# Presentation: 578319

## EU Laws That Could Affect Your Business Trade Winds ForumJonathan BenskySenior Commercial OfficerUS Mission to the European UnionMay 15, 2007

_***EU Laws That Could Affect Your Business ***_**Trade Winds Forum****Jonathan Bensky****Senior Commercial Officer****US Mission to the European Union****May 15, 2007**

## Today’s Issues

**Product Certification and Standards**
**The CE Mark**
**Metric labeling**
**Energy Using Products**
**WEEE-RoHS**
**REACH**

## Product Certification and Standards: Issues and Trends in the European Union

##  US REGULATORY APPROACH

**The market place can operate without intervention:**
**Legal liability of seller if product defective or hazardous**
**Consumer access to information about product quality**
**Size of market and extent of competition**
**U.S. laws and regulations on truth in labeling and advertising - with legal penalties for false information**

**Notes:**
Many say that the American propensity to litigate keeps the market relatively free of unsafe products.  However, the EU system is more heavy on legislation.  There is always the fear that the Europeans will require third party certification and come up with additional safety and quality marks.

##  EU REGULATORY APPROACH

**Emphasis on social and environmental aspects over business aspects.  **
**= Over regulation by US measure?**
**2005 “Better Regulation” campaign.**
**Reduce red tape, simplify and reduce regulation.  **
**Alternatives: promote EU standards as technical support to EU legislation.  **
**So far perhaps not much to show?**
**REACH, e.g.**

## Why Are Standards Important?

** **

**Principle non-tariff barrier **
**Affect >80% of world trade**
**Technical Barriers vs “Technical Hurdles”**

## Technical Barriers to Trade (TBT)

_**Code of Good Practice: Standards must:**_
**Give national treatment.**
**Be consistent with relevant international standards.**
**State product requirements in terms of   ****performance rather than design or description**
**Not create unnecessary obstacles to trade**
**Or can take to WTO**** **

## Unnecessary Obstacles to Trade

**Measures **_***may not***_** be more restrictive than necessary for a **_***legitimate***__** **_**objective, e.g.,**
**National security**
**Protection of human health and safety, or animal, plant life and health**
**Environmental protection**
**Prevention of deceptive practices**

## EU Regulations and Standards apply in:

- _[ ](http://secretariat.efta.int/)_

**27 EU Member States**
**Four EFTA Member States:**
**Iceland,Liechtenstein,Norway, Switzerland**
**Others, e.g., Turkey.**
**Others by default**
**setting a standard others feel forced to meet**

**Notes:**
Iceland, Liechtenstein, Norway and Switzerland are members of EFTA.  They are all full members of CEN and CENELEC.

(history:  The EFTA Convention established a free trade area among its Member States in 1960. In addition, the EFTA States have jointly concluded free trade agreements with a number of countries worldwide. Iceland, Liechtenstein and Norway entered into the Agreement on the European Economic Area (EEA) in 1992, which entered into force in 1994. The current contracting parties are, in addition to the three EFTA states, the European Community and the 25 EC Member States. )

## The EU’s Standards Outreach

**The EU has a planned an aggressive program to export its standards to enhance international trade for EU companies**
**At least $50 million per year**

## EU - Three Standards Developing Organizations

**EU - Three Standards Developing Organizations**

**CENELEC:  The ****European Committee for Electrotechnical Standardization. **
**CEN: The European Committee for Standardization**
**ETSI:  The European Telecommunications Standards Institute**
**Only ETSI open to anyone interested**
**As are the 450 US standards bodies**

**Notes:**
Europe has only three

## New Approach Legislation: The “CE Mark” 

**Mandatory  safety labels on**
**product and **
**packaging**

**Notes:**
CE is jokingly referred to as “confusion everywhere” or “Chinese exports”, Conformite europeenne” 

It has recognition beyond the EU-25 + 3 through the EU’s promotion of the new approach regulatory model.  Turkey, for instance, already accepts CE marked products.

CE mark is a safety mark and there should not be national safety marks.  It’s illegal to apply CE mark when it is not required although market surveillance’s role monitoring illegal use is weak.  

