Thank you to everyone who supported our efforts to change the way that EU legislation is made – making it more transparent, accountable and protective of child health.
MEPs in the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) voted on 29th February on hundreds of amendments to a report on the Commission proposal for a new regulation on Food for infants & young children and for special medical purposes. There are ongoing discussions and it is not clear when the issue will be debated in the full plenary.
see Glenis Willmott MEP’s Blog
Click here for IBFAN’s point by point commentary
What happened?
The good news is that many of the amendments we wanted were adopted including the calls for the precautionary principles, better safeguards on contaminants and pesticides, slightly stricter controls on claims, a delay in the decision regarding Growing Up milks, more oversight from the European Parliament and EFSA and post market surveillance.
The bad news is that the most important one (Compromise Amendment no 12) did not get through. THis amendment would have called for follow-on milk advertising to be controlled in the same way as infant formula. Also passed were some worrying amendments and text – one that was completely misleading about breastfeeding and low birth weight babies.
One good thing – the exploitative and ridiculous idea of foods targetting the elderly did not get through. Whatever next!
I’ll post more details here when I’m absolutely sure what got through and what didn’t. The next stage will be a vote of all MEPs in the Strasbourg Plenary, currently planned for 17th April
Much will depend on the rigour of the European Food Safety Authority (EFSA) so I will be interested to attend the Information Session on Implementing Rules of EFSA’s Independence Policy next Monday.
Click here for the COMPROMISE AMENDMENTS We were supporting nos 6,7,8, 9 and 13 – which all got through and 12 which did not.
We were also supporting the following single amendments:
3,4,8, 13 (Precautionary principle) 14,17 (controls on pesticides) 18,21,22 (better Parliamentary /EFSA oversight) ,27,38,41,45,47,52,53,54 (strengthened democratic oversight) ,61 (controls on exports) 81,85,91,103 (caution on Nano technology), 104,106,107,173 (appropriate language for Exports) ,175,179,190,193,194,195,196 (calling for no advertising of foods for infants and young children), 199 (refers to independent qualified professionals) ,204, 213 (lowest possible pesticide residues), 216,225 (calling for post-market monitoring) ,240 (no advertising of Follow-on milks) , 250 (caution on Nano technology) 254,256, 259,261 (Transparency), 279 (review of GUMs)
We are strongly opposed to amendments Nos 125, 126, 127 which all refer to products for infants “in good health”
This is outside our remit but I strongly oppose Amendment 133 – which opens the door for an entirely unnecessary and exploitative food pyramid targeting the elderly. The industry was criticised when it brought this idea up at the last Platform on Diet and Physical Activity.
MEP Amendments 57-156 and 168-262
IMCO amendments 1-30
ENVI DRAFT Report (amendments 1-57)
Legal status for growing-up milk and toddler milk
Please support the Consolidated amendment no 6
(19 a) The Commission should clarify, after consulting the European Food Safety Authority, the status of milks intended for infants between and 12 and 36 months (also known as ‘growing-up milks’ (GUMs)) which are currently regulated by different EU regulations , and submit a report to the European Parliament and the Council assessing whether further legislative acion is required, at the latest 1 year after the date of the entry into force of this Regulation. if appropriate the report should be accompanied by a legislative proposal
Labelling, presentation and advertising of food
Please support compromise amendment No 7 Part 1 (Covering AMs 41 and 216 (rapporteur), AM 193 (Rossi), AM 194 (Schlyter and Schaldemose), AM 195 (Schlyter and Schaldemose), AM 240 Sârbu, Willmott, Schaldemose))
3. The labelling, presentation and advertising of food referred to in Article 1(1) shall be accurate, clear and easy to understand for consumers and must not be misleading. It shall not attribute properties to such products for the prevention, treatment or cure of human disease, or imply such properties.
Please support Compromise amendment No 7 Part 2 3 a. The labelling of infant formulae and follow-on formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. Graphic representations for easy identification of the product and for illustrating methods of preparation shall, however, be permitted. Directive 2006/141 will be amended accordlingly.
Please support Compromise amendment 8 covers amendments 43 (rapporteur), AM 197 (Sarbu), 198 (Rossi), 199 (Liotard), 200 (Gardini), 201 (Girling), 202 and 206 (De Lange) and 203 (Sonik))
The dissemination of any useful information or recommendations with reference to the categories of food referred to in points (a), (b) (c) and (ca) of Article 1 (1) may be made exclusively to persons having qualifications in medicine, nutrition or pharmacy. Additional information by health care professionals to the final consumer shall only be of a scientific and factual nature and shall not constitute advertising.
