# Presentation: 043340

##  Regulatory Challenges in the EU Market Jonathan BenskySenior Commercial OfficerUS Mission to the European UnionTradewinds II, Istanbul, April 14, 2008

-  ***Regulatory Challenges in the EU Market****** *****Jonathan Bensky****Senior Commercial Officer****US Mission to the European Union****Tradewinds II, Istanbul, April 14, 2008**

## The EU Big Picture

_**The Opportunity**_
**500 million consumers**
**Largest economy in the world (in Euros)**
**One set of rules**
**Not 27**
**But not all the time**
**Liberalization**
**EU investing in itself**

_**The Challenge**_
**Fragmented single market**
**More so for services**
**Eurocentric approach**
**Regulatory approach**
**Regulations**
**Etc****.**

## EU Regulatory Environment

**Tradition of top-down regulation**
**Decision-making processes are complex and often closed**
**Influencing the outcome is difficult**

## Selected Topics

_**Standards**_
**Including the CE Mark**
**Metric labeling**
_**Market Access and Compliance**_
_**RFID’s**_
_**The EU’s Environmental Regulatory Agenda**_
**WEEE/RoHS**
**REACH**
**Energy Using Products (EuP)**
_**The Bigger Picture**_

## Role of Standards in EU Regulation

**EU **_***“OLD Approach”***_** Directives **
**	**** ****No CE mark – mandatory standards**
**EU **_***“NEW Approach”***_** Directives **
**	****CE marking – voluntary standards**

## OLD  Approach Directives

**Provide detailed technical specifications for products**
**Old Approach products/sectors include****:**
**Motor Vehicles (type approval)**
**Chemicals (marketing approval)**
**Cosmetics (self-certification with notification)**
**Pharmaceuticals (pre-market approval)**

## NEW Approach Directives

**Apply to over 25 products or product families**
**Contain “essential requirements” related to safety, health and/or the environment **
**Permit compliance with these requirements using harmonized European standards**
**Require a CE Mark**

##  Importance of EN Standards

**Mandated by the Commission/Linked to regulation**
**Voluntary use of EN standards (some exceptions)**
**European Standards Organizations: ETSI/CENELEC/CEN:**
**ETSI: **** ****European Telecommunications Standards Institute**
**Information and Communication Technologies (ICT) - telecommunications, broadcasting and related areas**
**CENELEC:  ****European Committee for Electrotechnical Standardization**
**Electrical installations, household appliances, renewable energies, E-accessibility.**
**CEN:  ****European Committee for Standardization**
**Everything else.**

**Notes:**
References of EN standards are published in the Official Journal.

Use of EN standards is voluntary with two exceptions: 
when mentioned in the text of the legislation (a test method) 
construction product standards.

Military and defense equipment is usually excluded from the scope of EU legislation.  Standards are developed in other fora (e.g. milspecs).

EU standardization is often closely clinked to international standardization (SIO/IEC), in particular for electrical/electronic products and medical devices. However, by issuing mandates on a regular basis, the Commission drives the need for standards in a lot of sectors, e.g. construction products and machinery.   These harmonized EN standards are developed on a regional basis, by the ESOs.   The regional standardization process is closed to non-EU based manufacturers, which has led to a few difficulties, e.g. adoption of technology specific standards.   It is important to track what is happening in EU standardization and to notify us early on when problems surface.

## What is 					Marking?

**A mandatory label on the product and/or packaging **
**A Safety Mark, not a Quality Mark**
**An EU-wide “passport” for market access, including EEA countries, for about 25 products/product categories**
**A compliance mark with “essential requirements” related to safety, health and/or environment **
**Compliance with these requirements using harmonized European standards**

**Notes:**
Prior to exporting, manufacturers have to consider mandatory product certification requirements in the EU.  Compliance with EU requirements may take between 6-12 months and longer.  It is not equivalent to U.S. requirements.  

