Novel foods approval changes set for the EU
The scene is set for changes in novel foods approval in the EU, with the publication at the end of 2013 of a proposal to overhaul access to the system.
The planned changes are unlikely to be implemented before 2016, but some of the revisions go beyond the administrative.
For instance, they include a faster procedure for vetting traditional foods from elsewhere in the world. If an applicant can show a ‘history of safe food use’ in a third country for at least 25 years and there are no objections from Member States (MSs) or the European Food Safety Authority (EFSA), the food can be approved without the risk assessment process other candidates face.
Virtually all the changes proposed by the European Commission (EC) are similarly designed to reduce the regulatory burden regarding novel foods, but the likely impact of some of them is less clear cut.
Status quo (Return to top)
Under the existing regulation from 1997 (EC 258/1997), applicants apply for approval via the regulator in an individual MS, such as the Food Standards Agency in the UK. The national body then orders a risk assessment by a competent authority – the Advisory Committee on Novel Foods and Processes (ACNFP) is the British example – and submits its findings to the EC. The EFSA is only required to carry out a further risk assessment if one or more of the other MSs still voice credible concerns about the safety of the novel food.
Approvals are currently granted specifically to the applicant. This means any other players seeking to introduce similar products have to apply separately, although there is a simplified procedure if the products are ‘substantially equivalent’.
The most widely-reported change in the EC’s proposal is to centralise the process, with applications by-passing national bodies and heading to EFSA for a risk assessment. What’s more, it eliminates the need for a simplified procedure by replacing the current regime of applicant-specific approvals with generic approvals. To reward innovation, the generic approvals rule gives successful applicants five years to market foods before others can follow suit based on the original applicant’s data. However, other companies are free to apply at any time using their own data.
This streamlined approach received a cautious welcome. “Generally speaking, regulations are problematic for industry because they create a hurdle to overcome before firms can go to market. Harmonised legislation across Europe is therefore hugely beneficial to business, but how that is implemented and made easier for applicants is important,” explains Clare Mills, professor of allergy at the University of Manchester. Mills is also a member of the ACNFP, but stresses she is expressing her views and not speaking for the committee.
With novel food applications, EFSA is more remote from most of the food firms and local enforcement bodies around the EU than the equivalent national competent authorities, so might centralising the procedures create a bigger barrier? Mills says care will be needed to ensure that doesn't happen, especially when it comes to dealing with smaller firms in parts of the EU where basic challenges such as language differences might be an issue: “It may be that the way EFSA operates could be made more accessible. Maybe they should work with local competent authorities,” she suggests.
Unauthorised products (Return to top)
Observers, including Mills, are clear that a well-informed industry and accessible process is key to preventing unauthorised products slipping through the net. There are already concerns about that happening under the current system, with an unknown number of unauthorised products ending up in shops, where they may pose an unquantified risk.
Mills says the problem probably results from a combination of local enforcement personnel being hard pressed and a lack of awareness among smaller firms and retailers. “Food is a hugely complex area and people underestimate the knowledge they need about food safety – and not just microbiological safety,” she says. “The big food manufacturers have a lot of very talented people but there are a lot of small food businesses and the regulations around food safety may be baffling to them.”
However, the Food Standards Agency (FSA) is clear where the responsibility lies. “The onus is on food businesses to ensure they comply with all relevant aspects of food law, including the novel food regulation. The requirement for novel foods to undergo a safety assessment and approval before they can be marketed in the EU has been in place for more than 15 years and we have not identified any food sector that is unaware of the need to obtain approval for novel foods,” says Sandy Lawrie, head of novel foods at the FSA and ACNFP secretary.
New initiative (Return to top)
Even so, the FSA introduced a new initiative last October to help communicate the status of potential novel foods more effectively and to give interested parties the opportunity to provide evidence of a significant history of consumption in the EU prior to May 15 1997, which is the cut-off date for determining whether or not a food is ‘novel’. Under the arrangement, the FSA publishes relevant information on its website, including letters inviting interested parties to submit any evidence.
Two ingredients are currently listed for review, namely Acacia rigidula (blackbrush acacia) and raspberry ketones, both of which are used in food supplements that claim weight loss properties. “We anticipate that the measures we have implemented to ensure advice is better communicated will also reduce uncertainty regarding the regulatory requirements for individual products,” says Lawrie.
Of course, the longer-term future of this initiative is now uncertain, since the FSA could find itself stripped of its involvement in risk assessments for novel foods when the proposed changes are implemented.
Both the existing novel foods regulation and the new proposals cover foods that have been produced using novel processes, as well as novel materials. However, the new version highlights nanotechnology, which isn’t the case in the original regulation.
“It has become much clearer with the new proposal,” says David Carlander, director of advocacy for the Nanotechnology Industries Association. He says an important development is the inclusion of the now-standard EU definition of engineered nanomaterials, which first appeared in the Food Information Regulation in 2011 (EU 1169/2011). The definition covers materials with 50% or more particles with at least one dimension of 100nm or less.
Nanotech’s front line (Return to top)
Crucially, the explanatory Q&A for this EU definition excludes non-particular materials such as proteins or micelles. Without this exclusion, it might cover everyday foods, such as mayonnaise or homogenised milk. Carlander suspects emerging encapsulation technologies will be on the front line of nanotech in foods. “The EU position on a number of these is not yet set in stone. There are still grey zones,” he says.
Kathy Groves, project manager of microscopy at Leatherhead Food Research, agrees, as encapsulation delivers functional food advances. “You might want a new way to add fat-soluble vitamin D or A to a drink. You need to make it encapsulated or so small that it becomes miscible,” she says. However, she doubts regular, easily broken down ingredients will present a risk. It is nanoparticles that could survive digestion in their new form that should be the focus of future safety research, she says. These might include trace elements such as iron or selenium.
