Organic and Natural: Caveat Emptor

Apr 1, 2009 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Title: Organic and Natural: Caveat Emptor
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Keywords: natural | organic | regulation

Abstract: Previous columns have discussed Canadian Natural Health Products regulations but have steered clear of the natural and organic debate, although this author previously published an article that debates animal versus vegetable ingredients, in which he explains that a chemical is a chemical regardless of its origin; a molecule of glycerin is just that, whether from natural sources like animal or vegetable fat, or from petroleum or biodiesel sources.

Every once in a while, readers ask how topics are selected for this column. This time, the idea came from an e-mail inquiring what COSMOS standards are. Previous columns have discussed Canadian Natural Health Products regulations but have steered clear of the natural and organic debate, although this author previously published an article1 that debates animal versus vegetable ingredients, in which he explains that a chemical is a chemical regardless of its origin; a molecule of glycerin is just that, whether from natural sources like animal or vegetable fat, or from petroleum or biodiesel sources.

COSMOS is an independent effort in the European Union (EU) aimed to outline organic and natural standards, with draft guidelines published in November 2008. But how is it different than other standards? This calls for a review of the various natural and organic standards for the personal care industry and how they have evolved.

What is Natural?
According to the author, when he first began to learn during the Dark Ages, the elements of earth, air, fire and water were understood to be natural; thus everything made from them was considered natural. Later, industry expert Ken Klein stated that anything made from the first 92 elements of the periodic table are natural, and that no man-made elements should be used in products claiming to be natural; however, this philosophy did not seem a sufficient answer for what marketers where claiming.

An Internet investigation retrieved several meanings for the term natural, among which were: being present in or produced by nature; i.e., a natural pearl; being inherent or not acquired; not being produced or changed artificially; and not being altered, treated or disguised.

The US Food and Drug Administration (FDA) does not define natural in the Food, Drug and Cosmetic Act or any other FDA regulation; the closest definition2 for natural personal care products was established in Canada as a regulated category called Natural Health Products. This regulation, which went into effect on Jan. 1, 2004, defines natural health products (NHPs) as: vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicine such as traditional Chinese medicine, probiotics, and other products like amino acids and essential fatty acids.

While these materials are found in nature, Canada took it a step further to describe acceptable substances as being synthetic duplicates of those materials listed above. Synthetic duplicates are substances that share identical chemical structures and pharmacological properties with their natural counterparts; an example of such is vitamin E and dl alpha-tocopherol.

A semi-synthetic substance may also be acceptable as an NHP, provided that it shares identical chemical structures and pharmacological properties with its natural counterpart. Semi-synthetic substances are produced by processes that chemically change a related starting material that has been extracted or isolated from a plant or a plant material, an alga, a fungus or a non-human animal material. An example of such is ginsenosides, which are produced from the starting compound betulafolienetriol.

In the end, whatever marketing deems natural is natural; the critical inference is that consumers believe products marketed as natural are safer than products that are not marketed as natural. This has given rise to an increase in use of the word organic within the cosmetic industry.

Organic
Recalling studies from his youth, the author notes that the term organic originally referred to the chemistry of the carbon atom. Then in 1973, an organization called the California Certified Organic Farmer was formed to promote organic farming in California, instilling in the public a new sense of the word organic. This group became one of the first to certify products with an organic seal of approval on the label. In 1979, the state made the organic labeling of foods a law subject to their controls.

In 1980, the US Department of Agriculture (USDA) published its “Report and Recommendations on Organic Farming,”3 in which organic farming was described as a “production system that avoids or largely excludes the use of synthetically compounded fertilizers, pesticides, growth regulators and livestock feed additives. To the maximum extent feasible, organic farming systems rely upon crop rotations, crop residues, animal manures, legumes, green manures, off-farm organic wastes, mechanical cultivation, mineral-bearing rocks and aspects of biological pest control to maintain soil productivity and tilth, to supply plant nutrients and to control insects, weeds and other pests.”4

Reasons for interest in this system included:

