In August 2022, the European Commission has proposed to add a new entry to Annex XVII to REACH Regulation (EC) No 1907/2006, to restrict synthetic polymer microparticles in cosmetics, detergents, waxes, polishes, air care products, medical devices, products for agricultural and horticultural uses, granular infill for use on synthetic sports surfaces.

Definition
“Synthetic polymer microparticles” are defined as 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:

1. All dimensions of the particles are ≤ 5 mm;
2. The length of the particles is ≤ 15 mm and their length to diameter ratio is > 3.

However, following polymers are excluded from the designation “synthetic polymer microparticles”:

1. Polymers that are the result of a polymerisation process that has taken place in nature, which are not chemically modified substances;
2. Polymers that are degradable as proved in accordance with Appendix;
3. Polymers that have a solubility greater than 2 g/L as proved in accordance with Appendix;
4. Polymers that do not contain carbon atoms in their chemical structure.

Restriction
According to proposed regulation, 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, in mixtures in a concentration ≥ 0.01% by weight, for uses in: 

1. Encapsulation of fragrances (after 6 years of the date of entry into force of this amending Regulation);
2. Rinse-off products, as defined in point (1)(a) of the Preamble to Annexes II to VI to Cosmetics Regulation (EC) No 1223/2009, unless such products are covered by point (a) of this paragraph or contain synthetic polymer microparticles for use as an abrasive, i.e. namely to exfoliate, polish or clean (“microbeads”) (after 4 years of the date of entry into force of this amending Regulation);
3. (i) Lip products, as defined in point (1)(e) of the Preamble to Annexes II to VI to Cosmetics Regulation (EC) No 1223/2009, unless such products are covered by points (a) or (b) of this paragraph or contain microbeads (after 12 years of the date of entry into force of this amending Regulation);
   (ii) Nail products, as defined in point (1)(g) of the Preamble to Annexes II to VI to Cosmetics Regulation (EC) No 1223/2009, unless such products are covered by points (a) or (b) of this paragraph or contain microbeads (after 12 years of the date of entry into force of this amending Regulation);
   (iii) Make-up, within the scope of Cosmetics Regulation (EC) No 1223/2009, unless such products are covered by points (a) or (b) of this paragraph or contain microbeads (after 12 years of the date of entry into force of this amending Regulation);
4. Leave-on products, as defined in point (1)(b) of the Preamble to Annexes II to VI to Cosmetics Regulation (EC) No 1223/2009, unless such products are covered by points (a) or (c) of this paragraph (after 6 years of the date of entry into force of this amending Regulation);
5. (i) Detergents, as defined in Article 2(1) of Detergents Regulation (EC) No 648/2004, unless those products are covered by point (a) of this paragraph or contain microbeads (after 5 years of the date of entry into force of this amending Regulation);
   (ii) Waxes, polishes, air care products unless those products are covered by point (a) of this paragraph or contain microbeads (after 5 years of the date of entry into force of this amending Regulation);
6. Medical devices, within the scope of Medical Device Regulation (EU) 2017/745, unless those devices contain microbeads (after 6 years of the date of entry into force of this amending Regulation);
7. Fertilising products, as defined in Article 2, point (1), of Regulation (EU) 2019/1009, which do not fall within the scope of that Regulation (after 5 years of the date of entry into force of this amending Regulation);
8. Plant protection products, within the meaning of Article 2(1) of Regulation (EC) No 1107/2009, and biocidal products as defined in Article 3(1), point (a), of Regulation (EU) 528/2012 (after 8 years of the date of entry into force of this amending Regulation);
9. Products for agricultural and horticultural uses not covered by points (g) or (h) (after 5 years of the date of entry into force of this amending Regulation);
10. Granular infill for use on synthetic sports surfaces (after 6 years of the date of entry into force of this amending Regulation).

Labelling Requirement
For lip products, nail products and make-up that contain synthetic polymer microparticles shall contain the following labelling (after 8 years of the date of entry into force of this amending Regulation, until 12 years of the date of entry into force of this amending Regulation):

“This product contains microplastics.”

It shall be clearly visible, legible and indelible text on the label, the packaging, the safety data sheet, or the package leaflet.

Exemption
The above requirements do not apply to the following synthetic polymer microparticles:

1. Synthetic polymer microparticles which are contained by technical means so that releases to the environment are prevented when used in accordance with the instructions for use during the intended end use;
2. 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 scope of this entry;
3. Synthetic polymer microparticles which are permanently incorporated into a solid matrix during intended end use.

The above requirements do not apply to the following situation and products:

1. Synthetic polymer microparticles for use at industrial sites;
2. Medicinal products within the scope of Directive 2001/83/EC and veterinary medicinal products within the scope of Regulation (EU) 2019/6;
3. EU fertilising products within the scope of Regulation (EU) No 2019/1009;
4. Food additives within the scope of Regulation (EC) No 1333/2008;
5. In vitro diagnostic devices, including devices within the scope of Regulation (EU) 2017/746.

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