# CSEU "Boilerplate" language for EUR Post CCG's

# CY2007

# Chapter 3: Selling U.S. Products and Services 

-   [Using an Agent or
    Distributor](#using-an-agent-or-distributor-return-to-top)

-   [Direct Marketing](#direct-marketing-return-to-top)

-   [Selling to the
    Government](#selling-to-the-government-return-to-top)

-   [Electronic Commerce](#electronic-commerce-return-to-top)

-   [Trade Promotion and
    Advertising](#trade-promotion-and-advertising-return-to-top)

-   [Sales Service/Customer
    Support](#sales-servicecustomer-support-return-to-top)

-   [Protecting Your Intellectual
    Property](#protecting-your-intellectual-property-return-to-top)

-   [Local Professional
    Services](#local-professional-services-return-to-top)

-   [Web Resources](#web-resources-return-to-top)

## Using an Agent or Distributor [**Return to top**](#ch3)

Companies wishing to use distribution, franchising and agency
arrangements need to ensure that the agreements they put into place are
in accordance with EU and Member State national laws. Council Directive
86/653/EEC establishes certain minimum standards of protection for
self-employed commercial agents who sell or purchase goods on behalf of
their principals. In essence, the Directive establishes the rights and
obligations of the principal and its agents; the agent's remuneration;
and the conclusion and termination of an agency contract, including the
notice to be given and indemnity or compensation to be paid to the
agent. U.S. companies particularly should be aware that the Directive
states that parties may not derogate certain requirements. Accordingly,
the inclusion of a clause specifying an alternate body of law to be
applied in the event of a dispute will likely be ruled invalid by
European courts.
<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31986L0653:EN:HTML>

The European Commission's Directorate General for Competition enforces
legislation concerned with the effects on competition in the internal
market of such \"vertical agreements.\" Most U.S. exporters are small-
and medium-sized companies and are therefore exempt from the Regulations
because their agreements likely would qualify as \"agreements of minor
importance,\" meaning they are considered incapable of affecting
competition at the EU level but useful for cooperation between SMEs.
Generally speaking, companies with fewer than 250 employees and an
annual turnover of less than EUR 50 million are considered small- and
medium-sized undertakings. The EU has additionally indicated that
agreements that affect less than 10 percent of a particular market are
generally exempted as well (Commission Notice 2001/C 368/07).
<http://eur-lex.europa.eu/LexUriServ/site/en/oj/2001/c_368/c_36820011222en00130015.pdf>

The EU also looks to combat payment delays with Directive 2000/35/EC.
This covers all commercial transactions within the EU, whether in the
public or private sector, primarily dealing with the consequences of
late payment. Transactions with consumers, however, do not fall within
the scope of this Directive. In sum, the Directive entitles a seller who
does not receive payment for goods/services within 30-60 days of the
payment deadline to collect interest (at a rate of 7 percent above the
European Central Bank rate) as compensation. The seller may also retain
the title to goods until payment is completed and may claim full
compensation for all recovery costs.
<http://ec.europa.eu/comm/enterprise/regulation/late_payments/>

## Direct Marketing [**Return to top**](#ch3)

*Introduction*

There is a wide range of EU legislation that impacts the direct
marketing sector. Compliance requirements are stiffest for marketing and
sales to private consumers. Companies need to focus, in particular, on
the clarity and completeness of the information they provide to
consumers prior to purchase, and on their approaches to collecting and
using customer data. The following gives a brief overview of the most
important provisions flowing from EU-wide rules on data protection,
distance selling and on-line commerce. Companies are advised to consult
the information available via the hyper-links, to check the relevant
sections of national Country Commercial Guides, and to contact the
Commercial Service at the U.S. Mission to the European Union for more
specific guidance.

*Processing Customer Data*

The EU's general data protection Directive (95/46/EC) spells out strict
rules concerning the processing of personal data. Businesses must tell
consumers that they are collecting data, what they intend to use it for,
and to whom it will be disclosed. *Data subjects* must be given the
opportunity to object to the processing of their personal details and to
opt-out of having them used for direct marketing purposes. This opt-out
should be available at the time of collection and at any point
thereafter. This general legislation is supplemented by specific rules
set out in the \"Directive on the processing of personal data and the
protection of privacy in the electronic communications sector\"
(2002/58/EC). This requires companies to secure the prior consent of
consumers before sending them marketing emails. The only exception to
this opt-in provision is if the marketer has already obtained the
intended recipient's contact details in the context of a previous sale
and wishes to send them information on similar products and services.
[[http://ec.europa.eu/justice_home/fsj/privacy/law/index_en.htm]{.underline}](http://europa.eu.int/comm/justice_home/fsj/privacy/law/index_en.htm)

*Transferring Customer Data to Countries Outside the EU*

The EU\'s general data protection Directive provides for the free flow
of personal data within the EU but also for its protection when it
leaves the region's borders. Personal data can only be transferred
outside the EU if adequate protection is provided for it or if the
unambiguous consent of the data subject is secured. The European
Commission has decided that a handful of countries have regulatory
frameworks in place that guarantee the adequate protection of data
transferred to them -- the United States is not one.

The Department of Commerce and the European Commission negotiated Safe
Harbor to provide U.S. companies with a simple, streamlined means of
complying with the adequacy requirement. It allows those U.S. companies
that commit to a series of data protection principles (based on the
Directive), and who publicly state that commitment by
\"self-certifying\" on a dedicated website, to continue to receive
personal data from the EU. Signing up is voluntary but the rules are
binding on those who do. The ultimate means of enforcing Safe Harbor is
that failure to fulfill the commitments will be actionable as an unfair
and deceptive practice under Section 5 of the FTC Act or under a
concurrent Department of Transportation statute for air carriers and
ticket agents. While the United States as a whole does not enjoy an
adequacy finding, companies that join up to the Safe Harbor scheme will.

EU based exporters or U.S. based importers of personal data can also
satisfy the adequacy requirement by including data privacy clauses in
the contracts they sign with each other. The Data Protection Authority
in the EU country from where the data is being exported must approve
these contracts. To fast track this procedure the European Commission
has approved sets of model clauses for personal data transfers that can
be inserted into contracts between data importers and exporters. The
most recent were published at the beginning of 2005. Most transfers
using contracts based on these model clauses do not require prior
approval. Companies must bear in mind that the transfer of personal data
to third countries is a processing operation that is subject to the
general data protection Directive regardless of any Safe Harbor,
contractual or consent arrangements.

[[http://www.export.gov/safeharbor/]{.underline}](http://www.export.gov/safeharbor/)

[[http://ec.europa.eu/justice_home/fsj/privacy/modelcontracts/index_en.htm]{.underline}](http://europa.eu.int/comm/justice_home/fsj/privacy/modelcontracts/index_en.htm)

*Distance Selling Rules*

•   Distance and Door-to-Door sales

The EU's Directive on distance selling to consumers (97/7/EC) set out a
number of obligations for companies doing business at a distance with
consumers. It can read like a set of onerous \"do's\" and \"don'ts,\"
but in many ways it represents nothing more than a customer relations
good practice guide with legal effect. Direct marketers must provide
clear information on the identity of themselves as well as their
supplier, full details on prices including delivery costs, and the
period for which an offer remains valid -- all of this, of course,
before a contract is concluded. Customers generally have the right to
return goods without any required explanation within seven days, and
retain the right to compensation for faulty goods thereafter.

Similar in nature is the Doorstep Directive (85/577/EEC) which is
designed to protect consumers from sales occurring outside of a normal
business premises (e.g., door-to-door sales) and essentially assure the
fairness of resulting contracts.

Key Link:
[[http://ec.europa.eu/consumers/cons_int/safe_shop/index_en.htm]{.underline}](http://europa.eu.int/comm/consumers/cons_int/safe_shop/index_en.htm)

•  Distance Selling of Financial Services

Financial services are the subject of a separate Directive that came
into force in June 2002 (2002/65/EC). This piece of legislation amends
three prior existing Directives and is designed to ensure that consumers
are appropriately protected in respect to financial transactions taking
place where the consumer and the provider are not face-to-face. In
addition to prohibiting certain abusive marketing practices, the
Directive establishes criteria for the presentation of contract
information. Given the special nature of financial markets, specifics
are also laid out for contractual withdrawal.

