Any innovative or traditional food product that has no significant history of human consumption in the European Union before 15 May 1997 would be considered novel in the EU, and must undergo a rigorous pre-market safety assessment, according to the European novel food regulation (1). This means that a company cannot market a novel food in the EU if it hasn’t been given clearance under this regulation.
For example, stevia is currently sold as a ‘natural’ sweetener outside the EU. An application was submitted in 1998 for the authorisation of the placing on the EU market of stevia (the plants and dried leaves of stevia rebaudiana Bertoni) as a novel ingredient. But the data provided in this application wasn’t sufficient to demonstrate the safety of this product.
Consequently, stevia hasn’t been authorised for sale as a food or food ingredient in the EU. Any company can still apply for the authorisation of stevia as a novel food ingredient in the EU if they feel that they can demonstrate its safety according to the assessment criteria set in (EC) 258/97. In 2007, the European Stevia Association (Eustas) submitted a novel food dossier to the German competent authority, which hasn’t yet completed its initial assessment.
Another example is the traditional ingredient baobab fruit pulp, which is widely used and safely consumed in Africa and was approved as a novel food ingredient in the EU in June 2008, almost two years after the submission of the novel food application.
The onus is on a manufacturer or an importer of a product to demonstrate that their product isn’t novel. Unfortunately, the novel food regulation doesn’t define what constitutes ‘human consumption to a significant degree’, which is the central criterion for establishing whether a food falls within the scope of the regulation. However, it’s understood that significant consumption would be demonstrated by evidence of sale to the general public in a range of locations, and in non-trivial amounts, before the cut-off date of 15 May 1997. This can prove quite often challenging to demonstrate for the industry, as some sales records are destroyed after five years. The solution is then to look at any publications showing that the product has been marketed and consumed before 15 May 1997.
There are 27 competent authorities on Novel Foods in the EU, one for each member state. They’re responsible for deciding if an ingredient should be considered novel or not and they all meet regularly in Brussels to discuss this with the Commission. A Commission Novel Food catalogue is available online.
A novel food can fall into one of four categories:
Genetically modified (GM) foods originally fell under the scope of the novel foods regulation, but in 2003, a new European legal framework for GM foods was adopted for their approval, labelling and traceability. GM foods were therefore removed from the scope of the novel food regulation.
There are two ways of having a novel food authorised in the EU. The first one is the full novel food procedure. It can be very costly and time-consuming for companies to achieve approval for marketing their novel food product under this procedure, which isn’t centralised. A member state must give an opinion on a novel food dossier within three months, but this timeframe is frequently extended as additional data is often required from the applicant to complete the assessment of the dossier.
Once the initial assessment is completed, the remaining 26 member states are consulted and they can raise comments or objections within two months. If objections are raised, the European Food Safety Authority is asked to provide an opinion. Based on this, a final decision on whether to approve or reject the novel food product must be reached between member states through a qualified majority vote in Brussels. The whole process of assessing a full novel foods dossier can take as little as eight months. However, the majority of cases take two to three years, or more.
The cost of building a full novel food dossier may also vary between £250,000 to £500,000. This is often due to the amount of information required to demonstrate the safety of the product, such as compositional data, estimated nutritional intake and a full toxicological and allergenicity assessment. Each approval is addressed to the applicant and the only way a competing company can also market the same novel food ingredient is to claim substantial equivalence.
Claiming substantial equivalence to a product marketed in the EU is a simpler way of getting a novel food product onto the EU market. This procedure was originally set up for assessing GM products, which are now excluded from the novel food regulation. Only certain novel food categories can be assessed through this process: new microorganisms, fungi or algae and their extracts, new plants or their extracts, and food isolated from animals.
Equivalence with an existing product must be demonstrated using five criteria:
Once one of the 27 EU competent authorities has provided a positive opinion on a substantial equivalence dossier, the applicant can immediately start marketing its novel food product in the EU. The whole process can be completed within six to 12 months, and a large number of substantial equivalence dossiers have been approved over the past 12 years. The majority of these relate to noni juice – a ‘superfruit’ juice from the Pacific islands – and food products enriched with plant sterols.
An increasing number of plant sterol enriched products – including yellow fat spreads, milk drinks and yogurts, cheese products and salad dressings – are therefore now available throughout the EU. This category of novel food products is the only one for which specific labelling legislation has been produced (2), so that consumers who wish to lower their cholesterol are fully informed about the appropriate use of these products.
The novel food legislation is currently under review to bring it up to date with other food legislation that has been published over the past 13 years (eg legislation on food supplements, 2002; fortified foods, 2006; and food additives, 2008). A new draft regulation was published in January 2008.
In the draft, the Commission is proposing a clarification of the definition of novel foods, to include the use of new technologies such as nanotechnologies. The cut-off date of 15 May 1997 will still apply so, as years go by and sales documents are destroyed, it may become even harder for companies to demonstrate that their product isn’t novel.
A centralised procedure for the assessment of novel food dossiers has been proposed within the draft regulation, with opinions likely to be directly obtained from the EFSA. The simplified application procedure would also enable applicants to submit one application for approval that covers novel foods as well as other categories of ingredients such as food additives, food enzymes and food flavourings (the ‘one door, one key’ approach). Any authorisation will be generic and not addressed to a specific company, and therefore the substantial equivalence procedure has been removed in the new proposal.
A further suggestion is for a separate notification procedure to be established for traditional foods from third countries based on them being demonstrated to have a history of safe use in the country of origin. This may help speed up authorisation for the marketing of these products in the EU. The new proposals also set out data protection rules (five years) in a bid to provide protection for newly developed foodstuffs once authorised.
This Commission proposal needs to be adopted though the co-decision procedure, which involves consideration by the European Parliament and the Council of the European Union.
The European Parliament has recently published its first comments, and voting has been postponed until autumn 2009 when the new European Parliament will be in place. It may take another two years before the new novel regulation is adopted and published, so the current novel food requirements will remain with us for a little while longer.
1. Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 (Off. J. European Communities 1997, 40 (L43), 14/2/97, 1-7)
2. Commission Regulation (EC) No. 608/2004 of 31 March 2004 (Off. J. European Union 2004, 47 (L97), 44-5) came into force in April 2004
Annie-Laure Robin is the European regulatory team leader of Regulatory Services for Leatherhead Food Research, which offers food and beverage manufacturers a full regulatory service and gives information on the regulatory situation in each EU member state.
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