END0019 - Evidence on Energy drinks

Introduction

I am a toxicologist with extensive knowledge in both European and international regulatory affairs concerning food ingredients, additives and contaminants.

I received my B.Sc. with honours in biochemistry from the University of London and a Ph.D. in clinical pharmacology/toxicology under the guidance of Professor A. Renwick OBE from the University of Southampton. I also completed a post-doctoral fellowship in metabolism and pharmacokinetics from the University of Southampton.

I worked in the scientific and regulatory affairs division of a multi-national food company and two leading European contract research organizations that conducted drug metabolism and pharmacokinetics studies and phase I clinical trials.

For the last sixteen years, I have advised and assisted international clients with scientific, regulatory and toxicological issues, particularly with regard to the design and development of scientific research programs, regulatory strategies for food additives, food enzymes, foods that are Generally Recognized As Safe (“GRAS”) and novel foods.

Since 2011, I have been involved in researching, evaluating and analyzing the ingredients in energy drinks. I have not only researched the individual ingredients of energy drinks, but also whether there are any potential adverse effects from the combination of their primary ingredients. I have been hired to consult with energy drink companies to evaluate energy drink safety, including analyzing consumption data by different subpopulations (including adolescents). I have also supervised teams of experts to evaluate whether the ingredients in energy drinks meet the US FDA GRAS requirements.

Commentary on Parliament Inquiry

The recent request for submissions in respect to the United Kingdom’s Parliamentary Inquiry into energy drinks contains terms of reference that relate to the potential safety of energy drinks, and by inference caffeine and other ingredients contained therein, especially in young people (i.e., adolescents). The safety of caffeine and of energy drinks has been the subject of extensive review. Presented below is commentary on the available data in relation to the terms of reference of the Inquiry, specifically:

The evidence on the potential physical and mental health effects of energy drinks on children and young adults.

What links there are between use of energy drinks and other behaviours, and whether energy drink consumption drives those behaviours or vice versa.

What the evidence is on the risks being increased, or reduced, through the way energy drinks are consumed.

As the individual statements are inter-related, the forthcoming commentary addresses these terms of reference as a whole.

First, the main component of most energy drinks is caffeine with minor ingredients including glucuronolactone and taurine. The pharmacokinetics and metabolism of caffeine have been extensively studied in experimental animals and humans.

Plasma caffeine concentrations have been assessed following the delivery of caffeine via coffee or as anhydrous caffeine dissolved in water during exercise (Hodgson et al., 2013).[1] Eight (8) trained cyclists with low habitual caffeine intake (≤300 mg caffeine per day) consumed the test preparations (i.e., coffee, anhydrous caffeine + water, decaffeinated coffee, water) within 15 minutes in a randomized cross-over fashion. The caffeinated test drinks provided 5 mg caffeine per kg body weight to each subject. Peak plasma levels were attained at 60 minutes with maximum caffeine concentrations of 38.2±2.8 and 33.5±5.0 μM for the coffee and caffeine treatments respectively, and no differences in the plasma concentration time-profiles were observed between these groups. These results demonstrate that the pharmacokinetics of caffeine, as naturally present within coffee, do not differ from an equivalent dose of anhydrous caffeine dissolved in an equivalent volume of water.

Previously, in a random-, double-blind placebo controlled within subject study of 13 habitual consumers of caffeine (colas and coffee), Ligouri et al. (1997)[2] reported that ingestion of 400 mg of caffeine as either 12 oz unsweetened coffee, 24 oz sugar free cola, or 3 capsules, had variable effects on peak caffeine levels in saliva as measured 15 min before and 30, 60, 90, 120, 180 and 240 min post dosing. The peak saliva caffeine levels were similar between coffee (9.7 ± 1.2 μg/mL) and cola (9.8 ± 0.9 μg/mL) and slightly higher than with capsule consumption (7.8 ± 0.6 μg/mL). Peak levels were reached earlier with coffee (42 ± 5 min) and cola (39 ± 5 min) compared to capsule ingestion (67 ± 7 min).

Most recently, the plasma pharmacokinetics of caffeine have been compared following delivery of an equivalent dose via hot and cold coffee and energy drinks, consumed quickly (within 2 minutes) or slowly (within 20 minutes) (White et al., 2016).[3] Twenty-four (12 men, 12 women; aged 18 to 30 years) healthy, non-caffeine naïve subjects (habitual consumption of 1 to 3 caffeinated beverages per day) consumed hot coffee over 20 minutes, cold coffee over 2 minutes, cold coffee over 20 minutes, sugar-free energy drink over 2 minutes, and sugar-free energy drink over 20 minutes, each providing 160 mg caffeine. The mean caffeine concentration-time profiles for each test condition were similar and standard deviations overlapped at all time-points. No significant differences between the 5 test conditions were reported for caffeine for each of area under the curve (AUC) from zero to infinity, time to maximum plasma concentration, mean residence time, mean absorption time, half-life, or clearance divided by assumed bioavailability. The results of this study demonstrate that the vehicle, temperature, and time taken to ingest an equivalent dose of caffeine do not affect the absorption or exposure to caffeine.

As a result, the available pharmacokinetic data indicate that the amount and presence time of caffeine in the body is not significantly changed by the source from which it comes, especially when consumed in beverage form. The body does not experience unique exposures to caffeine from energy drinks relative to other beverage sources containing similar levels.

Secondly, contrary to popular perception, children and adolescents have been consuming caffeine for years, and overall, in these populations “energy drink” consumption is not the largest source of caffeine. Children and adolescents have historically consumed caffeine in the diet via coffee, soft drinks, chocolate, and other food products.

In a study of caffeine intake in the US, Mitchell et al. (2014)[4] reported that the mean caffeine intakes in persons aged 6 to 12 and 13 to 17 were 36.6 and 83.2 mg/day (on average less than the amount of caffeine in 1 cup of coffee). In 13 to 17 year old consumers of energy drinks, an average of 58.7 mg/day of caffeine was derived from this source. At the 90th percentile, 13 to 17 year old energy drink consumers consumed 132.9 mg of caffeine from this source. Studies have likewise shown that energy drinks constitute a small amount of total caffeine consumption for European adolescents (Zucconi, 2013).[5] Such data do not indicate excess caffeine intake by young people due to energy drink consumption.

