Guide to doing Business with the EU

Constanta, June 29th 2012

Luc Van Looveren Expert EU related business information 1

Contents 1. General Information about the European Union 2. Importing goods into / from the European Union 3. Taxation of goods in the European Union 4. Producing and/or selling goods and services in the European Union 5. Intellectual property rights in the European Union 6. Finding business partners in the European Union 7. Starting a business in the European Union 8. Market information 9. Legal (contractual) aspects of doing business with the EU 10. Opportunities of public markets in the European Union 11. Euro 12. Other information 13. Solving problems in doing business in the EU 14. Useful addresses 2

I.

1.1.

1.2.

General Information about the European Union European institutions and policies Information and advice for businesses – Enterprise Europe Network (EEN) 3

I.

1.1.

General Information about the European Union European institutions and policies Information source 1: The EU at a glance Website: http://europa.eu/abc/index_en.htm

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

Information source 3: Channels for general questions Website: http://europa.eu/geninfo/mailbox/index_en.htm

4

I.

1.2.

General Information about the European Union Information and advice for businesses – Enterprise Europe Network (EEN) http://www.enterprise-europe-network.ec.europa.eu/index_en.htm

Watch

videoclip

5

2.4.

2.5.

2.6.

2.7.

2.

2.1.

2.2.

2.3.

Importing goods into / from the European Union Customs code numbers and import duties Customs documents Import tariff quotas Anti-dumping measures Rules of origin Import licenses for textiles and steel Customs and security 6

2.

2.1.

Importing goods into / from the European Union Customs code numbers and import duties Information source 1: Website: Information source 2: Website: TARIC database of the European Commission http://ec.europa.eu/taxation_customs/dds2/taric Export Helpdesk for developing countries http://exporthelp.europa.eu/ Additional information source: ‘Binding Tariff Information’ (BTI) service Website: http://ec.europa.eu/taxation_customs/common/databases/ebti/index_en.htm

FAQ: consult the document http://ec.europa.eu/taxation_customs/dds2/taric/help/dds_tar_faq_en.pdf

7

Finding info on import tariffs via TARIC

http://ec.europa.eu/taxation_customs/dds2/taric

Example: Biscuits 1) Find the product code via the Browse or Advanced search option 2) Select the country of origin, e.g. Belarus

8

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

EA = agricultural component ADFM = additional duty on flour contents Composition: Milk fat: Milk proteins: >= 1.5 < 3 % 2.5 < 6 % Starch / Glucose: > 5 < 25 % Sucrose / Invert Sugar / Isoglucose: >= 5 < 30 %

Finding info on import tariffs via Export HELPDESK

http://exporthelp.europa.eu

Example: Biscuits 1) Find the product code via the Browse or Search option 2) Select the country of origin, e.g. Belarus

10

IMPORT TARIFFS: EXAMPLE 11

2.

2.2.

Importing goods into / from the European Union Customs documents Information source 1: Export Helpdesk for developing countries (Requirements and Taxes) Information source 2: Export Helpdesk for developing countries (Preferential Arrangements) 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 12

Information source: Export HELPDESK http://exporthelp.europa.eu

13

14

15

2.

2.4.

Importing goods into / from the European Union 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.htm

anti-dumping measure s 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/ 16

ANTI-DUMPING DUTIES: EXAMPLES 17

2.

2.5.

Importing goods into / from the European Union 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 for developing countries Web address: http://exporthelp.europa.eu/ Remark: Belarus is temporarily suspended from GSP, while some other countries have not yet complied with the administrative cooperation requirements, which are a pre-condition for goods to be granted the benefit of the preference. If in doubt, your competent customs authorities will advise.

18

PREFERENTIAL IMPORT DUTIES: EXAMPLE 19

http://ec.europa.eu/taxation_customs/customs/customs_duties/rules_origin/preferential/article_839_en.htm

20

PREFERENTIAL IMPORT DUTIES – GSP LIST RULES: EXAMPLE 21

2.

2.6.

Importing goods into / from the European Union Import licenses for textiles and steel Information source: Website: European Commission – Trade Issues - SIGL http://trade.ec.europa.eu/sigl/ Textiles search Steel search Footwear 22

23

IMPORT LICENCES FOR TEXTILES 24

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).

25

2.

2.7.

Importing goods into / from the European Union 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.htm

contact 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 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.

26

2.

2.7.

Importing goods into / from the European Union 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/ Dual use goods are products and technologies normally used for civilian purposes but which may have military applications 27

2.

2.8.

