Showing posts with label Authorization. Show all posts
Showing posts with label Authorization. Show all posts

Tuesday, December 18, 2012

ECHA Lists 54 Substances of Very High Concern

The European Chemicals Agency (ECHA) plans to add another set of substances of very high concern (SVHC) to the candidate list under the REACH Regulation. The 54 new substances brings the total on the candidate list to 138. Most of the substances listed are CMRs, i.e., carcinogenic, mutagenic or reproductive toxicants, or PBTs, i.e., persistent, bioaccumulative and toxic. Three of the new substances are listed because they exhibit "equivalent concern," a more nebulous characteristic that covers any toxicity or other concern that does not fit neatly into one of the other categories, e.g., endocrine disruption, or in this case, strong respiratory sensitizers.


All of the substances on the candidate list are evaluated for inclusion on the Annex XIV Authorization list.

The full list of candidate list substances can be found in the table here.

Tuesday, July 3, 2012

ECHA Adds Thirteen Substances to Candidate List

The European Chemicals Agency (ECHA) has added thirteen new substances of very high concern (SVHCs) to the REACH candidate list.  This list serves as a staging area for substances to be added to Annex XIV of REACH, which puts them on a track to be banned pending authorization for limited uses for limited time periods.

According to ECHA:

"Four have been identified as SVHCs under the precondition that they contain certain carcinogenic constituents above the concentration limit for classifying these substances as carcinogenic. Five of the new SVHCs have been included in the Candidate List following a scrutiny of the comments received during the public consultation and the unanimous agreement of the Member State Committee (MSC). The further eight substances, which did not receive comments challenging the identification as SVHCs during public consultation, were directly added to the Candidate List."

More information and the full candidate list of substances can be found on the ECHA site.

Thursday, June 21, 2012

ECHA Calls for Comment on 10 Chemicals to be Banned

ECHA, the European Chemicals Agency based in Helsinki, issued a request for comment yesterday on proposals to ban ten additional chemicals under the Authorization phase of REACH.  All of the chemicals have been on the "candidate list" of Substances of Very High Concern (SVHC).  Currently there are 84 substances on the candidate list, of which 14 have already been placed in Annex XIV for eventual removal from the marketplace.  The first sunset date is in early 2013, pending applications for authorization from manufacturers who want to keep the chemical on the market while they develop alternatives.

The ten chemicals out for public comment are:

  • Pentazinc chromate octahydroxide 
  • Arsenic acid
  • Formaldehyde, oligometric reaction products with aniline (technical MDA)
  • Potassium hyroxyoctaoxodizincated dichromate
  • Strontium chromate
  • 1,2-Dichloroethane (EDC)
  • Dichromium tris(chromate)
  • 2,2'-dichloro-4,4'-methylenedianiline (MOCA)
  • N,N-Dimethylacetamide (DMAC)
  • Bis(2-methoxyethyl) ether (Diglyme)
According to ECHA, interested parties may submit comments on the draft recommendation by September 19, 2012.


More information can be found on the ECHA site.

Tuesday, February 28, 2012

ECHA Proposes to List 13 Chemicals as Substances of Very High Concern Under REACH

The European Chemicals Agency (ECHA) has proposed to add 13 additional chemicals to their candidate list of Substances of Very High Concern (SVHC).  Each of the chemicals "is classified as carcinogenic, mutagenic or toxic for reproduction."  Stakeholders and other interested parties are urged to comment on the proposed listings.  Besides toxicity, "information on the uses of the substances is invited."

The public consultation "will be open for 45 days and will end on 12 April 2012."  After the consultation period, ECHA will consider all comments and then make final decisions on including the substances on the candidate list.  Eventually these substances could be included on the REACH Annex XIV Authorisation List. If that happens then companies will have to apply for authorisation, that is, apply to have their substance remain on the market, usually only for specific controllable uses, limited volumes, and for a limited period of time while substitutes are developed.


