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Regulatory: Updates to Independent EU Cosmetic Directive

David C. Steinberg, Steinberg & Associates

The abridged version of this column appears here courtesy of Cosmetics & Toiletries magazine

Every once in a while, readers ask how topics are selected for this Cosmetics & Toiletries magazine 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.

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.

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.

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.

  • 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, 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  

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).

This Steinberg column, entitled "Organic and Natural: Caveat Emptor,"  is available in full on Cosmetics & Toiletries magazine's Web site.

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  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 (Accessed Feb 4, 2009)
  3. Report and Recommendations on Organic Farming, USDA Web site, available at (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 (Accessed Feb 4, 2009)
  5. ATTRA Web site, National Sustainable Agriculture Information Service, available at (Accessed Feb 4, 2009)
  6. Illustrative “Positive List” of Ingredients, Natural Products Association Web site, available at (Accessed Feb 4, 2009)
  7. 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 (Accessed Feb 4, 2009)
  8. 100 Percent Pure Web Site, available at (Accessed Feb 4, 2009)

David C. Steinberg founded Steinberg & Associates, a consulting firm based in Plainsboro, New Jersey, USA, in 1995. He also was co-founder of the graduate program in cosmetic sciences at Fairleigh Dickinson University, where he lectured for 18 years on the chemistry of cosmetic ingredients. He has more than 35 years of experience in marketing, technical service and regulatory affairs in the personal care industry, and was president of the Society of Cosmetic Chemists in 1991. He is a frequent speaker worldwide on cosmetic regulations, cosmetic preservation, sunscreen chemistry and the chemistry of cosmetic ingredients.