Skincare Regulations in the European Union

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Skincare Regulations in the European Union

This guide covers requirements for skincare products, such as body lotion and soap. While we mainly focus on the Cosmetic Products Regulation and how it relates to skin care products, we also cover other relevant regulations, that is the REACH Regulation, the POPs Regulation, and Commission Decision (EU) 2021/1870.

Methodology: We list examples of skincare products provided in Annexes II to V of the Cosmetic Products Regulation. Also, we list examples of restricted substances from the following sources:

a. Annex II of the Cosmetic Products Regulation

b. Annex III to V of the Cosmetic Products Regulation (only substances for which skincare products are specifically mentioned)

c. Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products (only substances for skincare care products are specifically mentioned)


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Cosmetic Products Regulation

Examples of skincare products

The Preamble to Annexes II to VI of the Cosmetic Products Regulation lists the definitions for various types of cosmetics. Here we list the definitions that are relevant for skincare products:

a. Rinse-off products – Cosmetic products meant for removal after application on the hair, skin, or mucous membranes.

b. Leave-on skin products – Cosmetic products meant to remain in contact with the hair, skin, or mucous membranes for a long time.

c. Skin products – Cosmetic products meant for application on the skin.

We also list several examples of skincare products, taken from Annexes III–V of the regulation:

  • Soap
  • Callosity softener/remover
  • Rinse-off products
  • Leave-on products
  • Anti-perspirants
  • Body lotion
  • Depilatories

Prohibited substances in skincare products

Annex II of the regulation lists substances banned from use in cosmetic products. This prohibition is not unique to skincare products. Some substances are prohibited when specifically used in hair products, for instance. Note that we could not find substances specifically banned from use in skincare products.

Here we list some examples of prohibited substances from Annex II:

  • N-(5-Chlorobenzoxazol-2-yl)acetamide
  • (2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts
  • Deanol aceglumate (INN)
  • Spironolactone (INN)
  • [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid (Tiratricol (INN)) and its salts

Restricted substances in skincare products

Annex III contains substances subject to certain restrictions. We list below a few examples of restricted substances relevant to skincare products, and some of the conditions for restrictions. Note that additional conditions might exist, and are available in the regulations

Substance Product type / Body parts Maximum concentration / Other restrictions Warnings / Conditions of use

Hydrogen peroxide

Skin products

4 % of H2O2, present or released

Contains hydrogen peroxide

Avoid contact with eyes

Rinse immediately if product comes into contact with them.

Aluminium zirconium chloride hydroxide complexes

Anti-perspirants

20 % (as anhydrous aluminium zirconium chloride hydroxide)

5.4 % (as zirconium)

Do not apply to irritated or damaged skin

Benzoic acid, 2-hydroxy-

Body lotion

0.5 %

Not to be used for children under 3 years of age

(1-Hydroxyethylidene-diphosphonic acid) and its salts

Soap

0.2 % (as etidronic acid)

N/A

Allowed colorants in skincare products

Annex IV contains substances permitted for use in colorants in cosmetic products. Here are a few examples of such substances relevant to skincare products, and some of the conditions for restrictions.

Substance Product type / Body parts Maximum concentration / Other restrictions Warnings / Conditions of use

Sodium tris(1,2-naphthoquinone 1-oximato-O,O’)ferrate(1-)

Rinse-off products

N/A

N/A

2,4-Dihydro-5-methyl-2-phenyl-4-(phenylazo)-3H-pyrazol-3-one

Rinse-off products

N/A

N/A

N,N’-(3,3′-Dimethyl[1,1′-biphenyl]-4,4′-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide]

Rinse-off products

Maximum 3,3′-dimethylbenzidine concentration in the colouring agent: 5 ppm

N/A

Hydrogen 9-[(3-methoxyphenyl)amino]-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, sodium salt

Rinse-off products

N/A

N/A

Allowed preservatives in skincare products

Annex V contains a list of substances permitted for use as preservatives in cosmetic products. We list below some examples of substances relevant to skincare products, and examples of the conditions for restrictions.

