LEGAL NOTICEThis document contains guidance only.

It is intended to explain obligations and how to fulfil them. However readers are reminded that the text of the original regulation, directive or standard is the only authentic legal reference and that the information in this document does not constitute legal advice.

The British Toy and Hobby Association does not accept any liability with regard to the contents of this document.

LEGAL NOTICEThis document contains guidance only.

It is intended to explain obligations and how to fulfil them. However readers are reminded that the text of the original regulation, directive or standard is the only authentic legal reference and that the information in this document does not constitute legal advice.

The British Toy and Hobby Association does not accept any liability with regard to the contents of this document.

Chemical  Safety  Assessment  –  CMR  Guidance  Revised  Toy  Safety  Directive  2009/48/EC  

 Contents    

1. Obligations    2. Introduction    3. Overview  

 4. Definitions  

 5. The  Two  Approaches  

 • Materials  Approach  using  the  Toyograph  • CAS  Number  Approach  

   

Annex  1   How  to  use  the  European  Chemical  Substances  Information  System  

   

 Record  of  Amendments  

 Version   Date   Amendment  

 Section/page  affected  

1   22/7/2013   First  Published                            

                 

     

         

   

 1. Obligations of Economic Operators

Obligation Manufactuer Importer Distributor Authorised

Representative

Carry out the conformity assessment

A4(2) A19 Obligated A6(2) Ensure its

done No obligation No obligation

Carry out the Safety Assessment

A4(2) A18

Obligated A6(2) Ensure its

done No obligation No obligation

To establish your company’s role under the revised Toy Safety Directive please see the separate BTHA guidance on the Obligations of Economic Operators, which should be read first.  2. Introduction    The   revised  Toy  Safety  Directive   (2009/48/EC)  was  adopted  by   the  European  Parliament  on  18   December   2008   and   the   final   text   was   formally   adopted   and   published   in   the   Official  Journal  of  the  European  Union  (OJ)  on  30  June  2009    The   Toy   Safety   Directive   requires   that   toys   and   components   of   toys   shall   not   contain  substances   classified   as   CMR   -­‐   Carcinogenic,   Mutagenic,   or   toxic   for   Reproduction   -­‐   (CLP  Regulation  (EC)  1272/2008  classification,  labelling  and  packaging  of  substances).    Substances  of  Categories  1A,  1B  or  2  shall  not  be  used  with  certain  exceptions:    • Accessibility  

If  the  substance  or  mixture  is  not  accessible  to  the  child  in  foreseeable  use  then  the  CMR  requirement  does  not  apply.  Care  must  be  taken  to  ensure  that  the  substance  or  mixture  is  not  restricted  in  other  regulations,  standards  or  directives.    

• Amount  present  If  the  substance  or  mixture  is  present  in  concentrations  below  the  classification  limits  in  Directive  1999/45/EC  (until  31  May  2015)  or  Regulation  (EC)  No  1272/2008  (from  1  June  2015).  

 • Appendix  A  

Appendix  A  contains  a  list  of  CMR  substances  that  have  been  evaluated  as  being  safe  for  use  in  toys  and  the  general  requirement  does  not  apply.    

• Appendix  C  Appendix  C  sets  lower  limits  for  concentrations  of  substances  that  those  listed  in  Directive  1999/45/EC  or  Regulation  (EC)  No  1272/2008  for  toys  intended  for  children  under  three  years  or  to  be  placed  in  the  mouth.  

 This  guide  is  intended  to  show  Manufacturers  how  to  assess  their  products  for  the  presence  of  CMRs  as  required  by  the  Toy  Safety  Directive.    

Important:  The  information  is  this  document  is  for  guidance  only.  If  substances  are  identified  at  concentrations  below  the  limits  specified  then  this  only  satisfies  the  compliance  aspects  of  CMRs  related  to  classification.  The  Toy  Safety  Directive  also  requires  the  chemical  safety  aspects  to  be  taken  into  consideration  and  it  is  the  manufacturers  responsibility  to  ensure  that  the  presence  of  CMRS  below  the  concentration  limit  does  not  adversely  affect  children’s  health.  For  many  substances  classified  as  CMR  other  limits  or  restrictions  may  apply  at  concentrations  below  those  in  CLP.  These  limits  or  restrictions  may  be  in  particular  standards  or  in  REACH  Annex  XVII.    3. Overview    This  guide  outlines  two  basic  approaches  that  can  be  used  either   individually  or  together  to  assess  materials  in  products  for  the  presence  of  CMR’s.    These  approaches  are:    

• Materials  approach  using  the  Toyograph    

If  a  full  bill  of  substances  is  not  available  then  a  simplified  approach  based  on  the  information  in  Toyograph  or  similar  tool  kit  can  be  used.      Toyograph  is  an  on  line  resource  designed  to  allow  Manufacturers  to  use  the  Bill  of  Materials  to  determine  which  materials  are  at  risk  of  containing  restricted  chemicals  above  the  limits  specified  in  legislation  or  at  levels  that  may  be  a  safety  concern.    

