FTS DOC ITA

Moderator: Linda Abbruzzese

May 6, 2008

10:00 am CT

Woman: (Unintelligible). Oh and one more thing…

Coordinator: Welcome...

Woman: Oh.

Coordinator: And - welcome and thank you for standing by. I’d just like to inform all participants that your lines have been placed in a listen only mode until the question and answer session of today’s conference. Today’s call is also being recorded. If you have any objections, you may disconnect at this time.

I would now like to turn the meeting over to Miss Linda Abbruzzese. Ma’am you may begin.

Linda Abbruzzese: Thank you. Good morning. Thank you for joining us on our webinar on EU standards and compliance. I am pleased to note that we have more than 43 people registered for this webinar today. I am Linda Abbruzzese, International Trade Specialist for the Marketing Communications Office for the US Commercial Service at the Department of Commerce.

This webinar is being brought to you in cooperation by the US and Foreign Commercial Service. I’d like to welcome all the US Commercial Service clients and other webinar participants in the export community who are joining us from all across the USA to learn about the EU standards and compliance. I’d like to also give a special thanks to Barbara Lapini, International Trade Specialist in the Trade Information Center for her help in making this webinar organized and well produced.

Our speakers come to us from the US Mission in the European Union. They are Standards Attache, Louis Santamaria and Compliance Attache Ashley Miller, Standards Specialist Sylvia Mohr, and Compliance Specialist Susana Getman. All speakers will be available at the end of the presentation to answer your questions. Contact information will be provided at the end of the presentation, and they will be able to answer your specific questions.

Now for those of you who just joined, you can still log onto the webinar by entering the URL website and pass codes per instructions that were sent to you by email. We do have a few housekeeping details to make sure everyone gets the most benefit from this morning’s webinar.

You will be able to hear the presentation via your telephone and view it simultaneously via your computer. If you are not hooked up to both, please take a moment to do this. If you are experiencing any technical difficulties, please press star zero any time during the presentation.

Now because of the large number of participants online, we now have more than 33 -- it is not logistically feasible to take voice questions. However, we do invite you to type in questions on your screen as they occur to you during the presentation. There is a box at the bottom of the screen on which you can click and type in your questions any time during the presentation.

We will compile the questions and present as many as time allows after the presentation. Five questions which are not answered during the webinar due to time constraints will receive personal answers via email. In addition, all listeners will be provided with information for any individual follow up counseling export assistance or market research.

Now for those of you who just joined us and logged in, you can still join in our internet conference. Now I’d like to introduce (Paul Butcher), Deputy Director of the Office of Europe, who will give a brief introduction.

(Paul Butcher): Thank you kindly Linda and thanks again to Barbara for putting together this webinar. And folks thanks to all of you out there. We’re pleased that you could join us for this webinar on European Union standards and compliance.

Today you will be briefed by several of our commercial service and market accessing client staff located in the US mission to the European Union in Brussels, Belgium. And we particular want to thank the staff there, because it is 5 pm there their time, so we appreciate their staying on extra today to do this important program.

Today you will all receive an overview of some critical issues, regulations, and policies that affect not only American and other non-EU companies, but all firms that conduct business in the European Union. What may appear to be some daunting challenges as we go through the PowerPoint, the key point to remember is the each of you has at your disposal a team of devoted American and local staff on whom we rely on so much at our European Union mission.

So let’s kick off this webinar by introducing Louis Santamaria, our standards officer, who has a wealth of standards experience, having served in that same capacity in Mexico city up until last summer. And Louis also was the previous senior commercial officer in Venezuela and the principal commercial officer in Barcelona so he does know Europe quite well. And I’m pleased to introduce Louis at this time. Louis?

Louis Santamaria: Thank you, (Paul). Hello everybody. Good morning and good afternoon wherever you may be. I’d like to take a look at the - today’s program with you before we pass the microphone let’s say to my colleagues. First of all in the room I’ll remind you are Ashley Miller, Susana Getman, Sylvia Mohr, and myself.

Today’s program will consist of a review of the EU markets, will highlight opportunities and resources available to you. We’ll talk about European trade agreements compliance, emphasizing how your company can benefit from trade agreements and ensure a level playing field in the European market.

We’ll talk about the latest developments in EU marking -- that’s Sylvia -- (Reach) (unintelligible) (Ross) EUP metrics, we’ll give brief updates, and we’ll end up describing our new Europe regional standards market access and compliance program.

And before - and at the end of that we will end up with a slide where our individual email addresses will be noted so that you can communicate with us directly, send us questions that we may not have time to address individually during the webinar. So with that, let’s turn the program over to Ashley Miller.

Ashley Miller: And the next slide really is the bottom line of what we’re talking about throughout all the regulations specifically that we address today and all the standards issues. What we’re really trying to ensure here is that any regulation proposed or enacted, any standard proposed or enacted in the European Union does not guarantee the level playing field for US companies.

So we’re making sure that regulations and standards and technical issues in the European Union don’t tip the scales to the disadvantage of American companies. We work very closely with American companies here in Brussels and in the United States and all over Europe when they have any sort of inkling that something coming on the - coming down the line in terms of European union standards or regulations, are going to affect them adversely. So they let us know as well as possible so we can start the process to affect change before something gets enacted.

So we just - we have a very proactive approach and we really are working as hard as we can to monitor these regulations to make sure that they don’t disadvantage US companies.