CE marking affects most manufactured goods such as medical devices, toys, pressure equipment, building products.
Unregulated products, such as ladders, child care articles, furniture are subject to the general product safety directive (no specific marking, only clear instructions and warning labels, if necessary)

CE marking is accepted in all EU 27 member states, as well as the European Economic Area countries Norway, Liechtenstein and Iceland.  Switzerland has signed Mutual Recognition Agreements (accepts CE marking). Turkey has unilaterally adopted CE marking legislation in anticipation of EU membership.  Sometimes, Turkish authorities interpret EU legislation differently which causes problems at the border.

## Requiring CE Marking:

**Low Voltage**
**Simple Pressure Vessels**
**Toys**
**Construction Products**
**Electromagnetic compatibility**
**Personal Protective Equipment**

**Non-automatic weighing scales**
**Machinery**
**Gas appliances**
**Medical Devices**
**Telecom and radio Terminal Equipment**
**Lifts**
**(list is not exhaustive)**

**Notes:**
Non exhaustive list of new approach (CE marking) directives.

Several directives may apply to one product, such as prescription sunglasses (medical device and personal protective equipment), ICT equipment=low voltage (use of electricity), EMC (emission/immunity) and RTTE (use of frequency)

Sometimes overlapping/borderline legislation: medical device/machinery, or medical device/biocide

## Here’s How: CE Marking Step-by-Step

**Find the applicable Directive(s) – www.newapproach.org**
**Determine essential requirements**
**Note harmonized EN standards**
**Choose appropriate conformity assessment module **
**Locate Notified Bodies http://ec.europa.eu/enterprise/newapproach/nando/**
**Create Declaration of Conformity/Compile Technical File**
**Place CE mark**
**Consider using consultants**

**Notes:**
We recommend using the following steps to go through the CE marking process.   Each step is linked to a website where manufacturers can download information free of charge.   (More websites available upon request).

1-7: Steps for the manufacturer to take, often based on self-certification unless the legislation says otherwise (e.g. high risk products: implantable medical devices, woodworking machinery, or toys not made to EU standard).  Conformity assessment of high risk products involves the services of a notified body (accredited EU based laboratory).   There are U.S. based subcontractors or CABs (conformity assessment bodies under the U.S./EU MRA)

Step 8 is the easiest route because manufacturers will be assisted throughout the process by technical experts who can identify what is relevant/not relevant.   To find consultants, go to  www.export.gov (CE marking page) or our website (business service providers)

## Metric Labeling

**From January 1, 2010 the European Union will allow **_**only metric measurement units **_
***Unless the rule is changed before then***
_***Declared US Policy: The metric system of measurement is the preferred system of weights and measure for U.S. trade and commerce***_**.**** **
**But then there****’****s the US Fair Packaging and Labeling Act (FPLA)**

## The EU Metric Bottom Line – Unless the law is changed

**1980:  EU made metric units only legal units of measure. For transition, other units, e.g., US customary, allowed temporarily (dual labels)**
**Final 10 year postponement ends 12/31/2009 **
**Thereafter: US customary units will  be illegal in EU. **
**Will apply to:  labels, packaging, advertising, catalogs, technical manuals, user instructions, etc.**

## The US Federal Metric Bottom Line (unless the law is changed)

** ****D****esigned to encourage metric system use in the US.  **
** ****Requires that consumer package labels  be dual  labeled; i.e., both metric and US customary, or imperial, units**
** ****So the FLPA **_***does not***_** allow metric only labels.**** **

**The US Federal Metric Bottom Line**** (unless the law is changed)**

##  States allowing metric only labels 

## CSEU - Standards Program

**Framework is USDoC *****Standards Initiative***
**Key point / objective...provide “*****early warning*****”**
**Client counseling...Certification  (Sylvia) **
**Maintain network of standards contacts in Europe**
**Market intelligence and reporting**
***2008 priorities, e.g.,**** *** **
**  ****New legislation: Energy Using Products**
**  ****Review of construction products directive**
**  ****Review of pressure equipment directive**
**  ****Review of toy / product safety directives**
**  ****Strengthening the New Approach Regulatory Model**

## CSEU Standards Program – The TEC

**The Transatlantic Economic Council (TEC)**
**The current driving force**
**Many standards-related TEC items, e.g., **
**Electrical equipment (SDoC), **
**Metric labeling, **
**Biofuels, **
**EuP**
**e-Accessibility**

