July 15, 2008
The Natural discussion continues
The Society of Cosmetic Chemists has weighed in on the question of "natural" at its annual scientific seminar last month in Orlando, according to a recent Happi article entitled "It's Not Natural..." The article discusses both natural and organic definitions, most of which we have mentioned here in previous posts.
Speakers at the conference pointed out that there are six major organizations trying to define natural, which is not exactly true; five them are working on organic standards and only one (NPA) has even dealt with the term "natural" in their standard. The NIRC and the IANPP weren't even mentioned, but they aren't major organizations so I supposed they don't count.
Issues other than standards, but related to natural/organic manufacturing including green chemistry and sustainable packaging. There was a review of regulatory issues, pointing out that there is no general consensus on the meaning of "natural" and that because the FDA has no definition, it may be up to the Feceral Trade Commission (FTC) might resolve the issue based on whether claims made are "clear and definitive".
What is clear at present is that the whole discussion of natural is not definitive, as pointed out at the seminar, and as pointed out on this blog.
Posted by Rob on July 15, 2008 in Regulatory Issues, Standards | Permalink | Comments (0) | TrackBack
July 11, 2008
FDA enters debate on Natural
We've blogged before on the meaning of "natural" when applied to skin and body products, discussing in particular the definitions put forth by the Natural Products Association (NPA) and the Natural Ingredients Resource Center (NIRC). Now the FDA (Food and Drug Administration) has reversed itself in a ruling on high fructose corn syrup (HFCS) and ruled that it can be considered "natural" under certain manufacturing processes, according to an article in FoodNavigator-USA, a food industry publication. The ruling came in a letter from the FDA to the Corn Refiner's Association (CRA).
It appears that the ruling is based on technicality having to do with the production process for HFCS. Even though the process uses a synthetic fixing agent, it supposedly doesn't come into contact with the HFCS, so that it is acceptable as "natural". As the article points out, however, the Sugar industry as well as other consumer groups argue that HFCS isn't natural because
its chemical bonds are broken and rearranged in the manufacturing process.
What this really points out is that there isn't yet a good standard definition for what is "Natural". According to the FDA letter, it makes decisions on a case-by-case basis.
A search of the FDA website reveals this interesting statement:
The term "natural" has not been defined in FDA's law (the Federal Food, Drug, and Cosmetic Act) or in FDA's regulations.
A review of the Google Results for "FDA natural" reveals a number of recent "natural" issues with the FDA, including in addition to HFCS the issues of Stevia, various "natural" cures for cancer and other diseases, some paranoia about health freedom, and the discussion of whether they will define "natural." This blog post from April 2008 is a good discussion of some of the issues, although it is now outdated by the new FDA ruling.
According to SourceWatch, a website that tracks "the names behind the news" the CRA has spent $20-30 million on a public relations and advertising campaign in support of HFCS.
The FDA now seems to have thrown in its lot with the CRA. I'm sure we haven't heard the last of it.
Posted by Rob on July 11, 2008 in Regulatory Issues, Standards | Permalink | Comments (0) | TrackBack
June 29, 2008
Pine Oil Tick and Mosquito Repellent
In one of those strange serendipitous moments that can happen with Google Alerts, I visited an article entitled "Tick and Mosquito Repellent Can Be Made Commercially from Pine Oil" which describes "a naturally-occurring compound prepared from pine oil" that deters mosquito biting and repels ticks.
After I read the press release, which contains the curious statement
Some segments of the public perceive efficient synthetic active ingredients as somehow more dangerous than botanical compounds, giving additional importance to the discovery of plant-based isolongifolenone.
my interest was piqued , so I read the patent which has been issued covering the preparation of the compound and "its use in repelling arthropods". Would this product meet the requirements of the NPA Natural Products standard? Would it meet the requirements of the NIRC definition of "Natural"? It's been over 40 years since I had my last chemistry course, but I think I can figure this out.
Reading through the patent, some interesting facts are revealed. Deet has long been considered the standard for mosquito repellency,
However, Deet is a plasticizer and clinical literature reports the association of Deet with neurotoxicity in humans (Robbins, P. J., and M. G. Cherniack. J. Toxicol. Environ. Health, 18: 503-525 (1986)). Thus, there is a great need for effective alternatives to Deet.