Louis Santamaria: Let’s talk a little bit about the opportunities and the challenges. The positive side of the balance sheet -- the opportunities -- well it’s a market of more than 500 million consumers, it’s the largest economy in the world measured in Euros. In fact there is one set of rules -- or at least they’re trying to develop it in that manner -- not 27 individual rules of 27 individual member states, but not necessarily all the time. The - we’ll talk about later that the single market design is very much still on the drawing board. It’s not a 100% reality yet.

Slowly but surely the market’s being liberalized. EU is investing in itself. It really does portend to be increasingly a better and better market for US companies. And don’t forget the EU is our number one trading partner in the world. Some of the statistics that I’ve hard and will repeat to you just for the sense - to give you the sense of drama, we do more business in a single day with the EU than we do with many large economies in the world, such as China, in a single day. So more trade for Europe than anyone else. I think more than 80% in fact.

On the negative side of the balance sheet, it is a fragmented single market. And even more so for services as compared with goods and products. Very much a Euro central approach. EU regulators tend to invent their regulations with their stakeholders and not consult with the United States unless we insist on it. The regulatory approach is complicated, cumbersome, and oftentimes described as secretive. There are myriad regulations, et cetera et cetera.

So in a nut shell, once you stay the course and figure out with the help of the commercial service what all the rules and regulations are that you have to follow to get your product into the European market, the benefits are outstanding. Ashley?

Ashley Miller: And a little bit more - to build a little bit more on what Louis just talked about in the EU regulatory environment, again it is quite different from the united states, but really is a Euro central regulatory approach. There’s a tradition of top down regulation, and to talk quickly about something called the precautionary principal where Europe really regulates much more than the United States.

If they have a cautionary reason to regulate, they will regulate, whereas in the United States, it’s a more wait and see approach. Lot of that is due to the difference in our legal systems. We have a regulatory process that works a lot off case law, and that’s not the same in the United States.

So companies are really dealing with a different overarching environment here that they heed to, you know, that you all need to sort of think about. Like Louis said, it’s Eurocentric. Again, the decision making processes are complex because they involve, as Louis talked about, the one set of rules among 27 nations.

So you have European institutions in Brussels that guide the regulatory process. You have implementation going on in the individual member state level in Germany and France and Austria. So you sort of have a regulatory approach in Brussels getting implemented in the different member states. And there’s some friction there so you have to not only track what’s going on in the member states where you do business but also what’s going on in Brussels.

And then again, because there’s so many actors influencing the outcome, it’s very difficult. So you talk to the European parliament, you talk to the German government, do you talk to the European Commission, the bureaucracy that runs the European union, or usually the answer is, “You need to talk to all of them.”

So again, the environment is quite different than the United States. And again, as Louis said, once you sort of get your feet on the ground and get stable in the market, it’s a great place to stay, but it’s an entry that can be often difficult.

Now I want to talk a little bit about the market access and compliance program and shifting gears from sort of the bigger picture to specifically what the market access and compliance program does in the European - in Brussels and specifically with the European Union.

What we are committed to doing is helping US companies resolve market access barriers. And I’ll go through a list of what we mean by market access barriers. But really tacking those barriers one at a time to make sure that your company has the best access to the market as it possibly can.

We also look very closely again, monitoring regulations and standards and the different EU laws to make sure that they don’t violate US trade agreements. And it’s really important that we do that lock, stock, and barrel with companies and trade associations in the United States and in Europe. They may pick up on something in the letter of a new regulation, and we can figure out that it really does violate a trade agreement.

One of the most - our most important trade agreement with European Union is the WTO -- the World Trade Organization agreement. So we are constantly monitoring to make sure that whatever regulation or EU law goes into effect that it does not violate the basis of the WTO World Trade Organization agreement.

We also have some leverage in looking at where EU member states, individual countries -- Romania, Italy, Cypress -- do not implement EU legislation correctly. There is a very specific process that allows Brussels based institutions to hold member states accountable for not enforcing the EU law. And that is helpful to us and to our companies. There’s a specific point of helpful leverage. So we’re monitoring on these three levels at all times on conjunction with US companies.

Specifically let’s talk about some of the types of barriers. We have tariffs, which are pretty easily accessed (unintelligible) discriminatory (unintelligible) we have right now a big problem with high tech problems in the European Union. And those being laid on the table for increasing tariff rates, which goes against the WTO agreement.

Custom problems -- (non) - (unintelligible) again this goes back to burdens and technical regulations and standards -- duplicative testing, difficult labeling and certification processes. Intellectual property -- we have often in individual member states, especially some of the newer member states in Eastern European, some really problem with weak IT enforcement. The laws on the books look good but there’s a big problem in Czechoslovakia with, you know, huge markets that are basically (unintelligible) good shop.

Also government procurement processes can also be quite secretive as to who gets different awards for different tenders and how US companies get into that game. And then we also have internal market barriers, which goes back to again the presentation of the market. The goal is the single market, but the reality is we do have fragmentation.

There is a place on - I just want to highlight the website to allow you to go. You can report a barrier not only to so that works at the Department of Commerce but also on this website, which we’ll help someone get back to immediately if you don’t know how to call. It’s a very easy process.

So that’s a little bit about the make access and compliance program. I’m going to pass it over to Sylvia to talk about again CE marking and how to sort of get your goods into the European Union.

Sylvia Mohr: That’s right. Thank you very much, Ashley.

CE marking -- CE doesn’t mean confusion everywhere, although sometimes people do get the impression that CE was created as another trade barrier for US exports. As a matter of fact, it has simplified exports for US manufacturers because it’s created a single market . It allows about 80% of all manufactured goods to travel freely throughout the European Union (is) 27 member states.

