NEW NITRIFYING AGENTS REGULATION: REDUCTION OF NITRATE AND NITRITE USE
For years, the reduction of nitrifying agents (nitrates and nitrites) in the meat industry has been a topic of discussion. Finally, on October 9, 2023, the European Union published Regulation 2023/2108, which came into effect on October 29, 2023, and will require many meat product manufacturers to modify their formulations.
Although companies have a two-year adaptation period (until October 9, 2025), this regulation will bring significant changes to the formulation of numerous meat products in Spain. The permitted levels of nitrites (E-249: potassium nitrite and E-250: sodium nitrite) and nitrates (E-251: sodium nitrate and E-252: potassium nitrate) will be reduced. Additionally, for the first time in the EU, mandatory regulation of residual nitrite levels and indicative nitrate levels has been established.
It is important to note that these new nitrate and nitrite limits will be mandatory starting October 9, 2025. However, meat products marketed before this date can remain on the market until the end of their shelf life.
Below, we will detail the changes in the maximum permitted levels of nitrifying agents and the natural alternatives offered by Amerex Ingredientes.
What Is the Technical Functionality of Nitrites and Nitrates in Meat Products?
To understand this regulation, it is essential to know the technological function of nitrifying agents in meat products, as nitrites and nitrates play a key role in the food safety of meat products.
Their main function is to inhibit the growth of pathogens such as Clostridium botulinum, preventing the development of dangerous toxins. In addition, they contribute to the stability of the colour, aroma and flavour of meat products, thanks to their antioxidant and technological properties. This dual function (preservation and sensory quality) makes them difficult to replace, especially considering the risk of contamination by Clostridium, one of the most dangerous bacteria in the food industry.
As a result, nitrifying agents are widely used in the meat industry.
What New Reference Does the Reform Introduce for Residual Levels of Nitrites and Nitrates?
Initially, the European Commission proposed mandatory residual values for both nitrites and nitrates. However, in the final version of the regulation only nitrites have mandatory residual limits, since nitrates have indicative values only
If indicative nitrate values are exceeded, meat companies must investigate the cause. This could create conflicts with health authorities, as the application of penalties or requirements will depend on the criteria of each regional authority in Spain.
What Are the New Permitted Levels of Nitrates and Nitrites?
Below, we indicate what the new nitrate and nitrite levels will be for the different meat products, in this case, meat companies will be able to choose between two mutually exclusive options for use:
1. General Use of Nitrifying Agents in Meat Products and Certain Meat Preparations
The authorised uses and maximum quantities of nitrites that may be added during processing are as follows:
| NITRITES (E-249 – E-250) | Current Legislation | New Limits (Effective October 9, 2025) |
| 08.2 Meat Preparations (Spain: marinated pork loin, marinated pork skewer, marinated pork jowl, marinated pork rib) | 150 ppm added (NaNO₂) | 120 ppm added / 67 ppm residual (NaNO₂) or 80 ppm added / 45 ppm residual (NO₂) |
| 08.3.1 Unheated Meat Products | 150 ppm added (NaNO₂) | 120 ppm added / 67 ppm residual (NaNO₂) or 80 ppm added / 45 ppm residual (NO₂) |
| 08.3.2 Heat-Treated Meat Products | 150 ppm added (NaNO₂) | 120 ppm added / 67 ppm residual (NaNO₂) or 80 ppm added / 45 ppm residual (NO₂) |
| 08.3.2 Sterilized Meat Products (F◦ > 3.00) | 100 ppm added (NaNO₂) | 80 ppm added / 40 ppm residual (NaNO₂) or 55 ppm added / 25 ppm residual (NO₂) |
| 08.3.4 Traditional Cured Products | 150-180 ppm added / 50-175 ppm residual (NaNO₂) | 150 ppm added / 50-150 ppm residual (NaNO₂) or 105 ppm added / 30-105 ppm residual (NO₂) |
As mentioned above, it should be borne in mind that the residual values are mandatory.
As far as nitrates (E-251 – 252) are concerned, their use is still limited in several categories:
| NITRATES (E-251 – E-252) | Current Legislation | New Limits (Effective October 9, 2025) |
| 08.2 Meat Preparations | NOT AUTHORIZED | NOT AUTHORIZED |
| 08.3.1 Unheated Meat Products | 150 ppm added (NaNO₃) | 120 ppm added / residual (NaNO₃) or 90 ppm added / residual (NO₃) |
| 08.3.1 Unheated Meat Products (Nitrate-Free Sausages & Large Bacon Pieces) | 150 ppm added (NaNO₃) | 150 ppm added / residual (NaNO₃) or 110 ppm added / residual (NO₃) |
| 08.3.2 Heat-Treated Meat Products | NOT AUTHORIZED | NOT AUTHORIZED |
| 08.3.4 Traditional Cured Products | 250-300 ppm added / 10-250 ppm residual (NaNO₃) | 250 ppm added / 10-205 ppm residual (NaNO₃) or 180 ppm added / 7-150 ppm residual (NO₃) |
Residual values for nitrates are only indicative. However, if exceeded, companies must investigate the cause.
