Regulatory Limits for Food Additives

For all permitted food additives, their purity criteria must conform with the specifications established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), as stipulated under Regulation 15(4).

http://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/en/

Company does not need to pay any application fees when applying for the use of new food additives in food.

The current permitted food additives and their conditions for use are stipulated under the Food Regulations.

You may also refer to the List of Food Additives Permitted under the Singapore Food Regulations and Food Additives Search Function published on the SFA website.

The procedure to apply for the use of new food additives can be found in the Guidance Information on Requirements for Use of Food Additives.

Carbon monoxide (CO) is not a permitted food additive under the Food Regulations. Intentional use of carbon monoxide to preserve the colour of frozen fish (e.g. tuna) or meat is not permitted as this practice will mislead consumers with regard to the freshness and quality of the product.

Taurine is currently only allowed for use in special purpose food products. Food manufacturers have to ensure that the levels of taurine is safe and suitable for consumption by the target group of consumers, based on the recommended daily consumption as indicated on the label. You may refer to Regulation 247(1) of the Food Regulations for the definition of special purpose food.

SFA notes that there is increasing interest by the food industry in the use of fermentates, referring to whole mixtures of non-viable microorganisms and their metabolites. In principle, SFA has no objection to the use of the fermentates in food, provided that:

(a) The microorganism used has a long history of safe use in food production such Saccharomyces cerevisiae and various L(+) lactic acid producing bacteria including Bifidobacteria spp, Lactobacillus spp, and Lactococcus lactis.
(b) A deliberate step in the manufacturing process proven to be sufficient to inactivate the microorganism is taken.
(c) The substrates and/or raw materials used in fermentation should comprise only food ingredients and food additives that are of food-grade purity (i.e., conform to JECFA specifications).
(d) The fermentates should not be refined or further processed to selectively concentrate specific components (if so, the refined component could be assessed as a food additive).
(e) The microbial fermentates are manufactured under a suitable food safety management system (e.g. Hazard Analysis Critical Control Point (HACCP), Good Manufacturing Practices (GMP) and risk mitigation steps that have been established.

As caffeine is not considered a food additive by the Joint FAO/WHO Expert Committee on Food Additives, it is also not regulated as a food additive in Singapore.

In general, soft drinks may contain caffeine as a form of flavouring. When present in cola-type soft drinks, levels of caffeine up to 50 mg per serving are generally acceptable. The only category of food which may have higher levels of caffeine added is special dietary energy foods (including energy gels, energy bars), which should be clearly labelled as such specified under Regulation 9B(1) of the Food Regulations.

Edible coatings are considered food additives. SFA has made available tools and resources to assist food businesses to check if the additives present in their food products are permitted under the Food Regulations. Please see Regulatory Limits for Food Additives for more information.

Processing aids may be used in the manufacture of food products provided that:
- the use of processing aids complies with the Codex Guidelines on Substances Used as Processing Aids (CAC/GL 75-2010); and
- the processing aids do not migrate any harmful substances to the finished product.

In the absence of a definition for "processing aids" under the Food Regulations, the current definition for "processing aids" as stipulated in the Codex Procedural Manual may be taken as a reference:


"Processing aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials,foods or its ingredients to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues oderivatives in the final product."

Regulation 15(3) of the Food Regulations provides for “carryover” of food additives into the final food product.

To paraphrase the regulation, a food product may contain added ingredients which may, in turn, contain permitted food additives. The quantities of the food additives present in the added ingredients must be within the levels specified under the Food Regulations. Under such circumstances, the food additives are deemed to be carried over into the food product.

Regulation 15(3):
Notwithstanding paragraph (1), any food containing as an added ingredient any specified food may contain any such permitted food additive of the description for and of an amount appropriate to the quantity of such specified food in accordance with these Regulations.

In terms of labelling, Regulation 5(4)(b) of the Food Regulations requires that all ingredients (including additives) used in prepacked food must be declared in descending order of the proportion by weight in which they are present. Where the food contains ingredients that are made of two or more constituents (i.e. compound ingredients), the constituents, including carried over food additives, of the compound ingredient must be declared accordingly under the statement of ingredients. For processing aids, SFA is agreeable with the recommendations of Codex on the declaration of processing aids in the statement of ingredients, as laid out in the following standards.

