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Microplastics, the first restrictions in the Old Continent in a mini-reform of the REACH regulation

The European Commission has adopted the first restrictions on certain uses of microplastics, in a mini-reform of REACH (Registration, Evaluation, Authorization and restriction of Chemicals) Regulation (EC) No 1907/2006. (1)

The measures concern synthetic polymer microparticles deliberately included in some products to perform various functions. With broad exemptions and progressiveness justified by the need to 'limit disturbances' in the poisons market.

Fertilizers, pesticides and other substances intended for use in agriculture – in addition to food additives – are partly covered by the new rules, including various exemptions and long transitional periods.

1) Microplastics, environmental disaster and public health risks

Microplastic pollution it is one of the most severely under-reported environmental and public health disasters. (2) These microparticles, as seen:

– are ubiquitous in fresh water e salads, the agricultural soils e the atmosphere,

microplastics restrictions
Figure 1 – Human exposure and the path of micro- and nanoplastic particles in the human body. Maxi B. Paul, Valerie Stock,, Julia Cara-Carmona, Elisa Lisicki, Sofiya Shopova, Valérie Fessard, Albert Braeuning, Holger Sieg, Linda Böhmert. Micro- and nanoplastics – current state of knowledge with the focus on oral uptake and toxicity. Nanoscale Adv, 2020, 2, 4350-4367. doi: 10.1039/D0NA00539H

– reach humans through the air, drinking water e Foods (Eg. aquatic organisms, fruits and vegetables e other foods),

– until it reaches and deposits in human tissues (e.g. placenta, blood, lungs).

2) Microplastics, classification and sources

JRC – Joint Research Center, European Commission - includes among microplastics all solid particles (between 0,1 and 5.000 μm, in general) composed of mixtures of polymers and functional additives, often also characterized by the presence of impurities.

Microplastics they are deliberately added to various product categories (e.g. pesticides and fertilizers, materials and objects in contact with food, cosmetics), to perform specific functions, as well as resulting from the wear and tear of objects of different sizes (e.g. fabrics, tires ). (3,4)

3) European Union, mild initiatives to reduce plastic

The European Council has repeatedly urged the Commission to propose measures to reduce the dispersion of plastic residues of all forms (macro and micro) in the marine environment, including through a ban on the use of polymers in specific products such as cosmetics, hygiene products staff and cleaners. (5) From words to deeds:

– the European Commission has adopted the 'European Strategy for Plastics in the Circular Economy', within which the Single Use Plastics Directive. With some critical issues, even in the implementation phase in the Member States (e.g Italy),

– the European Court of Auditors, in relationship 'EU action to tackle plastic waste' (2020), analyzed the ineffectiveness of the measures adopted compared to the objectives set. Also with regards to the problem of microplastic pollution.

4) First restrictions on the use of microplastics in the mini-reform of the REACH regulation. Excursus

THROW (European Chemicals Agency) has published a dossier – at the request of the Commission, pursuant to the REACH regulation, Annex XV – which includes:

  • analysis of risks to the environment associated with the intentional use of microplastics,
  • risk management proposal, which includes a ban on the use of microplastics in some sectors resulting in their inevitable release into the environment,
  • impact assessment of the proposed measures, thanks to which an estimated reduction in the release of 500.000 tonnes of plastic into the environment in the twenty years following the introduction of the aforementioned ban.

The file of ECHA considered the dimensions and groups of polymers of greatest interest, excluding biodegradable or water-soluble ones as well as natural polymers that are not chemically modified, proposing standard test methods and thresholds for the evaluation of biotic degradability or solubility. Also proposing the duration of transitional periods, where deemed necessary, in the introduction of the ban on the use of plastic polymers on various product categories.

RAC and SEAC – 'Committee for Risk Assessment' and 'Committee for Socio-economic Analysis', in ECHA – then adopted opinions that partially agree with the initial dossier, proposing a series of changes. (6) The European Commission then adopted the current mini-reform of the REACH Regulation on 25 September 2023, via Regulation (EU) 2023/2055. (7)

5) Restrictions on the deliberate use of microplastics in some products, the new EU rules

Restrictions introduced in the mini-reform of the REACH regulation concern 'synthetic polymer microparticles', defined as 'solid polymers that satisfy both of the following conditions:

(a) are contained in particles and constitute at least 1% by weight of such particles, or create a continuous surface coating on the particles,

(b) at least 1% by weight of the particles referred to in point (a) meets one of the following conditions:

(i) all particle sizes are equal to or smaller than 5 mm,

ii) the length of the particles is equal to or less than 15 mm and their length/diameter ratio is greater than 3'.