Importing goods into / from the European Union Sustainable International Trade 1) 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/ 2) Specific organisations: Food products Clothes Wood Fish Textile Certification: http://www.maxhavelaar.nl/ http://fairwear.org/ http://www.fsc.org/ http://www.msc.org/ http://www.oeko-tex.com

http://certification.controlunion.com/ 28

3.

3.1.

Taxation of goods in the European Union 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 ’ 29

30

3.

3.2.

Taxation of goods in the European Union 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

31

4.

4.1.

4.1.1.

4.1.2.

4.1.3.

4.1.4.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods Industrial products covered by the new approach (CE-marking) in technical harmonisation Foodstuffs Chemical products Other products 32

4.

4.1.

4.2.

4.3.

4.4.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods Environmental rules for commercialising goods in the European Union Voluntary eco-management and eco-label schemes Internal market rules regarding the freedom to provide services in the European Union 33

4.

4.1.

4.1.1.

4.1.2.

4.1.3.

4.1.4.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods Industrial products covered by the new approach (CE-marking) in technical harmonisation Foodstuffs Chemical products Other products 34

4.

4.1.

Producing and/or selling goods and services in the European Union 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 legislation Website: 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/index_en.htm

35

4.

4.1.

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

36

4.

4.1.

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

http://www.newapproach.org

Texts of European harmonised standards may be ordered from National Standardisation bodies: CEN national members http://www.cen.eu/cen/Members/Pages/default.aspx

CENELEC national members http://www.cenelec.eu/Cenelec/CENELEC+in+action/Web+Store/Standards/default.htm

ETSI national members http://portal.etsi.org/Portal_Common/home.asp

37

4.

4.1.

Producing and/or selling goods and services in the European Union 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 System http://ec.europa.eu/enterprise/newapproach/nando/ 38

4.

4.1.

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

39

4.

4.1.

Producing and/or selling goods and services in the European Union 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) can be found at: http://ec.europa.eu/enterprise/sectors/mechanical/international competitiveness/agreements/index_en.htm

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

40

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

41

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

42

Lifts

Websites with practical info on CE marking in the EU

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

43

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

44

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

45

Selling industrial products requiring CE marking (e.g. construction products) in the EU I. Introduction: Concept of the New Approach and the Global Approach

1) Council regulation of 1985 on the

New Approach to technical harmonisation and standardisation

: A new regulatory technique and strategy !

46

Selling industrial products requiring CE marking in the EU I. Introduction: Concept of the New Approach and the Global Approach

Legislative harmonisation

Community.

is limited to

essential requirements

that products placed on the Community market must meet, if they are to benefit from the free movement within the The

technical specifications

of products meeting the essential requirements set out in the directives are laid down in

harmonised standards .

Application of harmonised or other standards remains

voluntary

, and the manufacturer may always apply other technical specifications to meet the requirements.

Products manufactured in compliance with harmonised standards benefit from a

presumption of conformity

with the corresponding essential requirements.

47

Selling industrial products requiring CE marking in the EU I. Introduction: Concept of the New Approach and the Global Approach

2) Council Decision

93/465/EEC

: general guidelines and detailed procedures for conformity assessment that are to be used in New Approach Directives.

Conformity assessment is based on: manufacturer’s internal design and production control activities; third party type examination combined with manufacturer’s internal production control activities; third party type or design examination combined with third party approval of product or production quality assurance systems, or third party product verification; third party unit verification of design and production; or third party approval of full quality assurance systems.

48

Selling industrial products requiring CE marking in the EU II. Standard elements of New Approach Directives

1. SCOPE

The scope defines the range of products covered by the directive or the nature of hazards to avert.

Examples: 1) toys directive

A toy = any product or material designed or clearly intended for use in play by children of less than 14 years of age

2) construction products directive

A construction product = any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works.

49

Selling industrial products requiring CE marking in the EU II. Standard elements of New Approach Directives

1. SCOPE

Several directives may apply to the same product and all of them must be applied for a correct CE marking!

Ex.: - machine directive + - low voltage directive + - EMC directive (! + other laws in the field of environment: ROHS, WEEE, packaging waste) 50

Selling industrial products requiring CE marking in the EU II. Standard elements of New Approach Directives

2. ESSENTIAL REQUIREMENTS

- are set out in the annexes to the directives; - include all that is necessary to achieve the objective of the directive.

Products may be placed on the market and put into service only if they are in compliance with the essential requirements.

Example: Machine Directive (Annex I) 1.2.4. Stopping Device

Normal Stopping

Each machine must be fitted with a control whereby the machine can be brought safely to a complete stop.

