Ghid de a face afaceri cu UE Guide to doing Business with the EU

Training in Moldova, August 2014http://chamber.md

Luc Van LooverenSenior Advisor EU relations

Voka – CCI Antwerp-Waasland1

Contents 1.   General Information about the European Union2.   Importing goods into / from the European Union3.   Taxation of goods in the European Union4.   Producing and/or selling goods and services in the European Union5.Intellectual property rights in the European Union6.Finding business partners in the European Union7.Starting a business in the European Union8.Market information9.Legal (contractual) aspects of doing business with the EU10.Opportunities of public markets in the European Union11.Euro12.Other information13.Solving problems in doing business in the EU14.Useful addresses

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I. General Information about the European Union 1.1. European institutions and policies

1.2. Information and advice for businesses – Enterprise Europe Network (EEN)

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I. General Information about the European Union 1.1. European institutions and policies

Information source 1:          How the EU worksWebsite:          http://europa.eu/about-eu/index_en.htm

Information source 2:          Overview of the policies                           Website:          http://europa.eu/pol/index_en.htm

Information source 3:          Channels for general questionsWebsite:                  http://europa.eu/contact/index_en.htm

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I. General Information about the European Union 1.2. Information and advice for businesses – Enterprise Europe Network (EEN) http://een.ec.europa.eu/

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6Select a country with EEN officesSelect a country with EEN offices

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2. Importing goods into / from the European Union 2.1. Customs code numbers and import duties

2.2. Customs documents (requirements)

2.3. Import tariff quotas

2.4. Anti-dumping measures

2.5. Rules of origin

2.6. Import licenses for textiles and steel

2.7. Customs and security

2.8. Fair and sustainable international trade

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2. Importing goods into / from the European Union 2.1. Customs code numbers and import duties

Information source 1:         TARIC database of the European CommissionWebsite: http://ec.europa.eu/taxation_customs/dds2/taric

Information source 2: Export Helpdesk Website:                http://exporthelp.europa.eu/ 

Additional information source:  ‘Binding Tariff Information’ (BTI) serviceWebsite:             http://ec.europa.eu/taxation_customs/common/databases/ebti/index_en.htm

FAQ, e.g. about the calculation of import duties for agricultural components: consult the document   http://ec.europa.eu/taxation_customs/dds2/taric/help/dds_tar_faq_en.pdf

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111) Find the product code via the Browse or Advanced search option2) Select the country of origin, e.g. Moldova

Finding info on import tariffs via TARIChttp://ec.europa.eu/taxation_customs/dds2/taric

Example: Biscuits

TARIC search: example of calculation of agricultural component in import duties

EA = agricultural componentADFM = additional duty on flour contents

Composition:Milk fat: >= 1.5 < 3 %Milk proteins: 2.5 < 6 %Starch / Glucose: > 5 < 25 %Sucrose / InvertSugar / Isoglucose: >= 5 < 30 %

EA = agricultural componentADFM = additional duty on flour contents

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Finding info on import tariffs via Export HELPDESKhttp://exporthelp.europa.eu

Example: Biscuits

1) Find the product code 2) Select the country of origin, e.g. Moldova3) Select an EU country of destination

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IMPORT TARIFFS: EXAMPLE

2. Importing goods into / from the European Union 2.2. Customs documents (requirements)

Information source 1: Export Helpdesk  (see next slides)

Website: http://exporthelp.europa.eu/

2.3. Import tariff quotas

Information source : AUTONOMOUS TARIFF QUOTAS - database 

Website:  http://ec.europa.eu/taxation_customs/dds2/taric/quota_consultation.jsp?Lang=en

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Information source: Export HELPDESKhttp://exporthelp.europa.eu

Some EU laws may require from exporters to prepare some specific documents, e.g. health certificates

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Consult here practical info about general documents needed for exporting to the EU

19Follow this path for finding out which document is needed for getting preferential import tariffs in the EU

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Exporters need a EUR.1 document or – for transations <= 6000 EUR – an invoice declaration

2. Importing goods into / from the European Union 2.4. Anti-dumping measures

Information source 1: European Commission – Summaries of EU legislation                                   (summary of anti-dumping rules)

Web address: http://europa.eu/legislation_summaries/alphabetical_index/index_a_en.htmanti-dumping measures

Anti-dumping and anti-subsidy measures list

Information source 2: European Commission – DG Trade

Web address: http://ec.europa.eu/trade/tackling-unfair-trade/trade-defence/

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ANTI-DUMPING DUTIES: EXAMPLES

2. Importing goods into / from the European Union 2.5. Rules of origin

Information source 1: European Commission – Taxation and Customs union – Rules of Origin

Web address:  http://ec.europa.eu/taxation_customs/customs/customs_duties/rules_origin/index_en.htm

Information source 2: European Commission – Export Helpdesk  (see next slide)

Web address: http://exporthelp.europa.eu/

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Consult the Community Customs Code for checking rules of origin related to certain product codes

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RULES OF ORIGIN: EXAMPLE

2. Importing goods into / from the European Union 2.6. Import licenses for textiles and steel

Information source: European Commission – Trade Issues - SIGL Website: http://trade.ec.europa.eu/sigl/

Textiles search Steel searchFootwear

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IMPORT LICENCES FOR TEXTILES

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For every search the following information will be available:

Quota level (= quantitative limit set for a specific quota year);

Working level (= quota level as adjusted following the use of flexibility provisions provided for under the relevant legal texts);

Amount licensed (= amount of goods for which the licensing authorities in the Member States have issued import authorisations and which have been set off against the quantitative limit in question);

Amount pending (= amount for which there is no available quota unless or until the working level is adjusted by the use of flexibility provisions);

MS utilisation of Quota Level (%) (= the extent to which the quota level has been utilised by the Member States);

MS utilisation of Working Level (%) (= the extent to which the working level has been utilised by the Member States);

SC licensed (= amount for which the licensing authority in the Supplier Country has issued export authorisations);

SC utilisation of Working Level (%) (= the extent to which the quota level has been utilised by the Supplier Country).