Please support Compromise Amendment NO 12 by the GREENS AND SOCIALISTS (Sarbu, Schlyter and Liotard) which replaces amendments 240 and 196
Advertising of infant formulae and follow-on formulae shall be restricted to publications specialising in baby care and scientific publications and shall contain only information of a scientific and factual nature. Member States may further restrict or prohibit such advertising. The advertising of infant formulae and follow-on formulae shall be such that it enables consumers to make a clear distinction between infant formula and follow-on formula and avoid any risk of confusion between the above mentioned categories of products.
The are many other good amendments about safety of ingredients, monitoring and
marketing. Here are some of the most important:
No 61 Daciana Sarbu – Exports
Having regard to the Council Resolution of 18th June 1992 on the marketing of breast-milk
substitutes in third countries by Community-based manufacturers.
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No 196 from Carl Schlyter, on behalf of the Greens which states:
3 c.” Advertising of infant formulae, follow-on formulae and of any other kind of food intended for infants or young children shall be prohibited. This includes advertisements in publications, point-of-sale advertising, giving samples or any other promotional device to induce sales directly to the consumer. “
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197 Daciana Octavia Sârbu, Glenis Willmott, Christel Schaldemose
4. The dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively by persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.4. The dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively by persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care. Such information shall not constitute advertising or promotional material.
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225 Carl Schlyter on behalf of the Verts/ALE Group
(f a) a requirement for post-market monitoring in order to ensure that the specific legislative requirements e.g. regarding pesticides, contaminants, labelling and advertising are met.
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240 by Daciana Octavia Sârbu, Glenis Willmott, Christel Schaldemose
Article 14 of Commission Directive 2006/141/EC is amended as follows:
“Article 14
1. Advertising of infant formulae and follow-on formulae shall be restricted to publications specialising in baby care and scientific publications. Member States may further restrict or prohibit such advertising. Such advertisements for infant formulae and follow-on formulae shall be subject to the conditions laid down in Article 13(3) to (7) and Article 13(8)(b) and contain only information of a scientific and factual nature. Such information shall not imply or create a belief that bottlefeeding is equivalent or superior to breast feeding.
2. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula or follow-on formulae directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales.
3. Manufacturers and distributors of infant formulae and follow-on formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers.”
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Amendment 13 Frederique Ries (Rapporteur) ALDE Liberal calls for precautionary principle
European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety establishes common principles and definitions for Union food law in order to ensure a high level of protection of public health and consumer interests, while allowing the effective functioning of the internal market. It establishes the principles of risk analysis in relation to food, sets out the precautionary principle as a provisional risk management measure and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the European Food Safety Authority (hereinafter referred to as ‘the Authority’). Therefore, certain definitions laid down in that Regulation must also apply in the context of the present Regulation. Moreover, for the purpose of this Regulation, the Authority should be consulted on all matters likely to affect public health.
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See the Press release about the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) debate on 20th December 2011.
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Several of our concerns have been addressed in the ENVI report on the EU Commission’s proposals to revise the legislation on baby and specialised foods. MEPs have also submitted many amendments which, if adopted, would go a long way to bring EU legislation into line with the International Code and subsequent WHA Resolutions.
The strongest amendment is no 196 on Article 9 parag 3c (new) from Carl Schlyter, on behalf of the Greens which states:
3 c.” Advertising of infant formulae, follow-on formulae and of any other kind of food intended for infants or young children shall be prohibited. This includes advertisements in publications, point-of-sale advertising, giving samples or any other promotional device to induce sales directly to the consumer. “
The report, drawn up by the Rapporteur, Frederique Ries, includes welcome references to safety, prohibition of pesticides, a regularly updated list of ingredients, and calls for the Precautionary Principle to be used for both the internal market and exports.
The ENVI report prepared by Frederique Ries also includes this overarching paragraph: (29b) This Regulation cannot be fully effective as regards protection of the most vulnerable consumers and, a fortiori, its nutritional benefits, unless it is backed up by a robust and independent assessment system (composition, labelling, reformulation) before and after the marketing of food products, responsibility for which lies principally with the European Food Safety Authority, in cooperation with the competent national authorities.
The Amendments will be voted in the ENVI committee on the 29th February
IBFAN comments on the Commission’s proposals to revise PARNUTs Directive on specialised foods
• The main proposal to revise and limit the scope of PARNUTs is welcome.