51

Selling industrial products requiring CE marking in the EU II. Standard elements of New Approach Directives

3. PRESUMPTION OF CONFORMITY

Products that comply with

national standards transposing harmonised standards

presumed to comply with the corresponding essential requirements are Examples – Machine Directive EN 115-1:2008+A1:2010

(new)

Safety of escalators and moving walks - Part 1: Construction and installation EN 349:1993+A1:2008 Safety of machinery - Minimum gaps to avoid crushing of parts of the human body 52

Selling industrial products requiring CE marking in the EU II. Standard elements of New Approach Directives

4. CONFORMITY ASSESSMENT

Before placing a product on the Community market, the manufacturer must subject the product to a

conformity assessment procedure

provided for in the applicable directive, with the view to affixing the

CE marking.

53

Selling industrial products requiring CE marking in the EU II. Standard elements of New Approach Directives

5. NOTIFIED BODIES

Third party conformity assessment is carried out by notified bodies, which have been designated by the Member States among bodies that fulfil the requirements laid down in the directive and that are established on their territory.

Member States notify and monitor Conformity Assessment Bodies.

54

Selling industrial products requiring CE marking in the EU III. Simultaneous application of New Approach directives and other EU laws

New Approach directives and the

Directive on general product safety

The Directive on general product safety applies to consumer products provided that: - the product is not covered by New Approach Directives or other Community legislation; or - not all aspects of safety or categories of risk are covered by New Approach directives or other Community legislation.

55

Selling industrial products requiring CE marking in the EU III. Simultaneous application of New Approah directives

New Approach directives and the

Directive on product liability.

The Directive on product liability (85/374) is applicable to all products covered by New Approach Directives.

The Directive on product liability (85/374) covers any product manufactured or imported into the Community which causes damage to individuals or private property. The directive establishes a strict liability regime on manufacturers and importers in the Community.

56

Selling industrial products requiring CE marking in the EU IV. Placing on the market and putting into service

Placing on the market

free of charge).

Putting into service

= making a product available for the first time (for payment or = taking place at the moment of first use within the EU by the end user.

Concrete: a product must comply with the applicable NA directives when it is placed on the Community market for the first time and put into service.

Example: sending an imported machine for testing to a potential buyer / client in the EU

57

Selling industrial products requiring CE marking in the EU V. New Approach Directives for various products

Low voltage equipment (2006/95) Simple pressure vessels (87/404) Toys (88/378) Construction products (89/106) Electromagnetic compatibility (2004/108) Machinery (2006/42) Personal protective equipment (89/686) Non-automatic weighing instruments (90/384) Active implantable medical devices (90/385) Gas appliances (90/396) Hot water boilers (92/42) Civil exlosives (93/15) Pyrotechnical products (2007/23/EC) Medical devices (93/42) cont’d on next slide 58

Selling industrial products requiring CE marking in the EU V. New Approach Directives

Equipment to be used in potentially explosive atmospheres (94/9) Recreational craft (94/25) Lifts (95/16) Refrigeration appliances (96/57) Pressure equipment (97/23) Telecommunications terminal equipment (98/13) In vitro diagnostic medical devices (98/79) Radio and telecommunications terminal equipment (99/5) Cable way installations designed to carry persons (2000/9) Noise emission by equipment used outdoors (00/140) 59

Selling industrial products requiring CE marking in the EU VI. Responsibilities

The

manufacturer

must ensure a correct application of NA directives (CE-marking obligations).

If the manufacturer is established outside the EU, he can appoint an

representative

. If not, following will be held responsible:

authorised

a) for placing on the market importer , bringing the product on the market distributor , who sells the product after import in the EU assembler or installer b) for putting into service only user 60

Selling industrial products requiring CE marking in the EU VII. Compliance with Directives

Essential requirements:

lay down the

necessary elements for protecting the public interest

health and safety) by defining the results to be obtained or the hazards to be dealt with but without specifying the technical solutions for doing so; (in particular: are

mandatory

. Only products complying with essential requirements may be placed on the market and put into service; must be

applied as a function of the hazards inherent to a given product

(manufacturers need to carry out risk analysis to determine the essential requirement applicable to the product = documentation to be included in the technical documentation).

