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MBBT (Nano) is now permitted as a UV filter, at a maximum authorized level of 10% and with restricted applications, in cosmetic products.

SAFEGUARDS | Cosmetics, Personal Care & Household NO. 098/18

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2,2′-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethyl-butyl)phenol)/Bisoctrizole (INCI name: Methylene Bis-Benzotriazolyl Tetramethylbutylphenol), MBBT, is allowed for use in cosmetic products with a maximum authorized level of 10% as a UV filter; whereas the nano form of MBBT is not currently regulated.

In light of SCCS opinion SCCS/1546/15, which advised the safe use level of MBBT (nano) as a UV-filter in cosmetic products, the European Commission has adopted the opinion and updated the requirement in Commission Regulation (EU) 2018/885, which includes the use of MBBT (nano) as a permitted UV filter with a restricted application in cosmetic products.

The regulation was published on June 20, 2018, and will be effective from July 11, 2018.  

Entry Amended

Reference Number 23’
Chemical name/ INN/ XAN 2,2′-Methylenebis(6-(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole
Name of Common Ingredients Glossary Methylene BisBenzotriazolyl Tetramethylbutylphenol
CAS number 103597-45-1
EC number 403-800-1
Maximum concentration in ready for use preparation 10%*
Remark* In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column ‘g’, i.e. 10%

Entry Added

Reference Number 23a
Chemical name/ INN/ XAN 2,2′-Methylenebis(6-(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole
Name of Common Ingredients Glossary Methylene BisBenzotriazolyl Tetramethylbutylphenol (nano)
CAS number 103597-45-1
EC number 403-800-1
Maximum concentration in ready for use preparation 10%*
  • Not to be used in applications that may lead to exposure of the end user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed:
  • Purity ≥ 98,5 %, with 2,2′-methylene-bis- (6(2H-benzotriazol-2-yl)-4-(isooctyl)phenol) isomer fraction not exceeding 1,5 %;
  • Solubility < 5 ng/L in water at 25 °C;
  • Partition coefficient (Log Pow): 12,7 at 25 °C;
  • Uncoated;
  • Median particle size D50 (50 % of the number below this diameter): ≥ 120 nm of mass distribution and/or ≥ 60 nm of number size distribution.
Remark* In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column ‘g’, i.e. 10%

Next step:

Methylene BisBenzotriazolyl Tetramethylbutylphenol (nano) can now be used as UV filter in cosmetics; industry shall pay attention to the restrictions on its application.

Source of Information:

  • SCCS Opinion SCCS/1546/15 (Revision of 25 June 2015) (1)
  • Commission Regulation (EU) 2018/885 of 20 June 2018 amending Annex VI to Regulation (EC) 1223/2009 of the European Parliament and of the Council on cosmetic products (2)

SGS is committed to providing information about development in regulations for consumer products as complimentary services. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Please do not hesitate to contact us for further information.

For enquiries, please contact:

Queenie TSE
Consumer and Retail
Cosmetics, Personal Care and Household (CPCH)
Senior Technical Service Executive
t: +852 2765 3672 (ext 1672)

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