Polymers

Polymers

Polymers are currently exempted from the registration and evaluation under REACH according to “ECHA Guidance for monomers and polymers; April 2012; Version 2.0”. A substance is considered a Polymer if the following criteria apply:

• 3M+1 rule: Polymer molecules contain a sequence of at least 3 monomer units, which are covalently bound to at least one other monomer unit or other reactant
• > 50 % by weight consists of polymer molecules
• < 50 % by weight of polymer molecules present the same molecular weight

The European Commission is working on a proposal for the registration process of polymers. The current plans include the following steps:

Assessment of all Polymers

In the 8th Meeting of REACH and CLP Competent Authorities Sub-Group on Polymers on 2 May 2022 criteria for Polymers Requiring Registration (PRR) have been proposed. According to current plans all polymers need assessment against these PRR criteria.:

Polymers that meet at least one of the criteria listed above are Polymers Requiring Registration (PRR) and need to register.

There are two exceptions of polymers which do not require assessment against all PRR-criteria:

- Polymeric Precursors: are handled like intermediates under SCC (strictly controlled conditions) to produce other polymers or articles.

- non-PRRs: Polyesters made out of an EU-list of monomers containing monomers considered to be of low hazard. In other jurisdictions these non-PRRs are referred to as PLCs (polymers of low concern).

Notification of all Polymers

As currently planned, in a first step all polymers as defined by REACH Art. 3(1) and 3(5) from the threshold of 1 tpa will need to be notified with a basic set of information (e.g. CAS, name, basic physico-chemical properties, PRR or non-PRR conclusion).

Grouping of polymers for registration and formation of joint submissions

The plans are that during a "pre-registration phase” for PRRs proposals to group polymers could be submitted based on factors such as chemical composition, MW and/or hazard information. This will be the foundation for the formation of PIEFs (Polymer Information Exchange Forum) and joint submissions.

Registration

According to these plans all polymers meeting PRR criteria need to be registered. The timeframe needs to be determined.

To be prepared for the new requirements it seems to be inevitable to have a deep knowledge of your polymers. If you decide to stay ahead of the process, we could support you by collecting analytical data. LAUS is also your trusted partner when it comes to the registration of PRRs.

An important first step is the determination of the molecular weight distribution by Gel Permeation Chromatography (GPC). This method provides basic information like the number average molecular weight (MWn) and the oligomer content and allows to decide if your substance is a polymer per ECHA definition:

• OECD 118: Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation Chromatography
• OECD 119: Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation Chromatography

Other basic information may include physico-chemical data, such as

• Log Kow
• Physical state
• Solubility
• Viscosity
• Ionicity
• Surface activity

Monomers

Monomers have to be registered in accordance with the normal registration obligation under REACH. Please find more information here.

We also offer analytical evaluation to determine the weight percent of monomer substance(s) or other substance(s) in the form of monomeric units, or substances chemically bound to polymer molecules:

• Mass Spectrometry
• Gas Chromatography
• FTIR spectroscopy (Matching with Polymer Data Bank)
• Nuclear Magnetic Resonance spectroscopy

Recycled Polymers/Recyclates

Mechanical or chemical recycling of plastic waste which results in one or more substances, in a mixture, or in an article after one or more recovery steps is considered as a manufacturing process. Therefore, recycled polymers/recyclates are subject to REACH.

We offer the necessary analytical determinations to identify your recyclate by comparison of FTIR spectra with our polymer database.

K-REACH

In Korea (K-REACH) registration is required for all polymers. They are divided into two groups: PLCs (Polymers of Low Concern) need an exemption dossier and non-PLCs need a full dossier according to K-REACH requirements.

LAUS can support you with studies for the characterization of your polymer and for dossier endpoints.

Don’t hesitate to contact us to receive a proposal for testing of your polymers.