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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.

Table of contents


Introduction:

Summary

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).

Any questions? We want to hear from you!

The guide covers legislation harmonized by the EU, but does not describe specific rules that apply within individual EU member states. 

Please contact the trade section of the Mission of Canada to the European Union at BREUTD@international.gc.ca if you have specific questions or are facing issues about an EU-level regulation or legislation.

Contact the Trade Commissioner Service for information about country-specific legislation, opportunities or potential barriers to trade. Trade commissioners in one of our 24 offices in the EU will assist you.

Register a trade barrier you have encountered in an EU market with Global Affairs Canada.

Disclaimer

This guide:

The Government of Canada:

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 comprising 28 member states with a combined population of over 509 million. 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 member states.

1.1 EU and other European countries

Image of map showing member states of the European Union
Source: European Commission

A variety of economic groupings make Europe a dynamic place to conduct business.

The EU is the largest trading bloc in the world, with preferential access to several neighboring countries, featuring industries that are deeply integrated into broader regional value chains.

The following 27 member states belong to the European Union:

EU candidates

The following countries are recognized as candidates to join the EU although accession timelines have not been set:

Bosnia and Herzegovina and Kosovo have not been granted candidate country status although their prospects for joining the EU are well-defined.

Iceland, Liechtenstein, Norway and Switzerland are European Free Trade Association countries. Although not members of the EU, they participate in the EU’s internal market as part of the European Economic Area.

Turkey has a customs union with the EU.

1.2 The EU economy in the world

As a single entity, the EU is:

In 2018, the EU:

With a combined population of over 340 million, 19 EU member states have adopted the euro, the EU’s common currency. More EU members and future members are expected to adopt the euro in the future.

According to the World Bank, economic growth in the EU has been increasingly steady, both in terms of pace and composition. Following the financial crisis spanning the last decade, the EU economy has enjoyed several consecutive years of recovery, which is now reaching all EU member states where private consumption represents the main driver of growth.

The Euro area and EU economies have experienced the fastest pace of growth for the area in a decade: up 2.4% for each in 2017 and 1.8% and 1.9% in 2018, respectively.

This strong economic performance is set to continue in 2019, with growth of 2.3% for the Euro area and 2.0% for the EU.

The EU labour market, although uneven, continues to improve overall. The employment rate has returned to pre-crisis levels, although large jobs deficits persist in some countries. While growth expectations have improved, uncertainty arising as a result of Brexit is putting a strain on the European economy.

More information about Brexit:

Section 1.3.3: The United Kingdom, Brexit and Canada

1.3 Canada and the EU

1.3.1 Trade facts

Canada and the EU enjoy a strong bilateral trading relationship in both goods and services.

The EU is Canada’s second most important trading partner after the United States. The entry into force of CETA has significantly expanded commercial opportunities between the parties.

In 2018:

In 2018, the most important category of goods traded between Canada and the EU were:

In 2018, trade in services between Canada and the EU was valued at $45.5 billion (€ 72.3 billion). Services traded between Canada and the EU include transportation, travel, insurance and communication.

1.3.2 Comprehensive Economic and Trade Agreement

The EU and Canada signed the Comprehensive Economic and Trade Agreement (CETA) on October 30, 2016. CETA entered into force on September 21, 2017.

With its provisional application, all economically significant parts of the agreement are now in force.Footnote 1 The agreement will take full effect once all EU member states have formally ratified it.

Duties (tariff lines) on 98% of products that the EU trades with Canada have been removed. Over the course of the next seven years, a further 1% of tariff lines will be phased out, making 99% of all Canadian goods entering the EU market duty-free.

Other key benefits of CETA:

Cutting red tape

Under CETA, Canada and the EU member states (the “Parties”) have agreed to:

Access to EU government procurement contracts

Under CETA, Canadian companies can now:

Practical guidance on EU government procurement

EU Government Procurement Guide for Canadian companiesFootnote 2.

Preferential access

Preferential access is granted to:

Regulatory cooperation

CETA facilitates trade by:

CETA also includes protocols 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 will save companies time and money in getting their products to market.

Increased mobility for company employees

Temporary entry provisions make it easier for highly skilled professionals and businesspeople to move across borders and work in the EU.

These provisions:

More information about labour mobility

Chapter 8.3: Labour mobility under CETA

1.3.3 The United Kingdom, Brexit and Canada

The United Kingdom is an important market for Canada. The U.K. market represents Canada’s fourth largest merchandise export destination, after the United States, the EU-27 and China.

In 2018

In 2015

Several factors currently make the United Kingdom an ideal point of entry for Canadians to the EU:

Brexit and Canada

Canada’s access to the United Kingdom market remains covered under CETA until the United Kingdom withdraws from the EU.

Following the implementation of Brexit, Canada’s market access to the United Kingdom in both trade and services, as well as the modalities of Canada-U.K. trade, will be reassessed. The post-Brexit EU-United Kingdom relationship will determine the relationship between Canada and the EU and between Canada and the United Kingdom.

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.

Refer to the following resources for up-to-date information on Brexit issues:

1.4 EU bodies and laws: the basics 

The EU Treaties establish and set out the composition of the EU. The three primary EU decision-making institutions are:

The EU also has several specialized agencies that implement legislation and policy or provide advice to EU institutions. These agencies include the European Food Safety Agency and the European Chemicals Agency. 

Decentralised agencies in Europe

The EU’s key regulatory decisions derive from:

Regulations

Example of regulations

Directives

Example of directives

Decisions

Example of decisions:

Reference tools for European laws:

1.5 Helping Canadian exporters

The Canadian Trade Commissioner Service (TCS) helps Canadian companies and organizations succeed globally. The TCS comprises a network of trade offices in Canada and around the world, including offices in 24 EU member states.

This network provides Canadian businesses with:

The TCS offers information about:

Get help from the Trade Commissioner Service:

Other partners offer services or information useful for preparing or implementing export strategies for European markets. For example, the 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 such as chambers of commerce and 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.

Information about Canada-EU trade

1.5.1 CETA and the government of Canada

On September 26, 2014, Canada and the EU concluded CETA negotiations. The agreement removes most tariffs and creates new opportunities for businesses, including SMEs. The benefits for Canadian businesses are expected to be significant.

CETA has dedicated committees under many of its chapters whereby representatives of the EU and representatives of Canada meet to consider issues that are referred to the committee by one of the parties.

The Canadian Trade Commissioner Service has offices in 24 EU locations. Trade commissioners are ready to help Canadian businesses overcome trade barriers and other difficulties, including with respect to procurement markets.

Register a trade barrier and let the Trade Commissioner Service help you

Table of contents

Chapter 2: Customs

Although the EU is commonly referred to as a customs union, the EU’s customs territory differs 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 that are not covered by the Treaties.

These include:

Andorra, San Marino and Turkey are part of customs unions with the EU.

Portions of the territories of some member states are not part of the EU customs territory.

Territorial Status of EU Countries and certain territories

EU member states have abolished customs duties and controls between and among themselves and apply the same tariffs on goods imported from outside the EU (Common Customs Tariff).

The same rules apply regardless of where in the EU the goods are declared. Once the goods have cleared customs, they may circulate freely and be sold anywhere within the EU customs territory.

More information about exporting goods from Canada

2.1 Classifying goods

To determine the customs duty rate of a good and to obtain an export licence for it, you must first know the classification of the good.

The classification is needed to:

The EU system of classifying goods comprises a 10-digit coding system consisting of three integrated components. The first component (first 6 digits) is based on the Harmonized System (HS) nomenclature, which is the international system for classifying goods developed and updated by the World Customs Organization. Canada, the EU and other countries use the HS system. That system is hierarchical, organized 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, however, while the first 6 digits of the code are common to all markets, the other 4 digits are unique to the EU.

World Customs Organization – What is the harmonized System (HS)?

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 together with explanatory notes is updated annually. The CN is used to determine the EU’s common customs tariff for a good.

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 comprises the 8-digit CN code plus 2 additional digits, which is the third component of TARIC sub-headings.

TARIC Consultation

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

TARIC is also the EU’s integrated tariff online database.

To use TARIC you must first find the classification of a good. Then find a good’s tariff code:

Browse or Advanced Search

Identify the appropriate section, chapter and subheadings of the Combined Nomenclature for the HS, CN and TARIC by choosing the correct goods description.

Example:

The code for importing Frozen Atlantic Salmon into the EU in Table 1 above is 0303 13 00 10.

Correctly classifying goods is essential to avoid delays in clearing goods through customs and incurring additional duties or penalties.

National customs authorities also provide BTI rulings, which indicate the correct tariff classification for particular goods. The BTI rulings are binding on the customs authorities across the EU and BTI holders for a period of three years from issuance.

2.2 Calculating customs duties: rules of origin and valuation

Most customs duties are expressed as ad valorem duty, a percentage of the import price. Some products, however, are subject to either a

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 a factor of 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 product reaches the EU customs frontier. Since the provisional entry into force of CETA on September 21, 2017, customs duties on imports of goods originating in Canada have been eliminated or will be removed progressively by the EU within a period of seven years in accordance with the agreed time-schedule.

Example:

The applicable duty to the cereal imports for the first 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 decreased progressively until the eighth year following the entry into force of CETA at which time imports of cereal into the EU from Canada will be duty free.

Use TARIC to find:

To use TARIC to find customs duties and EU measures:

The origin rules must be satisfied before the preferential tariff can be applied.

Exporters may also apply to the national authorities of the EU’s member states for Binding Origin Information (BOI). This includes BOI for preferential origin under CETA. A BOI is valid for three years upon issuance throughout the EU customs territory. BTI and BOI increase the predictability and guarantee the application of CETA rules of origin and tariffs to imported goods.

Protocol on rules of origin and origin procedures and its Annexes (pages 443 and onwards of CETA:

2.3 Value-added tax

Goods imported into the EU are subject to import value-added tax (VAT) at their point of entry into the EU. Goods that enter one member state but are intended for use in another member state, 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:

More information on VAT rates

As part of its VAT Action Plan presented in April 2016 toward a Single VAT area, the European Commission proposed to replace the current transitional VAT system with a definitive VAT system. The definitive system would be based on the principle of taxation at the rate applicable in the destination member state instead of the rate applicable at the point of entry in the EU.

Under the current rules, VAT is suspended for goods imported into one EU country but intended for use or consumption in another. In the Commission’s proposal, this special regime would become the rule.

