Nitrates (NO3) and nitrites (NO2) are chemicals that can be found naturally in our food and water. In nature, nitrates are readily converted to nitrites and vice versa. Nitrates and nitrites are currently authorised as food additives within the EU. These additives function as preservatives in food and they are both used extensively to enhance the colour and extend the shelf life of processed meats. Nitrite is considered the active curing ingredient responsible for the preservation of the food in combination with other ingredients, like salt. Nitrate, when added to food, converts to nitrite before exerting a preservative function.
Nitrite prevents the growth of a harmful bacterium called Clostridium botulinum and it may also have preservation effects on other harmful and spoilage bacteria. In addition, nitrite develops cured meat flavour and colour and retards the development of rancidity and off-odours and off-flavours during storage of cured meats. Nitrite is responsible for the characteristic pink colour of cured meats.
The use of nitrates and nitrites in food products must comply with the provisions set out in Annex II part E of Regulation (EC) No. 1333/2008 on food additives which is in force since 1 June 2013. This Regulation is transposed into Irish legislation by S.I. No. 330 of 2015. The maximum levels at which nitrates and nitrites may be used, and also the specific foodstuffs in which they may be used as well as their conditions of use are also established by Regulation (EC) No. 1333/2008 as amended. These levels are set at values which ensure that a person consuming a typical diet would not exceed the Acceptable Daily Intake (ADI) established for these additives. Purity criteria have also been established for nitrates and nitrites via Regulation (EC) No. 231/2012 as amended.
Two main nitrite and nitrate salt forms are allowed. These are sodium and potassium nitrite and sodium and potassium nitrate. These substances have been attributed E numbers (E 250, E 249, E 251 and E 252 respectively). In accordance with EU legislation, nitrates and nitrites are permitted for use in foods such as cheese, raw and processed meats(1), and processed fish and may only be sold in a mixture with salt or a salt substitute when labelled for food use. This is designed to limit the amount of nitrite that can be added and to prevent accidental poisoning through the addition of excessive quantities of nitrite to food.
For further Information see our FAQ on nitrites and nitrates.
(1) Nitrates are not permitted to be added directly to heat-treated meat products however, they may be present in some heat-treated meat products resulting from natural conversion of nitrites to nitrates in a low-acid environment.
Foodstuffs containing nitrites/nitrates must comply with both the labelling provisions for food as laid down in Regulation (EU) No. 1169/2011 as amended and with the more specific labelling requirements for food additives as laid down in chapter IV of Regulation (EC) No. 1333/2008 on food additives. Regulation (EU) No. 1169/2011 requires the labelling of additives in the list of ingredients on pre-packaged foodstuffs by:
- the functional class of the additive, and
- the specific name or designated E number
Therefore, for sodium/potassium nitrite, the following should appear on the label:
- Preservative: Sodium nitrite, Potassium nitrite, or
- Preservative: E250, E249
The same rules apply to the use of sodium or potassium nitrate in foods (E 251 and E 252 respectively).
If you are thinking of removing nitrite/nitrate from your meat product, then you have a responsibility to ensure that the reformulated meat product is safe during its whole shelf life under reasonable conditions of consumer misuse. You must also ensure that the new product is in compliance with the laws governing additive usage and the laws governing food labelling. Overall, your label must not mislead the consumer to the extent that they buy your product in preference to similar products. Finally, you must be able to provide all necessary evidence demanded by the competent authorities who are charged with ensuring compliance with the food law.
Can I use ingredients that are also sources of nitrite/nitrate to replace sodium or potassium nitrite/nitrate?
You cannot use ingredients that are also a source of nitrite/nitrate if used for the intended technological purpose of preservation or colouring in the final food. Such use would be considered a deliberate use of a food additive.