• CAS  number  approach    If  a  full  bill  of  substances  is  available  with  a  complete  CAS  number  listing  with  weights  or  concentrations  then  this  approach  can  be  used.    

 In  many  cases,  a  combination  of  the  two  approaches  may  be  appropriate.      Where  companies  have  any  doubt  about  their  ability  to  assess  their  products  for  compliance  to  the  CMR  requirements,  third  party  expert  help  may  be  needed.    Separate  BTHA  Guidance  is  available  with  regards  to  Safety  Assessments  and  How  to  Use  the  Toyograph.    4. Definitions    CMR:   A   substance   or   mixture   classified   under   Regulation   (EC)   No   1272   as   carcinogenic,  mutagenic  or  reprotoxic.    Substance:   A   pure   chemical   compound  or   chemical   element   such   as   a   pigment  or   polymer  additive.    Mixture:  One  or  more  substances  that  are  present  in  combination  but  without  any  chemical  reaction  taking  place.  Most  toy  materials   fall   into  this  category  such  as  plastics  that  contain  the  base  polymer,  a  pigment  and  any  number  of  additives.    Carcinogen:   A   substance   or   a   mixture   of   substances   that   induce   cancer   or   increase   its  incidence.  

 Mutagen:   A   substance   or   a  mixture   of   substances   that   can   cause   permanent  mutations   in  human  cells  that  can  be  transmitted  to  future  generations.    Reprotoxin:  A   substance  or  mixture  of   substances   that   can  cause  adverse  effects  on   sexual  function  or  fertility,  or  adversely  affect  the  development  of  children  in  the  womb,  after  birth  or  up  to  sexual  maturity.    Classification:   CMRs   are   classified   as   Category   1A,   1B   or   2   depending   on   the   strength   of  evidence  that   the  substance  causes   the  adverse  effect   in  humans.  For  example  a  substance  classified  as  a  Category  2  carcinogen  is  only  suspected  of  causing  cancer  in  humans.      CAS  Number  CAS   Registry  Numbers   are   unique   numerical   identifiers   assigned   by   the   Chemical   Abstracts  Service  to  every  chemical  described  in  the  open  scientific  literature      

 5. The  two  approaches    Materials  Approach  using  the  Toyograph    In  the  Toyograph,  each  of  the  available  materials  has  been  assessed  for  the  presence  of  priority  substances  including  substances  of  very  high  concern  (SVHC).    The  majority  of  SVHC  are  also  classified  as  CMRs.    Other  substances  that  are  not  SVHC  but  may  be  likely  to  be  found  in  a  particular  material  and  have  a  CMR  classification  are  also  listed  in  priority  substances  on  the  material  report.    Appendix  A  and  Appendix  C  will  be  added  to  the  material  sheets  once  particular  substances  have  been  included  and  published  in  the  Official  Journal.      

     

   CMRs  are  restricted  by  the  Directive  in  accessible  materials.    N.B  this  guide  deals  with  the  TSD  restrictions  and  other  CMR  limits  from  other  legislation  may  also  apply.  

   

If  a  material  sheet  is  not  available,  Manufacturers  must  obtain  further  information  about  the  material  and  use  the  CAS  number  approach.    (The  current  scope  of  the  Toyograph  can  be  found  on  the  Toyograph  website.  

   

If  priority  substances  are  not  listed  there  is  a  low  probability  that  the  material  contains  CMRs.  It’s  important  to  note  that  the  Material  Reports  consider  only  generic  and  typical  material  usage  (see  below).      The   material   sheets   do   not   cover   specialist   additives   or   particular  pigments.    Any  specialist  additives  should  be  assessed  using  the  CAS  Number  approach.      Certain  substances  are  exempted  under  Appendix  A  in  the  Toy  Safety  Directive  in  certain  conditions.          There  is  a  range  of  concentration  limits  that  can  be  applied  to  specific  substances  but  this  approach  assumes  a  maximum  concentration  of  0.1%  for  each  substance  based  on  SVHC  criteria.  This  allows  a  margin  of  safety  even  if  the  bill  of  materials  or  bill  of  substances  does  not  have  sufficient  detail  to  calculate  the  individual  concentration.    Manufacturers  need  to  determine  the  concentration  of  the  substance  in  the  material  to  ascertain  if  the  material  is  in  compliance.        Appendix  C  of  the  Directive  sets  lower  limits  for  concentrations  of  substances  that  those  listed  in  Directive  1999/45/EC  or  Regulation  (EC)  No  1272/2008  for  toys  intended  for  children  under  three  years  or  to  be  placed  in  the  mouth.    

