Workshop on nanomaterials

Transcription

1 Workshop on nanomaterials Helsinki, Annankatu 18, P.O. Box 400, FI Helsinki, Finland Tel Fax echa.europa.eu

2 2 Workshop on nanomaterials LEGAL NOTICE Neither the European Chemicals Agency nor any person acting on behalf of the Agency is responsible for the use which might be made of this report. The opinions expressed in this document may not reflect an official position of the European Chemicals Agency or the organisations that participated in the workshop. Workshop on nanomaterials - proceedings Reference: ECHA-12-R-05-EN Publ.date: September 2012 Language: EN European Chemicals Agency, 2012 Cover page European Chemicals Agency Reproduction is authorised provided the source is fully acknowledged in the form Source: European Chemicals Agency, and provided written notification is given to the ECHA Communication Unit (publications@echa.europa.eu). If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: European Chemicals Agency Mailing address: P.O. Box 400, FI Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland

3 Workshop on nanomaterials 3 Table of Contents 1. INTRODUCTION SCIENTIFIC AND REGULATORY ASPECTS OF NANOMATERIALS EVALUATION Scientific challenges of evaluating dossiers containing nanoforms Scientific challenges in dealing with the risk of nanomaterials Feedback from the first meeting of the Group Assessing Already Registered Nanomaterials (GAARN) Nanomaterials under REACH Regulatory status of dossiers containing nanoforms Key points of discussion Discussion on points 2.1, 2.2 and Discussion on points 2.4 and NANOMATERIALS WORKING GROUP CONCLUSIONS AND FOLLOW-UP APPENDIX

4 4 Workshop on nanomaterials 1. INTRODUCTION Between May 2012, the European Chemicals Agency (ECHA) hosted a workshop to discuss the scientific and regulatory aspects of nanomaterials (NMs) evaluation under Regulation (EC) No 1907/2006 (REACH). The purpose of the workshop was to share experiences with and generate consensus among Member State competent authorities (MSCA) and Member State Committee (MSC) members on safety information for NMs in REACH registration dossiers. Based on the findings and recommendations from the workshop, ECHA and ECHA s current legal analysis, will also start to address the first NM substances under compliance check in 2012 and further into 2013 as well as MSCAs concerning the three CoRAP (Community Rolling Action Plan 1 ) substances including possible NMs to be evaluated in 2012 (silicon dioxide), 2013 (silver) and titanium dioxide (2014). The workshop was attended by 56 representatives from the Member State competent authorities, members of the Member State Committee, European Commission (DG Enterprise (DG ENT), DG Environment (DG ENV) and Joint Research Centre (JRC), Accredited Stakeholder Observers, Group Assessing Already Registered Nanomaterials (GAARN) members and ECHA. The participants were welcomed by ECHA s Executive Director Geert Dancet and Director of Regulatory Affairs Jukka Malm. Speakers from ECHA and the European Commission addressed the scope and legal provisions of NM evaluation under REACH and experience gained from the ECHA and JRC bilateral project on assessment of NMs in REACH registration dossiers. Scientific challenges related to the toxicity of NMs were presented by speakers from the Finnish Safety and Chemicals Agency (TUKES) and Finnish Institute of Occupational Health (FIOH). ECHA also presented the conclusions and next steps from the first meeting from the Group Assessing Already Registered Nanomaterials (GAARN), held the day before the workshop at the ECHA premises, with the purpose to build a consensus in an informal setting on best practices in assessing and managing the safety of NMs under the REACH Regulation. In the afternoon of the first day, the Netherlands competent authority (CA) presented their experience on the ongoing evaluation of one NM under substance evaluation. The German CA presented a practical guide prepared by the DE CAs with the purpose of aiding registrants to prepare their dossiers if registering NMs under REACH. Following these presentations, three break-out groups were formed to discuss NM-related issues in registrations dossiers and ECHA s currently used legal approach to address them. To encourage transparent registration of NMs under REACH, they were given the task of commenting on ECHA s approach and proposing a way forward on how to address the registration and evaluation of NMs. In the morning session of the second day, the rapporteurs reported on the findings of each break-out group to the plenary. The reports were followed by a plenary discussion. The afternoon session of the second day was devoted to discuss the mandate and setting-up of the ECHA NM working group (ECHA-NMWG) similar to ECHA s PBT working group. After a discussion of the issues presented, the workshop was resumed with a wrap-up and final conclusions by ECHA s Director of Regulatory Affairs Jukka Malm and Head of Unit for the Evaluation Unit 1 Wim De Coen (Chair of ECHA s Task Force on NMs). 1