61

Selling industrial products requiring CE marking in the EU VII. Compliance with Directives

Hamonised standards:

are European standards which are adopted by European standards organisations and follow a mandate issued by the Commission after consultation with the EU Member States; Examples: 1) 2) Construction products (blinds / shutters curtain walling) EN 13561:2004 - External blinds – Performance requirements including safety EN 13659:2004 - Shutters – Performance requirements including safety EN 13830:2003 - Curtain walling – product standard Machines EN 13862, Publication date:2002-04-01 – Floor cutting-off machines – Safety 62

Selling industrial products requiring CE marking in the EU

Examples of European Standards in the field of sustainable construction

:

Thermal performance of buildings and building components (CEN/TC 89): http://newapproach.cen.eu/cen/stdlist.asp?dir_area=89/106/EEC&prod_fam=CEN/TC%2089 Thermal insulating materials and products (CEN/TC 88): http://newapproach.cen.eu/cen/stdlist.asp?dir_area=89/106/EEC&prod_fam=CEN/TC%2088 63

Selling industrial products requiring CE marking in the EU VII. Compliance with Directives

Presumption of conformity

Conformity with a national standard that transposes a harmonised standard, whose reference has been published

, confers a presumption of conformity with the essential requirements of the applicable NA directive that is covered by such a standard.

References (titles, identification nrs.) of harmonised standards

directives are published in the Official Journal. An updated list of such references for each NA directive can be found at: http://www.newapproach.org

for New Approach

MS must publish the reference of the national standard that transposes a harmonised standard .

The

application of harmonised standards remains voluntary

directives. Thus, the product may be manufactured directly on the basis of the essential requirements.

in the field of New Approach 64

Selling industrial products requiring CE marking in the EU VII. Compliance with Directives

Conformity assesment procedures: modules

Conformity assessment is subdivided into modules, which comprise a limited number of different procedures applicable to the widest range of products.

The modules relate to the

design phase of products , their production phase or both

.

8 basic modules (A, B,… H) and 8 possible variants can be combined with each other in a variety of ways (e.g. B+C = EC type examination + EC Conformity declaration with the type).

Each NA directive describes the range and contents of possible conformity assessment procedures, which are considered to give the necessary level of protection. The directives also set out the criteria governing the conditions under which the manufacturer can make a choice, if more than one option is provided for.

65

Selling industrial products requiring CE marking in the EU VII. Compliance with Directives

Conformity assesment procedures: technical documentation

The

manufacturer must draw up a technical file

about: (documentation) with information - the design, - manufacture and - operation of the product 66

Selling industrial products requiring CE marking in the EU VII. Compliance with Directives

EC Declaration of Conformity

The

manufacturer or the authorised representative in the EU Declaration of Conformity

must draw up an

EC

as part of the conformity assessment procedure provided for in the New Approach directives.

This declaration should contain all relevant information to identify: - the directives according to which it is issued, as well as - the manufacturer or authorised representative - the notified body, if applicable - the product and where appropriate - a reference to harmonised standards or other

normative documents.

67

CE marking in the EU - examples

Example 1: operating tables Q1: Is CE – marking relevant? Yes Q2: Which EU-Directive(s) is (are) relevant?

Are their electrical components ? Yes Relevant EU-Directives:

Low Voltage Directive (LVD) 2006/95/EC EMC-Directive 2004/108/EC (Electromagnetic Compatibility

Is an operating a medical device ?

Yes Relevant EU-Directive:

Directive 93/42/EEC regarding medical devices

68

CE marking in the EU - examples

Example 1: operating tables Is there a harmonized standard available as a technical solution for complying with the essential requirements of the Medical Devices Directive?

Yes, HS can be found at following website: http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list references/medical-devices/index_en.htm

EN 60601-2-46:1998

Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998) HS for compliance with the LVD and EMC – Directive can be consulted at: http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list references/index_en.htm

69

CE marking in the EU - examples

Example 2: outdoor play equipment Q1: Is CE – marking relevant? Yes Q2: Which EU-Directive(s) is (are) relevant?

Relevant EU-Directive: The

Toy Safety Directive

70

CE marking in the EU - examples

Example 2: outdoor play equipment Is there a harmonized standard available as a technical solution for complying with the essential requirements of the Toy Safety Directive?

