{"id":3803,"date":"2014-06-06T09:58:39","date_gmt":"2014-06-06T14:58:39","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=3803"},"modified":"2014-06-06T09:58:39","modified_gmt":"2014-06-06T14:58:39","slug":"echa-keeps-the-ball-rolling-on-authorisation-under-reach","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2014\/06\/06\/echa-keeps-the-ball-rolling-on-authorisation-under-reach\/","title":{"rendered":"ECHA keeps the ball rolling on Authorisation under REACH"},"content":{"rendered":"<p><em>Alissa Sasso<\/em> is a Chemicals Policy Fellow<em>.<\/em><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">In our last update on the European Union\u2019s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), <\/span><a href=\"https:\/\/blogs.edf.org\/health\/2014\/02\/06\/a-reach-milestone-first-authorisation-application-passes-the-european-chemicals-agency\/\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">we noted a major milestone<\/span><\/a><span style=\"color: #000000;font-family: Calibri;font-size: medium\"> under the \u201cA\u201d of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The authorisation process is continuing to move along: <\/span><a href=\"http:\/\/echa.europa.eu\/web\/guest\/addressing-chemicals-of-concern\/authorisation\/applications-for-authorisation\/received-applications\"><span style=\"color: #0000ff\"><span style=\"font-family: Calibri\"><span style=\"font-size: medium\">as of May 19<\/span><sup><span style=\"font-size: small\">th<\/span><\/sup><\/span><\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">, ECHA has received 13 applications for 35 uses of six different substances on the Authorisation list. Interest in ECHA\u2019s authorisation work is also increasing, eliciting a greater variety of stakeholder input than in the first round.\u00a0 <!--more--><\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">For a refresher on authorisation under REACH, click <\/span><a href=\"https:\/\/blogs.edf.org\/health\/2014\/02\/06\/a-reach-milestone-first-authorisation-application-passes-the-european-chemicals-agency\/\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">here<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">. <\/span><\/span><\/span><\/p>\n<p><b><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">Additional phthalate applications spark public interest<\/span><\/span><\/span><\/b><\/p>\n<p><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">Our last blog post covered an application for authorisation of a very narrow use of Bis(2-ethylhexyl)phthalate (DEHP) by Rolls Royce: in the manufacture of fan blades for plane engines; a final decision from the European Commission on that application is pending. <\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">ECHA received seven additional applications covering 16 uses for DEHP and another phthalate on the authorisation list: Dibutyl phthalate (DBP). You can see a summary of the uses applied for <\/span><a href=\"http:\/\/echa.europa.eu\/addressing-chemicals-of-concern\/authorisation\/applications-for-authorisation-previous-consultations\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">here<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">. <\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">The ECHA Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) have published a draft opinion on one use of DBP applied for by Sasol-Huntsman, determining the application <\/span><a href=\"http:\/\/chemicalwatch.com\/19331\/echa-publishes-opinion-on-authorisation-of-dbp-use?q=authorisation\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">\u201cdemonstrated adequate control of risks\u201d<\/span><\/a><span style=\"color: #000000;font-family: Calibri;font-size: medium\"> (<i>Chemical Watch<\/i>, subscription required). In this application, <\/span><a href=\"http:\/\/echa.europa.eu\/addressing-chemicals-of-concern\/authorisation\/applications-for-authorisation-previous-consultations\/-\/substance\/4815\/search\/+\/term\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">DBP is used<\/span><\/a><span style=\"color: #000000;font-family: Calibri;font-size: medium\"> as an absorption solvent in the manufacture of another compound, maleic anhydride. The Committees have yet to publish opinions on the other applications for these phthalates; you can see the status of all applications <\/span><a href=\"http:\/\/echa.europa.eu\/addressing-chemicals-of-concern\/authorisation\/applications-for-authorisation-previous-consultations\/-\/substance\/4815\/search\/+\/term\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">here<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">.<\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">During the public consultation period for the seven additional phthalate applications, ECHA received 120 comments, way up from the five comments received on the first application by Rolls Royce. There are several reasons for the increase in stakeholder participation. First, the applications cover a greater variety of uses than that proposed by Rolls Royce. Applicants for these more recent authorizations, some of which are chemical manufacturers rather than downstream users, are only providing broad use descriptions and alternatives assessments. This has prompted many comments from<\/span><a href=\"http:\/\/chemicalwatch.com\/18034\/echa-publishes-comments-on-phthalate-authorisation-consultations?q=%22echa%20publishes%20comments%22\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\"> both EU member state authorities and NGOs<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">, calling on ECHA to reject these applications and require detailed descriptions and separate assessments for each specific use (<i>Chemical Watch, <\/i>subscription required). <\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">Additionally, many NGO comments address the lack of detail and transparency in the broad information on these uses that is being shared with the public. This information is provided by the companies applying for authorisations, and <\/span><a href=\"http:\/\/www.eeb.org\/EEB\/?LinkServID=D3B592E6-5056-B741-DB4B95B097C2D86F\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">NGOs have accused ECHA of broadly accepting all of their confidentiality claims<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">. They argue that the lack of detail provided to the public makes it more difficult for third parties to assess or recommend alternatives.\u00a0 <\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">Finally, <\/span><a href=\"http:\/\/newsletter.echa.europa.eu\/home\/-\/newsletter\/entry\/1_14_applications-for-authorisation-on-the-increase;jsessionid=39148429E052E5B37B566C927E214B89.live1\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">according to ECHA<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">, many of the comments were prompted by the proposed large-volume use of DEHP as a plasticizer in a wide range of consumer plastic products; commenters noted that the potential for exposure to this chemical, should an authorisation be granted, is far greater than from the single narrow use proposed by Rolls Royce. <\/span><\/span><\/span><\/p>\n<p><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">Interestingly, several NGOs and the Lowell Center for Sustainable Production at the University of Massachusetts submitted comments on alternatives to DEHP. Not only is there global interest in the EU\u2019s authorisation process, but it is eliciting substantive comments aimed at promoting safer substitution even from groups outside the EU.<\/span><\/span><\/span><\/p>\n<p><b><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">Other authorisation applications hit close to home<\/span><\/span><\/span><\/b><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">ECHA has also received four applications for uses of diarsenic trioxide and the lead chromate pigments, Yellow 34 and Red 104. You can view the status of the committee decisions as they are published and all public comments submitted for these substances <\/span><a href=\"http:\/\/echa.europa.eu\/addressing-chemicals-of-concern\/authorisation\/applications-for-authorisation-previous-consultations\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">here<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">. <\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">Applications for two uses of hexabromocyclododecane (HBCDD, abbreviated as HBCD in the U.S.), have also been received, both of them for use as a flame retardant in expanded polystyrene foam in building applications. HBCD is undergoing a risk assessment by the U.S. EPA as part of its <\/span><a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/2013wpractivities.html\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">2013 TSCA Work Plan<\/span><\/a><span style=\"color: #000000;font-family: Calibri;font-size: medium\">, and it was the subject of a <\/span><a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/actionplans\/hbcd.html\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">U.S. EPA Action Plan<\/span><\/a>\u00a0<span style=\"font-family: Calibri\"><span style=\"font-size: medium\"><span style=\"color: #000000\">issued in 2010.\u00a0EPA\u2019s <\/span><\/span><\/span><a href=\"http:\/\/www.epa.gov\/dfe\/pubs\/projects\/hbcd\/about.htm\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">Design for the Environment (DfE) program completed an alternatives assessment<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: medium\"><span style=\"color: #000000\"> for certain uses of HBCD in 2013, including for the two uses for which authorisations are being sought under REACH. <\/span><\/span><\/span><\/p>\n<p><span style=\"font-family: Calibri\"><span style=\"font-size: medium\"><span style=\"color: #000000\">Despite the flurry of activity on HBCD in both the EU and the U.S., this flame retardant is still in production and use here at home. \u00a0See EDF\u2019s <i>Toxics Across America<\/i> map showing its sites of manufacture and import; two chemical names and CAS#s represent HBCD: <\/span><\/span><\/span><\/p>\n<ul>\n<li><a href=\"http:\/\/www.edf.org\/health\/toxics-across-america\/map?cas=25637-99-4\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">Hexabromocyclododecane (HBCD) (CAS # 25637-99-4)<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: medium\"><span style=\"color: #0000ff\">: <\/span>imported by BASF at one site (to directly access EPA\u2019s CDR data on this chemical, click <\/span><\/span><a href=\"http:\/\/java.epa.gov\/oppt_chemical_search\/?redirectFrom=true&amp;casno=25637-99-4\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">here<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: medium\">) ;<span style=\"color: #000000\"> and <\/span><\/span><\/span><\/li>\n<li><a href=\"http:\/\/www.edf.org\/health\/toxics-across-america\/map?cas=3194-55-6\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">1,2,5,6,9,10-Hexabromocyclododecane (CAS # 3194-55-6)<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: medium\"><span style=\"color: #0000ff\">: <\/span>manufactured by Albemarle at one site; imported by Dow at one site (to directly access EPA\u2019s CDR data on this chemical, click <\/span><\/span><a href=\"http:\/\/java.epa.gov\/oppt_chemical_search\/?redirectFrom=true&amp;casno=3194-55-6\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">here<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: medium\">)<span style=\"color: #000000\">. <\/span><\/span><\/span><\/li>\n<\/ul>\n<p><b><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">What\u2019s coming next<\/span><\/span><\/span><\/b><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">ECHA has said that it <\/span><a href=\"http:\/\/newsletter.echa.europa.eu\/home\/-\/newsletter\/entry\/1_14_applications-for-authorisation-on-the-increase;jsessionid=39148429E052E5B37B566C927E214B89.live1\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">expects to receive a total of 20 authorisation applications this year<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"font-size: medium\">, for<span style=\"color: #000000\"> trichloroethylene (applications are due October 21<\/span><\/span><span style=\"color: #000000\"><sup><span style=\"font-size: small\">st<\/span><\/sup><span style=\"font-size: medium\">) and several chromium-containing substances (applications are not due until 2015). <\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">We\u2019ve <\/span><a href=\"https:\/\/blogs.edf.org\/health\/2011\/11\/22\/twin-dangers-from-tce-widespread-exposure-and-now-a-strong-link-to-parkinson-disease\/\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">previously blogged<\/span><\/a><span style=\"color: #000000;font-family: Calibri;font-size: medium\"> about the widespread exposure to TCE and evidence of its link to Parkinson\u2019s Disease. TCE is also an EPA Work Plan chemical for which a <\/span><a href=\"http:\/\/www.epa.gov\/climatechange\/pdfs\/CI-health-and-society-2014.pdf\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">draft risk assessment<\/span><\/a><span style=\"color: #000000;font-family: Calibri;font-size: medium\"> for particular uses was issued last year that indicated \u201ca potential concern for human health under specific exposure scenarios\u2026\u201d. You can see sites of production and import of TCE (CAS # 79-01-6) in the U.S. on <\/span><a href=\"http:\/\/www.edf.org\/health\/toxics-across-america\/map?cas=79-01-6\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">EDF\u2019s <i>Toxics Across America<\/i> map<\/span><\/a><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">. <\/span><\/span><\/span><\/p>\n<p><b><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">ECHA\u2019s balancing act<\/span><\/span><\/span><\/b><\/p>\n<p><span style=\"font-family: Calibri\"><span style=\"color: #000000\"><span style=\"font-size: medium\">Though much of the EU\u2019s progress on managing chemical risks under REACH is receiving little notice here in the U.S., many of these chemicals are in production and use here. The alternatives assessment process that is a key element of REACH authorisation will be particularly interesting to follow. For some of the uses alternatives may be difficult to find: Because the authorisation process is onerous and expensive, the sought-after uses are likely considered critical by the applicants, and they may already have looked into alternatives before pursuing authorisation. Where that turns out to be case, decisions on authorisation applications will highlight uses of hazardous chemicals for which no feasible alternative currently exists and could be a driver for research and development to identify alternatives.<\/span><\/span><\/span><\/p>\n<p><span style=\"color: #000000;font-family: Calibri;font-size: medium\">On a broader level, states and organizations in the U.S. will be able to learn from ECHA\u2019s progress on this front.\u00a0 As discussed in a <\/span><a href=\"https:\/\/blogs.edf.org\/health\/2014\/03\/13\/no-more-california-dreamin-first-three-priority-products-proposed\/\"><span style=\"color: #0000ff;font-family: Calibri;font-size: medium\">previous blog post<\/span><\/a><span style=\"font-size: medium\"><span style=\"color: #000000\"><span style=\"font-family: Calibri\">, the California Department of Toxic Substances Control is beginning to implement its own alternatives analysis requirements for a few priority products; and various groups in the U.S. have also released their own principles and tools for alternatives assessment. As we\u2019ve stressed before, transparency is key. A lack of transparency on the part of companies applying for authorisations is a frequent complaint voiced by observers of the REACH authorisation process. As ECHA currently relies on voluntary submissions during the public consultation to inform a robust alternatives assessment process, it will be interesting going forward to see how they balance the protection of business information with the need to gather useful and insightful public comments. <\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Alissa Sasso is a Chemicals Policy Fellow. In our last update on the European Union\u2019s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we noted a major milestone under the \u201cA\u201d of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The &#8230;<\/p>\n","protected":false},"author":8643,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44],"tags":[446],"coauthors":[],"class_list":["post-3803","post","type-post","status-publish","format-standard","hentry","category-policy","tag-reach"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/3803","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/users\/8643"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=3803"}],"version-history":[{"count":0,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/3803\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=3803"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=3803"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=3803"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=3803"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}