Furthermore, the Commission issued a proposal on January 18, 2018, to amend Directive 2006/112 regarding VAT rates.

The proposal aimed to

Example

Some EU countries currently apply reduced VAT rates for children’s clothes that are below 5% while others are not permitted to do so.

Under the proposed new rules, every EU country will be allowed to apply a reduced VAT rate to children’s clothes.

In addition 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 in general. The Commission’s proposal however maintains a list of products to which the standard rate of minimum 15% must always be applied, to be updated with the entry into force of the new provision. This list includes products such as weapons, alcoholic beverages, gambling services and tobacco.

The entry into force of the new provisions on VAT rates is part of the evolution toward a more definitive VAT regime set for 2022.

Example

Table 2 shows the import charges calculated on a small shipment of frozen Atlantic salmon exported from Canada to Belgium after converting Canadian dollars to euros. The product’s HS code is 0303 13 00 10.

Table 2: Calculating import VAT (euros)
GoodsInvoice PriceShipping and insuranceCustoms valueCustoms dutyValue for VATVAT (Belgium)Total duties and VAT
Frozen Atlantic Salmon6002008002% = 168166% = 48.9664.96

2.4 VAT on electronic services

In 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 such as business to consumer must, like their EU counterparts, charge and account for VAT.

Suppliers must register for VAT in the EU member state where their non-business customer resides. Businesses can complete a single registration that is valid throughout the EU.

Mini One Stop Shop (MOSS)

Compliance with VAT obligations by online businesses will become even easier since the adoption of new rulesby the Council of the EU that will extend the MOSS to 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.

VAT on e-commerce 

Note: the above does not apply to non-EU companies supplying EES to business customers in the EU (business to business) that do not need to charge VAT. EU business customers pay the VAT under a reverse-charge mechanism.

DG Taxation and Customs Union (TAXUD)

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

Member states can set higher excise rates than the minimum rates set by EU rules.

General overview of excise duties

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. 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 should take advantage of TRQ by learning how each is administered.

Agriculture sector exporters should refer to:

Exporting your agri-food products to the EU (Agriculture Canada website) 

Agreed TRQs on certain goods will gradually increase each year for a period of six years after entry into force of CETA.

Examples:

Import licences

Imports of some agricultural products such as cereals, milk products, beef, wine, 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.

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:

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 detail to identify it.

Such an origin declaration can be found in CETA Annex 2 to the Protocol on rules of origin and origin procedures.

Protocol on rules of origin and origin procedures

In Canada, the Canada Border Services Agency (CBSA) requires all exporters of commercial goods to have a Business Number assigned by the Government of Canada. The Business Number must be entered into 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 but have to complete field 5 of the origin declaration.

2.8 Making export easier

Canadian exporters must manage many documents when exporting goods to the EU market. Using freight forwarders and customs brokers can make the process easier.

Table of contents

Chapter 3: EU sanitary and phytosanitary requirements

Overview

Goods imported into the EU must meet sanitary and phytosanitary requirements that protect human, animal and plant health.

3.1 Food safety

EU legislation on food safety governs production, labelling and tracking of food products 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 fact-based advice on food-safety issues. The EFSA is independent from the European Commission’s directorate general responsible for food safety.

EU food legislation and import requirements are constantly evolving.

Refer to European Commission Food Safety for current information.

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.

These include:

EU legislation establishes official controls along the food chain:

3.1.2 Food labelling and packaging: overview

3.1.2.1 Food labelling

New EU rules on labelling on food information for consumers came into effect on December 13, 2014.

Under Regulation 1169/2011, EU food labels must:

More information on food safety

In addition to general rules, specific labelling rules apply to:

3.1.2.2 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 such as packaging materials, cutlery and dishes must be safe and that they:

The Regulation lists materials and articles such as plastics, ceramics and glass that may be covered by specific measures.

The list includes information about:

The labels for materials and articles that come into contact with food must include either of the following unless it is obvious that the article is not for food contact:

Food contact materials

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:

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

More information about animal products

At the border inspection post, each consignment is subject to a documentation check, an identity check and, as appropriate, physical checks.

If a product fails any of these checks, it is not allowed into the EU and may be destroyed or returned to the country of origin. If the product is compliant, the exporter receives a Common Veterinary Entry Document, and the product 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, the Catch Certification Office in the Department of Fisheries and Oceans is the issuing authority.

European Union

Canada

3.3 Plant health

Plant health control

The EU Plant Health Directive 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 must:

More information about plant health control

In October 2016, Regulation 2016/2031 on protective measures against plant pests was adopted and will be applicable from December 14, 2019.

Plant health control

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

Related legislation

The EU is implementing the Regulatory Fitness and Performance Programme (REFIT) to review most of its legislation, including in food safety. This could result in proposals for changes to existing legislation.

REFIT – Making EU laws simpler and less costly

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Chapter 4: Product safety and chemical safety

For many products, EU legislation is limited to establishing essential health, safety and environmental requirements. Technical details are left to voluntary European harmonized standards that aim to ensure product safety across the single market. Compliance with harmonized standards provides a presumption of conformity with the essential requirements they aim to cover, providing their references have been published in the Official Journal of the European Union.