2. Importing goods into / from the European Union

2.7. Customs and security

2.7.1. AEO – Authorized Economic Operator

Information source:          European Commission – DG Taxation and Customs Union        

Website: http://ec.europa.eu/taxation_customs/customs/policy_issues/customs_security/aeo/index_en.htmcontact points in the Member States' customs authorities (pdf 51.0 KB) 

A list with AEO can be consulted at an electronic database.

2.7.2. EORI – Economic Operators Registration and Identification Number

Any economic operator established in the EU needs to have an EORI number. Economic operators established outside the EU have to be assigned an EORI number if they lodge a customs declaration, an Entry or an Exit Summary Declaration.

Information source:          European Commission – DG Taxation and Customs Union

Website:       http://ec.europa.eu/ecip/security_amendment/who_is_concerned/index_en.htm A list with valid EORI nos. can be consulted at an electronic database.

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2. Importing goods into / from the European Union

2.7. Customs and security

2.7.3. Transfers of dual-use goods between EU countries

Information source:          European Commission – DG Trade

Website:                           http://ec.europa.eu/trade/creating-opportunities/trade-topics/dual-use/ 

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Dual use goods are products and technologies normally used for civilian purposes but which may have military applications

2. Importing goods into / from the European Union 2.8. Fair and sustainable international trade 1) Fair Trade Organisations operating at a global level:

-The World Fair Trade Organization (WFTO) is the global representative body of over 450 members committed to 100% Fair Trade. 

Website: http://www.wfto.com              

-The organization FAIRTRADE INTERNATIONAL represents 24 organizations working to secure a better deal for producers. From its headquarters in Bonn, Germany, it sets international Fairtrade standards and supports Fairtrade producers.

Website: http://www.fairtrade.net/

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2. Importing goods into / from the European Union 2.8. Fair and sustainable international trade 

2) Organisations / labels for fair and sustainable trade in various sectors

Agriculture               http://www.ecocert.com http://bonsucro.comFood products          http://www.maxhavelaar.nl/Clothes http://fairwear.org/Wood http://www.fsc.org/ http://www.pefc.orgFish http://www.msc.org/Textile http://www.oeko-tex.com

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3) Timber Trade – EUTR / FLEGT

Information source 1: European Commission –  EU TR (Timber Regulation)Website: http://ec.europa.eu/environment/forests/timber_regulation.htm

Obligation for companies =  to keep records of their suppliers and customers

Information source 2: European Commission – FLEGT (Forest Law Enforcement, Governance and Trade Licencing Scheme)Website: http://ec.europa.eu/environment/forests/flegt.htm                    http://www.euflegt.efi.int/portal

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3. Taxation of goods in the European Union 3.1. Value Added Tax (VAT)

Information source: European Commission – DG Taxation and Customs Union Website: http://ec.europa.eu/taxation_customs/taxation/vat/index_en.htm

‘How VAT works – Rates’‘Traders – VAT in the EU’‘Traders – VAT Invoicing rules’‘Traders – Checking a VAT number – database’‘Traders – VAT refunds’ 

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3. Taxation of goods in the European Union 3.2. Excise duties

Information source: European Commission – DG Taxation and Customs Union Website: http://ec.europa.eu/taxation_customs/taxation/excise_duties/index_en.htm

‘Alcoholic beverages – rates’‘Tobacco products – rates’‘Energy products and electricity – rates’

EMCS (Excise Movement and Control System) 

Website: http://ec.europa.eu/taxation_customs/taxation/excise_duties/circulation_control/index_en.htm

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods

4.2. Environmental rules for commercialising goods in the European Union

4.3. Voluntary eco-management and eco-label schemes

4.4. Internal market rules regarding the freedom to provide services in the European Union

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation4.1.2. Foodstuffs4.1.3. Chemical products4.1.4. Other products (textile products, footwear, leather, furniture, motor vehicles) 

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) 

in technical harmonisation

  

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) 

in technical harmonisation

  

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Http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/index_en.Htm

4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation

A/   Web pages with general information on European technical harmonisation and standardisation principles

Information source 1: European Commission – Summaries of EU legislationWebsite: http://europa.eu/legislation_summaries/internal_market/index_en.htm

Information source 2: European Commission – EUR-Lex database (= full texts of EU legislation)Website: http://eur-lex.europa.eu/en/index.htm Information source 3: New Approach website (= references to laws and harmonised standards)Website: http://www.newapproach.org

Information source 4: European Commission – DG Enterprise and Industry                                    (= EU policy on new approach in technical harmonisation)Website: http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation

Information source 4: European Commission – DG Enterprise and Industry 

This website contains also a broader guidance on CE marking at following web page:http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/professionals/index_en.htm

B/   General guide / publication

‘Guide to the Implementation of Directives Bases on New Approach and Global Approach’http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

 

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation

C/ Following websites list harmonised standards for each sector covered by the new approach in technical harmonisation: http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.htmlhttp://www.newapproach.org

Texts of European harmonised standards may be ordered from National Standardisation bodies:

