Exporting to the EU – A guide for Canadian business
Gain key insights into the business environment in European markets to help your Canadian small or medium-sized enterprise succeed.
- Chapter 1 - The EU and EU markets:
- 1.1 EU membership
- 1.2 The EU economy in the world
- 1.3 The EU and Canada
- 1.4 EU institutions and laws
- 1.5 Assistance for Canadian exporters
- Chapter 2 - Customs:
- 2.1 Classifying your goods
- 2.2 Calculating customs duties: rules of origin and valuation
- 2.3 VAT (value-added tax)
- 2.4 VAT on electronic services
- 2.5 Excise duties
- 2.6 Other import measures
- 2.7 Documentation and customs clearance
- 2.8 Making export easier
- Chapter 3 - EU sanitary and phytosanitary requirements:
- 3.1 Food safety
- 3.2 Animal health
- 3.3 Plant health
- Chapter 4 - Product safety and chemical safety:
- 4.1 General product safety directive
- 4.2 CE marking
- 4.3 Chemicals - REACH.
- 4.4 Biocides and plant protection products
- 4.5 Cosmetics
- 4.6 Pharmaceuticals
- 4.7 Medical devices
- Chapter 5 - Packaging and labelling:
- 5.1 Mandatory labels
- 5.2 Voluntary labels
- Chapter 6 - EU consumer rights:
- 6.1 EU Consumer protection directives
- 6.2 Guarantees
- 6.3 Data protection
- Chapter 7 - Intellectual property:
- 7.1 Your IP strategy for Europe
- 7.2 Patents
- 7.3 Trademarks
- 7.4 Designs
- 7.5 Copyright
- 7.6. Geographical indications and other quality labels
- Chapter 8 - Business travel:
- 8.1 Passports and visas
- 8.2 Temporary entry of materials
- 8.3 Labour mobility Under CETA
- 8.4 Mutual recognition agreements
- 8.5 General travel tips and assistance
The purpose of this guide is to provide Canadian businesses, particularly small and medium-sized enterprises (SMEs), with an overview of the European Union (EU) and relevant EU legislation affecting their exports to Europe.
Understanding EU regulatory requirements is key to export success in the EU. This guide provides certain key information needed to access the EU market, and answers some of the questions most frequently asked by Canadian exporters about topics such as conformity – or 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.
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 particularly with the opportunities created by the Canada-EU Comprehensive and Economic Trade Agreement (CETA).
We want to hear from you!
Any specific questions or issues you may be facing with an EU-level regulation or legislation can be reported to the appropriate point of contact at the Mission of Canada to the European Union.
Please note that this Guide covers legislation harmonized by the EU, but does not describe specific rules that exist within EU Member States – which remain fully applicable on their respective territories. Any questions with respect to country-specific legislation, opportunities or potential barriers to trade can be addressed to the Trade Commissioner Service in one of our 24 offices in the EU, who will be able to assist you.
It is also possible to register a trade barrier you may be observing in a given market on the Global Affairs Canada 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. Unless expressed otherwise, all references to “$” are references to Canadian dollars.
Chapter 1: The EU and EU markets
The EU is a powerful economic and political union comprised of over 500 million people across 28 Member States. Despite historic and geographic divisions, the EU has established a single market, developed many common policies, liberalized inter-country travel and launched a common currency shared by 19 countries.
1.1 EU membership
Source: European Commission
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.
Countries recognized as candidate countries to join the EU are Albania, the former Yugoslav Republic of Macedonia (fYRoM), Montenegro, Serbia and Turkey; however, no firm timelines exist for the accession of these countries to the EU. Other countries or entities which have a well-defined prospect of joining the EU in the future, but have not yet been granted candidate country status are Bosnia and Herzegovina and Kosovo.
On March 29, 2017, the United Kingdom notified the EU of its intention to leave the EU (“Brexit”). Negotiations of a withdrawal agreement between the United Kingdom and the EU are, as of the date of this Guide, on-going. At this time, it is expected that the United Kingdom will cease to be a member of the EU on March 30, 2019; however, if an agreement for a transition period after this date of withdrawal is agreed, it is expected that the United Kingdom will continue to follow EU law until the end of December 2020. Future legislation of the United Kingdom will likely be heavily influenced by the nature of any trade agreement the United Kingdom and the EU might conclude.
Although not members of the EU, European Free Trade Association countries (Iceland, Liechtenstein, Norway, Switzerland) participate in the EU’s internal market as part of the European Economic Area, while Turkey has a customs union with the EU. These economic groupings make Europe a dynamic place to conduct business, as the largest trading block in the world with preferential access to several neighboring countries – with industries that are deeply integrated into broader regional value chains.
1.2 The EU economy in the world
Taken as a single entity, the EU represents the world’s second largest economy with a total population of over 509 million and a GDP of over $21.7 trillion ( 2016). The EU is also incredibly diverse, with both large and small national economies as well as advanced and emerging markets. It is the world’s largest trading block and a major importer and exporter of goods and services. In 2016, the EU had the second largest share of global exports and imports of goods and its exports of goods were equivalent to 15.6% of the world total. Imports to the EU include primary products, raw materials and energy, along with capital equipment, chemicals and consumer goods.
19 EU Member States (with a combined population of over 340 million people) have adopted the Euro – the EU’s common currency – and this number is likely to increase with the adoption of the common currency by existing and future members of the EU.
According to the World Bank, economic growth in the EU has been increasingly steady, both in terms of its pace and make-up. Following the financial crisis of the last decade, the EU economy has now enjoyed several consecutive years of recovery, which is now reaching all EU Member States with private consumption representing the main driver of growth. The Euro area and EU economies are both estimated to have grown by 2.4% in 2017 – the fastest pace in a decade for the area – with this strong economic performance set to continue in 2018 and 2019 with growth of 2.3% and 2.0% respectively in both the Euro area and EU.
The EU labour market continues to improve (although it remains uneven) and the employment rate has returned to pre-crisis levels (although large jobs deficits persist in some countries). Moreover, while growth expectations have improved, the uncertainty concerning the duration of exit negotiations and an agreement on future relations between the EU and the United Kingdom – “Brexit” - are putting a strain on the European economy ( Refer to section 1.3.3)
1.3 The EU and Canada
Canada and the EU enjoy a strong bilateral trading relationship in both goods and services. After the United States, the EU is Canada’s second most important trading partner – and, with the entry into force of CETA, is expected to offer even more commercial opportunities. In 2016, trade in goods with the EU accounted for 9.6% of Canada’s total trade with the world (the EU accounted for 8% of Canada’s total exports). Canada, in turn, accounted for almost 2% of the EU’s total external trade in goods. The value of this bilateral trade in goods between the EU and Canada in 2016 was approximately $90.85 billion.
The most important category of goods traded in 2016 between Canada and the EU were machinery (which accounted for 23.6% of EU exports to Canada and 13.7% of its imports), transport equipment (which accounted for 18.7% of EU exports and 11.4% of its imports), and chemical and pharmaceutical products (which accounted for 16.7% of EU exports and 7.5% of its imports).
Trade in services between Canada and the EU is also significant (and has grown the fastest in recent years) amounting to $45.53 billion in 2015. Examples of services traded between Canada and the EU are transportation, travel, insurance and communication.
1.3.2 The Canada-EU Comprehensive Economic and Trade Agreement (CETA)
The Canada-EU Comprehensive Economic and Trade Agreement (or CETA) was signed by the EU and Canada on October 30, 2016 and has entered into force provisionally on September 21, 2017.
With its provisional application all economically significant parts of the Agreement are now in forceFootnote 1. The agreement will take full effect once all EU Member States have formally ratified it.
As of the date of this Guide, duties on 98% of products (tariff lines) that the EU trades with Canada have been removed. Over the course of the next 7 years, a further 1% of tariff lines will be phased out, for a total of 99% of all Canadian goods entering the EU market duty-free.
Apart from the tariff reductions, other key benefits of CETA are:
» Cutting red tape
Under CETA, Canada, the EU and its Member States (the “Parties”) have agreed to modernize, simplify and standardize customs procedures to reduce transaction costs on goods resulting from customs processes. The Parties have committed to implement simplified and, where possible, automated procedures for the efficient release of goods such as:
- the release of goods at the first point of arrival;
- the simplified documentation requirements for the entry of low-value goods and pre-arrival processing; and
- issuing (upon request) specific clarification on the tariff classification of goods leading to increased transparency.
» Access to EU government procurement contracts
Under CETA, Canadian companies can now bid on EU government procurement opportunities and supply their goods and services to the EU Member State governments, regional and local government entities, and the large group of entities operating in the utilities sector. This opens a substantial market worth an estimated $1.9 trillion annually. For further information on the EU’s procurement markets, opportunities and CETA coverage, please consult the EU Government Procurement Guide for Canadian companiesFootnote 2.
» Liberalization of services
An important aspect of CETA for small businesses and SMEs is that Canadian service providers now enjoy preferential access to and receive better treatment in the EU market than most other foreign businesses. Preferential access is granted to all Canadian service sectors, with the exception of certain sectors that have been specifically excluded.
» Regulatory cooperation
CETA seeks to facilitate trade by encouraging regulatory cooperation between the parties, to identify and remove barriers to trade and investment. It seeks to promote good practices, transparency and early engagement, notably by providing a platform for regular information sharing between Canadian and EU regulators.
