Developing effective product dossiers for regulatory approval of new animal feed products

2021 ◽  
pp. 213-232
Author(s):  
Manfred Lützow ◽  
Keyword(s):  
European Union ◽  
Animal Feed ◽  
Regulatory Approval ◽  
Feed Additive ◽  
The European Union ◽  
Food Standards ◽  
Effective Product ◽  
Key Steps

This chapter describes the key steps in compiling product dossiers required to gain regulatory approval for new animal feed products. As an example, the chapter describes the data needed for a feed additive dossier in the European Union (EU) as mandated by the European Food Standards Agency (EFSA).

scholarly journals Effect of probiotic Clostridium butyricum CBM 588 on microbiota and growth performance of broiler chickens

2019 ◽  
Vol 64 (No. 9) ◽  
pp. 387-394
Author(s):  
Roman Svejstil ◽  
Vladimir Plachy ◽  
Miroslav Joch ◽  
Hana Salmonova ◽  
Dagmar Duskova ◽  
...  
Keyword(s):  
Growth Performance ◽  
Broiler Chickens ◽  
Volatile Fatty Acids ◽  
Animal Feed ◽  
Anaerobic Bacteria ◽  
Clostridium Butyricum ◽  
Feed Additive ◽  
Plate Count ◽  
The European Union ◽  
Plate Count Method

Clostridium butyricum CBM 588 is used as a probiotic in eastern Asian countries and has been recently approved as an animal feed additive in the European Union. The purpose of this study was to evaluate the effect of C. butyricum MIYAIRI 588 (CBM 588) on abundance of selected genera of caecal and crop bacteria, volatile fatty acids and growth performance of broiler chickens. We studied counts of anaerobic bacteria in caeca and crops of broiler chickens by plate-count method and evaluated their growth performance. CBM 588 significantly reduced E. coli counts in caeca of broiler chickens at days 10 and 42 and also enhanced their growth performance. Additionally, it significantly increased the amount of butyrate in the caeca that provides energy to enterocytes, resulting in increased weight gains. Out of the obtained results we conclude that C. butyricum CBM 588 influences caecal microbiota of broiler chickens and positively affects their growth performance.

scholarly journals A Review of Coffee By-Products Including Leaf, Flower, Cherry, Husk, Silver Skin, and Spent Grounds as Novel Foods within the European Union

Foods ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. 665 ◽  
Author(s):  
Tizian Klingel ◽  
Jonathan I. Kremer ◽  
Vera Gottstein ◽  
Tabata Rajcic de Rezende ◽  
Steffen Schwarz ◽  
...  
Keyword(s):  
European Union ◽  
Animal Feed ◽  
Safety Data ◽  
Coffee Bean ◽  
Green Coffee ◽  
The European Union ◽  
Spent Coffee Grounds ◽  
Novel Food ◽  
Coffee Grounds ◽  
By Products

The coffee plant Coffea spp. offers much more than the well-known drink made from the roasted coffee bean. During its cultivation and production, a wide variety of by-products are accrued, most of which are currently unused, thermally recycled, or used as animal feed. The aim of this review is to provide an overview of novel coffee products in the food sector and their current legal classification in the European Union (EU). For this purpose, we have reviewed the literature on the composition and safety of coffee flowers, leaves, pulp, husk, parchment, green coffee, silver skin, and spent coffee grounds. Some of these products have a history of consumption in Europe (green coffee), while others have already been used as traditional food in non-EU-member countries (coffee leaves, notification currently pending), or an application for authorization as novel food has already been submitted (husks, flour from spent coffee grounds). For the other products, toxicity and/or safety data appear to be lacking, necessitating further studies to fulfill the requirements of novel food applications.

scholarly journals The role of food standards in international trade: assessing the Brazilian beef chain

2006 ◽  
Vol 10 (spe) ◽  
pp. 33-51
Author(s):  
Luciana Marques Vieira
Keyword(s):  
European Union ◽  
Supply Chains ◽  
Large Scale ◽  
International Markets ◽  
International Standards ◽  
Rapid Expansion ◽  
The European Union ◽  
Full Compliance ◽  
Food Standards ◽  
Managerial Implications

The purpose of this paper is to identify how Brazilian beef managers have responded to a rapid expansion and intensification of standards for beef exports. This issue relates to how some Brazilian beef exporters are strategically repositioning themselves in the supply chains. The literature of this study reviews global chain governance and international standards. The method uses case studies consisting of six medium and large scale beef exporters who export fresh beef to the European Union. The main findings describe the kinds of governance that stimulate upgrading and transferral of the best practices and, consequently, full compliance with mandatory standards. This study suggests that standards do matter for companies trying to increase international competitiveness. These results contribute an understanding of the Brazilian beef chain, and also of other supply chains coping with demanding and changing international markets. Managerial implications show the challenges facing Brazilian beef exporters in their efforts to sustain exports to the European Union and how they are using chain governance to improve their compliance with international standards and increase competitiveness.

scholarly journals Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders

2021 ◽  
Vol 8 ◽  
Author(s):  
Jorn Mulder ◽  
Robin Verjans ◽  
Ciska Verbaanderd ◽  
Elias Pean ◽  
Just Weemers ◽  
...  
Keyword(s):  
European Union ◽  
Medicinal Product ◽  
Marketing Authorisation ◽  
Therapeutic Indication ◽  
Regulatory Approval ◽  
The European Union ◽  
Regulatory Requirements ◽  
Marketing Authorisation Holder ◽  
Investigator Initiated Trials

After marketing authorisation, the development of a medicinal product often continues with studies investigating new therapeutic indications. Positive results can potentially lead to changes to the terms of the marketing authorisation, such as an extension of therapeutic indication(s). These studies can be initiated and sponsored by the marketing authorisation holder (MAH) or by others. When results from an investigator-initiated trial suggest that an authorised medicinal product is safe and effective for a new therapeutic indication, physicians may want to treat their patients with this medicinal product. In such a situation, it is desirable to extend the therapeutic indication(s) via the regulatory approval process, as this can facilitate patient access within the European Union. There may however be challenges when the MAH did not conduct the study and might not have access to the data. In this perspective, we focus on the possibilities to extend the therapeutic indication(s) of an already authorised medicinal product based on results from investigator-initiated trials. We address: (1) the advantages of an extension of indication; (2) the regulatory requirements for a variation application; (3) investigator-initiated trials as a basis for regulatory approval; (4) the role of the MAH in extending the indication. With this article, we want to emphasize the importance of a collaborative approach and dialogue between stakeholders with the aim to facilitate access to effective medicinal products.

scholarly journals Survey of mycotoxin feed contamination in Croatia

2012 ◽  
Vol 28 (2) ◽  
pp. 167-177 ◽  
Author(s):  
J. Pleadin ◽  
N. Persi ◽  
A. Vulic ◽  
M. Zadravec
Keyword(s):  
European Union ◽  
Quantitative Determination ◽  
Aflatoxin B1 ◽  
Animal Feed ◽  
The European Union ◽  
Fusarium Mycotoxins ◽  
Elisa Method ◽  
Pig Feed ◽  
Mean Concentration

The aim of this study was to investigate the contamination of feed with mycotoxins. A total of 103 samples of feed for poultry, pig and calves was collected at different animal feed factories in the central, eastern and north region of Croatia. The quantitative determination of aflatoxin B1 (AFB1), ochratoxin A (OTA), zearalenone (ZEA), deoxynivalenol (DON), fumonisins B1, B2 and B3 (FUM) and T-2 toxin (T-2) concentration was done using the validated ELISA method. The observed results indicated an increased contamination of pig feed with Fusarium mycotoxins DON and ZEA with mean concentrations of 1454?1444 ?g/kg and 153?161 ?g/kg, higher than recommended in 20% and 5% of the samples, respectively. Higher DON concentrations than recommended were also observed in 7% of calves feed with a mean concentration of 1140?1288 ?g/kg. The concentrations of AFB1, OTA and FUM in all the investigated samples in all country regions were according to the maximum allowed or recommended values in the European Union.

