In Amending RoHS, the European Union Restricts Hazardous Substances in Medical Devices, Electronic Toys and Other Products

This post was written by David Wagner.

On May 27, the European Council, which represents the governments of EU Member States, revised the Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS Directive), and extended a ban on certain hazardous substances to a wider range of products, including medical devices, electronic toys, electrical appliances, cables, and spare parts. First adopted in 2003, the RoHS Directive bans six hazardous substances in electrical and electronic equipment, including lead, mercury and cadmium. With the amendment, the ban will now in principle apply to all electrical and electronic equipment as well as to cables and spare parts. Certain transitional periods are provided for, e.g., monitoring and control devices and medical devices will be covered in three years, in vitro medical devices in five years and industrial control appliances in six years. There are also a few exceptions such as photovoltaic panels that produce energy from solar light and energy-saving light bulbs. EU countries are required to adopt the revised RoHS legislation into their national legal codes within 18 months.

 

Cadmium in Jewelry and Plastics Banned in Europe in December 2011

This post was written by David Wagner.

On May 20, the European Commission adopted an amendment under its REACH law to ban the use of cadmium in jewelry, plastics, and brazing sticks (which are used to join metals) and create new restrictions on its use. The amendment will enter into force on December 20, 2011. The European Commission stated that high levels of cadmium have been found in some jewelry articles, especially in imported imitation jewelry. It also found that consumers including children risked being exposed to cadmium through skin contact or through licking. The new legislation prohibits the use of cadmium in all types of jewelry products, except for antiques

The legislation also prohibits cadmium in all plastic products while encouraging the recovery of PVC waste for use in a number of construction products. Because PVC can be recovered a number of times, the REACH amendment allows the re-use of recovered PVC containing low levels of cadmium in a limited number of construction products. In order to fully inform buyers, construction products that will be made of this recovered PVC will be marketed with a specific logo.

Cadmium is also present in brazing sticks, which is an alloy used to join dissimilar materials, and it is used for specific applications such as amateur railroad modeling. The European Commission found that fumes released during the brazing process are highly dangerous if inhaled. The legislation prohibits the use of brazing materials except for very specific professional uses.

The use of cadmium in the European Union is already restricted under REACH in paints and consumer goods (see Annex XVII of REACH). In addition, cadmium is banned from electrical and electronic products under the EU's Restriction of Hazardous Substances (RoHS) Directive.

It's Official: the Environmental Law Resource is a Top 50 Environmental Law Blog

This post was written by David Wagner.

We’re in – LexisNexis has selected Reed Smith's Environmental Law Resource blog as one of the Top 50 Environmental Law & Climate Change Blogs for 2011. We were recognized as "preeminent thought leaders in the blogosphere" who "offer some of the best writing out there." LexisNexis found that our blog contains "a wealth of information for all segments of the environmental law and climate change industry, and includes timely news items, expert analysis, practice tips, frequent postings and helpful links to other sites and sources."

The 50 honorees were grouped into 10 categories and our blog was one of just 4 blogs honored under the "Litigation" category.

We’re thrilled and certainly appreciate the recognition. Even more importantly, we appreciate your interest in our blog.

REACH: An Enforcement Update

This post was written by Paul Dillon.

In the months leading up to the REACH first registration date on 1 December 2010, the focus of the European Chemicals Agency (ECHA) was understandably on the 25,000 registration dossiers submitted. But the ECHA’s focus is shifting and it is now turning its attention to compliance. This comprehensive client bulletin identifies 10 REACH enforcement trends in Member States and what to expect from regulators in the near future, including site inspections. It then recommends ways to prepare for an inspection.

 

The Environmental Law Resource Nominated for LexisNexis Top 50 Environmental Law Blogs

This post was written by David Wagner.

It's really nice to be recognized. In fact, we're thrilled that LexisNexis has nominated Reed Smith's Environmental Law Resource as one of the Top 50 Environmental Law & Climate Change Blogs for 2011. Even better, they grouped the 50 nominees into 11 categories and our blog was one of just 7 blogs nominated under the "Litigation" category. LexisNexis selected the nominees based on "timely topics, quality writing, frequent posts and that certain something 'extra' that keeps a web audience coming back for more."

