The REACH Regulation 1907/2006 defines a monomer as a substance which, via the polymerization reaction, is converted into a repeating unit of the polymer sequence.
A polymer is a substance consisting of molecules characterized by the sequence of one or more types of monomer unit.
ECHA�s Guidance for monomers and polymers gives precise definitions of a:
- Polymer molecule: �a molecule that contains a sequence of at least 3 monomer units, which are covalently bound to a least one other monomer unit or other reactant�
- Monomer unit: �means the reacted form of a monomer substance in a polymer (for the identification of the monomeric unit(s) in the chemical structure of the polymer the mechanism of polymer formation may, for instance, be taken into consideration)
- Sequence: �a continuous string of monomer units within the molecule that are covalently bonded to one another and are uninterrupted by units others than monomer units.
- Other Reactant: �Refers to a molecule that can be linked to one or more sequences of monomer units but which cannot be regarded as a monomer under the relevant reaction conditions used for the polymer formation process�
Obligations
Polymers:
Polymers are exempted from REACH registration and evaluation. They represent a low concern due to their high molecular weight.
Monomers:
Monomers have to be REACH registered. Monomers molecules are of higher concern than polymer molecules. REACH registration is required when the reacted monomer (used to manufacture the polymer) has not already been registered by an actor up the supply chain and:
- Represents more than 2% of the total composition of the polymer, and
- Exceeds 1 tonne or more per year.
These conditions are cumulative.
Manufacture / import of monomers
Article 6 of REACH requires manufacturers or importers of monomers to register their monomers. Nevertheless, intermediates i.e. substances used as monomers in the manufacturing of polymers do not need to be registered and do not require authorization under REACH for such uses.
The manufacturer or importer of a monomer substance must comply with the REACH regulation as standard substances do:
- General rules on restrictions
- Information down the supply chain
- CLP classification
- Labeling
Manufacture / import of polymers
Polymers are exempted from the provisions by REACH regulation under the title II article 2(9).
According to the 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 already been registered by an actor up the supply chain, if both of 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)
- The total quantity of such monomer 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).�
NB:Stabilizers present in the final polymer are an essential part of the integrity of the material, and therefore, do not need to be registered as opposed to all other additives.
Registration
The REACH registration process requires EU manufacturers and importers of chemicals to submit a registration dossier to ECHA when they place more than 1 metric tonne per year of a chemical on the EU market. The REACH dossier includes information on substances such as physical and chemical properties, effects on human health, effects on the environment and the evaluation which proves the above statements.
Restrictions
Polymers and monomers must comply with the REACH Regulation and its annexes. Annex XVII sets up the frame for restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles). Restrictions on a monomer apply to polymers only if the concentration of the unreacted monomer in the polymer exceeds concentration limits listed in Annex XVII of REACH.
Classification and labeling
As a manufacturer or an importer of a polymer you must classify and label the polymer in accordance with the CLP regulation No 1272/2008. In the case your polymer is classified as hazardous, you must notify ECHA as mentioned in article 39(6) of the CLP regulation. This notification has to be done within one month after the substances is placed on the market.
NB: The classification of the polymer should take into account the classification of all of its constituents such as unreacted monomers.
The REACH Regulation 1907/2006 defines a monomer as a substance which, via the polymerization reaction, is converted into a repeating unit of the polymer sequence.
A polymer is a substance consisting of molecules characterized by the sequence of one or more types of monomer unit.
ECHA�s Guidance for monomers and polymers gives precise definitions of a:
- Polymer molecule: �a molecule that contains a sequence of at least 3 monomer units, which are covalently bound to a least one other monomer unit or other reactant�
- Monomer unit: �means the reacted form of a monomer substance in a polymer (for the identification of the monomeric unit(s) in the chemical structure of the polymer the mechanism of polymer formation may, for instance, be taken into consideration)
- Sequence: �a continuous string of monomer units within the molecule that are covalently bonded to one another and are uninterrupted by units others than monomer units.
- Other Reactant: �Refers to a molecule that can be linked to one or more sequences of monomer units but which cannot be regarded as a monomer under the relevant reaction conditions used for the polymer formation process�
Obligations
Polymers:
Polymers are exempted from REACH registration and evaluation. They represent a low concern due to their high molecular weight.
Monomers:
Monomers have to be REACH registered. Monomers molecules are of higher concern than polymer molecules. REACH registration is required when the reacted monomer (used to manufacture the polymer) has not already been registered by an actor up the supply chain and:
- Represents more than 2% of the total composition of the polymer, and
- Exceeds 1 tonne or more per year.
These conditions are cumulative.
Manufacture / import of monomers
Article 6 of REACH requires manufacturers or importers of monomers to register their monomers. Nevertheless, intermediates i.e. substances used as monomers in the manufacturing of polymers do not need to be registered and do not require authorization under REACH for such uses.
The manufacturer or importer of a monomer substance must comply with the REACH regulation as standard substances do:
- General rules on restrictions
- Information down the supply chain
- CLP classification
- Labeling
Manufacture / import of polymers
Polymers are exempted from the provisions by REACH regulation under the title II article 2(9).
According to the 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 already been registered by an actor up the supply chain, if both of 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)
- The total quantity of such monomer 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).�
NB:Stabilizers present in the final polymer are an essential part of the integrity of the material, and therefore, do not need to be registered as opposed to all other additives.
Registration
The REACH registration process requires EU manufacturers and importers of chemicals to submit a registration dossier to ECHA when they place more than 1 metric tonne per year of a chemical on the EU market. The REACH dossier includes information on substances such as physical and chemical properties, effects on human health, effects on the environment and the evaluation which proves the above statements.
Restrictions
Polymers and monomers must comply with the REACH Regulation and its annexes. Annex XVII sets up the frame for restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles). Restrictions on a monomer apply to polymers only if the concentration of the unreacted monomer in the polymer exceeds concentration limits listed in Annex XVII of REACH.
Classification and labeling
As a manufacturer or an importer of a polymer you must classify and label the polymer in accordance with the CLP regulation No 1272/2008. In the case your polymer is classified as hazardous, you must notify ECHA as mentioned in article 39(6) of the CLP regulation. This notification has to be done within one month after the substances is placed on the market.
NB: The classification of the polymer should take into account the classification of all of its constituents such as unreacted monomers.