It also includes protocol on conformity assessment, which when implemented will allow Canadian companies in a number of sectors to have their products tested and certified for the EU market in Canada. This in turn is expected to save companies time and money in getting their products to market.
» Increased mobility for company employees
New temporary entry provisions -make it much easier for highly skilled professionals and businesspeople (including short-term business visitors, investors, intra-company transferees, senior managers, and trainees) to move across borders and work in the EU – further reducing costs for Canadian companies doing business in the EU.
See Chapter 8.3 of this Guide for more information on labour mobility under CETA.
Given the above benefits, it is expected that CETA will be of particular benefit to small Canadian businesses and SME who will enjoy preferred access to the EU market, lower input costs and lower costs of red tape.
1.3.3 Brexit and Canada
On March 29, 2017, the United Kingdom gave formal notice of its intention to leave the EU. Negotiations of a withdrawal agreement between the United Kingdom and the EU are currently on-going. At this time, it is expected that the UK will cease to be a member of the EU on March 30, 2019; however, if a post-Brexit transition period is agreed, the UK would continue to follow EU law until the end of December 2020. Future legislation of the United Kingdom will likely be heavily influenced by the nature of any trade agreement the United Kingdom and the EU may reach. The European Commission maintains an updated website with recent developments on the preparations for and negotiations of the Brexit.
Currently, and for the full period that precedes the withdrawal of the United Kingdom from the EU, Canada’s access to the United Kingdom market remains covered under CETA. Canada’s market access to the United Kingdom following the implementation of Brexit in both trade and services, as well as the modalities of Canada-UK trade have, as of the date of this Guide, yet to be determined. It is therefore difficult to assess at this point any potential economic impact Brexit could have on Canada or the EU, as it will largely depend on the nature of new post-Brexit EU-United Kingdom relationship.
The United Kingdom is an important market for Canada as it represents Canada’s fourth largest merchandise export destination (after the United States, the EU-27 and China). In 2016, Canada’s exports to the United Kingdom totalled $ 17.1 billion, 3.3% of Canada’s total exports. Canadian purchases of British goods totalled $8.3 billion, or 1.5% of total imports. Canadian exports to the United Kingdom are dominated by minerals and metals. In 2015, mining (i.e, gold and silver ore) accounted for 60.6% of total Canadian exports to the United Kingdom, while primary metals follow at 11.6%. Transportation equipment exports (mostly aerospace products and their parts) rank third at 4.2%.
In the same year, Canadian direct investment in the United Kingdom reached almost $93 billion. Until now, several factors have contributed to make the United Kingdom an ideal point of entry for Canadians to the EU, including its favorable business environment, its status as a major financial hub, as well as its membership in the EU and deep integration into EU value chains. With Brexit, a number of companies that were using the United Kingdom as a distribution hub for their products and services in the EU may have to reassess their strategy.
1.4 EU institutions and laws
Detailed information on how EU institutions work to create legislation and regulation is beyond the scope of this guide.
Nevertheless, it is important to understand some basics about the EU and the kinds of rules it can produce.
Decision-making in the EU is diffuse and primarily involves 3 main institutions: the Council of the EU (with representatives of the executive governments of all 28 Member States), the European Parliament (whose representatives are directly elected by EU citizens), and the European Commission (which serves as the executive branch and is referred to as the so-called “Guardian of the EU Treaties” which establish and set out the composition of the EU). The European Commission currently has a President and 27 Commissioners that together make up the College of 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). A list of all EU agencies and bodies can be accessed by the following link.
In this guide, you will see references to various types of EU rules and regulations. The key decisions taken by the EU come in the form of:
1. Regulations – these have binding legal force throughout every Member State and enter into force on a set date across the EU (e.g. Member States have an obligation to enforce the EU regulation as of this date).
- For example: Regulation (GDPR Regulation)
2. Directives – these require certain outcomes that must be achieved by all Member States; however each Member State is free to decide how to introduce (or transpose) directives into national laws. Directives allow for a certain degree of harmonization across the EU, with specificities in the interpretation and application mandated by Member States.
- For example: Directive (on consumer rights)
3. Decisions – these are EU laws adopted in relation to specific judicial cases and directed to individual or several Member States, companies or private individuals. Decisions are binding upon those to whom they are directed.
- For example: Decision (prevention of terrorism)
To find EU laws (including directives and regulations) please see the following link; to find summaries of EU legislation, please see the following link.
1.5 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:
- Insights into the national markets in the EU, including market facts and reports, information on trade events and practical advice on local markets;
- Sector-specific information; and
- Information on market opportunities and assistance in finding business partners specifically in the EU.
Other partners offer services or information useful for preparing or implementing export strategies for European markets. For example, EEN Canada™ ( Enterprise Europe Network) 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.
For additional information on Canada-EU trade, consult the following websites:
- Industry Canada – Trade data on- line (provides statistics by product categories and industrial sectors)
- European Commission – Trade with Canada
- Agriculture and Agrifood Canada
On September 26, 2014, Canada and the EU celebrated the historic conclusion of the CETA negotiations. As noted above, the agreement removes most tariffs and creates new opportunities for businesses, including SMEs. The benefits for Canadian businesses are expected to be significant.
1.5.1 CETA and the involvement of the government of Canada
Canada’s Trade Commissioner Service is present in all EU 24 markets and ready to support SMEs overcoming trade barriers and other difficulties with respect to, inter alia, procurement markets. CETA has dedicated Committees under many of its chapters, whereby representatives of the EU and representatives of Canada meet to consider, among others, issues that are referred to it by one of the parties. We strongly encourage Canadian companies to bring any issues or questions to the attention of the government of Canada.
Table of contents
Chapter 2: Customs
The EU is commonly referred to as a “Customs Union”. Yet, the customs territory of the EU is different from the territory covered by the EU Treaties. In addition to the territories of the 28 (current) EU Member States, the EU customs territory includes territories which are not covered by the Treaties, namely: Monaco, certain Cyprus territories, the Channel Islands and the Isle of Man. The EU is also part of customs unions with Andorra, San Marino and Turkey.
On the other hand, some parts of the Member States’ territories are not in the customs territory of the EU. This is the case for instance of some overseas territories.
EU Member States have abolished customs duties and controls between and among themselves. The 28 EU Member States apply the same tariff on goods imported from outside the EU (the so-called 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.
This section covers customs rules and procedures in the EU. For export procedures in Canada, see the guide “ Exporting goods from Canada: A handy guide” available on the Canada Border Services Agency website.
2.1 Classifying your goods
The classification of a good allows the determination of its customs duty rate. Such a classification is also useful to apply for export licences, in order to find out whether a good is subject to export restrictions, to issue certificates of origin, to claim an export refund, to determine the excise duty where applicable or to benefit from a reduced value added tax rate where applicable.
The EU system of classifying goods is a 10-digit coding system consisting of 3 integrated components. The first component (first 6 digits) is based on the Harmonized System Nomenclature (HS), the international system for classifying goods developed and updated by the World Customs Organisation (WCO), and used by Canada, the EU and other third countries. This system is organized in a hierarchical structure by sections, chapters (2 digits), headings (4 digits) and sub-headings (6 digits).
Knowing the HS code or classification in other countries helps identify how the EU classifies a product. But it is not necessarily the same. The first 6 digits of the code are common to all markets; the remaining 4 digits are unique to the EU.
The Combined Nomenclature (CN), the EU’s 8-digit coding system, is a further development of HS code with additional EU subdivisions (second component). The EU’s Combined Nomenclature (updated every year) is available on the EU website, together with explanatory notes. The CN is used for the EU’s common customs tariff.
The Integrated Tariff (TARIC) provides information on all trade policies and tariff measures applicable to specific goods in the EU, such as tariff suspension or trade remedy measures. It is made up of the 8-digit CN code plus 2 additional digits (third component of TARIC subheadings).
|Section||I||Live animals; Animal products|
|HS Chapter - International||2 digits||03||Fish and crustaceans, molluscs and other aquatic invertebrates|
|HS Heading -International||4 digits||0303||Fish frozen, excluding fish fillets and other fish meat|
|HS Sub-heading -International||6 digits||0303 13||Atlantic Salmon (Salmo salar) Danube salmon (Hucho hucho)|
|CN code -European||8 digits||0303 13 00||Atlantic Salmon (Salmo salar) Danube salmon (Hucho hucho)|
|TARIC code - European||10 digits||0303 13 00 10||Atlantic Salmon (Salmo salar)|
TARIC is also the EU’s integrated tariff online database. You can use it to find the classification of a good. To find a good’s tariff 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).
For example, the code for importing Frozen Atlantic Salmon into the EU is 0303 13 00 10.
Classification of products is a complex task, given the wide variety of products traded. Correct classification is important, as it determines applicable duties and controls. Incorrect classification may result in delays in clearing goods through customs and may also result in additional duties and even penalties. The Binding Tariff Information (BTI) database, accessible by the public, provides good reference for correct classification of goods.
For further certainty with respect to classification, national customs authorities also provide BTI — rulings which are binding (both on the customs authorities across the EU and the BTI holders) and indicate the correct tariff classification for particular goods. A BTI is valid for a period of 3 years throughout the EU since its issuance. To obtain a BTI, contact the customs authorities of any of the EU’s Member States.
