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 prohibition 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 prohibition 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 prohibition of 55 allergenic fragrances in 
toys, as listed in the table in the first paragra ph of point 11 of Part III of Annex II  to 
that Directive , in order to protect children from allergies that those fragrances can 
cause when used in toys . 
(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 fragrances is a common,  
significant  and relevant problem in Europe, a nd 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 many 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 products, 
other consumer products, pharmaceuticals and occupational e xposures, 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.  
(3) A survey of allergenic substances in products for children carried out b y 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.  
(4) The Expert Group on Toys Safety advise s the Commission in the preparation of 
legislative proposals and policy initiatives  in the area of toy safety.  The mission of its 
                                                 
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 subgroup on C hemicals  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 rec alled, 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 therefo re present irrespective of whether the allergenic 
substance is used in cosmetics or in toys. Con sequently, 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 thorough account 
of the opinions of the SCCS and of its predecessor committees on allergenic 
fragrances in cosmetic products when regulating allergenic fragrances in toys.  
(6) Directive 20 09/48/EC allows the Commission to prohibit or to require labelling of 
allergenic fragrances in toys. Contrary to Regulation (EC) No 1223/2009  of the 
European Parliament and of the Council5, which regulates cosmetic products, it does 
not allow the Commissio n to set maximum limits for allergenic fragrances.  
(7) In its opinion of 26 and 27  June 2012  the SCCS concluded that cosmetic products 
containing atranol or chloroatranol are not safe . The SCCS thus confirmed the opinion 
of the Scientific Committee on Consumer  Products (SCCP) of 7  December 20046 that 
atranol and  chloroatranol  should not be present in consumer products. The subgroup 
Chemicals therefore recommended, at its meeting on 3  May 20187, to prohibit  the use 
of atranol  and chloroatranol  in toys, by adding  them to the table in the first paragraph 
of point 11 of Part III of Annex II to Directive  2009/48/EC.  
(8) In its opinion of December 19998, the Scientific Committee on Cosmetic Products and 
non-food Products intended for Consumers (SCCNFP), which was a predec essor of 
the SCCS, included methyl heptine carbonate among the fragrance chemicals less 
frequently reported as contact allergens. On the basis of that opinion, methyl heptine 
carbonate was included among the allergenic fragrances that have to be listed on the 
toy, on an affixed label, on the packaging or in an accompanying  leaflet , in accordance 
with the third  paragraph of point 11 of Part III of Annex II to Directive  2009/48/EC. In 
its opinion of 25 September 20019, the SCCNFP recommended that the level of methyl 
heptine carbonate in finished cosmetic products should not exceed 0 ,01 %. 
                                                 
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 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 
on cosmetic products (OJ L 342, 22.12.2009, p. 59).  
6 SCCP opinion on on atranol and chloroatranol present in natural extracts (e.g. oak  moss and tree m oss 
extract) , 7 December 2004 (SCCP/00847/04).   
 https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_006.pdf   
7 Minutes of the Meeting of the Subgroup  “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  
8 Opinion concerning Fragrance Allergy in Consumers – A review of the problem. Analysis of the need 
for appropriate consumer information and identification of  consumer allerge ns, 8 December 1999 
(SCCNFP/0017/98  Final),  Table 6b, p. 23.   
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out98_en.pdf   
9 Opinion concerning An initial List of Perfumery Materials which must not form Part of Cosmetic 
Products except subject to the Restrictions and Conditions laid down , 25 September 2001  
(SCCNFP/0392/00 final ), p. 8.  
https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out150_en.pdf    
EN 3  EN (9) Consideri ng the above, and in particular the SCCS opinion concluding that cosmetic 
products containing atranol or chloroatranol are not saf e, the SCCP opinion that 
atranol and chloroatranol should not be present in consumer products and the SCCNFP 
opinion that methyl heptine carbonate should not exceed 0,01  % in  cosmetic products, 
the Expert Group on Toys Safety recommended, at its meeting on 13  September 2019, 
to prohibit t he use of atranol, chloroatranol and m ethyl heptine carbonate  in toys.  
(10) In light of the opinions of the SCCS, the SCCP and the SCCNFP, and of the 
recommendation of the Expert Group on Toys Safety the use of atranol , chloroatranol 
and methyl heptine carbonat e in toys should be prohibited.  
(11) Directive 2009/48/E C should therefore be amended accordingly.  
(12) 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 , 
HAS ADOPT ED 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 forthwith communicate to the Commission 
the text of those provisions.  
They shall apply those provisions from … [18 months + 1  day after publicatio n in 
the OJ ]. 
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 Directive shall enter into force on the twentieth day following that of it s 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 Leyen