UK Food Law News (02-55)

Food Law News - UK - 2002

FSA Letter, 23 May 2002

ADDITIVES - Temporary national authorisation to market aspartame-acesulfame salt

Application for temporary national authorisation to market aspartame - acesulfame salt in the UK under the sweeteners in food regulations 1995 (as amended).

The Food Standards Agency has received an application from the Holland Sweetener Company seeking approval to market aspartame - acesulfame salt in the UK.

Comments on the proposal are required by 15 August 2002.

The Company's request

The Holland Sweetener Company has requested approval to market aspartame - acesulfame salt as a sweetener in the UK. In line with the provisions of the relevant European legislation, the approval would be for a period of two years pending consideration of the company's application for European Union (EU) wide approval of the product.

Legal Framework

The relevant legislation for the approval of sweeteners within the EU is as follows:

the Food Additives 'Framework' Directive (89/107/EEC) (as amended) provides for the harmonisation of Member States' controls on food additives and sets out general criteria for their use; and
the Sweeteners Directive (94/35/EC) (as amended) defines the term 'sweetener'; lists permitted sweeteners and, by cross reference, the purity criteria with which they must comply; sets down conditions of use for sweeteners in food; and sets down certain additional labelling requirements for these products.

The provisions of the Sweeteners Directive are implemented in the UK by the Sweeteners in Food Regulations 1995 (as amended).

Article 5 of the Food Additives Framework Directive permits any Member State to provisionally authorise the marketing and use of an additive within its territory which is not included in the relevant list (i.e. the list of permitted additives in the relevant directive). Such authorisation is permitted for a maximum of two years, during which time the applicant is required to seek EU-wide approval. The Member State must also ensure that foodstuffs containing the additive are officially monitored.

In February 1999, the Holland Sweetener Company officially applied for approval of aspartame - acesulfame salt on an EU-wide basis. The European Commission's Scientific Committee on Food (SCF) has advised on the safety of this salt (see below). The Commission has already taken the first steps towards issuing a formal proposal for various amendments to the EC Sweeteners Directive, including the addition of aspartame - acesulfame salt to the list of approved sweeteners. However, the process for legal adoption of these amendments is complex and the timetable for completion is uncertain.

The product is a chemical combination of the two intense sweeteners aspartame (E951) and acesulfame K (E950) at an equivalent mixture of 1:1

For the purposes of ingredient listing, the product would be known as 'aspartame - acesulfame salt'. As the salt is not yet approved for use in the EU it does not have an 'E' number.

Safety Assessment

The SCF is the independent scientific committee that advises the European Commission on questions concerning consumer health and food safety. In March 2000, the SCF gave its opinion on the safety of this salt. It considered that:
"a) the salt represents an alternative source of aspartame and acesulfame ions to the two already permitted sources (E951 and E950), b) potential exposure is the same with an equivalent blend of aspartame and acesulfame-K, c) the use of this substance raises no additional safety considerations the Committee regards as acceptable the use of aspartame-acesulfame salt as an additive.

It should be ensured that consumption of this substance is taken into account when estimating intakes of aspartame and acesulfame-K in relation to the ADIs for these substances."

A copy of the SCF's statement can be seen on the European Commission's website at:
http://europa.eu.int/comm/food/fs/sc/scf/out57_en.html

Benefits

The Food Additives Framework Directive requires that new additives are approved only where there can be demonstrated a reasonable technological need and where there are demonstrable advantages of benefit to the consumer - commonly referred to as the 'case of need'. Intense sweeteners have benefits for those wishing to reduce their sugar or calorie intake and for diabetics. The manufacturer claims the following consumer and industry benefits for aspartame - acesulfame salt when compared with a physical mixture of the two individual sweeteners:

It dissolves in water significantly more rapidly than an equivalent blend of aspartame and acesulfame-K. Instant powder products such as desserts, toppings, powder beverage mixes perform better during reconstitution by the consumer. Similarly, table-top sweeteners dissolve faster, especially in cold beverages.
It is more stable in certain applications than aspartame alone. Therefore, it can be used in applications where aspartame has either required encapsulation for protection or has been substituted by sweeteners of inferior taste such as saccharin. The consumer benefits from products of an improved taste and prolonged shelf life.
It improves the sweetness of chewing gum and gives the gum a very long-lasting quality without recourse to encapsulation of the sweetener, for example with polymer coatings. The consumer experiences an improved product quality at potentially lower costs.
It disperses easily in previously difficult applications, such as sugar-free hard candy and sugar-free chocolate, where a blend of sweeteners is difficult to employ.
In instant powder products, the salt provides a guaranteed balanced sweetness throughout the dissolution process where a blend of the two individual sweeteners does not, since acesulfame K dissolves faster than aspartame.
It is not hygroscopic and thus much easier to store and requires less stringent packaging. This benefits products that are stored in containers that are repeatedly opened and closed allowing contact with atmospheric moisture.
It has superior powder-flow properties and thus avoids inconsistencies in powdered products in which the consumer may previously have experienced variations in taste quality and/or sweetness level.
The potassium in acesulfame K is eliminated when the salt is made, as is the moisture contained in aspartame. Therefore, the salt represents a more concentrated source of sweetness without the functionless presence of potassium and water.

Next Steps

Once the consultation period has been completed, the Agency intends to proceed as follows:

The FSA will make all comments publicly available via our Library and website. Therefore, if you would prefer your comments not to be made public, please indicate this clearly in your reply stating your reasons.
Comments received will then be taken into consideration by the Agency when a decision is made whether to proceed with the temporary national authorisation of aspartame - acesulfame salt.
If the decision is made to proceed with the authorisation, this will be implemented by an amendment of the Sweeteners in Food Regulations 1995 (as amended) and parallel legislation in Northern Ireland. These amendments would be taken forward in England, Scotland, Wales and Northern Ireland and would, in turn, be subject to separate consultation exercises.

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