2.2 Calculating customs duties: rules of origin and valuation
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, liter, 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 effective 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 paid until the EU customs frontier. Since the provisional entry into force of CETA on September 21, 2017 (refer to Chapter 1.3.2 of this Guide for more information on CETA), customs duties on imports of goods originating in Canada have been eliminated or will be removed progressively by the EU within a period of 7 years in accordance with the agreed time-schedule ( refer to Annex 2-A of CETA).
For instance, the applicable duty to the cereal imports for the 1st year of entry into force of CETA was 87.5% of the duty amount calculated in accordance with the above–mentioned methodology. The duty level will be further decreased progressively until the 8th year of enter into force of CETA when the imports of cereal from Canada become completely duty free.
To find out the duties applicable to any product (including detailed information on tariff phase-out over 3 to 7 years following implementation of CETA, and comparisons with duties applicable to Canadian products in other markets), search any HS code in the Canadian Tariff Finder. Alternatively, the EU’s TARIC database is one of most useful tools to find out the duty level currently applicable to any product to be imported into the EU, and can be used as follows: 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, see below) that apply to the product (provided that the product is deemed to originate from Canada under CETA rules of origin (see below)).
The origin rules set out in the Protocol on rules of origin and origin procedures and its Annexes (pages 443 and onwards of CETA) must be satisfied before the preferential tariff can be applied. Refer to guidance on the CETA rules of origin for the most frequently asked questions about the origin rules.
Binding Origin Information (BOI), including the BOI for preferential origin under CETA, is also made available upon application before the national customs authorities of the EU’s Member States. A BOI is valid for 3 years all over the EU customs upon its issuance. BTI and BOI help increase the predictability and guarantee the application of CETA origin and tariff to the imported goods. See also the guidance on Binding origin information from the European Commission’s website.
Additional information on the calculation of customs duties in the EU can be found on their website.
2.3 VAT (value-added tax)
Goods imported into the EU are subject to import VAT at their point of entry into the EU. When the goods are imported into one Member State but are intended for use in another Member State, they are eligible for a VAT suspensive arrangement. Under this arrangement, the VAT will be charged at the point of final destination 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%, and reduced rates may not be less than 5%. For some goods or services, the reduced rate cannot be lower than 12% although certain EU countries are allowed to maintain reduced rates lower than the 5% minimum. The goods subject to reduced VAT rates are mentioned in the Annex III to the Directive 2006/112 on the common system of VAT and are available on the EU website.
As part of its VAT Action Plan towards a Single VAT area presented in April 2016, the European Commission proposed to replace the current transitional VAT system with a definitive VAT system based on the principle of taxation at the rate applicable in the Member State of destination instead of the rate applicable at the point of entry in the EU. This is already possible under the current rules if goods imported into one country but intended for use or consumption in another are placed under VAT suspensive arrangements. In the Commission’s proposal, this special regime would become the rule. On the same line of action, the European Commission issued a Proposal on 18 January 2018 to amend Directive 2006/112 as regards rates of value added tax aimed at creating a level playing field across the EU while introducing more flexibility, simplifying rules and reducing overall costs for SMEs. The proposal aims to change the current exception based system with a system based on general rules. For example, under the current system some EU countries apply reduced VAT rates for children’s clothes of below 5% while others are not permitted to do so. Under the proposed new rules, every country will be allowed to apply a reduced VAT rate to children’s clothes. In addition, next to the existing 0% and minimum 5% reduced rates, all Member states will be able to set reduced rates between 0 and 5% on products and services. The Proposal also abolishes the current list of goods and services to which reduced rates can be applied and replaces it by a new list of products to which the standard rate of minimum 15% must always be applied. This list includes products such as weapons, alcoholic beverages, gambling and tobacco.
The entry into force of the new provisions on VAT rates has been linked to the introduction of a more definitive VAT regime, which is intended for 2022. Refer to the European Commission fact sheet for updates on next steps and further details on the objectives of this proposal.
Additional information regarding the VAT Action Plan and the Proposal on VAT rates is available on the EU 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.
|Goods||Invoice Price||Shipping and insurance||Customs value||Customs duty||Value for VAT||VAT (Belgium)||Total duties and VAT|
|Frozen Atlantic Salmon||euro 600||euro 200||euro 800||2% = euro 16||euro 816||6% = euro 48.96||euro 64.96|
2.4 VAT on electronic services
Since January 2015, the country of taxation for telecommunications, broadcasting and electronic services (ESS) changed from the supplier’s country to the customer’s country.
This means that Canadian sellers of services supplied electronically to private consumers in the EU (business to consumer) must, like their EU counterparts, charge and account for VAT.
To that end, they must register for VAT in the EU Member State where their non-business customer resides. A Mini One Stop Shop (MOSS) procedure enables businesses to complete a single registration valid throughout the EU.
Compliance with VAT obligations by online businesses will become even easier since the adoption by the Council of the EU of new rules which will notably extend the MOSS for the VAT registration of distance sales and establish a new portal for distance sales from third countries with a value below €150.This will reduce the costs of complying with VAT requirements for business-to-consumer transactions. More information about VAT on e-commerce is available on the Council of the EU website.
It should be noted that the above does not apply to non-EU companies supplying EES to business customers in the EU (business to business) which 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.
2.5 Excise duties
Certain goods, such as alcohol, tobacco and energy products, are subject to excise duty. A product becomes subject to excise duties when they are 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. In circumstances where the duty is paid in a Member State other than the one of final destination, a system of reimbursement is in place to avoid double taxation.
Some examples of goods subject to excise duties include alcohol, tobacco and energy products. EU rules set minimum excise duty rates; Member States can, however, set higher rates.
The European Commission publishes a general overview of excise duties, along with additional details by product type.
2.6 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 has been 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.
CETA provides for more preferential TRQs for specific goods imported into the EU from Canada. These goods subject to CETA specific TRQs are identifiable in Tariff Schedules (pages 201-216 of CETA) by the notation in the fifth column (“Note”). Details of these CETA specific TRQs can be found in Annex 2-A of the agreement (pages 181-190 of CETA). As with CETA’s tariff elimination program, agreed TRQs on certain goods will gradually increase on an annual basis for a period of 6 years after CETA became effective. Below are examples of TRQs from CETA Annex 2-A:
- TRQ for Bison is 3,000 (Metric tonnes - Carcass Weight Equivalent) for year 1 and each subsequent year;
- TRQ for Pork is 12,500 (Metric tonnes - Carcass Weight Equivalent) for year 1 with a progressive increase each year up to 75,000 for year 6 and each subsequent year;
- TRQ for Sweetcorn is 1,333 (Metric tonnes) for year 1 with a progressive increase each year up to 8,000 for year 6 and each subsequent year.
» 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 the competent authority of the importing Member State. The licences are generally issued automatically on request, except when tariff rate quotas apply. For information about licensing requirements, consult the TARIC database. The European Commission provides as well more information about import licenses.
2.7 Documentation and customs clearance
All goods imported into the EU must be declared to the customs authorities of the country of import using the Single Administrative Document (SAD).The SAD is the common import declaration form for all EU countries and is usually completed by the importers 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.
In order to benefit from the CETA preferential tariff or the TRQs, Canadian exporters are required to make an origin declaration on invoices or any other commercial documents that describes the originating product in sufficient details in order to enable its identification. Such origin declaration can be found in Annex 2 to the Protocol on rules of origin and origin procedures of CETA (page 463 of CETA). In Canada, all exporters of commercial goods are required by the Canada Border Services Agency (CBSA) to have a Business Number. This Business Number assigned by the Government of Canada must be indicated in field 2 of the origin declaration. In such cases, a signature on the origin declaration is not necessary, and field 5 of the origin declaration may be left blank. Exporters of non-commercial goods are exempted from reporting the Business Number in field 2 and have to complete field 5 of the origin declaration instead.
Additional information concerning the EU import procedures and documents for customs clearance may be found on the European Commission’s DG Trade website. See also the first section of the Guidance on the Rules of Origin, which describes the new proof or origin system under CETA.
2.8 Making export easier
Canadian businesses must manage a lot of documents when exporting goods to the EU market. To make exporting easier, Canadian exporters may wish to use freight forwarders and customs brokers. For assistance, Canadian exporters may consult the guide “ Exporting goods from Canada: A handy guide”. Additional information may also be found on the Canada Border Services Agency website.
EU information is also available online through sites such as the Commission’s Directorate General for Taxation and Customs Union, the EU Member States customs authorities, the EU export helpdesk, and the EU Customs Code.
Table of contents
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 food that is placed on the EU market, including imports. 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 SANTE), the directorate general in charge for food safety. 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:
- General food law: Regulation (EC) 178/2002 on the general principles and requirements of EU food law;
- Hygiene legislation: the so-called “food-hygiene package” sets out general rules on hygiene (Regulation N. 852/2004) and specific rules for foods derived from animals (Regulation N. 853/2004);
- EU legislation on monitoring residues and contaminants in food is described on these web pages:
- Control of contaminants in foodstuffs;
- Control on pesticide residues in plant and animal products intended for human consumption;
- Residues of veterinary medicinal products.