Tran et al. (2016)[6] investigated the change in percent caffeine consumers over time based on data from NHANES 2003 to 2012 surveys in adolescents (13 to 17 years), young adults (18 to 24 years), and adults (25 to 29 years) and reported that the percent of caffeine consumers remained relatively constant over time in each of the age groups. Tran et al. (2016) reported that mean total caffeine intake showed a statistically significant decline over the 10 survey years in adolescents (13 to 17 years), while mean intakes in young adults (18 to 24 years) fluctuated over the time period with no discernable trends, and mean intakes in adults (25 to 29 years) decreased, but not significantly. The 90th percentile intakes did not differ significantly in any of the 3 population groups over the 10-year period. Intake of caffeine from energy drinks increased slightly without significance in teenagers and adults and increased significantly in young adults. Overall, the data indicate that caffeine consumption from soda is decreasing, while caffeine consumption from coffee, tea, and energy drinks has been increasing; however, as discussed above, the evidence shows that overall intakes of caffeine are either decreasing or remaining stable.

Tran et al. (2016) noted that the introduction of new sources of caffeine did not result in an increase in the percentage of caffeine consumers. Similar findings of a constant percentage of consumers over time have been reported for children, adolescents, and young adults aged 2 to 22 years between 2003 and 2012 (Branum et al., 2014)[7] and for adults between 2001 and 2010 (Fulgoni et al., 2015).[8] These results demonstrate that despite the addition of new caffeine sources, the percentage of caffeine consumers is not expanding.

Drewnowski [9] and Rehm (2016) investigated a similar, but slightly longer time period of 1999 to 2012 from the WWEIA and NHANES surveys and also reported a significant decreasing trend in mean caffeine intakes in children aged 4 to 19 years. When analyzed by age group, significant decreases in mean caffeine intakes between 1999/2000 and 2011/2012 were reported for 4 to 8, 9 to 13, 14 to 19, 20 to 34, and 34 to 49-year-olds.

Overall, the results of the various analyses demonstrate that mean intakes of caffeine have decreased significantly over time in children, adolescents, and young adults, while remaining stable in older adults. High-level consumers (i.e., 90th percentile) were investigated in only one study, and based on that data appear to have remained stable between the years of 2003 to 2013 in adolescents, young adults (18 to 24 years), and adults (25 to 29 years).

The reported changes in source of caffeine intake over time suggest that a ‘substitution effect’ is occurring, wherein consumers are substituting one caffeine source for another. Tran et al. (2016) specifically investigated this effect in energy drink consumers who had a caffeine intake in the upper 50th percentile of caffeine intake, and reported a statistically significant inverse relationship between caffeine intake from energy drinks and caffeine intake from each of coffee, tea, and soda. These results demonstrate that a substitution effect is indeed occurring. Tran et al. (2016) also presented data to demonstrate that caffeine consumers are able to self-regulate their caffeine intake irrespective of source. Caffeine intakes consumed over 30-minute time periods were assessed and the results demonstrated that the mean total intake of caffeine was the same whether the intake resulted from an energy drink alone or an energy drink plus another caffeinated product. These results demonstrate that if an individual is consuming another caffeine-containing product, the intake of an energy drink is decreased compared to if the individual was only consuming an energy drink.

Third, the safety of caffeine, including safety in children, has been subject to review by several regulatory authorities, including EFSA (2015) and Health Canada (Nawrot et al., 2003).[10]

The European Food Safety Authority (EFSA)’s Panel on Dietetic Products, Nutrition, and Allergies (NDA Panel) reviewed the available scientific data on the intake of caffeine from all sources and possible adverse health effects in the general population, as well as in specific sub-groups of the population (e.g., children, adolescents, adults, the elderly, pregnant and lactating women, and subjects performing physical exercise) (EFSA, 2015). In adults, EFSA (2015) concluded that single doses of caffeine of 200 mg and cumulative doses of 400 mg consumed throughout the day (approximately 3 and 5.7 mg/kg body weight for a 70-kg individual, respectively) do not result in safety concerns for healthy adults in the general population. In EFSA’s evaluation of caffeine, the NDA Panel reviewed 3 publications in which the behavioral or cognitive effects of the acute consumption of caffeine in children and adolescents were investigated (EFSA, 2015). All 3 of these studies were included in Health Canada’s safety assessment of caffeine (Nawrot et al., 2003). In contrast to the conclusions of Nawrot et al. (2003), the NDA Panel considered that there was no effect of single doses of caffeine ranging from 2.5 to 10 mg/kg body weight on most self-reported measures of anxiety in children, as caffeine intakes were not significantly associated with anxiety and caffeine concentrations in saliva were generally not associated with anxiety in a study by Bernstein et al. (1994).[11] EFSA’s NDA Panel also reviewed 4 studies in which the behavioral effects of caffeine consumption by children and adolescents for periods of up to 2 weeks were investigated (EFSA, 2015). EFSA concluded that “Single doses of caffeine of no concern derived for adults (3 mg/kg body weight per day) may also apply to children, considering that caffeine clearance in children and adolescents is at least that of adults, and that the limited studies available on the acute effects of caffeine on anxiety and behavior in children and adolescents support this level of no concern”. In addition, EFSA (2015) noted that habitual consumption of up to 3 mg/kg bw/day by children/adolescents does not present a safety concern. Moreover, EFSA reported that the effects of caffeine in young persons are not unique, they are similar to those experienced by adults (i.e., there is no unique safety concern for caffeine in children). EFSA noted the “rather conservative” nature of the 3 mg/kg bw/day safe exposure level in children. Furthermore, the EFSA evaluated the combination of other constituents within energy drinks and addressed the potential interactions of glucuronolactone and taurine with caffeine. The EFSA Committee concluded that it is unlikely that glucuronolactone and taurine would interact with caffeine and that the exposure to these ingredients at levels commonly used in energy drinks was of no safety concern. In addition, a “first principles” analysis (i.e. very general concepts of pharmacology, toxicology and pharmacokinetics) was conducted to identify potential theoretical interactions. This analysis found no evidence to indicate a potential for interaction between those ingredients contained within energy drinks.

It should be noted that caffeine, and other methylxanthine derivatives such as theophylline and theobromine, have a long-history of safe use for pediatric treatment of apnea and attention deficit disorder in children and infants. The results of a systematic review and meta-analysis identified no adverse clinical outcomes resulting from the use of caffeine in infants less than 3 days of age at loading doses ranging from 20 to 80 mg/kg body weight with maintenance doses of 5 to 10 mg/kg body weight/day for unspecified durations (Kua and Lee, 2017).[12] It also is considered safe and acceptable for adults and for children 12 years of age (i.e., adolescents) to use caffeine in over-the-counter stimulant products to restore mental alertness or wakefulness during fatigue or drowsiness in doses of 100 to 200 mg not more often than every 3 to 4 hours (21 CFR 340.50; U.S. FDA, 2016).[13] Such use could theoretically result in 1600 mg/day doses of caffeine in young persons over the age of 12, yet FDA has considered such products safe and effective since the 1980s.

