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Food: new legislation to make the use of additives in the EU safer and more transparent

The use of additives1 in food will soon become even safer and more transparent than it currently is thanks to two pieces of legislation adopted by the European Commission.

"Today represents a landmark in our efforts to strengthen food safety in the European Union," Health and Consumer Policy Commissioner, John Dalli, said. "The adoption of two regulations on additives will further empower citizens and industry alike as they will make it easier for everyone concerned to know exactly what additives are allowed in foodstuffs," he added. "In a nutshell, this means a better informed citizen and, at the same, an EU Food Industry properly equipped to come up with new innovative and safe products," Commissioner Dalli concluded.

The two regulations establish two new lists.

The first concerns additives in foodstuff and it will come into application in June 2013 (this grace period for the application was deemed necessary to allow the Union's food industry to adapt to the new rules). This list, which is also available in a database online (, will allow consumers, food business operators and control authorities to easily identify which additives are authorised in a particular foodstuff.

The second list regards additives in food ingredients, such as other additives, enzymes, flavourings and nutrients and it will apply 20 days after its publication in the EU's Official Journal.

The establishment of the two lists is an important step in the implementation of framework Regulation (EC) No 1333/2008 on food additives adopted in December 2008.


Transparency is one major benefit of the new legislation. The authorised uses of additives are from now on listed according to the category of food to which they may be added. The Commission considers this an important improvement compared to the old lists that were dispersed over several annexes in three different directives.

The new list makes it obvious, for instance, that in some food categories the authorised additives are very limited or even not allowed at all. This is the case, for instance, for unflavoured yoghurt, butter, compote, pasta, simple bread, honey, water and fruit juice.

In other categories, usually those concerning highly processed foodstuffs – such as, for example, confectionary, snacks, sauces and flavoured drinks – a large number of additives are authorised.

Moreover, the list of additives that may be added to other additives, enzymes, flavourings and nutrients will further ensure that exposure to additives through these ingredients remains limited.

What else changes by the new legislative provisions

Apart from the establishment of the two lists, the new legislation also provides for:

  • well determined conditions under which additives may be added to food

  • a food categorisation with the additives listed in a clear way according to the categories of food to which they may be added

  • a programme for the full re-evaluation of the safety of all authorised additives

  • clear guidelines and instructions for the applicants requesting new uses of food additives

General background on additives

The general conditions for the use of food additives were set by the European Parliament and the Council in the 2008 framework regulation and remain in force. This regulation establishes general framework, principles and objectives to which all specific legislation on additives refers. It requires that the use of additives is safe, technologically justified, does not mislead the consumer and has advantages and benefits for the consumer.

Re-evaluation of additives

In March 2010, the Commission adopted a programme for the re-evaluation of all authorised food additives. The European Food Safety Authority (EFSA) must re-evaluate all additives by 2020. Re-evaluation is prioritised on the basis of when a food additive was last evaluated, the availability of new scientific information, the extent of use of a food additive and the human exposure to it.

Food colours are first on the priority list. Seventeen colours have already been re-evaluated. For three of them, the Commission has already proposed revised use levels since EFSA estimates that exposure to those additives can be potentially too high for certain groups of consumers.

Due to new scientific information higher priority has been given to the sweetener aspartame, which will be re-evaluated by September 2012.

Guidelines and instructions

In March 2011, the Commission adopted a measure specifying the data necessary to authorise a new use for an additive. These include toxicological data for the risk assessment and information demonstrating that the use of the additive is technologically justified, may have benefits for the consumer and will not be misleading.

In order to help future applicants, the Commission has prepared a practical guide, which is available on the internet ( This will allow applicants to introduce complete dossiers that can be efficiently handled. The Commission is convinced that this can stimulate responsible innovation by the Food Industry.

An example of such an innovative product is the natural sweetener, steviol glycosides, which are derived from the Stevia ribaudiana plant. The Commission also adopted today a regulation authorising its use in several food categories.

EFSA was requested to assess the safety of the substance. It concluded that the sweeteners are not carcinogenic, genotoxic or associated with any reproductive/developmental toxicity, and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight/day. Conservative estimates of steviol glycosides exposure, both in adults and in children, suggest that it is likely that the ADI would be exceeded at the maximum proposed use levels.

In order to ensure that the exposure is safe for the consumer, the requested uses and use levels had to be revised. The regulation adopted today mirrors the outcome of this process.

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Contacts :

Frédéric Vincent (+32 2 298 71 66)

Aikaterini Apostola (+32 2 298 76 24)

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