Food additive controls: Some international comparisons

Food additive controls

A comparison is provided of the design and operation of regulatory institutions in the UK, USA, France and the Federal Republic of Germany in the field of food additives. Significant similarities and differences are highlighted and particular attention is paid to the ways in which the institutions cope with scientific uncertainties and conflicts of interest. Hypotheses are subsequently explored which suggest standards by reference to which ‘best practice’ could be de- veloped.

John Abraham is a research student in the Social Implications of Technical Change programme at the University of Sussex, and Erik Millstone is a lecturer at the Science Policy Research Unit of the Uni- versity of Sussex, Falmer, Brighton, East Sussex, BNl 9RF, UK.

No order of priority in authorship is implied by the order of the authors’ names, which is alphabetical only.

‘J. Verrett and J. Carper, Earing May Be Hazardous to Your Health, Anchor Press, New York, 1974, p 24. *M. Miller, Danger: Additives At Work, London Food Commission, December 1985, p 23. %ee, eg, H.F. Steward, ‘Food additives - their utilization and control with special reference to the case of cyclamates’, unpublished thesis, University of Man- chester. Januarv 1971. D 15: cf R. Seal. ‘The importance*of addkives’,.food Manu- facture, Vol 60, No 8, August 1985, pp 20-23. ?See, eg, F. Lawrence, ed, Additives: Your Complete Survival Guide, Century, Lon- don, 1986; M. Jacobson, Eater’s Digest, Anchor Doubleday, Garden City, NY, 1972, 1976 and 1985; Katalyse Environ- mental Group Koln, Chemie in Lebensmit-

continued on page 44

Some international comparisons

John Abraham and Erik Millstone

Much of the food consumed in the industrialized countries, as measured by economic value, is processed into ‘convenience foods’. For the purposes of this discussion, food additives are defined as substances that are intentionally added to processed food products. This definition excludes substances which become constituents of human food either as accidental contaminants or through their intentional use as agricultural chemicals or in food packaging.

This century has witnessed a great deal of innovative work in both the development of new food additives, and new uses for existing additives. The total use of food additives in the USA, for example, rose by over 50% (measured by weight) between 1955 and 1965. In 1974 it was estimated that 1.06 billion lb of food additives went into American food - two and a half times the weight reported for 1955.’ Miller has estimated that in 1985 the UK food industry used more than 200 000 tonnes of food additives, and that the total had grown tenfold over a 30-year period.2 Indeed since many of the new products introduced by the food industry depend so heavily on additives, many of them could not be marketed at all without additives.3

There is concern is some quarters that the use of food additives may have had, and may be having, adverse effects on some aspects of consumers’ nutrition, health and economic interests.4 Governments have a responsibility, and accept that they have the responsibility, to regulate the use of additives so as to protect the health of the general public. In order to do this, they seek to rely on the experimental science of toxicology to determine the safety or toxicity of food additives.

There are two basic approaches to the regulation of additives: negative listing and positive listing. With the former the government produces a list of prohibited additives but permits all others, and it is generally the responsibility of government to identify and demonstrate that an additive poses a toxic hazard. By contrast, under a positive list system the government lists all those compounds which are permitted, while simultaneously prohibiting all others. With a positive list system it is generally the responsibility of industry to finance research to produce data which will satisfy an official regulatory authority. The current position is that most countries operate a mixed list system, where some classes of additives such as preservatives and colours are covered by a

0306-9192/89/010043-15$3.00 0 1989 Butterworth & Co (Publishers) Ltd 43

continued from page 43 feln, Zweithausendeins, Frankfu~ am Main, 1982; P. Visintin, ‘Additivi: venti anni di storia’. Quademi. No 36, December 1986, p 35 et seq. ‘E. Millstone, ‘Food additive requlation in the UK’: Food Policy, Vol 10, No-3, August 1985, pp 237-252; E. Millstone, food Additives, Penguin, Hammondswo~h, 1986, Ch 4, pp 74-105. 6D. Conning, ‘New approaches to toxicity testing’, in G. Gibson and R. Walker, eds, Food Toxicology - Real or Imaginary Problems, Taylor & Francis, London, 1985, p 11. ‘C. Feldberg, ‘international implications of the Redbook’, in Food, Drug and Cosmetic Law ~ou~na/, Vol 38, 1983, p 372; cf 8. Gillespie et a/, ‘Carcinogenic risk assessment in the USA and UK: the case of aldrin/dieldrin’, Social Studies of Science, Vol 9, 1979, pp 265-301. ‘J.M. Barnes and F.A. Denz, ‘Experi- mental methods used in determining chro- nic toxicity: a critical review’, Pharmaco- to@& &view, Vol6, 1954, pp 391-242. gD. Salsbura. ‘The lifetime feedinq study in mice and ray&-an examination of ss valibity as a bioassay for human carcinogens’, Fundamenfal and Applied Toxicology, Vol 3, No 1-2, 1983, p 64. “D. Conning, op tit, Ref 6, p 11. “See, eg, M. Jacobsen, 1976, op tit, Ref 4; Food Additives Campaign Team, ‘Food additives-a new national policy’, New Health, January 1986, p 51; Katalyse Environmental Group K6ln, op tit, Ref 4; Ministry of Agriculture, Fisheries and Food, Food Science Division, Survey of Consum- er A~ifudes to food Additives, HMSO, London, 1986; Eating What Comes Natur- a//y?, report from Presto, 1986; A. Bradley, ‘Consumer attitudes towards food additives’, in Additives in Food, Drink, Cosme- tics and Medicines, Association of County Councils, London, 1987, p 95ff; and Con- sumer’s Association, Survey on Attitudes to Food Additives, London, September 1984.

positive list, while others such as flavourings may be covered by a negative list.

