Last reviewed 2 October 2023
In this feature, Caroline Raine discusses the European restriction on microplastics, explaining the legal requirements and the potential impact to businesses.
Microplastics are a subgroup of polymers and have a strong political focus.
The European Chemicals Agency (ECHA) describe microplastics as: “solid plastic particles composed of mixtures of polymers and functional additives. They may also contain residual impurities. Microplastics can be unintentionally formed when larger pieces of plastic, like car tyres or synthetic textiles, wear and tear. But they are also deliberately manufactured and added to products for specific purposes, such as exfoliating beads in facial or body scrubs.”
The challenge with microplastics is that they are highly persistent in the environment, and have been found in food and drinking water, as well as our oceans. ECHA has decided to take action. Microplastics are found in cosmetics, detergents, paints, fertilisers, plant protection products, to name just a few, and even in Astroturf.
In 2017, the European Commission requested ECHA to assess the scientific evidence for taking regulatory action at the EU level on microplastics that are intentionally added to products. Then in January 2019, ECHA proposed a wide-ranging restriction on microplastics which is expected to prevent the release of 500,000 tonnes of microplastics over 20 years.
Intention to prepare restriction dossier
17 January 2018
Call for evidence
1 March–May 2018
30–31 May 2018
Submission of restriction dossier
11 January 2019
Public consultation if the Annex XV dossier
20 Match 2019–20 September 2019
Draft SEAC opinion
Consultation on draft SEAC opinion
1 July–1 September
Combined final opinion submitted to the Comission
Draft amendment to the Annex XVII (draft restriction) by Comission
30 August 2022
Discussions with Member State authorities and vote
Scrutiny by Council and European Parliament
Restriction adopted (if agreed)
Published September 2023. In force 17 October 2023
The actual restriction is very brief. There is to be a ban of placing on the market for applications where release is considered unavoidable. There are exemptions for different applications, and there are labelling and instructions for use requirements. There is also a need to do reporting to ECHA and there will be the implementation of an inventory.
The restriction prohibits placing on the market as substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0.01% by weight.
this does not apply to placing on the market of synthetic polymers microparticles, on their own or in mixtures, placed on the market before 17 October 2023.
Synthetic polymer microparticles: polymers that are solid and which fulfil both of the following conditions are:
contained in particles and constitute at least 1% by weight of those particles; or build a continuous surface coating on particles
at least 1% by weight of the particles referred to in point (a) fulfil either of the following conditions:
all dimensions of the particles are equal to or less than 5mm
the length of the particles is equal to or less than 15mm and their length to diameter ratio is greater than 3.
This does not apply to the placing on the market of the following synthetic polymer microparticles, as substances on their own or in mixtures:
synthetic polymer microparticles which are contained by technical means so that releases to the environment are prevented when used in accordance with the instructions for use during the intended end use
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 entry
synthetic polymer microparticles which are permanently incorporated into a solid matrix during intended end use.
And where the concentration of synthetic polymer microparticles cannot be determined by available analytical methods or accompanying documentation, only the particles of at least the following size shall be taken into account:
0,1μm for any dimension, for particles where all dimensions are equal to or smaller than 5mm
0,3μm in length for particles that have a length that is equal to or smaller than 15mm and a length to diameter ratio greater than 3.
Definitions are given as the following.
“Particle” means a minute piece of matter, other than single molecules, with defined physical boundaries.
“Solid” means a substance or a mixture other than liquid or gas.
“Gas” means a substance or mixture which at 50°C has a vapour pressure greater than 300kPa (absolute), or is completely gaseous at 20°C at a standard pressure of 101,3 kPa.
“liquid” means a substance or mixture that meets any of the following conditions.
The substance or mixture at 50°C has a vapour pressure of not more than 300 kPa, is not completely gaseous at 20°C and at a standard pressure of 101,3 kPa, and has a melting point or initial melting point of 20°C or less at a standard pressure of 101,3 kPa
The substance or mixture fulfils the criteria in the American Society for Testing and Materials (ASTM) D 4359-90 Standard Test Method for Determining Whether a Material Is a Liquid or a Solid.
The substance or mixture passes the fluidity test (penetrometer test) described in chapter 2.3.4 of Part 2 of Annex A to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) concluded at Geneva on 30 September 1957.
“make-up product” means any substance or mixture intended to be placed in contact with specific external parts of the human body, namely the epidermis, eye brows and eye lashes, with a view to, exclusively or mainly, changing their appearance.
The following polymers are considered exempt.
Polymers that are the result of a polymerisation process that has taken place in nature, which are not chemically modified substances.
Polymers that are degradable as proved in accordance with Appendix [X].
Polymers that have a solubility greater than 2 g/L as proved in accordance with Appendix 16.
Polymers that do not contain carbon atoms in their chemical structure.
A transitional arrangement isin place, see the table below.
