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Additives authorised for production of foodstuffs

07/18/2017
 

As regards production of foodstuffs, it is possible to use only the additives authorised by a procedure in accordance with the Regulation (EC) No. 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings and which are given in the lists of food additives of the European Union in Annex II and Annex III to the Regulation (EC) No. 1333/2008 on food additives.  

The following information is provided in the registration of food additives in the European Union lists in Annexes II and III:
a) name of the food additive and relevant E identification
b) foodstuffs that may include the food additive
c) conditions under which the food additive in question may be used
d) eventual restrictions of direct sale of the food additive to end consumers.  
The Union lists of food additives authorised for the use in foodstuffs and conditions of use were approved  
Food additives database available on the European Commission website – DG SANTE (Directorate General for Health and Food Safety) can be used for searching authorised food additives, information on conditions of use and information.
The above mentioned database allows searching for additives authorised by legal regulations for the given category of foodstuffs.

Transitional measures:

The Union list of food additives authorised for use in foodstuffs and conditions for use – Annex II to the Regulation (EC) No. 1333/2008:  

Annex II to the Regulation (EC) No. 1333/2008 as amended by the Regulation (EU) No. 1129/2011 shall be used from 1 June 2013 except for the use of the below given additives:
  • basic methyl methacrylate copolymer (E 1205), authorised for use by the Regulation (EU) No. 1129/2011 on the surface of food supplements as of entry into force of the Regulation (i.e. from 2 December 2011)
  • silica (E 551) maximum amount of which was increased in salt substitutes pursuant to the Regulation (EU) No. 1129/2001, as of entry into force of this Regulation (i.e. from 2 December 2011).
Foodstuffs that are placed on the market before 1 July 2013 in accordance with current legal regulations (i.e. the Decree No. 4/2008 Coll., stipulating types and conditions of using additives and extraction solvents in foodstuffs production) but are not in accordance with the Regulation (EU) No. 1129/2011 may be still placed on the market until the end of minimum durability period or expiry date.

The Union List of Food Additives, including carriers, authorised for use in food additives, food enzymes and food flavorings and nutrients – Annex III to the Regulation (EC) No. 1333/2008:

Regulation (EU) No. 1130/2011 amended the Annex III to the Regulation (EC) No. 1333/2008 on food additives.
Regulation (EU) No. 1130/2011 shall be applied from 2 December 2011.
Annex III is divided into 5 parts, different transitional measures are applied for individual parts of the Annex:
Part 2 – food additives other than carriers authorised in food additives
Part 3 – food additives including carriers authorised in enzymes
Part 5, section A – food additives authorised in nutrients, except for nutrients designed for use in foodstuffs for infants and small children
Preparations that are not in accordance with parts 2 and 3 and/or section A of the part 5 of Annex III but are in accordance with the Decree No. 4/2008 Coll., may be placed on the market for the period of 24 months following entry into force of the Regulation (EU) No. 1130/2011 (i.e. from 2 December 2011). Foodstuffs containing such preparations that are placed on the market in accordance with the Decree No. 4/2008 Coll., during the above mentioned period, may be sold until all stocks are used up.
Part 1 – carriers authorised in food additives
Part 4 – food additives including carriers authorised in food flavorings
Preparations that are not in accordance with parts 1 and 4 of Annex III but are in accordance with the Decree No. 4/2008 Coll., may be placed on the market until 31 May 2013. Foodstuffs containing such preparations that are placed on the market in accordance with the Decree No. 4/2008 Coll., during the above mentioned period, may be sold until all stocks are used up.

Until the transitional measures given in the Regulation (EU) No. 1129/2011 and the Regulation (EU) No. 1130/2011 are in effect, relevant provisions of the Directives implemented in the Decree No. 4/2008 Coll. shall be applied:

  • Article 2(1), (2) and (4) of the Directive 94/35/EC and Annex;
  • Article 2(1) - (6), (8), (9) and (10) of the Directive 94/36/EC and Annexes I - V
  • Article 2 and 4 of the Directive 95/2/EC and Annexes I - VI.

Authorising steviol glycosides (E 960)

The use of new additive – steviol glycoside (E 960) as sweeteners is authorised by the Regulation (EU) No. 1131/2011 amending Annex II to the European Parliament and Council Regulation (EC) No. 1333/2008, regarding steviol glycosides. The use of E 960 additive is authorised as of entry into force of the Regulation (EU) No. 1131/2011 (i.e. from 2 December 2011) – in total in 31 different foodstuff categories (for example non-alcoholic beverages, desserts, confectionery and table sweeteners.
The Regulation (EU) No. 1131/2011 can be found under the following link.

Comment:
Specific requirements on the E 960 sweetener are stipulated in the Commission Regulation (EU) No. 231/2012 of 9 March 2012 stipulating the specifications for food additives given in Annexes II and III to the European Parliament and Council Regulation (EC) No. 1333/2008.

Current information on changes in legislation requirements

Tightening of limits for Quinoline Yellow, Sunset Yellow FCF and Cochineal Red

On 17 March 2012 the Commission Regulation (EU) No. 232/2012 of 16 March 2012 (The Commission Regulation (EU) No. 232/2012 can be found here), amending the Annex II to the European Parliament and Council Regulation (EC) No. 1333/2008, regarding the conditions of use and level of use of Quinoline Yellow (E 104), Sunset Yellow FCF (Gelborange S) (E 110) and Ponceau 4R, Cochineal Red A (E 124) tightening the limit values for the below given coloring agents, was published in the Official Journal of the EU.
  • Quinoline Yellow (E 104)
  • Sunset Yellow FCF (Gelborange S) (E 110)
  • Ponceau 4R, Cochineal Red A (E 124)*
These are three of six coloring agents in which the Regulation (EC) No. 1333/2008 stipulates as a precaution in connection to the so-called “Southampton study” the obligation to state notification of the possibility of adverse effect on activity and attention of children.  
Decrease of limit values for the aforementioned coloring agents should guarantee that newly decreased ADI (acceptable daily intake) values set by the European Food Safety Authority (EFSA) are not exceeded even in the case of consumers with high consumption of the relevant products, in particular children.  
New limits on the content of the aforementioned coloring agents in certain foodstuffs shall come into force from 1 June 2013, however, foodstuffs produced in accordance with the existing requirements of legal regulations that are placed on the market before this date may be sold until all stocks are used up. 

Update of specifications for food additives

On 22 March 2012 the Commission Regulation (EU) No. 231/2012 of 9 March 2012 laying down specifications for food additives given in Annexes II and III to the European Parliament and Council Regulation (EC) No. 1333/2008 was published in the Official Journal of EU. The text of the Commission Regulation (EU) No. 231/2012 can be found here.
The aforementioned Regulation updates the specifications for food additives that are currently stipulated by the Ministry of Health of the Czech Republic Decree No. 235/2010 Coll., on requirements on purity and identification of additives.   
  • The new Regulation acknowledges specifications and analytical techniques that are stipulated in the Codex Alimentarius prepared by the joint committee of experts of FAO/WHO for food additives (hereinafter JECFA). 
  • The specifications do not include organoleptic tests related to taste of additives.
  • The sum parameter “heavy metals” is replaced by parameters related to individual heavy metals related to toxicity.
  • The current provision on polycyclic aromatic hydrocarbons are too general and not related to safety and for this reason they were replaced by maximum limits for individual polycyclic aromatic hydrocarbons relevant for food additives E 153 vegetable carbon and E 905 microcrystalline wax.  
  • Maximum limits for formaldehyde in Carrageenan (E 407) and Eucheuma gum / processed euchema seaweed (E 407a), in specific microbiological criteria for agar (E 406) and for the content of Salmonella spp. in mannitol produced by fermentation (E 421 II.) were set.  
  • Maximum limits for aluminum in food additives were set for relevant cases.
  • In accordance with the Commission Regulation (EU) No. 258/2010 of 25 March 2010 imposing special conditions for importing guar gum originating from or sent from India due to risks of contamination by pentachlorophenol and dioxins (4), maximum limits for contaminating component pentachlorophenol in guar gum (E 412) were set.    
  • In order to avoid contamination of final foodstuffs exceeding permissible quantity, maximum limits for 3-MCPD in food additive glycerol (E 422) were set. 
The Regulation (EC) No. 231/2012 repeals with effect as of 1 December 2012 the existing directives containing current purity criteria for additives:
  • 2008/60/EC
  • 2008/84/EC
  • 2008/128/EC
The Regulation enters into force on 1 December 2012 except for requirements on additives steviol glycoside (E 960) and methacrylate copolymer (E 1205), in force from 11 April when the Regulation becomes valid. Foodstuffs containing food additives that were in accordance with legal requirements before 1 December 2012 may be sold until all stocks are used up.  

Limitations on food additives with aluminum

On 4 May 2012 the Commission Regulation (EU) No. 380/2012 of 3 May 2012 amending Annex II to the European Parliament and Council Regulation (EC) No. 1333/2008, concerning the conditions of use and used quantities of food additives containing aluminum, was published in the Official Journal of E. Commission Regulation (EU) No. 380/2012 can be found here.
Tightening up the rules for using additives containing aluminum is based on the opinion of the European Food Safety Authority (EFSA) which recommended to lower the tolerable daily intake of aluminum. EFSA also thinks that revised tolerable daily intake is in the case of above-average consumers, in particular children, generally exceeded in a significant part of the European Union.
EFSA is the opinion that the main source of exposure to aluminum compounds among general population is foodstuffs as the consequence of direct occurrence of aluminum in foodstuffs, as well as as the consequence of utilization of aluminum compounds in food processing, including food additives.  
It is therefore suitable to change the current conditions for using additives containing aluminum and to lower the levels for using food additives containing aluminum, including aluminum paints, to ensure that the revised tolerable daily intake is not exceeded.
You can read about more detailed information in the article: Limitation of additives with aluminum in the EU. (in Czech language only)
Article by: Kateřina Pavelková – Control Laboratories and Certification Department (CAFIA Headquarters)