The purpose of this article is to compare the ways in which food additives are currently regulated in several major industrialized countries. We shall describe the institutions and operations of the several systems, and then explore how adequately they cope with the tasks they are required to perform. Our objective is to identify best current practice and ways in which regulatory institutions and policies may be improved. The main focus will be on the contrast between the UK and the USA, although the French and FR German systems will also be discussed.

Scientific uncertainty

As Millstone has argued elsewhere, toxicology is a science characterized by a great deal of uncertainty and ignorance.5 The food industry recognizes the necessity for conducting safety evaluations in accordance with standard protocols, but has few illusions about its scientific adequacy. As Conning says: ‘It has been easier and cheaper to provide the regulatory system with the data it needs, rather than to argue the scientific point.” Feldberg and others point out that two governments can review an identical set of data and come to contradictory assessments of safety and regulatory decisions.’

Since 1954 a large set of unresolved problems and uncertainties in toxicology has been identified.’ Furthermore, in 1983 Salsburg provided the first quantitative estimates of the validity of animal bioassays for human carcinogens, and concluded that these tests are more often wrong than they are right in detecting the toxicity of chemicals known by epidemiology to be human carcinogens.” Nevertheless, at present regulatory agencies have to rely on extrapolations from tests with laboratory animals, which often involve feeding high doses for relatively short times, to make judgements about humans consuming chemicals for long periods. The difficulty of such extrapolation has been described as ‘one of the most intransigent problems of toxicology’.“’

All regulatory authorities are faced by the problem of scientific uncertainly. but there are significant differences in the ways in which different countries recognize, respond to and cope with such uncertainty. The complexities of the regulators’ role, and the difficulties of their tasks, are compounded by the fact that the interests of consumers can and sometimes do conflict with industrial interests. The use of additives to extend the shelf-lives of products, or more often as cosmetics, may benefit manufacturers in ways that may not necessarily suit consumers’ interests. There can be arguments as to which group should receive the benefit of those doubts. Regulators have to make policies in this highly contested space.

The argument that there is a need for food additives is generally provided by the food industry. By contrast, consumer groups in the USA, the UK and in Europe argue that consumers have few needs, if any, for additives. ” In so far as additives serve to protect consumers . from food poisoning, they are generally reckoned to be necessary, but other uses. especially cosmetic functions, have been extensively

contested.

FOOD POLICY February 1989

Figure 1. The formation of an EEC directive.

Source: L.E. Parker, ‘Regulatory approaches to food coloration’, in J. Walford, ed, Developments in Food Co/ours 2, Elsevier Applied Science Publishers, Lon- don, 1964, p 6.


The role of the EEC

The use of additives in all the member states of the EEC is constrained by EEC-wide regulations which are set in Brussels. These controls are currently introduced in the form to directives from the Council of Ministers under Article 100 of the Treaty of Rome. The main concern in Brussels has been the achievement of harmonization between the widely differing national systems of regulation in the member states.

The initiative to introduce new proposals, or to modify existing ones, may be taken by industrial trade associations, national governments, the Commission, the Council or Parliament. The initiative goes, in the first place, to the European Commissioner and it is the Commission which has the main responsibility to draft directives, and to consult on these drafts with interested parties. An organogram representing the existing procedure is given in Figure 1. The section of the Commission which is concerned with this field is the foodstuffs division of Directorate General III (DGIII) responsible for the Internal Market and Industrial Affairs.

Both before and after drafting directives, the Commission consults with the Scientific Committee for Food (SCF) of the EEC and with interest groups representing industry, consumers and enforcement officers at national and European levels. The statute which established the SCF does not require that these experts be consulted on all relevant subjects, but in practice it is hard to imagine that a Commission

Trade

associations

European European

Council Parliament

may suggest the

initiation of

proposals to

1 European fommission 1

which consults

National and European

interest groups

Scientific Committee

for Food

and prepares draft

proposals to submit to

Council of Ministers

I which refers them to

whose opinion goes to

(COREPER)

FOOD POLICY February 1989 45

‘*Cf R.Haigh, ‘The activities of the Scien- tific Committee for Food of the Commis- sion of the European Communities’, in C.L. Galli et al, eds, Chemical Toxicology of food, ElsevierINorth Holland, Amsterdam, the Netherlands, 1978, p 82. ‘%ee SCF Report No 10, 1980, p 7. 14Numbers are assigned to additives with the prefix ‘E’ to provide a system of EEC-wide identification of compounds, and their use indicates that the EEC Council of Ministers has approved the compounds for use in food and drink. 15E. Millstone, ‘Food additives: a technology out of control?‘, New Scientist, 18 October 1984, pp 20-24. j6B.H. MacGibbon, ‘Control of food additives and contaminants in the United King- dom’, in G. Gibson and Ft. Walker, eds, Food Toxicology-Real or Imaginary Prob- /ems, p 41, Table 1. “Ibid. “See, eq. C.L. Weedon, ‘Food additives and coniaminants and the role of the FACC’, in Food Quality and Safety: A Century of Progress, HMSO, London, UK, 1976, pp 47-51.

proposal which did not have the blessing of the SCF would be supported by the Economic and Social Committee or the Parliament.” Members of the SCF are chosen by the Commission from amongst qualified scientists from member states, and its personnel are not supposed to act as either industrial or consumer representatives.

