A ranar 17 ga Mayu, 2024, Jarida ta Ƙungiyar Tarayyar Turai (EU) ta buga (EU) 2024/1328, tana sake fasalin abu na 70 na jerin abubuwan da aka iyakance a cikin Annex XVII na ka'idar REACH don ƙuntata octamethylcyclotetrasiloxane (D4), decamethyl cyclopentasiloxane (cyclopentasiloxane). , da dodecylhexasiloxane (D6) a cikin abubuwa ko gauraye. Sabbin sharuɗɗan tallace-tallace don wanke kayan kwalliyar da ke ɗauke da D6 da kayan kwalliyar mazaunin da ke ɗauke da D4, D5, da D6 za su fara aiki a ranar 6 ga Yuni, 2024.
Dangane da ka'idar REACH da aka zartar a cikin 2006, sabbin ƙa'idodin sun taƙaita amfani da sinadarai guda uku masu zuwa a cikin kayan kwalliya marasa gonococcal da sauran samfuran mabukaci da ƙwararru.
Octamethylcyclotetrasiloxane (D4)
Bayani na CAS 556-67-2
EC No 209-136-7
·Decamethylcyclopentasiloxane (D5)
Bayanan CAS 541-02-6
EC No 208-764-9
Dodecyl Cyclohexasiloxane (D6)
Lambar CAS 540-97-6
EC No 208-762-8
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401328
Laboratory Certificate na EU CE
Takamammen sabbin ƙuntatawa sune kamar haka:
1. Bayan Yuni 6, 2026, ba za a sanya shi a kasuwa: (a) a matsayin wani abu da kansa; (b) A matsayin wani ɓangare na sauran abubuwa; Ko (c) a cikin cakuda, ƙaddamarwa daidai yake da ko mafi girma fiye da 0.1% na nauyin abin da ya dace;
2. Bayan Yuni 6, 2026, ba za a yi amfani da shi azaman busasshiyar tsaftacewa mai bushewa don yadi, fata, da Jawo.
3. A matsayin keɓe:
(a) Don D4 da D5 a cikin kayan kwalliyar da aka wanke, aya ta 1 (c) yakamata a yi amfani da ita bayan 31 ga Janairu, 2020. Dangane da wannan, "kayan shafawa na ruwa" yana nufin kayan shafawa kamar yadda aka bayyana a cikin Mataki na 2 (1) (a) na Doka ( EC) Babu 1223/2009 na Majalisar Turai da na Majalisar, wanda, a ƙarƙashin yanayin amfani na yau da kullun, ana wanke shi da ruwa bayan amfani;
(b) Duk wani kayan shafawa ban da waɗanda aka ambata a sakin layi na 3 (a), sakin layi na 1 za a yi amfani da su bayan Yuni 6, 2027;
(c) Don na'urorin (likita) kamar yadda aka bayyana a cikin Mataki na 1 (4) na Doka (EU) 2017/745 da Mataki na 1 (2) na Dokokin (EU) 2017/746 na Majalisar Turai da Majalisar, sakin layi na farko zai kasance. nema bayan Yuni 6, 2031;
(d) Don magungunan da aka ayyana a cikin Mataki na 1, batu na 2 na Directive 2001/83/EC da magungunan dabbobi da aka ayyana a cikin Mataki na 4 (1) na Doka (EU) 2019/6, sakin layi na 1 za a yi amfani da shi bayan Yuni 6, 2031;
(e) Don D5 a matsayin sauran ƙarfi don bushewar bushewa don bushewa yadudduka, fata, da Jawo, sakin layi na 1 da 2 za a yi amfani da su bayan Yuni 6, 2034.
