Proposal for a COUNCIL DIRECTIVE amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead
Date: 2016-09-09
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: European standard, lead, product safety, safety standard, technical standard, technological change, toxic substance, toy industry

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   EUROPEAN COMMISSION  Brussels, 9.9.2016  COM(2016) 560 final 2016/0267 (NLE)   Proposal for a COUNCIL DIRECTIVE amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead (Text with EEA relevance) {SWD(2016) 289 final} {SWD(2016) 290 final}  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Directive 2009/48/EC on the safety of toys lays down, in the table under point 13 of part III of 
Annex  II,  migration  limits,  from  toys  or  components  of  toys,  for  a  range  of  elements, 
including  lead,  in  dry,  liquid  and  scraped-off  toy  material.  In  order  to  ensure  adequate 
protection of children, Directive 2009/48/EC empowers the Commission to amend point 13 of 
part III of Annex II for the purpose of its adaptation to technical and scientific developments. 
In  accordance  with  Article  46(1)  of  Directive  2009/48/EC,  those  measures  shall  be  adopted 
following the regulatory procedure with scrutiny referred to in Article 47(2) of the Directive. 

With the objective of strengthening the limit values for lead in toys on the basis of the latest 
scientific  evidence  from  the  European  Food  Safety  Authority  (EFSA),  the  Commission 
prepared a draft directive which was put to the vote in the Toy Safety Committee established 
by Article 47 of Directive 2009/48/EC. The Committee did not deliver an opinion on the draft 
directive at its meeting of 14 January 2015. 

In  accordance  with  Article  5(a)  of  Decision  1999/468/EC,  in  case  the  Committee  gives  a 
negative  opinion  or  where  no  opinion  is  delivered,  the  Commission  is  obliged  to  submit  a 
proposal relating to the measures to be taken to the Council and to forward it to the European 
Parliament at the same time. The Council has to act on the proposal by a qualified majority 
within two months from the date of referral. If the Council opposes the proposed measure, it 
is not adopted. If the Council envisages adopting the proposed measure, or if the Council does 
not  act,  the  proposed  measure  is  submitted  to  the  European  Parliament.  If  the  European 
Parliament  opposes  the  proposed  measure  by  a  majority  of  its  component  members  within 
four  months  from  the  date  of  referral  to  the  Council,  it  is  not  adopted.  If  the  European 
Parliament does not oppose within that time period, the proposed measure must be adopted. 

An  erratum  to  the  2008  report  of  the  Dutch  National  Institute  for  Public  Health  and  the 
Environment (RIVM) underlying the migration limits in the table under point 13 of part III of 
Annex II of Directive 2009/48/EC was published shortly after the Committee meeting of 14 
January  2015.  The  erratum  considered  that  the  limits  for  elements  in  dry  and  liquid  toy 
material had been calculated erroneously in 2008. The calculation had been based on amounts 
of material that were assumed to be ingested by children once every day, however ingestion 
would  happen  only  once  every  week.  Consulted  by  the  Commission  on  the  matter,  the 
Scientific Committee for Health and Environmental Risks (SCHER) contended in April 2016 
that the daily ingestion was appropriate, thereby confirming that the methodology of the 2008 
RIVM  report  to  calculate  safe  limits  for  elements  in  toys  is  correct.  Accordingly,  the  same 
methodology  should  be  applied  for  revising  the  limits  for  lead  in  toys;  the  present  proposal 
does so. 

• 

Consistency with existing policy provisions in the policy area 

As the abovementioned scientific evidence shows, the level of protection against exposure to 
lead, as established in 2009 in point 13 of part III of Annex II to Directive 2009/48/EC is no 
longer  appropriate.  Therefore,  it  is  necessary  to  amend  the  current  migration  limits  for  lead 
and align them with the latest scientific data, in order to reduce children's exposure to lead. 

