We have been receiving many questions lately about the EU/ECHA proposal to ban microplastics in consumer goods. It appears to be unclear to many manufacturers what exactly will be banned and how, and most importantly what will be the practical consequences for their “business”. In this insight I will outline my current understanding and interpretation of the proposed ban.
The microplastics ban will apply to all intentionally added ingredients in consumer products (e.g. cosmetics and personal care products, household- and cleaning products, etc.), which are considered “microplastics” and are present in a concentration > 0,01% (w/w) in the finished product. According to the currently proposed definition, microplastics are micro-particles made of solid polymer (solid particles) with a spheric dimension =< 5 mm or with a rod-like dimension =< 15 mm length (L/D ratio >3).
It is very important to distinguish and avoid confusion between, on the one hand polymers (which is a very wide and diverse group of substances, including e.g. sugars, proteins, etc.), and on the other hand microplastics.
· Microplastics are always (made of) polymers, with very specific physico-chemical properties, namely being solid insoluble and non-degradable particles with small dimensions.
· Polymers on the other hand are certainly not always (micro)plastics, like for example sugars and proteins. They can be soluble and/or biodegradable molecules or liquids, and are therefore not regarded as “microplastics”.
Therefore, not all polymers are being banned! The ban only applies to those polymers which are also defined as microplastics.
In simple terms and focusing on cosmetic products, polymers which are present in finished products satisfying the following conditions are not in the scope of the proposed ban:
· soluble polymers (solubility > 2 g/L), e.g. some polyacrylic emulsifiers and/or gelling agents
· (bio)degradable polymers
· natural polymers (which are not chemically modified), e.g. alginates, pectins, guar, etc.
Important to note is that some polymers may be exempted (not considered as microplastics) or banned (considered as microplastics) under specific conditions depending on the way they are processed/ modified/ formulated/ used.
The final processing, modification and formulation of the raw material can make that some polymers in the finished products become dissolved (thus exempted) or become solid particles (thus banned). Since the same general INCI name may apply to the polymer in both cases, erroneous conclusions may be drawn, in particular when the assessment is based on the polymer’s general INCI name only (e.g. acrylates copolymer, acrylates crosspolymer, etc.).
In those cases it is essential to verify the exact physico-chemical properties and state of the ingredient in the finished product as formulated AND as used. This will require detailed expert assessment of ingredients’ technical data, possibly in collaboration with the supplier of the raw material when additional data is needed for the assessment.
· Contain intentionally added microplastics in quantity >0,01% w/w in finished product
· In the form of solid, non-degradable polymers
· With particle size < 5 mm (spheric) or < 15 mm (rod-like)
· Do not contain intentionally added microplastics in quantity > 0,01% w/w in finished product
· Any polymers present in the product are soluble and degradable, or natural
As a starting point, it is most important to evaluate formulations and ingredients against the microplastic definition, and to identify those which will become non-compliant. Although the exact definition is rather broad and complex, an experienced formulation chemist should be able to identify the ingredients in question.
For our clients that use our Product Regulatory Information Management System (PRIMS), the system will automatically flag the ingredients, formulations and products that may be affected by the ban and that may require action (e.g. reformulation) and show the currently foreseen deadlines for specific product categories.
The exact deadlines for different product categories are not final yet. The current proposal suggests the following deadlines for different product groups starting from the date of Entry into Force (EiF) of the legislation:
· Starting from the EiF for all cosmetics and personal care products containing microplastics used as abrasives (also known as microbeads), e.g. toothpastes, scrubs, exfoliators, etc.
· EiF + 4 year for rinse-off cosmetics and personal care products
· EiF + 6 year for leave-on cosmetics and personal care products
In addition to the market ban, some additional requirements such as reporting/notifying to the authorities and labeling/information sharing may apply in specific situations.
We foresee the proposed ban to be approved sooner or later, and consumer attention to microplastics to grow. There are still uncertainties and changes expected in the proposed ban on microplastics towards the final approval and publication. Nevertheless, it is important to start evaluating your formulations and ingredients against the microplastic definition short term.
We will share more information as soon as the details and additional requirements become more clear and certain.
To discuss the microplastics ban in more detail or to learn more about our PRIMS system, feel free to contact me personally.