Yes, HS can be found at following website: http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list references/toys/index_en.htm

71

CE marking in the EU - examples

Example 2: outdoor play equipment Harmonised Standards EN 71-1:2005+A9:2009 EN 71-2:2006+A1:2007 EN 71-3:1994 EN 71-3:1994/A1:2000/AC:2000 EN 71-3:1994/AC:2002 EN 71-4:2009 activities EN 71-5:1993 Safety of toys - Part 1: Mechanical and physical properties Safety of toys - Part 2: Flammability Safety of toys - Part 3: Migration of certain elements Safety of toys - Part 4: Experimental sets for chemistry and related Safety of toys - Part 5: Chemical toys (sets) other than experimental sets EN 71-5:1993/A1:2006 EN 71-5:1993/A2:2009 EN 71-7:2002 EN 71-8:2003+A4:2009 Safety of toys - Part 7: Finger paints - Requirements and test methods Safety of toys - Part 8: Swings, slides and similar activity toys for indoor and outdoor family domestic use EN 62115:2005 Electric toys - Safety IEC 62115:2003 (Modified) + A1:2004 !‘The producer must verify which standards from this list are relevant for his products 72

CE marking in the EU - examples

Example 2: outdoor play equipment Harmonised Standards

Example: Wooden Garden Swing Set (producer: Treetops)

• • • • This is an installation of a wooden garden swing set which is suitable for children from 1 year.

It comprises a Wooden Double Swing Set a Double Rocker Swing, a Rubber Swing Seat and a Tyre Ring.

The footprint is 2.8 x 1.75m.

Treetops wooden children's swing sets and outdoor wooden climbing frames and garden play equipment are architect designed and strictly tested to meet British and European Safety Standard EN71-8 for use in private gardens and bear the CE mark 73

CE marking in the EU - examples

Example 3: construction products – windows and doors Q1: Is CE – marking relevant? Yes Q2: Which EU-Directive(s) is (are) relevant?

Relevant EU-Directive: Directive 89/106/EEC (Construction Products Directive) 74

CE marking in the EU - examples

Example 3: construction products - windows and doors Harmonised Standard

EN 14351-1:2006+A1:2010 (new)

Windows and doors - Product standard, performance characteristics - Part 1: Windows and external pedestrian doorsets without resistance to fire and/or smoke leakage characteristics HS can be searched at following website: http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards legislation/list-references/construction-products/index_en.htm

75

CE marking in the EU - examples

Example 4: personal protective equipment (PPE) – protective gloves and helmets Q1: Is CE – marking relevant? Yes Q2: Which EU-Directive(s) is (are) relevant?

Relevant EU-Directive: The PPE Directive 89/686/EEC 76

CE marking in the EU - examples

Example 4: personal protective equipment (safety gloves and helmets) Harmonised Standards EN 374-1:2003 Protective gloves against chemicals and micro-organisms - Part 1: Terminology and performance

EN 397:1995

requirements EN 374-2:2003 Protective gloves against chemicals and micro-organisms - Part 2: Determination of resistance to penetration EN 374-3:2003 Protective gloves against chemicals and micro-organisms - Part 3: Determination of resistance to permeation by chemicals

EN 374-3:2003/AC:2006

EN 388:2003 Protective gloves against mechanical risks

EN 407:2004

Industrial safety helmets

EN 397:1995/A1:2000

Protective gloves against thermal risks (heat and/or fire)

EN 420:2003 EN 420:2003/AC:2006 EN 421:1994

Protective gloves - General requirements and test methods Note 4 Protective gloves against ionizing radiation and radioactive contamination

EN 443:2008 EN 511:2006

Helmets for fire fighting in buildings and other structures Protective gloves against cold HS can be searched at following website: http://ec.europa.eu/enterprise/sectors/mechanical/documents/standardization/personal-protective equipment/standards/index_en.htm

77

4.

4.1.

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

Foodstuffs I. EUROPEAN FOODSTUFFS LEGISLATION Information sources: - Summaries of EU legislation (see previous sldes) - EUR-LEX ( “ ) - European Commission – DG Health and Consumer Protection Website: http://ec.europa.eu/food/food/index_en.htm

II. HACCP AND FAO / WHO FOOD STANDARDS Information source: Codex Alimentarius Website: http://www.codexalimentarius.net

‘ Official Standards – Special Publications ’ ‘ Official Standards – Official Codex Standards – List ’ 78

4.

4.1.

4.1.2.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods Foodstuffs III. SCIENTIFIC ADVICE ON FOOD SAFETY Information source: The European Food Safety Authority Website: http://www.efsa.europa.eu/ 79

4.

4.1.

4.1.2.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods Foodstuffs IV. SPECIFIC LABELS FOR FOODSTUFFS IV.1. Geographical indications & designations of origin, certificates of specific character of foodstuffs Information source: European Commission – DG Agriculture Website: 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 80

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.

81

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 "Champagne" under specific circumstances.

) 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 82

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. 83

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. 84

4.

4.1.

4.1.2.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods 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 85

V. EU REGISTER ON NUTRITION AND HEALTH CLAIMS Information source: European Commission Website: http://ec.europa.eu/nuhclaims/ 86

87

4.

4.1.