Use of microplastics in
17 October 2027
rinse-off cosmetic products
17 October 2028
detergents/waxes/polishes and air care products, fertilising products outside the scope of application of Regulation (EU) 2019/1009, for products for agricultural and horticultural uses
17 October 2029
the encapsulation of fragrances, leave-on cosmetic products, medical devices within the scope of Regulation (EU) 2017/745, granular infill for use on synthetic sports surfaces
17 October 2031
in plant protection products and biocidal products
17 October 2035
in lip products, nail products and make-up
From 17 October 2025 suppliers are expected to provide instructions for use and disposal to avoid releases of synthetic polymer microparticles to the environment.
The following information must be provided.
Instructions for use and disposal to avoid releases of synthetic polymer microparticles to the environment.
The following statement: “The synthetic polymer microparticles supplied is subject to conditions laid down by entry 78 of Annex XVII to Regulation (EC) 1907/2006 of the European Parliament and of the Council”.
The information on quantity or as applicable, concentration of synthetic polymer microparticles in the substance or mixture.
Information on the identity of the polymers contained in the substance or mixture that enables manufacturers, industrial downstream users and other suppliers to comply with their obligations laid down in paragraphs 11 and 12.
From 17 October 2026 suppliers of products containing synthetic polymer microparticles and from 17 October 2025 suppliers of products containing synthetic polymer microparticles 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.
There is also a requirement for the statement “This product contains microplastics” to be added to the label, packaging and safety data sheets during the transitional period ie from 17 October 2031 until 16 October 2035. Products placed on the market before 17 October 2031 are not required to bear that statement until 17 December 2031.
Starting from 2026 manufacturers and industrial downstream users of synthetic polymer microparticles in the form of pellets, flakes, and powders used as feedstock in plastic manufacturing at industrial sites, and, starting from 2027, other manufacturers of synthetic polymer microparticles and other industrial downstream users using synthetic polymer microparticles at industrial sites shall submit the following information to the Agency by 31 May of each year.
A description of the uses of synthetic polymer microparticles in the previous calendar year.
For each use of synthetic polymer microparticles, generic information on the identity of the polymers used.
For each use of synthetic polymer microparticles, an estimate of the quantity of synthetic polymer microparticles released to the environment in the previous calendar year, which shall include also the quantity of synthetic polymer microparticles released to the environment during transportation.
For each use of synthetic polymer microparticles, a reference to the derogation laid down in paragraph 4, point (a).
From 2027, suppliers of products containing synthetic polymer microparticles referred to in paragraphs 4, points (b), (d) and (e), and paragraph 5, placed on the market for the first time to professional users and the general public, shall submit the following information to the Agency by 31 May of each year:
A description of the end uses for which the synthetic polymer microparticles were placed on the market in the previous calendar year;
for each end use for which the synthetic polymer microparticles were placed on the market, generic information on the identity of the polymers placed on the market in the previous calendar year;
for each end use for which the synthetic polymer microparticles were placed on the market, an estimate of the quantity of synthetic polymer microparticles released to the environment in the previous calendar year, which shall include also the quantity of synthetic polymer microparticles released to the environment during transportation.
For each use of synthetic polymer microparticles, a reference to the applicable derogation or derogations laid down in paragraph 4, point (b), (d) or (e), or 5 point (a), (b) or (c).
Manufacturers, importers and industrial downstream users of products containing synthetic polymer microparticles shall provide specific information on the identity of polymers covered by this entry contained in those products and the function of those polymers in the products to competent authorities upon their request.
If the information is not available to industrial downstream users, they shall request it from their supplier within seven days from the receipt of the request from the competent authorities and shall inform the authorities of the request made without delay.
Having received the request, the suppliers shall provide the requested information within 30 days to the industrial downstream user or directly to the competent authority requesting it.
Where the supplier provides the information to the industrial downstream user, the industrial downstream user shall forward that information to the competent authorities without delay. Where the supplier provides the information directly to the authority, it shall without delay inform the industrial downstream user concerned to that effect.
Manufacturers, importers and industrial downstream users of products containing polymers claimed to be excluded from the designation of synthetic polymer microparticles on grounds of degradability or solubility shall provide, without delay, information proving that those polymers are degradable in accordance with Appendix 15 or soluble in accordance with Appendix 16, as applicable, to competent authorities upon their request.
The regulation also has Appendices that contain the Rules on proving degradability and solubility.
HSE and Microplastics
In the HSE workplan for 2022/2023 the Health and Safety Executive (HSE): “also identified intentionally added microplastics in substances, mixtures and articles as a priority for investigation. Defra are therefore commissioning an evidence project to review emissions of intentionally added microplastics and the risks they pose (both to human health and the environment). The results of this evidence project will be used to inform the Government’s approach to managing intentionally added microplastics, whether through UK REACH or an alternative route.”
If your products contain microplastics then start to prepare by creating a plan to remove microplastics from your products. Be ready to update your labels and safety data sheets submit information to ECHA from 2026/2027 depending on your market use.