There can be several other marks on a product, each representing the mandatory mark for a country/region, such as FCC and UL for the U.S. and CSA for Canada.  There can also be conformity assessment marks on a product such as the Keymark (CEN).  This is voluntary.  And last but not least the quality marks, such as the German GS (gepruefte Sicherheit – tested safety). 

A kind of passport valid in the 25 EU member states + 3 EEA 

## CE Mark: Demonstrating Conformity with/without EU standards

**Demonstrating Conformity****with European Standards (EN)****= “presumption of conformity”**
**Demonstrating Conformity with non-European standards = a lot of paperwork**

**Notes:**
A hallmark of the New Approach is CE Marking and using EU standards is how you demonstrate conformity with the Directives.

## CE Mark: New Approach Directives

**Machinery**
**Gas Appliances**
**Simple Pressure Vessels**
**Pressure Equipment**
**Toys**
**Construction Products**
**Personal Protective Equipment**
**Hot Water Boilers**
**Recreational Crafts**
**Marine Equipment**
**High Speed Rail Systems**

**Lifts and Cableways**
**Measuring Instruments**** **
**Non-automatic Weighing Instruments**
**Active Implantable Medical Devices, IVD, Medical Devices**
**Radio Telecom & Terminal Equipment (RTTE)**
**Civil Explosives**
**Potential Explosive Atmospheres**
**Electromagnetic Compatibility**
_***Energy Using Products (EuP***__***)***_

**Notes:**
 Here is a list which products and product related aspects are covered.  
New legislation is adopted on a regular basis.  EUP for instance is in the pipeline.  Existing legislation is reviewed (low voltage, EMC and medical devices).  

## CE Mark: Directives based partly on the New Approach

**Low Voltage**
**Packaging & Packaging Waste**
**Noise Emission**
**Energy Efficiency Requirements for Household Refrigerators**
**Transportable Pressure Equipment**
**Energy Efficiency Requirements for Ballasts for Fluorescent Lighting**
**Interoperability of the Trans****-****European Conventional Rail system**

## CE Mark:the future

**Updating existing legislation **
**EMC, Machinery, Medical Devices and others**
**Adoption of new legislation**
**EUP, Human Tissue Engineering**
**Review of the New Approach principles**
**Harmonized definitions**
**Improved working of accredited test laboratories**
**Better coordination among inspection authorities**
**  **

**Notes:**
The European Unions’ legislative bodies are working on 
Review of existing legislation to update and simplify where possible
Draft new legislation: EUP, human tissue engineering
To improve the functioning of the single market in order to create a level playing field, the EU launched a review of the new approach regulatory model.  
Definitions (manufacturer, importer, placing on the market, etc) are to be harmonized
Test laboratories will have to be accredited.  They will be working more closely together
Inspection authorities will be coordinating more effectively in order to improve market surveillance
(The review of the new approach is still in the draft stage)

## The EU Metric Directive

**The EU has been officially metric-only since 1980**
**With ten year exemptions permitting dual labeling in 1980, 1990 and 2000.**
**The next exemption expires December 31, 2009**
**The US is officially metric, too**
**Federal Law requires dual labeling**

**Notes:**
Going well beyond labeling, the Metric Directive will make the sole use of metric units obligatory in all aspects of life in the European Union, extending to areas such as product literature and advertising.   

## The EU Metric Directive: The Bottom Line

**Beginning January 1, 2010, the European Union will allow **_***ONLY METRIC UNITS***_
_***Unless the Directive is changed***_

_**Using U.S. customary**_
_**units on labels, **_
_**packaging,**_
_**advertising,**_
_**catalogs, technical**_
_**manuals, and/or**_
_** **__**user instructions**_
_***WILL BE ILLEGAL***__** in**_
_**the European Union**_

**Notes:**
Going well beyond labeling, the Metric Directive will make the sole use of metric units obligatory in all aspects of life in the European Union, extending to areas such as product literature and advertising.   

## EU Metric labeling - What’s next?

**Change requires:**
**Commission proposal**
**Commission “consultation” ended March 1**
**200 + comments**
**A recent helpful hint**
**European Parliament and Council “co-decision” in favor**
**Could take two years (or less)**

**Notes:**
The Commission is finally thinking as we are on this issue with the change of the head of Unit, Mr. Menidiatis (Pressure equipment, medical devices, metrology)
.  Principal Administrator Daniel Hanekuyk.  Productive meeting in July.

