Lambros Kromidas, Shiseido Americas Corp.01.19.23
By permission, the following is content taken from a December 2022 webinar given by the UK Cosmetic, Toiletry and Perfumery Association (CTPA; https://www.ctpa.org.uk/) December 2022, by Caroline Rainsford (Head of Scientific Services) and Francesca Rapolla (Scientific Affairs Manager). CTPA is a great resource for regulatory information regarding the EU and UK. The webinar referred to, and others, can be accessed at: https://www.ctpa.org.uk/webinar-archive. I remain grateful to Caroline and Francesca of CTPA for collaborating with me to write this timely and informative article on the proposed EU restriction on microplastics – they made it easy for me and the readers to understand this otherwise confusing proposal.
For context and perspective on the proposed EU restriction on microplastics, it is best to start with the origins and development of the proposed restrictions. No surprise there was much ado and pressure from several non-governmental organizations that eventually led to EU member state legislation. The story begins with microbeads. Plastic microbeads are a subset of “microplastics” as defined by the European Chemical Agency (ECHA). The ECHA definition includes solid polymers that are not traditionally considered to be plastic—more on that to follow. The UK banned the use of microbeads in rinse-off cosmetic products in January 2018 and the sale of such products as of June 2018. The same year, France banned them in rinse-off cosmetic products for exfoliation or cleaning. On July 1, 2018, Sweden imposed a ban on cosmetic products intended to be rinsed off or spat out. There may have been other European jurisdictions that took related actions.
Microbead legislation was, of course, not isolated to the EU. The US banned the manufacture of rinse-off cosmetic products for cleansing and exfoliation in July 2017 and the sale of cosmetic products with microbeads the following year. Canada banned them in cosmetic products for cleansing or hygiene in July 2018. Australia banned them in rinse-off cosmetic products for cleansing and exfoliation in June 2018. About a year earlier, South Korea banned them in cosmetic products and sanitary aids (e.g., toothpaste).
Getting back to the EU, the European Commission (EC) funded a couple of research projects such as EPHEMARE (https://jpi-oceans.eu/archive/ephemare.html) to investigate ecotoxicological effects of marine microplastics and PLASTOX (https://jpi-oceans.eu/en/plastox-2016-2018) to investigate the ingestion, food chain transfer and ecotoxicological impact of microplastics. In January 2018 the EC adopted the European Strategy for Plastics (https://www.eubusiness.com/topics/environ/plastics-strategy) and as such, asked ECHA to prepare a REACH (Registration, Evaluation, Authorization, Restriction of Chemicals) restriction dossier on intentionally added microplastics.
The aim of REACH (https://echa.europa.eu/regulations/reach/understanding-reach) is the protection of human health and the environment. As per website, “in principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
“If the risks cannot be managed, authorities can restrict the use of substances in different ways.”
Polymers are exempt from the registration; however, their monomers are in scope of the legislation. As part of the evaluation aspects of REACH, any substance that poses an unacceptable risk to human health and/or the environment that is deemed to require Community-wide action can be restricted. As such, the manufacture, import, placing on the market or use of a substance can be made subject to certain conditions.
Microplastics are deemed to have an unacceptable risk because of their persistence properties; however, it has not been fully demonstrated that there is a direct toxicity related to persistence. But what are microplastics? Broadly, the term refers to any solid synthetic non-degradable polymer as well as plastics. All substances with these properties are, therefore, identified as “microplastics.” Examples include PET, PP and PE. Such polymers have a long-term environmental persistence and therefore the potential for environmental concentrations are to keep rising especially “from the fragmentation of larger plastic articles” (ECHA’s Committee for Risk Assessment (RAC)).
The restrictions aim to prevent the release of microplastics to the environment. The task will cost the EU an estimated €5 billion a year. A publication of the draft restriction as of Dec. 12, 2022, can be found at: https://ec.europa.eu/transparency/comitology-register/screen/documents/083921/3/consult?lang=en.
