Performance Evaluation of LC-MS Methods for Multimycotoxin Determination

2019 ◽  
Vol 102 (6) ◽  
pp. 1708-1720 ◽  
Author(s):  
Michelangelo Pascale ◽  
Annalisa De Girolamo ◽  
Vincenzo Lippolis ◽  
Joerg Stroka ◽  
Hans G J Mol ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
European Commission ◽  
The United States ◽  
Performance Criteria ◽  
Screening Methods ◽  
The European Union ◽  
Future Challenges ◽  
Surveillance Programs ◽  
European Standards

Abstract The co-occurrence of regulated mycotoxins in foods and feeds, together with modified (“masked”) and emerging mycotoxins, has been increasingly reported worldwide in recent years. Therefore, sensitive, accurate, and validated methods for the simultaneous determination of these hazardous contaminants in different matrices are highly demanded to fulfil regulatory requirements and to carry out reliable surveillance programs. In these last years, LC-MS methodologies for multimycotoxin screening and/or quantification are being routinely used in control laboratories. However, to date, only one European Standard for multimycotoxin determination is based on LC-MS (EN 16877:2016). The need for standardized LC-MS methods for multimycotoxin determination has been highlighted by regulatory authorities and scientific advisory bodies, including the U.S. Food and Drug Administration and the European Commission. The European Committee for Standardization (CEN) has issued calls for tender for the development of standardized LC-MS methods for mycotoxins in food and animal feeding stuffs. As deliverables, some LC-MS based methods for multimycotoxin determination are currently under approval as European Standards. In addition, the European Commission has recently established specific criteria with which screening methods for mycotoxins, including LC-MS methods, have to comply for use for regulatory purposes. Validation procedures by single-laboratory and collaborative trials have been defined. This paper provides insights and advances on guidelines and tools for performance evaluation of LC-MS methods intended for quantitative determination and for semiquantitative screening of multimycotoxins. In particular, performance criteria set in the European Union and the United States are critically overviewed, and expectations, needs, and future challenges relevant to LC-MS methods for multimycotoxin determination are also discussed.

Performance Evaluation of LC-MS Methods for Multimycotoxin Determination

2019 ◽  
Vol 102 (6) ◽  
pp. 1708-1720 ◽  
Author(s):  
Michelangelo Pascale ◽  
Annalisa De Girolamo ◽  
Vincenzo Lippolis ◽  
Joerg Stroka ◽  
Hans G.J. Mol ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
European Commission ◽  
The United States ◽  
Performance Criteria ◽  
Screening Methods ◽  
The European Union ◽  
Future Challenges ◽  
Surveillance Programs ◽  
European Standards

The co-occurrence of regulated mycotoxins in foods and feeds, together with modified (“masked”) and emerging mycotoxins, has been increasingly reported worldwide in recent years. Therefore, sensitive, accurate, and validated methods for the simultaneous determination of these hazardous contaminants in different matrices are highly demanded to fulfil regulatory requirements and to carry out reliable surveillance programs. In these last years, LC-MS methodologies for multimycotoxin screening and/or quantification are being routinely used in control laboratories. However, to date, only one European Standard for multimycotoxin determination is based on LC-MS (EN 16877:2016). The need for standardized LC-MS methods for multimycotoxin determination has been highlighted by regulatory authorities and scientific advisory bodies, including the U.S. Food and Drug Administration and the European Commission. The European Committee for Standardization (CEN) has issued calls for tender for the development of standardized LC-MS methods for mycotoxins in food and animal feeding stuffs. As deliverables, some LC-MS based methods for multimycotoxin determination are currently under approval as European Standards. In addition, the European Commission has recently established specific criteria with which screening methods for mycotoxins, including LC-MS methods, have to comply for use for regulatory purposes. Validation procedures by single-laboratory and collaborative trials have been defined. This paper provides insights and advances on guidelines and tools for performance evaluation of LC-MS methods intended for quantitative determination and for semiquantitative screening of multimycotoxins. In particular, performance criteria set in the European Union and the United States are critically overviewed, and expectations, needs, and future challenges relevant to LC-MS methods for multimycotoxin determination are also discussed.