##  Energy-Using Products Directive  (EuP)

**Eco-design Requirements for**** Energy-Using Products (EuP)**
**First “New Approach” Directive aimed at design, not performance**
**No one yet knows measurement**
**If your industry involved, get involved**** **

**Notes:**
The Directive 2005/32/EC on the eco-design of Energy-using Products (EUP), such as electrical and electronic devices or heating equipment, provides coherent EU-wide rules for eco-design and ensure that disparities among national regulations do not become obstacles to intra-EU trade. The Directive does not introduce directly binding requirements for specific products, but does define conditions and criteria for setting, through subsequent implementing measures, requirements regarding environmentally relevant product characteristics (such as energy consumption) and allows them to be improved quickly and efficiently. Products that fulfill the requirements will benefit both businesses and consumers, by facilitating free movement of goods across the EU and by enhancing product quality and environmental protection. The Directive constitutes a breakthrough in EU product policy and introduces many innovative elements together with concrete application of the principles of the "better regulation" package.
By encouraging manufacturers to design products with the environmental impacts in mind throughout their entire life cycle, the Commission implements an Integrated Product Policy (IPP) and accelerates the move towards improving the environmental performance of energy-using products. After adoption of the Directive by the Council and the European Parliament, the Commission, assisted by a Committee, will be able to enact implementing measures on specific products and environmental aspects (such as energy consumption, waste generation, water consumption, extension of lifetime) after impact assessment and broad consultation of interested parties.
There are not obligations for all energy-using products, but only for those meeting criteria such as important environmental impact and volume of trade in the internal market and clear potential for improvement, for example where market forces fail to make progress in the absence of a legal requirement.
This policy initiative is expected to increase the effectiveness and synergies of other EU legislative acts and initiatives concerning environmental aspects of products. Examples of related measures are the Directives regulating the management of waste from electrical and electronic equipment (WEEE) and the use of certain hazardous substances used in this equipment (RoHS)  as well as Directives related to the energy efficiency of appliances such as the Energy labeling Directive.  Existing Directives on minimum energy efficiency requirements shall be considered as implementing this Directive for the products that they cover with regard to energy efficiency during use.
Products which have been awarded the Eco-label will be considered as compliant with the implementing measures in so far as the Eco-label  meets the requirements of the implementing measure. Although the EMAS registration on its own does not grant presumption of compliance to the products manufactured by the enterprise, enterprises which have an EMAS registration, which includes product design, may use directly their environmental management system for demonstrating that their product complies with the applicable implementing measure.

## EuP: 1st 14 “Implementing Measures”

**Battery chargers and external power supplies (complete)**
**Public street lighting (due Spring 2007)**
**Personal Computers (desktops & laptops) and computer monitors (due Spring 2007)**
**Consumer electronics: televisions (due Spring 2007)**
**Office lighting (due Spring 2007)**
**Standby and off-mode losses of EuPs (due Spring 2007)**
**Standby and off-mode losses (due Spring 2007)**

## EuP: 1st14 “implementing measures”

**Water heaters (gas/oil/electric) (due Fall 2007)**
**Imaging equipment: copiers, faxes, printers, scanners, etc  (due Fall 2007)**
**Standby and off-mode losses (due Spring 2007)**
**Residential room conditioning appliances including  ventilation) (due Fall 2007)**
**Electric motors 1-150 kW, water pumps (commercial buildings, drinking water, food, agriculture), circulators in buildings, ventilation fans (nonresidential) (due Fall 2007)**
**Commercial refrigerators and freezers, including chillers, display cabinets and vending machines (due late Spring 2007)**
**Domestic dishwashers and washing machines (due late spring 2007)**

## Slide 23

## EuP- what’s next

**Next 5 “implementing measures ” for product groups “having significant greenhouse gas emission reduction potential”:**
**Solid fuel small combustion installations**
**Laundry driers**
**Vacuum cleaners**
**Set-top boxes **
**Domestic lighting**** **
**     *****Links to all the studies can be found through the EU Commission Directorate General for Energy and Transportation website: ***_***http://ec.europa.eu/energy/demand/legislation/eco_design_en.htm***_

