Towards a review of the EC Recommendation for a definition of the term "nanomaterial": Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation

This report provides the JRC's scientific-technical evaluation of options to clarify the EC Recommendation on a definition of nanomaterial, published in 2011 (EC Recommendation 2011/696/EU). It is a follow-up report of two previous JRC publications, which compiled feedback on the experiences of stakeholders with the EC nanomaterial definition collected by JRC in 2013 and early 2014 (EUR 26567 EN, 2014), and provided an assessment of the collected information (EUR 26744 EN, 2014). The three JRC reports are part of the review process foreseen in the 2011 EC Recommendation. The evaluation shows that the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental as well as manufactured nanomaterials. Moreover, because of the regulatory purpose of the definition, there is little evidence to support deviating from size as the sole defining property of a nanoparticle or from the range of 1 nm to 100 nm as definition of the nanoscale. Besides the need for clarification of some terms used in the definition additional implementation guidance would be useful. The role of the volume specific surface area deserves clarification and a method to prove that a material is not a nanomaterial would be helpful. A strategy how to avoid unintended inclusion of materials and the list of explicitly included materials deserve also attention.JRC.I.4-Nanobioscience

Towards a review of the EC Recommendation for a definition of the term "nanomaterial" Part 2: Assessment of collected information concerning the experience with the defintion

This report provides the JRC assessment of feedback on the experiences of stakeholders with the EC nanomaterial definition, published in 2011 (EC Recommendation 2011/696/EU). The report is a follow-up report of the previous JRC report (EUR 26567 EN, 2014), which compiled feedback collected by JRC in 2013 and early 2014, partly through a dedicated survey. Based on the current report, JRC will prepare a set of recommendations for the revision of the EC nanomaterial definition, as part of the review process foreseen in the 2011 EC Recommendation.JRC.D.2-Standards for Innovation and sustainable Developmen

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"; Part 1: Compilation of information concerning the experience with the definition

In October 2011 the European Commission (EC) published a Recommendation on the definition of nanomaterial (2011/696/EU). The purpose of this definition is to enable determination when a material should be considered a nanomaterial for regulatory purposes in the European Union. In view of the upcoming review of the current EC Definition of the term 'nanomaterial' and noting the need expressed by the EC Environment Directorate General and other Commission services for a set of scientifically sound reports as the basis for this review, the EC Joint Research Centre (JRC) prepares three consecutive reports, of which this is the first. This Report 1 compiles information concerning the experience with the definition regarding scientific-technical issues that should be considered when reviewing the current EC definition of nanomaterial. Based on this report and the feedback received, JRC will write a second, follow-up report. In this Report 2 the JRC will provide a detailed assessment of the scientific-technical issues compiled in Report 1, in relation to the objective of reviewing the current EC nanomaterial definition.JRC.I.4-Nanobioscience

Validation of an Analytical Method for the Determination of Glycerolthiheptanoate (GTH) in Processed Animal By-products: Results of a Collaborative Study

The performance characteristics of a method for the determination of the marker substance glycerol triheptanoate (GTH) in processed animal by-products (ABPs) based on gas chromatography (GC) coupled to mass spectrometry (MS) were determined via a collaborative study. Within the European Union GTH needs to be added to the portion of processed ABPs that must not enter the feed and food chain (Categories 1 and 2) at a minimum concentration of 250 mg kg-1 related to the fat fraction of the test samples analysed. The test materials included in the validation study consisted of three meat and bone meal (MBM) and three fat samples that contained GTH at different concentrations ranging from 61 to 455 mg kg-1. The obtained relative standard deviation of repeatability (RSDr) varied from 3.4 to 7.8% and the relative standard deviation of reproducibility (RSDR) varied from 9.0 to 16.5%, corresponding to HORRAT values that were in all cases equal or below the critical value of 2.0. The estimated trueness expressed in terms of average concentration obtained in the study compared to the target concentrations of GTH in all test materials varied from 95 to 107 % confirming acceptable values for the trueness of the method. Based on the acceptable values for the precision and trueness the method is fit for the intended purpose and can be used for official control purposes to determine GTH in processed animal by-products from Category 1 and Category 2.JRC.DG.D.6-Food Safety and Qualit

