Nanomaterials are chemical substances
Particles at nanoscale can be made from many different substances such as carbon, metals metal oxides as well as polymers. It is difficult to provide an exact figure of how many nanomaterials are currently on the market and even more challenging to give an estimation of how many more are possible to produce in a laboratory environment.
Under REACH, the legal obligation on manufactures and importers to register and to show safe use, also applies to substances with nanoforms. On the other hand, only a few EU regulations have explicit legal requirements on nanomaterials such as the cosmetics and novel food regulations. As REACH does not have explicit provisions on nanomaterials, it has resulted in only a few registrations containing nanospecific information.
At the same time, the lack of specific provisions does not hamper proactive companies to transparently report on the nanoforms of the substance covered by the registrations. Reporting of nanospecific information has been made possible since 2010 when a voluntary tick box in IUCLID was introduced.
More information about registered substances that contain nanomaterials:
Registrants under REACH can chose to provide information on nanomaterials to ECHA by indicating the presence of a nanomaterial form in the composition of the substance, by indicating that the physical state of the substance is a nanomaterial, or by providing specific studies on a nanomaterial in an endpoint study record.
REACH is an overarching regulation for chemicals. Therefore, the way REACH defines chemical substances is important in a much broader sense as its concepts are reflected in other legislation:
'Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition’
It is important to note that many nanomaterials occur naturally and may therefore not fall under existing chemical legislations that address manufactured substances, such as REACH, unless they are intentionally chemically modified in any way. Other nanomaterials are formed as by-products, for example, from fossil fuels combustion using e.g., diesel engines. Such particles, however, fall under various environmental regulations such as those safeguarding ambient air quality.
Are there many more nanomaterials out there?
The estimates of the actual number of nanomaterial substances on the EU market vary.
There are probably more substances with nanoforms on the market than those currently registered under REACH. There are several reasons for this, including:
- Regulatory uncertainty: although the term ‘substance’ cover nanomaterials, as does the scope of the REACH Regulation, the regulation does not explicitly mention nanomaterials, nor does it provide explicit requirements. Some manufacturers/importers may interpret this as there being no obligation to provide nano specific information in their registration dossiers. The European Commission is currently preparing to amend the REACH annexes to make the requirements for nanoforms of substances explicit.
- Challenges in measurement: while the term nanomaterial is simple, measuring whether a form of a substance is a nanoform is often not simple. It requires precise and sometimes expensive instruments to do so. Therefore, with no explicit legal requirements to perform the test, manufacturers/importers may choose not to.
- Low volumes: some substances with nanoforms may be on the market at such low volumes, that they do not require registration under REACH. The deadline for registering low-volume chemicals (1-100 tonnes per year) is 31 May 2018.
There could be many reasons why the number of registered substances with nanoforms is low. It is also likely that there are several substances registered that are manufactured or put on the market as nanomaterials, where companies have chosen not to explicitly provide nano specific information in the registration dossier.
Nevertheless, as the regulatory issues are resolved, the available nano specific information gathered through the implementation of REACH is expected to increase.