New proposal for Novel Foods RegulationPosted: January 10, 2014 | |
Novel Foods (NF) are all foods that were not used for human consumption to a significant degree within the EU prior to 1997. One of the most well known examples is BECEL, a margarine containing plant sterols with a cholesterol lowering activity. So far, Novel Foods were covered by Regulations 258/97 and 1852/2001, but obtaining market access for a novel food within this regulatory framework could easily take three years. Therefore, between 2008 and 2011, a new proposal for the NF Regulation was discussed. This proposal has never been adopted by Union legislator, due to a number of bottlenecks including food produced from cloned animals. On 18 December 2013, the Commission has published a new proposal for a NF Regulation, which is the subject of this blog post. One of the aims is to shorten the authorisation procedure to 18 months. How? Continue reading.
Food from cloned animals no longer covered
In order to find a solution for the sensible issue of food from cloned animals, the current proposal for the NF Regulation simply no longer covers such food. Instead, two separate proposals have been prepared: (1) a Directive on the cloning of animals of various species kept and reproduced for farming purposes and (2) a Directive on the placing on the market of food from animal clones. These two proposals will – at least temporarily – ban the use of the cloning technique in the EU for farm animals and the imports of these animal clones. The marketing of food from animal clones, such as milk or meat, will also be prohibited. Cloning will however not be prohibited for purposes of research or conservation of rare breeds and endangered species. Furthermore, cloning will be allowed for the production of pharmaceuticals and medical devices, where the use of this technique can be justified.
Subject matter, scope and definitions
General criteria for the NF definition remain unchanged: they should be safe and not mislead the consumer. The definition of NF is however considerably changed, now that food from cloned animals is no longer included. Futhermore, only one out of four previous NF categories is maintained, namely food to which a new production process is applied. 3 new categories are introduced, being
(i) food containing of or consisting of engineered nano materials;
(ii) vitamins and minerals to which a new production process has been applied or consisting of or containing engineered nano materials; and
(iii) food used exclusively in food supplements prior to 1997, where it is intended to be used in foods other than food supplements.
It should be observed that it is unclear if this list of categories is of an exhaustive enumeration. Also, the introduction of nanomaterials may have huge implications for manufacturers of medical or baby foods. Those foods, although regulated by Regulation 609/2013 inter alia, could be covered by the NF definition, for instance when there was a significant change in the production process or particle size.
Three major changes
The new proposal for the NF Regulation aims to simplify and streamline the regulatory process, while it continues to ensure food safety. More concretely, three major changes are being proposed.
(1) There will be one centralized procedure for NF assessment and authorisation, aimed at the reduction of the authorization procedure from 3 years in average to 18 months.
(2) Introduction of simplified and more proportionate procedure for placing on the market of traditional foods from third countries.
(3) Introduction of a data protection regime covering newly developed scientific evidence and proprietary data during a maximum period of 5 years.
Ad (1) Central authorisation procedure
NF will continue to require pre-market authorisation. Currently, such authorisation is applied for at a national level. The Commission subsequently circulates initial national assessments to all Member States (MS). If these do not raise any reasoned safety objections, the NF can be marketed. However, in the majority of the 68 NF authorisations granted between 2000 and 2013, such objections were raised and an EFSA safety opinion was obtained. The current NF regulation does not set a time frame therefore and quite often, the 60 days term for the MS to provide their opinion is not enforced. This explains why authorisation procedures can last up to 6 years. Under the new NF Regulation, an application for a NF authorisation should be directly made to the Commission. Where the Commission requests a safety opinion, EFSA shall adopt such opinion within 9 months from the date of receipt of a valid application. Subsequently, the Commission shall publish a draft authorisation decision within 9 months from the date of publication of the EFSA opinion. The system of individual authorisations will be replaced by a system of generic authorisations and the “simplified procedure” based on substantial equivalence will cease to exist. Authorised NF will be included into a so-called Union list.
Ad (2) Simplified authorisation of traditional foods
The new NF Regulation introduces a simplified and more proportionate procedure for placing on the market traditional foods from third countries, provided that a history of safe use can be demonstrated. This should be confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a large part of the population of a third country. An applicant who intends to place on the EU-market a traditional food for a third country shall notify that intention to the Commission. When the Commission does not receive any reasoned safety objections within 4 months, the food applied for can be marketed in the EU. In case of any objections, the applicant can file a new application taking into account said objections, which the Commission forwards to EFSA. EFSA shall subsequently adopt, within 6 months from the date of a valid application, its safety opinion. Finally, the Commission shall publish a draft authorisation decision within 3 months from the date of publication of the EFSA opinion.
Ad (3) Data protection
On request of the applicant, data protection is available for newly developed scientific evidence or scientific data supporting the application. This measure was introduced in order to support innovation in the EU-food industry. A similar mechanism is also contained in the Health Claim Regulation for so-called “new function” claims under article 13.5. Under both Regulations, data protection implies that data covered may not be used for the benefit of a subsequent application during 5 years, in the case of a NF to be calculated from the inclusion of the NF in the Union list. Such individual authorisation should however not prevent other applicants from filing applications on the basis of their independently generated scientific data, which may be identical with or similar to the protected data.
Transitional measures, monitoring and timelines
NF that were authorized prior to the entry into force of the new NF Regulation, will be included in the Union list too. As a consequence, a food that was legally placed on the market prior to the application of the new NF Regulation may be further marketed. However, it is mandatory for those foods to undergo the authorisation procedure laid down in the new NF Regulation. Likewise, when a NF is authorized and included in the Union list, the Commission may introduce post-market requirements to monitor the use of the authorized NF, so to ensure that the food is within safe limits as established by EFSA. The new NF Regulation expected to enter into force in 2016 at the earliest, when the Council and the Parliament will have adopted their positions on this topic as well.
Over time many food business operators started to doubt if a new proposal for the NF Regulation would be published at all. The mere fact that this finally happened can be called a positive fact. Also, this proposal contains various positive elements, such as more defined timelines within the authorization procedure for EFSA. However, it should be noted that authorisation delays could still easily increase. For instance, if EFSA requests additional information from the applicant, the authorisation for sure will not make it within 18 months. Furthermore, the authorisation of traditional foods from third countries will take, as a very minimum, 13 months if an EFSA opinion is requested. In line with the number of times an EFSA opinion is requested for NF, it is not unrealistic to expect this will happen most of the times. The procedure provided is therefore not necessarily “simplified” in view of a food that in other parts of the world is considered safe. Also, the proposal still does not contain at all a fixed term in which the MS should provide their reasoned objections, if applicable. At any rate, many items covered by the NF Regulation are still open, since the NF definition does not seem to be of an exhaustive nature. Furthermore, the Commission has received implementing powers to (i) decide whether a particular food falls within the NF definition, (ii) design a procedure to collect information on human consumption of particular foods prior to 1997 and (iii) update the Union list. Finally, legal uncertainty is bound to arise regarding already authorized NF, as they will have to undergo the authorization procedure again under the new NF Regulation.
Image from Clinton Smith Design Consultants