However, they are excluded from this definition:

'a) polymers derived from polymerization processes that have taken place in nature, regardless of the extraction process, which are not chemically modified substances,

(b) degradable polymers as demonstrated in accordance with Appendix 15,

(c) polymers having a solubility greater than 2 g/l, as demonstrated in accordance with Appendix 16,

d) polymers that do not contain carbon atoms in their chemical structure'.

5.1) Exemptions

REACH Regulation already excludes from its field of application products already subject to sector regulations, with regard to both individual substances and their mixtures in the finished state, intended for the end user. (8) The following are therefore at least partially excluded from the scope of application of the mini-reform, without prejudice to the information duties (see above, paragraphs 5.2,5.3):

  • medicines and veterinary medicines,
  • EU fertilising products,
  • foods and food additives,
  • in vitro diagnostic medical devices.

Excluded also microparticles of synthetic polymers intended for use at industrial sites, as well as:

(a) microparticles of synthetic polymers contained by technical means so as to avoid releases into the environment when used in accordance with the instructions for use during the intended end use,

(b) microparticles of synthetic polymers whose physical properties are permanently changed during the intended end use such that the polymer no longer falls within the scope of this entry,

c) synthetic polymer microparticles permanently embedded in a solid matrix during the intended end use.

5.2) Prohibitions

The microparticles of synthetic polymers cannot be marketed as such nor be used in products to give them the desired characteristics if present at a concentration equal to or greater than 0,01% of the weight. In cases where it is impossible to determine the concentration of microparticles through analytical methods or accompanying documents, only those of the following dimensions are taken into consideration:

  • 0,1 μm on any side, for particles having all dimensions of a maximum of 5 mm,
  • 0,3 μm in length, for particles having a maximum length of 15 mm and a length/diameter ratio greater than 3.

5.3) Duties of information to users and consumers

Information duties specific to users and consumers can be absolved with text messages, in some cases also with pictograms – depending on the different types
of product – on labels, safety data sheets, information leaflets. And among other things, the possibility of using digital tools to provide (without particular evidence) information electronically is envisaged.

Providers of synthetic polymer microparticles for industrial uses, starting from 17 October 2025, must provide the following information:

(a) instructions for use and disposal explaining to downstream industrial users how to prevent the release of synthetic polymer microparticles into the environment,

b) the declaration 'The synthetic polymer microparticles supplied are subject to the conditions set out in Annex XVII, entry 78, to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council’,

(c) information on the quantity or, where applicable, concentration of microparticles of synthetic polymers present in the substance or mixture,

d) generic information on the identity of the polymers contained in the substance or mixture, to enable manufacturers, industrial downstream users and other suppliers to fulfill their obligations on reporting to ECHA (see paragraph 5.3 below).

The labels of food additives and in vitro diagnostic medical devices - from 17.10.26 and 17.10.27, respectively - must contain instructions for use and disposal, in order to explain to professional users and the public how to prevent the release of microparticles of synthetic polymers.

5.4) Annual reports to be sent to ECHA

Manufacturers and users downstream must submit to ECHA by 31 May each year – starting from 2026 (only in the case of microparticles of synthetic polymers in the form of pellets, flakes and powders, used as raw materials in the manufacture of plastic at industrial sites) and from 2027 (in other cases) – a series of information:

(a) description of the uses of synthetic polymer microparticles in the previous calendar year,

(b) general information on the identity of the polymers used for each use of synthetic polymer microparticles,

(c) for each use of synthetic polymer microparticles, an estimate of the quantity of synthetic polymer microparticles released into the environment in the previous calendar year, including also the quantity of synthetic polymer microparticles released into the environment during transport,

(d) for each use of synthetic polymer microparticles, a reference to the exemption for use in industrial sites. (9)

Identity and function of the polymers contained in the products must be provided to the competent authorities upon request. If the information is not available, it must be requested from the suppliers or, if the latter does not intend to report it to the operator, it must act as a direct intermediary with the competent authorities.

The operators that produce and use microparticles of synthetic polymers excluded from the new rules for reasons of degradability or solubility must provide information to support the demonstration that the polymers are actually degradable or soluble, based on the new modalities defined by Appendix 15 and Appendix 16, respectively .