**Notes:**
• set-top boxes (possible split into «simple converter
boxes» for free-to-air broadcast/TV, and complex
boxes for pay content

## WEEE & RoHSSituation Report

## Waste Electrical and Electronic Equipment Directive (WEEE)

**WEEE targets landfill electrical waste.**
**“****Environmental Clause” based – so EU law is only a minimum.**
**Producers must register in each member state as part of WEEE compliance.  **
**On August 13, 2005, “producers” of EEE became financially responsible for the collection and recycling of EEE. **
**For B2B sales, some countries may allow different arrangements (e.g. customers paying).**
**Equipment must be marked with crossed-out “wheelie bin” symbol.**
**Member States may require documentation to contain collection & recycling information too.**

## The “Restriction of Hazardous Substances” (RoHS) Directive

**The RoHS Directive targets reducing environmental impact of WEEE****.**
**“****Internal Market Clause” based, so Member States can’t go beyond it.**** **
**From July 1****st**** 2006, RoHS b****ans m****ercury, cadmium, lead, hexavalent chromium, PBB and PBDE in most electrical and electronic products**

## CSEU WEEE/RoHS Website

**A Counseling Tool**
**Coordinated EU wide website **
**Lists country specific information**
**Includes the latest information we have on WEEE & RoHS.  **
**Lists country specific information **
**Practical content, e.g., FAQ**** ****and RoHS exemptions documents**

## WEEE/RoHS Revision

**The EU is committed to reviewing WEEE and RoHS.**
**Lengthy period of study and public consultation has begun.**
**Proposals expected from EC in 2008.**
**“****No holds barred****”**** opportunity to improve the way ****WEEE & RoHS**** work.**
**New Directives to come into force 2011-2012**.

##  REACH: A Very Brief Introduction

**Notes:**
Timely presentation:
Entry into force of REACH on June 1st
growing number of businesses focusing on compliance
US SMEs need to be informed: U.S. Roadshows and webinars
Who is impacted? Companies producing, using chemicals

Content of presentation:
What REACH means for US companies
How CS can help them prepare for REACH

## What is REACH?

**The new EU chemicals policy**
**REACH stands for the ****R****egistration, ****E****valuation and ****A****uthorization of ****Ch****emicals**
**Industry to provide **chemical safety** information to a new European Chemicals Agency**
**Entry into force: **_**1 June 2007**_** in 27 EU countries**
**First business-relevant deadline: ****1 June 2008**

**Notes:**
What is REACH?

- The new EU chemicals policy
- REACH stands for the Registration, Evaluation and Authorization, and restriction of Chemicals
- REACH is about chemical safety. The objective of REACH is to ensure that chemicals are safe for health and the environment. Industry will have to provide this safety information to a new European Chemicals Agency which is being set up in Helsinki, Finland.
Entry into force: 1 June 2007 in 27 EU countries
1st business-relevant deadline: 1 June 2008 (pre-registration)

## REACH Coverage:  Examples

**REACH Coverage:  Examples**

**Notes:**
REACH applies to chemicals used in industrial processes but also in consumer products
Almost all Showcase Europe sectors impacted

## REACH: What chemicals are covered?

**Registration **
**IN:**** Chemicals > 1 metric ton/ year/ company (30,000 chemicals – no list)**
**OUT:**** chemicals below 1 ton, covered by equivalent legislation (pharmaceuticals, biocides, pesticides), of low risk, occurring in nature, polymers**
**Authorization **
**Substances of very high concern (1,500 chemicals)**

**Notes:**
Registration – Evaluation – Authorization and Restrictions of Chemicals
Presentation focusing on Registration and Authorization, that place duties on industry (burden of proof on industry: they have to prove that their substances are safe)
Evaluation of dossiers and substances, as well as Restrictions on the marketing and use of substances (ex: EU ban on asbestos) done by authorities.