We certainly appreciate your interest in our blog and, if you want to support our nomination, LexisNexis is inviting comments.

 

Six Chemicals Are Banned under EU's REACH Law

This post was written by David Wagner.

After 2½ years of consultations and studies, last week the European Commission formalized the first bans on chemicals under REACH (Regulation on the Registration, Evaluation and Authorization of Chemicals). Under the terms of the ban, musk xylene; solvent hardener 4,4'-diaminodiphenylmethane (MDA); flame retardant hexabromocyclododecane (HBCDD); and plasticizers bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), and dibutyl phthalate (DBP) must be phased out, with various sunset dates set between 2014 and 2015.

With this determination, the “authorization” part of REACH is now in play. Depending on the substance, companies have between 24 and 30 months to apply for authorizations to continue to use the substances in specific applications. Requests for authorization must be accompanied by a substitution plan and evidence either that the substances can be used safely or that there is a strong socioeconomic case for their continued use.
 

Proposed Federal Regulations Related to Nanomaterials Coming in February?

This post was written by David Wagner.

If the U.S. Environmental Protection Agency (USEPA) stays on schedule, look for February to bring two proposed rules regarding nanomaterials. One proposed rulemaking would establish reporting requirements for certain nanoscale materials. The other proposal is a significant new use rule that would require persons who manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to notify the Agency at least 90 days before they make, import, or use that nanoscale chemical. Both were previewed in USEPA’s FY 2011 Regulatory Agenda.

Proposed Reporting of Nanoscale Materials under TSCA Section 8(a)

Under section 8(a) of the Toxic Substances Control Act (TSCA), this month USEPA plans to propose reporting requirements for persons who are manufacturing, importing, or processing nanoscale materials in commerce. The rule would require these persons to notify USEPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities would provide USEPA with an opportunity to evaluate the information and consider additional action under TSCA.

Proposed Significant New Use Rule

Also in February, USEPA intends to propose a significant new use rule (SNUR) under section 5(a)(2) of TSCA that would designate as a significant new use, any use of chemical substances as nanoscale materials after the proposed date of the rule. The SNUR would require persons who manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to submit a notice to the Agency at least 90 days before commencing that activity. The SNUR would identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary Nanoscale Materials Stewardship Program and other information. The required notification would provide USEPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risks to human health or the environment.

California Issues Significantly Revised Green Chemistry Regulations

This post was written by Eric McLaughlin.

California’s Department of Toxic Substances Control (DTSC) released a revised version of the Safer Consumer Product Alternatives Regulations (SCPA Regulations) for public comment on November 16, 2010. Once finalized, the SCPA Regulations will implement California’s Green Chemistry Initiative, a new program aimed at refocusing the regulation of chemicals used in consumer products. DTSC will accept comments on these regulations – which were revised in response to extensive comments the agency received on the previous draft published in September – until December 3, 2010. Comments may be submitted only concerning the revised portion of the SCPA Regulations and new documents that DTSC has added to the rulemaking file.

The revisions made to the current draft of the SCPA Regulations are substantial. Significant changes were made to clarify and streamline the regulations, including moving a number of provisions from the body of the regulations to the definitions section and eliminating other elements of the regulations altogether (e.g., the Guiding Principles and tiered alternatives analysis process). The resulting regulations are much easier to understand and apply, and are 30 pages shorter than the previous iteration.
 

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EU's REACH Enforcement Project to Target Downstream Users Who Formulate Mixtures

This post was written by David Wagner.

We’ve been discussing the November 30, 2010 REACH registration requirements on the blog, and now it’s time to address upcoming REACH enforcement efforts. On October 15, 2010, the European Chemicals Agency (ECHA) announced a project to inspect formulators of mixtures, that is, companies that purchase chemicals to prepare formulations such as paints, dyes, and industrial compounds. The enforcement project, which is designed to test REACH compliance, is slated for 2011.

