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[Updated] EU Safety Gate Alerts 1,089 Batches of Non-compliant Cosmetics in 2023, with 95.5% Containing Prohibited Ingredients

1) Most non-compliant cosmetics were notified by Italy, Hungary and Romania. 2) Perfume tops the list of non-compliant cosmetics, followed by deodorant, face and body cream, shampoo, and hairstyling product. 3) The main non-compliance reasons for the notified cosmetics include detection of prohibited ingredient, failing to meet the use condition, unqualified labelling, and risk of being contaminated.

Editor's notes: This article was originally published on July 17, 2023, and was updated on January 24, 2024, as per the latest developments.

For the purpose of effective market surveillance, the European Commission has developed the rapid alert system Safety Gate (formerly known as RAPEX) to ensure cooperation among all economic operators, online marketplace providers, and market surveillance authorities. This system enables national authorities in 30 countries (EU countries plus Iceland, Liechtenstein and Norway) to quickly exchange information and measures taken against dangerous non-food products, and thus makes member countries possible to screen their markets and take appropriate action should the same product be found in their territory. 

In 2023, EU Safety Gate circulated 1,089 alerts on non-compliant cosmetics. These cosmetics were notified by 16 countries, among which Italy ranked Top 1 with an inundatory 60%, followed by Hungary and Romania. 

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In terms of product category, perfume (44.4%) tops the list of non-compliant cosmetics, followed by deodorant (8.4%), face and body cream (6.4%), shampoo (4.7%), and hairstyling product (3.9%). 

02-non-compliant-product-categories-top-5-2.pngAmong the notified cosmetics, the primary reason for non-compliance is the detection of prohibited ingredient (95.5%). Other reasons mainly include failing to meet the use condition (2.3%), unqualified labelling (0.7%), risk of being contaminated (0.7%), and excessive concentration of heavy metal (0.3%).

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Noteworthy Compliance Requirements for the Above-mentioned Notified Cosmetics

1. Ingredient

In 2023, 95.5% non-compliant cosmetics were found containing prohibited ingredients. The ingredients detected in these alerts include:

No.

Detected Prohibited Ingredient

CAS No.

Risk

1

2-(4-tert-butylbenzyl) propionaldehyde / Butylphenyl Methylpropional (BMHCA)

80-54-6

BMHCA may harm the reproductive system and the health of unborn child. It may also cause skin sensitization.

2

Barium Peroxide

1304-29-6

Barium Peroxide releases Barium, which can be easily absorbed and has toxic effects on the body, impairing muscle as well as heart and kidney activity, and leading to arrythmia, paralysis or gastrointestinal alterations. 

3

Cloprostenol Isopropyl Ester

157283-66-4

Cloprostenol Isopropyl Ester can cause eye and ophthalmic defects, and should not be used by pregnant or breastfeeding women, as it may affect the child. It should be used under the supervision of ophthalmologist. 

4

Formaldehyde

50-00-0

Formaldehyde is a skin sensitiser that can trigger allergic reactions and may cause cancer.

5

Glucocorticoids / Corticosteroids

/

Exposure to Corticosteroids could cause skin irritation, and may lead to endocrine problems. Their application should be limited to cases where they are medically prescribed.

6

Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC or Lyral)

51414-25-6 / 31906-04-4

HICC is a skin sensitiser that triggers allergic reactions or contact dermatitis.

7

Hydroquinone

123-31-9

Hydroquinone can cause skin irritation and dermatitis.


Notes: Hydroquinone is prohibited in cosmetics with the exception of its professional use in artificial nail systems. 

8

Isobutylparaben

4247-02-3

Isobutylparaben might be toxic for reproductive development, especially for the male reproductive system.

9

Mercury

7439-97-6

Mercury can cause damage to the kidneys, brain and nervous system as it accumulates in the body. Additionally, it may affect the reproduction, and the development of unborn child.

10

N-Methyl-2-pyrrolidone / 1-methyl-2-pyrrolidone / N-Methylpyrrolidone

872-50-4

Exposure to N-Methylpyrrolidone can cause acute health effects such as headache, stomach pain, and vomiting. Prolonged or repeated contact with this substance can lead to a skin rash, blisters, dryness, and redness. 

11

Octamethylcyclotetrasiloxane (D4)

556-67-2

D4 is highly persistent and bioaccumulative. It can pose risk to aquatic life and the environment, and is suspected of being toxic to reproduction.

12

Pigment Blue 15 / CI 74160

147-14-8

Pigment Blue 15 has the potential to induce contact allergies, and may cause skin and eye irritations. It is banned for use in hair dye products. 

13

Pigment Yellow 12 / CI 21090

6358-85-6

Pigment Yellow 12 may cause eye irritation and inflammation. Prolonged or repeated contact with this substance may also lead to skin irritation. It is banned for use in hair dye products.

