Daniel Greenberg, Agilex Fragrances11.02.16
Everyone has secrets—some bigger and more important than others. The way we handle secrets is sometimes as important as the secrets themselves. When choosing between divulging a secret or keeping it hidden, one must choose wisely, as the consequences of such decisions could be great.
Consumer product companies face similar scenarios. They have trade secrets to protect and entities like NGOs or competing businesses constantly try to force out proprietary product formulations, manufacturing processes and sensitive R&D data. NGOs, specifically, have found powerful ways to advocate for more information disclosure, and fragrances, in particular, have been identified as fertile ground for current NGO initiatives. Actions taken under the guise of information disclosure concern many raw material, fragrance and consumer product companies. Revealing a fragrance’s components is problematic and could set a precedent with serious repercussions for both businesses and relevant markets while providing little usefulness to consumers. The effectiveness of a fragrance disclosure has yet to be seen.
A handful of companies during the past year or two have started to market their products using “fragrance transparency” or “complete fragrance disclosures,” meaning that these companies are going beyond the raw material level, down to the component level in order to reveal fragrance ingredients. These claims can be difficult to substantiate as fragrances are made from a variety of chemicals and tracing those chemicals down to fractions of a percent can prove daunting. Materials such as aldehydes, esters, ketones and more may all be components in a fragrance raw material; moreover, it is very common to find different families of chemicals, both natural and synthetic, in one consumer fragrance. Most consumers are not aware of how specialized the fragrance industry is and therefore, consumer perception of fragrance related topics can be skewed. Yet, industry professionals who understand fragrance on an expert level take these actions as a significant shift in how consumer product companies handle fragrance and how consumers might be asking more questions about fragranced products than ever before.
Regulatory Initiatives
Fragrance transparency, sometimes referred to as fragrance disclosure, is not unique to the private sector and has found a home in politics, again, through the intervention of NGOs. Various state governments and, to a lesser extent, the federal government, have shown some level of interest in this topic, regardless of concepts like intellectual property or trade secret preservation. Vermont H706, California AB708 (defeated), Rhode Island SB2698, Rhode Island HB7915 and Minnesota SF3197, among others, are all pieces of proposed legislation that reference fragrance disclosures in some form, usually in the context of personal care products. Even the recent Toxic Substances Control Act reform has some verbiage that leans toward transparency, but stops short of requiring fragrance disclosures. Although disclosures of this sort have yet to be enacted into law, the sheer amount of proposals shows that this matter is not going away any time soon. With the government, NGOs and consumer product companies focusing their attention, as well as their resources, on this topic, many question the importance of fragrance disclosure and wish to find out if fragrance disclosures are just as important to consumers.
To answer these questions on a global scale is a challenging task as different regions around the world operate under different sets of consumer product laws. Therefore, in an attempt to make my argument concise, this article is limited to the US market and personal care products. However, similar concepts would also apply to foreign markets and other products, such as household cleaners or air fresheners, to some extent. With regard to these limits, there are five pieces of official literature that help describe fragrance’s place on a product label: the United States Federal Food, Drug, and Cosmetic Act (FD&C Act), the “Consumer Bill of Rights,” the Fair Packaging and Labeling Act (FPLA), Code of Federal Regulations Title 21 Section 701.3 (21 CFR 701.3), and the IFRA transparency list.
In short, the FD&C Act gave jurisdiction to the FDA over regulations regarding food, drugs and cosmetics. It established general guidelines for “misbranding” in order to protect the Americans from deceitful and unsubstantiated marketing claims. Years later, in 1962, President John F. Kennedy laid out what would come to be called the “Consumer Bill of Rights.” Originally, the “Consumer Bill of Rights” promoted consumers’ right to safety, to be informed, to choose, and to be heard. This “bill” has since evolved to include four more rights and has been adopted by the United Nations as “The United Nations Guidelines for Consumer Protection.” Although this is not law and simply a reference point for consumer legislation, it remains one of the cornerstones of consumer-company relationships. The FPLA added further consumer protection by requiring the ingredient list and other information on a product’s label. When it comes to a product’s ingredient list, 21 CFR 701.3 outlines specifically and legally that “fragrance” is allowed on the ingredient list without going deeper to list what chemicals make up the fragrance itself and lastly, International Fragrance Association’s transparency list specifies all the fragrance chemicals used by member companies allowing for consumers to look up these chemicals at their convenience. This list has been compiled in an attempt to meet consumer demands for more information on the products they buy. With all five of these pieces in mind, Americans can start to feel safe in what they buy. However, the fragrance disclosure efforts outlined previously continue to build momentum and the legislation, documentation, and other forms of consumer protection/communication show no promise of stopping the growth of this movement. Therefore, it may be appropriate to ask if the protection and disclosure currently available to Americans is enough to ensure consumer safety, or does consumer product legislation need to become more robust?