• Codex General Standard for Labelling of Food Additives When Sold as Such (CODEX STAN 107-1981) and
• Codex General Standard for the Labelling of Prepackaged Food (CODEX STAN 1-1985)

In the absence of a definition for "processing aids" under the Food Regulations, the current definition for "processing aids" as stipulated in the Codex Procedural Manual may be taken as a reference –

“Processing aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product.”

Your company must be able to justify for the presence of undeclared processing aids in the final food product, as and when necessary.  Please see Labelling Requirements for Food for more information on labelling requirements for prepacked food.

Under Regulation 28(6) of the Food Regulations, triethyl citrate may be used as a whipping agent in the following foods at levels not exceeding 2500ppm:

1. liquid egg products;
2. dried egg products, whether or not heat coagulated;
3. heat coagulated egg products.

 

Permitted anti-caking agents are listed under the Regulation 16(3) of the Food Regulations, and may be used in foods up to a concentration of no more than 2% on a dry basis, unless otherwise prohibited by the individual food standards.

Dimethyl polysiloxane is listed as a permitted anti-foaming agent under Regulation 16A(3) of the Food Regulations. It may be used in those specified food categories under Regulation 16A(3), up to the maximum permitted levels specified therein.

Tocopherols (INS 307), including D-alpha tocopherol (INS 307a), mixed tocopherol concentrate (INS 307b) and DL-alpha tocopherol (INS 307c), are permitted anti-oxidants listed under Regulation 17 of the Food Regulations.

Tea polyphenol is not a permitted antioxidant for use in food.

Prior to 1 February 2019, propionic acid was listed as a permitted Class II chemical preservative under Regulation 19(2)(b)(v) of the Food Regulations and may only be added to specific food products listed in the Fourth Schedule, up to the maximum levels specified therein. With effect from 1 February 2019, propionic acid has been reclassified as a permitted Class I chemical preservative under Regulation 19(2)(a)(iii), and may be used in food under good manufacturing practice, unless otherwise prohibited by individual standards. "Good manufacturing practice means that the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect.

Where two or more permitted Class II chemical preservatives are used in the same product, the sum of their respective percentages must not exceed 100%, as stipulated under Regulation 19(3)(b)(ii) of the Food Regulations.

The percentage use level for each Class II chemical preservative in an admixture may be calculated using the formula below:
 

Amount of permitted Class II chemical preservative added (ppm) / Maximum permitted level of Class II chemical preservative (ppm)] x 100% = Y

Example: An admixture of permitted Class II Chemical Preservatives, (Chemical X + Chemical Y + ….) when added to the same food product must be less than 100%

Y1 + Y2 + Y3 +… ≤100%

There generally three classes of chemical preservatives under the Food Regulations:

Class I chemical preservatives listed under Regulation 19(2)(a) may be added to food under good manufacturing practice, unless otherwise prohibited by individual food standards.

Class II chemical preservatives listed under Regulation 19(2)(b) may only be added to the food categories listed under the Fourth Schedule of the Food Regulations, up to the maximum levels specified therein. Food categories that are not listed under the Fourth Schedule are not allowed to be added with any of the permitted Class II chemical preservatives. A blank under a specified column in the Schedule would mean that the Class II chemical preservative is not permitted for use in the respective food category.

Class III chemical preservatives listed under Regulation 19(2)(c) may only be added to the food categories listed under the Fourth Schedule of the Food Regulations, up to the maximum levels specified therein.

Part II of the Fifth Schedule of the Food Regulations permits the use of “any colouring matter natural to edible fruits and vegetables”, as well as “any colouring matter from flowers, leaves, roots and other plant parts which are customarily used in the preparation of food”.

“Gardenia yellow” (INS 164), which belongs to these categories of colouring matter, may be added to food under good manufacturing practice, unless otherwise prohibited by individual food standards.

“Good manufacturing practice” means that the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect.

