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.

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.

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.

ECHA Adds 20 More Chemicals to Substances of Very High Concern List

The European Chemical Agency (ECHA) has added twenty additional substances to the Candidate List of Substances of Very High Concern (SVHC).  This brings the list up to a total of 73 chemicals.  Eight of the newly added chemicals were automatically added since no comments challenging their inclusion were received from the public.  The other 12 received unanimous agreement of the Member State Committee.

Of the 20, all but one were added because they have been identified as carcinogenic and/or toxic for reproduction. For the first time, however, one chemical was added to the Candidate List on the basis of "equivalent concern."  Specifically, the substance 4-tert-octyl phenol was "identified as an SVHC because of its endocrine disrupting properties" and "probable serious effects to the environment."  The use of endocrine disrupting properties to list a chemical is somewhat controversial as there is still significant uncertainty surrounding the methodologies used to make the determination.  Validation of a suite of endocrine disruption tests is ongoing, with mixed results.

The Candidate List serves as a launching point for ECHA to add chemicals to the Annex XIV of the REACH regulation, also known as the Authorization List.  Chemicals that are put on Annex XIV are slated for replacement and manufacturers are required to apply for "authorization" for continued use, which is limited to specific uses, volumes and risk management measures, all while working against a deadline for substitution of less hazardous substances.


More information and the list of substances is available on ECHA's recently revamped web site.

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.

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.

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.