There is a concern associated with microplastic pollution and its impact on the environment and human health among scientists, policy makers and the public. Once in the environment, microplastics do not degrade and tend to accumulate. It is unknown whether and to what degree microplastics bioaccumulate in humans. Mean intake of microplastics in humans via their diet are at levels considered to be safe; however, some individuals may sometimes exceed these limits. Likewise, there is no evidence of widespread ecological risk from microplastic pollution yet, risks are likely to become widespread within a century if pollution continues at its current rate because they are practically impossible to remove from environment after release.
The definition of a microplastics
Microplastics are intentionally added to a range of products such as cosmetics, detergents, fertilizers, plant protection products, cleaning products and even medical products, medical devices, and food supplements.
Microplastic is defined as synthetic material consisting of solid polymer containing particles, to which additives or other substances may have been added or build a continuous surface coating on particles, and where ≥ 1% w/w of those particles have fulfilled the following:
- all dimensions of the particles are equal to or less than 5mm, or
- for fibers, the length is equal to or less than 15mm and their length to diameter ratio is greater than 3.
The following polymers are not part of the definition:
- natural polymers that have not been chemically modified,
- water-soluble polymers,
- degradable polymers,
- polymers without carbon atoms in their chemical structure.
To ensure high level of protection of human health and the environment the European Commission presented the first legislative proposal on the limitation of synthetic polymer microparticles in the EU market that will be enforced through the REACH Regulation (Regulation (EC) No 1907/2006).
The proposal includes three types of measures:
- restriction on the placing on the marketof microplastics as substances on their own or in
mixtures in a concentration equal to or greater than 0,01 % by weight where their use will result in polluting the environment,
- labelling requirement, which means that any supplier will have to provide sufficient information either on labels, in the instructions for use, or in the Safety Data Sheet (SDS), to avoid releasing microplastics in the environment,
- annual reporting requirement, to monitor the effectiveness of the requirement to provide instructions for use and disposal and to improve the quality of information available to assess the potential for risks in the future.
From the proposing restriction several uses or sectors were excluded from the prohibition to avoid overregulation. For industrial sites it is considered that emission of synthetic polymer microparticles is controlled. Also, derogations from the ban on the placing on the market are medicinal products, veterinary medicinal products, fertilizing products, and food additives. In-vitro diagnostic devices can also control the risk of releases by setting conditions of use and disposal.
In 2017, the European Commission (EC) requested the European Chemicals Agency (ECHA) to assess the scientific evidence for taking regulatory action at EU level on microplastics that are intentionally added to products.
In 2019 ECHA published the Annex XV dossier where it concludes that the intentional use of microplastics poses a risk to the environment that is not adequately controlled and needs to be addressed on a Union-wide basis. ECHA estimated than, currently, more than 42000 tonnes of microplastics are released into the environment every year. The plan tries to prohibit the use of microplastics in products such as cosmetics, detergents, fertilizers, medical devises, etc.
Public consultation on restriction proposal was organized in 2018 and 2019.
ECHA’s Committee for Risk Assessment (RAC) adopted its opinion with respect to the Annex XV in June 2020. RAC supports restricting the use of intentionally added microplastics while recommending more stringent criteria for size limit to not promote a shift to smaller particle sizes to circumvent the restriction. RAC also proposed more rigorous measures for biodegradable polymers.
In December 2020, the ECHA’s Committee for Socioeconomic Analysis (SEAC) adopted its opinion after short public consultations. It endorsed ECHA’s proposal but provided several recommendations for the European Commission to think about throughout the decision-making process. SEAC also advocated a lower size limit for microplastics of 1 nm, among other things. It was also suggested that a temporary lower size limit of 100 nm be implemented to guarantee that the limitation may be enforced by the detection of microplastics in goods.
In February 2021 RAC and SEAC submitted combined opinion to the Commission.
The Commission consulted the public and stakeholders with more technical knowledge again in short period of three months in 2022.
And finally on August 2022, the EC published its long-awaited restriction proposal, more available here. The Commission’s draft regulation was discussed for the first time with the Member States in the REACH Committee on 23 September 2022, check it here.
Eventually, the EU Member States will vote on the draft regulation in the REACH Committee. Before the restriction can be adopted, it is scrutinized by the European Parliament and the Council. Legislation is likely to be adopted in the first half of 2023.
Potential transition periods
Until restrictions come into force, the sectors or products identified during the restriction process, specific transitional periods were proposed to allow sufficient time for concerned stakeholders to comply with the restriction and transition to suitable alternatives. Such transitional periods are also necessary for the Member States to prepare for the reinforcement of the restriction.
Cosmetic products: For rinse-off and leave-on cosmetics products, there might be a transition period of four and six years, respectively, if they contain microplastics but no microbeads. For products containing microbeads (an abrasive to exfoliate, polish or clean), no transition period was proposed as they can be easily replaced by alternatives such as coconut shells or olive seeds. For lip products, nail products and make-up twelve years transition period is proposed due to their low contribution to the overall emissions of microplastics.
Medical devices and in vitro diagnostic medical devices: For devices cover by Regulation (EU) 2017/745 of the European Parliament, 6 years were considered necessary for reformulation and transition to suitable alternatives. The measure is justified with reference to the cost effectiveness of previous restrictions for substances with similar concerns. Continued use of existing medical devices and in vitro diagnostic medical devices is foreseen with improvements to risk management measures implemented to prevent release of microplastics throughout the product life-cycle.
Uses and technical functions of microplastics in cosmetic products and medical devices and in vitro diagnostic medical devices
Cosmetic products – Microplastics are used in cosmetic products to provide variety of functions, e.g., exfoliating/cleansing functions, opacity control, smooth and silky feeling in products and an illuminating effect on the skin. They can be used in lipstick, loose or pressed powders and liquid or thick emulsions with powdery feel. Microplastics may also be used as a carrier for other ingredients.
Medical devices and in vitro diagnostic medical devices – Microplastics have various functions in medical devices (MD) and in vitro diagnostic medical devices (IVD MD). Microplastics in medical devices are used as polymeric filters, adsorber and absorber granulates and in ultrasound devices. Microplastics, often with inorganic (e.g. iron oxide) cores and chemically functionalized surfaces, are ubiquitous as reagents in IVD medical devices and are essential in all automated IVD tests conducted worldwide. Microplastics are also frequently used in the manufacturing of IVD reagents and devices (e.g. chromatography columns used to purify antibodies).
On the basis of estimates for the resources to complete these reformulations for all concerned products, total reformulation costs are estimated at €9.2 billion.
The proposed restriction is estimated to result in a cumulative emission reduction of approximately 400 thousand tonnes of microplastics over the 20 year period following its entry into force.
Regulating microplastics is based on current knowledge on science and the uses of microplastics. Science will evolve and the impact or the proposed restriction may be different from what is estimated in this restriction proposal. Therefore, it is proposed to collect additional information on the uses so that if additional measures are needed in the future, they would be based on the best possible information. The restriction will be reviewed 5 years after entry into force.