New Food Additive Legislation - How is it Different?

What is the new food additive legislation?
Regulation (EC) No 1333/2008 applied from 20th January 2010 and lays down rules on food additives used in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in food trade, taking into account, where appropriate, the protection of the environment.

The Regulation provides for:

Community lists of approved food additives
Conditions of use of food additives in foods, including in food additives (these will be set out in Annexes II and III and in the meantime the Annexes to the previous three directives on food additives continue to apply)
Rules on the labelling of food additives sold as such

The Regulation prohibits the placing on the market of a food additive or any food in which such a food additive is present if the use of the food additive does not comply with the requirements set out in the Regulation. Only food additives included in the European Community list may be placed on the market as such and used in foods under the conditions of use specified therein.

What will be contained in the Annexes to the new legislation?
See below a list of the contents of the new Annexes coming into effect under  Regulation 1333/2008 :

Annex I: Functional classes
Annex II: Food categories and the additives permitted for use within them and their conditions of use
Annex III: Food additives permitted for use in food additives, enzymes and flavourings and their conditions of use
Annex IV: Traditional foods where certain MS may continue to prohibit certain categories of additives (none in Ireland)
Annex V: Certain food colours and their associated labelling requirements – Southampton Colours

When will the new Annexes with lists of approved additives and conditions for their use be completed?
The Annexes have already been agreed at Member State level but with the transitional arrangements in place, they will not come into effect until April 2013. Until then the approved additives and conditions for use set out in the previous legislation (i.e. the directives on colours, sweeteners and additives other than colours and sweeteners) continue to apply.

What are the main changes in the new legislation?
A key element of the new legislation is that it harmonises the requirements of three pieces of legislation covering food additives, food colourings and sweeteners and that authorisations will be based on a food categorisation system. This differs from previous legislation in that rather than listing the different sweeteners, colours and additives and setting out their uses and conditions of use, the new legislation sets out foods under a food categorisation system and all additives associated with a particular category will be listed.

In the most part, there will be no changes to approved use criteria for the majority of food additives in the new legislation. However, there will be minimal changes in some instances, so manufacturers are advised to review the new Annexes to  Regulation 1333/2008  when they become available to determine any potential issues. Manufacturers may wish to review product specification to ensure compliance with the new Annexes in advance of the Annexes coming into force. It is worth noting that there have not been any additional uses permitted in the new Annexes, but in certain instances maximum levels permitted for particular additives in specific foods have been reduced.

Is the carry-over principle still allowed in the new legislation?
Yes. The carry-over principle refers to additives being carried over into a food by virtue of being used in one of the ingredients of that food.

The carry-over principle, as set out in Article 18 of the Regulation, permits the presence of additives in:

(a) a compound food other than as referred to in Annex II, where the food additive is permitted in one of the ingredients of the compound food

(b) a food to which a food additive, food enzyme or food flavouring has been added, where the food additive:
is permitted in the food additive, food enzyme or food flavouring in accordance with this Regulation; and
has been carried over to the food via the food additive, food enzyme or food flavouring; and
has no technological function in the final food

(c) a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with this Regulation

There is also a provision in legislation for what is known as reverse carry-over. In this instance, an intermediate ingredient can contain an additive that it would not normally be permitted to contain, on the basis that the additive is permitted for use in the final foodstuff and that the intermediate ingredient is used solely for the final foodstuff.

However, the carry-over and reverse carry-over principle does not apply to infant formulae, follow-on formulae, processed cereal-based foods and baby foods and dietary foods for special medical purposes intended for infants and young children as referred to in  Directive 89/398/EEC , except where specifically provided for.

In Annex II of the new legislation, the carryover principle will not be permitted in any of the exempted foodstuffs (April 2013).

What are the food categories?
Annex II of  Regulation 1333/2008 will contain the food categories. Additives permitted to be used in specific food types will be listed against each category/sub-category, together with conditions of use. The food category system will consist of 19 food categories with sub categories specified within these. To date the following food categories have been created:

0. All categories of foodstuffs
1. Dairy products and analogues
2. Fats, oils and fat emulsions
3. Edible ices
4. Fruit and vegetables
5. Confectionary
6. Cereals and cereal products
7. Bakery wares
8. Meat
9. Fish and fisheries products
10. Eggs and egg products
11. Sugars, syrups, honey and table-top sweeteners
12. Salts, spices, soups, sauces, salads and protein products
13. Foodstuffs intended for particular nutritional uses as defined by  Directive 2009/39/EC
14. Beverages
15. Ready-to-eat savouries and snacks
16. Desserts excluding products covered in category 1, 3 and 4
17. Food supplements as defined in  Directive 2002/46/EC  (excluding food supplements for infants and young children – to be confirmed)
18. Processed foodstuffs not covered by categories 1 to 17

Further detail can be found in relation to sub categories in Appendix 2 of the  FSAI's Guidance on Food Additives

While Annex ll will contain a listing of the food categories and conditions of use for food additives, in addition to this, the conditions of use of the authorised additives will be also provided in the form of an online, searchable database. It is also the intention of the European Commission to provide additional information on the interpretation of the Food Categorisation System in the form of a guidance document.

Where is this legislation, including the food categories, available?
At present the completed Annexes II and III of Regulation 1333/2008 are not available as they have not as yet been formally published. On completion and adoption of the new legislation the information will be available on the European Commission's website

When will manufacturers need to comply with the changes in the legislation?
A review of the general and specific conditions of use for food additives has been carried out at EU level and adopted by the Standing Committee on the Food Chain and Animal Health (Annex II and III of Reg 1333/2008). These Annexes are expected to be published in the official Journal in October 2011, followed by a transitional period of 18 months, meaning the new Annexes will not come into effect until April 2013.

The use of food additives already permitted in Directives 94/35/EC, 94/36/EC and 95/2/EC will continue to be permitted until the above Annexes to Regulation 1333/2008 come into effect.

Also of note, new controls in relation to flavouring and enzymes are at the developmental stage at EU level and it is unlikely there will be any changes as regards these control of these substances prior to 2012.