The amendment of Regulation (EU) No 438/2013 corrects for a mistake in the regulation that would have limited the use of silicon dioxide and silicate in food supplements to 1% - well below the levels that are safely used in supplements currently.
The error, which was spotted by members of Food Supplements Europe, occurred when the additives were transposed into the new Regulation that comes in to force on June 1st.
Had the mistake not been updated before this point, the new regulation would have led to the majority of food supplements within the UE failing to meet the regulation and so being wiped from the market, the trade body said.
“We welcome the decision of the European Commission to correct the error,” said Ingrid Atteryd, chair of the Swedish food supplements association Föreningen Svensk Egenvård and member of Food Supplements Europe.
“We are pleased to see that the amendment was published before Regulation 1129/2011 takes effect on 1 June,” she added.
Food Supplements Europe said that while the level of silicon dioxide and silicates (E 551 - E 559) for food supplements was set in the original food additives legislation (Directive 95/2/EC) as Quantum satis.
However, a different regulation published in 2011 (Regulation 1129/2011) set a new maximum level of 1% in error, said the group.
“The original version of the additives legislation is very clear in the Quantum satis level that is set for these additives in food supplements, and the new level limit was simply a drafting error,” explained Atteryd.
The additives are used as both an anti-caking agent and stabilisers in many supplement products. As a result usage levels typically exceed 1%, Food Supplements Europe said.
“If this incorrect entry had remained in the additives legislation, once the transition period ended a large number of food supplements would have needed reformulation or been wiped off the market immediately.”
The amending Regulation, found in full here, will enter into force on 1 June 2013.