4.1.3.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods 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 88

4.

4.1.

4.1.3.

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

http://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 System http://esis.jrc.ec.europa.eu/ 89

4.

4.1.

4.1.3.

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

90

4.

4.1.

4.1.3.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods 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 / 91

Community Register for Biocidal Products: examples

Active substance Boric acid Boric oxide Brodifacoum EC number 233-139-2 215-125-8 259-980-5 Bromadiolone Clothianidin Copper (II) hydroxide Copper (II) oxide 249-205-9 Carbon dioxide Carbon dioxide 204-696-9 204-696-9 Chlorophacinone 223-003-0 433-460-1 243-815-9 215-269-1 CAS - number 10043-35-3 1303-86-2 56073-10-0 Producttype 8 8 14 28772-56-7 124-38-9 124-38-9 3691-35-8 210880-92-5 26427-59-2 1317-38-0 14 14 18 14 8 8 8 Inclusion Dir.

2009/94/EC 2009/98/EC 2010/10/EU 2009/92/EC 2008/75/EC 2010/74/EU 2009/99/EC 2008/15/EC 2012/2/EU 2012/2/EU

92

4.

4.1.

4.1.3.

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

93

4.

4.1.

4.1.3.

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

94

4.

4.1.

4.1.3.

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

95

4.

4.1.

4.1.3.

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

96

4.

4.1.

4.1.3.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods 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/ 97

EXAMPLE FROM COSING - database

Substance: Colouring agent CI 26105

Substance CAS # EINECS/ELINCS # INN/ISO/AN Cosmetic Directive Other Directives/Regulations Annex/Part,Ref # SCCS opinions Colouring agent CI 26105 85-83-6 201-635-8 88/233/EEC II/379 Chemical/IUPAC Name Identified INGREDIENTS or substances e.g.

Note Current Version Other Versions • 1-(2-Methyl-4-(2 methylphenylazo)phenylazo)-2-naphthol; Scarlet red SOLVENT RED 24 v.3

v.1

v.2

98

4.

4.1.

4.1.3.

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

99

4.

4.1.

4.1.3.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods 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 : Legal framework : http://ec.europa.eu/health/human-use/index_en.htm

http://ec.europa.eu/health/human-use/legal-framework/index_en.htm

Medicines for children : http://ec.europa.eu/health/human-use/paediatric-medicines/index_en.htm

Orphan medicinal products : http://ec.europa.eu/health/human-use/orphan-medicines/index_en.htm

Advanced therapies : http://ec.europa.eu/health/human-use/advanced-therapies/index_en.htm

Herbal medicinal products : http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm

100

4.

4.1.

4.1.3.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods Chemical products PHARMACEUTICALS Specific information:

2) Medicinal products for veterinary use

General info : http://ec.europa.eu/health/veterinary-use/index_en.htm

Legal framework : http://ec.europa.eu/health/veterinary-use/legal-framework/index_en.htm

Maximum Residue Limits : http://ec.europa.eu/health/veterinary-use/maximum-residue-limits/index_en.htm

EMEA – European Medicines Agency

http://www.ema.europa.eu

101

Invented name Active substance EMEA Decision number PIP number Pharmaceutical form(s) Condition(s)/indiciation(s) Route(s) of administration PIP applicant Decision type

EMEA – EXAMPLE OF SEARCH

Paracetamol P/96/2008 EMEA-000130-PIP01-07 Solution for infusion Moderate pain and fever Intravenous Applicant: Baxter World Trade SA/NV E-mail: [email protected]

Country: Belgium Phone: +32 26501679 Fax: +32 26501679 P: decision agreeing on a Paediatric Investigation Plan, with or without partial waiver(s) and or deferral(s) 102

4.

4.1.

4.1.3.

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

http://ec.europa.eu/health/documents/community-register/index_en.htm

3) European Pharmacopoeia Online

http://online.pheur.org/entry.htm

103

4.

4.1.

4.1.3.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods Chemical products CLASSIFICATION AND LABELLING OF CHEMICALPRODUCTS Information source: EUROPEAN COMMISSION – DG ENTERPRISE AND INDUSTRY CLP / GHS Web page Website: http://ec.europa.eu/enterprise/sectors/chemicals/classification/index_en.htm

Information source: EUROPEAN COMMISSION - JOINT RESEARCH CENTRE Website: 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=15 104

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 CD

A 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 CD

A module of Dangerous Substances CD , it provides full coverage of EU rules governing cosmetic products.

105

4.

4.1.

4.1.4.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods 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/textile/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) 106

4.