- EU rules on microbiological criteria for foodstuffs may also be found online, along with information on legislation for food additives and flavorings, and special rules on Genetically Modified Organism and a newly adopted regulation for novel foods. The European Commission also adopted special rules on labelling and nutrition.
There are special rules on labelling and nutrition in the European Union.
EU legislation establishes official controls along the food chain, namely Regulation 854/2004 (products derived from animals) and Regulation 882/2004 (verification of compliance with laws on feed and food, and animal health and welfare).
3.1.2 Food labelling and packaging
The following is an overview of the EU’s food labelling and packaging regime.
18.104.22.168 Food labelling
On December 13, 2014, new EU rules on food labelling ( Regulation 1169/2011 on food information to consumers) entered into effect.
Under the new regulation, EU food labels must include information about nutrition, list all potential allergens (e.g. 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 see European Commission:
- Q&As on new EU labelling requirements;
- EU register of permitted nutrition and health claims made on foods; and
- The European Commission (DG SANTE) food labelling web page.
In addition to general rules on food labelling, specific labelling rules apply to:
- Fishery products
- Novel foods
- Organic products
- Nutrition and health claims
- Preserved milk
- Edible caseins and caseinates
- Fruit juices and similar products
- Wines and wine sector products
- Aromatized drinks
- Spirit drinks
- Cocoa and chocolate
- Food additives
- Food flavourings
- Food enzymes
- Mineral waters
- Food supplements
- Gluten-free foodstuffs
- Addition of vitamins & minerals
- Dietetic foods
- Foods for infants & young children
- Foods for weight reduction
- Foods for special medical purposes
- Foods for sports people
- Foods for diabetics
- Quick frozen foodstuffs
22.214.171.124 Food packaging
Canadians exporting foodstuffs to the EU must ensure that the packaging complies with the EU requirements for food contact materials.
Regulation (EC) 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 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 odor or taste of the food.
The Regulation establishes a list of materials and articles (e.g. 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’s DG SANTE 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).
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). This applies to animals, as well as animal products during evolving disease situations in the Member States.
- 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:
- The European Commission’s Animal health webpage (DG SANTE);
- Factsheet: Health control of fishery products for human consumption
- Factsheet: EU import conditions for fresh meat and meat products
- CFIA – meat exports to the EU
- CFIA – exports of animal products and by-products to the EU
- CFIA – exports of fish and seafood to the EU
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.
In October 2016, Regulation 2016/2031 on protective measures against plant pests has been adopted and will be applicable from December 14, 2019.
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.
- Marketing requirements for seeds and plant propagating material;
- Organic products;
- Health control of feedingstuffs of non-animal origin;
- Health control of foodstuffs of non-animal origin.
For more information:
- The European Commission’s plant health webpage (DG SANCO).
The EU is undertaking Regulatory Fitness and Performance Programme (REFIT) of most of its legislation, including those in food safety with potential proposals for change of the existing legislation. For more information visit the European Commission’s DG SANTE website.
Table of contents
Chapter 4: Product safety and chemical safety
The single market for products is achieved through EU-wide harmonized rules that ensure product safety. For many products, the EU legislation is limited to establishing essential health, safety and environmental requirements, and leaves the technical details to voluntary European harmonized standards. Compliance with harmonized standards provides a presumption of conformity with the essential requirements they aim to cover, if their references have been published in the Official Journal of the European Union. National rules can also apply in addition. Compliance with these rules allows goods to be sold and traded freely in the EU.
Specific EU-wide harmonized rules apply to chemicals, biocides, plant protection products, cosmetics and pharmaceuticals.
This chapter provides information on EU environmental, health and safety regulations.
4.1 General product safety directive
Products placed on the EU market must comply with the requirements of the General Product Safety Directive (GPSD) 2001/95/EC to the extent they are not covered by sector-specific EU harmonization legislation. The GPSD requires manufacturers to place only safe products on the market.
Market-surveillance activities are carried out by member states. Through the EU Rapid Alert System for non-food dangerous products ( RAPEX), member states immediately share information between themselves and the European Commission about dangerous products. For any given product, this can result in marketing restrictions, withdrawals or recalls. In the case of serious product risks to the health and safety of consumers in various Member States, the GPSD also provides for the possibility for the European Commission to take temporary emergency measures.
In addition, producers can be held liable for defective products, i.e. products not providing the safety that a person is entitled to expect, under Council Directive 85/374/EEC concerning liability for defective products.
For more information see the European Commission’s webpages on the GPSD and liability for defective products.
4.2 CE marking
4.2.1 What is CE marking?
The CE mark (short form for European Certification) is a symbol affixed to a product by its producer to certify that the product has been assessed, before being placed on the EU market, and meets all EU requirements for safety, health and environmental protection.
A product with the CE mark can be sold anywhere in the European Economic Area, a market of some 500 million consumers (see chapter 1).
Manufacturers are responsible for ensuring product compliance and affixing the CE mark.
4.2.2 Which products require CE marking?
The CE mark is mandatory for certain product groups. The product groups are listed on the European Commission’s website with a description of the applicable requirements. The list currently includes the following 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
- Low-voltage devices
- Measuring instruments
- Medical devices
- Noise emission in the environment
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio 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.
It is prohibited to use the CE mark on a product that does not fall into one of these categories.
The CE mark does not apply to foodstuffs, motor vehicles, chemicals, cosmetics, pharmaceuticals and biocides.
4.2.3 When can the CE mark be affixed on a product?
The six steps to CE Marking
- 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.
The European Commission identifies six steps which manufacturers have to follow before being in a position to affix the CE mark:
Manufacturers established in Canada have the same obligations as EU manufacturers: to ensure that the product conforms with all relevant EU safety requirements. When importing from non-EU countries, importers must check that products fulfil all EU safety, health and environmental protection requirements before placing them on the market. The importer has to verify that:
- the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market,
- the necessary documentation such as the EU Declaration of Conformity and the technical documentation is available upon request,
- contact with the manufacturer is possible at any time
Manufacturers may appoint an authorized representative established in the EU to carry out certain administrative tasks on its behalf. It is mandatory to appoint an authorized representative only for medical devices. The appointment must be explicit and in writing, defining clearly the tasks delegated to the representative. The representative can be an importer or distributor established in the EU.
It is the manufacturer’s responsibility to identify the directives that apply to a product. More details on this process and a list of directives can be found in the Canadian Trade Commissioner Service’s white paper Six Steps to CE Marking.
Once it has been established that a product falls under the scope of EU legislation, it must be assessed whether it complies 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 a presumption of conformity with the relevant essential requirements. The use of harmonized standards is voluntary. Companies are free to choose other ways to fulfill the essential requirements. However, European harmonized standards are a reliable way to ensure compliance and the only way to benefit from the presumption of conformity with EU legislation.
If you use Harmonized Standards, you can get the CE mark for your product and sell it in the EU.
Whenever possible, Canadian exporters are advised to follow harmonized standards.
References for European Harmonized Standards are listed on the European Commission’s website. You can buy copies of the harmonized standards documents from the European Standards Organizations: European Committee for Standardization (CEN) (general standards), European Committee for Electrotechnical Standardization (CENELEC) (electro technical 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.
Conformity assessment is the process, carried out by the manufacturer, to demonstrate whether a product fulfills its specified requirements.
It involves various checks on the design and manufacture of products which are responsibility. Full details about conformity-assessment procedures (referred to as modules) are included in the annexes of the directives.
For some products, a notified body must be involved in testing and certification (this is clearly indicated in the directives). Notified bodies are authorized third-party conformity-assessment bodies. To find a notified body, such as certified labs in North America, see the NANDO database.
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 dedicated webpage on the European Commission’s website and the Blue Guide on the implementation of EU product rules.
The 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 upon request for control purposes.
The 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.
The CE mark must be affixed by the manufacturer or an authorized representative. The European Commission’s Blue Guide describes the requirements for the affixing of the CE mark (e.g. in terms of size and location on the product).
For more information:
- The Canadian Trade Commissioner Service produced a white paper on the CE mark available at Six Steps to CE Marking.
4.3 Chemicals - REACH
REACH ( Regulation EC 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals) is the general EU framework for the regulation of chemicals. 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 competent authority for the application of REACH is the European Chemicals Agency (ECHA), an agency based in Helsinki (Finland) which manages to a large extent the registration, evaluation, authorization and restriction processes that apply to chemical substances throughout the EU, together with authorities from the Member States and with the European Commission.
4.3.1 Who does REACH impact?
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 mixtures and in finished products (articles). As such, REACH affects virtually every industrial sector from chemicals, plastics and cosmetics to e.g. automotive, aerospace, household cleaners, computers and textiles.
REACH affects almost all products manufactured in Canada and exported to the EU.
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, you can comply with REACH either through your EU importer, who will turn to you for information needed to achieve compliance, or by appointing an Only Representative (“OR”) 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 (“OR”) and REACH business service providers.
4.3.2 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 manufactured 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 ECHA. The mandatory content of the registration dossier is set out in REACH, and includes 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. The registration obligation also applies to imported mixtures and articles containing substances intended to be released from the article under normal or reasonably foreseeable conditions of use. See the ECHA website for more information on registration.