CEN national membershttp://www.cen.eu/cen/Members/Pages/default.aspxCENELEC national membershttp://www.cenelec.eu/Cenelec/CENELEC+in+action/Web+Store/Standards/default.htmETSI national membershttp://portal.etsi.org/Portal_Common/home.asp  48

4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation

D/   Notified bodies

Lists of notified bodies, including the identification number of a notified body as well as the tasks for which it has been notified, can be found in following website: Nando (New Approach Notified and Designated Organisations) Information Systemhttp://ec.europa.eu/enterprise/newapproach/nando/  

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation

E/   Product liability and general product safety

The EU's Directive on product liability can be consulted at:http://eur-lex.europa.eu/Notice.do?val=115911:cs&lang=en&list=115911:cs,&pos=1&page=1&nbl=1&pgs=10&hwords= The EU’s General product safety directive can be found at:http://eur-lex.europa.eu/Notice.do?val=272287:cs&lang=en&list=272287:cs,258366:cs,258142:cs,&pos=1&page=1&nbl=3&pgs=10&hwords=

More info can be consulted at:http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm Specific info on RAPEX (Rapid Alert System for non-food consumer products) can be consulted at:http://ec.europa.eu/consumers/safety/rapex/index_en.htm  

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation

F/   Agreements with third countries

A list of Mutual Recognition Agreements (MRA) and related info can be found at:

http://ec.europa.eu/enterprise/policies/single-market-goods/international-aspects/mutual-recognition-agreement/background-documents/index_en.htm

http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=mra.main

G)   CE mark

The CE mark may be downloaded in different electronic formats from the following site:http://ec.europa.eu/enterprise/faq/ce-mark.htm

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Websites with practical info on CE marking in the EU

Cableways

   http://ec.europa.eu/enterprise/sectors/mechanical/cableways/index_en.htm

Construction products

http://ec.europa.eu/enterprise/sectors/construction/index_en.htm

Electrical safety: Low Voltage Directive (LVD)

http://ec.europa.eu/enterprise/sectors/electrical/lvd/index_en.htm

    

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Websites with practical info on CE marking in the EU

Electromagnetic Compatibility (EMC)

http://ec.europa.eu/enterprise/sectors/electrical/emc/index_en.htm

Explosives for civil uses

http://ec.europa.eu/enterprise/sectors/chemicals/specific-chemicals/explosives/index_en.htm

Gas appliances

http://ec.europa.eu/enterprise/sectors/pressure-and-gas/gas_appliances/index_en.htm

    

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Websites with practical info on CE marking in the EU

Websites with practical info on CE marking in the EU

 

Lifts

http://ec.europa.eu/enterprise/sectors/mechanical/lifts/index_en.htm

Machinery

http://ec.europa.eu/enterprise/sectors/mechanical/machinery/index_en.htm

Noise emissions for outdoor equipment

http://ec.europa.eu/enterprise/sectors/mechanical/noise-outdoor-equipment/index_en.htm

    

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Websites with practical info on CE marking in the EU

Websites with practical info on CE marking in the EU

Equipment and protective systems for potentially explosive atmospheres (ATEX)

http://ec.europa.eu/enterprise/sectors/mechanical/atex/index_en.htm

Medical devices

http://ec.europa.eu/health/medical-devices/index_en.htm

Personal Protective Equipment (PPE)

http://ec.europa.eu/enterprise/sectors/mechanical/personal-protective-equipment/index_en.htm

    

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Websites with practical info on CE marking in the EU

Websites with practical info on CE marking in the EU

    

Pressure equipment

http://ec.europa.eu/enterprise/sectors/pressure-and-gas/pressure-equipment/index_en.htm

Radio and telecommunications terminal equipment (R&TTE)

http://ec.europa.eu/enterprise/sectors/rtte/index_en.htm

Recreational craft

http://ec.europa.eu/enterprise/sectors/maritime/recreational-craft/index_en.htm

    

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Websites with practical info on CE marking in the EU

    

Toys

http://ec.europa.eu/enterprise/sectors/toys/index_en.htm

    

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.2. Foodstuffs

I.   EUROPEAN FOODSTUFFS LEGISLATION

Information sources: - Summaries of EU legislationhttp://europa.eu/legislation_summaries/internal_market/index_en.htm- EUR-LEXhttp://eur-lex.europa.eu/en/index.htm- European Commission – DG Health and Consumer Protectionhttp://ec.europa.eu/food/food/index_en.htm

II.   HACCP AND FAO / WHO FOOD STANDARDS

Information source: Codex AlimentariusWebsite: http://www.codexalimentarius.net 

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Consult the alphabetical index for finding titles and summaries of EU laws, e.g. in the field of foodstuffs

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Find here EU laws on foodstuffs

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Click on a line for reading more (title + summary of EU laws)

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Click on this ref. no. for consulting the full tekst of an EU law at the database of EUR-LEX

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Click on the Romanian version or any other language version for reading the full tekst of this EU Regulation

66Example of title + first Article of an EU law in the

field of agro-food sector

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Consult this website for a detailed overview of EU foodstuffs legislation and, for example, info on importing conditions

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Read here which food sectors – with animal ingredients – are already allowed to export to the EU

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Consult a list of approved establishments (e.g. factories) by country or by sector

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Canada has already much more sectors (with animal based ingredients) open for export to the EU compared with Moldova.