In its announcement, the ECHA said that, while formulators of mixtures are not responsible for registering substances under REACH, they have supply chain responsibilities (e.g., safety data sheet requirements) that relate to obligations under REACH and the Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation). In particular, the ECHA stated “inspectors will control the supply-chain related obligations for substances in the mixtures prepared by formulators as well as the CLP notification requirements. They will also check if the substances placed on the market in mixtures are registered or pre-registered. In addition, the inspectors will raise awareness of the future obligations for Downstream Users with relation to the extended safety data sheet.”

The enforcement project, known as “REACH-EN-FORCE 2”, will be implemented by the EU’s Forum for Exchange of Information on Enforcement. Although REACH enforcement is the responsibility of Member State authorities, the Forum is tasked with, among other responsibilities, performing joint inspections and highlighting compliance problems.
 

With REACH Registration Less Than Two Months Away, Here's the Latest

This post was written by David Wagner.

At this week’s Fifth Stakeholders’ Day, which was broadcast over the web, the European Chemicals Agency (ECHA) reported that a little less than half of the substance registrations – about 2,000 – have been submitted in advance of REACH's November 30, 2010 deadline. As we’ve discussed on the blog, the European Union’s REACH law requires about 5,000 substances produced in or imported into the European Union to be registered with the ECHA by November 30 or their supply on the EU market will be illegal. Next month’s deadline applies to substances produced in or imported in annual volumes of 1,000 metric tons or more, and to volumes of one metric ton or more of the most hazardous classes of substances that are carcinogenic, mutagenic, or toxic to reproduction.

At the October 4 event, ECHA stated that it expects about 3,000 substances to fall into the high volume category, and between 1,500 and 2,000 to fall into the lower volume hazardous categories. They also reported that the ECHA had received over 4,000 dossiers addressing over 2,000 substances and compared these numbers to an expected total of 38,000 dossiers covering almost 5,000 substances. Recall that, under REACH, companies producing the same substance are required to work together in a Substance Information Exchange Forum (SIEF) and share data. ECHA expects a lot more dossiers than substance registrations because once the lead registrant of a SIEF submits a dossier, other companies manufacturing or importing the same substance must submit supplementary dossiers.

ECHA also reported that, to allow companies to check on the status of substance registrations, they will publish a list of registered substances by the end of October, and update that list weekly. When it’s available, we’ll publish a link to the ECHA’s list on our blog.
 

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Progress Made In the Development of California's Green Chemistry Regulations

This post was written by Eric McLaughlin.

Since the enactment of California’s two landmark green chemistry laws in September 2008 (AB 1879 and SB 509), significant effort has been made to develop their implementing regulations. This process has proven to be difficult and controversial, because a compromise must be reached between numerous competing concerns, most notably the legislative mandate to protect human health and the environment, and the significant costs to be imposed on companies manufacturing and selling consumer products in California. The process has also come under intense nationwide scrutiny, because California's Green Chemistry Initiative is considered a possible model for national chemical policy reform.

State regulators at the Department of Toxic Substances Control (DTSC) have until January 1, 2011 to enact the final version of the green chemistry regulations, known as the Safer Consumer Products Alternatives (SCPA) regulations. An informal rulemaking process has been used to shape the regulatory framework and extensive public comment has been received from stakeholders, including the scientific community, industry and environmentalists. The most recent draft of the SCPA regulations was released on June 23, 2010 and public comments were accepted through July 15, 2010.

California’s green chemistry laws are intended to completely refocus the regulation of chemicals in consumer products on the beginning of the product life cycle – the design phase. This approach will enable determinations to be made about which chemicals should be used in which products, and weighing the potential effects of those products on human health and the environment before they occur. Drafting the regulations to accomplish this goal, however, has prompted much debate throughout the informal rulemaking process, which has intensified as the SCPA regulations have taken shape, and has focused on six main issues: (1) scope of the regulations; (2) prioritizing chemicals of concern; (3) alternatives analysis; (4) confidential business information; (5) conflicting and duplicative regulations; and (6) the cost of implementation. This post summarizes the status of these issues.

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More Confidentiality Issues For Chemicals in the EU; This Time They Also Involve the Classification, Labeling and Packaging Regulation

This post was written by Todd Maiden and David Wagner.