The use of nitrates and nitrites must comply with the food additives legislation, including the conditions of use laid down in Annex II part E to Regulation (EC) No. 1333/2008 as amended as well as the purity criteria in the Annex to Regulation (EC) No. 231/2012. The use of ingredients that are also sources of nitrite/nitrate, such as vegetable extracts or fermented vegetable broths, has been discussed on a number of occasions at the Commission working party on food additives and also at the EU Standing Committee on the Food Chain and Animal Health. On these occasions it was agreed by the Commission and all Member States, that such a practice would be a deliberate use of a food additive if used for the intended technological purpose of preservation or colouring in the final food.
Nitrites added to food for preservation or colouring purposes, via other ingredients like vegetable extracts/fermented broths would not currently be permitted by Regulation (EU) No. 1333/2008 as these extracts have not been approved as preservatives and their use would also not comply with the current purity criteria laid down in Regulation (EC) No. 231/2012.
In September 2018, a further opinion was issued on use of vegetable extracts rich in constituents capable of performing a technological function. This opionion:
- reconfirmed the validity of the previous 2006 and 2010 statements
- stated that the scope of both statements is not limited only to (fermented/non-fermented) extracts containing high levels of nitrate/ nitrite but it shall be generally applicable to all plant extracts which, when added to foods, achieve a level of constituents (or their precursors) capable of performing a technological function in foods
- stated that such use of extracts that deliver a technological function (e.g. preservative, antioxidant, stabiliser (colour stabiliser) etc.) in foods to which they are added is deemed a deliberate use as a food additive
Consequently, such use is deemed to meet the definition of a food additive and so it must comply with the conditions set out in the food additive legislation (including relevant specifications) and be labelled in accordance with the appropriate provisions for labelling of food additives.
In addition, a number of plant extracts can perform both flavouring and additive functions. When flavourings have a technological function as food additives, the food additive legislation shall apply. In this case the extracts cannot be claimed to be used as flavourings.
What are the restrictions on the use of the word ‘natural’ on the food label of a meat product where nitrite has been removed?
The word “natural” is often used as a marketing term by food businesses and is currently not defined in legislation governing foodstuffs. However, general food legislation places on obligation on food businesses to ensure that the labelling, advertising and presentation of food, and the information made available about it through whatever medium, should not mislead consumers.
More specifically, the legislation requires that the labelling and methods used must not be such as could mislead the consumer to a material degree by suggesting that the foodstuff possesses special characteristics when in fact all similar foodstuffs possess such characteristics. A food business operator must be able to substantiate any claim made by them in relation to their product.
Therefore, in order not to mislead the consumer and thereby breach the labelling legislation the use of the word ‘natural’ would have to be in keeping with a general understanding of the meaning of that word in the context of food by the majority of consumers and cannot be used to imply that the food is different if all similar foods possess the same characteristics.
The FSAI has produced a guidance document for the use of food marketing terms including the term ‘natural’.
Legislation on flavourings sets out the requirements for use of the word ‘natural’ in relation to flavourings used in foodstuffs. For general ingredients, there is no definition of the word natural as discussed above. However, the labelling of foods requires that the labelling and methods used must not be such as could mislead the consumer to a material degree by suggesting that the foodstuff possesses special characteristics when in fact all similar foodstuffs possess such characteristics. Where ingredients do not possess special characteristics when compared with similar ingredients in other foodstuffs, then the word “natural” should not be used except where it is specifically permitted by legislation, e.g. ‘natural flavouring’. Further information on the use of the term ‘natural’ can also be found in the FSAI's guidance document on food marketing terms.
Safety cannot be taken for granted unless a full validation of the new preservation system in the food is carried out. Nitrate has been traditionally used to prevent meat products from causing botulism caused by the harmful bacterium, Cl. botulinum. The removal of nitrite can be likened to the removal of a hurdle to the growth of Cl. botulinum. To maintain the safety of the food, another similar hurdle must be used to replace nitrite or otherwise the ‘height’ of the remaining hurdles has to be increased to prevent Cl. botulinum from growing. For example, to reinstate the safety of the food you may have to reduce the shelf life and/or increase the salt level (and therefore increase the water activity: Aw) and/or decrease the pH and/or add a different preservative. In effect, you will have to reformulate the product, validate the shelf life and readjust the HACCP system to ensure the food can be manufactured safely on a consistent basis.