In  its  Decision  2012/160/EU,  the  Commission  acknowledged  that  the 2009  migration  limits 
for lead no longer offer an appropriate level of protection for children. 

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• 

Consistency with other Union policies 

At EU level, the presence of lead in ceramics and plastic materials which come into contact 
with food is already restricted. Regulation (EC) No 1907/2006 ("REACH") restricts the use of 
lead  carbonates  and  sulphates in  paint  and  the marketing  of  lead  in  jewellery.  REACH  also 
restricts the marketing and use of lead in articles supplied to the general public, but exempts 
toys from this restriction in view of the specific migration limits for lead in toys laid down in 
Directive 2009/48/EC. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The legal basis for the proposal is Article 46(1)(b) of Directive 2009/48/EC on the safety of 
toys. 

• 

Subsidiarity (for non-exclusive competence)  

The  objective  of  the  proposal  is  to  ensure  a  high  level  of  safety  for  children  whilst  re-
establishing the internal market. Individual actions undertaken by Member States, such as the 
differing national limit which Germany is allowed to maintain - following the judgment of the 
General  Court  of  14  May  2014  in  case  T-198/12  -  until  the  date  of  entry  into  force  of  EU 
provisions  setting  new  limits  for  lead  in  toys,  lead  to  unequal  levels  of  protection  for 
European  children  as  well  as  a  fragmentation  of  the  internal  market  and  create  barriers  to 
trade in toys. 

Since Directive 2009/48/EC exhaustively sets the rules for ensuring toy safety and the internal 
market  for  toys,  amending  the  Directive  with  regard  to  the  applicable  limits  for  lead  is  the 
only  way  to  ensure  the required  high  level  of  safety  for  children  and  the  functioning  of  the 
internal market. 

• 

Proportionality 

In  view  of  the  neurodevelopmental  effects  of  lead  on  children,  which  result  in  particular  in 
learning  deficits,  exposure  of  children  to  lead  should  be  reduced  to  the  maximum  extent 
possible, including exposure through toys. This objective does not imply developing policy in 
new  areas  since  EU  legislation  on  toy  safety  exists,  including  an  empowerment  to  the 
Commission  to  adopt  implementing  acts  to  achieve  the  objective.  Other  measures  than 
amending the current migration limits for lead and aligning them with the latest scientific data 
would be less effective in  terms of  protection of children, who are a particularly  vulnerable 
segment of the population. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Stakeholder consultations 

The  Commission  informed  all  concerned  stakeholders  (Member  States,  industry,  consumer 
protection  associations,  standardisation  bodies,  Notified  Bodies)  on  its  initiative  during  the 
meeting of the Expert Group on Toy Safety in April 2011; several Member States supported 
the revision of the limit values for lead. Some preferred to do so based on a Tolerable Daily 
Intake (TDI) allocation of 5%, another referred to a TDI allocation of 10% coupled with an 
exception or with a transitional period. The Expert Group did not object to the use of a TDI 
allocation  of  10%.    One  Member  State  called  for  an  impact  assessment  to  be  performed. 

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Subsequently,  a  number  of  Member  States  expressed  support  for  a  5%  allocation  and 
exemption for the arts and crafts toys. 

Following this, the Commission received position papers from the toy industry, indicating that 
the  Commission's  initiative  would  have  important  impacts  on  the  sector's  competitiveness. 
The  main  impact  highlighted  by  industry  was  its  incapacity  to  continue  marketing  certain 
categories of toys. Taking this into account, the Commission further consulted the toy sector 
via a targeted public consultation. The targeted group of stakeholders received information on 
the initiative and was invited to express their opinion on the identified problems, options and 
other relevant issues. The consultation was published on the "Your voice in Europe" portal, as 
well as on the DG ENTR webpage dedicated to toy safety and ran from 13 February 2012 to 7 
May 2012. Additionally, business associations were informed about the consultation via email 
and  were  asked  to  circulate  the  information  amongst  their  members.  The  results  of  the 
consultation  were  published  and  business  associations  were  duly  informed  about  their 
publication. 