Who’s Right?
It’s a tough question and it seems that all parties involved have warranted support for their own views. One major point of contention involves choosing between a consumer’s “right to know” and a company’s trade secret. Should a consumer’s “right to know” trump a company’s trade secret? Should it be the other way around? Could both be correct? The “Consumer Bill of Rights” states a consumer has a right to be informed and to be heard. Does this mean that a consumer has the right to get all the information he or she requests? Probably not. Trade secrets are a part of a company’s intellectual property and if the reveal of a trade secret opens up the opportunity for competition among competitors, then it’s beneficial to the company that the trade secret stays secret. This illustrates a limitation, a qualifier to the “Consumer Bill of Rights.” It’s these practical limitations on ideas/rights such as these that truly outline their usefulness. The “Consumer Bill of Rights” does not act as carte blanche for consumer demands regarding sensitive information. Simply put, consumers can expect to be protected to a certain degree as they have certain rights as consumers, but the rights of one entity (e.g. consumer) cannot violate the rights of another entity (e.g. businesses and corporations) and fragrance disclosures may be such a violation.
Some consumers have more serious concerns rather than asking for information simply to have it. Many consumers ask, “how can a consumer feel confident about the safety of a product if they don’t know what’s in it?” More to the point, how does someone handle a product that contains an ingredient of concern, such as an allergen? Most of the time product safety is taken care of by the legally mandated ingredient list on the back of every consumer product. Consumers can simply look up and avoid ingredients that they know are bad for them. Furthermore, toxicological testing and/or clinical trials performed by the manufacturing company help to ensure that a cosmetic would not be considered “adulterated” and does not harm a user, but what about the exception of fragrance? As stated in 21 CFR 701.3, it is perfectly legal to put “fragrance” on your ingredient list while avoiding the subcomponents that make up the fragrance. This exception not only protects a fragrance company’s trade secret but it also avoids increasing the length of a product’s ingredient list unnecessarily. As stated previously, fragrances can be made up of hundreds of chemicals and to list an entire formulation, sometimes down to one part per million, would be impractical for a product label. Yet, allergen content could cause a user to have a severe allergic reaction. In practicality, many fragrances do have known allergens in them, but because the FDA does not have the authority to require allergen content listed on a product’s label, such content remains a mystery. This is why many medical professionals recommend “fragrance free” products for consumers with allergies or sensitive skin. So, perhaps this is an area where US cosmetics regulations can improve, but is it a reason to ask for a full fragrance disclosure? I don’t think so. If the US could mandate a disclosure of known allergens like the regulations used in the EU to disclose the 26 most prevalent allergens on their products’ labels, then this would allow for a consumer to get the information he needs while protecting a fragrance company’s trade secret. In fact, Reckitt Benckiser has been using this very strategy for its products since 2014.
What’s of Value?
Overall, it seems like alternative solutions can be found for all of the major problems that fragrance disclosures are supposed to solve, but what many consumers, politicians, and finished product companies may not realize is that a full fragrance disclosure is not that valuable to consumers and disclosing a fragrance’s ingredients is a relatively pointless exercise.
First, IFRA and the Research Institute on Fragrance Materials study fragrance raw materials, assess them for safety, and issue guidance on how to use a raw material within safe limits through a risk based classification system. This allows all member companies to formulate fragrances within safe limits and ensure fragrance safety if used as intended.