Key Link:
[[http://ec.europa.eu/consumers/cons_int/fina_serv/index_en.htm]{.underline}](http://europa.eu.int/comm/consumers/cons_int/fina_serv/index_en.htm)

*Direct Marketing Over the Internet*

The e-commerce Directive (2000/31/EC) imposes certain specific
requirements connected to the direct marketing business. Promotional
offers must not mislead customers and the terms that must be met to
qualify for them have to be easily accessible and clear. The Directive
stipulates that marketing e-mails must be identified as such to the
recipient and requires that companies targeting customers on-line must
regularly consult national opt-out registers where they exist. When an
order is placed, the service provider must acknowledge receipt quickly
and by electronic means, although the Directive does not attribute any
legal effect to the placing of an order or its acknowledgment. This is a
matter for national law. Vendors of electronically supplied services
must also collect value added tax (VAT).

Key Link:
[[http://ec.europa.eu/internal_market/e-commerce/index_en.htm]{.underline}](http://europa.eu.int/comm/internal_market/en/ecommerce/index.htm)

## Selling to the Government [**Return to top**](#ch3)

The EU public procurement market, including EU institutions and Member
States, totals around EUR 1,600 billion per year. This market is
regulated by two EU Directives which apply for contracts above certain
agreed thresholds. Under the agreed thresholds, each EU Member State has
developed its own procurement law, which is not regulated by the EU
public procurement Directives, although the general principles of the EU
Treaty regarding non-discrimination and free movement of goods apply
even below the thresholds. The two EU public procurement Directives are:
Directive 2004/18 on Coordination of procedures for the award of public
works, services and supplies contracts, and Directive 2004/17 on
Coordination of procedures of entities operating in the Utilities
sector, which covers water, energy, transport and postal services. Those
Directives are implemented in each EU Member State's national
procurement legislation. Two Remedies Directives outline the procedures
that EU Member States ought to put in place in case of violation of the
EU public procurement law: Directive 89/665 on the "Coordination of the
laws, Regulations and administrative provisions relating to the
application of review procedures to the award of public supply and
public works contracts" for the classic sectors, and Directive 92/13 for
remedies in the utilities sector.

Two proposals for new Directives, scheduled for 2007, are under
discussion by EU institutions. First, a proposal for a new Remedies
Directive, which would increase possibilities for aggrieved companies to
complain in pre-contractual period, is being discussed by the EU
institutions. Second, a proposal for a Directive covering defense
procurement would detail which particular less sensitive armaments
procurement will be covered by EU Directives and which sensitive items
will be allowed to benefit from an exemption of the law.

Most tenders from European public contracting authorities for public
supplies whose value is above the agreed thresholds are open to
U.S.-based companies by virtue of the WTO Government Procurement
Agreement (GPA). The GPA allows U.S. firms to bid on all supplies and
services and some construction works contracts above thresholds
contracted by EU central public contracting authorities. However, there
are restrictions for U.S. suppliers in the utilities sector both in the
EU Utilities Directive and in the EU coverage of the GPA. The Utilities
Directive allows EU contracting authorities in these sectors to either
reject non-EU bids where the proportion of goods originating in non-EU
countries exceeds 50% of the total value of the goods constituting the
tender, or are entitled to apply a 3% price difference to non-EU bids in
order to give preference to the EU bid. These restrictions are applied
when no reciprocal access for EU companies in the U.S. market is
offered.

The website of the U.S. Mission to the EU also has a database of all
European public procurement tenders that are open to U.S.-based firms by
virtue of the GPA. This database is free of charge, contains on average
6,000 to 10,000 tenders and is updated twice per week.

For more information, please see the website of the U.S. Commercial
Service at the U.S. Mission to the European Union dedicated to
procurement and the market research page which contains a handful of
reports on EU tendering and government procurement.

Key Links: <http://www.buyusa.gov/europeanunion/euopportunities.html>

<http://www.buyusa.gov/europeanunion/mrr.html>

## Electronic Commerce [**Return to top**](#ch3)

In July 2003, the European Union (EU) started applying Value Added Tax
(VAT) to sales by non-EU based companies of Electronically Supplied
Services (ESS) to EU based non-business customers. U.S. companies that
are covered by the rule change must collect and submit VAT to EU tax
authorities. European Council Directive 2002/38/EC changed the EU rules
for charging Value Added Tax.

U.S. businesses mainly affected by this rule change are those that are
U.S. based and selling ESS to EU based, non-business customers or those
businesses that are EU based and selling ESS to customers outside the EU
who no longer need to charge VAT on these transactions.

There are a number of compliance options for businesses. The Directive
created a special scheme that simplifies registering with each Member
State. The Directive allows companies to register with a single VAT
authority of their choice. Companies have to charge different rates of
VAT according to where their customers are based but VAT reports and
returns are submitted to just one authority. The VAT authority
responsible for providing the single point of registration service is
then responsible for reallocating the collected revenue among the other
EU VAT authorities.

Key Links:

<http://ec.europa.eu/taxation_customs/taxation/vat/how_vat_works/e-services/index_en.htm>

## Trade Promotion and Advertising [**Return to top**](#ch3)

*General Legislation*

Laws against misleading advertisements differ widely from Member State
to Member State within the EU. To respond to this imperfection in the
Internal Market, the Commission adopted a Directive, in force since
October 1986, to establish minimum and objective criteria regarding
truth in advertising. The Directive was amended in October 1997 to
include comparative advertising. Under the Directive, misleading
advertising is defined as any \"advertising which in any way, including
its presentation, deceives or is likely to deceive the persons to whom
it is addressed or whom it reaches and which, by reason of its deceptive
nature, is likely to affect their economic behavior or which for those
reasons, injures or is likely to injure a competitor.\" Member States
can authorize even more extensive protection under their national laws.
Comparative advertising, subject to certain conditions, is defined as
\"advertising which explicitly or by implication identifies a competitor
or goods or services by a competitor.\" Member States can, and in some
cases have, restricted misleading or comparative advertising.

The EU's Television without Frontiers Directive lays down legislation on
broadcasting activities allowed within the EU. It is currently being
reviewed to adapt to advances in internet, mobile phones and digital TV
technologies. It partially lifts Regulations on advertising and product
placement and proposes to ban advertising to children of food and drink.
The new rules should be adopted in 2007.

Following the adoption of the 1999 Council Directive on the Sale of
Consumer Goods and Associated Guarantees, product specifications, as
laid down in advertising, are now considered as legally binding on the
seller. (For additional information on Council Directive 1999/44/EC on
the Sale of Consumer Goods and Associated Guarantees, see the legal
warranties and after-sales service section of 4.4, below.)

The EU adopted Directive 2005/29/EC concerning fair business practices
in a further attempt to tighten up consumer protection rules. These new
rules will outlaw several aggressive or deceptive marketing practices
such as pyramid schemes, \"liquidation sales\" when a shop is not
closing down, and artificially high prices as the basis for discounts in
addition to other potentially misleading advertising practices. Certain
rules on advertising to children are also set out.

Key Link:
<http://ec.europa.eu/comm/consumers/cons_int/safe_shop/fair_bus_pract/index_en.htm>

*Medicine*

The advertising of medicinal products for human use is regulated by
Council Directive 2001/83/EC. Generally speaking, the advertising of
medicinal products is forbidden if market authorization has not yet been
granted or if the product in question is a prescription drug. Mentioning
therapeutic indications where self-medication is not suitable is not
permitted, nor is the distribution of free samples to the general
public. The text of the advertisement should be compatible with the
characteristics listed on the product label, and should encourage
rational use of the product. The advertising of medicinal products
destined for professionals should contain essential characteristics of
the product as well as its classification. Inducements to prescribe or
supply a particular medicinal product are prohibited and the supply of
free samples is restricted.