Essentially the process of producing takes isolongifolene, which is a naturally occurring component of Pinus longifolia, and converts it to isolongifolenone, which is also naturally occurring in smaller quantities. This is done via oxidation with tert-butyl hydroperoxide in the presence of a catalyst chromium hexacarbonyl. The process has a high yield but may not meet the natural standard because benzene is used to recover the catalyst (which itself is a considered toxic).
According to Wikipedia
In common with many of the other homoleptic metal carbonyls (e.g. nickel carbonyl and iron carbonyl), chromium hexacarbonyl is toxic and thought to be carcinogenic.
Tert-butyl hydroperoxide doesn't have its own entry in Wikipedia, but a search of the ToxSeek database reveals 143 entries. Without detailed analysis, one can only conclude that it is a toxic hazard.
The NPA Natural Standard
To see what this means, let's look at the definition of natural in the NPA Standard:
Ingredients that come or are made from a renewable resource found in nature (Flora, Fauna, Mineral), with absolutely no petroleum compounds.
OK, that may work, except for the Tert-butyl hydroperoxide, benzene and the chromium hexacarbonyl. A check of the NPA Standard's list of prohibited ingredients doesn't have any of those on it, except for the prohibition on petroleum. We can only conclude from this standard that the isolongifolenone would only be natural if all the traces of either the catalyst or the chemical used to remove it are completely removed.
A look at the processes allowed or disallowed in the NPA Standard reveals that this process is not on either list. Not surprising, considering that it wasn't known when the standard was written.
NIRC Definition of Natural
The NIRC definition of Natural requires a natural material to be "present in or produced by nature, produced using minimal physical processing, and directly extracted using simple methods, simple chemical reactions or resulting from naturally occurring biological processes." Based on this part of the definition, our product would seem to pass. However, the NIRC definition goes on to require that "Natural Ingredients are . . . not produced synthetically, free of all petrochemicals, not extracted or processed using petrochemicals, [and] not extracted or processed using anything other than natural ingredients as solvents."
So it looks like it won't meet this requirement either, even worse than the NPA definition, because of the petrochemical ban and the non-natural catalyst and solvent situation. Even if you could get all traces of the chemicals removed from the isolongifolenone, the processing is not natural.
Conclusion
Based on this analysis, the repellent isolongifolenone cannot be considered a "natural" product under the definitions of either the NPA or the NIRC.
Related Information
While researching this subject, I came across a 2005 Indian study on the effectiveness of Pine Oil as an insect repellent. The pine oils used in the study was analyzed, but didn't reveal the presence of either of the two compounds involved in the patent (they were probably included in the 13% unidentified ingredients. The paper states that pine oil is used traditionally as a repellent in India.
Posted by Rob on June 29, 2008 in Essential Oils/Plant Extractions, Research, Safety/Toxicity, Standards | Permalink | Comments (0) | TrackBack
June 18, 2008
NPA moves ahead with its "Natural" Product Seal
The Natural Products Association (NPA) has announced that applications for its "Natural Standard" certification are available. The certification process will be based on the NPA Standard published on May 1 [PDF] and discussed here previously (which is not quite ready for prime time, in this reviewer's opinion). Certification will cost $500 per product for members of the NPA, and $1,250 for non-members. The standard requires that labeled products must be made with at least 95% all natural ingredients.
Since the NPA's membership fees for suppliers are not posted on their website, it's difficult to determine what impact this will have on small suppliers who would like to use the seal. Since the public seems to be more aware of the "Organic" designation, and there are two competing seal programs (OASIS and NSF/ANSI) out there, it may turn out that there isn't even a place for a natural products standard and certification program. There have been other attempts to define "natural" products, notably the Natural Ingredients Resource Center (NIRC) and the Campaign for Safe Cosmetics (CFSC). The problem with all of these is that they tend to define "Natural" (a positive) by stating what isn't natural (a negative definition).
The NPA definition of "Natural" from their May 1 version of the standard is:
Ingredients that come or are made from a renewable resource found in nature (Flora, Fauna, Mineral), with absolutely no petroleum compounds.
The NPA goes on in their draft standard to specifically list allowed and prohibited ingredients (although the natural ingredients are on an attached list that doesn't seem to be attached) and then has an "Illustrative List of Allowed Ecological Processes".
