Open Access Grey Literature

Assessment of Probiotics in Infant Formula and Cereal Based Baby Foods Containing Bifidobacterium lactis Bb12– Update 2014

Jørgen Lassen, Siamak Yazdankhah

European Journal of Nutrition & Food Safety, Page 101-103
DOI: 10.9734/EJNFS/2015/14818

“Assessment of benefits and risks of probiotics in processed cereal-based baby foods supplemented Bifidobacteriumn lactis Bb12” from 2010 answered a request from the Norwegian Food Safety Authority focusing on the age groups 4-6 months, 6-12 months and 1-3 years. However, the use of infant formula intended for newborns, supplemented with this probiotic, was neither asked by the NFSA nor assessed by VKM.

The notifier of the baby foods intended for infants and small children has provided information on three different cereal-based products intended for age-groups over 4 months and one infant formula intended for newborns, all supplemented with B. lactis. In its letter the company concludes that their products supplemented with B. lactis do not pose any health and safety risk.

Regarding health effect, we have already mentioned in our assessment (Halvorsen et al. 2010) that: “It is not the mandate of this report to evaluate the health claims related to the products as these health claims are assessed by EFSA.”

Our main conclusions regarding safety were as follows:
“No serious adverse events are reported, but neither has the effect of long-term intake of a single bacterial strain been studied. Furthermore, cereals supplemented with B. lactis Bb12 intended for infants and toddlers have not been studied regarding safety. We are not aware of any in vivo studies explicitly concerning the ability of B. lactis Bb12 to influence gene expression of epithelial cells”.

Furthermore, we were concerned regarding presence of antibiotic resistance gene against tetracycline (tetW) in the B. lactis Bb12. In the answer to the question from NFSA regarding antibiotic resistance gene in L. lactis Bb12, we concluded that:

“Consumption of probiotic microororganism B. lactis Bb12 that harbour gene encoding resistance against tetracycline (tetW) may increase the risk of the transfer of such genes to the resident microbiota and pathogenic bacteria and hence increase development of bacterial resistance. High similarity has been observed between tetW gene in bacteria of human and environment origin and B. lactis Bb12. This suggests the spread of tetracycline resistance gene (tetW) between bacteria of various origins. However, the transfer of tetracycline resistance gene (tetW) to other bacteria as a consequence of consumption of Bb12 has not been studied.”

As we have already mentioned in our assessment (Halvorsen et al. 2010). “It is important to note that the infant’s diet comprises a restricted variety of foods, which often are taken several times a day during a period of life when a stable intestinal flora is not yet established. The establishment of a normal intestinal microbiota takes at least two years and thus the intake of large numbers of probiotic bacteria in monoculture during the first years of life may greatly influence this process.”

According to the “Guideline for evaluation of probiotics in food” (FAO/WHO 2002): ‘‘….the onus is on the producer to prove that any given probiotic strain is not a significant risk with regard to transferable antibiotic resistance or other opportunistic virulence properties.”

The tet(W) gene in Bifidobacterium seems to be integrated in the chromosome and its surrounding regions vary depending on the strain, but very often the gene is flanked by transposase target sequences or genes coding for transposase, an enzyme that catalyzes the movement of DNA fragments between different locations by recognizing specific target sequences, suggesting that, under adequate conditions, the gene could be transferred (Gueimonde et al. 2013). The presence of a tetracycline resistance gene, tet(W), flanked by a putative transposase gene in B. animalis subsp. lactis was also confirmed in other strains of Bifidobacterium than Bb12 (Stahl & Barrangou 2012).

Among the data provided by the notifier, we could not identify any new studies regarding the above mentioned concerns.

As already mentioned, our assessment from 2010 did not include probiotic-supplemented infant formula intended for use by newborns. It seems likely that the same concerns as for the cereal-based products will be valid in this age group and possibly of even greater importance.

Among the literature provided by the notifier was also the position paper from 2011 of the ESPGHAN Committee on Nutrition (ESPGHAN 2011). Among their general conclusions are:

• (Conclusion 1): “For healthy infants, the available scientific data suggest that the administration of currently evaluated probiotic-supplemented formula to healthy infants does not raise safety concerns with regard to growth and adverse effects”.

But none the less:

• (Conclusion 5): “In general, there is a lack of data on the long-term effects of the administration of formula supplemented with probiotics. Such data would be of particular importance if the effects persisted after the administration of the probiotics has ceased.”

And concludes lastly;

• (Conclusion 6): “Considering the above, the Committee does not recommend the routine use of probiotic-supplemented formula in infants.”

Our view is in accordance with these conclusions.

