Tag Archive for: REACH

Verdant Proudly Sponsors Prop.65 Clearinghouse's Green Chemistry Conference

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Green Chemistry:

Verdant is pleased to announce its sponsorship of the Prop.65 Clearinghouse Green Chemistry Annual Conference.  This year’s conference will be held on Tuesday, April 9, 2013, at the The City Club of San Francisco, 155 Sansome Street.

  • Verdant attorney, Philip Moffat, will present on “REACH 2013.”
  • Verdant attorney, Catherine Lin, will present on “Supply Chain Management.”

More information about the conference is available here and an agenda is available here.   A copy of Mr. Moffat’s presentation is available here [PDF].

EU Commission Releases Roadmap on Substances of Very High Concern

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EU REACH Substances of Very High Concern:

Last week, the EU Commission released its Roadmap on Substances of Very High Concern (SVHC). The Roadmap outlines a process for identifying and assessing potential SVHCs within the following categories: substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs); substances that are persistent, bioaccumulative or toxic for the environment (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances of equivalent concern, such as endocrine disruptors. The Roadmap estimates that the process will evaluate up to 440 substances, a far lower number than the 1,900 substances originally anticipated, with an initial goal of completing 80 assessments by the end of 2014.

The Roadmap follows the Commission’s commitment to compile a comprehensive REACH candidate list of SVHCs and is designed to help meet the Commission’s plan to include all currently known SVHCs on the candidate list by 2020.

The SVHC Roadmap proposes first screening substances with REACH registration dossiers by applying a minimum quantity threshold and generally exempting substances registered only for intermediate uses. The second step entails conducting a “Risk Management Options” (RMO) analysis. Under this approach, the best regulatory option to manage a particular risk is chosen after considering actions available within REACH (like imposing authorization, restriction or substance evaluation requirements) or under other legislative schemes, such as RoHS. For example, the Roadmap suggests that substances with demonstrated risk should be restricted under REACH.

The roadmap is downloadable as a PDF from the EU website.

EU Member State Committee Identifies 5 More SVHCs

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REACH/SVHCs/Authorization

During meetings held from June 6 – 8, 2012, the EU’s Member State Committee (MSC) unanimously agreed on the identification of five substances of very high concern (SVHCs).  SVHCs are thought to have serious and often irreversible effects on human health and the environment.  The five substances identified by the MSC are diborontrioxide and the following four dyes:  C.I. Basic Violet 3; C.I.Basic Blue 26; C.I. Solvent Blue 4; and 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol.  The listing for the four dyes will clarify that the substances will only be identified as SVHCs when the concentration of the impurities Michler’s ketone or Michler’s base is equal to or higher than 0.1%.

SVHCs include substances that have one or more of the following hazard characteristics: Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2); Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB); or cause probable serious effects to human health or the environment (e.g. Endocrine Disruptors).  REACH, the primary regulation for industrial chemicals, aims at ensuring that the risks resulting from the use of SVHCs are controlled and that the substances are replaced where possible.

The five substances will be added to the Candidate List and may subsequently become subject to authorization under REACH Title VII.  When an SVHC becomes subject to authorization, persons using or making it available on the EU market must apply for authorization within a prescribed deadline (i.e., the “sunset date”), seeking approval of nonexempt uses while also including an analysis of possible substitutes.  If they can show that the risks from their uses are adequately controlled (except non-threshold CMRs and PBTs/vPvBs), or that the socio-economic benefits outweigh the risks and no suitable alternatives exist, then their uses of the SVHC are “authorized” to continue.

Even without being selected for authorization, inclusion of substances on the Candidate List immediately triggers certain regulatory obligations. 

  • EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) 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. This information must contain as a minimum the name of the substance.
  • EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
  • EU and EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet.
  • EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

More information about the MSC is available here, and information about the process for identifying SVHCs is available here.

European Chemical Industry Debuts Chemical Combination Screening Tool – Concludes Regulating Individual Chemicals is Usually Adequate

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Chemical Mixture Risk Assessment:

May 31, the European Chemical Industry Council (Cefic) unveiled a tool for assessing the risks posed by chemical combinations: the Maximum Cumulative Ratio (MCR) (see e.g., news release, combination effects tools).  MCR compares the toxicity of individual chemicals to the cumulative toxicity of all chemicals in an exposure scenario.  Cefic argues that in most exposure scenarios the risk of one or two chemicals contribute nearly all risk of harm.  The organization notes that prioritization of chemical combinations is necessary to identify combinations of concern that warrant full risk assessment. 