Austrian Veto against European Union Membership Negotiations with Turkey

2020 ◽  
Vol 8 (1) ◽  
pp. 103-122
Author(s):  
Ewa Kaczan-Winiarska
Keyword(s):  
European Union ◽  
European Commission ◽  
Security Policy ◽  
Negotiation Process ◽  
Point Of View ◽  
The European Union ◽  
Strategic Partner ◽  
Key Factor ◽  
European Standards ◽  
The Eu

The Austrian government is extremely sceptical about the accession negotiations which are conducted by the European Commission on behalf of the European Union with Turkey and calls for the negotiation process to end. Serious reservations of Vienna have been raised by the current political situation in Turkey under the rule of President Recep Tayyip Erdogan, as well as by the standards of democracy in Turkey, which differ greatly from European standards. Serious deficiencies in rule of law, freedom of speech and independence of the judiciary, confirmed in the latest European Commission report on Turkey, do not justify, from Vienna’s point of view, the continuation of talks with Ankara on EU membership. In fact, Austria’s scepticism about the European perspective for Turkey has a longer tradition. This was marked previously in 2005 when the accession negotiations began. Until now, Austria’s position has not had enough clout within the European arena. Pragmatic cooperation with Turkey as a strategic partner of the EU, both in the context of the migration crisis and security policy, proved to be a key factor. The question is whether Austria, which took over the EU presidency from 1.7.2018, will be able to more strongly accentuate its reservations about Turkey and even build an alliance of Member States strong enough to block Turkey’s accession process.

Position of OLAF in a multi-level governance system of the European Union

2019 ◽  
Vol 3 ◽  
pp. 103-120
Author(s):  
Janusz Ruszkowski
Keyword(s):  
European Union ◽  
European Commission ◽  
Precise Determination ◽  
The European Union ◽  
Governance System ◽  
Agent Theory ◽  
System A ◽  
Multi Level ◽  
The One

The author aims to investigate the position of OLAF in the multi-level governance system (MLG) of the European Union with specific inter-institutional consequences of such location, assuming that OLAF is not a classical supranational institution. In the research subject an important role is played by the European Commission (EC), which established OLAF and gave it specific competences to act. These facts are fundamentally important for further considerations, so they can have a major impact on the precise determination of OLAF’s position in the MLG. If OLAF as an agent and supervisor has control powers over supranational institutions, including its principal, a supranational European Commission, it is unlikely that it would also be a supranational institution. This article demonstrates, that OLAF is not a classic supranational institution because it exhibits strong features of a supra-supranational institution operating in a multi-level EU governance system. A helpful theoretical and methodological research tools we consider the Principal/Agent Theory (PAT) and its combination Principal/Supervisor/Agent Theory (PSAT) on the one hand, and the concept of multi-level governance (MLG) on the other hand.

scholarly journals Determination of Zeranol and its Metabolites in Bovine Muscle Tissue with Gas Chromatography-Mass Spectrometry

2012 ◽  
Vol 56 (3) ◽  
pp. 335-342 ◽  
Author(s):  
Iwona Matraszek-Żuchowska ◽  
Barbara Woźniak ◽  
Jan Żmudzki
Keyword(s):  
Mass Spectrometry ◽  
Gas Chromatography ◽  
Muscle Tissue ◽  
Solid Phase ◽  
Performance Criteria ◽  
Gas Chromatography Mass Spectrometry ◽  
The European Union ◽  
Bovine Muscle ◽  
Chromatography Mass Spectrometry

Abstract This paper describes the quantitative method of determination of chosen substances from resorcylic acid lactones group: zeranol, taleranol, α-zearalenol, β-zearalenol, and zearalanone in bovine muscle tissue. The presented method is based on double diethyl ether liquid-liquid extraction (LLE), solid phase extraction (SPE) clean up, and gas chromatography mass spectrometry (GC-MS) analysis. The residues were derivatised with a mixture of N-methyl-N-trimethylsilyltrifluoroacetamide, ammonium iodide, and DL-dithiothreitol (1,000:2:5, v/w/w). The GC-MS apparatus was operated in positive electron ionisation mode. The method was validated according to the European Union performance criteria pointed in Decision Commission 2002/657/EC. The average recoveries of all analytes at 1 μg kg-1 level were located between 83.7% and 94.5% values with the coefficients of variation values <25%. The decision limits (CCα) and detection capabilities (CCβ) for all analytes ranged from 0.58 to 0.82 μg kg-1 and from 0.64 to 0.94 μg kg-1, respectively. The procedure has been accredited and is used as a screening and confirmatory method in control of hormone residues in animal tissues.

