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EU Revises the Restriction of Synthetic Polymer Microparticles

Date:2022-10-17 09:17:34 Classification :【Statute】 Visits:

In August 2022, the European Commission proposed to add a new restriction item to Annex XVII of REACH Regulation (EC) No 1907/2006 to restrict synthetic polymer microparticles in cosmetics, detergents, waxes, polishes, air care products, medical devices, agricultural and horticultural products, and particle fillers on artificial sports (places) surfaces.


Synthetic polymer microparticles are defined as: solid polymers, which (1) are contained in the particles and account for at least 1% (by weight) of these particles, or (2) form a continuous surface coating on the particles, and at least 1% (by weight) of these particles meet any of the following conditions:


All particle sizes ≤ 5 mm;

Particle length ≤ 15 mm, its length diameter ratio> 3。

However, the following polymers do not fall into the definition of synthetic polymer microparticles:


Polymers produced during polymerization in nature, and these polymers are not chemically modified substances;

Demonstrate degradable polymers according to the appendix;

Polymers with a solubility greater than 2 g/L are certified according to the appendix;

A polymer without carbon atoms in its chemical structure.


Limits


According to the proposed regulation, synthetic polymer microparticles shall not be marketed as substances, and shall not be marketed in mixtures with concentrations ≥ 0.01% by weight, when they are used to:


Perfume packaging (after 6 years from the date of entry into force of this amended regulation);

Products to be rinsed (products to be rinsed as defined in point (1) (a) of the preamble to Annex II to VI of Cosmetics Regulation (EC) No 1223/2009, unless such products belong to point (a) of this paragraph or contain synthetic polymer micro particles ("micro beads") used as abrasives (i.e. exfoliating, polishing or cleaning) (4 years after the date of entry into force of this revised Regulation);

(i) Lip products (lip products as defined in point (1) (e) of the preamble to Annex II to VI of the Cosmetic Regulation (EC) No 1223/2009, unless such products belong to point (a) or (b) of this paragraph or contain beads (12 years after the effective date of this revised regulation);

(ii) Nail products (nail products as defined in point (1) (g) of the preamble to Annex II to VI of the Cosmetic Regulation (EC) No 1223/2009, unless such products belong to point (a) or (b) of this paragraph or contain beads (12 years after the date of entry into force of this revised Regulation);

(iii) Cosmetics (Cosmetics within the scope of Regulation (EC) No 1223/2009 on Cosmetics, unless such products belong to point (a) or (b) of this paragraph or contain beads (12 years after the date of entry into force of this revised Regulation);

Resident products (resident products defined in point (1) (b) of the preamble of Annex II to VI of Cosmetics Regulation (EC) No 1223/2009, unless such products belong to point (a) or (c) of this paragraph (6 years after the date of entry into force of this revised regulation);

(i) Detergents (detergents as defined in Article 2 (1) of the Detergent Regulation (EC) No 648/2004, unless these products belong to point (a) of this paragraph or contain beads (five years after the date of entry into force of this revised Regulation);

(ii) Waxes, polishes, air care products (unless these products fall under point (a) of this paragraph or contain beads (five years after the date of entry into force of this amended regulation);

Medical devices (medical devices within the scope of the Medical Devices Regulation (EU) 2017/745, unless these devices contain beads (six years after the effective date of this revised regulation));

Fertilizer products (fertilizer products as defined in point (1) of Article 2 of Regulation (EU) 2019/1009, but not falling within the scope of this Regulation (5 years after the effective date of this revised Regulation));

Plant protection products, biocidal products (plant protection products referred to in Article 2 (1) of Regulation (EC) No 1107/2009, and biocidal products defined in Point (a) of Article 3 (1) of Regulation (EU) 528/2012 (8 years after the effective date of this revised regulation);

Agricultural and horticultural products (agricultural and horticultural products not covered by point (g) or (h) (five years after the date of entry into force of this revised regulation));

Particulate fill for artificial movement (site) surfaces (after 6 years from the date of entry into force of this revised Regulation).


Label requirements


For lip products, nail products and cosmetics containing synthetic polymer particles, the following labels shall be included (after 8 years from the date of entry into force of this revised regulation, until 12 years from the date of entry into force of this revised regulation):

"This product contains microplastics."

The text shall be clear, legible and indelible and shall be marked on the label, package, safety data sheet (SDS) or the leaflet accompanying the package.


Exemption


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


Technical means have been adopted to prevent the contained synthetic polymer micro particles from being released to the environment during the expected end use period when they are used according to the instructions;

During the expected end use, the physical properties of the synthetic polymer micro particles will change permanently, so that the polymer will no longer fall into the scope of this restriction item;

Synthetic polymer microparticles permanently incorporated into the solid matrix during the intended end use.

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


Synthetic polymer microparticles for industrial sites;

Medicines within the scope of Directive 2001/83/EC and veterinary drug products within the scope of Regulation (EU) 2019/6;

EU fertilizer products within the scope of Regulation (EU) No 2019/1009;

Food additives within the scope of Regulation (EC) No 1333/2008;

In vitro diagnostic devices, including devices within the scope of Regulation (EU) 2017/746.


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