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Animal based foodstuffs: sectors requiring to have an approved establishment

MoldovaJuly 2014

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4. Producing and/or selling goods and services in the European Union 4.1. Internal market rules regarding the free movement of goods 4.1.2. Foodstuffs

III. SCIENTIFIC ADVICE ON FOOD SAFETY

Information source: The European Food Safety Authority

Website: http://www.efsa.europa.eu/

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.2. Foodstuffs

IV. SPECIFIC LABELS FOR FOODSTUFFS

IV.1.   Geographical indications & designations of origin, certificates of specific character of foodstuffs

Information source: European Commission – DG AgricultureWebsite: http://ec.europa.eu/agriculture/quality/index_en.htm

PDO - covers agricultural products and foodstuffs which are produced, processed and prepared in a given geographical area using recognised know-how.PGI – covers agricultural products and foodstuffs closely linked to the geographical area. At least one of the stages of production, processing or preparation takes place in the area.TSG - highlights traditional character, either in the composition or means of production

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Agricultural products and foodstuffs as Traditional Specialities Guaranteed (TSGs) (Reg. (EC) 509/2006) Example: Pizza Napoletana

The EU’s member states, on 9 December 2009, backed a proposal to register ‘Pizza Napoletana’ as a ‘traditional speciality guaranteed’, under the Union’s quality labelling scheme.

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Protection of Geographical Indications (PGI) and Designations of Origin (PDO) (Reg. (EC) 510/2006)

Example: Champagne (PDO, France)

Champagne is a sparkling wine produced by inducing the in-bottle secondary fermentation of wine to effect carbonation. It is produced exclusively within the Champagne region of France, from which it takes its name. While the term "champagne" is used by some makers of sparkling wine in other parts of the world, numerous countries limit the use of the term to only those wines that come from the Champagne appellation. In Europe, this principle is enshrined in the European Union by Protected Designation of Origin (PDO) status. Other countries, such as the United States, have recognized the exclusive nature of this name, yet maintain a legal structure that allows longtime domestic producers of sparkling wine to continue to use the term "Champagne" under specific circumstances.

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Protection of Geographical Indications (PGI) and Designations of Origin (PDO) (Reg. (EC) 510/2006)

Example: Tarta de Santiago (PGI, Spain)Tarta de Santiago is a traditional cake from northern Spain. The tarta is dense and rich in flavor and is well-known in Santiago, Spain as a delectable treat used to lure passers-by into restaurants or cafés. 

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The DOOR database includes product names registered as PDO, PGI or TSG as well as names for which registration has been applied. 

E-BACCHUS is the database on geographical indications protected in the European Community for wines originating in Member States and third countries. 

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4.1. Internal market rules regarding the free movement of goods

4.1.2. Foodstuffs

IV.SPECIFIC LABELS FOR FOODSTUFFS

IV.2. “BIO” Label for organic farming

Information source: European Commission – DG Agriculture

Website: http://ec.europa.eu/agriculture/organic/splash_en

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V.   EU REGISTER ON NUTRITION AND HEALTH CLAIMS

Information source: European Commission

Website: http://ec.europa.eu/nuhclaims/

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4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

1) General info Information source: European Commission – DG Enterprise and Industry Website: http://ec.europa.eu/enterprise/index_en.htm

2) Specific chemical products: see next slides

85

4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

1. Dangerous substances and preparations

Specific information about REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and GHS (Globally Harmonised System of Classification and Labelling of Chemicals):http://ec.europa.eu/enterprise/reach/index_en.htmhttp://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/index_en.htm More specific, Guidance Documents about REACH and CLP can be consulted at:http://echa.europa.eu/support EU policy in the field of dangerous preparations:http://ec.europa.eu/enterprise/chemicals/legislation/dangerous/index_en.htm ESIS – European chemical Substances Information Systemhttp://esis.jrc.ec.europa.eu/

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

2. Plant protection products Information about EU legislation on plant protection products:http://ec.europa.eu/food/plant/protection/index_en.htm   

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

3. Biocides The European Biocides Directive (BPD):http://ec.europa.eu/environment/biocides/ Community Register for Biocidal Products:https://webgate.ec.europa.eu/env/r4bp/

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Community Register for Biocidal Products: examples

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Boric acid   233-139-2 10043-35-3 8 2009/94/ECBoric oxide   215-125-8 1303-86-2 8 2009/98/ECBrodifacoum   259-980-5  56073-10-0  14 2010/10/EU

Bromadiolone   249-205-9 28772-56-7 14 2009/92/ECCarbon dioxide   204-696-9 124-38-9 14 2008/75/ECCarbon dioxide   204-696-9 124-38-9 18 2010/74/EUChlorophacinone   223-003-0 3691-35-8 14 2009/99/ECClothianidin   433-460-1  210880-92-5  8 2008/15/ECCopper (II) hydroxide   243-815-9 26427-59-2 8 2012/2/EU

Copper (II) oxide   215-269-1 1317-38-0 8 2012/2/EU

Active substance   EC number CAS - number Producttype Inclusion Dir.

