MICROPLASTICS:

On the 27th of September 2023 the European Commission has published Regulation 2055/2023, which amends Regulation (CE) n. 1907/2006 (REACH).
The amend consist of the introduction of entry 78 of Annex XVII of REACH Regulation, which limits microparticles of synthetic polymers, and of two new Appendixes, 15 and 16, which define the rules to demonstrate polymers biodegradability and solubility.

DEFINITION:

Are considered synthetic polymer microparticles (SPM): Solid polymers which satisfy both following conditions:
(a) are contained in particles and constitute at least 1% by weight of those particles or create a continuous surface coating on the particles;
(b) at least 1% by weight of the above particles meet one of the following conditions:
(i) all particle sizes are equal to or less than 5 mm;
(ii) the particle length is equal to or less than 15 mm and their length-to-diameter ratio is greater than 3.

The following polymers are excluded from the definition of synthetic polymer microparticles:

(a) polymers resulting from a polymerization process that has occurred in nature, independently of the extraction process, and which are not chemically modified substances;
(b) degradable polymers (demonstrated in accordance with Appendix 15);
(c) polymers with a solubility greater than 2 g/l (demonstrated in accordance with Appendix 16);
(d) polymers that do not contain carbon atoms in their chemical structure.

MAIN EXEMPTIONS AND OBBLIGATIONS

The restriction does not apply to the placing on the market of SPMs in medicinal products, fertilizers, food additives, diagnostic medical devices, or foods.
The restriction does not apply to raw materials or products for industrial use (derogation 4a).
From October 17, 2025, suppliers of SPMs for industrial use will be required to provide users with important additional information on the SPMs supplied, including:

a) quantity or concentration of SPMs;
b) the statement “The synthetic polymer microparticles supplied is subject to conditions laid down by entry 78 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council”
c) IFUD – instructions for use and disposal
d) Identity of SPMs

The restriction does not apply to the placing on the market of the following synthetic polymer microparticles, whether as substances on their own or in mixtures:

Derogation 5a) synthetic polymer microparticles contained by technical means to prevent releases into the environment when used in accordance with the instructions for use during the intended end-use;
Derogation 5b) synthetic polymer microparticles whose physical properties are permanently modified during the intended end-use, such that the polymer no longer falls within the scope of this entry;
Derogation 5c) synthetic polymer microparticles permanently embedded in a solid matrix during the intended end-use.

From the 17th October 2025, suppliers of products benefiting from one of the exemptions referred to in paragraph 5 shall provide instructions for use and disposal, explaining to professional users and the public how to prevent releases of synthetic polymer microparticles into the environment (IFUD).

SPECIFIC EFFECTIVE DATES

17th October 2027

• Rinse-off cosmetic products – (except synthetic polymer microparticles to be used for the encapsulation of fragrances or products containing synthetic polymer microparticles to be used as abrasives, i.e. for exfoliating, polishing or cleaning (“microspheres”))

17th October 2028

• Detergents, waxes, polishes, and air fresheners (except synthetic polymer microparticles used for fragrance encapsulation or products containing microspheres)
• Fertilizing products not covered by Regulation (EU) 2019/1009
• Products intended for agricultural and horticultural uses not covered by the categories of: fertilizers, phytosanitary products and seeds treated with such products, biocides

 17th October 2029

• synthetic polymer microparticles used for fragrance encapsulation
• Leave-on cosmetic products (except synthetic polymer microparticles used in fragrance encapsulation or lip, nail, and makeup products)
• Medical devices (except when such devices contain microspheres)

 17th October 2031

• Phytosanitary products and seeds treated with such products, as well as biocides
• Granular infill used on synthetic sports surfaces

17th October 2035

• Lip products, nail products and make-up products (except where such products are rinse-off products or synthetic polymer microparticles intended for use in the encapsulation of fragrances or products containing microspheres)

Reporting

From 2027, suppliers of SPMs exempted from paragraph 4a and industrial downstream users using synthetic polymer microparticles at industrial sites and falling under derogation 5 who place the product on the market for the first time, will have to manage the annual reporting obligations. – HERE FOR MORE INFORMATION

OUR SERVICES

• VERIFICATION OF COMPLIANCE WITH THE REACH DEFINITION OF A POLYMER
• SUPPORT IN THE APPLICATION OF DECISION-MAKING CRITERIA TO DETERMINE WHETHER A SUBSTANCE MEETS THE DEFINITION OF A MICROPLASTIC
• DATA GAP ANALYSIS AND STRATEGY
• ASSESSMENT OF SUPPLIER DOCUMENTATION
• SUPPORT IN DRAFTING CUSTOMER DECLARATIONS
• TECHNICAL AND REGULATORY CONSULTING
• REPORTING

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