5 Workshop on nanomaterials 5 2. SCIENTIFIC AND REGULATORY ASPECTS OF NANOMATERIALS EVALUATION 2.1. Scientific challenges of evaluating dossiers containing nanoforms ECHA and the JRC presented an overview of the conclusions and recommendations from the joint project entitled Scientific technical support on assessment of NMs in REACH registration dossiers and adequacy of available information" commissioned by DG ENV. The aim of the project was to assess REACH registration dossiers covering NMs submitted by the 2010 registration deadline and to identify general issues, which could be used in the process of developing options for adapting the REACH Regulation in relation to registration and assessment of NMs. 45 REACH registration dossiers that were expected to cover NMs were examined for all aspects of the dossier, including substance identification, physico-chemical properties, (eco)toxicological properties, and exposure assessment. The presentation highlighted the main challenges in the assessment of the dossiers and a number of issues that should be addressed in order to improve the quality of available information on NMs. Among the key issues is the challenge of identifying which dossiers actually address NMs and the need for increased clarity in the scope of dossiers with regard to NMs covered. It was pointed out that the dossiers lacked sufficient information to identify/characterise each nanoform, and that the identification was mainly based on chemical composition. When multiple forms of a substance (bulk and nanoform) were included in a dossier, different forms were not addressed transparently throughout the dossier. Information on the characterisation of NMs (e.g. granulometry/surface area) was generally scarce and the methods used were not always considered suitable for measuring the particle size of NMs. In addition to the challenges related to substance identity, it was found that test data provided for physico-chemical, human health and environmental endpoints generally did not describe the test material in great detail. Further, descriptions of sample preparation, which is an important aspect known to influence the outcome of a given study, were varying and sometimes lacking. Furthermore, in cases where dossiers covered multiple forms of a substance (e.g. bulk and nanoforms), it was noted that justifications for using data from one form to cover the hazard from the second form were generally missing. Based on these findings, the project suggested general and endpoint specific options for adapting REACH for substance identification and physicochemical properties, human health hazards, environmental fate, environmental hazards, and exposure assessment and risk characterisation. An assessment of consequences of these suggested adaptations for economy, environment, consumers and human health is currently being performed as the second phase of the project. The full report including findings and proposed options can be found at: Scientific challenges in dealing with the risk of nanomaterials A speaker from the Finnish Safety and Chemicals Agency (TUKES, FIN-CA) presented the scientific challenges in determining the (eco)toxicological, environmental effects of NMs, and a speaker from the Finnish Institute of Occupational Health (FIOH) presented scientific findings that provide evidence that some nanoforms may induce human health effects that are not necessarily expected from the bulk counterpart. With regard to current knowledge about potential environmental and health risks from NMs, both speakers considered the suitability of some existing OECD/EU test methods. Based on ongoing OECD work, it might be concluded that most, but not all, of the OECD currently used

6 6 Workshop on nanomaterials test methods are appropriate for NM testing. However, inclusion of additional endpoints or minor modifications may significantly improve the nano-specific sensitivity of these (test) guidelines. The OECD WPMN (Working Party of Manufactured Nanomaterials) is currently developing and finalising (test) guidelines specifically tailored for NMs in the following areas: Sample preparation and dosimetry (top priority) Inhalation toxicity Genotoxicity 2.3. Feedback from the first meeting of the Group Assessing Already Registered Nanomaterials (GAARN) ECHA provided feedback from the first GAARN meeting held on 29 May At the beginning of the presentation, key GAARN objectives were introduced: To build a consensus in an informal setting on best practices in assessing and managing the safety of NMs under REACH To increase confidence and mutual understanding among stakeholders (ECHA, Commission, MSCAs, representative registrants). The discussion in the first GAARN meeting focused on substance identification, physical chemical properties and aimed to initiate discussion on how NMs/nanoforms can be addressed in registration dossiers. Participants of the meeting stressed the importance of regulatory acceptance of the current EU Commission recommendation on the definition of nanomaterials. Key aspects motivating the discussion regarding characterisation of nanoparticles: Different methods are available and several methods are needed to characterise the nanoform, one would not provide the overall picture. No method fits to all types of NMs. There are methods available to measure the primary/constituent particles. The lack of standardised methods is not a reason for failing to provide any data on the nanoform. Similarities with other REACH requirements (SID). Possibility for similarities with the approach that needs to be taken with regard to registration of some types of UVCBs (e.g. manufacturing process). In addition, there were identified challenges with regard to registration dossiers for REACH within the joint submission. At the end of presentation, priorities for the next GAARN meeting were highlighted: Focus on ecotoxicity and toxicity data in relation to safety of the nanoforms. Address the surface treatment in relation to safety and hazards. Feedback from ongoing projects (e.g. JRC standardisation project) on the methods to characterise NMs.

