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UPDATE –
EU’s REACH Chemical Regime passed the the December 1, 2008 deadline to “pre-register” all chemicals, or “articles” (i.e. products) containing chemicals which are exported to or produced in the European Union (EU.)
If you are a importing for the first time a phase-in substance in quanties of one ton or more per year after December 1, 2008 you can submit a late pre-registation. Click here for more details. Late pre-registration does NOT apply to companies that failed to meet the original pre-registation deadline and already import or manufacture in the EU. These companies can not continue importing the substance until they have submitted a full registration dossier fo rthe relevant tonnage.
What’s NEW?
Public consultation on additionnal substances for the Candidate List: ECHA launched a public consultation on 15 substances for their inclusion on the Candidate List of Substances of Very High Concern. The commenting period is open for 45 days, until 15 October. ECHA will then consult its Member State Committee and publish an updated Candidate List end of December/ early January 2010. The Candidate List is updated twice a year and currently contains 15 substances.
Guidance in a Nutshell: The European Chemicals Agency has published a new guidance document for REACH. This Guidance in a Nutshell explains in brief the provisions of Regulation (EC) No 1907/2006 (REACH Regulation) that apply to substances in articles.
The list of chemicals exempt from registration under Reach ( annex IV and V) has been published in the EU official journal. Draft guidance related to the exemptions in annex V is now available.
How REACH applies to nanomaterials.
NAM staff continues to follow developments on REACH and stands ready to work with the U.S. Government to assist member companies which either: 1) encounter difficulties from European customers or government officials regarding pre-registered articles or 2) somehow missed the pre-registration deadline. Details: Shaun Donnelly (202) 637-3142."EU’s REACH Chemical Regime at the Three Month-Mark. We are three months past the long-dreaded December 1, 2008 deadline to “pre-register” all chemicals, or “articles” (i.e. products) containing chemicals which are exported to or produced in the European Union (EU.) So far, implementation and enforcement across the EU seem to be proceeding with fewer problems than one might have expected in a system which pre-registered over 2.75 million individual uses of specific chemicals. But NAM continues to urge vigilance as most of the 27 individual EU member country governments are still enacting their national rules and organizing their implementation/enforcement regimes. NAM staff continues to follow developments on REACH and stands ready to work with the U.S. Government to assist member companies which either: 1) encounter difficulties from European customers or government officials regarding pre-registered articles or 2) somehow missed the pre-registration deadline. Details: Shaun Donnelly (202) 637-3142."
Are You Affected by REACH and Is Your Product “REACH Compliant”?
REACH” stands for Registration, Evaluation and Authorization of Chemicals. It is a complicated and costly new chemicals management program that the European Union (EU) approved in 2007.
The REACH legislation took legal effect on June 1, 2007, with the establishment of the new European Chemicals Agency (EChA) in Helsinki. From June 1 to December 1, 2008, companies had the opportunity to participate in a simplified “pre-registration” process at no cost under which they could receive permission to complete the full registration at a later date (as late as June 2018 for some products). Under the legislation, a manufacturer anywhere in the world is required to register chemical substances that it exports to the EU in quantities of one or more tons annually.
ATTENTION: REACH APPLIES TO NON CHEMICAL MANUFACTURERS, TOO
All manufacturers that trade with Europe or supply companies that do should take careful note of this new regulatory program. Even companies that do not trade directly with Europe may be affected because their customers in the U.S. or around the world will require inputs that comply with the EU requirements or their suppliers may suddenly discontinue longstanding product lines that are no longer profitable as a result of the REACH restrictions.
All manufacturers that trade with Europe or supply companies that do should take careful note of this new regulatory program. Even companies that do not trade directly with Europe may be affected because their customers in the U.S. or around the world will require inputs that comply with the EU requirements or their suppliers may suddenly discontinue longstanding product lines that are no longer profitable as a result of the REACH restrictions.
While REACH will have its most direct impact on chemical producers, manufacturers of a wide range of non-chemical products and components for these products will also be affected. REACH covers products or “articles” that:
- Release chemical substances in normal or foreseeable use (e.g., textile products)
- Release chemical substances in the disposal of the product (e.g., automobiles and auto parts)
- Contain 0.1 percent by weight of “substances of very high concern” or “SVHC” (e.g., substances in some electronic components)
For articles, the one-ton minimum requirement noted above applies to the amount of the substance that is expected to be released from the products either in use or disposal and not the total weight of the products themselves. As a further clarification, the one-ton registration limit applies to the amount that each manufacturer or importer brings into the EU and not to total imports of the substance into the EU from all sources.
As an article maker, you may have to comply with Reach:
1. If your product releases a substance and is imported to, or made in, Europe (REACH, Article 7). If your product is imported into the EU, and it releases a substance – for example you manufacture a printer that releases ink – then you may have to register that substance.
2. If your product contains an SVHC and is imported to, or made in, Europe (REACH Article 33). If your product is imported into the EU, and it contains an SVHC, you may have an additional set of obligations under REACH.
