As the European Commission undertakes public consultation regarding its proposed regulation of nanomaterials, Tatiana Santos from the European Environmental Bureau (EEB) explains why none of the options on the table are good enough.
In its Second Regulatory Review of Nanomaterials, the European Commission reiterated its view that REACH (the European Community Regulation on chemicals and their safe use) is the best framework for the risk management of nanomaterials. But the reality is that most nanomaterials are not even registered under REACH, let alone risk managed. There is a little knowledge of which nanomaterials are used and made in Europe: we do not know which are on the market, who produces or uses them, or the amounts in which they are made. The principle of “no data, no market” is simply not applied to nanomaterials. To date, only 11 have been registered as such, but it is safe to say there are more than 11 on the European market. In Germany alone, 207 nanomaterials were identified by the Resina research project and only 5% of nanomaterials have been registered under REACH. The information provided for the 11 registered is inadequate, suffering from major deficiencies on identification, classification and risk characterisation.
Since the Commission couldn’t ignore these facts, it promised to produce an impact assessment of regulatory options, “to ensure further clarity on how nanomaterials are addressed and their safety demonstrated in registration dossiers”. But the only options considered involve the amendment of REACH annexes. Thus it has dismissed two key options: a specific nanomaterials Regulation; and changes to the main text of the REACH Regulation, both backed by NGOs, some member states and the European Parliament.
The Commission’s new strategy for wasting time is a public consultation on six options for changing the REACH annexes. Respondents are asked to give their opinion on “cost, safety and overall efficiency of the regulatory process”.
In our view, the public consultation should be looking at how to ensure nanomaterials are properly registered under REACH – not on how costly action would be. The existing lack of information should be enough reason to act. Indeed, the costs of inaction should be compared to the costs of action, and the health and environmental benefits of strict regulation should be considered. The Commission, against precautionary principle rules, is placing the burden on respondents to prove there is a risk before taking action, using an impact assessment on the costs/benefits. But an accurate impact assessment is not possible because we lack the necessary information on exposure. This is a vicious circle: without information on exposure, the risk cannot be characterised, and REACH will not be amended. Moreover, without a proper registration system (through an amended REACH), we will never have information on exposure. Therefore, REACH must be amended if we are to properly characterise the risks.
The European Environmental Bureau (EEB) wonders what the real purpose is of a consultation on costs and the effectiveness of taking action. A likely outcome – as with the REACH Review’s SMEs survey – is that little action will follow, as firms producing and using nanomaterials will only highlight the costs. On the other hand, the benefits of tighter controls cannot be estimated as not even the risks are known.
Moreover, the consultation options are lacking additional proposals on specific information requirements, which are essential for the characterisation of nanomaterial risks, such as morphology/shape/aspect ratio, agglomeration/aggregation index in air and water-systems, rigidity, aspect ratio distribution, extra tests for genotoxicity, catalytic properties, radical formation potential or photo degradation properties.
Concerning the different options:
- Option 1 as the Commission has already recognised that action is needed, this option would be inappropriate as it assumes no new policy actions;
- Option 2 is to further clarify (with no additional measures) several aspects of the registration. In our view, it is good option, but insufficient;
- Option 3 is to introduce non-binding measures. However, voluntary measures have been shown not to work. ECHA has already invested a huge amount of public resources in training the industry; developing guidance materials, workshops, seminars and working groups, but this has not served its purpose. Six years after REACH came into force, the chemicals industry maintains tight secrecy about the nanomaterials it makes and uses;
- Option 4 contains a few additional measures to demonstrate safe use. Again: good, but insufficient;
- Option 5, which grants nanomaterials specific regulatory exemptions, contradicts the Second Regulatory Review’s statement that “more specific requirements for nanomaterials within the framework have proven necessary”. If nanomaterials deserve to be treated the same way as other substances, nanomaterial producers should have to prove their nanomaterials are safe before placing them in the market, as happens with other chemicals. However, this does not happen, as nanomaterials are not even registered; and
- Option 6 integrates options 2 and 4, and is the only one we could accept, as it considers scientific recommendations, and would partially fill the knowledge gap on nanomaterials. However, it will not be sufficient as it leaves out hundreds of nanomaterials produced in the EU in annual volumes below 10 tonnes, and does not incorporate the Commission’s regulatory definition of nanomaterials. The amendment of REACH is the only way of overcoming this problem, but sadly, there is not enough political will for this to happen.
Tatiana Santos is a senior policy officer with the European Environmental Bureau (EEB)
This article originally appeared on the Chemical Watch website.