The Commission plans to present a new framework for information to
patients on medicines in 2007. The framework would allow industry to
produce non-promotional information about their medicines while
complying with strictly defined rules and would be subject to an
effective system of control and quality assurance.

Key Link:
[http://ec.europa.eu/eur-lex/pri/en/oj/dat/2001/l_311/l_31120011128en00670128.pdf](http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_311/l_31120011128en00670128.pdf)

######## Food

On July 16, 2003, the Commission adopted a proposal for a Regulation on
nutrition and health claims made on foods (COM 2003/424) supplementing
2000/13/EC on the labeling, presentation and advertising of foodstuffs.
The proposal is expected to be adopted by the end of 2006. The proposed
Regulation would set rules on the use of language such as \"low fat" and
\"light,\" among others. The proposal seeks to harmonize the rules for
making claims throughout the EU and establish what nutrition and health
claims are allowable.

Key link:
[[http://ec.europa.eu/comm/food/food/labelingnutrition/claims/index_en.htm]{.underline}](http://ec.europa.eu/comm/food/food/labellingnutrition/claims/index_en.htm)

*Food Supplements*

Directive 2002/46/EC establishes rules relating to the labeling of food
supplements and the maximum levels of vitamins and minerals in
particular. In Summer 2007, the European Commission will evaluate if
items other than minerals and vitamins need to be included in this
Directive.

Key link:
<http://ec.europa.eu/food/food/labellingnutrition/supplements/index_en.htm>

*Tobacco*

The EU Tobacco Advertising Directive bans tobacco advertising in printed
media, radio, internet and sponsorship of cross-border events or
activities. Advertising in cinemas and on billboards or merchandising is
allowed though these are banned in many Member States. Tobacco
advertising on television has been banned in the EU since the early
1990s, and is governed by the TV Without Frontiers Directive.

Key link:
<http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/tobacco_en.htm>

## Sales Service/Customer Support [**Return to top**](#ch3)

Conscious of the discrepancies among Member States in product labeling,
language use, legal guarantee, and liability, the redress of which
inevitably frustrates consumers in cross-border shopping, the EU
institutions have launched a number of initiatives aimed at harmonizing
national legislation. Suppliers within and outside the EU should be
aware of existing and upcoming legislation affecting sales, service, and
customer support.

######## Product Liability

Under the 1985 Directive on liability of defective products, amended in
1999, the producer is liable for damage caused by a defect in his
product. The victim must prove the existence of the defect and a causal
link between defect and injury (bodily as well as material). A reduction
of liability of the manufacturer is granted in cases of negligence on
the part of the victim.

Key link:
<http://ec.europa.eu/comm/consumers/cons_safe/prod_safe/defect_prod/index_en.htm>

*Product Safety*

The 1992 General Product Safety Directive introduces a general safety
requirement at the EU level to ensure that manufacturers only place safe
products on the market. It was revised in 2001 to include an obligation
on the producer and distributor to notify the Commission in case of a
problem with a given product, provisions for its recall, the creation of
a European Product Safety Network, and a ban on exports of products to
third countries which are not deemed safe in the EU.

Key link:
<http://ec.europa.eu/comm/consumers/cons_safe/prod_safe/index_en.htm>

######## Legal Warranties and After-sales Service

Under the 1999 Directive on the Sale of Consumer Goods and Associated
Guarantees, professional sellers are required to provide a minimum
two-year warranty on all consumer goods sold to consumers (natural
persons acting for purposes outside their trade, businesses or
professions), as defined by the Directive. The remedies available to
consumers in case of non-compliance are:

\- repair of the good(s);

\- replacement of the good(s);

\- a price reduction; or

\- rescission of the sales contract.

Key link:
<http://ec.europa.eu/comm/consumers/cons_int/safe_shop/guarantees/index_en.htm>

Other issues pertaining to consumers' rights and protection, such as the
New Approach Directives, CE marking, quality control and data protection
are dealt with in Chapter 5 of this report.

## Protecting Your Intellectual Property [**Return to top**](#ch3)

*Copyright*

The EU's legislative framework for copyright protection consists of a
series of Directives covering areas such as the legal protection of
computer programs, the duration of protection of authors' rights and
neighboring rights, and the legal protection of databases. Almost all
Member States have fully implemented the rules into national law; and
the Commission is now focusing on ensuring that the framework is
enforced accurately and consistently across the EU.

The on-line copyright Directive (2001/29/EC) addresses the vexed problem
of protecting rights holders in the online environment while protecting
the interests of users, ISPs and hardware manufacturers. It guarantees
authors' exclusive reproduction rights with a single mandatory exception
for technical copies (to allow caching), and an exhaustive list of other
exceptions that individual Member States can select and include in
national legislation. This list is meant to reflect different cultural
and legal traditions, and includes private copying \"on condition right
holders receive fair compensation.\"

Key Link: <http://ec.europa.eu/internal_market/copyright/index_en.htm>

###### Patents

EU countries have a \"first to file\" approach to patent applications,
as compared to the \"first to invent\" system followed in the United
States. This makes early filing a top priority for innovative companies.
Unfortunately it is not yet possible to file for a single EU-wide patent
that would be administered and enforced like the Community Trademark
(see below). For the moment the most effective way for a company to
secure a patent across a range of EU national markets is to use the
services of the European Patent Office (EPO) in Munich. It offers a
one-stop-shop that enables rights holders to get a bundle of national
patents using a single application. However these national patents have
to be validated, maintained and litigated separately in each Member
State. EPO's web site is <http://www.european-patent-office.org/>.

Key Link: <http://ec.europa.eu/internal_market/indprop/index_en.htm>

*Trademarks*

The EU-wide Community Trademark (CTM) can be obtained via a single
language application to the Office of Harmonization in the Internal
Market (OHIM) in Alicante, Spain. It lasts ten years and is renewable
indefinitely. For companies looking to protect trademarks in three or
more EU countries the CTM is a more cost effective option than
registering separate national trademarks. On October 1, 2004, the
European Commission (EC) acceded to the World Intellectual Property
Organization (WIPO) Madrid Protocol. The accession of the EC to the
Madrid Protocol establishes a link between the Madrid Protocol system,
administered by WIPO, and the Community Trademark system, administered
by OHIM. As of October 1, 2004, Community Trademark applicants and
holders are allowed to apply for international protection of their
trademarks through the filing of an international application under the
Madrid Protocol. Conversely, holders of international registrations
under the Madrid Protocol will be entitled to apply for protection of
their trademarks under the Community Trademark system.

Key Links: <http://oami.eu.int/en/default.htm>

<http://www.wipo.int/madrid/en>

*Designs*

The EU adopted a Regulation introducing a single Community system for
the protection of designs in December 2001. The Regulation provides for
two types of design protection, directly applicable in each EU Member
State: the registered Community design and the unregistered Community
design. Under the registered Community design system, holders of
eligible designs can use an inexpensive procedure to register them with
the EU's Office for Harmonization in the Internal Market (OHIM), based
in Alicante, Spain. They will then be granted exclusive rights to use
the designs anywhere in the EU for up to twenty-five years. Unregistered
Community designs that meet the Regulation's requirements are
automatically protected for three years from the date of disclosure of
the design to the public.

Key Links: <http://oami.eu.int/en/design/default.htm>

####### Trademark Exhaustion

Within the EU, the rights conferred on trademark holders are subject to
the principle of \"exhaustion.\" Exhaustion means that once trademark
holders have placed their product on the market in one Member State,
they lose the right to prevent the resale of that product in another EU
country. This has led to an increase in the practice of so called
\"parallel importing\" whereby goods bought in one Member State are sold
in another by third parties unaffiliated to the manufacturer. Parallel
trade is particularly problematic for the research-based pharmaceutical
industry where drug prices vary from country to country due to national
price Regulation. Community wide exhaustion is spelled out in the
Directive on harmonizing trademark laws. In a paper published in 2003,
the Commission indicated that it had no plans to propose changes to
existing legal provisions.