The  Commission  also  collected  position  papers  from  consumer  protection  associations,  in 
particular from ANEC and BEUC. ANEC and BEUC support the revision of the limit values 
for  lead  in  toys,  in  order  to  increase  as  much  as  possible  children's  protection  against  lead 
exposure and related health consequences. 

The  consultation  was  complemented  by  interviews  with  stakeholders  carried  out  by  two 
external consultants in the framework of their respective studies: one on health costs related to 
children exposure to lead via toys, the other on the initiative's effects on the competiveness of 
the toy sector (see below). 

The impact of the 5% allocation and the fact that only few toys/toy materials may have to be 
adapted to new limit values for lead were discussed with all stakeholders at the meeting of the 
Expert  Group  on  Toy  Safety  in  May  2014.  A  range  of  Member  States  preferred  a  5% 
allocation of the toxicological reference value, while others favoured 10%. Stakeholders from 
the toy industry and consumer representatives were equally split in their views. 

• 

Collection and use of expertise 

Two studies were carried out by external consultants: one on health costs related to children 
exposure 
toys 
(http://ec.europa.eu/DocsRoom/documents/6655/attachments/1/translations/en/renditions/nati
ve),  the  other  on  the  initiative's  effects  on  the  competiveness  of  the  toy  sector 
(http://ec.europa.eu/DocsRoom/documents/6654/attachments/1/translations/en/renditions/nati
ve). 

lead 

via 

to 

• 

Impact assessment 

The Commission prepared an impact assessment on the 'Revision of the limit values for lead 
in toys' to underpin this amendment [insert link to summary when publicly available] which 
received  a  positive  opinion  from  the  Impact  Assessment  Board  (Ares(2013)66470  - 
18/01/2013). 

The  impact  assessment  examined  the  several  policy  alternatives:  (1)  baseline  "no  change" 
scenario, (2) complete revision of the current limits, (3) partial revision of the current limits, 
and  (4)  soft  law  /self-regulatory  approach.  Under  the  baseline  scenario,  no  new  costs  are 
foreseen,  but  the  scenario  would  not  bring  any  improvement  to  the  protection  of  children's 
health. The complete revision, in line with latest scientific knowledge, will present the highest 
benefits as it would result in a high protection of children from lead exposure, but may come 
at a significant cost to the industry, as certain categories of toys might be completely banned 

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from  production  in  the  worst  case.  The  partial  revision  would  not  reduce  the  exposure  of 
children for those toys that may actually contain too much lead, leading to much more limited 
benefits  than  the  complete  revision,  but  would  avoid  the  potential  ban  from  the  market  of 
certain toys and would entail limited costs for industry. Soft law /self-regulatory approaches 
would imply limited costs for industry, but would be most of the time inefficient and would 
lead therefore to limited increase in the level of children's protection.  

The final proposal opts for the complete revision, which will present the highest benefits as it 
would result in a high protection of children from lead exposure; it was also considered that 
data from 2 500 toy samples in Germany showed that toys placed on the market complied at 
rates of 91% to 100% with the stricter lead limits envisaged by the proposal. The following 
impacts were estimated for the complete revision option as laid down in the proposal: 

Health  impacts:  The  reduced  exposure  of  children  to  lead  in  toys  would  result  in  an 
incremental benefit compared to the "no change" scenario of € 836 million for behaviour and 
attention problems (ADHD) and € 1 176 million for reduced IQ. 

Economic  impacts:  Industry  would  be  affected  in  its  capacity  to  market  certain toys1,  made 
with  raw  materials  naturally  contaminated  with  lead.  Industry  foresees  an  increase  in 
production  costs,  and  a  reduction  in  the  product  range.  The  option  results  in  an  estimated 
impact that would amount to € 89 million of production value. The worst case scenario would 
be a de-facto ban of certain toys. This potential ban may lead to a further loss of production 
up to a total displacement of these toys in the EU. This would imply a loss of € 217 million as 
a worst case. 

