UK Government raises concerns about Probiotics

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See previous blog entry HERE

The EU Parliament's ENVI Committee yesterday voted unanimously for the new proposals for a Regulation on food intended for infants and young children, food for special medical purposes.  This will now go forward for the final vote in the full EU Parliament in Strasbourg  in June. 

One of the things we have been lobbying for in these proposals is the issue of 'optional ingredients' and the pre-authorisation of all ingredients used in baby formulas and foods, so we are pleased that once this regulation is adopted these issues can be considered in the new delegated acts.  Whatever happens, there will be more oversight from Parliament on all new ingredients. 

The UK Government's Advisory Committee on Nutrition (SACN)  has been strongly supporting this call, and in 2007 said  "If an ingredient is unequivocally beneficial as demonstrated by independent review of scientific data it would be unethical to withhold it for commercial reasons. Rather it should be made a required ingredient of infant formula in order to reduce existing risks associated with artificial feeding. To do otherwise is not in the best interests of children, and fails to recognise the crucial distinction between these products and other foods."

Most recently, during the Standing Committee meeting of 29 April,  the UK Government referred to SACN's concerns regarding  the suitability of probiotics.   You can find this in  Item M.3 in the  Minutes of the meeting



(Section General Food Law)


M.3 Request from United Kingdom of discussion on the assessment of the suitability of the use of a probiotic strain in infant formula and follow-on formula.

"The UK informed the Committee of the way it handled a notification received from a manufacturer of an infant formula containing a specific voluntary ingredient (the micro-organism Lactobacillus fermentum). The UK delegation explained that their Scientific Advisory Committee on Nutrition’s Subgroup on Maternal and Child Nutrition assessed the suitability of the ingredient in infant formula and follow-on formula for particular nutritional uses by infants in accordance with articles 5 and 6 of Directive 2006/141/EC. Following the conclusion that the evidence presented was not sufficient to demonstrate such suitability, the UK authorities concluded that the product in question would not comply with Directive 2006/141/EC and agreed with the manufacturer a procedure to remove the ingredient from products on the UK market. The UK delegation first underlined that it was aware of the product having been notified in other Member States and it asked other delegations to confirm that this was indeed the case. Several Member States confirmed that either this product or other products with similar ingredients were notified in their territory. Different reactions were reported with respect to the right of these products to be placed on the market.

 The UK delegation then asked the Commission whether the procedure they followed was in line with EU legislation. The Commission explained that, in line with EU law and the rules of the Treaty, a Member State can restrict the marketingof an infant formula or a follow-on formula if they have justified grounds to do so. In particular, in the case of infant formulae and follow-on formulae containing ingredients not specified in Directive 2006/141/EC, Articles 4 to 6 of the Directive are relevant. According to these Articles, when a food business operator places a product with a new ingredient on the market, a dossier substantiating that the ingredient is safe and suitable for the intended purpose, must be available. The Member State may request to evaluate that dossier if they wish to do so and it is their right to consider that the ingredient does not meet the requirements of Articles 4 to 6 and to refuse the placing on the market of products with such ingredient. In this context, the Commission recalled that the concept of suitability includes elements of safety and expected benefits and that in order to assess the latter, evaluations carried out by EFSA on specific substances in the context of the implementation of Regulation (EC) No 1924/2006 on nutrition and health claims can also provide a useful tool for national competent authorities.

 The UK delegation finally underlined that they would support the establishment of a centralised prior authorisation procedure at EU level for addition of new nonessential ingredients to infant formulae and follow-on formulae, based on the advice of the European Food Safety Authority with regard to the safety and suitability of the ingredient. The Commission concluded that it will be possible to further discuss this issue during discussions on the forthcoming delegated act on infant formulae and follow-on formulae."