Overall, there is no evidence to indicate that caffeine sourced from “energy drinks” acts any differently than caffeine from other sources such as coffee and tea. Intake data indicate that since the introduction of caffeine-containing “energy drinks” several decades ago, there has not been a resultant increase in the mean amount of caffeine consumed by children and adolescents. In fact, recent data indicate that even in the subpopulations that consumes energy drinks, caffeine exposures per week are generally about the amount of caffeine contained in one 500 ml energy drink can (Zuconi, 2013). Consumption of energy drinks does not increase caffeine intake, rather it tends to displace caffeine intake from other sources, most notably other beverages. As a result, from the perspective of intake, there is no evidence to indicate increasing caffeine exposures in children and adolescents are occurring due to energy drink consumption. Finally, the safety of caffeine in children, including energy drink consumption, as well as the potential for interaction between the ingredients, has been extensively evaluated, the results of which have been reviewed by many regulatory authorities including EFSA. EFSA (2015) concluded that in children acute or habitual consumption of caffeine at doses of up to 3 mg/kg bw/day posed no safety concerns. The results of EFSA’s review have been corroborated by more recent studies. While case reports have been cited to infer hazards associated with energy drink consumption, such information is limited and does not account for the inadequacies inherent in case reports present in various databases. In conclusion, there is no evidence to indicate that current rates of energy drink consumption by children and adolescents poses any safety concerns.

April 2018

Curriculum Vitae

Ashley Roberts, Ph.D.

EXPERIENCE

Senior Vice President, Food and Nutrition Group
Intertek • 2014 – Present

Intertek Cantox • 2010 – 2013

Cantox Health Sciences Inc.* • 2001 – 2010

Responsibilities: Include directing the Food and Nutrition group; responsible for both safety and efficacy related topics on an international basis. Further roles include development and design of scientific research programs for food ingredients, additives and contaminants. Development of international regulatory strategies for food additives and ingredients. Calculation of qualitative human health risk assessments for food components, contaminants and foods. Preparation of documents and reports for submission to international regulatory authorities. Has international recognition from both a scientific and regulatory standpoint and has developed strong relationships with regulatory authorities on a global basis.

*Cantox Health Sciences Inc., was acquired by Intertek Group plc in April 2010.

Scientific & Regulatory Affairs Manager • Tate & Lyle Specialty Sweeteners • 1991 – 2001

Responsibilities: To manage the worldwide safety and regulatory strategy. To design, develop and undertake toxicology and clinical safety studies in co-operation with leading toxicologists, academics, hospitals and contract research organizations throughout Europe and North America. To provide overall data interpretation, toxicological evaluation, safety assessment and the preparation of reports specific for the different worldwide regulatory authorities. To write detailed scientific position papers in response to specific questions from different regulatory authorities. To present data and detailed scientific arguments to regulatory authorities, scientific groups and at scientific meetings throughout the world. To deal and work closely with regulatory authorities and government departments throughout the world including Western and Eastern Europe, North America and the Far East.
Achievements: Successful undertaking and completion of toxicological scientific data-base and safety evaluation of a major novel food additive which has gained world-wide regulatory approval.

Research Manager, Merthyr Tydfil • Simbec Research Ltd. • 1989 – 1990

Responsibilities: To manage clinical pharmacology studies of novel and established pharmaceuticals in many therapeutic regions from design and inception through to final reporting. Managing clinical and research staff. To liaise with the world’s leading pharmaceutical companies on study design and protocol development. To prepare and present detailed information to the Ethical Committee to seek approval for the conduct of such studies. To manage and organise staff in the undertaking of the actual experimentation. To undertake data analysis and result interpretation for clients. To undertake the final report writing along with presentation of the results to the clients.
Achievements: Successful conduct of many studies enabling major pharmaceutical companies to file product license applications. Worked closely on several medicines which have now gained worldwide recognition.

Laboratory Development Manager • Peter Hand Animal Health Ltd. • 1988 – 1989

Responsibilities: Managing a group of laboratory personnel and secretarial staff. Overall responsibility for development of animal health care products and for providing the technical and scientific information relating to regulatory applications. Development of new veterinary pharmaceutical products. Preparation of study protocols. Analytical method development and sample analysis. Result analysis and data interpretation. Preparation of reports and documents for regulatory authorities, including pharmacology/toxicology expert reports. Responsible for purchase of latest laboratory technology and recruitment of staff for the laboratory.
Achievements: Major involvement in the company being granted two new medicinal product licenses.

Research Fellow • Clinical Pharmacology Group, University of Southampton • 1985 – 1987

Responsibilities: To undertake pre-clinical research in the areas of metabolism and pharamcokinetics. To take Medical Student Pharmacokinetic lectures and tutorials.

Ph.D. Studentship • University of Southampton • 1982 – 1985

My research provided me with the opportunity to study mechanisms in toxicity, resulting from the daily administration of cyclohexylamine a toxic metabolite of cyclamate. This research also provided me with the opportunity to collaborate with Senior Toxicologists from the British Industrial Biological Research Association (BIBRA). The research was sponsored by the Calorie Control Council (USA) and the International Life Sciences Institute European Technical Cyclamate Committee.

Additional responsibilities included demonstrating Pharmacology Practicals to medical students. Supervising MSc and BSc students with final year projects in Toxicology and Clinical Pharmacology.

Achievements: Awarded a British Pharmacology Society bursary to present my research at the World Toxicology Congress in Japan (1986).

Research Scientist • Huntington Research Centre • 1980 – 1982

Responsibilities: To develop, conduct and report metabolism and pharmacokinetic studies with pharmaceuticals, agrochemicals and food additives in animals and man. To assist in the writing of study protocols and reports. Undertake the majority of the experimentation involved in the project and supervise laboratory and animal technicians.

EDUCATION

Ph.D. • 1987 • University of Southampton

B.Sc. (Honours), Biochemistry • 1980 • University of London

PROFESSIONAL societies/associations

• American Herbal Products Association (AHPA) – Member

• British Industrial Biological Research Association (BIBRA) - Member

• The British Toxicology Society (BTS) – Full Member

• Canadian Institute of Food Science and Technology (CIFST) – Member

• Institute of Food Technologists (IFT) – Regulatory Member

• International Life Sciences Institute (ILSI) – Member of the Acceptable Daily Intake and Food Chemical Intake task force.

