Microplastics Regulation: a regulatory turning point for the cosmetics industry in Europe
Microplastics at the heart of environmental and regulatory concerns
Microplastics, these tiny but persistent particles, are a major concern.
environmental and health. Used in cosmetic products for their properties
functional (exfoliating, film-forming, or even to improve texture), they are now targeted
by ambitious European regulations aimed at limiting their dispersion in the environment.
Their accumulation in soil, aquatic environments, and even in the food chain is a cause for concern.
increasingly. Recent studies highlight their potentially harmful effects on wildlife, as well as
emerging risks to human health.
Faced with these challenges, the European Union has launched a structured response. While some Member States
had already taken individual measures, the European Commission wanted to harmonize these
initiatives. It has mandated the European Chemicals Agency (ECHA) to propose a
restriction based on robust scientific data. Regulation (EU) 2023/2055 is the
result.
Scope and definition of microplastics
ECHA defines microplastics as particles smaller than or equal to 5 mm in size, containing a solid polymer, with or without additives.
On this basis, Regulation (EU) 2023/2055 restricts the intentional use of microparticles.
of synthetic polymers (MPS) in products placed on the European market, above a threshold of
concentration of 0.01% by mass. This restriction came into effect on October 17.
2023 following publication of the regulation.
The regulatory definition of microplastics is based on several criteria: particle size,
mass percentage, nature of the polymer. A polymer is considered an MPS if it cumulatively meets these three conditions:
1. Polymers must be both:
- Solids; and
- Either synthetic polymers or chemically modified natural polymers; and
- Organic (i.e., containing carbon atoms anywhere in their structure),
and - Non-degradable, when tested in accordance with Appendix 15 of Annex XVII of
REACH; and - «Insoluble,» meaning that they do not have a solubility greater than 2 g/L when they
are tested in accordance with Appendix 16 of Annex XVII of REACH
2. Polymers must meet one of the following two criteria:
- Be present in particles at a concentration greater than or equal to 1% by weight
(i.e., the weight of the polymer(s) represents between 1% and 100% of the total weight of
the particle that contains them); or - Form a continuous coating around particles (including those with a liquid core, such as
vesicles). In this case, no concentration limit applies. The coating must
be continuous, i.e., it cannot consist of isolated areas of polymers that do not
do not touch each other. However, it is not necessary for this coating to cover the entire surface.
Surface: the presence of small gaps in the coating is tolerated.
3. At least 1% by weight of the particles containing or coated with solid polymers must
measure 5 mm or less in all dimensions. Certain polymer particles
synthetic fiber types have a length greater than 5 mm but less than 15 mm. Being
Given that these fiber-like particles are highly persistent and contribute to the identified risk,
Annex XV considered that they should be included in the scope of
the restriction.
A polymer (or combination of polymers) that meets the three conditions above is a
MPS. If it does not meet one or more of these three conditions, it is not an MPS and is therefore not
affected by the restriction.
Certain substances are excluded from this definition, including soluble polymers or
biodegradable, or are subject to exemptions provided for in specific cases:
- MPS used exclusively on industrial sites; ;
- MPS used in specific contexts covered by other regulations such as
in medicines, fertilizers, medical devices, or even in
food additives, among other things; ; - MPS encapsulated so as not to be released into the environment; ;
- Those whose properties are permanently altered before the end of the product's life; ;
- Those irreversibly integrated into a solid matrix.
Identification scheme for MPS subject to restrictions under Regulation (EU) 2023/2055 (Scheme extracted from the published guide) by the European Commission – Explanatory Guide 2025)
This decision tree guides operators in assessing the presence and possible restriction of synthetic polymer microparticles (SPM) in substances or mixtures placed on the market. It is based on a three-tiered approach (Tier 1 to Tier 3) to determine:
- If the polymers present meet the regulatory definition of SPM,
- If their concentration exceeds the regulatory threshold of 0.01% by mass,
- And if restrictions apply.
References to other figures or sections of the regulation facilitate detailed interpretation of the evaluation criteria.
Implementation schedule
In order to allow the industry sufficient time to adapt, differentiated transition periods
have been defined according to product categories:
- Since July 1, 2018: Microbeads are prohibited in rinse-off products.
- By October 17, 2027: End of the transition period for all rinsed products.
- By October 17, 2029: End of the transition period for non-rinsed products and
encapsulated fragrances. - By October 17, 2035: End of the transition period for makeup products,
lip and nail products.
Certain specific uses, such as encapsulated fragrances or glitter (made of plastic and aluminum), benefit from extended deadlines, given the lack of viable alternatives to date.
Accountability and transparency
Starting October 17, 2025, suppliers of synthetic polymer microparticles intended for
be used on industrial sites, must provide the following information:
- Instructions for use and disposal intended for downstream industrial users, in order to
explain to them how to limit the release of synthetic polymer microparticles into
the environment; ; - The following statement: «The synthetic polymer microparticles provided are
subject to the conditions set out in entry 78 of Annex XVII to Regulation (EC) No. 1907/2006
of the European Parliament and of the Council.» - Information on the quantity or, if applicable, the concentration of microparticles of
synthetic polymers present in the substance or mixture; ; - Generic information on the identity of polymers contained in the substance or
mixture, allowing manufacturers, downstream industrial users, and others
suppliers to comply with their obligations.
Furthermore, as of October 17, 2025, suppliers of food additives containing MPS and
products in which MPS remain confined (e.g., in a solid matrix) must all
provide instructions for use and disposal to professional users and the
general public, in order to prevent the release of synthetic polymer microparticles into
the environment.
The same will apply from October 17, 2026, for suppliers of in vitro diagnostic devices.
These instructions must be available in the official languages of the countries where the products are sold.
marketed, and also available in digital format.
Between October 17, 2031, and October 16, 2035, lip, nail, and makeup products
must bear the statement: «This product contains microplastics,» except for those placed on the market
before that date.
Reporting requirements for exempt industrial uses
For industrial uses benefiting from exemptions, specific reporting obligations are
introduced. They must provide the following information:
- Description of the uses concerned,
- Identification of polymers used,
- Estimated quantities of MPS released into the environment.
Supply chain actors subject to this obligation will have to submit to ECHA,
before May 31 of each year, the estimated emissions of MPS related to the use of these substances
or products.
This requirement aims to assess the effectiveness of the utilization and disposal measures put in place for
exemptions, as well as the restriction as a whole. The data collected will be
centralized by ECHA, then forwarded to Member States and the European Commission, in order to
to identify:
- Uses requiring enhanced risk management; ;
- Those for which emissions decrease significantly over time.
A defining step towards a more sustainable industry
The gradual ban on intentional microplastics marks an important step in the European Union's environmental policy. It is pushing the cosmetics industry to adapt its practices, develop more sustainable alternatives, and increase transparency towards consumers.
consumers.
And what about Lelégard Laboratories in all this?
At Lelégard Laboratories, we use compliance as a differentiator. Our team
Our team of experts supports you every step of the way to anticipate and smoothly integrate the requirements of the
Regulation (EU) 2023/2055: analysis of your formulas, identification of the substances concerned,
evaluation of exemptions, labeling information, reporting to ECHA, etc.
Our goal? To help you turn this regulatory constraint into opportunity for innovation,
transparency and promotion of your environmental commitments.
Save time,
Secure your product launches,
And make compliance a strategic asset for your brand.