Measuring the Welfare Effects of Country of Origin Rules: A Suggested Methodology

2010 ◽  
Vol 10 (1) ◽  
pp. 1850188 ◽  
Author(s):  
Joseph Pelzman ◽  
Amir Shoham
Keyword(s):  
Free Trade Agreements ◽  
Trade Agreements ◽  
The United States ◽  
Trade Flows ◽  
The European Union ◽  
Rules Of Origin ◽  
Suggested Approach ◽  
Transformation Rules ◽  
The Impact

The United States and the European Union have generated dozens of bilateral Regional Trading Agreements (RTA) across the globe. All of these trading arrangements have detailed agreements on rules of origin (ROOs). Those rules are required in order to ensure that the perceived benefits of the Free Trade Agreements (FTA) are not subverted or deflected. These rules have their greatest impact on a firm's cost structure when applied to the trade of intermediate goods. Determination of the origin of final goods becomes more complicated where imported intermediates are used and the WTO 'substantial transformation' rules are implemented. There is relatively little literature on the impact of these rules of origin on trade. (Cadot et al., 2006; Duttagupta and Panagariya, 2002; and Falvey and Reed, 1998, 2002). The existing literature hypothesizes that these rules can easily be used to restrict or suppress trade between countries, or to divert trade away from more efficient suppliers to less efficient ones. The empirical evidence to support the trade distortions is based on the number and complexity of the rules of origin. In order to determine the degree to which the post-RTA trade flows are indeed affected by ROO requires a micro-based review of increased transaction costs, rather than the number of rules. The intent of this paper is to suggest a formal methodology, which relies on the literature about tariff-equivalents, to evaluate rules of origin requirements. The suggested approach, applied at the 5-digit HS level will provide a more robust evaluation of ROOs. The suggested methodology could also be used to investigate the oft-asserted hypothesis that with time and reduced tariff barriers, the costs associated with ROOs will diminish.

DTCA of Prescription Medicines in the European Union: Is There Still a Need for a Ban?

2010 ◽  
Vol 17 (5) ◽  
pp. 471-484 ◽  
Author(s):  
Mareen Poser
Keyword(s):  
European Union ◽  
European Commission ◽  
General Public ◽  
Information Provision ◽  
The United States ◽  
The European Union ◽  
Medicinal Products ◽  
Prescription Medicines ◽  
Direct To Consumer Advertising ◽  
The Impact

AbstractThe pharmaceutical sector is one of the main markets in the European Union. The consumption of medicines is high and steadily increasing. However, the pharmaceutical market is subject to a wider range of restrictions than almost any other sector. The restrictions mainly apply to information provision and advertising practice within the community. One of the main features in pharmaceutical regulation is the ban on direct-to-consumer advertising (DTCA) of prescription medicines. However, an abolition of the ban is controversial in the European Community, especially as the pharmaceutical industry keeps pleading for its ability to use the highly effective marketing strategy of DTCA to promote prescription medicines to the general public. Such advertising is only allowed in two jurisdictions in the world, New Zealand and the United States. In both systems the impact of DTCA on the consumer and the economy has been subject to research. The outcome of these studies is outlined in this article. Since the European Commission has provided a new proposal to amend the current information practice regarding prescription medicines in 2008 (European Commission, Proposal for a Directive of the European Parliament and of the Council Amending, as Regards Information to the General Public on Medicinal Products Subject to Medical Prescription, Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, COM/2008/0663 final) it is time to examine different options to regulate the provision of information and discuss the need for a ban of DTCA.

scholarly journals Developing EU environmental standards for the food, drink and milk industries: key environmental issues and data collection

2020 ◽  
Author(s):  
German Giner Santonja ◽  
Panagiotis Karlis
Keyword(s):  
Data Collection ◽  
European Commission ◽  
Environmental Issues ◽  
The European Union ◽  
Policy Integration ◽  
Environmental Standards ◽  
Industrial Emissions ◽  
Best Available Techniques ◽  
Systematic Determination

Abstract Background The European Commission organised the review of the best available techniques reference document for the food, drink and milk industries according to the provisions of the Industrial Emissions Directive (Directive 2010/75/EU). Under this policy, an exchange of information between Member States, industrial organisations, non-governmental organisations promoting the protection of the environment and the European Commission took place. Results A crucial part for developing these EU environmental standards was a systematic determination of the key environmental issues of the food, drink and milk sector. Key environmental issues were defined for emissions to air and water, and for energy and water consumption. The key environmental issues were systematically determined by using four criteria proposed by the European Commission. Moreover, a data collection procedure was designed and real-plant emissions and consumption data were obtained for the first time from a representative variety of food, drink and milk installations across the European Union. Conclusions The development of the EU environmental standards for the food, drink and milk sector are based on a systematic determination of the key environmental issues and on a representative data collection for this sector. This paper also highlights the main normative, organisational and procedural factors addressed during the environmental policy integration carried out to develop these standards.

scholarly journals DETERMINATION OF A CHILD’S HABITUAL RESIDENCE IN INTERNATIONAL CHILD ABDUCTION CASES: CHARTING THE WAY TOWARDS HARMONIZATION

