Annex XVII of EU REACH adds a new microplastics restriction clause

Mondo Technology Updated on 2024-01-31

On September 27, 2023, the European Commission approved and published Regulation (EU) 2023 2055 adding a new restriction item to Annex XVII of the EU REACH Regulation (EC) No 1907 2006, item 78to restrict synthetic polymer microparticles (SPM) ("microplastics") for various uses, unless exempted.

The EU microplastics ban came into force on 17 October 2023 (except for specific products with a transition period).。The ban does not apply to products that have been placed on the EU market before the date of implementation of the regulation (i.e. 17 October 2023).

Under the requirements of the new regulation, EU manufacturers, importers and downstream industrial users of products containing synthetic polymer microparticles (SPM) ("microplastics") (e.g. glitters), plastic microbeads) are required to provide the competent authorities with the properties of the polymers contained in these products and the function of these polymers in the products. If it is claimed that the product does not fall within the definition of the regulation on the grounds of degradability or solubility, it must also be provided with certification upon request by the competent authority.

Synthetic polymer microparticles in the new regulations refer to solid polymers that meet the following two conditions:

1.contained in a particle and this part of the mass accounts for at least 1% of the particle, or forms a continuous surface coating on the particle;

2.The above-mentioned solid polymers contained in particles with at least 1% mass must be met.

i) All particle sizes are equal to or less than 5 mm, or.

ii) Conditions in which the length of the particles is equal to or less than 15 mm and the ratio of their length to diameter is greater than 3.

However, the following polymers are excluded from this scope, they include:

a) Substances that are naturally polymerized and do not change their chemical properties during the extraction process;

b) Certified degradable polymers in accordance with Annex 15 of the REACH Regulation;

c) Polymers with a certified solubility greater than 2 g l in accordance with Annex 16 of the REACH Regulation;(d) Polymers that do not contain carbon atoms in their chemical structure.

Depending on the role of synthetic micropolymers in different products and the ease with which alternative technologies are available in the industry, the EU has different transition periods for different types of chemicals

In addition, between October 17, 2031 and October 16, 2035, lip products, nail polishes, and makeup products containing synthetic micropolymer particles should provide "This product contains microplastics. (this product contains micro-plastics.and that portion should be displayed on the label in a clearly visible, legible and indelible form of text.

What are microplastics?

According to Regulation (EU) 2023 2055, microplastic particles refer to particles in a solid state, which meet::(1) At least 1% of the particles are (a) 5 mm in size or (b) 15 mm in length and have an aspect ratio of 3or (2) the formation of a continuous surface coating on the particles.

Is the control of microplastics mandatory?

The control of microplastics is included in Annex XVII of the REACH Regulation, which is a mandatory requirement。However, the control also lists the restrictions (specific conditions), and the products that fall within the scope of the regulation will meet the restriction requirements and information requirements in order according to the different time points set by the regulations.

What are the regulatory limits for microplastics?

Microplastics that meet the dimensions specified in the regulations shall not be placed on the market as substances alone;Or to increase popularity (such as aspects such as color, texture, packing, water absorption, fluidity or heat resistance), microplastics are added to the mixture when the concentration is equal to or greater than 001% is also not allowed to be put on the market.

Which products are not covered by the regulation?

The following products are exempt from the restrictions of the regulation

1) Polymers produced by spontaneous polymerization in nature, unrelated to the extraction process and not chemically modified;

2) Proven (bio)degradable polymers according to Appendix 15 of the REACH Act;

3) Polymers with solubility certified according to Appendix 16 of the REACH Regulation 》 2g L;

4) Polymers that do not contain carbon atoms in their chemical structure, such as inorganic polymers;

5) (only) polymers or their mixtures for use at industrial sites (specific instructions are required from October 17, 2025);

6) Medicinal products for human use regulated by EU Directive 2001 83 EC, and veterinary medicinal products within the scope of Regulation (EU) 2019 6;

7) Products within the scope of the EU Fertilizer Regulation (EU) 2019 1009;

8) Products within the scope of the EU Food Additives Regulation (EC) No 1333 2008 (instructions for use and disposal are required from October 17, 2025);

9) In vitro diagnostic devices, including those within the scope of Regulation (EU) 2017 746 (instructions for use and disposal are required from October 17, 2026);

10) Foodstuffs within the meaning of Article 2 of Regulation (EC) No 178 2002 but not covered by Regulation (EC) No 1333 2008, as well as feed as defined in paragraph 4 of Article 3 of the Regulation;

11) Man-made polymer particles that are protected by specific technical means so that they are difficult to release into the environment during the intended use in accordance with the instructions for use (instructions for use and disposal are required from October 17, 2025);

12) a permanent change in the physical properties of the artificial polymeric particles during the intended period of use such that they no longer fall within the scope of the regulation (instructions for use and disposal are required as of October 17, 2025);

13) Artificial polymeric particles permanently bound to a solid matrix during their intended end-use (instructions for use and disposal are required as of October 17, 2025).

14) Products that have been placed on the EU market before the date of implementation of the regulation (i.e. October 17, 2023).

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