The SCF judges the acceptability, or otherwise, of additives solely by the criterion of their putative safety in use.13 The members of the SCF reach their judgements on the basis of data supplied to the committee by industrial firms, trade associations and governments, and in the light of reports from the Joint Export Committee on Food Additives (JECFA) of the UN FAO and the WHO. The SCF also provides recommendations to the Council of Ministers as to the assignment of E-numbers to particular chemical substances. The responsibility for deciding whether or not to award an E-number to a compound currently rests with the Council and not with the Commission or the SCF.‘”

Regulatory institutions in the UK

In the UK there are two government departments which are concerned with regulating the industrial use of additives. and they are the Ministry of Agriculture, Fisheries and Food (MAFF) and the Department of Health and Social Security (DHSS). At least 23 distinct groups of additives are regulated by the use of positive lists.‘5 The first positive list, which covered only preservatives, was introduced in 1925, and that for colours was introduced as recently as 1957 under the provisions of the Food and Drugs Act of 1955. The current approach to additive regulation derives from Section I of the 1955 Act, which has been updated and consolidated most recently into the Food Act 19X4. This prohibits the addition of any substance to food which would ‘render the food injurious to health’.lh Section 4 of the 1984 Act requires ministers to take account of ‘the desirability of restricting, so far as practicable, the use of substances of no nutritional value’.”

Ministers make regulations on the basis of advice from expert committees and interested parties. The Food Act empowers ministers to define the scope of regulatory control and that scope could be markedly tighter or looser under different policies without necessitating altera- tions in the law. Applications to market or to use new additives, or for new uses of existing additives (in those categories covered by positive lists), are referred to the Food Advisory Committee (FAC). Until November 1983 MAFF was advised by two committees in this field, namely the Food Additives and Contaminants Committee (FACC), and the Food Standards Committee (FSC), but at that time they were merged into the FAC, consisting then of 14 members, but increased to 15 in January of 1987. (The membership of the FAC is given in the Appendix.)

The membership of the FAC is chosen by ministers at MAFF. Government policy is that committee members are chosen because of their personal authoritative expertise and not as representatives of organizations or interested parties.” Of the 15 people on the FAC in 1987 at least seven were, or had been, employed by the food industry. Two members, including the chairman, are governors of the British Nutrition Foundation (BNF) which is funded by the UK food industry. There are four scientists and three members who might be interpreted as consumer representatives.

Two criteria are used to evaluate additives belonging to categories for

46 FOOD POLICY February 1989


which there are positive lists. These are ‘need’ and ‘safety in use’. The FAC assesses ‘need’ before safety is considered, because no matter how safe an additive might be, it is policy to prohibit compounds unless they are, in some sense, needed. This means that it must perform a function which is not yet performed by any additive already permitted, or else perform it more effectively or more safely.

If there is a ‘need’ for some additive then the FAC subcontracts consideration of safety to the Committee on Toxicity (COT), the membership of which is the responsibility of the ministers at the DHSS. This toxicological assessment is conducted by reviewing complex sets of technical data. The provision of this information is primarily the responsibility of the firms concerned, but the COT may also review data obtained from other regulatory agencies and expert committees such as the US Food and Drug Administration, JECFA and the SCF. Given the role of the Official Secrets Act in relation to the British committee system, it is not possible directly to assess whether or not the FAC, the COT and its sub-committees take account of commercial benefits. There is, however, some evidence that commercial benefits do play a role in the committees’ recommendations.‘”

A firm may either conduct its own safety evaluation work, or subcontract it to a commercial laboratory; or it may turn to the shared industrial facility at the British Industrial Biological Research Associa- tion (BIBRA). When the FAC has received a report from the COT it will then provide a report and recommendations to ministers which will then, normally, be published.20 Ministers are not bound to accept the recommendations of the FAC, but they are normally required to follow two full rounds of consultation before setting specific regulations, except in emergencies. In the first place, comments on the FAC report are invited from all interested parties.

Ministers then review the FAC report alongside a brief prepared by civil servants from the comments which MAFF has received. At this stage ministers may then decide to issue proposals for amendments to existing regulations, or for new regulations. Following the publication of draft regulations there is a further opportunity for comment from, and consultation with, interested parties, and only after that final round of consultation will ministers sign regulations which are then sent to Parliament. If these are not challenged in the House, then they become law after 21 days. Only once in the last 30 years have MPs availed themselves of the opportunity to intervene, otherwise all regulations have been approved by Parliament ‘on the nod’.*’

Regulatory institutions in France

The difference between the French and British systems can, to a first approximation, be characterized by saying that in the UK everything is permitted unless it is explicitly prohibited, while in France everything is prohibited unless it is explicitly permitted.

lgSee, eg, COT, Guidelines for the Testing The Service de la RCpression des Fraudes (SRF), which has been

of Chemicals for Toxicity, HMSO, 1982, pp responsible for regulating food additives since 1905, is currently

6-7. responsible to the Ministry of Finance and Economics. The SRF is

‘qhe COT report is itself also published, institutionally and politically separate from any sponsorship functions. usually as an appendix lo the FAC report. “Joyce Butler, ‘Artificial sweeteners’,

The French food processing industry receives specific support from

Hansard, 9 November 1967, pp 1365- other ministries, but regulatory and innovation policies are generally 1401. distinct,


Food additive cmtrols

A simplified representation of the organization of the French regulatory structure can be found in Figure 2. The process of regulatory review can be initiated by a firm, a trade association (or syndicat) or by the government. Industry may submit a dossier, or set of dossiers, in support of a petition for permission to introduce a new additive, or a new use for an already permitted substance, which is then referred by the SRF to two statutory expert review panels. These are the Conseil Superieur d’Hygiene Publique de France (CSdH) and the Academic de Medecine (AdM). There are important differences from the British situation. The FAC and COT are not statutory bodies and a British government can reform, ignore or disband these committees without introducing any legislation. The French government, by contrast, is legally obliged to consult these institutions.