More information and the list of chemicals can be found on the ECHA web site.

Monday, January 30, 2012

ECHA Says "Only Representatives" Can Apply for Chemical Authorization

According to the European Chemicals Agency (ECHA):

"In December 2011, the European Commission services informed ECHA that, in their view, an Only Representative (OR) of a non-EU manufacturer can also apply for authorisation. Following this, ECHA updated the webforms to allow ORs to send their applications while developing long term functionalities in REACH-IT. The relevant Data Submission Manual Part 22 - How to Prepare and Submit an Application for Authorisation using IUCLID 5 is also being updated and will be published once the new version of IUCLID is released, which is currently expected to be during summer 2012."

Previously it was assumed that only a European registrant could apply for authorization under REACH.  Authorization is the process by which companies can apply to keep certain uses of their Substances of Very High Concern (SVHC) that have been targeted for banning on the market for a limited period of time while alternatives are developed.

More information on applying for authorization can be found on the ECHA site.

Tuesday, January 3, 2012

ECHA Recommends 13 Substances of Very High Concern be Banned

According to the European Chemicals Agency (ECHA):

"The European Chemicals Agency has submitted to the European Commission a recommendation that thirteen Substances of Very High Concern should in future not be used without authorisation. These substances are all classified because of their carcinogenic, mutagenic or toxic to reproduction (or a combination thereof) properties. They are used in applications where there is potential for worker exposure.

The thirteen substances and their main uses within the scope of authorisation are:
  • Trichloroethylene (carcinogen). A substance mainly used in surface cleaning, in textile scouring, in adhesives and as a heat transfer fluid.
  • Chromium trioxide (carcinogen, mutagen). A substance mainly used for metal finishing and as a catalyst.
  • Acids generated from chromium trioxide and their oligomers (group containing: chromic acid, dichromic acid, oligomers of chromic acid and dichromic acid) (carcinogen). A substance that could be used to replace chromium trioxide in many of its uses.
  • Sodium dichromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment.
  • Potassium dichromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment and as a processing aid.
  • Ammonium dichromate (carcinogen, mutagen, toxic for reproduction). A substance with currently no uses in the scope of authorisation. It could however be used to replace other chromium(VI) substances.
  • Potassium chromate (carcinogen, mutagen). A substance mainly used in metal surface treatment.
  • Sodium chromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment.
  • Cobalt(II) sulphate (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
  • Cobalt dichloride (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
  • Cobalt(II) dinitrate (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
  • Cobalt(II) carbonate (carcinogen, toxic for reproduction). A substance mainly used in fertilisers and in surface treatment processes.
  • Cobalt(II) diacetate  (carcinogen, toxic for reproduction). A substance mainly used as a catalyst and in surface treatment processes."
More information can be found on the ECHA site.

Tuesday, August 30, 2011

EU Proposes to Ban 20 Chemical Substances

ECHA, the European Chemicals Agency based in Helsinki, has proposed a list of 20 chemical substances for eventual banning under the EU REACH program.  The August 29, 2011 proposal would label these chemicals as "substances of very high concern" (SVHC), which would make them eligible for placement on the "candidate list."  Once on the candidate list the substances may then be placed on Annex XIV of REACH, which requires manufacturers to apply for authorization for continued use.  Any authorization would be limited to specific uses that can control for the hazardous properties of each substance, and authorization is for a limited time period - just long enough for companies to find substitutes.

Nineteen of the 20 substances are proposed because of their "potentially serious effects on human health." These are classified as carcinogenic and/or toxic for reproduction.  One substance is proposed to be identified as a "substance of equivalent concern...because of its endocrine disrupting properties and potential for serious effects to the environment."

The substances are listed in the table of the ECHA press release here.

Interested parties have until October 13, 2011 to comment on any of the proposed SVHCs. ECHA notes that comments "should focus primarily on the hazardous properties that qualify the chemicals as SVHCs and on the substance identity."  They also ask for "further information on the uses, exposures and availability of safer alternative substances or techniques."

Unless dropped from the list based on comments received, these 20 will join the 53 substances already on the Candidate List. Some of these have already been added to Annex XIV.

More information on the REACH authorization process can be found on ECHA's web site.

Friday, June 17, 2011

ECHA Recommends 13 Chemicals for REACH Authorization (i.e., for the EU "to be banned" chemicals list)

The European Chemicals Agency (ECHA) has recommended thirteen additional chemicals for inclusion on its Annex XIV Authorization list.  These chemicals had been listed on ECHA's "candidate list" of Substances of Very High Concern" (SVHC).  Following consultation and comment, the 13 chemicals could be added to the list of chemicals that will be phased out from continued use, unless the manufacturer/importer applies for an "authorization" for an extended phase out period.  This is the third time ECHA has recommended a set of chemicals for inclusion on Annex XIV.


The following substances are on the third recommendation list:

  1. Chromium trioxide;
  2. Chromic acid, Oligomers of chromic acid and dichromic acid;
  3. Sodium dichromate;
  4. Potassium dichromate;
  5. Ammonium dichromate;
  6. Potassium chromate;
  7. Sodium chromate;
  8. Trichloroethylene;
  9. Cobalt(II) sulphate;
  10. Cobalt dichloride;
  11. Cobalt(II) dinitrate;
  12. Cobalt(II) carbonate;
  13. Cobalt(II) diacetate.
According to ECHA's press release:

Using the web forms available on ECHA’s website, interested parties are invited to comment, in particular on the uses that should be exempted from the authorisation requirement.

More information about how to comment and the authorization process can be found here.

Tuesday, May 31, 2011

Seven New "Substances of Very High Concern" Named by ECHA's Member State Committee

The Member State Committee (MSC) of the European Chemicals Agency (ECHA) in Helsinki, Finland, has named an additional seven substances as Substances of Very High Concern (SVHC) under the REACH chemical regulation in Europe.  Listing of these chemicals is based on them being CMR, i.e., being either carcinogenic, mutagenic, or reproductive toxins.  The seven substances are:
  • 2-ethoxyethylacetate
  • strontium chromate
  • 1,2-benzenedicarboxylic acid, di-C7-11 branched and linear esters (DHNUP)
  • hydrazine
  • 1-methyl-2-pyrrolidone
  • 1,2,3-trichloropropane
  • 1,2-benzenedicarboxylic acid, di-C6-8 branched alkyl esters, C7-rich (DIHP)
All seven new substances are to be listed on the candidate list.  DHNUP and DIHP will join other phthalates on the candidate list.  Ultimately, substances on the candidate list could be added to Annex XIV of REACH, which means they would be subject to banning unless manufacturers successfully apply for authorization for continued use. Authorization is normally for a very limited period of time (e.g., 4-5 years), generally is restricted to specific uses, and must be accompanied by a plan to find suitable, less hazardous, substitutes.

Once the MSC formally presents its recommendations to ECHA, the Agency will add the substances to the candidate list.

The ECHA announcement can be read here.

The current candidate list can be found here.

Monday, May 2, 2011

ECHA Explains How Companies Can Apply for Chemical Substance Authorization Under REACH

The European Chemicals Agency (ECHA) held a seminar on April 12, 2011 to guide companies in how to apply for REACH authorization of chemicals placed on Annex XIV.  Now they have made the seminar presentations available online for all to download.  The seminar "was primarily targeted to potential applicants for an authorisation, and in particular for the first substances included in the Authorisation List, as well as the substances in ECHA's second recommendation for the inclusion of substances in the Authorisation List."

According to ECHA, about 40 people participated in the seminar.

The seminar agenda can be viewed here.  Topics included the content requirements for the Authorization application, the tools and guidance available from ECHA, and then an open discussion period where ECHA representatives and presenters answered questions.

The seminar presentations can be downloaded here.

Wednesday, April 6, 2011

ECHA Provides Tools to Help Chemical Companies Prepare Authorization Applications for REACH

Now that the first deadline for REACH registration has passed, and responsible parties at registering companies have had a chance to take a vacation and catch up on other work, it's time for some companies to turn their attention to the "A" in REACH - Authorization.  And the European Chemicals Agency (ECHA) has now provided some tools to help companies do just that.

Authorization, of course, is the part of REACH where ECHA has determined that a particular "substance of very high concern" presents too great a risk and therefore intends to remove it from commerce.  Manufacturers of those chemicals put onto Annex XIV of REACH, the authorization list, must apply to receive authorization to continue using the chemical.  If no authorization is granted the chemical will be banned from commerce in the EU at the end of the specified sunset perios, which for the handful of chemicals added so far is 2014 or 2015.  If authorized, the chemical would be limited to uses that are critical and can be controlled, and where there are no available substitutes, and for only a limited period of time allotted to find or develop a substitute.

The new tools include "templates to document an analysis of alternatives, a socio-economic analysis and a substitution plan."   There is also a "Fee Calculator" to estimate how much it will cost to submit their application (but not how much to prepare the application). There are also a new Data Submission Manual that "explains in detail how to prepare an Application for Authorisation using IUCLID 5.3, and how to use the web forms for dossier submission."

More information is available on the ECHA web site.

Guidance on how to prepare the authorization application can be downloaded as a PDF here.

Guidance on how to prepare the socio-economic analysis can be downloaded as a PDF here.

Wednesday, February 23, 2011

US Chemical Makers to Seek Authorization for Continued European Use of Phthalates Under REACH Regulation


As noted previously the European Commission has announced that "six substances of very high concern will be banned within the next three to five years unless an authorisation has been granted to individual companies for their use." Three of these substances (DBP, BBP, and DEHP) fall into a general category called phthalates and now a major US trade association has indicated that phthalate manufacturers they represent will file applications for authorization to continued use in "important medical applications."  According to Steve Risotto, Phthalate Esters Panel, quoted in the American Chemical Council (ACC) statement:
"There is a large body of scientific information and a number of government safety assessments in the U.S. and abroad that give the manufacturers of these three phthalates confidence that their products are being used safely. In fact, phthalates are one of the most extensively studied groups of chemical compounds in the world." 
US manufacturers "will work with European regulatory authorities" (primarily the European Chemicals Agency, ECHA, in Finland) to "submit all the necessary data and seek approval for the continued use of these substances."  Without authorization, use of all six of the substances of very high concern (SVHC) will cease at their sunset dates in either 2014 or 2015. According to ECHA, these SVHCs are "are carcinogenic, toxic for reproduction or persist in the environment and accumulate in living organisms."

More information on phthalates can be found on the Phthalates Wikipedia page or ACC's Phthalate Esters Panel web page.  For contrasting information from an NGO activist organization, the Environmental Working Group also has a Phthalate web page.

Tuesday, February 22, 2011

ECHA Says - Time to Start Preparing Chemical Authorization Applications Under REACH

I mentioned last week that the European Commission had formally published the first six chemical substances onto Annex XIV of REACH, the Registration Evaluation and Authorization (and Restriction) of CHemicals regulation in Europe.  Now ECHA, the European Chemicals Agency in Helsinki, Finland, is telling companies that manufacture those six chemicals that the time is now to start preparing their authorization applications if they want to save some uses of those chemicals for a period of time beyond the assigned "sunset" dates.  Authorization would only be for specific uses and for specific periods of time, though renewals are possible.

Applications can be pretty comprehensive.  They require a full Chemical Safety Report, which summarizes the health and safety hazard data, the exposure potential for all uses, and demonstrates how the risk will be controlled for specific uses.  In addition, companies have to provide a "alternatives analysis," i.e, an analysis of existing or potential chemicals of lower risk that can be substituted for the Annex XIV listed "substances of very high concern (SVHC)."  For chemicals in which no alternative appears to be available, the companies requesting authorization must describe a plan for how they (or someone else) might develop an alternative. Companies can also provide a socioeconomic assessment (SEA) in which they quantify the societal benefit of the chemical substance, or the loss of such benefit should it be removed from the market with no suitable alternative.

Since it is likely that a particular chemical substance would have more than one manufacturer, authorization applications may be made both by individual companies and by groups of companies.  An authorization fee would be charged to cover the costs of the ECHA review. 

To facilitate the preparation of the application ECHA has recently published two new guidance documents.  The first "explains how to prepare an application for authorisation, the analysis of alternatives and the substitution plan."  The second "shows how to prepare a socio-economic analysis if the risks of the continued use of the substance cannot be adequately controlled."  Both documents can be downloaded here.

Thursday, February 17, 2011

First Set of Chemical Substances Ready to be Phased Out (aka banned) by Europe's REACH

The first six chemical substances to be given the hangman's noose, er, put on the REACH authorization list, have been announced by the European Commission.  These "substances of very high concern" had been put onto a "candidate list" for comment, but as of today have been moved to the authorisation list itself, which is known as Annex XIV under Europe's REACH regulation





The six substances are:
  • musk xylene
  • MDA
  • HBCDD
  • DEHP
  • BBP
  • DBP
[Okay, I realize the short forms and initials won't be recognizable to some; you can see full names in the press release here.]

Now that these six are in Annex XIV they "cannot be placed on the market or used unless authorisation has been granted for a specific use."  Obviously they are already on the market so for each substance there is a "sunset date" after which they can no longer be manufactured or imported in Europe unless an authorization application is filed and accepted.  Sunset dates for these six chemicals are in 2014 or 2015.  So manufacturers need to be developing an authorization application, which must include substantial health and safety data, information on the uses, a socioeconomic analysis to demonstrate why the societal benefit for keeping them on the market, and the specific uses that will be supported.  Only those uses that are deemed to be of sufficient need and can be controlled will be approved for continued use, and then only for a specified time frame (e.g., 5 years) to allow development of alternatives.

And the company applying for the authorization is responsible for identifying an alternative or providing a plan for how they will develop one.  Of course, competing companies may already have alternatives that can easily slip into the void but that couldn't compete with the usually lower cost, but more hazardous, chemical that already dominated market share.

Keep in mind that these are just the first six chemicals to be put on Annex XIV.  There are many more already on the candidate list, with more to be added periodically.  Manufacturers of chemicals that are "substances of very high concern" should be working to either find alternatives or to argue why they should not be put on the authorization (i.e., to be banned) list.

Tuesday, December 21, 2010

ECHA Recommends 8 Substances of Very High Concern be Subject to Authorization

While most attention has been on meeting registration deadlines and dealing with the new classification and labeling scheme, the European Chemicals Agency (ECHA) has also been busy at work assessing substances of very high concern (SVHC).  Yesterday ECHA recommended the addition of 8 chemicals to the candidate list for inclusion in the authorization annex based on carcinogenicity and/or reproductive toxicity issues.
The eight substances are:
  • Diisobutyl phthalate – DIBP (toxic to reproduction). A substance used as plasticiser for nitrocellulose, polyacrylate and polyacetate dispersions;
  • Diarsenic trioxide – As203 (carcinogen). A substance used in the manufacture of glass with special properties and of zinc;
  • Diarsenic pentaoxide – As205 (carcinogen). A substance which could be used as a replacement for diarsenic trioxide, no known current uses in the EU;
  • Lead chromate (carcinogen and toxic to reproduction). A substance used as pigment and in the manufacture of pyrotechnics;
  • Lead sulfochromate yellow - C.I. Pigment Yellow 34 (carcinogen and toxic to reproduction). A pigment used to colour plastics and coatings;
  • Lead chromate molybdate sulphate red - C.I. Pigment Red 104 (carcinogen and toxic to reproduction). A pigment with similar uses as lead sulfochromate yellow;
  • Tris(2-chloroethyl)phosphate – TCEP (toxic to reproduction). A substance used as a plasticiser and viscosity regulator with flame-retarding properties for coatings;
  • 2,4-Dinitrotoluene - 2,4-DNT (carcinogen). A substance mainly used in explosives and propellants for ammunition.
The European Commission makes the final decision on the inclusion of the substances in Annex XIV of the REACH Regulation.  This now makes 46 chemicals on the candidate list waiting for addition to Annex XIV, after which they would only be eligible for continued use if manufacturers or importers applied for authorization and could show a combination of controlled use and a plan for finding substitutes.  Any authorization would be limited both temporally and with restrictions in the specific uses allowed.

More on the ECHA recommendations and the authorization process can be found on the ECHA web site.

Monday, December 6, 2010

ECHA Will Add 8 Chemicals to its Substances of Very High Concern List

Now that the European Chemicals Agency (ECHA) has succeeded (mostly) in handling the thousands of substance registrations due by November 30th, they will continue to look at Substances of Very High Concern (SVHCs).  To that end they will be adding eight SVHCs to its list of substances to be controlled under the Authorization part of REACH.
 
The substances are:
- Di-isobutylphthalate (DIBP)
- Diarsenic trioxide
- Diarsenic pentaoxide
- Lead chromate
- Lead sulfochromate yellow (C.I. Pigment Yellow 34)
- Lead chromate molybdate sulphate red (C.I. Pigment Red 104)
- Tris(2-chloroethyl)phosphate (TCEP)
- 2,4-dinitrotoluene (2,4-DNT)
 
But that isn't all. ECHA also has proposed another eight substances for inclusion on the candidate list, which depending on feedback from stakeholders, could also end up being added to the Authorization Annex under REACH. Those eight are:
 
- Chromium trioxide
- Acids generated from chromium trioxide and their oligomers
- Cobalt(II)sulphate
- Cobalt(II)dinitrate
- Cobalt(II)carbonate
- Cobalt(II)diacetate
- 2-methoxyethanol
- 2-ethoxyethanol

More to come.

Sunday, September 26, 2010

Europe Adopts First Chemicals for its Authorization List under REACH

We now have our first list of chemicals added to Annex XIV for possible Authorization.  This past week the EU’s REACH Committee adopted a list of six substances the European Chemical's Agency (ECHA) has proposed as substances of very high concern.

The six listed in Annex XIV are:

  • 5-tert-butyl-2,4,6-trinitro-m-xylene (also known as musk xylene)
  • 4,4’ – diaminodiphenylmethane (MDA)
  • Hexabromocyclododecane (HBCDD)
  • Bis(2-ethylhexyl)phthalate (DEHP)
  • Benzyl butyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
All six were previously listed on ECHA's "candidate list," which is the first step in the REACH Authorization process.  Following the opportunity for stakeholders to comment, the chemicals now are formerly added to Annex XIV of REACH. 

And here is where things get really interesting.  Now that these six (and many more in the future) are in Annex XIV, they are now considered to be on the chopping block.  These six chemicals will be banned after a designated time period unless manufacturers make formal application for "authorization."  Authorization means they could be allowed to continue certain uses of the substance, but only under strictly controlled conditions for a finite period of time to allow the development or discovery of a substitute substance.  Meanwhile the stigma of being listed will likely cause downstream users to search for alternative formulations for their products, so the incentives for finding replacements are based both on regulatory deadlines and market economics.

Tuesday, July 13, 2010

Six Chemicals in Draft Proposal to be Added to REACH Authorization Annex


The European Commission has drafted a proposal to amend Annex XIV of the REACH regulation. Annex XIV lists the substances which are subject to the authorization requirements. For those who have followed The Dake Page, all of the substances listed in the various candidate lists (and upcoming ones) are in line for the authorization phase should manufacturers or importers choose to support continued limited uses pending development of replacements.

