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.
The Canada-United Kingdom Trade Continuity Agreement entered into force on April 1, 2021 - preserving preferential market access for both Canadian and UK businesses. Visit Doing business in the UK for more information on accessing the UK market.
- Chapter 1 - The EU and EU markets
- 1.1 EU and other European countries
- 1.2 The EU economy in the world
- 1.3 Canada and the EU
- 1.4 EU bodies and laws: the basics
- 1.5 Helping Canadian exporters
- Chapter 2 - Customs
- 2.1 Classifying goods
- 2.2 Calculating customs duties: rules of origin and valuation
- 2.3 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 exporting 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 European Certification
- 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 Find an IP Professional
- 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).
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.
- provides general information to readers who take full responsibility for its use
- is not a substitute for professional or legal advice
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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 27 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
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:
The following countries are recognized as candidates to join the EU although accession timelines have not been set:
- former Yugoslav Republic of North Macedonia (fYRoM)
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:
- the world’s largest trading bloc
- the world’s second-largest economy, with a total population of over 511 million and a GDP of over $21.7 trillion
- diverse, with both large and small national economies as well as advanced and emerging markets
- a major importer and exporter of goods and services
In 2018, the EU:
- held the second-largest share of global exports and imports of goods
- exported goods equivalent to 15.5% of the world total
- imported primary products, raw materials and energy, along with capital equipment, chemicals and consumer goods
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.
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.
- Canada’s trade in goods with the EU accounted for 10% of its total trade with the world
- the EU accounted for approximately 8% (7.62%) of Canada’s total goods exports
- Canada accounted for 2% of the EU’s total external goods trade
- bilateral trade in goods between the EU and Canada was valued at approximately $90.9 billion
In 2018, the most important category of goods traded between Canada and the EU were:
- machinery (25.6% of EU exports to Canada and 24.3% of its imports)
- chemical and pharmaceutical products (16.2% of EU exports and 9.1% of its imports)
- transport equipment (15.6% of EU exports and 9.1% of its imports)
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:
- modernize, simplify and standardize customs procedures to reduce transaction costs on goods resulting from customs processes.
- implement simplified and, where possible, automated procedures for the efficient release of goods such as:
- release of goods at the first point of arrival
- simplified documentation requirements for the entry of low-value goods and pre-arrival processing
- increased transparency arising from clarification upon request of tariff classifications of goods leading
Access to EU government procurement contracts
Under CETA, Canadian companies can now:
- bid on EU government procurement opportunities
- 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
- access a $1.9-trillion annual market
Practical guidance on EU government procurement
EU Government Procurement Guide for Canadian companiesFootnote 2.
Preferential access is granted to:
- Canadian small and medium-sized enterprises in the EU market
- most Canadian service sectors (certain sectors have been excluded)
CETA facilitates trade by:
- encouraging regulatory cooperation between the Parties
- identifying and removing barriers to trade and investment
- providing a platform for regular information sharing between Canadian and EU regulators to promote good practices, transparency and early engagement
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.
- cover short-term business visitors, investors, intra-company transferees, senior managers, and trainees
- reduce costs for Canadian companies doing business in the EU
More information about labour mobility
Chapter 8.3: Labour mobility under CETA
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:
- Council of the EU, with representatives of the executive governments of all 27 member states
- European Parliament, whose representatives are directly elected by EU citizens
- European Commission, which is referred to as the Guardian of the EU Treaties, is the executive branch comprising a president and 27 commissioners that together make up the College of Commissioners
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:
- confer binding legal force throughout every member state
- enter into force on a set date across the EU for each member state
Example of regulations
- allow for a certain degree of harmonization across the EU
- require all member states to achieve certain outcomes
- grant freedom to member states on how to transpose directives into national law
- allow member states to apply their own interpretations and applications when transposing
Example of directives
- EU laws adopted in relation to specific judicial cases
- directed to individual or several member states, companies or private individuals
- binding upon those to whom they are directed
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:
- on-the-ground intelligence
- problem-solving services
- qualified contacts
- strategic alliances
- practical advice on international markets
The TCS offers information about:
- national markets in the EU, including market facts and reports, information on trade events and practical advice on local markets
- specific sectors
- market opportunities
- finding EU business partners
Get help from the Trade Commissioner Service:
- Find a trade commissioner
- Step-by-Step Guide to Exporting
- Country and sector information for international business
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 27 EU member states.
Information about Canada-EU trade
- Industry Canada – Trade data online
- European Commission – Trade with Canada
- Agriculture and Agrifood Canada
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 27 (current) EU member states, the EU customs territory includes territories that are not covered by the Treaties.
