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SAMR Uncovers 27 Non-Compliant Cosmetic Products

  •   3 Aug 2018
  •    Hedy He
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    Takehome:

    The major reasons for cosmetic inspection failure are the use of banned ingredients, inconsistencies between cosmetic ingredients, labels and administrative license and false production date.

    On Jul 18, Jul 20 and Aug 1, 2018, SAMR released 3 announcements detailing data derived from a national cosmetic market sampling and inspection program. A total of 27 cosmetic products were found unqualified. Acne products, sunscreens and hair dyes accounted for the majority of inspection failures. Reasons for inspection failures mainly included the use of banned ingredients, inconsistencies between cosmetic ingredients, labels and administrative license and false production date. The following table shows details:

    No.

    Product

    Subject

    Inspection Result

    Problem

    1

    Aloe acne cream

    Miconazole

    0.51μg/g

    Detection of banned ingredients

    Griseofulvin

    1.02μg/g

    2

    Acne clean lotion

    Ofloxacin

    17.3μg/g

    3

    Anti-acne cream

    Metronidazole

    6789μg/g

    4

    Acne clean essential oil

    Ofloxacin

    1684μg/g

    5

    Oil control and anti-acne cream

    Metronidazole

    4132μg/g

    Ofloxacin

    5877μg/g

    6

    Acne treatment gel

    Metronidazole

    8024μg/g

    7

    Sunscreen

    Butyl methoxydibenzoylmethane

    No detection

    Absence of butyl methoxydibenzoylmethane and octocrylene which are claimed on administrative license and labels

    Octocrylene

    8

    Sunscreen

    Butyl methoxydibenzoylmethane

    No detection

    Absence of butyl methoxydibenzoylmethane and bis-ethylhexyloxyphenol methoxyphenyl triazine which are claimed on administrative license and labels

    Bis-ethylhexyloxyphenol methoxyphenyl triazine

    9

    Sunscreen

    Bis-ethylhexyloxyphenol methoxyphenyl triazine

    0.24%

    Contain bis-ethylhexyloxyphenol methoxyphenyl triazine which is not listed on the label and administrative license

    10

    Sunscreen

    Benzophenone-3

    No detection

    Absence of benzophenone-3, 4-methylbenzylidene camphor, Butyl methoxydibenzoylmethane and Ethylhexyl salicylate which are claimed on administrative license and labels

    4-methylbenzylidene camphor

    Butyl methoxydibenzoylmethane

    Ethylhexyl salicylate

    11

    Sunscreen

    Butyl methoxydibenzoylmethane

    No detection

    Absence of butyl methoxydibenzoylmethane and ethylhexyl methoxycinnamate which are claimed on administrative license and labels

    Ethylhexyl methoxycinnamate

    12

    Sunscreen

    Benzophenone-3

    No detection

    Absence of benzophenone-3, 4-methylbenzylidene camphor and Butyl methoxydibenzoylmethane which are claimed on administrative license and labels

    4-methylbenzylidene camphor

    Butyl methoxydibenzoylmethane

    13

    Sunscreen

    /

    /

    The production date on administrative license is inconsistent with the actual

    14

    Sunscreen

    /

    /

    15

    Sunscreen

    /

    /

    16

    Sunscreen

    /

    /

    17

    Sunscreen

    Ethylhexyl salicylate

    Detection

    Contain ethylhexyl salicylate and homosalate which is not listed on the label and administrative license

    Homosalate

    4-methylbenzylidene camphor

    No detection

    Absence of 4-methylbenzylidene camphor which is claimed on administrative license and labels

    18

    Hair dye

    M-aminophenol

    No detection

    1. The label is inconsistent with the administrative license
    2. Absence of M-aminophenol, P-phenylenediamine and Resorcinol which are claimed on administrative license and labels

    P-phenylenediamine

    Resorcinol

    19

    Hair dye

    P-phenylenediamine

    Detection

    Contain P-phenylenediamine, M-aminophenol and Resorcinol which are not listed on the label and administrative license

    M-aminophenol

    Resorcinol

    4-amino-2-hydroxytoluene

    No detection

    Absence of 4-amino-2-hydroxytoluene and 1-naphthol which are claimed on administrative license and labels

    1-naphthol

    20

    Sunscreen

    4-methylbenzylidene camphor

    2%

    1. Contain 4-methylbenzylidene camphor, butyl methoxydibenzoylmethane and ethylhexyl methoxycinnamate which are not listed on the label
    2. No approval number on product package