National standards and rules can also apply. Compliance with these rules allows products to be sold and traded freely in the EU.

Specific EU-wide harmonized rules apply to chemicals, biocides, plant protection products, cosmetics and pharmaceuticals.

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. This can result in marketing restrictions, withdrawals or recalls of a product. In the case of serious product risks to the health and safety of consumers in various member states, the GPSD also provides the option for the European Commission to take temporary emergency measures.

In addition, producers can be held liable for defective products, that is, products not providing the safety that a person is entitled to expect under Council Directive 85/374/EEC concerning liability for defective products.

 More information about product safety requirements

4.2 European Certification

4.2.1 CE marking

The CE symbol is affixed to a product by its manufacturer before being placed on the EU market to certify that the product has been assessed and complies with all EU requirements for safety, health and environmental protection.

A product with the CE mark can be sold anywhere in the European Economic Area, which unites the EU Member States and the three EEA EFTA States (Iceland, Liechtenstein, and Norway) into an internal market.

4.2.2 Which products require CE marking?

The CE mark is mandatory for certain product groups. The European Commission lists the 25 product groups that require the CE mark along with the applicable directives, technical documents and other instructions includes the following categories:

In some cases, a single product can belong to more than one category.

The CE mark does not apply to foodstuffs, motor vehicles, chemicals, cosmetics, pharmaceuticals and biocides.

Note: It is prohibited to use the CE mark on a product that does not fall into one of the categories that require the mark.

4.2.3 CE process

When importing from non-EU countries, importers in the EU must check that products fulfil all EU safety, health and environmental protection requirements before placing them on the market.

Manufacturers established in Canada have the same obligations as EU manufacturers to ensure that their products conform with all relevant EU safety requirements.

The importer has to verify the following:

Manufacturers may appoint an authorized representative established in the EU to carry out certain administrative tasks on its behalf.

Note: It is mandatory to appoint an authorized representative 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.

Once it has been established that a product falls under the scope of EU legislation, the manufacturer must confirm that it complies with the essential requirements in 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. Although manufacturers are not required to use the harmonized standards, full compliance with the standards is a reliable way to ensure compliance with the relevant essential requirements of the EU directives. Whenever possible, Canadian exporters are advised to follow the harmonized standards.

More information about CE harmonized standards

Conformity assessment

The manufacturer must assess the product’s conformity to demonstrate whether it fulfills the specified requirements in the directives.

Conformity-assessment procedures are included in the annexes of the directives.

For some products, a notified body must be involved in testing and certification, for example, laboratories. Notified bodies are authorized third-party conformity-assessment bodies. Conformity assessment is the responsibility of the manufacturer, regardless of whether the manufacturer conducts the assessment, which is possible for most products, or involves a notified body. The manufacturer must document the information obtained during the conformity-assessment procedure 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 (DoC) is a formal declaration in the official language of the country of import into the EU, signed by the manufacturer or an authorized representative, that the product meets all requirements of the applicable directive(s). The DoC must be kept with the technical file. Some directives require that products be accompanied by the DoC.

Conformity assessment 

Six steps to CE marking

The European Commission has consolidated into the six steps what manufacturers have to do before they may affix the CE mark.

4.3 Chemicals - REACH

Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) (Regulation EC 1907/2006)) is the general EU framework for the regulation of chemicals.

REACH ensures that industry manages the risks that chemicals may pose to health and the environment and for providing relevant information to users along the supply chain. The European Chemicals Agency (ECHA), based in Helsinki, Finland, is the competent authority for the application of REACH. ECHA, together with authorities from the member states and the European Commission, manages the registration, evaluation, authorization and restriction processes that apply to chemical substances sold throughout the EU.

4.3.1 REACH mandate

REACH applies to:

REACH affects:

Canadian exporters without a presence in Europe can comply with REACH through an:

To locate an Only representative, contact:

4.3.2 Complying with REACH

REACH is one of the EU’s most complex pieces of legislation:

REACH registration

For substances manufactured or imported in quantities of one tonne or more per year per company (legal entity), EU manufacturers and importers must submit a registration dossier to ECHA. The requirement to register also applies to imported mixtures and articles containing substances intended to be released from the article under normal or reasonably foreseeable conditions of use.

The mandatory content of the registration dossier is:

For quantities of ten tonnes and more, exporting companies must also submit a safety assessment:

Registration of a dossier to ECHA

Phase-in substances

The registration process for chemicals already manufactured or placed on the market started in 2008, before the entry into force of REACH. These products are referred to as phase-in substances and are subject to the imposition of various REACH registration deadlines depending on their tonnage.

The last deadline was May 31, 2018, for the registration of substances manufactured or imported in quantities between one and 100 tonnes per year that were pre-registered. New (“non-phase-in”) substances must be registered immediately once the yearly weight imported reaches one tonne.

Substances imported in excess of one tonne 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. The companies must still register some information separately. Pre-registrants of the same substance are grouped into substance information exchange forums. In some cases, industry groups have also set up consortia to generate and manage the necessary data for joint sharing and registration.

More information about REACH

REACH evaluation

The REACH evaluation process covers:

In either case, authorities may require registrants to conduct further testing.

REACH authorization

Substances whose properties can be harmful to health or the environment may be identified as substances of very high concern (SVHCs) under certain conditions.