And it’s like a passport basically -- a mandatory passport which covers safety, not quality requirements for products. It is a marking of compliance with essential requirements. It’s basically a regulatory model for product certification that allows a lot of choices. And those choices are how to meet the requirements in the legislation. And one of the tools is actually (user) harmonized standards.

The product requiring CE market -- and this is not an exhaustive list; just an indication -- are listed here. And they can actually range from simple to rather complex. By simple I basically mean that products such as toys -- non electrical toys or sunglasses that are covered under personal protective equipment -- do not require a lot of extensive testing, nor do they require the involvement - mandatory involvement of test laboratories.

But it’s possible that there are high risk products or more complex products. And here I’m thinking of a machine that is also about special equipment, low voltage, of (unintelligible) compactability, or I’m thinking about an implant - a medical device implant. Usually that requires the services of a test laboratory.

And as you just - as you can tell, sometimes more than one directive applies to a product, and it’s not just a directive that comes with CE marking. It can be a directive that is about chemicals or that’s about (unintelligible). So it is a complex environment for which you can take a number of steps in order to get CE marking.

And those steps - it’s about self-help guides for neutral market and neutral export manufacturers. And we always start with Step number 1 actually being (unintelligible) for the simple reason that the scope gives room for interpretation. There is guidance, but sometimes products are borderline.

If you - if we take a (unintelligible) that carries surgical instruments in the hospital environment, should that be classified as a medical device or not? A disinfectant used in a hospital for dental purposes or specific medical purposes -- is that a medical device or not? So it’s very important to read the directive, pay attention to the scope, and (read) guidance.

Essentially clients can also be (rather vague). And in order to meet the requirements, you may be best advised to use EU wide harmonized (standards), specifically because these standards have been mandated by the Commission to the European standards organization -- and there are three. And the purpose was to - the develop standards that perfectly address essential requirements.

They’re not mandatory. They’re voluntary. But you’ve got to bear in mind that when you’re using American standards, it may not be the right answer to the essential requirements, and therefore your conformity assessment or compliance might be challenged.

Oftentimes (EM) standards are based on international standards developed by (ISO) or (IUC). Choice of conformity assessment module -- again, as I said, some products are rather simple and allow self-certification based on Module A, but some manufacturers have a quality assurance systems in place based on (ISO) 9000 or even another system. And that’s the highest level of conformity assessment.

(Looking at) notified bodies, notified bodies is a term that basically means a (unintelligible) laboratory based in the European Union. And it is not always mandatory to use a notified body. As I said, for some high risk products it is mandatory. Otherwise, it’s okay to use a laboratory that is based in the United States.

Creation of a declaration of conformity compiling a technical file applying CE marking are crucial steps in the process. But bear in mind that if steps one to seven are too complicated to handle, it is best to recruit the services of a consultant who can prepare a package with the right sort of standards information and essential requirements.

Now you may wonder how well does this CE marking system work because the European Union is very proud of its achievements and has been promoting the CE marking legislation in other areas in (financial) legislation begins to look like CE market legislation, and the concept is exported outside of EU.

Well within the EU it’s still a work in progress to some extent. And they recently found, after a study, that there is room for improvement, because the problems that still exist are that some member states have additional requirements or that different notified bodies have different interpretations on classification.

One would for instance classify a medical devices Class 2A, and another would probably evaluate it as a 2B. Lack of coordination among markets (unintelligible) have meant that sometimes a product was taken off the market because it was found dangerous where other countries found it with minor adjusted - adjustments acceptable to be brought on the market.

Sometimes (an) illegal (use of) CE marking, it is not allowed on products that are not subject to CE marking. And unregulated products, another area that really is - causes a lot of problems, because exactly the - because it is confusing for manufacturers to determine what is regulated and what is not regulated.

As a result of the review of the new and global approach, which is basically the official word for CE marking legislation, we will in the future see improved market surveying. (Customs) authorities are probably going to coordinate actions in certain timeframes, certain products, and so on.

The importer’s role will be more emphasized. He will be - supposed to ask more questions from the manufacturer before he actually agrees to become the importer. There will be one accreditation body per country, (harmonized) definitions, conformity assessment, interpretations will be more streamlined. At the moment there are differences for (my) legislation, and we will also - we see the new website making it clearer for manufacturers which products are unregulated.

In order to finalize the review of the new (unintelligible) global approach, the European Commission has launched a package of goods in the single market with - which essentially was (proposed) in 2007 by the Commission and was adopted by the European Parliament. It is now in Council. Council’s ministers, who will be adopting it within the next couple of months.

So essentially what does this package mean? It is a regulatory toolbox, which looks a lot like the toolbox now available, basically building on the existing CE marking legislation. But it’s going to make it more streamlined, better - more tightened, more improved. It is meant to improve the functioning of the single market increasingly. And now I turn it over to Ashley to discuss (Reach).

Ashley Miller: Thank you Sylvia. Again, we’re just going -- I should have said this at the beginning of Sylvia’s presentation -- we’re going in now to some of the specific regulatory challenges that we have in front of us. And (Reach) is one that we are working very diligently on in the mission and with - in collaboration with Washington, because it is a new EU chemicals policy. It’s basically a registration system for chemicals -- the chemical management system.

It replaces all the old chemical EU laws about - rolls about 40 laws into one policy, so it’s very broad reaching. It stands for Registration, Evaluation, and Authorization of Chemicals. It really relies and put the onerous on industry to provide chemical safety information to a new agency. They’ve created a completely new agency -- a new European institution -- to manage this regulation, and it’s called the European Chemicals Agency.