The restriction is strictly on intentionally added “microplastics” in consumer products. “Microplastics” are solid, non-biodegradable synthetic polymers of a specific size and contain carbon atoms. Microplastics can also form coatings on other solid material. All these parameters will be clarified below. But for now, readers should be aware that if their product releases “microplastics” into the environment, it will be banned. However, if the “microplastic” in one’s product loses its characteristics before the product enters the environment, it is not banned but rather derogated under specific conditions.
Certain shampoo formulas contain microplastics, according to the EU. Now let’s clarify the microplastic parameters. The figure on the next page shows that microplastic particles can be on their own, part of a powdery ingredient or as a coating. It is important to note that if a solid particle that is not a microplastic (e.g., titanium dioxide, zinc oxide, cellulose, etc.) but is coated with a microplastic, it becomes microplastic (Figure 1).
Figure 1
Regarding size, the figure shows that the microplastic particle dimensions are equal to or less than 5mm with a lower limit of 100nm. Actually, no lower limit is mentioned in the proposed regulation, but 100nm is understood for enforceability purposes. If the microplastic particle is not spherical, it is covered if the long dimension is equal to, or less than, 15mm and the length is more than three times the diameter (Figure 2).
Figure 2
Regarding the carbon atom containing criterion, the figure below shows that the polymer backbone does not have to be of carbon atoms but will still be considered a microplastic if it has side chains of carbon atoms and meets all the other parameters. Polymers that contain no carbon atoms whatsoever, are out of the scope of this restriction (Figure 3).
Figure 3
Polymers that are biodegradable as per OECD and ISO test methods are exempt from the restriction. The test methods are organized into five groups. To be considered degradable, a microplastic must meet the pass criteria in any of the permitted test methods in groups 1 to 3, which include different “ready biodegradability,” biodegradability in seawater and tests demonstrating inherent degradation. One may also rely on group 4 or 5 tests, which include ISO standards for plastic degradation, OECD tests for transformation in soil, aquatic sediment, and mineralization in surface water. If group 4 and 5 tests are relied on, degradability in at least three environmental compartments; fresh or estuarine water or sediment, marine water or sediment, marine water/sediment interface, or soil, needs to be shown. If using a blend of polymers, both the individual polymer and the blend needs to be tested. The polymer tested of course needs to have the same physical characteristics as the polymer used in the product.
There are two other key parameters that must also be discussed and clarified. Namely, solubility criteria of the microplastic and “naturalness.” The restriction excludes “polymers that have a solubility greater than 2 g/L as proved in accordance with Appendix [Y].” When testing for solubility, one must do so with Good Laboratory Practices (i.e., in a GLP laboratory). The permitted test methods are OECD Guideline 120 and OECD Guideline 105 (water solubility).
Again, the test material must have the same physical characteristics as the polymer in the product and tested under the conditions of temperature 20⁰C, pH 7, Loading 10g/1000mL, for 24 hr test time. The restriction excludes “polymers that are the result of a polymerization process that has taken place in nature, which are not chemically modified substances.” That means that naturally derived or modified natural substances are not exempt.
Instructions for use and disposal for both ingredient suppliers and finished product manufacturers can be communicated in a variety of ways such as using text or pictograms on the label or on the SDS (Safety Data Sheet). Digital information can be provided in addition. Suppliers of ingredients must provide a statement that the product is subject to this REACH restriction, with information on the quantity or concentration of microplastics in the supplied ingredient, as well as technical information about the microplastics so that manufacturers can comply with their obligations. Manufacturers or brand owners must also provide instructions for use and disposal for consumers, to avoid microplastic release to the environment. Eight years after publication of the restriction, nail and makeup products must carry the following label: “This product contains microplastics.” It’s important to remember that these products will be banned 12 years after the restriction is published.
Both ingredient supplier and finished product manufacturers reporting to ECHA include the description of the uses of the microplastics for the previous year, generic information on the identity of the polymers, and an estimate of the quantity of each microplastic type released to the environment the previous year. Generic information is ok for ECHA purposes but in the case of a request from authorities, more precise information will be needed.