## Market Access & Compliance

_**Objective:**_**   Assist in resolving market access barriers, cases where EU may violate U.S. trade agreements or cases where EU Member States do not implement EU legislation**
_**Example:**_** Market Access barriers for pharmaceutical companies regarding market authorization, pricing/reimbursement at MS level**
**Report a barrier:  **_**[www.tcc.export.gov](http://www.tcc.export.gov/)**_
**	****	**

## US-EU IPR Enforcement Cooperation

_**Objective:**_** Govt-to-industry & govt-to-govt meetings to discuss cooperation in:**
**Third Country Cooperation**
**Customs Enforcement**
**Public-Private Partnerships:  SME outreach, trade fairs, public awareness**
_**Example:**_** Successful US-EU joint seizure of over 360,000 counterfeited integrated circuits**

**Notes:**
Next meeting May 16, 2008!

Carried out in November and December 2007, Operation INFRASTRUCTURE resulted in the seizure of over 360,000 counterfeit integrated circuits and computer network components bearing over 40 different trademarks. These products were selected for the joint operation because they present safety and security risks in addition to infringing IPRs. 

The U.S. and the EU announced on February 22 the results of Operation Infrastructure, the first joint IPR (Intellectual Property Rights) enforcement operation undertaken by the U.S.’s Customs and Border Protection and the European Union. Carried out in November and December 2007, Operation INFRASTRUCTURE resulted in the seizure of over 360,000 counterfeit integrated circuits and computer network components bearing over 40 different trademarks. These products were selected for the joint operation because they present safety and security risks in addition to infringing IPRs. 
At their 2006 Summit, the European Union and the United States committed to implementing the “EU-U.S. Action Strategy for the Enforcement of Intellectual Property Rights (IPR).” This operation, targeting counterfeit semiconductors and computer networking equipment implemented the “joint IPR border enforcement action” portion of the strategy. 
Below is a press release issued jointly by the U.S. Customs and Border Protection (Department of Homeland Security) and the European Commission:
U. S. Customs and Border Protection and European Union ANNOUNCE JOINT operation in combating pirated goods               
 Washington, D.C. – Today, U.S. Customs and Border Protection (CBP) Assistant Commissioner for the Office of International Trade Dan Baldwin and Director-General Robert Verrue, European Commission Tax and Customs Directorate, announced the results of Operation INFRASTRUCTURE which took place in November/December 2007.
Operation INFRASTRUCTURE resulted in the seizure of over 360,000 counterfeit integrated circuits and computer network components bearing over 40 different trademarks. 
“The success of Operation INFRASTRUCTURE clearly demonstrates our commitment to jointly working with our European counterparts to stop the international flow of illicit goods, and protect our consumers and businesses from these harmful products,” said CBP Assistant Commissioner Baldwin. “It is important to also recognize that there is a vitally important but discreet role that these components play in the everyday infrastructure of our societies. We therefore need to be able to rely on systems that are supported by them across various sectors, particularly as it relates to national security.” 
Operation INFRASTRUCTURE was the first joint Intellectual Property Rights (IPR) enforcement operation undertaken by CBP and the European Union. The two administrations worked together to establish mutually beneficial objectives. 
Mr. R. Verrue, Director-General for Taxation and Customs at the European Commission, stated “We will continue to build upon this operation, and a growing cooperation with our U.S. colleagues, to combat the global trade in fake goods. The U.S. and EU are fully committed to effectively combating counterfeiting and piracy at home and abroad. In addition, this also shows that Customs administrations are prepared to tackle difficult enforcement challenges and issues, especially when the health and safety of our citizens is at stake.” 
Computer networking hardware is the infrastructure of modern business, healthcare, education, and communication and information networks. The counterfeiting of networking hardware and Integrated Circuits (ICs) has critical infrastructure, national security, and health and safety implications. Counterfeit hardware lacks the quality assurance and manufacturing standards of genuine hardware. As a result, there is a much higher failure rate for counterfeit hardware. Many counterfeit products fail on installation and more fail weeks or months after installation. Failures impose significant labor, equipment and lost productivity costs on individuals and organizations that depend on these networks. 
ICs are used in a wide range of applications, including automobiles, aircraft, computers, telecommunications, medical devices, and consumer electronics. IC counterfeiting damages the brand reputation of the rights holders and of the manufacturer that utilizes the counterfeit IC in manufacturing when the final product fails or does not perform to expectations. 
At their 2006 Summit, the European Union (EU) and the United States committed to implementing the “EU-US Action Strategy for the Enforcement of Intellectual Property Rights (IPR).” This operation, targeting counterfeit semiconductors (integrated circuits - ICs) and computer networking equipment, implemented the “joint IPR border enforcement action” portion of the strategy as agreed to by the EU and US. These products were selected for the joint operation because they present safety and security risks in addition to IPR infringement risk. 
Counterfeit network hardware and ICs are just two examples of the many fake goods that threaten the safety of consumers and the ability of companies to fairly compete in the marketplace. Counterfeiting and piracy is a global problem requiring cooperation between private industry and governments to stem the flow of fakes in order to promote economic development and protect consumers. 
U.S. Customs and Border Protection is the unified border agency within the Department of Homeland Security charged with the management, control and protection of U.S. borders at and between official ports of entry. CBP is charged with keeping terrorists and terrorist weapons out of the country while enforcing hundreds of U.S. laws. 