• Growing up milks and Toddler Milks – like follow-on milks – are unnecessary products, which encourage bad eating habits in children and should ideally not be on the market. However if its impossible to ban their sale, they should never be referred to specifically in any legal text. They could perhaps be caught by these regulations if the safeguards cover all foods for infants and young children. If necessary the generic term ‘milks for older babies’ could be used. (see note 1-2)
• There should be pre-authorisation of all novel and existing ingredients for all foods for infants and young children, especially pre-term formulas, formulas for special purposes and normal formulas. The pre-authorisation should include a rigorous evaluation for safety and efficacy, involving independent systematic reviews of the totality of research. The ENVI report includes a provision saying that: Vitamins, minerals, amino acids and other substances may be added to food referred to in Article 1(1), provided that such substances meet the following conditions….. (Note 3) This should be deleted because it leaves the door open for optional ingredients and promotional claims.
As stated by the UK Government’s Scientific Advisory Committee on Nutrition (SACN) 2007:
“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.”
• Our recommendations to EFSA for improving the level of science are here: http://info.babymilkaction.org/node/502
• All products should be labelled and presented in such a way as to avoid any risk of confusion between infant formulae, pre-term /specialised formulas and formulas for older babies.
• As mentioned in the Report, the Precautionary Principle must be used as an overarching safeguard when dealing with products targetting vulnerable groups.
• Health and nutrition claims should not permitted for any foods for infants or young children. (for comments see our briefing http://info.babymilkaction.org/pressrelease/pressrelease06apr11
• Safeguards must be included to prevent the promotion of ‘formulas for mothers’ These products are widely promoted in Asia, often sharing the same brand name as breastmilk substitutes and promoting these products by default. They are unnecessary, expensive, and undermine confidence in wholesome family foods.
• Formulas for special medical purposes, pre-term babies and for older babies must fall under the same marketing restrictions as infant formulas, and be in line with the recommendations of the World Health assembly. Pre-term and sick babies are even more vulnerable and need greater protection not less.
• There must be more transparency of the procedures, in relation to minutes, observer access etc etc, with more power, oversight and right of veto given to Parliament.
• Exports: The safeguards contains in the COUNCIL DIRECTIVE 92/52/EEC must be retained and strengthened to:
The EU as a major exporting region must require all exports of foods for infants and young children to be in the appropriate language and without promotional images and text. Many countries do NOT have specific legislation to take care of this. For example, Indonesia has no law requiring imports to be in the correct language, apart from requiring imports to carry a sticker with nutrition information. Laos apparently allows imports to be in the exporters language. Mozambique requires imports to be in Portuguese, the official language, however, like many countries in this region it struggles to ensure that the imports comply. Thailand has a law requiring all imports to be in the correct language, but its baby food marketing law is weak so other aspects of the Export Direct may not be covered.
It is essential that the EU as a major exporting region requires that health, nutrition and promotional claims are not permitted. Health and nutrition claims on an ever increasing number of products are used wherever they are not specifically banned. Claims are distorting parents perceptions about the nutritional value of products, tricking parents into believing that they have to use this or that fortified milk or food if they want a clever, healthy child. The DHA claim that MEPs debated in March 2011 is not even substantiated for the EU context. Even if EU procedures are improved as we propose (http://info.babymilkaction.org/node/502 ) risks assessments would not address global settings. Claims should never be permitted on exports unless the importing countries specifically authorise them. This would be unlikely if strict independent risk assessment procedures are followed..
Unless the recommended changes are made it export regulations must ensure that the Regulation:
• covers all foods for infants and young children(removing the reference to ‘healthy infants’ )
• does not permit health and nutrition claims – the EU must not lower global standards. (See Note 4 for text of Codex Guidelines for the use of Nutrition and Health claims (CAC/GL 23-1997, Rev. 1-20041) and WHA Res 63.23 )
• specifies that products are labelled and presented in such a way as to avoid any risk of confusion between infant formulae, specialised formulas and formulas for older babies.
• specifies that complementary foods (baby foods) for infants and young children do not share the same brand names as formula milks.
• specifies that the age of introduction of complementary foods is 6 months in line with World Health assembly Recommendation and policies over 70 countries.
• incorporate the provisions of COUNCIL RESOLUTION of 18 June 1992 on the marketing of breast-milk substitutes in third countries by Community-based manufacturers (92/C 172/01) which encourages: “compliance with the International Code of Marketing of Breast-milk Substitutes when these products are placed on sale in export markets, in so far as this does not conflict with the provisions in force in the countries concerned” and offers EU “effective support to competent authorities to apply the International Code in their territory.”
• ensures that all references to the International Code include the subsequent relevant WHA Resolutions.
Diary Notes:
MEPs will submit comments and suggestions for improvements to the Report so please do share the ideas listed below. The deadline for ENVI amendments is 18 January with a vote in Committee on 29 February. The issue is scheduled for a vote in plenary on 17 April. The Internal Market and Consumer Protection Committee(IMCO) will also submit comments. The deadline for IMCO amendments is 12th January.
The link to the recording of the ENVI debate is here:
the link to the IMCO debate is here: http://www.europarl.europa.eu/ep-live/en/committees/video?event=20111220-1500-COMMITTEE-IMCO&vodtype=Live
Note 1
There is no proven medical or nutritional need for formulas to be marketed especially for older babies. After the age of 1 year, the milk recommended as part of a diet to ensure children grow and develop well is full fat cows milk, and there is no need for modified cows milk at this stage as the nutritional emphasis should be on food.
The German Consumer Association survey found that these miks (called Kindermilch) were up to four times more expensive than normal milk, costing parents up to 245 euros more each year and commonly had twice as much sugar as normal milk. http://www.vzhh.de/ernaehrung/129727/kostenfalle-kindermilch.asp
The Infant Formula Directive already permits a wide compositional range of nutrients that meet the requirement for formulas for older infants and young children and there is nothing to stop parents continuing to feed standard infant formulas throughout the first and second year if that is their choice.
Heavily fortified modified milks for children over the age of 1 year are generally not required, and there is no evidence that adding additional nutrients as supplements to diets is advantageous for children, and some evidence emerging that high intakes of iron in particualr are potentially harmful.
See comments to Codex here: http://info.babymilkaction.org/sites/info.babymilkaction.org/files/IBFAN%20on%20FUF%2011_0.pdf
Iron-Fortified vs Low-Iron Infant Formula Developmental Outcome at 10 Years
Betsy Lozoff, MD; Marcela Castillo, PhD; Katy M. Clark, MA; Julia B. Smith, EdD Arch Pediatr Adolesc Med. Published online November 7, 2011. This study from Chile indicates that infants with high iron levels at 6 months, who were fed iron-fortified formulas had IQ levels 10 points lower at the age of 10 years than infants who had low-iron levels
Note 2 The Federal Institute for Risk Assessment (BfR). 16.08.2011 formulas for babies over 1 year. ” According to the Federal Institute for Risk Assessment (BfR), toddler milk does not, however, offer any advantage compared to reduced fat cow milk, as recommended by nutritional scientists for infants. “From a nutritional and physiological point of view these special toddler milks are not necessary”, says BfR President Professor Dr. Andreas Hensel. Enriched vitamins and minerals in those products rather result in an uncontrolled increase in the supply of some nutrients whereas other vitamins and minerals are included in lower amounts than in cow milk. Furthermore, it is currently not sufficiently proven in scientific terms that a reduced protein supply in early childhood reduces the risk of obesity and adiposity during the later childhood. The fat content of toddler milk is more or less comparable to the content of whole milk and hence higher than the content in reduced fat milk.”
www.bfr.bund.de/en/press_information/2011/29/toddler_milk_drinks_are_not_better_than_cow_milk-126749.html
Note 3 The Codex Guidelines for the use of Nutrition and Health claims (CAC/GL 23-1997, Rev. 1-20041) states in Para 1.4 that: Nutrition and health claims shall not be permitted for foods for infants and young children except where specifically provided for in relevant Codex standards or national legislation.
WHA 2010 Resolution 63.23 calls on Member States (4) to end inappropriate promotion of food for infants and young children and to ensure that nutrition and health claims shall not be permitted for foods for infants and young children, except where specifically provided for, in relevant Codex Alimentarius standards or national legislation;
PRETERM FORMULAS : WHO recommends that low-birth-weight (LBW) infants, including those with very low birth weight (VLBW), should be fed mother’s own milk. If these infants cannot be fed mother’s own milk, they should be fed donor human milk (in settings where safe and affordable milk banking facilities are available or can be set up) or standard infant formula. Very-low-birth-weight infants who cannot be fed mother’s own milk or donor human milk should be given preterm infant formula if they fail to gain weight despite adequate feeding with standard infant formula. http://www.who.int/elena/titles/supplementary_feeding/en/index.html# So in terms of legislation, pre-term babies is in any case covered by default in the 3 categories, but there would be no harm having a special category for formulas for very tiny babies.
“Formulas for special nutrition’ There is no need for a special category for “formulas for special nutrition’ – which would could lead to confusion circumvention of advertising and labeling restrictions. Formulas such as Cow&Gate Comfort –marketed for the “dietary management of colic and constipation’ don’t even carry the warning or statements affirming the superiority of breastfeeding.
http://www.cowandgate.co.uk/our_products/baby_milks/comfort_milk
http://ec.europa.eu/food/food/labellingnutrition/nutritional/docs/sanco_11224_2011_rev5_en.pdf