EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) XXX  draft  
  
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)   EN 2   EN 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 C ommission 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 t he 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 C ouncil 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 a nd 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 Commiss ion 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 i n 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 th e 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.  EN 3   EN • Consistency with o ther 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 mark eting 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 inter nal 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 pop ulation.  
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
• Stakeholder  consultations  
The Commission informed all concerned stakeholders (Member States, industry, consumer 
protection associations, standardisati on 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. EN 4   EN Subsequently, a number of Member States expressed support for a 5% al location and 
exemption for the arts and c rafts toys . 
Following this, the Commission received positi on 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 t he 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 publish ed 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 t he information amongst their members. The results of the 
consultation were published and business associations were duly in formed about their 
publication.  
The Commission also collected position papers from consumer protection associations , in 
particular fr om 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 be low). 
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 Sta tes 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 to lead via toys  
(http://ec.europa.eu/DocsRoom/documents/6655/att achments/1/translations/en/renditions/nati
ve), the other on the initiative's effects on the competiveness of the toy sector  
(http://ec.europa.eu/Doc sRoom/documents/6654/attachments/1/translations/en/renditions/nati
ve). 
• 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 publi cly 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 EN 5   EN 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 limit ed costs for industry. Soft law /self -regulatory approach es 
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 s howed 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 e xposure 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 mi llion 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 q uestion 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 Enterpris e and 
Industry in the framework of the Impact Assessment. Page 69.  EN 6   EN 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 r ow in the table  in point 13 of p art 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. Accordin gly, an  impleme ntation 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, in cluding  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 m arket 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 p art 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 mate rial 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.  EN 7   EN 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 Functioni ng of the European U nion, 
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) 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. T he 
limits for lead are 13,5  mg/kg, 3,4  mg/kg  and 160  mg/kg in each toy material, 
respectively.  
(2) 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 exce ed a certain level, called 'tolerable daily intake'. In th at report, a tolerable daily 
intake of 3,6  microgram per kilogram body weight per day was determ ined as the 
toxicologic al reference value  for lead . 
(3) Since children are also exposed to lead from  sourc es 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 
Committee, in order to ensure that only traces of lead that are compatible with go od 
                                                 
2 OJ L 170, 30.6.2009, p. 1.  
3  'Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on 
elements' , J.G.M. Van Engelen , et al. (2008) RIVM report 320003001/2008 , 
http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf   
4 Scientific Committee on Toxicity, Ecotoxicity and Environment (CSTEE) , Opinion on the "Assessment 
of the bioavailabil ity of certain elements in toys", adopted on 22 June 2004, p. 3.  
5 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.  EN 8   EN 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.  
(4) 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 th at 
new scientific knowledge published by EFSA, the tolerable daily intake should no 
longer be used as the toxicological reference value6. 
(5) According to EFSA,  the new toxicological reference to be used for establishing lead 
limits is the BMDL 01 (benchmark dose limit) relating to neurodevelopmental effects. 
The BMDL 01 is the lower confidence limit (95 th percentile) of the benchmark dose of 
a 1% extra risk of int ellectual deficits in children measured by the Full Scale IQ score, 
i.e. a decrease in IQ by 1 point on that scale7. The BMDL 01 is equivalent to a lead 
intake of 0,5 microgram per kilogram body weight per day.  
(6) The Committee for Risk Assessment (RAC) establ ished under the European 
Chemicals Agency (ECHA) agreed with EFSA that the BMDL 01 is the highest 
tolerable exposure for lead8. Since the current average blood lead levels in European 
children are up to four times higher than th e 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. 
(7) Applying the latest scientific developments to the methodology in the 2008  RIVM 
report to calculate safe limit s 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% allocati on of the BMDL 01 for the protection of children's 
health.  
(8) 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 rec ommendations for limit values were based, 
should be expressed as weekly amounts instea d of d aily 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 purp oses of laying 
down revised limits for lead in toys.  
(9) Directive 2009/48/EC should therefore be amended accordingly.  
                                                 
6 EFSA CONTAM Panel (201 3), Scienti fic Opinion on Lead in  Food , p. 5. Applied in: SCHER (2011) , 
Opinion on a Lead Standard in Drinking Water , adopted on 11 January 2011.  
7 EFSA CONTAM Panel (2013 ), Scienti fic Opinion on Lead in Food  , p. 5, p. 98  
8 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.  
9 Ibíd. 
10  http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf   
11  Scientific Committee on Health and Environmental Risks (SCHER), Final Opinion on "Estimates of the 
amount of toy materials inges ted by children", adopted on 8 April 2016. 
http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_170.pdf   EN 9   EN (10) The committee established under  Article 47 of Directive 2009/48/EC delivered no 
opinion on the measures provided for in this Directive, the C ommission 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  
in dry, brittle, powder -
like or pliable toy 
material  mg/kg  
in liquid or sticky toy 
material  mg/kg  
in scrap ed-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 to comply with this Directive. They shall forthwith 
communicate to the Commission the text of those provisions.  
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.  
Article 3 
This Direct ive shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
Article 4 
This Directive is addressed to the Member States.  
Done at Brussels,  
 For the Council  
 The President