3. If your customers import, or make, products in Europe. Just because you don’t import your product into EU does not mean that REACH doesn’t apply to you. Do you sell to a distributor that imports to Europe? Does your product end up incorporated into another product that is imported into the EU? If yes, then the burden of registration and SVHC management and reporting will get pushed up the supply chain to you.
4. If your suppliers, or their customers, import products into Europe. As these REACH article requirements get pushed up the supply chain, and REACH chemical requirements are imposed on global manufacturers, the world’s supply chains will be affected.
Even in cases where the manufacturer knows that its products are not covered by the requirements (e.g., on substances of very high concern), it may be asked by customers exporting to the EU to document this fact so that they can substantiate their own compliance to EU authorities. Manufacturers with no direct or indirect links to the EU could also be affected because their own suppliers have decided to discontinue products that may face restrictions in the EU and are thus no longer commercially viable.
HOW TO COMPLY WITH REACH?
The 4 Elements of REACH
The European Chemicals Agency (ECHA) oversees the four key procedures of the law:
1. Registration: Registration is an information gathering and risk management exercise.
Manufacturers of substances that are imported into the EU in quantities over 1 metric ton per year must register these substances by submitting a dossier which includes data on the chemical’s properties, uses, and safe management. The goal is to have one registration per substance so companies may have to register jointly. Companies in Europe, the U.S. or elsewhere can begin through a simplified “pre-registration” process on June 1, 2008 (see below).
2. Evaluation: The Agency evaluates the registration information to determine the
chemical’s hazards and risks.
3. Authorization: Authorization applies to SVHCs and will be company-specific, use-specific, and time-limited. Lists of candidate and official SVHCs will be issued on a rolling basis. The 1 metric ton threshold doesn’t apply to authorization.
4. Restriction: The goal of authorization is to find safe alternatives for the SVHCs and eventually restrict, or ban, these substances for specific uses.
Special Requirements for Non-European Firms
To participate in pre-registration as well as full registration, however, U.S. companies must either have an established business in the European Union or contract with a European firm/entity to act on their behalf. The REACH program includes provisions for European firms to represent non-European firms in the pre-registration and registration process in so-called “Only Representative” arrangements.
So how can a non-European company achieve REACH Registration to ensure that they can continue to do business in the EU? There are three options:
- Set up a European based company: Establishing a European company may be costly and need careful management.
- Work through importer(s) inside the EU: May need to disclose confidential business and formulation information to each of your importers for them to submit a REACH registration. May restrict development of future distribution channels into Europe
- Appoint an Only Representative: (Companies should consider the following potential advantages:
• An independent third party takes on all obligations of the importers under REACH. The Importers then become downstream users.
• If an importer registers a product, the importing company in Europe will own the registration. It may then be more difficult for the U.S. manufacturer to expand or change the route to the European market.
• If an importer in Europe changes supplier, the non-EU manufacturer may lose access to the European market.
NOW THAT I KNOW I MAY BE AFFECTED BY REACH WHAT ARE MY NEXT STEPS?
It is essential that manufacturers work quickly to assess the impact of REACH on their own particular situation (products, inputs, customers, suppliers, etc.)
- Do you know the chemical composition of your products?
- Do they include substances that are likely to be “substances of very high concern” (e.g., carcinogenic, mutagenic and bio-accumulative) as defined in the EU?
- Are you exporting your products to the European Union either directly or indirectly?
- Have you communicated with customers and suppliers to determine the impact of REACH on them and any special information requirements that they plan to impose because of REACH?
- Are you acquainted with information sources on the REACH program?
- If your company is not established Europe, do you know European firms that can provide REACH “Only Representative” services?
Internet and Other Resources
Additional information on REACH can be found on the ANSI Website at www.ansi.org/chemicals. The American National Standards Institute (ANSI) and the NAM have established a Manufacturers Network on Chemical Regulation to assist manufacturers by providing up-to-date information and share best practices. ANSI is serving as the overall network coordinator with NAM support. Companies or organizations affected by REACH and other foreign chemical regulations are strongly urged to join the network. For additional information, contact Kathleen Tuohy in ANSI’s New York at KTuohy@ansi.org or (212) 642-4928. Catherine Robinson is the NAM point of contact crobinson@nam.org and (202) 637-3403).
The U.S. Department of Commerce can also be very helpful to individual U.S. firms regarding REACH. For up to the minute information on REACH contact Flavie Guerin (English speaking) Flavie.Guerin@mail.doc.gov or +32-2-508-2841 in Foreign Commercial Service office in the U.S. Mission to the European Union in Brussels, Belgium. You can also contact Don Wright Don_Wright@ita.doc.gov at (202) 482-5844) at Commerce headquarters in Washington.
Other useful sources of information can be found on the Internet at:
European Chemical Agency REACH Website
http://echa.europa.eu/reach_en.asp
European Chemical Agency FAQs on REACH
http://www.buyusa.gov/europeanunion/faqs_on_reach.pdf
List of REACH Service Providers (provided by U.S. Department of Commerce)
http://www.buyusa.gov/europeanunion/reach_bsp.html
U.S. Commerce Department FAQs on REACH
REACH and CLP -- U.S. Commercial Service U.S. Mission to the European Union
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