Key Link: <http://ec.europa.eu/internal_market/indprop/tm/index_en.htm>

## Local Professional Services [**Return to top**](#ch3)

A wide variety of service providers is available to support U.S.
companies doing business in the European Union (EU), from the largest
global firms to small niche players. The U.S. Commercial Service EU
website (see below) lists various professional service providers and
additional information is available upon request.

Key link: <http://www.buyusa.gov/europeanunion/services.html>

Also, see EU Member State Country Commercial Guides which can be found
at the following website:
<http://www.buyusainfo.net/adsearch.cfm?search_type=int&loadnav=no>

## Web Resources [**Return to top**](#ch3)

EC Directive on Commercial Agents

<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31986L0653:EN:HTML>

Guidelines on "Vertical Agreements"

<http://eur-lex.europa.eu/LexUriServ/site/en/oj/2001/c_368/c_36820011222en00130015.pdf>

EC Directive on Late Payments

<http://ec.europa.eu/comm/enterprise/regulation/late_payments/>

EC on Data Protection

<http://ec.europa.eu/justice_home/fsj/privacy/law/index_en.htm>

Safe Harbor

<http://www.export.gov/safeharbor/>

Model Contracts for the transfer of personal data

<http://ec.europa.eu/justice_home/fsj/privacy/modelcontracts/index_en.htm>

Ensuring safe shopping across the EU

<http://ec.europa.eu/consumers/cons_int/safe_shop/index_en.htm>

Financial services

<http://ec.europa.eu/consumers/cons_int/fina_serv/index_en.htm>

Electronic commerce

<http://ec.europa.eu/internal_market/e-commerce/index_en.htm>

European public procurement tenders open to U.S. companies

<http://www.buyusa.gov/europeanunion/eu_tenders.html>

Procurement

<http://www.buyusa.gov/europeanunion/euopportunities.html>

EU Tenders Website

[http://ted.europa.eu](http://ted.europa.eu/)

Market Research Reports

<http://www.buyusa.gov/europeanunion/mrr.html>

eVAT

<http://ec.europa.eu/taxation_customs/taxation/vat/how_vat_works/e-services/index_en.htm>

EC Internal Markets official documents

<http://ec.europa.eu/comm/consumers/cons_int/safe_shop/fair_bus_pract/index_en.htm>

Medicinal products for human use

<http://ec.europa.eu/eur-lex/pri/en/oj/dat/2001/l_311/l_31120011128en00670128.pdf>

Food labeling

<http://ec.europa.eu/comm/food/food/labellingnutrition/claims/index_en.htm>

Food Supplements

[http://ec.europa.eu/food/food/labelingnutrition/supplements/index_en.htm](http://ec.europa.eu/food/food/labellingnutrition/supplements/index_en.htm)

Tobacco

<http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/tobacco_en.htm>

Liability of defective products

<http://ec.europa.eu/comm/consumers/cons_safe/prod_safe/defect_prod/index_en.htm>

Safety of products

<http://ec.europa.eu/comm/consumers/cons_safe/prod_safe/index_en.htm>

Sale of goods and guarantees

<http://ec.europa.eu/comm/consumers/cons_int/safe_shop/guarantees/index_en.htm>

Copyright and Neighboring Rights

<http://ec.europa.eu/comm/internal_market/copyright/index_en.htm>

European Patent Office

<http://www.european-patent-office.org/>

Industrial property

<http://ec.europa.eu/internal_market/indprop/index_en.htm>

Office for Harmonization in the Internal Market (OHIM)

<http://oami.eu.int/en/default.htm>

WIPO Madrid System

<http://www.wipo.int/madrid/en>

OHIM Community Design

<http://oami.eu.int/en/design/default.htm>

Exhaustion of trademark rights

<http://ec.europa.eu/internal_market/indprop/tm/index_en.htm>

Professional service providers

<http://www.buyusa.gov/europeanunion/services.html>

EU Member State Country Commercial Guide

<http://www.buyusainfo.net/adsearch.cfm?search_type=int&loadnav=no>

*Other useful websites:*

The EU Online

<http://ec.europa.eu/index_en.htm>

European Commission

<http://ec.europa.eu/index_en.htm>

EU Press Room

<http://ec.europa.eu/press_room/index_en.htm>

The EU in the World

<http://ec.europa.eu/comm/world/>

EU Relations with the US

<http://ec.europa.eu/comm/external_relations/us/intro/index.htm>

DG Trade

<http://ec.europa.eu/trade/index_en.htm>

DG Enterprise

<http://ec.europa.eu/enterprise/index_en.htm>

EUR- Lex -- Portal to EU law

<http://ec.europa.eu/eur-lex/en/index.html>

Eurostat -- EU Statistics
<http://epp.eurostat.ec.europa.eu/portal/page?_pageid=1090,30070682,1090_33076576&_dad=portal&_schema=PORTAL>

Summaries of EU Legislation -- SCAD PLUS

<http://ec.europa.eu/scadplus/scad_en.htm>

One Stop Internet Shop for Business

<http://ec.europa.eu/youreurope/index_en.html>

Euro Info Centers

<http://ec.europa.eu/enterprise/networks/eic/eic.html>

######### AmCham EU

<http://www.eucommittee.be/>

*EU News Sources:*

EurActiv.com -- EU news, policy positions & EU actors online

<http://www.euractiv.com/en/HomePage>

EUObserver

<http://euobserver.com/>

EU Politix

<http://www.eupolitix.com/EN/>

[]{#ch4 .anchor}

# Chapter 4: Leading Sectors for U.S. Export and Investment 

-   [Commercial Sectors](#commercial-sectors-return-to-top)

### Commercial Sectors [**Return to top**](#ch4)

Showcase Europe provides U.S. exporters a broad perspective on Europe.
Organized around eight key sectors with the greatest market potential
for U.S. exporters, Showcase Europe provides a framework for
coordination and cooperation among the U.S. Department of Commerce\'s
U.S. Commercial Service offices throughout Europe. Sectors include
aerospace, automotive, energy/power generation, environmental
technologies, information and communication technologies, medical and
pharmaceutical, safety/security, and travel and tourism.

In addition, the Quicktake Program provides an overview of market
potential for a U.S. company\'s products from market specialists across
Europe. Surveys cover current and future demand, competition, and
suggested next steps.

Key Links: <http://www.buyusa.gov/europe>

> <http://www.buyusa.gov/quicktake>

# Chapter 5: Trade Regulations and Standards

-   [Trade Barriers](#trade-barriers-return-to-top)

-   [Import Requirements and Documentation](#seventeen)

-   [Labeling and Marking
    Requirements](#labeling-and-marking-requirements-return-to-top)

-   [Prohibited and Restricted Imports](#twentythree)

-   [Customs Regulations and Contact
    Information](#customs-regulations-and-contact-information-return-to-top)

-   [Standards](#standards-return-to-top)

-   [Trade Agreements](#trade-agreements-return-to-top)

-   [Web Resources](#twentysix)

## Trade Barriers [**Return to top**](#chapter-5-trade-regulations-and-standards)

[]{#seventeen .anchor}

For information on existing trade barriers, please see the National
Trade Estimate Report on Foreign Trade Barriers, published by USTR and
available through the following website: <http://www.ustr.gov/> or
<http://www.useu.be/> or
[http://useu.mission.gov](http://useu.mission.gov/). Information on
agricultural trade barriers can be found at the following website:
<http://www.useu.be/agri/usda.html>. To report existing or new trade
barriers and get assistance in removing them, contact either the Trade
Compliance Center at <http://www.trade.gov/tcc> or the U.S. Mission to
the European Union at <http://www.buyusa.gov/europeanunion>

## Import Requirements and Documentation [**Return to top**](#chapter-5-trade-regulations-and-standards)

*Import Licenses*

The Integrated Tariff of the Community, referred to as TARIC (acronym
for \"Tarif Intégré de la Communauté\"), is designed to show various
rules applying to specific products being imported into the customs
territory of the EU or, in some cases, when exported from it. To
determine if a license is required for a particular product, check the
TARIC.

The TARIC can be searched by country of origin, Harmonized System (HS)
Code, and product description on the interactive website of the
Directorate-General for Taxation and the Customs Union. The TARIC is
updated annually.

It is important to note that the World Customs Organization has released
the third update in more than 20 years to the HS Code. There are major
production classification revisions to chapters 84 and 85. This affects
not just the EU, but all 121 contracting parties to the HS starting
January 2007.

In addition, many EU Member States maintain their own list of goods
subject to import licensing. For example, Germany\'s \"Import List\"
(Einfuhrliste) includes goods for which licenses are required, their
code numbers, any applicable restrictions, and the agency that will
issue the relevant license. The Import List also indicates whether the
license is required under German or EU law. For information relevant to
Member State import licenses, please consult the relevant Member State
Country Commercial Guide.

Key Link:
[http://ec.europa.eu/taxation_customs/common/databases/taric/index_en.htm](http://ec.europa.eu/comm/taxation_customs/common/databases/taric/index_en.htm)

*Import Documentation*

####### Non-agricultural Documentation

The official model for written declarations to customs under \"Normal
Procedure\" is the Single Administrative Document (SAD). European Free
Trade Association (EFTA) countries including Norway, Iceland,
Switzerland, and Liechtenstein also use the SAD. However, other forms
may be used for this purpose. Information on import/export forms is
contained in Title VII, of Council Regulation (EEC) No. 2454/93, which
lays down provisions for the implementation of Council Regulation (EEC)
No. 2913/92 establishing the Community Customs Code (Articles 205
through 221). Articles 222 through 224 provide for computerized customs
declarations and Articles 225 through 229 provide for oral declarations.

Additional information on import/export documentation can be found in
Title III, of Council Regulation (EEC) No. 2913/92 of October 12, 1992,
establishing the Community Customs Code (Articles 37 through 57).

Goods brought into the customs territory of the Community are, from the
time of their entry, subject to customs supervision until customs
formalities are completed.

Goods presented to customs are covered by a summary declaration, which
is lodged once the goods have been presented to customs. The customs
authorities may, however, allow a period for lodging the declaration,
which cannot be extended beyond the first working day following the day
on which the goods are presented to customs. The summary declaration can
be made on a form corresponding to the model prescribed by the customs
authorities. However, the customs authorities may permit the use, as a
summary declaration, of any commercial or official document that
contains the particulars necessary for identification of the goods. It
is encouraged that the summary declaration be made in computerized form.

The summary declaration is to be lodged by:

-   the person who brought the goods into the customs territory of the
    Community or by any person who assumes responsibility for carriage
    of the goods following such entry; or

-   the person in whose name the person referred to above acted.

Non-EU goods presented to customs must be assigned a customs-approved
treatment or use authorized for such non-Community goods. Where goods
are covered by a summary declaration, the formalities for them to be
assigned a customs-approved treatment or use must be carried out:

-   45 days from the date on which the summary declaration is lodged in
    the case of goods carried by sea;

-   20 days from the date on which the summary declaration is lodged in
    the case of goods carried other than by sea.

Where circumstances so warrant, the customs authorities may set a
shorter period or authorize an extension of the period.

######## Batteries

New EU battery rules came into force on 26 September 2006 following the
publication of the Directive on batteries and accumulators and waste
batteries and accumulators (Directive 2006/66) in the EU\'s Official
Journal. This new Directive replaces the original Battery Directive of
1991 (Directive 91/157). The new Directive applies to all batteries and
accumulators put on the EU market including automotive, industrial and
portable batteries. It aims to protect the environment by restricting
the sale of batteries and accumulators that contain mercury or cadmium
(with an exemption for emergency and alarm systems, medical equipment
and cordless power tools) and by promoting a high level of collection
and recycling. It places the responsibility on producers to finance the
costs associated with the collection, treatment, and recycling of used
batteries and accumulators. The Directive also includes provisions on
the labeling of batteries and their removability from equipment. EU
Member States must implement the EU Directive into their national law by
September 26, 2008. For more information, see our market research
report: <http://www.buyusainfo.net/docs/x_8086174.pdf>

######## WEEE & RoHS

EU rules on waste electrical and electronic equipment (WEEE), while not
requiring specific customs or import paperwork, may require U.S.
exporters to register the products with a national WEEE authority, or
arrange for this to be done by a local partner. Similarly, related rules
for EEE restricting the use of the hazardous substances (RoHS) lead,
cadmium, mercury, hexavalent chromium, PBBs, and PBDEs, do not entail
customs or importation paperwork. However, U.S. exporters may be asked
by a European RoHS enforcement authority or by a customer to provide
evidence of due diligence in compliance with the substance bans on a
case-by-case basis. U.S. exporters seeking more information on WEEE and
RoHS Regulations should visit:
<http://www.buyusa.gov/europeanunion/weee.html>

*Agricultural Documentation*

Phytosanitary Certificates: Phytosanitary certificates are required for
most fresh fruits, vegetables, and other plant materials.

Sanitary Certificates: For commodities composed of animal products or
by-products, EU countries require that shipments be accompanied by a
certificate issued by the competent authority of the exporting country.
This applies regardless of whether the product is for human consumption,
for pharmaceutical use, or strictly for non-human use (e.g., veterinary
biologicals, animal feeds, fertilizers, research). Many of these
certificates are uniform throughout the EU, but the harmonization
process has not been finalized yet. During this transition period,
certain Member State import requirements continue to apply. Up-to-date
information on harmonized import requirements can be found at the
following website: <http://www.useu.be/agri/certification.html>.

Sanitary Certificates (Fisheries): Since April 2006, the EU has accepted
the U.S. seafood inspection system as equivalent to the European one.
Consequently, a specific public health certificate must accompany U.S.
seafood shipments. EU Decision 2006/199/EC places specific conditions on
imports of fishery products from the U.S. Sanitary certificates for
shellfish are covered by Commission Decision 1996/333/EC and must be
used for gastropods, bivalve mollusks, tunicates and echinoderms. The
two competent Authorities for issuing sanitary certificates are the FDA
and the U.S. Department of Commerce, National Marine Fisheries Service
(NMFS/USDC).

Since May 1, 2004, aquaculture products coming from the United States
are subject to specific animal health legislation, i.e. Regulations
2003/804/EC and 2003/858/EC. An animal health certificate, in addition
to a public health certificate, must accompany shipments of aquaculture
live bivalve mollusks and finfish. This animal health certificate is not
required in the case of live bivalve mollusks intended for immediate
human consumption. For further information, please contact the NOAA
Fisheries office at the U.S. Mission to the EU.

On November 20, 2006, the Commission published an amendment to
Regulations 2003/804/EC and 2003/858/EC. Decision 2006/767/EC, in force
as of November 27, 2006, modifies the conditions of imports of
aquaculture live bivalve mollusks as well as fishery products for human
consumption.

A new EU Hygiene law has been in force since January 1, 2006. This new
set of Regulations aims to simplifying existing rules and at
guaranteeing safer food. To facilitate the implementation of the revised
rules, the Commission recently published implementing measures and
transitional arrangements that are also effective as of January 1, 2006.
These guidelines can be found below:

-   [Commission Regulation
    2073/2005](http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_338/l_33820051222en00010026.pdf)

-   [Commission Regulation
    2074/2005](http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_338/l_33820051222en00270059.pdf)

-   [Commission Regulation
    2076/2005](http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_338/l_33820051222en00830088.pdf)

From May 1, 2007, a second set of new hygiene laws will be in place.
They will greatly modify import requirements for animal and animal
products.

For detailed information on import documentation for seafood, please see
the following web sites: <http://www.nmfs.noaa.gov/ocs/tradecommercial>
or <http://www.cfsan.fda.gov/>.