4. A matsayin keɓewa, sakin layi na 1 ba ya aiki:
(a) Sanya samfuran D4, D5, da D6 akan kasuwa don amfani da masana'antu masu zuwa: - azaman monomers don samar da polymers na organosilicon, - azaman matsakaici don samar da sauran abubuwan silicon, - azaman monomers a cikin polymerization, - don ƙira. ko (sake) marufi na gauraye-Ana amfani da su don samar da kaya- Ba a yi amfani da shi don maganin saman ƙarfe ba;
(b) Sanya D5 da D6 a kasuwa don amfani da su azaman na'urori (likita) kamar yadda aka bayyana a cikin Mataki na 1 (4) na Dokokin (EU) 2017/745, don magani da kula da tabo da raunuka, rigakafin raunuka, da kulawa. na stoma;
(c) Sanya D5 a kasuwa don masu sana'a don tsaftacewa ko mayar da fasaha da kayan tarihi;
(d) Ƙaddamar da D4, D5, da D6 akan kasuwa a matsayin reagents na dakin gwaje-gwaje don bincike da ayyukan ci gaba a ƙarƙashin sharuɗɗa.
Laboratory Certificate na EU CE
5. A matsayin keɓewa, batu (b) na sakin layi na 1 bai shafi D4, D5, da D6 da aka sanya a kasuwa ba: - a matsayin abubuwan da aka haɗa na polymers na organosilicon - a matsayin abubuwan da ke tattare da polymers na organosilicon a cikin gaurayawan da aka ƙayyade a sakin layi na 6.
6. A matsayin keɓewa, batu (c) na sakin layi na 1 baya shafi gaurayawan da ke ɗauke da D4, D5, ko D6 a matsayin ragowar organosilicon polymers waɗanda aka sanya a kasuwa a ƙarƙashin yanayi masu zuwa:
(a) Matsayin D4, D5 ko D6 daidai yake da ko ƙasa da 1% na nauyin abin da ya dace a cikin cakuda, wanda aka yi amfani da shi don haɗawa, rufewa, gluing da simintin gyare-gyare;
(b) Cakuda na kayan kariya (ciki har da suturar jirgi) tare da ƙaddamarwa na D4 daidai ko ƙasa da 0.5% ta nauyi, ko ƙaddamar da D5 ko D6 daidai ko ƙasa da 0.3% ta nauyi;
(c) Matsayin D4, D5 ko D6 daidai yake da ko ƙasa da 0.2% na nauyin abin da ya dace a cikin cakuda, kuma ana amfani dashi azaman kayan aikin (likita) kamar yadda aka ayyana a cikin Mataki na 1 (4) na Dokokin (EU). ) 2017/745 da Mataki na 1 (2) na Doka (EU) 2017/746, sai dai kayan aikin da aka ambata a sakin layi na 6 (d);
(d) D5 maida hankali daidai ko kasa da 0.3% ta nauyin cakuda ko D6 maida hankali daidai ko žasa da 1% ta nauyi na cakuda, amfani da matsayin kayan aiki da aka ayyana a cikin Mataki na ashirin da 1 (4) na Regulation (EU) 2017 / 745 don haƙoran haƙora;
(e) Matsayin D4 a cikin cakuda daidai yake da ko ƙasa da 0.2% ta nauyi, ko ƙaddamar da D5 ko D6 a cikin kowane abu a cikin cakuda daidai yake da ko ƙasa da 1% ta nauyi, ana amfani dashi azaman insoles na silicon ko takalman dawakai don dawakai;
(f) Matsakaicin D4, D5 ko D6 daidai yake da ko ƙasa da 0.5% na nauyin abin da ya dace a cikin cakuda, wanda aka yi amfani da shi azaman mai tallata adhesion;
(g) Matsayin D4, D5 ko D6 daidai yake da ko ƙasa da 1% na nauyin abin da ya dace a cikin cakuda, wanda aka yi amfani da shi don bugu na 3D;
(h) Matsayin D5 a cikin cakuda daidai yake da ko ƙasa da 1% ta nauyi, ko ƙaddamarwar D6 a cikin cakuda daidai yake da ko ƙasa da 3% ta nauyi, ana amfani dashi don saurin samfuri da masana'anta, ko aikace-aikacen ayyuka masu girma da aka daidaita ta ma'auni na ma'adini;
(i) D5 ko D6 maida hankali ne daidai ko kasa da 1% na nauyin kowane abu a cikin cakuda, amfani da kushin bugu ko masana'antu; (j) Mahimmancin D6 daidai yake da ko ƙasa da 1% na nauyin cakuda, ana amfani da shi don tsabtace ƙwararru ko maido da fasaha da kayan tarihi.