Earlier this month, the Environmental Law Resource addressed how to make valid confidentiality claims for chemical information in a REACH registration dossier, and reminded readers that the first wave of REACH registration dossiers must be submitted by November 30, 2010. In particular, the November 30 deadline applies to substances that are manufactured in or imported into the EU in volumes of 1 metric ton or more annually and to certain compounds that are particularly hazardous to human health or the aquatic environment. However, upcoming confidentiality issues and deadlines related to chemicals in the EU are not limited to REACH; there are also similar issues for chemicals under the EU’s Regulation on the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation).

First, some background on the CLP Regulation. It introduces the United Nations’ globally harmonized system for classification and labeling of chemicals into Europe. It also requires, by January 3, 2011, companies that manufacture, import, use, or distribute chemical substances or mixtures to notify the European Chemicals Agency about the classifications of and labels for any substance or mixture, regardless of its annual tonnage, before they place it on the European Union’s market. For each substance, information on the classification and labelling will be published.

The link between REACH and the CLP regulation is that both contain hazard communication tools: the CLP establishes labeling rules and REACH establishes rules for Safety Data Sheets. Moreover, the CLP Regulation amended some of the Safety Data Sheet requirements in REACH, and these changes will be phased in over the next 5 years.

On August 13, 2010, the European Chemicals Agency issued an alert explaining that companies not required to register by the November 30, 2010 REACH registration deadline but still obligated to notify regulators on the classification and labelling of substances under the CLP Regulation can, in certain cases, keep the substances name confidential.

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How to Make Valid Confidentiality Claims under EU's REACH Law

This post was written by David Wagner.

On July 30, the European Chemicals Agency (ECHA) released a new guidance manual that gives step-by-step instructions on how to make confidentiality claims for chemical information in a REACH registration dossier. This includes how to make confidentiality claims for chemical names and the estimates of the amount produced. The manual also outlines the procedure that ECHA will follow to assess a registrant’s confidentiality claims and to potentially reject them by formal decisions, as well as the appeal procedure for rejected claims.

The manual explains that, in certain circumstances the International Union of Pure and Applied Chemistry chemical name can be claimed as confidential but registrants who take this approach must provide a “public name” for the chemical. ECHA broadly explains that the public name should disclose a maximum amount of information on the chemical structure of the substance, while protecting those features of the chemical structure that are considered confidential and the disclosure of which would potentially harm the registrant. If you are not clear about what that means, stay tuned. ECHA stated that it is analyzing various naming systems and plans to issue a practical guide on how to derive a “public name”.

Keep in mind that, by November 30, 2010, REACH registration dossiers must be submitted for substances manufactured in, or imported into, the EU in volumes of 1,000 metric tons or more per year, and for some hazardous substances at lower volumes.
 

U.S. General Accounting Office Provides Recommendations to USEPA on the Regulation of Nanomaterials

This post was written by David Wagner.

Underscoring the U.S. Environmental Protection Agency (USEPA) intent to issue rules regulating nanomaterials this year, the U.S. Government Accountability Office (GAO) raised some concerns and offered remedies in its report issued late last month titled, “Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk”.

In the report, GAO (an investigative arm of the U.S. Congress) stated its concerns that products with nanomaterials may be entering the market without USEPA review of all available information on their potential risk. Moreover, USEPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the relevant statutes include volume-based regulatory thresholds that may be too high to effectively regulate the production and disposal of nanomaterials.

Before offering recommendations, the GAO report discussed the growing world market for products that contain nanomaterials, which is expected to reach $2.6 trillion by 2015. The report identified a variety of products that currently incorporate nanomaterials already available in commerce across the following eight sectors: automotive; defense and aerospace; electronics and computers; energy and environment; food and agriculture; housing and construction; medical and pharmaceutical; and personal care, cosmetics, and other consumer products. Within each of these sectors, GAO also identified a wide variety of other uses that are currently under development and are expected to be available in the future. According to GAO, the extent to which nanomaterials present a risk to human health and the environment “depends on a combination of the toxicity of specific nanomaterials and the route and level of exposure to these materials.”

