Intention appears in unpublished draft document on the upcoming EU chemicals strategy for sustainability
The European Commission is planning to introduce PMTs and vPvMs as “categories” of substances of very high concern (SVHCs) under REACH.
The plan raises the possibility of hundreds of additional chemicals being identified as SVHCs on the basis that they are persistent, mobile and toxic (PMT) or very persistent, very mobile (vPvM), and without reference to “equivalent level of concern”.
The Commission’s intention is set out in an unpublished draft communication document on the upcoming EU chemicals strategy for sustainability, circulated in June and recently seen by Chemical Watch. It is not final and is subject to change before publication, expected in the autumn.
“The first step to achieve [introduction of PMTs and vPvMs] will be to strengthen information requirements in order to perform comprehensive environmental risk assessment under the relevant legislation,” the document also says.
The intention is one of several relating to persistence. The Commission says in the document that it will also “propose hazard classes and criteria” in the CLP or the Globally Harmonized System (GHS) of classification and labelling of chemicals to “fully address environmental toxicity, persistency, mobility and bioaccumulation”.
Scientists say that mobility should be considered in regulatory risk assessment of chemicals in order to fill an important gap, relating to certain chemicals that pose a threat through contamination of water sources.
Last year, the EU’s Scientific Committee on Health, Environmental and Emerging Risks (Scheer) identified PMT substances as one of 14 emerging issues.
Later in the year, an initiative led by the German Environmental Agency (UBA) finalised criteria for identification of PMT and vPvM substances to facilitate risk management. Over 100 scientists representing regulatory agencies, academia and industry approved the final report. EU member states and NGOs voiced general support for implementation of the criteria under REACH, but Cefic said that they are “not fit for purpose” and could lead to unnecessary regulation. In May, European industry research organisation Ecetoc presented preliminary results of an ongoing project that suggest monitoring data does not support the threshold for aquatic mobility implied by the criteria.
Carcinogens, mutagens and reprotoxins, as well as certain types of chemicals that are both persistent and bioaccumulative, can be routinely identified as SVHCs, according to Article 57 of REACH. Chemicals falling outside of this subset – including those that are both persistent and mobile – may be identified as SVHCs “on a case-by-case basis”, if there is “equivalent level of concern”.
The plan was welcomed by one architect of the criteria, Hans Peter Arp of the Norwegian Geotechnical Institute (NGI) and the Norwegian University of Science and Technology. Last year, an investigation by Professor Arp and another scientist identified 260 REACH registered substances meeting the PMT and vPvM criteria, including 122 that should be prioritised for further investigation in relation to potential risk management.
“As a scientist working with both hazard and risk of PMT and vPvM substances, I really like the phrasing: ‘the first step to achieve this will be to strengthen information requirements in order to perform comprehensive environmental risk assessment under the relevant legislation’. Certainly for both hazard and risk assessment of PMT and vPvM substances, we need better quality data, particularly related to environmental half-lives, the sorption properties of ionic and ionisable substances, leaching tests and exposure modelling. This could all be propelled through new regulatory requirements encouraging more, and better, data requirements for environmental properties.”
Professor Arp also praised the statement in the document about CLP and GHS. “PMT and vPvM substances in drinking water and remote aquatic ecosystems is a global, trans-boundary concern, not just a European one. This needs to be addressed on the international level.”
The Commission and Cefic declined to comment for this article.
Chemical Watch, 9 July 2020