Bernard Bottex

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

Update: use of the benchmark dose approach in risk assessment

Abstract The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the NOAEL approach for deriving a Reference Point (RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to apply the BMD approach. Model averaging is recommended as the preferred method for calculating the BMD confidence interval, while acknowledging that the respective tools are still under development and may not be easily accessible to all. Therefore, selecting or rejecting models is still considered as a suboptimal alternative. The set of default models to be used for BMD analysis has been reviewed, and the Akaike information criterion (AIC) has been introduced instead of the log‐likelihood to characterise the goodness of fit of different mathematical models to a dose–response data set. A flowchart has also been inserted in this update to guide the reader step‐by‐step when performing a BMD analysis, as well as a chapter on the distributional part of dose–response models and a template for reporting a BMD analysis in a complete and transparent manner. Finally, it is recommended to always report the BMD confidence interval rather than the value of the BMD. The lower bound (BMDL) is needed as a potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL per ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re‐evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 SC guidance was used, in particular when the exposure is clearly smaller (e.g. more than one order of magnitude) than the health‐based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the expected wide application of the BMD approach.

Guidance on the assessment of the biological relevance of data in scientific assessments

Abstract EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered.

Pest categorisation of Synchytrium endobioticum

Abstract The Panel on Plant Health performed a pest categorisation of the fungus Synchytrium endobioticum, the causal agent of potato wart disease, for the European Union (EU). The identity of the pest is well established and reliable methods exist for its detection and identification. S. endobioticum is present in most continents. The pest is listed in Annex IAII of Directive 2000/29/EC and is present with a restricted and fragmentary distribution in the EU. The major host is Solanum tuberosum (potato), but in Mexico, the pest also affects wild Solanum spp. S. endobioticum could potentially enter the EU through multiple pathways associated with soil as substrate for non‐host plants, contaminant or commodity. The presence of the pest in 16 EU Member States characterised by different climatic conditions suggests that it could establish in the rest of the EU. The disease induces the formation of warts on potato tubers, stolons and stem bases reducing plant growth and yield and making tubers unmarketable. Additional losses may occur during storage. The only available strategy to control the disease and prevent it from spreading is the application of strict phytosanitary measures and the cultivation of potato varieties resistant to the pathotype(s) present in the infested field(s). Specific phytosanitary measures exist (Council Directive 69/464/EEC) for the control of potato wart disease in the EU. The main uncertainties refer to the distribution and host range of the pest, and the importance of some pathways of entry. S. endobioticum meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering S. endobioticum as a potential Union regulated non‐quarantine pest are not met since, in addition to potato seed tubers, soil (as commodity, substrate or contaminant) and ware potato tubers are major means of spread.

Pest categorisation of Fusarium oxysporum f. sp. albedinis

Abstract The Panel on Plant Health performed a pest categorisation of the soil‐borne fungus Fusarium oxysporum f. sp. albedinis, the causal agent of Fusarium wilt of date palm, for the EU. The identity of the pest is well established and reliable methods exist for its detection/identification. The pest is listed in Annex IIAI of Directive 2000/29/EC and is not known to occur in the EU. Fusarium oxysporum f. sp. albedinis is present in Morocco, Algeria and Mauritania. Its major host is Phoenix dactylifera, which is the only Phoenix species known to be affected by the pest. Uncertainty exists about the host status of Lawsonia inermis, Medicago sativa and Trifolium spp. cultivated as intercrops in the infested areas and reported as being symptomless carriers of the pest. The pest could potentially enter the EU on host plants and soil/growing media originating in infested Third countries. The current pest distribution and climate matching suggest that the pest could establish and spread in the EU wherever the host is present. In the infested areas, the pest causes vascular wilt resulting in yield/quality losses and plant death. It is expected that pest introduction and spread in the EU could impact date production. The pest is expected to have high environmental consequences in the Elche area (Spain), which is a UNESCO World Heritage Site, as well as other EU areas where P. dactylifera is grown as an amenity tree. Current EU phytosanitary measures are not fully effective at mitigating the risk of introduction and spread of the pest in the EU. Fusarium oxysporum f. sp. albedinis meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. As the pest is not known to occur in the EU, this criterion to consider it as Union regulated non‐quarantine pest is not met.

Pest categorisation of Thecaphora solani

Abstract The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solani is present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introduction into the EU is prohibited. The major host is Solanum tuberosum (potato), but various other tuber‐forming Solanum species are also affected. The pest has also been reported on Solanum lycopersicum (tomato), and wild solanaceous plants are also affected. All the major hosts and pathways of entry are currently regulated. Host availability and climate matching suggest that T. solani could establish in parts of the EU and further spread by human‐assisted means. The disease induces gall formation on potato tubers, stolons and underground stem parts, reducing yield and making tubers unmarketable. The pest introduction in the EU would potentially cause impacts to potato production. In the infested areas, the only available strategy to control the disease and prevent it from spreading is the application of quarantine and sanitation measures and the cultivation of resistant varieties. The main uncertainties concern the host range, the biology and epidemiology of the pest, and the potential of the pest to enter the EU through three unregulated minor pathways. T. solani meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering T. solani as a potential Union regulated non‐quarantine pest are not met, since the pest is not known to occur in the EU.