It is important to remember that the restriction is currently in draft proposal stage and therefore transition periods may change before the final restriction is published. The current best estimates for publication of the restriction are shown in Figure 4.
Figure 4
Transition periods after publication are as shown in Figure 5 and 6.
Figure 5
Figure 6
It is not possible to compile a list of ingredients and the reader must be aware that the same INCI name could be a film-former, a solid, a wax, or dissolved in different formulations. What’s more, the same INCI name could be in scope within some products and out of scope in others. It is therefore up to each company to evaluate its product portfolio and work with polymer suppliers, or downstream users, to understand the individual impact. For example, if synthetic, solid, non-biodegradable polymer Y with carbon atoms if used in a shower gel and remains in the solid form, is in scope of the microplastics restriction. On the other hand, if used in a cream eyeshadow and does not remain in the solid form, as it’s solubilized in the emulsion, it is in scope of the restriction, but derogated outside of the ban. Labelling and reporting requirements will apply.
some examples
For better understanding, let’s look at some hypothetical scenarios.
Scenario 1. A body lotion contains starch taken from potatoes; is this ingredient in scope, or out of scope, of the restriction? Since it is a natural polymer where the polymerization has taken place in nature and it hasn’t been chemically modified (e.g., the extraction process is mechanical and hasn’t altered the chemistry), it is out of scope. Furthermore, it may also be out of scope because it probably meets the biodegradation criteria—something that needs to be proven through the mandatory test methods.
Scenario 2. A company is wondering if synthetic, non-degradable polymer A is in scope of the restriction in any of the products in which it is used. It is used across skin care, sun care and hair care products. Polymer A has a water solubility greater than 2g/l according to the test method in the restriction appendix. In which of these product categories can polymer A be used? All of them since polymers with a water solubility greater than 2g/l are out of scope. They are out of scope because these polymers will not be solid if they reach the aquatic environment.
Scenario 3. A company uses polymer B, a silicone with carbon-based side chains, in a shampoo and it does not dissolve in the shampoo. It has the following properties: solid, synthetic, not water soluble and not biodegradable. Is this polymer within scope of the restriction? Yes! It meets the microplastic definition. What is the transition period before the deadline for placing a shampoo containing this ingredient on the market? Four years.
Scenario 4. Manufacturer A purchases a raw material from supplier B which meets the definition of a microplastic. Manufacturer A formulates the raw material into a moisturizer at its manufacturing site in the EU. The raw material is not water soluble, but it dissolves when formulated into the moisturizer and is no longer a solid within the formulation. Is the moisturizer (the finished product) within scope of the restriction? No, because it does not contain a microplastic (a solid particle) when it is placed on the market. Is the raw material within scope of the restriction when sold by supplier B? Yes, it is a solid synthetic polymer meeting the definition of a microplastic. If so, what obligations does supplier B have? Instructions for use and disposal for downstream users, to avoid microplastic release to the environment; a statement that the product is subject to this REACH restriction; information on the quantity or concentration of microplastics in the supplied ingredient; technical information about the microplastics so that manufacturer can comply with its obligations; reporting to ECHA. Are there any obligations for manufacturer A when formulating at the manufacturing site with this ingredient? Yes, although the finished product itself is out of scope, a “microplastic” has been used at the industrial site so manufacturer A has reporting obligations to ECHA.
Some mascara polymers are considered microplastics.
Scenario 5. A mascara contains polymer X which is a microplastic according to the definition in the restriction, but a film former which loses its microplastic characteristics at point of use. Is the mascara (the finished product) within the scope of the restriction? Yes, but subject to derogation because the microplastic loses its microplastic characteristic at point of use. Does the mascara have any labelling and/or reporting obligations? Yes, both. From when do these obligations apply? Two years after publication for labelling and three years after publication for reporting. The mascara is manufactured outside the EU and imported by a brand owner (EU RP) to be sold in the EU. Are there any requirements for the manufacturing site? The manufacturer is outside of the EU jurisdiction and therefore has no obligations to report to ECHA or obligations at the factory site. No instructions for use and disposal. However, the EU-based brand owner, who is a downstream user, has obligations under the microplastics restriction for labelling and reporting, as mentioned already. The non-EU based product manufacturer, may therefore help the downstream user by supplying the relevant technical information to help the downstream user meet its legal obligations; e.g., polymer identity and concentration in the product.
