Introducing food ingredients

Food legislation is a complex matter. Since the publication of the White Paper on Food Safety in 2000, a considerable number of Regulations, Directives and Guidelines on the safety of food and feed – including ingredients – have been published. For companies involved in food and feed and ingredients production, trade and transport, it is not always easy to keep information about food and feed legislation up to date. Moreover, it is not that simple to apply and to interpret this legislation.

Food Law

Recently the General Food Law (Regulation 178/2002/EC), shortly GFL, entered into force. This regulation lays down (among other points) the general principles and requirements of food law.

Food and foodstuff

A ‘food’ or ‘foodstuff’ as defined in the GFL, means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. This definition is very broad. Given this definition any ‘food ingredient’ can thus be regarded as ‘food’ and must comply with the GFL.

Food safety

When discussing the legislative aspects of foods and food ingredients, Art. 14 (GFL) is of particular importance: food shall not be placed on the market if it is unsafe. It also shows that food shall be deemed to be unsafe if it is considered to be injurious to health or unfit for human consumption. In this article, circumstances are outlined for determining whether a food is unsafe, injurious to health and unfit for human consumption. Concerning the safety of a food, regard shall be given to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and to the information provided to the consumer. This includes information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.

Responsibilities of the food producer

Food producers have responsibilities regarding foods. Art. 19 (GFL) lays down that if a food producer considers or has reason to believe that a food which it has imported, produced or distributed is ‘not in compliance with the food safety requirements’, he shall immediately initiate procedures to withdraw this food from the market where the food has left the immediate control of that initial food producer. He must also inform the competent authorities thereof. If the food may have reached the consumer, then he shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient. If a food producer considers or has reason to believe that a food which he has placed on the market may be ‘injurious to human health’ then he shall immediately inform the competent authorities of the action taken to prevent risks to the final consumer.

Product liability

The liability for defect products has been laid down in the Directive 85/374/EEC. This directive has been implemented in the Member States. On the basis of this directive the producer shall be liable for damage caused by a defect in his product. Products include foods, food ingredients and raw materials. A food is defective when it does not provide the safety that a person is entitled to expect, taking all circumstances into account, such as the presentation and the use which could reasonably be expected. So unsafe foods are defect products. The scope of the notion ‘damage’ has been limited to damage caused by death or by personal injuries, and damage to any item of property other than the defective product itself, provided that this item is of a type ordinarily intended for private use or consumption and was used by the injured person mainly for his own private use or consumption. The producer of a defect product has, among others, the following defence: if he proves that he did not put the product into circulation or that it is probable that the defect did not exist at the time when the product was put into circulation by him, or that this defect came into being afterwards. To recover his damage the injured person must prove the damage, the defect and the causal relationship between defect and damage, which is not usually easy.

Review of the safety of a food or foodstuff

Given the injunction to put unsafe foods on the market, the responsibilities of the food producer and the possibilities for the consumer to recover his damage caused by a defect food, it will be clear that it is very important for a food producer to review the safety of a food; Particularly if a producer aims to introduce a new food on the market. Foods are produced everywhere in the world and are exported worldwide. But are they safe products?

Qualification and permissibility

Ingredients can be among others food ingredients, food additives, colours, flavours, spices, enzymes, vitamins and minerals. Depending on the function of the food or ingredient, different regulations may apply. Where the function of a food or a specific ingredient in a final product may vary, a proper qualification of this food or ingredient is needed. For instance, citric acid can be added as a food additive, E 330, in almost every food. However, it can also be used as a food ingredient in food supplements. It is therefore of utmost importance to qualify the food or ingredient before permissibility can be researched. A complicating factor is that much legislation is not harmonised among EU Member States; for example, regarding the use of enzymes.

If an ingredient and its amount are permitted, then the use of it in this food is permitted. It is also possible that the ingredient has been forbidden or the amount added is too high. For permission to be granted it is then necessary to remove the respective ingredient or lower the amount added.