And also the - another goal of REACH is to provide more communication throughout the supply chain. So Finnish produce - users of - or producers of Finnish goods aren’t using chemicals without having a clear understanding of their safety impact on consumers of that product.

And there is a general EU objective here to substitute more dangerous chemicals for safer ones, and that process I’ll talk about a little bit more. It’s called - the authorization is the A part of REACH.

In terms of coverage, you are essentially affected by REACH if you belong to a supply chain producing or using chemicals. So again, it is a very broad and far reaching regulation, covering almost about 30,000 chemicals. Not only just chemicals as we know them, but also in preparation such as paint, cleaning products, cosmetics, and also in finished goods, as I sort of highlighted on the last slide.

So textiles that have chemicals in them, cars that have chemicals in them, batteries that have chemicals in them. There’s two ways that these imported or Finnish products are affected. If they contain substances that intentionally release the chemical -- and I think the example here on the slide is a scented candle. Another example that we’ve been working on is a printer cartridge. A printer produces a substance intentionally to be released, which is the ink.

And also to the extent that imported articles contain substances of very high concern. And this list isn’t finalized yet, but again a lot of consumer goods. Consumer electronics in the sort of body of working has chemicals or dangerous products that also need to be disclosed among the supply chain.

Certain chemicals are exempted. And companies that fall into that category at this point are very happy -- medicinal products for one, food additives for another, because those are governed by another set of regulations.

Just real quickly REACH obligations. Not getting too much into the dirty details, but you must - REACH really goes live on June 1, so the - although the regulation has passed about a year - (it was enforced about a year ago). It’s really going live on June 1, 2008, so we’re about a month away.

Suppliers have an obligation to register chemicals exported to the EU that’s over one ton per year per company, which is an important threshold to consider. Again, it’s one ton. If you fall under one ton, you don’t have an obligation. You have to send a registration (document to) the chemicals (agency), pay the registration fee. And I think the real overarching (unintelligible) here is no data, no market. So if you can’t produce data for these registration dossiers, you essentially are not going to be able to enter the EU market.

For existing substances -- so substances that have already been on the market -- they are allowed to pre-register and don’t have to be the dossier or pay the registration fee quite yet. They just have to fill in some basic information to pre-register, and that’s what starts on June 1 also and goes through December 1, 2008.

The authorization procedure will kick in in a little bit of a distance. These are the most dangerous substances, and they have to be authorized for use. And for that we have a little more time, again because we don’t even know the substances that they’re considering most dangerous until the end of this year.

And essentially the important thing for American companies to understand is that REACH obligations must be fulfilled by an E - your EU importer or an EU legal entity. If your company has a legal entity in the EU, they can do the pre-registration and the registration, or you can appoint what’s called an only representative -- just someone to represent you for the purposes of pre-registration and registration.

Again, without much further adieu, just want to let you know some of the different services we’ve been offering to help with REACH. Again, because it’s a concern for so many companies. We do counseling, webinars such as this one, but specifically focused on REACH. We have a webpage that gives you all the latest information that we’ve been able to discern it coming out of Brussels and out of the European Chemicals Agency, which is based in Helsinki. And so there you have our website to turn to.

I’m going to pass it over now to Susana Getman to talk about WEEE and (Ross) dresses, another regulatory issue that we’ve been watching very closely.

Susana Getman: Okay, so yes WEEE and (Ross) are two directives that are affecting US companies that sell electrical and electronic equipment to Europe. The WEEE directive -- it stands for Waste of Electric and Electronic Equipment -- is aimed at limiting the land filling of electrical waste. It sets out the financial and other responsibilities for electrical and electronic producers with regard to the collection and recycling of waste of the electrical and electronic equipment at the end of life.

The directive includes a list of electrical and electronic equipment. One of the main categories is IT and telecommunications equipment. Also included are large household appliances, consumer equipment, lighting equipment, electrical tools, toys, and so forth as a big list.

As far as (Ross) is concerned, that is a directive on the restrictions of hazardous substances. And it’s aimed at reducing the environmental impact of waste of electrical or electronic equipment by banning the use of certain hazardous substances in the electronic equipment, including some heavy metal such as mercury, lead, cadmium, (unintelligible) chromium, (unintelligible) flame retardants, though there are certain exceptions and there is a possibility to apply for exemption, for specific substances and specific applications.

For example, for lead and solar and servers, there’s (unintelligible) an exemption. There’s an exception for some type of medical devices. These exemptions can be applied for on a regular basis and are reviewed every four years, so some companies are able to get around the (Ross) directive.

But the main problem with these two directives is that they’re very complex and compliance is costly. And it differs from member state to member state. That’s the main issue. And some - companies must register in each country and member states where they’re selling and putting products on the market, so there’s different processes for registering, there’s different languages, there’s different information needed. So that makes it very costly and time consuming.

So what are we doing - what’s happening now with the two directives? They’re being reviewed. There’s a consultation process that’s gone on, and the (Ross) consultation has already closed. But the WEEE consultation is still (unintelligible) until June 5. And what the European Commission is doing is taking input from stakeholders and will propose new legislation by the end of the year. And then it must go through the whole long company-decision procedure, so the new rules will take effect around 2012 probably.

And what our office is doing - we have a specialist in our office who couldn’t be here today, but his name’s (Chris Sherwood), and he works on counseling companies and providing emails with updates on what’s - what new developments are going on in the two directives. He has a website, which I’ll give you in a moment, to regularly update our companies and also webinars such as these, and trainings and events at trade fairs. And all of this is listed on our website, which I’ll give you in a moment.

