Updates in Commission Regulation (EU) 2020/1682, of November 12, 2020, will restrict HEMA and Di-HEMA TMHDC in cosmetic products (under Annex III of (EC) 1223/2009).

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 170/20

 SG 17020 Nail Polish

Updates in Commission Regulation (EU) 2020/1682, of November 12, 2020, will restrict HEMA and Di-HEMA TMHDC in cosmetic products (under Annex III of (EC) 1223/2009).

The regulation will become effective on December 2, 2020, the 20th day following its publication.

  • From June 3, 2021, products containing these substances and not complying with those conditions shall not be placed on the Union market
  • From September 3, 2021, products containing that substance and not complying with those conditions shall not be made available on the Union market

Commission Regulation (EU) 2020/1682 of November 12,2020 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

Changes Add Add 
Annex III III
Ref #   313 314
Substance Identification Chemical Name/INN 2-Hydroxyethyl Methacrylate
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
INCI Name HEMA
DI-HEMA TRIMETHYLHEXYL DICARBAMATE
CAS # 868-77-9
41137-60-4/ 
72869-86-4
 

EC # 212-782-2
255-239-5/ 
276-957-5
Restrictions Product type, body parts
Nail products 
Nail products 
Other Professional use only
Professional use only
Wording of conditions of use and warnings
  • For professional use only
  • Can cause an allergic reaction
  • For professional use only
  • Can cause an allergic reaction

Remark

  • 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 is also known as Di-HEMA TMHDC.

The Scientific Committee on Consumer Safety (SCCS) has studied and provided its opinion (SCCS/1592/17) on the safety of these two cosmetic ingredients. HEMA and Di-HEMA-TMHDC are not likely to pose a risk of sensitization when they are applied appropriately to the nail plate at concentrations of up to 35% and 99% respectively as part of an artificial nail modeling system, and provided that their use is restricted to the nail plate only and contact with adjacent skin is avoided. Additionally, SCCS commented that both HEMA and di-HEMA-TMHDC are weak to moderate sensitizers and pose a risk of sensitization from misuse of the products, from inappropriate application or from unintentional contamination of the skin adjacent to the nails under normal and reasonably foreseeable conditions of use. 

The European Commission considers ‘possible misuse, inappropriate or unintentional use’ within the scope of normal or reasonably foreseeable conditions of use. A high level of precision is needed during the application of nail products in order to avoid contact with the skin adjacent to nail plate. Considering that cosmetic products made available on the market must be safe for human health when used under normal or reasonably foreseeable conditions of use, a distinction between professional and consumer use of cosmetic products shall be made and appropriate warnings should be labeled on the package of such products. 

References

[1] Commission Regulation (EU) 2020/1682
[2] SCCS opinion (SCCS/1592/17)

With the development of new products, regulations for cosmetics, personal care and household are fast changing and increasingly complex. To stay up-to-date with the latest legislation, check out our powerful regulatory compliance platform, SGS Digicomply.

Next Step

Cosmetic manufactures and importers shall be aware of the transition period of fading out the use of HEMA and Di-HEMA TMHDC in non-professional nail polish. For professional nail polish containing the concerned substances, manufactures shall be alerted to meet the new requirement on product packaging at defined timeline. 

For enquiries, please contact:

Queenie Ho-yan TSE 
Assistant Technical Service Manager
t: +852 2765 3672

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