These substances include:

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. Substances identified as SVHCs are listed on the REACH candidate List.

Once a substance is recorded in the Candidate List, it can be listed in REACH Annex XIV as a substance that requires authorization.

Authorization is a complex process. Companies have an obligation to show that:

Substances on the Authorisation list cannot be placed on the EU market or used after a given date, unless

EU manufacturers, importers, Only Representatives (OR), and downstream users of chemicals can apply for authorisation.

The Candidate list of SVHCs and the Authorisation list are updated regularly.

REACH restrictions

Restrictions can be imposed on substances that pose unacceptable risks.

A restriction may apply to

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, including distributors and consumers. Manufacturers or importers must prepare Safety Data Sheets for all dangerous substances or mixtures in accordance with REACH Annex II, and these must be passed down the supply chain.

Guidance on the compilation of safety data sheets

If a finished product or article contains a substance on the Candidate List of SVHCs in a concentration above 0.1 percent by weight, the EU manufacturer or importer must provide users with information on the safe use of the product.

For complex objects, this threshold applies to each article composing the complex object. ECHA must also be notified if an article contains a substance on the Candidate List.

ECHA Guidance on substances in articles

Note: Canadian exporters need to stay up-to-date with how REACH impacts their products. REACH regularly updates the lists of substances affected by REACH.

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.

4.4 Biocides and plant protection products

The EU regulation on the use and placing on the market of biocidal products came into effect September 1, 2013. BPR, Regulation (EU) N. 528/2012 replaces 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.

Annex V of the Biocidal Products Regulation

The authorization of biocidal products involves:

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. These include textiles or furniture treated with or incorporating a biocidal product. This has important implications for exporters to the EU because articles can be treated only with active substances approved in the EU. Labelling requirements for some treated articles also apply.

A significant number of active substances are under review. For these, the BPR provides for a number of transitional measures allowing them to enter the EU market:

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

The centerpiece of the EU regulatory regime for plant protection products (PPPR) is Regulation 1107/2009.

PPPR provides a dual authorization system for plant protection products:

The PPPR contains provisions on data protection, confidentiality of information and data sharing.

In Europe, pesticide is a broad term that covers non-plant/crop uses as well as biocides.

More information about use of plant protection products

4.5 Cosmetics

Before it can be placed on the EU market, the manufacturer of a cosmetic product must designate a responsible person such as an EU manufacturer, importer or a third party to ensure that the product complies with the applicable EU legislation. The Responsible Person compiles the technical documentation for the cosmetic product and includes this documentation along with the results of safety assessments in the product information file. The authorities may request the file.

Before a cosmetic product can be placed on the EU market, the Responsible Person must

Cosmetic products product labelling and claims are regulated under Regulation No 1223/2009/ CE.

The cosmetics regulation lists banned and restricted substances.

Colorants, preservatives and UV filters, including nanomaterials, must be explicitly authorized.

Restrictions on ingredients are listed on CosIng, the European Commission database for information on cosmetic substances and ingredients.

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.

4.6 Pharmaceuticals

4.6.1 Marketing authorization

To enter the EU, medicinal products for human use must be authorized at either the member state level 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:

Regulation (EC) No 726/2004 Annex I

At the member-state level, companies have the choice between

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:

4.6.2 Good manufacturing practice

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

Applicable legislation

4.7 Medical devices

In May 2017, two EU regulations on medical devices provisionally entered into force: 

These new regulations replace existing legislation. Following a transition period, they will be fully implemented on May 26, 2020, and May 26, 2022, respectively.

Medical devices are classified based on their degree of invasiveness and their intended use. 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.

Only medical devices that comply with the MDR may be placed on the market or put into service in the EU.

Borderline products 

The medical devices legislation establishes essential safety and performance requirements that must be met. Manufacturers can rely on harmonized EU standards to benefit from a presumption of conformity with these requirements and affix the CE mark. In some cases, the conformity assessment can include notified bodies.

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.

More information about medical devices

Table of contents

Chapter 5: Packaging and labelling

A multitude of product labels exist in the EU, including:

Products imported into the EU need to satisfy these labelling requirements.

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

Image showing European Commission’s product warning labels

The classification, labelling and packaging (CLP) regulation covers chemical substances and mixtures composed of two or more chemical substances, including consumer items such as paints and detergents.

Note: the CLP Regulation does not apply to medicinal and cosmetic products, medical devices, waste and foodstuffs.

The CLP Regulation follows the United Nations Globally Harmonized System of the Classification and Labelling of Chemicals system (GHS). It classifies chemicals according to their hazardous properties, for example, explosive, flammable and/or toxic.

Any package containing substances or mixtures classified as hazardous must be clearly labelled with the information listed in Article 17 of the CLP Regulation.

This information includes:

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

The CLP Regulation also provides conditions for the application, format, readability and location of labels.

Packaging containing hazardous substances and mixtures must:

Additional packaging requirements may apply such as child-resistant fastenings and tactile warnings.

5.1.2 Energy labelling

The EU energy label on a product provides the consumer with information concerning its energy efficiency.

Energy labels are mandatory for all appliances and energy-related products, including in the commercial and industrial sectors, sold in the EU for which a label exists.