- Cyprus (certain territories)
- Channel Islands
- Isle of Man
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:
- determine whether the good is subject to export restrictions
- issue certificates of origin
- claim an export refund
- determine the excise duty where applicable
- benefit from a reduced value-added tax rate where applicable
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.
|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.
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.
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
- specific duty, which is a fixed amount per physical unit, for example kilogram, litre, or percentage of alcohol content, or
- mixed duty, which is 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 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.
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:
- duties applicable to a product
- information about tariff phase-out for the product three to seven years following implementation of CETA
- comparisons with duties applicable to the product in other markets
To use TARIC to find customs duties and EU measures:
- Enter the product code and the country of origin.
- Click on retrieve 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:
- standard rates may not be less than 15%
- reduced rates may not be less than 5%
- for some goods or services, the reduced rate cannot be lower than 12%
- certain EU countries may maintain reduced rates lower than 5%
More information on VAT rates
- EU VAT Rate – Trade Help Desk (general information)
- Goods subject to reduced VAT rates
- Directive 2006/112 on the common system of VAT (Annex III)
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
- create a level playing field across the EU
- introduce more flexibility
- simplify the regime by replacing the current exception based system with a system based on general rules
- reduce overall costs for SMEs
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.
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.
|Goods||Invoice Price||Shipping and insurance||Customs value||Customs duty||Value for VAT||VAT (Belgium)||Total duties and VAT|
|Frozen Atlantic Salmon||600||200||800||2% = 16||816||6% = 48.96||64.96|
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)
- CETA provides for more preferential TRQs for specific goods imported into the EU from Canada. goods subject to CETA-specific TRQs - CETA pages 201-216 for
- CETA pages 181-190 Annex 2-A
Agreed TRQs on certain goods will gradually increase each year for a period of six years after entry into force of CETA.
- TRQ for Bison is 3,000 (Metric tonnes - Carcass Weight Equivalent) for year one and each subsequent year
- TRQ for Pork is 12,500 (Metric tonnes - Carcass Weight Equivalent) for year one with a progressive increase each year up to 75,000 for year six and each subsequent year
- TRQ for Sweetcorn is 1,333 (Metric tonnes) for year one with a progressive increase each year up to 8,000 for year six and each subsequent year
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:
- commercial invoices
- transport documents such as bills of lading
- certificates of origin
- import licences
- inspection certificates such as health, veterinary or plant-health certificates.
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.
- Checklist for Exporting Commercial Goods from Canada
- Commission’s Directorate General for Taxation and Customs Union
- EU National Customs Websites
- Documents for customs clearance
- 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.
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.
- general food law: Regulation (EC) 178/2002 on the general principles and requirements of EU food law
- hygiene legislation: the 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:
- control of contaminants in foodstuffs
- rontrol of pesticide residues in plant and animal products intended for human consumption
- Residues of veterinary medicinal products
- EU rules on microbiological criteria for foodstuffs
- information on legislation for food additives and flavorings, and special rules on Genetically Modified Organisms and a newly adopted regulation for novel foods
- European Commission’s special rules on labelling and nutrition
EU legislation establishes official controls along the food chain:
- Products derived from animals - Regulation 854/2004
- Regulation 882/2004 for verification of compliance with laws on feed and food, and animal health and welfare
3.1.2 Food labelling and packaging: overview
126.96.36.199 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:
- include information about nutrition
- list all potential allergens (e.g. nuts, cow’s milk, shellfish)
- meet new standards for legibility
- list product origin (some products)
- indicate date of freezing (unprocessed frozen meat and fishery products)
More information on food safety
- Q&As on new EU labelling requirements
- EU register of permitted nutrition and health claims made on foods
- European Commission (DG SANTE) - food labelling
In addition to general rules, specific labelling rules apply to:
188.8.131.52 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:
- be manufactured in line with good manufacturing practices (Regulation 2023/2006)
- 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 lists materials and articles such as plastics, ceramics and glass that may be covered by specific measures.
The list includes information about:
- authorized substances
- purity standards
- special conditions of use
- provisions for ensuring traceability
- rules for the authorization of substances
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:
- text “food contact”
- wine glass and fork symbol, which identifies that the material used in the product is safe 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:
- originate in countries approved by the EU for those categories of products
- come from approved processing establishments in Canada approved to export to the EU
- are accompanied by a health certificate signed by the Canadian Food Inspection Agency during evolving disease situations in the member states
- have passed health controls such as veterinary checks carried out at the border inspection post in the EU country of arrival
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 Commission - Animals
- Health control of fishery products for human consumption
- 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 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:
- be accompanied by a plant-health certificate issued by the CFIA
- 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
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.
