This page provides an overview of the questions most frequently asked of the US Department of Commerce with regard to the EU’s RoHS Directive, and of the answers we typically provide. While we make every effort to keep the information contained accurate and up-to-date, it does not constitute legal advice, nor have any legal effects. The only authorities able to make authoritative statements on the questions below are the courts in each of the EU countries, and in some cases the European Commission and European Court of Justice.

We will update these pages frequently. If you have any comments or questions, please do not hesitate to contact us.

Scope

Is it true that medical devices and monitoring & control instruments may be included in RoHS soon?

Yes. Categories 8 and 9, as defined in Annex 1A and 1B of the WEEE Directive, are currently excluded from the RoHS Directive by virtue of Article 2, paragraph 1 of the RoHS Directive. But Article 6 of the RoHS Directive provides for the European Commission to propose inclusion by 2005. For various reasons, the Commission has not yet proposed inclusion of Categories 8 and 9. However, a study has been carried out for the Commission by an independent consultant Dr. Paul Goodman of ERA Technology) into what the feasibility and desirability of an inclusion might be. The ERA report was published in July 2006, and will be followed by a public consultation on its results. The Commission will then subject its ideas on revision to an impact assessment, and then its proposals will be published and will go through the normal EU legislative procedure. This process will take several years, so it is unlikely that any inclusion would enter into force before 2010 at the very earliest.

How can I be sure that my products are included in Category 8 or Category 9, and therefore excluded from the RoHS Directive?

There is no authoritative way of confirming what categories your products are in. Unfortunately, no matter how convincing a case you build, you may still find that one or more Member States will disagree with you. Essentially it will be down to an opinion that you can prepare.

As part of the study carried out by REA Technology (see above), some assessment had to be made of the scope of these categories. While Dr. Paul Goodman cannot provide any legally binding statements, he is well placed to provide guidance on this matter. There are consultancies and law firms that can also help you to build up a case for inclusion in Categories 8 and 9. Some of these are listed on our [Business Service Providers page]. The key is to give evidence to the RoHS enforcement authorities and to your customers that you have gone through a process of considering what category the products in question belong to, and providing supporting evidence. It might be worth looking at EU legislation on medical devices, for example. If your products are covered by that, then it is reasonable to assume you are covered by Category 8.

If/when medical devices and monitoring and control instruments do get brought into the scope of RoHS, will there be any exemptions?

Almost certainly. If you have an exemption in mind, bear in mind the advice provided above on how to ask for it. The earlier and the more often you make your views known to the European Commission on this, the more likely they will be to be taken into account!

I make equipment that is sold to the military and/or the government. Am I covered by RoHS?

For some background, refer to the related information in the WEEE Frequently Asked Questions.
There is some debate about this, but the most common view around Europe is that equipment sold to the military or governments or companies for national security purposes are not covered by RoHS. This does not mean that such equipment is excluded from RoHS if it is sold to customers who use it for purposes other than national security. Different countries have different views on this. If you are selling to a government, the best advice is to check with that government what their policy is. If you are selling to companies, be very careful about the purposes for which they will be using your products.

Exemptions

Exemption? Exclusion? What’s the difference? And does it matter?

It is important to understand the difference between exclusions and exemptions under WEEE and RoHS. The WEEE Directive has no exemptions; only exclusions. This means that certain types of equipment are out of the scope of WEEE entirely. The RoHS Directive takes its scope from the WEEE Directive, with some exceptions: medical devices and monitoring and control instruments (Categories 8 & 9). These are "excluded" from the scope of RoHS. So if your equipment is covered by WEEE, it is covered by RoHS, unless it is a medical device or a monitoring and control instrument. This type of equipment does not have to comply with any of the substance bans.

The "exemptions" are a series of applications of banned substances that are exempted from some of the RoHS requirements. For example, there is an exemption for lead in solders in servers. This does not mean that servers are out of the scope of RoHS; on the contrary, they are fully covered by the RoHS Directive bans on cadmium, mercury, and even lead, except for lead used in solders. Exemptions will be reviewed at least every four years, but there is no guarantee that they will not be reviewed sooner, since the legislation allows the EU to add or remove exemptions based on technological progress.

How do I get a RoHS exemption?

The steps in the procedure are as follows:

1. You (or your trade association) submits exemption requests to the European Commission via the Commission’s website.
2. When the European Commission has collected a number of requests that it deems are worth rolling into a package of requests, it launches a public consultation on those requests.
3. The public consultations typically last a couple of months or so.
4. When the consultations are closed, a consultant is appointed to assess the merit of the various requests.
5. The consultant carries out a study and files a report, normally within 3 months.
6. The European Commission then considers the report and issues a proposal for a Decision (legislative text), for consideration by Member State experts and for comment by the European Parliament. There is no deadline for this step, but the Member State experts must be given at least 30 days' notice before they are required to vote.
7. Member State experts vote on the proposed Decision.
8. The Decision comes legally into force on publication in the EU's Official Journal (typically a few weeks after adoption). The whole process can take a very long time. The first set of exemption requests was submitted in late 2003-early 2004, the consultation was launched in June 2004 and closed in July 2004, and the Decision was not finally adopted until October 2005! We are aware of at least one exemption that was requested in 2004 and is still pending.

What are the “winning” and “losing” arguments for a RoHS exemption?

A good proportion of industry exemption requests get thrown out. It is therefore critical to understand what makes a good request. You may find the following tips helpful.

