Written by Aaron Gupta
The Managing Director of Kanegrade, Aaron has over a decade of experience in Flavours, Natural Colours and Fruit Powders as well as other ingredients. Passionate about technical, regulatory and quality matters, as well as delivering great taste experiences with consumer products.
‘Flavouring preparations’ are ingredients commonly used in flavourings, made from natural raw materials; they are complex mixtures of naturally present substances.
For example, cinnamon oil is a flavouring preparation containing a mixture of substances which contribute to its recognisable flavour such as cinnamaldehyde, eugenol and linalool to name just a few.
How can this lovely tasting (and natural) ingredient possibly be harmful?
Too much of a good thing?
Flavouring preparations are designed to be consumed in small doses and are therefore much more highly concentrated than the foods they are derived from.
It is often assumed anything natural and plant derived is safe and healthy; but unfortunately you can have too much of a good thing.
Anyone who has attempted the early 2000’s ‘Cinnamon Challenge’ will know that it’s called a challenge for a reason. Thankfully, it takes a bit of effort to consume such high amounts of cinnamon, which is good as it’s not advisable.
Tolerable Daily Intake (TDI)
Cinnamon contains a naturally occurring chemical compound called ‘coumarin’, which in sensitive persons can cause liver damage.
The European Food Safety Authority (EFSA) established a Tolerable Daily Intake (TDI) of 0.1 mg of coumarin per kg of body weight.
It is not permitted to add this compound as an isolated substance to foods; however, it may be found in natural flavourings when coumarin-containing plant materials are used.
Regulation of Restricted Substances
Because of the highly concentrated nature of flavourings, it is necessary to regulate the levels of certain substances known as restricted substances (such as coumarin) in foods overall.
Maximum levels of certain substances are stipulated in the European Flavouring Regulations (EC Regulation 1334/2008) based on safety assessments by the European Food Safety Authority (EFSA).
11 Restricted Substances
There are 11 substances listed in Part B of Annex III with restrictions based on their end use. Legal restrictions apply to the particular food for example ‘dairy products’, ‘soups and sauces’, ‘chewing gum’ etc.
In most circumstances, these substances are found in such low levels that they do not limit the use of the flavouring; however, where restricted substances are present in flavourings (even at low levels), reputable flavour houses including Kanegrade will provide information regarding the level of restricted substances on product specifications.
Regardless of whether the restricted substance limits the dose of the flavouring, the information is necessary for the manufacturer to carry out their legal assessments for the overall finished product, since they may include other sources of the restricted substance.
Examples of Restricted Substances
Here are just a few examples of restricted substances and their well-known sources:
- Coumarin is naturally found in cinnamon.
- Pulegone is naturally found in peppermint.
- Safrole is naturally found in anise, nutmeg and black pepper.
- Thujone is naturally found in oregano and sage.
In conclusion, restricted substances can be naturally present in flavourings.
When using flavourings, it’s important to be aware of the maximum level (ML) for the compound food you are putting the flavouring in.
The restricted substances can limit the flavouring dose, but typically there are other factors limiting the dose such as the flavour strength or the additives which are used as carriers.
Checking restricted substances is just one aspect of ensuring the overall finished product is safe and legal based on the end use.
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EU Law on Restricted Substances
REGULATION (EC) No 1334/2008 Annex III Part B:
Maximum levels of certain substances, naturally present in flavourings and food ingredients with flavouring properties, in certain compound food as consumed to which flavourings and/or food ingredients with flavouring properties have been added
| Name of the substance | Compound food in which the presence of the substance is restricted | Maximum level mg/kg |
| Beta-asarone | Alcoholic beverages | 1,0 |
| 1-Allyl-4-methoxybenzene, Estragol (*1) | Dairy products | 50 |
| Processed fruits, vegetables (incl. mushrooms, fungi, roots, tubers, pulses and legumes), nuts and seeds | 50 | |
| Fish products | 50 | |
| Non-alcoholic beverages | 10 | |
| Hydrocyanic acid | Nougat, marzipan or its substitutes or similar products | 50 |
| Canned stone fruits | 5 | |
| Alcoholic beverages | 35 | |
| Menthofuran | Mint/peppermint containing confectionery, except micro breath freshening confectionery | 500 |
| Micro breath freshening confectionery | 3 000 | |
| Chewing gum | 1 000 | |
| Mint/peppermint containing alcoholic beverages | 200 | |
| 4-Allyl-1,2-dimethoxy-benzene, Methyleugenol (*1) | Dairy products | 20 |
| Meat preparations and meat products, including poultry and game | 15 | |
| Fish preparations and fish products | 10 | |
| Soups and sauces | 60 | |
| Ready-to-eat savouries | 20 | |
| Non-alcoholic beverages | 1 | |
| Pulegone | Mint/peppermint containing confectionery, except micro breath freshening confectionery | 250 |
| Micro breath freshening confectionery | 2 000 | |
| Chewing gum | 350 | |
| Mint/peppermint containing non-alcoholic beverages | 20 | |
| Mint/peppermint containing alcoholic beverages | 100 | |
| Quassin | Non-alcoholic beverages | 0,5 |
| Bakery wares | 1 | |
| Alcoholic beverages | 1,5 | |
| 1-Allyl-3,4-methylene dioxy benzene, safrole (*1) | Meat preparations and meat products, including poultry and game | 15 |
| Fish preparations and fish products | 15 | |
| Soups and sauces | 25 | |
| Non-alcoholic beverages | 1 | |
| Teucrin A | Bitter-tasting spirit drinks or bitter (1) | 5 |
| Liqueurs (2) with a bitter taste | 5 | |
| Other alcoholic beverages | 2 | |
| Thujone (alpha and beta) | Alcoholic beverages, except those produced from Artemisia species | 10 |
| Alcoholic beverages produced from Artemisia species | 35 | |
| Non-alcoholic beverages produced from Artemisia species | 0,5 | |
| Coumarin | Traditional and/or seasonal bakery ware containing a reference to cinnamon in the labelling | 50 |
| Breakfast cereals including muesli | 20 | |
| Fine bakery ware, with the exception of traditional and/or seasonal bakery ware containing a reference to cinnamon in the labelling | 15 | |
| Desserts | 5 | |
| (*1) The maximum levels shall not apply where a compound food contains no added flavourings and the only food ingredients with flavouring properties which have been added are fresh, dried or frozen herbs and spices. After consultation with the Member States and the Authority, based on data made available by the Member States and on the newest scientific information, and taking into account the use of herbs and spices and natural flavouring preparations, the Commission, if appropriate, proposes amendments to this derogation. (1) As defined in Annex II, paragraph 30 of Regulation (EC) No 110/2008. (2) As defined in Annex II, paragraph 32 of Regulation (EC) No 110/2008. | ||
