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Labeling Claims—Untangling the Rules

By: David C. Steinberg
Posted: September 3, 2009, from the September 2009 issue of GCI Magazine.

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The 7th Amendment to the Cosmetic Directive, under Article 7a part (g), states that one must have “proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product.” In relation to this, as part of the product information package, companies are required to list an EU address that the Competent Authorities may contact in order to inspect evidence of the claims made.

Going further with labeling requirements, the 8th Amendment, known as a recast since it changes the Cosmetic Directive to Cosmetic Regulations, has been approved but at press time had not yet been published in the Official Journal of the European Union. It states that:

  • Names, trademarks, pictures and other signs should not be used to imply that products have characteristics or functions that they do not have;
  • The commission will adopt a list of common criteria for claims that may be used for cosmetic products. Three years after the Cosmetic Regulations are implemented (approximately 2012), the commission will submit to the Parliament and Council a report regarding the use of claims on the basis of common criteria; and
  • The “responsible person” (a new provision within the regulations) may allow the fact that no animal tests have been carried out by the manufacturer or ingredient suppliers to comply with this regulation.

Proof of Claims

Since claims substantiation is expensive, some companies seek ways to make claims without doing the work or incurring the expense. Frequently they rely upon claims made by ingredient suppliers. In the U.S., the National Advertising Division (NAD) of the Council of Better Business Bureaus acts as the watch dog for all consumer advertising claims. This group does not accept ingredient claims as a base for finished goods claims. In the EU, ingredient suppliers’ claims have been accepted provided that manufacturers use the exact same ingredient and at the exact same dosage in a formulation. However, with the recast (previously described), it is likely this will not be permitted in the future.


In my 40 years in the personal care industry, I cannot recall a time when so many new laws were being introduced in the U.S. Congress and state legislative bodies for the regulation of cosmetics. It is clear that the NGOs are active and probably successfully swaying public (and now political) opinion toward the idea that cosmetics contain unsafe ingredients and that the public needs more protection by added legislation.

Such legislation takes the form of banning ingredients, even when overwhelming scientific evidence supports their safety, and calling for the FDA’s pre-approval of all ingredients for use in cosmetics. If this comes to pass, ingredient approvals by the FDA will likely advance at the same pace as approvals for new UV filters—just three have been approved in 30 years. Further, where will the money come from to pay for this? User fees. This will drive all small- to medium-sized entrepreneurial companies out of business.

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