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Guide on the application of REACH Regulation

2.4 REACH AND POLYMERS

2.4.1 Polymers and monomers

Polymers have wide application in day to day life such as packaging, building and
construction, transportation, electric and electronic equipment, agriculture, medicine, sports
goods, textile, paper, leather, coatings and other domestic uses.

Historically polymers are considered to be materials of low concern due to high molecular
weight, low reactivity and low bioavailability.

Polymers have been exempted under REACH from Registration and Evaluation

However they may be subjected to Authorization and Restriction based on:

■ – Established toxicological criteria

■ – Building blocks ….SVHC present ≥0.1%

Article 2(9) of REACH states that the provisions of Titles II (Registration) and VI (Evaluation)
shall not apply to polymers.

In other words manufacturers / importers of a polymer are generally not required to provide
to the Agency [ECHA], any information related to the intrinsic properties of the polymer itself,
with the exception of its Classification and Labelling.

Polymers have reduced obligations. Monomers do not.

Article 6(3) of REACH states that any manufacturer/importer of a polymer shall however
submit a

registration to the Agency for the monomer substance(s) or any other substance(s) (such as
additives), that have not already been registered by an actor up the supply chain, if both
the following conditions are met:

■ The polymer consists of 2% w/w or more of such monomer or other substance in the
form of monomeric units and chemically bound substances.

and

■ The total quantity of such monomer substance or other substance [i.e. the quantity of
these substances ending up in the final polymer as unbound or chemically bound to
the polymer makes up ≥1 ton per year.

While reviewing Polymers for exemptions, one has to first understand the definition of
Polymers.

REACH [Article 3(5)]: – criteria for polymer

Substances consisting of molecules are characterized by the sequence of one or more
types of monomer units (repetitive units). Such molecules must be distributed over a range of
molecular weights, wherein the molecular weight is primarily attributed to difference in the
number of repetitive monomer units.

Thus Polymers require two conditions to be fulfilled

■ A simple weight majority of molecules containing at least three monomer units (n=3)
which are covalently bound to at least one other monomer unit or other reactant.

■ Less than a simple weight majority of molecules of the same molecular weight.

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