An ingredient can also be ‘novel’. On the basis of Regulation (EC) No 258/97 such an ingredient or food has not hitherto been used for human consumption to a significant degree within the European Community. In order to attain permission the person responsible for placing the food on the Community market shall submit a request to the Member State in which the product is to be placed on the market for the first time. Examples of recent permissions are the use of phytosterols in a certain number of foods and the use of isomaltulose. It should be noted that only the applicant may put the novel food or ingredient on the market. If anyone else aims to put the same food or food ingredient on the market then he should submit his own application. However, if foods or food ingredients which are substantially equivalent to existing foods or ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein, a shorter procedure can be followed. A well-known example is the food ‘Noni’ juice (juice of the fruit Morinda citrifolia).

Concerning the use of genetically modified food (and feed) the Regulation (EC) No 1829/2003 applies. If someone aims to place such a food on the market then he has to obtain an authorisation for which an application shall be submitted to the competent national authority of a Member State. Specific rules are in place for obtaining permission to put new food additives, colours, flavours, enzymes, vitamins or minerals on the market.

In our experience it is very important to have a complete dossier of the required information for applications for novel foods and GMO food and feed. Applications have been refused due merely to a lack of information.

Safety assessment

Unsafe food shall not be placed on the market. To determine whether the food or food ingredient is safe, a safety assessment has to be carried out. In principle the permissibility of the ingredients used will make the food safe. But often because of the nature and/or the amount of the ingredients such an assessment is needed to know the safety of the food. An example of the ‘nature’ is the use of herbs and herb preparations in food supplements. Salt is an example of the ‘amount’ in a food. However, salt has been used in foods since human memory, the safety as such is debatable. Eating a few salt cubes is not innocent because of the effect on the blood pressure. That is why we strongly advise to carry out a safety assessment to acquire know-how about the safety of the food. In our experience risk assessments are often not carried out in the case of new foods made of (well) known ingredients, which are added in significant higher amounts, such as vitamins and minerals.

Labelling

If the permissibility of a food has been verified and it is safe then it may be placed on the market. Moreover, the product requires a correct label. The required label information has been harmonised in the Directive 2000/13/EC. These rules are implemented in national legislation. Still more detailed labelling requirements are laid down for GMO, allergens, claims and food supplements. In principle the labels in the Member States contain the same information. Only the required language differs. Despite the harmonised rules there are differences regarding the interpretation. An example is the labelling of allergens. The Commission and interest groups issue Guidelines and Guidance Documents to harmonise this labelling.

Verification

Once the food is marketed verification of specifications might still be important for the producer or trader. ‘Is the product exactly what it says it is?’ Microbiological and sensory aspects can be verified once the product is on the market. Also the label information can be verified. In our experience these aspects do not always meet the specifications. The sensory aspects and label information are the main defects that were found during verifications.

Other rules

There are also other rules concerning production of foods. The GFL lays down rules for the food producer to trace the suppliers and the customers. In the case of product liability it is very important to trace them but also to have in place systems to trace the used ingredients within the businesses under their control.

Recent developments in food (ingredients) legislation

The rules concerning hygiene have recently been revised. The new regulations are based (among others) on the implementation of a ‘farm to table’ approach and have been applicable since 1 January 2006. A ‘Hazard Analysis and Critical Control Point’ system (HACCP) for all food producers has been introduced. Microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food producers have been laid down. There are criteria for food safety and process hygiene.

The European Commission is currently working on new regulations regarding food additives, enzymes and flavourings. New rules concerning enzymes have been laid down in a draft regulation. Enzymes were usually classified in some Member States, for example the Netherlands, as processing aids. The new draft regulation has narrowed the definition of processing aids, stating among others that the substance enzyme must be intentionally removed after treatment or processing. This modified definition may result in enzymes being classified as additives or as enzymes.

Summary

Food legislation is a complex matter. Given the injunction to put unsafe foods on the market, the responsibilities of the food producer and the possibilities for the consumer in the case of damage caused by a defect food it will be clear that it is very important to review the safety of a food. TNO Quality of Life has developed a plan for the introduction and verification of safe foods. The experts and lawyers of TNO use this plan to advise clients who plan to put a (new) food or food ingredient on the market or to verify existing foods.