## Labeling and Marking Requirements [**Return to top**](#chapter-5-trade-regulations-and-standards)

[]{#twentythree .anchor}

An overview of EU mandatory and voluntary labeling and marking
requirements has been compiled in a market research report that is
available on <http://www.export.gov/mrktresearch/index.asp>

The subject has been also been covered in the section about standards
(see below)

## Prohibited and Restricted Imports [**Return to top**](#chapter-5-trade-regulations-and-standards)

The TARIC is designed to show various rules applying to specific
products being imported into the customs territory of the EU or, in some
cases, when exported from it. To determine if a product is prohibited or
subject to restriction, check column five of the TARIC for that product
for the following codes:

CITES Convention on International Trade of Endangered Species

PROHI Import Suspension

RSTR Import Restriction

For information on how to access the TARIC, see the Import Requirements
and Documentation Section above.

Key Link:
[http://ec.europa.eu/taxation_customs/common/databases/taric/index_en.htm](http://europa.eu.int/comm/taxation_customs/common/databases/taric/index_en.htm)

## Customs Regulations and Contact Information [**Return to top**](#chapter-5-trade-regulations-and-standards)

Regulation 648/2005 is the "Security Amendment" to the Customs Code
(Regulation 2913/92) and outlines the implementing provisions for
Authorized Economic Operators, risk management procedures, pre-departure
declarations, and improved export controls.

Tariffs and Import Taxes: Information on customs valuation is contained
in Title II, Chapter Three, of Council Regulation (EEC) 2913/92,
establishing the Community Customs Code, titled, \"Value of Goods for
Customs Purposes\" (Articles 28 through 36). The primary basis for
determining customs value set out in Articles 29 is:

\"\... the transaction value, that is, the price actually paid or
payable for the goods when sold for export to the customs territory of
the Community\...\"

Article 29 lists the following conditions, which must be met in
determining customs value:

-   There are no restrictions as to the disposal or use of the goods by
    the buyer, other than restrictions which are imposed or required by
    a law or by the public authorities in the community, limit the
    geographical area in which the goods may be resold, or do not
    substantially affect the value of the goods;

-   The sale or price is not subject to some conditional consideration
    for which a value cannot be determined with respect to the goods
    being valued;

-   No part of the proceeds of any subsequent resale disposal or use of
    the goods by the buyer will accrue directly or indirectly to the
    seller, unless an appropriate adjustment can be made in accordance
    with Article 32; and

-   The buyer and seller are not related, or, where the buyer and seller
    are related, that the transaction value is acceptable for customs
    purposes.

The \"price actually paid or payable\" in Article 29 refers to the price
for the imported goods. Thus the flow of dividends or other payments
from the buyer to the seller that do not relate to the imported goods
are not part of the customs value.

Articles 32 and 33 provide for adjustments to the value for customs
purposes. Article 32 lists charges that are added to the customs value,
such as, commissions and brokerage, costs of containers, packing,
royalties and license fees, and the value of goods and services supplied
directly or indirectly by the buyer in connection with the production
and sale for export of the imported goods. Article 33 lists charges that
are not included in the customs value, such as, charges for transport,
charges incurred after importation, charges for interest under a
financing arrangement for the purchase of the goods, charges for the
right to reproduce imported goods in the Community, and buying
commissions.

Effective July 1, 1995, the Commission amended Article 147(1) of
Regulation 2454/93 of the Customs Code which affects valuation in the
case of successive sales. This amendment \"defaults\" valuation to the
last sale, but allows the value of an earlier sale if it can be
demonstrated that such a sale took place for export to the EU. The
evidentiary requirements to support the bona fides of any earlier sales
will be based upon commercial documents such as purchase orders, sales
contracts, commercial invoices, and shipping documents.

Key Link:
[http://ec.europa.eu/taxation_customs/customs/index_en.htm](http://europa.eu.int/comm/taxation_customs/customs/customs.htm)

For contact information at national customs authorities, please visit:

<http://ec.europa.eu/taxation_customs/common/links/customs/index_en.htm>

## Standards [**Return to top**](#chapter-5-trade-regulations-and-standards)

-   [Overview](#overview-return-to-top)

-   [Standards Organizations](#standards-organizations-return-to-top)

-   [Conformity Assessment](#conformity-assessment-return-to-top)

-   [Product Certification](#product-certification-return-to-top)

-   [Accreditation](#accreditation-return-to-top)

-   [Publication of Technical
    Regulations](#publication-of-technical-regulations-return-to-top)

-   [Labeling and Marking](#labeling-and-marking-return-to-top)

### Overview [**Return to top**](#standards-return-to-top)

Products tested and certified in the United States to American standards
are likely to have to be retested and re-certified to EU requirements as
a result of the EU's different approach to the protection of the health
and safety of consumers and the environment. Where products are not
regulated by specific EU technical legislation, they are always subject
to the EU's General Product Safety Directive as well as to possible
additional national requirements.

European Union standards created under the New Approach are harmonized
across the 25 EU Member States and European Economic Area countries to
allow for the free flow of goods. A feature of the New Approach is CE
marking. While harmonization of EU legislation can facilitate access to
the EU Single Market, manufacturers should be aware that Regulations and
technical standards might also function as barriers to trade if U.S.
standards are different from those of the European Union.

The European Union is currently undertaking a major revision of the New
Approach which will enhance some aspects, especially in the areas of
market surveillance. To follow the revision, please visit
<http://ec.europa.eu/enterprise/newapproach/review_en.htm>

Agricultural Standards

The establishment of harmonized EU rules and standards in the food
sector has been ongoing for several decades, but it took until January
2002 for the publication of a general food law establishing the general
principles of EU food law. This Regulation introduced mandatory
traceability throughout the feed and food chain as of Jan 1, 2005. For
specific information on agricultural standards, please refer to the
Foreign Agricultural Service's website at:

<http://useu.usmission.gov/agri/>

### Standards Organizations [**Return to top**](#standards-return-to-top)

EU standards setting is a process based on consensus initiated by
industry or mandated by the European Commission and carried out by
independent standards bodies, acting at the national, European or
international level. There is strong encouragement for non-governmental
organizations, such as environmental and consumer groups, to actively
participate in European standardization.

Many standards in the EU are adopted from international standards bodies
such as the International Standards Organization (ISO). The drafting of
specific EU standards is handled by three European standards
organizations:

CENELEC, European Committee for Electrotechnical Standardization

(<http://www.cenelec.org/Cenelec/Homepage.htm>)

ETSI, European Telecommunications Standards Institute
(<http://www.etsi.org/>)

CEN, European Committee for Standardization, handling all other
standards

(<http://www.cen.eu/cenorm/index.htm>)

Standards are created or modified by experts in Technical Committees or
Working Groups. The members of CEN and CENELEC are the national
standards bodies of the Member States, which have \"mirror committees\"
that monitor and participate in ongoing European standardization. CEN
and CENELEC standards are sold by the individual Member States standards
bodies. ETSI is different in that it allows direct participation in its
technical committees from non-EU companies that have interests in Europe
and gives away its individual standards at no charge on its website. In
addition to the three standards developing organizations, the European
Commission plays an important role in standardization through its
funding of the participation in the standardization process of small-
and medium-sized companies and non-governmental organizations, such as
environmental and consumer groups. The Commission also provides money to
the standards bodies when it mandates standards development to the
European Standards Organization for harmonized standards that will be
linked to EU technical Regulations. In the last year, the Commission
began listing their mandates on line and they can be seen at
<http://ec.europa.eu/enterprise/standards_policy/mandates/>. All the EU
harmonized standards, which provide the basis for CE marking, can be
found on <http://www.newapproach.org/>.

