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.

ECHA Requests Updated Information on SVHCs to Assess Whether Their Uses Should Be Subject to Authorization

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REACh:

The European Chemicals Agency (ECHA) is currently considering whether to recommend that two Substances of Very High Concern (SVHCs), which were added to the Candidate List in January 2010, should have their uses subject to the Authorization process.  For these two substances, ECHA is requesting specific information to help the Agency with its decision.  The Agency also is requesting more general information on the twelve other SVHCs that were placed on the Candidate list in January.

The two SVHCs currently under close review are 2,4-dinitrotoluene (CAS No. 121-14-2) and lead chromate (CAS No. 7758-97-6).  ECHA has indicated that it is requesting information on their uses and releases to assess whether they should be recommended for the Authorization process.  Persons holding relevant information that might be adversely affected by authorization are probably considering their response.  ECHA contracted with Risk and Policy Analysts Limited (RPA) to collect the information on ECHA’s behalf, and a questionnaire has been developed and is available for anyone interested in providing information.  The questionnaire can be downloaded at: http://www.rpaltd.co.uk/news-dnt.shtml.  The deadline for submitting responses is 28 May 2010.  For those readers less familiar with the Authorization process, additional details are available at: http://echa.europa.eu/chem_data/authorisation_process_en.asp.

For the other twelve SVHCs placed on the Candidate List in January, ECHA is requesting accurate and up-to-date information on the volumes available on the European market, as well as information on their uses, releases and exposures.  This information will help ECHA decide whether to eventually recommend some of these substances for the Authorization process.  These substances include:

  • Anthracene oil (CAS No. 90640-80-5);
  • Anthracene oil, anthracene paste, distn. lights (CAS No. 91995-17-4);
  • Anthracene oil, anthracene paste, anthracene fraction (CAS No. 91995-15-2);
  • Anthracene oil, anthracene-low (CAS No. 90640-82-7);
  • Anthracene oil, anthracene paste (CAS No. 90640-81-6);
  • Pitch, coal tar, high temp. (CAS No. 65996-93-2);
  • Aluminosilicate Refractory Ceramic Fibres;
  • Zirconia Aluminosilicate, Refractory Ceramic Fibres;
  • Diisobutyl phthalate (CAS No. 84-69-5);
  • Lead chromate molybdate sulphate red (C.I. Pigment Red 104) (CAS No. 12656-85-8);
  • Lead sulfochromate yellow (C.I. Pigment Yellow 34) (CAS No. 1344-37-2); and
  • tris(2-chloroethyl)phosphate (CAS No. 115-96-8).