Labels provide information about a product’s:

The energy labelling regulation sets a framework for the adoption of product-specific energy labels, including those for televisions, washing machines and dishwashers. Following the adoption of this regulation, an energy-rating scale from A (most efficient) to G (least efficient) will replace the rating system currently in use (A+++ to G).

The regulation :

Regulation (EU) No. 2017/1369 framework for energy labelling

5.1.3 Electrical and electronic equipment

Image showing European Commission symbol indicating that equipment should not be placed in the normal waste stream

Waste electrical and electronic equipment (WEEE) directive

The WEEE 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:

After August 15, 2018, the legislation will apply to all electrical and electronic equipment unless the equipment falls under one of the exceptions mentioned in Article 2 of the WEEE directive.

The WEEE directive requires that waste electrical and electronic equipment bear a symbol depicting a waste bin with an X indicating that it should not be placed in the normal waste stream.

WEE Directive - 2012/19/EU 

Restriction of the use of certain hazardous substances in electrical and electronic equipment directive

While the WEEE directive aims to divert e-waste from landfills, the directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) aims to reduce the hazardous content of electrical and electronic equipment.

RoHS restricts the use of certain hazardous substances in electrical and electronic equipment, including

More about the RoHS directive

5.1.4 Cosmetics labels

The cosmetics regulation sets out labelling requirements for cosmetic products. Both containers and packaging must be clearly marked with the following information:

Refer to Chapter 4: Product Safety and Chemical Safety of this guide for EU requirements for the composition and marketing of cosmetic products.

Image showing symbol indicating that that a leaflet accompanying the product lists relevant information
Leaflet accompanying the product lists relevant information.
Image showing European Commission date of minimum durability symbol
Period after opening.
Image showing European Commission date of minimum durability symbol
Date of minimum durability

More information about cosmetic labels

5.1.5 Genetically modified organisms

Products containing genetically modified organisms (GMOs) and food and animal feed derived from them need to be labelled indicating they contain GMOs. This requirement applies to both pre-packaged and non-pre-packaged products.

5.2 Voluntary labels

5.2.1 Ecolabel

Image showing European Commission Ecolabel logo

The EU Ecolabel system is a voluntary labelling system that promotes and identifies “green” products. CETA supports the system as part of promoting sustainable development (Article 22.3.2(a)).

The Ecolabel is awarded to products with reduced environmental impacts throughout their lifecycles. Products must comply with criteria related to energy consumption and pollution.

Criteria exist for more than 20 product types, including:

More information about Ecolabel

5.2.2 Organic products

Image showing European Commission organic production logo

To be marketed in the EU as organic, a product must comply with food-import requirements and organic-product legislation on organic production and labelling of organic products.

The use of the EU organic production logo is:

If used on imported products, the place where the agricultural raw materials that make up the product have been farmed must appear in the same visual field as the logo.

Article 25 (1) of Organic production and labelling of organic products - Regulation (EC) No. 834/2007

Labels must be clearly visible on product packaging and reference the certification control body:

Refer to Chapter 3: EU sanitary and phytosanitary requirements

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. However, they must be accompanied by an electronic certification of inspection that must be completed using the electronic Trade Control and Expert System (TRACES).

More information about using the organic logo

5.2.3 Prepackaged products

Image showing European Commission e-mark logo. Indicates that a product meets measurement standards.

The e-mark on pre-packaged goods indicates that the package was filled in accordance with the standardized method provided by the directive on pack sizes. Containers with the e-mark must also indicate the quantity of the product expressed as either weight or volume.

The directive applies to packages between:

The e-mark is not mandatory, but it is recognized throughout the EU as a measurement “passport.” The packer (or the importer) is responsible for the accuracy of all measurements.

More information about using the e-mark

Directive 76/211/ EEC

European Commission - Legal metrology

5.2.4 Green dot

Image showing European Commission Green Dot logo. Indicates that a product meets design and manufacture of packaging standards.

The EU packaging and packaging waste directive covers the handling of all packaging and packaging waste for industrial, commercial and household products sold in the EU.

The directive:

Pro Europe is the umbrella organization for European packaging and packaging waste-recovery and recycling schemes, including the Green Dot program. The Green Dot on packaging indicates that the company has joined a packaging-recycling scheme in accordance with the directive.

More information about using the Green dot

Table of contents

Chapter 6: EU consumer rights

The European Union, its member states and the local courts have a tradition of strong consumer protection through comprehensive legislation. Contracts are usually interpreted to give consumers the advantage.

6.1 EU Consumer protection directives

In the EU, breach of consumer law is considered contrary to public order and will generally result in a contract being nullified if requested by the consumer. Consumers in the EU are protected by following four directives:

These directives only apply if the habitual residence of the consumer is in an EU member state, provided that the trader pursues its commercial activities in that country of residence or, by any means, directs such activities to that country.

Canadian exporters of consumer goods to the EU will need to comply with the following requirements:

A commercial practice is regarded as misleading if

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.

Refer to Annex I of the unfair commercial practices directive for a list of commercial practices that are in all circumstances unfair.

A commercial practice is regarded as aggressive if:

Contracts 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.

