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Summary of EU "microplastics" restriction action routes and regulatory control situation

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2023-12-14

Summary of EU "microplastics" restriction action routes and regulatory control situation

The term 'microplastics' was proposed by Professor Richard Thompson, a marine biologist at the University of Plymouth in the UK, in 2004. It refers to plastic fragments with a diameter less than 5 millimeters that are difficult to distinguish with the naked eye.
These difficult to decompose plastic fragments are difficult to remove once they enter the environment. At the same time, the smaller density and volume allow these fragments to diffuse from the origin to any location, including the South and North Poles, with atmospheric circulation, surface water, ocean currents, etc., causing permanent pollution.
These microplastics can be consumed by various animals such as seabirds and turtles, causing harm to local animals and accumulating along the food chain, ultimately accumulating in higher organisms, including humans. The microplastics scattered in the soil can alter soil properties and affect the growth of some animals and plants.
In addition, due to the large specific surface area of microplastics, they have also become a medium for the transmission of some pathogens and toxic substances.
There are currently two recognized sources of microplastics - "primary microplastics" and "secondary microplastics".
Primary microplastics refer to plastic particles that are already smaller than 5mm before entering the environment.
Secondary microplastics are small plastic fragments formed by natural weathering and fragmentation of larger plastics after entering the environment.
Due to the widespread use of plastics and the current unsustainable consumption pattern of plastics, global plastic emissions have reached a total of 11 million tons and will triple in the next 40 years.
It is reported that in terms of primary microplastics emissions, in 2021 alone, the EU expects 52140 to 184290 tons, equivalent to 2100-7300 trucks filled with particles, to be discharged into the environment during the production and manufacturing process of microplastics, posing huge risks to the environment and human health.

1、 EU Strategic Direction and Progress

Faced with the risks posed by microplastic emissions, the European Commission proposed microplastic pollution as a formal issue in its January 2018 EU Plastic Strategy.
In the March 2020 Action Plan for the Circular Economy, the European Commission promised to address the issue of microplastics in the environment by limiting their use and emissions.
In the May 2021 Zero Pollution Action Plan, the European Commission proposed a strategic goal of reducing microplastic emissions by 30% by 2030.
In order to achieve this goal, the EU divides microplastics into three categories for management based on their sources:
Primary microplastics actively added to the product;
Primary microplastics unintentionally discharged during production, manufacturing, and transportation;
Secondary microplastics derived from the physical degradation of ordinary plastics during use and disposal.
In September 2023, the European Commission issued a notice, which approved a resolution in Brussels to restrict the release of microplastics and their related products within the EU, in order to reduce environmental pollution caused by microplastics.

2、 EU Control Regulations and Measures

Currently, the European Union does not have a complete law applicable to microplastics, but rather achieves the control of microplastics by modifying existing regulations and proposing proposals related to microplastics. The most typical and crucial ones are the "microplastic restriction case" and "plastic particle emission management proposal" that have been successively released since the second half of this year.
Next, we will sort out the main regulations and control measures related to microplastics based on the EU classification mentioned above:
Control direction one:
Active addition of microplastics - EU policy: partially prohibited
The scope of coverage includes: plastic masterbatch, dye particles, flash powder, microspheres, sequins, polymer slow-release agents, etc.
（1） EU REACH Regulation Annex XVII Restriction List
On September 25, 2023, the European Commission, through years of discussion on microplastics restrictions, amended Annex 17 of the EU REACH regulation to restrict the placement of microplastics themselves and their related products within the EU. This is also the most significant and widespread restrictive measure taken by the European Union in recent years on microplastic pollution.
The revised REACH Regulation Annex XVII adds Article 78, which comprehensively controls the "synthetic polymer particles" within its definition. Except for the exemption clauses in Article 4 and 5, all synthetic polymer particles and mixtures with a content greater than 0.01% are prohibited from being placed.
For some industries with low emissions and no substitutes, such as beauty, toiletries, horticulture, healthcare, etc., the restriction order provides a certain buffer period, but imposes strict information disclosure requirements.
The specific regulations are as follows:
1. Definition of Synthetic Polymer Particles
Synthetic polymer particles include all synthetic polymer particles with a size of less than 5mm, or synthetic polymer fibers with a length of less than 15mm and a aspect ratio greater than 3. The following polymers are not within the definition of "synthetic polymer particles":
Natural polymers without chemical modification (unaffected by their extraction process);
Proving degradable polymers;
Proof of polymer with solubility greater than 2 g/L;
A polymer without carbon atoms in its chemical structure.