Second, there is a very important concept in toxicology and medicine called the “dose-response relationship.” Initially stated by the physician Paracelsus as “sola dosis facit venenum” which translates to “the dose makes the poison,” this concept states that most chemicals themselves are not inherently dangerous but rather it’s the identity of the chemical itself in addition to a dose/concentration high enough to cause a bodily effect. A good example of this concept is acetaminophen or Tylenol. Acetaminophen is hepatotoxic, damaging to the liver, and yet it is sold as an over-the-counter drug. The reason for acetaminophen’s continued sales regardless of its hepatotoxicity is because acetaminophen is only hepatotoxic at high concentrations; when used at therapeutic levels it’s an effective pain reliever.
This concept rings true for fragrances too. A fragrance may not cause a bodily response if it is used at a low concentration. By providing a formula disclosure with names only, a consumer could not determine if a chemical is included in a product at a concentration that would yield a reaction such as an allergic response. Therefore, if a consumer gets a qualitative fragrance disclosure and sees what makes up a fragrance, the consumer would only be able to avoid ingredients that they know are bad for them, again, such as known allergens. It turns the situation into a “yes or no” scenario instead of a “maybe” which may be an example of over-simplifying the situation and could add to consumer confusion. Furthermore, with chemical names such as “(e)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one” consumers have yet another barrier-to-entry and the task of deciphering what this name means may be too troublesome. Publically available information can only go so far and many times can be misleading or even inaccurate.
Lastly, it’s worth noting that perfumers themselves and their work should be protected when it comes to inquires of this sort. Most perfumers go through a rigorous perfumery apprenticeship to hone their skills and the efforts that perfumers put into their training should translate into the value of the fragrances they make. This means that consumers who like and use fragranced products should not take perfumers’ specialized skills for granted. Many times formulating a fragrance is about producing an aroma that tests best with a consumer population rather than admiring the beauty or complexity of a scent, making fragrance development sometimes challenging. Additionally, perfumers must overcome many technical challenges from fragrance stability and compatibility to regulatory restrictions, NGO demands, and shrinking raw material palettes caused by consumer trends such as the desire for “natural” products.
Information Dumping
With these obstacles in mind, perfumers do not have an easy job and they have been backed into a corner in more ways than one. Forcing perfumers and the companies they work for to give up their formulations seems to be adding insult to injury. If consumers truly love their lavender fragranced candles, jasmine air fresheners, grapefruit facial scrubs, or musky aftershaves, then those consumers should know that a lot of time and effort goes into developing these fragrances and fragrances should be appreciated instead of threatened.
Fragrance disclosure is a potentially dangerous issue and dumping more information into the public domain is not the answer, despite what NGOs say. Consumers experience information overload on a daily basis. This concept is not new, but consumers and businesses alike have not really spent time to determine how such information should be processed, used or understood. A day may come where a distinction may need to be made between information that is useful and information that is minutia. In a world with ever-increasing access to information, the methods used to interpret and sort such information will become important. The interpretation will then dictate how such information can be used. Additionally, developing a “method for interpretation” may take a specialized degree, a college education or specific training.
Therefore, trying to understand a fragrance disclosure is like someone without a medical degree trying to diagnose an illness through WebMD. Information taken out of context could be more harmful than beneficial.
Chemical safety and use is an intellectual specialty and it should not be assumed that everyone is an expert in everything. In these cases, where specialized information is vast, the background knowledge is not known, or certain complexities are not familiar, a consumer should be able to trust product manufacturers and look to them for product safety, rather than trusting themselves to understand the information they have been given. Don’t expect a consumer to read a clinical trial report and determine from it that a product is safe to use.
Building Trust
Allergens should be put on consumer product labels in the US along with other chemicals that might be of concern to consumers, but a full fragrance disclosure has no usefulness without hurting the very people who brought these fragrances to life. The focus for NGOs, consumers, legislators and businesses should not be the release of privileged information, but rather the building and strengthening of the relationships between these groups and rekindling trust.
Consumers should continue to question the products they use but realize that asking the right questions is a better strategy than asking for piles of information that, in the end, may not even be usable to the layman. “Is this product safe,” is as valid a question as any other and something that a consumer product company should be able to answer even if the route to get to that answer is a complicated one. Consumers have little to gain from receiving a formula, and consumer product companies have everything to lose. Products which use “fragrance transparency” will certainly have the world watching. The outcome of these initiatives will hopefully shed some light on this issue and determine if a full fragrance disclosure is not only what consumers want, but if fragrance disclosures can bring about true change in consumer safety and understanding.