Cefic references Maximum Cumulative Ratio (MCR) as a Tool for Assessing the Value of Performing a Cumulative Risk Assessment (in International Journal of Environmental Research and Public Health) for full discussion of the application of MCR.  The article comprises an investigation of the magnitude of toxicity from multiple chemical exposure that is missed in scenarios where no cumulative risk assessment is conducted.  U.S. Geological Survey water quality data were used for the evaluation. From 5 to 81 chemicals were present in the 3,000 samples analyzed.  The authors estimate that approximately 20 percent of cumulative toxicity –compared to component chemical toxicity– is missed where cumulative risk assessments are not conducted.  However, mixture toxicities were dominated by only a fraction of chemical compounds present.

Because risk is usually driven by one or two chemicals in a combination, Cefic believes that controlling individual substances through the current regulatory schemes will often control the risk from combination exposures.

Cefic notes that MCR is based on the WHO risk assessment framework (see e.g., Combined Exposure Risk Assessment Workshop Report) and relies on cumulative risk assessment theories from the European Scientific Committees (see e.g., Environmental Risk Assessment of Mixtures Symposium).

ECHA Publishes the 2011- 2013 Work Program of the REACH and CLP Enforcement Forum

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REACH/CLP Enforcement:

On July 6, 2011, the European Chemicals Agency (ECHA) published the 2011 -2013 work program for the Forum on Exchange of Information on Enforcement of the REACH and CLP Regulations.  The program lists the Forum’s current and upcoming activities, a description of the activities, the expected time frame for each, and its priority.  Readers less familar with the REACH and CLP Regulations should know that the Forum coordinates a network of authorities responsible for enforcement of the regulations in each country or “Member State.”

Very high priority activities for the work period include the follwing: 

  • EU-wide coordinated REACH Enforcement Projects (REFs) such as the coordinated project concerning downstream user obligations of formulators of mixtures;
  • clarification of the links between ECHA, Member State competent authorities and Member State enforcement authorities;
  • access to REACH-IT by Member State enforcement authorities;
  • cooperation with customs authorities, including execution of a coordinated enforcement initiative; and
  • preparation of advice concerning the enforceability of REACH restriction proposals.

In addition, new rules of procedure for the Forum adopted at the recent ECHA Management Board meeting are published, along with minutes of the Forum meeting held in March of this year. 

Copies of the documents are avaialble here.

Downstream User Reports-ECHA Webinar Tue May 31

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Readers interested in learning more about downstream user reporting may login to the webinar Tuesday May 31 or download a recorded version of the program from the ECHA website.

The webinar will be addressed to all downstream users of registered substances interested in learning more about downstream user reports and how to submit them to ECHA successfully.

Webinar
Date: 31 May 2011
Time: 11:00 AM Eastern European Time
(4:00 AM Eastern U.S. Time)
Register at: https://echa-events.webex.com/echa-events/onstage/g.php?t=a&d=701184789

Participants will receive practical information on how to complete a downstream user report using IUCLID5 and successfully submit it to ECHA via REACH-IT. Participants wishing to benefit from this training should have elementary knowledge of IUCLID5.

Downstream users may need to report their uses if these are not covered by the exposure scenarios provided by their suppliers. Exposure scenarios are part of the extended safety data sheets under REACH.

Producers, formulators, industrial users, other professional users, re-importers, and other downstream users can learn more about obligations under REACH from ECHA. Downstream user obligations include informing customers of hazards, providing risk management advice to formulators and suppliers, and, for chemicals of very high concern, warning customers and users about the parameters of and protocols for 

ChemSec Adds 22 Chemicals to "SIN List"

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REACh:

On May 3, 2011, the EU environmental group, the International Chemical Secretariat (ChemSec), announced the addition of 22 chemicals to its so-called “Substitute It Now!” list or “SIN List.”  ChemSec supposedly selected the chemicals based “solely” on their endocrine disrupting properties.  Although there is no established EU definition for what constitutes an endocrine disrupting chemical (EDC), according to the USEPA and the NRDC, an endocrine disruptor is a synthetic chemical that, upon absorption into the body, either mimics or blocks hormones and disrupts the body’s normal functions.  According to ChemSec’s press release, EDCs “interfere with our hormone system and have been increasingly linked to a range of health problems including cancer, diabetes, behavioural and attention deficit disorders, as well as impaired fertility.” The group added the chemicals in part to force EU regulators to begin selecting EDCs for the authorization process set out in the EU’s primary chemical control law, titled “Registration, Evaluation, Authorisation, and Restriction of Chemicals” (REACh).