- marketing requirements for marketing requirements for seeds and plant propagating material
- organic products
- health control of food and feed of non-animal origin[AM2]
- European Commission Food Safety
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
Table of contents
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:
- 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, 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:
- manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market
- necessary documentation such as the EU Declaration of Conformity and the technical documentation is available upon request
- manufacturer can be readily contacted
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
- European Harmonized Standards
- European Committee for Standardization (general standards)
- European Committee for Electrotechnical Standardization (electro technical standards)
- ETSI (telecommunications standards)
- Council of Canada/ Conseil canadien des normes
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.
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:
- all categories of chemical substances manufactured, imported or used in the EU, with a few exceptions
- chemicals contained in mixtures and in finished products
- almost every industrial sector from chemicals, plastics and cosmetics to the automotive, aerospace, household cleaners, computers and textiles sectors
- almost all products manufactured in Canada and exported to the EU.
Canadian exporters without a presence in Europe can comply with REACH through an:
- EU importer, or;
- Only Representative (OR) established in the EU.
To locate an Only representative, contact:
- Contact the Mission of Canada to the EU
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.
- Get expert advice to ensure your product complies with REACH.
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:
- set out in REACH
- includes information on the properties, uses and classification of the substance, as well as guidance on safe handling
For quantities of ten tonnes and more, exporting companies must also submit a safety assessment:
Registration of a dossier to ECHA
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
The REACH evaluation process covers:
- dossier evaluation to ensure dossiers comply with the applicable requirements, for example, testing proposals and compliance checks
- substance evaluation to ensure the substance does not pose a risk to human health or the environment that needs further investigation
In either case, authorities may require registrants to conduct further testing.
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:
- persistent, bio-accumulative and toxic substances
- substances considered of equivalent concern such as endocrine disruptors
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:
- risks to health and the environment are adequately controlled
- socio-economic benefits outweigh the risks
- suitable substitutes are unavailable
Substances on the Authorisation list cannot be placed on the EU market or used after a given date, unless
- an authorization has been granted for their specific use or has been applied for in due time or
- their use is exempted from authorization as is the case for instance for intermediates
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.
Restrictions can 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
- substances that do not require registration, for example, those imported in quantities under 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, 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.
- Classification and Labelling Inventory
- the CLP regulation on the classification, labeling and packaging
- European Chemicals Agency (ECHA)
- ECHA contacts
- REACH guidance documents
- REACH, CLP and biocides for non-EU companies
- Registration, Evaluation, Authorisation of Chemicals (REACH) Legislation
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:
- Centralized decisions on the acceptability or non-acceptability of active substances on the basis of harmonized criteria are made at the EU level.
- Authorization of plant protection products is granted by member states according to different formulations under various agricultural, plant health and environmental conditions.
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
- Regulation 396/2005 legal limits for pesticide residues in food and feed
- ED criteria for pesticides
- Plant Protection Products Regulation
- Regulation (EC) No 1107/2009 placing of plant protection products on the market
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
- notify the European Commission about the cosmetic product via the Cosmetic Products Notification Portal
- inform national authorities of any serious undesirable effects attributable to the use of the product
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.
4.6.1 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:
- mandatory for certain types of medicines such as those used to treat AIDS, cancer or diabetes
- optional for others
Regulation (EC) No 726/2004 Annex I
At the member-state level, companies have the choice between
- decentralized procedure where companies apply for a marketing authorization of a medicinal product simultaneously in several countries with one member state being the reference country
- mutual-recognition procedure where companies that have a medicine authorized in only one country can apply for that 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
- 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 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.
- Directive 2001/83/EC, medicinal products for human use
- Directive 2001/82/EC, medicinal products for veterinary use
4.7 Medical devices
In May 2017, two EU regulations on medical devices provisionally entered into force:
- Regulation (EU) on medical devices 2017/745 (MDR)
- Regulation (EU) on in vitro diagnostic medical devices 2017/746 (IVMDR)
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.
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:
- EU labels
- national labels
- mandatory labels
- voluntary labels
- environmental, energy, food and cosmetic labels
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
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:
- name of the substance or mixture
- name, address and telephone number of the supplier
- nominal quantity of the substance or mixture made available to the general public
- product identifiers
Substances or mixtures classified as hazardous must also include, where applicable:
- signal words such as “danger” or “warning”
- hazard pictograms
- hazard statements such as “fatal if swallowed”
- appropriate precautionary statements such as “keep out of the reach of children”
- supplemental information
The CLP Regulation also provides conditions for the application, format, readability and location of labels.
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.
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:
- noise emissions
- consumption of water and energy
- energy-efficiency rating
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 :
- provides customers with access to the database of product labels and information sheets
- bans “defeat devices” that alter the product’s performance under test conditions
- requires the provision of standard product information regarding energy efficiency and consumption
Regulation (EU) No. 2017/1369 framework for energy labelling
5.1.3 Electrical and electronic equipment
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:
- 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
- automatic dispensers.
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
- heavy metals such as lead, mercury, cadmium
- hexavalent chromium
- flame retardants such as polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE)
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:
- name and address of the 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) marked with the appropriate symbols
- special provisions for small products that are difficult to label
Refer to Chapter 4: Product Safety and Chemical Safety of this guide for EU requirements for the composition and marketing of cosmetic products.
Leaflet accompanying the product lists relevant information.
Period after opening.
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
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:
- rinse-off cosmetic products
- household appliances
- wooden furniture
More information about Ecolabel
- European Commission - Product Groups and Criteria
- How to apply for EU Ecolabel
- Regulation (EC) No 66/2010
- European Commission - Ecolabel
- EU brochure on the Ecolabel
5.2.2 Organic products
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:
- mandatory for organic pre-packaged foods produced in the EU
- voluntary for any organic products imported into the EU
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
- Regulation (EC) No. 834/2007
- Commission Regulation (EC) 1235/2008
- European Commission - The organic logo
- European Commission - Organics at a glance
- Canadian Food Inspection Agency - Organic Products
5.2.3 Prepackaged products
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:
- 5 gram to 10 kilogram
- 5 millilitres to 10 litres
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
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.
- makes industry responsible for the collection and recycling of packaging waste
- sets environmental requirements for the design and manufacture of packaging, including restrictions on certain heavy metals
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:
- unfair terms directive
- unfair commercial practices directive
- misleading advertising directive
- consumer rights directive
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:
- 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
- do not engage in unfair commercial practices such as misleading or aggressive practices
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 cause 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.
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:
- 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
- it likely causes him or her to purchase the product or service that he or she would not have purchased otherwise
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:
- 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 allowed
- 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.
- Traders have 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 this obligation 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 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.
- The consumer rights directive provides for a list of exceptions from the right of withdrawal. These include service contracts after the service has been fully performed, goods made to the consumer’s specifications, goods that are liable to deteriorate or expire rapidly, digital content, newspapers and magazines.
More information about consumer protection directives
- Directive 93/13/EEC
- Directive 2005/29/EC
- Directive 2006/114/EC
- Directive 2011/83/EU
- European Commission - Consumers
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:
- EU consumers have two years to request repair or replacement if the goods are not in conformity with the sales contract, that is, if they are defective or not as advertised.
- The seller must repair or replace faulty goods free of charge.
- If repair or replacement is not possible or impractical, the consumer may request a refund or price reduction.
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.
- regulates the processing of personal data by individuals, companies or organizations
- 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 GDPR sets out the following main principles relating to the processing of personal data:
- 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
- accountability for data processing
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:
- 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
- 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.
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 and 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
- 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
- seek rectification of inaccurate personal data
- be notified of breaches of data security
- restrict data processing
- require the erasure of personal data
When personal data is transferred from the EU to Canada, the GDPR requires that the level of protection of personal data:
- must be similarly guaranteed under Canadian law
- 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 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:
- a company has adopted binding corporate rules
- these rules 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 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:
- €10 million or 2% of group global turnover for less serious violations of the GDPR
- €20 million or 4% of group global turnover for more serious breaches
Canadian businesses should determine whether the GDPR is applicable if:
- they are dealing with the data processing relevant to the offering of goods or services
- the behaviour of the data controller or data processor is monitored
Companies must comply with the GDPR if it is applicable.
More information about data protection
- Regulation (EU) 2016/679
- Commission Decision
- 2018 reform of EU data protection rules
- Communication from the Commission to the European Parliament and the Council: Exchanging and Protecting Personal Data in a Globalised World
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:
- European Patent Office (EPO)
- European Union Intellectual Property Office (EUIPO), which is the agency responsible for the registration of trademarks and designs
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
- Contact the Canadian Trade Commissioner Service for the names of qualified IP professionals
- Refer to Intellectual Property for Exporting Businesses for a list of registered IP agents for patents and trademarks in Canada. Many of these agents have associate firms in Europe
A patent is a legal title that can be granted for any invention having a technical character provided that it is:
- involves an inventive step
- can be used in an 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.