7 Workshop on nanomaterials Nanomaterials under REACH A joint presentation from DG ENV and DG ENTR from the European Commission gave an overview of NM related activities, with an emphasis on REACH Implementation Projects on Nanomaterials. The EU approach to nanotechnologies is safe, integrated and responsible development. This ensures a high level of protection of human health and the environment integrating simultaneously the development of competitiveness and safety aspects in nanotechnologies and managing the evolving nanotechnologies in a scientifically sound manner. It was emphasised that these aims are in line with REACH aims (Article 1.1.). It was pointed out that Commission document CA/59/2008 reflects how REACH applies to NMs. Even though there are no specific provisions for NMs, the REACH requirements apply to NMs as the substance definition covers also the substance at nano scale as well as nanoform vs. bulk and agglomerates and aggregates (CA/59/2008). At the EU level, there are many activities targeted to regulate NMs such as competent authorities for REACH and CLP (CARACAL) and CARACAL s subgroup on NMs (CASG Nano), the adopted EU Recommendation on the definition, the finalised REACH Implementation Projects on nanomaterials (RIPoN) 1, 2 & 3, the second Regulatory review of NMs and REACH Review The original CASG Nano mandate from 2008 was presented with its advisory activities concerning NM substance identification (materialised in RIPoN 1), physico-chemical properties, human health toxicity, ecotoxicity, fate, degradation and aquatic environmental testing as well as to testing strategies for NMs, and the IR-CSA for NMs (in RIPoN 2 & 3). The regulatory framework for NMs was discussed and it was highlighted that the Regulatory Review of NMs as well as the REACH Review in 2012 will elaborate on this issue as well as present further Commission plans Regulatory status of dossiers containing nanoforms ECHA presented a legal perspective on how to deal with NMs in already submitted dossiers in the frame of REACH Regulation. The Agency pointed out the challenges for registrants and authorities due to the rapid development of NMs as a class of chemicals, lack of explicit reference to NMs in the REACH Regulation or of specific guidelines for NMs and also due to the limited experience of authorities and of the registrants. In addition, there is an ongoing scientific discussion regarding NM characterisation, assessment of their hazards, exposure and risks. It was highlighted that a prerequisite for the proper determination of the hazards and risks is the characterisation of the nanoforms and that this is the first priority for ECHA regarding the evaluation of NMs. The legal basis for actions taken by ECHA depends on the content of the dossier: Compliance check (CCH) in case of registration dossiers referring to possible NMs (Article 41 of REACH). Verification of the information on the forms of the substances covered by registration dossiers not referring to NMs (Article 36 of REACH). The consequence of the CCH is that on the basis of Article 41, ECHA can require the registrant to update the dossier e.g. with granulometry information allowing the authorities to determine the actual size of the substance and its forms. Article 36 decisions require registrants to provide information on the form of the substance that they must have had in order to determine the scope of their registration. Although, ECHA does not request registrants under Article 36 decisions to perform specific studies, it requests them to provide ECHA with the information they had available at the time of the submission. Data on NMs can also be required via the substance evaluation process but for a decision a prerequisite is to determine the registrants manufacturing or importing the substance in a nanoform. Incentives for registrants to characterise NMs under any of these processes encourages them to progressively consider the assessment of risks and submit adequate data.