4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

4. Fertlizers

Information about EU Legislation on fertilizers:http://ec.europa.eu/enterprise/chemicals/legislation/fertilizers/index_en.htm

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

5. Detergents

Information about EU Legislation on detergents:http://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htm 

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

6. Explosives

Information about EU Legislation on explosives:http://ec.europa.eu/enterprise/chemicals/legislation/explosives/index_en.htm 

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

7. Pyrotechnic Articles Information about EU Legislation on pyrotechnic articles:http://ec.europa.eu/enterprise/chemicals/legislation/pyrotechnic/index_en.htm

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

2) Specific chemical products

COSMETICS

EU policy in the field of cosmetics:http://ec.europa.eu/consumers/sectors/cosmetics/documents/ CosIng is a specific database with information on cosmetic ingredients contained in the Cosmetics Directive 76/768/EEC, the Cosmetics Regulation (EC) No. 1223/2009, the Inventory of Cosmetic Ingredients and scientific opinions on cosmetic substances of the Scientific Committees:http://ec.europa.eu/consumers/cosmetics/cosing/

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Substance: Colouring agent CI 26105

Substance Colouring agent CI 26105 CAS # 85-83-6 EINECS/ELINCS # 201-635-8 INN/ISO/AN Cosmetic Directive 88/233/EEC Other Directives/RegulationsAnnex/Part,Ref # II/379 SCCS opinions

Chemical/IUPAC Name1-(2-Methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol; Scarlet red

Identified INGREDIENTS or substances e.g.

•SOLVENT RED 24

NoteCurrent Version v.3

Other Versionsv.1v.2

Substance: Colouring agent CI 26105

EXAMPLE FROM COSING - database

4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

COSMETICS

Guidelines for the interpretation of the Cosmetics Directive :http://ec.europa.eu/consumers/sectors/cosmetics/documents/guidelines/index_en.htm Borderline products:http://ec.europa.eu/consumers/sectors/cosmetics/cosmetic-products/borderline-products/index_en.htm Sunscreen products:http://ec.europa.eu/consumers/sectors/cosmetics/cosmetic-products/sunscreen-products/index_en.htm Hair dyes safety:http://ec.europa.eu/consumers/sectors/cosmetics/cosmetic-products/hair-dye-products/safety-strategy/index_en.htm 

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

PHARMACEUTICALS

EU policy in the field of pharmaceuticals – general info:http://ec.europa.eu/health/index_en.htm

Specific information:

1) Medicinal products for human use:

General info : http://ec.europa.eu/health/human-use/index_en.htmLegal framework :  http://ec.europa.eu/health/human-use/legal-framework/index_en.htmMedicines for children :  http://ec.europa.eu/health/human-use/paediatric-medicines/index_en.htmOrphan medicinal products :  http://ec.europa.eu/health/human-use/orphan-medicines/index_en.htmAdvanced therapies :   http://ec.europa.eu/health/human-use/advanced-therapies/index_en.htmHerbal medicinal products : http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

PHARMACEUTICALS

Specific information:

2) Medicinal products for veterinary use

General info : http://ec.europa.eu/health/veterinary-use/index_en.htmLegal framework : http://ec.europa.eu/health/veterinary-use/legal-framework/index_en.htmMaximum Residue Limits : http://ec.europa.eu/health/veterinary-use/maximum-residue-limits/index_en.htm EMEA – European Medicines Agency

http://www.ema.europa.eu 

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Invented name -Active substance ParacetamolEMEA Decision number P/96/2008PIP number EMEA-000130-PIP01-07Pharmaceutical form(s) Solution for infusionCondition(s)/indiciation(s) Moderate pain and feverRoute(s) of administration Intravenous

PIP applicant

Applicant: Baxter World Trade SA/NVE-mail: veronique_verstraeten@baxter.comCountry: BelgiumPhone: +32 26501679Fax: +32 26501679

Decision typeP: decision agreeing on a Paediatric Investigation Plan, with or without partial waiver(s) and or deferral(s)

EMEA – EXAMPLE OF SEARCH

4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

PHARMACEUTICALS - Reference documents

1) EU Legislation – Eudralex http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm

2) Community Register – authorised medicinal productshttp://ec.europa.eu/health/documents/community-register/index_en.htm   

3) European Pharmacopoeia Onlinehttp://online.pheur.org/entry.htm

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

PHARMACEUTICALS - Reference documentsEuropean Pharmacopoeia Online

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

CLASSIFICATION AND LABELLING OF CHEMICALPRODUCTS

Information source: EUROPEAN COMMISSION – DG ENTERPRISE AND INDUSTRYCLP / GHS Web page

Website:                   http://ec.europa.eu/enterprise/sectors/chemicals/classification/index_en.htm

Information source: EUROPEAN COMMISSION - JOINT RESEARCH CENTREWebsite: http://esis.jrc.ec.europa.eu

Information source:    Ellis Publications BV                                   CD-ROMs :                Dangerous substances / Cosmetics / Euro Transport         Website :                    http://www.ellispub.com/index.php?page_id=15 

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.3. Chemical products

103

Finding info on correct labelling of chemicals at: http://esis.jrc.ec.europa.eu

Ellis publications: examples

Dangerous Substances CD- The consolidated text of Directive 67/548/EEC including all the Annexes, merged with the EINECS and ELINCS inventories. All legislation and proposed legislation on the classification, packaging and labelling of dangerous preparations- The list of dangerous substances in 8 EU official languages- Legislation covering the restrictions on the marketing and use of certain dangerous substances and preparations, major accident hazards of industrial activities (SEVESO) and the COMAH directive, the protection of workers from dangerous substances, the import and export of certain chemical products Euro Transport CDA module of Dangerous Substances CD, this CD-ROM provides full coverage of the safety regulations for the transport of dangerous goods by road, rail, inland waterway and sea.Cosmetics CDA module of Dangerous Substances CD, it provides full coverage of EU rules governing cosmetic products.

