Responses	  to	  REACH	  Regulation	  	  	  August 24, 2012GIC	   Environmental	   Technology	   Sub-­‐Committee	  	
  The	  REACH	  Regulation	
  became	  effective	  on	  June	  1,	  2007.	  Following	  successive	  announcements	  of	  the	  candidate	  list	  of	  the	  Substances	  of	  Very	  High	  Concern	
  (SVHC)	  by	  the	  European	  chemicals	
  Agency	  (ECHA),	  questions	
  about	
  glass	  increased.	  Consequently,	  the	  Environmental	  Technology	  Sub-­‐Committee	  of	  the	  Glass	  Industry	  Conference	  of	  Japan	  has	  collected	  information	  on	  the	  REACH	  Regulation	  and	  discussed	  how	  to	  respond	  to	  it.	  This	  is	  the	  Sub-­‐Committee’s	  view	  on	  this	
  issue.	  
	  1.	  Registration	
  under	  the	  REACH	  regulation	  	  1.1	  Glass	  Products	  	  Article	  3(3)	  of	  the	  REACH	  Regulation	  defines	  an	  article	  as	  “an	
  object	
  which	  during	  production	  is	  given	  a	  special	
  shape,	  surface	  or	  design	
  which	  determines	  its	  function	  to	  a	  greater	
  degree	  than	  its	  chemical	  composition”.	
  From	  the	  above	  definition,	  the	  glass	  products,	  such	  as	  glass	  bottle,	
  glass	
  fiber	  or	  sheet	
  glass	  etc.	  are	  considered	  as	  “ARTICLE”	
  under	  the	  REACH	  Regulation.	  
So,	  most	
  glass	  products	  are	  not	  subjects	  to	  registration.	  	
  1.2	  Glass	  as	  the	  material	
  glass	  	  Since	  the	  REACH	  Regulation	  requires	  registration	  of	  all	  substances,	  it	  was	  required	  to	  clarify	  whether	  the	  glass	
  before	
  being	
  shaped	  comprised	  a	  substance	  or	  a	  mixture	  of	  substances.	  Although	  some	
  people	  considered	
  glass	  as	  a	  mixture	  of	  substances,	  eventually	  it	  was	
  judged	  that	  "Glass	  is	  treated	  as	  a	  UVCB	  (Substance	  of	  Unknown	  or	  Variable	  composition,	  Complex	  reaction	  products	  or	  Biological	  materials).”1)	  Registration	  is	  usually	  required	  for	  substances,	  but	  the	  EU	  Official	  Journal2)	  (p.	  6)	  states	  that	
  glass	  is	  a	  substance	  on	  the	  list	  of	  the	  exemptions	  from	  the	  obligation	  to	  register	  under	  certain	  conditions.	  Some	  substances	
  whose	  safety	  is	  widely	
  known	  are	  exempt	  from	  obligation	  of	  registration,	  but	  hazardous	  substances	  will	  never	  be	  exempt	
  from	  it.	  Because	
  glass	  is	  chemically	
  stable	  and	  therefore	  is	  exempted	  from	  registration,	
  there	  is	  no	  need	  to	  register	
  glass.	  But,	  to	  clarify	  the	  conditions	  for	  exemption	  of	  registration,	  it	  is	  recommended	  to	  refer	  the	  REACH	  Dossier3)	  to	  check	  whether	  a	  substance	  is	  required	  to	  be	  registered	  or	  not.	  	  	  	  Responses to REACH Regulation 12.	  Notification	  and	  communication	  in	  the	  supply	
  chain	  for	  SVHC	  	  If	  a	  SVHC	  contains	  in	  an	  article	
  exceed	  0.1%	  by	  weight,	
  under	  the	  REACH	  Regulation,	  manufacturers	  are	  obligated	  to	  communicate	  all	  relevant	  information	  to	  their	  clients.	  
Moreover,	  if	  the	  SVHC	  exceeds	  1	  ton	  per	  year	  and	  exposure	  to	  them	
  cannot	  be	  eliminated,	  manufacturers	  have	  an	  obligation	  to	  notify	
  ECHA.	  
However,	
  under	  the	  REACH	  Regulation,	
  glass	  is	  treated	  as	  a	  UVCB.	
  Hence,	  even	  if	  a	  SVHC	  is	  used	  as	  a	  raw	  material	  in	  the	  process	  of	  glass	  production,	  the	  glass	  manufacturers	  have	  no	  obligation	  to	  communicate	  information	  on	  the	  respective	  raw	  material	
  (SVHC)	  or	  to	  notify	
  ECHA.	  
The	  European	
  glass	  industry	  has	  adopted	  the	  same	
  stance	  toward	  the	  issue,	  and	  expresses	  its	  view1)	  that	
  “Glass	  is	  regarded	  as	  a	  substance	
  under	
  REACH.	  The	  articles	
  made	  by	  the	  glass	  industry	  consist	  of	  the	  substance	
  glass,	
  which	  is	  not	  on	  the	  “candidate	
  list”	  and	  can	  be	  assumed	
  never	  to	  be	  on	  it.	
  Thus,	  there	  is	  no	  duty	
  under	  Article	  33	  to	  communicate	  information	  on	  substances	  in	  articles	  for	  articles	  made	  entirely	  of	  glass.”	  	  3.	  Frequently	
  asked	  questions	  and	  answers	  	
  Q1:	  Is	  a	  registration	  required	  for	  lead-­‐glass	  products	  exported	  to	  Europe?	  
	  A1:	  The	  REACH	  Registration	  is	  not	  required	  for	
  glass	  products,	
  since	  they	  are	  articles.	  