• International Society of Regulatory Toxicology and Pharmacology (ISRTP) - Member

• International Sweeteners Association (ISA) – Past Chairman Elect of the Scientific and Regulatory Committee

• Society of Toxicology (SOT) - Member

Toxicology Forum – Member
Food Safety and Quality Program Advisory Board, McGill University – Member 2014-Present

ABSTRACTS & pRESENTATIONS

2017 • “Steviol Glycoside Safety Evaluation” • Istanbul, Turkey

Presented at Low and No-Calorie Sweeteners (Conf. II), December 2.

2017 • “Steviol Glycoside Safety Evaluation” • Ankara, Turkey

Presented at Low and No-Calorie Sweeteners (Conf. I), December 1.

2017 • Potential Impact of U.S. Guidance to Reduce the intakes of Added Sugars on Estimated
Daily Intakes of Non-Nutritive Sweeteners” • Naples, FL
Presented at the Calorie Control Council - 2017 Annual Meeting & Educational Symposium, Nov. 6.

2017 • “Sweetener Safety” • Festival City, Dubai

Presented at the Dubai Nutrition Conference, October 26-27.

2017 • “Overview of Stevia Approvals by the Global Safety Authorities” • Buenos Aires, Argentina

Presented at the ILSI at 21st International Congress of Nutrition (ICN2017) - Sponsored Scientific Symposium: 144/129 - Stevia: An Ally to Support Nutrition and Health. Organized by: International Stevia Council (ISC) (Belgium) & Calorie Control Council (CCC) (USA), October 17.

2017 • “Global Safety and Regulatory Processes for the Evaluation of Low‐Calorie Sweeteners”
• Buenos Aires, Argentina
Presented at the ILSI at 21st International Congress of Nutrition (ICN2017), October 17.

2017 • “Approaches to Safety Assessment of Low Calorie Sweeteners & Global Regulatory Development Status” • New Delhi, IndiaPresented at ILSI India, Conference on Sweetness: Role of Sugar & Low-Calorie Sweeteners, September 20.

2017 • “Safety Evaluation of Low/No Calorie Sweeteners” • Beijing, China

Presented at the Science, Safety and Innovation of Sugars & Sweeteners Workshop, August 8.

2017 • “The Use of Chemical-Specific Adjustment Factors (CSAF’s) in the Derivation of the ADI Using Steviol Glycosides as a Case Example”• Las Vegas, NV
Presented at IFT 2017 Annual Meeting and Expo; Session: Deriving an Acceptable Daily Intake (ADI) for Steviol Glycosides Utilizing Chemical-Specific Adjustment Factors Food Additive Safety: Using Chemical-Specific Adjustment Factors (CSAFs) when Estimating Acceptable Daily Intakes (ADIs),
June 28.

2017 • “Update on Low/No/Reduced Calorie Sweeteners & Possible Impacts on the Microbiome”• Santiago, Chile
Presented at: The Symposium for “Sugar reduction in Foods: From Evidence to Action”.
A joint event with Sochital (the Chilean Society of FS&T) and Sochinut (the Chilean Society of Nutrition), May 30.

2017 • “Update on Low/No/Reduced Calorie Sweeteners & Possible Impacts on the Microbiome” • Lima, Peru
Presented at: Nutrition Congress (XIII Peruvian Congress of Nutrition and XII International Course of Nutrition and Nutrition Update), May 26.

2017 • “Sweeteners: Do They Bear a Carcinogenicity Risk” • Sao Paulo, Brazil
Presented at: ILSI Brazil – IX Updates on Food Safety Sweeteners, International Life Sciences Institute (ILSI), March 28.

2016 • “Update on Low/No/Reduced Calorie Sweeteners & Possible Impacts on the Microbiome” • Clearwater Beach, FL
Presented at the Calorie Control Council – 2016 Annual Meeting & Education Symposium &
50th Anniversary Celebration, November 7.

2016 • “The Metabolism and Pharmacokinetics of Steviol Glycosides and Their Impact on the ADI.” • Rome, Italy
Presented at Euro Toxicology 2016, 7th Euro-Global Summit on Toxicology and Applied Pharmacology, October 24-26.

2016 • “Stevia Sweeteners: The Past the Present and the Future; and Do High Intensity Sweeteners Modulate the Gut Microbiome?” • Buenos Aires, Argentina

Presented at the Symposium on Low and No Calorie Sweeteners: Myths and Realities, organized by the AATA (Argentine Association of Food Technologists) together with the Argentine Nutrition
Society (SAN), August 4.

2015 • “Regulatory Overview: Chinese Doing Business in the European Union” • Paris, France

Presented at Food Ingredients Europe (FI Europe), December 3.

2015 • “Regulatory requirements for food ingredients added to foods for nutritional health purposes; and Regulatory impact of newly reported data on L-arginine” • Paris, France
Presented at the International Council on Amino Acid Sciences (ICAAS), Paris, France, October 15.

2015 • “Health Claims: Comparing the New Japanese Regulation to that of the US, Australia, and Europe” • Tokyo, Japan

Presented at Health Ingredients Japan 2015, October 8.

2015 • “The Safety & Regulatory Process for High Intensity Sweetener Approval in the U.S.”
• West Lafayette, IN

Presented at workshop on “High Intensity Sweeteners: Evolving Science, Exploding Controversy”, Purdue University, September 22-24.
2015 • “Clarifying the Complexities in the Regulation of New Food Ingredients in Key Global Markets” • Mississauga, ON

Hosted by Intertek Scientific and Regulatory Consultancy via webinar, August 25.

2014 • “A Hard Look at FDA’s Review of GRAS Notices” • Washington, DC

Presented at the International Society of Regulatory Toxicology and Pharmacology’s “Workshop on GRAS Determinations”, Washington, DC, October 14.

2014 • “Health Claim Comparison Between the EU and China” • Shanghai, China

Presented at Food Ingredients China 2014, March 25

2013 • “Analytical and Toxicity Study Requirements for Gaining Regulatory Approval”
• Tokyo, Japan

Presented at Health Ingredients Japan, October 11.

2013 • “Safety Assessment of Caffeine in Foods and Beverages” • Washington, DC

Presented August 5 via webcast for The National Academies’ Planning Committee on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements - Session: Safety Assessment of Caffeine in Foods and Beverages, August 5-6.