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.4. Other products

1) Textile products Information on EU laws related to production and selling of textile products in the European Union. General info:   http://ec.europa.eu/enterprise/sectors/textiles/index_en.htm

Environmental issues:  http://ec.europa.eu/enterprise/sectors/textiles/environment/index_en.htm

          Subjects: - IPPC (Integrated Pollution Prevention & Control)- Emission Trading System (EU ETS)- Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals      (REACH)

  

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4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.4. Other products

2) Footwear

Information on EU legislation related to production and selling of footwear in the European Union:http://ec.europa.eu/enterprise/footwear/index_en.htm

 

3) Leather

Information on EU legislation related to production and selling of leather in the European Union:http://ec.europa.eu/enterprise/sectors/leather/index_en.htm

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Three parts of the footwear UpperThis is the outer face of the structural element 

which is attached to the outersole.

Lining and sockThese are the lining of the upper and the insole, 

constituting the inside of the footwear article.

Outer SoleThis is the bottom part of the footwear article, 

which is subjected to abrasive wear and attached to the upper.

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Pictograms of footwear materials

Leather Coated leather Textile Other material

4. Producing and/or selling goods and services in the European Union

4.1. Internal market rules regarding the free movement of goods

4.1.4. Other products

4) Furniture

Information on EU legislation related to production and selling of furniture in the European Union: http://ec.europa.eu/enterprise/furniture/index_en.htm 

5) Motor vehicles

Information on EU legislation related to production and selling of motor vehicles in the European Union: http://ec.europa.eu/enterprise/automotive/index_en.htm Information on clean and energy-efficient road transport vehicles can be consulted at following website: http://www.cleanvehicle.eu/

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4. Producing and/or selling goods and services in the European Union

4.2. Environmental rules for commercialising goods in the European Union

4.2.1.  Packaging and packaging waste obligations 1.  Legal framework for packaging waste in the EU

Information source:               European Commission  -  DG EnvironmentWebsite:                                http://ec.europa.eu/environment/waste/packaging_index.htm

2.  Packaging waste recovery organisations in the EU

Information source:               Packaging Recovery Organisation EuropeWebsite:                                http://www.pro-e.org

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4. Producing and/or selling goods and services in the European Union

4.2. Environmental rules for commercialising goods in the European Union

4.2.2.  Electrical and electronic equipment: WEEE and ROHS

WEEE = Waste Electrical and Electronic Equipment ROHS = Restriction of the use of certain hazardous substances

Information source:               European Commission  -  DG EnvironmentWebsite:                                http://ec.europa.eu/environment/waste/weee_index.htm

Socket Saver (Lead-free)WEEE recovery organisations in the EU

Information source:               WEEE ForumWebsite:                                http://www.weee-forum.org/

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4. Producing and/or selling goods and services in the European Union

4.2. Environmental rules for commercialising goods in the European Union

4.2.3.  Eco-design for energy using products

Information source:           European Commission  -  DG Enterprise and Industry

Website:  

http://ec.europa.eu/enterprise/policies/sustainable-business/sustainable-product-policy/ecodesign/index_en.htm

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4. Producing and/or selling goods and services in the European Union

4.3. Voluntary eco-management and eco-label schemes

4.3.1.  EMAS – Eco-management and audit scheme

The Eco-Management and Audit Scheme (EMAS) is the EU voluntary scheme for organisations  willing to commit themselves to evaluate, improve and report on their environmental performances. The Commission has developed an EMAS SME toolkit to provide SMEs with an easy step-by-step explanation to reach registration with the EU Eco-Management and Audit Scheme. 

Information source: European Commission  -  DG Environment Website: http://ec.europa.eu/environment/emas/index_en.htm

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4. Producing and/or selling goods and services in the European Union

4.3. Environmental issues in SME management , design and production of goods

4.3.2.  Eco-label schemes for industrial products

The EU awards a Community eco-label to products and services  with a reduced environmental impact. 

Information source: European Commission  -  DG Environment Website: http://ec.europa.eu/environment/ecolabel/index_en.htm

‘Ecolabelled products - Product categories’‘Ecolabelled products – Finding products’

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Example of Ukrainian producer of all purpose cleaner who obtained the Ecolabel

for its product

4. Producing and/or selling goods and services in the European Union

4.3. Environmental issues in SME management , design and production of goods

4.3.3.  Energy Star – energy efficiency programme

The ENERGY  STAR is a voluntary appliance specific label, identifying to consumers appliances that meet certain standards regarding energy efficiency.

Equipment covered: - computer equipment- displays- imaging equipment

Information source: EU Energy Star Website: http://www.eu-energystar.org

Companies can consult here a database with info on EU Energy Star qualified office equipment.

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4. Producing and/or selling goods and services in the European Union

4.4. Internal market rules regarding the freedom to provide services in the European union

4.4.1. The European Services Directive

Information source: European Commission  -  DG Internal Market Website: http://ec.europa.eu/internal_market/services/services-dir/index_en.htm

Click on ‘points of single contact’ at the home page of the above mentioned website or go directly to http://ec.europa.eu/internal_market/eu-go/ if you are interested in the national implementation of the Services Directive in the Member States. 

Click on the country of your choice and find all available information from the competent national authorities.

