Report of the Scientific Panel on the Use of Benzoic Acid in Carbonated Drinks in Nigeria Constituted

REPORT OF THE SCIENTIFIC PANEL ON THE USE OF BENZOIC ACID IN CARBONATED DRINKS IN NIGERIA CONSTITUTED

BY THE

HONOURABLE MINISTER OF HEALTH

PROF. ISAAC F. ADEWOLE FAS, FSPSP, FRCOG, DSc. (Hons)

DECEMBER, 2017

TABLE OF CONTENTS

TABLE OF CONTENTS ...... i ACKNOWLEDGEMENTS ...... iii ACRONYMS ...... iv EXECUTIVE SUMMARY...... v 1.0 PREAMBLE ...... v 2.0 TERMS OF REFERENCE ...... v 3.0 MEMBERSHIP OF THE PANEL...... vi 4.0 METHODOLOGY OF WORK ...... vi 5.0 FINDINGS AND RECOMMENDATIONS ...... vii TOR 1 - Ascertain the safety of benzoic acid as a preservative in Carbonated Drinks...... vii TOR 2 - Determine if the use of benzoic acid can be replaced in foods ...... ix TOR 3 - Ascertain if the levels of benzoic acid can be further reduced below 250mg/kg ...... x TOR 4 - Know how often we should monitor and change safety levels ...... xi TOR 5 - Give any other advice that may be deemed necessary...... xi 6.0 Conclusions ...... xii CHAPTER ONE ...... 1 1.1 INTRODUCTION ...... 1 1.1.1 Immediate Response Of The Federal Government ...... 1 1.1.2 Letters Of Concern From The Presidency...... 1 1.1.3 Constitution of the Scientific Investigative Panel ...... 2 1.1.4 Terms Of Reference (TOR)/Mandate ...... 3 1.1.5 Membership Of The Panel ...... 3 1.1.6 Duration Of The Assignment ...... 3 1.2 METHODOLOGY OF WORK ON THE ASSIGNMENT ADOPTED BY THE SCIENTIFIC PANEL...... 4 1.2.1 Meetings ...... 4 1.2.2 Interaction With Major Stakeholders: ...... 4 1.2.3 Sessions With The Stakeholders...... 4 1.2.4. Outcome Of The Interactive Sessions ...... 5 1.2.5 Review Of Submissions By The Stakeholders ...... 6 1.2.6 Sampling And Testing Of Carbonated Drinks From Different Parts Of the Country...... 6 1.2.7 Laboratory Analysis Of The Sampled Products...... 7 1.2.8 Literature Review ...... 7 CHAPTER TWO ...... 8 2.1 CONSIDERATION OF THE TERMS OF REFERENCE (TOR)...... 8

i 2.1.1 TOR I - Ascertain the Safety of Benzoic Acid as a Preservative in Carbonated Drinks...... 8 2.1.2 TOR II - Determine if the use of benzoic acid can be replaced in foods ...... 10 2.1.3 TOR III - Ascertain if the levels of benzoic acid can be further reduced below 250mg/kg ...... 12 2.1.4 TOR IV - Know How Often We Should Monitor and Change Safety Levels ...... 15 2.1.5 TOR V - Give any other advice that may be deemed necessary...... 16 2.2 PUBLIC AND CONSUMERS' REACTION TO THE SAGA AND APPROPRIATE RESPONSE BASED ON THE PANEL FINDING ...... 17 2.2.1 Commencement of the Saga ...... 17 2.2.2 Allusions and Perceptions from the Public ...... 17 2.2.3 Concerns of the consuming public ...... 18 2.2.4 Other public and consumers' reactions ...... 18 2.2.5 Possible overall local change for soft drink content and manufacturing technology for improved safety ...... 19 CHAPTER THREE ...... 21 3.1 RECOMMENDATIONS: ...... 21 3.1.1 Recommended Appropriate Future Response Based on The Panel Findings ...... 21 CHAPTER FOUR ...... 22 4.1 CONCLUSIONS: ...... 22 LIST OF APPENDICES ...... 23 BIBLIOGRAPHY ...... 24 PICTURES OF THE INAUGURATION CEREMONY ...... 25 APPENDIX I – FMOH PRESS RELEASE...... 26 APPENDIX II – NAFDAC LABORATORY RESULTS ANALYSIS ...... 28

ii ACKNOWLEDGEMENTS

The panel wishes to appreciate the Hon. Minister of Health for his ingenuity and resilience in ensuring the safety and protection of lives of Nigerians by acting decisively in setting up this investigative scientific panel on the use of Benzoic acid in carbonated drinks. We the members of the panel consider ourselves privileged to have been selected into this national assignment. Equally to be appreciated are all the stakeholders particularly the National Agency for Food & Drug Administration & Control (NAFDAC) to have contributed immensely towards the success of this assignment.

iii ACRONYMS

• AFBTE- Association of Food, Beverage and Tobacco Employees • CAC- CODEX Alimentarius Commission • CCA- CODEX Committee Africa • CPC- Consumer Protection Council • CSO- Civil Society Organization • EU- European Union • EWG- Electronic Working Group • EFSA- European Food Safety Authority • FSAN- Food Safety and Applied Nutrition • FDS- Food and Drug Services • GRAS- Generally Regarded as Safe • GIT- Gastro Intestinal Tract • HMH- Honourable Minister of Health • ICCON- Institute of Chartered Chemists Of Nigeria • IPAN- Institute of Public Analyst of Nigeria • IMCFS- Inter Ministerial Committee on Food Safety • JECFA- Joint Expert Committee on Food Additives • MLs- Maximum Limits • MDA- Ministries, Departments and Agencies. • NAFDAC- National Agency for Food and Drug Administration and Control • NIFST- National Institute for Food Science and Technology. • NIS- Nigerian Industrial Standard • NBC- Nigerian Bottling Company • NFSMC- National Food Safety Management Committee • NPFSIS- National Policy on Food Safety and Implementation Strategy • ONSA- Office of the National Security Adviser • SON- Standards Organization of Nigeria • TOR- Terms of Reference • UK- United Kingdom • WHO- World Health Organization

iv EXECUTIVE SUMMARY

1.0 PREAMBLE

The use of benzoic acid in the production of carbonated drinks in Nigeria generated significant national interest by the public following the Lagos High Court judgment in the case between Fijabi Holdings versus Nigeria Bottling Company (NBC) and the National Agency for Food & Drug Administration & Control (NAFDAC) on the 15th of February 2017. The outcome of the judgment delivered by Honourable Justice Adedayo Oyebanji led to a public outcry about the public health safety of consumers due to an alleged unacceptable high level of benzoic acid and its derivatives in soft drinks manufactured and sold within the country. Of utmost importance was particularly, the court’s decision that when Vitamin C (ascorbic acid) is used alongside benzoic acid, a chemical compound (Benzene), which is known to be carcinogenic at certain levels, may be produced. To address the public outcry on the use of benzoic acid in carbonated soft drinks in the country, the Honourable Minister of Health, Prof. Isaac Adewole, FAS initially constituted an emergency AdHoc Committee within FMoH. However, letters of concern were received on 10th April and 4th May respectively from the Offices of the National Security Adviser and His Excellency the Vice President which inter alia directed the HMH to “urgently [carry out] a review of all recent researches and findings made on the health implications of the use of benzoic acid in the affected soft drinks”. The Hon. Minister of Health in an apparent swift reaction, characteristic of his pragmatic approach to matters of health had informed an in-house meeting on the 20th of April 2017 of his resolve to set up an Independent Scientific Panel of credible, experienced members from key relevant Government Regulatory Institutions (NAFDAC, Food and Drug Department of FMoH, SON, CPC, CSO, Academia, and AFBTE- MAN) to promptly investigate and proffer solutions on the use of Benzoic acid & its derivatives as a preservative/additive in packaged foods, most especially carbonated soft drinks in Nigeria. 2.0 TERMS OF REFERENCE

The Honourable Minister personally inaugurated the Panel on the 9th of August, 2017 with the following mandate as Terms Of Reference (TOR). 1. Ascertain the safety of benzoic acid as a preservative in carbonated drinks. 2. Determine if the use of benzoic acid can be replaced in foods 3. Ascertain if the Levels of benzoic acid can be further reduced below 250mg/kg 4. Know how often to monitor and change safety levels 5. Give any other advice that may be deemed necessary.

