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Consumer Products

Restrictions on cosmetic preservatives ramp up

With fewer preservatives in use, chemists worry about protecting consumer products from contamination

by Marc S. Reisch
November 28, 2016 | APPEARED IN VOLUME 94, ISSUE 47

Credit: Shutterstock
Formulators are increasingly concerned about microbial contamination in cosmetics.

It has been a slow war of attrition. For the past decade, environmental groups have called out a growing number of cosmetic preservatives as suspected endocrine disruptors, cancer-causing agents, and skin irritants. Regulators have examined the claims and in some cases enacted restrictions on widely used preservatives.

Now the list of useful preservatives is down to a handful, say cosmetic formulators and suppliers. And because of the high cost of developing new preservatives and strictures against animal testing, few qualified alternatives are in the offing.

Without a preservative, often used at less than 1%, skin creams, makeup, and shampoos can become contaminated with mold, fungi, and bacteria. Some contaminants can spoil the appearance and smell of cosmetics. Others can lead to skin, scalp, and eye infections, or even worse.

Bad actors include Staphylococcus aureus, a gram-positive bacteria that can cause skin infections, and Escherichia coli, a gram-negative bacteria that can cause stomach cramps and diarrhea when people share cosmetics. “Consumers assume that preservatives are bad without understanding how necessary they are,” says Janet Blaschke, chief executive officer of the consulting firm International Cosmetics & Regulatory Specialists.

Preservatives are meant “to keep cosmetics safe throughout their useful life from production until the last bit is used at the bottom of the jar,” Blaschke says. She fears that, over time, bacteria will build up resistance to the diminishing number of options now available. She doesn’t see alternatives such as single-use or aseptic packaging as realistic—both because of the additional cost and because of the increased packaging waste.

When it comes to preservatives, the most important regulator is the European Union. The EU has a list of allowable preservatives, known as Annex V, that not only governs preservative use in the 28-nation alliance but also influences regulations in many other countries. Although the list contains more than 50 approved ingredients, often only two or three options are appropriate for a particular formulation, formulators and preservative suppliers say.

Consumers assume that preservatives are bad without understanding how necessary they are.
Janet Blaschke, CEO, International Cosmetics & Regulatory Specialists

Among the preservatives European authorities have restricted are methylisothiazolinone and the mixture of methylisothiazolinone and methylchloroisothiazolinone for use in cosmetics, such as lotions, that remain on the skin. The restrictions, effective earlier this year for the combination and in 2017 for the single ingredient, were widely expected. Most everyone, including their maker, Dow Chemical, agreed the ingredients can irritate skin.

An unfavorable review by the Scientific Committee on Consumer Safety (SCCS), an EU panel of experts, judged one widely used preservative, poly(hexamethylene) biguanide hydrochloride (PHMB), not safe for use at a maximum concentration of 0.3% because of cancer concerns. SCCS is now considering whether PHMB is safe for use at concentrations of up to 0.1%, says PHMB maker Lonza. That opinion is expected in December.

Insiders also say EU authorities may soon ban chloroacetamide. French authorities banned it in 2012, but it still appears on the Annex V list of allowable preservatives. The U.S. Cosmetic Ingredient Review, a government-sanctioned industry organization, determined in 1991 that the ingredient is “a potential human sensitizer” and thus not safe for cosmetic use.

EU authorities have examined other preservatives on Annex V and found them acceptable but sometimes at reduced allowable use levels. The widely used preservative phenoxyethanol received a clean bill of health earlier this year. In 2015, phenylphenol got a passing grade but at reduced use levels. SCCS said it did not have enough data to judge safe use of sodium o-phenylphenate and potassium o-phenylphenate.

A 2013 SCCS review of parabens, compounds the advocacy organization Environmental Working Group has targeted as endocrine system disruptors, found they were safe to use. SCCS did recommend new, lower concentration limits for propylparaben and butylparaben, both of which it judged to have “a weak endocrine-modifying potential.”

EC = European Commission. SCCS = Scientific Committee on Consumer Safety, which advises EC on the safety of preservatives.
Sources: European Commission, Agence
EC = European Commission. SCCS = Scientific Committee on Consumer Safety, which advises EC on the safety of preservatives.
Sources: European Commission, Agence

Rob Taalman, director of research and science at Cosmetics Europe, which represents European cosmetics makers, says the parabens recommendation reflects the EU’s risk-based assessment process for cosmetic ingredients. An ingredient “may have an intrinsic undesirable property, but EU authorities don’t automatically ban it,” he says. Preservatives are used in cosmetics to ensure public safety, he notes.

