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  • [환경] Request for Review of Regulation According to the Partial Amendment Order of the Enforcement Rule of the Cosmetics Act
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2018-06-11
    • Opinion Submission Deadline : 2018-07-22

(1) Reasons for Proposal

This Amendment aims to obligate all cosmetic products to label allergy-inducing ingredients and to label the content of raw materials subject to a determined standard for usage in cosmetics with labels or advertisements indicating that they may be used by infants or children to provide diverse and specific information on cosmetics to customers, thereby helping them in their product choices.

Also, this Amendment aims to streamline the process of business closure by allowing a maufacturer-seller or manufacturer of cosmetics, where he/she reports his/her business closure, to cancel her/his business registration at a single agency pursuant to the Value-Added Tax Act; and newly insert the standards for imposing a suspension of sales business when engaging in advertising during the period of suspension of advertising for cosmetics, thereby making rational improvements to the administrative procedures and strengthening the effectiveness of administrative measures.

(2) Major Provisions

A. Streamline the procedures for reporting on business closure, etc. (Article 15 (2) and (3), newly inserted)

Prescribe that a cosmetics manufacturer-seller may report the business closure and cancel such business registration at the same time at a single agency.

B. Add labeling items for cosmetics targeted at infants and children (Article 19 (4) 8, newly inserted)

Where restricted raw materials have been used in cosmetics targeted at infants and children, require him/her to label the content of such raw materials

C. Label fragrance ingredients which cause allergies (Article 19 (6), attached Table 4, item (e) amended)

Change a provision for such labeling from a recommendation to an obligation

D. Add administrative measure standards (attached Table 7, item (e), newly inserted)

Add regulations concerning administrative measures on ‘advertising during period of suspension of advertising’ in the current administrative measure standards.

(3) Amendment Details

Partial Amendment to the Enforcement Rule of the Cosmetics Act

The Enforcement Rule of the Cosmetics Act shall be partially amended as follows.

The details of Article 15 other than the title shall be paragraph 1, and paragraphs 2 and 3 shall each be newly inserted as follows:

2. A person who intends to report on business closure according to paragraph 1 and also wishes to report on a business closure according to Article 8 (6) of the Value-Added Tax Act shall submit a Business Closure Declaration according to Form 9 of the Enforcement Rule of the Value-Added Tax Act along with the Business Closure Form according to paragraph 1. In such cases, the Regional Director of the Ministry of Food and Drug Safety shall send the Business Declaration along with the Business Closure Form to the head of the competent tax office without delay (including sending through the information network system).

3. Where the head of the competent tax office accepts the business closure under paragraph 1 according to Article 13 (5) of the Enforcement Decree of the Value-Added Tax Act, and sends it to the Regional Director of the Ministry of Food and Drug Safety, the Business Closure Form according to paragraph 1 shall be deemed to have been submitted.

Article 19 (4) 8 shall be newly inserted as follows.

8. In case of falling under any of the following items, the contents of raw materials whose standards for usage were designated and publicly announced according to Article 8 (2) of the Act:

A. Products for infants according to attached Table 3 (1), item (a); and

B. Cosmetics which intend to be labeled and advertised that such cosmetics may be used by children (no less than four (4) years of age and no more than seventeen (17) years of age).

Attached Table 4, sub-paragraph 3, item (e) shall be as follows:

 (e) Fragrance ingredients may be labeled as “flavor.” Provided, that in case there is an allergy-inducing ingredient in the components of the fragrance ingredient that have been determined and publicly announced by the Minister of Food and Drug Safety, the name of such allergy-inducing ingredient shall be stated and labeled.

Attached Table 7, sub-paragraph 1, item (f) shall be deleted; item (g) shall become item (f), item (h) shall become item (g), and item (i) shall become item (h).

Attached Table 7, sub-paragraph 2, item (e) shall be newly inserted as follows:

Violation

Related

Article

Administrative Measure Standards

First

Second

Third

Fourth

(e) Conducting business during period of business suspension

Article 24, sub-paragraph 14





1) Conducting business during period of business suspension (excluding cases where the suspension was limited to advertising)


Cancellation of registration




2) Conducting advertising during period of business suspension


Suspension of sales for three (3) months





Addenda

Article 1 (Enforcement Date)
These Rules shall enter into force one (1) year from the date of its promulgation: Provided, that the amended provisions of Article 19 and attached Table 4 shall enter into force on January 1, 2020.

Article 2 (Applicability to Reporting on Business Closure, etc., of Cosmetics Manufacturing Business, etc.)
The amended provisions of Article 15 shall apply to cases of manufacturing or manufacturing and sales businesses reporting on business closure after these rules enter into force.

Article 3 (Transitional Measures concerning Statements on Packaging of Cosmetics):
(1) Statements on packaging of cosmetics subject to the amended provisions of Article 19 and attached Table 4 at the time these Rules enter into force shall follow the former provisions. Such labeled cosmetics packaging may be used for one (1) year from the date of enforcement of this Rule notwithstanding the amended provisions of Article 19 and attached Table 4.
(2) Cosmetics packaging that contain statements and labels pursuant to the amended provisions of Article 19 and attached Table 4 may be used up to the date of enforcement after promulgation.

Article 4 (Transitional Measures concerning Administrative Measure Standards)
 Administrative measures regarding violations conducted prior to the enforcement of this Rule shall follow the former provisions notwithstanding the amended provisions of attached Table 7.


Regulatory effect assessment
  • 20180525_규제영향분석서(화장품법 시행규칙 일부개정령안)_ 수정 v.3.hwp [download]
Legislative proposal (draft)
  • 20180525_화장품법_시행규칙_일부개정령(안)_수정_v.3.2.hwp [download]