About the Author
Daniel Greenberg, regulatory compliance associate, works for Agilex Fragrances, Piscataway, NJ. Website: www.agilexfragrances.com
Consumer product companies face similar scenarios. They have trade secrets to protect and entities like NGOs or competing businesses constantly try to force out proprietary product formulations, manufacturing processes and sensitive R&D data. NGOs, specifically, have found powerful ways to advocate for more information disclosure, and fragrances, in particular, have been identified as fertile ground for current NGO initiatives. Actions taken under the guise of information disclosure concern many raw material, fragrance and consumer product companies. Revealing a fragrance’s components is problematic and could set a precedent with serious repercussions for both businesses and relevant markets while providing little usefulness to consumers. The effectiveness of a fragrance disclosure has yet to be seen.
A handful of companies during the past year or two have started to market their products using “fragrance transparency” or “complete fragrance disclosures,” meaning that these companies are going beyond the raw material level, down to the component level in order to reveal fragrance ingredients. These claims can be difficult to substantiate as fragrances are made from a variety of chemicals and tracing those chemicals down to fractions of a percent can prove daunting. Materials such as aldehydes, esters, ketones and more may all be components in a fragrance raw material; moreover, it is very common to find different families of chemicals, both natural and synthetic, in one consumer fragrance. Most consumers are not aware of how specialized the fragrance industry is and therefore, consumer perception of fragrance related topics can be skewed. Yet, industry professionals who understand fragrance on an expert level take these actions as a significant shift in how consumer product companies handle fragrance and how consumers might be asking more questions about fragranced products than ever before.
Regulatory Initiatives
Fragrance transparency, sometimes referred to as fragrance disclosure, is not unique to the private sector and has found a home in politics, again, through the intervention of NGOs. Various state governments and, to a lesser extent, the federal government, have shown some level of interest in this topic, regardless of concepts like intellectual property or trade secret preservation. Vermont H706, California AB708 (defeated), Rhode Island SB2698, Rhode Island HB7915 and Minnesota SF3197, among others, are all pieces of proposed legislation that reference fragrance disclosures in some form, usually in the context of personal care products. Even the recent Toxic Substances Control Act reform has some verbiage that leans toward transparency, but stops short of requiring fragrance disclosures. Although disclosures of this sort have yet to be enacted into law, the sheer amount of proposals shows that this matter is not going away any time soon. With the government, NGOs and consumer product companies focusing their attention, as well as their resources, on this topic, many question the importance of fragrance disclosure and wish to find out if fragrance disclosures are just as important to consumers.
To answer these questions on a global scale is a challenging task as different regions around the world operate under different sets of consumer product laws. Therefore, in an attempt to make my argument concise, this article is limited to the US market and personal care products. However, similar concepts would also apply to foreign markets and other products, such as household cleaners or air fresheners, to some extent. With regard to these limits, there are five pieces of official literature that help describe fragrance’s place on a product label: the United States Federal Food, Drug, and Cosmetic Act (FD&C Act), the “Consumer Bill of Rights,” the Fair Packaging and Labeling Act (FPLA), Code of Federal Regulations Title 21 Section 701.3 (21 CFR 701.3), and the IFRA transparency list.
In short, the FD&C Act gave jurisdiction to the FDA over regulations regarding food, drugs and cosmetics. It established general guidelines for “misbranding” in order to protect the Americans from deceitful and unsubstantiated marketing claims. Years later, in 1962, President John F. Kennedy laid out what would come to be called the “Consumer Bill of Rights.” Originally, the “Consumer Bill of Rights” promoted consumers’ right to safety, to be informed, to choose, and to be heard. This “bill” has since evolved to include four more rights and has been adopted by the United Nations as “The United Nations Guidelines for Consumer Protection.” Although this is not law and simply a reference point for consumer legislation, it remains one of the cornerstones of consumer-company relationships. The FPLA added further consumer protection by requiring the ingredient list and other information on a product’s label. When it comes to a product’s ingredient list, 21 CFR 701.3 outlines specifically and legally that “fragrance” is allowed on the ingredient list without going deeper to list what chemicals make up the fragrance itself and lastly, International Fragrance Association’s transparency list specifies all the fragrance chemicals used by member companies allowing for consumers to look up these chemicals at their convenience. This list has been compiled in an attempt to meet consumer demands for more information on the products they buy. With all five of these pieces in mind, Americans can start to feel safe in what they buy. However, the fragrance disclosure efforts outlined previously continue to build momentum and the legislation, documentation, and other forms of consumer protection/communication show no promise of stopping the growth of this movement. Therefore, it may be appropriate to ask if the protection and disclosure currently available to Americans is enough to ensure consumer safety, or does consumer product legislation need to become more robust?