Due to the EU's vigorous promotion of its regulatory and standards
system as well as its generous funding for its business development, the
EU's standards regime is wide and deep - extending well beyond the EU's
political borders to include affiliate members (countries which are
hopeful of becoming full members in the future) such as Albania,
Bulgaria, Croatia, FYR of Macedonia, and Turkey. Another category,
called \"partner standardization bodies\" includes the standards
organizations of Bosnia and Herzegovina, Egypt, Serbia and Montenegro,
Russia, Tunisia, the Ukraine and Australia, which are not likely to join
the EU or CEN any time soon, but have an interest in participating in
specific CEN technical committees. They agree to pay a fee for full
participation in certain technical committees and agree to implement the
committee's adopted standards as national standards. Many other
countries are targets of the EU's extensive technical assistance
program, which is aimed at exporting EU standards and technical
Regulations to developing countries, especially in the Mediterranean and
Balkan countries, Africa, as well as smaller programs for China and
Latin America.

To know what CEN and CENELEC have in the pipeline for future
standardization, it is best to visit their websites. CEN's \"business
domain\" page provides an overview by sector and/or technical committee
whereas CENELEC offers the possibility to search its database. ETSI's
portal (<http://portal.etsi.org/Portal_Common/home.asp>) leads to
ongoing activities.

With the need to adapt more quickly to market needs, European standards
organizations have been looking for \"new deliverables\" which are
standard-like products delivered in a shorter timeframe. While few of
these \"new deliverables\" have been linked to EU Regulations,
expectations are that they will eventually serve as the basis for
EU-wide standards.

Key Link: <http://www.cenorm.be/cenorm/workarea/sectorfora/index.asp>.

### Conformity Assessment [**Return to top**](#standards-return-to-top)

Conformity Assessment is a mandatory step for the manufacturer in the
process of complying with specific EU legislation. The purpose of
conformity assessment is to ensure consistency of compliance during all
stages of the production process to facilitate acceptance of the final
product. EU product legislation gives manufacturers some choice with
regard to conformity assessment, depending on the level of risk involved
in the use of their product. These range from self-certification, type
examination and production quality control system, to full quality
assurance system. You can find conformity assessment bodies in
individual Member State country in this list by the European Commission.

Key Link: <http://ec.europa.eu/enterprise/newapproach/nando/>

To promote market acceptance of the final product, there are a number of
voluntary conformity assessment programs. CEN's certification systems
are the Keymark, the CENCER mark, and the European Standard Agreement
Group. CENELEC has its own initiative. ETSI does not offer conformity
assessment services.

### Product Certification [**Return to top**](#standards-return-to-top)

To sell products on the EU market of 25 Member States as well as Norway,
Liechtenstein and Iceland, U.S. exporters are required to apply CE
marking whenever their product is covered by specific product
legislation. CE marking product legislation offers manufacturers a
number of choices and requires decisions to determine which
safety/health concerns need to be addressed, which conformity assessment
module is best suited to the manufacturing process, and whether or not
to use EU-wide harmonized standards. There is no easy way for U.S.
exporters to understand and go through the process of CE marking, but
hopefully this section provides some background and clarification.

Products manufactured to standards adopted by CEN, CENELEC and ETSI, and
published in the Official Journal as harmonized standards, are presumed
to conform to the requirements of EU Directives. The manufacturer then
applies the CE marking and issues a declaration of conformity. With
these, the product will be allowed to circulate freely within the EU. A
manufacturer can choose not to use the harmonized EU standards, but then
must demonstrate that the product meets the essential safety and
performance requirements. Trade barriers occur when design, rather than
performance, standards are developed by the relevant European
standardization organization, and when U.S. companies do not have access
to the standardization process through a European presence.

The CE marking addresses itself primarily to the national control
authorities of the Member States, and its use simplifies the task of
essential market surveillance of regulated products. Although CE marking
is intended primarily for inspection purposes by Member State
inspectors, the consumer may well perceive it as a quality mark.

The CE marking is not intended to include detailed technical information
on the product, but there must be enough information to enable the
inspector to trace the product back to the manufacturer or the
authorized representative established in the EU. This detailed
information should not appear next to the CE marking, but rather on the
declaration of conformity, the certificate of conformity (which the
manufacturer or authorized agent must be able to provide at any time,
together with the product\'s technical file), or the documents
accompanying the product.

### Accreditation [**Return to top**](#standards-return-to-top)

Independent certification bodies, known as notified bodies, have been
officially accredited by competent authorities to test and certify to EU
requirements. However, under U.S.-EU Mutual Recognition Agreements
(MRAs), notified bodies based in the United States and referred to as
conformity assessment bodies, are allowed to test in the United States
to EU specifications, and vice versa. The costs are significantly lower
which results in U.S. products becoming more competitive. At this time,
the U.S.-EU MRAs cover the following sectors: EMC (in force), RTTE (in
force), medical devices (in transition), pharmaceutical (on hold),
recreational craft (in force) and marine equipment (in force). The U.S.
Department of Commerce, National Institute of Standards and Technology
(NIST), has a link on its website to American and European Conformity
Assessment bodies operating under a mutual recognition agreement.

Key Link: <http://ts.nist.gov/Standards/Global/mra.cfm>

Accreditation is handled at Member State level. \"European
Accreditation\"
([http://www.european-accreditation.org/default_flash.htm](http://www.european-accreditation.org/))
is an organization representing nationally recognized accreditation
bodies. Membership is open to nationally recognized accreditation bodies
in countries in the European geographical area that can demonstrate that
they operate an accreditation system compatible with EN45003 or ISO/IEC
Guide 58.

### Publication of Technical Regulations [**Return to top**](#standards-return-to-top)

The Official Journal is the official gazette of the European Union. It
is published daily and consists of two series covering draft and adopted
legislation as well as case law, questions from the European Parliament,
studies by committees, and more
(<http://europa.eu.int/eur-lex/lex/JOIndex.do?ihmlang=en>). It lists the
standards reference numbers linked to legislation
(<http://www.newapproach.org/Directives/DirectiveList.asp>). National
technical Regulations are published on the Commission's website
<http://ec.europa.eu/comm/enterprise/tris/> to allow other countries and
interested parties to comment.

Member countries of the World Trade Organization (WTO) are required
under the Agreement on Technical Barriers to Trade (TBT Agreement) to
report to the WTO all proposed technical Regulations that could affect
trade with other member countries. **Notify Us** is a free, web-based
e-mail subscription service that offers an opportunity to review and
comment on proposed foreign technical Regulations that can affect your
access to international markets. Register online at Internet URL:
<http://tsapps.nist.gov/notifyus/data/index/index.cfm>

### Labeling and Marking [**Return to top**](#standards-return-to-top)

Manufacturers should be mindful that, in addition to the EU's mandatory
and voluntary schemes, national voluntary labeling schemes might still
apply. These schemes may be highly appreciated by consumers, and thus,
become unavoidable for marketing purposes.

Manufacturers are advised to take note that all labels require metric
units although dual labeling is also acceptable until end of December
2009. The use of language on labels has been the subject of a Commission
Communication, which encourages multilingual information, while
preserving the right of Member States to require the use of language of
the country of consumption.

The EU has mandated that certain products be sold in standardized
quantities. Council Directive 80/232/EC provides permissible ranges of
nominal quantities, container capacities and volumes for a variety of
products. Please note that this legislation is currently being reviewed
in an effort to simplify it.

Key Link:

<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31980L0232:EN:HTML>

*The Eco-label*

EU legislation in 1992, revised in 2000, distinguishes environmentally
friendly products and services through a voluntary labeling scheme
called the Eco-label. Currently, the scheme applies to 7 product groups:
cleaning products, appliances, paper products, clothing, lubricants,
home and garden products and tourism services. The symbol, a green
flower, is a voluntary mark. The Eco-label is awarded to producers who
can show that their product is less harmful to the environment than such
similar products. This "green label" also aims to encourage consumers to
buy green products. However, the scheme does not establish ecological
standards that all manufacturers are required to meet to place product
on the market. Products without the EU Eco-label can still enter the EU
as long as they meet the existing health, safety, and environmental
standards and Regulations.

The EU Eco-label is a costly scheme (up to EUR 1,300 for registration
and up to EUR 25,000/year for the use of the label, with a reduction of
25 percent for SMEs) and has therefore not been widely used so far.
However, the Eco-label can be a good marketing tool and, given the
growing demand for green products in Europe, it is likely that the
Eco-label will become more and more a reference for green consumers.