Social costs (impact on employment): The selected option results in an estimated impact that 
would  amount  to  662  lost  jobs,  representing  €  8,5  million.  The  worst  case  scenario  -  a  de-
facto ban of certain toys – would amount to 2 112 lost jobs representing € 27,5 million.  

• 

Regulatory fitness and simplification 

The proposal does not exempt micro-enterprises, because the risks for children's health from 
exposure  to  the  highly  toxic  metal  lead  in  toys  are  no  different  whether  the  toys  are 
manufactured by micro-enterprises or by other enterprises. 

The  proposal  contains  no  specific  provisions  to  minimize  compliance  costs  for  SMEs  and 
other  stakeholders,  since  Directive  2009/48/EC,  which  is  being  amended  by  the  present 
proposal, does not contain such provisions either. 

The  risks  which  the  proposal  aims  to  address,  namely  risks  for  children's  health  from 
exposure  to  the  highly  toxic  metal  lead  in  toys,  only  occur  in  the  physical  world,  through 
exposure  to  physical  toys.  Accordingly,  the  "Digital  Check"  and  the  question  whether  the 
proposal  is  internet  ready  and  appropriate  for  both  the  physical  and  digital  environment  is 
irrelevant. 

4. 

BUDGETARY IMPLICATIONS 

None. 

1 

These  toys  are  arts  and  crafts  toys,  which  make  up  for  about  6.5  %  of  the  toy  sales  in  the  EU  on 
average.  See:  Ecorys  (2012)  Competitiveness  Proofing  Toy  Related  Industry.  Impact  of  new  lead 
migration  limits  on  the  competitiveness  of  European  manufacturers.  Study  for  DG  Enterprise  and 
Industry in the framework of the Impact Assessment. Page 69. 

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5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

Directive 2009/48/EC has been transposed by all Member States; only Germany is allowed to 
temporarily maintain its national limit for lead (see above). The three current migration limits 
for  lead  are  contained  in  one  row  in  the  table  in  point  13  of  part  III  of  Annex  II.  The 
amendment of the migration limits implies replacing the current three migration limits in the 
table by three new migration limits. The implementation in Member State law will imply the 
same. Accordingly, an implementation plan does not appear necessary. 

No  monitoring  and  evaluation  tools  are  foreseen  specifically  for  this  proposal.  Directive 
2009/48/EC contains an obligation for Member States to send to the Commission a report on 
the application of the directive, including its amendments. Such a report had to be sent by July 
2014,  and  every  five  years  thereafter.  It  has  to  contain  an  evaluation  of  the  situation 
concerning the safety of toys and of the effectiveness of the directive, as well as a presentation 
of the market surveillance activities performed by each Member State. 

• 

Explanatory documents (for directives) 

A  similar  past  amendment  (Commission  Directive  2012/7/EU)  has  not  created  any 
implementation  issues,  and  neither  have  other  amendments  (Commission  Directives 
2014/79/EU,  2014/81/EU,  2014/84/EU,  (EU)  2015/2115,  (EU)  2015/2116  and  (EU) 
2015/2117).  Accordingly,  the  process  is  by  now  routine  and  explanatory  documents  on  the 
transposition do not appear necessary. 

• 

Detailed explanation of the specific provisions of the proposal 

Article 1 of the proposal replaces the current migration limits of point 13 of part III of Annex 
II to Directive 2009/48/EC for lead by the following new migration limits: 2,0 mg/kg in dry 
toy material , 0,5 mg/kg in liquid toy material and 23 mg/kg in scraped-off toy material. 

Article  2  of  the  proposal  lays  down  the  obligation  for  Member  States  to  transpose  the 
amended  migration  limits  by  the  date  falling  18  months  after  publication  in  the  Official 
Journal  of  the  European  Union,  to  apply  them  from  that  date  and  to  communicate  the 
transposition measures to the Commission. 