So you as a company- what can you do, what can you ask yourself? First of all are you covered? Are you covered only by WEEE or are you covered also by (Ross)? (Ross) actually takes its scope from WEEE, so if normally you’re covered by WEEE you should also be covered by (Ross).

So first of all check are you covered for WEEE -- waste of electrical electronic equipment. There is no Pan-European collection and recycling scheme, but if you do export to many of the EU members states, you can consider meeting your obligation in a Pan-European way.

There are some specialist consultant fees that for a single fee you can outsource your WEEE registration and membership collective - membership of collective compliance fees and so forth. You can have consultants to do all that for you. Otherwise you can, you know, look to take care of each of your obligations in each of the member states.

For (Ross) it’s important that you should ensure that compliance is part of your commercial relationships with EU customers, and you should try to ensure that your supply chain and manufacturing process is controlled and that restricted substances don’t enter into your supply chain. It’s very important and (unintelligible) (aspect).

And finally, as I mentioned, here’s our website where you can get a good start on many frequently asked questions. It has links to documents, member state information, EU websites. And then of course if you have questions, please do contact us. Our specialist, (Chris Sherwood)'s contact details are on that webpage, and you can - it's a wealth of information.

So if you’re an electrical and electronic equipment producer, please do visit the website. And another (unintelligible) regulatory issue, which Sylvia will go over with you.

Sylvia Mohr: That’s right. I’ve already mentioned it in passing when I talked about CE marking legislation. And EUP -- Energy Using Products -- is also about CE marking, but CE marking of somewhat different kind. It’s not for product safety, it’s about designing for the environment. Already at the design stage, manufacturers will have to consider the lifecycle of the components and the product itself. So we in (Ross) - WEEE is at the end of the lifecycle, (Ross) is about banning hazardous substances, and EUP is about designing for the environment.

At the moment, the - we have a framework directive, which gives the general concept. But it doesn’t have a lot of meat to it yet because the meat will be in the implementing measures. And that’s what the European Commission has been working on for the past year or so -- working on a number of studies that will lead to directives or regulations and that will specify what levels to need - which test method will recommend users’ voluntary standards and so on.

And of course this will primarily affect not - mostly and only at the moment affect US electronic manufacturers, but there is a (unintelligible) (talk) about extending the context to other products other than electrical products of course.

Here on this slide we’ve listed a number of studies that are under way, and have been completed, and where we might see implementing measures coming out towards the end of this year. The question now remains to be seen what sort of conformity assessment module will be optional for manufacturers. And we of course hope that it’s going to be based on self certification.

Here are the target sectors that you can look at. The website will be - can be provided upon request where you can actually look up the different studies and what they have in the pipeline. And this I turn over to Louis for the next part, which is the metrics (unintelligible).

Louis Santamaria: Thank you Sylvia. To wrap up before we move on to questions and answer period, I’d like to cover three or four broad issues. One of the last regulatory cases that we’re monitoring is the EU directive that is currently in the process of being updated.

The story actually begins back in 1980 when the EU (unintelligible) metric units only the legal unit measure. And for transition purposes, other units, such as the US customary unit, found ounces, feet, and inches were allowed temporarily allowing for dual labels. A final ten year postponement ends in - at the end of 2009, and after that, it will be metric only. However - and this applies, by the way, to labeling, packaging, advertising, catalogs, technical manuals, user instructions, et cetera.

If we fast forward to today, in November 2007 the European Commission passed into the process a proposal to amend the directive to allow for dual labeling indefinitely. That proposal from the commission is still pending in the Council - the European Council, with possible changes required (unintelligible) the second meeting.

Our contacts tell us that there’s every hope that this process - this regulatory and legislative process will be completed happily for the desired outcome by the United States. And that is that the - that US traditional units will be allowed indefinitely along with metric. So we’re monitoring it, and we will report as soon as there is further news.

The other or - and other very big aspect of the work that the commercial service here (had the US mission to the EU works on), is the transatlantic economic framework, US/EU cooperation that began in its present form back in the April 2007 US/EU summit, which plans to reduce barriers to international trade and investments.

It was then the German presidency and Chancellor Merkel challenged the two transatlantic partners to create a transatlantic economic council that - whose purpose would be to ensure regulatory cooperation, reduction of barriers, and to lend political weight to those issues that may have been heretofore irresolvable.

The composition of the tech for US cabinet members and regulatory agencies, EU commissioners, there’s an advisory board consisting of the transatlantic business dialogue, consumers dialogue, and the legislator’s dialogue. The first full meeting of the tech was held in Washington in November 2007, and the second - or the next and second meeting will be held here in Brussels next Tuesday, May 13.

We bring up the techs to point out to you that the transatlantic dialogue handles - or we are currently handling a long list of issues, many of which are standards and compliance related. These include a request by the European Union that US regulators allow for a more supplier’s declaration of conforming the (S Stock) based approach to proving compliance in the United States for a specific range of electrical equipment.

REACH metric labeling we’ve just discussed. Those are major and priority issues (other than tech). Also cooperation of biofuels, energy using products we’ve discussed. There is the accessibility. It’s a very successful cooperation between the US and the EU in government procurement about the accessibility, and very specifically on the compliance side, intellectual property rights as example.

We talked early on about resources -- opportunities, resources that are available to you. And I’ like to round out our conversation today by signaling to you a new program which began as the Europe - as our Europe regional standards program and now includes market and access and compliance in the actions program for our offices in not only the 27 EU member sates, but several others, to a total of 35 countries in Europe.