2013 • “Regulatory Procedure of Submission and Approval of US GRAS and EU Novel Food” • Shanghai, China

Presented at Food Ingredients China 2013, March 26.

2012 • “Analytical and Toxicity Study Requirements for Gaining Regulatory Approval” • U.S.A. & Switzerland

Presented at the Intertek Cantox Workshop on Beyond the Great Wall: How to access the food and supplement markets in China, Arlington, VA, September 21 and in Geneva, Switzerland on October 16.

2012 • “Substantiating Immune Health Claims: Perspectives of Scientific/Regulatory Authorities in North America and Europe • Las Vegas, Nevada

Presented at IFT Annual Meeting; Session: Substantiating an Immune Health Claim – Three Perspectives, June 27.

2012 • “The GRAS Process for Feed” • Brussels, Belgium

Presented at the Intertek Cantox Workshop - Regulation of Animal Feed Ingredients in the
United States, February 16.

2011 • “Regulatory Developments for Supplements in the United States and Canada” • Las Vegas, NV

Presented at SupplySide West, October 10.

2011 • “EU Guidance on the Submission of a Dossier on Food Enzymes and the Latest Position on Health Claims” •

Presented at the Intertek Cantox Workshop on The Current Situations of Regulatory Approvals for Functional Food Ingredients in Overseas Market (Memorial Workshop on the 5th Anniversary of the Intertek Cantox Tokyo Branch Office), October 5.

2011 • “The Use of Animal Toxicological Studies of High Intensity Sweeteners in Predicting Effects on Human Weight Management” • Washington, DC

Presented at ILSI North America: Conference on Low-Calorie Sweeteners, April 7-8.

2010 • “How to Get Your Food Ingredients to the Marketplace in the U.S.; Regulation of Claims on Foods and Dietary Supplements in the U.S; Regulatory Overview of Food Ingredient Legislation in the EU; and Regulation of Claims in the European Union” • Seoul, South Korea

Presented at Cantox’s Workshop on Food Ingredients and Supplements: Gaining Access to the U.S., EU., and Korean Markets, October 20.

2010 • “An Overview of Japanese Food Regulations. Regulatory Processes for Food Product Approval in Japan” • Webcast

Institute of Food Technologists’ webcast: Global Regulatory Approval for Food Ingredients,
August 11.

2010 • “Progress of Health Claims in Europe: A New Perspective” • Brussels, Belgium

Cantox Workshop, February 23.

2010 • “Private Sector Experience: What Characterizes an Adequate Package?” • Washington, DC

Presented at the 35th Annual Winter Meeting of the Toxicology Forum, February 2-4.

2009 • “New Technologies and Development for Monitoring Safety of Functional Foods for Heart Health” • Winnipeg, MB

Presented at the Functional Foods for Heart Health: Continuum Between Science and Commercialization, University of Winnipeg, December 10.

2009 • “U.S. GRAS/NDI Notifications, and Health Claim Regulations” • Tokyo, Japan

Hayashi T, Roberts A. Presented at: Food Ingredients and Supplements: Gaining Access to the U.S., E.U., and China Markets, Oct. 13.

2009 • “Understanding the Latest European Regulations Regarding Food Additives, Novel Foods, Enzymes and Heath Claims” • Tokyo, Japan

Presented at Cantox’s Workshop on Food Ingredients and Supplements: Gaining Access to the U.S., E.U., and China Markets, October 13.

2009 • “Regulation of Claims in Europe” • Rosemont, IL

Presented at Health Claims in North America and Europe: Capitalizing on Recent Developments, May 28-29.

2009 • “How Does 912 Impact the Development of “Novel” Ingredients; and How to Gain Approval of a Health Claim in Europe” • Rosemont, IL

Presented at IFT - Wellness 09: At the Forefront of Food & Health, March 25-26.

2008 • “Chinese Food Regulatory Requirements” • Mississauga, ON

Presented at: “From Research to Revenue IV: Capturing Business Opportunities in Asia”, December 3.

2008 • “Metabolism and PK Studies and Their Impact on the Safety Evaluation of Rebaudioside A (Rebiana)” • Aspen, CO

Presented at The 34th Annual Summer Meeting of The Toxicology Forum, July 6-10.

2008 • “How Does 912 Impact the Development of “Novel” Ingredients?” • New Orleans, LA

Presented at IFT Annual Meeting & Food Expo, June 28 - July 1.

2007 • “Canadian Natural Health Products (NHP) Regulations” • Tokyo, Japan

Presented at Health Ingredients Japan 2007, November 20-22.

2007 • “Overview of Canada’s Natural Health Products and Functional Food Regulations ” • Tokyo, Japan

Presented at the Canadian Functional Foods and Natural Health Products Seminar and Tabletop Networking Reception, Canadian Embassy, November 19.

2007 • “A Global Perspective on Health-Related Claims Permitted on Foods and Food Ingredients Outside of the U.S. and an Overview of Steps to Developing a Global Strategy for Compiling Appropriate Scientific Data and Gaining Regulatory Approval of Such Claims” • Chicago, IL

Presented at 2007 IFT Annual Meeting & Food Expo, July 28 – August 1.

2006 • “How to Market Your Functional Foods and Nutraceuticals in the US, Canada, Europe and Japan” • Tokyo, Japan

CANTOX Seminar co-sponsored by the Canadian Embassy, November 29, held at the Canadian Embassy in Tokyo, Japan.

2006 • “How Can CANTOX Assist You Towards Marketing Success?” • Tokyo, Japan Presented at Health Ingredients Japan 2006, October 4-6.

2006 • “Safety Evaluation of Ferric Sodium Ethylenediaminetetraacetate (FeNaEDTA) for Use as a Source of Iron in Foods” • Tokyo, Japan

Presented at Health Food Exposition Japan 2006, May 30–June 1.

2006 • “Presentations: 1) US and EU Comparative Case Study; 2) Safety Evaluation of Old Food Ingredients with New Health Benefits in the US and EU; 3) Substantiation of Health Claims in the US and EU and 4) Substantiation of a Health Claim for Soy Protein in the UK and US” • Washington, DC

Presented at the US & EU Comparative Case Study Functional Foods and Supplements Workshop, April 4.

2004 • “Regulation & Safety Data Requirements for Introducing Products into the Health Food and Food Additive Markets in the US & EU” • Tokyo, Japan

Presented at Health Ingredients Japan 2004 Meeting, October 5-7.

2004 • “Health Claim Regulations in the US” • Tokyo, Japan

Presented at BioJapan 2004, September 29-30.