v 3.0 MEMBERSHIP OF THE PANEL

S/N NAME STATUS ORGANIZATION EMAIL 1. Distinguished Prof. Babajide Chairman Univ. of Lagos [email protected] Alo 2. Mrs. Yetunde O. Oni Secretary* NAFDAC [email protected] Mr. A. Mogbojuri Secretary*** om [email protected] 3. Pharm. (Mrs) G.M.O Member** FDS/FMOH [email protected] Chukwumah 4. Dr Barth Ugwu Member SON [email protected] 5. Dr Dahiru J. M. Adamu Member NIFST [email protected] m 6. Mr. Fubara Chuku Member FDS/FMOH [email protected] m 7. MrKelechi Oko Member CPC [email protected] 8. Dr. Perry T. Egedegu Member CSO [email protected]

9 AFBTE-MAN Member Not fully ………………………… represented1 ……. * Until Retirement from Service – September 28, 2017 ** Until Retirement from Service October 25, 2017 *** Ag. DG from September 28th- 3rd November, 2017

4.0 METHODOLOGY OF WORK

The Panel in the execution of its task: ➢ Held TEN Meetings/sittings, interacted with and invited memoranda from the relevant staff of the regulatory agencies and major manufacturers of Carbonated drinks in Nigeria namely NBC, 7UP and CHI ➢ Conducted a thorough review of the existing global literature and work done in other countries on the nature and safety of the use of Benzoic Acid as a preservative and found out that this chemical compound had been approved by the FAO/WHO Codex Alimentarius Commission and in use globally as a food preservative for ages and that indeed it is still most preferred to others mainly for its efficacy and suitability. It is also classified amongst the Generally Recognized As Safe (GRAS) additive in foods. ➢ Conducted random field sampling of different brands of carbonated drinks on the open market from the different geo-political zones of the country for laboratory analysis.

1AFBTE-MAN was represented by Mr. Vivian Ikem of the Nigerian Breweries PLC, Abuja Office at one meeting. No further representation even after reminders from the Panel

vi ➢ Conducted laboratory analysis (including replicate analysis) at three different NAFDAC laboratories (Central laboratory Oshodi Lagos, Kaduna laboratory and Port Harcourt laboratory) to ascertain the levels of compliance of benzoic acid and/or its derivatives used in these Products with Nigeria Industrial Standard (NIS) and CODEX – the international standards regulatory commission. ➢ The laboratory analysis and investigation of Levels of Benzoic Acid in the samples were at three different temperatures: Refrigerated (4oC), Room Temperature (25oC) and High temperature (40oC) 5.0 FINDINGS AND RECOMMENDATIONS

The Panel found as follows:

TOR 1 - ASCERTAIN THE SAFETY OF BENZOIC ACID AS A PRESERVATIVE IN CARBONATED DRINKS The Panel found that Benzoic acid and benzoates have been in wide use worldwide as food preservatives for many years now and are generally regarded as safe (GRAS). Benzoic Acid is a globally certified food preservative used across the world. Apart from it being abundantly available naturally, it has a number of other advantages such as: 1. It is not known to be harmful and for its very effective antimicrobial and antifungal activity. 2. It functions optimally in the pH range of 2.5- 4.0 which makes it very compatible with that of the stomach (1.5- 3.5). 3. It fits well with the chemistry and composition of the beverages. 4. Benzoic acid and its salts (benzoates) are rapidly absorbed in the Gastro- Intestinal Tract (GIT) and rapidly excreted through the liver where it conjugates with glycine and the resulting hippuric acid is excreted in rapidly urine thereby eliminating the dangers of accumulation of metabolites in the body (It is known that 75 to 100% of any benzoic acid dose is excreted within 6 hours and the remainder within 2-3days). 5. Wide application in foods, beverages and pharmaceuticals. It is approved \by International Food Safety regulators as a preservative 6. Simple technology in application. 7. It is so far known to be one of the safest, abundantly available and cheap preservatives and is classified amongst the Generally Recognized As Safe (GRAS) Products. The above GRAS status of Benzoic acid, not withstanding, necessary control measures must be put in place as excess intake of any substance has its negative consequences. Furthermore, such controls should as well take into account factors that affect chemical reactions, in particular, temperature and especially when used in combination with other products like Ascorbic acid.

vii

It is in consideration of the above that globally Scientific Research Organizations particularly, the Codex Alimentarius Commission (CODEX), specify and set the relevant allowable levels in foods, code of practice and guidelines relating to foods and food safety. The regulatory limits on the use of benzoic acid as a preservative in carbonated soft drinks vary from country to country- from one jurisdiction to another.

The CODEX allowable standard or permissible limit was 600mg/kg until recently reviewed in December 2016 to 250mg/kg (CODEX STAN 1992-1995 revised 2015 and 2016) and ratified in March 2017).

In Nigeria, the Maximum Limits for constituents in foods are set by the Standards Organization of Nigeria (SON). The standards for soft drink was first drawn in 1976 and revised subsequently in 1985, 1992, 2000, 2006 and then 2008 “to control the quality of soft drinks in the Nigerian market” and to stem “The influx of different carbonated and non-carbonated flavoured drinks in the Nigerian market”. The standards were set guided by the subsisting CODEX standard in consultation with relevant technical experts and other stakeholders and are usually set by taking into consideration environmental, shelf-life and other factors. The current Nigerian Industrial Standard (NIS) for benzoates/benzoic acid as published by the SON are as follows: 1. NIS 217: 2008 Standard for Soft Drinks (Currently under Review) Benzoic Acid (without Ascorbic acid) ………………. 300mg/kg Benzoic Acid (with ascorbic acid) …………………… 250 mg/kg 2. CODEX STAN 192 – 1995 (Current Edition) Benzoate (as Benzoic Acid) …………………………..250 mg/kg

In the EU, there are regulations controlling the maximum levels of benzoic acid and its salts for use in foodstuffs ready for consumption and the specific purity criteria of food additives. The EU including the UK sets a limit of 150mg/kg. The respective national standards vary widely among countries with some even exceeding the limit recommended by CODEX.

In the United States for example, benzoic acid and sodium benzoate is used as antimicrobial agents, flavouring agents and as adjuvants with a current maximum level of 0.1% in food meaning a limit of 1000mg/kg is allowed.

The Panel found and established from its thorough scientific analysis of randomly selected carbonated drinks on the Nigerian market that the Levels of benzoic acid

viii and/or its derivatives used by manufacturers fully comply with the existing Nigerian Industrial Standard (NIS) and that of CODEX.

Comparative studies with levels set by other countries and found out that apart from UK most other countries have values higher than that of Nigeria. It may be necessary to add that Nigeria uses the same value of 250mg / kg as Ghana. More importantly, the levels were not found to change with increasing temperature even to as high as 40oC. Similarly, the level of benzoic acid in products that contain both benzoic acid and ascorbic acid was not found to reduce at the high temperature. That the amount of Benzoic acid did not change meant that the acid did not decompose let alone combine with any other substance to form another chemical compound wanted or unwanted at all the selected afore mentioned temperatures. Hence, it can be safely concluded that the alleged conversion of benzoic acid to carcinogenic benzene in the products at high temperatures DOES NOT occur in the products on the Nigerian market.

TOR 2 - DETERMINE IF THE USE OF BENZOIC ACID CAN BE REPLACED IN FOODS The reasons for the application of any food additive including benzoic acid or any of its derivatives are based on its technological need. That need is anchored on the fact that, the additive, such as this preservative, is to prevent the food from spoilage or any deteriorative change that will affect the acceptability of the food or beverage, especially its safety. Replacement of the use of an existing substance becomes necessary when that substance is found to: • Have health hazards • Become too cost effective or scarce. • Require new technology amongst others. There are possible alternative food preservatives that may replace benzoic acid. However, these may not work/act as credibly as benzoic acid. The Panel found that so far, Benzoic acid application has not been known to violate any of the three reasons stated above and any other reason yet known. Therefore, there is no justifiable reason(s) to call for its replacement. The Panel found out that the companies (mostly multinational) are not considering replacement of the use of Benzoic Acid for now as there is not yet a suitable alternative. The Panel therefore submits that Benzoic acid, based on literature reviews, remains the chemical of choice to be used as preservative as in the current global practice. Benzoic acid is still being used the world over as beverages preservative of choice and some countries even allow much higher levels of the chemical than Nigeria.