A. Understand the two criteria that the EU is allowed to take into account, and what makes a bad argument.

1. Technical feasibility (good argument). Substitution is not possible, or is possible under such conditions as to be unfeasible in practice. There might not be adequate supply, for example.
2. Environmental impact (good argument). The negative environmental impact of not allowing the exemption would outweigh the positive environmental impact of the ban. This might be because of increased waste resulting from predictably higher failures, or because the substitutes are as toxic as the banned substances, etc.
3. Cost or cost/benefit (bad argument). The EU legislation does not permit cost to be taken into account in making a decision on exemptions. This does not mean that you cannot refer to the costs; indeed many EU regulators will be interested. It’s just not a valid legal reason for exempting.
4. Need more time (bad argument). Unless you can relate it to industry-wide problems, EU authorities are likely to take a dim view of this line of argument, since the legislation was being discussed as long as ten years ago and was adopted in 2002.
5. Supply chain would need to be changed (bad argument). The EU regards this as ground-breaking environmental legislation that aims to bring about radical change.

B. Refer to existing exemptions that follow similar logic or have similar characteristics.

C. Answer the questions that are asked in all the stakeholder consultations that the Commission runs.

D. Be aware that your competitors (both European and US) and environmental NGOs can contribute to stakeholder consultations on your exemption requests. Build your requests to withstand the assaults of such interested parties. Is your view that no substitutes exist supported by others in the industry? Does your competitor have a lead-free product line where you don’t? Remember that your credibility is at stake.

How do I know if an exemption request that has not (yet) been granted is still in with a chance of approval?

It is extremely difficult. There is no traffic-light list of “approved”, “under consideration”, and “rejected” exemptions. Only approved exemption requests are published in the European Union’s official journal. A reasonable guide is the opinion of the independent consultant hired to assess the exemption requests, but this report informs the Commission and the EU Member States; it does not bind them in any way. And these reports have not so far been made publicly available. 

Further exemptions information is provided on our RoHS Exemptions page. 

“Put on the Market”

Can my distributors continue to sell on non-RoHS-compliant products that I shipped to Europe before July 1 2006?

In theory yes, but in practice it depends on the country and on the distributor. The European Commission, whose job it is to make sure that EU laws are applied consistently across Europe, takes the view that if your products are “on the EU market” before July 1 2006, they are not covered by the RoHS Directive. However many Member States are taking a national view, whereby products put on their national markets after July 1 2006 must be compliant. So if you ship your products to the EU via Rotterdam and they arrive in June 2006, according to the European Commission, they can be sold freely in Europe after July 1st. But when they are shipped onwards to another country, that country make start the clock once the goods are on its territory, and ignore the fact that they entered the EU via Rotterdam before the deadline.
Unfortunately, even in countries that have legislation that endorses the European view of the Commission, we are aware that some distributors are refusing to sell products on.
Please note that “stockpiling” inventory in the EU with the express intention of getting around the RoHS deadline is likely to be considered illegal.

What do I do if my distributors refuse to sell my non-compliant products despite having bought them from me well ahead of the July 1st 2006 deadline?

Your distributor may have made a business decision to sell only RoHS-compliant products from July 1st (or even earlier). There is not much that you can do about this. But it may be the case that your distributor/re-seller doesn’t know that it is legal to sell non-compliant products after July 1st as long as they have been purchased in Europe before that date. In that case, you might be able to educate the distributor/re-seller by referring them to the European Commission’s interpretation of "put on the market", and, perhaps more importantly, the interpretation used by the relevant EU country in its legislation implementing RoHS. This can be in the form of guidance published on the government’s website or the enforcement authority’s website, or a letter from the government or the RoHS enforcement authority. If you need to ask for a letter, you should ask that the government or the enforcement authority confirm that they are following the European Commission’s interpretation of “put on the market”.

Enforcement

How will RoHS be enforced?

There is as yet no clear indication of how RoHS will be enforced across the EU. However a group of EU Member States have got together to agree on some common, non-binding guidance for their RoHS enforcement authorities. This document is available on our RoHS Enforcement page. It should be read in the knowledge that it does not bind Member States in any way.

Can I protect myself by doing due diligence on the parts my suppliers sell me?

To some extent. The EU Member States are currently planning a set of non-binding guidelines on RoHS enforcement. These guidelines take the approach that the first step of RoHS enforcement should normally be to ask a producer to provide evidence that they are compliant. The easiest way to do this is to show documentation of all relevant parts and components for RoHS compliance, referring to exemptions where applicable. This can be done by implementing an IT solution that tracks RoHS compliance at a supplier level. The key is to show that you have gone to some trouble to ensure compliance, and not that you are simply assuming it.

·Are there any standards that apply?
None that are recognized or accepted by all EU countries. The advice we are giving to companies is to follow best practice.

·Will I have to make declarations about the materials in my products to EU authorities?
It depends. Some countries may require this when they check up on your RoHS compliance efforts.

·Will my products be tested?
Possibly. We have heard that some NGOs, have plans to pull products off the shelf on July 1st and test them for compliance. We have no reason to believe that the producer would have to pay for such tests.

·What testing methods or standards will be used?
There are no EU-wide official test standards or methodologies. We are not convinced that industry would want them either.

·What penalties could I face if my products are found not to be compliant?
Penalties vary from small fines, to very large fines, and even to prison sentences, depending on the severity of the offence and the country. There is no EU-wide approach to penalties.

·How is RoHS being enforced in practice?
As of the end of 2006, we were not aware of any RoHS enforcement actions in Europe.

Can I advertise my products as being RoHS compliant?

Yes. There are no official marks or labels for RoHS compliance. We recommend US companies follow industry best practice.

Country Information

Don't forget! The EU's WEEE and RoHS Directives are implemented in EU countries by national WEEE and RoHS regulations. These vary considerably from country to country. We therefore strongly urge U.S. companies to get further information on WEEE and RoHS in the countries that interest them by clicking here.

Need More?

For futher information and assistance, [click here].