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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: 

http://www.efsa.europa.eu/en/events/event/111012.htm

http://flyonthewall.com/FlyBroadcast/efsa.europa.eu/Workshop1011/index.php?language=english&stream=wmv

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

Dear Catherine, 

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.

Best wishes

Patti Rundall

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: 

1. a clear separation of scientific assessment from the political process. 
2. EFSA's rules on conflicts of interest do not relate just to 'product specific' work.  EFSA opinions have global and industry wide implications.
3. experts with commercial conflicts of Interest are consulted in open meetings  but not  involved in the formulation of opinions 
4. all data submitted to EFSA for evaluation of foods for infants and young children is in the public domain
5. no claim is approved on the basis of cherry-picked, industry-funded, and possibly 'proprietary'  dossiers.  
6. EFSA always assess the totality of research including independent systematic reviews and peer reviewed papers.
7. EFSA consultations are open to the public
8. the term 'Trust' is replaced by the word  'credible' 
9. declarations of interest  include the proportion of income derived from commercial sources, to indicate the relevance and importance of the  interest. 
10. EFSA allocate a certain % of funds to  validate COI statements. 
11. DG Research provide 100% funding for research in the public interest and not encourage the involvement of commercial partners, especially for research on infant and young child feeding. 
12. EFSA's assessment of claims must include safety as well as efficacy. 
13. All ingredients used for infants and young children must  pre-authorised, ie thoroughly assessed  for safety and efficacy by a rigorous process whose objectivity and independence is not open to question. 
14. All Directives relating to infant feeding  must require a rigorous pre-authorisation system.  The  addition of  "other food ingredients, as the case may be." must not be permitted.  (2006/141/EC) 
15. If an ingredient is shown to be safe,  important for child health or reduces the inadequacies of breastmilk substitutes  it should be mandatory, in line with the opinion of the UK Government’s Scientific Advisory Committee on Nutrition (SACN) :"We find the case for labelling infant formula or follow on formula with health or nutrition claims entirely unsupportable. 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."  (5)

Specific comments relating to infant and young child feeding

Assessing Claims: 

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) 

NOTES:

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 

http://info.babymilkaction.org/pressrelease/pressrelease06apr1

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

IBFAN/Baby Milk Action/Baby feeding Law Group comments on the PANUTS revision. 2011

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

5 http://www.sacn.gov.uk/pdfs/position_statement_2007_09_24.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

http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154126.htm

10 ESPGHAN Comments on the Circular Letter CL 2005/53-NFSDU and on the Synopsis of comments received until 30 April (prepared by Germany)