Norwegian opinion on use of Antibiotics and Sulphonamides in cosmetics


Published 12.02.2013 | Modified 02.04.2013

Please note that the Annex II of the European cosmetic products directive (Council Directive 76/768/EEC) , the Annex II of EU Regulation 1223/2009 that on 11 July replaces the directive, and the corresponding attachments 2a and 2b belonging to our national cosmetics products regulation, includes some entries that are not for exact ingredients but for groups of ingredients.

Addressing the database erected by the European Commission and that usually is called CosIng (see the internet pages of the Commission) you can find out about specific ingredients sorting under the different groups of ingredients. At least two of these entries are, however, problematic because there is no unanimous consent among European competent authorities as to which ingredient belong to the group or not. Particularly, this concerns the following two entries:

  • No 39, Antibiotics
  • No 307, Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the –NH2 groups) and their salts.

Observe that the competent Norwegian authority in the field of cosmetic products, the Norwegian Food Safety Authority, has the following understanding of these two entries:

As concerns No 39 we consider anti-fungus medicinal remedies of the azole type to be included. The concept “antibiotics” has not been defined neither in the Council Directive 76/768/EEC nor in the EU regulation 1223/2009.

As concerns No 307 we perceive this prohibition to cover more sulphonamides than only the subgroup mentioned in the parenthesis and that is for sulfa drugs only. This means that among others the following ingredients (INCI name) are not allowed in cosmetics to be placed on the market in Norway. They may, however, be allowed in other countries within the EU that interpret the No 307 entry differently:

  • CETYLENEDIUREA/FORMALDEHYDE/TOSYLAMIDE CROSSPOLYMER
  • BENZENESULFONYLTROMETHAMIDE
  • BENZYLIDENECAMPHOR HYDROLYZED COLLAGEN SULFONAMIDE
  • ETHYL TOSYLAMIDE    (in use)
  • FORMALDEHYDE/MELAMINE/TOSYLAMIDE COPOLYMER
  • ISOBUTYL PHENYLHYDRAZINOYL METHANESULFONAMIDE
  • ISOPROPYLCHROMENAMIDO FLUOROBENZYL METHANESULFONAMIDE
  • METHOXYBENZOYL METHYLSULFONYL OXOPIPERIDINYL PIPERAZINECARBOXAMIDE  (in use)
  • MESYLOXYBENZYL ISOBUTYLBENZENESULFONAMIDE (in use)
  • METHOXYPHENYLSULFONAMIDO DIHYDROXYPROPANAMIDE
  • OXOBENZOXAZINYL NAPHTHALENE SULFOANILIDE
  • SODIUM BISCHLOROPHENYL SULFAMINE (in use)
  • SOLVENT YELLOW 172
  • T-BUTYLCHROMENAMIDO FLUOROBENZYL METHANESULFONAMIDE
  • T-BUTYLPHENYL IMIDAZOLYLPHENYL SULFONAMIDE
  • TOSYLAMIDE  (in use)
  • TOSYLAMIDE/EPOXY RESIN  (in use)
  • TOSYLAMIDE/FORMALDEHYDE (in use)

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