3. The European Council:

2021 ◽  
pp. 51-77
Author(s):  
Luuk van Middelaar ◽  
Uwe Puetter
Keyword(s):  
European Union ◽  
European Integration ◽  
Policy Development ◽  
European Council ◽  
The European Union ◽  
Treaty Of Lisbon ◽  
Heads Of State ◽  
Key Steps ◽  
Council Of Ministers ◽  
Institutional Actors

This chapter discusses the central role of the European Council in European Union (EU) politics and policymaking. Even though it was not listed among the EU’s core institutions until the Treaty of Lisbon, the European Council regularly intervenes in EU decision-making to make other institutional actors follow its guidance. Initially, it was meant to be predominantly an informal institution for direct exchanges between the heads of state or government of the member states. Yet it assumed responsibility for landmark decisions which paved the way for key steps in integration, such as EU enlargements and the euro. The European Council has arguably saved the Union from break-up by acting as its ultimate crisis manager and, at times, has skirted the boundaries of EU law by finding institutional compromises and fixes. The institution plays a guiding role, especially in relation to the Commission and the Council of the European Union, which was formerly known as the Council of Ministers. The European Council devises strategic guidelines for policy development, shapes processes of institutional reform, and breaks impasses when agreement cannot otherwise be found. Since the Treaty of Maastricht, European Council intervention has become a routine in new EU policy areas, such as euro area economic governance and foreign policy. The Treaty of Lisbon assigns the European Council its own full-time president and places the institution right after the European Parliament (EP) in the list of EU institutions. Even though it has shaped European integration since 1975, the European Council did not find much recognition in traditional theories of European integration. This has changed more recently, with renewed debate about intergovernmentalism in EU politics.

Nitrogen use and food production in European regions from a global perspective

2013 ◽  
Vol 152 (S1) ◽  
pp. 9-19 ◽  
Author(s):  
H. J. M. VAN GRINSVEN ◽  
J. H. J. SPIERTZ ◽  
H. J. WESTHOEK ◽  
A. F. BOUWMAN ◽  
J. W. ERISMAN
Keyword(s):  
European Union ◽  
Food Production ◽  
Food System ◽  
Animal Feed ◽  
Global Perspective ◽  
The European Union ◽  
Cereal Production ◽  
N Pollution ◽  
Energy Chain ◽  
N Use

SUMMARYCurrent production systems for crops, meat, dairy and bioenergy in the European Union (EU) rely strongly on the external input of nitrogen (N). These systems show a high productivity per unit of land. However, the drawback is a complex web of N pollution problems contributing in a major way to degradation of ecosystems. European Union Directives and national policies have improved nutrient management and reduced fertilizer N use in most European countries, which has curbed the N pollution trends particularly in regions with high stocking rates of animals. However, improvement is slowing down and environmental targets for N are not within reach. Building on the 2011 European Nitrogen Assessment, the current paper reviews key features of the complex relationships between N use and food production in Europe in order to develop novel options for a more N-efficient, less N-polluting and secure European food system. One option is to relocate feed and livestock production from Northwestern to Central and Eastern Europe. This would allow a reduction of N rates and N pollution in cereal production in Northwest Europe by 30% (50 kg N/ha), while increasing total cereal production in Europe. Another option is a change towards legume-based cropping systems to produce animal feed, in order to decrease dependence on N fertilizer and feed imports. The greatest challenge for Europe is to decrease the demand for feed commodities, and thus for land and N, by a shift to more balanced (and healthier) diets with less animal protein. These drastic changes can be stimulated by targeted public–private research funding, while the actual implementation can be enhanced by smart payment schemes using, for example money from the Common Agricultural Policy, certification and agreements between stakeholders and players in the food and energy chain. Involving networks of consumers, producers and non-governmental organizations is critical. An effective strategy starts with convincing consumers with a Western diet to eat less meat and dairy by communicating the associated health benefits and smaller ecological footprints. Internalizing the cost of N pollution leading to increased prices for N-intensive food products may also enhance involvement of consumers and provide financial resources to compensate farmers for loss of income and extra costs for stricter N measures.

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