FDA instructs manufacturers to collect samples of recently
produced and retained products, especially those that are water-based, when the manufacturer is unable to produce challenge
test documentation or the adequacy of preservation is otherwise
in doubt or non-traditional preservative systems are used.
“The FDA is not concerned with traditional preservatives such
as parabens, quaternium- 15 and DMDM hydantoin,” he said.
A Bright Outlook
Continued expansion of natural or nature-identical preservative
ingredients is critical for the future of preservatives, said Franz of
Vigon.“Increasing demand from the end consumer for preserva-
tives that are natural and that provide multifunctional benefits
are forthcoming in this sector,” he said.
“We see a continued drive to reformulate the preservation
package to assure both proper preservation
and safety. There is not significant traction
in the industry to move to preservative-free
products in a big way in personal care ap-
plications; the cost of recalls and poten-
tial damage to the brand is significant, and
data on new product launches from Mintel
GNPD supports this,” added Vaughn Biege
of Emerald. “According to our analysis, new
product launches of beauty and personal
care products without antimicrobials repre-
sent about 19% of all new product launch-
es—holding steady in share over the last five
years—and even fewer of these products
bear an associated ‘free from additives and
antimicrobials’ claim on its label.’”
The demand for alternative preservatives
with mild safety profile will keep growing,
noted Fana Makonnen of Inolex.
“Consumers want safe and natural products that are certified because they have been
screened to a standard that identifies them to
be natural and safe,” she explained.
As preservative chemistries are increas-
ingly under attack from non-scientific NGOs
and consumer groups, it is important for the
scientific community to work together to
support “tried and true” preservatives, said
Sedlewicz of schülke inc. She added, “The
risk to the consumer of unpreserved or un-
der-preserved products should be our focus.
Not every preservative can work in every
formulation or against every organism. The
fewer preservatives we have to work with,
the more difficult it will be for formulators to
produce adequately preserved products that
are safe in the hands of the consumer.”
All in all, the industry is dealing with a
gap, and it will be a while until there is clo-
sure, noted Eylon of Sharon Laboratories.
“It’s a gap between the wishes of the con-
sumers (even if not the majority) for ‘free
of… everything’ and the needs of the formu-
lator to deliver a safe product, but one that
the marketing group can sell.”•
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