Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.
The European Chemicals Agency (ECHA) has been busy this week implementing the EU's chemical regulation, REACH (short for Registration, Evaluation, Authorization and Restriction of Chemicals).
On Monday, ECHA announced it has added 20 more Substances of Very High Concern (SVHCs) to REACH's Candidate List. These SVHCs are now eligible for later addition to Annex XIV, the list of SVHCs subject to Authorization.
Separately, the agency today forwarded its final recommendation that 13 chemicals already on the Candidate List be formally added to Annex XIV. (We had blogged earlier about ECHA's initial recommendation proposing these 13 SVHCs for Authorization.) If the European Commission confirms this addition, after a specified sunset date, the use of these will be allowed only if specifically authorized by EU authorities.
Additions to the Candidate List
ECHA announced the addition of 20 chemicals to the Candidate List of Substances of Very High Concern through a press release issued on Monday. The release also notifies companies of obligations triggered by the new status of these chemicals. The addition of these 20 chemicals is a significant step in several ways.
First, the flagging of these chemicals as Substances of Very High Concern is bound to prompt market responses in Europe and beyond. Chemical Watch's evaluation of innovation under REACH (subscription required) notes that placing a chemical on the Candidate List is a strong motivator for substitution, just as ECHA projected in a 2007 report.
Second, some or all of these chemicals may ultimately be included in Annex XIV for Authorization, which bans or curtails the uses of a listed chemical (see more detail in the section on Authorization below).
Third, one of the 20 chemicals – 4-tert-octylphenol (which ECHA identifies using its more formal name 4-(1,1,3,3-tetramethylbutyl)phenol) – is the first to be identified as a SVHC based on endocrine-disrupting activity. That activity has triggered the criterion that allows ECHA to identify a chemical of "equivalent concern" as a SVHC and add it to the Candidate List. Using "equivalent concern" as the justification for this candidate chemical is an important milestone in the management of health risks posed by endocrine disruptors.
Of the remaining 19 chemicals, 12 were added due to their status as carcinogens while six others were added because they are toxic to reproduction. One chemical was both a carcinogen and toxic to reproduction. (See here for ECHA's description of the various criteria REACH delineates for identifying SVHCs. With the addition of these 20 chemicals, the Candidate List now has 73 listings that include 79 unique Chemical Abstracts Service (CAS) registration numbers.)
Our analysis of the 18 new chemicals with CAS numbers (two of the 20 do not have CAS numbers) yielded the following information on their presence in U.S. commerce:
- 15 of the 18 new CAS numbers are on the public portion of the USEPA's Toxic Substances Control Act (TSCA) Inventory, which lists the approximately 67,000 chemicals that have been in commerce in the U.S at some point since 1979. (Overall, 61 of the 79 Candidate List CAS numbers are on the public TSCA Inventory.)
- Nine of the 18 new CAS numbers were reported publicly under the USEPA's 2006 Inventory Update Rule (IUR), which required companies to report on chemicals produced or imported at levels of 25,000 lbs or more per year. (Overall, 45 of the 79 Candidate List CAS numbers were reported under the 2006 IUR.
[NOTE: Additional Candidate List chemicals may be on the full Inventory if their chemical identities are declared confidential; or may have been manufactured or imported in the U.S. yet not reported in 2006, if they fall below the reporting threshold of 25,000 pounds per year per site or if their chemical identities are declared confidential.]
Table 1 at the end of this post includes information on the hazards, uses, and U.S. production volumes of the 20 chemicals.
Additions to Annex XIV for Authorization
Today's final recommendation from ECHA to add 13 more chemicals to Annex XIV is the third such recommendation (see the other two here). If the European Commission confirms this addition, these 13 chemicals will join the six inaugural chemicals that were added to Annex XIV in February of this year (see our blog post on that occasion), and also some or all of eight pending chemicals that were proposed for addition in December 2010. According to a Chemical Watch article, the new set of 13 chemicals is expected to be added in February of 2013.
ECHA's press release notes that the 13 chemicals are carcinogenic, mutagenic, and/or toxic to reproduction AND have uses that may lead at least to worker exposure.
