The REACH data requirements are set out for polymers and the final report has been published
REACH does not currently require registration or evaluation of polymers, but under Article 138(2) the Commission is required to review the risks they pose and the need for registration of certain types of polymers.
This is an important challenge and the Commission has been working hard on the proposal.
The EU executive has held two workshops to advance discussions on the topic. And it has commissioned Wood consultancy to conduct research to determine which polymers should be registered first, under a tiered approach.
On July 2020 a final report has been published from consultancy groups Wood and Peter Fisk Associates (PFA). A summary of its key findings, including criteria for selecting polymers for registration, were outlined to the Competent Authorities for REACH and CLP.
The two firms were contracted by the European Commission to:
- Propose criteria for the identification of PRRs (polymers requiring registration), including the possibility of grouping PRRs, based on physicochemical properties and/or indication of hazard.
- Estimate the potential risks to human health and the environment posed by PRRs in comparison with other substances.
- Test and validate assumptions in a workshop.
- Provide a detailed cost-benefit analysis of the registration requirements that could be used by the Commission in a subsequent impact assessment. A series of testing strategies are proposed that enable an initial assessment. The results will indicate which further tests are relevant to derive a meaningful chemical safety assessment based on the polymer properties.
Two previous studies were completed for the European Commission on the issue, in 2012 and 2015. Additionally, at international level, the OECD completed its own review in 2009, intended to define criteria and approaches for polymers of low concern (PLC).
The report sets out a possible approach to grouping of polymers. Most current approaches to grouping are based on similarity of hazards and similarity of exposure or use. The estimation of the risks posed by polymers requiring registration in comparison with other chemicals is currently limited in its extent owing to the lack of useable data. In this report, two main types of grouping of polymers are identified:
- Grouping to identify which polymers meet the criteria for ‘polymers requiring registration’, and to allow the manufacturers/importers of similar types of PRR to consider future collaboration on registration; and
- Grouping of polymers in relation to the specific registration requirements, in order to facilitate cost-effective registration of PRR in line with the ‘one substance, one registration’ principle and to reduce testing costs and avoid unnecessary testing (e.g. through read-across of data).
* The 12 hazard classes: (Acute Tox. 1 to Acute Tox. 4); (Muta. 1A, Muta. 1B or Muta. 2); (Carc. 1A, Carc. 1B or Carc. 2); (Repr. 1A, Repr. 1B, Repr. 2 or Lact.); (Asp. Tox. 1 ); (Resp. Sens. 1, 1A or 1B); (Skin Sens. 1, 1A or 1B); (STOT SE1 to SE3); (STOT RE 1 and STOT RE 2); (Eye Dam. 1 or Skin Corr. 1, 1A, 1B or 1C); (Aquatic Acute 1, Aquatic Chronic 1 to 4); (Ozone). Under the Chemicals Strategy, work is ongoing to add new hazard classes to CLP for substances that are ED, PBT, vPvB, PMT and vPvM. Once those new classes for critical hazards have been added to CLP, they would also be added to the hazard classes which would make a polymer a PRR.
** Surface activity criterion covers anionic, non-ionic and amphoteric polymers.
*** Substances of concern: Still to be defined.
- PE1: if the candidate polymer is a polyester from an approved list, it is not considered a polymer requiring registration regardless of the number average molecular weight or oligomer content,
- MW1: polymers with number average molecular weight (MWn) of <1000 Da are considered as polymers requiring registration.
- MW2: polymers with 1000 < MWn <10,000 Da are considered a PRR if they contain >10% oligomer content of molecular weight below 500 Da or >25% oligomer content of molecular weight below 1000 Da.
- RFG1: a polymer with 1000 < MWn < 10,000 Da containing reactive functional groups (in either the high-concern category and/or moderate concern category) is a PRR
- MW3: polymers with MWn ≥10,000 Da are considered a PRR if they contain >10% oligomer content of molecular weight below 500 Da or >25% oligomer content of molecular weight below 1000 Da. There are no restrictions on the nature and content of reactive functional groups.
- C1: The polymer is a polymer requiring registration if it is a cationic polymer, with the exception for polymers with low cationic density, i.e. a polymer whose cationic group has a combined equivalent weight greater than 5,000 Da.
- AN1: anionic polymers are a PRR. The highest priority would be for such polymers that are surface active, with the exemption for polymers with low anionic density, i.e. a polymer whose anionic group has a combined equivalent weight greater than 5,000 Da.
- AN2: a polymer is a PRR if it is expected to become an anionic polymer, i.e. if it contains groups reasonably anticipated to become anionic (e.g. acid groups or salts of acid groups) and/or be anionic in a natural aquatic environment (4 < pH <9). The highest priority would be for such polymers that are surface active. Exceptions to this is represented by polymers with a low anionic density, i.e. a polymer whose anionic group as a combined equivalent weight greater than 5,000 Da.
- AM1: amphoteric polymers are PRR, with exemption for polymers with low cationic and anionic density, i.e. a polymer whose cationic and anionic groups each have a combined equivalent weight greater than 5,000 Da.
- NI1: nonionic polymer with surface active properties is a PRR.
- SN1: polymers that are suspected to present an equivalent hazard or are suspected they may possess hazardous properties should be considered as PRR.
According to the report, the number of polymers on the market is about 200.000.
Half of them will be polymers of low concern (PLCs). This leaves us with 100,000. Of those, only 33,000 will be defined as polymers requiring registration (PRRs) under REACH, according to the proposed framework for prioritization. Furthermore, the similar polymers should be covered by a single registration dossier.
People and the environment are widely exposed to polymers, the main constituents of plastics, as these chemicals continue to build up in terrestrial and ocean ecosystems and production is predicted to continue increasing.
The REACH registration must be a goal to guarantee a high level of protection of human health and the environment, seeking rational criteria to reduce the number substances and consequently the burden on industry.