Yet for companies, a government stamp of approval isn’t always enough. Following criticism from outside groups, some consumer product formulators have banned what they consider chemicals of concern. For example, Johnson & Johnson removed formaldehyde-releasing preservatives, which might evoke an allergic response, from all its products. It also removed parabens from baby products.

Andrea Mitarotonda, chief scientific officer of Neal’s Yard Remedies, a U.K.-based cosmetics retailer and formulator, notes that any suspicion, even if undeserved, can prompt corporate action. Without waiting for the outcome of an investigation, companies often reformulate entire ranges of products so they don’t have to face “the detrimental consequence of a possible ban later,” he explains.

Questioning old standby preservatives is not necessarily a bad thing, Mitarotonda observes. “What was considered safe 20 years ago, tested using methods and protocols available at that time, needs to be reviewed in light of the knowledge and technologies available now,” he says.

Neal’s Yard Remedies draws on the ingredients from the Annex V list, but Mitarotonda is also interested in using them in combination with natural alternatives not on the list. “Very few formulators will be aware of the chemistry of essential oils or plant extracts, which is obviously a shame as they may be missing out on opportunities to use substances to enhance the preservation profile of their products.”

Some industry players are leery of essential oils and plant extracts, which are often called “nonpreservative preservatives.” Oils and extracts can vary in quality and consistency, notes David Steinberg, a cosmetic formulation consultant. “How do you guarantee the purity of extracts compared with the purity of synthetic preservatives like parabens?” he asks.

Steinberg also wonders about the efficacy of alternative preservatives, noting that they don’t have the long history of use and characterization that backs the traditional sort. Recalls of contaminated cosmetics are dwarfed by those of clothing, toys, and other consumer products on the EU’s Rapid Alert recall database, he says. But he notes a subtle rise in cosmetic recalls in the past few years, which he attributes to lower levels of effective preservatives and the use of alternatives.

Some products that are primarily added as emollients or conditioners, for instance, can also have preservative qualities, notes Rick Strittmatter, global microbial control R&D director at Dow. Like plant extracts, they also fall into the category of nonpreservative preservatives and “can clearly play a preservation role,” he says.

But the assessment of such preservatives “also must be subject to the same risk-based approach that traditional preservatives have been subject to,” Strittmatter says. “If it is being used as a preservative, it needs to be assessed on a level playing field.”

Companies are pursuing all preservative options to combat the shrinking arsenal of traditional products. Niall D’Arcy, project manager for the Ireland-based consulting firm Biocide Information, sees a business opportunity because the new products are generally more expensive than parabens and other traditional ingredients. He says the $1 billion-a-year global market for preservatives of all types is growing 4 to 5% annually.

Of the more than 50 preservatives listed on Annex V, only about one-third are in regular use, says Andrea Wingenfeld, a technical marketing manager at the specialty chemical maker Ashland. Temperature sensitivity, pH sensitivity, and antimicrobial activity all play a role in the choice a formulator makes. In addition, formulators may avoid using a preservative approved in Europe or other regions if that preservative has been the subject of negative publicity, she says.

For leave-on products such as sunblock or makeup, the choice of preservatives is especially limited, Wingenfeld says. Since the bans on use of isothiazolinones, formulators rely mostly on phenoxyethanol, benzyl alcohol, and organic acids, she notes.

Although they do not like the attacks on what they view as beneficial ingredients, preservative suppliers acknowledge market realities. Lonza, for instance, just revamped its FormulaProtect online preservative selector tool, which allows users to avoid controversial products such as formaldehyde donors and instead choose “less controversial products,” says Phil Hindley, Lonza Consumer Care’s global marketing head for preservation.

Lonza is also interested in developing new preservatives that are acceptable to regulators, formulators, and environmental groups. Hindley says he is open to working with all stakeholders to develop such alternatives (see sidebar). But only a “robust solution” with performance, safety, and cost benefits will work in the long run, he says.

Other challenges to the development of new preservatives are the time, cost, and effort required to win regulatory approval. Ashland’s Wingenfeld says it took eight years from the time authorities received a dossier on the most recent addition to Annex V, citric acid/silver citrate, until it appeared in 2014. Given that timetable, “most companies will not see a business case in commercializing new preservatives,” she says.

The ban on animal testing for cosmetics, in place in Europe since 2009, makes it difficult for developers to submit required safety data on a new preservative, Wingenfeld adds. Cosmetics Europe’s Taalman says member companies are working with regulators to qualify new skin exposure and risk-assessment models.

