ECHA

ECHA is moving ahead with the evaluation of nanomaterials, following the agreement of the Member States' competent authorities during its workshop on nanomaterials at the end of May.

The common approach is pragmatic and step-wise, balancing the scientific uncertainties with the legislative framework of REACH. The Agency is a focal point for the nano-related discussions through the establishment of a nanomaterials' working group and by taking over the coordination of the Group Assessing Already Registered Nanomaterials (GAARN). Both involve the Commission, national authorities and other stakeholders.

The nano particles, which represent a giant leap in modern chemistry and which have formed a growing multi-billion Euro industry, have intensified the scientific and regulatory discussions in REACH. Wim De Coen, ECHA's Head of Unit for Evaluation I and the leader of the Agency's task force on nanomaterials, is quick to point out: "The scientific uncertainty of nanos forces the regulator to be more cautious, but it does not mean stigmatising nanos." He clarifies that ECHA's approach responds to the recommendations of the Scientific Committee which advises the European Commission on Emerging and Newly Identified Health Risks (SCENIHR) to assess nanoforms on a case-by-case basis.

"From an early stage, we have not considered nanos to be more hazardous than any other substances." Dr De Coen explains that the classical principles of toxicology (i.e. hazard assessment) do not necessarily apply to all types of nanomaterials because of their tiny size and their relatively large surface area. Furthermore, experts involved in the work of the Organisation of Economic Cooperation and Development (OECD) on the safety of manufactured nanomaterials have acknowledged that adaptation of current test guidelines may be necessary in some cases and that specific guidance will have to be developed, for example, on sample preparation and dosimetry.

REACH AND CLP NANO BASICS

The starting point is the REACH and CLP definitions for substances. They are not explicit about nanomaterials, but apply to them as to all other forms of chemicals. This was again confirmed by the Second Regulatory Review of Nanomaterials, published this month*, which states that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures.

The next step was the recent recommendation** of the European Commission on the definition of nano, which provides more clarity in the debate between regulators and registrants regarding the size (in the range of 1 nm-100 nm) and number (50 % or more as default) of particles in a nanomaterial. ECHA will use this definition as the benchmark for registration and evaluation.

From the GAARN forum, where companies shared their experience from the registration of nanos for the first REACH deadline, and the recent workshop on nanomaterials, another important message for current and future registrants came forward: nanos are synthesised by design; they do not occur by accident. If companies make them, they know what specific properties they want them to have in order to achieve their market objective. These properties should be documented in the registrants' dossiers and the information provided should be in line with the new harmonised definition for nanomaterials. ECHA and the Member States are in agreement on this approach.

DEALING WITH THE NANO INFORMATION GAP

Following the first REACH registration deadline in 2010, ECHA has been screening the dossiers containing nanos in a common project with the European Commission's Joint Research Centre (JRC). Since nanomaterials are registered together with bulk materials, the project team expected that many of those substances, which exist both in the bulk and in the nanoform, would be reported on both types of properties in the registration dossier. "We have found a surprinsingly low number of explicit claims that the This is the case even for substances, which are included in the OECD list of manufactured nanomaterials", says Frank Le Curieux, who is a member of ECHA's task force on nanomaterials and represented the Agency in the tenth OECD Working Party on Manufactured Nanomaterials.

This lack of nano-specific information prompted ECHA to act using both the carrot and the stick. The Agency is now implementing a two year programme for internal and external capacity building, sharing experience, participation in and contribution to international regulatory activities.

ECHA is providing feedback and advice to registrants on nanos and supporting the preparations for REACH 2013. This advice is based on compliance checks of registration dossiers, the results from the ongoing JRC project and the good practice of registrants taking part in the GAARN initiative. ECHA has also released new annexes to the Guidance on Registration specific for nanomaterials.