## Standards & Compliance: Helping US Exporters

_**Hurdles:**_
**Complexity & Time/cost**
**Confusion about Single Market vs national requirements**
**Confusion about voluntary vs mandatory**
_**Our Services:**_
**8 step CE Marking guide**
** ****Answers to detailed certification/standards questions **
**CE Marking Advocacy, if required**
_***May 6 webinar @1030 EDT***_

## Radio Frequency ID (RFID)

**EU prepares for mass market RFID technology.**
**Current hot topic:**
**Privacy: ****European Commission Recommendation May 2008**
**Upcoming issues:**
**Environmental**
**Health**
**Governance (“Internet of Things”)**
**Significant EU-U.S. dialogue, including TEC.**
**USEU encouraging EU to avoid pre-emptive regulation of fast-developing technology**

## Privacy (“Data Protection”)

**EU has horizontal and vertical privacy legislation.**
**Perception in EU that U.S. is soft on privacy. **
**Hot Issues:  PNR/SWIFT/Data Sharing for Law Enforcement**
**USEU (DOJ/DHS/DOS/DOC) seek to **
**Inform EU officials about USG approach **
**Manage issues as they arise.**
**Compliance with EU and U.S. rules difficult and complex, as well as politically very sensitive**
***Safe Harbor (******http://www.export.gov/safeharbor/)***

## WEEE & RoHS Directives - 1

**WEEE Directive aims to limit the landfilling of electrical waste.**** **
**Producers must pay for collection and recycling of EEE.**
**RoHS Directive aims to reduce environmental impact of WEEE.**
**Several heavy metals & some flame retardants banned in EEE.**
**Legislation is still new; compliance costly and complex, e.g., member state by member state**

## WEEE & RoHS Directives - 2

**Both Directives being reviewed **
**New legislation to be proposed this year**
**To take effect o/a 2012.**
**Public consultations on all aspects****.**
**CSEU provides:**
**Counseling (over 200 companies 2006-7)**
**Email updates**
**Web site**
**Webinars & other public events**

## REACH

**	****IF YOU BELONG TO A SUPPLY CHAIN PRODUCING OR USING  CHEMICALS AND EXPORTING TO EUROPE, YOU MAY BE AFFECTED BY REACH**

## REACH coverage

_***REACH deals with substances:***_
**Substances as such**
**Substances in preparations (mixtures) **
**Substances in products (Articles)**
**Only substances have to be registered, preparations or articles do not**

_***Impact on U.S. business:***_
**Non-EU companies do not have direct obligations under REACH**
**Your importer is REACH obligated**
**But you need to ensure your products comply**

**Notes:**
If you belong to a supply chain producing/ using chemicals and exporting to Europe, you need to know about REACH

REACH deals with substances:
Substances as such
Substances in preparations (mixtures) – cleaning products, paints, cosmetics, inks
Substances in finished products (Articles): - huge impact of REACH: Everything from toys to laptops and cars will be affected. 
Only substances have to be registered, preparations or articles do not
Impact on US business, or why you are here!