Registration of substances above 1 ton: 
companies that manufacture or import into the EU more than 1 metric ton of a chemical substance per year are required to register the chemical in a database run by the Agency.
registration will apply to approximately 30,000 chemicals. The Commission does not maintain a list of substances subject to registration. The number of 30,000 is an estimation of the number of chemicals currently on the EU market in volumes above 1 ton. 
Exemptions from registration: REACH does not apply to chemicals below 1 ton, pharmaceuticals, biocides, pesticides, chemicals of low risk or occurring in nature (oxygen), polymers (but monomers have to be registered)

Authorization of the most toxic substances: 
There will be tough controls on “substances of very high concern”. They will have to be authorized for the EU market
Substances of very high concern include carcinogens, endocrine disruptors
Approximately 1,500 substances will require authorization for the EU. They will first appear on a ‘candidate list’ of substances subject to authorization on the agency website and then in annex to the REACH regulation

## REACH: why should US business care?

**No exports to Europe unless chemicals registered and, if necessary, authorized**
**REACH is addressed to EU chemical manufacturers, importers, and users **
**Manufacturers outside of the EU are not covered by REACH - extraterritoriality**
**However, **_**US-based companies are indirectly impacted by REACH**_**:**
**EU importers will require substantial information**
**Possibility for non-EU based companies to use an “only representative”**

**Notes:**
Why should US companies care about REACH?

No exports to Europe unless chemicals registered and, if necessary, authorized 
Who is responsible?
REACH places obligations on EU-based entities: chemical manufacturers, importers, users of chemicals 
Manufacturers outside of the EU are not covered by REACH
However, US-based companies are indirectly impacted by REACH: Substantial information will be required by the EU importer for registration and authorization (product composition, tonnages,...). 

Non-EU entities can use an EU-based representative (“only representative” with experience in chemical handling) to meet REACH requirements: a costly option (consultants, lawyers, laboratories will act as only representatives) but it gives more control over registration and avoids disclosure of sensitive information to the importer. As far as we know, few entities so far are willing  to act as only representative because of the issue of responsibility. 

US-based companies need to understand the obligations of their importer or only representative and provide support.

## REACH: REGISTRATION

**EU manufacturers and importers must  register substances in quantities ****above **1 **metric ton/year**** **
**Submission of a *****registration dossier***** to the European Chemicals Agency:**
**Registrant must be EU-based (importer/ only representative)**
**Deadlines/information required based on volume**
**On-line registration on the Agency’s website**
**Joint submission of registrations (consortia)**
**Registration fee (Estimation: 500 – 24,000 Euros/ substance)**

**Notes:**
REACH requires EU manufacturers and importers of chemicals (above 1 metric ton/ year) to obtain information on their properties, uses and safe ways of using them.

Each manufacturer and importer must submit a registration dossier documenting the data and assessments to the Agency.

The registrant needs to be EU-based. In the case of a US exporter, his importer or only representative will submit the registration.

Deadlines and information requirements depend on volume: highest volumes will be registered first and will require more testing than small volumes.

On-line registration – format for registration dossier to be made available on the Agency’s website

Joint submission of registrations: in cases where a substance is manufactured or imported by more than one company, they are required to jointly submit information to the Agency (One substance – one registration). Companies can opt-out from consortia and submit the registration on their own but the registration fee will be higher. 

Registrants must pay a fee for submitting a dossier. The EU is expected to publish a specific regulation on fees by 1 June 2008. So far, our understanding is that the fee would range from 500 to 24,000 Euros per substance. The lowest fees would be for low volume chemicals registered by SMEs and consortia. 

Pre-registration: The first business-relevant deadline under REACH is pre-registration, on 1 June 2008.
Pre-registration is not mandatory but highly recommended:
companies must pre-register their substances in 2008 if they want continue marketing them until full registration is completed by the required deadlines (2010, 2013 or 2018, depending on volume). 
pre-registration also enables registrants to share data with others and prepare joint submission of registration.
The pre-registration period is limited from 1 June 2008 to 1 December 2008. Only submit basic information has to be submitted and there are no fees (pre-registration done by the importer or only representative)

## REACH: PRE-REGISTRATION

_**June 1 - December 1, 2008 **__***Only***_
**Key to continue export until registration process completed (2010 - 2018)**
**Allows data sharing between registrants**
**A simple post-card exercise. No fees for pre-registration**

**Notes:**
REACH requires EU manufacturers and importers of chemicals (above 1 metric ton/ year) to obtain information on their properties, uses and safe ways of using them.