Pest categorisation of Apiosporina morbosa

Abstract The Panel on Plant Health performed a pest categorisation of the fungus Apiosporina morbosa, the causal agent of black knot, for the EU. The identity of the pest is well established and reliable methods exist for its detection/identification. The pest is listed in Annex IIAI of Directive 2000/29/EC and is not known to occur in the EU. Apiosporina morbosa is present in Alaska, Canada, Mexico and the continental states of the USA. The major hosts of A. morbosa are Prunus domestica and Prunus cerasus; the host status of other Prunus species and hybrids is uncertain because of contradictory reports or lack of information. The pest could potentially enter the EU on host plants for planting and plant parts originating in infested third countries. Wood of Prunus spp. is also a pathway of entry, but of minor importance. The current pest distribution and climate matching suggest that the pest could establish and spread in the EU wherever the hosts are grown. In the infested areas, the pest causes girdling of twigs and occasionally of larger branches, whereas trees with multiple infections loose vigour, bloom poorly, and become unproductive, stunted and susceptible to winter injury and infection by other pathogens. The presence of black knots makes trees unsuitable for timber production. It is expected that the pest introduction and spread in the EU would impact host production. Uncertainty exists on whether the agricultural practices and chemical control methods applied in the EU could prevent the establishment and spread of A. morbosa. A. morbosa meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. As the pest is not known to occur in the EU, this criterion to consider it as Union regulated non‐quarantine pest is not met.

Pest categorisation of Stagonosporopsis andigena

Abstract The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The major cultivated host is Solanum tuberosum (potato); other tuber‐forming Solanum species and wild solanaceous plants are also affected. All hosts and pathways of entry of the pest into the EU are currently regulated. Host availability and climate matching suggest that S. andigena could establish in parts of the EU and further spread mainly by human‐assisted means. The pest affects leaves, stems and petioles of potato plants causing lesions and premature leaf drop but not the underground parts, including tubers. The disease causes yield reductions up to 80%, depending on the susceptibility of potato cultivars. Early application of fungicide sprays and cultivation of resistant potato cultivars are the most effective measures for disease management. The pest introduction in the EU would potentially cause impacts to potato production. The main uncertainties concern the host range, the maximum period the pest survives on host debris in soil, the maximum distance over which conidia of the pest could be dispersed by wind‐blown rain, and the magnitude of potential impacts to the EU. S. andigena meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering S. andigena as a potential Union regulated non‐quarantine pest are not met, since the pest is not known to occur in the EU.

Pest categorisation of Colletotrichum gossypii

Abstract The Panel on Plant Health performed a pest categorisation of Colletotrichum gossypii, the fungal agent of anthracnose and ramulosis diseases of cotton, for the EU. The identity of the pest is well established and reliable methods exist for its detection/identification. The pest is present in most of the cotton‐growing areas worldwide, including Bulgaria and Romania in the EU. Colletotrichum gossypii is listed as Glomerella gossypii in Annex IIB of Directive 2000/29/EC and is not known to occur in Greece, which is a protected zone (PZ). The only hosts are Gossypium species, with G. hirsutum and G. barbadense being the most susceptible. The pest could potentially enter the PZ on cotton seeds originating in infested third countries or EU infested areas. Entry into PZ by natural means from EU infested areas is possible, although there is uncertainty on the maximum distance the pest can travel by wind or insects. Bolls and unginned cotton are minor pathways of entry. Pest distribution and climate matching suggest that the pest could establish and spread in cotton‐producing areas of northern Greece. In the infested areas, the pest causes damping‐off, leaf/boll spotting, boll rot, witches’ broom symptoms and stunting resulting in yield and quality losses. It affects also the lint and seeds reducing fibres quality and seed germinability. It is expected that its introduction and spread in the EU PZ would impact cotton yield and quality. The agricultural practices and control methods currently applied in Greece would not prevent pest establishment and spread. Colletotrichum gossypii meets all the criteria assessed by EFSA for consideration as potential quarantine pest for the EU PZ of Greece. The criteria for considering C. gossypii as a potential Union regulated non‐quarantine pest are also met since cotton seeds are the main means of spread.

Pest categorisation of small‐spored Alternaria carrying the genes for the AM‐ or AK‐toxin biosynthesis

Abstract The Panel on Plant Health performed a pest categorisation of small‐spored Alternaria carrying the genes for the AM‐ or AK‐toxin biosynthesis, for the EU. The identity of the pests is clearly defined and reliable methods exist for their detection/identification. They are listed in Annex IIAI of Directive 2000/29/EC as Alternaria alternata (non‐European pathogenic isolates). Their distribution in the EU is restricted though with some uncertainty. The AM‐toxin producer Alternaria affect Malus spp. and Pyrus communis (European pear), whereas the AK‐toxin producer affect Pyrus pyrifolia, Pyrus bretschneideri and Pyrus ussuriensis (Asian pears). The pests could potentially enter the EU on host‐planting material and fruit originating in infested countries. There are no biotic/abiotic factors limiting their potential establishment and spread in the EU, as their epidemiology is similar to that of other well‐established Alternaria spp. Apples and European pears are widespread in the EU; Japanese pears are also present, but no data was found on their abundance/distribution. In the infested areas, the pests cause premature defoliation, fruit spotting and rot resulting in yield/quality losses. It is expected that the introduction and spread of the pests in the EU could impact apple and pear production, although the magnitude is unknown. Cultural practices and chemical measures may reduce the inoculum and the disease, but they cannot eliminate the pests. Phytosanitary measures are available to mitigate the risk of introduction and spread of the pests. The pests do not meet all the criteria assessed by EFSA for consideration as potential Union quarantine pests, as they are not under official control in those EU restricted areas where they have been found. The pests do not meet all the criteria assessed by EFSA to consider them as Union regulated non‐quarantine pests, as host plants for planting are not the main means of pest spread.