EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products  
 
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic p roducts1, and in particular Article 31(1 ) thereof,  
Whereas:  
(1) The substances 2-hydroxyethyl methacrylate (HEMA ) and 11,14 -Dioxa -2,9-
diazaheptadec -16-enoic Acid, 4,4,6,16 -tetramethyl -10,15 -dioxo,2 -[(2-methyl -1-oxo-2-
propenyl)oxy]ethyl ester  (Di-HEMA Trimethyl hexyl Dicarbama te or Di -HEMA 
TMHDC) are currently not subject to prohibition or restriction pursuant to  Regulation 
(EC) No 1223/2009.  
(2) On 2 July 2014, the Swedish Medical Products Agency , which is the  Swedish 
competent authority  for the purposes of Regulati on (EC) No 1223/2009 , adopted and 
communicated a decision under Article 27 of Regulation (EC) No 1223/2009  
introducing provisional restrictive measures on a nail cosmetic product that had caused 
a high number of undesirable effects. The substances identified as likely to cause th ose 
undesirable effects were HEMA and Di -HEMA TMHDC.   
(3) According to Article 27(2) of Regulation (EC) No 1223/2009 , the Swedish Medical 
Products Agency communicated  immediately to the Commission and the competent 
authorities of the other Member States the measures taken and any supporting data . 
(4) The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of  21-
22 June 20182 that ‘HEMA and di -HEMA -TMHDC, when applied appropriately to the 
nail plate (..) as part o f an artificial nail modelling system, are not likely to pose a risk 
of sensitisation, provided that their use is restricted to the nail plate only and contact 
with the adjacent skin is avoided’.   The SCCS further concluded that ‘[b]oth HEMA 
and di -HEMA -TMHDC are weak to moderate sensitisers and pose a risk of 
sensitisation from misuse of the products or from inappropriately carried out 
application or from unintentional contamination of the skin adjacent to the nails under 
normal and reasonably foreseeable conditions of use’.  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1592/17 ; 
https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_214.pd
f EN 2  EN (5) According to Article 3 of Regulation (EC) No 1223/2009, cosmetic product s made 
available on the market must  be safe for human health when used under normal and 
foreseeable conditions of use.  
(6) When assessing ‘normal and foreseeable condit ions of use’, account has to be tak en of 
possible misuse, inappropriate or unintentional use. In the case of products requiring 
high level of precision, it is necessary to  take into account situations of insufficient 
precision in their application.  
(7) Cases of sensitisation to nail products containing HEMA and Di -HEMA TMHDC 
reported in some Member States le ad the Commission to the conclusion that there is a 
risk that such  products may be applied with insufficient precision , causing contact 
with the skin adjacent  to the nail plate.  
(8) A distinction  should b e made  between professional and consumer use of cosmetic 
product s. Higher safety standards are expected from professionals . In particular, a 
professional is expected to have more skills, experience and knowledge on the use of a 
cosmetic product compared to the consumer.  
(9) Possible health and safety risks for professionals  are regulated by certain  Union 
Directives laying down  minimum requirements, in particular Council Directive s 
89/391/EEC3 and 98/24/EC4. Addition al professional safety rules  may apply . 
(10) As regards consumers, s ince the SCCS opinion considers the substances HEMA and 
Di-HEMA TMHDC safe in nail products only when applied  on the n ail plate and since 
‘normal and forese eable conditions of use’ should take into account the possibility of 
application on the skin adjacent to the nail plate, there is a potential risk to human 
health from the use of HEMA and Di -HEMA TMHDC in nail products.  
(11) As the use of nail products contain ing HEMA and Di -HEMA TMHDC by 
professional s is expected to be safer for the consumer, such products should be used 
only by professionals and therefore the warning ‘for professional use only’ should be 
added o n the package of such products.  
(12) To draw attentio n of b oth professionals and consumers  to the potential health risk, the 
warning ‘can cause an allergic reaction’  should be added  on the package of  nail 
product s containing HEMA and Di -HEMA TMHDC .  
(13) Therefore, the safeguard measure taken by Sweden should be considered as justified. 
Consequently, i t is necessary  to impo se a restriction on the use of HEMA and Di -
HEMA TMHDC  in nail products . 
(14) Annex III to Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(15) It is appropriate to provide for a reasonable period of time in order for the industry to 
adapt to the new requirements.  
(16) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing Committee on Cosmetic Products,  
                                                 
3 Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage 
improvements in the safety and health of workers at work ( OJ L 183, 29.6.1989, p. 1 ). 
4 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from 
the risks related to chemical agents at work (fourteenth individual Directive within the meaning of 
Article 16(1) of Directiv e 89/391/EEC) ( OJ L 131, 5.5.1998, p.  11). EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex  III to Regulation (EC) No 1223/2009 is amende d in accordance with the Annex  to this 
Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Reg ulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen