364 JOURNAL OF COSMETIC SCIENCE REGULATORY UPDATE ON PRESERVATIVES - WORLDWIDE Focus Janet Winter Blaschke International Cosmetics & Regulatory Specialists, L.L.C. Cosmetic chemists anl their companies are constantly searching for a "worldwide product" It is an understandable goal that companies have a goal of having one version of a product worldwide. Whether or not this is possible, the first stumbling block for the formulator and microbiologist is the challenge of acceptable preservatives. Companies are constantly in search of a "universal formula". Sometimes formulators will tell marketers that they have a "worldwide formula" for a product. When you hear this terminology, it is time for some additionr1I reser1rch. Each country in the world has its own regulatory system. Along with those systems come ingredient restrictions Preservatives are at the top of these lists. Preservative lists fall into three categories: 1) Positive Lists 2) Negative lists :{) Restrictive Lists Positive lists are those which communicate only which preservatives are acceptable. Negative lists are those which delineate preservatives that are not acceptable under any circumstances. Restrictive lists document which preservatives are acceptable, but only under certain circumstances. Ofl en these Hre restrictions on percent.r1ge limits of use of the actual ingredient,' or components of that ingredient, and types of use, such as leave-on products or rinse-off products Preservatives are significant in that they have specific biological activity for their intended purpose. This functionality increases the scrutiny of the products, especially by governments ancl sometimes by consumer groups as well. These can often, rightly or wrongly, bear fruit in regulations that are designed to protect the health of consumers. !\Jany of the preservatives that arc currently in use have been used for decades. With the advent of different scientific approaches, and histor)· of use, some of these long-standing ingredients are under scrutiny. The world is continuing to shrink. However, that does not mean that things are getting simpler. It only means that there is more information that is shared for the governments to analyze. In the U.S. Regulatory landscape, FD.:-\ requires Lhe producers of finished product to assure the products' safety for use by the consumers. This is true for Cosmetics and Over­ t he-Counter (OTC) Drugs. In the European Union, there is a different approach. Acceptable preservatives are listed in a Positive list. This list is also a restrictive list., such that it defines certain use conditions for the ingredients. This can include specific products (for eye makeup only), product usage (not for use in products that are dispensed in aerosol form) and limits of usa�e in some or all products (e.g., 1 % in rinse-off products, 0.5 % in leave-on products). Previously the E.U. has exercised the right to put preservatives on a "Provisionally allowed" list. There can also be a Negative list which provides for preservatives that are forbidden to be used in any type of Cosmetic product. Of timely importance is the issue of safe use by the consumer by the use of date­ identifying products. l\Iost recently, the European Union enacted the Seventh Amendment to the Cosmetic Directive, which requires some kind of dating on almost all Cosmetic products. This new requirement, known as the Period After Opening (PAO) affects all

2005 ANNUAL SCIENTIFIC SEMINAR companies. Within those companies, those most directly affected are the Cosmetic Chemists and Microbiologists. The Period After Opening (strictly speaking, not an Expiration Date), is difficult to determine, yet this function of the Chemists and Microbiologists affects the entire company. With rapid product development timelines, this dilemma is intensified and is a challenge for all concerned. The parameters of determining the Period After Opening are many faceted. This requirement is completely new to our industry, and the implementation date was March 11, 2005. Japan has its own set of regulations. They too, have a positive list of preservatives that can be used. If the preservative is not on the positive list, it may not be used to preserve Cosmetic products. Historically, Japan was one of the most difficult markets for preservative acceptance. The .tvlinistry of Health and Welfare (now the Ministry of Health, Labor and Welfare), which is similar to our FDA, had a strict requirement for any ingredient to be approved before being used. For many years, Formaldehyde donor preservatives were not iipproved. Industry provided information citing the safety of these ingredients in other markets. The l\linistry responded by noting their belief that the skin of the Japanese consumer was different and more sensitive than Caucasian skin. Therefore the safetv of wide use in other mnrkets was irrelevant for their safety concerns. Some preservatives frequently used in the U.S. are unacceptable in other countries. They also sometimes have different limitations for use. Unfortunately, it is not until a new market is approached, that these difference� come to light. Foresight and knowledge of the regulations can streamline the development process and can help eliminate additional formulation work. \\'hen dealing with restricted amounts of ingredients, it is absolutely necessary to determine the presence and level of all preservatives in the finished product. Sometimes the presence of preservatives is overlooked, usually due to its presence in ancillary raw materials. l\fany companies have found that there are preservatives present in some raw materials. such a� surfactants and liquid botanical extracts. These preservatives must be taken into account by virtue of their contribution to the finished product. If government authorities test the product off the shelf for preservative levels, they will be checking for all preservatives, regardless of the contributor. Formulators are constantly faced with challenges choosing preservatives that are acceptable in International markets, not just in Japan, and in Europe, but in countries such as Australia. Korea and Taiwan. Recoming knowledgeable in the regulations affecting preservatives in various countries is imperative in designing formulas that will be acceptable in International markets. The definition of an International market must be carefully discussed. Often technical experts consider the U.S , Europe and Japan to be the only International markets. Other countries must also be considered when formulating. Formulators and .Microbiologists alike must now become experts in the field of Regulator�· Affairs in order to stay competitive in our ever shrinking world. 365