The REACH restriction on microplastics 'Regulation (EU) 2023/2055', will have a big impact on the cosmetics industry.
REACH restriction
The synthetic polymer microparticles shall not be placed on the market as substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic (‘intentionally-present’), in mixtures in a concentration equal to or greater than 0,01 % by weight.
Placing on the market
- The ban applies to placing substances on the market.
- ‘Placing on the market’ under REACH means that it is forbidden by this date to introduce new products to the market and it is also forbidden to continue selling existing products that are already on the shelves (unless a sell through period is explicitly stated in the entry of the restriction).
- This is different from the Cosmetics Regulation where there is usually a sell through period!
Definition of synthetic polymer microparticles (SPM)
Polymers that are solid and which either are contained in particles and constitute at least 1% by weight of those particles, or build a continuous surface coating on particles, where at least 1% by weight of those particles fulfil either of the following conditions:
- all dimensions of the particles are equal to or less than 5 mm;
- the length of the particles is equal to or less than 15 mm and their length to diameter ratio is greater than 3.
Lower Size limit Enforceability
Where the concentration of synthetic polymer microparticles covered by this entry cannot be determined by existing analytical methods to verify the compliance with the concentration limit [0.01% by weight] only the particles of at least the following size shall be taken into account:
- 0.1 µm for any dimension, for particles where all dimensions are equal to or smaller than 5 mm;
- 0.3 µm for any dimension, for particles that have a length that is equal to or smaller than 15 mm and a length to diameter ratio greater than 3.
Important points on Definition
- The use of INCI names in identifying microplastics in cosmetic and personal care products is misleading.
- INCI names are based on chemical composition, and materials with the same INCI name can have different physical characteristics. Not all polymers are microplastics, as their classification depends on factors like particle size and environmental persistence. The key distinction is that microplastics are solid particles, and this can't be inferred from the INCI name.
- Also, it is not possible to definitively confirm whether a polymer is in scope just from the INCI name, because the polymer may be soluble, subject to the film former derogation, biodegradable, etc.
- Note that suppliers have an obligation to label SPMs.
Important dates for the Ban of SPM in cosmetic products
- From 17 October 2023: Ban on the placing on the market of 'microbeads' i.e. synthetic polymer microparticles for use as an abrasive, i.e. namely to exfoliate, polish or clean, mainly used in rinse-off cosmetic products. Incompliant products already on the market do not need to be withdrawn.
- Also, 'loose glitter' on its own or in products for which no transitional period is laid down under paragraph 6 of the Restriction (e.g., toys, textiles) is banned as of 17 October 2023. Incompliant products already on the market do not need to be withdrawn. Nevertheless, note that glitter in formulations is subject to different transition periods depending on different product categories (see transitional periods below).
- From 17 October 2027: Ban on the placing on the market of microplastics in cosmetic rinse-off products. Note that incompliant products already available on the market before that date shall be withdrawn.
- From 17 October 2029: Ban on the placing on the market microplastics in leave-on cosmetics (except for makeup, lip and nail products). Note that incompliant products already available on the market before that date shall be withdrawn.
- Ban on the placing on the market of microplastics in makeup, lip and nail products from 17 October 2035, provided that from 17 October 2031, such products still containing microplastics should be labelled ‘Contains Microplastics.’ Note that incompliant products already available on the market before that date shall be withdrawn.
Outside the Scope of the Ban (Derogations) concerning the Cosmetic Sector
- Polymers that are the result of a polymerisation process that has taken place in nature independently of the process through which they have been extracted, which are not chemically modified.
- Polymers that have a solubility greater than 2 g/L.
- Polymers without carbon atoms in their structure.
- (Bio-) degradable polymers [needs to be proven in at least three different environmental compartments]
- 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 definition e.g., film formers (Derogation 5b). However, note that there are labelling and reporting obligations.
- Microplastics used at industrial sites (Derogation 4a). However, note that there are reporting obligations.
Derogation 4a
- Synthetic polymer microparticles (SMP) used at industrial sites.
- Producers may receive SPM from raw materials suppliers (who have labelling obligations).
- During the manufacture of the product the SPM may cease to meet the definition e.g., because they are no longer particles.
- This is the case for example if the SPM dissolve as part of the manufacturing process.
- The use of SPM in these circumstances is permitted [good news].
- However , there is an obligation to Report [not so good news].
Derogation 5b
- 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 definition e.g., film formers as well as microplastic particles that cease to exist at the point of use, such as in instances where they dissolve (e.g., polyelectrolytes or certain detergents), permanently swell in water or exceed the specified size dimensions (>5mm).
- Temporary changes in microplastic form are not covered by the exemption from the ban.
- The Restriction aims to cover SPM which enters the environment.
- If during the use of the product by the consumer the SPM cease to meet the definition e.g., because the particles form a film, it is not banned [good news].
- As already mentioned, this derogation could also apply to swellable polymers.
- Under the current restriction, these products need to be labelled with Instructions for Use and Disposal [bad news].
- Note that synthetic polymer microparticles which lose their physical properties because they swell when formulated by uptake of water or a solvent, are not subject to labeling/reporting requirements, because they are not present as microplastics in formulations. However, only suppliers and downstream users using SPM at industrial sites have reporting obligations (derogation 4a).
Instructions for Use and Disposal
- Cosmetics Europe also proposed that sealed packaging should be excluded from the obligations as well as cases where the residue is difficult to access to rinse (e.g., mascara).
- The Commission has accepted in writing (although not yet as part of the guidance) that the Instructions for Use and Disposal message is consistent with the legislation and need not apply to sealed packaging but insists that Instructions for Use and Disposal need to be applied in all other cases.
- However, note that the Commission is preparing ‘Q&A’ guidance, but this will not be available until the end of the year, lateness of this with regard to Instructions for Use and Disposal labelling.
Reporting requirements
Suppliers of SPM as substances on their own or in mixtures, for use at industrial sites
- Quantity and concentration of SPM
- Generic information on identity.
This is an obligation to report to manufacturers, industrial downstream users and other suppliers not to ECHA (from 2025).
Suppliers and downstream users using SPM at industrial sites under derogation 4a
- Uses of SPM in previous calendar year
- Generic information on identity
- For each use estimate of releases (including transportation)
This is an obligation to report to ECHA (annually) from 2027.
Suppliers of products placed on the market for the first time under derogation 5b [e.g., film formers]
- Description of end uses
- Generic info on identity
- Estimate of releases for each end use
- Reference to applicable derogation
This is an obligation to report to ECHA (annually) from 2027.
Manufacturers, importers, industrial downstream users of products containing SPM
If requested by national authorities:
Specific information on the identity of polymers covered by the Restriction contained in those products and the function of those polymers in the product.
Next Steps
- Considering all transition periods for products covered by this entry, the suppliers of products placed on the market shall collect information on whether polymers contained in their products fall under the definition of SPM – if they are exempted – the basis for the exemption and what is the applicable deadline for either phase-out, labelling or reporting.
- Also, suppliers of SPM containing products, could make sure that manufacturers, importers, and industrial downstream users can provide specific information on the identity of polymers (as laid down in points 2.1 to 2.2.3 and points 2.3.5, 2.3.6 and 2.3.7 of Annex VI to REACH regulation, where applicable), and the function of the polymers contained in the product, to competent authorities upon their request.
- Lastly, suppliers of products containing SPM, claimed to be excluded from the designation of synthetic polymer microparticles on grounds of degradability or solubility could make sure that manufacturers, importers, and industrial downstream users can provide, without delay, information proving that those polymers are degradable under Appendix 15 or soluble under Appendix 16, as applicable, to competent authorities upon their request.