TOR 3 - ASCERTAIN IF THE LEVELS OF BENZOIC ACID CAN BE FURTHER REDUCED BELOW 250MG/KG The Panel submits that the environmental conditions in Europe where the allowable level is lower at 150mg/kg is very different from Nigeria. Countries in Europe are in the temperate region which is colder and food products can be kept from spoilage for longer time. At cold climates the rate of chemical reactions which give rise to degradation or spoilage of food substances is slower while high temperatures speeds up such reactions and equally increase the rate of food spoilage. In Nigeria with hot climate, coupled with the common habits of displaying these products in the sun during marketing, a higher level of preservative would be required to keep such foods safe within the expected shelf life. Laboratory tests and investigations on levels in Nigerian products The Panel considered it necessary to undertake laboratory investigations of carbonated soft drinks to (a) confirm present levels of the candidate chemical (b) examine the stability of the candidate chemicals at high temperatures towards a preliminary assessment of possible generation of benzene under some storage conditions. Two hundred and two (202) carbonated drinks were sampled from the different geopolitical zones in Nigeria and subjected to approve analytical protocols. From the laboratory results the panel came to a conclusion as follows: 1. All the analyzed carbonated drinks are in compliance with NIS standards for benzoic acid. 2. There was no significant difference in the levels of benzoic acid at the different temperatures in the various products analyzed including Fanta Orange that contains both benzoic acid and ascorbic acid. Hence storage in the sun or at the relatively hot parts of Nigeria did not produce reduction of the benzoates or any subsequent generation of the carcinogen- benzene.

The Panel however further submits that CODEX continues to review standards set. In the case of Benzoic Acid, the Commission recently reviewed and reduced the maximum allowable levels from 600mg/kg to 250mg/kg in December 2016 and ratified in March 2017. Hence, continuous scientific investigations for new technologies and monitoring of the safe levels of the preservatives and other additives in Nigeria should be intensified which could lead to recommendations of the possibilities of reduced allowable levels in future.

x TOR 4 - KNOW HOW OFTEN WE SHOULD MONITOR AND CHANGE SAFETY LEVELS The Panel considers that monitoring-compliance or general surveillance are key elements of a national food safety programme. Following the saga that precipitated the constitution of this Panel, it is obvious that the nation needs to step up our monitoring and surveillance activities of foods and products on the Nigerian market. It is clear that going by global best practices, consideration of changes to standards and safe levels should be undertaken at least once every two (2) years. Promulgation of new standards must be based on robust market and consumer surveys across all the geopolitical zones, epidemiological data and human health surveys, backed by robust laboratory analysis of the products’ contents. After extensive consultation and deliberations, the Panel concluded that an efficient Food Safety Monitoring Programme be put in place by the Federal Government using the National Policy on Food Safety and Its Implementation Strategy (NPFSIS), 2014 as a possible instrument. This policy if fully implemented takes care of the plausible challenges that may face monitoring activities for the enhancement of food safety.

TOR 5 - GIVE ANY OTHER ADVICE THAT MAY BE DEEMED NECESSARY. The Panel considered two issues as important to be contained in our Report: 1. Government and Consumer public reaction on the saga 2. Exploring technical changes locally for soft drink additives and manufacture

Based on the findings of the panel, the following are our recommendations: 1. An International or National Press Conference is recommended in which the Minister for Health, Representatives of the Presidency, DGs of NAFDAC, SON, CPC, Chairman of the Panel, representatives of relevant professional bodies, Civil Society and NGOs will address the public through the press and reassure the public based on the findings of this panel. 2. FMoH/ NAFDAC to embark on a massive public enlightenment in selected locations across the geo political zones of the country to: • reassure Nigerians on the safety of soft drinks and food consumed in Nigeria • explain the basis for different limits of additives in different countries and • give information on government actions to protect the citizens. This public enlightenment will further serve to disabuse the minds of the public that the causes of cancer and organ failure are due to the consumption of soft drinks containing benzoic acid, its derivatives and Vitamin C. 3. That government and industry put in place adequate measures to support research so that new innovations in the science of food and drinks can be

xi identified and utilized for the benefit of government, industry and the public at large rather than a sole dependence on off shore research findings. 4. The existing surveillance and compliance monitoring strategy of additives in foods by regulators in Nigeria- SON and NAFDAC need to be stepped up. 5. FMoH needs to expedite action on the presentation and adoption of the “National Food Safety & Quality Bill” and the “Food Safety Institutional Reform Framework” by the Federal Executive Council and the Act at the National Assembly; 6. Provision of adequate funds for the National Food Safety Management Committee to enable her: • Effectively coordinate Food Safety Activities of the MDAs; • Arrange quarterly meetings; and • Implement the National Policy on Food Safety. 6.0 CONCLUSIONS

In conclusion, the Panel resolved that: • Benzoic Acid and its derivatives are still safe to use singly or in combination provided there is compliance with NIS/ CODEX recommended levels. • The Panel found and established from its thorough scientific analysis of randomly selected carbonated drinks on the Nigerian market Established that the Levels of benzoic acid and/or its derivatives used by manufacturers fully comply with the existing Nigerian Industrial Standard (NIS) and that of CODEX. • More importantly, the levels were not found to change with increasing temperature even to as high as 40oC. Similarly, the level of benzoic acid in products that contain both benzoic acid and ascorbic acid was not found to reduce at high temperature. Hence, it can be safely concluded that the alleged conversion of benzoic acid to carcinogenic benzene in the products at high temperatures DOES NOT occur in the products on the Nigerian market • Exporters should comply with national export regulations and guidelines as put in place by NAFDAC and ensure they understand the Technical Regulations of the Recipient country prior to export.

xii CHAPTER ONE

1.1 INTRODUCTION

1.1.1 IMMEDIATE RESPONSE OF THE FEDERAL GOVERNMENT To address the public outcry, the Honourable Minister of Health, Prof. Isaac Adewole constituted an emergency ad-hoc Committee on the 17th of March 2017 that included officers from the National Agency for Food and Drug Administration and Control (NAFDAC), Standards Organization of Nigeria (SON), and the Food & Drug Services Department of the Ministry. The Committee deliberated on the matter. This climaxed in the issuance of a public statement signed by the Director, Media and Public Relations of the Ministry. (Appendix I)

1.1.2 LETTERS OF CONCERN FROM THE PRESIDENCY The National Security Adviser wrote a letter, with Ref No: NSA/304/S dated 10th April 2017, to the Honourable Minister of Health requesting to know the opinion and position of the Federal Ministry of Health on the safety status of benzoic acid in the soft drinks and urged the Ministry to investigate the levels of additives in food in Nigeria and with reference to global best practice and the internationally acceptable levels. In addition, the office of His Excellency the Vice President of the Federal Republic of Nigeria, Prof. Yemi Osinbajo wrote via the Deputy Chief of Staff to the President in a letter with Ref No: SH/OVP/DCOS/LGR&C/FMOH/102 dated 4th May 2017; directing the Honourable Minister of Health to “urgently [carry out] a review of all recent researches and findings made on the health implications of the use of benzoic acid in the affected soft drinks”.

1 On the 20th April, 2017, the Ag Director- General of NAFDAC- Mrs. Yetunde O. Oni via a letter Ref. NAFDAC/AGDG/3/SMG/620/Vol.1 to the National Security Adviser (NSA) in the Presidency gave an initial response to the 10th April letter of the NSA. In the response letter, the Ag DG provided information on the current Nigerian Industrial Standard set in Year 2008 on allowable levels of Benzoic Acid in Soft Drinks (as published in NIS 217: 2008 of SON) viz: i. Sodium or potassium salts of Benzoic Acid. This shall be used to give a benzoic Acid content not exceeding 300mg/kg for products not containing Ascorbic Acid ii. Sodium or potassium salts of Benzoic Acid. This shall be used to give a benzoic acid content not exceeding 250mg/kg for products that contain Ascorbic Acid” The response letter also clarified the status of the relative maximum allowable levels of the use of Benzoic Acid as preservative in soft Drinks in eight other countries including the United Kingdom of 150mg/kg at the lower end and the United States of America that allows up to 1000mg/kg at the upper end.

1.1.3 CONSTITUTION OF THE SCIENTIFIC INVESTIGATIVE PANEL The Honourable Minister of Health- Prof Isaac F. Adewole, FAS in an in-house meeting on the 20th of April 2017 informed the meeting of his resolve to set up an Independent Scientific Panel to consider the use of Benzoic acid & its derivatives as a preservative/additive in packaged foods, most especially carbonated soft drinks in Nigeria. The Honourable Minister personally communicated in a letter Ref FDS/FSQP/MA/I/69 dated 11th May 2017, to the selected members and entities of their nomination and appointment into the Panel. This Independent Scientific Panel was inaugurated on the 9th of August 2017 by the Honourable Minister of Health. During the inauguration, the Honourable Minister mandated the Panel: 1. To use both their academic & work experience to scientifically & impartially deliberate on the terms of reference; 2. To map out strategies to carryout investigation on the current levels of benzoic acid in soft drinks within the country; and

3. To submit a comprehensive and objective report of the impact of the use of benzoic acid in carbonated drinks as soon as possible.

