London High Court case over - now it's time to act over illegal infant formula labelling says Baby Milk Action Press release 29 February 2008 The baby food industry challenge to the UK Infant Formula and Follow-on Formula Regulations at the High Court in London came to an end today with the Judge, Mr Justice Mitting, ruling that companies will have 2 years to bring labels into line with the 2007 version of the Regulations which were due to come into force on 11 January 2008. Companies will have to comply with all other parts of the Regulations immediately. The Infant and Dietetic Food Association (IDFA) has sought a Judicial Review which led to the suspension of the Regulations in England, Wales and Northern Ireland and the two-day High Court hearing that has just been completed. The Regulations remained in force in Scotland, pending the Judicial Review there which took place last week, but has not yet seen a judgement. Baby Milk Action was allowed by the English court to intervene on behalf of the Baby Feeding Law Group and the Breastfeeding Manifesto Coalition, two coalitions representing 38 health professional and lay organisations, including 5 Royal Colleges and two major unions. Patti Rundall OBE, Policy Director of Baby Milk Action was permitted to give an oral submission in which she stressed the urgent health consequences if the industry won its case (Notes 2 and 3) and how company promotion was undermining the health messages professionals were trying to convey. She highlighted the fact that companies had already been using the labeling sections they liked - such as introducing new claims - but was refusing to use the sections which safeguard health, such as the requirement to make a clear distinction between follow-on formula for older babies and infant formula for newborns or the improved warnings regarding contamination. She also showed that labels on the market are still non-compliant with the previous 1995 Regulations and that companies have already been warned by Trading Standards they must change these labels. Now that the ruling has been made, Baby Milk Action is calling for Trading Standards to act to take non-compliant labels off the market. Both 1995 and 2007 Regulations allow only a limited number of claims on labels. In July 2007 Lynne Jones MP tabled an Early Day Motion calling for the law to be enforced. See our press release with pictures of non-compliant labels at: http://archive.babymilkaction.org/press/press20july07.html Both the 1995 and 2007 Regulations also prohibit idealizing text and images from labels. Trading Standards have already warned various companies they must change their labels to comply. Mike Brady, coordinator of a monitoring project on behalf of the Baby Feeding Law Group, a coalition of 22 health professional and mother support groups, said: "This will hopefully be a hollow victory for the companies as we have been able to present evidence to the court showing that labels on the market are non-compliant with both the 1995 and 2007 version of the Regulations. Let us hope Trading Standards officers will now move to have illegal labels removed from the market. Companies introduced new labels from April 2007 after being reminded of the provisions by the authorities, but did not remove all non-compliant claims. The public have been subjected to this misleading promotion for far too long. "We did want the 2007 labelling provisions to come into force immediately as associated Guidance Notes recommend companies bring their warnings and instructions into line with the Food Standards Agency guidance to parents to reduce the risks of possible contamination with harmful bacteria. The FSA introduced their guidance to parents in 2005 and it is very troubling that companies have won this delay until 2010 - this unwillingness to provide essential information on how to reduce known risks with powdered formula shows the contempt with which companies treat those parents who do use it." The case revolved around whether one word - ‘Products’ - in the EU Directive from which the regulations derive was intended, by the unknown bureaucrat in Brussels who drafted it, to refer to just the formula or also to the label. It is accepted that companies have 2 years to change the composition of the formula. The manufacturers banded together to argue in three separate hearings – in Edinburgh, London and Belfast - that the word ‘product’ was meant to include the label and new provisions designed to stop cross promotion of products and improve information to parents should also be delayed by 2 years. Baby Milk Action submitted written evidence that showed that repeatedly in the Directive the same word ‘product’ was used to refer to the formula alone. The Government also made these points and the judge agreed that this approach was valid. However, on one occasion only, other than the occasion at the heart of the case, the context meant that the draftsman intended the word to cover labelling as well. The judge indicated that were it not for that one other occasion he might have been persuaded that the word did not extend to include labelling. The UK Government