{"id":13603,"date":"2025-07-08T08:20:38","date_gmt":"2025-07-08T00:20:38","guid":{"rendered":"https:\/\/li-on.biz\/?p=13603"},"modified":"2025-07-21T09:12:32","modified_gmt":"2025-07-21T01:12:32","slug":"reach%e9%99%84%e9%8c%84xvii%e6%96%b0%e5%a2%9e%e5%b0%8ddmac%e8%88%87nep%e7%9a%84%e9%99%90%e5%88%b6","status":"publish","type":"post","link":"https:\/\/li-on.biz\/en\/reach%e9%99%84%e9%8c%84xvii%e6%96%b0%e5%a2%9e%e5%b0%8ddmac%e8%88%87nep%e7%9a%84%e9%99%90%e5%88%b6\/","title":{"rendered":"REACH Annex XVII adds restrictions on DMAC and NEP"},"content":{"rendered":"<p class=\"translation-block\">On June 3, 2025, the European Commission published in its Official Journal the amending Regulation (EU) 2025\/1090 to Annex XVII (Restrictions, Annex 17) of the REACH Regulation, adding item 80, N,N-dimethylacetamide (DMAC), and item 81, 1-ethylpyrrolidin-2-one (NEP), to Annex 17 of the REACH Regulation.<\/p>\n\n\n\n<p><strong>The new provisions are as follows:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Substance Information<\/strong><\/td><td><strong>Restrictions<\/strong><\/td><\/tr><tr><td>80. N,N-\u4e8c\u7532\u57fa\u4e59\u91af\u80fa(DMAC)&nbsp;<br>N,N-dimethylacetamide<br>CAS&nbsp;\u865f: 127-19-5<br>EC \u865f: 204-826-4<img fetchpriority=\"high\" decoding=\"async\" height=\"412\" src=\"https:\/\/cti-cert.com.tw\/upload\/images\/202506091125508565.png\" width=\"412\"><\/td><td class=\"translation-block\">1. From 23 December 2026, the substance shall not be placed on the market as a pure substance, as a component of other substances or in a mixture with a concentration of 0.3% or more, unless manufacturers, importers and downstream users include in the relevant chemical safety reports and safety data sheets (SDS) derived no-effect levels (DNELs) related to worker exposure to DMAC of 13 mg\/m<sup>3<\/sup> for long-term inhalation exposure and 1.8 mg\/kg bw\/day for long-term dermal exposure. <br>2.From 23 December 2026, the substance shall not be manufactured or used as a pure substance, as a component of other substances or in a mixture with a concentration of 0.3% or more, unless the manufacturer and downstream users have implemented appropriate risk management measures and provided appropriate operating conditions to ensure that workers' exposure is below the above DNELs. <br>3.As a derogation from 1 and 2 above, the above obligations shall apply from 23 June 2029 to the placing on the market of the substance for use or use as a solvent in the production of man-made fibers.<\/td><\/tr><tr><td>81. 1-\u4e59\u57fa-2-\u5421\u54af\u70f7\u916e&nbsp;<br>(NEP)1-ethylpyrrolidin-2-one<br>CAS\u865f: 2687-91-4<br>EC\u865f: 220-250-6<img decoding=\"async\" height=\"415\" src=\"https:\/\/cti-cert.com.tw\/upload\/images\/202506091125503249.png\" width=\"415\"><\/td><td class=\"translation-block\">1.\u00a0From 23 December 2026, the substance shall not be placed on the market as a pure substance, as a component of other substances or in a mixture with a concentration of 0.3% or more, unless manufacturers, importers and downstream users include in the relevant chemical safety reports and SDS the derived no-effect levels (DNELs) related to worker exposure of 4.0 mg\/m<sup>3<\/sup> for long-term inhalation exposure and 2.4 mg\/kg bw\/day for long-term dermal exposure. <br>2.From 23 December 2026, the substance shall not be manufactured or used as a pure substance, as a component of other substances or in a mixture with a concentration of 0.3% or more, unless manufacturers and downstream users implement appropriate risk management measures and provide appropriate operating conditions to ensure that worker exposure is below the established DNELs.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Reference Link<\/strong>: [<a href=\"https:\/\/echa.europa.eu\/view-article\/-\/journal_content\/title\/echa-weekly-4-june-2025\">ECHA News<\/a>][<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2025\/1090\/oj\">Original text of regulations<\/a>]<\/p>\n\n\n\n<p><strong>Restricted Background<\/strong><\/p>\n\n\n\n<p><strong>DMAC<\/strong><strong>Both N,N-dimethylacetamide (DMAC) and NEP (1-ethylpyrrolidone) are dipolar aprotic solvents commonly used in the production of various formulations, including agrochemicals, pharmaceuticals, and fine chemicals. DMAC is also used as a coating solvent and is widely used in the production of man-made fibers and films, as well as in the production of wire insulation varnishes. NEP can be used as a cleaning agent, adhesive, and release agent. Under EU CLP Regulation (EC) No. 1272\/2008, DMAC is classified as a Category 1B reproductive toxicant and a Category 4 acute toxicant, while NEP is classified as a Category 1B reproductive toxicant.<\/strong><\/p>\n\n\n\n<p>The restriction proposal points out that the health risks of DMAC (N,N-dimethylacetamide) and NEP (1-ethylpyrrolidone) used in industrial and professional applications, particularly those involving high-temperature processes, open processes, and processes requiring manual operation, are not adequately controlled. Therefore, the restriction report proposes setting binding derived no-effect levels (DNELs) for the exposure risks of these two substances through inhalation and dermal contact as the best risk management option.<\/p>","protected":false},"excerpt":{"rendered":"<p>2025&nbsp;\u5e74 6 \u6708 3 \u65e5, \u6b50\u76df\u59d4\u54e1\u6703\u5728\u5176\u5b98\u65b9\u516c\u5831\u4e0a\u767c\u4f48 REACH \u6cd5\u898f\u9644\u9304XVII (\u9650\u5236\u7bc7 [&hellip;]<\/p>","protected":false},"author":104,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[79],"tags":[],"class_list":["post-13603","post","type-post","status-publish","format-standard","hentry","category-echa"],"acf":[],"_links":{"self":[{"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/posts\/13603","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/users\/104"}],"replies":[{"embeddable":true,"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/comments?post=13603"}],"version-history":[{"count":0,"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/posts\/13603\/revisions"}],"wp:attachment":[{"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/media?parent=13603"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/categories?post=13603"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/li-on.biz\/en\/wp-json\/wp\/v2\/tags?post=13603"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}