Stefanie Geiser, EAS regulatory affairs manager, said that as the European Commission has indicated it intends to present its proposal for an article 13.1 "Union list" of claims to the Standing Committee for discussion and potential adoption only by the end of 2011, it was unlikely that any ban on rejected claims would come into force before spring or summer 2012.
The European Commission is awaiting the final batches of article 13.1 claims opinions from the European Food Safety Authority (EFSA), expected in June and September, before it can finalize its proposal for the Union list.
EFSA has completed 80% of its article 13.1 claims assessments for all substances excluding botanicals, with around 600 claims still to be assessed.
¡°If the Commission¡¯s proposal is adopted at the end of the year, there must still be a final adoption process, which includes a three-month European Parliament scrutiny procedure,¡± Ms. Geiser said. ¡°In addition, the Commission will most likely also provide a post-article 13 list transition period of some months. Therefore it¡¯s unlikely that we will see a ban on any article 13.1 claims before summer 2012. However, the ban is immanent and companies should be carefully monitoring the EFSA opinions and planning future strategies for marketing products that currently bear article 13.1 claims.¡±
EFSA issued a set of 442 article 13.1 claims opinions in April, of which Ms. Geiser said only 22% were positive, with nearly one third of those having already been assessed before.
Positive assessments included claims on the blood cholesterol lowering effect of unsaturated fatty acids (MUFAs and PUFAs), and dental health claims for sugar-free chewing gum (with carbamide/fluoride) and sugar replacers.
¡°One surprise in the April batch, in light of EFSA¡¯s trend so far, has been a first positive opinion for an antioxidant claim¡ªon polyphenols from olive oil and the protection of lipids from oxidative damage,¡± said Ms. Geiser. ¡°Until now EFSA had only issued positive antioxidant claims opinions for vitamins and minerals.¡±
Unfavorable opinions on the April batch focused on claims relating to immune response or natural defences, digestive or intestinal health, and vitality or anti-aging effects of probiotics, plant extracts and many other ingredients.
Negative opinions also related to the health effects of amino acids, of which only one opinion for an amino acid has received a positive opinion so far. For probiotics published to date too, with the exception of the effect of certain live yogurt cultures with starter micro-organisms Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus on lactose digestion, all EFSA opinions have been unfavorable.
To address how food businesses can benefit from what has already been learned in the claims evaluation process, and to help companies offset possible challenges and plan strategies for the future regulatory environment, Ms. Geiser and EAS colleagues will host a workshop in Brussels on Thursday, June 9 titled ¡°Claims: Dealing with the present, planning for the future.¡±