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In the EU, 8 More Substances Added to the REACH Candidate List

This post was written by David Wagner.

On June 18, the European Chemicals Agency added eight substances to its Candidate List of “Substances of Very High Concern” under REACH, bringing the total to 38. A chemical’s placement on the Candidate List may lead to the phase out or restriction of that substance. The newly added substances are ammonium dichromate, boric acid, disodium tetraborate, potassium chromate, potassium dichromate, sodium chromate, tetraboron disodium heptaoxide, and trichloroethylene.

Although these substances are not formally restricted, the addition of substances to the Candidate List triggers obligations for manufacturers and importers. Most noteworthy is the requirement to provide safety data sheets to their customers for listed substances. Producers of products containing the substances must also provide safe-use information to consumers on request.  Additional obligations, including future requirements, can be found here.

USEPA Proposal Would Require a Clean Water Act Permit for Certain Pesticide Applications

This post was written by David Wagner.

For the application of pesticides, the U.S. Environmental Protection Agency (USEPA) is taking a new position – it now aims to bring pesticide applicators under the Clean Water Act’s (CWA) permitting program. Earlier this month, USEPA released a draft CWA National Pollutant Discharge Elimination System (NPDES) pesticide general permit for point source discharges from the application of pesticides to waters of the United States. Under the Bush Administration, USEPA had issued a rule stating that these Clean Water Act permits were not required for applications of pesticides to U.S. waters. An appeals court decision vacated the rule in April 2009 and triggered the development of this proposal.

USEPA estimates that the court’s decision will require approximately 365,000 pesticide applicators nationwide, including farmers, land managers and other entities, to obtain NPDES permits by April 2011. The draft pesticide general permit covers applicators of biological pesticides and chemical pesticides that leave a residue in four categories of pesticide uses:

  • Mosquito and other flying insect pest control
  • Aquatic weed and algae control
  • Aquatic nuisance animal control
  • Forest canopy pest control
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With a REACH Registration Deadline Later This Year, the EU Chemicals Agency Addresses Some Issues

This post was written by David Wagner.

In the past two weeks, the European Chemicals Agency (ECHA) has revised its online registration tool and clarified several issues, including the definition of “intermediate”.

REACH-IT, the Agency’s online registration tool, will now allow the members of a joint submission, when attempting to register their substances, to submit their dossiers as soon as the lead dossier has been accepted for processing. Under REACH, companies producing or importing the same substance must prepare a joint registration and nominate a lead registrant who will submit the registration dossier to ECHA. Prior to the change, ECHA would have had up to three months to review and process the dossier before issuing a registration number. Under the initial procedure, companies other than the lead registrant would have been unable to submit their own registration without first receiving the registration number. Now, with the change, ECHA stated that “members of a joint submission do not need to wait until the lead registrant has been informed that his dossier is complete and received the registration number before members can submit their dossiers.”

Also, based on some confusion among industry groups, ECHA restated the meaning of the term “intermediate." ECHA underlined that “an intermediate is a substance used in the manufacturing of another substance whereby the intermediate is itself transformed into that other substance” and added that “substances used in the production of articles cannot be regarded as intermediates.” Intermediates must be registered under REACH but are subject to lesser data collection and submission requirements than non-intermediate substances.

Under REACH, by November 30, 2010, registration dossiers must be submitted for substances manufactured in, or imported into, the EU in volumes of 1,000 metric tons or more per year, and for some hazardous substances at lower volumes.

In Pennsylvania, Proposed Regulation to Require Public Disclosure of Chemicals Used in Hydraulic Fracturing

This post was written by Nicolle Snyder Bagnell and Ariel Nieland.

During a Marcellus Shale public forum meeting held last week near Scranton, Pennsylvania, the Pennsylvania Department of Environmental Protection (DEP) proposed a new regulation to be added to the most recent draft of proposed legislation regulating well construction. Under the proposed regulation, gas drilling companies would have to provide information about chemical usage on a well-by-well basis. This new proposal would require each company, upon completion of well construction, to disclose in a report a list containing all the names and total volume of chemicals used in the hydraulic fracturing process. The new proposal will be presented at a Pennsylvania Environmental Quality Board meeting for discussion on May 19, 2010. Scott Perry, director of DEP's Bureau of Oil and Gas Management, explained that this proposed regulation was drafted in response to a growing desire by the public for increased transparency with respect to well site development.

