Exfoliating acids and peels

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• Corrective measures where a product placed on the market is not in conformity

  “Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.”

• Notify Competent national authorities of the Member States in which the product was made available and of the Member State where the product information file is readily accessible: notification of authorities where the product presents a risk to human health

  “Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States …”

• Manufacture must follow good manufacturing practice

  “The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article …”

• Get a cosmetic product safety report (CPSR) from a qualified safety assessor before the first sale

  “the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.”

• Have the safety assessment done by a qualified assessor (a diploma in pharmacy, toxicology, medicine or a similar discipline)

  “shall be carried out by a person in possession of a diploma or other evidence of formal qualifications …”

• Hold a declaration: product information file, kept for ten years after the last batch was placed on the market, containing the product description, the safety report (Art. 10(1)), the manufacturing method and GMP statement, proof of the claimed effect where justified, and animal-testing data (Art. 11(2))

  “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it.”

• Disclose: PIF accessible to authority at address on label, in understandable language

  “The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.”

• Notify the product in the EU Cosmetic Products Notification Portal (CPNP) before placing it on the market

  “Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission: …”

• Add the original label, and a photo of the packaging where legible, to the CPNP notification

  “the responsible person shall notify to the Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging …”

• Notify European Commission (CPNP): update of notified information when it changes

  “Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay.”

• Disclose: public access to composition and undesirable effect data

  “the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects …”

• Notify Competent authority of the Member State where the serious undesirable effect occurred: notify serious undesirable effects

  “In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred: …”

• 2351 more rules found in this law.

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• Corrective measures where a product placed on the market is not in conformity

  “Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.”

• Notify Competent authorities: notification of authorities where the product presents a risk to human health

  “Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent …”

• Good manufacturing practice

  “The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article …”

• Get a cosmetic product safety report (CPSR) from a qualified safety assessor before the first sale

  “In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.”

• Have the safety assessment done by a qualified assessor (a diploma in pharmacy, toxicology, medicine or a similar discipline)

  “shall be carried out by a person in possession of a diploma or other evidence of formal qualifications …”

• Hold a declaration: product information file (product description, safety report, manufacturing method and GMP statement, proof of claimed effect where justified, animal testing data), kept ten years after the last batch placed on the market, readily accessible to the competent authority at the address notified under Art. 13, contents in English

  “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.”

• Disclose: make the product information file readily accessible at the address notified under Article 13, in English

  “The responsible person must make the product information file readily accessible to a competent authority in an electronic or other format …”

• Keep the product information file in English

  “The information contained in the product information file must be in English.”

• Notify the product to the Secretary of State on the Submit Cosmetic Product Notification service (SCPN) before placing it on the market

  “Before placing a cosmetic product on the market, the responsible person must submit by electronic means the following information to the Secretary of State— …”

• Add the original label and a photo of the packaging to the SCPN notification

  “When a cosmetic product is placed on the market, the responsible person must notify to the Secretary of State the original labelling and, where reasonably legible, a photograph of the corresponding packaging …”

• Notify Secretary of State (SCPN): update of SCPN information when it changes

  “Where any information provided under this Article in relation to a cosmetic product changes, the responsible person must provide an update by electronic means to the Secretary of State without delay.”

• Cosmetic claims comply with the common criteria of Commission Regulation (EU) 655/2013

  “A responsible person must ensure that the wording of any claim in relation to a cosmetic product is in compliance with the common criteria set out in the Annex to Commission Regulation (EU) No 655/2013 …”

• 2282 more rules found in this law.

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• Label: labelling information in English

  “A responsible person must not make a cosmetic product available on the market unless the information required by paragraphs (1)(b) to (d), (1)(f) and (2) to (4) of Article 19 of the EU Cosmetics Regulation is provided in English, whether or not it is also in another language.”

• Label: labelling of products not pre-packaged or packaged at the point of sale at the purchaser's request

  “Where cosmetic products are not pre-packaged, or are packaged at the point of sale at the purchaser's request, information required to be provided in accordance with Article 19(1) (which provides for labelling) of the EU Cosmetics Regulation must appear on the container in which the product is exposed for supply or on a notice in immediate proximity to that container; …”

• Label: labelling of products pre-packaged for immediate sale

  “Where cosmetic products are pre-packaged for immediate sale, the information required to be provided in accordance with Article 19(1) of the EU Cosmetics Regulation must appear on an attached label, tag, tape or card, or in an enclosed leaflet.”

