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Polymers and REACH |
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Polymers and Reach Regulation (EC) No 1907/2006
A polymer is a substance consisting of molecules characterised by the sequence of one or more types of monomer unit. Such molecules must be distributed over a range of molecular weights. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.
Polymer molecules are exempted from registration and evaluation under REACH (Article 2(9)). They are generally regarded as representing a low concern due, however polymers may still be subject to authorisation and restriction. However, the monomers or other substances used as building blocks of the polymer may still be required to be registered (Article 6(3)).
All the monomers and other substances, which need to be registered, can benefit from the extended deadlines for registration only if they have been pre-registered between the 1st June 2008 and 1st December 2008.
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| Definitions
REACH defines a monomer as a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process (Article 3(6)).
In accordance with REACH (Article 3(5)), a polymer is defined as a substance meeting the following criteria:
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Over 50 percent of the weight for that substance consists of polymer molecules (see definition below); and, |
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The amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance. |
A polymer manufacturer is defined as any legal or natural person established within the Community, who manufactures a polymer substance, or isolates a polymer substance in its natural state, (Article 3(8) and 3(9)).
Should additives be present in the polymer to preserve the stability of the polymer and impurities from the manufacturing process, then they are considered to be part of the substance and do not have to be registered separately. Stabilisers include, for example, heat stabilisers, anti-oxidants (both useful during extrusion) and light stabilisers (e.g. for preservation during use). Impurities are unintended constituents of the polymer such as catalysts residues or unreacted monomers.
Should substances be added to improve the performance of the polymer that are not necessary for preserving the stability of the polymer they are considered as a preparation or article. Examples of such substances include pigments, lubricants, thickeners, antistatic agents, antifogging agents, nucleating agents and flame-retardants. In these instances normal registration requirements apply.
In the case where a given substance can be used both for preserving the stability of the polymer and for improving its performance (e.g. if the substance acts as a light stabiliser and a flame retardant), consider only the quantities necessary to preserve the stability of the polymer substance. The quantity of the substance that is not necessary to preserve the stability of the polymer cannot be regarded a part of the polymeric substance. It should be considered as another substance within a preparation. As such it may need to be registered.
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Registration Obligation of Manufacturer/Importer of Polymers
Polymers are exempted from the provisions on registration of Title II of REACH (Article 2(9)).
In general the manufacturer or importer of a polymer is not required to provide to the Agency any information related to the intrinsic properties of the polymer itself, with the exception of its classification and labelling when applicable.
The manufacturer or importer must however, submit a registration for the monomer substances (s) or any other substance (s) that have not already been registered up the supply chain. For most polymer manufacturers the situation will generally be that the suppliers of these substances will register their monomers and other substances.
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Naturally occurring polymers or chemically modified naturally occurring polymers
A naturally occurring polymer is exempted from any registration provisions under Title II, provided that the polymer fulfils the definition of a naturally occurring substance (according to article 3(39)). In addition the polymer must not been chemically modified and should not meet the criteria for classification as dangerous in accordance with Directive 67/548/EEC (see Article 2(7)(b) and Annex V(8)). Under these circumstances, there is no requirement to identify the monomers or any other substances constituting the building blocks of the polymer.
If, however, a naturally occurring polymer has been chemically modified (e.g post-treatment of a natural polymer) and/or meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC, the manufacturer or importer of this polymer would have to submit a registration of the monomers or any other substances in accordance with Article 6(3).
The monomers and any other substances from which the natural polymer was derived can be considered as naturally occurring and do not need to be registered unless they meet the criteria for classification as dangerous in accordance with Directive 67/548/EEC (see Article 2(7)(b) and Annex V(8)).
The substances used for the modification of the natural polymer and ending up chemically bound within that polymer need to be registered according to the REACH requirements.
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Re-cycled Polymers
Polymer substances from waste are exempted from the obligation to register the monomer(s) or any other substance(s) meeting the provisions of Article 6(3) in the recycled polymer, provided that these substance(s) constituting the recycled polymer have been registered (Article 2(7)(d)).
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Classification and Labelling
The importer or manufacturer of a polymer has to classify and label the polymer. Also, if it is classified as dangerous according to Directive 67/548/EEC and if the polymer is put on the market on its own or in a preparation above the concentration limits specified in Directive 1999/45/EC, where relevant, resulting in the classification of the preparation as dangerous, he must notify the Agency. This notification has to be done by the 30th November 2010 if the polymer is already on the market or, from the 1st December 2010 onwards, as soon as the substance is put on the market (Articles 112(b) and 116)
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Information down the supply chain
The manufacturer or importer of a polymer must provide his customer(s) with a safety data sheet (SDS) for the polymer if this polymer substance meets the criteria for classification (Article 31). If relevant information about the polymer necessary to enable appropriate risk management is available, the supplier must provide that information to his customer(s), together with details of any eventual authorisation granted or denied in his supply chain (Article 32).
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