Corporate Crime analysis: Will the proposed revision of the Novel Food Regulation provide for a simplified authorisation procedure for novel food? Dr Ina Gerstberger, head of the German food and drink and life sciences team, believes it is doubtful whether the procedure itself will be faster than it is today and expresses concern that it infringes the constitutional principles of the EU and national law of the member states.
Original news
New EU safety evaluation for 'novel foods', LNB News 26/06/2015 56
"Draft plans to encourage food innovation via a new, simplified authorisation procedure for novel foods have been endorsed by the EU Environment Committee. MEPs insisted that foods from cloned animals must be clearly included in the scope of the regulation, along with the precautionary principle, measures to keep nanomaterials under scrutiny and animal testing restrictions."
What is the background to the novel food proposal?
Harmonised regulations governing so-called novel foods have been in existence since 1997. The term 'novel food' relates to those foods that have not been used for human consumption to a significant degree within the EU before 15 May 1997 (entry into force date of the current Novel Food Regulation (EC) 258/97) and, in addition, fall into one of currently four categories of foods. Such categories of foods comprise:
- natural products like plants, fungi, algae or micro-organisms
- foods that have been isolated from these respective natural products, also animals (but not the animal as such)
- food for which a new production process is applied, giving rise to significant changes in the composition or structure, or
- where the food possesses a new or intentionally modified primary molecular structure
Foods qualifying as 'novel' may not be placed on the EU market prior to authorisation or, in certain cases in which these foods are at least essentially similar to either traditional or already authorised novel foods, by notification and proof of such equivalence. The authorisation procedure poses the main problem for companies intending to market a food classified as novel because it is costly--not only in the preparation of the application dossiers and associated safety related research in general but also time-consuming and disadvantageous for the first applicant.
The duration of the normal authorisation procedure may take up to 30 months on average. The applicant can choose which of the member states' authorities would best be qualified for the initial assessment of its novel food dossier. To date, only a few authorisations have been granted by the competent national authority. In most cases, an additional assessment is triggered by comments or objections, either in the initial assessment report or from other member states' representatives. As a consequence, the European Commission, more particularly the European Food Safety Authority (EFSA), is being involved in the authorisation procedure too, which further extends the duration of the process.
Once a novel food is authorised, competitors may start distributing their own product in the event they can prove its essential similarity to the authorised food. The notification process may take only a few months and, accordingly, is much cheaper. The originator company does not profit from data protection or exclusive use unless its product is a 'true' novel food due to changes in the molecular structure or composition arising from the applied manufacturing process which may be subject to patent protection. In relation to natural products--for example noni juices, baobab, chia seeds etc--the initial applicant may not easily earn back its financial investment.
What exactly is being proposed in relation to novel foods?
The new proposal for a revision of the current Novel Food Regulation intends to simplify and streamline the authorisation process by introducing a new centralised authorisation procedure on one hand, but will equally make provisions for a facilitated notification procedure for traditional third country foods (from non-EU countries). Traditional third country foods are only those foods derived from primary production, regardless of whether they are processed or unprocessed foods. Those foods need to demonstrate consumption in a third country for at least 25 years as part of the normal diet. Non-food uses (eg use as medicine) or uses not related to a 'normal diet' will not be considered under the 25-year history of safe food use.
As in the case of health and nutrition claims, the European Commission will establish a EU list of authorised novel foods setting out their conditions of use and labelling requirements. Likewise, the revised Novel Food Regulation will provide a five-year data protection period for newly developed scientific evidence and proprietary data, but only for the initial applicant. In cases where the initial applicant has applied for a health claims authorisation for the same food as well as data protection, both protection periods may run concurrently on request.
Finally, the revised Novel Food Regulation will amend and extend the current product categories, introducing new categories such as food consisting of, isolated from or produced:
- from material of mineral origin
- from cell or tissue culture derived from animals, plants, micro-organisms, fungi or algae
- consisting of engineered nanomaterial
- from animals or their parts--except for animals obtained by traditional breeding practices that have been used within the EU before 15 May 1997 and where the food from those animals has a history of safe food use within the EU
The last category should cover whole insects, or their parts, which are already marketed as new protein sources in the EU.
Will the revised Novel Food Regulation improve the current legal situation?