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2016/0267 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending, for the purpose of adapting to technical progress, Annex II to Directive 
2009/48/EC of the European Parliament and of the Council on the safety of toys, as 
regards lead 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 
June 2009 on the safety of toys2, and in particular Article 46(1)(b) thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

2 
3 

4 

5 

Directive 2009/48/EC lays down migration limits for toys or components of toys, for a 
range  of  elements,  including  lead,  in  dry,  liquid  and  scraped-off  toy  material.  The 
limits  for  lead  are  13,5 mg/kg,  3,4 mg/kg  and  160 mg/kg  in  each  toy  material, 
respectively. 

Those  limits were  based on the recommendations  of the Dutch National Institute for 
Public  Health  and  the  Environment  (RIVM)  in  a  2008  report3.  The  RIVM 
recommendations were based on the conclusion that exposure of children to lead may 
not exceed a certain level, called 'tolerable daily intake'. In that report, a tolerable daily 
intake  of  3,6 microgram  per  kilogram  body  weight  per  day  was  determined  as  the 
toxicological reference value for lead. 

Since  children  are  also  exposed  to  lead  from  sources  other  than  toys,  only  a  certain 
percentage  of  the  toxicological  reference  value  should  be  allocated  to  toys.  The 
Scientific  Committee  on  Toxicity,  Ecotoxicity  and  Environment 
(CSTEE) 
recommended that 10% of the maximum tolerable intake of lead should be allowed as 
the  maximum  contribution  from  toys4.  The  Scientific  Committee  for  Health  and 
Environmental  Risks  (SCHER)  concurred  with  the  approach  that  the  uptake  of  lead 
from toys should not exceed 10% of a toxicology-based reference value5. Furthermore, 
since lead is considered particularly toxic, its limits in Directive 2009/48/EC were set 
at  half  the  level  considered  safe  according  to  the  criteria  of  the  relevant  Scientific 

J.G.M.  Van 

OJ L 170, 30.6.2009, p. 1. 
'Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on 
elements', 
320003001/2008, 
al. 
http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf  
Scientific Committee on Toxicity, Ecotoxicity and Environment (CSTEE), Opinion on the "Assessment 
of the bioavailability of certain elements in toys", adopted on 22 June 2004, p. 3. 
Scientific Committee on Health and Environmental Risks (SCHER), Opinion on the "Evaluation of the 
Migration Limits for Chemical Elements in Toys", adopted on 1 July 2010, p. 5. 

(2008)  RIVM 

Engelen, 

report 

et 

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Committee, in order to ensure that only traces of lead that are compatible with good 
manufacturing practice should be present. Accordingly, the limits for lead were set in 
that Directive at 5% of the tolerable daily intake, determined as the migration of lead 
from toys. 

The European Food Safety Authority (EFSA) concluded that for lead, as a toxic metal, 
there is no threshold below which the exposure to lead has no critical health effects. 
Even  low-level  exposure  to  lead  may  cause  neurotoxicity,  namely  damage  to  the 
nervous system and brain, in particular learning deficits. Therefore, according to that 
new  scientific  knowledge  published  by  EFSA,  the  tolerable  daily  intake  should  no 
longer be used as the toxicological reference value6. 

According to EFSA, the new toxicological reference to be used for establishing lead 
limits is the BMDL01 (benchmark dose limit) relating to neurodevelopmental effects. 
The BMDL01 is the lower confidence limit (95th percentile) of the benchmark dose of 
a 1% extra risk of intellectual deficits in children measured by the Full Scale IQ score, 
i.e.  a  decrease  in  IQ  by  1  point  on  that  scale7.  The  BMDL01  is  equivalent  to  a  lead 
intake of 0,5 microgram per kilogram body weight per day. 