The SIN List is an inventory of chemicals that ChemSec developed.  Chemicals on the list purportedly meet the Substance of Very High Concern (SVHC) criteria established under REACh.  SVHCs are those chemicals that may be especially harmful to human health or the environment and thus may be considered for the REACH authorization process, which contemplates substitution of such chemicals for those that are “safer.”  ChemSec developed the list to encourage early substitution and to suggest “candidates” for authorization.

According to ChemSec, many of the 22 chemicals are “commonly found in toys, food packaging, and cosmetics….”  The chemicals that ChemSec selected are:

  • 3-benzylidene camphor
  • 4-methylbenzylidene camphor
  • 4-nitrophenol
  • 4,4´-dihydroxybenzophenone
  • Benzophenone-1
  • Benzophenone-2
  • Benzophenone-3
  • Butylparaben
  • Dicyclohexyl phthalate (DCHP)
  • Diethyl phthalate (DEP)
  • Dihexyl phthalate (DHP)
  • Ethylhexyl methoxycinnamate
  • Metam natrium
  • Methyl tertiary butyl ether (MTBE)
  • Pentachlorophenol
  • Perchloroethylene
  • Propylparaben
  • Quadrosilan
  • Resorcinol
  • Tert-butylhydroxyanisole
  • Thiram
  • Zineb

Thus far, the European Commission has embraced the SIN List and its recent additions. On May 19, 2011, in his opening speech at the annual Helsinki Chemicals Forum, Janez Potocnik, European Commissioner for Environment, said “The recently published second edition of the SIN list, which also includes substances with endocrine disrupting properties, should indicate to you the substances the European Commission will take into consideration for placement on the candidate list.” Potocnik also referred to the European Commission’s goal that another 90 substances should be added to the Candidate List for Authorization by the end of next year: “Now that we are working at full speed getting 136 substances of very high concern on the REACh candidate list by 2012, and even more by 2020, the dream of green chemistry is becoming a reality.”

Companies manufacturing, importing, or using chemicals in the EU will undoubtedly take seriously Mr. Potocnik’s remarks.  Moreover, they are certain to continue monitoring the SIN List and consider its potential implications when making product and raw material selections.

EU Environmental Groups Sue ECHA to Force the Disclosure of Companies Manufacturing or Importing Chemicals on the “SIN List”

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REACh:

On May 9, 2011, two EU environmental groups, the International Chemical Secretariat (ChemSec) and ClientEarth, announced that they had initiated a lawsuit against the European Chemicals Agency (ECHA).  The groups filed the lawsuit in the General Court of the EU with the goal of forcing ECHA to publicly disclose the names of companies manufacturing or importing chemicals currently listed on ChemSec’s so-called “Substitute It Now!” list or “SIN List.”  The groups also seek volume information.  ChemSec and ClientEarth want the names and volume information so that they can pressure ECHA and the companies to substitute the chemicals for ones that supposedly are “safer.”  The groups submitted their initial request on December 1, 2010, and after a series of escalating and more formal requests, ECHA issued its final denial on March 7, 2011.  Now, in response to the lawsuit, ECHA has announced that it will release some of the information.  A spokesperson for the groups says that they intend to pursue the case in light of ECHA’s inadequate response.  Additional details are set out below.

ECHA received the names and volume information when the companies submitted their registration dossiers in partial fulfillment of their obligations under the regulation, “Registration, Evaluation, Authorisation, and Restriction of Chemicals” (REACh).  For readers less familiar with the regulation of chemicals, REACh is the primary EU chemical control law.  It applies to most chemicals, except for those used in pharmaceuticals, pesticides, or other products regulated under different EU laws.  Companies that manufacture or import nonexempt chemicals in the EU above 1 metric ton per year are required to submit a registration dossier to ECHA.  The dossier includes certain data and other information about the chemical, its uses, as well as the manufacturer or importer.  ECHA and the EU countries (called Member States) review the dossier to decide whether a chemical should be banned or its use limited through the so-called restriction or authorization processes established under REACh.  Additional testing or other information may also be requested.

The SIN List is an inventory of chemicals that ChemSec developed.  Chemicals on the list purportedly meet the criteria established under REACh for identifying Substances of Very High Concern (SVHC).  SVHCs are those chemicals that may be especially harmful to human health or the environment and thus may be considered for the REACH authorization process, which expressly contemplates substitution of such chemicals for those that are “safer.”

The lawsuit is currently pending before the General Court of the European Union.  The General Court handles cases filed by private individuals, companies and some organizations, and cases relating to competition law (antitrust for American readers).  The General Court provides the first level of judicial review.  Afterwards, a case can be appealed to the European Court of Justice.  The Court of Justice interprets EU law to ensure the law is applied consistently in all EU countries.  The Court of Justice also settles legal disputes between EU governments and EU institutions.  Individuals, companies, or organizations can also bring cases before the Court if they feel their rights have been infringed by an EU institution.  The Court of Justice has one judge per EU country.