Non-EU companies do not have direct obligations under REACH:
Your importer is REACH obligated
But you need to ensure your products comply, if you want to remain on the EU market
No exports to Europe unless chemicals are registered/ authorized
Requests for information all along the supply chain: Substantial information will be required by the EU importer. Possible shift from non-EU to EU suppliers to avoid registration.
- The impact is different for each company: 
 	- Where are you in the supply chain?
	- What are you exporting to the EU?
	- Do you have production processes in the EU?
= > Registration/notification of substances
Increasing pressure from customers to disclose information

## Preparing for Registration (1)

**Registration applies to substances of 1 ton or more/ year**
**Exemptions:**
**Check volume and scope**
**The REACH Navigator: **_**[http://reach.jrc.it/navigator_en.htm](http://reach.jrc.it/navigator_en.htm)**_

| Substances exempted from registration | Substances regarded as registered |
| --- | --- |
| Food or feedingstuffs
Medicinal products
Annex IV substances (on-going revision)
Annex V substances (on-going revision)
Recycled or recovered substances already registered
Re-imported substances
Polymer
PPORD | Active substance for use in biocides
Active substance for use in plant protection products
Notified substances |

**Notes:**

Registration obligations apply to substances manufactured or imported in quantities of 1 ton or more per year

Some substances are exempt from Registration: they include chemicals in food and medicines, that are covered by other EU laws. 
Natural substances  if they are not dangerous and have not been chemically modified (annex IV - list of substances and annex V - list of criteria)
Revision of annex IV and V: by June 1, may add or delete substances - status?
polymers (but monomers have to be registered)
Some substances are regarded as registered - substances used in biocides/ pesticides

Check volume and scope . If you are below 1 ton. You may not need to go further
Check the scope
REACH navigator: help identify if you are within the scope of REACH, if you benefit from one of the above exemptions. An interactive tool, Q&As

## Preparing for registration (2)

**Pre-registration:**
**Pre-registration starts on June 1st**
**Open ONLY 1 June – 1 December 08**
**Allows for extended Registration deadlines (2010 – 2013 – 2018)**
**Format: IUCLID 5 software or REACH-IT system: **_**[http://iuclid.eu](http://iuclid.eu/)**_
**No fees, limited dossier (company and contact information,substance name, envisaged registration deadline and tonnage band)**
**SIEF formation (Substance Information Exchange Forum)**
**SIEF brings together pre-registrants of the same substance**
**Aim of SIEF: **
**Share data**
**Agree on classification and labeling**
**Prepare for the joint submission of registration**** **

**Notes:**

Pre-registration:
Pre-registration starts on 1 June - it’s the first business-relevant deadline under REACH
Open for 6 months only (1 June – 1 December 08)
Allows for extended Registration deadlines (2010 – 2013 – 2018), depending on the substance and its volume. (If you miss the pre-registration deadline, you must do a full registration on 1 June to stay on the market).
= for phase-in substances only (imported cosmetics ingredients do not have phase-in status, no EINECS numbers, pre-registration not possible)
Format: The pre-registration/ registration has to be submitted electronically. You can use the IUCLID 5 software (database) or pre-register through the REACH-IT system (IT system of ECHA). 
Light procedure: No fees, limited dossier

But Pre-registration gets you into a SIEF – a Substance Information Exchange Forum (a database of contacts of pre-registrants and data holders)– companies who have pre-registered the same substance will be grouped in a SIEF. They will have to agree on C&L and are required to share data and to submit a joint registration. 

