, except rail, and by air71235, 7321
Financial services
(a) Insurance services
(b) Banking and investments services
ex 81
812
814
Accounting, auditing and bookkeeping services (sub-central)862
Market research and public opinion polling services864
Advertising services871
Publishing and printing services on a fee or contract basis88442

8.3 Understanding EU Government (Public) Procurement Rules

Government (Public) Procurement

When national, regional and local authorities in the EU buy goods or services, they must follow EU procurement rules. There are three EU public-procurement directives:

  • The public sector directive: Directive 2004/18 on coordination of procedures for the award of public works contracts, public supply contracts and public service contracts;
  • The utilities directive: Directive 2004/17 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors;
  • The defence procurement directive: Directive 2009/81 dealing with defence and security procurement.

The directives detail rules applicable to contracts, including contract-award criteria, and on publication, technical specifications and public-procurement procedures.

They also establish thresholds for the publication of contracts in the EU Official Journal – TED (updated on 1 January 2014):

  • €134,000 for supply and services contracts (for central government authorities);
  • €5,186.000 for works contracts.

For tenders of lesser value, national rules apply.

New EU procurement rules: In February 2014, the EU adopted:

  • A directive on government (public) procurement (Directive 2014/24/EU replaces 2004/18/EC);
  • A directive on procurement by entities operating in the utilities sectors—water, energy, transport and postal-services sectors (Directive 2014/25/EU replaces directive 2004/17/EC);
  • A new directive on concession contracts (Directive 2014/23/EU).

Member states have until April 2016 to transpose the new rules into national laws.

The reform simplifies procedures and introduces rules on electronic procurement. It introduces provisions allowing environmental, social and innovation considerations to be taken into account.

For more information, please see the:

EU brochure on new rules on public contracts and concessions;

EU handbook on Environmental Government (Public) Procurement;

TED database – Tenders Electronic Daily.

Contracts with EU institutions

The procurement procedure for the three main EU institutions (European Commission, European Parliament and Council) is governed by the Financial Regulation (Regulation 996/2012 on the financial rules applicable to the general budget of the Union, and Regulation 1268/2012 on the rules of application of Regulation 966/2012).

Among EU institutions, the European Commission, which is in charge of implementing EU policies, awards the largest number of contracts (approximately 9,000 every year).

Tenders from the European Commission are published on the TED database.

See also the EU brochure on Doing business with the European Commission.

For more information:

Tender notices by EU institution.

Chapter 9 - Business Travel

9.1 Passports and Visas

Canadian citizens travelling to Europe for short-term tourism or business trips do not need visas. Visa rules differ depending on whether the EU country is party to the Schengen Convention.

Schengen Area countries:

The Schengen AreaFootnote 7 is an area without controls at borders between countries that are party to the Schengen Convention. Controls are maintained at the border of the Area and Convention countries follow common visa rules. EU citizens and non-EU citizens can all move freely within the Schengen Area.

Canadian travellers spending fewer than 90 days in any 180-day period in the Schengen Area do not require visas; they must, however, hold a Canadian passport valid for at least three months after the date of return. This short-stay calculator can help travellers.

Travellers are advised to get a passport stamp when entering and exiting the Schengen Area to avoid difficulties with local police and other authorities. If you plan to stay in the Schengen Area longer than 90 days, contact the appropriate embassy or consulate and apply for a visa. Long-stay visas remain subject to national conditions.

For short stays (less than 90 days in the Schengen Area) Canadian passport holders do not need visas.

Non-Schengen Area countries:

Currently, six EU member states are not party to the Schengen Convention. The UK and Ireland opted out of the Convention, while Bulgaria, Romania, Cyprus and Croatia have applied to join. None of these EU countries imposes visas on Canadian citizens for short-duration tourism and business trips. You should, however, contact the relevant embassy or consulate for information about maximum durations of stay (currently, six months in the UK and 90 days in other countries) and about required travel documents. The following links can also be helpful:

Non-Canadian citizens:

The European Commission website includes a list of countries whose nationals need visas for the Schengen Area.

