2.2.2016 EN Official Journal of the European Union L 25/30 COMMISSION DELEGATED REGULATION (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 11(1) thereof, Whereas: (1) Commission Directive 1999/21/EC (2) lays down harmonised rules on dietary foods for special medical purposes in the framework of Directive 2009/39/EC of the European Parliament and of the Council (3). (2) Directives 2009/39/EC and 1999/21/EC are repealed by Regulation (EU) No 609/2013. That Regulation lays down general compositional and information requirements for different categories of food, including food for special medical purposes. The Commission has to adopt specific compositional and information requirements for food for special medical purposes, taking into account the provisions of Directive 1999/21/EC. (3) Food for special medical purposes is developed in close cooperation with health care professionals to feed patients affected by or malnourished because of a specific diagnosed disease, disorder or medical condition that makes it impossible or very difficult for those patients to satisfy their nutritional needs through the consumption of other foods. For that reason, food for special medical purposes must be used under medical supervision, which may be applied with the assistance of other competent health professionals. (4) The composition of food for special medical purposes may differ substantially depending, among others, on the specific disease, disorder or medical condition for the dietary management of which the product is intended, on the age of the patients and the place in which they receive health care support, and the product's intended use. In particular, food for special medical purposes can be classified in different categories depending on whether its composition is standard or specifically nutrient-adapted for a disease, disorder or medical condition and on whether or not it constitutes the sole source of nourishment for the persons for whom it is intended. (5) Because of the wide diversity of food for special medical purposes, the rapidly evolving scientific knowledge on which it is based, and the need to ensure adequate flexibility to develop innovative products, it is not appropriate to lay down detailed compositional rules for such food products. It is however important to set principles and requirements specific to them in order to ensure that they are safe, beneficial and effective for the persons for whom they are intended on the basis of generally accepted scientific data. (6) In particular, the nutritional composition of food for special medical purposes developed to satisfy the nutritional requirements of infants should be based on that of infant formula and follow-on formula, in order to take into account the specificities of the nutritional requirements of infants. However, taking into account that infant formula and follow-on formula are intended for healthy infants, derogations should be provided for food for special medical purposes developed to satisfy the nutritional requirements of infants when this is necessary for the intended use of the product. (7) It is important to set basic rules concerning the content of vitamin and mineral substances in food for special medical purposes in order to ensure the free circulation of products which are different in composition and the protection of consumers. Such rules should be based on those of Directive 1999/21/EC, given that they have ensured an adequate framework for food for special medical purposes so far. Rules should include minimum and maximum amounts, in the case of products considered to be nutritionally complete for covering the nutritional requirements of the patient, and maximum amounts only, in the case of products considered to be nutritionally incomplete, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. (8) Pursuant to Regulation (EU) No 609/2013, the Commission has to adopt provisions restricting or prohibiting the use of pesticides and on pesticide residues in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children. Adopting provisions that are in line with the current scientific knowledge requires a significant amount of time, given that a comprehensive evaluation has to be carried out by the European Food Safety Authority on a number of aspects, including the appropriateness of the toxicological reference values for infants and young children. (9) Directive 1999/21/EC does not lay down such provisions. Commission Directives 2006/125/EC (4) and 2006/141/EC (5), however, do currently lay down specific requirements in this respect for foods for healthy infants and young children, based on two opinions given by the Scientific Committee for Food (SCF) on 19 September 1997 (6) and 4 June 1998 (7). (10) Taking into account the date of 20 July 2015 set by Regulation (EU) No 609/2013 for the adoption of this Delegated Regulation, the relevant existing requirements of Directives 2006/125/EC and 2006/141/EC should, at this stage, be taken over. However, it is appropriate to use the terminology of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (8). (11) A very low residue limit of 0,01 mg/kg for all pesticides is set on the basis of the precautionary principle. In addition, more severe limitations are set for a small number of pesticides or metabolites of pesticides for which even a maximum residue level (MRL) of 0,01 mg/kg might, under worst-case intake conditions, lead to an exposure exceeding the acceptable daily intake (ADI) for infants and young children. (12) A prohibition of the use