8 8 Workshop on nanomaterials 2.6. Key points of discussion Discussion on points 2.1, 2.2 and 2.3 The discussion started with a further explanation of the criteria used to split in categories the dossiers assessed within the project referred in point 2.1. Further, it was clarified that the key objective was to identify the scientific and regulatory challenges that may prevent registration of NMs under REACH. During the discussion, several MSCAs expressed their opinions of addressing the various issues arising in relation to the NM characterisation. Warning signals motivating the discussion included the possibility of interactions of NMs with the living organisms at the cellular and sub-cellular levels. In the case of NMs, it has been clearly demonstrated that the mass concentration is not the most relevant parameter to correlate with measured effects, thus upsetting the traditional interpretation of the measures of (eco)toxicity. It is clearly shown that at equal mass, NMs are more toxic than products of the same chemical composition but of greater size. Although several studies have found a correlation between the specific surface area and the toxicity, there seems to be a consensus in the scientific community to agree that several factors contribute to the toxicity of NMs. The presence of contaminants such as metals can also promote the formation of free radicals and inflammation. Similarly, the particle chemical composition and leaching in the body of components present on its surface, the colloidal properties and surface of nanoparticles, compartmentalisation in the respiratory tract and the bio-persistence are factors that render the understanding of their (eco)toxicity more complex. In addition, the slow dissolution of some nanoparticles or some of their components in the body may become a major element determining their toxicity. These factors will therefore influence their functional, toxicological and environmental impact Discussion on points 2.4 and 2.5 Current status and activities concerning NMs under different legislative frameworks, both at EU and national levels were profoundly discussed. Discussion about whether other agencies than ECHA have implemented the Commission recommendation to define NMs took place. It was clarified that EFSA has actively considered it and have issued guidance. Furthermore under the new Biocidal Products Regulation, NMs will be considered separately and under the cosmetics legislation there is a working group on NMs to implement the definition. In addition, it was clarified that there is no exact timeline for a REACH review in relation to NMs. It was emphasised that although REACH is generally good for NM evaluation, it would profit from fine modifications to ensure a harmonised approach regarding NMs. For Article 36, the approach should be substance specific as for some substances the definition works in a straightforward manner while for others more characterisation might be needed to clarify its status vis-à-vis for definition. The registrants should look into the substance and if there are nanoforms, more information should be provided.

9 Workshop on nanomaterials 9 It was clarified that the submission of information under Article 36 is an obligation that stands on its own. An absence of reply would be a breach of Article 36 obligations and the follow-up could thus be an issue for the national authorities responsible for enforcement under REACH. Regarding the follow-up of a registrant response to Article 36, clarification was provided that within CCH going further to risk and hazard characterisation parallel to the substance characterisation would be very difficult. Firstly, the substance characterisation should be known; the rest of the assessment is a further step to be discussed.

10 10 Workshop on nanomaterials 3. NANOMATERIALS WORKING GROUP The afternoon session of the second day was devoted to discussing and supporting the mandate and setting-up of the ECHA NMs working group (ECHA-NMWG) that would provide advice on scientific and technical principles related to NMs under REACH. The working group on NMs would act independently but report to the relevant ECHA committees (similar to the already existing PBT working group). The mandate of this working group will be further consolidated with the MSCAs.

11 Workshop on nanomaterials CONCLUSIONS AND FOLLOW-UP ECHA organised a workshop concerning its first experiences with NMs under REACH with an emphasis on the evaluation process. In the two day event, ECHA, MSCAs, Accredited Stakeholders and the European Commission discussed how NMs in general have been characterised in registration dossiers. Currently, the scope of the registration (i.e. whether and how many nanoforms are included) is often unclear and the level of nano specific information provided (e.g. substance characterisation, hazards, exposure and risks) shows significant room for improvement. Over 50 expert participants from the MSCAs discussed the scientific and technical challenges as well as the regulatory processes that REACH offers to address safety aspects of NMs. ECHA agreed with MSCA representatives on a common approach to addressing the current information requirements in NM dossiers, taking into account the scientific uncertainties and legislative framework provided by REACH. The workshop provided recommendations on how to proceed with NM substances under evaluation in the near future, paving the way for ECHA to continue further dossier evaluation activities on these dossiers. ECHA will implement the European Commission recommendation on the definition of an NM as a benchmark in assessing substances and invites registrants to proactively characterise their substances in light of this definition. ECHA's first aim is to provide clarity on the physico-chemical characteristics of NMs and will use the available REACH instruments to obtain available data or request new data to be generated. The workshop confirmed that such a gradual approach combined with a collaborative and constructive interaction with registrants would be the first step towards future safety assessments of NMs under REACH. The plan to set up an ECHA working group on NMs that would provide advice on scientific and technical principles related to NMs under REACH was discussed and supported at the workshop. The working group on NMs would act independently but report to the relevant ECHA committees (similar to the already existing PBT working group). The mandate of this working group will be further consolidated with the MSCAs. ECHA intends to disseminate the best practices that are currently collected from relevant stakeholders that registered NMs and which were discussed in the first GAARN (Group Assessing Already Registered Nanomaterials) meeting prior to the workshop. Based on the practical challenges and successful experiences shared at this meeting, and with the support of the recently updated guidance concerning NMs, the Agency hopes to facilitate the work of those registrants that intend to register their NMs at the next registration deadline. These best practices will be published on ECHA's website by this summer.