List of embassies or consulates in Canada.

Visa requirements for the Schengen Area

Visa requirements for the Schengen Area

Source: European Commission, DG Home Affairs.

Border controls:

Border officials in EU countries may ask for other supporting documents, such as letters of invitation, proof of lodging, return tickets, etc. Contact the appropriate embassy or consultate for precise requirements.

For more information:

Canada:

EU:

9.2 Temporary Entry of Materials

When bringing professional equipment to Europe, it is recommended that you first contact the relevant consulate or embassy for customs information.

You might also want to consider purchasing an ATA Carnet. The ATA Carnet (Admission temporaire/ Temporary admission) is an internationally-recognized customs document for the temporary importation of goods, typically for trade shows, demonstrations, exhibitions or commercial samples. The ATA carnet allows the temporary importation of goods, free of customs duties and taxes.

The Canadian Chamber of Commerce has published a web page on How to Apply for a Carnet.

For more information:

The International Chamber of Commerce.

9.3 Travel tips and assistance

To assist business and other travellers, the Government of Canada provides country-specific information on safety and security, local laws and culture, entry and exit requirements, and health.

Travelling in Europe is the European Union’s official website for people travelling in the 28 countries of the EU. You will find practical information on documents, the Euro, exchange rates, time zones, healthcare, etc.

More information about the 28 countries in the EU.

Chapter 10 - Glossary

Council of the European Union

Council of the European Union

The Council (also known as the Council of Ministers or EU Council) is composed of 28 ministers, each representing a national government. National governments usually assign ministers with expertise in whatever issue dominates the EU Council’s current agenda (e.g. economic and financial affairs, telecommunications and energy, environment, agriculture and fisheries, etc).

The EU Council is responsible for passing laws, normally in conjunction with the European Parliament. The two bodies also share equal responsibility for adopting the EU budget. The EU Council signs agreements between the EU and other countries.

Each member state holds the Presidency of the EU for six months. The next countries to hold the EU Presidency are: Latvia (January–June 2015), Luxembourg (July–December 2015), the Netherlands (January–June 2016) and Slovakia (July–December 2016).

Customs Union

The EU Customs Union refers to the elimination of all duties and trade restrictions between member states, and the implementation of a common customs tariff for goods imported from outside the EU. For businesses, the EU customs union also means the common application of customs procedures across the EU. The same rules apply to imported goods regardless of where they enter the EU; once the goods pass through customs, they can move freely within the EU.

Directive

A directive is EU legislation that sets out a goal for all EU countries. Member states have some discretion on how they implement EU directives into national law. See also “Regulation.”

ECHA

ECHA

The European Chemicals Agency (ECHA) is responsible for the implementation of key regulations related to chemicals, such as REACH, the Classification, Labelling and Packaging Directive (CLP) and the Biocides Regulation.

Economic and Monetary Union

The Economic and Monetary Union (EMU) is one major step in the integration of EU economies. It involves the coordination of economic and fiscal policies of member states, a common monetary policy and a common currency—the Euro— currently shared by 19 member states.

EFSA

EFSA

The European Food Safety Authority (EFSA) provides independent scientific advice on issues related to food safety to EU decision-makers. EFSA’s role is to assess and communicate risks associated with the food chain.

EMA

EMA

The European Medicines Agency is the EU agency responsible for the scientific evaluation of medicines for use in the EU. The EMA is also responsible for coordinating the monitoring of medicines in the EU (pharmacovigilance) and for establishing safe limits for residues of veterinary medicinal products in foods derived from animals.

EPO

EPO

The European Patent Office (EPO) is a body of the European Patent Organisation, an intergovernmental organization, whose examiners decide whether to grant a patent for an invention. Patents granted by the European Patent Office are called European patents.