Part II of the Fifth Schedule of the Food Regulations permits the use of “any colouring matter natural to edible fruits and vegetables”, as well as “any colouring matter from flowers, leaves, roots and other plant parts which are customarily used in the preparation of food”.

“Gardenia blue” (INS 165), which belongs to these categories of colouring matter, may be added to food under good manufacturing practice, unless otherwise prohibited by individual food standards.

“Good manufacturing practice” means that the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect.

The Food Regulations do not specify the definition for the claim, natural, for colouring matters. The onus is on the food business to ensure that the voluntary claim you intend to make, is truthful and can be substantiated. In general, colouring matters under Part II of the Fifth Schedule may be regarded as 'natural' provided that they are obtained from natural food sources and not chemically synthesised or altered.

Paprika extract (INS 160c(ii)) can be considered as a colouring matter “natural to edible fruits and vegetables”, as well as a colouring matter “from flowers, leaves, roots and other plant parts which are customarily used in the preparation of food” under Part II of the Fifth Schedule of the Food Regulations. It is allowed for use in food under good manufacturing practice, unless otherwise prohibited by individual food standards.

Titanium dioxide (INS 171) is listed as a permitted colouring matter under Part II of the Fifth Schedule of the Food Regulations, and may be used in food under good manufacturing practice, unless otherwise prohibited by individual food standards

The colour obtained from Monascus purpureus (Red Yeast Rice), is a permitted colouring matter for use in food under good manufacturing practice, unless otherwise prohibited by individual standards.

Chlorella or whole extracts of chlorella are permitted food ingredients. SFA would have no objection if the use of chlorella or its whole extracts in food results in it imparting colour to the food.

“Lac colour”, if referring to the colouring matter obtained from the scarlet resinous secretion of the insect Laccifer lacca, is not a permitted food additive under the Food Regulations

The import, manufacture and sale of food containing Lac colour is not permitted under the Food Regulations.

Under Part II of the Fifth Schedule of the Food Regulations, gold, silver and aluminium in leaf or powder form are solely allowed for the external colouring of dragees and the decoration of food.

Permitted emulsifiers / stabilisers, which are listed under the Sixth Schedule of the Food Regulations, may be added to food under good manufacturing practice, unless otherwise prohibited by individual food standards under the Food Regulations. "Good manufacturing practice" means that the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect.

Emulsifiers and stabilisers which are listed under Regulations 21(3) and 21(3A) may only be used in the specific food categories and up to the maximum levels specified therein.

Glyceryl monostearate, also known as Mono- and Diglycerides of Fatty Acids (INS 471), is listed as a permitted emulsifier under the Sixth Schedule of the Food Regulations and may be used in food under good manufacturing practice, unless otherwise prohibited by individual food standards.

Disodium 5-ribonucleotide (INS 635) is a mixture of disodium 5’-guanylate (INS 627) and disodium 5'-inosinate (INS 631). Both INS 627 and INS 631 are permitted flavour enhancers under Regulation 23(2) of the Food Regulations and maybe added to food under good manufacturing practice, unless otherwise prohibited by individual food standards. 

L-theanine is a permitted flavour enhancer under Regulation 23(2)(e) of the Food Regulations, for use only in brewed tea, soft drinks, chocolate, chocolate confectionery, sugar confectionery, at levels up to 1000 ppm.

Paprika oleoresin is regarded as a flavouring substance in Singapore.

As the safety of paprika oleoresin (INS 160c(i), FEMA 2834) has been evaluated by JECFA and FEMA, we would have no objection to its use as a flavouring agent in food, under good manufacturing practice, provided that the flavouring preparation does not contain any of the prohibited substances listed under Regulation 22(7) of the Food Regulations.

Sodium succinate, if referring to disodium succinate (FEMA 3277, FL no. 08.113), has been evaluated and endorsed by recognised international bodies such as the Flavour and Extract Manufacturers Association (FEMA) and the European Food Safety Authority (EFSA) for use as a flavouring substance. We would have no objection to its use as a flavouring agent in food, provided that the flavouring preparation does not contain any of the prohibited substances listed under Regulation 22(7) of the Food Regulations.

