Posted on August 4, 2010 by David Wagner

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.
 

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Posted on June 24, 2010 by David Wagner

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.

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Posted on June 10, 2010 by David Wagner

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.

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Posted on February 4, 2010 by David Wagner

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.

The listing, however, does triggers immediate obligations. For example, suppliers of articles in the EU that contain substances on the Candidate List in a concentration above 0.1% have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. Suppliers of substances on the Candidate List also have to provide their customers with a safety data sheet. Additional obligations, including future requirements, can be found here.

The 14 substances added to the Candidate List are five variations of anthracene oil and paste, a form of coal tar used in manufacturing electrodes, aluminosilicate refractory ceramic fibers, zirconia aluminosilicate, 2,4-dinitrotoluene, diisobutyl phthalate, lead chromate, tris(2-chloroethyl)phosphate, and two lead-based pigments.
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Posted on September 23, 2009 by David Wagner

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.

The European Union Chemicals Agency, which administers REACH, has since issued two press releases on the matter.  It maintains that it expects the final costs and number of animals used to remain close to original estimates.  The regulators claim that the study well overestimated the number of substances that will require a full set of testing data and that the testing costs were grossly overestimated. 

In a related development, the Organization for Economic Co-operation and Development (OECD) is drawing up guidance for an extended one-generation reproductive toxicity test.  Under the guidance, tests beyond the first generation would be conducted only if a specific cause for concern arose in the first-generation offspring.  The OECD will hold a meeting in October to discuss outstanding technical issues, including what would be considered as a trigger for additional tests.  Draft guidelines are expected to be submitted for approval in March 2010.  If approved, the guidelines would be published and in place before testing begins in December 2010.
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Posted on July 27, 2009 by David Wagner

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.

The ECJ ruling originates from legal proceedings instituted in the High Court of Justice in the UK in 2007 by 4 companies (international polymer manufacturers and importers) challenging a number of the provisions of REACH. Whilst the English court rejected certain claims relating to the validity of Articles 5 and 6(1) of REACH, it referred questions concerning the interpretation and validity of Article 6(3) to the ECJ.

So, what was at issue here? Pursuant to Article 2(9) of REACH, polymers are exempt from the general obligation to register substances under Article 5 of REACH. Polymers are large molecules composed of repeating structural units of monomers – for example, plastics are polymers. Monomers are small molecules that may become chemically bonded to other monomers to form a polymer – for example, butene and propene are monomers.

The claimants stated that whilst polymers are exempt, Article 6(3) appears to require “reacted” monomers contained within imported polymers to be registered under REACH. They argued that, due to the polymerisation, monomers no longer exist as individual substances and do not present themselves to humans or the environment independently of the polymers in which they have been incorporated. The claimants therefore argued that the requirement to register “reacted” monomers was irrational, discriminatory and disproportionate.

Article 6(3) provides that “monomer substances” which are contained in polymers must be registered if two conditions are met: (i) if the monomer substance makes up more than 2% of the weight of the polymer; and (ii) if the monomer substance makes up one tonne or more per annum.

The ECJ clarified the interpretation of “monomer substance” in Article 6(3) by simply referring to the wording of other articles of REACH. The ECJ stated that “it is clear from the wording of Article 3(5) of the REACH Regulation that polymers are composed of monomer units, which are defined as monomer substances in a reacted form”. Therefore, “monomer substance” related only to “reacted” monomers which are incorporated in polymers.

The ECJ also commented that “unreacted” monomers would need to be registered according to Articles 6(1) and 6(2) of REACH in as much as they constituted substances on their own.

The ECJ stated that “the obligation to register monomer substances is designed to protect human health and the environment since those substances have inherent characteristics liable to have an adverse effect on them”.

The ECJ also rejected the claimants’ challenge to the validity of Article 6(3) of REACH, stating that “the obligation to register reacted monomer substances which are components of polymers does not go beyond that which is necessary to meet the objectives of the REACH Regulation”.

In conclusion, this preliminary ruling will disappoint the manufacturers and importers of polymers who were hopeful of some last minute relief from the obligation to register monomer substances under REACH. However, the decision cannot come as a big surprise. In essence, this was an attempt to create a new exemption for “reacted” monomers that clearly does not currently exist under REACH.

Polymer manufacturers and importers find themselves in the same position as manufacturers and importers of other “substances”. They must either register the monomer substance themselves or they can rely on the registration of the monomer substances by their EU monomer producer or the Only Representative of their non-EU monomer producer, as appropriate.
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Posted on June 12, 2009 by David Wagner

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.

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Posted on January 13, 2009 by David Wagner

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.   

