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Preservative Update: Frequency of Use Through 2018

Contact Author David C. Steinberg, Steinberg & Associates, Plainsboro Township, NJ, U.S.
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To read the full article, complete with tables, click through to the October 2019 digital magazine.

The last time a “Frequency of Use” report was published for preservatives was in 2014. Since then, two major events have happened that impacted the list. For readers who immediately go to the tables, you will be shocked by the numbers. What happened?

First, the number of formulations registered with the U.S. Food and Drug Administration (FDA) through the voluntary cosmetic registration program (VCRP) dropped from 48,423 to 6,406; meanwhile, in Canada, where registrations are mandatory, the number rose from 150,258 to 202,583. Why?

Voluntary versus mandatory registration: Those who have heard me speak or have read my writing on this subject know that I favor mandatory registration of cosmetic formulations and re-registration every year. Further, the registrations should be the responsibility of the manufacturer and should include the ranges for all ingredients included therein (similar to Canada’s program). The registration must also include the name, address and contact information for the name on the packaging, along with the manufacturer.

The reason for this is simple: How can the cosmetic industry be held accountable to self-regulate if the FDA does not know who makes and who sells cosmetics, or what they contain? Furthermore, while all the bills introduced to Congress in the past few years require mandatory registrations, they also include many restrictions that will be harmful to our industry.

The other reason is that the VCRP is the source that prioritizes which ingredients the Cosmetic Ingredient Review (CIR) examines. But being a voluntary program, and with such a poor number of registrations, the VCRP leaves the CIR with inadequate data to perform its reviews.

So, why the large drop in U.S. registrations? Several years ago, the FDA cleaned out the VCRP listings since so many registrations were from companies no longer in existence. Unfortunately, the industry has done little since to update and/or register products. Canada’s regulations, in contrast, require companies to keep their filings current—including those that are discontinued.

Bans and restrictions: The second major event has been the regulatory ban and restriction of many preservatives worldwide. Most of these come from nongovernmental organizations’ (NGOs’) distaste for preservatives in general. It seems today that attacks are made every two or three months on the most popular preservatives. Our consultancy frequently receives calls asking which preservatives can be used as replacements; my answer is usually to manufacture products aseptically, and possibly fill in unit doses—or resort to prayer.

But in all seriousness, the major impact from a regulatory basis has been decisions by the European Union (EU) and Canada to ban or restrict certain preservatives; following are the three most prominent examples.

Canada’s Prohibited Hot List

Canada prohibited the following preservatives by adding them to its “Hot List.” Note that this list is divided into two categories—prohibited and restricted chemicals. There are more than 475 prohibited chemicals listed, of which maybe 10 have been used in cosmetics. Recent additions include: thimerosal, chloramine T, chloroacetamide and phenyl mercuric acetate. These have not been used in the U.S. in decades.

Canada’s Restricted Hot List

Canada also restricted the following preservatives by placing them on its restricted Hot List...

Continue reading in the October 2019 digital magazine...

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