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4. Producing and/or selling goods and services in the European Union

4.4. Internal market rules regarding the freedom to provide services in the European union

4.4.2. The Posting of Workers Directive

Information source: European Commission - DG Employment, Social Affairs and Equal                                     Opportunities Website: http://ec.europa.eu/social/main.jsp?catId=471&langId=en

A worker is "a posted worker" when he is employed in one EU Member State but sent by his employer on a temporary basis to carry out his work in another Member State

118

5. Intellectual property rights in the European Union

5.1. Protection of patents in the EU

5.2. Protection of trademarks in the EU

5.3. Protection of models and designs in the EU

119

5. Intellectual property rights in the European Union

5.1. Protection of patents in the EU

Information source:           European Patent Office

Website:                            http://www.epo.org/index.html

Useful guides: “About us - publications” 

Online filing of a patent application: http://www.epoline.org

Patent applications at Register Plus: https://register.epoline.org/espacenet/regviewer

Exercise on next slide: search patents related to “bread” 

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5. Intellectual property rights in the European Union

5.2. Protection of trademarks in the EU

Information source 1:           Office for Harmonisation in the Internal Market (OHIM)

Website:                               http://oami.europa.eu/

Information source 2:           World Intellectual Property organization: Madrid System for the International Registration of MarksWebsite:               http://www.wipo.org/madrid/en/index.html

5.3. Protection of models and designs in the EU

See above: OAMI

122

Community Trade Mark: Example

123

Trade mark No: 002108918 Type of mark: Figurative

Filing date: 27/02/2001 Date of registration: 03/02/2003

Nice Classification: 16, 21, 25, 32, 42 Status: Registered

Publication of registration

Name of the owner: The Coca-Cola Company

Applicant’s reference: CE-20010292

Trade mark basis: CTM

Community Trade Mark: Example

124

Trade mark No: 0926155 Type of mark: Figurative

Date of international registration:

24/04/2007

Nice Classification: 16, 20, 35, 43 Status: International registration accepted

Name of the owner: Inter IKEA Systems B.V.

Trade mark basis: IR designating the EC

6. Finding business partners in the European Union 6.1. Publication of trade and cooperation proposals in the EU

6.2. Finding R&D partners in Europe

125

6. Finding business partners in the European Union 6.1. Publication of trade and cooperation proposals in the EU

Information source 1:         European Commission – DG Enterprise and Industry                                           Enterprise Europe Network

Website:                             http://www.enterprise-europe-network.ec.europa.eu/index_en.htm

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6. Finding business partners in the European Union

6.2. Finding R&D partners in Europe

Information source 1:          Community Research & Development Information Service (CORDIS)

Website:                              http://cordis.europa.eu/         Search partners via:         http://cordis.europa.eu/partners

Information source 2:          EUREKA (Network for Market Oriented R&D)

Website:                              http://www.eureka.be/home.do

EUREKA Clusters are long-term, strategically significant public-private partnerships.EUREKA Umbrellas are thematic networks that focus on a particular technology or business sector. Their goal is to generate and support R&D projects in their specific field of operation.EUREKA’s Eurostars Programme is the first European funding and support programme to be specifically dedicated to research-performing SMEs.

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7. Starting a business in the European Union 7.1. Legal requirements and incentives for creating a company in the EU

7.2. Social security systems in the EU

7.3. Taxation in the EU Member States 

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7. Starting a business in the European Union 7.1. Legal requirements and incentives for creating a company in the EU

Information source 1: European Commission                                           Your Europe - Business               Website: http://ec.europa.eu/youreurope/business/index_en.htm

Info on legal requirements, administrative procedures, etc. 

Information source 2:        European Commission – DG Enterprise and Industry                                          Enterprise Europe Network (EEN)Website: http://www.enterprise-europe-network.ec.europa.eu/index_en.htm

Info about following topics:

economic indicators; formalities for starting a business;inward investment incentives; labour law; social security;direct and indirect taxes; agreements on prevention of double taxation;useful contacts

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7. Starting a business in the European Union 7.2. Social security systems in the EU

Information source:    European Commission – DG Employment, Social Affairs & Equal Opportunities                                  MISSOC – Mutual Information System on Social Protection in the EU Member States and the EEA                                          Website: http://ec.europa.eu/social/main.jsp?catId=815&langId=en

MISSOC Database

7.3. Taxation in the EU Member States

Information source: European Commission – DG Taxation and Customs Union 

Website:            http://ec.europa.eu/taxation_customs/taxation/gen_info/info_docs/tax_inventory/index_en.htm

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8. Market information

8.1. Statistical info about external trade of the EU

8.2. Trade fairs in the EU (and worldwide

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8. Market information

8.1. Statistical info about external trade of the EU

Information source 1: European Commission – DG Trade – Exports Helpdesk for developing countries

Website: http://exporthelp.europa.eu/thdapp/comext/ComextServlet?languageId=EN

Information source 2: Eurostat – Statistical Office of the European Communities

Website: http://epp.eurostat.ec.europa.eu/portal/page/portal/statistics/themes

Information source 3: ITC (International Trade Centre)  -  Trade Map

Website: http://www.trademap.org

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Example of trade statistics: import or export of biscuits between The EU and Ukraine

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8. Market information

8.2. Trade fairs in the EU (and worldwide

Information source 1:      AUMA

      http://www.auma.de

Information source2 :       M+A Expo Database

Website:                           http://www.expodatabase.com/

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9. Legal (contractual) aspects of doing business with the EU 9.1. Contracts with EU enterprises

9.2. Incoterms

9.3. Documentary credits

9.4. Electronic invoicing 

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9. Legal (contractual) aspects of doing business with the EU 9.1. Contracts with EU enterprises