No. First of all, it will definitely bring more foods within its scope and thus change the currently applied general principle of free marketability of foodstuffs into a general principle of prohibition without authorisation, which should actually be restricted to products with a known or at least likely health risk. It is doubtful whether the amended approach is justified in terms of ensuring a high level of consumer protection, particularly for foodstuffs of natural origin. It makes no difference whether the revision proposal extends the current categorisation to nearly all foodstuffs or whether it requires 'only' significant consumption to a significant degree before the cut-off date of 15 May 1997 for the classification of a novel food. Although sticking to the categorisation has already been welcomed for allowing a better delimitation to non-novel foods, the political compromise reached is, in view of the above, mere window-dressing. Ultimately, it will be at the sole discretion of the Commission to decide, by means of implementing acts, whether a particular food falls within the definition of a 'novel food'.
Since the revision proposal allows the Commission/EFSA to extend time periods within the authorisation procedure under duly justified, ad hoc or 'exceptional circumstances', it is doubtful whether the procedure itself will be faster than it is today.
Equally, there are doubts whether the facilitated notification procedure for traditional third country foods will frequently be applied to such foods from primary production, since the qualification as 'traditional third country food' requires proof of use in the normal diet of a significant number of people in the non-EU country for more than 25 years. Special uses or dual uses (eg also for medicinal purposes, depending on dosage) will not be taken into account. The 25-year period is even longer than the current period of more than 18 years for proving significant consumption of a food in the EU for non-novelty and one may question the ratio between such long periods.
From a legal perspective, the revision proposal still has several deficiencies and infringes the constitutional principles of EU and national law of the member states, for instance:
- the principle of non-discrimination in view of certain natural product categories over others in terms of only partly granting exceptions for safe food use (eg fungi, algae, minerals versus plants and animals) but also in view of food supplements consumption versus other dosage forms of consumption of foodstuffs
- the principle of illegitimate retroactive application in view of extending the scope to currently non-novel and long-time marketed foodstuffs (despite allowing for transitional measures in this respect) but likewise in constantly increasing the requirements for non-novelty evidence since 1997, despite knowledge of the expiry of retention periods for the respective commercial documents
- the principle of proportionality in view of regulating foodstuff of natural origin without considering alternative less restrictive and costly means of proving safety other than by an authorisation procedure
How might this affect the agri-food sector?
Due to the extension of the product categories, in future more foods will be considered 'novel' and thus subject to the normal authorisation procedure. This might restrict innovation and new product development in the EU food sector, which is largely dominated by smaller and medium sized companies often limited in their financial capacities. Only the large food companies might profit from the new provisions, as they would ensure a monopoly distribution of certain products (if data protected) over at least five years.
What should lawyers advising in this area be aware of?
Lawyers advising in this area should be aware that due to the amended scope of application of the Novel Food Regulation nearly every food could, in principle, be considered 'novel'. In order to overcome the 'novel food threat' it will therefore be vital to gather information on significant consumption of the respective food or food ingredient prior to May 1997. This is already proving to be a challenging task. But, given that the illegal distribution of non-authorised novel foods is and will be considered a criminal offence, it's better to be prepared and/or advise clients conservatively.
What's next for novel foods in the EU?
The first reading of the European Parliament is currently scheduled for the end of October 2015. It is likely that the revision proposal will be adopted after four Trilog discussions and a positive vote from the European Parliament Committee on the Environment, Public Health and Food Safety. The new provisions will apply two years after the entry into force date--ie most likely from the end of 2017. However, various derogations for certain provisions will apply earlier, either from entry into force of the revision proposal or from the application of implementing delegated acts.
Dr Ina Gerstberger has almost 15 years' experience in delivering regulatory, IP and contractual advice to companies marketing foodstuffs, feedstuffs, cosmetics, medical devices, pharmaceuticals and biocides. Ina guides clients through all stages of project development. She frequently represents clients in court, especially in disputes concerning unfair competition law and in administrative or criminal proceedings. Ina is particularly experienced in product classification and the assessment of the marketability of ingredients in foods. She has an in-depth understanding of the use of botanicals in food supplements and functional foodstuffs in Germany, the UK, Spain, France and Belgium. She lectures in food law at the SRH Riedlingen University and from autumn 2015 on delimitation issues at the University of Augsburg.
Interviewed by Kate Beaumont.
This article was first published on Lexis®PSL Corporate Crime on 10 July 2015.