Open Access Grey Literature

An Australian Process that Assesses Country BSE Food Safety Risk

Hong Jin, Leise Berven, Rosalind Dalefield, James Conlan, Marion Healy, Scott Crerar

European Journal of Nutrition & Food Safety, Page 121-125
DOI: 10.9734/EJNFS/2015/16124

Background: Bovine spongiform encephalopathy (BSE) is a transmissible, fatal neurodegenerative disease of cattle. Recognised in 1986, the disease causes a spongiform degeneration of the neural network in the brain and spinal cord of infected cattle leading to incoordination, ataxia and ultimately death of the infected animal [1]. The agent causing BSE in cattle is a structurally modified prion protein. The BSE epidemic that started in the United Kingdom (UK) resulted in the destruction of more than 3.3 million cattle in the UK alone [2]. Variant Creutzfeldt-Jacob Disease (vCJD), a fatal neurodegenerative human disease described for the first time in 1996, is putatively linked to the consumption of specified tissues from the carcase of cattle infected with the BSE agent that causes BSE [3]. By June 2014, 184 people have died of vCJD infection and most of these lived in the UK

As a result of the worldwide prohibition on processed animal proteins being fed to cattle, BSE is no longer a major threat to food and feed safety provided that appropriate control measures are effectively implemented.

This paper discusses Australia’s approach to conducting country assessments to determine the food safety risk posed by the classical form of BSE but does not discuss the atypical forms of BSE, i.e. the H-type BSE and L-type BSE, identified more recently [4,5].

Australia has not recorded a case of BSE. In recognition of Australia’s effective BSE surveillance and control measures it has been assigned by its trading partners and the World Organisation for Animal Health (the OIE) the most favourable BSE risk status. In response to the identification of the linkage between BSE and vCJD in the BSE inquiry report [6], the Australian Government in 2001 introduced measures that prohibited the importation of beef and beef products from all countries that had reported cases of BSE. The Australia New Zealand Food Standards Code was amended in 2002 to ensure that beef and beef products sold in Australia were only derived from animals free of BSE. Some products were exempted from this requirement including: (a) collagen and gelatine sourced from bovine skins and hides; (b) bovine fat or bovine tallow at no more than 300 g/kg in a food product; and (c) dairy products sourced from bovines. Countries without BSE cases and wishing to export beef or beef products to Australia at the time were assessed by Food Standards Australia New Zealand (FSANZ) for country BSE risk status using a method based on the geographical BSE risk assessment methodology [7] between 2001 and 2003. As a result, retorted beef products were permitted for importation into Australia from 27 countries that included Argentina, Brazil, Chile, Croatia, Latvia, Lithuania, Mexico, New Zealand, Sweden, and Vanuatu.

In view of the updated scientific information on BSE, the Australian Government announced a revised BSE food safety policy in 2009 that permitted the importation of beef and beef products from any country, providing that the country had been assessed by FSANZ as having appropriate and effective BSE controls in place. Countries wishing to export fresh beef (chilled or frozen) to Australia need to apply to the Australian Department of Agriculture for assessment of a broader range of animal health and quarantine risks.

Since the announcement of the revised BSE food safety policy, FSANZ received submissions from 16 countries requesting country BSE food safety assessment and determination of their country’s BSE food safety risk status.

This extended abstract describes an Australian process developed and applied by FSANZ for assessing country BSE food safety risk.

Aims: To describe the features of a process developed and applied by FSANZ for assessing country BSE food safety risk.

Study Design: The Australian process that assesses country BSE food safety risk is comprised of: 1) a food safety risk assessment across the beef supply chain; 2) a framework to assure the quality of the assessment outcomes; and 3) a set of arrangements to deliver transparent risk communication.

Place and Duration of Study: FSANZ, Canberra, Australia, between April 2010 and December 2014.

Methods: The Australian process to assess country BSE food safety risk was developed in accordance with the 2009 Australian Government’s BSE food safety policy, and the principles described in the BSE chapter of the Terrestrial Animal Health Code published by the OIE.

Results: The BSE food safety assessment: The food safety assessment across the beef supply chain for BSE risk is comprised of: (a) a desk-based assessment that evaluates information provided by the applicant country; and (b) an in-country verification assessment that verifies the effectiveness of the key BSE control measures implemented in the applicant country. The desk-based assessment evaluates the applicant country’s response to the Australian Questionnaire to Assess BSE Risk (the Questionnaire),, information provided as appendices to the applicant country’s response to the Questionnaire, and any relevant information that is publicly accessible. The latter may include data and information published by the applicant country, relevant statistics and audit reports published by the OIE, the European Commission, the United States of America and others, and articles in relevant scientific journals. In addition to undertaking a desk-based assessment for each applicant country, FSANZ risk assessors conducted in-country inspections of all applicant countries that have been assessed to date, to verify the effectiveness of BSE-related controls. The in-country verification inspection assesses the competent authority’s oversight of BSE control and prevention measures, verifies the effectiveness of BSE related control measures implemented on beef and/or dairy farms, in feed producing establishments, and at slaughtering and rendering establishments in the applicant country.