L-alanine, if it refers to DL-alanine (FEMA 3818, JECFA 1437, FL No. 17.024), has been evaluated and endorsed by recognised international bodies such as the Flavour and Extract Manufacturers' Association of the United States (FEMA), and the European Food Safety Authority (EFSA) for use as a flavouring agent.

We would have no objection to the use of DL-alanine as a flavouring agent in food as long as the flavouring preparation does not contain prohibited substances stipulated under Regulation 22(7) of the Food Regulations.

Under regulation 22(6) of the Food Regulations, natural flavouring essences or extracts shall be preparations in any permitted solvent or any combination of permitted solvents, with or without sweeteners other than sweetening agents, permitted colouring matter or chemical preservatives, of sapid or odoriferous principles, or both, derived from a plant after which the flavouring extract or essence is named.

Flavouring agents, including both natural flavouring agents and synthetic flavouring essences or extracts are regulated under Regulation 22 of the Food Regulations. Flavouring agents do not include substances that impart a sweet taste to food; such substances would be regulated as sweetening agents under the Food Regulations. 

In general, we would have no objection to the use of flavouring substances that have been evaluated and endorsed by recognised international bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the Flavour and Extract Manufacturers Association (FEMA), or the European Food Safety Authority (EFSA) as a flavouring agent in food, provided that the flavouring preparations do not contain any of the prohibited substances listed under Regulation 22(7) of the Food Regulations.

Companies producing novel food products are required to conduct and submit safety assessments of their products for SFAs review before they are allowed for sale. SFA has published details on our novel food regulatory framework and requirements on safety assessment of novel foods on our website.  

In general, an in-depth literature review of input materials and manufacturing processes is needed in the safety assessment of novel foods to identify the food safety hazards that may be present in the novel food, and the tests needed may vary depending on the nature of the novel food.


SFA does not require novel food applications to be submitted only from companies that are incorporated in Singapore, and we can also review submissions made by companies based outside of Singapore. Overseas novel food companies should note that novel foods that are manufactured outside of Singapore and which have been successfully undergone the review process and allowed for sale in Singapore would be subject to requirements for the import of food into Singapore.

Herbal or botanical ingredients, when added to food products, should not confer any medicinal and/or therapeutic properties to the food. This is because food is generally consumed ad libitum and for nutritional purposes, as opposed to medicines and pharmaceuticals, which are consumed to treat or alleviate a condition of the body.

You may refer use the Chinese medicinal materials (CMM) Search Tool in the SFA website for the list of CMM commonly used in food,

Herbal or botanical ingredients, when added to food products, should not confer any medicinal and/or therapeutic properties to the food. This is because food is generally consumed ad libitum and for nutritional purposes, as opposed to medicines and pharmaceuticals, which are consumed to treat or alleviate a condition of the body. New applications for the use of botanical ingredients in food therefore, may only be considered if the ingredient does not impart any medicinal or therapeutic property to the food product. If this is the case, your company may then proceed with the application by providing us with the following information for each ingredient:

1. Information relating to the identity of the ingredient including

   (i) The full scientific name of the botanical species used
   (ii) The exact part of the named species that will be used.
   (iii) Chemical specifications for the ingredient used, including levels of active components present.

1. Brief description of the manufacturing process of the ingredient.
2. Types of food products intended to be added with the ingredient, and the amount of the ingredient present in per serving of the products.
3. The intended purpose for the addition of the ingredient at the levels present in the product
4. Supporting information on the history of use of the ingredient in food
5. Documentary references indicating that the level of ingredient used will not impart any medicinal or therapeutic properties to food.
6. Documentary proof that the safe use of ingredient in food, has been assessed and approved by food safety authorities in major developed countries such as Australia, Canada, the European Union, New Zealand, Japan, and the United States of America.
7. Documentary proof that the safe use of ingredient in food, has been assessed and approved by food safety authorities in major developed countries such as Australia, Canada, the European Union, New Zealand, Japan, and the United States of America.

Under Regulation 26(4)(c) of the Food Regulations, EDTA, if referring to Calcium disodium ethylenediaminetetraacetate, may be used only in those specified food categories, up to the maximum levels specified therein.