Raman spectroscopy for quality control and detection of substandard painkillers

Raman spectroscopy and multivariate data evaluation were used to verify the chemical nature and the content of the active pharmaceutical ingredients (acetylsalicylic acid, ibuprofen and paracetamol) in painkillers. A class-modelling approach (SIMCA) of spectral data was used to verify that the correct API was indeed present in the pharmaceutical preparation and to prove the selectivity of the developed method towards other commercial APIs; PLS regression was used for the verification of the API amount. The root mean square error (RMSE) of the PLS models for the quantitation of the APIs were 11.3 % for paracetamol, 13.2 % for acetylsalicylic acid, and 6.2 % for ibuprofen in drug preparations containing the API at levels between 7.1 and 92.3 %. This level of accuracy appears to be acceptable for a rapid screening method, which makes it fit-for-purpose for deployment in customs and forensic laboratories involved in the surveillance of the legal and illicit drug market.JRC.F.4-Fraud Detection and Preventio

Chemometric approach for discriminating tobacco trademarks by near infrared spectroscopy

Cigarettes are consumer products with a broad market-driven orientation. In order to satisfy the different needs of smokers, cigarette brands with different aroma, taste and appearance are available on the market. In this study near infrared (NIR) spectroscopy in combination with chemometrics was applied in order to distinguish cigarette brands by analysing the tobacco. Calibration models were developed to differentiate three tobacco brands and their respective producers. The developed models also allowed the discrimination of the tobacco according to their geographical origin and may serve as a tool for the detection of counterfeit tobacco.JRC.F.4-Fraud Detection and Preventio

Development of a real-time PCR method for the simultaneous detection of mackerel and horse mackerel

We have developed a real-time PCR method for the simultaneous detection of horse mackerel (Trachurus trachurus) and mackerel (Scomber scombrus) DNA. This method has been designed to be used as an extension to our previously published method for the simultaneous detection of several fish species. A fragment of the parvalbumin gene was used as target for the development of the reported method. The results showed the required specificity, efficiency of the real-time PCR reaction and comparable selectivity with the previously reported method, therefore their possible complementarity for food and feed analysis is discussed. Additionally, the developed method combined with melt curve analysis allows the differentiation between both fish species which can have interesting applications for authenticity studies.JRC.D.5-Standards for Food Bioscienc

Differentiation of coccidiostats-containing feed additives by Mid and Near Infra-Red Microscopy

Coccidiostats belong to the group of feed additives, which are authorised within the European Union exclusively for specific preparations. These preparations do not only contain one or more coccidiostats as active substance(s) but also various ingredients such as the carrier, which are included in the European legislation authorising the product. In order to allow the full traceability of the use of feed additives and to check for compliance with legal provisions, there is a strong need for analytical methods that enable the rapid characterisation of these products. This paper describes the applicability of non-destructive techniques such as Mid Infra-Red (MIR) and Near Infra-Red (NIR) microscopy supported by multivariate analysis for the characterisation of coccidiostats-containing feed additives. The application of these methods demonstrated that different feed additives could be distinguished from each other even when containing the same active substance. The use of chemometrics turned out to be crucial especially in cases, where the differentiation of spectra by visual inspection was very difficult.JRC.D.5-Standards for Food Bioscienc

Identification of botanical and geographical origin of distillers dried grains with solubles by near infrared microscopy

Nowadays there is a strong need for methods capable of differentiating distillers dried grains with solubles (DDGS) according to their geographical and/or botanical origin. In this study, near infrared microscopy (NIRM) has been applied to differentiate corn and wheat DDGS samples and to differentiate corn DDGS from USA, Europe an China. Two multivariate prediction models have been developed for the discriminations. The models have been validated by cross validation and with an external set of samples and have been used to predict the botanical and geographical origin. Furthermore the probability of wrong prediction of the models has been calculated, to assess their performance profile. The prediction showed very good capability of the model to classify samples according to their botanical origin, whereas satisfying results were exclusively obtained when separating samples from China against the pooled set of samples from USA and EuropeJRC.D.5-Standards for Food Bioscienc

Occurrence of NDL-PCB in Food and Feed in Europe

A significant part of the human exposure to PCBs derives from food. Food of animal origin is the main contributor to dietary PCB exposure. The PCB burden in animals derives mainly from feed. This paper provides some information on background levels of non-dioxin-like PCBs in food and feed and might assist in the calculation of exposure of the EU population to these contaminants, including the identification of the main sources of dietary exposure and the relative importance of dietary and non dietary sources.JRC.D.8-Food safety and qualit