Origins and Development of the Restriction
For context and perspective on the proposed EU restriction on microplastics, it is best to start with the origins and development of the proposed restrictions. No surprise there was much ado and pressure from several non-governmental organizations that eventually led to EU member state legislation. The story begins with microbeads. Plastic microbeads are a subset of “microplastics” as defined by the European Chemical Agency (ECHA). The ECHA definition includes solid polymers that are not traditionally considered to be plastic—more on that to follow. The UK banned the use of microbeads in rinse-off cosmetic products in January 2018 and the sale of such products as of June 2018. The same year, France banned them in rinse-off cosmetic products for exfoliation or cleaning. On July 1, 2018, Sweden imposed a ban on cosmetic products intended to be rinsed off or spat out. There may have been other European jurisdictions that took related actions.Microbead legislation was, of course, not isolated to the EU. The US banned the manufacture of rinse-off cosmetic products for cleansing and exfoliation in July 2017 and the sale of cosmetic products with microbeads the following year. Canada banned them in cosmetic products for cleansing or hygiene in July 2018. Australia banned them in rinse-off cosmetic products for cleansing and exfoliation in June 2018. About a year earlier, South Korea banned them in cosmetic products and sanitary aids (e.g., toothpaste).
Getting back to the EU, the European Commission (EC) funded a couple of research projects such as EPHEMARE (https://jpi-oceans.eu/archive/ephemare.html) to investigate ecotoxicological effects of marine microplastics and PLASTOX (https://jpi-oceans.eu/en/plastox-2016-2018) to investigate the ingestion, food chain transfer and ecotoxicological impact of microplastics. In January 2018 the EC adopted the European Strategy for Plastics (https://www.eubusiness.com/topics/environ/plastics-strategy) and as such, asked ECHA to prepare a REACH (Registration, Evaluation, Authorization, Restriction of Chemicals) restriction dossier on intentionally added microplastics.
Microplastics REACH Restriction Proposal
The aim of REACH (https://echa.europa.eu/regulations/reach/understanding-reach) is the protection of human health and the environment. As per website, “in principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU. “If the risks cannot be managed, authorities can restrict the use of substances in different ways.”
Polymers are exempt from the registration; however, their monomers are in scope of the legislation. As part of the evaluation aspects of REACH, any substance that poses an unacceptable risk to human health and/or the environment that is deemed to require Community-wide action can be restricted. As such, the manufacture, import, placing on the market or use of a substance can be made subject to certain conditions.
Microplastics are deemed to have an unacceptable risk because of their persistence properties; however, it has not been fully demonstrated that there is a direct toxicity related to persistence. But what are microplastics? Broadly, the term refers to any solid synthetic non-degradable polymer as well as plastics. All substances with these properties are, therefore, identified as “microplastics.” Examples include PET, PP and PE. Such polymers have a long-term environmental persistence and therefore the potential for environmental concentrations are to keep rising especially “from the fragmentation of larger plastic articles” (ECHA’s Committee for Risk Assessment (RAC)).
The restrictions aim to prevent the release of microplastics to the environment. The task will cost the EU an estimated €5 billion a year. A publication of the draft restriction as of Dec. 12, 2022, can be found at: https://ec.europa.eu/transparency/comitology-register/screen/documents/083921/3/consult?lang=en.
The restriction is strictly on intentionally added “microplastics” in consumer products. “Microplastics” are solid, non-biodegradable synthetic polymers of a specific size and contain carbon atoms. Microplastics can also form coatings on other solid material. All these parameters will be clarified below. But for now, readers should be aware that if their product releases “microplastics” into the environment, it will be banned. However, if the “microplastic” in one’s product loses its characteristics before the product enters the environment, it is not banned but rather derogated under specific conditions.
