Microplastics in cosmetics: plastics we use in our daily life eventually end up in the environment where they stay for centuries and degrade into smaller and smaller pieces. These small pieces (typically smaller than 5 mm) are called microplastics. Microplastics can be added to cosmetic products for specific purposes, such as exfoliating beads in facial or body scrubs (microbeads) or decorative glitters in make-up products.

Further to ECHA’s – the European Chemical Agency- evaluation, a restriction of use of synthetic polymer microparticles (aka microplastics), the COMMISSION REGULATION (EU) 2023/2055, has been officially published on September 27^th, 2023.

Microplastics in cosmetics restriction

Microplastics under the scope of this regulation are solid synthetic polymers microparticles which fulfil the following conditions:

• They form particles; or are contained in particles and constitute at least 1 % by weight of those particles; or build a continuous surface coating on particles
• Dimensions criteria:
  • All dimensions are 5 mm maximum and 0.1 µm minimum
  • OR (for fibers) the length is maximum 15 mm and minimum 0.3 µm and the ratio length/diameter is greater than 3
• They DO NOT result from a polymerization process that has taken place in nature
• They ARE NOT biodegradable
• They have a water solubility below 2g/L
• They contain at least a carbon atom in their chemical structure

Solid synthetic polymers microparticles that fall under this definition shall not be placed on the market as substances on their own, or in a concentration equal to or greater than 0.01 % by weight, as of October 17^th, 2023.

There are exceptions and transition periods. This regulation also comes with labelling obligations and reporting requirements.

Microplastics in cosmetics exceptions

Exception means that even though a material qualifies as a microplastic, the restriction would not apply.

4a derogation

The restriction does not apply to the placing on the market of synthetic polymer microparticles, as substances on their own or in mixtures, for use at industrial sites. This is the so-called “4a derogation”.

5b derogation

There are several other exceptions but only one is relevant to the cosmetic sector: the so-called “5b derogation”.

This “5b derogation” states that the restriction shall not apply to the placing on the market of synthetic polymer microparticles the physical properties of which are permanently modified during intended end use in such a way that the polymer no longer falls within the scope of this regulation (see above).

In practice, it means that the microparticle no longer fulfill size criteria or solid-state criteria. This provision would derogate film-forming functions of microplastics in cosmetic products since the microplastic particles cease to exist at the point of use: e.g. they ‘dissolve’, ‘merge’ or permanently ‘swell’ in contact with water to such an extent that they can no longer be considered to be particles as they have lost their interface or do not fulfil size dimensions criteria (too big or too small).

It is worth noticing that a permanent modification is necessary to quality for this derogation.

It is largely under the responsibility of raw material suppliers and product manufacturers to provide this information.

Substantiating the derogation 5b via appropriate testing and reasoning is definitely the tricky point of this regulation. In the absence of Commission’s guidelines to clarify how this derogation can be adequately justified, the responsibility falls on the industry to explore and identify suitable solutions. Biorius understands this constraint and is definitely a good partner to contact for any questions that you may have on this topic.”

Microplastics in cosmetics Labelling Obligations

Products subject to 5b derogation

From 17 October 2025, suppliers of products containing synthetic polymer microparticles that qualify for the 5b derogation shall provide instructions for use and disposal explaining to professional users and the general public how to prevent releases of synthetic polymer microparticles to the environment.

It is important to distinguish 2 cases:

• The microparticles that lost their microplastic characteristics (according to 5b) when formulating the product (e.g.: viscosity agent, gel forming). A such product does not require to be labelled.
• The microparticles present in the cosmetic formula, but which lose their microplastic characteristics during their use by the consumer (e.g.: hair fixing sprays). A such product requires labelling.

These instructions for use and disposal shall be provided in the form of clearly visible, legible and indelible text or in the form of pictograms.

The text or pictograms shall be placed on the label, the packaging, or the package leaflet of the products containing synthetic polymer microparticles.

In case instructions are provided in the form of a text, they shall be in the official languages of the Member States where the substance or mixture is placed on the market.

General labelling obligations

From 17 October 2031, lip products, nail products, and make-up products containing synthetic polymer microparticles shall provide the following statement: “This product contains microplastics.”

Products placed on the market before 17 October 2031 must bear this statement at latest on december 17^th, 2031.

Reporting Obligations for cosmetics

From 2027, industrial downstream users using synthetic polymer microparticles at industrial sites (located in the EU) are subject to annual reporting obligations in accordance with Article 111 of the REACH Regulation (EC No 1907/2006). The following information shall be submitted to ECHA by 31 May of each year, for each use of synthetic polymer microparticles:

• A description of the use(s) of microplastic in the previous calendar year,
• For each use, generic information on the identity of the polymer(s) used,
• For each use, an estimate of the quantity of microplastics released to the environment in the previous calendar year.
• A reference to the derogation 4a

Furthermore, from 2027, any company placing on the market for the first time a product containing microplastic eligible to “5b Derogation”, shall submit to ECHA, by 31 May of each year, for each use of synthetic polymer microparticles:

• A description of the intended end use(s) for which the microplastic were placed on the market in the previous calendar year,
• For each intended end use, generic information on the identity of the polymer(s) placed on the market,
• For each intended end use, an estimate of the quantity of microplastics released to the environment, including during transportation, in the previous calendar year,
• A reference to the derogation 5a

Transition periods and deadlines

Transition periods are granted for some microplastics used in cosmetics but there is no transition period for microbeads (to exfoliate, polish or clean). Microbeads contained in rinse-off products, lip products, nail products, and make-up products, will get banned as soon as the Regulation is enforced, i.e. October 17^th, 2023.

The impact of this immediate ban of microbeads is expected to be limited considering that microbeads were already banned in numerous countries within the EU (e.g. microbeads are banned since 2018 in France in rinse-off products).

Summary of transition period for cosmetics

• October 17^th, 2023: Ban of microbeads to exfoliate, polish or clean in rinse-off products, in lip products, in nail products, and in make-up products
• October 17^th, 2027: ban of every microplastics in rinse-off products
• October 17^th, 2035: ban of every microplastics in lip products, nail products, and make-up products
• October 17^th, 2029: ban of every microplastics in any other cosmetic products and for fragrance encapsulation

Below a summary of deadlines for labelling and reporting requirements:

• October 17^th, 2025: product subject to 5b derogation must provide instructions for use and disposal
• May 31^st, 2027: reporting requirements for
  • industrial site using microplastics eligible to derogation 4a
  • product containing microplastics eligible to derogation 5b
• October 17^th, 2031: lip, nail, and make-up products shall bear “This product contains microplastics”

Already today, we recommend that you contact the manufacturers of your products and/or raw material suppliers and check with them whether the synthetic polymers microparticles used in your products fall into the scope of this regulation.

Non exhaustive list of polymers that may qualify as microplastics and possibly subject to restriction