The presence of TCE among the recommended chemicals is notable because of both widespread exposure and its recent designation by EPA as a human carcinogen. A recent blog post by EDF Health Scientist Jennifer McPartland describes health risks from inhalation in addition to recent findings that link exposure to this solvent to Parkinson disease. EPA has summarized the extensive evidence of TCE's toxicity (including carcinogenicity) in its September 2011 Integrated Risk Information System (IRIS) review.
Nearly all of the 13 chemicals (represented by 15 CAS numbers) are in active commerce in the U.S.:
- 14 of the 15 CAS numbers are on the public US TSCA Inventory.
- 11 of the 15 CAS numbers were publicly reported under the U.S.'s 2006 Inventory Update Rule (IUR).
Assuming these 13 chemicals are added to Annex XIV and become subject to Authorization, many or most of their uses will be banned in the EU. But there are two routes under REACH through which companies may pursue an "authorization" and continue to use them.
1) For certain SVHCs, authorization of a use must be granted if a company submits information demonstrating the use of control measures that "adequately control" its risks.
2) However, that route to authorization cannot be used for SVHCs that are:
- persistent, bioaccumulative, and toxic (PBTs);
- very persistent and very bioaccumulative (vPvB);
- PBT- or vPvB-like and of equivalent concern; or
- carcinogens, mutagens, or reproductive toxicants (CMRs) for which it is not possible to determine a threshold of effect.
REACH deems these chemicals as simply too risky for the "adequate control" approach. Instead, companies seeking authorization for these chemicals must establish that the economic and social benefits of using the chemical exceed the risks AND that there are no acceptable substitutes. (See ECHA's page on Authorization for more detail).
A complete list of the 13 chemicals and related information is available on ECHA's website.
Table 1. The 20 chemicals added to the Candidate List on December 20, 2011
|Name||CASNumber||Classification or reason for inclusion||Commercial/ Consumer Uses||Industrial Uses||2006 IUR Volume|
|Zirconia Aluminosilicate Refractory Ceramic Fibres||N/A||Reason for inclusion is carcinogenicity||??||??||??|
|Calcium arsenate||7778-44-1||Not classified; reason for inclusion is carcinogenicity||N/A||REACH: Manufacture of metals and alloys||N/A|
|Bis(2-methoxyethyl) ether||111-96-6||ESIS*: Category 2 reproductive toxicant: May impair fertility; May cause harm to the unborn child||IUR**: Variably reported as adhesives and sealants, automotive products, paints and coatings, and OtherREACH: Consumer use advised against||IUR** andREACH: Solvents||1-10 million lbs/year|
|Aluminosilicate Refractory Ceramic Fibres||N/A||Reason for inclusion is carcinogenicity||??||??||??|
|Potassium hydroxyoctaoxo-dizincatedi-chromate||11103-86-9||Not classified; reason for inclusion is carcinogenicity||No consumer uses reported under REACH||REACH: Chemical manufacturing; industrial coatings and sealants; vehicle coatings; paints and paint thinners/ removers||N/A|
|Lead dipicrate||6477-64-1||Not classified; reason for inclusion is toxicity for reproduction||Chemical not reported under REACH or the IUR||Chemical not reported under REACH or the IUR||N/A|
|N,N-dimethylacetamide||127-19-5||ESIS*: Category 2 reproductive toxicant: May cause harm to the unborn child||IUR**: Variably reported as photographic supplies, confidential business information (CBI), and not readily obtainable (NRO)REACH: Use as a laboratory chemical by professional workers||IUR**: Variably reported as CBI, NRO, intermediates, solvents, and OtherREACH: Chemical manufacturing, solvent, laboratory chemical, additive in coatings, use in fiber production||50-100 million lbs/year|
|Arsenic acid||7778-39-4||Not classified; reason for inclusion is carcinogenicity||Consumer and commercial uses not reported under IUR or REACH||IUR**: Industrial processing and use information not reportedREACH: Industrial end use and production of copper foil||1-10 million lbs/ year|
|2-Methoxyaniline; o-Anisidine||90-04-0||ESIS*: Category 2 carcinogen: May cause cancer||IUR**: Product category and use in children's products is NRO||IUR**: Use as an intermediateREACH: Use as an intermediate; intermediate for chemicals for dyes||500,000 to 1 million lbs/ year|
|Trilead diarsenate||3687-31-8||Not classified; reason for inclusion is carcinogenicity and toxicity for reproduction||No consumer uses reported under REACH||REACH: Use as a constituent in manufacturing metals and alloys||N/A|
|1,2-dichloroethane||107-06-2||ESIS*: Category 2 carcinogen: May cause cancer||IUR**: Variably reported as rubber and plastic products, NRO, and OtherREACH: Use as a laboratory chemical by professional workers||IUR**: Variably reported as CBI, NRO, Other, intermediate, and processing aidREACH: Use as an intermediate, solvent, production of vinyl chloride, manufacture of dichloroethane, production of polymers, processing aid, laboratory chemical||1 billion lbs and greater|
|Pentazinc chromate octahydroxide||49663-84-5||Not classified; reason for inclusion is carcinogenicity||No consumer uses reported under REACH||REACH: Chemical manufacturing, aerospace coatings, and vehicle coatings||N/A|
|4-(1,1,3,3-tetramethylbutyl)phenol||140-66-9||Reason for inclusion is "Equivalent level of concern having probable serious effects to the environment"||IUR**: Product category and use in children's products is CBIREACH: Professional and consumer use of coatings, inks, paints, and adhesives||IUR**: Intermediate in resin and synthetic rubber manufacturingREACH: Industrial application of coatings or inks; manufacture of tires and rubber products; production of ethoxylates; formulation of adhesives and paints||50 – 100 million lbs/ year|
|Formaldehyde, oligomeric reaction products with aniline||25214-70-4||Not classified; reason for inclusion is carcinogenicity||No consumer uses reported under REACH||REACH: Use as an intermediate, manufacture of 4,4'-Methylenedianiline (MDA), filament winding||N/A|
|Bis(2-methoxyethyl) phthalate||117-82-8||ESIS*: Category 2 reproductive toxicant: May cause harm to the unborn child; possible risk of impaired fertility||Chemical not reported under REACH or the IUR||Chemical not reported under REACH or the IUR||N/A|
|Lead diazide, Lead azide||13424-46-9||ESIS*: Categories 1 and 3 reproductive toxicant: May cause harm to the unborn child; possible risk of impaired fertility||No consumer uses reported under REACH||REACH: Chemical manufacturing, use in detonators, dextrinated lead azide||N/A|
|Lead styphnate||15245-44-0||ESIS*: Categories 1 and 3 reproductive toxicant: May cause harm to the unborn child; possible risk of impaired fertility||Consumer and commercial uses not reported under IURREACH: Professional use in primer ammunition and pyrotechnic articles||IUR**: Industrial processing and use not reportedREACH: Chemical manufacturing||Less than 500,000 lbs/ year|
|2,2'-dichloro-4,4'-methylenedianiline||101-14-4||ESIS*: Category 2 carcinogen: May cause cancer||IUR**: Product category and use in children's products is NRO||IUR**: Manufacturing of urethane and other foam products (except polystyrene)REACH: Storage and transfer, quality control, manufacture of pre-polymer||500,000- 1 million lbs/ year|
|Phenolphthalein||77-09-8||ESIS*: Category 2 carcinogen, Category 3 mutagen, and Category 3 reproductive toxicant: May cause cancer; possible risk of impaired fertility||Chemical not reported under REACH or the IUR||Chemical not reported under REACH or the IUR||N/A|
|Dichromium tris(chromate)||24613-89-6||ESIS*: Category 2 carcinogen: May cause cancer||Consumer and commercial uses not reported under IUR||IUR**: Industrial processing and use not reportedREACH: Chemical manufacturing, formulation of metal treatment products, anti-corrosion primers for steel and aluminum, laboratory reagent, surface treatment||Less than 500,000 lbs/ year|
* To view the European Chemical Substances Information System (ESIS) data for a chemical, follow the link, select "CAS#" from the left pull-down menu, and enter the CAS number in the search box.
** To view the IUR data for a chemical, follow the link and enter the CAS number in the search box.