2 1.1.4 TERMS OF REFERENCE (TOR)/MANDATE The Scientific Panel had the following as its mandate: 1. Ascertain the safety of benzoic acid as a preservative in Carbonated Drinks; 2. Determine if the use of benzoic acid can be replaced in foods; 3. Ascertain if the levels of benzoic acids can be further reduced below 250mg/kg 4. Know how often we should monitor and change safety levels; 5. Give any other advice that may be deemed necessary.

1.1.5 MEMBERSHIP OF THE PANEL S/N NAME STATUS ORGANIZATION EMAIL 1. Distinguished Prof. Chairman Univ. of Lagos [email protected] Babajide Alo 2. Mrs. Yetunde O. Oni Secretary* NAFDAC [email protected]

Mr. A. Mogbojuri Secretary*** andyjuri@yahoo 3. Pharm. (Mrs) G.M.O. Member** FDS/FMOH [email protected] Chukwumah 4. Dr Barth Ugwu Member SON [email protected] 5. Dr Dahiru J. M. Adamu Member NIFST [email protected] 6. Mr. Fubara Chuku Member FDS/FMOH [email protected]

7. Mr Kelechi Oko Member CPC [email protected] 8. Dr. Perry T. Egedegu Member CSO [email protected]

9 AFBTE-MAN Member Not fully represented2 ……………………………….

* Until Retirement from Service – September 28, 2017 ** Until retirement from Service 25th October, 2017 *** Ag. DG from September 28th – 3rd November, 2017

1.1.6 DURATION OF THE ASSIGNMENT The Honourable Minister of Health while inaugurating the panel requested the Panel to submit, if possible, its report within two (2) weeks. However, it took the Panel about 14 weeks to conclude its investigation and submit its reports due to the enormity of the assignment.

2AFBTE-MAN was represented by Mr. Vivian Ikem of the Nigerian Breweries PLC, Abuja Office at one meeting. No further representation even after reminders from the Panel

3 1.2 METHODOLOGY OF WORK ON THE ASSIGNMENT ADOPTED BY THE SCIENTIFIC PANEL.

The Panel in its effort to ensure that the desired objectives were thoroughly achieved adopted the following procedures in executing the assignment – meetings, interrogation of literature, interaction with stakeholders, sampling and laboratory analysis of major products in the market and report collation.

1.2.1 MEETINGS The Panel held TEN Meetings and sittings in the Offices of NAFDAC in Abuja and Lagos.

1.2.2 INTERACTION WITH MAJOR STAKEHOLDERS: Four major producers/stakeholders of carbonated drinks in the country were invited for interactive sessions as shown in the table below:

Stakeholder Representative Date NBC/Coca-Cola Mr. Clem Ugorji. (Coca-Cola Nigeria- PAC 24/08/2017 Nigeria Director) Mr. Bartholomew Adaba (Coca-Cola Nigeria - QSE Manager) Mr. Nureni Opaleye (NBC LTD-Comm. SRA Manager) Mr. M. Aminu (NBC LTD -North Rep. PAC Manager) Seven-Up Bottling Mr. Adekunle Olusuyi 24/08/2017 company (Head Quality and Regulatory Compliance Directorate) CHI Nigeria Limited Mr. Sadiq Kassim-Director of Operations. 06/09/2017 Mr. Muhsin Sadiq-Assistant to DOP DANSA Nigeria No representation to the meeting and no Limited response to the general questions sent to all the stakeholders.

1.2.3 SESSIONS WITH THE STAKEHOLDERS. Each of the invited stakeholders as listed above was required to address the following general questions in succession: 1. Brands of products manufactured by the company indicating those that contain benzoic acid and its derivatives. 2. The company’s products containing ascorbic acid in combination with benzoic acid.

4 3. What are the composition or levels of substances of interest (Benzoic and Ascorbic Acid) contained in their products? 4. Identify how the levels are determined (Method of identification). 5. Is the company aware of Nigerian Standards for benzoic and ascorbic acid in soft drinks? 6. If yes to (5) above, are the products in compliance with the Nigerian Standards? 7. Does the company have a monitoring strategy or protocol for these substances for products in trade? 8. Does the company have any possible replacement for Benzoic Acid for the products you manufacture?

1.2.4. OUTCOME OF THE INTERACTIVE SESSIONS During the interactive sessions, the following submissions were made: 1. NBC/Coca-Cola Representatives of the Company submitted that: a. Fanta Orange and Limca are the only products containing benzoic acid in combination with ascorbic acid. b. Fanta Orange contains benzoic acid at the level of 190-193mg/kg and ascorbic Acid -8mg/kg while Limca has Benzoic Acid 1.27mg/kg and Ascorbic Acid -50mg/kg. c. The levels of benzoic acid and ascorbic acid are determined in their local laboratory using an already established Company-developed Standard Operating Procedure. d. NBC/Coca-Cola is aware of Nigerian standards for benzoic acid as set by SON and their products are all in compliance with the standards. e. NBC/Coca-Cola Group have protocols for all their products e.g Trade age survey (first in first out) f. NBC/Coca-Cola Group do not have a replacement for benzoic acid at present and are not currently considering a replacement. 2. Seven Up Bottling Company Representatives of the Company submitted that: a. None of its products has ascorbic acid in them. b. Seven-Up Company uses the testing protocol as approved by SON to determine the levels of benzoic acid in their products. c. Seven-Up is aware of Nigerian standards for benzoic acid as set by SON and they are in compliance with the standards. d. Seven-Up Company has a monitoring survey for all their products. e. Seven-Up Company do not have a replacement for benzoic acid at present and are not currently considering a replacement f. The products with benzoic acid and the levels are:

5 • Seven-Up ------141.94mg/kg • Seven-Up free ----- 133.63mg/kg • Seven-Up H20------133.69mg/kg • Pepsi light ------145.34mg/kg • Miranda Orange----- 154.68mg/kg • Miranda Pineapple --138.26mg/kg • Teem Lemon ------155.46mg/kg • Teem Bitter Lemon -154.51mg/kg • Mountain Dew ------139.63mg/kg • Teem Tonic ------156.39mg/kg

3. CHI Ltd: The CHI representative responded that none of its products have Benzoic Acid or its salts as a preservative.

1.2.5 REVIEW OF SUBMISSIONS BY THE STAKEHOLDERS The panel reviewed all the documents forwarded by the three stakeholders and came up with the following conclusions: 1. The NBC/Coca-Cola and Seven-Up Bottling Company have some of their products containing Benzoic and/or Ascorbic Acid. 2. The levels of Benzoic and Ascorbic Acid in their products are in compliance with SON (CODEX) levels. 3. NBC/Coca-Cola Nigeria uses their local laboratories, accredited SON laboratories and their laboratories in Brussels and South Africa for analysis and monitoring of their products, 4. Seven-Up Nigeria uses their local laboratories and accredited SON laboratories. 5. The three organizations are aware of Nigerian standards for Benzoic Acid as 300mg/kg alone and 250Mg/kg when in combination with Ascorbic Acid. 6. All the companies have a monitoring strategy and protocol for their products in trade. 7. NBC/Coca-Cola and Seven-Up Bottling Company do not currently have replacements for Benzoic Acid as a preservative as it is considered as one of the safest preservative for use in carbonated drinks for now.

1.2.6 SAMPLING AND TESTING OF CARBONATED DRINKS FROM DIFFERENT PARTS OF THE COUNTRY. Different brands of carbonated drinks were randomly sampled by staff of the Food Safety and Applied Nutrition Directorate (FSAN) of NAFDAC from the different geopolitical zones of the country for laboratory analysis.

6 1.2.7 LABORATORY ANALYSIS OF THE SAMPLED PRODUCTS. Carbonated drinks on the Nigerian market were sampled and were analysed (including replicate analysis) at three different NAFDAC laboratories (Central laboratory Oshodi Lagos, Kaduna laboratory and Port Harcourt laboratory). The analytical protocol designed included: Investigation of Levels of Benzoic Acid in the samples at three different temperatures: • Refrigerated (4oC) • Room Temperature (25oC) • High temperature (40oC) The results obtained are fully presented in Appendix II.

1.2.8 LITERATURE REVIEW The Panel investigated some existing literature on the subject matter including: • Work done in other countries on the safe use of Benzoic Acid in carbonated drinks and other food products. • Levels of benzoic acid in carbonated drinks across the world.