14

Pyrithione Zinc

13463-41-7

Pyrithione Zinc is toxic if swallowed, and causes damage to organs through prolonged or repeated exposure.

15

Sodium Perborate

15120-21-5

Sodium Perborate releases Boron, which is prohibited in cosmetic products. Ingestion or contact with an excessive quantity of Boron may harm the reproductive system or the development of unborn child. 

16

Sodium Tetraboratxe

1330-43-4

Sodium Tetraborate is irritating to eyes, skin and respiratory tract. It may also be toxic for reproduction.

2. Use condition

Among non-compliant cosmetics notified in 2023, 2.3% of them failed to meet the use conditions established in Regulation (EC) No 1223/2009 (Cosmetics Regulation). ChemLinked has sorted out the ingredients involved in these non-compliance cases, and detailed their corresponding use conditions in the table below:

No.

Ingredients

CAS No.

Use Conditions

1

2,4-Diaminophenoxyethanol

70643-19-5

2,4-Diaminophenoxyethanol can be used in products intended for colouring eyelashes, or as a hair dye substance in oxidative hair dye products. After mixed under oxidative conditions, its concentration applied to hair or eyelashes must not exceed 2% as hydrochloride.

2

Acid Black 1 / CI 20470 

1064-48-8

When Acid Black 1 is used as a hair dye substance in non-oxidative hair dye products, its maximum concentration applied to hair must not exceed 0.5%.

3

Hydrogen Peroxide

7722-84-1

The maximum concentration of Hydrogen Peroxide in cosmetics is:
a. Hair products: 12% of H2O2 (40 volumes), present or released;  
b. Skin products: 4% of H2O2, present or released;
c. Nail hardening products: 2% of H2O2, present or released;
d. Oral products, including mouth rinse, toothpaste and tooth whitening or   bleaching products: 0.1% of H2O2, present or released;
e. Tooth whitening or bleaching products (only sold to dental practitioners): > 0.1% and
6% of H2O2, present or released;
f. Products intended for eyelashes: 2% of H2O2, present or released.

4

Kojic Acid

501-30-4

When Kojic Acid is used as a skin lightening agent in cosmetics, its maximum concentration shall not exceed 1%. 

5

m-Aminophenol

591-27-5

m-Aminophenol can be used in products intended for colouring eyelashes, or as a hair dye substance in oxidative hair dye products. After mixed under oxidative conditions, its concentration applied to hair or eyelashes must not exceed 1.2%.

6

Methylchloroisothiazolinone   (MCI) and Methylisothiazolinone (MI)

26172-55-4,   2682-20-4

MCI and MI can be used only in rinse-off products.

7

Phenyl Methyl Pyrazolone

89-25-8

When Phenyl Methyl Pyrazolone is used as a hair dye substance in oxidative hair dye products, after mixed under oxidative conditions, its concentration applied to hair must not exceed 0.25%.

8

p-Phenylenediamine (PPD)

106-50-3

When p-Phenylenediamine is used as a hair dye substance in oxidative hair dye products, after mixed under oxidative conditions, its maximum concentration applied to hair must not exceed 2% calculated as free base.

9

Resorcinol

 108-46-3

The maximum concentration of Kojic Acid in cosmetics is:
a. Hair dye substance in oxidative hair dye products: 1.25%
b. Products intended for colouring eyelashes (for professional use only): 1.25%
c. Hair lotions and shampoos: 0.5%. 

10

Salicylic Acid

69-72-7

The maximum concentration of Salicylic Acid in cosmetics is:
a. Rinse-off hair products: 3%;
b. Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant: 0.5%;
c. Other products: 2%. 

3. Labelling

Fragrance substances are organic compounds widely used in perfumes and other perfumed cosmetics. For sensitive consumers, their presence may trigger allergy symptoms, even at a much lower concentration than the maximum permitted levels. In order to ensure cosmetic's safe use, the Cosmetics Regulation stipulates that, the presence of the fragrance allergen shall be indicated in the ingredients list when its concentrations exceed 0.01% in rinse-off products and 0.001% in leave-on products.

In 2023, nine fragrance allergens were detected in cosmetics that failed to comply with the above labelling requirement. These allergens are Amyl Cinnamal (CAS No. 122-40-7), Benzyl Alcohol (CAS No. 100-51-6), Benzyl Benzoate (CAS No. 120-51-4), Benzyl Salicylate (CAS No. 118-58-1), Citral (CAS No. 5392-40-5), Citronellol (CAS No. 106-22-9 / 26489-01-0), Coumarin (CAS No. 91-64-5), Linalool (CAS No. 78-70-6), Hexyl Cinnamal (CAS No. 101-86-0). 

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