7. A matsayin keɓewa, sakin layi na 1 da 2 ba su shafi jeri akan kasuwa ko amfani da D5 azaman mai narkewa a cikin tsarin tsabtace bushewa mai ƙarfi da aka sarrafa don yadi, fata, da Jawo, inda ake sake yin fa'ida ko ƙonewa.
Wannan doka za ta fara aiki ne a rana ta 20 daga ranar da aka buga ta a cikin Jarida ta Tarayyar Turai, kuma za ta kasance tana da ƙarfi gabaɗaya kuma ta kasance kai tsaye ga duk ƙasashe membobin EU.
Tambarin takaddun shaida
Taƙaice:
Saboda D4, D5, da D6 kasancewa abubuwan damuwa (SVHC), suna nuna tsayin daka da bioaccumulation (vPvB). Hakanan ana gane D4 a matsayin mai jurewa, bioaccumulative, da mai guba (PBT), kuma lokacin da D5 da D6 suka ƙunshi 0.1% ko fiye na D4, ana kuma gane su a matsayin masu sifofin PBT. Yin la'akari da cewa haɗarin PBT da samfuran vPvB ba su da cikakken sarrafawa, ƙuntatawa shine ma'aunin gudanarwa mafi dacewa.
Bayan ƙuntatawa da sarrafa samfuran kurkura da ke ɗauke da D4.D5 da D6, za a ƙarfafa ikon sarrafa samfuran da ba ruwan kurkura da ke ɗauke da D4.D5 da D6. A lokaci guda kuma, idan aka yi la'akari da yanayin aikace-aikacen fa'ida na yanzu, ƙuntatawa kan amfani da D5 a cikin yadi, fata, da tsabtace bushewar Jawo, da kuma ƙuntatawa kan amfani da D4.D5 da D6 a cikin magunguna da magungunan dabbobi, za a jinkirta su. .
Ganin babban aikace-aikacen D4.D5 da D6 a cikin samar da polydimethylsiloxane, babu wasu ƙuntatawa masu dacewa akan waɗannan amfani. A lokaci guda, don fayyace cakuda polysiloxane wanda ke ɗauke da ragowar D4, D5, da D6, an kuma ba da iyakokin taro masu dacewa a cikin gaurayawan daban-daban. Kamfanoni masu dacewa yakamata su karanta bayanan da suka dace a hankali don gujewa samfurin kasancewa ƙarƙashin ƙayyadaddun bayanai.
Gabaɗaya, ƙuntatawa akan D4.D5 da D6 suna da ɗan ƙaramin tasiri akan masana'antar silicone na gida. Kamfanoni na iya saduwa da mafi yawan ƙuntatawa ta yin la'akari da saura batutuwa na D4.D5 da D6.
Lab Gwajin BTF, kamfaninmu yana da dakunan gwaje-gwaje masu dacewa da lantarki, ka'idojin aminci Laboratory, Laboratory mitar rediyo mara waya, dakin gwaje-gwaje na baturi, dakin gwaje-gwajen sinadarai, dakin gwaje-gwaje na SAR, dakin gwaje-gwaje na HAC, da sauransu. Mun sami cancanta da izini kamar CMA, CNAS, CPSC, A2LA, VCCI, da dai sauransu. Kamfaninmu yana da ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun injiniyoyi, waɗanda za su iya taimaka wa kamfanoni su magance matsalar. Idan kuna da gwajin da suka dace da buƙatun takaddun shaida, zaku iya tuntuɓar ma'aikatan Gwajin mu kai tsaye don samun cikakkun bayanan farashi da bayanan sake zagayowar!
Lokacin aikawa: Yuli-31-2024