13 Dec 2018
New Information Requirements Concerning Nanomaterials Published
Hong Kong manufacturers may know that nanomaterials are present in everyday consumer goods, such as clothing and shoes; cosmetic products including sun cream, deodorant and toothpaste; electronics and computers; home furnishings; household products including kitchen utensils; food and food packaging; sports equipment; and children’s toys and games.
The REACH Regulation is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a “substance” in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH, such as the registration of substances manufactured at 1 tonne or more and providing information in the supply chain, apply to nanomaterials as for any other substance.
New Commission Regulation 2018/1881 amends several annexes of the REACH Regulation, in order to clarify what information companies placing substances on the market in nanoform need to provide in their registration dossiers. the European Commission adopted these new amendments on 3 December, and they will begin applying on 1 January 2020.
The main goal of the recently introduced revisions is to systematically assess the hazardous properties of nanomaterials, to define the risks they may cause to health and the environment, to unfold the necessity to adopt further risk management measures and to find ways of using them safely in the production of products containing nanomaterials.
In 2011, the EU adopted a definition of nanomaterial by means of Recommendation 2011/696/EU. According to this Recommendation, a nanomaterial is “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 %”.
The amendments that will become mandatory at the start of 2020 for new as well as existing registrations will significantly clarify REACH registration requirements with regard to nanomaterials. The amendments include the following:
- Requirement to identify and characterise nanoforms of any substance covered by the registration. They can be documented individually or jointly in sets of similar nanoforms by providing clear identification of size, shape, and surface chemistry of particles of the nanoforms covered by the registration.
- Compilation of basic information on volumes and uses of nanoforms.
- Clarifications of how obligations on substance apply to all nanoforms covered by the registration: performance of chemical safety assessment (and application of its conclusions when applying adequate risk management measures), documentation of information requirements on hazard assessment and application of adaptation possibilities, etc.
- Introduction of requirements for adequate sample preparation, route of exposure and characterisation of test material when in nanoform, consideration of appropriate metrics when reporting the results and specific principal physico-chemical properties that can support the safety assessment of nanomaterials (dissolution rate, dispersion stability of nanoforms).
- Qualification of existing adaptation possibilities to ensure their responsible application to nanoforms and modification of the information requirement where the test method is not applicable/informative for nanoforms.
In order to fulfil the new information requirements, companies must first assess whether the new requirements apply in respect of their substances.
The industry has broadly supported the adoption of the amendments, promising help to create a more predictable regulatory environment for the nanomaterials industry. However, a few content-related concerns have been raised on the application of the new amendments by the European Chemical Industry Council (CEFIC) and the Center for International Environmental Law (CIEL). CEFIC emphasises the fact that while the annexes’ revisions have been adopted and are due to enter into force in 2020, the process for revising the Commission’s Recommendation on the nanomaterial definition is still ongoing. CIEL, on the other hand, has concentrated its criticisms more on the fact that registrants may still attempt to limit the amount of information they provide to ECHA.
ECHA nevertheless invites all registrants of the substances concerned to familiarise themselves with the amendments, and assess the actions that they may have to take to fully comply with them. This is because the amendments to the REACH Regulation could have wide ranging effects on many companies.
Hong Kong traders may be relieved to learn that the European Chemicals Agency (ECHA) is currently updating ECHA guidance which will make the requirements easier to grasp and implement. ECHA is also working on the adaptation of REACH-IT submission tools, presumably for the orderly inputting of the required information.