Euro

The Euro is the currency currently shared by 19 of EU member states, which together form the Eurozone.

European Central Bank

European Central Bank

The European Central Bank (ECB) is responsible for managing the Euro and the EU’s monetary policy. Its main tasks are to maintain price stability in the Eurozone (the 19 countries sharing a common currency) and to issue the Euro.

European Commission

European Commission

The European Commission (EC) is the executive body of the EU. It is responsible for managing and implementing the EU budget, policies, programmes and laws, which are adopted by the Parliament and Council.

The EC submits proposed legislation (consisting mainly of directives and regulations), to the European Parliament and the Council for consideration.

The EC monitors the application of EU laws by member states. The EC can take member states to the European Court of Justice to oblige them to comply with EU law.

The EC is comprised of one President and 27 Commissioners who are appointed to five-year terms by national governments, subject to the approval of the European Parliament. The EC has a total staff of approximately 30,000 people assigned to specific policy areas known as Directorates-General (DGs).

European Court of Auditors

European Court of Auditors

The European Court of Auditors has one member from each EU country, appointed to six-year terms by member states. The Court monitors the EU’s financial activities.

European Court of Justice

European Court of Justice

The European Court of Justice includes one judge appointed by each member state to a six-year term. The Court to ensures compliance with EU laws and treaties.

European Parliament

European Parliament

The European Parliament (EP) is comprised of 751 representatives elected by citizens of EU member states to five-year terms. The EP shares legislative and budgetary powers with the Council of the EU. The EP has the right to approve and dismiss the European Commission. The EP oversees a wide range of international agreements, including trade agreements, negotiated by the European Commission.

OHIM

OHIM

OHIM, the Office for Harmonization in the Internal Market, is both an agency of the EU and and an industrial property office responsible for the registration of trademarks and designs.

Regulation

A regulation is a legislative act enforceable in all member states. See also directive.

Single Market

The EU’s single market, also referred to as the internal market, facilitates the movement of people, capital, goods and services across the EU through harmonized rules and standards.

Annex 1 - List of websites

Introduction & Charter 1: The EU and EU Markets

EU legislation

EU member countries

Statistics

CETA (Canada - European Union Comprehensive Economic and Trade Agreement)

The EU Single Market

Schengen Area

Assistance for Canadian exporters to the EU

Chapter 2: Customs

Exporting from Canada

Classifying goods

Customs Duty, Excise Duty, Import VAT and other import measures

Customs documentation

Chapter 3: EU Sanitary and Phytosanitary Requirements

Food laws

Food labelling

Food packaging

Animal health

Plant health

Chapter 4: Product Safety

General Product Safety Directive

CE Marking

REACH

Biocides

Cosmetics

Pharmaceuticals

Chapter 5: Packaging and Labelling

Chemicals

Energy

Electrical and electronic waste

Cosmetics

Ecolabel

Energy Star

Organic products

Prepackaged products

Green dot

Chapter 6: EU Consumer Rights

New consumer rights directive

Guarantees

Data protection

Chapter 7: Intellectual Property

Patents

Trade Marks

Designs

Copyright

Chapter 8: Government (Public) Procurement

Chapter 9: Business Travel

Footnotes

Footnote 1

European Commission, DG Economic and Financial Affairs.

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Footnote 2

The Eurozone is an economic and monetary union (EMU) of 19 European Union (EU) member states that have adopted the euro (€) as their common currency.

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Footnote 3

The European Commission estimates that the Single Market has created 2.75 million new jobs since 1993, increased growth by 2.15 percent and generated more than €800 billion in additional wealth.

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Footnote 4

The Schengen Area is the area comprising 26 European countries that have abolished passport and any other type of border control at their common borders.

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Footnote 5

European Commission.

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Footnote 6

Special Drawing Rights.

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Footnote 7

The 26 countries of the Schengen Area are: Austria, Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain and Sweden, along with Liechtenstein, Iceland, Norway and Switzerland who are not EU countries.

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