China Imposes Additional Requirements on the Import and Export of 154 Chemicals and 16 Ozone Depleting Substances

This post was written by Amanda Tao and David Wagner.

In the past month, China's Ministry of Environmental Protection has released two directories of substances requiring additional certifications and permitting for import and export. The directories address 154 chemicals and 16 ozone depleting substances. The Chemicals Directory for which Import and Export are Strictly Controlled updates a previous list to include nine more chemicals than the previous directory of 2008. The additional chemicals are Tributyltin-oxide, Tributyltin fluoride, Chlorotributylstannane Tributyltin chloride, Tri-n-butyltinmethacrylate, Tributyltin benzoate, Tributyltin linoleate and Tributyltin naphthenate. Companies importing or exporting any chemicals on the list must apply to the ministry for an environmental management certificate.

The Directory on Ozone Depleting Substances for which Import and Export are Strictly Controlled, released on January 6, 2010, requires companies seeking to import or export a listed substance to apply for the approval from the National Administration on Import/Export of Ozone Depleting Substances, and then apply for an import/export permit from licensing organizations authorized by the Ministry of Commerce and then present the permit to clear customs.
 

In the EU, 14 Substances are Added to Candidate List for Restriction under REACH

This post was written by Todd Maiden and David Wagner.

On January 13, 2010, the European Chemicals Agency added 14 substances to its Candidate List of “Substances of Very High Concern” under REACH, nearly doubling the original list of 16. The determination to include new substances on the Candidate List was based on their hazardous properties, the volumes used and the likelihood of exposure to humans or the environment.

A chemical’s placement on the candidate list may lead to the phase out or restriction of that substance. Fifteen chemicals were placed on the Candidate List in October 2008 and, of those, seven were proposed for phase out or restriction in June 2009. The European Commission has not yet adopted a decision banning or restricting any of the substances.

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Researchers and Regulators Are Debating the Costs of REACH

This post was written by David Wagner.

In the last several weeks, there’s been some back and forth between researchers and regulators on how REACH legislation will affect costs and loss of animal lives.  In a study published on August 26 in the journal Nature, the researchers reported that toxicity testing required by REACH will cost $13.6 billion, or six times more than estimated, and require 54 million research animals, or 20 times higher than the previous estimate.  The study reports that the European Union’s cost estimate was based on preregistration of 29,000 substances which was well below the actual preregistration total of 140,000 substances.  Accounting for redundancies and mistakes in preregistration, the study estimated that a conservative estimate puts preregistration at about 68,000 substances.  Using this number as the basis for its analysis, the study determined that REACH’s costs are likely to be substantially higher, largely because of a requirement to test chemicals’ effects on reproductive systems in two generations of animals -- a test that requires a large number of test subjects. But the study’s results have been challenged by the regulators.

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The EU's ECJ Rejects First Legal Challenge to the Registration Requirements of the REACH Regulations

This post was written by Nick Elliot.

On 7 July 2009, the European Court of Justice (ECJ) delivered its first judgement relating to the interpretation and validity of a provision of the REACH Regulations (REACH). This legal challenge concerned the interpretation and validity of Article 6(3) of REACH concerning the registration requirements applicable to “monomer substances”. However, it should come as no great surprise that the ECJ firmly rejected the legal challenge in its entirety.

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Seven Chemicals Proposed for Restriction Under EU's REACH Law

This post was written by David Wagner.

On June 1, 2009, the European Chemicals Agency proposed that seven chemical substances should be phased out or restricted under the EU’s REACH law. The European Commission will finalize the proposal through a regulatory process and, if adopted, the seven substances would be included in REACH’s Annex XIV list of substances subject to authorization. As a result, the substances could not be placed on the EU market unless granted exemptions for specific uses.