4.1.

4.1.4.

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

107

Three parts of the footwear

Upper

This is the outer face of the structural element which is attached to the outersole.

Lining and sock

These are the lining of the upper and the insole, constituting the inside of the footwear article.

Outer Sole

This is the bottom part of the footwear article, which is subjected to abrasive wear and attached to the upper.

108

Pictograms of footwear materials

Leather Coated leather Textile Other material

109

4.

4.1.

4.1.4.

Producing and/or selling goods and services in the European Union Internal market rules regarding the free movement of goods 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/ 110

4.

4.2.

4.2.1. Producing and/or selling goods and services in the European Union Environmental rules for commercialising goods in the European Union Packaging and packaging waste obligations 1. Legal framework for packaging waste in the EU Information source: European Commission - DG Environment Website: http://ec.europa.eu/environment/waste/packaging_index.htm

2. Packaging waste recovery organisations in the EU Information source: Packaging Recovery Organisation Europe Website: http://www.pro-e.org

111

4.

4.2.

4.2.2. Producing and/or selling goods and services in the European Union Environmental rules for commercialising goods in the European Union 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 Environment Website: http://ec.europa.eu/environment/waste/weee_index.htm

Socket Saver (Lead-free)

WEEE recovery organisations in the EU Information source: WEEE Forum Website: http://www.weee-forum.org/ 112

4.

4.2.

4.2.3. Producing and/or selling goods and services in the European Union Environmental rules for commercialising goods in the European Union 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

113

4.

4.3.

4.3.1. Producing and/or selling goods and services in the European Union Voluntary eco-management and eco-label schemes 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

provide SMEs with an easy step-by-step explanation to reach registration with the EU Eco- Management and Audit Scheme. to Information source: European Commission - DG Environment Website: http://ec.europa.eu/environment/emas/index_en.htm

114

4.

4.3.

4.3.2. Website: Producing and/or selling goods and services in the European Union Environmental issues in SME management , design and production of goods 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 http://ec.europa.eu/environment/ecolabel/index_en.htm

‘ Ecolabelled products - Product categories’ ‘ Ecolabelled products – Finding products’ 115

116

4.

4.4.

4.4.1.

Producing and/or selling goods and services in the European Union Internal market rules regarding the freedom to provide services in the European union 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.

117

4.

4.4.

4.4.2.

Producing and/or selling goods and services in the European Union Internal market rules regarding the freedom to provide services in the European union 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.

5.1.

5.2.

5.3.

Intellectual property rights in the European Union Protection of patents in the EU Protection of trademarks in the EU Protection of models and designs in the EU 119

5.

5.1.

Intellectual property rights in the European Union 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” 120

121

5.

5.2.

Intellectual property rights in the European Union 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 Marks Website: 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

Trade mark No: Filing date: Nice Classification: Publication of registration Name of the owner:

002108918 27/02/2001 16, 21, 25, 32, 42 The Coca-Cola Company

Applicant’s reference: Trade mark basis:

CE-20010292 CTM Type of mark: Date of registration: Figurative 03/02/2003 Status: Registered 123

Community Trade Mark: Example

Trade mark No: Date of international registration: Nice Classification: Name of the owner: 0926155

24/04/2007 16, 20, 35, 43 Inter IKEA Systems B.V.

Type of mark: Figurative

Status: International registration accepted

Trade mark basis:

IR designating the EC 124

6.

6.1.

6.2.

Finding business partners in the European Union Publication of trade and cooperation proposals in the EU Finding R&D partners in Europe 125

6.

6.1.

Finding business partners in the European Union 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

126

127

6.

6.2.

Finding business partners in the European Union 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.

128

7.

7.1.

7.2.

7.3.

Starting a business in the European Union Legal requirements and incentives for creating a company in the EU Social security systems in the EU Taxation in the EU Member States 129

7.

7.1.

Starting a business in the European Union Legal requirements and incentives for creating a company in the EU Information source 1: Website: European Commission Your Europe - Business http://ec.europa.eu/youreurope/business/index_en.htm

Information source 2: Website: Info on legal requirements, administrative procedures, etc. European Commission – DG Enterprise and Industry Enterprise Europe Network (EEN) 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 130

7.

7.2.

Starting a business in the European Union 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 7.3.

MISSOC Database 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

"Taxes in Europe" database 131

8.

8.1.

8.2.

Market information Statistical info about external trade of the EU Trade fairs in the EU (and worldwide 132

8.

8.1.

Market information 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: Website: Eurostat – Statistical Office of the European Communities http://epp.eurostat.ec.europa.eu/portal/page/portal/statistics/themes 8.2.