The adequacy of the BSE-related food safety control measures developed by the applicant country and the effectiveness of their implementation are assessed against the following key areas:

1) The likelihood of the introduction and release of the BSE agent through importation of live cattle, bovine commodities and animal feed products; 
2) The likely exposure of domestic cattle herds to the BSE agent via potential recycling of the BSE agent within the animal feed system; 
3) The specific food safety controls around beef and beef products produced for human consumption; 
4) The adequacy of BSE control and prevention related infrastructure including an animal identification and traceability system, and the competent authority’s oversight of BSE prevention and control measures; and
5) BSE notification, laboratory diagnostic and surveillance activities.

A detailed BSE food safety assessment report is prepared to describe the BSE food safety controls established by the applicant country and the effectiveness of their implementation. The report recommends a BSE food safety risk category for the applicant country as part of the overall conclusion. This BSE food safety risk category then determines the trading conditions for beef products that may be exported from the applicant country to Australia.

Governance and quality assurance: The FSANZ country BSE food safety assessment process is supervised by the Australian BSE Food Safety Assessment Committee comprised of experts in the fields of food safety and risk assessment, animal health, animal and agricultural production systems, international trade, and animal identification and traceability. The assessment report prepared by FSANZ is peer reviewed by food safety and veterinary experts, and comments are also invited from the competent authority of the applicant country. The assessment outcomes including the recommended BSE risk status are reviewed and endorsed by the Australian BSE Food Safety Assessment Committee and subsequently approved by the Chief Executive Officer of FSANZ prior to notification to the applicant country and the Australian Department of Agriculture. The Australian Department of Agriculture establishes the export certification required from the competent authority of the applicant country based on the BSE risk status assigned.

Risk communication and transparency: Once a country’s status is finalised, FSANZ communicates the assessment outcome to the applicant country and relevant stakeholders including the OIE. The full country BSE food safety assessment report is subsequently published at

Consistency with established international risk assessment framework: The Australian process to assess country BSE food safety risk is consistent with the risk assessment framework applied by the OIE [8] in determining a country’s BSE risk status for animal health purposes. The OIE framework is comprised of: (1) release assessment; (2) exposure assessment; (3) BSE notification and investigation assessment; (4) BSE diagnosis assessment; and (5) BSE surveillance assessment. The Australian country BSE food safety assessment, based on the above OIE framework, addresses additional elements around food safety systems and controls in the applicant country aimed at preventing the contamination of beef and beef products for human consumption with the BSE agent and their tracing within the human food supply chain. Consequently, slaughterhouse operations, cattle identification and traceability, meat traceability and recall systems in the applicant country are examined for their effectiveness to ensure the safety and traceability of exported products of bovine origin.

The final outcome of the country BSE food safety assessment conducted by FSANZ is a categorisation of an applicant country’s BSE food safety risk status. A Category 1 country risk status is applied to countries for which there is a minimal likelihood that the BSE agent has or will become established in the national herd of the applicant country and will enter the human food supply chain. Beef and beef products produced in countries with a Category 1 status are considered to pose a minimal risk to human health. The Australian Category 1 BSE risk status is broadly equivalent to the OIE’s “negligible” country BSE risk status for animal health. A Category 2 country risk status means that countries have effectively implemented appropriate BSE control measures to prevent both the introduction and amplification of the BSE agent in a country’s cattle population, and contamination of the human food supply with the BSE agent. However, there are identified risk factors, for example some of the measures may not have complied with international standards for sufficient duration to achieve Category 1 status. Beef and beef products produced in countries with a Category 2 status are also considered to pose a minimal risk to human health. The Australian Category 2 risk status is broadly equivalent to the OIE’s “controlled” country BSE risk status for animal health. More stringent export certification requirements apply to Category 2 countries in that they are additionally required to certify that BSE specific risk materials are removed and appropriate stunning techniques are practiced during the slaughtering process.

Countries that are not categorised as Category 1 or Category 2 risk status are unable to export beef products to Australia.

At the time of preparation of this publication, FSANZ has completed BSE food safety assessments for nine applicant countries. Among the 16 country submissions received, two countries have since withdrawn their applications. BSE food safety assessments for the remaining countries are expected to be completed by mid-2016

Conclusion: The Australian process that assesses country BSE food safety risk has utilised an established international risk assessment framework for determining a country’s BSE animal health risk status and built upon this to incorporate additional elements to address the food safety and traceability of beef products. The in-country verification step to assess the effectiveness of a country’s BSE-related controls has provided Australia with further assurances around the safety of beef products that may potentially be exported to Australia.