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• Quality control standard of Schedule 1 and post-market safety standard of Schedule 2

  “별표 1의 품질관리기준을 준수할 것 2. 별표 2의 책임판매 후 안전관리기준을 준수할 것 …”

• Test: quality inspection of each manufacturing batch before the cosmetic is distributed

  “제조번호별로 품질검사를 철저히 한 후 유통시킬 …”

• Notify MFDS: reporting of new safety or efficacy information and adverse effects

  “제품과 관련하여 국민보건에 직접 영향을 미칠 수 있는 안전성ㆍ유효성에 관한 새로운 자료, 정보사항(화장품 사용에 의한 부작용 발생사례를 포함한다) 등을 알게 되었을 때에는 식품의약품안전처장이 정하여 고시하는 바에 따라 보고하고, 필요한 안전대책을 마련할 것 …”

• Hold a declaration: retain stability-test data for 1 year after the expiry date of the last batch for products containing 0.5 % or more of retinol, ascorbic acid, tocopherol, peroxide compounds or enzymes

  “다음 각 목의 어느 하나에 해당하는 성분을 0.5퍼센트 이상 함유하는 제품의 경우에는 해당 품목의 안정성시험 자료를 최종 제조된 제품의 사용기한이 만료되는 날부터 1년간 보존할 것 …”

• Notify MFDS through the 화장품업 단체: annual production or import results report

  “화장품책임판매업자는 지난해의 생산실적 또는 수입실적을 매년 2월 말까지 …”

• Notify MFDS: ingredient list report: before distribution and on change

  “화장품책임판매업자는 화장품의 제조과정에 사용된 원료의 목록을 화장품의 유통ㆍ판매 전까지 보고해야 한다. 보고한 목록이 변경된 경우에도 또한 같다.”

• Label: mandatory label element: Name and content of an ingredient used as part of the product name (fragrance products excepted)

  “3. 성분명을 제품 명칭의 일부로 사용한 경우 그 성분명과 함량(방향용 제품은 제외한다)”

• Label: mandatory label element: Content of human cell or tissue culture fluid where contained

  “4. 인체 세포ㆍ조직 배양액이 들어있는 경우 그 함량 …”

• Label: mandatory label element: Content of the raw material where the product is advertised as natural or organic

  “5. 화장품에 천연 또는 유기농으로 표시ㆍ광고하려는 경우에는 원료의 함량 …”

• Label: mandatory label element: Marking in legible Korean (Hangul); Chinese characters or foreign words may be added

  “1. 한글로 읽기 쉽도록 기재ㆍ표시할 …”

• Label: mandatory label element: Ingredient names as standardised general names

  “2. 화장품의 성분을 표시하는 경우에는 표준화된 일반명을 사용할 것 …”

• Warning: Precaution statement (Schedule 3)

  “화장품 사용 시 또는 사용 후 직사광선에 의하여 사용부위가 붉은 반점, 부어 오름 또는 가려움증 등의 이상 증상이나 부작용이 있는 경우에는 전문의 등과 상담할 것 …”

• 19 more rules found in this law.

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• Register with the MFDS as a cosmetics manufacturer or responsible seller (화장품책임판매업) before selling

  “① 화장품제조업 또는 화장품책임판매업을 하려는 자는 각각 총리령으로 정하는 바에 따라 식품의약품안전처장에게 등록하여야 한다.”

• Hold a declaration: 책임판매관리자 (responsible sales manager) appointed and quality/post-market safety management standards met

  이를 관리할 수 있는 관리자(이하 "책임판매관리자"라 한다)를 두어야 한다.

• Notify MFDS: report of ingredient list to MFDS before distribution

  “화장품책임판매업자는 총리령으로 정하는 바에 따라 화장품의 생산실적 또는 수입실적, 화장품의 제조과정에 사용된 원료의 목록 등을 식품의약품안전처장에게 보고하여야 한다. 이 경우 원료의 목록에 관한 보고는 화장품의 유통ㆍ판매 전에 하여야 한다.”

• Recall of harmful cosmetics

  “지체 없이 해당 화장품을 회수하거나 회수하는 데에 필요한 조치를 하여야 한다 …”

• Notify MFDS: recall of hazardous cosmetics on the market

  “회수계획을 식품의약품안전처장에게 미리 보고하여야 한다.”

• Hold a declaration: 화장품 안전성 평가 자료 (product safety data reviewed by a qualified assessor, kept on file)

  “화장품의 유통ㆍ판매 전에 제품별로 화장품이 안전함을 입증할 수 있는 자료 …”

• Hold a declaration: 화장품 안전성 평가 자료 (product safety data reviewed by a qualified assessor, kept on file)

  “화장품의 유통ㆍ판매 전에 제품별로 화장품이 안전함을 입증할 수 있는 자료 …”

• Hold a declaration: 화장품 안전성 평가 자료 (product safety data reviewed by a qualified assessor, kept on file)

  “화장품의 유통ㆍ판매 전에 제품별로 화장품이 안전함을 입증할 수 있는 자료 …”

• Label: mandatory label element on outer and primary packaging: Name, operator name, batch number and expiry/PAO on the primary pack of a primary+secondary pack

  “1. 화장품의 명칭 2. 영업자의 상호 3. 제조번호 4. 사용기한 또는 개봉 후 사용기간 …”

• Label: mandatory label element on outer and primary packaging: Price (가격)

  소비자에게 화장품을 직접 판매하는 자(이하 "판매자"라 한다)가 판매하려는 가격을 표시하여야 한다 …

• No labelling or advertising that is false or likely to deceive or mislead consumers

  “4. 그 밖에 사실과 다르게 소비자를 속이거나 소비자가 잘못 인식하도록 할 우려가 있는 표시 또는 광고 …”

• Hold a declaration: evidence substantiating factual claims in labelling and advertising, submitted to the MFDS within 15 days of request

  “영업자 및 판매자는 자기가 행한 표시ㆍ광고 중 사실과 관련한 사항에 대하여는 이를 실증할 수 있어야 한다.”

• 26 more rules found in this law.

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• Must not contain (+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate

  “(+/-)-테트라하이드로풀푸릴; 119738-06-6 …”

• Must not contain Cantharidine

  “(1R,2S)-헥사히드로-1,2-디메칠-3,6-에; 56-25-7 …”

• Must not contain Endrin

  “(1R,4S,5R,8S)-1,2,3,4,10,10-헥사클로로; 72-20-8 …”

• Must not contain (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene (isodrin-ISO)

  “(1R,4S,5R,8S)-1,2,3,4,10,10-헥사클로로; 465-73-6 …”

• Must not contain 아세틸콜린 요오드

  “(2-아세톡시에칠)트리메칠암모늄히드; 51-84-3; 아세틸콜린 …”

• Must not contain (2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts

  “(2-아세톡시에칠)트리메칠암모늄히드; 51-84-3; 아세틸콜린 …”

• Must not contain 아세틸콜린 클로라이드

  “(2-아세톡시에칠)트리메칠암모늄히드; 51-84-3; 아세틸콜린 …”

• Must not contain 아세틸콜린 브로마이드

  “(2-아세톡시에칠)트리메칠암모늄히드; 51-84-3; 아세틸콜린 …”

• Must not contain 아세틸콜린퍼클로레이트

  “(2-아세톡시에칠)트리메칠암모늄히드; 51-84-3; 아세틸콜린 …”

• Must not contain (2-Isopropylpent4-enoyl)urea (apronalide)

  “(2-이소프로필펜트-4-에노일)우레아; 528-92-7 …”

• Must not contain (2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-ylmethyl]oxirane; Epoxiconazole

  “(2RS,3RS)-3-(2-클로로페닐)-2-(4-플; 133855-98-8 …”

• Must not contain (3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone

  “(3-클로로페닐)-(4-메톡시-3-니트로페; 66938-41-8 …”

• 1936 more rules found in this law.