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Directorate-General for Health and Food Safety
Terms of Reference
The SCCNFP recently reviewed the safety of hydrogen (carbamide) peroxide in tooth whitening products following a request to increase the permitted level in Annex III of Directive 76/768/EEC from 0.1 to 3.6%.
Subsequently to this review, the SCCNFP adopted an opinion (doc. n° SCCNFP/0058/98) in the 7th Plenary meeting of 17 February 1999.
The conclusion given in this opinion was :
The content of hydrogen peroxide in tooth whitening products should not exceed 3.6% (10% carbamide peroxide). Tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"). The products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
It was the opinion of the Commission services, responsible for the regulation of cosmetic products within the Community, that it would be inappropriate to provide for such an ingredient, with the restrictions specified in the opinion of the SCCNFP, in Directive 76/768/EEC on cosmetic products.
Mandate
Following the restrictions advised in the opinion of the SCCNFP, tooth whitening products containing 3.6% hydrogen peroxide should not be used during pregnancy or by tobacco or alcohol users, thereby excluding over 50% of the general population.
In order for the material to be used in cosmetic products, it is proposed that a level is found which allows free use by the majority
Therefore, the SCCNFP is asked to address the following questions :
* Based upon the scientific data presented to date, which level can hydrogen peroxide be safely used in a cosmetic product without necessitating warning statements against use during pregnancy or by tobacco and alcohol users?
* At which concentration can hydrogen peroxide be safely used in cosmetic products that are freely available to consumers (i.e. distribution is not restricted to healthcare professionals)?
* Does the SCCNFP recommend any modifications or amendments to its previous opinion on the safety of hydrogen peroxide in oral care cosmetic products based on the dossier submitted?
* Does the SCCNFP maintain the necessity for the previously advised warning statements and restrictions on the use of hydrogen peroxide (and equivalent) in oral care cosmetics products, in the light of the latest submission.
Clarification
The SCCNFP re-evaluated the questions raised by COLIPA in Submission II and decided to remove the term "during pregnancy or" from the Opinion since based on toxicokinetic considerations it is unlikely that hydrogen peroxide reaches the foetus.
With the above exception the SCCNFP hereby confirms its opinion concerning hydrogen (carbamide) peroxide) in tooth whitening products of 17 February 1999 and recommends no other modifications or amendments to this opinion. Moreover, the SCCNFP states that, based upon the scientific data presented to date, hydrogen (carbamide) peroxide can be safely used in a cosmetic product without necessitating warning statements against use by tobacco and alcohol users at a maximum level of 0.1%.
Up to a concentration of 0.1%, hydrogen (carbamide) peroxide can be safely used in cosmetic products that are freely available to the consumer (i.e. their distribution is not restricted to healthcare professionals). Consequently, the SCCNFP maintains the necessity for the advised warning statements and restrictions on the use of hydrogen peroxide (and equivalent) in teeth bleaching products.
The revised Opinion reads :
The content of hydrogen peroxide in tooth whitening products should not exceed 3.6% (10% carbamide peroxide). Tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"). These products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used by habitual tobacco and alcohol users.
The SCCNFP has reviewed the use of hydrogen peroxide and hydrogen peroxide releasing substances in tooth pastes and mouth-rinses (doc. n° SCCNFP/0158/99).
The SCCNFP recently reviewed the safety of hydrogen (carbamide) peroxide in tooth whitening products following a request to increase the permitted level in Annex III of Directive 76/768/EEC from 0.1 to 3.6%.
Subsequently to this review, the SCCNFP adopted an opinion (doc. n° SCCNFP/0058/98) in the 7th Plenary meeting of 17 February 1999.
The conclusion given in this opinion was :
The content of hydrogen peroxide in tooth whitening products should not exceed 3.6% (10% carbamide peroxide). Tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"). The products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
It was the opinion of the Commission services, responsible for the regulation of cosmetic products within the Community, that it would be inappropriate to provide for such an ingredient, with the restrictions specified in the opinion of the SCCNFP, in Directive 76/768/EEC on cosmetic products.
Mandate
Following the restrictions advised in the opinion of the SCCNFP, tooth whitening products containing 3.6% hydrogen peroxide should not be used during pregnancy or by tobacco or alcohol users, thereby excluding over 50% of the general population.
In order for the material to be used in cosmetic products, it is proposed that a level is found which allows free use by the majority
Therefore, the SCCNFP is asked to address the following questions :
* Based upon the scientific data presented to date, which level can hydrogen peroxide be safely used in a cosmetic product without necessitating warning statements against use during pregnancy or by tobacco and alcohol users?
* At which concentration can hydrogen peroxide be safely used in cosmetic products that are freely available to consumers (i.e. distribution is not restricted to healthcare professionals)?
* Does the SCCNFP recommend any modifications or amendments to its previous opinion on the safety of hydrogen peroxide in oral care cosmetic products based on the dossier submitted?
* Does the SCCNFP maintain the necessity for the previously advised warning statements and restrictions on the use of hydrogen peroxide (and equivalent) in oral care cosmetics products, in the light of the latest submission.
Clarification
The SCCNFP re-evaluated the questions raised by COLIPA in Submission II and decided to remove the term "during pregnancy or" from the Opinion since based on toxicokinetic considerations it is unlikely that hydrogen peroxide reaches the foetus.
With the above exception the SCCNFP hereby confirms its opinion concerning hydrogen (carbamide) peroxide) in tooth whitening products of 17 February 1999 and recommends no other modifications or amendments to this opinion. Moreover, the SCCNFP states that, based upon the scientific data presented to date, hydrogen (carbamide) peroxide can be safely used in a cosmetic product without necessitating warning statements against use by tobacco and alcohol users at a maximum level of 0.1%.
Up to a concentration of 0.1%, hydrogen (carbamide) peroxide can be safely used in cosmetic products that are freely available to the consumer (i.e. their distribution is not restricted to healthcare professionals). Consequently, the SCCNFP maintains the necessity for the advised warning statements and restrictions on the use of hydrogen peroxide (and equivalent) in teeth bleaching products.
The revised Opinion reads :
The content of hydrogen peroxide in tooth whitening products should not exceed 3.6% (10% carbamide peroxide). Tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"). These products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used by habitual tobacco and alcohol users.
The SCCNFP has reviewed the use of hydrogen peroxide and hydrogen peroxide releasing substances in tooth pastes and mouth-rinses (doc. n° SCCNFP/0158/99).
