Proposed REACH annex amendments for nanomaterials need more detail, according to a position paper by the Centre for International Environmental Law (Ciel), the European Environmental Citizens Organisation for Standardisation (Ecos) and the German Öko-Institut.
As pressure grows for the European Commission to revise REACH annexes for nanomaterials, the paper discusses the Commission’s proposed amendments, as presented to the competent authorities’ sub-group on nanomaterials (CASG-nano) in 2014 .
The organisations welcome the inclusion of a nano definition in REACH Annex VI. However, they point out that proposals for characterising nanoforms only cover minimum requirements. “Important information is missing”, including particle-size distribution outside of the 1nm to 100nm range, says the paper.
Surface chemistry and charge, and whether particles form clumps and clusters, during use and release, should also be considered, it adds. It also points out that information on surface treatment, coating or functionalisation remains “extremely limited”, despite being relevant for risk assessment.
The position paper refers to a 2014 study by Risk and Policy Analysts (RPA), pointing to a lack of nanoform information in registration dossiers.
Last week, Geert Dancet, head of Echa, said that 40% of dossier compliance check decisions are currently appealed and that some companies are even challenging the premise that REACH covers nanoforms.
Ciel and partners suggest that physico-chemical and (eco-)toxicological information should be included in registration dossiers, when nanoforms are used in consumer products. “With this amendment, an important loophole regarding the risk assessment for most of the existing nanomaterials … would be closed,” they write.
Nanoparticles should be fully characterised before grouping for read-across and toxicological assessment, stresses the paper. “Allowing the grouping for (eco)toxicological assessment of non-characterised nanoforms would defeat the purpose of most of the proposed amendments,” it says. “It is scientific nonsense to group several uncharacterised materials for the purpose of hazard assessment.”
At its 15th meeting on 4-7 November, the OECD’s Working Party on Manufactured Nanomaterials (WPMN) will discuss a progress report on physical-chemical properties for grouping for read-across. It will also wrap up case studies on exposure assessment for gold and silver nanoparticles.
The main focus of the meeting will be to plan the WPMN’s programme of work for 2017 to 2020. To help with this, the working party will hear presentations from various delegations, explaining particular policy challenges, said chair Peter Kearns.
At the meeting, the WPMN will also begin to review the OECD Council recommendation on the safety of nanomaterials, last agreed in 2013.
CASG-nano’s last meeting was in December 2014 . «
Article of Emma Davies
Position paper : http://www.ciel.org/wp-content/uploads/2015/10/Position-Paper-REACH-Annexes-Final.pdf
RPA report, 2014 : ec.europa.eu/DocsRoom/documents/10150/attachments/1/translations/en/renditions/native%20
Cet article n’engage que son auteur/ This article is the sole responsibility of the author