Who’s Right?
It’s a tough question and it seems that all parties involved have warranted support for their own views. One major point of contention involves choosing between a consumer’s “right to know” and a company’s trade secret. Should a consumer’s “right to know” trump a company’s trade secret? Should it be the other way around? Could both be correct? The “Consumer Bill of Rights” states a consumer has a right to be informed and to be heard. Does this mean that a consumer has the right to get all the information he or she requests? Probably not. Trade secrets are a part of a company’s intellectual property and if the reveal of a trade secret opens up the opportunity for competition among competitors, then it’s beneficial to the company that the trade secret stays secret. This illustrates a limitation, a qualifier to the “Consumer Bill of Rights.” It’s these practical limitations on ideas/rights such as these that truly outline their usefulness. The “Consumer Bill of Rights” does not act as carte blanche for consumer demands regarding sensitive information. Simply put, consumers can expect to be protected to a certain degree as they have certain rights as consumers, but the rights of one entity (e.g. consumer) cannot violate the rights of another entity (e.g. businesses and corporations) and fragrance disclosures may be such a violation.
Some consumers have more serious concerns rather than asking for information simply to have it. Many consumers ask, “how can a consumer feel confident about the safety of a product if they don’t know what’s in it?” More to the point, how does someone handle a product that contains an ingredient of concern, such as an allergen? Most of the time product safety is taken care of by the legally mandated ingredient list on the back of every consumer product. Consumers can simply look up and avoid ingredients that they know are bad for them. Furthermore, toxicological testing and/or clinical trials performed by the manufacturing company help to ensure that a cosmetic would not be considered “adulterated” and does not harm a user, but what about the exception of fragrance? As stated in 21 CFR 701.3, it is perfectly legal to put “fragrance” on your ingredient list while avoiding the subcomponents that make up the fragrance. This exception not only protects a fragrance company’s trade secret but it also avoids increasing the length of a product’s ingredient list unnecessarily. As stated previously, fragrances can be made up of hundreds of chemicals and to list an entire formulation, sometimes down to one part per million, would be impractical for a product label. Yet, allergen content could cause a user to have a severe allergic reaction. In practicality, many fragrances do have known allergens in them, but because the FDA does not have the authority to require allergen content listed on a product’s label, such content remains a mystery. This is why many medical professionals recommend “fragrance free” products for consumers with allergies or sensitive skin. So, perhaps this is an area where US cosmetics regulations can improve, but is it a reason to ask for a full fragrance disclosure? I don’t think so. If the US could mandate a disclosure of known allergens like the regulations used in the EU to disclose the 26 most prevalent allergens on their products’ labels, then this would allow for a consumer to get the information he needs while protecting a fragrance company’s trade secret. In fact, Reckitt Benckiser has been using this very strategy for its products since 2014.
What’s of Value?
Overall, it seems like alternative solutions can be found for all of the major problems that fragrance disclosures are supposed to solve, but what many consumers, politicians, and finished product companies may not realize is that a full fragrance disclosure is not that valuable to consumers and disclosing a fragrance’s ingredients is a relatively pointless exercise.
First, IFRA and the Research Institute on Fragrance Materials study fragrance raw materials, assess them for safety, and issue guidance on how to use a raw material within safe limits through a risk based classification system. This allows all member companies to formulate fragrances within safe limits and ensure fragrance safety if used as intended.
Second, there is a very important concept in toxicology and medicine called the “dose-response relationship.” Initially stated by the physician Paracelsus as “sola dosis facit venenum” which translates to “the dose makes the poison,” this concept states that most chemicals themselves are not inherently dangerous but rather it’s the identity of the chemical itself in addition to a dose/concentration high enough to cause a bodily effect. A good example of this concept is acetaminophen or Tylenol. Acetaminophen is hepatotoxic, damaging to the liver, and yet it is sold as an over-the-counter drug. The reason for acetaminophen’s continued sales regardless of its hepatotoxicity is because acetaminophen is only hepatotoxic at high concentrations; when used at therapeutic levels it’s an effective pain reliever.
