Cosmetic Safety Assessments: What Are They Good For?
Unfortunately, in the world of business, financial interests may sometimes conflict with the safety and health of consumers. All fields are affected food, drug… but what about safety assessments of cosmetic products?
At Evalulab, we conduct studies on the effects AND safety of cosmetic and other skin care products. When toxic agents such as irritants or allergens in cosmetics products, the resulting adverse effects may cause considerable discomfort to the consumer. Consumers will cease to purchase products that cause discomfort or more serious health issues. Therefore, safety with regard to cosmetic products is a vital issue, not only for the health of the consumer, but also for the financial health of the product on the market.
The differences between safety tests and an efficacy tests:
Efficacy testing is important for verifying and demonstrating the marketing claims of each product, in order to ensure that the product functions as claimed (ensuring longevity on the market) and to protect consumers against fraudulent claims about the efficacy of cosmetic products.
Safety testing is essential to evaluate the product based on skin tolerance, ensuring consumer protection. In vivo studies are used to investigate the toxicological potential of a cosmetic ingredient when applied to human skin. They provide for the determination of the no effect level (NOEL) or the non observed adverse effect (NOAEL) and also the likely effects after the exposure under exaggerated use conditions. Observations on human subjects have to be used to conduct adequate analysis of potential adverse effects of a chemical ingredient or of a cosmetic product.
The Types of Safety Tests:
- Sensitivity / Irritation Tests like HRIPT (human repeat insult patch tests), simple 48 hour patch tests or ophthalmologic tests are based on clinical visual and tactile assessments and instrumental measurements, and are conducted under the supervision of a dermatologist or ophthalmologist, who signs each report. Pending the results of the study, claims such as “hypo-allergenic,” “dermatologist tested” or “ophthalmologist tested” and “non-irritating” can be made on the product label. These are industry recognized studies and at Evalulab, they are conducted under Good Clinical Practice (GCP) guidelines.
- Compatibility Tests intend to confirm that there are no harmful effects when applying a cosmetic product for the first time to the human skin or mucous membrane. Depending on the protocol and intended assessments, claims such as “non-comedogenic,” “tear free” or sensitive skin can be made on the product label.
- Use Tests / Consumer Acceptability Tests are based on the self-perception of the study subjects themselves in order to confirm the fulfillment of the expectations for the product, used under normal conditions.
- Solar protection studies like the “Broad spectrum” test or SPF determination are also considered safety tests.
The U.S. Food and Drug Administration (FDA) and The European Union Cosmetics Directive** require that every cosmetic product in the market has a safety dossier (file) containing the completed safety and efficacy testing and a safety assessment toxicity certificate. The Canadian government regulates the cosmetics industry through Health Canada but the basis for the regulatory authority comes from the FDA Cosmetic Regulations, and is enforced by Product Safety Officers or a professional association (such as the Canadian Dermatology Association).
Further Information on the Safety Assessment of a Cosmetic Product
A safety assessment of any cosmetic product relates to the intended manner of use, as indicated on the product label. These instructions are important as they indicate the amount of substance that should be applied to the skin or mucous membranes, ingested or inhaled. In general, the potential of a cosmetic product for sensitization, (allergy), toxicity or other types of systemic (toxic) effects will be evaluated on the basis of the properties of the ingredients. A toxicology expert called “Safety Assessor”, responsible for product safety, is required for assessing the toxicity profile. This expert must have a diploma in the field of pharmacy, toxicology, dermatology or medicine.
In Canada, the CDA (Canadian Dermatology Association) logo is a proof to guarantee a safety assessment of the product to the consumer. In order to receive the right to use the logo on the product label, the products must to comply with several criteria: They must proven to be non-comedogenic, non-irritating, hypo-allergenic, minimally or non-perfumed, and with regard to sunscreen products, they must contain a broad spectrum UVA block and UVB SPF (Sun Protection Factor) ≥ 30. If sunscreens meet the criteria listed above, the manufacturer may display the Canadian Dermatology Association’s logo.
*Sensitivity: hyper-reactivity to external factors. Reactions may include itching, burning, stinging, sensation of tightness. Irritation: non-mmunological mediated inflammation of the skin induced by external agents. Symptoms may include: erythema, dryness, scaling, itching, burning, and/or tingling.
**United States: FDA according to the Code of Federal Regulations (21 CFR 740.10) => http://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfcfr/CFRSearch.cfm?fr=740.10
Health Canada => http://www.hc-sc.gc.ca/cps-spc/cosmet-person/cons/safety-innocuite-eng.php
European Union Cosmetics Directive: Guidelines for the safety assessment of a cosmetic product (edition 2004 – COLIPA) => http://www.cosmeticseurope.eu/safety-and-science-cosmetics-europe/safety-in-cosmetics/safety-assessment.html
Sources:
http://personalcaretruth.com/2011/05/safety-assessments-for-cosmetic-finished-goods/
http://safecosmetics.org/section.php?id=75
http://www.dermatology.ca/programs-resources/programs/recognized-products/
http://personalcaretruth.com/2010/10/cosmetic-safety-is-ensured-worldwide/