Registration dossier (data properties, uses, assess risks and recommend risk management measures) - dossier must contain info article 10

## Authorization

**Applies to substances of very high concern (SVHC)**
**SVHC on a Candidate List**
**1,500 substances (or less?) (CMRs, PBTs, vPvBs, endocrine disruptors)**
**Watch for Candidate List: summer 08, on the ECHA website**
**A “black list?”**
**SVHC on Annex XIV will require Authorization**
**1****st**** substances in Authorization annex: summer 2010?**
**Deadlines after which substances will be banned if not authorized**
**Authorization granted:**
**If adequate control or socio-economic benefits**
**Applications for authorization must include an analysis of substitutes**

**Notes:**
Authorization applies to SVHC:  Note, virtually all chemicals go thru registration, about 5 percent will go thru Authorization.

SVHC will be listed on the so-called Candidate List for authorization. Its publication is foreseen for summer 08 and available on the ECHA website (candidate list inclusion process starting June 08)
The list should include approximately 1500 substances. Watch out for publication

The substances on the candidate list will then be gradually be included on annex XIV (process starting 1 June 2009), the list of substances subject to authorization, with specific deadlines after which substances will be banned if not authorized. 
(Substances will stay on the market until then (if not killed by black list effect of the candidate list). Not like ROHS , no exemption process – need to get authorization for specific uses). Get a sense of when your substance will be listed for authorization (priority to high volume, wide dispersive use, PBTs, vPvBs). You will need to defend the use of your substance.

Industry will have to submit applications to the Agency on authorization for the continued use of these substances. 
Companies applying for authorization will have to demonstrate that risks associated with uses of these substances are adequately controlled or that there is an overall benefit for society of using these substances (where no alternative exists)
Applicants will also have to investigate the possibility of substituting these substances with safer alternatives , and prepare substitution plans if appropriate (if a suitable alternative is identified). The idea behind the authorization system is that SVHC are progressively substituted by safer alternatives. 

We are concerned that the Candidate List will have a black list effect, sending a signal to the market that these substances will be banned. We are asking the Commission to produce guidance that will minimize this black list effect and avoid premature substitution of chemicals that may not be safer for the environment.

## What is an Article?

***“******An object, which during production, is given a special ***_***shape, surface, or design***_*** that determines its function to a greater degree than does its ***_***chemical composition***_***.”***
**Shape, surface or design must be more important than the chemical composition**
**Article or substance/ preparation in a container?**
**Articles:  cars, computers, clothes, batteries, packaging**
**Substance/ preparation in a container: wet cleaning wipes**
**Why does the distinction matter? **
**Limited requirements for Articles**

**Notes:**
What is an Article?
An article is an object, composed of one or more substances or preparations, given a specific shape, surface or design. 
The shape, surface, or design must be more important than chemical composition

1st step is to answer the following question:
What is more relevant for the function of the object: the shape or the chemical composition?
If shape> chemical composition = article
If chemical composition> shape = subst/ preparation in a container

Check if the object is considered an article or a substance/ preparation under REACH
Latest interpretation from the Commission
Only guidance - not binding, only indicative - in the end industry is responsible to determine if article or container.

Why the distinction matters: better to be considered an article (art 7) than preparation (art 6: registration of all substances in the preparation, labeling)

## Articles - Registration

**Registration of substances intended to be released from Articles**
**Registration required if substance:**
**Is “****intended to be released**** under normal or reasonably foreseeable conditions of use”**
**Totals ****above 1 ton**** in firm’s annual article exports **
**Registration deadlines/requirements: same as substances and preparations**
**No need to register:**
** ****if substance already registered for that use (in **_**any**_** supply chain)**

**Notes:**
Once you have determined that you export articles – not substances or preparations – then what are the requirements?