The registration process for chemicals already manufactured or placed on the market before the entry into force of REACH (“phase-in” substances) started in 2008, with various registration deadlines imposed on businesses depending on their tonnage. The last deadline was May 31, 2018 for the registration of substances manufactured or imported in quantities between 1 and 100 tons per year which were pre-registered. New (“non-phase-in”) substances must be registered immediately once the yearly volume imported reaches one ton.
Substances imported in excess of one ton per year per company must be registered with the European Chemicals Agency (ECHA).
Substances imported by more than one ton per year per company must be registered with the European Chemicals Agency (ECHA) REACH requires manufacturers and importers of identical substances to cooperate by sharing data and submitting joint registration dossiers (although companies must still register some information separately). Pre-registrants of the same substance are grouped in Substance information exchange forums (SIEFs) and in some cases industry groups have also set up consortia to generate and manage the necessary data for joint registration. For more information on data sharing and joint submission, see Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data-sharing together with, European Chemical Agency and REACH guidance on data sharing and registration.
» REACH evaluation:
The evaluation process under REACH covers both dossier evaluation (testing proposals and compliance check) and substance evaluation. It enables authorities to determine whether registration dossiers comply with the applicable requirements (dossier evaluation) and whether the substance poses a risk to human health or the environment which needs to be further investigated (substance evaluation). In both cases, authorities may require registrants to conduct further testing.
» REACH authorisation:
Under REACH, substances that have properties that can be harmful to health or the environment may be identified as substances of very high concern (SVHCs) under certain conditions. These include carcinogens, persistent, bioaccumulative and toxic substances (PBT) and substances considered of equivalent concern (e.g. endocrine disruptors). Once they are identified as an SVHC, substances are listed on the REACH Candidate List of SVHCs. Once a substance is listed in the Candidate List, it can be subsequently included in REACH Annex XIV as a substance that requires authorisation (also referred to as the “authorisation list”).
Substances on the Authorisation list cannot be placed on the EU market or used after a given date, unless an authorisation has been granted for their specific use (or has been applied for in due time) or their use is exempted from authorisation (this is the case for instance for intermediates). EU manufacturers, importers, Only Representatives (OR), and downstream users of chemicals can apply for authorisation. Authorisation is a complex process; companies must show that the risks to health and the environment are adequately controlled, 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 or identified as such, as they may be withdrawn from the market or banned and inclusion on the Candidate List triggers obligations. The Candidate List of SVHCs and the Authorisation List are regularly updated on the ECHA website.
» REACH restrictions:
Restrictions can also be imposed on substances that pose unacceptable risks. A restriction may apply to any substance on its own, in a mixture or in an article, including those that do not require registration, for example, substances manufactured or imported below one tonne per year Substances restricted in the EU are listed in REACH Annex XVII and on ECHA’s website.
4.3.3 Supply chain communication
Suppliers of chemicals and mixtures must communicate information about hazards, use and risks to downstream users, distributors and consumers. Safety Data Sheets 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 (articles) 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 (for complex objects, this threshold applies to each article composing the complex object), the EU manufacturer or importer must provide users with information on the safe use of the substance. ECHA 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 Guidance on Substances in Articles.
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.
4.3.4 Classification and labelling requirements
REACH requires that EU manufacturers and importers classify and label all substances subject to registration and authorisation, and submit this information to the EU.
Classification and Labelling Inventory, a database managed by ECHA.
Classification and labeling rules are governed by the CLP regulation on the classification, labeling and packaging of substances and mixtures, described further in 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:
- European Chemicals Agency (ECHA) website;
- ECHA contact page;
- REACH guidance documents; and
- REACH, CLP and biocides for non- EU companies.
4.4 Biocides and plant protection products
The EU 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 the old Directive 98/8/ CE.
Biocidal products are used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism .They include disinfectants, preservatives, pest control products and others (the product-types are included in Annex V of the BPR).
The authorization of biocidal products involves two steps: approval of the active substance at the EU level; and product authorization at the national level. The BPR 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.
A significant number of active substances are under review included in the Review Programme; for these the BPR provides for a number of transitional measures allowing their placing on EU market. For more information please see: the European Chemicals Agency (ECHA) web page on the Biocidal Products Regulation.
- 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.
The centerpiece of the EU regulatory regime for plant protection products is Regulation 1107/2009 (PPPR). PPPR provides a dual authorization system for plant protection products with centralized decision on the EU level on the acceptability or non-acceptability of active substances on a basis of harmonized criteria and the authorization of plant protection products granted by Member States due to different formulations under different agricultural, plant health and environmental conditions.
In Europe, the term ‘pesticide’ is a broader term that also covers non plant/ crop uses, but also biocides.
The PPPR contains provisions on data protection, confidentiality of information and data sharing.
The legal limits for pesticide residues in food and feed are covered by Regulation 396/2005.
Recent developments include the adoption by the European Commission of the ED criteria for pesticides (including biocides).
For more information, please see: the European Commission’s web page on the Plant Protection Products Regulation.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.
Cosmetic products are regulated in the EU through Regulation No 1223/2009/ CE.
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 draws up the technical documentation for the cosmetic product (product information file, PIF), including the results of safety assessments, accessible to authorities. Before placing a cosmetic product on the EU market, the Responsible Person must notify the cosmetic product to 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.
Cosmetic products must be labelled according to the Cosmetic Regulation, including claims.
The Cosmetics 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.
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 the ban on animal testing.
For more information:
European Commission DG GROW web
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
4.6.1 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 EU 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, valid 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. Various rules have also been adopted to address the particularities of certain types of medicinal products and promote research in specific areas:
- Medicinal products for rare diseases (‘Orphan medicines’)
- Medicinal products for children
- Advanced therapy medicinal products
4.6.2 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.
For more information:
European Commission (DG SANTE) medicinal products web page.
- See Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
- Medicinal products for veteran use are also regulated in the EU ( Directive 2001/82/EC).
4.7 Medical devices
In May 2017, two new EU regulations on medical devices entered into force: Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVMDR”).These new regulations replacing the existing legislation will enter into force after a transitional period, on May 26, 2020 and May 26, 2022 respectively.
The MDR applies to any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to be used for human beings for medical purposes, including devices for the control or support of conception and products specifically intended for the cleaning, disinfection or sterilization of devices. Medical devices may only be placed on the market or put into service in the EU if they comply with the MDR. Information on borderline products is available on the European Commission’s website. Medical devices are classified based on their degree of invasiveness and there intended use.
The medical devices legislation establishes essential safety and performance requirements that have to be met be medical devices. Manufacturers can rely on harmonized EU standards to benefit from a presumption of conformity with these requirements and affix the CE mark (see Chapter 5). In some cases, the conformity assessment can include notified bodies (see Chapter 5).
The medical devices legislation also contains provisions on the use of certain chemical substances in medical devices, such as substances which are carcinogenic, mutagenic or toxic to reproduction and endocrine disruptors.
For more information and guidance please see:
- European Commission (DG Growth) medical devices webpages
- See Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/ EEC and 93/42/EEC and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
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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. Products need to satisfy these labelling requirements when imported into the EU.
This section is a general introduction to the most common labels. Country-specific labelling and packaging requirements can also apply and should be checked for each market.
See also 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 ( Regulation (EC) No.1272/2008 for the classification, labelling and packaging of substances and mixtures) sets out the classification, labelling and packaging requirements for substances and mixtures placed on the EU market.
The CLP Regulation 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.
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.). Information on self-classification and harmonized classification and labelling in accordance with the CLP Regulation is available on the European Chemicals Agency’s website.
Any package containing substances or mixtures classified as hazardous must be clearly labelled with the information listed in Article 17 of the CLP Regulation, including:
- The name of the substance or mixture;
- The name, address and telephone number of the supplier;
- The nominal quantity of the substance or mixture made available to the general public, and
- Product identifiers.
Substances or mixtures classified as hazardous must also include, where applicable:
- Signal words (such as “danger” or “warning”);
- Hazard pictograms (see symbols below);
- Hazard statements (such as “fatal if swallowed”);
- Appropriate precautionary statements (such as “keep out of the reach of children”); and
- Supplemental information.
The CLP Regulation also provides conditions for the application, format, readability and location of labels.
The hazard pictograms are in the shape of a red diamond with a white background. The symbols reproduced below refer to (from left to right): corrosive, health hazard, explosive, flammable, oxidizing, acute toxicity, serious health hazard, gas under pressure and hazardous to the environment.
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.
Additional packaging requirements may apply such as child-resistant fastenings and tactile warnings.
- See the CLP Regulation webpages on the European Chemicals Agency’s website.
- The European Chemicals Agency (ECHA) also published guidance documents and Q&As on the CLP Regulation.
- See Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (latest consolidated version on March 8, 2018).
5.1.2 Energy labelling
The EU energy label provides the consumer with information concerning energy efficiency of products.
Energy labels are mandatory for all appliances and energy-related products sold in the EU for which a label exists. The initial scope (household appliances) has been extended to include energy-related products in the commercial and industrial sectors.
The Energy Labelling Regulation (EU) No. 2017/1369 sets a framework for the energy label. It provides for the adoption of product-specific labels, 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 current scale of A+++ to G labels will gradually be replaced by a scale from A (most efficient) to G (least efficient) following the adoption of the Energy Labelling Regulation.
