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REACH

Polymers and monomers

Do I have to register polymers?
According to Article 2(9) of REACH polymers do not have to be registered, but according to Article 6(3) of REACH, the monomer substance(s) and other substances of the polymers that have not already been registered by an actor up the supply chain, are to be registered if both the following conditions are met:
- 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) (i.e. free or unbound monomers shall not be considered when checking this condition);
 
- 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 in the final polymer unbound or chemically bound to the polymer)
 
The REACH Regulation defines polymers in Article 3(5) and monomers in Article 3(6) of REACH.
 
The European Commission may according to Article 138(2) of the REACH Regulation present legislative proposals with requirements for the registration of polymers once a practicable and cost-effective way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established.
 
Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Can I register monomers as intermediates in accordance with Article 17(2) or 18(2) of the REACH Regulation?
According to Article 6 (2) of REACH, the reduced registration provisions with regard to on-site isolated and transported intermediates do not apply to monomers. This means that a full registration dossier must be submitted even if a monomer is used as an intermediate under strictly controlled conditions.
What is an impurity in a polymer?

An impurity in a polymer is defined as an unintended constituent present in the manufactured polymer substance. It may originate from the starting materials, such as the monomers or any other reactants, or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added. Examples of impurities in a polymer include unreacted monomers or other reactants, residual polymerisation catalyst, or any contaminant from the manufacturing process. The definition and detailed guidance on how to handle impurities can be found in Section 4.2.- 'Substances of well defined composition', Section 4.3.- 'UVCB substances', and Chapter 5- 'Criteria for checking if substances are the same' of the Guidance for identification and naming of substances Under REACH and CLP: http://echa.europa.eu/guidance-documents/guidance-on-reach

What is an additive in a polymer?
Some substances are commonly added to polymers for the purpose of adjusting or improving their appearance and/or the physicochemical properties of polymeric material.
 
Additives which are necessary to preserve the stability of a polymer must be regarded as a part of the polymer in accordance with Article 3(1) of REACH. Any other unbound "additive" must be regarded as a component of a mixture and not as an additive in accordance with Article 3(1) of REACH.
 
Thus, the importer of a polymer containing additives does not need to register these additives provided that the additives are added to preserve the stability of the polymer. Note however that there is the general obligation to register substances imported in a polymer mixture in quantities of at least 1 tonne per year. Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Beside registration requirements, do I have other obligations for polymers under REACH?

The provisions under the REACH Regulation with regard to information in the supply chain (Title IV), authorisation (Title VII), restrictions (Title VIII) and classification and labelling C&L (Title XI) may also apply to polymers. Further information on this issue is provided in Section 3.2.2- 'Application for authorisation', Section 3.2.3- 'Compliance with restrictions', 3.2.4- 'Classification and labelling', and Section 3.2.5- 'Information down the supply chain' of the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Are there registration obligations for manufacturers and importers of natural polymers that have not been chemically modified?3
Natural polymers are understood as polymers which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not fulfil the criteria set out in Article 3(39) of the REACH Regulation).
 
Following Article 2(9) of the REACH Regulation, any polymer meeting the criteria of Article 3(5) of the REACH Regulation does not have to be registered.
 
According to Article 6(3) of the REACH Regulation any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that meet the criteria mentioned in the respective article. However, monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) in natural polymers can, for practical reasons, be treated as "non-isolated intermediates" and do not have to be registered.
 
3This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.
Are there registration obligations for manufacturers and importers of natural polymers that have been chemically modified?

Natural polymers are understood as polymers, which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not meet the criteria set out in Article 3(39) of the REACH Regulation).

Following Article 2(9) of the REACH Regulation, any polymer meeting the criteria of Article 3(5) of the REACH Regulation does not have to be registered. This includes natural polymers, which are chemically modified (e.g. post-treatment of natural polymers).

Monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) originating from the natural polymer can for practical reasons be treated as "non-isolated intermediates" and do not have to be registered. The substances used to chemically modify the natural polymer and which are chemically bound within the final polymer need to be registered according to the REACH requirements.

This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.

Importers of polymers are obligated to register monomers or other substances chemically bound to the polymers. Do they have to submit spectral data and chromatograms of the original substances used to manufacture the polymers?

Yes. The registration of a monomer or other substance chemically bound to a polymer has to include spectral data and a chromatogram of the original monomer or other substance used to manufacture the polymer.

If it is not technically possible, or if it does not appear scientifically necessary to include this information, the reasons need to be clearly stated. Generic spectral data or a generic chromatogram cannot be accepted as this would not reflect the actual composition of the monomer or other substance used to manufacture the polymer.

It may be the case that a company imports a type of polymer from different sources, and therefore a monomer or other substance used in the manufacture of this polymer probably also stems from different sources. Even when a company imports a polymer from just one source, it can happen that a monomer or other substance used in the manufacture of this polymer stems from different sources.

In these cases, the importer of the polymer is responsible for assessing the sameness of the monomer or other substance from the different sources. If they consider that the substances from the different sources are the same, they have to submit just one registration for this substance with one set of spectral data and one representative chromatogram. In this process, they might still have found out that the substance from the different sources has different impurity profiles. They need to then refer to these different compositions of the substance in their registration dossier.

Are natural proteins and hydrolysed natural proteins polymers as defined in the REACH Regulation?

Natural proteins may be considered as polymers under REACH provided that they have at least 50 weight percent of polymer molecules (in this case, molecules including a sequence of at least four amino acid monomer units) and the content of molecules presenting the same molecular weight remains below 50 weight percent.

Similarly, hydrolysed natural proteins may be considered as polymers if they fulfil the abovementioned criteria. If the degree of hydrolysis is to such an extent that less than 50 percent of the weight of the substance consists of polymer molecules (as defined in chapter 2.2 of the Guidance for monomers and polymers) and/or the amount of polymer molecules presenting the same molecular weight is at least 50 weight percent, the hydrolysed natural protein is not a polymer and, hence, is not covered by the registration exemption for polymers under REACH.

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