2. Exemption situation (paragraphs 4 and 5 of the original text):
(1) Exemption from polymer particles governed by other regulations, such as drugs, food additives, and fertilizers. Such situations require registration in accordance with corresponding regulations;
(2) Exemption from industrial uses that do not face consumers, such as polymer masterbatch suppliers selling their products to downstream plastic product processors for processing into plastic mineral water bottles;
(3) Exemption from the following technically controllable emission risks:
Synthetic polymer particles that are difficult to release into the environment during expected use due to specific technical means of protection;
The physical properties of synthesized polymer particles are permanently altered during the expected final use period, so that the polymer no longer falls within the scope of this regulation;
Synthetic polymer particles that are permanently bound to a solid matrix during their intended end use.
For example, if the physical size of the plastic masterbatch changes after being processed into a mineral water bottle and does not meet the range of polymer particles, the above (b) applies and is exempted.
3. Buffer situation (Article 6 of the original text):
Synthetic polymer particles for encapsulation of perfume, grace period until October 17, 2029;
Rinse the product, with a grace period until October 17, 2027;
Lip products, nail products, and cosmetics within the scope of this regulation can be extended until October 17, 2035;
Residency products, grace period until October 17, 2029;
Detergents, waxes, polishing agents, and air care products, with a grace period until October 17, 2028;
Medical devices, grace period until October 17, 2029.
Fertilizer products that meet the definition of fertilizer regulations but are not within the scope of the regulations, with a grace period until October 17, 2028;
Plant protection products and biocidal products, with a grace period until October 17, 2031;
Agricultural and horticultural products not covered above, with a grace period until October 17, 2028;
The particle filling material on the surface of artificial sports (venues), with a grace period until October 17, 2031.
Note: The above products must comply with the corresponding regulatory definitions and do not contain synthetic polymer particles used as abrasives, such as peeling, polishing, or cleaning "microspheres".
4. Case analysis
Q: If a supplier produces polymer pigment masterbatches (size<5 mm), will they be affected by this restriction order?
A: Due to the size of the product falling within the definition of polymer particles and being difficult to degrade or dissolve, its market launch in the European Union will be restricted according to the restriction order.
But according to the exemption clause, if it is used for industrial purposes, it can still supply downstream factories within the EU. At the same time, suppliers and downstream industrial users should promptly report basic information such as the properties, usage, uses, and emissions of plastic to the competent authorities.
Whether the related products produced by downstream factories can continue to face the EU consumer market depends on whether the products of downstream factories comply with the aforementioned technical exemption clauses or comply with the relevant buffer period regulations. Under the conditions of compliance with regulations, production and sales can be carried out under the conditions of meeting the information notification of competent authorities and consumers' right to know.

（2） EU Fertilizer Regulations
The amendment to Annex XVII of the EU REACH regulation exempts plastic additives for EU fertilizer products within the scope of Regulation (EU) 2019/1009, in order to avoid duplicate jurisdiction with the provisions on microplastics in the EU fertilizer regulation.
Therefore, the market placement of fertilizer products by suppliers and manufacturers should be carried out in accordance with this regulation.
Regarding the use of polymers in fertilizers, the 2019 EU Fertilizer Regulations only exempt two types of polymers, namely nutritional polymers and other polymers added as slow-release carriers or water retaining agents, and provide detailed specifications for the performance parameters of polymer particles. At the same time, requirements have been made for the functional design and manual content of fertilizer products that use corresponding polymers.
The specific regulations related to polymer parameters are as follows:
1. Nutritional polymers:
It is only added to the fertilizer as a control over the release rate of individual nutrients, and the following conditions must be met simultaneously:
(1) The corresponding monomer should complete REACH regulatory registration;
(2) At least 60% of the polymer can be dissolved in a phosphate buffer solution with a pH of 7.5 at 100 ° C;
(3) The final degradation products are only ammonia (NH3), water, and carbon dioxide (CO2);
(4) The free formaldehyde content of the polymer shall not exceed 600ppm.
2. Polymers other than nutritional polymers:
Only added as a "water retaining agent", "coating agent" or "binding" material to fertilizers, and must simultaneously meet the following conditions:
(1) The polymer materials used for "water retaining agents" and "coating agents" used after July 16, 2026 shall comply with the biodegradation standards specified in this regulation;
(2) The polymer materials used in "water retaining agents" and "coating agents" should undergo acute toxicity experiments on plant growth, acute toxicity experiments on earthworms, and soil microbial nitrification inhibition experiments to ensure that the polymer and its degradation products do not have overall adverse effects on animal and plant health and the environment during reasonable use;
(3) The water retention period of the "water retaining agent" should be less than the interval between two fertilizations designed for the fertilizer.
3. Response suggestions
Due to the comprehensive prohibition of polymers that do not meet the conditions in fertilizer regulations, polymer suppliers related to fertilizers should timely complete the corresponding REACH registration and physical, chemical, degradation, toxicological and other tests based on the specific functional types of their products, or redesign their product formulas.
Control direction 2:
Leakage of microplastics during use - EU policy: mandatory training, mandatory third-party certification, etc
The scope of coverage includes the production and consumption of plastic particles.

3、 Proposal by the European Commission to reduce plastic particle emissions

1. Control subject:
(1) Economic operators who handled more than 5 tons of plastic particles within the EU last year;
(2) EU carriers and non EU carriers transporting plastic particles within the EU.
On October 16, 2023, the European Commission once again proposed a proposal related to microplastic pollution, imposing mandatory regulations on another major source of microplastic pollution - "unintentional leakage during use", in order to reduce the loss of plastic particles during production, transportation, and use, such as spillage from synthetic devices.
The corresponding mandatory measures will be implemented within 18 months after the proposal consultation period is passed. The details of this regulation are derived from earlier industry Clean Action Plans (OCS) and the Convention for the Protection of the Environment of the Northeast Atlantic (OSPAR).
The main content includes:
(1) Enforce enterprises to set corresponding operating standards and provide training to employees;
(2) Compulsory third-party certification of enterprises;
(3) Compulsory enterprise information notification;
(4) Develop standardized statistical methods and accountability mechanisms with a maximum fine of no less than 4% of total revenue.
In addition, in order to save social costs, some requirements have been lowered for small and medium-sized enterprises (SMEs) and large enterprises with operating volumes less than 1000 tons/year. For example, the mandatory third-party certification for SMEs has been changed to self declaration. For medium-sized enterprises with operating volumes greater than 1000 tons/year, the transition period has been extended from 24 months to 36 months, and the certification validity period has been extended from 3 years to 4 years.
2. Response suggestions
At present, the regulation is still in the solicitation period for proposals, and the relevant enterprises involved in the proposal can participate in official discussions in a timely manner and carry out compliance responses as soon as possible during the solicitation period.
Control direction three:
Micro plastics produced by physical degradation of large plastic products in the environment - EU policy: advocating sustainable consumption and improving plastic product standards
The scope of coverage includes: disposable plastic products, paints, tires, synthetic fibers, construction fabrics, and other downstream chemical products
At present, the EU does not have a fully covered law in this field to regulate the microplastic emissions of all plastic products. Instead, it controls them through segmented regulations in various industries within the strategic framework of "Green Europe" and "Plastics" mentioned at the beginning.
For example, the "Disposable Plastic Regulations" corresponding to disposable plastic products, the "Sustainable Product Ecological Design Regulations" proposal corresponding to paints, synthetic fibers, and building fabrics, the "Building Product Management Regulations", and the "Tire Order 7" and "Tire Labeling Regulations" corresponding to the tire industry have put forward more requirements for plastic consumer goods in various industries, such as "wear resistance, aging resistance, recyclability, and biodegradability".
At the same time, it is mandatory for products to indicate on their packaging the potential environmental pollution they may cause, in order to reduce the pollution caused by plastic products to the environment and the discharge of microplastics. At the same time, regulations such as the Industrial Emission Law are passed to regulate the discharge of plastic pollutants in industrial production and other processes.
Due to the wide range and variety of plastic products, relevant enterprises need to find corresponding standards and laws based on their own products for compliance analysis, reduce emissions, and increase their market competitiveness while protecting the environment.