However, at the moment, it’s not easy to qualify a new preservative, Taalman says. “We are basically stuck,” he says, at least until new testing protocols are approved, and that is at least a few years off.

Cosmetic products today are by and large safe, Blaschke, the consultant, emphasizes. By worrying about preservative options now, formulators and suppliers “are trying to keep up their good record,” she says, and keep crises from occurring down the road. 

Contest will offer cash for new preservatives

A group of consumer product formulators, preservative makers, retailers, and nongovernment organizations is coming together under the banner of the Green Chemistry & Commerce Council (GC3) to stage a crowdsourcing competition for new preservative technologies.

Details on the competition, to be managed by the open innovation expert InnoCentive, are still being worked out. But when the competition gets under way in about six months, it’s expected to offer up to 10 prizes of $5,000 to $10,000 apiece for early-stage ideas and $20,000 to $25,000 for more advanced preservative concepts, according to Monica Becker, codirector of GC3, an organization of chemical makers, product manufacturers, and retailers.

The goal, Becker says, is to accelerate commercialization of safe and effective preservative systems. Contest-judging criteria, now being developed, are likely to echo a “need statement” GC3 developed with a number of formulators about a year ago. The statement called for preservatives that are biodegradable, free of carcinogen and endocrine disruption concerns, and not likely to build microbial resistance.

The contest backers don’t want intellectual property rights, Becker says. Instead, their goal is “to bring promising technology to light” and connect innovators to companies with which they can partner to develop, test, register, and manufacture inherently safer preservatives.

“We want to help academic researchers or small companies who don’t have the resources to get new ‘green’ preservatives to market,” she says.

In all, 17 entities are backing the contest. Among them are retailers Walmart and Target. Both firms have pressured suppliers to reduce or eliminate ingredients in household goods that they deem harmful to human health and the environment.

Consumer goods makers such as Johnson & Johnson, which pledged to eliminate certain chemicals of concern from its products in 2012, are among the backers. Additional contest underwriters include the advocacy group Environmental Defense Fund and large preservative makers such as Dow Chemical, Lonza, and Schülke & Mayr.

The preservation project has been two years in the making, Becker says. An executive at J&J got the ball rolling when he watched a webinar on open innovation at which Becker was a speaker.

When they talked, Becker and the J&J executive realized that many companies in the personal care and household products space share a need for new, safe, and effective preservatives, Becker recounts. “We thought we could make it a collaborative effort,” she says.

After gathering an initial group of formulators, Becker also drew in preservative makers. Though not initially involved, large retailers heard about it and asked to join, she says.

Becker says she is hoping the challenge will attract a large number of entries. “We’ve never done anything like this before. I’m cautiously optimistic,” she says.


A list of contest supporters that agreed to be named:

▸ Babyganics
▸ Beautycounter
▸ Beiersdorf
▸ Dow Chemical
▸ Environmental Defense Fund
▸ Johnson & Johnson
▸ Lonza
▸ Method
▸ Schülke & Mayr
▸ Seventh Generation
▸ Target
▸ Walmart

CORRECTION: This story was updated on Dec. 7 to indicate that the Scientific Committee on Consumer Safety unfavorably reviewed poly(hexamethylene) biguanide hydrochloride because of cancer concerns only.



