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News 15.07.2011

Article 13.1 Claims Negative List Not Expected Before Summer 2012 Says EAS

The threat of a first EU-wide ban on the use of article 13.1 claims on the European Commission’s negative register is not…

The threat of a first EU-wide ban on the use of article 13.1 claims on the European Commission’s negative register is not expected before summer next year, international food policy consultancy EAS has said.

Stefanie Geiser, EAS Regulatory Affairs Manager, said that 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 finalise its proposal for the Union list.

EFSA has completed 80 percent 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,” 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 Geiser said only 22 percent 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 – on polyphenols from olive oil and the protection of lipids from oxidative damage,” said Geiser. “Until now EFSA had only issued positive antioxidant claims opinions for vitamins and minerals.”

Unfavourable opinions on the April batch focused on claims relating to immune response or natural defences, digestive or intestinal health, and vitality or anti-ageing 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 yoghurt cultures with starter micro-organisms Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus on lactose digestion, all EFSA opinions have been unfavourable.

Notes to Editors:

  1. EAS provides strategic consulting advice on international regulation on food and nutritional products. It provides companies with regulatory and strategic advice for the marketing and approval of their products in Europe, Asia and Latin America.
  2. EAS also advises governments, trade associations and companies on the impact of global policy.
  3. EAS has offices in Argentina, Belgium, Italy and Singapore.
  4. For more information on EAS Europe contact EAS, 50 Rue de l’Association, 1000 Brussels, tel.: (+32) (0) 2 218 14 70, email or visit
  5. For information on EAS Asia contact EAS Strategic Advice Pte Ltd, 3 Killiney Road, 07- 04 Winsland House I, Singapore 239519, tel: (+65) 68 38 12 70, email: or visit
  6. For more information on EAS Latin America contact EAS América Latina S. A., Calle Lola Mora, 421 – 5th floor – No. 502, 1107 Buenos Aires, tel: (+54) 911 4071 0455, email: or visit

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