Each manufacturer and importer must submit a registration dossier documenting the data and assessments to the Agency.

The registrant needs to be EU-based. In the case of a US exporter, his importer or only representative will submit the registration.

Deadlines and information requirements depend on volume: highest volumes will be registered first and will require more testing than small volumes.

On-line registration – format for registration dossier to be made available on the Agency’s website

Joint submission of registrations: in cases where a substance is manufactured or imported by more than one company, they are required to jointly submit information to the Agency (One substance – one registration). Companies can opt-out from consortia and submit the registration on their own but the registration fee will be higher. 

Registrants must pay a fee for submitting a dossier. The EU is expected to publish a specific regulation on fees by 1 June 2008. So far, our understanding is that the fee would range from 500 to 24,000 Euros per substance. The lowest fees would be for low volume chemicals registered by SMEs and consortia. 

Pre-registration: The first business-relevant deadline under REACH is pre-registration, on 1 June 2008.
Pre-registration is not mandatory but highly recommended:
companies must pre-register their substances in 2008 if they want continue marketing them until full registration is completed by the required deadlines (2010, 2013 or 2018, depending on volume). 
pre-registration also enables registrants to share data with others and prepare joint submission of registration.
The pre-registration period is limited from 1 June 2008 to 1 December 2008. Only submit basic information has to be submitted and there are no fees (pre-registration done by the importer or only representative)

## REACH: AUTHORIZATION

**REACH authorization:**
** ****ensure that *****substances of very high concern***** are:**
_**Adequately controlled **__***and***_
_**progressively replaced by safer alternatives**_** **
_***Or***_** ****only used where there is an overall benefit to society of using these substances**

**Notes:**
Authorization applies to substances of very high concern such as carcinogens, toxic substances or endocrine disruptors. 

Substances subject to authorization cannot be placed on the market or used unless the company is granted an authorization for a specific use. Authorization is company-specific, use-specific and time-limited. Substances that enter the authorization process are put under considerable pressure as they end up being authorized for a limited period of time or banned. Companies who are producing or using these substances will have to defend their use.

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 
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. 
There will be a fee for authorization. The Commission will shortly come up with a regulation on fees. The latest estimate is that it will be approximately 50,000 Euros per substance.

## Special Rules for Imported “Articles”	

**Articles releasing a substance: **
**Articles containing a SVHC:**

**Registration**
**(Registration dossier, **
**starting in 2008)**

**If the chemicals is:**
** ****intended to be released**
** ****> 1 metric ton**
** ****not already registered for that use**

- Notification

**If the chemicals is:**
** ****on the Candidate List**
** ****> 0.1% **
** ****> 1 metric ton**
** ****not already registered for that use**
** ****exposure cannot be excluded during entire life cycle**

**(Open issue: is this an article or a preparation in a container?)**

**(Simplified procedure, **
**starting in 2010)**

**Notes:**
Special rules for substances in finished products (articles). They are subject to registration or notification, if they meet a number of conditions.

An article is a finished product, like cars, textiles, electronic chips. 

Registration: REACH requires all substances that are intended to be released from articles to be registered according to the normal rules for registration ( described slide 6 – submission of a registration dossier starting in 2008, with deadlines in 2010, 2013 or 2018 depending on tonnage), if they are exported to the EU in quantities over 1 metric ton per company, per year. Registration is not required if the substance has already been registered for that use (by anyone). A classic example is the ink in a pen, that is intentionally released. Chemicals in the ink, above 1 ton and not already registered for use in a pen, have to be registered. However, Member States are currently questioning whether a pen is an article or a container for a preparation (the ink). 
Note: If it’s a preparation in a container, article 6 on substances and preparations applies instead of article 7 on Articles. It will be more burdensome and costly for US exporters: all substances in the ink will have to be identified and registered. 

Notification:
All substances included in the so-called candidate list of substances of very high concern subject to authorization, which are present in articles above a concentration limit of 0.1% and above 1 metric ton must be notified to the Agency. For example, a dye in a shirt would have to be notified. 
It is not necessary to notify if exposure to that substance can be excluded.

