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Evaluation of safety and authorisation of additives in the EU

12/23/2011
 
Before it is used in a foodstuff, each additive (food additive) must undergo an independent evaluation of its safety. Further, the justification and necessity of using an additive in a foodstuff must be proved. All food additives in the EU must be assessed by the European Food Safety Authority (EFSA) before they are used in a foodstuff. Food additive safety assessment is carried out by the EFSA scientific panel focusing on food additives – Panel on food additives and nutrient sources added to food (ANS). Link to EFSA - ANS webpage here.

Assessing additives safety

First, all available toxicology data are usually assessed and human and animal models are observed. The required toxicology data contain information on metabolism, sub-chronic and chronic toxicity, carcinogenicity, genotoxicity, potential impact on reproduction, etc. Using multigenerational studies and studies focusing on observing food intake during life, the maximum permissible level of additive that does not have a known toxic effect – so called NOAEL (No-Observed-Adverse-Efect Level) is set. Therefore it is a quantity of an additive that will not cause any harm to health in case of long-term administering to test animals (usually rats, rabbits,) in basic ration (in vivo tests). 
In the next step the NOAEL value is divided by a safety factor which is usually 100. Thanks to this factor differences in extrapolation of animal model to human and individual differences in human population in reaction to an additive are taken into consideration. This value is called Acceptable Daily Intake - ADI. ADI value indicates quantity of a food additive that can be consumed every day without representing a risk to consumer´s health. In other words, it is a quantity of an additive that will not cause any harm to health if taken in food for the entire duration of one´s life.  

Comparing daily intakes with ADI values

In general, it is recommended to use the lowest quantity of a food additive and only in the case when this use is justified and has a technological role. To ensure that ADI value is not exceeded even when people will consume products containing a certain food additive in a quantity exceeding average consumption, the EU legislation requires to take studies observing changes and specifics in dietary habits, for example children, vegetarians etc. into consideration. Therefore, ADI values can be compared with estimated average consumption of a certain additive and estimated maximum consumption within entire population and also within certain population groups. If intakes are within ADI, there is no reason for a concern. Also, if daily intake of a certain additive occasionally exceeds ADI, the risk of adverse effects on health is improbable thanks to the safety factor. If the data on intake show that ADI could be exceed more frequently, or even regularly by a certain population group, EFSA may propose to decrease the permitted value of an additive in a foodstuff or it can limit the types of foodstuffs for which an additive is authorised.  
Panel on food additives and nutrient sources added to food (ANS). ANS scientific panel evaluates the risk of additives used in food production, it issues statements and provides professional consultations to risk managers. ANS panel bases its risk evaluation on scientific knowledge, in particular materials provided by applicants for authorisation of additives. Most of the tasks of the ANS scientific panel are related to authorising additives, however, the panel´s activity includes also revision of all available, relevant scientific studies and data related to toxicity of additives and exposure of population to additives. The EFSA panel also evaluates safety of additives on the basis of ad-hoc requirements of the European Commission if there are doubts concerning the safety of a certain authorised additive, for example in relation to new scientific information and studies.   
EFSA panel is also responsible for reevaluation of safety of additives authorised by the EU for use before 20 January 2009.
Statements of EFSA on safety of individual additives are available on EFSA website in the "Register of Questions database
Panel members are appointed by the Management Board of the European Food Safety Authority based on results of a selection procedure. In order to ensure independent activity of the panel, the members present to the panel the Declaration of Interest. The list of ASN panel members is available on EFSA web pages: http://www.efsa.europa.eu/en/ans/ansmembers.htm
Note:
ASN scientific panel followed up the activity of the Scientific Committee on Food attached to the European Commission that was established as an advisory body of the European Commission within assessing nutritional, hygienic and toxicological properties of chemical substances and their effects on health.  

Program for reevaluation of authorised food additives

The European Commission set in accordance with the Regulation (EC) No. 1333/2008 on food additives a program for reevaluating safety of additives, within which the European Food Safety Authority (EFSA) shall reevaluate safety of food additives authorised by the Union before 20 January 2009.
Specific time frame for reevaluating safety of food additives is regulated in the Regulation (EU) No. 257/2010, setting up a program for reevaluating authorised food additives in accordance with the European Parliament and Council Regulation (EC) No. 1333/2008 on food additives. The reevaluation of the safety of all additives should be performed until the end of 2020.
The order of priorities for reevaluating currently authorised food additives was set based on the following criteria: time period between the last evaluation of a food additive performed by the SCF committee or EFSA, new scientific discoveries that are available, degree of using food additive in foodstuffs and exposure of human to food additives and also taking the result of the Commission´s report on intake of food additives in the European Union from 2001 into account.    
More detailed information on time schedule for reevaluation of safety of individual additives is available on the web pages of the European Food Safety Authority: http://www.efsa.europa.eu/en/topics/topic/additives.htm

Authorisation of additives

The procedure for authorising additives is regulated by the Regulation (EC) No. 1331/2008 setting up a single procedure for assessing and authorising food additives, food enzymes and food flavorings.
The single authorisation procedure may include:
  • adding a substance to the Community List;
  • removing a substance from the Community List;
  • adding, removing or changing the conditions, specifications or restrictions related to adding a substance to the Community List.

Authorisation procedure is initiated upon request of the European Commission, a Member State or a stakeholder.
The Applicant sends application for update of the list of authorised additives directly to the European Commission.
In case of application for authorisation of a new additive the European Commission asks the European Food Safety Authority (EFSA) for evaluation of safety of the additive. In the period of 9 months the EFSA shall issue a statement on the safety of the additive on the basis of which EC jointly with national experts from individual Member States shall consider authorisation of the additive. Other factors are also taken into consideration: technological need of using the additive, potential risk of misleading a consumer in consequence of using the additive, advantages and benefits of using the additive for a consumer.  
Subsequently, the Standing Committee on the Food Chain Animal Health votes on authorisation of the new additive.
In case of a positive statement the proposal is presented to the Council and European Parliament which may refuse it if they come to the conclusion that adding the new additive is in violation of the rules set by applicable legal regulations of the EU. 
More detailed information on the process of authorising additives and instructions and guidelines for applicants applying for addition of an additive to the list of authorised substances is provided on the web pages of the EC Directorate General for Health and Food Safety (DG SANTE):
http://ec.europa.eu/food/food/fAEF/authorisation_application_en.htm
The list of authorised additives is given by the Decree No. 4/2008 Coll., of the Ministry of Health of the Czech Republic laying down the types and conditions of using additives and extraction solvents in foodstuff production and in Annexes II and III to the Regulation (EC) No. 1333/2008 on food additives. More detailed information on authorised additives can be found in the Article “Additives authorised for production of foodstuffs”.
Links to web pages focusing on the issues of food additives

Article by:
Pavla Kundríková and Kateřina Pavelková – Control, Laboratories and Certification Department (CAFIA Headquarters)