indicated to the court that they would be prepared to give a delay until June 2008 to help manufacturers have time to comply had they lost the case. Having lost today, the UK Government applied for and was granted leave to appeal. The Government has also given repeated undertakings to review the operation of the Regulations during the next 12 months and to revise them if they are not effective in protecting the right of parents and carers to receive objective and accurate information on infant feeding and has indicated this review will proceed. Most aspects of the regulations now come into force and the behaviour of companies in changing labels can be evaluated, including whether they improve warnings and instructions. Patti Rundall OBE, Policy Director of Baby Milk Action, spoke in the hearing and said afterwards : "This is a very disappointing judgment which turned on the meaning of the one word 'product'. In our view there are many other aspects that could have been considered. Trying to establish what was in the mind of the drafters in a Directive such as this which has been in formation for over 25 years, is not a good approach in my view. Many people, including Member States, have had input into the process and there are clearly different opinions about the meaning of various Articles. "The legal action itself shows the irresponsibility of the manufacturing companies in seeking judicial review purely for their own commercial purposes, putting those way ahead of the need for new labelling to protect the health of babies. Their actions could have serious social, health and environmental consequences." An important point that Baby Milk Action stressed in our written evidence was that the choice of form or method (criminal, civil or other controls) by which Member States implement Directives is a matter for them provided they achieve the intended result (note 6). Contamination of powdered formula with Enterobacter Sakazakii has led, in rare cases, to brain damage and death of infants. Baby Milk Action calls upon the manufacturers, notwithstanding today’s judgement, to make the changes immediately and to show that they are not deliberately attempting to confuse parents and withhold essential safety advice and calls upon Trading Standards to take action over labels that do not comply with the old or new Regulations. Graham Ross, legal advisor to Baby Milk Action, said: "This victory does not protect them from immediate civil liability to parents for injuries to babies not prevented by clearly worded labelling in the form set out within the Regulations, albeit such will not now be enforceable by criminal sanction until 2010." For further information contact: Mike Brady: 020 3239 9222 or Patti Rundall: 07786 523493 or Graham Ross: 07973 243257 Notes: The controls called for by health advocates protect the right of all parents - those who bottlefeed and those who breastfeed - to base their decisions on evidence-based independent information rather than misleading commercial promotion. Health costs: The 2006 National Institute for Health and Clinical Excellence (NICE) clinical guidelines on ‘Postnatal care: Routine postnatal care of women and their babies’ Reference: CG37 outlines these costs: Cost assumptions on an increase of breastfeeding of 11% is estimated to save approximately £5m per annum (for 3 just three illnesses, otitis media, asthma and gastroenteritis) Breastfeeding reduces the risk of babies developing many illnesses. The lower incidence of illness is associated with a reduced risk of later childhood disease as well as protecting the mother’s health. It has been suggested that the lower incidence of illness which would be associated with higher breastfeeding rates could also lead to significant cost savings in the treatment of some illnesses, such as gastro-enteritis, otitis media and asthma. Breastfeeding also provides an ideal window of opportunity for obesity prevention, and exclusive breastfeeding protects against rapid weight gain during infancy. The UK has breastfeeding rates amongst the lowest in the industrialised world. Despite government commitments to improve breastfeeding rates there has been little change, with initiation rates of just 76%, meaning a quarter of infants receive no breastmilk at all. Breastfeeding rates then decline rapidly as the promotion by the manufacturers represented by the Claimants, and exposed in Baby Feeding Law Group monitoring shows undermines breastfeeding and encourages mothers to use formula. In the UK few infants are breastfed at 6 months. Government figures show just 48% are breastfed at 6 weeks The baby formula market is increasing steadily and has almost doubled since 1995. It is now worth aprox £199 million per year. Marketing practices that breach the provisions of the Code and Resolutions are receiving ever greater resources from the industry. Robert Madelin, Director General of the EU Commission’s Health and Consumer Protection Directorate (DG SANCO ) has confirmed this: “Firstly, in accordance with Article 249 EC Treaty, Directives are binding as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods".