| Literature DB >> 28911452 |
Meng-Hsuan Chung1, Wei-Sheng Huang2, Yu-Chang Chang1, Yu-Hsuan Chen1, Ming-Shin Lee1, Shou-Chieh Huang1, Yu-Pen Chen1, Daniel Yang-Chih Shih1, Hwei-Fang Cheng1.
Abstract
The Food and Drug Administration in Taiwan is responsible for the quality regulation and control of cosmetics. In order to have a clear understanding of the trends in the product quality monitoring outcomes and the regulatory control measures over the past years, this study has put together the reports of nine cosmetic surveillance projects conducted between 1982 and 2012. The findings can be used as a reference in developing a more solid quality monitoring plan and management system for cosmetic products. Results show that permanent wave products, hair dye products, and phthalate esters in cosmetic products have the highest average noncompliance rates at 39.2%, 14.2%, and 11.2%, respectively. These are followed by the average noncompliance rates of mercury in products, sunscreen products, and microorganisms in products, at 8.5%, 7.1%, and 5.5%, respectively, and the remaining three projects averaging below 4.1%. Since 1997, when new standards were announced and assistance to manufacturers was reinforced, the noncompliance rates of permanent wave products decreased annually, until 2007, when it was fully qualified for the standards. Overall, the study showed that the noncompliance rates of permanent wave products and for levels of phthalate esters, mercury, and hydroquinone in cosmetic products have all decreased in the previous years. The results of surveillance projects conducted after 2005 revealed only one noncompliance sample with lead, arsenic, and cadmium, whereas the surveillance projects on permanent wave products and chloroform- and 1,4-dioxane-containing products revealed full compliance with regulation standards. However, the noncompliance rates for microorganisms in cosmetics and the ingredients in hair dye products and sunscreen products were still high. These high-risk products must be monitored. These surveillance projects are conducted to ensure the safety of cosmetics in the market.Entities:
Keywords: Cosmetics; Medicated cosmetics; Noncompliance; Quality surveillance
Year: 2014 PMID: 28911452 PMCID: PMC9355008 DOI: 10.1016/j.jfda.2014.03.002
Source DB: PubMed Journal: J Food Drug Anal Impact factor: 6.157
The monitoring projects and noncompliance rates (%) of cosmetics from 1982 to 2012.
| Year | Project | |||||
|---|---|---|---|---|---|---|
|
| ||||||
| Permanent wave products | Hair dye products | Sunscreen products | Microorganisms in products | Mercury in products | Lead, arsenic, and cadmium in products | |
| 1982 | — | — | — | 20 (2/10) | — | — |
| 1984 | 90.0 (27/30) | — | — | — | — | — |
| 1985 | 80.0 (72/90) | — | — | — | 12.4 (25/202) | — |
| 1986 | — | — | — | — | 13.7 (34/248) | — |
| 1987 | — | — | — | — | 15.0 (45/300) | — |
| 1990 | 95.7 (67/70) | — | — | — | — | — |
| 1992 | — | 26.7 (8/30) | — | 10.4 (21/201) | — | — |
| 1993 | 62.0 (67/108) | — | — | — | — | — |
| 1994 | 42.5 (51/120) | — | — | — | 10.0 (10/100) | — |
| 1998 | 5.7 (6/105) | — | — | — | 1.3 (1/80) | — |
| 1999 | — | — | 12.4 (17/137) | — | — | — |
| 2000 | — | 0.9 (1/118) | 6.3 (10/159) | — | — | — |
| 2001 | — | — | 3.5 (4/114) | — | 2.4 (2/85) | — |
| 2002 | — | 19.5 (16/82) | 3.9 (4/103) | — | — | — |
| 2004 | 3.6 (6/165) | — | — | — | 0.0 (0/121) | — |
| 2005 | — | — | 7.4 (6/81) | — | 0.4 (1/247) | 0.5 (1/191) |
| 2006 | — | — | 10.0 (5/50) | 0 (0/51) | — | — |
| 2007 | 0 (0/68) | — | — | 3.4 (5/149) | — | — |
| 2008 | — | — | — | 7.4 (4/54) | — | — |
| 2010 | — | 29.4 (15/51) | — | — | — | — |
| 2011 | — | — | — | — | — | 1.0 (1/99) |
| 2012 | — | — | — | 9.4 (5/53) | — | — |
| Average noncompliance rate | 39.2 (296/756) | 14.2 (40/281) | 7.1 (46/644) | 7.1 (37/518) | 8.5 (118/1383) | 0.7 (2/290) |
The table presents noncompliance rates (noncompliance number/total sampling number).
The noncompliance rates without the results of the background survey in 1982, 1992, and 2006.
Quality-monitoring projects and noncompliance rates (%) of cosmetics from 1994 to 2012.
| Year | Project | |||||
|---|---|---|---|---|---|---|
|
| ||||||
| Products with hydroquinone | Products with salicylic acid | Products with phthalate esters | Products with methanol | Products with chloroform | Products with 1,4-dioxane | |
| 1994 | 12 (14/100) | — | — | — | — | — |
| 1996 | 2.0 (2/102) | — | — | — | — | — |
| 1997 | 0.0 (0/50) | — | — | — | — | — |
| 2000 | — | 3.1 (2/65) | — | — | — | — |
| 2001 | 3.8 (3/79) | — | — | 7.8 (4/51) | — | — |
| 2002 | 4.6 (4/87) | — | — | — | — | — |
| 2004 | — | — | — | 0.9 (1/112) | — | — |
| 2005 | 1.6 (4/247) | — | — | — | — | — |
| 2006 | — | — | — | 1.9 (2/103) | 0.0 (0/103) | — |
| 2007 | — | 5.3 (3/57) | — | — | — | — |
| 2009 | — | — | 14.9 (13/87) | — | — | — |
| 2011 | — | 0.0 (0/31) | 9.1 (4/44) | — | — | 0.0 (0/81) |
| 2012 | — | — | 7.1 (4/56) | 3.6 (2/56) | — | — |
| Average noncompliance rate | 4.1 (27/665) | 3.3 (5/153) | 11.2 (21/187) | 2.8 (9/322) | 0.0 (0/103) | 0.0 (0/81) |
The table presents noncompliance rates (noncompliance number/total sampling number).
Fig. 1The results of the quality monitoring of marketed hair dye products.
Fig. 2The results of the quality monitoring of marketed sunscreen products.