Risk Assessment of nanomaterials from an industry perspective Jenny Holmqvist
European Chemical Industry Council - Cefic We are the forum and the voice of the chemical industry in Europe With a Brussels based office of 160 people we are working with over 4.000 industry experts across the chemical industry Cefic s membership entails around 29.000 companies (96% have less than 250 employees) Together they have a direct employment of nearly 1.2 million people and represents 29% of the world production of chemicals Cefic represents the raw materials producers, of which some also provides finished products on the market In our membership less than 20 substances are produced at the nano scale Nanomaterial Nano products 2
The concept of Risk and Risk Assessment Hazard (source of potential harm) * Exposure (pathway) = Risk (the probability of an adverse effect to occur) Perception Risk Assessment is the process of identifying, analysing and evaluating the risks 3
How are uncertainties addressed Precautionary Principle; applies when there are grounds for concern due to insufficient, inconclusive or uncertain scientific evidence Risk assessment; not an exact science, built around estimations and correlations Impact of uncertainty; the use of assessment factors and the assumption that humans are the most sensitive species. Risk assessment; a moving target, development in methodologies, understanding and interpretation of results is a continuous process 4
Risk Assessment paradigm in REACH Collect available information Properties, manufacturing process, use, exposure, existing RMM Hazard Assessment Classification, PBT assessment, dose/concentration response characterisation Exposure Assessment Exposure scenarios (RMM and OC), estimate exposure levels Risk Characterisation Document & Communicate Yes Risk controlled? No Iteration CSR, SDS and label 5
Collection of available information Current industry practice; Data exists at company level For some materials there is comprehensive information dossiers containing Epi studies Information on the bulk can be used as a base for further assessment. Current publicly published data is often based on indicative studies rather than OECD protocols Further refinement of existing protocols; More information will be accessible in the public domain through the OECD Sponsorship Program, ongoing FP7 projects, REACH registrations and CLP notifications 6
Hazard Assessment Current industry practice; Generation of information in REACH is based on a tiered and risk based approach depending on volume Context of regulation adverse effects What is adverse? Case by case assessment Test methods are in general applicable with attention to dosing, characterisation and sample preparation Granulometry needs to be improved; additional phys-chem properties Read across from the bulk is possible with scientific justification Up to date, no new nano specific effects have been demonstrated Further refinement of existing protocols; - RIP-oNs (evaluation of existing guidance applicability to nanomaterials) - redraft of the chapter on granulometry, further research needs are identified - OECD thorough assessment of test methods - Preliminary results confirms the applicability with some adaptations regarding dosimetry and sample preparation - FP7 outcomes (MARINA, Nano Genotox) - Other metrics than mass could be useful for a small group of materials further research needed 7
Exposure Assessment Current industry practice; Determination of potential for exposure is essential, especially for the end use Manufacturing process in closed systems Tier 1 models can give an indication of the level of exposure The added contribution of ind. emissions is complex to measure in the env. Occupational measurements are possible but sensitive to background levels Majority of the products currently on the market uses nanomaterials incorporated into a matrix such as paint with negligible exposure to nano particles for the consumers Further refinement of existing protocols; - RIP-oNs (evaluation of existing guidance applicability to nanomaterials) - Tier 1 models results must be strengthened with measurements - Background levels addressed - FP7 projects with industry involvements aims at develop/improve methods for measuring exposure to nanomaterials. - NanEx - NanoCare 8
Documentation and Communication Extended SDS Reg. Dossier CLP not. SDS 9
Communication remains a challenge It is all about providing the right information to the right person at the right time whilst taking existing limitations into account. Emerging technologies have to be developed in a sustainable manner to be viable where communication is the most important tool Investments for future applications makes some information highly Confidential Business Information Organising and actively participating in dialogues Companies are increasingly publishing their toxicological test reports on their websites Voluntary programs to generate and increase information sharing, transparency and communication globally; GPS 10
Conclusion Nanomaterials can be assessed ; The risk assessment paradigm, its guidance and the existing test methods are in general applicable Research from both industry and public institutions should be decision-oriented and transparent and aim to bring further refinement of current risk assessment protocol To meet Europe s challenges, particularly in energy-efficiency, health and welfare, the development of nanotechnology is a must and will increasingly be needed for our leading technologies 11
Thanks for listening! Contact details; jho@cefic.be 12
This paper was produced for a meeting organized by Health & Consumers DG and represents the views of its author on the subject. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Health & Consumers DG's views. The European Commission does not guarantee the accuracy of the data included in this paper, nor does it accept responsibility for any use made thereof.