The seven were selected from the Agency’s October 2008 list of 15 candidate substances and the determination was based on their hazardous properties, the volumes used and the likelihood of exposure to humans or the environment. The seven substances are musk xylene; solvent hardener 4,4'-diaminodiphenylmethane (MDA); flame retardant short chained chlorinated paraffins (SCCPs); flame retardant hexabromocyclododecane (HBCDD); and plasticizers bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), and dibutyl phthalate (DBP). These chemicals are the first substances that would be subject to restrictions under REACH.

At the UN, Nations Agree to Add Nine Chemicals to Annexes of Banned and Restricted Substances

This post was written by David Wagner.

On May 9, 2009, parties to the Stockholm Convention on Persistent Organic Pollutants (Stockholm POPs) agreed to add 9 new substances to the treaty’s annexes of banned or restricted substances. The Stockholm POPs treaty is an international agreement that initially targeted 12 substances to be eliminated from global commerce, and this month’s decision is the first addition of chemicals to the treaty since the original listing was adopted in 2001.

The decision to add substances was made at the 4th conference of the treaty’s parties. The additions include PFOS, a chemical used in many electronic applications, such as semiconductor chips, photo imaging, textiles, and fire fighting foam; lindane, a pesticide that has been used to combat head lice; chlordecone, an agricultural pesticide; and hexabromobiphenyl, an industrial chemical that has been used as a flame retardant.

 

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REACH Pre-Registration Has Closed - Now What Should You Do?

This post was written by David Wagner, Lou Naugle, Nick Elliot and Todd O. Maiden.

With REACH Pre-Registration closed for existing substances, the European Union’s new chemical regime has shifted to the stage called pre-SIEF or Pre- Substance Information Exchange Forum. Following a relatively brief pre-SIEF phase for each substance, a SIEF will form from a pre-SIEF after potential registrants have agreed they intend to register the same substance. Keep in mind that after a substance is Pre-Registered, an extended deadline for Registration, based on volume and nature of the substance, is established ranging from 2010 to 2018. In preparing for Registration, the key issues for potential registrants to understand include collaborating efficiently when sharing data, understanding the roles of the SIEF and consortia, protecting confidential business information, and complying with European Community competition law.

As an initial step, a Pre-Registrant should see who else has pre-registered the same substance. The information should be displayed on a substance specific pre-SIEF page available through the European Chemicals Agency’s REACH-IT portal. A substance’s pre-SIEF page should include information on substance identification and company contact information for each Pre-Registrant (e.g., the company contact person or the only representative. Companies that have pre-registered a substance will automatically become listed on the pre-SIEF page of this substance. The information on the substance’s pre-SIEF page may also identify the SIEF formation facilitator for that substance or provide contact information to initiate discussions on pre-SIEF organization or on the “substance sameness” assessment (discussed below). If you pre-registered through an only representative and do not have access to this information, you may want to contact your only representative for log-in and password information.   

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REACH Pre-Registration Closes November 30, 2008: What Are You Doing? What Should You Be Doing?

This post was written by David W. Wagner,  Marie Albertini, Nick R. Elliot, Todd O. Maiden.

REACH is the European Union's new chemical management regime that is having a global impact. In addition to significant obligations for EU companies involved in the manufacture, import, downstream use, or distribution of about 30,000 chemical substances, non-EU companies involved in supply chains importing into Europe are facing requirements under this law. And the law extends well beyond chemical manufacturers and importers, as it applies to any sector using chemical substances, including, for example, electronic equipment, plastics, telecommunication equipment, IT products, commodities that contain chemicals (such as petroleum products and metals), and many others.

The first REACH requirement—pre-registration—closes Nov. 30, 2008. Manufacturers and importers who pre-register their substances by this deadline can then take advantage of the extended time available to complete the registration process—up until June 2018 for low-volume, low-toxicity substances. If the pre-registration window is missed, then the consequences can be severe: substances will be considered to be “new” chemicals, and a full registration must be completed before the substance can be legally marketed in the EU. Moreover, companies involved in a global supply chain of a chemical substance may face supply chain pressure, or requests for disclosure of potential uses and exposure information.