Regulatory actions are also now under way. ECHA has sent draft decisions requesting nano-specific information from registrants of dossiers in which nano properties were not sufficiently documented (under Art. 41 of REACH). Registrants who may be manufacturers of nanos, but did not indicate this in their dossiers, have received letters under Article 36 of the REACH Regulation, which imposes on registrants the duty to gather and provide on request ‘all the information the registrant requires to carry out his duties under this Regulation'. "These Article 36 letters by no means request the generation of new information," Wim De Coen points out. "This is their main difference with the draft decisions. An Article 36 decision is asking a company to submit to ECHA already available information regarding a specific property, in this case particle characteristics; because we have reason to believe that the company may already have such information. Of course, this is legally binding and registrants need to reply. Not replying means enforcement actions", Dr De Coen stresses and advises registrants to update their dossiers.

To support industry in providing complete information, ECHA has developed a questionnaire. "The more information you give already, the more unlikely you are to receive a draft decision" , Wim De Coen highlights and insists that ECHA has a pragmatic approach. "Currently, we are looking for a constructive and proactive response from registrants to provide us with information on their nanomaterial properties. This is also a wake-up call for future registrants: it is necessary to include nano-specific information in the dossiers."

STEPPING UP NANOMATERIALS' SAFETY

Both the draft decisions and the Article 36 letters request registrants to characterise their nanomaterials. "Our aim is to provide clarity primarily on the particle characteristics. This is the first step. What we want at this stage is for companies not to go away and say they cannot characterise their material. Yes, this is scientifically challenging, but we know from the discussions with registrants that it is possible", says Dr De Coen. For example, the manufacturers will tend to know which properties they need: size, form, surface, volume, surface treatment. This is exactly the type of information that ECHA requires.

"Currently, we are not instructing registrants which method to use. There are many methods available and we let them decide which ones are the most suitable to describe the characteristics of their specific nanoforms. Our aim is to develop a matrix approach, so that all registrants who wish to cover nanomaterials in their registration should be able to document it with the best available methods", says Dr De Coen. One of the most important messages from the last GAARN meeting was the ‘can do' approach. "Documenting the characteristics of your particles is just a start. If the registrants do not do it, we will not achieve any breakthrough in the nano discussion."

Focusing on the physico-chemical properties is the first step in ECHA's strategy and one of the main outcomes from the workshop with the Member States. This will be the approach to follow through evaluation. "First we want to clean up the landscape", says Dr De Coen, continuing "Let's resolve in the first place the uncertainty about the particulate aspects such as size, shape and surface treatment. Then we can go further towards addressing the potential hazards. The hazards will be largely driven by the physico-chemical characterisation, so it will only be possible to do this gradually." By knowing the properties of the substances and their characteristics better, it will be easier for registrants to find the best approach to start testing and address the potential hazards strategically, from a risk perspective.

In parallel with the work done by the registrants, ECHA is setting up a working group on nanomaterials to informally provide scientific advice on any aspects of nanomaterials under REACH and CLP. Frank Le Curieux and Ofelia Bercaru, who are in charge of gathering the nominations and preparing the first meeting of the group, stress that the activities of the working group should not interfere with ECHA's decision-making. On the contrary, it aims to facilitate ECHA's functioning by bringing in scientific expertise that can clarify nano-issues at the Member State Committee level. "With the increased knowledge, it should be possible in the future to identify and test the nanoforms that are relevant for the safe use of a given chemical", says Wim De Coen. "We aim at setting up, collectively with the Commission, Member States and stakeholders, a level playing field for manufacturers of nanomaterials. Where needed, dossier and substance evaluation are crucial for getting this job done. If we can achieve this, we will improve European competitiveness and innovation, as well as safeguard chemical safety to protect human health and the environment."

ECHA is starting a series of webinars on nanomaterials. The first one will take place on 30 October.

The Agency now has a dedicated section for nanomaterials on its website.

Best practice on physicochemical and substance identity information for nanomaterials - Report from first GAARN meeting

Workshop on Nanomaterials Proceedings

ECHA Guidance on Information Requirements and Chemical Safety Assessment - recommendations for nanomaterials
 

*Communication on the Second Regulatory Review of Nanomaterials (COM(2012) 572 final)

**Commission Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU)

DID YOU KNOW?

The revised EU Biocides Regulation has already taken on board the nanoscale. It contains explicit requirements for the labelling of biocidal products for non-agricultural uses, by indicating the material and using the word "nano". The text refers to the EC definition of nanomaterials and asks for a separate evaluation of the risks deriving from them.