2020 ◽  
Vol 28 (2) ◽  
pp. 481-501
Author(s):  
Abdul Ghafur Hamid
Keyword(s):  
The United States ◽  
The European Union ◽  
Habitual Residence ◽  
Child Abduction ◽  
The United Kingdom ◽  
International Child ◽  
Underlying Principle ◽  
Recent Developments ◽  
Changing Trend

The 1980 Child Abduction Convention is aimed at addressing the increasingly disturbing problem of trans-border parental child abduction, its key mechanism being to promptly return an abducted child to his or her country of ‘habitual residence.’  In essence, habitual residence is established as the chosen personal connecting factor in international child abduction cases. However, in view of the failure of the Convention to define the term, it has become the responsibility of the courts around the world to improvise their own standards for the determination. The objectives of the present paper, therefore, are to assess the deplorable situation of fragmented approaches and standards used by the courts in determining habitual residence of a child and to explore the recent developments in judicial pronouncements in order to be able to demonstrate the changing trend in the jurisprudence of the courts. To achieve these, the paper looks into and appraises the decisions of the courts of the United States of America, Canada, the European Union, the United Kingdom and other common law countries. The paper concludes that the changing trend is clearly discernible and a number of courts of States parties are increasingly applying a hybrid or combined approach rather than various subjective and one-sided approaches and thus moving towards the achievement of harmonization in the determination of a child’s habitual residence, the underlying principle of the Convention.  

scholarly journals Developing EU environmental standards for the food, drink and milk industries: key environmental issues and data collection

2020 ◽  
Author(s):  
German Giner Santonja ◽  
Panagiotis Karlis
Keyword(s):  
Data Collection ◽  
European Commission ◽  
Environmental Issues ◽  
The European Union ◽  
Policy Integration ◽  
Environmental Standards ◽  
Industrial Emissions ◽  
Best Available Techniques ◽  
Systematic Determination

Abstract Background: The European Commission organised the review of the Best Available Techniques Reference Document for the Food, Drink and Milk Industries according to the provisions of the Industrial Emissions Directive (Directive 2010/75/EU). Under this policy, an exchange of information between Member States, industrial organisations, non-governmental organisations promoting the protection of the environment and the European Commission took place. Results: A crucial part of developing these EU environmental standards was the systematic determination of the key environmental issues of the food, drink and milk sector. Key environmental issues were defined for emissions to air and water, and for energy and water consumption. The key environmental issues were systematically determined using four criteria proposed by the European Commission. Moreover, a data collection procedure was designed and real-plant emissions and consumption data were obtained for the first time from a representative variety of food, drink and milk installations across the European Union. Conclusions: The development of the EU environmental standards for the food, drink and milk sector are based on a systematic determination of the key environmental issues and on a representative data collection for this sector. This paper also highlights the main normative, organisational and procedural factors addressed during the environmental policy integration carried out to develop these standards.

scholarly journals PREDATORY PRICING: SINGLE- FIRM DOMINANCE, EXCLUSIONARY ABUSE AND PREDATORY PRICES (PART 3)

Obiter ◽  
2021 ◽  
Vol 42 (3) ◽  
Author(s):  
Jan Louis Van Tonder
Keyword(s):  
The United States ◽  
Traditional Theory ◽  
Constitutional Court ◽  
The European Union ◽  
Predatory Pricing ◽  
Section 8 ◽  
Appeal Court ◽  
Economic Concept ◽  
The Law

Important pronouncements of legal principle were recently made by the Competition Appeal Court and Constitutional Court on the determination of predatory pricing under section 8 of the Competition Act 89 of 1998. These pronouncements must now be seen in the context of the subsequent commencement of the Competition Amendment Act 18 of 2018. In light of these developments, this three-part series of articles evaluate the law relating to the economic concept of predatory pricing under the Competition Act. In this context, the crucial elements of dominance and abuse are also discussed. The first in this series of three articles critically evaluated the law on the determination of single-firm dominance under section 7 of the Competition Act. The second article discussed the basic forms of abuse, the meaning of abuse, tests that have been developed to identify exclusionary conduct, the criticism of the traditional theory of predatory pricing, the main strategic economic theories of predatory pricing and non-pricing theories of predation. This article focuses on the law of predatory prices under section 8(1)(c) and 8(1)(d)(iv) of the Competition Act. Pursuant to section 1(3) of the Competition Act, when interpreting or applying the Competition Act, appropriate foreign and international law may be considered. This is complementary to section 1(2)(a), which directs that the Competition Act must be interpreted in a manner that is consistent with the Constitution and which gives effect to the purposes set out in section 2. In light hereof and where appropriate, the South African position is mainly compared with the position in the European Union and the United States.

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