A copy of the legal compliant, called an Application for Annulment, is available here.  In it, ChemSec and ClientEarth include numerous allegations challenging the substantive basis and procedures ECHA used in delaying its response and ultimately denying the groups’ request.  A discussion of the legal principles set out in the complaint and an evaluation of the merits of the allegations are beyond the scope of this post.  However, they may be reviewed more closely in a subsequent post.

In response to the lawsuit, ECHA announced on May 11, 2011, that it will begin to publish certain information from the registration dossier contained in the safety data sheet (SDS), including company names.  In addition to the company’s name, ECHA said that it will also make further elements contained in the SDS publicly available such as the REACH registration number and whether the substance meets some of the SVHC criteria.  However, ECHA noted that companies will be able to keep the information confidential, provided that a valid justification is given and accepted by ECHA.   According to the agency, providing this information will require significant revisions to ECHA’s databases so it is currently unable to commit to releasing the information in the immediate future.  ChemSec and ClientEarth have stated publicly that they find ECHA’s response inadequate and plan to proceed with their lawsuit.

EU Environmental Law Group Releases Reports on Member State Implementation and Enforcement of REACh

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REACh:

The EU public interest environmental law group, ClientEarth, recently released a series of progress reports summarizing Member State activities under the European Union (EU) regulation: Registration, Evaluation, and Authorisation of Chemicals (REACh).  Each report reviews a different Member State’s efforts to implement and enforce REACh.  Reports also are available for three non-Member State countries that have enacted REACh – Lichtenstein, Norway, and Iceland.

The reports are essentially responses to a lengthy questionnaire from the European Commission.  Activities reviewed include communications between Member State authorities and EU authorities, such as the European Chemicals Agency (ECHA); operation of the national helpdesks; development and promotion of alternative test methods; participation on REACH committees; evaluation of substances; preparation of Annex XV dossiers; and details concerning enforcement-related activities, such as inspections and the imposition of sanctions.  The reports may prove useful to companies wanting insight into the level and types of enforcement activity occurring within the countries regulating their operations.

ClientEarth received the reports through a public records request, insisting that their broad dissemination was necessary “so that [the public] can know if REACH is really working.” (Critics probably think they know the answer already.)  The reports are available here.

Six SVHCs Selected for Burdensome Authorization Process under REACh

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REACh:

On February 11, 2011, the European Commission (EC or Commission) announced that six substances of very high concern (SVHC) have been moved from the so-called “Candidate List” to Annex XIV of the regulation known as “REACh.”  Annex XIV lists those substances subject to the “authorisation” procedures set out in Title VII of the regulation.  The six substances are the first to be selected for authorisation.  They are: 5-ter-butyl-2,4,6-trinito-m-xylene (musk xylene); 4,4′-diaminodiphenylmethane (MDA); hexabromocyclododecane (HBCDD); bis(2-ethylexyl) phthalate (DEHP); benzyl butyl phthalate (BBP); and dibutyl phthalate (DBP).  The substances were selected for authorisation because it was determined that they are carcinogenic, toxic for reproduction, or persist in the environment and accumulate in living organisms. 

Now that the substances are subject to authorisation, they will be banned from use or placement on the market within the next three to five years, unless an authorisation is granted to individual companies to continue their specific use(s).  Companies wanting to use these substances or place them on the market will need to demonstrate that the required safety measures have been taken to adequately control the risks, or that the benefits for the economy and society outweigh the risks.  Where feasible alternative substances or techniques exist, a timetable for substitution will also have to be submitted.

For each substance, a “sunset date” is provided, ranging from 2014 to 2015.  From this date, the substance may only be placed on the market or used if an authorisation has been granted or an application for authorisation has been made before the “latest application date” (i.e., the date by which anyone wishing to keep using a listed chemical after the sunset date must make an application).  Companies must submit their applications to the European Chemicals Agency (ECHA).  The Agency’s Risk Assessment Committee and Socio Economic Committee will then consider each application and submit their opinions to the Commission. The Commission will make the final decision concerning whether to grant authorisation.

Readers should recall that the authorisation requirements apply regardless of the tonnage at which the substance is placed on the market or used.  There are no lower limits for the authorisation requirement.  However, some uses of substances, such as intermediates, may be excluded. 

More information about this development is available here.  An overview of the authorisation process is available here and here.  Guidance on preparing an application for authorisation is available here.  And a current version of the SVHC Candidate List is available here.