Committee Organic Production « Baby Food » Committee Organic Production 16/17 April 2018 DG AGRI B.4

Main issues presented for discussion Interpretation of the current rules on organic production and practices of the organic « baby food » sector New rules introduced into the draft back-log implementing act and the organic reform Articulation between horizontal rules (DG SANTE) and organic production rules Consequences for the updtae of Annex IX on Non-organic agricultural ingredients 1 2 3

Current rules and interpretation Article 19 (2) (b) of Reg 834/2007 only …minerals, trace elements, vitamins, as well as amino acids and other micronutrients in food-stuffs for particular nutritional uses may be used, and only in so far as they have been authorised in accordance with Article 21 Article 21 of Reg 834/2007 the autorisation of products and substances for use in organic production and their inclusion in a restricted list of the products and substances referred to in Article 19(2(b) shall be subject to the objectives and principles laid down in title II and the following criteria, which shall be evaluated as a whole: (i) alternatives authorised in accordance with this chapter are not available; (ii) without having recourse to them, it would be impossible to produce or preserve the food or to fulfill given dietary requirements provided for on the basis of the Community legislation In addition, the products and substances referred to in Article 19(2)(b) are to be found in nature and may have undergone only mechanical, physical, biological, enzymatic or microbial processes, except where such products and substances from such sources are not available in sufficient quantities or qualities on the market

Current rules on organic production Article 27 (1) (f) of Reg 889/2008 Only the following substances can be used in the processing of organic food minerals (trace elements included), vitamins, aminoacids, and micronutrients, only authorised as far as their use is legally required in the foodstuffs in which they are incorporated COM interpretation Ares (2016) 7232896 Foodstuff intended for particular nutritional uses like processed cereal-based foods and baby foods for infants and young children and infant formulae and follow-on formulae supplemented « with vitamins and minerals of non-agricultural origin » cannot be labelled as organic Important issue for the organic « baby food » sector Comments received from stakeholders and Member States

New rules Draft « back-log » implementing act and organic reform Point 2.2.2 (f) of Part IV processed food production rules of Annex II In the processing of food, the following products and substances may be used: (f) Minerals (trace elements included), vitamins, amino-acids and micronutrients, provided that: (i) their use in food for normal consumption is ‘directly legally required’, in the meaning of being directly required by provisions of Union law or provisions of national law compatible with Union law, with the consequence that the food cannot be placed at all on the market as food for normal consumption if those minerals, vitamins, amino acids or micronutrients are not added; or (ii) as regards food placed on the market as having particular characteristics or effects in relation to health or nutrition or in relation to needs of specific groups of consumers: - in products referred to in points (a) and (b) of Article 1(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council their use is authorised by that Regulation and acts adopted on the basis of Article 11(1) of that Regulation for the products concerned, or - in products regulated by Commission Directive 2006/125/EC, their use is authorised by that Directive.

« Baby food » Products covered by the organic reform points (a) and (b) of Article 1(1) of Regulation (EU) No 609/2013 Infant formula and follow-on formula Processed cereal-based food and baby food Infant means a child under the age of 12 months Young child means a child aged between one and three years Young child formulae (Growing-up milks, toddlers’ milk milk based drink for young children) not covered by Reg (EU) No 609/2013

Infant formula and follow-on formula Infant formula means food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding Follow-on formula means food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in progressively diversified diet of such infants

Processed cereal food and baby food Processed cereal-based food means food: Intended to fulfill the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation, to ordinary food Pertaining to one of the following categories: Simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquid Cereals with added high protein food which are or have to be reconstituted with water or other protein-free liquid Pastas which are to be used after cooking in boiling water or other appropriate liquids Rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids Baby food means food: intended to fulfill the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food, excluding Processed cereal-based food; and milk-based drinks and similar products intended for young children

Articulation between horizontal rules and organic production rules Art 6(2) Reg (EU) 609/2013 The requirements laid down in this Regulation shall prevail over any conflicting requirement of Union law applicable to food Art 2(5) organic reform This Regulation applies without prejudice to other specific Union provisions relating to the placing of products on the market

Horizontal rules (DG SANTE) Reg (EU) No 609/2013 framework legislation on foods for infants and young children- contains definitions of the different products and, in Annex the list of authorised sources of vitamins and minerals and certain other nutrients that can be used in the manufacturing of the products Commission Delegated Regulation (EU) 2016/127 supplementing Reg (EU) No 609/2013 on infant formula and follow-on formula (applicable from 2020) contains specific compositional requirements it shall repeal and replace Directive 2006/141/EC on infant formulae and follow-on formulae Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children (currently being revised) contains compositional criteria Commission Regulation (EU) 2017/2158 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food

Infant formula, follow-on formula essential composition Commission Directive 2006/141/EC Infant formula: Annex I lipids (point 5.7 long chain polyunsaturated fatty acids), fructo-oligosaccharides and galacto-oligosaccharides (point 9 « may be added to infant formula »), mineral substances (point 10), vitamins (point 11), min and max limits for minerals and vitamins Follow-on formula: Annex II lipids (point 4.7 long chain polyunsaturated fatty acids), fructo-oligosaccharides and galacto-oligosaccharides (point 7 « may be added to follow-on formula »), mineral substances (point 8), vitamins (point 9), min and max limits for minerals and vitamins

Infant formula, follow-on formula compositional requirements Commission Delegated Regulation (EU) 2016/127 will repeal and replace Directive 2006/141/EC from 22.2.2020 (22.2.2021) Infant formula: Annex I lipids (point 5.6 docohexaenoic acid, point 5.7 other long-chain polyunsaturated fatty acids may be added), fructo-oligosaccharides and galacto-oligosaccharides (point 9 « may be added to infant formula »), mineral substances (point 10), vitamins (point 11), min and max limits for vitamins and minerals Follow-on formula: Annex II lipids (point 4.6 docosahexaenoic acid, point 4.7 other long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids may be added), fructo-oligosaccharides and galacto-oligosaccharides (point 7« may be added to follow-on formula »), mineral substances (point 8), vitamins (point 9), min and max limits for vitamins and minerals

Processed cereal-based foods and baby foods for infants and young children Essential composition Commission Directive 2006/125/EC currently being revised Processed cereal-based foods for infants and young children: Annex I Minerals (point 5), Vitamins (point 6), max limits for vitamins, minerals and trace elements, if added (point 6) Baby foods for infants and young children: Annex II vitamins (point 5), max limits for vitamins, minerals and trace elements, if added (point 6)

Issues raised by MS IT, UK , FR growing milk for 1-3 years old FR if needed to add to Annex IX non-organic agrciultural ingredients ARA (arachidonic acid), ARASCO DHA Docosahexaenoic acid, DHASCO Galacto-oligosaccharide Lacprodan (whey protein hydrolisate) BE mitigation measures on acrylamide and asparaginase from/by GMOs in baby food and, processed cereal-based food intended for infants and young children as defined in Reg 609/2013

Conclusions Sensitive issue need to always keep in mind the overall objectives and principles of organic production Need to resolve the issue for the current rules until the entry into application of the organic reform Draft back-log implementing act Need to ensure consistency between horizontal rules (DG SANTE) and organic production rules Interpretation of the rules (ie growing milk for 1-3 years old) Revision of Annex IX of Reg 889/2008(precise references and uses, consistency/cross references to DG SANTE legislation)