The consumer rights directive adds additional rules of conduct for traders to protect consumers:

More information about consumer protection directives

6.2 Guarantees

Under the product warranty directive, a two-year guarantee period applies to the sale of all consumer goods in the EU starting from the date of delivery of the goods:

Additional commercial guarantees must be clearly drafted and indicate any additional rights.

Note: in some EU member states, legislation provides longer guarantee periods than that specified in the directive.

More information about guarantees

6.3 Data protection

The general data protection regulation (GDPR) applies directly throughout the EU and the European Economic Area (EEA) as of May 25, 2018.

The GDPR:

The GDPR sets out the following main principles relating to the processing of personal data:

The territorial scope of the GDPR reaches beyond the EU.

It applies to Canadian businesses where the business is engaged in the processing of personal data belonging to EU data subjects in the following cases:

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.

This obligation to designate an EU representative does not apply in the following cases:

The GDPR confers new rights on data subjects and extends existing ones.

Under the GDPR, data subjects have the right to:

When personal data is transferred from the EU to Canada, the GDPR requires that the level of protection of personal data:

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 that under the terms of Canada’s Personal Information Protection and Electronic Documents Act (“PIPEDA”) Canada was deemed to provide an adequate level of protection for personal data transferred from the EU to recipients in Canada. This assumption remains in force under the GDPR, which was not in effect at that time.

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 does so, Canadian businesses must comply with the EC’s original decision on December 20, 2001.

In the absence of an adequacy regime with respect to a third country, the GDPR permits transfers outside the EU where:

Alternatively, appropriate safeguards might be put in place between contracting parties by the adoption of European Commission approved standard, or model, clauses 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:

Canadian businesses should determine whether the GDPR is applicable if:

Companies must comply with the GDPR if it is applicable.

More information about data protection

Table of contents

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 protects IPR against piracy, illegal trade and counterfeiting under the directive against unlawful acquisition, disclosure and use of trade secrets.

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:

Directive 2016/943/EU

7.1 Find an IP professional

Intellectual property rights are territorial: registration of intellectual property in Canada provides no protection in Europe. If you are considering exporting to the EU, you should seek professional advice to protect your intellectual-property rights.

Free help from the Government of Canada

7.2 Patents

A patent is a legal title that can be granted for any invention having a technical character provided that it is:

Patents offer protection for 20 years.

Inventions can be protected in Europe either through:

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.

Discussions are ongoing toward a unified patent system that would be 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.

The Unified Patent Court would be created for participating EU member states. A single patent court would ensure more legal certainty by avoiding parallel litigation before multiple national courts, which could result in different interpretations and rulings.

More information about patents

7.3 Trademarks

Trademarks are the indications such as words, phrases, logos and sounds that companies use to identify and distinguish their goods or services from those of their competitors. In the EU, trademarks are protected for renewable terms of 10 years by the directive on the harmonization of trade mark law.

Businesses can apply for:

With a single registration, the European Union trademark offers protection in all 28 EU member states.

The EU also maintains a database of geographical-indications that are associated with agricultural products 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.

More information about trademarks

7.4 Designs

Design refers to the appearance of the whole or part of a product resulting from the features of, in particular, the lines, contours, colors, shape, texture and/or materials of the product itself and/or its ornamentation. Design is regulated by the directive 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 community design protection throughout the EU.

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

More information about designs

7.5 Copyright

Copyright protects original creative material such as music, 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 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 useful in the event of disputes, but not mandatory. 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. A directive on collective rights management and multi-territorial licensing of rights in musical works for online uses has already been adopted.

More information about copyright

7.6. Geographical indications and other quality labels

7.6.1 Systems of protection

The European Union has set up a system for the valorization and protection of agricultural products and foodstuffs to

European regulations lay down three protection systems, each with its specific characteristics.


Image showing European Commission protected designation of origin logo.

Protected designation of origin (PDO)

The 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 and local expertise. The product must have been produced, processed and put together in that specific geographical area.

Examples:

PDO registered in Belgium: “Herve Cheese” (1996);“Ardenne Butter” (1996);“Wine of Cotes of Sambre and Meuse” (2004); Cremant and Sparkling Quality Wine of Wallonia (2008)

Other well-known PDO registrations: ”Normandie Camembert” (France); “Feta” (Greece);“Brie de Meaux” (France); “Pecorino Toscano” (Italy);“Queso Manchego” (Spain)


Image showing European Commission protected geographical indication logo.

Protected geographical indication (PGI)

The PGI may be attributed to agricultural products or foodstuffs that are from a specific region and for which a specific quality, reputation, or other characteristic may be attributed to that region. The product must have been produced and/or processed and/or put together in the specific geographical area.

The conditions required for attributing a protected geographical indication are more flexible than those required for a protected designation of origin.

A PGI:

  • can be attributed even if only one of the PGI criteria can be attributed to the product’s geographical origin
  • can be attributed if only one of production, processing or assembly are required to have taken place in the specific geographical area

Examples:

Ardenne Ham; Paté Gaumais; Brussels Chicory; Country wines from the Gardens of Wallonia; Mattons de Geraardbergen; Flat Potatoes of Florenville

Reblochon; Normandy Cider; Salt of Guerande; Nocciola del Piemonte


Image showing European Commission logo representing recognition as a traditional speciality guaranteed

Recognition as a traditional speciality guaranteed (TSG)

The 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, that is, the characteristics that 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.

Examples:

Geuze beers; Faro Beers; Kriek Beers; Lambic Beers

Mozzarella; Pizza Napoletana; Jamon Serrano; Bouchot Mossels

7.6.2 Procedures and registration 

PDO, PGI and TSG provide exclusive rights of use to producers of a product.

To receive this protection for a designation:

Note: This process is not open to individuals: only a national group of producers or collective processors of the product in question, often agricultural organizations, may file a request for a designation.

The registration procedure is carried out as follows:

The local authorities generally grant provisional protection to products during the review process.

Note: Specific arrangements are provided for wines and spirits.

European Commission, Rural agriculture and development

7.6.3 Protection

Once recognized, PDO and PGI confer a fairly broad protection. This protection is defined by Article 13.1 of the (EC) no. 510/2006:

  1. 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;
  2. 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”;
  3. 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;
  4. 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.

Table of contents

Chapter 8: Business travel

8.1 Passports and visas

Visa rules differ according to whether the EU country being visited is party to the Schengen Convention.

Schengen area countries

The Schengen AreaFootnote 3is 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 may move freely within the Schengen Area. 

Canadian travelers visiting the Schengen Area for short stays, that is fewer than 90 days in any 180-day period, do not require visas. They must, however, hold a Canadian passport valid for at least three months after the date of return.

Schengen short-stay calculator 

Travelers should:

Long-stay visas remain subject to national conditions.

Non-Schengen area countries

Six EU member states are not party to the Schengen Convention:

None of these six EU countries imposes the requirement for visas on Canadian citizens for short-stay tourism and business trips. Contact the relevant embassy or consulate if you plan to stay longer.

Embassies or consulates in Canada

Visas are required for the Schengen Area for longer-term stays (currently, six months in the United Kingdom and 90 days in the other countries) and along with required travel documents.

Contact the appropriate embassy or consulate for more information:

Visa requirements for the Schengen area

Countries whose nationals require visas for the Schengen Area

Border controls

Border officials in EU countries may ask for other supporting documents, such as:

Contact the appropriate embassy or consulate to find out what documents you will need to bring with you.

More information about travelling to Europe

8.2 Temporary entry of materials

When bringing professional equipment into Europe, you should:

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.

How to Apply for an ATA Carnet

8.3 Labour mobilitty under CETA

CETA facilitates labour mobility by permitting the temporary entry and stay of certain groups of business persons and business activities. CETA’s temporary entry and stay provisions are generally aimed at executive level and highly skilled professionals, as opposed to general labour or permanent employees.

Under CETA, labour mobility is only contemplated for temporary periods and does not address

While the scope of commitments relating to labour mobility in CETA are the best provided in any current free trade agreement, the rules under CETA are very detailed and specific for each category of visitor.

Visitors should not rely on CETA provisions but should consider each situation on a case-by-case basis:

In general, the following categories of persons are granted temporary mobility rights if they meet requirements established under CETA:

Short-term business visitors

Annex 10-D of CETA sets out a list of activities that are permitted for short-term business visitors:

The maximum period of stay for a short-term business visitor under CETA is 90 days in any six-month period.

Under CETA, short-term business visitors cannot:

A business visitor for investment purposes, on the other hand, is defined as an employee in a managerial position or specialist position who:

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 services span 37 sectors or sub-sectors of activity such as

The following categories of professionals are recognized under CETA:

For the purposes of this guide, contractual services suppliers are natural persons employed by a Canadian business that:

The contractual service provider must:

An independent professional:

The independent professional must possess at least six 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 a professional title where the service is provided may, however, be restricted.

Unlike for business visitors, CETA sets out certain minimum requirements for contractual service suppliers and independent professionals.

These include possessing a:

Contractual service suppliers and independent professionals are also subject to specific restrictions on the liberalization of professional services that differ in scope and sector among member states. These are set out in Annex 10-E of CETA.

Example:

With respect to architectural services and urban planning, and landscape architectural services, Canadian contractual service suppliers and independent professionals are subject to restrictions under CETA:

Contractual service suppliers and independent professionals may be admitted to the EU under CETA for a maximum cumulative period of 12 months during any 24-month period or the length of the contract, whichever is shorter.

Extensions may be granted to:

Intra-corporate transferees

CETA’s labour mobility provisions cover intra-corporate transferees. For the purposes of this guide, these are people who have been employed by a Canadian business or have been partners in a Canadian business for at least one year and who are temporarily transferred to an EU-based part of the business. Examples include a subsidiary, branch, or head company of the business in the EU.

The categories of intra-corporate transferees are limited to:

Each category has further requirements under CETA.

 Senior personnel and specialists:

Graduate trainees may seek admission for an initial period of one year or the length of the contract, whichever is shorter, but are not permitted to extend their work permits.

Investors

Under CETA, an 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.

These investors must meet certain eligibility requirements set out under CETA.

The investor may stay in the EU for an initial maximum period of one year. The length of stay may be extended, upon request and at the host party’s discretion.

More information about labour mobility

8.4 Mutual recognition agreements 

CETA includes a framework for the mutual recognition of 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.

Note: MRAs must be concluded at the Party level that is 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, local laws and culture, entry and exit requirements, and health.

More information about EU member countries

EU member countries in brief

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