The CSdH is the responsibility of the Directorate of Health and Hospitals in the Ministry of Health. Its members are appointed by ministers, but it has considerable autonomy. The CSdH is a large and important body which is required to provide the government with advice on a wide range of public health issues. In October 1984 it consisted of approximately 110 members. It covers a wide field by making extensive use of topic-specific working groups, and one of these groups has the responsibility to advise on additives.

The membership of the CSdH is determined ministerially, and strictly speaking appointments should be only for four years, but renewals frequently occur. Strictly speaking, too, members are appointed for their scientific and technical expertise, while at the same time there is an implicit expectation that they will represent particular sectional points of view such as consumers or an industrial sector.

The AdM is a relatively independent organization, independent of the food industry at any rate, and it receives some support from the Education Ministry. Its members are doctors drawn from a wide range of medical specialties. It does not include any representatives from interested groups or non-medical personnel. It too operates with working parties, and one group is responsible for additives. In the overall regulatory process the AdM plays a secondary role to that of the CSdH. By comparison with the British system, the French system is slower, more formal, more complex and more cautious.

The CSdH and the AdM both review separate dossiers on technological need and toxicological safety. They receive and review a great deal

Figure 2. Simplified diagrammatic outline of the process of authorizing

the use of food additives in France.

Approval requested from the SRFa

Notes: “Service de la RBpression des t Fraudes; %onseil Superieur d’Hygi&ne Publique de France; “Acadkmie de MBde-

SRF proposes changes to regulations for approval by the Ministries of

tine. Health, Agriculture, Industry, Economic, Financial and Consumer Affairs.



22See, eg, D. Gnauk, ‘International food legislation and its acceptance in the Feder- al Republic of Germany’, in Galli et al, op tit, Ref 12, p 93. 23The only other additives not covered are carbon dioxide and processing aids such as enzymes, which are intended to be absent from food products.

of raw data from the usual variety of sources. While French firms are often not required to repeat studies reported by JECFA and the SCF, they are sometimes required to produce safety data of their own. From time to time, however, the French government will organize or conduct safety tests of their own to try to confirm findings or resolve problems.

In France the two advisory bodies send their reports and recommendations to the SRF, brief summaries of which are then published in the journal Me’decine et Nutrition. While the SRF is obliged to consult the Conseil and the Academy it does not have to accept their advice. It can, and very occasionally does, override their advice.

Regulatory institutions in the Federal Republic of Germany

Since 1958 almost all categories of food additives have been covered by positive lists in FR Germany. This provision is slightly less comprehensive than might initially appear because in FR Germany the expression ‘food additives’ is defined so as to exclude natural and what are termed ‘nature-identical’ flavours. 22 Naturals and nature-identicals are categorized in FR Germany as food constituents, though there is a negative list covering this category. German additive regulations are therefore more comprehensive than those in other EEC countries, but their positive lists are not entirely exhaustive.23

The responsibility for regulating the use of additives in German food lies with the Ministry for Youth, Family and Health (Bundesminister- ium fur Jugend, Familie and Gesundheit - BMJFG). The Ministry (or BMG for short) acts with authority delegated to it from the Bundestag and in accordance with the provisions of the basic food law called the Lebensmittel und Bedarfsgegegenstande Gesetz (LMBG) enacted on 15 August 1974. While other ministries have responsibility for industrial sponsorship, the BMG deals with the food industry only on regulatory matters. It has been a long-standing policy of successive FR German governments not to permit any new additives, or any new uses for those additives which are already permitted, unless there are particularly strong grounds for so doing.

The BMG determines regulatory policy in the light of advice from two main groups of experts. One is the Federal Health Office (Bundesge- sundheitsamt - BGA) and the second is the German Research Society (Deutsche Forschungsgemeinschaft - DFG). As in Britain, the criteria of evaluation are ‘need’ and ‘safety in use’, but as in France both advisory groups make judgements on both criteria. Of the two sources of expert advice the BGA is considered to be the more important and more authoritative.

The BGA is not a ministry, but it is funded directly by the BMG with responsibility to provide the federal government with expert advice and research support across the entire range of health issues. Employees of the BGA are in effect arm’s_length civil servants. It is a large and influential organization with institutes, laboratories and offices through- out the country, and headquarters in West Berlin. While the BMG is obliged to consult the BGA on regulatory issues, the BGA does not have to wait to be asked for its advice. If it has evidence that an actual or potential hazard exists, then it reports directly to ministers.

When formulating its recommendations, the BGA reviews dossiers of evidence, primarily on safety but also on technological need provided by industry, and also from the SCF and JECFA. Rather like the US Food


Food addirive controls

and Drug Administration, however, the BGA has the resources and authority to conduct some safety studies of its own. In 1986, for example, the BGA was conducting safety tests on the controversial and problematic antioxidant butylated hydroxyanisole (also known as BHA and E32O) and on propionic acid (E280). The BGA will, under some circumstances, do safety studies under contract with industry. For example, the gum tragacanth (E413) is supplied by a large number of small companies, and they collectively paid for the BGA to study their product’s safety.

The DFG, which is a secondary source of advice for the BMG, has a number of expert commissions. One such commission advises the BMG on the use of food additives, and is called the Kommission fur Lebensmittel Zusatz und Inhaltstoffe. This DFG commission reviews essentially the same data as the BGA, and while it considers both criteria, ils primary emphasis is on technological matters, rather than safety. Specifically on matters of technology and the putative necessity of additives, the BMG receives advice from a third source, namely, the federal research institutes or Bundesf~~rschungsanst~~lten (BFAs).