  • Increased cost and uncertain availability of energy and chemicals; Increased resistance of weeds and insects to pesticides;
  • Decline in soil productivity from erosion and accompanying loss of organic matter and plant nutrients;
  • Pollution of surface waters with agricultural chemicals and sediment;
  • Destruction of wildlife, bees and beneficial insects by pesticides;
  • Hazards to human and animal health from pesticides and feed additives;
  • Detrimental effects of agricultural chemicals on food quality;
  • Depletion of finite reserves of concentrated plant nutrients (e.g., phosphate rock); and
  • Decrease in numbers of farms, particularly family-type farms, and disappearance of localized and direct marketing systems.5

By the late 1980s, a number of private and state-run certifying bodies were operating in the United States. Standards varied among these entities, causing trouble in commerce. Certifiers often refused to recognize products certified as organic by other agents, which was a problem particularly for organic livestock producers seeking feed, and for processors trying to source ingredients. In addition, a number of well-publicized incidents of fraud began to undermine the credibility of the organic industry.

In an effort to curb these problems, the organic community pursued federal legislation. The result was the Organic Foods Production Act of 1990, which mandated the creation of the National Organic Program (NOP) and the passage of uniform organic standards. These standards were incorporated into NOP regulations.6 Implementation of the regulations began on April 21, 2001, and all organic certifiers, producers, processors and handlers were required to be in full compliance by Oct. 21, 2002.7

Beyond federal legislation, the California Organic Products Act (COPA) was signed into law in 2003, and beginning Jan. 1, 2003, all products sold in California containing a total of less than 70% organic ingredients were no longer allowed to use the word organic on the front labeling panel. Later in 2003, the State Assembly repealed the non-food provision of the COPA but in the end, cosmetics remained a part of the Act.

With the growth of nationwide food stores based on certified organic foods, interest in the organic market has spread to cosmetics and other personal care products. From this interest, several groups have emerged with varying standards for organic certification; most use a seal that appears on product labels to indicate organic certification. Following are some of the major bodies, as well as their requirements. This is not a comprehensive list but it will provide an overview.

National Organic Program (NOP, United States): Within this program are four levels of organic claims for foods. The NOP defines the claims that can be used for agricultural products by their content, excluding water and salt. 100% Organic: For this claim, 100% of the ingredients in the product must be certified organic products and in this case, the USDA Organic seal may be used (see Figure 1).

  • Organic: To make this claim, 95% of the materials in the product must be certified organic products; the same USDA Organic seal may be used in this instance.
  • Made with organic ingredients: For this label claim, 70% to 94.99% of the product’s ingredients must be certified organic; in this case, use of the USDA Organic seal is not permitted.
  • Contains organic: This label claim requires less than 70% of certified organic ingredients in a product and also cannot bear the USDA Organic seal.

Natural Products Association (NPA, United States): This organization was founded in 1936 and was principally concerned with dietary supplements. The group represents more than 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health and beauty aids. On May 1, 2008, the group issued its certification program for personal care products. In order to display the NPA seal (see Figure 2), a product must meet the following requirements:

  • Contain at least 95% truly natural ingredients or ingredients that are derived from natural sources;
  • Contain no ingredients linked with potentially suspected human health risks;
  • Not be processed in ways that significantly or adversely alter the purity of its natural ingredients; Include ingredients derived from a purposeful, renewable/plentiful source found in nature (flora, fauna, mineral);
  • Be minimally processed and avoid the use of synthetic or harsh chemicals so as not to dilute the material’s purity; and
  • Should contain non-natural ingredients only where viable natural alternative ingredients are unavailable, and only when they pose absolutely no potentially suspected human health risks.

The Natural Products Association also has published8 a list including 839 ingredients that it considers meets these requirements.

Cosmetics Organic and Natural Standard (COSMOS, EU): As noted above, COSMOS is an independent effort in the EU, with its draft published in November 2008. This standard was developed from collaborations between working groups including: the Instituto per la Certificazione Etica e Ambientale (ICEA in Italy); the Federation of German Industries and Trading Firms for Pharmaceuticals, Health Care Goods, Dietary Supplements and Personal Hygiene products (BDIH in Germany); Bioforum in Belgium; the French Professional Association of the Ecological and Organic Cosmetics, and a French certification organization (Cosmebio/Ecocert in France); and an environmental charity promoting sustainable, organic farming and championing human health (The Soil Association in the UK). The COSMOS draft is available at www.cosmos-standard.org.  