Substance Product type / Body part Maximum concentration / Other restrictions Warnings / Conditions of use

Benzoic acid and its sodium salt

Rinse-off products

2.5 % (acid)

N/A

Biphenyl-2-ol

Leave-on products

0.15 % (as phenol)

N/A

5-Bromo-5-nitro-1,3-dioxane

Rinse-off-products

0.1 %

Avoid formation of nitrosamines

N/A

3-Iodo-2-propynylbutylcarbamate

Leave-on products

0.01 %

Not to be used in body lotion and body cream

Not to be used for children under 3 years of age

Allowed UV filters in skincare products

UV filters are substances meant to protect the skin from specific types of UV radiation by either reflecting, scattering, or absorbing it. Annex VI of the regulation contains substances that are permitted for use in UV filters in cosmetic products. Here are a few examples of such substances.

Substance Product type / Body parts Maximum concentration / Other restrictions Warnings / Conditions of use

Benzoic acid, 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester/Homosalate

Face products

7.34 %

N/A

2-Hydroxy-4-methoxy-benzophenone/Oxybenzone

Face products, hand products, and lip products

6 %

(Not more than 0,5 % to protect product formulation)

Contains Benzophenone-3

2-Hydroxy-4-methoxy-benzophenone/Oxybenzone

Body products

2.2 %

(Not more than 0,5 % to protect product formulation)

Contains Benzophenone-3

2-Cyano-3,3-diphenyl acrylic acid, 2- ethylhexyl ester/Octocrylene

Propellant spray products

9 %

N/A

Titanium dioxide

Face products (containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide)

25 % (Only in the pigmentary form)

Not to be used on the lips

 CRM substance restrictions

The regulation prohibits category 1A or 1B carcinogenic, mutagenic, and reprotoxic (CMR) substances, which can be found in Annex VI Part 3 of CLP Regulation. Here we list some of these substances:

a. mepanipyrim; 4-methyl-N-phenyl-6-(1-propynyl)-2-pyrimidinamine

b. hydroxylammonium hydrogensulfate; hydroxylamine sulfate (1:1)

c. (6R-trans)-1-((7-ammonio-2-carboxylato-8-oxo-5-thia1-azabicyclo-[4.2.0]oct-2-en-3-yl)methyl)pyridinium iodide

d. forchlorfenuron (ISO); 1-(2-chloro-4-pyridyl)-3-phenylurea

Keep in mind that the above substances only serves as examples, and are not specific for skincare products.

Nanomaterials

Nanomaterials are often used in skincare products to treat disorders such as acne and atopic dermatitis. Article 16 of the regulation sets notification requirements for nanomaterials.

The notification must include a list of required information, such as the nanomaterial’s toxicological profile.

Other requirements

Here are several other requirements that generally apply to products covered by the Cosmetic Products Regulation:

  • Safety assessment
  • Product information file
  • Notification
  • Labelling
  • Product claims
  • Cosmetic product safety report
  • Testing

Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products

This regulation restricts the use of several substances in leave-on cosmetics and rinse-off cosmetics. It lists numerous substances that are prohibited in the final product. Here are some of them:

REACH

The REACH Regulation covers some substances and mixtures that are used in cosmetics. We list below a few substances relevant to skincare products.

Substance Type of restriction Restriction Product type

Microplastics

Annex XVII

0.01% by weight

For leave-on and rinse-off cosmetics

Decamethylcyclopentasiloxane

Annex XVII / SVHC

0.1% by weight

For wash-off cosmetics

Octamethylcyclotetrasiloxane

Annex XVII / SVHC

0.1% by weight

For wash-off cosmetics

POP Regulation

The POPs Regulation prohibits persistent organic pollutants in mixtures and articles, including skin care products. Some POPs can be found in skin care products as they help to smooth the skin. Here are some examples:

  • Dieldrin
  • Endrin
  • Heptachlor
  • Toxaphene
  • (USA & EU)

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    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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