EFSA s Approach for the Safety Evaluation of Nanotechnology Products in the Food and Feed Area Dr. Anne Theobald Senior Scientific Officer Scientific Panel on food contact materials, flavourings, enzymes and processing aids (CEF) Unit
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The Central Question: Are these products safe???? 3
Risk assessment in the food area in Europe In the past the Scientific Committee on Food (SCF) Since 2002: EFSA was established as independent European Risk Assessment body 4
EFSA s Mission Provide independent scientific advice and support for EU legislation/policies in all fields that impact food and feed safety Provide independent information on all relevant matters Communicate the risks Network with MS 5
EFSA s Scientific Advice Scientific opinions, scientific statements and guidance documents by EFSA s 10 Scientific Panels and the Scientific Committee 6
Panel on food Panel on additives, Panel on food animal health flavourings, additives and and welfare processing aids nutrient and sources [AHAW] materials in contact [ANS] with Panel food [AFC] on food contact materials, enzymes, Panel flavourings on plant and protection processing aids Scientific products and [CEF] their Committee residues [PPR] Panel on plant health (PLH) Panel on dietetic products, nutrition and allergies [NDA] Panel on genetically modified organisms [GMO] Panel on biological hazards [BIOHAZ] Panel on contaminants in the food chain [CONTAM] Panel on additives and products or substances used in animal feed [FEEDAP]
EFSA s involvement Since 2006 an EFSA internal WG collects information on potential applications and scientific progress and reports to the SC and the Advisory Forum Involvement as observer at international level (OECD, ISO, SCENIHR, etc.) 8
EFSA s opinions on Nanotechnology Two mandates from the European Commission: In 2007 a request was received and an opinion adopted by the Scientific Committee in 2009 In 2009, a follow-up request was received and the opinion is in progress 9
1. Opinion Terms of Reference to produce a scientific opinion on the need for specific risk assessment approaches for technologies/processes and applications of nanoscience and nanotechnologies in the food and feed area. to identify the nature of the possible hazards associated with actual and foreseen applications in the food and feed area to provide general guidance on data needed for the risk assessment of such technologies and applications. 10
1. Opinion Conclusions The opinion is generic in nature and is not in itself a risk assessment of nanotechnologies as such or of tentative applications or possible uses thereof or of specific products. It considers Engineered Nanomaterials (ENM) and. It provides generic guidance for risk assessment. 11
1. Opinion Conclusions The nanospecific properties and characteristics of ENM are likely to affect their toxicokinetic behaviour and toxicity profile. The current risk assessment paradigm is applicable for ENM. Uncertanties e.g. measurement, exposure and toxicological data. The risk assessment of ENM has to be performed on a case-by-case basis. 12
http://www.efsa.europa.eu/fr/scdocs/doc/sc_op_ej958_nano_en, 0.pdf 13
2. Opinion: Background The present state of knowledge still contains many gaps preventing risk assessors from establishing the safety, according to standard procedures... The purpose of this request is to obtain guidance on risk assessment thus providing the necessary transparency for stakeholders and regulators in order to develop an appropriate approach for the assessment of engineered nanomaterials and other nanotechnologies. However, even with the current state of knowledge, use scenarios probably exist for which different risk assessment approaches could be considered 14
2. Opinion: Terms of Reference (1) EFSA is requested to prepare a guidance document (including food additives, enzymes, flavourings, food contact materials, novel foods, food supplements, feed additives and pesticides). This document should provide practical recommendations for the risk assessment of food related applications of nanotechnology to the extent possible with current knowledge. In the cases where knowledge is insufficient, it should indicate the endpoints and/or parameters that would have to be known in order to carry out a risk assessment. 15
2. Opinion: Terms of reference (cont d) (2) Consultation with stakeholders: The proposed guidance document should be subject to public consultation and if deemed appropriate discussed with stakeholders in a dedicated meeting prior to its adoption. (3) Follow-up: Subsequent to these opinions, the Commission invites EFSA to monitor scientific advances and keep the Commission informed on relevant developments and, when appropriate, to revise the draft document. A draft guidance document has been finalised and will be placed on EFSA s webpage for public consultation in the coming weeks 16
NO GUIDANCE???? 17
Guidance documents for RA Specific guidance documents are already in place for the RA in the following areas: Food additives Food supplements Food contact materials Active and Intelligent Packaging Flavouring substances Pesticides GMOs and GMMs etc 18
Guidance documents for RA Relate to preparation and submission of a dossier for safety evaluation of substances by a producer - before it can be placed on the market - for re-evaluation 19
Data requirements in Guidance documents Some elements are common: Identification of substance Manufacturing process Dietary exposure Toxicological studies Some information is specific: Environmental fate (pesticides, feed additives) Occupational health (pesticides, feed additives) Reaction and fate in food (food additives, flavourings, enzymes) Migration data into food (food contact materials) 20
Conventional RA vs RA of Nanomaterials 21
Identification of substance Analytical Methods suitable to: - Characterise and distinguish ENP from bulk material - Measure the ENP in the matrix (food, environmental samples, biological samples) 22
Toxicological data Benchmark with the Risk Assessment Paradigm: - Can we use the same toxicological test batteries (in vitro and in vivo)? - Do we need to address additional endpoints (WHICH)? - How do we interpret the findings from animal models? 23
EFSA risk assessment of ENM So far only two assessments have been provided by EFSA on risks of specific nanomaterials in food and feed: o ANS Panel: Submitted data were insufficient to adequately characterise silver hydrosol and the Panel could not provide an opinion. o CEF Panel: No safety concern for titanium nitride for use as food contact material on the basis of absence of migration into food simulant. Currently no new applications have been received. 24
Evaluation of ENM in FCM 1. CHARACTERIZE THE ENM IN FCM 2. DO THE ENM MIGRATE? 3. DO THEY MIGRATE AS ENM? Migration may be dependent on both the type of ENM and of FCM. Solubility of the ENM in food is an important parameter (general rule: no solubility little/no migration) 25
Evaluation of TiN ENM for use in PET 1. CHARACTERIZE THE ENM IN FCM In PET investigated by transmission electron microscopy, mainly agglomerates (> 100 nm) were observed, consisting of primary titanium nitride nanoparticles (EFSA 21 th list of substances, 27-11-2008) Note: Agglomerates/aggregates may have high surface properties, but other properties are reduced (like migration and translocation) 26
Evaluation of TiN ENM for use in PET 1. DO THE ENM MIGRATE? 2. DO THEY MIGRATE AS ENM? no migration of aggregates nor of individual ENM Availability of an analytical method to detect nano-tin in model medium (food simulants) down to 5 µg/l Application of migration modelling showed that migration was several orders of magnitude below this detection limit. 27
Evaluation of TiN ENM for use in PET 1. DO THE ENM MIGRATE? 2. DO THEY MIGRATE AS ENM? 3. DO THEY MIGRATE AS ENM? 28
Draft Novel Food Regulation: Article 3. 2.c) Definitions "engineered nanomaterial" means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale 29
Draft Novel Food Regulation: Article 3. 5 Definitions In view of the various definitions of nanomaterials published by different bodies at international level and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adapt point (c) of paragraph 2 of this Article to technical and scientific progress and to definitions subsequently agreed at international level 30
Thank you for your interest! anne.theobald@efsa.europa.eu http://www.efsa.europa.eu/ 31