Trade fairs in the EU (and worldwide Information source: M+A Expo Database Website: http://www.expodatabase.com/ 133

9.

9.1.

9.2.

9.3.

9.4.

Legal (contractual) aspects of doing business with the EU Contracts with EU enterprises Incoterms Documentary credits Electronic invoicing 134

9.

9.1.

Legal (contractual) aspects of doing business with the EU Contracts with EU enterprises Information source 1: ICC - International Chamber of Commerce Website: http://www.iccwbo.org

Bookstore ICC Model International Trademark License ICC Model International Transfer of Technology Contract ICC Model Turnkey Contract for Major Projects Drafting and negotiating International Commercial contracts ICC Legal Handbook on Global Sourcing Contracts ICC Model International Sale Contract ICC Model Occasional Intermediary Contract ICC Model Confidentiality Agreement ICC Model Commercial Agency Contract – 2 nd edition ICC Model Distributorship Contract ICC Short Form Model Contracts ICC Model Contract for the Turnkey Supply of an Industrial Plant ICC Model International Franchising Contract ICC Model Selective Distributorship Contract ICC Model Mergers & Acquisitions Contract 1 – Share Purchase Agreement ICC Force Majeure Clause 2003 – ICC Hardship Clause 2003 135

9.

9.1.

Legal (contractual) aspects of doing business with the EU 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 agreement

(13) ;

Construction, installation of plant, engineering

(3) ; (2) ;

Confidentiality and not-to-compete Data transfer

(1) ;

Distribution

(3) ;

E-Commerce, Internet and multimedia

(28) ;

Franchising Joint ventures, consortium and cooperation agreements

(2) ; (8) ;

ITC model contracts Licensing (patent, trademark and know-how)

(24) ;

Machinery (supply, etc.)

(4) ; (38) ;

Letter of intent / Memorandum of understanding Music

(4) ;

Procurement

(12) ;

Publishing

(18) ;

Research

(6) ;

Sale of manufactured and semi-manufactured goods Sale of perishable goods, commodities and raw materials - Cocoa

(4) ; (1);

Sale of perishable goods, commodities and raw materials - General

(5) ;

Sale of perishable goods, commodities and raw materials - Grains, oil seeds and feeding meals Sale of perishable goods, commodities and raw materials - Others

(1) ;

Services

(7) ;

Subcontracting

(1) ;

Technical assistance

(2) (35) ; (8) ; 136

9.

9.2.

Legal (contractual) aspects of doing business with the EU Incoterms Information source 1: ICC - International Chamber of Commerce Website: http://www.iccwbo.org

Information source 2: International Business Training Website: http://www.i-b-t.net/incoterms.html#FOB 137

138

9.

9.3.

Legal (contractual) aspects of doing business with the EU Documentary credits Information source 1: ICC - International Chamber of Commerce Website: 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 2008 Commentary on UCP 600 (2007) ICC Uniform Customs and Practice for Documentary Credits UCP 600 (2006) 139

9.

9.4.

Legal (contractual) aspects of doing business with the EU Electronic invoicing Information source: CEN Website: 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

Invoicing efforts;

which gives an quick overview about European e- 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 140

10.

10.1.

10.2. Opportunities of public markets in the European Union European tenders and grants Public procurement in the EU 141

10.

10.1.

Opportunities of public markets in the European Union European tenders and grants Information source 1: Website: European Commission – EuropeAid Co-Operation Office of the European Commission http://ec.europa.eu/comm/europeaid/index.htm

Information source 2: Website: European Commission – DG Enterprise and Industry – Access to finance http://ec.europa.eu/contracts_grants/grants_en.htm

142

10.

10.2. Opportunities of public markets in the European Union Public procurement in the EU Information source 1: Website: TED (Tenders Electronic Daily) http://ted.europa.eu/ Information source 2: Website: SIMAP http://simap.europa.eu/ 143

11.

11.1.

11.2.

Euro Euro foreign exchange rate Cross-border payments in euro 144

11.

11.1.

Euro 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

145

12.

12.1.

12.2.

Other information Identification of bar codes in EU Member States Identification of Global Location Numbers (GLN) 146

12.

12.1.

Other information Identification of bar codes in EU Member States Information source: Website: GS1 http://www.gs1.org/ 12.2.

Click here to find the GS1 Member Organisation nearest you Identification of Global Location Numbers (GLN) Information source: GS1 Website: http://www.gs1.org/glnrules/ 147

13.

13.1.

Solving problems in doing business in the EU 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

148