The approach taken by FSANZ in assessing a country’s BSE food safety risk has been well accepted by applicant countries, many of which have sought categorisation through Australia’s process to demonstrate their BSE risk status. The rigorous risk assessment and transparent risk communication practices applied by FSANZ in determining a country’s BSE food safety risk status has helped to ensure applicant countries’ engagement with and support of the assessment process.

Open Access Review Article

Chemical Sensitivity in the Elderly: Lessons Learned from Micronutrient Consumption in the Dutch Elderly Population

Lya G. Soeteman-Hernández, Eugène H. Jansen, Hans Verhagen, Elly J. M. Buurma-Rethans, Jan van Benthem

European Journal of Nutrition & Food Safety, Page 90-100
DOI: 10.9734/EJNFS/2015/14319

A food consumption survey in the Dutch elderly population (51-69 years of age) showed an increased trend in micronutrient supplement intake (36.4%; 120/347 participants). Because data on chemical sensitivity in the elderly is lacking, evaluation as to whether the current uncertainty factor (UF) of 10 is sufficient to protect the elderly was investigated using the micronutrient consumption data in the elderly Dutch population as a case study. Theories of ageing, and differences in toxicokinetic and toxicodynamics are briefly discussed in the context of chemical sensitivity in the elderly. Evidence suggests that for the healthy elderly, no additional default UFs are recommended because the present UF of 10 is probably sufficient. However, more research is needed to ensure that there is no additional risk, particularly in the not-so healthy elderly population. Although there is a trend of increased consumption of micronutrient supplements (i.e. vitamins and minerals) by the Dutch population, the existing European legislation for micronutrients in fortified foods (Regulation 1925/2006) and food supplements (Directive 2002/46) is now being translated to simultaneously set maximum levels of micronutrients in foods and in supplements. For the healthy elderly, no foreseeable risk is expected due to the consumption of micronutrients. For the unhealthy elderly, the effects of micronutrient consumption are not yet known and therefore, dietary supplement intakes need to be continuously monitored with detailed questioning on health status, supplement and prescription drug use. In addition, the generation of an international and up-to-date database on the composition of available dietary supplements is needed to fill the current data gaps.

Open Access Review Article

Perspectives on Low Calorie Intense Sweeteners with a Focus on Aspartame and Stevia

Caomhan Logue, Stephan J. A. C. Peters, Alison M. Gallagher, Hans Verhagen

European Journal of Nutrition & Food Safety, Page 104-112
DOI: 10.9734/EJNFS/2015/14815

The safety of some food additives/E-numbers, including low calorie (intense) sweeteners (LCS), is constantly the subject of dispute and controversy. However, since LCS have been assigned an acceptable daily intake (ADI) and an E-number following extensive assessment of available safety and toxicological data, consumer safety is assured. These substances have been carefully evaluated, for example by the European Food Safety Authority (EFSA), leading to the conclusion that they are essentially safe when consumption is below ADI levels. Although, intake data indicate that general consumption of LCS is relatively low, many people appear to remain concerned about their safety, particularly aspartame (E951). More recently, stevia (steviol glycosides, E960) has been marketed as a “natural” alternative to aspartame. However, it is unclear whether stevia can live up to its promises. With regards to public health, the real risk within our diet is not the safety of food additives, but rather more likely to be the potential impacts of consuming too much energy and/or an unhealthy dietary pattern.

Open Access Review Article

Short Review of Sulphites as Food Additives

Alvaro R. Garcia-Fuentes, Sabrina Wirtz, Ellen Vos, Hans Verhagen

European Journal of Nutrition & Food Safety, Page 113-120
DOI: 10.9734/EJNFS/2015/11557

Sulphites or sulphiting agents refer to sodium hydrogen sulphite, sodium metabisulphite, potassium metabisulphite, calcium sulphite, calcium hydrogen sulphite, and potassium hydrogen sulphite. As food additives, they are widely used by the food industry with a variety of commercial uses in food and beverages. Sulphites are effective bleaching agents, antimicrobials, oxygen scavengers, reducing agents, and enzyme inhibitors. Wine, beer, dehydrated fruits and vegetables, jam, juice, sugar, processed potatoes, seafood, meat and baked products are some of the food categories in which sulphites are added. Sulphites have been implicated in various health related issues. Asthmatic reactions and some antinutritional consequences such the degradation of thiamine (vitamin B1) are adverse reactions associated with sulphites. In many countries, sulphites have been regulated. Sulphites are generally recognized as safe in the USA with some exceptions when using in raw fruits and vegetables. In the European Union sulphites are also controlled, and the permitted amount varies according to the food product.