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2015 Annual Report

57

Risk Assessment

Management and

Research Outcomes

Cosmetics

Management

Appendix

National

Laboratory and

Testing Network

Risk Communication

and Consumer

Protection

International

Cooperation and

Cross-Strait Exchange

Food

Management

Medicinal

Products

Management

Policy and

Organization

Controlled

Drugs

Management

Medical

Devices

Management

(2) Adding Various Regulations and Hygiene Standards

Regulations from various countries are referenced to achieve harmonization of rules. Cosmetic

regulations and hygiene standards added or revised in 2014 are listed in Table 6-1.

2. Pre-Market Approval & Registration and Cosmetic Advertisement Examination

(1) Inspection and registration of medicated cosmetics

a. In 2014, TFDA handled a total of 1,900 cases of cosmetics inspection and registration

applications, of which 1,661 cases were approved (Table 6-2).

Date

Regulation / standard name

Summary

8 January

Amendments to

Regulations Governing

Maximum Residual Amounts of Heavy

Metals (Lead and Arsenic) as Impurities in

Cosmetics"

Residual lead or arsenic impurities in the final product should

not exceed 10 ppm and 3 ppm respectively

15 May

Amended

Guideline for the Use of

Preservative Ingredient and Dosage Limit

Requirement in Cosmetics

Amended the usage limits and published additional reminders

for the use of

Methylisothiazolinone

and

Mixture of 5-Chloro-

2-methyl- isothiazol-3(2H)-one and 2-Methyl- isothiazol-3(2H)-

one with magnesium chloride and magnesium nitrate

9 October

Amended the Management

Regulations

Governing the Composition of Camphor,

Menthol, and Methyl Salicylate in

Cosmetics

Removed the management regulation stipulating

cosmetics

containing Camphor as an ingredient should label in its

package insert or packaging that the product should not be

used by those with glucose-6-phosphate dehydrogenase

deficiency

Year

Total applications

Licenses granted

Approval rate

2010

1,594

1,437

90.2%

2011

1,634

1,519

93.0%

2012

1,721

1,482

86.1%

2013

1,650

1,506

91.3%

2014

1,900

1,661

87.4%

Table 6-1

Regulations and hygiene standards associated with cosmetics added or revised in 2014

Table 6-2

The number of approved cosmetics licenses issued from 2010 to 2014