When REACH was developed, the registration for polymers was deemed too difficult because of the complexity of the polymer market, in terms of size and variability of chemical substances in that market. However, Article 138(2) REACH specifies that the European Commission may make a legislative proposal aiming at registering a range of selected polymers after reviewing the need to do so and taking into account all the factors regarding human health, the environment, innovation and competitiveness.
All OECD countries use the OECD Polymer Definition as developed in 1990, whereas some countries transposed it into more quantitative terms:
“A 'POLYMER' means a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a 'MONOMER UNIT' means the reacted form of a monomer in a polymer.”
Under REACH, the following definitions are provided (Article 3):
- Monomer: "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))."
- Polymer: "a polymer is a substance consisting of molecules characterised by the sequence of one or more types of monomer units. 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."
In accordance with REACH (Article 3(5)), a polymer is defined as a substance meeting the following criteria:
- Over 50 percent of the weight for that substance consists of polymer molecules (see definition below); and,
- The amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance.
A further clarification of the definition of a polymer substance is provided in the ECHA Guidance on monomers and polymers.
Duties under REACH
So far, polymers as such are exempt from the registration obligation (Title II) and the evaluation (Title VI) under REACH (Article 2(9)), but registration is required for monomers and other substances comprising the polymer, if (Article 6(3) REACH):
- 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); and
- 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).
Although substances used as monomers in the manufacturing of polymers are by definition intermediates, they cannot be registered in accordance with the provisions which normally apply to on-site or transported isolated intermediates (Article 6(2)). In contrast, Articles 17 and 18 (on intermediates) do apply to the other substances (e.g. initiators, terminators, chain-transfer agents, post-reactants) used in the manufacture of the polymer.
It is worth noting that polymers are not exempted from the CLP Regulation. A polymer is a substance and as such has to be notified when placed on the market in cases where it fulfils the criteria for classification as hazardous (Article 39(b) CLP).
Polymers could be required to be registered at some point in the future. According to Article 138(2) REACH, the European Commission (EC) may come up with a legislative proposal to amend REACH requesting registration of a range of selected polymers.
Notably in other OECD countries, legislative regimes normally include provisions for polymers, whereas the concept of “Polymers of Low Concern” (PLC) is integrated. PLCs are assumed to have insignificant impact on human health and the environment.
Within the REACH review (process to identify potential needs to amend REACH), the possibilities of polymer registration requirements were assessed. Based on a first study (Risk & Policy Analyst Limited, 2012), the EC identified two registration approaches for further investigation: (i) Grouping polymers for registration, and (ii) defining a category (or categories) of polymers of low concern.
A further study analysed existing approaches outside the EU and proposed alternative options (other than the current one of no registration) which could be used in the EU and preliminarily assess feasibility and cost-effectiveness of these options. The final report (BIO by Deloitte, 2014) is available here.
The final decision on the polymer registration must try to minimise the costs for industry including those for innovation and competition, while maximising the benefits to human health and the environment. The recent studies mentioned above contribute to the conclusion that polymers might face additional regulatory requirements in the future.
Engineered or manufactured nanomaterials are substances that are intentionally produced, manufactured or engineered to have specific properties compared to the same material without nanoscale features. Their structures range from approximately 1 to 100 nm in at least one dimension.
Nanotechnology is rapidly expanding. A large number of products containing nanomaterials are already on the European market (e.g. batteries, coatings, antibacterial clothing, cosmetics, food products). Nanomaterials offer technical and commercial opportunities, but may pose risks to the environment and raise health and safety concerns for humans.
As part of its Communication on the Second Regulatory Review on Nanomaterials, the European Commission assesses the adequacy and implementation of the EU legislation for nanomaterials.
Current Status of nanomaterials under REACH
REACH was put in place to ensure chemical safety: Manufacturers, importers and downstream users have to ensure that the substances they manufacture and place on the market or use do not adversely affect human health or the environment.
REACH also applies to nanomaterials, i.e. it must be ensured that nanomaterials are produced, used and disposed of in a safe and sustainable way. In fact, nanomaterials meet the regulations’ substance definition. They underlie the same REACH requirements as bulk chemicals. REACH does not define nanomaterials as a “stand-alone” substance but runs both forms under the same substance identity. However, the registrant has to specify in the registration if the substance is also manufactured/imported in nanoform.
Nanomaterial can either be:
- A substance in its own right and registered as such (only in its nanoform)
- A form of a substance and included in the dossier of this (bulk) substance
The European Commission’s Second Regulatory Review on Nanomaterials concluded that the current regulatory framework, including REACH, is appropriate to cover nanomaterials. ECHA, through the REACH Implementation Projects on Nanomaterials, has created specific guidance documents with recommendations providing scientific and technical advice on key aspects of the implementation of REACH regarding nanomaterials.
The European Commission released a specific recommendation in 2011 on the definition of a nanomaterial. The recommendation should be used in different European Regulations, including REACH and CLP. A review of the recommended definition is expected:
“A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50% may be replaced by a threshold between 1% and 50%.
By derogation from the above [statement], fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials. […]”
So far, no formal Commission proposal for a possible amendment of the REACH Annexes for nano-specific information requirements has been released, but an impact assessment is under preparation and a study to support the Impact Assessment of relevant regulatory options for nanomaterials in the framework of REACH has been conducted.
Member States such as France, Denmark, Belgium and Sweden have launched initiatives for national registries for nanomaterials. For the EU, the Commission begun an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials. Supporting studies have been conducted to evaluate existing notification systems.
Besides the activities of the EU and its Member States, the OECD is working on approaches to adapt the hazard, exposure and risk assessment for manufactured nanomaterials to the specificities of nanomaterials. The OECD Chemicals Committee has established the Working Party on Manufactured Nanomaterials to address this issue and to study the practices of OECD member countries in regard to nanomaterial safety. A series of publications have been prepared, providing information related to human health and environmental safety.