12 12 Workshop on nanomaterials Appendix 1. Workshop on nanomaterials MAY 2012 GUIDO SACCONI ROOM - ECHA CONFERENCE CENTRE, ANNANKATU 18, HELSINKI, FINLAND FINAL AGENDA WEDNESDAY 30 MAY :30 Registration MORNING SESSION SETTING THE STAGE 8:45 15 min 1. Welcome Geert Dancet, Executive Director, ECHA 2. Introduction Jukka Malm Director of Regulatory Affairs, ECHA NANOMATERIALS PLENARY SESSION OPEN SESSION CHAIR JUKKA MALM, DIRECTOR OF REGULATORY AFFAIRS 9:00 9:30 3. Scientific challenges of evaluating dossiers containing nanoforms Overview of REACH registrations on nanomaterials based on the recommendations from the administrative agreement between DG JRC and DG ENV that aimed at providing Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information". 4. Scientific challenges in dealing with the risk of nanomaterials Scientific challenges in dealing with the risk of nanomaterials (e.g. available scientific arguments showing that nanoforms (may) induce new human health or environmental concerns that are not expected from the substance in non-nanoform) Evaluation, ECHA & DG JRC, European Commission presenters Finnish Safety and Chemicals Agency & Finnish Institute of Occupational Health, Finland presenters 10:00 20 min 10:20 20 min 10:40 Coffee 11:00 11:30 5. Feedback from 1st GAARN meeting Evaluation, ECHA presenter 6. Discussion on agenda points 3, 4 and 5 All 7. Nanomaterials under REACH Overview of nanomaterials related activities with emphasis on the REACH Implementation Project on nanomaterials. 8. Regulatory status of dossiers concerning nanoforms Legal perspective on how to deal with nanomaterials in already submitted dossiers in the frame of REACH Regulation DG ENV & DG ENTR, European Commission presenters Legal Affairs, ECHA presenter 12:00 12:30 13:30 9. Discussion on agenda points 7 and 8 All Lunch

13 Workshop on nanomaterials 13 NANOMATERIALS CLOSED SESSION AFTERNOON SESSION CHAIR WIM DE COEN, HEAD OF UNIT EVALUATION I 13:30 14:00 14:30 15:00 45 min 15: min 16:00 2 h 10. Preliminary impression of substance evaluation National Institute for Public Health and the Environment (RIVM), The Netherlands presenter 11. Characterisation of nanomaterials for registration purposes a practical guide Federal Institute for Occupational Safety and Health, Germany presenter 12. Introduction to the break-out groups Evaluation, ECHA 13. Break-out groups 3 break-out groups Coffee 18:00 End of day 1 19:30 Dinner 14. Break-out groups (continued) 3 break-out groups

14 14 Workshop on nanomaterials THURSDAY 31 MAY 2012 MORNING SESSION NANOMATERIALS CLOSED SESSION 09:00 90 min 10:30 15 min 10:45 60 min 11:45 60 min 12:45 13: Break-out groups (continued) 3 break-out groups Coffee 16. Report back from break-out groups Rapporteurs from 3 break-out groups 17. General discussion MSCA, COM & ECHA Lunch NANOMATERIALS PLENARY SESSION AFTERNOON SESSION OPEN SESSION CHAIR JUKKA MALM, DIRECTOR OF REGULATORY AFFAIRS 13:45 14:15 75 min 15: Nanomaterials Working Group Evaluation, ECHA presenter 19. Discussion on agenda point 18 All 20. Wrap-up and final conclusions All 16:00 End of the workshop

15 EUROPEAN CHEMICALS AGENCY ANNANKATU 18, P.O. BOX 400, FI HELSINKI, FINLAND ECHA.EUROPA.EU