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Health risk assessment of food additives

The additives authorised in the EU have been evaluated by international expert panels and accepted for use in foodstuffs. An essential requirement for the authorisation of an additive is that its use is safe in terms of health as far as the available scientific data allow a judgement on this.

Programme for the re-assessment of authorised food additives in the EU

Because some of the assessments of the authorised additives by international expert panels were carried out some time ago, a programme for the re-evaluation of all additives was set up in the EU. However, it was not possible to re-assess the approximately 300 authorised additives at the same time. Priorities were therefore set by Regulation (EU) No 257/2010. According to this, food colourings had to be re-assessed by EFSA by the end of 2015, sweeteners by the end of 2020, and all other additives by the end of 2018 (although the EFSA has now been given longer deadlines for this).

In the EU, the European Food Safety Authority (EFSA) has been responsible since 2003. Until 2008, the EFSA expert panel involved in the health risk assessment of food additives was the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) and from 2008 to 2018, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS). Since 2018, the Panel on Food Additives and Flavourings (FAF) has been responsible. These expert panels replaced the Scientific Committee on Food (SCF) of the European Commission, which was dissolved in the spring of 2003.

Scientists of the BfR participate in the relevant committees. They collaborate on health risk assessments for new food additives and participate in the re-assessment of previously authorised additives.

Assessment criteria for food additives

Regulation (EU) No 234/2011 briefly describes the data required for the health risk assessment of new food additives in the EU. This includes information on intake, distribution in the body, metabolism, and excretion as well as information on sub-chronic and chronic toxicity, carcinogenicity, genotoxicity, and reproductive and developmental toxicity. Studies on other toxicological aspects may also be required. The applicant shall take into account the relevant guidance documents (Guidance documents) of the EFSA on the application process and health risk assessment.

As a rule, acceptable daily intakes (ADI) were derived for the authorised additives in the health risk assessment. These ADI values are based predominantly on the results of animal studies in which the animals received the respective additive with their feed in comparatively high concentrations (mostly on a daily basis over a long period of time). The dose up to which no adverse reactions occurred (i.e. no-observed-adverse-effect-level, NOAEL) is divided by an extrapolation factor (usually 100). This is meant to take into account uncertainties in the transfer of study results from animals to humans as well as individual differences. The ADI is thus often one hundredth of the NOAEL. It is specified in mg/kg body weight. This amount can be ingested daily for a lifetime without adverse effects. Occasional short-term exceedances of the ADI are tolerable under this ADI concept if (i) the magnitude of the exceedance is only of a level that still ensures a tolerable distance between the exposure and the NOAEL, (ii) there is no evidence that the effect relevant for deriving the ADI occurs after acute exposure, and (iii) they occur only so rarely that long-term exposure is not considerably affected by them. For some additives, no numerical ADI values have been derived. The conclusion of the assessment was then “acceptable” or “ADI not specified”.

Where available, data from human studies were also considered in the health assessment.

Scientific opinions on the health risk assessment of additives

Opinions of EFSA panels (currently FAF Panel, previously AFC and ANS Panels) can be found here:

Opinions of the former Scientific Committee on Food (SCF) of the European Commission

The Opinions of the Scientific Committee on Food (SCF) of the European Commission are also published.

The Assessments of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)  of the JECFA are first published (about two weeks after the meeting in question) as a summary, then (several months after the meeting) in more detail in the WHO Technical Report Series (TRS), and finally as a detailed monograph in the Food Additives Series (FAS) “Toxicological evaluation of certain food additives and contaminants”. On the WHO website, there is a database in which the assessment results for individual substances can be searched. 

Legal regulations

Food additives are substances that are added to food for technological reasons (e.g. to influence its texture, to give the food certain properties, or to achieve certain effects). Accordingly, different functional classes of food additives are distinguished in the EU.

Regulation (EC) No 1333/2008, which regulates the use of food additives in the EU, defines a food additive as “[...] any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods “.

Only approved additives may be used. In accordance with Regulation (EC) No 1333/2008, an authorisation for food additives only be granted only if

• they are harmless to health insofar as the available scientific data allow a judgement to be made in this respect
• they are technologically necessary
• consumers are not misled by their use

For the authorised additives, maximum use levels were derived for different foodstuff categories. The maximum levels are intended to ensure that the Acceptable Daily Intake (ADI) set at the European level is complied with. Additives that have no considerable hazard potential and are considered safe in normal use levels (e.g. calcium carbonate (E 170) or nitrogen (E 941)) and for which therefore no ADI has been derived at the European level are authorised without a specific numerical maximum level (quantum satis (qs)). According to “Good Manufacturing Practice”, they may be used only in the quantity necessary to achieve the desired effect.

All food additives authorised in the EU have an E-number. An E-number was (or is) assigned to additives, the use of which are considered safe by the Scientific Committee on Food (SCF) of the European Commission, which was dissolved in 2003, or by the expert panel of the European Food Safety Authority (EFSA), which has been responsible since 2003. Food additives must be listed on packaged foods in accordance with Regulation (EU) No. 1169/2011 (Food Information Regulation) usually with the class name (e.g. preservative) followed by their specific name or E-number.

The relevant legislation is also available on a website of the European Commission.

Database on conditions of use for food additives

The European Commission has created a database in which the authorised food additives and their conditions of use can be searched. This database is available in English. The information is based on the information in the Union list in the Appendix to Regulation (EC) No 1333/2008.

Monitoring of the legal regulations on the use of food additives

In Germany, the use of food additives is regulated by the directly applicable EU regulations of Regulation (EC) No. 1333/2008 and the relevant amendment ordinances. Purity criteria for food additives are regulated by Regulation (EU) No. 231/2012.

In the federal system of the Federal Republic of Germany, food monitoring (including the monitoring of additive use) is the responsibility of the authorities of the federal states (“Laender”). The respective supreme authorities at the federal state level coordinate – depending on the federal state – a multi-level organisation of authorities up to the local offices of food monitoring. For information on which authority is responsible in a specific case, please contact the highest authority of the federal state.

Food monitoring – List of primary authorities at the state level

Conditions of use for food additives at the global level

At the global level, standards on food additives are established by the Codex Committee on Food Additives (CCFA) of the Codex Alimentarius Commission (CAC) on the basis of the opinions of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The CCFA and the CAC are agencies of the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO). The relevant conditions of use are listed in the General Standard for Food Additives (GSFA). These are not legally binding in the EU but may be relevant when disputes between the EU and third countries are to be negotiated at the World Trade Organization (WTO). This is one of the reasons why the European Commission, together with the EU Member States, actively participates in the deliberations of the CCFA and the CAC.

The General Standard for Food Additives and other CCFA standards are available on the websites of the Codex Alimentarius.

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