EU REACH – DRAFT REGULATION ON MICROPLASTICS HAS BEEN APPROVED

by | Jun 6, 2023 | News-en

Published on 6 June 2023

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The latest version of the draft regulation on microplastics has been approved at the REACH Committee meeting on 26th – 27th April 2023.

 

CONTEXT

The experts representing the different Member States have approved the draft restriction on microplastics. This is the 7th version of the text since the initial draft was circulated on 5th September 2022. This version was released on 2nd May 2023. The draft must then pass through the Parliament and Council. It should be published in Q3/2023.

 

CONTEXT OF THE TEXT

The proposed restriction covers intentionally added polymers in all consumer and professional use products. Synthetic polymer microparticles shall not be placed on the market as substances on their own or, where synthetic polymer microparticles are present to confer a sough-after characteristic, in mixtures in a concentration equal to or greater than 0.01% by weight.

 

Reminder of the definition :

Synthetic polymer microparticles are polymers that are solid and which fulfill both of the following conditions:

  1. Are contained in particles and constitute at least 1% by weight of those particles, or build a continuous surface coating on particles
  2. At least 1% by weight of the particles referred to in point (a) fulfill either of the following conditions :
    • All dimensions of the particles are equal to or less than 5mm
    • The length of the particles is equal to or less than 15mm and their length to diameter ratio is greater than 3

 

EXCLUSIONS AND EXEMPTIONS

The following are excluded from the definition of synthetic polymers :

  1. Polymers that are the result of a polymerisation process that has taken place in nature, independently of the extraction process, and that are not chemically modified substances
  2. Polymers that are degradable, as proven in accordance with appendix [X] (see text of the appendix: 5 tests are detailed, with at least the need to meet the conditions of one of the first 3 tests)
  3. Polymers with a solubility of more than 2g/L, as proven in accordance with Appendix [Y] (see text in the Appendix: tests are those of OECD 105 or OECD 120)
  4. Polymers that do not contain carbon atoms in their chemical structure

 

Certain exemption criteria are defined in the case where releases to the environment are controlled. Some of these are particularly applicable to cosmetics. Criteria for exemption from the restriction of the maximum threshold of 0.01% by weight:

Criterion 4:

  1. Synthetic polymer microparticles for use on industrial sites

 

Criterion 5:

  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

 

LABELING AND REPORTING REQUIREMENTS

  • As a raw material supplier (suppliers of synthetic microparticle polymers), for users on industrial sites

LABELING: 24 months after the date of entry into force of this amending Regulation, suppliers of synthetic polymer microparticles exempted by criterion 4a (industrial site) shall provide the following information:

a) Instructions for use and disposal, explaining to industrial downstream users how to prevent releases of synthetic polymer microparticles into the environment

b) The following statement: “The synthetic polymer microparticles supplied is subject to conditions laid down by entry [entry number specified after publication] of the Annex of Regulation (EC) 1907/2006 of the European Parliament and of the Council”

c) Information on quantity or, as applicable, concentration of synthetic polymer microparticles in the substance or mixture

d) Information on the polymers contained in the substance or mixture

e) Information on the polymers contained in the substance or mixture that enables downstream users and other suppliers to comply with their respective obligations

Information to be provided on the SDS or packaging/notice, in a clear, legible, indelible way, possibly in the form of a pictogram, and in a dematerialized way.

 

REPORTING: 36 months after the date of entry into force, manufacturers must submit the following to ECHA before 31st May of each year:

a) Description of the uses of synthetic polymer microparticles in the previous year

b) For each use, an estimate of the quantities of synthetic polymer microparticles released into the environment in the previous year, including transport

c) For each use a reference to the derogation (criterion 4a)

 

  • As a user on an industrial site

REPORTING: 36 months after the date of entry into force, industrial downstream users using synthetic polymer microparticles at industrial sites must submit the following to ECHA by 31st May of each year:

a) Description of the uses of synthetic polymer microparticles in the previous year

b) For each use an estimate of the quantities of synthetic polymer microparticles released into the environment in the previous year, including transport

c) For each use a reference to the derogation (criterion 4a)

 

  • As supplier of product placing product on the market

LABELING: 24 months after the date of entry into force, suppliers of products containing synthetic polymer microparticles shall provide instructions for use and disposal explaining to professionals or the general public how to avoid the release of microparticles into the environment.

Information to be provided in a clear, visible, legible and indelible manner, possibly in the form of a pictogram, on the packaging or the leaflet, and in a dematerialised form.

 

REPORTING: 36 months after the date of entry into force, suppliers of products placed on the market for the first time for professional use or the general public must submit the following to ECHA before 31st May of each year:

a) The description of the end uses of synthetic polymer microparticles placed on the market in the previous year

b) For each end-use, the identity of polymers placed on the market in the previous year

c) For each end-use for which synthetic polymer microparticles were placed on the market, an estimate of the quantities of these microparticles released into the environment in the previous year, including transport

d) For each use, a reference to the applicable derogation (e.g. 5ab, b, or c)

The information must be made available to the authorities on request. The regulation also defines deadlines for the communication of data within the supply chain.

 

DEADLINES
For cosmetics, the transition periods are…

    • 4 years for rinsed cosmetic products
    • 6 years for non-rinsed cosmetic products
    • 12 years for lipsticks, nail polish, and make-up (with labelling after 8 years on the presence of microplastics)

 

For synthetic polymer microparticles encapsulating fragrances, the transition periods of 5 or 8 years may both be appropriate in terms of their economic costs and their economic benefits.

For detergents, waxes, polishes and air care products, a transitional period of 5 years was considered appropriate to give the industry sufficient time to reformulate their products and substitute synthetic polymer microparticles.

The deadlines concern both placing and availability on the market and making available on the market.

 

FOLLOW UP

If you need any further information about the future regulation on microplastics, please reach out to us via email: regulatory@jesozio.com, or through your designated Sales Representative.

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