The Regulation also provides customers access to the database of product labels and information sheets and bans “defeat devices”, which alter the products performance under test conditions.
The EU Energy Labelling Regulation also requires the provision of standard product information regarding among others energy efficiency, the consumption of energy and of other resources by products during use.
Example of the current energy label template for washing machines.
- See Regulation (EU) No. 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU.
5.1.3 Electrical and electronic equipment (WEEE and ROHS)
» 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, including equipment falling under the following categories:
- 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, leisure and sports equipment;
- Medical devices (with the exception of all implanted and infected products);
- Monitoring and controlling instruments; and
- Automatic dispensers.
After August 15, 2018, the legislation will apply to all electrical and electronic equipment unless they fall under one of the exceptions explicitly mentioned in Article 2 of the WEEE Directive.
» The RoHS directive
While the WEEE Directive aims to divert e-waste from landfills, its sister directive, the RoHS Directive ( Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment) aims to reduce the hazardous content of electrical and electronic equipment.
RoHS restricts the use of certain hazardous substances (heavy metals such as lead, mercury, cadmium, and hexavalent chromium and flame retardants such as polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE)) in electrical and electronic equipment.
For more information:
- European Commission DG Environment website.
- 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, and 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 ( Regulation (EC) No. 1223/2009) sets out labelling requirements for cosmetic products. 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, including nanomaterials (indicated in the list of ingredients with the word nano in brackets following the name of the substances);
- Country of origin for imported products;
- Date of minimum durability or period when the product is safe after opening (for products lasting more than 30 months) with the following symbols:
Chapter 4: Product Safety and Chemical Safety of this Guide covers EU requirements for the composition and marketing of cosmetic products.
The symbol showing a hand pointing at a book indicates that a leaflet accompanying the product lists relevant information.
Period after opening
*Special provisions apply to small products that are difficult to label.
Date of minimum durability
For addition information:
- See the European Commission DG GROW Cosmetics webpage.
- Council Regulation (EC) No. 1223/2009 on cosmetic products.
5.1.5 Genetically modified organisms (GMOs)
Products containing GMOs as well as food and animal feed derived from them need to be labelled as containing GMOs under Regulation (EC) No 1829/2003. This requirement applies to both pre-packaged and non—pre-packaged products. More information on labeling of GMOs is available at European Commission – Food Safety – Plants.
- See Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
5.2 Voluntary labels
The EU Ecolabel ( Regulation (EC) No 66/2010) is a voluntary environmental-labelling system that promotes and identifies “green” products. It is encouraged by CETA as part of promoting sustainable development (Article 22.3.2(a)).
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, rinse-off cosmetic products, footwear, textiles, paints, paper, computers, household appliances and wooden furniture. Ecolabel product groups and criteria are posted to the European Commission’s DG Environment website. To apply for the EU Ecolabel, see the step-by-step guide provided by the European Commission.
For additional information:
- Please see the European Commission’s DG Environment Ecolabel web page and the EU brochure on the Ecolabel.
- Regulation (EC) No. 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU ecolabel.
5.2.2 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 Regulation (EC) No. 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. If used on imported products, an indication of the place where the agricultural raw materials of which the product is composed have been farmed, shall also appear in the same visual field as the logo (Article 25(1) of Regulation (EC) No. 834/2007).
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 an electronic certification of inspection which must be completed using the electronic Trade Control and Expert System (TRACES) ( Commission Regulation (EC) 1235/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries).
For more information:
- A user manual and FAQs about the EU organic logo are available on the Commission DG Agriculture Organic Farming webpages.
- Canadian Food Inspection Agency – Organic products.
- See Regulation (EC) No. 834/2007 on organic production and labeling of organic products, and Regulation (EC) No. 1235/2008 on imports of organic products from third countries.
5.2.3 Prepackaged products
The e-mark on prepackaged goods indicates that the prepack was filled in accordance with the standardized method provided by Directive 76/211/ EEC on pack sizes. The Directive applies to packages within the 5 gram to 10 kilogram range (or 5 milliliters to 10 liters). 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 throughout the EU as a measurement “passport.” Responsibility for the accuracy of all measurements rests with the packer (or the importer).
For more information:
- See the European Commission’s DG GROW legal metrology webpages.
- See 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.
5.2.4 Green dot
The EU Packaging and Packaging Waste Directive ( 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:
- See the European Commission DG Environment webpage.
- See Directive 94/62 of the European Parliament and Council of 20 December 1994 on packaging and packaging waste.
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Chapter 6: EU consumer rights
The European Union, its Member States and the local courts have a tradition of strong consumer protection. Contracts are usually interpreted in the advantage of consumers and comprehensive legislation exists to protect consumers’ interest.
6.1 EU Consumer protection directives
The main EU legislative sources of consumer protection are the following:
- Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (“the Unfair Terms Directive”)
- Directive 2005/29/EC of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (“the Unfair Commercial Practices Directive”)
- Directive 2006/114/EC of 12 December 2006 concerning misleading and comparative advertising (“the Misleading Advertising Directive”)
- Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights. (“the Consumer Rights Directive”)
The above-mentioned directives apply if the consumer has its habitual residence in an EU Member State, provided that the trader pursues its commercial activities in the country of residence or, by any means, directs such activities to that country. Consequently, a Canadian business that exports consumer goods to the EU will need to comply with the following requirements (breach of consumer law is considered contrary to public order and will generally result in nullity of the contract if invoked by the consumer):
For all consumer contracts, the trader is required to provide a list of mandatory pre-contractual information to the consumer, 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.
Unfair commercial practices (i.e. misleading or aggressive practices) are prohibited.
A commercial practice is regarded as misleading if it contains false information and is therefore untruthful or in any way is likely to deceive the average consumer and causes the consumer to purchase the product or service that he or she would not have purchased otherwise. Standard terms are regarded as unfair if they generate a significant imbalance in the parties’ rights and obligations arising under the contract to the detriment of the consumer. ( Annex I of the Unfair Commercial Practices Directive provides a list of commercial practices which are in all circumstances unfair.)
A commercial practice is regarded as aggressive if, by harassment, coercion, or undue influence, it is likely to significantly impair the average consumer’s freedom of choice or conduct with regard to the product and thereby is likely to cause him or her to purchase the product or service that he or she would not have purchased otherwise.
Furthermore, terms must always be drafted in plain, intelligible language. Where there is doubt about the meaning of a term, the interpretation most favorable to the consumer shall prevail.
There is no European harmonization of language requirements. An exporter should therefore take into account the possibility of language requirements, introduced by individual Member States (for example, Italian for Italy).
The Consumer Rights Directive adds additional rules of conduct for the trader towards consumers:
- Traders need to provide clear and comprehensible pre-contractual information.
- 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
- Unless the consumer has commissioned the carrier himself to deliver the goods, the risk of loss of or damage to the goods shall pass to the consumer when he or she has acquired the physical possession of the goods.
- The trader has a maximum of 30 calendar days to deliver the goods to the consumer, unless the parties have agreed otherwise on the time of delivery. In the event the trader does not respect his obligation to deliver the goods within the time limit for delivery, the consumer has the right to cancel the purchase.
- For distance selling and off-premises contracts, additional pre-contractual disclosures need to be respected. Breach of this obligation may result in additional costs and charges for the trader, an extension of the withdrawal period to 12 months or nullity of the contract.
- Consumers have the a right to withdraw within 14 days of receiving the purchased goods or, in the case of service contracts, the day of conclusion of the contract. The trader needs to provide a model withdrawal form, prior to the conclusion of the contract. In the event of withdrawal, the purchase price must be refunded fully to the consumer, including the costs of delivery. The consumer bears the delivery costs of returning the goods.
- If a distance contract is concluded by electronic means and entails activating a button, this button shall be labelled only with the words “order with obligation to pay” or a corresponding unambiguous formulation. Breach of this obligation results in nullity of the contract.
- Finally, the Consumer Rights Directive provides for a list of exceptions from the right of withdrawal (for example: service contracts after the service has been fully performed, goods made to the consumer’s specifications, goods which are liable to deteriorate or expire rapidly, digital content, newspapers and magazines, et cetera).
For more information see European Commission DG Justice webpage on consumer rights.
- 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 (“the Product Warranty Directive”)
Under the Product Warranty Directive a 2-year guarantee applies to the sale of all consumer goods.
EU consumers have 2 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, EU consumers may request a refund or price reduction. The 2-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 EU Member States provides guarantees longer than the one specified in the European Product Warranty directive.
For more information see the European Commission DG Justice web page on sales and guarantees.
6.3 Data protection
Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (“General Data Protection Regulation – GDPR”) applies directly throughout the EU and the European Economic Area (EEA) as of May 25, 2018.
The GDPR regulates the processing of personal data by individuals, companies or organizations. The GDPR does not apply to the processing of personal data of deceased persons, legal entities, or the data processed by an individual for purely personal reasons.
The main principles relating to the processing of personal data as set in the GDPR are as follows:
- Lawfulness, fairness and transparency in data processing vis-à-vis data subjects;
- Purpose limitation for data collection;
- Minimization of data collection for specified, explicit and legitimate purposes;
- Accuracy of data collection;
- Data storage limitation;
- Integrity and confidentiality in data processing; and
- Accountability for data processing.