However,	  it	  is	  important	  to	  refer	  to	  the	  REACH	  Dossier3)	  and	  confirm	  that	  the	  glass	  is	  exempted	  from	  the	  registration.	  
It	  is	  important	  not	  to	  confuse	  the	  REACH	  Regulation	  with	  the	  RoHS	  Directive.	  In	  the	  RoHS	  Directive,	  lead	  is	  restricted	
  under	
  1,000	
  mg/kg	  or	  less,	  without	
  regard	  to	  its	  chemical	
  form.	  Meanwhile,	  the	  REACH	  Regulation	  is	  based	  on	  the	  premise	  that	  hazardous	
  levels	  vary	  by	  chemical	
  forms	  and	  physical	  properties,	  and	  even	  if	  heavy	  metals	  are	  contained	  in	  glass,	  the	  glass	  is	  exempted	  from	  registration,	  provided	  that	
  such	  heavy	  metals	  are	  solidified	  in	  the	  glass	  and	  not	  hazardous.	  Requirements	  may	  differ	  by	  law,	  so	  accordingly	  containment	  and	  hazardousness	  must	  be	  considered	  separately.	  
	  Q2:	  Sometimes	  our	  clients	  request	  us	  to	  present	  them	  with	  a	  certificate	  of	  non-­‐containment	  of	  SVHC.	  How	
  shall	  we	  deal	  with	
  these	  requests?	  
	  A2:	
  Under	  the	  REACH	  regulation,	
  glass	  is	  classified	  as	  a	  substance	  (UVCB),	  not	  as	  a	  mixture	  of	  substances.	  Therefore,	
  glass	  does	  not	  include	  such	  SVHC	  on	  the	  candidate	
  list.	
  Please	
  refer	  to	  Q3	  and	  A3.	  	   	   	   However,	  if	  a	  certificate	  of	  non-­‐containment	  is	  requested	  for	  specific	  compounds	  or	  a	  certificate	  of	  non-­‐use	  is	  requested	  for	  specific	  raw	  materials,	
  which	  are	  not	  required	  by	  the	  REACH	  regulation,	  it	  is	  adequate	  for	  you	  to	  reject	  the	  issuance	  of	  such	  a	  certificate	  in	  principle,	  because	  anything	  concerning	  composition	  or	  mixture	  of	  raw	  materials	  is	  related	  to	  the	  intellectual	  property	  rights.	  	  	  Responses to REACH Regulation 2Q3:	  Boric	  acid	  (H3BO3)	  or	  boron	  trioxide	
  (B2O3)	  is	  mentioned	  on	  the	  SVHC	  (candidate)	
  list.	  Is	  boric	  acid	  (H3BO3)	  or	  boron	  trioxide	
  (B2O3)	  contained	  in	  glass?	  
	  A3:	  No,	  it	  isn’t.	
  Boric	  acid	  (H3BO3)	  or	  boron	  trioxide	
  (B2O3)	  is	  sometimes	  used	  as	  raw	  material	  for	
  glass	  production,	  but	
  either	  decomposes	  thermally	  in	  an	  early	
  stage	  of	  the	  melting	  process.	  The	  pyrolytic	  products	  are	  incorporated	  into	  the	  glass	  network,	  finally	
  glass	  is	  obtained	  as	  a	  melting	  reaction	  product,	  through	  irregular	  and	  complex	  chemical	  reactions	  with	
  other	  contents	  such	  as	  silica	
  during	  the	  melting	  process.	  
The	  following	  formula	
  shows	  an	  example	  of	  a	  non-­‐hazardous	  product	  made	  of	  hazardous	  materials:	  HCl	  (deleterious	  substance)	   + 	   NaOH	  (deleterious	  substance)	   	  = NaCl	  (non-­‐hazardous	  substance)	   + 	   H2O	  (non-­‐hazardous	  substance).	  
In	  the	  case	  of	  borosilicate	
  glass	  as	  well,	
  there	  is	  no	  need	  to	  take	  special	  care	  of	  the	  produced	
  glass,	  although	  the	  raw	  materials	
  should	  be	  carefully	  handled.	  	  	  Q4:	  Some	
  sheets	  of	  SDS	  for	
  glass	
  state	  the	  CAS	  registry	  numbers	  of	  boric	
  acid.	  Are	
  these	  expressions	  correct?	   	  	  A4:	  Although	  the	  glass	  is	  not	  the	  mixture	  of	  oxides,	  it	  is	  convenient	  for	  both	  manufacturers	  and	
  users	  to	  identify	  the	  glass	
  types	  and	  express	
  glass	  compositions	  in	  terms	  of	  oxides	  of	  the	  constituent	  elements.	  Consequently,	  the	  CAS	  numbers	  will	  appear	  in	  the	  official	  gazette	  announcements	  such	  as	  the	  SDS.	  This	  is	  a	  traditional	  technical	
  custom	  in	  the	  glass-­‐manufacturing	  field.	  And	  unfortunately,	
  today,	  this	  causes	  some	  misunderstandings	  to	  communicate	  on	  glass.	  
However,	  in	  case	  of	  using	  glass	  products	  with	  the	  special	  use	  and	  treating	
  these	  numbers	  as	  useful	  reference	  information,	  this	
  custom	  can	  be	  regarded	  as	  appropriate	  communication.	  	  	  References	  1)	  Statement	  concerning	
  Glass,	
  Glass	  articles	  and	  the	  EU	  REACH	  Regulation	  F ebruary	  2009	  2)	  Commission	  Regulation	  (EC)	  No	  987/2008	  of	  8	  October	  2008	  3)	  REACH	  Dossier	  ( Brussels,	  12	  November	
  2009)	  	  	  	  	  	  	  	  Responses to REACH Regulation 3