These standards describe five categories of ingredients: water, minerals, physically processed agro-ingredients, chemically processed agro-ingredients and synthetic materials. The draft details what materials are and are not allowed. It is interesting to note the chemical reactions that are and are not allowed (see COSMOS Chemical Reactions).

Under Appendix II of the COSMOS standard, the following synthetic ingredients are allowed: benzoic acid, benzyl alcohol, dehydroacetic acid, denatonium benzoate, heliotropine, salicylic acid, sorbic acid and tetrasodium glutamate diacetate. The second part of Appendix II lists the mineral origin products allowed—which contradicts the initial five categories of organic ingredients listed since “mineral” is included one of the organic ingredient categories.

California Organic Program (United States): Products sold in California must comply with the 2003 COPA Act10 to be labeled organic. These products also must be at least 70% organic, not including water and salt content. Like the USDA program, this program attempts to apply a food law to cosmetics. All organic ingredients used in organic products must be certified by one of the organizations listed by the USDA. There are additional registration fees and other labeling requirements.

Organic and Sustainable Industry Standards (OASIS, United States): OASIS was developed and is observed by major cosmetic companies in the United States such as L’Oréal and Estée Lauder. This standard certifies products at two levels—organic or made with organic. The made with organic designation requires 70% minimum organic content with additional criteria for the remaining 30% of ingredients. The organic label claim will require a minimum of 85% organic content until January 2010, at which time it will increase to a requirement of 90% minimum organic content; the minimum requirement will increase a third time to 95% by 2012. Products that cannot achieve a 95% organic level, such as soap, must use the made with organic claim.

This interval approach takes into consideration the fact that at least two years are necessary for surfactant and emulsifier manufacturers to put enough products into the commercial stream to supply the industry with organic versions of functional ingredients. Since one of the goals of OASIS is to promote the development of more raw materials developed from organic starting materials, this approach works with chemical manufacturers to achieve these goals.11

Whole Foods—Premium Body Care Seal (United States): One of the major retail outlets for organic products is the Whole Foods supermarket chain. This group has established its own rules and symbol. As of press time, the author has not been able to obtain the rules or the symbol. The group lists more than 250 ingredients that are not allowed, and also does not allow animal testing or organic UV filters. The group is aligned with the Environmental Working Group (EWG).

Organic Consumers Association (United States): This final group was established in 1998 in opposition to the USDA’s NOP program, and deals primarily with the food area. It has been involved in litigation with other standards.12

Comments
What chaos. Why are there so many different organizations, standards, symbols—and now, lawsuits? There is only one answer: marketing. One may question whether the companies selling cosmetics stamped with these symbols care about anything more than selling products. The underlying message is that consumers have been misled to believe that these products are safer than non-natural or non-organic cosmetics. These organizations’ definitions are contradictory and in some ways, amusing. One set of rules states that water found in the Aloe barbadensis leaf is organic while water from the faucet is not. Water is water is water. Also, natural minerals are allowed as colorants but they cannot be processed; as a minor point, this means that with the exception of mica, none of these natural minerals would be permitted in cosmetics.

Natural iron oxides, for example, would be in violation of FDA, EU and Japanese standards since ground iron oxide ores have enough lead, mercury, arsenic, cadmium, etc., in them to keep Proposition 65 lawyers in California busy filing lawsuits forever. Natural does not mean safe. In fact, the NPA’s list of permitted “safe ingredients” includes 15 of the EU’s 26 listed fragrance allergens. Perhaps natural allergens are better, then? And while one firm stands behind the EWG and proclaims that synthetic UV filters are dangerous, only permitting ZnO and TiO2, the International Agency for Research on Cancer has in the meantime declared TiO2 to be a known human carcinogen; plus, synthetic ZnO is the only ZnO used since its natural ore only exists with lead.