7 CHAPTER TWO

2.1 CONSIDERATION OF THE TERMS OF REFERENCE (TOR).

Why the Concern? The concern is primarily on the fear of a cancer-causing agent- Benzene- being present in marketed soft drinks. Benzene is present in the general environment through human activities such as vehicle emissions, cigarette smoking etc. and may be produced commercially from processing of dyes, detergents or other chemicals. Since benzene is present ubiquitously, it may therefore contaminate food and water supplies. However, with respect to soft drinks manufacture, it was found in the early 1990s, that benzene could be formed in soft drinks containing both benzoic acid and/or its salts together with ascorbic acid (vitamin C) especially in the presence of light, elevated temperatures and trace metals especially Copper or iron. (Gardner and Lawrence, 1993) It is significant to note that the presence of benzoic acid or its salts and ascorbic acid (Vitamin C) in soft drinks does not necessarily result in the formation of benzene. Many factors e.g. pH, exposure to high temperatures and UV light, presence of certain minerals (metals) and some sweeteners may affect the formation of benzene in the drinks. Once benzene is formed, the content of benzoic acid in the drinks reduces. Hence the Panel aside from addressing the mandated Terms of Reference, conducted laboratory investigations on the levels of benzoic acid in selected soft drinks at different temperatures and conditions. Appendix II contains Tables showing these data. The results confirm that there were no reductions in the levels of benzoic acid or ascorbic acid indicative of the absence of formation of benzene in soft drinks under Nigerian conditions. The Panel exhaustively considered each of the Terms of Reference as transmitted to the Panel in our appointment letters. Hereunder are the Panel’s findings, observations and submission on each of the TORs.

2.1.1 TOR I - ASCERTAIN THE SAFETY OF BENZOIC ACID AS A PRESERVATIVE IN CARBONATED DRINKS. Benzoic acid and benzoates have been in wide use worldwide as food preservatives for many years now and are generally regarded as safe (GRAS). Benzoic Acid is a globally certified food preservative used across the world. The optimum antimicrobial activity occurs in the pH range of 2.5-4.0, indicating that the pKa of 4.2 for benzoic acid is the active form of the benzoate, and is the active form of its action as an antimicrobial agent. This also makes it suitable for preservation of foods and beverages which are naturally acidic. Other uses for benzoic acid and its salts include regulated

8 use as food preservatives, most suitable for foods, fruit juices, and soft drinks in an acidic pH range.

Benzoic Acid with chemical formula C7H6O2or C6H5COOH, -the simplest aromatic carboxylic acid- is a colorless crystalline solid, and its naturally occurring that is for years used as a food preservative. Significant amounts have been found in some fruits especially berry as well as honey. Most berries contain as much as 500mg/kg of benzoic acid. It is a common metabolite in plants and adequately studied in biological systems. Appreciable amounts have been found in gum benzoin (around 20%) and most berries (around 0.05%). Among animals, benzoic acid has been identified primarily in omnivorous species. Benzoic acid, its salts and esters are used as preservatives (up to 0.5 %, calculated as acid) and currently as disinfectants (up to 2.5 %, calculated as acid) in cosmetic products Apart from it being abundantly available naturally, it has a number of other advantages such as the following:- 1. It is not known to be harmful and for its very effective antimicrobial and antifungal activity. 2. It functions optimally in the pH range of 2.5- 4.0 which makes it very compatible with that of the stomach (1.5- 3.5). 3. It fits well with the chemistry and composition of the beverages. 4. Benzoic acid and its salts (benzoates) are rapidly absorbed in the Gastro- Intestinal Tract (GIT) and rapidly excreted through the liver where it conjugates with glycine and the resulting hippuric acid is excreted in rapidly urine thereby eliminating the dangers of accumulation of metabolites in the body (It is known that 75 to 100% of any benzoic acid dose is excreted within 6 hours and the remainder within 2-3days). 5. Wide application in foods, beverages and pharmaceuticals. It is approved by International Food Safety regulators as a preservative 6. Simple technology in application. 7. It is so far known to be one of the safest, abundantly available and cheap preservatives and is classified amongst the Generally Recognized As Safe (GRAS) Products.

The above GRAS status of Benzoic acid, not withstanding, necessary control measures must be put in place as excess intake of any substance has its negative consequences. Furthermore, such controls should as well take into account factors that affect chemical reactions, in particular, temperature and especially when used in combination with other products like Ascorbic acid. It is in consideration of the above that Scientific Research Organizations particularly, the Codex Alimentarius Commission (CAC), Technical Experts from Regional National Standards Bodies and stakeholders specify the relevant levels in the standard to give assurance in quality and safety.

9 REGULATING BENZOIC ACID USE GLOBALLY

The regulatory limits on the use of benzoic acid as a preservative in carbonated soft drinks vary from country to country- from one jurisdiction to another. Globally, the recognized standards, code of practice and guidelines relating to foods and food safety are set by the Codex Alimentarius Commission (CAC) established for that purpose by the United Nations through the Food & Agricultural Organization (FAO) and the World Health Organization (WHO).

The allowable standard or permissible limit was 600mg/kg until recently reviewed in December 2016 to 250mg/kg (CODEX STAN 1992-1995 revised 2015 and 2016) and ratified in March 2017).

In the United States for example, benzoic acid and sodium benzoate is used as antimicrobial agents, flavoring agents and as adjuvants with a current maximum level of 0.1% in food meaning a limit of 1000mg/kg is allowed.

In Nigeria, the Maximum Limits for constituents in foods are set by the Standards Organization of Nigeria (SON). The standard for soft drink was first drawn in 1976 and revised subsequently in 1985, 1992, 2000, 2006 and then 2008 “to control the quality of soft drinks in the Nigerian market” and to stem “The influx of different carbonated and non-carbonated flavoured drinks in the Nigerian market”. The standards were set guided by the subsisting CODEX standard in consultation with relevant technical experts and other stakeholders and are usually set by taking into consideration environmental, shelf-life and other factors. The current Nigerian Industrial Standard (NIS) for benzoates/benzoic acid as published by the SON are as follows: I. NIS 217: 2008 Standard for Soft Drinks (Currently under Review) Benzoic Acid (without Ascorbic acid) ………………. 300mg/kg Benzoic Acid (with ascorbic acid) …………………… 250 mg/kg II. CODEX STAN 192 – 1995 (Current Edition) Benzoate (as Benzoic Acid) ………………………… 250 mg/kg

2.1.2 TOR II - DETERMINE IF THE USE OF BENZOIC ACID CAN BE REPLACED IN FOODS The reasons for the application of any food additive including benzoic acid or any of its derivatives are based on its technological need. That need is anchored on the fact that,

10 the additive, such as this preservative, is to prevent the food from spoilage or any deteriorative change that will affect the acceptability of the food or beverage, especially its safety. Replacement of the use of an existing substance becomes necessary when that substance is found to: • Have health hazards • Become too cost effective or scarce. • Require new technology amongst others. So far, Benzoic acid application has not been known to violate any of the three reasons stated above and any other reason yet known. Therefore, there is no justifiable reason(s) to call for its replacement. The permission by any regulatory agency to allow the use of an additive will therefore be sufficient knowledge that is evaluated and conclusively found to satisfy these criteria:

i. The food additive does not pose a safety risk to the health of the consumer ii. There is a technological need for the use. iii. The consumer is not misled by the use of the food additive.

There are possible alternative food preservatives that may replace benzoic acid. However, these may not work/act as credibly as benzoic acid. Benzoic acid performs better than other alternatives when used specifically to arrest the activity of yeast and mould known to cause deterioration in sugar containing products.

The global choice of benzoic acid, especially as the most preferred additive in the preservation of carbonated beverages, is because of the quantum of knowledge about it (Codex Alimentarius Commission) including a number of other advantages as stated earlier in section 2.1.2 Overall, its easy metabolism and stability in foods (under processing and storage conditions) when compared to others puts the compound upfront as a desirable preservative/ additive for commercial use. In all the documents the Panel consulted so far, it is obvious that benzoic acid remains the preferred chemical in global use. The European Food Safety Authority (EFSA) in 2016 established a high-powered multidisciplinary Scientific Panel to re-evaluate the use of benzoic acid and its salts as food additives. The Panel investigated the absorption, distribution, metabolism and excretion of benzoates to issue a scientific opinion on possible replacement. “The results of the short –term and sub chronic studies on benzoic acid and its salts indicate that their toxicity is low and the Panel considered and stated clearly that the use of benzoic acid and its salts as food additives does not raise

11 any concern with respect to possibilities of genotoxicity or any carcinogenic potential. (EFSA, 2016) It is pertinent to mention that globally there have been attempted use of other preservatives and alternative technologies in the manufacture and safeguarding beverages and other foods. Some chemicals like Sorbic Acid and Sorbates to replace Benzoic Acid. However, experience from the attempted use of these alternatives did not recommend any further use as Benzoic Acid remained superior in the products. However, on evaluation of practicability, safety and compatibility, there has not been an unequivocal conclusion and acceptance that eliminated the use of benzoic acid without again putting the product and or the consumer at a greater risk. It is important to point out that the panel did not find any evidence to support the notion that the cost of benzoic acid use is the determining factor for its preference by industry. Locally, there has been some work done, in finding substitute for many of the commonly used preservatives, but it must be clearly stated that most of the research results need validation before any conclusions can be drawn and acceptable. (Onwordi et.al 2017, Kusi et.al. 2014) The Panel therefore submits that Benzoic acid, based on literature reviews, remains the chemical of choice to be used as preservative as in the current global practice. Benzoic acid is still being used the world over as beverages preservative of choice and some countries even allow much higher levels of the chemical than Nigeria.