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
- Patent protection in the EU
- The European Patent Office:
- Apply for a National patent
- How to apply for a European patent
- European Network of National Intellectual Property Offices
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:
- a national trademark at a national Intellectual Property Office
- a European Union trademark with the European Union Intellectual Property Office
With a single registration, the European Union trademark offers protection in all 27 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
- Directive 2015/2436/EU
- European Union Intellectual Property Office
- Apply for a European Union trade mark online
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
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
- Directive 2011/77/EU
- Directive 2014/26/EU
- Review of EU copyright rules
- European IPR Helpdesk
- National Intellectual Property Offices
- European Patent Office
- European Union Intellectual Property Office
- Canadian Intellectual Property Office
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
- promote the diversification of agricultural production
- protect the names of products against usurpations and imitations
European regulations lay down three protection systems, each with its specific characteristics.
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.
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)
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.
- 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
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
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.
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:
- register the designation
- use a specifications sheet to explain the conditions under which the protected designation may be used such as geographic area, required production method, know-how, elements of proof regarding the quality of the product related to the geographical environment
- submit the request
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:
- local authorities accept or deny a determined indication
- if accepted, the local authorities transmit the request to the European Commission (EC)
- EC performs a supplementary review and makes a final decision regarding the request
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
Once recognized, PDO and PGI confer a fairly broad protection. This protection is defined by Article 13.1 of the (EC) no. 510/2006:
- 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.
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
- get a passport stamp when entering and exiting the Schengen Area to avoid difficulties with local police and other authorities
- contact the appropriate embassy or consulate for the country you wish to visit and apply for a visa if you plan to stay in the Schengen Area longer than 90 days
Long-stay visas remain subject to national conditions.
Non-Schengen area countries
Five EU member states are not party to the Schengen Convention:
- Ireland opted out
- Bulgaria, Romania, Cyprus and Croatia have applied to join
None of these 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:
- Irish Naturalisation and Immigration Service
- Consulate General of the Republic of Cyprus in Toronto
- Embassy of Romania to Canada
- Bulgaria Ministry of Foreign Affairs
- Embassy of the Republic of Croatia in Canada
Visa requirements for the Schengen area
Countries whose nationals require visas for the Schengen Area
Border officials in EU countries may ask for other supporting documents, such as:
- letters of invitation
- proof of lodging
- return tickets
Contact the appropriate embassy or consulate to find out what documents you will need to bring with you.
More information about travelling to Europe
- Passport Canada
- Travel Advice and Advisories
- Non-EU citizens: new passport requirements for travelling to Europe
- European Commission - Schengen Area
8.2 Temporary entry of materials
When bringing professional equipment into Europe, you should:
- contact the relevant consulate or embassy for customs information
- 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.
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
- visa requirements
- permanent migration
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:
- temporary entry provisions differ for each EU member state
- the level of sectoral market access commitments and obligations granted to the different categories of business visitor varies among the member states
In general, the following categories of persons are granted temporary mobility rights if they meet requirements established under CETA:
- short-berm 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:
- meetings and consultations
- research and design
- marketing research
- training seminars
- salesFootnote 4
- after-sales or after-lease service
- commercial transactions
- tourism personnel
- translation and interpretation
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:
- engage in selling a good or a service to the general public
- receive remuneration from a source located within the country where they are staying temporarily
- 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
- does not engage in direct transactions with the general public
- 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 services span 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
- certain maintenance and repair services such as for vessels, rail transport equipment, motor vehicles, aircrafts and metal products
The following categories of professionals are recognized under CETA:
- contractual services suppliers
- 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
- has concluded a contract to supply a service to an EU consumer that requires the temporary presence 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 into the EU
- possess at least three years of professional experience in the sector of activity that is the subject of the contract
An independent professional:
- is a natural person engaged in the supply of a service
- is self-employed in Canada
- does not have an establishment in the EU
- has 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
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:
- university degree or a qualification demonstrating knowledge of an equivalent level
- 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 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.
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:
- depending on whether they are a contractual service provider or an independent professional
- in certain member states
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:
- the duration of stay, upon request
- work permits, at the host party’s discretion
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:
- senior personnel
- graduate trainee,
Each category has further requirements under CETA.
Senior personnel and specialists:
- may seek admission to the EU under CETA for an initial period of three years or the length of the contract, whichever is shorter
- may seek an extension of up to 18 months
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.
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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