The European Food Standards Authority (EFSA) published its draft guidance document earlier this month and is currently consulting with stakeholders. The industry had been keenly awaiting some signposting on what will be required of companies wanting to use claims on products under the new legislation, which came into effect at the beginning of this year.

Over the last five months a number of companies and bodies have expressed concerns about how the legislation would be interpreted, and what the impact will be on the industry - particularly for small and medium enterprises (SMEs).

ERNA secretary general Patrick Coppens said that the guidance was welcome, especially since it is intended to be a "living" document.

But he highlighted some areas that are still of concern.

These include the omission of guidance on protection of proprietary data. Coppens said the indication is that EFSA and EC maintain that no submissions under the article 18 procedure (those on the EC list that are based on newly developed evidence and which include a request for proprietary data protection) can be made until the positive list of established health claims under article 13 is drawn up. This will not be finalised until 2010.

"If this interpretation continues to prevail, companies that had intended to use the procedure face losing return on investment because they will not be able to protect their data for the next three years," he said.

EFSA said at the time of the publication of the draft that it expects to update it later to include applications for claims under article 18.

Other cloudy areas include claims relating to children's health and development. No guidance has been issued on these since it is not yet clear what exactly will fall into this category.

Moreover, the document does not provide any further information on what criteria will be used to assess the value of scientific evidence, upon which EFSA opinion will be based.

ERNA believes that these criteria should be clarified and made put up for public consultation.

The European Botanical Council (EBF) also recently expressed concern about scientific evaluation.

EBF said last month (prior to publication of the draft guidance) it is not clear at the moment how much weight will be given to traditional evidence for botanicals - nor are any criteria laid out for how scientific substantiation should be demonstrated in claims submissions.

ERNA is planning to submit full feedback on the draft guidance document.

"Although the deadline is sharp, we will study the document in detail and submit our comments," said Coppens.

The deadline for comments is June 17, and a stakeholder platform meeting is to be held in Parma, Italy on June 11.