2004 • “Food Law & Regulatory Processes for Food Product Approval in the European Union” • Toronto, Ontario

Presented at the Program in Food Safety, University of Toronto, September 13.

2003 • “The Regulatory Evaluation of Functional Foods and Nutraceuticals ” • Tokyo, Japan

Munro IC, Roberts A. CANTOX Seminar co-sponsored by the Canadian Embassy, September 4, Tokyo, Japan.

2003 • “Regulatory Processes for Food Product Approval in the European Union” • Toronto, Ontario

Presented at the Program in Food Safety, University of Toronto, September 13.

2003 • “Regulatory Process for Food Product Approval in the European Union” • Chicago, IL

Presented at the IFT Annual Meeting & Food Expo, July 13-16.

2002 • “Functional Foods and Nutraceuticals -- How to Launch Nutraceuticals on the U.S. Market” • Paris, France

A workshop conducted by Munro IC and Roberts A in association with Archimex, November 26.

Papers & publications

Martyn DM, Darch MN, Roberts A, Lee HY, Tian YT, Kaburagi N, Belmar P (2018). Low-/no-calorie sweeteners: a review of global intakes. Nutrients 10(3):357 [39pp plus supplemental tables]. DOI:10.3390/nu10030357.

Haighton L, Roberts A, Walters B, Lynch B (2018). Systematic review and evaluation of aspartame carcinogenicity bioassays using quality criteria. Regul Toxicol Pharmacol [Epub ahead of print - Jan. 12, 2018]. DOI:10.1016/j.yrtph.2018.01.009.

Martyn D, Lau A.; Richardson P, Roberts A (2017). Temporal patterns of caffeine intake in the United States. Food Chem Toxicol 111:71-83. DOI:10.1016/j.fct.2017.10.059.

Lynch BS, West S, Roberts A (2017). Safety evaluation of water-soluble palm fruit bioactives. Regul Toxicol Pharmacol 88:96-105. DOI:10.1016/j.yrtph.2017.05.021.

Magnuson BA, Roberts A, Nestmann ER (2017). Critical review of the current literature on the safety of sucralose. Food Chem Toxicol 106(Part A):324-355. DOI:10.1016/j.fct.2017.05.047.

Martyn DM, Lau AA, Darch MN, Roberts AS (2017). Benzoates intakes from non-alcoholic beverages in Brazil, Canada, Mexico and the United States. Food Addit Contam Part A Chem Anal Control Expo Risk Assess [epub ahead of print – Jun. 8, 2017]. DOI:10.1080/19440049.2017.1338836.

Grotz VL, Pi-Sunyer X, Porte D Jr, Roberts A, Trout J (2017). A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis. Regul Toxicol Pharmacol 88:22-33. DOI:10.1016/j.yrtph.2017.05.011.

Roberts A (2016). The safety and regulatory process for amino acids in Europe and United States. J Nutr. 146(12):2635S-2642S. DOI:10.3945/jn.116.234591.

Williams GM, Aardema M, Acquavella J Berry C Brusick D, Burns MM, Viana de Camargo JL, Gabarrant D, Greim HA, Kier LD, Kirkland DJ, Marsh G, Solomon KR, Sorahan T, Roberts A, Weed DL (2016). A review of the carcinogenic potential of glyphosate by four independent expert panels and comparison to the IARC assessment. Crit Rev Toxicol 46(Supp. 1):3-20.

Roberts A, Haighton LA (2016). A hard look at FDA's review of GRAS notices. Regul Toxicol Pharmacol 79(Suppl. 2):S124-S128.

Roberts A, Lynch B, Rogerson R, Renwick A, Kern H, Coffee M, Cuellar-Kingston N, Eapen A, Crincoli C, Pugh G Jr, Bhusari S, Purkayashtha S, Carakostas M (2016). Chemical-specific adjustment factors (inter-species toxicokinetics) to establish the ADI for steviol glycosides. Regul Toxicol Pharmacol 79:91-102.

Okado N, Hasegawa K, Mizuhashi F, Lynch BS, Vo TD, Roberts A (2016). Safety evaluation of nuclease P1 from Penicillium citrinum. Food Chem Toxicol 88:21-31.

Purkayastha S, Markosyan A, Prakash I, Bhusari S, Pugh G Jr, Lynch B, Roberts A (2016). Steviol glycosides in purified stevia leaf extract sharing the same metabolic fate. Regul Toxicol Pharmacol 77:125-133.

Roberts A (2016). Caffeine: an evaluation of the safety database. In: Gupta RC, editor. Nutraceuticals - Efficacy, Safety and Toxicity. San Diego (CA): Academic Press, pp. 417-434.

Roberts A (2016). The safety and regulatory process for low calorie sweeteners in the United States. Physiol Behav 164(Part B):439-444.

Okado N, Suji M, Ueda M, Mizuhashi F, Lynch BS, Vo T, Roberts A (2015). Safety evaluation of AMP deaminase from Aspergillus oryzae. Food Chem Toxicol 86:342-350.

Hearty A, Lau A, Roberts A (2014). Chewing gum intake in Europe: a survey of intakes in France, Germany, Italy, Spain and the UK. Food Addit Contam Part A 31(7):1147-1157.

Nakano M, Takahashi H, Koura S, Chung C, Tafazoli S, Roberts A (2014). Acute and subchronic toxicity studies of pyrroloquinoline quinone (PQQ) disodium salt BioPQQ™) in rats. Regul Toxicol Pharmacol 70(1):107-121.

Purkayastha S, Pugh G Jr, Lynch B, Roberts A, Kwok D, Tarka SM Jr (2014). In vitro metabolism of rebaudioside B, D, and M under anaerobic conditions: comparison with rebaudioside A. Regul Toxicol Pharmacol 68(2):259-268.

Roberts A (2014). Safety signals and surveillance. Safety assessment of caffeine in foods and beverages. Presented at: Pray L, Yaktine AL, Pankevich D, Rapporteurs. Caffeine in Food and Dietary Supplements: Examining Safety: Workshop Summary. Institute of Medicine (IOM), Board on Health Sciences Policy, Food and Nutrition Board (FNB), Planning Committee on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements. Washington (DC): National Academies Press (NAP), pp. 38-50.

Roberts A, Renwick AG (2014). Toxicokinetics (Chapter 5) In: Hayes AW, Kruger CL, editors. Hayes’ Principles and Methods of Toxicology, 6th edition. Baton Rouge (FL): CRC Press, pp. 215-245.

