Safety assessment of cosmetic product

[Manel Mou]

Please I need your opinion in the following:
our product is a cosmetic product for teeth whitening, a tablet intended to be dissolved by the user in water to generate gum brushing solution which its composition varies comparing to the initial formula of tablet (the water dissolution induces series of chemical reaction).
The cosmetic regulation 1223/2009 stipulates that safety assessment should be done on finished cosmetic products which is defined as cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype.
My question is : is it possible to assess the safety of the brushing solution and not the initial tablet especially that in the regulation it is mentioned that during Safety assessment, particular consideration shall be given to any possible impacts on the toxicological profile due to interaction of substances. (which I think it is our case)?

THANKS in advance for your help.

 

[Enghabashy]

*I see that the key with your notified body , There’s statement to be notified under Directive 76/768/EEC.& relevant regulatory procedure, evidence of formal qualifications, comply with Community EU legislation ;the updated / last version of good laboratory practice /other recognized international standards equivalent to EU/ ECHA; ---.

*maybe the assessment could be the both,--- before & after transfer to solution /gum /with water ; you should introduce safety / risk assessment of product before & after ; with referenced directives/STDs & technical file according regulations “could be : FDA,-- etc. ' & relevant harmonized "

* you can consider chemical/ products registration; material safety data sheet “ i.e: acc. ECHA “which should be submitted to regulatory requirements / authorized parties as well

*the output of assessment study should include PRODUCT SAFETY REPORT under ANNEX I

brochure /user manual --etc;

*try to consider & gathering knowledge/info., from other stakeholders including competitors & mothers companies ;*the clause 8 concern Toxicological profile of the substances with considering article 18