The framework on the standards side of the program is the US Department of Commerce Standards initiative, which emphasized US industries’ request to commerce for additional resources in the international field to provide early earnings to US companies. That means let us know ahead of time when regulations have been created or modified so that our products don’t get stuck at customs entering the market, but that we have sufficient early warning to prepare US products that comply with regulations.

So anyway, our program includes client counseling, product certification, as Sylvia just mentioned in some detail. We have people - our colleagues in the commercial services in the office in the certified countries in Europe. They are standards and market access points of contact.

We are emphasizing the generation of market intelligence and market reporting so as to fulfill our commitment to provide early warning. I will get - for - to give you some examples, in 2008 the priorities that we see on the radar screen include new legislation, specifically EUP -- energy using products -- which we know will be a major hurdle for US companies.

The review of structured products directives, the review of the pressure equipment directive, of course product safety and specifically toy safety new EU directives will require very, very rigorous compliance in those product sectors, and of course the general strengthening of the new approach regulatory model.

Ashley Miller: In terms of how we offer to help US exporters, I think we, again as Louis said, we are trying to set up with this regional program and have set up points of contact all across Europe. And that helps us better leverage as we sort of go back to the beginning of the program and talk about how we leverage our points of access to try and get a change in a regulatory - in a draft regulation or a change in a standard or is really trying to affect the process how we work best with our colleagues in the various member states and around Europe to make sure that we finance problems with early warning systems.

I think also another piece that we really try and help folks with is complication processes. So to the extent that there is a consultation process, we’ll make sure that as many contacts that we have in the industry know about it so they can specifically address the problems that we have directly to the proper European institution.

We also help overcome complexity of time and cost, can help answer questions about the single market versus national requirements -- so what’s happening on an EU level versus what’s happening at member state level -- and about what’s voluntary and what’s mandatory. And this is often a gray area.

We have a host of services, a lot of which we’ve highlighted already, including the fee, marking guide, certifications and standards questions, and marking advocacy. I talked about how you can report a barrier specifically that you have (earlier in my presentation), so there’s really a whole package of services that you can go to and find on our website specifically for having counterfeiting and piracy problems or related to IP.

So again, it’s really leveraging not only the resources we have in Brussels, but the work of all of our post offices throughout Europe that we think can best help and best address the issues that your companies are facing in Europe. So with that, I’m going to put our - give it back to Louis and we’ll give you some specific information.

Louis Santamaria: Let’s end the formal presentation part of today’s webinar. And before I ask Linda to take us to Q&A, I’d like to point out that on this slide you have our individual email addresses. If we can’t get to your questions, just - today, let us hear from you directly. Linda, for question and answers over to you.

Linda Abbruzzese: Thank you Louis and Thank you Ashley, Sylvia, Susana, and (Paul). These are for your presentations. Now we’ll have a sampling of more than five questions submitted by our participants. And for those of you whose questions we are not able to get to during this presentation, please do take a moment to write down that contact information that you see on your screen.

Also, PowerPoint presentation slide, a transcript, and this webinar will be archived live on our www.export.gov page under the line called view webinars. It’s on the right-hand side of the export.gov website.

Okay great. We’ll go to the first question that we have in our queue here. The question I have here is from - looks like here from (Brady Webb). He would like to know, “Are all EU regs originated from Brussels?”

Woman: Okay. Sorry...

Ashley Miller: We can’t see that question Linda. Can you read it again?

Linda Abbruzzese: Sure. (Brady Webb) has a question. The question is, “Are all EU regs originating from Brussels?”

Ashley Miller: Okay, what we see as the question are EU regulations - do EU regulations include plastics?

Linda Abbruzzese: That might be another question, but...

Ashley Miller: Okay.

Linda Abbruzzese: …both of those questions are just as good.

Ashley Miller: Okay. Do all - so the first one is do all EU regs on chemicals include plastics. And the short answer to that is yes. You know, plastics are definitely in terms of a REACH regulation, which is now sort of the overarching regulation of the chemicals industry, yes it definitely includes plastic.

I know the Society of Plastics Industries has been working somewhat on the implications, but there are a lot of (motimer) and polymer issues directly related to plastics involved in the REACH regulation. And again (Brady), we can talk about that specifically offline. So the short answer is yes.

Linda Abbruzzese: Okay, great. Thank you Ashley. I have another question here from (Shane Solomon). This person would like to know, “How can we register for REACH before the candidate list of substances of high concern is even released?”

Ashley Miller: Yes. Well again, it goes down to - (unintelligible) there’s two ways to answer that question. Pre-registration show - you’re not going to have to deal with the authorization procedure until 2009. So for those substances of very high concern, that’s not something that we need - that you need to register up front -- sort of waiting to see what substances there are, and then the authorization process will continue. So really what you’re just looking at right now is what’s in your supply chain, what’s coming in from your suppliers. And then as soon as that list comes out, you can check that again.

So the deadline for authorization isn’t looming. What’s more looming is the chemicals that you have in your supply chain. And if they’re already there and they’re already - you can just pre-register as existing substances, and then the authorization process will be handled after.

Linda Abbruzzese: Thank you Ashley. (Connie Hayes) has a question. “Do you anticipate any regulation with regards to the content format of material safety data sheets that are provided with exported products?”