BGA and BFA experts are independent scientists, while the DFG commission includes industrial representatives as well as academics. The DFG is independent of direct government control, and decides for itself whom to appoint to the commission. Strictly speaking, the commission members are supposed to be independent experts, but they are also free to act as consultants to industrial firms. They are, moreover, not required to reveal their interests to the BMG. As in France, however, experts who advise the government are, in principle at any rate, subject to civil liability for their advice. Consumer representatives do not sit as members on any of the official and formal advisory bodies.

The BMG has the responsibility to draft regulations in the light of the advice which they have received. These draft regulations are then sent to the Bundesrat and published (but without the technical or toxicological dossiers) and the explicit process of consultation then ensues. Section 39 of the 1974 Act enjoins the BMG to consult ‘experts , . . representing science, consumers, and the economic sector concerned’.2’ The BMG will receive submissions from these interest groups, and hold formal and informal meetings and discussions with them.

When consultation is completed the BMG finalizes its proposals, and for these to become law they must first be endorsed and approved by the Lander in the Bundesrat. Whilst the Bundesrat reviews the proposed regulations local and federal interest groups can seek to influence the process by lobbying their Lander representatives to the Bundesrat.

There is an alternative procedure through the German regulatory process. Section 37 of the basic food law (LMBG) empowers the BMG,

acting for the government, to grant temporary exemptions to the general prohibitions against additive use, subject to the agreement of the agriculture and finance ministries. Section 37 exemptions are granted to the particular users of food additives, rather than to their producers. They are valid, in the first place, for periods of up to two years, and may be renewed at least twice, to provide an opportunity for manufacturers to see whether or not an additive is desirable and useful.

Z4Lebensmittel und Bedarfsgegegen- While paragraph 3 of Section 37 states that ‘Exemptions may only be

stande Gesetz (LMBG), 15 August 1974, authorized if data justify the assumption that no hazard to health is

paragraph 39. foreseeable’, exemptions are sometimes introduced pending further



safety data, as long as those relate to minor questions. If there are serious doubts about safety, exemptions are not given.

It sometimes happens that when an exemption is granted there is no application for its renewal at the end of two years. Within a total of six years a final decision should be taken, either formally to change the regulations or to re-establish the initial prohibition. The procedure for obtaining an exemption (as defined in paragraph 4 of Section 37) does not require consultations with other firms, whereas a change in regulations requires agreement with the other ministries and other firms and consumer representatives. As a result. this procedure can be very attractive to industry. Once an additive has been permitted for six years, moreover, it then becomes hard for the government not to grant general permission.

The institutions of regulation in the USA

Since 1927 the main food additive regulatory authority in the USA has been the Food and Drug Administration (FDA), originally named the Food, Drug and Insecticide Administration. The FDA is a federal agency which is responsible for regulating interstate commerce, rather than actions which occur within individual states. The 1958 Food Additive Amendment and the 1960 Color Additive Amendment to the Food, Drug and Cosmetic Act of 1938 form the statutory bases for the regulation of additives, as well as for their categorization. The definitions in these amendments divided additives in the USA into four main groups: (i) those known strictly as ‘food additives’, (ii) those substances which are ‘generally regarded as safe’ (GRAS), (iii) ‘color additives’, and (iv) those compounds which had been approved for use in foods by the US Department of Agriculture (USDA) or the FDA before 1 January 1958 when the Food Additive Amendment was passed, and these are known as ‘prior sanctioned’ (or PS) substances.

In order to market or to use a ‘food additive’, a potential user is required to show to the FDA (a) that it will not adversely affect the health of consumers, and (b) that it is functional, in the sense of being capable of accomplishing its intended technical effect. This latter consideration is not identical to the criterion of need which is employed by the three West European countries considered previously. The FDA does not require that a new additive’s utility should be compared with those already listed. It only requires an additive to be effective, and does not require that substance to provide improvements beyond those already available. The FDA requires that a firm which petitions for permission to use an additive must submit, to the agency, data on safety. Like the German BGA, but unlike its British counterpart, the FDA is empowered to conduct research of its own to inform its toxicological evaluation of an additive.

The FDA is legally obliged to report in the Federal Register the filing of any petition for permission to use a food additive; and it must also publish any decision on whether.or not to grant approval. Anyone who opposes the agency’s action may file objections and request a formal evidential hearing. Pending such a hearing the FDA is not obliged to withhold its approval. If such a hearing occurs, it is the responsibility of the Commissioner of the FDA to reach a decision. This conclusion may,

25J S Turner, The Chemical Feast, Gross- man,‘New York, 1970, pp 30-37.

however, be subject to judicial review in the appellate courts, should an objector wish to pursue the matter further.*’ The FDA is also


Food udditive controls

accountable for its policies and its food safety research to Congress, through both congressional committees and other review bodies.

If a compound is categorized as a ‘food additive’ then the onus is on the petitioner to show that it is safe. For a substance already deemed to be GRAS, however, the FDA must demonstrate that there is a significant risk to the health of consumers in order for its use to be restricted or forbidden. If the FDA is not convinced that a chemical is GRAS, a petitioner may still obtain permission to market that chemical as a ‘food additive’. Similarly, if an additive ceases to be counted as GRAS then it automatically becomes treated as a ‘food additive’, in so far as it continues to be used. To enforce control over PS substances, the FDA must demonstrate that a PS substance is demonstrably ‘injurious to health’.