Have you been working to comply with REACH? Are you taking steps to ensure your supply chain will continue unaffected by REACH? If you have questions or concerns, please contact us. Reed Smith has been providing legal and strategic advice to a variety of clients on a range of REACH issues, including:

  • Advising multinational and U.S.-based companies on REACH’s legal implications and the principal mechanisms to participate in the pre-registration and registration processes
  • Counseling a multinational computer technology and electronics corporation on pre-registration requirements, REACH's regulation of substances of very high concern, Member States' enforcement, and issues unique to articles
  • Helping several U.S.-based companies with operations in the EU satisfy their pre-registration requirements, and advising on communications and contractual relations with their suppliers and customers
  • Advising a commodities trader on its REACH obligations and helping to develop a compliance strategy

REACHING OUT: REACH pre-registration phase begins

Following its official launch on June 1, the European Chemicals Agency (ECHA) has started to accept pre-registrations of chemicals under the REACH (Registration, Evaluation and Authorization of Chemicals) legislation. The 200 staff working at the agency have a mammoth task ahead of them, given that some 200,000 pre-registrations are expected.

REACH is designed to cut health risks associated with everyday chemicals by requiring companies to register safety information with the ECHA, and if necessary to substitute dangerous chemicals with safer alternatives.

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The European Court's Decision to Annul RoHS Exemption for Flame Retardants and Some Possible Implications

As of July 1, 2008, deca-BDE flame retardants are prohibited from new electrical and electronic equipment sold on the European Union market. The prohibition follows the European Court of Justice’s (ECJ) decision that annulled (i.e., voided) an exemption for deca-BDE (decabromodiphenyl ether) under the EU’s Restriction of Hazardous Substances (RoHS) Directive. While underscoring a global trend away from the use of deca-BDE, the decision also provides some insight into the judicial scrutiny of environmental legislation in the EU.

Although the RoHS Directive restricts the use in certain electrical and electronic equipment of six chemicals, it does provide for exemptions. Based on a risk assessment performed under the Existing Substances Regulation and, importantly, not the RoHS Directive, the European Commission had granted an exemption for deca-BDE. 

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Nanoscale Carbon and Graphite No Longer Exempt Under REACH

This post was written by David Wagner.

On Oct. 8, 2008, the European Commission amended REACH to remove nanoscale carbon and graphite from its list of exempted substances. The substances were originally listed in REACH's Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties. Following a review and a report by an expert committee, the Commission changed its position. According to the regulation, there is insufficient information for carbon (CAS No. 7440-44-0) and graphite (CAS No. 7782-42-5) to be listed in Annex IV, "in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion" in Annex IV. As a result, both substances are now required to be registered under REACH.

California Enacts Groundbreaking Green Chemistry Law

This post was written by Todd O. Maiden and Eric M. McLaughlin.

On Sept. 29, 2008, California Gov. Arnold Schwarzenegger signed two green chemistry bills—AB 1879 and SB 509—into law. This new green chemistry law totally refocuses chemical regulation in California, from reacting to chemicals after they have already been used in manufacturing or industrial processes, to assessing and regulating the use of chemicals in the design stage. The regulatory system created by the law will evaluate chemical risks and impose tailored restrictions based on science and the real-life impacts of chemical usage, rather than instituting an abstract chemical ban. California’s green chemistry law will take effect Jan. 1, 2009, which means the rulemaking process for the numerous regulations needed to implement the system will begin in earnest.

To achieve the goal of a regulatory system based on science and the real-life impacts of chemical usage and exposure, the green chemistry law was drafted using a comprehensive and collaborative approach. Implementation of the regulations will involve an interagency consultative process, incorporating chemical-related research done by other government agencies, and comments from stakeholders and the public. This approach, combined with the notice and comment requirements of the California Administrative Procedure Act, is intended to eliminate the ad hoc rulemaking seen with other environmental laws, such as California’s Proposition 65. Additionally, the scope of the law includes all chemicals used in consumer products, unlike the current patchwork of California laws that address only select product categories, such as lead in jewelry and on lunchboxes, chemicals in food containers, and household products such as light bulbs and batteries.

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