This contrasts with the NIRC definition (partially quoted):
Natural Ingredients include plant, animal, mineral or microbial ingredients...
present in or produced by nature.
produced using minimal physical processing.*
directly extracted using simple methods, simple chemical reactions or resulting from naturally occurring biological processes.*
Neither of these definitions really have much "meat" compared to the definitions included in the "real" standards that have been proposed (OASIS & ANSI/NSF Organic Standards), both of which have over 60 definitions of terms that need to be precise so people know what the standard really means.
The "Natural" standard process has not been transparent and subject to the scrutiny that it needs to be subjected to. Moving ahead with it before it has been vetted by the industry and consumers is definitely not in the best interest of either. There has been some discussion of these issues in closed mailing lists, but that does little to force the NCA to open up the process and produce a real standard that has some meaning and can work effectively.
For more information, an article in the June Perfumer&Flavorist discusses "The Case for Natural Personal Care Standards." (Sorry, they make you pay for it.) Although the article contains some misinformation, it is a generally good overview of the state of standards issues as it stood before the Natural Beauty Summit.
Posted by Rob on June 18, 2008 in Politics, Regulatory Issues, Safety/Toxicity, Standards | Permalink | Comments (2) | TrackBack
June 08, 2008
Natural Beauty Summit tackles certification fragmentation
Cosmetics Design-Europe reported on the natural Beauty Summit held last month in New York with the headline Natural Beauty Summit tackles certification fragmentation. We reported in this blog on the Summit before it happened, and although we were unable to attend, have been gathering information that goes beyond the sketchy report in CD-E, and we'll be reporting more in depth about the various standards and the process of their development in the near future.
Apparently the discussion got rather heated as the panel made presentations focusing on six different approaches to standardization for certification of natural and organic personal care products in North America: the USDA NOP, a Retailer's standard proposed by Whole Foods markets, Organic standards proposed by NSF and OASIS. CD-E referred to the NSF standard as being for consumer goods, but it appears to us to be equivalent to the OASIS standard and they seem to be two wheels on the same unicycle.
However, when it came to the panel discussion, Horst Rechelbacher, founder of Weleda and Intelligent Nutrients, and chair for the conference's first session on Sustainability, chose to challenge the panel on the fact that they were contributing to the fragmentation of the certification process and consumer confusion.
The panel discussion became heated, with Rechelbacher accusing the panel representatives of being self-serving and panel members defending themselves by explaining that the development of the market in the US had made private certification necessary.
Rechelbacher apologized for his comments, but stressed that he wanted to see greater regulatory harmonization.
The Natural Products standard proposed by the NPA apparently wasn't included in the discussion. As we pointed out in our discussion of that standard (see link) the orderly Standards development process mandated by ANSI isn't being followed by most of the standards developers. The one exception is the standard being proposed by NSF, which is going through the ANSI standards development process and has gone through it's first round of review, although the public has apparently not been brought in on the process yet. And neither have the independent small producers.
Coming soon: a comparison of the NSF and OASIS organic standards.
Posted by Rob on June 8, 2008 in Aromatherapy, Politics, Regulatory Issues, Standards | Permalink | Comments (0) | TrackBack
May 12, 2008
Organic/Natural Standards to be Discussed at Upcoming Meeting
The big players in the Beauty Products World are gathering together in New York later this week at "The Natural Beauty Summit" to "create a forum to learn and discuss the key challenges the cosmetics industry faces in the areas of natural and organic products as well as sustainability" . . . or so says the program for the conference, to be held at the Hilton Hotel in New York City May 15-17. This is a followon to a similar summit in Paris last November, to be followed by a sequel, again in Paris, in October 2008.
Sponsored by Organic Monitor and Beyond Beauty Paris, the main focus of this conference will be Natural Cosmetics with a major session on Standard & Regulatory Issues followed by a panel discussion, and the next day a Natural Cosmetics Workshop focusing on "an assessment of the growing number of standards and certifications for natural and organic cosmetics . . . [with] a critical review of the major standards, comparing and contrasting the similarities and differences between them."
The list of standards and proposed standards that will be covered at the session is:
- A Retail products standard proposed by Whole Foods
- the USDA National Organic Program Standard applied to Cosmetics
- the American NSF Standard
- the OASIS Standard
- A review of European natural and organic standards harmonization
- ECOCERT and BDIH
The aromaconnection blog will be following these issues closely as they develop. Notably missing from the above list is the NPA (Natural Products Association) standard we blogged about yesterday and last month. We are working on a table showing details of the standards and comparing their features. In fact, we are probably duplicating what may show up in the proceedings of the NBS (if there are any), but we hope to get it into print sooner.
Organic Monitor, one of the co-sponsors of the NBS, predicts that 2008 will be the beginning of "an industry shake-up" as various standards are unveiled in Europe and North America. In this linked article, they reference several standards that are not included on the list above. They also express concern about fragmentation that could lead to a reduction of trade, but express also the "more optimistic view" that Cosmetics might follow the lead of the textile industry and develop a harmonized global standard.
In the meantime the infighting has already begun. OCA and Dr. Bronner's have challenged what they call "weak" ECOCERT and OASIS standards, according to this OCA Press Release widely reported in the media mid-March. And as we reported yesterday, the C.A.M. Report is somewhat skeptical of the whole idea.
We can probably look forward to an exciting year!
Posted by Rob on May 12, 2008 in Marketing, Organizations, Politics, Regulatory Issues, Standards, Weblogs | Permalink | Comments (0) | TrackBack
May 11, 2008
Natural Products Association Rushes ahead with a "Natural" Product Standard
Without allowing much time for industry review and feedback, the Natural Products Association has moved to implement their "Standard and Certification for Personal Care Products." As discussed previously on this blog, a meeting was held to discuss this standard in early April, and based on our research online we suggested that more work was needed to integrate standards. The NPA has moved ahead and published what they describe as an "initial standard" on their website, and is setting up a seal of approval and a process for certification. The standard is intended to encompass "all cosmetic personal care products regulated and defined by FDA."
In my opinion, this is a preemptive move on the part of the NPA to seize the initiative in establishing a standard, without following the usual process for standards development. The international Standards Association (ISO), which is the authoritative international standards body, develops industry wide, voluntary standards based on a consensus of all interested parties. They suggest three main phases in the standards development process:
- The need for a standard is usually expressed by an industry sector, which communicates this need to a national member body. The latter proposes the new work item to ISO as a whole. Once the need for an International Standard has been recognized and formally agreed, the first phase involves definition of the technical scope of the future standard. This phase is usually carried out in working groups which comprise technical experts from countries interested in the subject matter.
- Once agreement has been reached on which technical aspects are to be covered in the standard, a second phase is entered during which countries negotiate the detailed specifications within the standard. This is the consensus-building phase.
- The final phase comprises the formal approval of the resulting draft International Standard (the acceptance criteria stipulate approval by two-thirds of the ISO members that have participated actively in the standards development process, and approval by 75% of all members that vote), following which the agreed text is published as an ISO International Standard.
Of course here we are not yet proposing an International Standard. The NPA is an industry sector, that has recognized a need for a standard. But that is where the process has broken down. There has been no public consensus building process, I haven't seen the establishment of a working group of technical experts, and even though the ISO suggests the publication of interim standards (which is what they are calling the current attempt).
The C.A.M. report takes a very skeptical attitude towards the NPA seal, essentially accusing the NPA of producing a marketing gimmick. He appears to have gotten his information from the press release and not the detailed standard, but who am I to argue with him? He's probably right.
Posted by Rob on May 11, 2008 in Marketing, Regulatory Issues, Standards | Permalink | Comments (0) | TrackBack
April 06, 2008
The Definition of Natural
UPDATED
At a webinar presented by Perfumer&Flavorist Magazine last month, there was a discussion of the definition of "natural" when used in the natural products industry, which of course includes the natural aromatic products that are the focus of this blog. The webinar grew out of a similar discussion by natural products retail brand owners and suppliers that was featured in a Special Naturals & Organics issue of "GCI (Global Cosmetics Industry): The Business magazine for the Global Beauty Industry," a sister publication of P&F.