Information source 1:        ICC  -  International Chamber of Commerce

Website:                           http://www.iccwbo.org

BookstoreICC Model International Trademark LicenseICC Model International Transfer of Technology ContractICC Model Turnkey Contract for Major ProjectsDrafting and negotiating International Commercial contractsICC Legal Handbook on Global Sourcing ContractsICC Model International Sale ContractICC Model Occasional Intermediary ContractICC Model Confidentiality AgreementICC Model Commercial Agency Contract – 2nd editionICC Model Distributorship Contract ICC Short Form Model ContractsICC Model Contract for the Turnkey Supply of an Industrial PlantICC Model International Franchising ContractICC Model Selective Distributorship ContractICC Model Mergers & Acquisitions Contract 1 – Share Purchase AgreementICC Force Majeure Clause 2003 – ICC Hardship Clause 2003 138

9. Legal (contractual) aspects of doing business with the EU

9.1. Contracts with EU enterprises

Information source 2:       Juris International  (International Trade Centre – UNCTAD / WTO)Website:                           http://www.jurisint.org/en/con/index.html

Model contracts for:

Agency (4) ; Audiovisual (13 ) ; Buy Back - Countertrade transactions (2) ; Confidentiality and not-to-compete agreement (13) ; Construction, installation of plant, engineering (3) ; Data transfer (1) ; Distribution (3) ; E-Commerce, Internet and multimedia (28) ; Franchising (2) ; ITC model contracts (38) ; Joint ventures, consortium and cooperation agreements (8) ; Letter of intent / Memorandum of understanding (8) ; Licensing (patent, trademark and know-how) (24) ; Machinery (supply, etc.) (4) ; Music (4) ; Procurement (12) ; Publishing (18) ; Research (6) ; Sale of manufactured and semi-manufactured goods (1); Sale of perishable goods, commodities and raw materials - Cocoa (4) ;Sale of perishable goods, commodities and raw materials - General (5) ; Sale of perishable goods, commodities and raw materials - Grains, oil seeds and feeding meals (35) ;Sale of perishable goods, commodities and raw materials - Others (1) ;Services (7) ; Subcontracting (1) ; Technical assistance (2) 

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9. Legal (contractual) aspects of doing business with the EU 9.2. Incoterms

Information source 1:       ICC  -  International Chamber of CommerceWebsite:                           http://www.iccwbo.org

Information source 2:       International Business TrainingWebsite:                           http://www.i-b-t.net/incoterms.html#FOB

 

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9. Legal (contractual) aspects of doing business with the EU 9.3. Documentary credits

Information source 1:       ICC  -  International Chamber of CommerceWebsite:                           http://www.iccwbo.org

Bookstore

Uniform Customs and Practice for Documentary Credit (UCP)

Users’ Handbook for Documentary Credits under UCP 600 (2008)ICC Uniform Rules for Bank-to-Bank Reimbursements under Documentary Credits (2008)The Complete UCP Uniform Customs and Practice for Documentary Credits (2008)Insights into UCP 600 – Collected Articles from DCI 2003 to 2008Commentary on UCP 600 (2007)ICC Uniform Customs and Practice for Documentary Credits UCP 600 (2006)  

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9. Legal (contractual) aspects of doing business with the EU

9.4. Electronic invoicing

Information source:          CENWebsite:                           http://www.e-invoice-gateway.net/

‘Good-Practice-Guidelines’ which support you in an easy start up on e-Invoicing;

Country related information about e-Invoicing which gives an quick overview about European e-Invoicing efforts;

A list of issues regarding e-Invoicing which shows critical points as well as possible solutions. Here you are invited to send an issue to the expert group (via mail form in this section):

Text of the new EU Directive on electronic invoicing.Go to documents  

 

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10. Opportunities of public markets in the European Union 10.1. European tenders and grants

10.2.  Public procurement in the EU

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10. Opportunities of public markets in the European Union 10.1. European tenders and grants

Information source 1: European Commission – EuropeAid Co-Operation Office of the European CommissionWebsite: http://ec.europa.eu/comm/europeaid/index.htm

Information source 2: European Commission – DG Enterprise and Industry – Access to finance

Website: http://ec.europa.eu/contracts_grants/grants_en.htm

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10. Opportunities of public markets in the European Union 10.2.  Public procurement in the EU

Information source 1: TED (Tenders Electronic Daily)

Website: http://ted.europa.eu/

Information source 2: SIMAP

Website: http://simap.europa.eu/ 

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11. Euro 11.1. Euro foreign exchange rate

11.2. Cross-border payments in euro  

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11. Euro 11.1. Euro foreign exchange rate

Information source:          European Central Bank Website:                           http://www.ecb.eu/stats/exchange/eurofxref/html/index.en.html

11.2. Cross-border payments in euro 

Information source:          European Commission – DG Internal Market Website:                           http://ec.europa.eu/internal_market/payments/crossborder/index_en.htm

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12. Other information 12.1. Identification of bar codes in EU Member States

12.2. Identification of Global Location Numbers (GLN)

 

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12. Other information 12.1. Identification of bar codes in EU Member States

Information source: GS1

Website: http://www.gs1.org/

Click here to find the GS1 Member Organisation nearest you

12.2. Identification of Global Location Numbers (GLN)

Information source:          GS1 Website:                           http://www.gs1.org/glnrules/

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 13. Solving problems in doing business in the EU  13.1. SOLVIT: a solution-oriented service for businesses Information source:          SOLVIT Website:                           http://ec.europa.eu/solvit    SOLVIT is an online problem solving network in which EU member states work together to solve problems caused by the misapplication of EU legislation by public authorities. 

Some examples of how SOLVIT has helped businesses and citizens can be found on: http://ec.europa.eu/solvit/site/success/index_en.htm. 

National SOLVIT-centres can be contacted via following webpage:http://ec.europa.eu/solvit/site/centres/index_en.htm 

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