Colour additives are regulated in the USA as a distinct category, and by the use of both provisional and permanent positive lists. The initial purpose of the provisional list was to allow time for the completion of safety testing on existing colours, which had been in wide commercial use for many years and which Congress assumed to be safe.2h

One further major difference between the European regulatory systems described and that in the USA is that an anti-cancer provision known as the Delaney Clause is an integral part of the 1958 Food Additive Amendment. According to this clause: ‘no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal or if it is found after tests which are appropriate for evaluation of safety of food additives to induce cancer in man or anima1’.27 The clause precludes the FDA from adopting either tolerance levels or risk/benefit analyses when assessing chemicals which are carcinogenic to either humans or animals. If the Delaney Clause were rigorously invoked then all carcinogenic additives would be banned from all interstate commerce. British, French, FR German and EEC legislation does not contain any equivalent provision. One of the distinctive features of the Delaney Clause is that it deprives (or at any rate was intended to deprive) the FDA of all discretion in relation to human and animal carcinogens. In the UK, France and FR Germany, since there is

no such matching legislation, regulators can make judgements of probabilities, compare risks with benefits, and exercise discretion when dealing with the uncertain field of carcinogenic toxicology. Similarly, with non-carcinogenic additives the FDA has less discretion than its counterparts in the UK, France and FR Germany. According to Degnan, the 1958 Food Additive Amendment explicitly requires the agency to be solely concerned with the evaluation of safety and effectiveness, and not with economic factors involved in their use.2x

Scientific advice on food additive toxicity

‘%.J. Taylor, Food Additives, Wiley, There is a fundamental difference between the British case and the

Chichester, UK, 1980, pp 74-81. three other national examples with which it is being contrasted. In 27See, eg, E.M. Mrak, Foreword, in F. Britain the government receives toxicological advice from one and only Coulston, ed, Regulatory Aspects of Carci- nogens and Food Additives: The De/any

one agency, while in France, FR Germany and the USA governments

Clause, Academic Press, New York, 1979, receive advice from two or more independent agencies. Uncertainty is p xix. 28F. H. Degnan, ‘The best proof of safety

not a necessary condition for disagreement, but it may be sufficient, and

for food additives and new animal drugs’, so receiving information and advice from several agencies provides the

Food, Drug and Cosmetic Law Journal, Vol conditions in which uncertainty is more likely to be revealed rather than

30, April 1981, p 189. concealed.


Food additive conrrols

The French government is always advised by the CSdH and the AdM, while the FR German government is counselled by the BGA and the DFG, and in both countries both committees assess both need and safety. In the USA the FDA frequently obtains scientific advice on the safety of additives from a multiplicity of sources. The FDA requires and receives technical data from industrial petitioners, and takes into account JECFA reviews, but it also calls for and receives advice from numerous other American public and private institutions such as the National Cancer Institute (NCI) and the Federation of American Societies for Experimental Biology (FASEB).2Y The American regulatory agency has far greater flexibility in deciding from where to obtain advice than the British, French or German, but only the British obtain monovocal advice.

“See, eg, Verrett and Carper, op tit, Ref 1, pp 67-70; Taylor, op &t, Ref 26, pp 79-80: and Ft. Gillette. ‘Academv food committees: new criticism of indu&y ties’, Science, Vol 177, 29 September 1972, p 1175. 3@r. Sky, ‘Agency implementation of the Freedom of Information Act’, Adminisfra- tive Law Journal, Vol 20, 1968, pp 449- 450. 3’Hansard, 6 March 1986, p 431. 32MAFF letter ‘To All Interested Parties’, 17 March 1987.

Freedom of information: openness or secrecy?

American institutions recognize, at least de jure if not always de facto, that the public interest is best served, and public confidence maintained, by lodging (almost) all the documents relevant to regulatory decisions in the public domain. Under the provisions of the 1966 US Freedom of Information Act (FOIA) the FDA is required to make the following available for public inspection: ‘(A) final opinions, including concurring and dissenting opinions as well as orders made in the adjudication of cases; (B) those statements of policy and interpretation which have been adopted by the agency and are not published in the Federal Register; and (C) administrative staff manuals and instructions to staff that affect a member of the public . . .‘30

Until 1986 the position was that all the technical and toxicological dossiers provided by the food industry to the British, French and FR German governments were on a basis of explicit confidentiality. Furthermore, JECFA and the SCF operate on an identical basis of secrecy. All of these governments and international agencies have expressed a preference for technical and toxicological information to be published, but they have never made it a condition for the submission or acceptance of any data. In March of that year, and in response to public pressure and parliamentary questions, the British minister announced a limited change of policy.3’ The proposed solution was to lodge a copy of all the unpublished parts of the toxicological dossiers in the British Library where they may be consulted, but the provisions of this proposal were to apply only to data submitted after July 1986.j2

In France and FR Germany the government and its regulatory agencies have adopted the policy of encouraging, but not requiring, publication. If industry chooses not to publish results, the regulatory communities in those countries respect industrial confidentiality; and the international agencies, JECFA and the SCF of the EEC, are similarly respectful.

Legislative and judicial review

In the comparative context, the United States is unique in yet another respect. It is only in the United States that comprehensive provision has been made for legislative and judicial oversight of the regulatory process. The Food and Drug Administration is fully answerable to Congress, which has the authority and mandate to subject agency


decisions and actions to public scrutiny and review. From time to time they exercise this power.3’ Not only may these matters be disputed in front of congressional committees, they can also be reviewed and revised by the courts. Individuals, organizations and firms can and do, from time to time, challenge the judgements of the FDA in the courts.

