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Shiseido Safety Assurance System

The Shiseido Safety Assurance System is the result of many years of research work on cosmetic safety assurance and decades of research work on alternatives to animal experiments by Shiseido. This system comprises three major steps (safety assurance by examining existing toxicological data, safety assurance by alternative methods, final safety assurance by human testing) and five elements, including two approaches used in alternative testing methods and the follow-up system. In each element, an appropriate battery of specific tests is performed for each assurance item.

Shiseido Safety Assurance System

Safety assurance by examining existing toxicological data

Experience and data obtained from many years of safety evaluation research by Shiseido are invaluable. Such information collected up to now has been organized as a database, which is accessible at all times and updated whenever new information, including the post-marketing data, becomes available. In addition to the in-house data, publicly available data such as articles and public reports/databases that have been confirmed as reliable are also actively used. Chemical substance safety data are constantly being updated around the world. We at Shiseido strive to obtain the appropriate data. We also consult with experts outside the company. To properly conduct safety assurance by examining existing toxicological data, researchers in charge of safety assurance constantly strive to improve their evaluation skills by participating in global-level safety evaluation events held by the industry or academic societies and frequent information exchanges with regulatory authorities.

Safety assurance by alternative methods Click here for details)

In silico/Expert System (Read across)

Evaluations are conducted using mathematical models or knowledge-base models.
Even if the new ingredient is not identical but similar to a known ingredient, safety data can be used in safety assurance as long as data are available that show specific similarities in chemical structure and/or biological reactions. The justification for using such data to evaluate each safety assurance item is checked by an expert in a relevant field.

In vitro testing

Safety can be evaluated in in vitro studies conducted with experimental models such as cell culture. Depending on the purpose, a variety of methods are available. In some cases, a battery of tests can be applied.

Final safety assurance by human testing Click here for details)

New ingredients for which safety has been demonstrated by existing toxicological data and by alternative methods undergo a final safety verification by human testing. Before undertaking this step, the decision to conduct human testing must undergo a rigorous review by the Human Testing Ethics Review Council based on the results of verifications and tests conducted up to that point in time.
Some final products containing an ingredient that has demonstrated safety may still have to undergo evaluation through the safety assurance process. Shiseido has ethically approved protocols in place for the conduct of such safety assurance processes, if any concern arises with the combination of ingredients.

Follow-up system Click here for details)

Shiseido has established an in-house system that promptly ascertains post-marketing use data and provide such data as feedback without delay. Through Shiseido’s dedicated information desk, we strive to collect all information including complaints from customers and inquiries from physicians, among other information. We also continuously collect information globally from public institutions and academic societies, and risk information is collected promptly and verified in-house.
Information gathered in this way allows Shiseido to take prompt and appropriate measures from the standpoint of customers and allows us to use the information in subsequent safety assurance.

Click here for actions to take when there are matters of concern

Safety assurance items assessed at Shiseido

Safety assurance items assessed at Shiseido for its cosmetics are presented below. These assurance items are classified into two categories: local toxicity (assessment of any direct adverse effects of the product on application sites, such as irritation) and systemic toxicity (assessment of any systemic adverse effects). Shiseido assures the safety of each item and takes steps to curb misuse and environmental (ecological) effects. Furthermore, such assurance-related information is also made available to healthcare providers if necessary.

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