Registration is required for articles with intended release.
What is an article with intended release?
Not many ex. In the guidance: scented candle, scented eraser, scented marker! (fragrance to be registered)

Registration is required if the following conditions are met:
·	The substance is intended to be released during normal and reasonable foreseeable conditions of use 
·	The total amount of the substance present in the articles exceeds 1 t/a per producer or importer

No need to register if the substance has been registered for that use. This applies to any supply chain (Meglena to advise on how to check that. Pre-registration can help determine who will register for that use)

Registration deadlines and requirements are the same as for substances and preparations (2010- 2013 – 2018 for pre-registered substances)

## Articles - Notification

**Notification to ECHA of SVHC in Articles required if substance**
**Is on the ****Candidate List**** (on ECHA website)**
**Above 1 ton**
**In ****concentration > 0.1%:**** applies to the article as produced or imported (not to the homogenous materials or parts of an article)**
**Exposure**** cannot be excluded during entire life cycle**
**No need to register:**
** ****if substance already registered for that use (in **_**any**_** supply chain)**** **
**Notification deadlines and requirements: limited dossier, 6 months after Candidate listing from 1 June 2011**

**Notes:**
Notification is required for substances of very high concern (SVHC)  present in articles and for which the following conditions are met: 

·	The substances are present in those articles in a concentration above 0.1% (w/w) - the 0.1% concentration applies to the whole article, not to the homogenous materials nor parts. Member states don’t all agree with that interpretation.
·	The total amount in those articles exceeds 1 t/a per producer or importer
	If there is exposure (ex. Lead in belt buckle: lead is a SVHC that may be included on the candidate list, there is exposure, check volume and concentration of lead)

No notification if the substance has already been registered for that specific use (in any supply chain)

Notification  is a lighter procedure than registration. It consists of sending a dossier to the agency with the name of the company, the identity of the substance, its classification and labeling , and a description of the use and the tonnage band. 
It has to be submitted to the agency, 6 months after SVHC appears on candidate list, starting in 2011

## Articles - Information

**To ensure article safe use, **_***Duty to communicate***_** information on SVHC in articles down supply chain:**
**Applies to substances:**
**On the ****Candidate List**** (on ECHA website)**
**In ****concentration >0.1%**** in the article**
**NO TONNAGE THRESHOLD: also applies <1 ton**
**Information to be communicated:**
**To whom?: to the recipient of the article/ to the consumer on request**
**What?: As a minimum, the name of the substance**
**When?: Directly after Candidate listing/ Within 45 days of receipt of the request**

**Notes:**
If SVHC have been identified in the article, Information on that substance has to be communicated down the supply chain

The objective is to ensure safe use of the article

Applies to substances:
On the Candidate List (on ECHA website)
In concentration >0.1% in the article
No tonnage threshold: also applies below 1 ton
Information to be communicated:
To whom? to the recipient of the article/ to the consumer on request
What? As a minimum, the name of the substance
When? Directly after Candidate listing/ 45 days to inform consumers (when you have 6 months to notify the agency)

Meglena Tips: Be ready to communicate

## New Guidance on Articles

**Specific requirements for substances in Articles**
**Guidance will help you answer the following:**
**Do your products meet the EU definition of Articles?**
**Are your Articles subject to:**
**Registration?**
**Notification?**
**Communication related to SVHC content?**
**Final guidance to be shortly available on the ECHA website (RIP 3.8):****  **_**[http://reach.jrc.it/guidance_en.htm](http://reach.jrc.it/guidance_en.htm)**_

**Notes:**
Publication RIP 3.8 on ECHA website: Spring 08

## New guidance on “Only Representatives”

**What is an *****Only Representative***** (OR)?**
**Non-EU companies may appoint an Only Representative to fulfill the obligations of their EU importer**
**OR will handle registration/ pre-registration, participation in SIEF**
**OR must be EU-based, with a background in chemicals handling**
**Only representative v. EU importer**
**Confidentiality and cost issues**
**Availability of Only Representatives?**
**Guidance remains unclear on some issues**
_**[http://reach.jrc.it/docs/guidance_document/registration_en.htm](http://reach.jrc.it/docs/guidance_document/registration_en.htm)**_

**Notes:**
New guidance on “Only Representatives”/ of non-EU manufacturers. The guidance was recently updated, and can be found on the agency’s website. 
what’s an only representative? your EU importer who has to comply with REACH
- You also have the option, as a non-EU company, to appoint an only representative to fulfil the obligations of your importer. 
The OR will handle the registration. He will also take care of pre-registration, and participation in the SIEfs
The OR must be: EU-based/ He must have a background in chemicals handling

( OR v importer): If you appoint an Only Rep: you don’t have to disclose info to the importer, and you can do business with several EU importers (not just with the one who registered your substance)
An issue is the Availability of OR: Because of responsibilities they have and the profile required , there are only few ORs on the market. At the US Mission, we are maintaining on our website a list of ORs to help you find one. 
Another issue is the cost of appointing an OR, which could be a real problem for SMEs.