The six chemicals proposed in the draft include musk xylene, MDA, HBCDD, DEHP, BBP and DBP into Annex XIV.

After the "sunset date," these substances would only be eligible to remain on the market for specific uses, and only for those specific operators who have applied for and been granted an authorization in accordance with REACH.

More in the coming days. Lots of US TSCA related activity.

Sunday, April 5, 2009

European Trade Union Lists 306 "Substances of Very High Concern" - Will this Blacklist Safe Chemicals?


The European Trade Union Confederation (ETUC), based in Brussels, published a "Trade Union Priority List for Reach Authorisation," featuring a list of 306 chemicals that ETUC says “are of very high concern.” ETUC is calling on European Union (EU) member states to include the list of 306 chemicals on the candidate list of substances for authorization under the EU’s Registration, Evaluation, and Authorisation of Chemicals (REACH) program.

As I have noted previously, REACH is the new chemical control law in Europe and it requires all manufacturers and importers of chemicals to "register" them within a specific time frame if they want to continue using chemicals that have already been on the market. New chemicals must be registered before going on the market, with registration requiring a substantial dossier compiling all of the health and safety data, as well as exposure scenarios for every intended use of the chemical.

In addition to the registration (the "R" in REACH), there is a requirement for certain "substances of very high concern" (SVHC) to receive authorization for continued use (the "A" in REACH). Authorization requires the manufacture to submit an application that includes all of the usual health and safety data in a dossier, and also a plan for its substitution by substances of lesser concern. Authorization is for a limited time and for specific uses only, and only to allow development of alternatives.

Last fall the European Chemicals Agency (ECHA) issued the first of what will be regular lists of "candidate" chemicals, i.e., those substances for which Authorization will be necessary of the manufacturers or importers want to keep the sustance on the market for a while longer (otherwise, they will simply be banned). The first candidate list contained 16 chemicals.

While only ECHA is responsible for issuing the candidate list, other organizations have jumped on the "list" bandwagon in an effort to suggest chemicals they think ECHA should nominate for Authorization. ETUC is particularly concerned about 191 chemicals identified as causing occupational diseases (e.g., acrylamide, bisphenol A, and formaldehyde). Last year a group of European environmental organizations under the collaboration name ChemSoc issued a SIN List (Substitute It Now) of substances they felt were of high concern. In addition, individual Member States of the European Union can suggest chemicals of particular interest to them.

As noted, only ECHA can issue the candidate lists, but with ETUC, ChemSoc and surely others issuing their own lists there is a definite potential for blacklisting. Even the candidate list itself doesn't say the chemicals listed need to be banned or severely restricted, only that they are in need of a much closer look. Some of the candidate list chemicals will eventually be removed as new information is made available by the manufacturers. But having a list of chemicals that someone arbitrarily says are of "very high concern" can be very damaging to busy as downstream users are hesitant to use chemicals that are being targeted. Compare the several hundreds of chemicals on ETOC's list (306) and the SIN list (200) versus only 16 on the first ECHA candidate list and you can see the potential for blacklisting even before there is any formal evaluation of the data.

ETUC says its goal is to contribute to the practical implementation of the authorization phase of REACH. ETUC says it endorses an approach where risks of certain chemicals are controlled and the most hazardous chemicals are replaced with safer alternatives. While all of the chemicals listed by ETUC supposedly meet the REACH criteria for classification as ‘substances of very high concern,’ (i.e., persistent, bioaccumulative, toxic or carcinogenic, mutagenic, or reproductive toxicants), the ETUC list goes further as it "ranks chemicals by reference to their intrinsic toxicological properties and identifies those that cause occupational diseases which are recognised at EU level.”

We'll see how these independent lists affect the market, which could very well substitute away from chemicals that can be safely used and toward chemicals that may actually have a greater impact on human health and the environment.