ADDITIVES - Application for National Approval of a New Sweetener 'Sucralose' under the Sweeteners in Food Regulations 1995 (As Amended)

The Company's request

Tate and Lyle have requested approval to market a new sweetener, sucralose, 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 by the European Commission of the company's application for EU wide approval of the product (see paragraph 4 below). Sucralose is manufactured by controlled chlorination of sucrose and is approximately 500-600 times sweeter than sugar. It is currently approved in several other countries world-wide, including Canada (since 1991), Australia (1993) and the US (1998/99).

The company's technological justification is available. The list of food categories for which the company is seeking approval to use sucralose, together with proposed usage limits is also available from the FSA web pages. Approval would also allow sucralose to be used in tabletop sweetener products.

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 which 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/EEC as amended). This directive 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 set down certain additional labelling requirements for these products.

Article 5 of the Food Additives Framework Directive permits Member States to provisionally authorise the marketing and use of an additive within its territory which is not included in the relevant list (i.e. are not included in 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.

Towards the end of 2000 Tate and Lyle also applied for approval of sucralose on an EU-wide basis. The European Commission's Scientific Committee on Food (SCF) has carried out a safety assessment of the sweetener (see below) and 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 sucralose to the list of approved sweeteners. However, the process for legal adoption of these amendments is complex and the timetable for completion is uncertain. We are also informed that the German authorities have recently granted national authorisation for the use of sucralose in a tabletop sweetener product.

Safety Assessment

The SCF is the independent scientific committee which advises the European Commission on questions concerning consumer health and food safety. It has assessed the data on the safety of sucralose and issued its opinion in September 2000. This concluded: 'that sucralose is acceptable as a sweetener for general food use and that a full Acceptable Daily Intake level (ADI) of 0-15mg/kg body weight can be established'. This was in line with the ADI set for sucralose by the Joint FAO/WHO Expert Committee on Food Additives in 1990. Copies of the full SCF opinion are available from the SCF website at www.europa.eu.int/comm/dg24/health/sc/scf/outcome_en.html

In the UK the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) is the independent expert committee which advises the UK government on food safety issues relevant to the use of additives. The COT has endorsed the SCF opinion on sucralose and the Food Standards Agency has concluded that it is unnecessary to carry out a further separate safety assessment of the product.

Consumer 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 manufacturers claim the following specific additional benefits for sucralose when compared with other sweeteners currently available for use by consumers and manufacturers:

• its flavour profile indicates that it is very similar to sugar (with less side/after tastes which are often associated with intense sweeteners);
• it is stable during high temperature processing (such as baking and pasteurisation). This will enable manufacturers to produce a wider range of calorie reduced products such as baked goods and cereals. It also means that the 'table top' product can be used by consumers at home in cooking or baking;
• it is stable during long term storage. This results in economic benefits to the consumer; and
• it blends well with sugars - enabling the production of more 'light' products which contain a reduced level of sugar.

Next steps

At the end of this consultation process the FSA intends to proceed as follows;

• It is intended that all comments will be publicly available through the FSA Library and a summary will also be placed on the FSA Website.
• Comments received will be taken into consideration by the Agency when a decision is made on whether to proceed with the approval of sucralose.
• If the consultation produces diverging views the FSA has the option of referring the issue to one of the Agency's independent advisory committees, the Food Advisory Committee for advice.
• If a decision is made to proceed with the national approval of sucralose, this will be implemented by an amendment to the Sweeteners in Food Regulations 1995 and the equivalent legislation in Northern Ireland. The draft amendment to these regulations would in turn be subject to a consultation exercise. Any such amendment will be taken forward separately on a devolved basis in England, Scotland, Wales and Northern Ireland.