It turns out that the "Natural" Products Industry has not yet agreed upon a definition of what "natural" products are. There is reference in both the Webinar and the article referenced above to an effort to develop a "Natural Personal Care Products Standard" being put together by the Natural Products Association (NPA)and to be discussed at their National Lobbying Day to be held in Washington, DC on April 8. Unfortunately the NPA didn't get their draft up on their website, so we can't link to the specifics. However, there are other definitions of "Natural" in use.
Burt's Bees has a definition posted on their website that is probably the draft, since the Chair of the NPA committee working on the Standard is from Burt's Bees. The draft requires that products labeled "Natural" must "be made with 95% truly natural ingredients, contain no ingredients with potential suspected human health risks, and use no products that significantly or adversely alter the purity/effect of the natural ingredients." "Natural" is defined as "Ingredients that come from a purposeful, renewable/plentiful source found in nature (flora, fauna, mineral) and using "Processes that are minimal and don't use synthetic/harsh chemicals, or otherwise dilute purity."
The standard goes on to define when non-natural ingredients can be used, and then provides a list of ingredients that should never be used, including (of interest to us because of their use in solvent extraction) Petro Chemicals, and finally to list Processes that should never be used: "Ethoxylation, sulfonation, polymerization and unfavorable varieties of quaternization — Industrial processes using caustic solvents that leave residual compounds and impurities that may end up concealed in the final consumer product."
The draft NCA definition is not the only one out there. The International Association of Natural Product Producers (IANPP) has produced two definitions, one for Natural Ingestible Ingredients and another for Natural Topical Ingredients. They are careful to set these definitions in a context that excludes "considerations such as safety, allergies, toxicity, animal testing, socially responsible packaging and business practices (fair trade, third world projects, responsible use and ingredient disposal, cooperative work environment), respect for endangered species, biodegradability/environmental friendliness, environmentally protective methods of production, etc." These, of course, are important, but in their opinion need to be considered separately from the definition of "natural."
The IANPP definition contains similar elements, but differs from the NCA definition in some significant ways:
- It doesn't deal with the issue of allowing a percentage of ingredients to not be natural.
- It contains a more precise processing limitation: "Any changes to the original natural ingredient must not undergo changes in one or more covalent bonds during manufacturing and/or processing."
- It requires that "solvents must be found in nature (originate from plant, animal or inorganic mineral sources) and the processing method must not introduce anything that is not of natural derivation"
- It defines synthetic "as a substance not derived from natural sources with biological and/or accepted food processing/handling techniques
- It lists acceptable and unacceptable processing methods (of interest to use, the acceptable list includes "cold pressing, ... natural water/alcohol extraction, ... extraction with natural solvents, expeller pressing (oils), steam distillation, [and] supercritical CO2 Extraction...." (ultrasonic extraction is missing from the list).
- The unacceptable processing method list contains only two items: Gamma Ray Irradiation and Synthetic solvent extraction.
- [I think they've made an error in their web page--under Gamma Ray Irradiation they list two bullets that seem to refer to preservatives], allowing Preservation by thermal, sound, or photochemical methods including microwave, ultrasound, UV, or infrared) but listing nuclear or thermo-nuclear preservative methods as Not Acceptable.
- They don't list specific banned chemicals, but instead ban artificial/synthetic "additives, colorings, coloring agents, preservatives, antibiotics, hormones, processing aids, carriers, synthetically derived and/or processed contaminants from packaging, GMO’s or other non-natural ingredients"
- Require that ingredients be "Be fully disclosed and documented regarding ingredient derivation and method of processing"
- Include the words “preserved with” on the label regarding preservative ingredients.
As mentioned in the GCI article, there are some other definitions of natural that are being used by some companies. These all need to be integrated together with a public discussion of the issues. The NPA intends to have a discussion, I'm sure, but so far it hasn't been out on the web where the small companies who may not be members of the NPA can access it.
I don't think either of the definitions discussed here are adequate to become the exact definition used by the industry. They use somewhat different approaches, and both contain elements that ought to be included. More discussion is definitely needed.
UPDATE: An attempt to contact the IANPP resulted in a response indicating that the IANPP has turned its project over to the NAP and that there should be some results by the end of this year.
Posted by Rob on April 6, 2008 in Aromatherapy, Perfumery, Regulatory Issues, Standards | Permalink | Comments (1) | TrackBack



