EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending Annex  II to Directive 2009/48/EC of the European Parliament and of the 
Council as regards the labelling of allergenic fragrances in toys  
 
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending Annex  II to Directive 2009/48/EC of the European Parliament and of the 
Council as regards the labelling of allergenic fragrances in toys  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
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 toys1, and in particular point (b) of the first subparagraph of 
Article 46(1) thereof,  
Whereas:  
(1) Directive 2009/48/EC lays down a general obligation to list on the toy, on an affixed 
label, on the packaging or in an accompanying leaflet, if added to a toy, the names of 
11 allergenic fragrances if the concentrations of those fragrances exceed 100  mg/kg in 
the toy or components thereof. Those all ergenic fragrances are listed in the table in the 
third paragraph of point 11 of Part II I of Annex II to that Directive.  
(2) The Scientific Committee on Consumer Safety (SCCS, which assists the Commission 
as an independent risk assessment body in the area of cosmetic products, notes in its 
opinion of 26 and 27  June 20122 that contact allergy to f ragrances is a common, 
significant and relevant problem in Europe and that exposure to fragrances occurs 
from the use of other consumer products, such as toys. The SCCS also notes that, in 
recent years, it has become a trend to add fragrance chemicals to m any types of 
consumer products, such as children’s toys, which may contribute significantly to the 
fragrance exposure of the consumer by the dermal route. The SCCS adds that the 
consumer is exposed to fragrance substances from a wide variety of cosmetic pr oducts, 
other consumer products, pharmaceuticals and occupational exposures, and that all 
those exposures are of importance in the context of contact allergy as it is not the 
source of exposure that is critical, but the cumulative dose per unit area.  In th e 
opinion, a number of established contact allergens in humans are listed in Table 13 -1.  
(3) A survey of allergenic substances in products for children carried out by the 
Environmental Protection Agency in Denmark3 shows the presence of allergenic 
fragrances in toys, namely modelling clays, slimes, a doll, a teddy bear, and rubber 
bands.  
                                                 
1 OJ L 170, 30.6.2009, p. 1.  
2 SCCS opinion on fragrance allergens in cosmetic products, 26 – 27 June 2012 ( SCCS/1459/11 ). 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf  
3 Ministry of Environment and Food of Denmark - Environmental Protection  Agency. Survey of 
allergenic substances in products targeted children – toys and cosmetic products. Survey of Chemical 
Substances in Consumer Products No. 148, 2016.   
https://www2.mst.dk/Udgiv/publications/2016/08/978 -87-93529 -00-7.pdf    
EN 2  EN (4) The Expert Group on Toys Safety advises the Commission in the preparation of 
legislative proposals and policy initiatives in t he area of toy safety . The mission of its 
subgrou p on Chemicals  in Toys (subgroup Chemicals)  is to provide advice with regard 
to chemical substances which may be used in toys.  
(5) The Expert Group on Toys Safety recalled, at its meeting on 13 September 20194, that 
an allergenic substance, whether present in cosmetic products or in toys, is always 
allergenic . That so -called intrinsic property of the substance is independent from the 
use of the substance and is therefore present irrespective of whether the allergenic 
substance is used in cosmetics or in toys. C onsequently, the Expert Group considered 
that an allergenic substance presenting a risk in cosmetic products could equally 
present a risk in toys. It therefore underlined the importance to take th orough account 
of the opinions of the SCCS and of its predec essor committees on allergenic 
fragrances in cosmetic products when regulating allergenic fragrances in toys.  
(6) At the meeting of the subgroup Chemicals of 3 May 20185, the majority of its 
members concluded that the established contact allergens in humans  listed in 
Table  13-1 of the SCCS opinion of 26 and 27 June 2012  should be added to the list of 
allergenic fragrances that have to be listed on the toy, on an affixed label, on the 
packaging or in an accompanying leaflet , laid down in the table in the thir d paragraph 
of point  11 of Part  III of Annex  II to Directive 2009/48/EC.  
(7) On 13 September 2019, the Expert Group on Toys Safety confirmed the conclusions 
of the subgroup Chemicals . 
(8) At its meeting  on 13 September 2019, the Expert Group on Toys Safety  noted t hat 
entry 4 in the table in the third paragraph of point  11 of Part  III of Annex  II to 
Directive 2009/48/EC on citronellol, CAS number 106 -22-9, covers only the mixture 
of the two enantiomeric forms of citronellol. The labelling requirements should 
however , according to the Expert Group, also cover the two individual enantiomeric 
forms listed as CAS  numbers 1117 -61-9 and 7540 -51-4 in Table  13-1 of the SCCS 
opinion of 26  and 27 June 2012.  
(9) In light of the SCCS opinion of 26  and 27 June 2012 and the recommenda tion of the 
Expert Group on Toys Safety of 13 September 2019, the allergenic fragrances listed in 
Table 13 -1 of the SCCS opinion of 26 and 27 June 2012 should be subject to labelling 
requirements when present in toys. The fragrances that are not yet subjec t to a 
prohibition or labelling requirements laid down in Directive 2009/48/EC, should 
therefore be included in the table in the third paragraph of point 11 of Part III of 
Annex II to that Directive.  
(10) Directive 2009/48/E C should therefore be amended accordi ngly.  
(11) The measures provided for in this Directive are in accordance with the opinion of the 
Committee established  under Article 47(1) of Directive 2009/48/EC,  
                                                 
4 Minutes of the meeting of the Expert Group on Toys Safety of 13 September 2019   
https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=1799
6  
5 Minutes of the Meeting of the s ubgroup Chemicals of the Expert Group on Toy Safety of 3 May 2018.  
https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeetingDoc&docid=1902
5.   
EN 3  EN HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex I I to Directive 2009/48/EC is amended in accordance with the Annex to this Directive.  
Article 2 
1. Member States shall adopt and publish, by … [18 months after publication in the 
OJ] at the latest, the laws, regulations and administrative provisions necessary to 
comply with this Directive. They shall forthw ith communicate to the Commission 
the text of those provisions.  
They shall apply those provisions from  … [18 months  + 1  day after publication in 
the OJ] . 
When Member States adopt those provisions, they shall contain a reference to this 
Directive or be acc ompanied 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 adop t in the field covered by this Directive.  
Article 3 
This Directive 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 Commission  
 The President  
 Ursula von der Le yen