The  Committee  for  Risk  Assessment  (RAC)  established  under  the  European 
Chemicals  Agency  (ECHA)  agreed  with  EFSA  that  the  BMDL01  is  the  highest 
tolerable exposure for lead8. Since the current average blood lead levels in European 
children are up to four times higher than the highest tolerable exposure level, and since 
no  threshold  for  the  neurodevelopmental  effects  can  be  established,  any  additional 
exposure must be avoided as far as possible9. 

Applying  the  latest  scientific  developments  to  the  methodology  in  the  2008  RIVM 
report  to  calculate  safe  limits  for  elements  in  toys  and  applying  the  approach  of 
Directive  2009/48/EC  in  managing  the  risks  of  particularly  toxic  elements  such  as 
lead, the limits for lead in toys laid down in Directive 2009/48/EC should be reviewed, 
and  should  be  set  at  a  5%  allocation  of  the  BMDL01  for  the  protection  of  children's 
health. 
An  erratum  to  the  2008  RIVM  report10,  published  in  2015,  considered  that  the 
amounts of dry and liquid toy material which children are assumed to ingest, amounts 
upon  which  the  2008  RIVM  report's  recommendations  for  limit  values  were  based, 
should  be  expressed  as  weekly  amounts  instead  of  daily  amounts.  SCHER 
subsequently  contended  that  the  ingestion  amounts  originally  recommended  are 
appropriate and should continue to be expressed as daily amounts rather than weekly 
amounts11, thereby confirming that the methodology used in the 2008 RIVM report to 
calculate  safe  limits  for  elements  in  toys  is  correct.  Accordingly,  the  methodology 
used in the 2008 RIVM report should continue to be applied for the purposes of laying 
down revised limits for lead in toys. 

EFSA CONTAM Panel (2013), Scientific Opinion on Lead in Food, p. 5. Applied in: SCHER (2011), 
Opinion on a Lead Standard in Drinking Water, adopted on 11 January 2011. 
EFSA CONTAM Panel (2013), Scientific Opinion on Lead in Food , p. 5, p. 98 
ECHA  (RAC)  (2013),  Opinion  on  an  Annex  XV  dossier  proposing  restrictions  on  lead  and  its 
compounds in articles intended for consumer use, adopted on 10 December 2013, ECHA/RAC/RES-O-
0000003487-67-04/F, p. 5. 
Ibíd. 
http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf  
Scientific Committee on Health and Environmental Risks (SCHER), Final Opinion on "Estimates of the 
amount 
2016. 
http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_170.pdf  

toy  materials 

8  April 

children", 

ingested 

adopted 

on 

by 

of 

(4) 

(5) 

(6) 

(7) 

(8) 

6 

7 
8 

9 
10 
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(9) 

Directive 2009/48/EC should therefore be amended accordingly. 

(10)  The  committee  established  under  Article  47  of  Directive  2009/48/EC  delivered  no 
opinion  on  the  measures  provided  for  in  this  Directive,  the  Commission  therefore 
submitted to the Council a proposal relating to those measures and forwarded it to the 
European Parliament, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

In the table under point 13 of part III of Annex II to Directive 2009/48/EC, the entry for lead 
is replaced by the following: 

Element  

mg/kg 

mg/kg 

mg/kg 

in dry, brittle, powder-
like or pliable toy 
material 

in liquid or sticky toy 
material  

in scraped-off toy 
material  

‘Lead 

2,0 

0,5 

23’ 

Article 2 

1. 

Member  States  shall  adopt  and  publish,  by  […(Fill  in  date  falling  18  months  after 
publication  in  the  OJ)]  at  the  latest,  the  laws,  regulations  and  administrative 
provisions  necessary 
this  Directive.  They  shall  forthwith 
communicate to the Commission the text of those provisions. 

to  comply  with 

They  shall  apply  those  provisions  from  […(Fill  in  same  date  as  in  previous 
subparagraph)]. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 3 

This Directive is addressed to the Member States. 

Done at Brussels, 

Article 4 

For the Council 
The President 

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