According to REACH ( art 3, 5) a Polymer is a substance meeting the following criteria:
(a) Over 50 percent of the weight for that substance consists of polymer molecules ; and,
(b) The amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance.
The preferred method to determine whether a substance falls under the definition of a polymer is Gel Permeation Chromatography (GPC). acording to OECD TG 118 (1996).
Polymers are exempt from the REACH registration obligation (Article 2, paragraph 9).
According to Article 6(3), the manufacturer or importer of a polymer must however submit a registration to the Agency for the monomer substance(s) or any other substance(s) that have not already been registered by an actor up the supply chain, if both the following conditions are met:
(a) the polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);
(b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year (the total quantity in this context is the total quantity of monomer or other substance ending up chemically bound to the polymer).
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.
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 gals are
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.
Two main types of grouping of polymers are identified:
* 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.
The criteria for defining the “Low Concern polymers - PLC”, still under discussion, are based on