48 FOODS CRITICALLY DEPENDENT ON SPECIFIC INGREDIENTS – Food and Drink – Good Manufacturing Practice, 7th Edition



Some foods are critically dependent for their preservation and/or specific properties and maintenance of quality during their expected life on the presence in the required amount(s) of one or more particular specific ingredients, usually at relatively low levels.


48.1 All product specifications should be validated as part of the design process before full production commences. Revalidation is required if there is a change to product formulation, ingredients supplier and so on to ensure that food safety will not be compromised (see Chapter 3). All ingredients must be declared ‘food grade’, and there must be documented evidence held by the manufacturer to substantiate this. Quantitative Ingredient Declarations (QUID) labelling must be complied with at all times for prepacked foods.

48.2 Where the preservation and/or specific properties of the product critically depend on the inclusion, at a specified level, of one or more specific ingredients, the importance and critical nature thereof should be emphasised in the training of production supervisors, operatives and quality control staff. Production methods and control procedures should include specific provision directed towards ensuring that the substances concerned are not accidentally omitted, nor added in incorrect quantity, nor unevenly distributed through the product, whether resulting from operator error or inaccurate functioning of automatic dispensing equipment. Whereas a deficiency would impair the preservation and/or specific properties of the food, an excess might, in the case of certain specific additives, exceed specified legal limits and/or be harmful to the consumer.

48.3 Because of the wide variety of possible combinations of circumstances, it is impossible to generalise as to specific production techniques or control measures required for the purpose indicated in 48.2. Where discrete batch quantities of any specific ingredient are required, it may be appropriate for these to be accurately weighed by or under direct supervision of laboratory or quality control staff. Where colour or a coloured ingredient is also part of the product formulation, consideration should be given to the feasibility of premixing or adding in the specific ingredient therewith, so that the visually obvious presence or absence of the colour in the batch acts as a ‘marker’ for the specific ingredients. Batch manufacturing records (see Chapter 13) should include provision for recording the addition of such substances, and operator training should emphasise the importance of filling these in at the time of making the addition and not filling in a succession of ticks and initials at some later convenient time. It is very important that the operator initials the entry for each batch so that in the event of non‐compliance there is traceability to a particular operator (see 13.8). At the end of a production run, there should be a cross‐check of the usage of the critical specific ingredients against the amount(s) required by the actual production volume during the run. Any discrepancy between the actual and expected amounts of a specific ingredient should be investigated.

Generally speaking, the natures of the substances likely to be involved do not lend themselves to continuous or rapid monitoring, so that analytical control provides only intermittent spot checks, which should, however, be carried out to confirm the effectiveness of the manufacturing disciplines on a retrospective basis. It is important to check the identity of raw material supplies, that is, that they are in fact the substances that they purport to be. It is evident that this assumes additional importance in the case of the specific ingredients referred to above.

In the event of identification of non‐conformance then corrective action procedures must be implemented (see Chapter 28) and if required product withdrawal or product recall instigated (see Chapter 27).