ORGANIC CERTIFICATION IN SELECTED EUROPEAN COUNTRIES: CONTROL FEES AND SIZE OF THE SECTOR

In the increasing organic market in Europe, more and more of the organic food is sold via big retail chains. This development implies that an increasing trade with organic food takes place over long distances and across borders in Europe. Therefore, the control of organic products through the food chain “from farm to fork” has become increasingly important, because the organic inspection and certification system is the only guarantee to the consumer that the organic food products they buy really are organic. At the European level quite a lot of research has been done on various aspects of organic farming and marketing of organic food products, but little is known about the organic certification system at EU level as regards efficiency, costs and size of the organic certification sector. As an outcome of the CERTCOST project, baseline information on the actors in the organic certification sector has been made available in the www.organicrules.org database for the study year 2008. The database contains statistic information, contact details and other relevant information on the actors involved in the organic certification chain (competent authorities, accreditation bodies, control authorities, control bodies, standards owners and authorities managing certification subsidies), and it covers 16 EU countries, 2 associated countries and an EU candidate country. This study intends to shed some light on the European certification sector with respect to the fees for control (inspection and certification) of organic operators (as far as they are publicly available) and to make an estimate of the size of the certification sector in the EU and two other European countries (Switzerland and Turkey) in staff full time years and costs. Data on publicly available fees for organic control plus public certification support measures influencing the actual control costs were collected by the CERTCOST partners from 19 European countries, for the certification database, www.organicrules.org. Afterwards a more detailed survey was carried out in 7 study countries (the Czech Republic, Denmark, Germany, Italy, the United Kingdom, Switzerland and Turkey) by means of detailed questionnaires, which were particularly aimed at the 4 types of actors involved in organic control (competent authorities, accreditation bodies, control authorities / control bodies and standards owners). The questionnaires were designed for collection of data for several tasks in the CERTCOST project, but relevant for this study were questions concerning control fees, hours spent on control and other costs related to the control (travel costs, overhead etc.). The questionnaire for the control bodies also contained questions concerning control fees for 3 farm cases and 2 processor cases in order to get comparable data on control fees and time spent on the control for different control bodies and countries. Besides, all actors were asked for information on the number of staff employed by them, measured in full time years, and the hours in a full time year for their organisation for estimation of the organic certification sector size. Transparency and the possibility to compare control fees of different control bodies within countries as well as between countries are important for the organic operators (farmers, processors, importers etc.) and stakeholders, and it is particularly relevant in countries where there are many control bodies to choose among, as for example in Germany, Italy, the United Kingdom and Turkey. It seems obvious that all control bodies offering their services to the organic operators should have a publicly available price list on their web site, as also stated in the requirements of ISO 65 (EN45011), according to which all approved control bodies are accredited. However, the percentage of control bodies in the 7 study countries, which did have public price lists on their web site, varied from 67 % in the Czech Republic, 50 % in Switzerland, 44 % in Italy and the United Kingdom, 20 % in Turkey, down to only 14 % in Germany. Denmark has a governmental certification system free of charge for all organic operators, for which reason there is no price list. The questionnaire survey showed that the control fees were calculated in many different ways by different control bodies, making it very difficult for the customers to estimate and compare prices. As it was expected that it would be difficult to compare control fees of different control bodies, the questionnaire contained questions on fees and hours spent on the control for 3 farm cases and 2 processor cases. In total 25 control bodies supplied data on the farm cases, of which 2 from the Czech Republic, 3 from Germany, 5 from Italy, 4 from the United Kingdom, 2 from Switzerland and 9 from Turkey. The number of respondents who filled in data on the processor cases was slightly lower. Comparison of control bodies within countries showed that there was not necessarily any correlation between the size of the fee and the time spent on the control. For comparison of the fees, hours spent on the control and the hourly rate between the countries minimum, maximum and average fees were calculated for each of the 3 farm cases and 2 processor cases for each country. The comparison showed that the variation in the size of the fee, the hours spent and the hourly rate could vary as much as or even more between control bodies within the same country as between countries. In general the Czech Republic had the lowest average fees – for the farm cases: 66-109 €, followed by Italy (262-375 €), Germany (350-420 €), United Kingdom (526-571 €), Turkey (544-798 €) and Switzerland (811-1003 €). For the processor cases the order of the countries as concerns fee size was the same. The main reason for the high control fees in Turkey is that the Turkish control bodies generally spent much more time on the inspection and certification (21-34 hours on average), than the control bodies in the other countries for the farm cases. The average time spent by the 4 EU countries was only 7-10 hours. In 11 of 16 Länder in Germany and in 18 of 19 regions and 1 of 2 provinces of Italy the regional governments subsidise organic control costs of organic farmers. Hereby farmers may get their control fee reduced or even get the whole control fee paid back, depending on the control body they use. The 5 German Länder involved in the study pay a support of 35 €/ha up to maximum 15 ha or 530 €, which is enough to cover all or most of the control fee for the 3 farm cases depending on the control body carrying out the control. Of the 2 Italian regions involved in the study, Marche had no support scheme, while Tuscany paid the actual documented control cost up to 3000 € per farm and year for a 5 year period. The study shows that the fee calculation of the control bodies is done in quite diverse ways. It also shows that in many cases the operators may save money by choosing the “right” control body, which however may change depending on the type and size of the farm or operation. For the sake of transparency it is recommended that the competent authorities and/or the accreditation bodies enforce on the control bodies that they must have easily accessible public price lists on their various services on their web sites. The study should also give an estimate of the size of the organic certification sector in the EU (competent authorities, accreditation bodies, control authorities, control bodies and standards owners) expressed in staff full time years. Filled in questionnaires were received from 49 respondents of which 12 competent authorities, 5 accreditation bodies, 2 control authorities, 28 control bodies and 2 standards owners. Based on the data received, it was estimated that about 1500 staff full time years were spent by competent authorities, accreditation bodies, control authorities and control bodies on organic control in the 27 EU countries in 2008. The figure may be higher, because the workforce of the accreditation bodies, control bodies and standards owners involved in accreditation and control according to private standards and standards outside the EU were not included, and work spent on import and export control was not included either. With 1500 employees the cost of the workforce of the organic certification sector was estimated to about 35-55 million €. Besides the staff wages, there are other fixed and variable costs plus overhead, which means that the annual turnover of the competent authorities, accreditation bodies, control authorities and control bodies in the EU-27 was probably at least around 70-110 million € in 2008. In Switzerland the 46 staff full time years in the organic certification sector corresponded to at least 2 million € in 2008, and the annual turnover of the organic certification sector was probably at least 4 million €. In Turkey the 35 staff full time years corresponded to at least 350,000 € in 2008, and the annual turnover of the organic certification chain was probably at least 700,000 €. This study is the first study to include competent authorities, accreditation bodies, control authorities and control bodies in an estimation of the size of the organic certification sector. (Standards owners and some accreditation bodies were left out due to too few responses or lack of information in the returned questionnaires). Therefore this study gives a better basis for calculation of the sector size in the EU in staff full time years and workforce costs than the few earlier studies carried out, because those were based on indirect estimates, while this study is based on the actors’ own assessment of staff full time years spent on implementation and control of the organic regulation EC 834/2007 in the 5 EU study countries and the national organic regulations in Switzerland and Turkey