Sylvia Mohr: This is Sylvia. I’m going to answer on behalf of (unintelligible) who handles this subject. Material safety data sheets are already covered in regulation. And in fact, the REACH legislation that Ashley mentioned today also changes the (MSDS) sheets somewhat. So I suggest we follow up after this webinar. And if you could, send either Ashley or me a question, that would be helpful, and we will be able to answer your specific question with regard to (MSDS).

Ashley Miller: And same with (Shane), too. We can specifically outline the difference between authorization and registration for you also.

Linda Abbruzzese: Okay, great. Thank you Sylvia and Ashley. (Michael Oggenbog) has a question. “If a product is found to require CE marking, what entity is authorized to certify compliance?”

Sylvia Mohr: Products that meet the CE marking and what entity is authorized to - well CE marking is about the manufacturer going through the process themself. Most of the time it’s about self-certification, so there is no outside body involved in the process except for high-risk products. And high-risk products you would have - the manufacturer would have to involve a notified body in a (unintelligible) laboratory. Other than that, there is no official entity involved in the process.

Linda Abbruzzese: Okay, great. Thank you, Sylvia. Looks like (Gina Bollock) has a question. “We have heard of very high cost for the (WRAS) approval for our water filtration systems to sell in the UK. Who can we work with on this approval?”

Sylvia Mohr: Water filtration system approval?

Linda Abbruzzese: Yes. It says here, “For the high cost for the (WRAS) approval for the water filtration system to sell in the UK, who can he work with on this (WRAS) approval?”

Sylvia Mohr: I would recommend contacting the commercial service in London to start with, and then I suggest he also send me an email because if this is an issue about cost of approval, the manufacturer always has a choice to work with other entities. But I would like to know more about the specific details in this case to be able to give a comprehensive answer.

Linda Abbruzzese: Okay, great. Thank you, Sylvia. Looks like (Linus Climavikus) has a question. He - this person would like to know, “Could someone speak more about the need to make sure the products -- the various directive, regulations -- as regulated by the governing body of the EU versus all individual member states?” I’ll repeat the question. It was kind of long.

“Could someone speak more about the need to make sure the products meet various directive and regulations as regulated by the governing body of the EU versus individual member states?”

Louis Santamaria: We’ve flipped a coin here to determine who can speak more to the question. And the winner is...

Sylvia Mohr: Okay I’ll get started on the subject. Directive - EU directives are always addressed to member states who transpose the text. And they may - as they transpose the text, meaning turn it international, they may add certain provisions that are not covered by the EU directive.

For example, a directive on toy safety has certain specific requirements concerning warning for children. However, the choice of language to be used on the labels would not be in the directive adopted by the Commission, but rather would be determined by the individual countries.

Now in terms of regulations, that’s basically a text that is adopted as is by the member states. That means that the member states cannot - usually don’t change a single word of the text. The text is adopted.

Another thing with the directives is that -- and I forgot to mention -- usually member states have to prepare an infrastructure to get ready for the new law, and there is a transition period, which can - (CE marking ) legislation is typically two years, whereas regulations there is very short transition or none whatsoever. The minute it’s adopted, very often the next day it’s enforced.

Ashley Miller: So just a couple of examples from what we talked about today. REACH is a regulation, which means it was transposed directly when it entered into (unintelligible) last year into member state law. Again, it goes live pretty much June 1, but REACH is a regulation, whereas we in (Ross) are directives.

And again, as Sylvia says, there can be some very - there’s more potential for variation throughout the member states when you’re dealing with a directive. But all of this begins in Brussels, I guess is the short answer, and then stands out to member states specifically.

Susana Getman: And just to give you an idea, about 80% of non (unintelligible) legislation starts off in Europe, and so there are - the member states maintain about 20% competence over their own legislation, but...

Ashley Miller: About 20% come from Europe -- from Brussels.

Susana Getman: Yes. So...

Linda Abbruzzese: Okay, great. Thank you Susana, Ashley, and Sylvia. The next question is from (Ron Maganel). He says, “We are selling the research prototype test system to a company in Stuttgart, Germany. It will be tested in their labs only. Do we still need to deal with CE marking, WEEE, and (ROHS)? If this ever becomes part of a product, it will be installed in the company’s products. Will we be an OEM to them, and do they deal with the marking?

Sylvia Mohr: These are several questions in one. Obviously it’s not going to be so easy to answer. In the sense - I wonder whether the prototype will be made available free of (choice) and not - in fact, normally even the prototype has to be (CE marked). And the purpose for - there reason why that is, is because - CE marking legislation is (unintelligible) product safety and consumer safety. Therefore, if it’s put on the market to be used by a consumer, it has to be guarantees that he - the consumer can use it safely. And that’s why there are very few exceptions to the general CE marking rule.

CE marking exceptions are for instance when manufacturers bring their prototypes to a trade fair and - with a purpose to exhibit it and demonstrate it in order to see whether there is actually enough interest in the market. Those are the exempt - exceptions to the general CE marking rule.

But I would say that this particular product would definitely be subject to CE marking even though it’s a prototype. But if you want to be absolutely sure, it is also an idea to ask member states (unintelligible) authority to see whether there are other exceptions.

Louis Santamaria: Hello this is Louis. In this particular case, since it would be helpful to know more about that the research prototype test system is, I would recommend to (Ron) that he send the question with a bit more detail directly to Sylvia. And it may be that our office in Germany -- one of our offices -- and the appropriate commercial specialist can also help. That would help us to help you better, (Ron). Thank you.

Susana Getman: And as far as (WEEE Ross) is concerned, it’s usually when the product is put on the market. So at this stage, doesn’t seem like it would apply. But as I said, you know, if you could send in the specific question to (unintelligible) pretty sure that would really help.

Linda Abbruzzese: Great. Thank you. (Joseph Vargas) has a question. “Is there a standard for volatile organic compounds for paints and coating?” And the second part of the question is, “Is there an EU standard for products in contact with (unintelligible) water?”

Sylvia Mohr: The answer to both questions is yes. There is a (VOC) directive and there is a requirement for material in contact with water under the construction products directive I believe. But of the top of my head I don’t know the numbers nor the exact title of the laws, but we’ll be happy to provide the information if you send me a question.

Linda Abbruzzese: Okay, thanks Sylvia. (Unintelligible) (Nova) has a question. “Where can we find the eight step CE marking guide? Is it available on the web?”

Sylvia Mohr: No. No and not yet. We’re working on an updating our website, and that will be one of the features. For the time being it can be supplied at the request of the company.

Louis Santamaria: Via email to Sylvia please.

Linda Abbruzzese: Great. Thank you. (Gina Bullock) has another question. “Are you aware of water filtration system approvals that are needed to sell into Europe? Who could we work with?”

Ashley Miller: I think this was already the question from before?

Sylvia Mohr: Water system approvals? If the water system is electrical or electronic, it meets CE marking, that’s one of the immediate answers that I can think of. In addition it could be environmental legislation that also comes into the picture. So basically that’s just a first impression. And like all other questions, happy to take this further if you send me an email. And I’m Sylvia.

Linda Abbruzzese: Okay. Great. Another question here from (Brady Webb) -- regarding the CE mark -- if my products do not require the CE mark, one f the government bodies presenting here issue a letter as such to reassure my EU customers and other who are not in the EU but recognize the CE mark?

Sylvia Mohr: Could you please repeat the question?

Linda Abbruzzese: Yes. This is from (Brady Webb) regarding the CE mark. He asks if his products do not require the CE mark, will one of the government bodies presenting here, issue a letter as such to reassure my EU customers and others who are not in the EU but who recognize the CE mark?

Sylvia Mohr: That’s a tough one to answer for the simple reason that it is illegal to apply CE marking where it’s not required. And if others in the market already have CE marking, then that could be a case to take up with relevant authorities at the Commission to determine should it or should it not be CE marked.

If the question comes back repeatedly from importers and distributors who feel that CE marking should be on the product, and they have their reasons to believe so, I think it would be helpful to create the standard kind of form.

The manufacturer does this himself based - and uses certain arguments based on guidance and EU law and EU reference numbers to make it clear to the importer, distributor or client that that - he has made a determination based on fact, and that’s why there should be no CE mark. I think that would be the best way forward.

Linda Abbruzzese: Okay, great. Thank you Sylvia. We have a couple more questions. And we still have more time, so if you have any questions, please feel free to input them into your boxes on the right hand side.

I’ll proceed with the next question from (Michael Guerrero). He asks, “Are the FAQ web pages for country specific application of WEEE and (ROHS) directives kept current? For example, the frequently asked question page for Spain was accurate as of June 21, 2005 and France has a link to a Word file with a date noted and Ireland was updated August 2006.

Susana Getman: Well we’re responsible here for updating the European frequently asked questions. And I mean the member states should be updating theirs. Now if this specific areas where they might look like it’s not updated, then maybe the best thing would be to contact your - the person in each of our commercial service offices in for example Spain or Ireland or France. But we’ll try to...

Louis Santamaria: (Michael), I - this is Louis. I will recommend the following. Send out some email, tell us which market you’re particularly interested in. We’ll send your email to our colleagues who are specifically responsible and they’ll reply to you.

So send us an email. You can send it to me, Louis, or to Susana or anyone one of us. Specify your markets and we’ll move from there. Thank you.

Linda Abbruzzese: Thank you Louis. (Isabel Nacoli) has a question. “Should I register a compound such as aluminum silicate, under REACH if (unintelligible) more than one ton and it is greater than .1% in the product of coated paper?”

Ashley Miller: (Isabel), I am going to look into that substance and get back to you. I’m not sure for that substance specifically. But yet, let - why don’t you send the question to me directly and I’ll confer with our other colleagues here and look into that substance. Oh, and this is Ashley Miller. Sorry.

Linda Abbruzzese: Great. Thank you Ashley. This is our last question for today. This is from (John Giordano). He asks, “Would the registration of a prescription product, such as prenatal vitamin and mineral, be directed to EU regulatory or rather be subject of the individual member state regulations?”

Ashley Miller: Well if you want to just spell to one member state, you can register it. You can get approval in the individual member state, and then it can be recognized throughout the EU, or you could register it in the central EU medicine agency. However, that’s not obligatory. You can - if you want to start off with just one member state and then have it recognized throughout the EU that’s possible.

Linda Abbruzzese: Great. Thank you Ashley. Everyone I’m afraid that is all the questions we have. Remember for you who have questions later on, please contact the speakers listed on your screen. Their email addresses are present on the slide. Also please check out their website at www.tcc.export.gov as well as the US commercial service website at www.export.gov for more information on exporting in other webinar events.

I’d like to thank everybody for joining us. And please check your email boxes for more information on upcoming webinars. Thank you.

Louis Santamaria: Thank you everybody.

Ashley Miller: Thank you.

Woman: Thank you.

Louis Santamaria: Any unanswered questions, please send them to us.

Coordinator: That concludes today’s conference call. You may disconnect at this time. Thank you for your participation

Linda Abbruzzese: Hey (Calvin)? (Calvin)?

END