2.1.3 TOR III - ASCERTAIN IF THE LEVELS OF BENZOIC ACID CAN BE FURTHER REDUCED BELOW 250MG/KG The Panel considered if the allowable level of benzoic acid and its salts in carbonated drinks can be reduced further below the current approved 250 mg/kg and 300mg/kg, just as has been achieved in Europe for instance where the allowable level has been set at 150mg/kg. However, it should be noted that the environmental conditions in Europe is very different from Nigeria. Countries in Europe are in the temperate region which is colder and food products can be kept from spoilage for longer time. At cold climates the rate of chemical reactions which give rise to degradation or spoilage of food substances is slower while high temperature speeds up such reactions and equally increase the rate of food spoilage. In Nigeria with hot climate, coupled with the common habits of displaying these products in the sun during marketing, a higher level of preservative would be required to keep such foods safe within the expected shelf life. Additives are inevitable necessities in foods. The preferred choice will be to have the food in its natural state. CODEX continues to review standards set. In the case of Benzoic Acid, the Commission has reviewed the maximum allowable levels from 600mg/kg to 250mg/kg in

12 December 2016(CODEX STAN 1992-1995 revised 2015 and 2016) and ratified in March 2017). The levels of the preservatives and other additives however are always monitored and reviewed when and where necessary based on continuous research findings. Presently, Codex Alimentarius Commission (CCFA 49) is considering the following three options that cover the range of Maximum Limits (MLs) recommended by the Electronic Working Group (EWG) for the use of benzoates in water- based flavored drinks. Option 1 A Maximum Limit (ML) of 150mg/kg for benzoates (INIS 210 – 213, as benzoic acid). Option 2 A Maximum Limit (ML) of 200 mg/kg for benzoates (INIS 210-213, as benzoic acid ) and the new note, “Except for use in beverages with a pH greater than 3.5 and concentrates at 500mg/kg as consumed, Option 3 A Maximum Limit (ML) of 250 mg/kg for benzoates (INIS 210- 213,as benzoic acid ) and the new note, “Except for use in beverages with a PH greater than 3.5 and concentrates at 500mg/kg as consumed. It should be highlighted that the Codex Committee Africa (CCAfrica) and Nigeria opted for option 3 based on findings by the Joint Expert Committee on Food Additives (JECFA) on exposure for benzoates in non- alcoholic soft drinks ; to prevent significant market disruption and negative impact on the safety of the product. The Panel examined standards in different countries across the globe. The EU had set 150mg/kg for some time now. But the US and Canada is not considering lowering its standards below 1000mg/kg. Ghana has reviewed its allowable limit since 2016 to 250mg/kg. South Africa allows 400mg/kg. Hence the respective national standards vary widely among countries with some even exceeding the limit recommended by CODEX (see Table below).

S/N COUNTRY/JURISDICTION MAX ALLOWABLE LEVELS OF BENZOIC ACID mg/kg 1 European Union including the UK 150 2 USA 1000 3 Canada 1000

13 4 Pakistan 1000 5 China 200 6 South Africa 400 7 Argentina 500 8 Australia 400 9 Brazil 500 10 Japan 600 11 Mexico 600 12 India 600 13 Malaysia 350 14 Ghana 250 15 Nigeria 250/300

Review of Results from Laboratories The Panel considered it necessary to undertake laboratory investigations of carbonated soft drinks to: 1. Confirm present levels of the candidate chemical; 2. Examine the stability of the candidate chemicals at high temperatures towards a preliminary assessment of possible generation of benzene under some storage conditions. Carbonated drinks on the Nigerian market were sampled and were analyzed (including replicate analysis) at three different NAFDAC laboratories (Central laboratory Oshodi Lagos, Kaduna laboratory and Port Harcourt laboratory).The analytical protocol designed included: Investigation of Levels of Benzoic Acid in the samples were at three different temperatures 1. Refrigerated (4oC) 2. Room Temperature (25oC) 3. High temperature (40oC) The results obtained are fully presented in Appendix II. Two hundred and two (202) carbonated drinks were sampled from the different geopolitical zones in Nigeria. All the sampled carbonated drinks were analysed at three (3) NAFDAC laboratories as follows: 1. Port-Harcourt Laboratory; 2. Oshodi Laboratory Lagos; 3. Kaduna Laboratory. From the laboratory results the panel concluded as follows:

14 1. All the analysed carbonated drinks are in compliance with NIS standards for benzoic acid; 2. There was no significant difference in the levels of benzoic acid at the different temperatures in the various products analysed including Fanta Orange that contains both benzoic acid and ascorbic acid. Hence storage in the sun or at the relatively hot parts of Nigeria did not produce reduction of the benzoates or any subsequent generation of the carcinogen- benzene.

2.1.4 TOR IV - KNOW HOW OFTEN WE SHOULD MONITOR AND CHANGE SAFETY LEVELS The Panel considers that monitoring-compliance or general surveillance are key elements of a national food safety programme. Following the saga that precipitated the constitution of this Panel, it is obvious that the nation needs to step up our monitoring and surveillance activities of foods and products on the Nigerian market. Going by global best practices, consideration of changes to standards and safe levels should be undertaken at least once every two (2) years. Promulgation of new standards must be based on robust market and consumer surveys across all the geopolitical zones, epidemiological data and human health surveys, backed by robust laboratory analysis of the products’ contents. After extensive consultation and deliberations, the Panel concluded that an efficient Food Safety Monitoring Programme be put in place by the Federal Government using the National Policy on Food Safety and Its Implementation Strategy (NPFSIS), 2014 as a possible instrument. This policy if fully implemented takes care of the plausible challenges that may face monitoring activities for the enhancement of food safety. Some of the challenges will include lack of awareness of the socioeconomic importance of food safety, paucity of data, lack of understanding of food safety rubrics and quality standards as enshrined in international agreements, inadequate infrastructure and capacity to execute global best practices in activities etc. One of the major findings of the Panel was the availability of a robust National Policy on Food Safety and Its Implementation Strategy (NPFSIS), 2014. This policy, which is currently under implementation is expected to improve the Food Safety structure in the country by making it more efficient and effective in dealing with all forms of food safety issues including, issues bordering on the monitoring of both nutritive and non-nutritive additives in foods. The Policy recommended the establishment of the two committees to drive its implementation. These committees are: 1. Inter-Ministerial Committee on Food Safety (IMCFS); 2. National Food Safety Management Committee (NFSMC).

15 These committees have, since their establishment/inauguration, made strides in the implementation of the policy. The NFSMC is majorly expected to coordinate all food safety issues across all MDAs with each MDA retaining their core mandates and functions. One of the major achievement of these committees is the development of two documents that would address the legal and institutional structure of food safety governance in Nigeria. These two documents are: 1. National Food Safety & Quality Bill; 2. Food Safety Institutional Reform Framework.

The National Food Safety & Quality Bill is expected to legally establish the National Food Safety Management Committee (NFSMC). This committee will have technical sub committees, most importantly a Scientific Sub Committee (Section 35), with the sole aim of “developing and proposing scientific opinions [for] the National Food Safety Management Committee, including the assessment of food and feed safety risks, and requesting information and research directed at providing information for the assessment of food and feed safety risks.” Food Safety Institutional Reform Framework is designed to have a radical, yet marginal change in the overall proposed reform of the institutions involved in Food Safety Controls in Nigeria, at both Federal and State Governments levels. In the first phase of the reform, it is recommended that NAFDAC undergo a fundamental internal restructuring to separate its structure, functions and staff between the control of drugs (and other substances) from the control of food safety. The latter would be developed under the Food Safety and Applied Nutrition Directorate. Importantly, the food control area would include a new food safety risk management function (this is defined in the Food Safety & Quality Bill) that will be responsible for the risk management decisions. Finally, it is highly recommended that in other to achieve the monitoring goals stated above, there is also the need for periodic collaboration between the regulatory agencies- NAFDAC, SON, CPC, relevant Universities and scientific research or professional institutes such as NIFST, IPAN, ICCON on food safety levels

2.1.5 TOR V - GIVE ANY OTHER ADVICE THAT MAY BE DEEMED NECESSARY. The Panel considered two issues as important to be contained in our Report: 1. Government and Consumer public reaction to the saga 2. Exploring technical changes locally for soft drink additives and manufacture.

16 2.2 PUBLIC AND CONSUMERS' REACTION TO THE SAGA AND APPROPRIATE RESPONSE BASED ON THE PANEL FINDING

The Panel's investigation looked at the commencement of the saga and the quick reactions that followed, some allusions and concerns by the public and the various platforms on which the public expressed their reactions. The Panel’s findings and responses are as follows:

2.2.1 COMMENCEMENT OF THE SAGA

The saga commenced after the judgment was made public in February 2017. The peak point of the saga was in the month of March 2017 when it went viral on media platforms. Both conventional and unconventional media became awash with reports of the outcome of the law suit brought against the Nigeria bottling Company and NAFDAC.

The various reactions and public perception pointed to the allusion that the NBC products in focus and in fact all other soft drinks containing benzoic acid and /or in combination with Ascorbic acid were poisonous.

The statements generally made by various groups at that time was on the possible dangers of taking Fanta orange and/or Sprite due to the use (not necessarily the levels) of benzoic acid and ascorbic acid as additives in the soft drinks.

Nigerians in their millions indeed reacted and in some cases with anger due to ignorance. The panel believes that some of these reactions may just have been more of an outpouring of emotions rather than being based on scientific interrogation of the facts. The reactions did not take into consideration the scientific and health regulations on the use of these additives in carbonated drinks as applicable in Nigeria.

2.2.2 ALLUSIONS AND PERCEPTIONS FROM THE PUBLIC

Some of other allusions and perceptions included that:

1. The use of benzoic acid or its derivatives in soft drinks will result in the production of benzene, a cancer-causing agent. 2. Consumption of any drink containing benzoic acid or its derivatives in combination with ascorbic acid will result to cancer. 3. Taking any soft drink containing benzoic acid and its salt and thereafter taking oranges or other citrus fruits was an invitation to cancer.

17 4. It was a risk to eat banana and at the same time drink a soft drink containing benzoic acid or its derivatives, as doing so had very serious adverse effects on human health 5. The bottlers of such soft drinks have over the years, fraudulently and intentionally exposed the Nigerian consumers to these dangers, otherwise how can Coca Cola and NBC explain the levels of benzoic acid being different for the UK, when the product in owned by the same company.

2.2.3 CONCERNS OF THE CONSUMING PUBLIC

The general consuming public in its reactions to the saga also expressed some concerns from which it drew some wrong conclusions. For examples, some of the concerns were that:

1. The most plausible cause of the recent and incessant cases of cancer and organ failure ravaging the citizenry in the country was because of extensive consumption of soft drinks containing benzoic acid, its derivatives and/or in combination with ascorbic acid. 2. The Nigeria government, its agencies and industry have failed in their duty of care and regulatory affairs by allowing the circulation of drinks that are not fit for human consumption

Most worrisome was the fact that these concerns were further fueled by the fact that almost every speaker, commentator, public analyst etc who spoke on the issue claimed expertise and became an emergency expert in the chemistry of benzoic acid and ascorbic acid and food additives. Consequently, consumers were fed with all sorts of misinformation that increased public anxiety.

2.2.4 OTHER PUBLIC AND CONSUMERS' REACTIONS The details of other public and consumer’s reactions on the saga came through various platforms as follows:

1. Civil Society Organizations blamed government for not doing what it was supposed to do in order to restore the consumer public confidence particularly in the semi urban and rural areas. 2. Some consumer protection NGOs were of the view that the indicted company ought to be sued for compensation to consumers for long years of abuse. 3. Media Outfits that allowed a free for all discussion and accepted write ups that did not reflect the true scientific and empirical angle to the whole saga.

18 4. Professional Bodies. Some science based professional bodies expressed caution and rather requested for evidence-based findings that can be used to resolve the matter 5. The Social Media offered opportunity to millions of Nigerians to join the discussion. Some expressing concerns, some to pour out their anger and disgust, some inquiring on the issue and some to educate others etc.

It is significant to note that the FMoH issued a Press Release during the saga to douse public outcry and allay fears of the consuming public. (Appendix I)

2.2.5 POSSIBLE OVERALL LOCAL CHANGE FOR SOFT DRINK CONTENT AND MANUFACTURING TECHNOLOGY FOR IMPROVED SAFETY The use of Benzoic acid singly at the appropriate levels has not been implicated in any health hazard. However, in combination with ascorbic acid there are concerns of possible production of benzene – a carcinogen under certain conditions. The Panel found and established from its thorough scientific analysis of randomly selected carbonated drinks on the Nigerian market that the Levels of benzoic acid and/or its derivatives used by manufacturers fully comply with the existing Nigerian Industrial Standard (NIS) and that of CODEX. More importantly, the levels were not found to change with increasing temperature even at temperatures as high as 40oC. Similarly, the Panel found that benzoic acid content in products that contain both benzoic acid and ascorbic acid was not found to reduce at the high temperature. Hence, it can be safely concluded that the alleged conversion of benzoic acid to carcinogenic benzene in the products at high temperatures DOES NOT occur in the products on the Nigerian market. Some manufacturers of carbonated drinks do not combine benzoic and ascorbic acid and still achieve the required preservation potential and nutrient values for Vitamin C. There is also some evidence that some manufacturers of carbonated drinks do not use benzoic acid as a preservative and still achieve their specified shelf lives. Considering the above, it is therefore easy to conclude that the use of the two acids is not mandatory but a mere shift or change in technology. It is therefore advisable and worth recommending that alternative additives be investigated by Nigerian soft drink manufacturers and if benzoic acid should be used at all then no product should contain the two candidate chemicals- benzoic acid and Vit C in combination, at least to allay the fears of consumers.

20 CHAPTER THREE

3.1 RECOMMENDATIONS:

In closing, the Panel posits that the HMH consider/approve the following recommendations as the long-term systematic way to monitor additives in food processing/production, as well as the entire food safety concerns.

3.1.1 RECOMMENDED APPROPRIATE FUTURE RESPONSE BASED ON THE PANEL FINDINGS Based on the findings of the panel, the following appropriate responses are recommended: 1. An International or National Press Conference is recommended in which the Minister for Health, Representatives of the Presidency, DGs of NAFDAC, SON, CPC, Chairman of the Panel, representatives of relevant professional bodies, Civil Society and NGOs will address the public through the press and reassure the public based on the findings of this panel. 2. Embark on a massive public enlightenment in selected locations across the geo political zones of the country to: a. reassure Nigerians on the safety of soft drinks and food consumed in Nigeria b. explain the basis for different limits of additives in different countries and c. what government is doing to protect the citizens. This public enlightenment will further serve to disabuse the minds of the public that the causes of cancer and organ failure are due to the consumption of soft drinks containing benzoic acid, its derivatives and Vitamin C. 3. That government and industry put in place adequate measures to support research so that new innovations in the science of food and drinks can be identified and utilized for the benefit of government, industry and the public at large rather than a sole dependence on off shore research findings. 4. The existing surveillance and compliance monitoring strategy of additives in foods need to be stepped up. 5. Expedite action on the Presentation and Adoption of the “National Food Safety & Quality Bill” and the “Food Safety Institutional Reform Framework” by the Federal Executive Council and the Act at the National Assembly; 6. Provision of adequate funds for the National Food Safety Management Committee to enable her: a. Effectively coordinate Food Safety Activities of the MDAs; b. Arrange quarterly meetings; and c. Implement the National Policy on Food Safety.

21 CHAPTER FOUR

4.1 CONCLUSIONS:

In conclusion, the Panel resolved that: • Benzoic Acid and its derivatives are still safe to use singly or in combination provided there is compliance with NIS/ CODEX recommended levels.

• The Panel found and established from its thorough scientific analysis of randomly selected carbonated drinks on the Nigerian market Established that the Levels of benzoic acid and/or its derivatives used by manufacturers fully comply with the existing Nigerian Industrial Standard (NIS ) and that of CODEX

• More importantly, the levels were not found to change with increasing temperature even to as high as 40oC. Similarly, the level of benzoic acid in products that contain both benzoic acid and ascorbic acid was not found to reduce at the high temperature. That the amount of Benzoic acid did not change meant that the acid did not decompose let alone combine with any other substance to form another chemical compound wanted or unwanted at all the selected afore mentioned temperatures. Hence, it can be safely concluded that the alleged conversion of benzoic acid to carcinogenic benzene in the products at high temperatures DOES NOT occur in the products on the Nigerian market. • Exporters should comply with national export regulations and guidelines as put in place by NAFDAC and ensure they understand the Technical Regulations of the Recipient country prior to export.

22 LIST OF APPENDICES

1. FMOH Press Statement. 2. NAFDAC Laboratory Results Analysis.

23 BIBLIOGRAPHY

Bridges JW, French MR, Smith RL, Williams RT (1970) The fate of benzoic acid in various species Biochemical Journal, 118:47–51.

CODEX Alimentarius Commission (CAC) vol 1A-1999 General Standard for Food Additives- Codex Standard 192-1995 (Rev8. 2007, Rev. 2015 and 2016) European Food Safety Authority (EFSA) (2016) Re-evalauation of benzoic acid (E 210), sodium benzoate (E211), potassium benzoate (E212) and calcium benzoate (E213) as food additives EFSA Journal 14 (4) pp. 110 European Food Safety Authority (EFSA) (2016) Scientific Opinion on the Re- evaluation of benzoic acid (E 210), sodium benzoate (E211), potassium benzoate (E212) and calcium benzoate (E213) as food additives EFSA Journal 14 (3) pp. 4433 Gardner, L.K. and Lawrence, G.D. (1993) Benzene Production from Decarboxylation of Benzoic Acid in the Presence of Ascorbic Acid and a Transition Metal CatalystJ. Agric Food Chem. vol 41 No 5, 1993, pp 693-695 Ibekwe, SE, Uwakwe AA and Monamu, MO, (2007), Effect of Oral Intake of Sodium benzoate on some haematological parameters of Wistar Albino Rats Scientific Research and Essays, Vol 2 pp 6-9 Janny, MA (2009) Benzene in Soft Drinks, Food Safety Focus, 36th Issue, July 2009 pp 1-3 JECFA (Joint FAO/WHO Expert Committee on Food Additives), 2015, Evaluation of certain Food Additives and Contaminants (Eightieth report of the Joint FAO/WHO Expert Committee on Food Additives) WHO Technical Report Series, No 995: Benzoates: DietaryExposure Assessment, 13-16 Kusi, JK and Acquaah, SO (2014) Levels of Benzoic Acid in Soft Drinks and Fruit Juices in Ghana IOSR Journal of Env Sc., Toxicology and Food Tech, Vol 8 No 12 pp 36- 39, Dec 2014 Onwordi, C.T., Olanrewaju, A.J., Wusu, A.D. and Oguntade, B.K. (2017) Levels of Benzoic Acid, Sulphur (IV) Oxide and Sorbic Acid in Carbonated Drinks Sold in Lagos, Nigeria Amer. J. of Food Sc & Tech. vol 5 No 2. Pp 38-44 VKM (Norwegian Scientific Committee for Food Safety), 2007, Impact on Health when Sugar is replaced with Intense Sweeteners in Soft Drinks Report 1.

24 PICTURES OF THE INAUGURATION CEREMONY

25 APPENDIX I – FMOH PRESS RELEASE

Background Arising from the recent court judgement on the case filed by Fijabi Holdings and another versus Nigeria Bottling Company and NAFDAC (joined as a nominal party), the Honourable Minister of Health summoned a meeting of the Department of Food and Drug Services, Federal Ministry of Health, National Agency for Food and Drug Administration and Control (NAFDAC) and Standards Organisation of Nigeria (SON) to address the related issues. The following were the findings: 1. Both Benzoic acid and Ascorbic acid (Vitamin C) are ingredients approved by International Food Safety regulators and used in many food and beverage products around the world. 2. Are levels of additives introduced as preservatives within specification? • Codex Alimentarius Commission (CAC) is the organ established by Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) to set internationally recognized standards, codes of practice, guidelines relating to foods, food production, and food safety. • In the case of Benzoic acid, the standard set by Codex was 600mg/kg until recently reviewed to 250mg/kg and adopted in 2016. (CODEX STAN 192-1995 revised 2015 and 2016). • With reference to the Codex standard and other relevant documents, Standards Organisation of Nigeria (SON) as the standard setting body in Nigeria in consultation with technical experts and relevant stakeholders elaborated the standard of benzoic acid in soft drinks to be at 250mg/kg based on the National climatic and storage conditions. This standard has been in existence since 1997 and revised in 2008. (NIS 217:2008) • The levels of benzoic acid in Fanta (1 batch) and Sprite (2 batches) presented by the claimant in the court are 188.64mg/kg, 201.06mg/kg and 161.5mg/kg respectively. • These levels are in compliance with both the Codex and Nigeria Industrial Standards. 3. Are Coca-Cola products manufactured in Nigeria safe for consumption? • Yes, the Coca-Cola products manufactured in Nigeria are safe for consumption in view of the following reasons: a. Risk assessment was conducted to ascertain maximum limits of food additives acceptable in foods. b. This takes into consideration the environmental, storage and distribution conditions as well as the shelf life of food products. c. NAFDAC and SON regularly monitor the manufacturing practices of Food industries and conduct laboratory analysis to ascertain continuous compliance with required national standards. d. There was a routine inspection conducted at Nigeria Bottling Company by NAFDAC officers in December 2016 which was satisfactory. 4. Why is there difference between the standard of Fanta and Sprite in Nigeria and the United Kingdom? • With reference to the Codex standards, each country or region is permitted to adapt a standard/limit based on country specific scientific evidence such as environmental, storage and distribution conditions.

26 • Benzoic acid as a preservative prevents the growth of microorganisms which thrive more at higher climatic temperatures like in Nigeria. • Due to the different environmental conditions obtainable in the UK, the standard for benzoic acid was set at a lower limit of 150mg/kg while in Nigeria it was set at 250mg/kg even below that of Codex (as at time of production of that batch; Codex limit was 600mgkg). • Food products being imported into a country must comply with the relevant standards of the destination country. NAFDAC has processes in place to ensure products imported into the country are evaluated to ascertain compliance with required Nigeria Industrial Standards. • The claimant did not obtain NAFDAC certification before export, otherwise, he would have been advised on the required standard of the destination country. 5. In view of the above, we would like to advise all Nigerians to take medicines with potable water. This would help to prevent unexpected drug-food interactions. 6. For the benefit of the health of all Nigerians, all bottling companies are encouraged to insert advisory warnings on all products as necessary. Signed, Akinola Boade Director, Media and Public Relations Federal Ministry of Health 17th March 2017

27 APPENDIX II – NAFDAC LABORATORY RESULTS ANALYSIS

Concentration of sodium benzoate (ppm) in some common soft drinks at different storage conditions

200 ROOM TEMPERATURE REFRIDGERATED INCUBATED 40C

180

160

140

120

100

40 Meanconcentration of sodium benzoate(ppm)

0 BIG COLA COCA COLA FANTA LA-CASERA SCHWEPPES SPRITE Soft drinks that contain only sodium benzoate

28 Concentration of sodium benzoate and ascobic acid (ppm) in some common soft drinks at different storage conditions 1600

1400

1200

1000 SODIUM BENZOATE AT ROOM TEMPERATURE SODIUM BENZOATE REFRIDGERATED 800 SODIUM BENZOATE INCUBATED 40C ASCOBIC ACID AT ROOM TEMPERATURE 600 ASCOBIC ACID REFRIDGERATED ASCOBIC ACID INCUBATED 40C 400

200

Meanconcentration of sodium benzoateand ascobic acid (ppm) 0 FANTA LA-CASERA SCHWEPPES Soft drinks that contain both sodium benzoate and ascobic acid

29 Concentration of ascobic acid (ppm) in some common soft drinks at different storage conditions

1600

1400

1200

1000

800 ROOM TEMPERATURE REFRIDGERATED 600 INCUBATED 40C

400 Meanconcentration of Ascobic acid(ppm) 200

0 FANTA LA-CASERA SCHWEPPES Soft driks that contain only ascobic acid

30 Chart showing the concentration of Benzoic Acid at different temperature as compared to National Standard

Refrigerator (5oC) Room Temperature (21oC) 40OC 60OC Codex Standard(250Mg/kg) Linear (Codex Standard(250Mg/kg))

300

250

200

150

100

0 Fanta Orange Fanta Fanta Apple Fanta Orange Fanta Mountain Dew Sprite 7up 7up Free Mirinda Mirinda Pineapple Pineapple Orange Pineapple