Guidance remains unclear on some issues, despite the recent update. And this is worring as the June 1st deadline approaches, and you need to finalize arrangements with OR and importers.
Uncertainties remain in particular regarding, the possibilities for non-EU manufacturers of substances/ to appoint an OR to cover that substance when included in preparations exported to the EU by their customers. If this is not possible, that could create confidentiality issues. We are raising this issue of lack of clear guidance with the Commission.

## REACH Fees

**Draft regulation, to be adopted by 1 June 08**
**Registration and Authorization fees:**
**depends on tonnage**
**whether joint or individual submission**
**Reduction for SMES**
**No fee for registration of a substance 1 – 10 tons **
**Examples:**
**1,200 ****Є**** (low vol/ joint submission)**
**31,000 ****Є**** (high vol/indiv reg) ******** SME reduction: 120 ****Є**
**Authorization: 50,000 ****Є**** (std charge) ******** SME reduction: 7,500 ****Є**
**Confidentiality requests:**
**Relevant tonnage band (1,500 ****Є), study summary (4,500 Є)**

**Notes:**
The REACH fees regulation
It’s a draft, it should be adopted by June 1st

Fees will be required for registration and authorisationThey will depend on tonnage and whether information has been submitted jointly or separately. 
In all cases, there is a  reduction for SMEs. For substances between 1-10 t, there is no registration fee, as long as the registration dossier contains the require information 

For example:
For Registration: 
The fee would be 1,200 Є (for a low volume chemical and a joint submission) up to 31,000 Є (for a high volume chemical and an individual submission.) – For an  SME: 120 Є (for low volume/ joint submission/ small company)
For Authorization :
The standard charge is 50,000 Є. It goes down to 7,500 Є for an SME

There are additional fees to protect confidential business information
for each type of information, there is a fee (for ex, to keep the tonnage band confidential, you need to pay 1,500 Euros; for a study summary: 4,500 Euros...) 
You will note that the extra charge for maintaining confidentiality is higher than the registration cost for an SME.  

## Energy Using Products (EuP)

**Goal - force energy conservation into product design by**
**Integration of energy conservation factors in product design**** - **_***Not into performance***_
**Including “life-cycle” conservation**
**Will affect most US electronics**
**This year:  **
**street lighting/office lighting**
**Stand by & off-mode losses/external power supplies****.**
**“****Simple” set top boxes **
**Self-declaration? – remains to be seen**

## EUP: Next Target Sectors

**Boilers and combi-boilers (gas/oil/electric)**
**Water heaters (gas/oil/electric)**
**Personal Computers (desktops & laptops) and computer monitors**
**Imaging equipment: copiers, faxes, printers, scanners, multifunctional devices**
**Consumer electronics: televisions**
**Residential room conditioning appliances (A/C & ventilation)**
**Domestic lighting (including incandescent bulbs)**

**Electric motors 1-150 kW, water pumps (commercial buildings, drinking water, food, agriculture), circulators in buildings, ventilation fans (nonresidential)**
**Commercial refrigerators and freezers, including chillers, display cabinets and vending machines**
**Domestic dishwashers and washing machines.**
**“****Complex” set top boxes**
**Laundry Driers/vacuum cleaners**
**Etc. **

## Slide 39

**Notes:**
Trade has steadily grown over the past five years

## CSEU Tenders Database

**All public procurement tenders open to ****US-based**** firms, in accordance with GPA, announced by European public authorities**
**Search facility by country, sector or ****keyword****Refined selection by keyword possible **
**For ****US-sourced supplies. Updated 2x per week; average 10,000 tenders**
**Go to “EU Tenders” in:****www.buyusa.gov/europeanunion**

## WWW.BUYUSA.GOV/EUROPEANUNIONWWW.USEU.BE