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. Notification will only start in 2010.

Guidance documents (RIPs):
RIP 3.8 on articles to help industry determine if chemicals in their products have to be registered or notified.  The draft is posted on our website.

## REACH: Major Compliance Deadlines

**REACH: Major Compliance Deadlines**

- Notification (for Articles)

- 1 - 100 tons

- 100 -
- 1000 tons

- 1000 + tons
- Most SVHC

- Pre-registration

**Registration**

- 2008

- 2018

- 2013

- 2010

**Notes:**

The first business relevant deadline is 1 June 2008: pre-registration – Only one year to prepare to prepare for REACH

30,000 chemicals registered over a period of 11 years (2008 – 2018):

Registration deadlines apply in 2010, 2013 and 2018 depending on the volume band and level of concern of the substance. Up to 11 years to register a low volume chemical (if pre-registered, otherwise full registration has to be done in 2008 to continue marketing).

For articles – deadlines relevant for US exports of finished products:
Registration (articles releasing a substance): starting in 2008, deadlines in: 2010, 2013, 2018 (same as substances and preparations)
Notification (articles containing substances of very high concern): starting in 2010

Note: the chart does not stop in 2018 as new chemicals, not currently on the market, will have to be registered or notified after that date. The 2010, 2013, and 2018 deadlines apply to existing chemicals, the so-called phase-in substances.

## Getting Ready for Reach–We Can Help

**Only one year to prepare for REACH:**
**Understand your obligations**
**Start with an inventory of substances exported to the EU**** **
**(****volumes, uses, chemicals subject to authorization, available studies, exemptions)**

**www.buyusa.gov/europeanunion/reach.html**

**Notes:**

CSEU advising companies to:
Get ready for REACH – only 1 year to prepare for REACH
By starting with an inventory of substances exported to the EU (check volumes, uses, SVHC in articles, if authorization is needed, available studies, do they benefit from any exemptions from REACH?)
And start talking with their suppliers, customers and importer (to better understand their obligations) 
Advice for the little guys. Global companies are already involved in compliance (3M has 200 people working on REACH)

For more information, check our website:
Includes the most important EU documents: legal text, FAQs and guidance documents, to be finalized in October. CSEU closely monitoring development of guidance documents by participating in RiPs process 
New IMI on REACH: REACH 101
Link to REACH helpdesks in member states: Each of the 27 EU states is required to have a helpdesk up and running by June 1st. 
List of REACH business service providers 
Dates for US Roadshows (8 June Houston) and webinars (24 May)

## Getting Ready for Reach–We Can Help

**CSEU website as a counseling tool:**
**EU guidance documents **
**New market research on REACH**
**Links to REACH helpdesks **
**List of REACH business service providers**
**Dates for U.S. Roadshows and Webinars**

**Notes:**

CSEU advising companies to:
Get ready for REACH – only 1 year to prepare for REACH
By starting with an inventory of substances exported to the EU (check volumes, uses, SVHC in articles, if authorization is needed, available studies, do they benefit from any exemptions from REACH?)
And start talking with their suppliers, customers and importer (to better understand their obligations) 
Advice for the little guys. Global companies are already involved in compliance (3M has 200 people working on REACH)

For more information, check our website:
Includes the most important EU documents: legal text, FAQs and guidance documents, to be finalized in October. CSEU closely monitoring development of guidance documents by participating in RiPs process 
New IMI on REACH: REACH 101
Link to REACH helpdesks in member states: Each of the 27 EU states is required to have a helpdesk up and running by June 1st. 
List of REACH business service providers 
Dates for US Roadshows (8 June Houston) and webinars (24 May)

## Slide 42

## CSEU Recent Market Research

**New Machinery Directive - Jan 2007**
**EU Funds for Research - Feb 2007**
**EUP - Feb 2007**
**EU Critical Infrastructure - March 2007**
**Health Claims - April 2007**
**Byrd Amendment Update - April 2007**
**Venture Capital in the EU - April 2007**
**REACH Update - April 2007**
**e-Commerce - May 2007**

## What Can We Do For You?www.buyusa.gov/europeanunionwww.buyusa.gov/europewww.useu.be