Organic research and development 1996-2010 - effects on industry and society

This publication contains the most important conclusions from the analysis and focuses on how the results from the research programmes DARCOF I-III and CORE Organic have been implemented in industry and society

A patient-derived xenograft pre-clinical trial reveals treatment responses and a resistance mechanism to karonudib in metastatic melanoma

Karonudib (TH1579) is a novel compound that exerts anti-tumor activities and has recently entered phase I clinical testing. The aim of this study was to conduct a pre-clinical trial in patient-derived xenografts to identify the possible biomarkers of response or resistance that could guide inclusion of patients suffering from metastatic melanoma in phase II clinical trials. Patient-derived xenografts from 31 melanoma patients with metastatic disease were treated with karonudib or a vehicle for 18 days. Treatment responses were followed by measuring tumor sizes, and the models were categorized in the response groups. Tumors were harvested and processed for RNA sequencing and protein analysis. To investigate the effect of karonudib on T-cell-mediated anti-tumor activities, tumor-infiltrating T cells were injected in mice carrying autologous tumors and the mice treated with karonudib. We show that karonudib has heterogeneous anti-tumor effect on metastatic melanoma. Thus, based on the treatment responses, we could divide the 31 patient-derived xenografts in three treatment groups: progression group (32%), suppression group (42%), and regression group (26%). Furthermore, we show that karonudib has anti-tumor effect, irrespective of major melanoma driver mutations. Also, we identify high expression of ABCB1, which codes for p-gp pumps as a resistance biomarker. Finally, we show that karonudib treatment does not hamper T-cell-mediated anti-tumor responses. These findings can be used to guide future use of karonudib in clinical use with a potential approach as precision medicine

Influence of demographic factors on antithrombin III activity in a healthy population

Antithrombin III (AT III) activity has been measured in 9669 healthy blood donors (5525 male and 4144 female). The distribution of AT III is approximately ‘normal’ with mean 105·6 iu/dl and standard deviation 11·2; however, definite age and sex related variations are evident. Pre‐menopausal females have lower mean AT III compared to their male contemporaries who have remarkably stable mean AT III until 45 years, after which there is a gradual decline. In contrast, post‐menopausal females have higher mean AT III than both males of the same age and younger pre‐menopausal females. Concurrent hormone replacement therapy inhibits this rise. The use of hormonal preparations is associated with a 4 iu/dl reduction of mean AT III in younger females but not in those over 30 years. Smoking may result in a mild increase in AT III of doubtful clinical significance. On‐going genetic and family studies are expected to predict a prevalence rate of congenital AT III deficiency in excess of the previously reported figure of 0·02%. The authors consider these observed variations as minor and recommend the use of a single reference range for AT III activity, but that particular care be taken when interpreting results in pill‐taking females and the elderly