The new flavour regulation 1334/2008 becomes applicable in January 2011, and the list of approved flavouring substances already used in the EU must be adopted by the end of this year.
This deadline was set independently of the timescale for establishing the list. But even though the list – featuring 2600 substances – began to be compiled in 1999 and EFSA’s original deadline for safety reassessment was 2005, it has not been able to give final opinions on around 400 of them.
The problem is that EFSA has required more data to complete its reviews, data that the industry have had difficultly in providing, originating from 90 day studies and general toxicity tests, however.
EFFA has pointed out that the potential economic impact of these substances not being on the EU list, and Michael Flueh, DG Sanco’s head of unit, chemicals, contaminants and pesticides said DG Sanco is currently carrying out in-house impact assessment to verify this data
“I think it is an important message,” he told delegates at the European Flavour Association (EFFA) conference in Brussels. “DG Sanco intends to find a solution to minimise impact on industry, but we cannot compromise food safety.”
He said the final decision is expected within the next four weeks, but added that shifting the deadline is not an option. There can be no extension again as would have to do through co-decision between the parliament and council again.
Completing the assessments
The European Commission has now asked EFSA to conclude safety reassessments of all the outstanding 400 by 2014. Flueh said the industry needs to ensure the dossiers are available to EFSA.
He called on all stakeholders make an effort to give the dossiers to allow EFSA to meet this deadline.
“You will not be able to keep substances on the market after 2014 if it is not fully assessed,” he emphasised. Having to remove substances from the market would result in a chaotic situation where substances currently being used in foods would no longer be legal.
The missing data was not necessarily requested at the start of the reassessment process, but EFSA deems it necessary in order to complete its work. The necessity of completing new 90-day and general toxicity studies means flavour companies must divert R&D budgets away from innovation and towards studies on well-established substances.
EFSA as a reference
The outstanding flavour substances have all been approved by the Joint WHO/UN Expert Committee on Food Additives (JECFA), a green light which is seen as adequate in some other parts of the world.
Flueh said that questions have been asked, especially from non-EU stakeholders, as to why the EU authorities cannot accept the evaluation of the on the outstanding flavourings.
“I would like to make it very clear the Commission takes into account Codex and JECFA, but our reference is EFSA,” he said.