Blue Frog reported back in September 2018 that ECHA had released the draft updates to REACH (Regulation (EC) No. 1907/2006) for the purpose of clarifying information requirements for those registering nanomaterials. It was previously identified by the Commission (2012) that "Regulation (EC) No 1907/2006 sets the best possible framework for the risk management of nanomaterials when they occur as forms of substances or mixtures but more specific requirements within the framework are necessary."
The draft updates has now been reviewed by the European Parliament and council and fully adopted (Regulation (EC) No 2018/1881). Therefore, the provisions previously mentioned within the draft which now form the official amendment must now be abided by (N.B. little changed between the draft and the adopted amendments). Currently, the definition of a nanomaterial follows the Commission Recommendation set in 2011 (2011/696/EU). Although, this is currently subject to review, but this review has been put on hold. Furthermore, the term "nanoform” has been adoptedwhich “is a nanomaterial with a specific shape and surface chemistry”.
The amendments are a welcome clarification for Registrants of nanomaterials under REACH. However, due to the technical difficulties and differing dynamics of materials at this scale, although the requirements are now defined, some test guidelines are still undergoing finalisation or simply not available. For example guidance on how best to assess (equipment and methods) morphological and chemical changes of nanomaterials during biodegradation would be highly useful in order to fulfil the requirements set out in Annex VIII Section 9.2. The development of specific bioaccumulation testing and identification of surrogate(s) for this endpoint where partition coefficients do not apply would also serve great purpose. There is recognition of such issues within Regulation (EC) No 2018/1881 stating: "The Agency, in cooperation with Member States and stakeholders, should further develop guidance documents for the application of the test methods and waiving possibilities for the standard information requirements provided by this Regulation for the purposes of Regulation (EC) No 1907/2006." The differences in materials and nanomaterials are further highlighted throughout the amendments with updates to the requirements for acute toxicity, mutagenicity and some waiving justifications which now may not apply or will only apply with sufficient justification (e.g. for nanoforms, the study may not be waived on the basis of high insolubility in water alone). It was also highlighted, that nanoform Registrations should be accompanied by a minimum suite of nano-specific characterisations such as shape, surface properties and size and further that such endpoints as dissolution rate should be measured also in relevant biological and environmental media as well as water. There may be further physico-chemical information in addition to those that identify nanoforms, but for those registering ≤10 T/year will not be required to submit such information for workability and proportionality (cost-wise) reasons. Further, for low volume phase-in nanoforms where existing (Q)SARs do not apply, the insolubility information should be applied as a surrogate for potential toxicological and ecotoxicological aspects for the nanoforms of a substance. Following on from this the Commission recognised that (Q)SARs reliant on water solubility and partition coefficient (which may not apply to many nanoforms) will be inappropriate. Therefore, in order to meet the three R's of toxicology and to ensure proportionate costs for a registrant other methods such as grouping and read-across should be sought where possible. There is currently a drive towards this processes by industry, academia and regulatory bodies seen in varying EU projects (e.g. GRACIOUS) and the activities highlighted by the EU nanosafety cluster.
Transformation of the nanomaterial during use is also addressed within the document and it is advocated that the downstream user should provide information of this up the supply chain to ensure that the use isadequately covered by the registration dossier of the manufacturer or importer, or alternatively cover the specific use in their own chemical safety report.
Further, in the preface to the amendments it is noted; Compliance to the regulation is not required immediately, but any registrants of nanomaterials should be aware that the nanoform amendments to Regulation (EC) No. 1907/2006 will apply from 1 January 2020, and that they must be compliant by this date.
This is a brief insight into some of the changes and technical difficulties surrounding the Registration of a nanoform. For more information please do not hesitate to contact us: kai.paul@bluefrogscientific.com.
