Article 13.4 - The next route for failed health claims?

Following the significant damage of the first wave of article 13.1 opinions by EFSA and subsequent 70% rejection rate, what can industry do now given EFSA will not re-assess these claims via the 13.1 process, even if new or additional data is available?

Well there are potentially 2 routes, firstly is article 13.5 for newly developed scientific data (submitted via the procedures under art 15-18), or secondly via Article 13.4 for claims which meet generally accepted scientific evidence.

Article 13.4 of the health claims directive (1924/2006) should be adopted in accordance with article 24(2) relating to the implementing procedures of the committee (dee specifically - Article 5 and 7 of 1999/468/EC). Unlike article 13.5 no detailed procedures are currently available for an article 13.4 submission. This may mean that EFSA will need to lay down these procedures and then gain approval from the committee before any stakeholder could resubmit a failed 13.1 claim via the 13.4 route. My guess is that like article 13.1, no specific procedures will be implemented, simply a resubmission of claims using the same format as 13.1 will be allowed, but with new or additional reference data. The concern, as with the origional 13.1 submissions is what is ‘generally accepted scientific evidence’?

Of importance are some key differences between article 13.5 and 13.4…

Article 13.4 relates to ‘changes’ to the community list, article 13.5 relates to ‘additions’. These 2 words maybe the key differences on attempting to discover a time frame for the possible implementation of article 13.4. In the case of article 13.5 it could be argued that as soon as any health claim had been approved by the commission, any subsequent submission could be classified as an ‘addition‘ to the list, as such the 13.5 processes for assessment could begin. In the case of 13.4, the terminology ‘changes’ to the list will mean we must wait until the current 13.1 opinions are ratified, which maybe another 6 months or even longer for those still to be assessed before we can use the 13.4 submission route for health claim approval.

It seems likely we will be able to implement article 13.4 towards the end of the first quarter of 2010, which may mean another shot at a health claim approval for the probiotics market which failed simple on issues of characterisation. Let’s hope this time EFSA provides better guidance and a greater ability to push for an approval with specifically designed dossiers, which were not possible under article 13.1.