European policy setting

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The Norwegian Food Safety Authority has prohibited the sale of Mead Johnson’s Nutramigen 2 LGG follow-on formula following two scientific opinions from the Norwegian Scientific Committee for Food Safety (VKM) and using the precautionary principle.1 Nutramigen 2 LGG is classified as a food for special medical purposes so it does not have to have its claims cleared by EFSA. It contains Lactobacillus rhamnosus GG - a ‘probiotic’ strain. VKM is especially concerned about the possible negative long-term effects of using LGG on the micro flora in the gut and on the immune system.

1. In the absence of a scientific consensus that harm would not ensue, the burden of proof falls on those who would advocate taking the action.

  • Norway is not a member of the EU but has an agreement to implement EU Directives. The Convention of the Rights of the Child (CRC) is LAW in Norway and its legislation adopted in August 2008 is stricter than the EU Directive in relation to follow-on formula advertising. (Luxembourg bans follow-on milk advertising).


EU Ombudsman decision 

After a 20-month investigation, the European Ombudsman has decided not to uphold our complaint of ‘maladministration’ by the European Commission. We alleged that the Commission had failed to protect public health and had ignored Member States’ obligations to implement the International Code. The Ombudsman’s opinion focuses only on whether the Commission carried out “its tasks” adequately.

“No maladministration has been found as regards the complainant’s allegation that the Commission failed adequately to carry out its tasks in relation to the functioning of the SCoFCAH. Consequently, the complainant’s claim relating to the working methods of the SCoFCAH and expert committees in general cannot be sustained. This does not, however, preclude the complainant from addressing, if she so wishes, a petition to the European Parliament and proposing changes to the Comitology legislative framework.”

The Ombudsman fails to question the Commission’s analysis of the status of the International Code or its importance: “In any case, although the Code was only a recommendation, not an international agreement or convention, and was, therefore, not binding, Directive 2006/141 and other relevant EC legislation have endorsed most of its guiding principles.” see:


Time to change the rules?

The Ombudsman decision, although disappointing, does imply that there may be merit in changing the way EU laws are formed. It may also have stirred things up a bit. The Commission seems to be responding a bit better to Member States, and in June agreed with the UK’s concerns about bogus claims. It has also started discussions on a revision of the hugely important but invisible PARNUTS Framework Directive.* The Infant Formula and Follow-on Formulae Directive (141/2006/EC) that governs all EU legislation on formulas came about because during the 1980s the European Parliament kept rejecting the Commission’s weak proposals and demanded the implementation of the International Code as a European Directive. Parliament also questioned the scientific basis for including follow-on formulas in the Directive. In 1989 the Commission changed the rules, and created PARNUTs - effectively transferring the power to initiate and finalize legislation on baby foods and specialised foods to the European Commission - an unelected body. Parliament no longer had to be consulted and discussions could take place behind closed doors.

PARNUTs has been a serious fault line which has run through the policy making process in Europe ever since with the Commission invariably putting the needs of industry before its responsibility to protect public health. We are calling for PARNUTS to be scrapped in favour of a more transparent and accountable process.

* Council Directive on Foodstuffs Intended for Particular Nutritional Uses (89/398/EEC)


Optional ingredients

A major problem is the fact that the EU formula Directive allows companies to add ‘optional’ ingredients, “as the case may be.” This is illogical and risky, especially since the EU Commission has used PARNUTs to argue against pre-authorisation of new ingredients. In our opinion ingredients should only be added when proven to be safe and essential through an independent review of all the evidence (that MUST include independently funded research). They should then be mandatory in all formulas of that type - not promoted, as they are, with claims. (For more about the risks see page 12 and INFACT Canada’s website:

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