How far can this go?13 Do natural or organic cosmetics impart real benefits or are they just another marketing fad? As the economy in the United States declines, it appears that consumers are still spending money for organic foods but are foregoing higher priced organic personal care products. This column is titled “Caveat Emptor,” which means “let the buyer beware.”

This column also calls to mind a quote by David Hannum, among others, that states: “There’s a sucker born every minute.” In this author’s opinion, that is what keeps these products on the store shelf.

Reproduction of all or part of this article is strictly prohibited.

References

1. DC Steinberg, Ingredient Review: Animal vs. Vegetable, A Continuing Controversy, Skin Inc. 11(3) 58–62 (Apr 1999)
2. Natural Health Products Regulations, Health Canada Web site, available at www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.php (Accessed Feb 4, 2009)
3. Report and Recommendations on Organic Farming, USDA Web site, available at http://nal.usda.gov/afsic/pubs/USDAOrgFarmRpt.pdf (Accessed Feb 4, 2009)
4. Ibid Ref 3, pp 13 5. Ibid Ref 3, pp 16–17 6. National Organic Program, USDA Web site, available at www.ams.usda.gov/nop (Accessed Feb 4, 2009)
7. ATTRA Web site, National Sustainable Agriculture Information Service, available at www.attra.org (Accessed Feb 4, 2009)
8. Illustrative “Positive List” of Ingredients, Natural Products Association Web site, available at www.naturalproductsassoc.org/site/DocServer/Natural_Ingredients_List.pdf?docID=7341 (Accessed Feb 4, 2009)
9. OASIS draft document, available at: www.oasisseal.org (Accessed Feb 4, 2009)
10. California Organic Products Act of 2003, California Department of Food and Agriculture Web site, available at www.cdfa.ca.gov/is/docs/copa2003.pdf (Accessed Feb 4, 2009)
11. Ibid Ref 9
12. Round One Legal Victory for Organic Consumers and Dr. Bronner’s against “Organic Cheater” Personal Care Brands and Certifiers, Organic Consumers Association Web site, available at www.organicconsumers.org/articles/article_15126.cfm (Accessed Feb 4, 2009)
13. 100 Percent Pure Web Site, available at www.100percentpure.com/fruitpigmentedintro.html (Accessed Feb 4, 2009)

 

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Figure 1. USDA Organic Seal

USDA Organic Seal

USDA Organic Seal

Figure 2. Natural Products Association Seal

Natural Product Association Certified

Natrual Products Association Seal

Figure 3. OASIS Organic Seal

OASIS Organic

OASIS Organic Seal

COSMOS Chemical Reactions

Allowed physical processes:

  • Extractions must use natural materials with any form of water or with a third solvent of plant origin such as ethyl alcohol, glycerin, vegetable oils and CO2 absorption (on an inert support that conforms to these standards);
  • Bleaching or deodorization (on an inert support conforming to these standards);
  • Grinding, centrifuging (solid/liquid separation, spin-drying);
  • Settling, decanting, desiccation or drying (progressive or not by evaporation/natural under sun);
  • Deterpenation (if fractionated distillation with steam);
  • Distillation, expression or extraction (steam);
  • Filtration and purification (ultra filtration, dialysis, crystallization and ion exchange);
  • Lyophilization, blending, percolation, cold pressure and hot pressure (depending on the fluidity of the fatty acids to be extracted);
  • Sterilization with thermal treatments (according to a temperature respectful of the active substances); and
  • Sifting, maceration and ultrasound

Allowed chemical processes:

  • Alkylation, amidation, calcination of plant residues and carbonization (resins, fatty organic oils);
  • Condensation/addition, esterification, etherification and fermentation (natural/biotechnological);
  • Hydration, hydrogenation, hydrolysis and neutralization (to obtain Na, Ca, Mg and K salts);
  • Oxidation/reduction processes for the manufacture of amphoterics; and
  • Saponification, sulphation and roasting

Unallowed processes:
Any other processes that are not listed above are not allowed, including but not limited to:

  • Bleaching or deodorization (on a support of animal origin);
  • Use of enzymes derived from GMOs;
  • Deterpenation (other than with beam);
  • Ethoxylation, irradiation and sulphonation (as the main reaction);

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