A short posting cannot discuss all of the issues in depth so what follows is an overview of key REACH considerations and requirements. Please feel free to contact the authors of this posting for more details. 

The initial task of the group of Pre-Registrants is to agree that they intend to register the same substance, based on chemical identity and the substance sameness assessment. The exchange of this information within the group of Pre-Registrants and the decision to form a SIEF will be led by a SIEF facilitator (if available). In addition to substance and company information on the pre-SIEF page found in the REACH-IT portal, the European Chemicals Agency published a list of Pre-Registered substances on Dec. 19, 2008 (http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx). 

Agreement on substance identity may in some cases require the exchange of detailed technical information on the composition of the substance, the raw materials used, the substance impurities, and possibly on the manufacturing process. Given that agreeing on substance sameness may in some cases involve the disclosure of confidential data, companies may want to preserve confidentiality in a secure exchange.

Moving to the next stage, a SIEF is formed from a pre-SIEF after the potential registrants have agreed they intend to register the same substance. As a potential registrant, obligatory participation in the SIEF following Pre-Registration is a means to (1) facilitate the exchange of information between potential registrants, thereby avoiding the duplication of studies, and (2) agree on classification and labeling. REACH provides for potential registrants to share information and work together to prepare a joint registration submission.

Participants in a SIEF are free to organize themselves in consortia or other forms of agreements as they see fit to carry out their obligations under REACH. Consortia are intended to provide a legal framework to deal with cooperation among SIEF participants and may include elements such as:

  • Adopting competition law compliance rules
  • Preserving the confidentiality of business information and data
  • Defining classification and labeling
  • Facilitating data-sharing and coordination

The activities of consortia may potentially give rise to EC competition law issues. Article 81 of the European Community Treaty prohibits any agreements or concerted practices that may result in the prevention, restriction or distortion of competition within the common market. In complying with data sharing and registration obligations, potential registrants should limit exposure to anti-competitive behavior by avoiding or carefully managing the exchange of commercially sensitive information and discrimination regarding consortium entry or sharing of costs. Adherence to a strict antitrust policy, including a well-thought out and transparent approach to dealings with competitors, is advisable.

Moreover, Article 82 of the EC Treaty prohibits the abuse of a dominant position, which can include a collectively dominant position, as may be held by a consortium. Article 82 EC is therefore aimed at preventing any undertaking, which holds a dominant position in a market, from abusing that position, by, for instance, directly or indirectly imposing unfair purchase or selling prices or other unfair trading conditions or limiting production, markets or technical development to the prejudice of consumers. The exclusion of a competitor from a consortium without objectively justified reasons may potentially be problematic under both Articles 81 and 82 EC, and so it is recommended that the admission of undertakings to any consortia be carefully managed in a way that avoids such risks.

Reed Smith's experience in this area suggests that information exchange, particularly in relation to future volumes, is regarded by the European Commission as being particularly sensitive – the Commission’s Directorate General for Competition has previously referred specifically to REACH as an area of interest to it and is currently consulting on the issue of information exchange.
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Posted on November 13, 2008 by David Wagner

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
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Posted on October 29, 2008 by David Wagner

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.

The legislation, which covers some 30,000 chemicals, no longer differentiates between existing and new chemicals, obliging all chemicals on the market to undergo rigorous testing. Before REACH, there was a general lack of knowledge regarding 99 percent of the chemicals - around 100,000 substances - that were placed on the EU market before 1981. Prior to that date, no stringent health and safety tests were needed to market chemicals in the EU.

Between now and Dec. 1, 2008, companies that manufacture or import more than one tonne of chemical substances per year should pre-register these chemicals online via the REACH-IT portal. The agency is expected to handle a staggering 200,000 pre-registrations overall. It is important for companies to pre-register as the failure to do so will mean that the chemical substance will be prohibited from use or manufacture in the EU until the chemical substance completes a formal registration process.

The pre-registration phase is meant to help companies identify and get in touch with other companies that are planning to register the same substance, giving them to sufficient time to set up a Substance Information Exchange Forum (SIEF)

Following the pre-registration phase, companies that have pre-registered will have until Dec. 1, 2010 for the final registration and market authorization of all substances produced or imported in quantities equal to or greater than 1,000 tonnes a year. A phased registration process is provided for those who have pre-registered chemical substances used or imported in volumes less than 1,000 tonnes per year. Companies that import or produce the smallest amounts of chemicals regulated under REACH, provided they have been pre-registered (approximately one tonne or more a year) will have until June 2018 to register these substances.
 
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Posted on October 10, 2008 by David Wagner

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.

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