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Dana Todd (November 28, 2016 9:27 PM)
First of all, thank you for writing about preservatives and raising the issue of this very complex challenge for the industry. As one of the millions of people who were sensitized by methylisothiazolinone, I can attest this is an important issue to solve. But, why aren't we equally focusing effort to educate and change consumer expectations? If you think about it...having a product you put on your face that can kill bacteria for a shelf life of 2 years - how is that even remotely a good idea? Because of this damned chemical, my life is completely changed now and I've got to watch what I touch, breathe and ingest. I'm not alone either - you can see some of the horrendous damage it causes to us here in this photo album The stories I've read over the years from victims who did nothing but use trusted products to wash their clothes, remove their makeup, block the sun, clean their baby's bums, cool their homes with A/C, etc. It's really tragic and I hope that the chemical industry will actually ramp up its own policing efforts instead of perpetuate the denial that we have seen to date. Given that the political climate will be changing to a more relaxed regulatory environment, I am terrified that I may never be able to leave the house again.
P Rokosh (November 28, 2016 11:53 PM)
I am thrilled that more companies are looking into the toxicity of preservatives. As someone who reacts to MI and MCI, I have become a label reader and do not allow anything with these products in my home or business - I also tell my network about the dangers of MI and MCI, and they share that info, so the number of consumers who are learning to read labels is growing.
Kindest regards.
Bianca Turner (November 29, 2016 12:49 AM)
I'm very happy that this is finally getting attention. Although it's becoming tougher for producers to make the products, they have a duty to keep it safe. I used Clarins for over 4 years until methylisothiazolinone built up in my system and now I'm highly allergic to it. I also understand its life long! The reactions are excruciating. I'm an attorney and I can't go to work even I have a reaction because my face is blood red and swollen. Since I've developed this allergy, I am finding sources everywhere. Even new clothes have it on, new towels, hair products etc. They have to remove it.
Linda watkins (November 29, 2016 4:36 AM)
I think that educating the people who are not aware of the damage these products do will go along way.once people are aware of what they are using and the risks they will be prepared to pay a little extra.
My life is completely different now because of methlchlorosothiazolinone I have had to leave various jobs in childcare because of using wipes, kitchen jobs because of cleaners etc. My home life too because it restricts not only what I use but everyone around me. When I do come into contact I end up on big courses of steroids ,lotions and potions and can't work I get very irritable and it has an effect on any relationship I have with anyone as I can't bear to be touched or get hot.
As far as I'm concerned the change needs to happen now it's affecting a lot more people than just those whose skin is affected. I could be at risk at the moment of losing my current job in a shop as I have had to have time off for my skin to get better and now they deem me unreliable.if I lose this job I'm not sure with this kind of history anyone else will employ me. So this will also affect my whole family . Any change can surely be a good one.
Linda B. Sedlewicz (December 2, 2016 4:46 PM)
Thank you for a thoughtful and informative article on a subject that is getting an undeserved amount of bad press recently. Although I sympathize with those people that have found that they are allergic, the actual percentage of the population allergic to various preservatives is 2-4%,depending on the active. I, personally, have a sensitization to vegetable gums (use thickeners and texturizing agents in almost all processed foods and various other products) that has landed me in the hospital once and come close a few times. I know I am in the minority, so I just read labels.

The risk of an improperly preserved personal care product is a risk to 100% of the people that purchase that product, not just the few that are allergic. It is important that activist groups don't pressure personal care manufacturers into removing preservatives that have worked safely in products for years in favor of chemistries that have not been as well studied or may not work as well.
Susan Magosin (December 8, 2016 7:56 AM)
I became sensitized to MI through using a suncreen that was labelled as for sensitive skin and Eczema Council approved. This allergy has horribly impacted my life and that of my family, nearly destroying my relationship with my husband due to my new "fears." The industry view that only a few people are affected and the greater good of the preservative is important is just horrifying, bordering criminal.

I develop angioedema from this chemical and have had four emergency department visits and two hospitalizations and now have to carry EpiPen with me everywhere. I hesitate to eat anywhere but home due to MI being in soaps including dishwashing soap and detergent. I threw-out my entire wardrobe and all linens. I am constantly trying to figure-out if a building, office, store, school or home I am entering has been recently painted or if someone just cleaned. I am afraid for anyone to touch me and hug me due to their likely use of hand soaps, moisturizers and their laundry items having MI. I am someone who has been healthy and without allergies!

I now can not vacation with my family as I can't use the hotel linens including bed sheets, need to be afraid of AC units/any air fresheners, can't use the pool nor the plates and utensils in the restaurant. AND I need to be wary of flying due to the cabin cleaners and jet fuel. I also am now fearful of getting my annual check-ups due to MI being present in air fresheners being used in waiting rooms, in cleaning products including the hand soaps the professional use and even in ultrasound gel.

The idea that MI is safe in rinse-off products is unfounded; it needs to be eliminated. I am thankful for having been diagnosed by patch testing but need to ask why do I need to live in such fear of something that is wholly unnecessary to be in personal products!
Emily (December 19, 2016 8:42 AM)
Thank you for this article. I believe MI should be banned, I am myself allergic to MI and was amazed of how many products have it. It is very easy to overdose on it: shampoo, wipes, conditioner, clothing balm, nail polish, shower gel etc. I am a label reader now and will be all my life. I think that the future trend should be for products with less parabens, even if they last less. I am buying products that have a shorter expiration date but know that they have less chemicals. My skin feels so much better. As previous readers have said, there must be a campaign to educate people into choosing paraben free products. It would also benefit the industry more because the buyer would need to shop more often instead of stocking up. With lower expiration dates, a customer would finish the product quicker and rebuy quicker. It is a win-win situation, both customer and the beauty industry.
Samuel Kiseegu (June 11, 2017 8:42 AM)

sensitize me if the preservatives below safe for use?
germall plus,
sodium benzoate,
formalin and
imidazolidinyl urea

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