The territorial scope of the GDPR reaches beyond the EU and therefore also applies to Canadian businesses where the business is engaged in the processing of personal data belonging to the EU data subjects.
The GDPR applies to Canadian businesses in the following cases:
- Where a Canadian business is established in the EU (whether or not the processing of personal data takes place within the EU),
- Where the processing relates to the offering of goods or services to data subjects in the EU, or
- Where the behaviour of EU resident data subjects is monitored.
A Canadian business that is subject to the GDPR as a data controller or processor, but which is not established in the EU, must designate a representative in the EU that can be addressed by supervisory authorities and data subjects on all issues related to processing of personal data. However, this obligation to designate an EU representative does not apply in the following cases:
- If data processing is occasional;
- If data processing does not include the large-scale processing of the special categories of data (such as health data as well as data revealing ethnic origin and political beliefs) or personal data relating to criminal convictions and offences and this processing is unlikely to result in a risk to the rights and freedoms of natural persons, or
- A public authority or body processes the personal data.
The GDPR confers new rights on data subjects and extends existing ones. Under the GDPR, data subjects have the right to request access to their data, the right to seek rectification of inaccurate personal data and to be notified of breaches of data security, the right to restrict data processing and to require the erasure of personal data and the right not to be subject to automated decision-making in certain circumstances.
Regarding the transfer of personal data from the EU to Canada, the GDPR requires, in principle, that the level of protection of personal data must be similarly guaranteed under Canadian law and should not be undermined by such transfer. The GDPR provides that the above safeguards are met if the European Commission has taken an “adequacy decision” – that is, a decision confirming the protection of personal data by the third country.
On December 20, 2001, the European Commission decided, under the pre-GDPR privacy regime, that Canada is considered to provide an adequate level of protection for personal data transferred from the EU to recipients subject to the Personal Information Protection and Electronic Documents Act (“PIPEDA”). Existing adequacy decisions under the old data protection regime as laid down in Directive 95/46/ EC, remain in force for GDPR purposes.
The European Commission is currently reviewing the data transfer agreements it has with the third countries, including Canada. The existing EU-Canada adequacy regime will remain in force until it is amended, replaced or repealed by the European Commission. Until the European Commission takes a new adequacy decision under the GDPR, Canadian businesses must comply with the following decision: Commission Decision of 20 December 2001 pursuant to Directive 95/46/EC of the European Parliament and of the Council on the adequate protection of personal data provided by the Canadian Personal Information Protection and Electronic Documents Act.
In the absence of the existence of a Commission “adequacy decision” with respect to a third country, the GDPR permits transfers outside the EU where a company has adopted binding corporate rules. These rules must commit the members of the relevant corporate group to specific standards with respect to data transferred outside the EU. Alternatively, appropriate safeguards might be put in place between contracting parties by the adoption of European Commission approved standard, or model, clauses, in order to ensure adequate levels of protection with respect to the transfer of personal data outside the EU.
Data subjects have a right to claim compensation in the event of an infringement of the GDPR, unless the controller or processor of the relevant data can show it was not negligent.
The GDPR also introduces a new regime of administrative fines and penalties that may be imposed in the event of a breach. The range of these fines and penalties are significant – from up to the higher of:
- €10 million or 2% of group global turnover for less serious violations of the GDPR; and
- €20 million or 4% of group global turnover for more serious breaches.
Canadian businesses which are dealing with the data processing relevant to the offering of goods or services as well as where the behaviour of data controller or data processor is monitored, should determine whether the GDPR is applicable. In the event that the GDPR is applicable, development and implementation of the rules compliant with the GDPR requirements is necessary.
For more information see European Commission:
- Data protection.
- Communication from the Commission to the European Parliament and the Council: Exchanging and Protecting Personal Data in a Globalised World.
- Commission Decision of 20 December 2001 pursuant to Directive 95/46/EC of the European Parliament and of the Council on the adequate protection of personal data provided by the Canadian Personal Information Protection and Electronic Documents Act.
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
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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 European Union Intellectual Property Office (EUIPO), the agency responsible for the registration of trademarks and designs. The EU protects intellectual property rights against piracy, illegal trade and counterfeiting. The EU adopted in 2016 a Directive against unlawful acquisition, disclosure and use of trade secrets ( Directive 2016/943/EU).
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.
Ensure you protect your intellectual property before entering the EU market. Get professional advice.
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.
Inventions can be protected in Europe either through:
- National patent filings, granted by National Patent Offices;
- European patent filings granted centrally by the European Patent Office ( EPO): A European patent shall, in each of the European contracting states for which it is granted, have the same effect of and be subject to the same conditions as a national patent granted by that state.
There are discussions for obtaining a Patent, effective in all EU member states with the exception of Italy and Spain. This “Unitary Patent” would 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, would 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.
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.
Trademarks are the indications, such as words, phrases, logos and sounds, used by companies to identify and distinguish their goods or services from those of their competitors. Trademarks are protected for renewable terms of 10 years ( Directive 2015/2436/EU on the harmonization of trade mark law in the EU).
Businesses apply for a National Trademark at a national Intellectual Property Office. It is also possible to apply for a European Union Trademark (EUTM) with the European Union Intellectual Property Office (EUIPO). With a single registration, the European Union Trademark offers protection in all 28 EU countries.
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:
European Union Intellectual Property Office (EUIPO):
Design refers to the “appearance of the whole or part of a product resulting from the features of, in particular, the lines, contours, colors, 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 European Union Intellectual Property Office ( EUIPO).A single application to EUIPO enables protection throughout the EU.
A Registered Community Design is valid for five years and can be renewed up to four times (a total of 25 years).
For more information:
EUIPO (European Union Intellectual
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 disputes. 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). A Directive ( 2014/26/EU) on collective rights management and multi-territorial licensing of rights in musical works for online uses has already been adopted.
For more information on copyright:
For additional information:
- European IPR Helpdesk;
- National Intellectual Property Offices;
- European Patent Office;
- European Union Intellectual Property Office.
7.6. Geographical Indications and other quality labels
7.6.1 Systems of protection: PDO, PGI and TSG.
The European Union has set up a system for the valorization and protection of agricultural products and foodstuffs in order to promote the diversification of agricultural production and to protect the names of products against usurpations and imitations.
European regulations (EC) no 509/2006 of March 20, 2006 on agricultural products and foodstuffs as traditional specialties guaranteed and (EC) no 510/2006 of March 20, 2006 on the protection of geographical indicators and designation of origin for agricultural products and foodstuffs lay down three (3) protection systems, each with its specific characteristics.
1. Protected designation of origin (PDO) can be granted to agricultural products or foodstuffs from a specific region whose quality or characteristics are essentially or exclusively due to the geographical environment, including natural and human factors (such as climate, soil conditions, local know-how, etc.). Furthermore, the product must have been produced, processed and put together in the specific geographical area.
- PDO registered in Belgium:“Herve Cheese” (1996);“Ardenne Butter” (1996);“Wine of Cotes of Sambre and Meuse” (2004); Cremant and Sparckling Quality Wine of Wallonia (2008)
- Other well-known PDO:”Normandie Camembert” (France); “Feta” (Greece);“Brie de Meaux” (France); “Pecorino Toscano” (Italy);“Queso Manchego” (Spain)
2. Protected geographical indication (PGI) may be attributed to agricultural products or foodstuffs which are from a specific region and for which a specific quality, reputation, or other characteristics may be attributed to that region. Furthermore, the product must have been produced and/or processed and/or put together in the specific geographical area.
- The conditions required for a protected geographical indication are more flexible than those required for a protected designation of origin. Thus, a PGI can be attributed even if only the product’s reputation can be attributed to its geographical origin. Furthermore, the production, processing and assembly are not all required to have taken place in the specific geographical area; only one is required to have done so.
- PGI registered in Belgium: « Ardenne Ham » (1996); Paté Gaumais « (2001) ; « Brussels Chicory » (2004); Country wines from the Gardens of Wallonia » (2004) ;“Mattons de Geraardbergen” (2008) « Flat Patatoes of Florenville » (2015).
- Other well-known PDI:” Reblochon” (France);“Normandy Cider” (France);“Salt of Guerande” (France); “Nocciola del Piemonte” (Italy)
3. Recognition as a traditional speciality guaranteed (TSG) is available for foodstuffs and agricultural products without a link to specific geographical area. This recognition is based on the specificity of the product, i.e. the characteristics which clearly distinguish it from other products or foodstuffs from the same category. These characteristics may be related to the product’s intrinsic qualities such as physical or chemical properties or the production method. Therefore, they must be produced according to a specific recipe or production method, but this may take place anywhere, without geographical requirements.
- TSG protected in Belgium:“Geuze beers”;“Faro Beers”; Kriek Beers”; “Lambic Beers”.
- Other well-known TSG:“Mozarella”; “Pizza Napoletana”;“Jamon Serrano”; “Bouchot Mossels”.
7.6.2 Procedures & registration
PDO, PGI and TSG provide exclusive rights of use to producers of the concerned product. To receive this protection, you must register the designation. A specifications sheet in which you explain the conditions under which the protected designation may be used (geographic area, required production method, know-how, elements of proof regarding the quality of the product related to the geographical environment, etc.) must be filed.
The request may be filed by a national group of producers or processors of the concerned product (often agricultural organizations).These indications are not open to individual use; they are meant for the collective interest. All those who meet the objective conditions of the specifications sheet will receive the right to use the protected indication.
The registration procedure is carried out in two (2) phases.
First, the local authorities (For instance, in Belgium: Walloon Region; Flemish Region and Brussel Capital Region) decide whether to accept a determined indication.
In the second phase, the request is transmitted by the local authorities to the European Commission, which performs a supplementary review and makes a final decision on recognizing the request designation.
During this two phases, the local authorities generally grant provisional protection to the products.
Specific arrangements are provided for wines and spirits.
For more information:
Once recognized, PDO and PGI confer a fairly broad protection. This protection is defined by Article 13.1 of the (EC) no 510/2006 which specifies:
- Any direct or indirect commercial use of a registered name in respect of products not covered by the registration in so far as those products are comparable to the products registered under that name or in so far as using the name exploits the reputation of the protected name;
- Any misuse, imitation or evocation, even if the true origin of the product is indicated or if the protected name is translated or accompanied by an expression such as “style”, “type”, “method”, “as produced in”, “imitation” or “similar”;
- Any other false or misleading indication as to the provenance, origin, nature or essential qualities of the products, on the inner or outer packaging, advertising material or documents relating to the product concerned, and the packing of the product in a container liable to convey a false impression as to its origin;
- Any other practice liable to mislead the consumer as to the true origin of the product.
This protection system is generally incorporated in the national law of each member state. (For Belgium, refer to the World Intellectual Property Organization)
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Chapter 8: Business travel
8.1 Passports and visas
Visa rules differ depending on whether the EU country being visited is party to the Schengen Convention or not.
» Schengen area countries:
The Schengen AreaFootnote 3 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 travelers 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 3 months after the date of return. This short-stay calculator can help travelers.
For short stays (less than 90 days in the Schengen Area) Canadian passport holders do not need visas.
Travelers 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.
» Non-Schengen area countries:
Currently, 6 EU Member States are not party to the Schengen Convention. The United Kingdom 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.
» List of embassies or consulates in Canada:
Visa requirements for the Schengen Area of stay (currently, 6 months in the United Kingdom 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.
No Visa required
EU States and territories of EU States not part of Schengen
Visa + airport transit visa (ATV) required by all Schengen States
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, and the like. You are strongly recommended to contact the appropriate embassy or consulate for precise requirements.
For more information:
- Validity of travel documents for the Schengen area;
- European Commission DG Home Affairs Schengen Area webpage.
8.2 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.
8.3 Temporary Entry under CETA
CETA facilitates labour mobility by permitting the temporary entry and stay of certain groups of business persons and business activities. It is also important to bear in mind that under CETA, labour mobility is only contemplated for temporary periods and does not address any visa requirements, permanent migration, citizenship or residency. In addition, CETA’s temporary entry and stay provisions are generally aimed at executive level and highly skilled professionals, as opposed to general labour or permanent employment.
While the scope of commitments relating to labour mobility are the best provided by the EU in any free trade agreement to date, the rules under CETA are very detailed and specific for each category of visitor. It is also important to keep in mind that the temporary entry provisions differ between EU Member State and, what is more, the level of sectoral market access commitments and obligations to the different categories of business visitor will vary from EU Member State to EU Member State. As such, it is necessary to examine each situation on a case-by--case basis before relying of these CETA provisions.
In general the following categories of persons are extended temporary mobility rights if they meet requirements established under CETA:
- Short-Term Business Visitors
- Contractual Service Suppliers and Independent Professionals
- Intra-Corporate Transferees
- Business Visitors for Investment Purposes
» Short-term business visitors
Annex 10-D of CETA sets out a list of activities that are permitted for short-term business visitors; namely the following:
- meetings and consultations; ?
- research and design;
- marketing research;
- training seminars;
- salesFootnote 4;
- purchasing; ?
- after-sales or after-lease service;
- commercial transactions; ?
- tourism personnel; and
- translation and interpretation.
The maximum period of stay for a Short-Term Business Visitor under CETA is 90 days in any 6-month period.
Under CETA, Short-Term Business Visitors cannot engage in selling a good or a service to the general public, cannot receive remuneration from a source located within the country where they are staying temporarily and cannot engage in the supply of a service to a consumer in the territory, unless specified otherwise in annex 10-D. A business visitor for investment purposes, on the other hand, is defined as an employee in a managerial position or specialist position who is responsible for setting up an enterprise but who does not engage in direct transactions with the general public and will not receive direct or indirect remuneration from a source in the EU.
» Contractual services suppliers and independent professionals
CETA also allows for the cross-border supply of professional services set out in Annex 10-E of CETA. These include 37 sectors or sub-sectors of activity such as accounting and bookkeeping services, taxation advisory services, architectural services, engineering services, medical and dental services, veterinary services, legal servicesFootnote 5, mining services as well as certain maintenance and repair services (such as vessels, rail transport equipment, motor vehicles, aircrafts and metal products). There are 2 types of professionals recognized under CETA: (a) contractual services suppliers and (b) independent professionals. For the purposes of this Guide, contractual services suppliers are natural persons employed by a Canadian business that does not have an establishment in the EU, but have concluded a contract to supply a service to an EU consumer that requires the presence - on a temporary basis - of its employees in the EU in order to fulfil the contract to supply a service. The contractual service provider must have been an employee for at least the year immediately preceding the date of submission of the application of entry to the EU and possess, as at the date of the submission, at least 3 years of professional experience in the sector of activity that is the subject of the contract.
An independent professional is, him- or herself, a natural person engaged in the supply of a service, but is established in Canada as being self-employed and who has no establishment in the EU and who have concluded a contract to supply a service to an EU consumer that requires his or her presence in the EU on a temporary basis in order to fulfil the service contract. In addition, the independent professional must possess at least 6 years professional experience in the sector of activity which is the subject of the contract as at the date of submission of an application for entry into the EU Member State. Entitlement to use his or her professional title where the service is provided may, however, be restricted.
Unlike a CETA Business Visitor, CETA sets out certain minimum requirements for Contractual Service Suppliers and Independent Professionals that must be satisfied including possessing (a) a university degree or a qualification demonstrating knowledge of an equivalent level and (b) a professional qualification (if this is required to practice an activity pursuant to the law, regulations, or requirements of the Party where the service is supplied).
Contractual Service Suppliers and Independent Professionals are also subject to specific reservations (or restrictions) on the liberalization of professional services. These are set out in Annex 10-E of CETA and differ in scope and sector from Member State to Member State. For example, with respect to architectural services and urban planning and landscape architectural services under CETA, Canadian Contractual Service Suppliers and Independent Professionals are subject to certain restrictions depending on whether they are a contractual service provider or an independent professional, as well as being subject to different restrictions in certain Member States.
Contractual Service Suppliers and Independent Professionals may be admitted under CETA for a maximum cumulative period of 12 months during any 24-month period (or the length of the contract, whichever is shorter) although the duration of stay may be extended, upon request and at the host party’s discretion, work permits may be extended.
» Intra-corporate transferees
Another category of person recognized by CETA’s labour mobility provisions are intra-corporate transferees, namely, people who, for the purposes of this Guide, have been employed by a Canadian business (or have been partners in a Canadian business) for at least 1 year and who are temporarily transferred to an EU part of the business (for example, a subsidiary, branch, or head company of the business in the EU). The categories of intra-corporate transferees are limited to senior personnel, specialist or graduate trainee, each of which has further requirements under CETA.
Senior personnel and specialists may seek admission under CETA for an initial period of 3 years (or the length of the contract, whichever is shorter) and may seek an extension of up to 18 months. Graduate trainees may seek admission for an initial period of 1 year (or the length of the contract, whichever is shorter) but are not permitted to seek extensions of their work permits.
A CETA investor is a natural person who establishes, develops, or administers the operation of an investment in a capacity that is supervisory or executive, and to which those persons or the enterprise employing those persons has committed, or is in the process of committing, a substantial amount of capital.
As with the case with other categories of persons, a potential CETA investor must meet certain specific eligibility requirements set out under CETA.
A CETA Investor may stay in the EU for an initial maximum period of 1 year although the length of stay may be extended, upon request and at the host party’s discretion.
For questions related to the Temporary Entry of Business Persons under Canada’s free trade agreements, please contact: enquiry-demande.TE@international.gc.ca.
8.4 Mutual recognition agreements
Complementary to this is the inclusion in CETA of a framework for the mutual recognition of professional qualifications (professional qualifications that are regulated by the CETA Parties). The framework agreement included in CETA permits - but does not mandate or otherwise require - sector specific mutual recognition agreements (“MRAs”) concluded by the relevant professional services sector, together with the licensing bodies of the said sector, to be recognized as binding under CETA. Please note that MRAs must be concluded at the Party level, i.e. between Canada and the EU.
8.5 General travel tips and assistance
To assist business and other travelers, the Government of Canada provides country-specific information on safety and security, local laws and culture, entry and exit requirements, and health. You will find practical information on documents, the Euro, exchange rates, time zones, healthcare, and other such practical information.
More information about the 28 countries in the EU.
Travelling in Europe is the European Union’s official website for people travelling in the 28 countries of the EU.
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