2. Use of nitrifiers in traditional meat products (Category 08.3.4):
Derogations exist for traditional cured products (In Category 08.3.4 ‘Traditional cured meat products with specific provisions for nitrites and nitrates’), such as cured ham, cured shoulder, cured loin, cured beef jerky, chorizo and salami. The new regulation allows flexibility with the mention of ‘and other similar products’.
Here are the new limits:
| Category 08.3.4. Traditional and traditionally cured meat products with specific provisions for nitrites and nitrates | NITRITES (E-249 – 250) | |
| CURRENT LEGISLATION | NEW LIMITS (from 9 October 2025) | |
| Cured ham, cured shoulder, cured loin, cured pork loin, jerky and similar products: dry-cured with a stabilisation period of at least 10 days followed by a maturation period of at least 45 days | Maximum Residual Amount 100 ppm (NaNO2) | 100 ppm residual (NaNO2) or 65 ppm residual (NO2) |
| Traditional sausage and chorizo and other similar products (matured for at least 30 days) | Not Authorised | Not Authorised |
| Category 08.3.4. Traditional and traditionally cured meat products with specific provisions for nitrites and nitrates | NITRATES (E-251 – 252) | |
| CURRENT LEGISLATION | NEW LIMITS (from 9 October 2025) | |
| Cured ham, cured shoulder, cured loin, cured pork loin, jerky and similar products: dry-cured with a stabilisation period of at least 10 days followed by a maturation period of at least 45 days | Maximum Residual Amount 250 ppm (NaNO3) | 205 ppm residual (NaNO3) or 150 ppm residual (NO2) |
| Traditional sausage and chorizo and other similar products (matured for at least 30 days) | Maximum Residual Amount 250 ppm (NaNO3) | 250 ppm additions and 130 ppm residual (NaNO3) or 180 ppm additions and 95 ppm residual (NO3) |
Why has it been decided to modify the nitrifiers regulation and reduce their use?
As we mentioned at the beginning of this blog, the need to reduce the use of nitrifiers has been discussed for several reasons.
Firstly, already in 2017 the European Food Safety Agency (EFSA) assessed the safety of nitrates and nitrites in food, concluding that the permitted levels were safe. However, it identified that certain population groups could exceed the Acceptable Daily Intake (ADI) for nitrites. This, coupled with concerns about the formation of nitrosamines, prompted the European Commission to reduce the permitted levels.
European countries such as Denmark already applied stricter limits, which made it difficult to export Spanish meat products to these markets. Pressure from these countries prompted the revision of the regulations, culminating in the publication of Regulation 2023/2108.
In the case of the Spanish meat sector, intensive work has been carried out with the Spanish Agency for Food Safety and Nutrition (AESAN) and the European Commission to achieve a balance between food safety and industrial viability, as the microbiological risk of contamination by Clostridium is not a minor issue and it is essential to ensure consumer safety.
As a result of these negotiations, the limits set in the final regulation were more reasonable and adaptable to the needs of the industry.
Nevertheless, with the entry into force of Regulation 2023/2108, Annex II of Regulation 1333/2008 and the Annex of Regulation 231/2012 have been amended, establishing new limits for nitrifiers in meat products within the EU.
What Nitrite Substitutes Does Amerex Offer?
At Amerex, we are experts in natural preservation and have developed alternative solutions to reduce or replace nitrifying agents.
In our case, our technology is based on the use of starters. Our product Biamex NC, has a very innovative technology for the generation of the typical colour that nitrifiers would provide. In this way, thanks to a fixation reaction of the meat/fish protein itself, you can achieve an optimal replacement of nitrates, nitrites and/or nitro salts. In addition, this product incorporates another of our strains of ferments specialised in the action against sporogens such as clostridium botulinum.
We have several success stories of this product together with other preservatives that can help you to reduce the use of nitrifiers in order to adapt to legislation. We have both preservation and organoleptic technology so that your product is safe and organoleptically optimal for the consumer.
Want to learn more about our solutions to ensure food safety? Contact us and discover how our natural preservatives can help protect your products:
- Email us at: imasd@amerexingredientes.com
- Call us at: 91 845 42 14
- Fill out the form below.
Nuria Lázaro is the R&D and Quality Manager for Amerex’s technical team. She holds a degree in Biology and a master’s degree in Biotechnology. She brings her experience in food preservation and safety, specializing in legislation and the development of new preservatives and antioxidants.