    Butyl methoxydibenzoylmethane

    2%

    Ethylhexyl methoxycinnamate

    4%

    21

    Sunscreen

    4-methylbenzylidene camphor

    No detection

    1. Absence of 4-methylbenzylidene camphor, butyl methoxydibenzoylmethane, octocrylene and ethylhexyl methoxycinnamate which are claimed on administrative licen
    2. The label and product name are inconsistent with administrative license

    Butyl methoxydibenzoylmethane

    Octocrylene

    Ethylhexyl methoxycinnamate

    22

    Sunscreen

    Benzophenone-3

    No detection

    1. Absence of 4-methylbenzylidene camphor, butyl methoxydibenzoylmethane, benzophenone-3 and ethylhexyl salicylate which are claimed on administrative license and labels
    2. Product name is inconsistent with administrative license

    4-methylbenzylidene camphor

    Butyl methoxydibenzoylmethane

    Ethylhexyl salicylate

    23

    Sunscreen

    Octocrylene

    No detection

    1. The label is inconsistent with administrative license
    2. Absence of octocrylene  which are claimed on labels

    24

    Sunscreen

    Ethylhexyl salicylate

    4%

    Contain ethylhexyl salicylate which is not listed on the label

    25

    Hair dye

    P-phenylenediamine

    0.013%

    Contain p-phenylenediamine which is not listed on the label

    26

    Hair dye

    4-chlororesorcinol

    0.059%

    1. Contain p-phenylenediamine which is not listed on the label

    2. Administrative license has expired

    27

    Hair dye

    M-aminophenol

    0.12%

    Contain m-aminophenol and 1-naphthol which are not listed on the label

    1-naphthol

    0.051%

    Circulation of products which violate the requirements articulated within "Regulations concerning the Hygiene Supervision over Cosmetics" and "Administrative Measures on Cosmetics Labeling (draft)" mandate that all associated distributors/retailers should immediately cease sales activities and issue an immediate recall. If the product label can be amended in such a way that the new label and ingredients comply with Chinese regulatory requirements it can be marketed again.

    Tips for Enterprises:

    1. Antibiotics are mainly secondary metabolites or synthetic analogues produced by bacteria, mold or other microorganisms, and are mainly used to treat various bacterial infections or fungal infections. Long-term exposure to antibiotic-containing cosmetics can sensitize individuals and cause contact dermatitis and antibiotic allergy, and increase the likelihood of pathogens developing resistance. Drug residues can also cause allergic reactions. Safety and Technical Standards for Cosmetics 2015 stipulates that use of antibiotics is banned in cosmetics.
    2. According to “Regulations concerning the Hygiene Supervision over Cosmetics”, acne products, sunscreens and hair dyes are special use cosmetics, which can only be manufactured after obtaining an administrative license. Any change/reformulation of ingredients has the potential to impact cosmetic safety and other indexes and requires submission of a new filing/registration application as a new product. The main problem of non-compliant acne, sunscreen and hair dye products found in this sampling inspection is that the actual detected ingredients are inconsistent with the ingredients claimed on the administrative license or labels, and violates "Regulations concerning the Hygiene Supervision over Cosmetics" and "Administrative Measures on Cosmetics Labeling (draft)".

    Annex:

    Exact Standard of Sunscreen and Hair Dyes Ingredients Mentioned in this News

    No.

    English/INCI Name

    Maximum concentration used in cosmetics

    Instruction on Labels

    1

    Butyl methoxydibenzoylmethane

    5%

    /

    2

    Octocrylene

    10% (acid)

    /

    3

    Bis-ethylhexyloxyphenol methoxyphenyl triazine

    10%

    /

    4

    Benzophenone-3

    10%

    Contains benzophenone-3

    5

    4-methylbenzylidene camphor

    4%

    /

    6

    Ethylhexyl salicylate

    5%

    /

    7

    Ethylhexyl methoxycinnamate

    10%

    /

    8

    Homosalate

    10%

    /

    9

    M-aminophenol

    1.0% ( Oxidation hair dyes)

    /

    10

    P-phenylenediamine

    2.0% ( Oxidation hair dyes)

    Contains phenylenediamins

    11

    Resorcinol

    0.5% ( Only applicable in hair lotion and shampoo)

    Contains resorcinol

    1.25% ( Oxidation hair dyes)

    12

    4-amino-2-hydroxytoluene

    1.5% ( Oxidation hair dyes)

    /

    13

    1-naphthol

    1.0% ( Oxidation hair dyes)

    Contains 1-naphthol

    14

    4-chlororesorcinol

    0.5% ( Oxidation hair dyes)

    /

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    ABOUT THE AUTHOR

    ChemLinked Editor

    Tracking regulatory change news in Asia Pacific area and focusing on cosmetic ingredient requirements, registration/filing/notification procedures of China and South Korea.

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