EU REACH requirements for nanomaterials - more efforts needed

As of 1st of January 2020, chemical companies manufacturing or importing nanomaterials, need to comply with the information requirements for nanomaterials in their REACH registration dossiers, as determined in Commission Regulation (EU) 2018/1881 of 3 December 2018. First of all, companies need to determine that the products they manufacture or import fall under the European Commission (EC) recommendation on the definition of a nanomaterial adopted in 2011. Secondly, they need to characterise the nanoform(s) according to the new requirements and demonstrate safe use for human health and environment.

Nanostrucure

However, many companies have a “wait and see” attitude as several guidance documents are still missing or not very well developed. In addition, several testing guidelines are not finalized or amended yet for nanomaterials. In practice, the uncertainty resulting in the “wait and see” attitude has led to confusing situations for co-registrants in case the lead registrant did not take action, as well as inefficient situations for lead registrants that took action but could not get all affected co-registrants aboard.

As a result, quite some companies are currently not compliant. Moreover, as the ECHA is proactively informing Member States’ Competent Authorities for enforcement actions, this is a risky situation for the market in general. Furthermore, an important part of the nanomaterial-related dossier updates submitted so far have been rejected after the (manual) Technical Completeness Check (TCC), resulting in a 4-months period within which a new update should be submitted. In case the new update would not pass the TCC either, the registrant would be faced with incompliance as well, which would also pose realistic threats to the nanomaterial market.

Therefore, both lead registrants and co-registrants are recommended not to postpone further action and to collaborate on their compliance strategy for nanomaterials.

As a first step, companies should fully characterise their nanoform(s) according to the updated REACH Annex VI, Subsection 2.4 (number based particle size distribution, shape, aspect ratio and other morphological characteristics (such as crystallinity), (Volume) Specific Surface Area ((V)SSA) and surface functionalisation or treatment) to allow their identification and grouping. For reasons of comparability, this should preferentially be done using the same methodology.

Secondly, a tiered and iterative endpoint coverage strategy should be developed to confirm the grouping of (sets of) nanoforms, considering that the available guidance still fails to provide clear information on several aspects of nanomaterial evaluation.

Arcadis helps companies to fulfill the nano-specific REACH requirements by:  

  • Providing technical advice on the characterisation of (potential) nanomaterials (including method optimisation) to investigate whether they comply with the prevalent definition in the EU
  • Defining initial sets of nanoforms
  • Initiating and monitoring (analytical) tests for nanomaterials with experienced research institutes or contract research organisations
  • Advising on endpoint coverage strategies, set up intelligent testing strategies, and develop grouping strategies, guaranteeing efficient allocation of time and budget
  • Offering expertise in hazard, exposure and risk assessment under REACH
  • Supporting in the interaction and discussion with the European Chemicals Agency and competent authorities
  • For the update of joint registration dossiers: gathering information from all registrants as a Trustee to avoid confidentiality issues when updating dossiers jointly
  • For co-registrants: update individual dossiers that rely on information in the joint dossier as well as individual dossiers addressing their nanomaterials via opt-out
  • Advice concerning cost sharing specifically for nanomaterial-related dossier updates


 




Nele Deleebeeck

‎Senior Environmental Toxicologist +32 492 73 04 90 Ask me a question
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