EUROPEAN CHEMICALS AGENCY

EUROPEAN CHEMICALS AGENCY ECHA - NANOMATERIAL WORKING GROUP (ECHA-NMWG)
EUROPEAN CHEMICALS AGENCY, ECHA, HELSINKI

The purpose of the NMWG group operation at the European Chemicals Agency, ECHS, is to contribute to the directives for risk assessment for nanoparticles in the frame of the REACH legislation and CLP Decree (classification, packaging and labelling of chemical substances) and the Decree on biocidal products.  The group has been active since January 2013 and was given the mandate to continue its activities in May 2014 (http://echa.europa.eu/regulations/nanomaterials).

Dr. Mojca Kos Durjava from the National Laboratory of Health, Environment and Food represents the Republic of Slovenia in the group NMWG at the ECHA. She was appointed as group member at the constitution of the group in January 2013 on the initiative of the Office for Chemicals of the Republic of Slovenia.

What is a risk assessment of chemicals?

A risk assessment of chemicals is of key importance in order to ensure that undesirable or harmful effects on the health of people, animals or the environment upon production or intended use are avoided. It is a matter of definition and a preferably quantitative determination of the risk, resulting in the definition of the dose – response ratio and the target population. In general, this is a procedure which includes the following elements:

  • identification of the hazardous nature of the chemical,
  • impact assessment,
  • estimation of exposure,
  • risk characterisation.

What are nanoparticles and why are amendments of the legislation for the risk evaluation of nanoparticles necessary?

A nanoparticle is a particle of matter, at least in one dimension smaller than 100 nanometres. Nanoparticles can be thin small plates with a thickness under 100 nm, small threads with a diameter under 100 nm or small particles under 100 nm in all three dimensions. Nanomaterial is a material containing nanoparticles. The dimension of nanoparticles is comparable to the dimension of individual parts of the living cell. Nanoparticles therefore could affect cell membranes, thus also the function of cells, some nanoparticles can also enter the cell, accumulating and influencing the mechanisms of the cell. The larger specific surface of the nanoparticles means also that the cell is exposed to more active molecules on the particle surface which can have positive (intrusion of active substances) and also negative consequences (i.e. toxicity, generation of free radicals).

To facilitate the risk assessment of products with nanoparticles the behaviour of the nanoparticles in different environments should also be taken into account and the legislation amended accordingly.

SUMMARIES OF THE MEETINGS OF THE Nanomaterial Working Group, ECHA, HELSINKI

5. NMWG meeting, 21 - 22 October 2014, ECHA, Helsinki
The discussion in the fifth meeting was focused on the presentation of the activities in the area of the nanomaterials at the OECD, the ECHA presentation of activities and the read-across and nanoparticle integration, the FP7 project NanoValid was presented, the industry presented 2 dossiers on nanomaterials, the ECHA presented the new concept “assessment entity”, being developed in the process of the development of the IUCLID6 software that should be used for the preparation of the dossier from 2016 onwards. The ECHA also presented the process of REACH instructions supplementation for nanomaterials, the instructions will be ready until 2018. The presentations were brought by representatives of the ECHA, of the industry and by other participants of the meeting. The work on the second day took place in groups, the first discussing the new concept of “assessment entity” and the second the environmental risk assessment and the risk assessment of nanomaterials for the environment. The discussion was focused on the carrying out of toxicity tests for algae and daphnids.

4. NMWG meeting, 24 - 25 June 2014, ECHA, Helsinki
The discussion in the fourth meeting was focused on read-across and nanomaterials integration and necessary information for these methods. The NMWG group has received the mandate to continue its work in May 2014, expanded also to the area of biocides (BPR).

3. NMWG meeting, 1 - 2 October 2013, ECHA, Helsinki
On the first day of the third meeting some cases of read-across for nanoparticles use were presented, the presentation of European FP7 research projects in the field of read-across for nanoparticles. NMWG subgroups for read-across, organic nanomaterials and nanoparticles characterisation were presented. The new concept of nanoparticles identification (SID), the generic form concept, was presented.  The large European research project NANoREG was also presented, engaging more than 60 partners from 14 EU member states. The NMWG group was divided into three subgroups on the second day of the third meeting, namely the subgroup for read-across, for organic nanomaterials and for nanoparticle characterisation.  Upon completion of work by groups, the work was discussed.

NMWG Group meeting, 27 June 2013, Webinar
The second meeting was organised as a webinar. The NMWG group divided into three subgroups, namely for read-across, for organic nanomaterials and for nanoparticle characterisation.

1. NMWG meeting, 23 January 2013, ECHA, Helsinki
In the first meeting, the debate was centred on the definition of nanoparticles, on the registration of nanoparticles, on the REACH and CLP legislation from the viewpoint of nanoparticles, a case of "nano" dossier evaluation has been presented and how to prepare the nanoparticles dossier.

LEGISLATION

 REACH
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
(http://www.uk.gov.si/si/delovna_podrocja/reach/)

 CLP
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
(http://www.uk.gov.si/si/delovna_podrocja/razvrscanje_pakiranje_in_oznacevanje_kemikalij/)

 BPR
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
(http://www.uk.gov.si/si/delovna_podrocja/biocidni_proizvodi/)

NANOPORTAL

http://www.uk.gov.si/si/delovna_podrocja/nanoportal/

CONTACT

dr. Mojca Kos Durjava, This email address is being protected from spambots. You need JavaScript enabled to view it.