5.5) Transitional periods

The new rules do not apply to microparticles placed on the market before 17 October 2023. Long transitional periods are defined for different sectors and products, 'in order to encourage and facilitate technological and market innovations, allowing the identification of valid alternatives for the market and the environment'. The application of the mini-reform is therefore postponed, depending on the uses of the microparticles, by:

– four years (17.10.2027) for 'rinse off' cosmetic products,

– five years (17.10.28) for detergents, waxes, polishes and products for perfuming the air, as well as for fertilizing products generic products (other than EU fertilising products) and other products intended for agricultural and/or horticultural uses,

– six years (17.10.29) for encapsulation of fragrances, 'do not rinse' cosmetic products, medical devices,

– eight years (17.10.31) for products plant protection (i.e. pesticides, herbicides, etc.) e cured seeds with these products, biocides; granular infill for use on synthetic sports surfaces,

– twelve years (17.10.35) for lip, nail and make-up products. These products may contain the words 'This product contains microplastics', mandatory from 17 October 2031. With the exception of products containing 'microspheres' (microparticles of synthetic polymers to be used as abrasives, i.e. to exfoliate, polish or clean), not subject to any transitional period.

6) Provisional conclusions

The mini-reform of the REACH regulation - although mild, full of exemptions and untimely in its application times - represents the first restriction on the intentional use of synthetic polymer microparticles in a series of products. In line with some incipits of 'Green Deal', 'Circular Economy Action Plan', 'Zero Pollution Action Plan'. Not enough for a significant reduction in microplastic pollution.

The 'Restrictions Roadmap under the Chemicals Strategy for Sustainability' published by the European Commission in 2022, moreover, had envisaged the progressive ban of thousands of other toxic chemical substances - including PVC, PFAS, flame retardants, parabens - to be concluded by 2030. But the Commission led by Ursula von der Leyen has privileged the private interests of the Corporations over the clear needs of protecting public health.

Dario Dongo and Andrea Adelmo Della Penna

Cover image: Challenges and pitfalls in the field of micro- and nanoplastics research (Paul et al., 2020. Citation in Figure 1)

Footnotes

(1) Commission Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII of Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) with regard to synthetic polymer microparticles. http://data.europa.eu/eli/reg/2023/2055/oj

(2) Paola Palestini, Dario Dongo. Microplastics and human health, the invisible evil. GIFT (Great Italian Food Trade).

(3) Munoz-Pineiro M. (2018). MICROPLASTICS: Focus on Food and Health. Publications Office of the European Union JRC110629, https://publications.jrc.ec.europa.eu/repository/handle/JRC110629

(4) Researchers divide microplastics into:

  • primary, i.e. released directly into the environment in the form of small particles (15-31% of microplastics in the seas), and
  • secondary, resulting from the degradation of larger objects (e.g. plastic bags, bottles, fishing nets. 68-81% of microplastics in the seas)

(5) See Council conclusions on 'The missing link – European Union Action Plan for the Circular Economy' and 'International ocean governance: an agenda for the future of our oceans'

(6) The dossier prepared by ECHA (pursuant to the REACH Regulation, Annex XV) and the opinions of the committees are available at the link https://echa.europa.eu/it/registry-of-restriction-intentions/-/dislist/details/0b0236e18244cd73

(7) The restrictions are adopted pursuant to the reg. (EC) n. 1907/2006, art. 68, par. 1

(8) See reg. (EC) n. 1907/2006, art. 2, par. 5 and 6

(9) Similar conditions apply to suppliers of medicines and veterinary medicinal products, food additives and in vitro diagnostic medical devices containing microparticles of synthetic polymers, placed on the market for the first time for professional users and the public:
(a) a description of the end uses for which the synthetic polymer microparticles were placed on the market in the previous calendar year,
(b) for each end use for which synthetic polymer microparticles have been placed on the market, generic information on the identity of the polymers placed on the market in the previous calendar year,
(c) for each end use for which synthetic polymer microparticles have been placed on the market, an estimate of the quantity of synthetic polymer microparticles released into the environment in the previous calendar year, including also the quantity of synthetic polymer microparticles released in the environment during transportation,
(d) for each use of synthetic polymer microparticles, a reference to the derogation(s) applicable to the specific products, or to the forms excluded from the scope

(10) Alessandra Mei. Approval of changes to REACH postponed. The chemistry lobby can cheer. GIFT (Great Italian Food Trade).

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

Andrea Adelmo Della Penna
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Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.

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