                           

Is  the  material  accessible?  

Priority  Substances?  

Is  a  Material  Sheet  Available?  

Other  Substances  present?  

Listed  in  Appendix  A?  

Check  presence  and  concentration  

CAS  number  approach    This  approach  is  the  most  accurate  and  reliable  method  for  determining  the  CMR  content  in  toy  materials.  It  requires  an  accurate  and  full  bill  of  substances  with  individual  CAS  numbers  and  individual  concentrations  of  the  substance  in  the  material  and/or  toy.      If  this  route  is  followed  care  must  be  taken  to  ensure  that  all  substances  are  listed  for  each  component  and  material  in  the  Bill  of  Materials.  If  this  is  not  the  case  further  information  should  be  obtained  from  the  vendor.      The  approach  can  be  used  however  to  check  particular  CAS  numbers  where  available  and  particularly  if  a  Toyograph  materials  sheet  is  not  available.      

   

 CMRs  are  restricted  by  the  Directive  in  accessible  materials.      

   Each  substance/material  listed  on  a  comprehensive  BOM  will  have  a  CAS  number.    

     Sources  of  information  are  available  to  identify  CMRs:      

Chemtrac    Available  to  BTHA  full  members  only    European  Chemical  Substances  Information  System  (http://esis.jrc.ec.europa.eu)    This  is  the  main  source  of  information  for  identifying  the  specific  concentration  limits  that  must  be  applied.  Guidance  on  using  the  European  Chemical  Substances  Information  can  be  found  in  Annex  I  of  this  document.    Toy  Safety  Directive  Appendixes  A  and  C  (this  information  will  also  be  available  in  Chemtrac)  

 CMRs  will  have  specific  concentration  limits  listed  in  Annex  VI  of  Regulation  (EC)  1272/2008  or  if  no  limits  are  shown  in  Annex  VI  then  the  generic  concentration  limits  as  per  the  following  table  are  applied.  The  generic  concentration  limits  can  be  found  in  Annex  I  of  Regulation  (EC)  1272/2008  

       Classification   Category   Default  

Concentration  Table  in  Annex  I  

Carcinogenic   1a/1b   0.1%   3.6.2  Carcinogenic   2   1%   3.6.2  Mutagenic   1a/1b   0.1%   3.5.2  Mutagenic   2   1%   3.5.2  Reprotoxic   1a/1b   0.3%   3.7.2  Reprotoxic   2   3%   3.7.2  

   

Manufacturers  need  to  determine  the  concentration  of  the  substance  in  the  material  to  ascertain  if  the  material  is  in  compliance.      Appendix  C  of  the  Directive  sets  lower  limits  for  concentrations  of  

substances  that  those  listed  in  Directive  1999/45/EC  or  Regulation  (EC)  No  1272/2008  for  toys  intended  for  children  under  three  years  or  to  be  placed  in  the  mouth.      

Is  the  material  accessible?  

Identify  CAS  Number  

 CMR?  

Identify  Applicable  Concentration  limit  

Concentrations  below  limits  incl.  Appendix  C?  

Annex  1  How  to  use  the  European  Chemical  Substances  Information  System  

 Access  the  ESIS  website:  (http://esis.jrc.ec.europa.eu)          

   

       

 Boric  acid  CAS  No  10043-­‐35-­‐3,  which  is  a  flame  retardant  found  in  paper  and  textiles,  is  used  as  an  example  of  a  substance  that  has  a  specific  concentration  limit.    

         

   

1.  Select  CLP/GHS  tab  

2.  From  the  dropdown  select  ‘Search  Annex  VI’  

3.  Enter  the  CAS  No  and  click  on  ‘Search’  

   

           

 

   

       

   

           

4.  From  the  search  results  screen,  click  on  the  index  number  to  

reveal  the  data    

 5.    Identify  the  CMR  classification  

 6.  Check  if  a  specific  concentration  limit  is  shown  for  that  classification  

 If  no  specific  concentration  limit  is  shown  as  in  the  example  below  (diisopentylphthalate  CAS  No  605-­‐50-­‐5),  refer  to  Annex  1  in  this  guide  for  the  default  concentration  limits.