Data protection key for Novel Foods reform

By Shane Starling

- Last updated on GMT

Pan-European consultation on reforming European Union Novel Foods
regulations should remove the controversial substantial equivalence
clause, according to an Irish Food Safety
Authority (FSAI) representative.

Substantial equivalence has been criticised for permitting products onto market that can demonstrate they are similar to products that have won Novel Foods approval, thereby offering little protection to those companies that have shelled out for the initial Novel Foods approval. Data protection ​ The FSAI's chief specialist in biotechnology, Dr Patrick O'Mahony, said substantial equivalence was "gone"​ as support for it dwindled. "It is already happening in that companies are being awarded Novel Foods status for individual products rather than general categories,"​ he said after attending a European Commission Novel Foods working group meeting last week in Brussels. "Companies are being afforded greater protection for the investment they make in ingredients and products and having them approved for use within the EU. We think that is a good thing."​ At the same time a balance was required between proprietary protection and the creation of false monopolies so data protection time-frames needed to be resolved. Five years has been suggested. He cited the example of Unilever who had spent roughly €20m on a plant sterol Novel Foods application. It was approved in 2003 but was followed onto market soon after with a raft of me-too products claiming substantial equivalence. O'Mahony said while the clause helped smaller innovative companies that may not have had the financial resources to go through the Novel Foods process, a level of data protection was required if it was not to inhibit innovation. UKconsultation ​ The UK Food Standards Agency yesterday issued a consultation of its own highlighting key areas of the European Commission reform proposal. They key areas are:

  • speeding up the process by centralising the authorisation procedure for novel foods

  • developing a simplified safety assessment system for traditional food from third (non-European Union) countries

  • clarifying the definition of novel food to take account of new technology, such as cloning and nanotechnology

  • updating the scope of the novel food regulation in relation to parallel legislation on specific categories of foods, such as sources of vitamins and minerals

  • providing a degree of data protection for those who develop innovative foods (substantial equivalence)

It has called for responses before June 20. Long-winded ​The notoriously laborious Novel Foods approval process has been criticised as being a break on innovation for the length of time it takes to process applications. There are claims applications on its books dating back as far as 2003. Since its inception in 1997, 65 applications have been processed with another 25 waiting for European Food Safety Authority (EFSA) assessments. One of the mooted reforms is a streamlining of the system so that EFSA carries out the safety assessment rather than a member state. This would remove approximately half a year from the process automatically. It only takes member state to raise a query and the process can be halted for months or years as it is dealt with. O'Mahony said certain member states that were ideologically opposed to functional foods consistently raised often very minor objections to Novel Foods applications, thereby ensuring almost every application endured an elongated assessment process. It is unlikely reforms will be codified until 2009 at the earliest.

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