In France and FR Germany there is no opportunity for individuals or organizations to challenge regulatory decisions in the courts, but in both these countries there are statutory arrangements which permit individuals who believe that they have suffered as a result of a negligent regulatory decision to take civil proceedings against expert advisers in the administrative courts. But in all the countries under discussion consumers who believe that they have been damaged by a commercial product may take civil legal proceedings against the manufacturers of the products concerned.‘”

Economic interests and consultative procedures

Whenever there are official proposals to amend regulations, the regulatory authorities in all these countries invite comments from interested parties, or at least from any who receive notification. These consultative mechanisms tend to be dominated by industrial representatives, partly because industrial interests are more involved and better organized but also because consumer groups often do not yet take an active interest in issues related to additives.

The EEC, British, French and FR German systems all operate on the assumption that there is no fundamental, or long-term, conflict of interest between industry and consumers, and so they aim at reaching a consensus, following the appropriate consultative procedures, which are taken to reflect scientific knowledge and the public interest.35 In the British case, however, the possibility of conflicts of interest is acknowledged in that members of the FAC are expected to declare any conflict of interest before particular meetings.3” A judicial process, such as may occur in the USA, is not necessarily a process of conciliation and

33For example, congressional intervention prevented the FDA from banning the artifi-

does -not necessarily aim at attaining -a balanced consensus, but

cial sweetner saccharin under the Delaney recognizes that there may be real conflicts of interest, and examines the

Clause following evidence in 1977 that it opposing positions of the protagonists to adjudicate between them. In causes cancer in the bladder of male rats. 34EEC Directive on Product Liability,

so far as there are genuine conflicts of interest between consumers and

Council Directive 85/374/EEC, adopted 25 industry, open adversarial structures may be more appropriate for

Julv 1985 and embodied in the UK in the determining regulatory policies than a closed group of technical experts, Cohsumer Protection Act 1987.

- _ - _

35Eg, RF. Curtis, Chairman of the FAC, especially if most of those experts acquired their expertise within

‘The work of the FAG, paper presented to industry.

the Food Safety Panei of the Society of Chemical Industry, 24 October 1984. 36J, Abraham, ‘Policy perspectives on Brit- Economic interests and scientific judgement ish food additive regulation by comparison with the United States’, unpublished MSc We cannot assume that expert advice is invariably objective in the sense thesis, University of Sussex, 1985; cf J. Erlichman, ‘Food watchdog denies conflict

of being interest-free. The selection and interpretation of experimental

of interest’, Guardian, 20 July 1987, p 4. procedures and results can readily be shown to be a function of 37See. ea. E. Millstone and J. Abraham. institutional and economic interests.37 Moreover. as Smvth argues. , ” Additives: A Guide for Everyone, Penguin, Harmondsworth, 1988.

technical facts and values in food toxicity cannot be readily separated.38

38T R Smyth, ‘The FDA’s Public Board of It is important to distinguish scientific from political considerations, but Inquiry and the aspartame decision’, Indi- we cannot assume that either science or politics can be discussed in ana kw Journal, Vol 58, 1983, pp 638- 639; cf J. D. Bernal, The Social hnction of

complete abstraction and isolation from the other.

Science, Routledge, London, 1973, pp Not only is the role of scientific advisors significant, but so too are the

42-48 and 107-l 10. scientific institutions which generate toxicological data. In the UK much



of BIBRA’s research is concerned with demonstrating the safety of food additives and other chemicals. BIBRA’s concern is with the needs of

industry rather than consumers.“’ Although the UK government is represented on BIBRA’s governing council, the BIBRA council is dominated by industrialists, and the food industry has an overwhelming majority on all policy-making committees.4” In short, practically all toxicologists engaged in safety evaluation work on additives in the UK are employed by industrial corporations or an industry-supported research centre. Moreover, this work is intended to provide data to meet regulatory requirements so as to enable food additives to be cleared for the market.

Current UK government policy requires that companies should bear the entire cost of safety evaluation work, and that it is their responsibility to organize, administer and report that work. There are, however, good reasons why this policy should be modified and these functions separated. Governments could organize and administer safety studies, and charge them directly to industry, secure, of course, in the knowledge that the cost will in due course be passed on to consumers.

In the USA, however, the suspicion that scientists have conflicting interests enjoys a high political profile.41 Indeed, one reason why the FDA requested FASEB, rather than the National Academy of Sciences (NAS), to conduct a major review of GRAS substances was that the FDA was concerned about the extent of industry representation on NAS panels. It is not that conflicts of interest arise in the USA in ways which do not occur in the UK, ‘but rather that American institutions recognize that fact explicitly and take it into account, at least in principle. In the EEC, the UK, France and FR Germany, on the other hand, issues of conflict of interest are either concealed or dealt with discreetly.

Conclusions

Any adequate regulatory regime needs to recognize the limitations of scientific advice, and to appreciate that there are potential and actual conflicts of interest between consumers and producers, and should then ensure that the benefit of the doubt is awarded to consumers. Furthermore, the objectives of regulation and the responsibilities of regulatory agencies should be explicitly defined, and be located, in the context of an overall policy to protect consumers by ensuring a safe, nutritious and adequate food supply. The achievement of this state of affairs is likely to depend on the factors discussed below.

(a) Separation of sponsorship and regulation

In each of the countries under review there are government departments responsible for additive regulation and for the sponsorship of the

39D.M. Conning, ‘Directors’ report’, B/BRA food industry. The UK is the only country in which the performance of

Annual Report 1983, p 5. both of these functions is delegated to the same ministry. Such an 40Anon, ‘Food additives: who is the pip- er?‘, Nafurel “O’ ***y 1g6gl PP 401-402;

arrangement would not be considered acceptable in the USA, France or

cf B/BRA Annual Repoti 1984185. FR Germany. The problem is that as long as an industry is regulated by

4’Gillette, op tit, Ref 29, pp 1174-l 175; cf the department which sponsors it there will always be a serious risk that J. Hightower, Eat Your Heart Out, Vintaae consumer urotection mav be subordinated to trade interests. To further Books, New York, NY, USA, 1976, pp 271 and 346, on the extent of exchange of

guard aga;nst the subordination of food safety considerations to trade

personnel between the food industry and interests, the criteria by which the acceptability of a particular additive the FDA. on a positive list is granted should be ‘need’ and ‘safety’, but ‘need’


Food additive comrols

should be defined by reference to consumers rather than producers. Producers may well have a need for some class of additives such as preservatives, but only in so far as their use serves the prior needs of consumers.

(hj Greater openness

The best protection for consumers against the industrial capture of regulatory institutions is for the regulatory process to be fully open to public scrutiny. Of the countries under discussion, it is only in the USA that all toxicological data on safety, and much of the technical data on their function, can be obtained and scrutinized. The American approach certainly lends itself most effectively to public and democratic participation, whereas the Europeans and JECFA operate with systems which can prevent independent scientists and citizens from gaining access to data on the toxicity and safety of food additives, or from the agendas and minutes of the regulators and policy makers. Regulators should not only act so as to protect the food safety of consumers but they should also be seen to act in that fashion.

(cj Acknowledgement of uncertainties and conflicts of interest

In the light of the extensive and profound uncertainties of toxicology, it is desirable that regulators should obtain their advice from a diversity of sources, both national and international. Since it can be difficult or impossible to obtain advice which is independent of all sectional interests, it is always appropriate to require advisors to declare any interests (such as consultancies, shares or memberships) which they may have. It is not clear, for example, that the American system would be prepared to recognize all the British, French and German advisors as sufficiently independent, since some of the members of the FAC, COT, CSdH and DFG are either direct employees of the industry being regulated, or serve as consultants to it.

Since it is entirely possible for two different national regulatory authorities to examine identical dossiers and yet reach contrary conclusions, it is desirable that the criteria of interpretation by which toxicological and technical data are evaluated should be made explicit and defensible.42 Consumers will expect that, while safety evaluation decisions may involve comparing health risks against health benefits, health risks from additives should not be set against commercial

benefits.

(dj Democratic participation and public confidence

Proper democratic control of food additives is more likely to be achieved if regulatory authorities are seen not as having the task of conciliating between conflicting interests, but as adjudicating between their varying points of view, and making judgements in consumers’ favour. This could be achieved in at least two ways. Either all interested parties could be represented on the regulatory body, with provision for a consumer majority in the event of a vote, or the regulatory authority could be statutorily independent, and subject to clear terms of

4qhis has occurred, for example, with reference, while receiving advice from all interested parties. If a

saccharin, amaranth and the pesticides structure is rather designed only for consensual agreement, then it may aldrin and dieldrin. For details on saccharin and amaranth see Millstone and Abraham,

not withstand public, judicial or legislative scrutiny.

op tit, Ref 37. For details on aldrin/dieldrin The opportunity for open judicial and legislative scrutiny of the

see Gillespie et al, op tit, Ref 7. regulatory process appears to provide consumers with the best grounds



for confidence in a regulatory regime. In this respect the USA provides the most interesting model. A substantially increased reliance on the courts would be difficult to achieve, expensive to conduct and possibly wasteful, too, but provision for legislative review does appear to provide one of the best avenues for regulatory reform in the UK, France and FR Germany.

(e) Safety research policy

One of the problems with some existing regulatory systems is that most of the participating institutions do not have adequate incentives for reducing the uncertainties in toxicological science. It follows from the analysis presented above that an adequate regulatory regime would be one in which the participants recognized the extent of the uncertainties, and pursued strategic research programmes aimed at reducing those uncertainties. To deal with these problems will require much basic toxicological research, which could most effectively be accomplished through negotiated international collaboration. At the national level it would be desirable to develop university and government-supported centres of expertise in toxicology. In the meantime, consumers’ interests will continue to be best served by ensuring that the benefit of the many doubts in toxicology is given to, and seen to be given to, consumers.

Appendix Membership of the UK Food Advisory Committee as of 30 October 1987

Prof F. Curtis (Chairman)

Dr M. Ashwell Mr M. J. Boxall Dr H. Eggins Dr W. Fulton Dr T. Gorsuch Mr A. Harrison Prof P. James Miss P. Mann Mr R. Manley Mr A. Skrimshire Mrs A. Stamper Mr A. Turner Prof P. Turner

Dr E. R. Young

Director of Food Research at the Agriculture and Food Research Council’s Institute of Food Research Principal of the Good Housekeeping Institute Company Secretary, Tesco plc Director of Bioquest Ltd Senior Technical Manager, Unilever plc Director, Reckitt & Colemans Public Analyst, Avon and Gloucester County Councils Director of the Rowett Research Institute Head of External Affairs, J. Walter Thompson Group Director of Trading Standards, Cheshire County Council Senior Manager, H. J. Heinz Co Ltd Vice-Chair of the National Federation of Women’s Institutes Consultant, formerly Chief Chemist at Cadbury-Schweppes plc Clinical Pharmacologist, St Bartholomew’s Hospital, and Chairman of the DHSS Committee on Toxicity Senior Registrar, Wycombe General Hospital

(Source: MAFF Press Release No 327/87, 30 October 1987.)


Documents

Food additive controls: Some international comparisons