The Complex Issue of Polyaminopropyl Biguanide

Biorius published an article on Polyaminopropyl Biguanide in its newsletter of January 2015. The article was relatively pessimistic about the future of this preservative and it was recommended at this time that problematic products be quickly reformulated.

The main trade associations (Cosmetics Europe, COSMED, EFfCI, etc.) tried to influence the EU Commission on the basis that, according to the SCCS, 0.3% of this preservative is not safe for cosmetic products but a safe level could be identified nevertheless.
In a personal communication, Cosmetics Europe informed Biorius a few months ago that 0.03% of Polyaminopropyl Biguanide is deemed safe and should be accepted by the SCCS. Therefore, Biorius reassured its clientsthat all products containing lessthan 0.03% of this preservative would probably not have to be reformulated.

However, and contrary to expectation, the EU Commission made staggering declaration at the regulatory congress of Chartres (France) held on November 17-19, 2015. Polyaminopropyl Biguanide is going to be delisted from Annex V and an amendment of the Cosmetics Regulation will be published beginning of 2016 to make the ban official (the ingredient being regarded as already banned). They do not exclude that the banned preservative could be relisted at a later stage with a maximum use level approved by the SCCS.

The Industry is unanimously against this regulatory measure and argued that banning an ingredient has irreversible consequences in terms of consumer acceptability. The trade associations continue to lobby against this ban and ask their members not to phase out the ingredient until a final conclusion is drawn on this dossier.

On the other hand, the EU Commission informed the Industry that some Member States have already started to control thissubstance in marketed products and to sue non-compliant companies (even though the topic is still debated in others). Obviously, nothing will be done by the EU Commission to solve this issue and Biorius can only recommend that products still containing Polyaminopropyl Biguanide be quickly reformulated.

Any questions?