A useful document was produced by CCFRA in 2009 called “The manufacture of vacuum and modified atmosphere packaged chilled foods: a code of practice. 2nd edition”, which provides good guidance to manufacturers.
Clostridium botulinum is a bacterium that exists in soils and is found throughout the environment. It produces spores which have great resistance to heat and chemical disinfectants. Cl. botulinum can be found in many raw foods including meat and is capable of producing a potent neurotoxin (poison that affects the functioning of brain and nerves) as it grows. The neurotoxin can kill at very low levels if victims are unable to seek immediate treatment. This condition is known as botulism.
For the purposes of this FAQ, there are two main forms of Cl. botulinum called Type I and Type II. Type I Cl. botulinum spores are the most heat resistant but cannot grow below 10º C. Type II Cl. botulinum spores are less heat resistant than Type I spores but can grow at temperatures as low as 3º C. Both types of Cl.botulinum do not thrive in the presence of air and are therefore considered strict anaerobes.
Nitrite, in combination with salt and pH, is used in cured meats to ensure their safety with respect to a number of pathogens including Cl. botulinum. To cause illness, spores of Cl. botulinum have to be able to germinate and then grow in the meat product until a point at which botulinum toxin is produced by the bacteria. Nitrite exerts a concentration-dependent antimicrobial effect in meat products, including inhibition of the outgrowth of spores of Cl. botulinum. The antimicrobial effect is also pH-dependent, increasing ten-fold for each unit fall in pH. In its review of nitrite, the EFSA Biohazard Panel in 2003 concluded that between 50-150 mg/kg nitrite is necessary to inhibit the growth of Cl. botulinum. The panel concluded that the ingoing amount of nitrite into the product was the important preservation factor.
What must I do to satisfy the competent authorities that my product is safe and labelled correctly, if I remove the sodium or potassium nitrite/nitrate from my meat product and replace it with an alternative ingredient that is also a source of nitrite/nitrate?
The competent authorities are the government bodies charged with ensuring compliance with the food law. Where sodium or potassium nitrite/nitrate has been removed from the meat product and replaced by an alternative ingredient that is also a source of nitrate/nitrite, the competent authority will require the food business operator to prove that the alternative ingredient is not having a preservative effect in the final product. The competent authority may request inter alia:
- (a) Full analytical results showing the levels of nitrate/nitrite in the meat product at the start and end of shelf life and the variability in those levels over several batches
- (b) Demonstrable evidence that the alternative ingredient is not providing a preservative effect and is not being added for the purposes of colouring the final meat product
- If (b) above is demonstrated to the satisfaction of the competent authorities, the food business operator (FBO) will also be required to provide at least the following information to verify that the reformulated meat product is still safe and can be produced safely on a consistent basis:
- (c) A full documented hazard analysis showing the major chemical, biological and physical hazards relevant to the product. If sodium or potassium nitrite/nitrate is removed from a meat product, then Cl. botulinum must be one of the hazards considered
- (d) A full documented validation study to support the safety of the product throughout the applied shelf-life, taking into account all the hazards including Cl. botulinum and any anticipated levels of consumer abuse, like storage of chilled meats in domestic refrigerators at temperatures above 5º C.
The FSAI's Guidance Note 18 - Validation of Product Self-life (Revision 2), page 27, Section 22.214.171.124, has further information on establishing the study conditions.
- (e) Identification of Critical Control Points at the production steps critical to ensuring the safety of the food, establishment of suitable critical limits based on the validation data used for shelf life determination and application of appropriate corrective actions to ensure food safety should the critical limits be exceeded
- (f) Full monitoring data to verify the functioning of the HACCP system
- (g) Documentation relating to the HACCP system.