I attended the EFSA consultative workshop on Independence and Scientific Decision-Making Processes in Brussels on 12th October. Following the meeting I sent this comment to key EFSA officials.
You can see the documentation and the webcast of the whole day on these links:
To: Catherine Geslain-Lanéelle, Executive Director, EFSA
Dirk Detken, Head of Legal and Regulatory Affairs
Hubert Deluyker, Director or Science Strategy and Coordination
Per Bergman, Acting Director of Scientific Evaluation of Regulated Products
Juliane Kleiner, Head of Unit, NDA Panel
Ariane Titz, Officer, Nutrition
Re: IBFAN comments on EFSA consultative workshop on Independence and Scientific Decision-Making Processes
It was very good to meet everyone last week. Thank you to all EFSA staff for organising such an interesting and important workshop. I really appreciate your willingness to discuss these complex issues so openly and welcome the opportunity to suggest ways to strengthen EFSA's rules of procedure so that the quality of science is improved and any commercial bias is minimised. The European public - and the world at large - expect and need EFSA to be a credible source of independent advice that consistently puts the interests of public health above the political pressure to boost the EU economy. The word 'independence' makes no sense otherwise.
In my anxiousness to keep my questions short I perhaps didn't make clear IBFAN's appreciation of EFSAs assessment of the majority of health and nutrition claims related to foods for infants and young children. But however careful EFSA might be, a chain is only as good as its weakest link, and any decision not supported by sound evidence on infant and young child feeding is likely to have a long-lasting harmful impact, not only on EU health but also globally, because breastmilk substitutes are the sole source of nutrition during a critical period of rapid growth and development minor modifications can have major effects on child health. (1)
For this reason IBFAN has paid close attention to the rules of transparency and independence relating to the scientific advice provided to the European Commission in this area. Since the adoption of the revised PARNUTs Framework Directive in 1989, the Commission has had the power to draft and adopt legislation on baby milks and foods with no legal requirement to routinely consult Parliament. As a consequence the Commission and Member States have made several decisions that have weakened safeguards on infant feeding, in contravention of the EU's obligations to the UN, and its horizontal duty set out in the Lisbon Treaty that: “A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities.”
Some of these decisions have been justified by 'advice' from the Scientific Committee for Food (SCF) which until 2000 did not require its members to made public declarations of interest. (2) In 1999, IBFAN wrote to Commissioner David Byrne and Glenys Kinnock MEP submitted a number of written questions to the Commission. In January 2000 Commissioner Liikanen responded by promising that the annual declarations of the SCF would be made public. In April 2000 we had an informal meeting with the Commission to discuss transparency in the context of the development of the proposed reorganisation of the Scientific Committees and the establishment of a new European Food Authority. (3)
PARNUTs is now being revised again and we are calling for much greater involvement of EFSA - hence our concern to ensure that EFSA's procedures are sound. (see our comments)
Thank you once again for arranging the meeting. Below are our suggestions which I would be more than happy to discuss in more detail if this would be helpful.
Policy Director, Baby Milk Action
Secretariat of the Baby Feeding Law Group
IBFAN suggestions for improving EFSA's independence, reducing the potential for bias and improving the quality of science
We acknowledge that the potential for bias is present in all research, and that 'independence' from commercial interest does not ensure quality. However, misleading findings and unintended consequences are reduced if research is commissioned and funded by a disinterested party rather than one active in the market and where academic rigour can be demonstrated in the research process. Problems are compounded by publication bias where trials with negative outcomes are less likely to be published.
Given that the health and nutrition claims that are assessed by EFSA for use on baby foods are generic and lead to policy decisions that have an impact far beyond the specific brand, the rationale for protecting commercial confidentiality and basing opinions on 'proprietary' data, is absent.
As a general safeguard, all research on humans should meet the highest ethical criteria, and should, ideally, be pre-registered with all results placed in the public domain. But in addition, public health policy, especially in the area of infant and young child feeding, should be predominantly informed by independent, publicly financed studies that are in the public domain and subjected to a rigorous peer review process in journals where authors are not permitted to select their own peer reviewers.
While the baby food industry has a responsibility to improve its products, research on babies - and babies under 12 weeks in particular - is fraught with ethical problems. Infants are an especially vulnerable group that do not consent on their own behalf so need special protection. Commercial involvement in such research also opens the door for coercion and inappropriate presentation of the risks involved. In addition, as you know, the absence of evidence to support the safe use of additives in foods for babies under 12 weeks has been a matter of discussion at several Codex meetings. (4)
We recommend that:
Specific comments relating to infant and young child feeding
The following example demonstrates the need for EFSA to include experts who have a thorough scientific knowledge of infant and young child feeding.
In 2009 EFSA gave a positive opinion which led to the approval of a health claim relating to DHA and visual acuity in follow-on formulas and baby foods, foods that are normally recommended for babies over 6 months. In a letter to the European Commission in September 2009, EFSA clarified its opinion saying:“The evidence, however, does not establish that starting DHA supplementation at 4-6 months in infants who had received a control (DHA-free) formula in the first months of life would have an effect on the visual development of those children... There are no data from specific randomised control trials supporting a benefit of DHA supplementation starting at 6 months of life in infants fed a DHA-free formula in the first 6 months of life....” [6)
EFSA 's approval of this claim conflicted with that of many leading health bodies, and with WHO: “WHO does not have a recommendation about the addition of docosahexaenoic acid (DHA) to formula milk.....to date no solid evidence exists to be able to say that adding DHA to infant formula will have important clinical benefits. Were WHO to give such a recommendation, it would have to follow a strict guideline development process based on grading of all available evidence collected through systematic reviews by expert panels free from conflict of interest.” (7)
In line with EU Health Claims regulations EFSA only assessed the 'efficacy' of the claim and had not looked at the risk. However on 25th March 2011, 10 days before the European Parliament was to vote on this partcular claim, EFSA's Director of Risk Assessment, Riitta Maijala, wrote to the Commission, saying "We are unaware of any factor in breast milk which is needed for DHA to exert its "optimal" effect." (8)
In fact synthesised DHA added to formulas is in a different biological environment to breastmilk, which is a species-specific, living substance. Formula contains no co-enzymes or co-factors to enable the fats to work optimally as they do in breastmilk. Indeed the US FDA , commented to Martek (the DHA manufacturer) in 2001: “The bioactive fatty acids ARA and DHA when consumed in mature human milk are part of a complex matrix that includes, for example, linoleic acid, alpha-linolenic acid, and other polyunsaturated fatty acids ...important physiologic considerations relative to the matrix are not accounted for by the simple addition of LCPUFAs to infant formula.” (9)
Pre-authorisation of ingredients.
EU Directive (2006/141/EC) allows the addition of "other food ingredients, as the case may be." This failure to require rigorous pre- authorisation of all ingredients has allowed companies to add any ingredient they choose - before its safety has been properly evaluated by a body such as EFSA and european babies have effectively been taking part in a mass uncontrolled trial. Manufacturers justify this practice by referring to a 'history of safe use' or suggesting that problems would come to light in consumer phone lines. There is no evidence to support such claims. (10)
Manufacturers who wish to market a new infant formula need only submit a label to the authorities. Member States may require a dossier to support safety or efficacy claims, but this is not a mandatory requirement. There is no notification procedure at all for follow-on milks. In the current reform of PARNUTs IBFAN is therefore calling for pre-authorisation of all ingredients and greater transparency and accountability of EU policy making process.
IBFAN and the Baby Feeding Law Group disagree with the Commission's assessment that the pre-authorisation of ingredients would be a ‘disproportionate burden' to industry, or that claims are an essential incentive to industry to improve products. We consider that health and nutrition claims are inappropriate for foods for infants and young children, in line with the SACN statement above. (5)
1 Baby Milk Action Press Release. 23.12.09. European opinion on baby foods influenced by industry funding http://www.babymilkaction.org/press/press23dec09.html
BMA Press release 6.4.11: European Parliament votes to block DHA health claim - but not by a large enough majority to guarantee action by the Commission
2 Baby Milk Action to to Robert Madelin, DG DGSANCO, June 2004. (attached)
3 Notes of a meeting between IBFAN and EU Commission about transparency and Scientific Committees, 27 April 2000 (attached)
Scientists Bow to call for more transparency: European Voice, March 2000 (attached) and the British Medical Journal March 2000
4 MATTERS REFERRED TO THE COMMITTEE BY THE CODEX ALIMENTARIUS COMMISSION AND/OR OTHER CODEX COMMITTEES
CX/NFSDU 07/29/2 ftp://ftp.fao.org/codex/ccnfsdu29/nf29_02e.pdf
6 EFSA to EU Commission 3.9.09
7 WHO to Glenis Willmott MEP: http://info.babymilkaction.org/sites/info.babymilkaction.org/files/WHO%20DHA_0.PDF
8 Riitta Maijala to Eric Poudelet,EU Commission. 25.3.11 (attached)
9 FDA Agency Response Letter GRAS Notice No. GRN 000041 CFSAN/Office of Premarket Approval
10 ESPGHAN Comments on the Circular Letter CL 2005/53-NFSDU and on the Synopsis of comments received until 30 April (prepared by Germany)
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|IBFAN Commission.Apr 00.doc||47.5 KB|
|Corregendum EP - 28.03.2011.pdf||252.06 KB|
|BMA BFLG IBFAN PARNUTs PDF.pdf .pdf||212.54 KB|