Microplastic Parameters
Certain shampoo formulas contain microplastics, according to the EU. Now let’s clarify the microplastic parameters. The figure on the next page shows that microplastic particles can be on their own, part of a powdery ingredient or as a coating. It is important to note that if a solid particle that is not a microplastic (e.g., titanium dioxide, zinc oxide, cellulose, etc.) but is coated with a microplastic, it becomes microplastic (Figure 1).Figure 1
Regarding size, the figure shows that the microplastic particle dimensions are equal to or less than 5mm with a lower limit of 100nm. Actually, no lower limit is mentioned in the proposed regulation, but 100nm is understood for enforceability purposes. If the microplastic particle is not spherical, it is covered if the long dimension is equal to, or less than, 15mm and the length is more than three times the diameter (Figure 2).
Figure 2
Regarding the carbon atom containing criterion, the figure below shows that the polymer backbone does not have to be of carbon atoms but will still be considered a microplastic if it has side chains of carbon atoms and meets all the other parameters. Polymers that contain no carbon atoms whatsoever, are out of the scope of this restriction (Figure 3).
Figure 3
Polymers that are biodegradable as per OECD and ISO test methods are exempt from the restriction. The test methods are organized into five groups. To be considered degradable, a microplastic must meet the pass criteria in any of the permitted test methods in groups 1 to 3, which include different “ready biodegradability,” biodegradability in seawater and tests demonstrating inherent degradation. One may also rely on group 4 or 5 tests, which include ISO standards for plastic degradation, OECD tests for transformation in soil, aquatic sediment, and mineralization in surface water. If group 4 and 5 tests are relied on, degradability in at least three environmental compartments; fresh or estuarine water or sediment, marine water or sediment, marine water/sediment interface, or soil, needs to be shown. If using a blend of polymers, both the individual polymer and the blend needs to be tested. The polymer tested of course needs to have the same physical characteristics as the polymer used in the product.
There are two other key parameters that must also be discussed and clarified. Namely, solubility criteria of the microplastic and “naturalness.” The restriction excludes “polymers that have a solubility greater than 2 g/L as proved in accordance with Appendix [Y].” When testing for solubility, one must do so with Good Laboratory Practices (i.e., in a GLP laboratory). The permitted test methods are OECD Guideline 120 and OECD Guideline 105 (water solubility).
Again, the test material must have the same physical characteristics as the polymer in the product and tested under the conditions of temperature 20⁰C, pH 7, Loading 10g/1000mL, for 24 hr test time. The restriction excludes “polymers that are the result of a polymerization process that has taken place in nature, which are not chemically modified substances.” That means that naturally derived or modified natural substances are not exempt.
Labelling and Reporting Aspects
Even if a product is derogated out of the scope of the ban because the “microplastic” ingredient no longer meets the definition of a microplastic when the product is used, companies still have some obligations. Ingredient suppliers need to provide instructions for use and disposal for downstream users to avoid or minimize microplastic release in the environment. They also must provide technical information on the polymers to downstream users. Finally, conducting yearly reporting to ECHA of the estimated release of the microplastic ingredient into the environment from the supplier’s own uses. Finished product manufacturers must provide instructions for use and disposal for consumers, to avoid microplastic release to the environment in some cases through product labelling. Manufacturers also must conduct yearly reporting to ECHA on estimated microplastics releases to the environment from their own uses and use by downstream users. Each actor only reports the releases associated with their own use, meaning that double reporting to ECHA is hopefully avoided.Instructions for use and disposal for both ingredient suppliers and finished product manufacturers can be communicated in a variety of ways such as using text or pictograms on the label or on the SDS (Safety Data Sheet). Digital information can be provided in addition. Suppliers of ingredients must provide a statement that the product is subject to this REACH restriction, with information on the quantity or concentration of microplastics in the supplied ingredient, as well as technical information about the microplastics so that manufacturers can comply with their obligations. Manufacturers or brand owners must also provide instructions for use and disposal for consumers, to avoid microplastic release to the environment. Eight years after publication of the restriction, nail and makeup products must carry the following label: “This product contains microplastics.” It’s important to remember that these products will be banned 12 years after the restriction is published.
Both ingredient supplier and finished product manufacturers reporting to ECHA include the description of the uses of the microplastics for the previous year, generic information on the identity of the polymers, and an estimate of the quantity of each microplastic type released to the environment the previous year. Generic information is ok for ECHA purposes but in the case of a request from authorities, more precise information will be needed.
Timelines
It is important to remember that the restriction is currently in draft proposal stage and therefore transition periods may change before the final restriction is published. The current best estimates for publication of the restriction are shown in Figure 4.Figure 4
Transition periods after publication are as shown in Figure 5 and 6.
Figure 5
Figure 6
Ingredients Within Scope
It is not possible to compile a list of ingredients and the reader must be aware that the same INCI name could be a film-former, a solid, a wax, or dissolved in different formulations. What’s more, the same INCI name could be in scope within some products and out of scope in others. It is therefore up to each company to evaluate its product portfolio and work with polymer suppliers, or downstream users, to understand the individual impact. For example, if synthetic, solid, non-biodegradable polymer Y with carbon atoms if used in a shower gel and remains in the solid form, is in scope of the microplastics restriction. On the other hand, if used in a cream eyeshadow and does not remain in the solid form, as it’s solubilized in the emulsion, it is in scope of the restriction, but derogated outside of the ban. Labelling and reporting requirements will apply.some examples
For better understanding, let’s look at some hypothetical scenarios.
Scenario 1. A body lotion contains starch taken from potatoes; is this ingredient in scope, or out of scope, of the restriction? Since it is a natural polymer where the polymerization has taken place in nature and it hasn’t been chemically modified (e.g., the extraction process is mechanical and hasn’t altered the chemistry), it is out of scope. Furthermore, it may also be out of scope because it probably meets the biodegradation criteria—something that needs to be proven through the mandatory test methods.
Scenario 2. A company is wondering if synthetic, non-degradable polymer A is in scope of the restriction in any of the products in which it is used. It is used across skin care, sun care and hair care products. Polymer A has a water solubility greater than 2g/l according to the test method in the restriction appendix. In which of these product categories can polymer A be used? All of them since polymers with a water solubility greater than 2g/l are out of scope. They are out of scope because these polymers will not be solid if they reach the aquatic environment.
Scenario 3. A company uses polymer B, a silicone with carbon-based side chains, in a shampoo and it does not dissolve in the shampoo. It has the following properties: solid, synthetic, not water soluble and not biodegradable. Is this polymer within scope of the restriction? Yes! It meets the microplastic definition. What is the transition period before the deadline for placing a shampoo containing this ingredient on the market? Four years.
Scenario 4. Manufacturer A purchases a raw material from supplier B which meets the definition of a microplastic. Manufacturer A formulates the raw material into a moisturizer at its manufacturing site in the EU. The raw material is not water soluble, but it dissolves when formulated into the moisturizer and is no longer a solid within the formulation. Is the moisturizer (the finished product) within scope of the restriction? No, because it does not contain a microplastic (a solid particle) when it is placed on the market. Is the raw material within scope of the restriction when sold by supplier B? Yes, it is a solid synthetic polymer meeting the definition of a microplastic. If so, what obligations does supplier B have? Instructions for use and disposal for downstream users, to avoid microplastic release to the environment; a statement that the product is subject to this REACH restriction; information on the quantity or concentration of microplastics in the supplied ingredient; technical information about the microplastics so that manufacturer can comply with its obligations; reporting to ECHA. Are there any obligations for manufacturer A when formulating at the manufacturing site with this ingredient? Yes, although the finished product itself is out of scope, a “microplastic” has been used at the industrial site so manufacturer A has reporting obligations to ECHA.
Some mascara polymers are considered microplastics.