Key Links: <http://buyusainfo.net/docs/x_4284752.pdf>

> <http://ec.europa.eu/comm/environment/ecolabel/index_en.htm>
>
> <http://www.eco-label.com/>.

In June 2005, the European Commission tabled a Communication designed to
launch a debate on the best way ahead regarding the eco-labeling of
fisheries products. This initiative follows the growing interest by
environmental Non-Governmental Organizations and increased public
interest in food products associated with considerations related to
environmental sustainability. A number of eco-labeling schemes have
already been established with regard to fisheries products and other
initiatives are being developed. It is not always easy to establish how
reliable some eco-labeling claims are. International guidelines on
eco-labeling have recently been adopted by the [Food and Agriculture
Organization (FAO)](http://www.fao.org/)
([www.fao.org](http://www.fao.org/)) and discussions on these issues and
their potential effects on free trade areas are progressing in other
international fora such as the [World Trade Organization
(WTO)](http://www.wto.org/) ([www.wto.org](http://www.wto.org/)).

Companies selling a broad range of electrical goods in Europe are
required to comply with the Waste Electrical and Electronic Equipment
Directive (WEEE) and since July 2006 they need to conform to the
Restriction of Use of certain Hazardous Substances Directive (RoHS). One
of the requirements is that electrical goods be marked so that consumers
do not put them in with municipal waste. For details on WEEE and RoHS
requirements and implementation, please see the following website:
<http://www.buyusa.gov/europeanunion/weee.html>.

Manufacturers and distributors should be aware of specific requirements
regarding the labeling and traceability of foodstuffs, including
seafood, which are covered by several EU Regulations:

• Regulation 178/2002/EC

• Directive 2000/13/EC, last amended by Directive 2003/89/EC as regards
indication of the ingredients present in foodstuffs.

• Commission Directive 2005/26/EC.

• Council Regulation 104/2000/EC (seafood)

• Commission Regulation 2065/2001/EC (seafood, only for retail channels)

## Trade Agreements [**Return to top**](#chapter-5-trade-regulations-and-standards)

[]{#twentysix .anchor}For a list of trade agreements with the EU and its
Member States, as well as concise explanations, please see
<http://tcc.export.gov/Trade_Agreements/index.asp>

## Web Resources [**Return to top**](#chapter-5-trade-regulations-and-standards)

Office of the U.S. Trade Representative

<http://www.ustr.gov/>

U.S. Mission to the EU (USEU) website

[http://www.useu.be](http://www.useu.be/) or
[http://useu.usmission.gov/]{.underline}

Foreign Agricultural Service website, USEU

<http://www.useu.be/agri/usda.html>

Trade Compliance Center

<http://www.trade.gov/tcc>

U.S. Mission to the European Union

<http://www.buyusa.gov/europeanunion>

USDA Audit, Review & Compliance

<http://www.ams.usda.gov/lsg/arc/audit.htm>

EC's TARIC -- online customs tariff database

<http://ec.europa.eu/comm/taxation_customs/common/databases/taric/index_en.htm>

Batteries

<http://www.buyusainfo.net/docs/x_8086174.pdf>

WEEE & RoHS

<http://www.buyusa.gov/europeanunion/weee.html>

Harmonized import requirements

<http://www.useu.be/agri/certification.html>

EU Hygiene guidelines

[Commission Regulation
2073/2005](http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_338/l_33820051222en00010026.pdf)

[Commission Regulation
2074/2005](http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_338/l_33820051222en00270059.pdf)

[Commission Regulation
2076/2005](http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_338/l_33820051222en00830088.pdf)

National Marine Fisheries Service's Trade & Commercial Services website

<http://www.nmfs.noaa.gov/ocs/tradecommercial>

USDA Center for Food Safety and Applied Nutrition

<http://www.cfsan.fda.gov/>

EU mandatory and voluntary labeling and marking requirements

<http://www.export.gov/mrktresearch/index.asp>

EC Taxation and Customs Union

<http://ec.europa.eu/comm/taxation_customs/customs/index_en.htm>

National customs authorities

<http://ec.europa.eu/taxation_customs/common/links/customs/index_en.htm>

EC Regulation on animal by-products

<http://ec.europa.eu/scadplus/leg/en/lvb/f81001.htm>

Major Revision of the New Approach

<http://ec.europa.eu/enterprise/newapproach/review_en.htm>

EC Certification of Animal Products

[http://useu.usmission.gov/agri/certification.html](http://www.useu.be/agri/certification.html)

EU-approved U.S. Establishments

[http://useu.usmission.gov/agri/estab.html](http://www.useu.be/agri/estab.html)

EU Marketing Standards for Fruits & Vegetables

[http://useu.usmission.gov/agri/Fruit-Veg.html](http://www.useu.be/agri/Fruit-Veg.html)

Non-Hormone Treated Cattle (NHTC) Program

<http://www.ams.usda.gov/lsg/arc/nhtc.htm>

Organic Foods Legislation

[http://useu.usmission.gov/agri/organic.html](http://www.useu.be/agri/organic.html)

CENELEC, European Committee for Electrotechnical Standardization

<http://www.cenelec.org/Cenelec/Homepage.htm>

ETSI, European Telecommunications Standards Institute

<http://www.etsi.org/>

CEN, European Committee for Standardization

[http://www.cen.eu/cenorm/index.htm](http://www.cenorm.be/)

Standardization mandates

<http://ec.europa.eu/enterprise/standards_policy/mandates/>

ANSI, American National Standards Institute

<http://www.ansi.org/>

New Approach Legislation and Standardization in the Internal Market

<http://www.newapproach.org/>

ETSI's e-Standardization portal

<http://portal.etsi.org/Portal_Common/home.asp>

Advisory and coordinating bodies to CEN

<http://www.cenorm.be/cenorm/workarea/sectorfora/index.asp>

Accredited test laboratories in the EU

<http://ec.europa.eu/enterprise/newapproach/nando/>

Government-to-Government Mutual Recognition Agreement Information

<http://ts.nist.gov/Standards/Global/mra.cfm>

European co-operation for Accreditation

<http://www.european-accreditation.org/default_flash.htm>

European Union law portal

<http://europa.eu.int/eur-lex/lex/JOIndex.do?ihmlang=en>

List of EU Directives and Standards

<http://www.newapproach.org/Directives/DirectiveList.asp>

EC Technical Regulations Information System

<http://ec.europa.eu/comm/enterprise/tris/>

Proposed Foreign Technical Regulations

<http://tsapps.nist.gov/notifyus/data/index/index.cfm>

EC Directive on packaging

<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31980L0232:EN:HTML>

EU Eco-label Homepage

<http://buyusainfo.net/docs/x_4284752.pdf>

<http://ec.europa.eu/comm/environment/ecolabel/index_en.htm>

<http://www.eco-label.com/>

FAO

[www.wto.org](http://www.wto.org/)

[Food and Agriculture Organization (FAO)](http://www.fao.org/)

WTO

[www.wto.org](http://www.wto.org/)

[World Trade Organization (WTO)](http://www.wto.org/)

# Chapter 7: Trade and Project Financing

-   [Project Financing](#fiftyseven)

## Project Financing [**Return to top**](#ch7)

#### 

#### *Tendering for European public procurement contracts*

The U.S. Mission to the European Union in Brussels has developed a tool
to help U.S.-based companies bid on public procurement supplies
contracts in particular. All contracts for supplies that are procured by
European public authorities (national government departments, regional
agencies and public institutions, city authorities) above established
thresholds are open to U.S.-based companies by virtue of the Government
Procurement Agreement, of which the U.S. and the EU are parties. All the
tenders in this database are based on a selection of tenders published
in the EU Official Journal, that are open to GPA member countries. The
database contains on average 6,000 to 10,000 tenders and is updated
twice per week.

<http://www.buyusa.gov/europeanunion/eu_tenders.html>