The European Food Safety Authority (EFSA) last month published its final guidance for data required to assess new food flavourings under the flavouring regulation 334/2008, which was adopted at the end of 2008 as part of the Food Improvement Agents package of regulations.
The guidance, which was previously aired in draft form, was developed with the input of the European Flavour Association (EFFA). Consultant Joy Hardinge, chair of EFFA’s flavour expert committee, told FoodNavigator.com that representatives were able to put their views across to EFSA – and a lot of those views will be taken on board.
“We welcome the guidance document because having guidance is better for both sides,” she said, adding that it is guidance so “is not hard and fast”.
“As long as there is some pragmatism we feel quite positive”.
There are one or two concerns about how well it will work, “but once the first dossiers are submitted we will see how it works”.
The areas of concern include protection of confidential data, especially details of the production process. “We understand it is important that information is available,” said Hardinge, but there are occasions when confidentiality over technical know-how should be maintained.
The emphasis on intake and exposure from all sources is also somewhat problematic. While industry knows how much of a substance is in a flavour, it is not always easy to take on board other sources.
EFSA is currently doing a lot of work on harmonising methods for calculating dietary exposure, but harmonisation on a global scale would be helpful too.
The guidance document is divided into two parts.
Part A covers flavouring substances – that is, chemically defined substances with flavouring properties. Hardinge said that the data needs included in the guidance document are generally very similar to what has been provided in the past because EFSA has been evaluating flavouring substances for some time.
She expects that dossiers on as many as 50 new flavouring substances could be submitted by industry per year.
Part B covers categories of flavourings other than flavouring substances, such as non-food flavour precursors and thermal flavours, wide groups of materials that require a more general approach.
Hardinge expects only very few such substances to be submitted each year, but the guidance accepts that these will have to be tackled on a more ad hoc basis with documentation tailored to the product.
The European Commission will draw on the guidance when putting together its implementing measures for the FIAP package of regulations, which has to be in place by the end of the year. One set of implementing measures will cover flavours, additives and enzymes, probably in different articles.
This means that some elements of the guidance are likely to become requirements, but only the “key bits that have to be in the dossier”.
She also said the industry is aware that more guidance will come. “Some bits need more explanation, we expect more discussion”.
EFSA has 9 months to assess each dossier and give its opinion, but if its panel has questions the clock stops. After that, the Commission has another 9 months to write it into regulation, so it could take as long as 2 years.