Roberts A (2013). Safety Assessment of Caffeine in Foods and Beverages. Presented August 5 via webcast for The National Academies’ - Session: Safety Assessment of Caffeine in Foods and Beverages - Washington, DC, August 5-6.

Kitadate K, Homma K, Roberts A, Maeda T (2013). Thirteen-week oral dose toxicity study of Oligonol containing oligomerized polyphenols extracted from lychee and green tea. Regul Toxicol Pharmacol 68(1):140-146.

Konishi T, Aoshima T, Mizuhashi F, Choi SSH, Roberts A (2013). Safety evaluation of glucose oxidase from Penicillium chrysogenum. Regul Toxicol Pharmacol 66(1):13-23 & [Corrigendum 66(3):300].

Magnuson B, Munro I, Abbot P, Baldwin N, Lopez-Garcia R, Ly K, McGirr L, Roberts A, Socolovsky S (2013). Review of the regulation and safety assessment of food substances in various countries and jurisdictions. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 30(7):1147-1220.

Fernstrom JD, Munger SD, Sclafani A, de Araujo IE, Roberts A, Molinary S (2012). Mechanisms for sweetness. J Nutr 142(6):1134S-1141S.

Clarke K, Tchabanenko K, Pawlosky R, Carter E, Todd King M, Musa-Veloso K, Ho M, Roberts A, Robertson J, Vanitallie TB, Veech RL (2012). Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. Regul Toxicol Pharmacol 63(3):401-408.

Clarke K, Tchabanenko K, Pawlosky R, Carter E, Knight NS, Murray AJ, Cochlin LE, King MT, Wong AW,

Roberts A, Robertson J, Veech RL (2012). Oral 28-day and developmental toxicity studies of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate. Regul Toxicol Pharmacol 63(2):196-208.

Fujii H, Nishioka N, Simon RR, Kaur R, Lynch B, Roberts A (2011). Genotoxicity and subchronic toxicity evaluation of Active Hexose Correlated Compound (AHCC). Regul Toxicol Pharmacol 59(2):237-250.

Lynch B, Simon R, Roberts A (2011). Subchronic toxicity evaluation of aloesin. Regul Toxicol Pharmacol 61(2):161-171.

Lynch B, Simon R, Roberts A (2011). In vitro and in vivo assessment of the genotoxic activity of aloesin Regul Toxicol Pharmacol 61(2):215-221.

Tarka SM, Roberts A (2011). Letter to the Editor – Stevia: it’s not just about calories. Open Obes J 3:85-85.

Uchida M, Tsuboi H, Takahashi Arita M, Nemoto A, Seki K, Tsunoo H, Martyres S, Roberts A (2011). Safety of high doses of Propionibacterium freudenreichii ET-3 culture in healthy adult subjects. Regul Toxicol Pharmacol 60(2):262-267.

Uchida M, Yoda N, Terahara M, Seki K, Choi SS, Roberts A (2011). Safety evaluation of Propionibacterium freudenreichii ET-3 culture. Regul Toxicol Pharmacol 60(2):249-261.

Roberts A, Renwick AG (2009). Toxicokinetics (Chapter 6) In: Ballantyne B, Marrs TC, Syversen T, editors. General and Applied Toxicology: Vol. 1, 3rd edition. West Sussex, UK: John Wiley & Sons Limited, pp. 147-180.

Bidlack WR, Birt D, Borzelleca J, Clemens R, Coutrelis N, Coughlin JR, Dunaif JE, Ebert A, Hall R, Heimbach JH, Helferich W, Magnuson B, McColl DB, McQuate RS, Munro I, Petersen B, Roberts A, Scimeca J, Slayne M, Trautman T, contributors (2009). Making decisions about the risks of chemicals in foods with limited scientific information (An IFT Expert Report). Compr Rev Food Sci Food Safety 8:269-303. DOI:10.1111/j.1541-4337.2009.00081.x.

Day AG, Brinkmann D, Franklin S, Espina K, Rudenko G, Roberts A, Howse KS (2009). Safety evaluation of a high-lipid algal biomass from Chlorella protothecoides. Regul Toxicol Pharmacol 55(2):166-180.

Roberts A, Munro I (2009). Stevioside and related compounds: therapeutic benefits beyond sweetness [with rebuttal from Varanuj Chatsudthipong and Chatchai Muanprasat]. Pharmacol Ther 122(3):e1-e2, author rebuttal, e3.

Curry LL, Roberts A (2008). Subchronic toxicity of rebaudioside A. Food Chem Toxicol 46(Suppl. 7):S11-S20.

Curry LL, Roberts A, Brown N (2008). Rebaudioside A: two-generation reproductive toxicity study in rats. Food Chem Toxicol 46(Suppl. 7):S21-S30.

Fujii H, Nishioka H, Wakame K, Magnuson BA, Roberts A (2008). Acute, subchronic and genotoxicity studies conducted with Oligonol, an oligomerized polyphenol formulated from lychee and green tea extracts. Food Chem Toxicol 46(12):3553-3562.

Roberts A, Renwick AG (2008). Comparative toxicokinetics and metabolism of rebaudioside A, stevioside, and steviol in rats. Food Chem Toxicol 46(Suppl. 7):S31-S39.

Roberts A, Rogerson R (2008). Chinese approach on regulating food additives, novel foods, functional foods and dietary supplements (Chapter 19). In: Bagchi D, editor. Nutraceutical and Functional Food Regulations in the United States and Around the World. (Food Science and Technology International Series). New York (NY)/Toronto (ON): Elsevier, pp. 291-303.

Zhang B, Maniatis T, Song Y, Zhang W, Zhang X, Li N, Chen J, Wong AW, Roberts A (2008). Evaluation of magnolia bark extract in chromosomal aberration assays. Mutat Res 654(2):133-137.

Blum R, Kiy T, Tanaka S, Wong AW, Roberts A (2007). Genotoxicity and subchronic toxicity studies of DHA‑rich oil in rats. Regul Toxicol Pharmacol 49(3):271-284.

Blum R, Kiy T, Waalkens-Berendsen I, Wong AW, Roberts A (2007). One-generation reproductive toxicity study of DHA-rich oil in rats. Regul Toxicol Pharmacol 49(3):260-270.

Goodfellow G, Lee-Brotherton V, Daniels J, Roberts A, Nestmann E (2007). Assessment of the antibacterial agent, triclosan, under use conditions. Am J Infect Control (UNPUBLISHED).