This concept rings true for fragrances too. A fragrance may not cause a bodily response if it is used at a low concentration. By providing a formula disclosure with names only, a consumer could not determine if a chemical is included in a product at a concentration that would yield a reaction such as an allergic response. Therefore, if a consumer gets a qualitative fragrance disclosure and sees what makes up a fragrance, the consumer would only be able to avoid ingredients that they know are bad for them, again, such as known allergens. It turns the situation into a “yes or no” scenario instead of a “maybe” which may be an example of over-simplifying the situation and could add to consumer confusion. Furthermore, with chemical names such as “(e)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one” consumers have yet another barrier-to-entry and the task of deciphering what this name means may be too troublesome. Publically available information can only go so far and many times can be misleading or even inaccurate.
Lastly, it’s worth noting that perfumers themselves and their work should be protected when it comes to inquires of this sort. Most perfumers go through a rigorous perfumery apprenticeship to hone their skills and the efforts that perfumers put into their training should translate into the value of the fragrances they make. This means that consumers who like and use fragranced products should not take perfumers’ specialized skills for granted. Many times formulating a fragrance is about producing an aroma that tests best with a consumer population rather than admiring the beauty or complexity of a scent, making fragrance development sometimes challenging. Additionally, perfumers must overcome many technical challenges from fragrance stability and compatibility to regulatory restrictions, NGO demands, and shrinking raw material palettes caused by consumer trends such as the desire for “natural” products.
Information Dumping
With these obstacles in mind, perfumers do not have an easy job and they have been backed into a corner in more ways than one. Forcing perfumers and the companies they work for to give up their formulations seems to be adding insult to injury. If consumers truly love their lavender fragranced candles, jasmine air fresheners, grapefruit facial scrubs, or musky aftershaves, then those consumers should know that a lot of time and effort goes into developing these fragrances and fragrances should be appreciated instead of threatened.
Fragrance disclosure is a potentially dangerous issue and dumping more information into the public domain is not the answer, despite what NGOs say. Consumers experience information overload on a daily basis. This concept is not new, but consumers and businesses alike have not really spent time to determine how such information should be processed, used or understood. A day may come where a distinction may need to be made between information that is useful and information that is minutia. In a world with ever-increasing access to information, the methods used to interpret and sort such information will become important. The interpretation will then dictate how such information can be used. Additionally, developing a “method for interpretation” may take a specialized degree, a college education or specific training.
Therefore, trying to understand a fragrance disclosure is like someone without a medical degree trying to diagnose an illness through WebMD. Information taken out of context could be more harmful than beneficial.
Chemical safety and use is an intellectual specialty and it should not be assumed that everyone is an expert in everything. In these cases, where specialized information is vast, the background knowledge is not known, or certain complexities are not familiar, a consumer should be able to trust product manufacturers and look to them for product safety, rather than trusting themselves to understand the information they have been given. Don’t expect a consumer to read a clinical trial report and determine from it that a product is safe to use.
Building Trust
Allergens should be put on consumer product labels in the US along with other chemicals that might be of concern to consumers, but a full fragrance disclosure has no usefulness without hurting the very people who brought these fragrances to life. The focus for NGOs, consumers, legislators and businesses should not be the release of privileged information, but rather the building and strengthening of the relationships between these groups and rekindling trust.
Consumers should continue to question the products they use but realize that asking the right questions is a better strategy than asking for piles of information that, in the end, may not even be usable to the layman. “Is this product safe,” is as valid a question as any other and something that a consumer product company should be able to answer even if the route to get to that answer is a complicated one. Consumers have little to gain from receiving a formula, and consumer product companies have everything to lose. Products which use “fragrance transparency” will certainly have the world watching. The outcome of these initiatives will hopefully shed some light on this issue and determine if a full fragrance disclosure is not only what consumers want, but if fragrance disclosures can bring about true change in consumer safety and understanding.
About the Author
Daniel Greenberg, regulatory compliance associate, works for Agilex Fragrances, Piscataway, NJ. Website: www.agilexfragrances.com