Li N, Song Y, Zhang W, Wang W, Chen J, Wong AW, Roberts A (2007). Evaluation of the in vitro and in vivo genotoxicity of magnolia bark extract. Regul Toxicol Pharmacol 49(3):154-159.

Liu Z, Zhang X, Cui W, Zhang X, Li N, Chen J, Wong AW, Roberts A (2007). Evaluation of short-term and subchronic toxicity of magnolia bark extract in rats. Regul Toxicol Pharmacol 49(3):160-171.

Cremer DR, Rabeler R, Roberts A, Lynch B (2006). Long-term safety of α-lipoic acid (ALA) consumption: a 2-year study. Regul Toxicol Pharmacol 46(3):193-201.

Cremer DR, Rabeler R, Roberts A, Lynch B (2006). Safety evaluation of α-lipoic acid (ALA). Regul Toxicol Pharmacol 46(1):29-41.

Wolterbeek AP, Roberts A, Korte H, Unkila M, Waalkens-Berendsen DH (2004). Prenatal developmental toxicity study with 7-hydroxymatairesinol potassium acetate (HMRlignan) in rats. Regul Toxicol Pharmacol 40(1):1-8.

Roberts A, Renwick AG, Sims J, Snodin DJ (2000). Sucralose metabolism and pharmacokinetics in man. Food Chem Toxicol 38(Suppl. 2):S31-S41.

Sims J, Roberts A, Daniel JW, Renwick AG (2000). The metabolic fate of sucralose in rats. Food Chem Toxicol 38(Suppl. 2):S115-S121.

Roberts A (1999). Sucralose and diabetes. FFI J (182):49-52.

Roberts A, Renwick AG (1989). The pharmacokinetics and tissue concentrations of cyclohexylamine in rats and mice. Toxicol Appl Pharmacol 98(2):230-242.

Roberts A, Renwick AG, Ford G, Creasy DM, Gaunt I (1989). The metabolism and testicular toxicity of cyclohexylamine in rats and mice during chronic dietary administration. Toxicol Appl Pharmacol

98(2):216-229.

Roberts A (1987). The Metabolism and Pharmacokinetics of Cyclohexylamine and Their Relevance to Testicular Toxicity. [Ph.D. Thesis]. Southampton, England, University of Southampton, Clinical Pharmacology Group Faculty of Medicine.

Angelo MJ, Pritchard AB, Hawkins DR, Waller AR, Roberts A (1986). The pharmacokinetics of dichloromethane. I. Disposition in B6C3F1 mice following intravenous and oral administration. Food Chem Toxicol 24(9):965-974. DOI:10.1016/0278-6915(86)90325-X.

Angelo MJ, Pritchard AB, Hawkins DR, Waller AR, Roberts A (1986). The pharmacokinetics of dichloromethane: II. Disposition in Fischer 344 rats following intravenous and oral administration. Food Chem Toxicol 24(9):975-980. DOI:10.1016/0278-6915(86)90326-1.

Roberts A, Renwick AG (1985). The effect of saccharin on the microbial metabolism of tryptophan in man. Food Chem Toxicol 23(4&5):451-455. DOI:10.1016/0278-6915(85)90139-5.

Roberts A, Renwick AG (1985). The metabolism of 14C -cyclohexylamine in mice and two strains of rat. Xenobiotica 15(6):477-483.

ABSTRACTS AND POSTERS

Purkayastha S, Markosyan A, Prakash I, Bhusari S, Pugh G, Lynch B, Roberts A (2016). Steviol glycosides in purified stevia leaf extract sharing the same metabolic fate [55th Society of Toxicology Annual Meeting, New Orleans, LA, Mar. 17]. Toxicol Sci (Toxicologist Suppl.):[Abstract 3789; Poster Board: P481].

Roberts A (2016). The metabolism and pharmacokinetics of steviol glycosides and their impact on the ADI. Presented at: 7th Euro-Global Summit on Toxicology and Applied Pharmacology, Oct. 24-26, 2016. Rome, Italy.

Aardema M, Acquavella J, Berry C, Brusick D, Burns B, de Camargo JLV, Garabrant D, Greim H, Kier L, Kirkland D, Marsh G, Roberts A, Solomon K, Sorahan T, Weed D, Williams G (2015). Expert Panel Review of the Carcinogenic Potential of the Herbicide Glyphosate.

Roberts A, Lynch B (2014). Assessing Potential Interactions of “Active” Ingredients in Food. [presented at the 53rd Society of Toxicology Annual Meeting, Phoenix, Arizona, March 27]. Abstract -343i - Poster Board 572.

Choi S, Howse K, Roberts A (2011) Approach for determining if data on heterologous strains of similar species would support the safety of a particular strain where data are lacking [SOT 50th annual Meeting, Washington, D.C. presented March 9, 2011, Abstract Number: 2441].

Roberts A (2006). Investigation of the molecular mechanism of hepatotoxicity of a G-protein couples receptor antagonist using toxicogenomics. Toxicologist 90(1, Suppl.):203 [abstract 995].

Thompson C, Roberts A (2006). Utility of toxicogenomics in the elucidation of the hepatoxic mechanism of a discontinued drug candidate. Toxicologist 90(1, Suppl.):265-266 [abstract 1300].

Roberts A, Lynch BS, Wolterbeek AB, Korte H, Unkila M, Waalkens-Berendsen DH (2006). Safety assessment of 7-hydroxymatairesinol (HMR) lignan. Toxicologist 90(1, Suppl.):477-478 [abstract 2335].

Goodfellow G, Lee-Brotherton V, Daniels J, Roberts A, Nestmann E (2003). Antibacterial resistance and triclosan. Toxicol Sci [abstract 1470].

Roberts A (1996). Species differences in pharmacokinetics: An aid to toxicological evaluation. Eur Teratol Soc p. 45.

Renwick AG, Roberts A, Sims J (1991). Sucralose metabolism and pharmacokinetics in man. Eurotox. 310.

Roberts A, Renwick AG (1988). The fate of cyclohexylamine in rat and mouse in relation to testicular toxicity. Human Toxicol 7(2):229.

Roberts A, Renwick AG, Creasy DM, Ford GP, Gaunt IF (1988). The DA rat as an aid to toxicological evaluation. Human Toxicol 7(2):228.

Roberts A, Renwick AG, George CF (1985). The pharmacokinetics and tissue distribution of cyclohexylamine in the rat and mouse. Toxicol Lett 31.

Roberts A, Renwick AG, George CF (1985). Salicylate pharmacokinetics: An undergraduate practical. Br J Clin Pharmacol 20.

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