of certain pesticides would not necessarily guarantee that food for special medical purposes developed to satisfy the nutritional requirements of infants and young children is free from those pesticides, since some pesticides are persistent in the environment and their residues can be found in the food. For that reason, those pesticides, are considered not to have been used if residues are below a certain level. (13) Food for special medical purposes has to comply with Regulation (EU) No 1169/2011 of the European Parliament and of the Council (9). In order to take account of the specific nature of food for special medical purposes, this Regulation should lay down additions and exceptions to those general rules, where appropriate. (14) Providing all information that is necessary to ensure the appropriate use of food for special medical purposes should be mandatory for this type of food. That information should include information on the properties and characteristics in relation to, among others, the special processing and formulation, nutritional composition and rationale of use of the product that make it useful for its specific intended purpose. Such information should not be considered as nutrition and health claims within the meaning of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (10). (15) The nutrition declaration for food for special medical purposes is essential in order to guarantee its appropriate use, both for patients consuming that food and for health care professionals who recommend its consumption. For that reason and in order to provide more complete information to patients and healthcare professionals, the nutrition declaration should include more particulars than those required by Regulation (EU) No 1169/2011. In addition, the exemption provided for in point 18 of Annex V to Regulation (EU) No 1169/2011 should not apply and the nutrition declaration should be mandatory for all food for special medical purposes, irrespective of the package or container size. (16) Consumers of food for special medical purposes have different nutritional needs than the normal population. The expression of nutrition information on the energy value and the amount of nutrients of food for special medical purposes as a percentage of daily reference intake values set out in Regulation (EU) No 1169/2011 would mislead consumers and should therefore not be allowed. (17) The use of nutrition and health claims authorised under Regulation (EC) No 1924/2006 to promote food for special medical purposes would not be appropriate, since consumers of such products are patients suffering from a disease, disorder or condition and are, therefore, not part of the general healthy population. In addition, food for special medical purposes is to be used under medical supervision and its consumption should not be promoted through the use of nutrition and health claims directly targeting consumers. For those reasons, the use of nutrition and health claims should not be allowed for food for special medical purposes. (18) In the past years, an increasing number of products have been placed on the market as food for special medical purposes developed to satisfy the nutritional requirements of infants. These products are sometimes promoted with means directly targeting consumers that are not subject to the restrictions under Union legislation applicable to infant formula and follow-on formula. In order to avoid possible abuses linked to the misclassification of products, reduce confusion for consumers on the nature of the different products being offered to them and guarantee conditions of fair competition, it seems appropriate to introduce additional restrictions on the labelling, presentation, advertising, and promotional and commercial practices of food for special medical purposes developed to satisfy the nutritional requirements of infants. Those restrictions should be similar to those applicable to infant formula and follow-on formula for healthy infants, with adjustments taking into account the intended use of the product and without prejudice to the need to provide food information to patients and health care professionals to ensure the product's appropriate use. Given that food for special medical purposes is to be used under medical supervision, those restrictions should not make it more difficult for food business operators to communicate with health care professionals and should allow health care professionals to assess the suitability of different products for their intended use. (19) Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (11) requires Member States to enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution. In this context, in order to facilitate the efficient official monitoring of food for special medical purposes, food business operators placing food for special medical purposes on the market should provide the national competent authorities with a model of the label used and all relevant information considered necessary to demonstrate compliance with this Regulation, unless Member States have a different efficient monitoring system. (20) In order to enable food business operators to adapt to the new requirements, this Regulation should apply from a date that is 3 years after its entry into force. Taking into account the number and importance of the new requirements applicable to food for special medical purposes developed to satisfy the nutritional requirements of infants, in respect of such products this Regulation should apply from a date that is 4 years after its entry into force, HAS ADOPTED THIS REGULATION: Article 1 Placing on the market Food for special medical purposes may only be placed on the market if it complies with this Regulation. Article 2 Compositional requirements 1. Food for special medical purposes is classified in the following three categories: (a) nutritionally complete food with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended; (b) nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended; (c) nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment. The food referred to in points (a) and (b) of the first subparagraph may also be used as a partial replacement or as a supplement to the patient's diet. 2. The formulation of food for special medical purposes shall be based on sound medical and nutritional principles. Its use, in accordance with the manufacturer's instructions, shall be safe, beneficial and effective in meeting the specific nutritional requirements of the persons for whom it is intended, as demonstrated by generally accepted scientific data. 3. Food for special medical purposes developed to satisfy the nutritional requirements of infants shall comply with the compositional requirements set out in Part A of Annex I. Food for special medical purposes other than that developed to satisfy the nutritional requirements of infants shall comply with the compositional requirements set out in Part B of Annex I. 4. The compositional requirements set out in Annex I shall apply to the food for special medical purposes ready for use, marketed as such or after preparation in accordance with the manufacturer's instructions. Article 3 Requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children 1. For the purposes of this Article, ‘residue’ means the residue of an active substance as referred to in Article 2(2) of Regulation (EC) No 1107/2009 used in a plant protection product as referred to in Article 2(1) of that Regulation, including metabolites and products resulting from the degradation or reaction of that active substance. 2. Food for special medical purposes developed to satisfy the nutritional requirements of infants and young children shall not contain residues at levels exceeding 0,01 mg/kg per active substance. Those levels shall be determined by generally accepted standardised analytical methods. 3. By way of derogation from paragraph 2, for the active substances listed in Annex II, the maximum residue levels specified in that Annex shall apply. 4. Food for special medical purposes developed to satisfy the nutritional requirements of infants and young children shall only be produced from agricultural products for the production of which plant protection products containing the active substances listed in Annex III have not been used. However, for the purpose of checks, plant protection products containing the active substances listed in Annex III are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. 5. The levels referred to in paragraphs 2, 3 and 4 shall apply to the food for special medical purposes ready for use, marketed as such or after preparation in accordance with the manufacturer's instructions. Article 4 Name of the food The name of food for special medical purposes shall be as set out in Annex IV. Article 5 Specific requirements on food information 1. Unless otherwise provided in this Regulation, food for special medical purposes shall comply with Regulation (EU) No 1169/2011. 2. In addition to the mandatory particulars listed in Article 9(1) of Regulation (EU) No 1169/2011, the following shall be additional mandatory particulars for food for special medical purposes: (a) a statement that the product must be used under medical supervision; (b) a statement whether the product is suitable for use as the sole source of nourishment; (c) a statement that the product is intended for a specific age group, as appropriate; (d) where appropriate, a statement that the product poses a health hazard when consumed by persons who do not have the disease, disorder or medical condition for which the product is intended; (e) the statement ‘For the dietary management of …’ where the blank shall be filled in with the disease, disorder or medical condition for which the product is intended; (f) where appropriate, a statement concerning adequate precautions and contra-indications; (g) a description of the properties and/or characteristics that make the product useful in relation to the disease, disorder or medical condition for the dietary management of which the product is intended, in particular, as the case may be, relating to the special processing and formulation, the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product; (h) where appropriate, a warning that the product is not for parenteral use; (i) instructions for appropriate preparation, use and storage of the product after the opening of the container, as appropriate. The particulars referred to in points (a) to (d) shall be preceded by the words ‘important notice’ or their equivalent. 3. Article 13(2) and (3) of Regulation (EU) No 1169/2011 shall also apply to the additional mandatory particulars referred to in paragraph 2 of this Article. Article 6 Specific requirements on the nutrition declaration 1. In addition to the information referred to in Article 30(1) of Regulation (EU) No 1169/2011, the mandatory nutrition declaration for food for special medical purposes shall include the following: (a) the amount of each mineral substance and of each vitamin listed in Annex I to this Regulation and present in the product; (b) the amount of components of protein, carbohydrate, fat and/or of other nutrients and their components, the declaration of which would be necessary for the appropriate intended use of the product; (c) information on the osmolality or the osmolarity of the product where appropriate; (d) information on the source and the nature of the protein and/or protein hydrolysates contained in the product. 2. By way of derogation from Article 30(3) of Regulation (EU) No 1169/2011, the information included in the mandatory nutrition declaration for food for special medical purposes shall not be repeated on the labelling. 3. The nutrition declaration shall be mandatory for all food for special medical purposes, irrespective of the size of the largest surface of the packaging or container. 4. Articles 31 to 35 of Regulation (EU) No 1169/2011 shall apply to all the nutrients included in the nutrition declaration for food for special medical purposes. 5. By way of derogation from Article 31(3) of Regulation (EU) No 1169/2011, the energy value and the amounts of nutrients of food for special medical purposes shall be those of the food as sold and, where appropriate, those of the food ready for use after preparation in accordance with the manufacturer's instructions. 6. By way of derogation from Article 32(3) and (4) of Regulation (EU) No 1169/2011, the energy value and the amount of nutrients of food for special medical purposes shall not be expressed as a percentage of the reference intakes set out in Annex XIII to that Regulation. 7. The particulars included in the nutrition declaration for food for special medical purposes that are not listed in Annex XV to Regulation (EU) No 1169/2011 shall be presented after the most relevant entry of that Annex they belong to or are components of. Particulars not listed in Annex XV to Regulation (EU) No 1169/2011 that do not belong to or are not components of any of the entries of that Annex shall be presented in the nutrition declaration after the last entry of that Annex. The indication of the amount of sodium shall appear together with the other minerals and may be repeated next to the indication of the salt content as follows: ‘Salt: X g (of which sodium: Y mg)’. Article 7 Nutrition and health claims Nutrition and health claims shall not be made on food for special medical purposes. Article 8 Specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants 1. All mandatory particulars for food for special medical purposes developed to satisfy the nutritional requirements of infants shall appear in a language easily understood by the consumers. 2. The labelling, presentation and advertising of food for special medical purposes developed to satisfy the nutritional requirements of infants shall not include pictures of infants, or other pictures or text which may idealise the use of the product. However, graphic representations for easy identification of the product and for illustrating methods of preparation shall be permitted. 3. The labelling, presentation and advertising of food for special medical purposes developed to satisfy the nutritional requirements of infants shall be designed in such a way that it enables consumers to make a clear distinction between such products and infant formula and follow-on formula, in particular as to the text, images and colours used, so as to avoid any risk of confusion. 4. Advertising of food for special medical purposes developed to satisfy the nutritional requirements of infants shall be restricted to publications specialising in baby care and scientific publications. Member States may further restrict or prohibit such advertising. Such advertising shall contain only information of a scientific and factual nature. The first and second subparagraphs shall not prevent the dissemination of information exclusively intended for health care professionals. 5. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of food for special medical purposes developed to satisfy the nutritional requirements of infants directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales. 6. Manufacturers and distributors of food for special medical purposes developed to satisfy the nutritional requirements of infants shall not directly 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. Article 9 Notification When food for special medical purposes is placed on the market, the food business operator shall notify the competent authority of each Member State where the product concerned is being marketed of the information appearing on the label, by sending to it a model of the label used for the product, and of any other information the competent authority may reasonably request to establish compliance with this Regulation, unless a Member State exempts the food business operator from that obligation under a national system that guarantees an efficient official monitoring of the product concerned. Article 10 Directive 1999/21/EC In accordance with Article 20(4) of Regulation (EU) No 609/2013, Directive 1999/21/EC is repealed with effect from 22 February 2019. However, Directive 1999/21/EC shall continue to apply until 21 February 2020 to food for special medical purposes developed to satisfy the nutritional requirements of infants. References to Directive 1999/21/EC in other acts shall be construed as references to this Regulation in accordance with the scheme set out in the first paragraph. Article 11 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 22 February 2019, except in respect of food for special medical purposes developed to satisfy the nutritional requirements of infants, to which it shall apply from 22 February 2020. For the purposes of the second subparagraph of Article 21(1) of Regulation (EU) No 609/2013, in respect of food for special medical purposes developed to satisfy the nutritional requirements of infants the later date referred to in the second paragraph of this Article shall be considered as the date of application. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 25 September 2015. For the Commission The President Jean-Claude JUNCKER (1) OJ L 181, 29.6.2013, p. 35. (2) Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29). (3) Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (OJ L 124, 20.5.2009, p. 21). (4) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16). (5) Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1). (6) Opinion of the Scientific Committee for Food on a maximum residue limit (MRL) of 0,01 mg/kg for pesticides in foods intended for infants and young children (expressed on the 19 September 1997). (7) Further advice on the opinion of the Scientific Committee for Food expressed on the 19 September 1997 on a Maximum Residue Limit (MRL) of 0,01 mg/kg for pesticides in foods intended for infants and young children (adopted by the SCF on 4 June 1998). (8) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (9) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). (10) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, p. 9). (11) Regulation (EC) No 178/2002 of the 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 (OJ L 31, 1.2.2002, p. 1). ANNEX I COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(3) PART A Food for special medical purposes developed to satisfy the nutritional requirements of infants 1. Products referred to in Article 2(1)(a) developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 1. 2. Products referred to in Article 2(1)(b) developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 1, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 3. Maximum levels of vitamins and mineral substances present in products referred to in Article 2(1)(c) developed to satisfy the nutritional requirements of infants shall not exceed those specified in Table 1, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 4. Where this is not contrary to the requirements dictated by the intended use, food for special medical purposes developed to satisfy the nutritional requirements of infants shall comply with the provisions relating to other nutrients applicable to infant formula and follow-on formula, as the case may be, laid down in Commission Delegated Regulation (EU) 2016/127 (1). Table 1 Values for vitamins and minerals in food for special medical purposes developed to satisfy the nutritional requirements of infants Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamins Vitamin A (μg-RE) (2) 16,7 43 70 180 Vitamin D (μg) 0,48 0,72 2 3 Vitamin K (μg) 0,24 6 1 25 Vitamin C (mg) 0,96 7,2 4 30 Thiamin (μg) 9,6 72 40 300 Riboflavin (μg) 14,3 107 60 450 Vitamin B6 (μg) 4,8 72 20 300 Niacin (mg) (3) 0,1 0,72 0,4 3 Folate (μg-DFE) (4) 3,6 11,4 15 47,6 Vitamin B12 (μg) 0,02 0,12 0,1 0,5 Panthotenic Acid (mg) 0,1 0,48 0,4 2 Biotin (μg) 0,24 4,8 1 20 Vitamin E (mg α-tocopherol) (5) 0,14 1,2 0,6 5 Minerals Sodium (mg) 6 14,3 25 60 Chloride (mg) 14,3 38,2 60 160 Potassium (mg) 19,1 38,2 80 160 Calcium (mg) (6) 12 60 50 250 Phosphorus (mg) (7) 6 24 25 100 Magnesium (mg) 1,2 3,6 5 15 Iron (mg) 0,07 0,6 0,3 2,5 Zinc (mg) 0,12 0,6 0,5 2,4 Copper (μg) 14,3 29 60 120 Iodine (μg) 3,6 8,4 15 35 Selenium (μg) 0,72 2 3 8,6 Manganese (μg) 0,24 24 1 100 Chromium (μg) — 2,4 — 10 Molybdenum (μg) — 3,3 — 14 Fluoride (μg) — 47,8 — 200 PART B Food for special medical purposes other than that developed to satisfy the nutritional requirements of infants 1. Products referred to in Article 2(1)(a) other than those developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 2. 2. Products referred to in Article 2(1)(b) other than those developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 2, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 3. Maximum levels of vitamins and mineral substances present in products referred to in Article 2(1)(c) other than those developed to satisfy the nutritional requirements of infants shall not exceed those specified in Table 2, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. Table 2 Values for vitamins and minerals in food for special medical purposes other than that developed to satisfy the nutritional requirements of infants Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamins Vitamin A (μg-RE) 8,4 43 35 180 Vitamin D (μg) 0,12 0,65/0,75 (8) 0,5 2,5/3 (8) Vitamin K (μg) 0,85 5 3,5 20 Vitamin C (mg) 0,54 5,25 2,25 22 Thiamin (mg) 0,015 0,12 0,06 0,5 Riboflavin (mg) 0,02 0,12 0,08 0,5 Vitamin B6 (mg) 0,02 0,12 0,08 0,5 Niacin (mg NE) 0,22 0,75 0,9 3 Folic Acid (μg) 2,5 12,5 10 50 Vitamin B12 (μg) 0,017 0,17 0,07 0,7 Panthotenic Acid (mg) 0,035 0,35 0,15 1,5 Biotin (μg) 0,18 1,8 0,75 7,5 Vitamin E (mg α-TE) 0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ 0,75 0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal 3 Minerals Sodium (mg) 7,2 42 30 175 Chloride (mg) 7,2 42 30 175 Potassium (mg) 19 70 80 295 Calcium (mg) 8,4/12 (8) 42/60 (8) 35/50 (8) 175/250 (8) Phosphorus (mg) 7,2 19 30 80 Magnesium (mg) 1,8 6 7,5 25 Iron (mg) 0,12 0,5 0,5 2 Zinc (mg) 0,12 0,36 0,5 1,5 Copper (μg) 15 125 60 500 Iodine (μg) 1,55 8,4 6,5 35 Selenium (μg) 0,6 2,5 2,5 10 Manganese (mg) 0,012 0,12 0,05 0,5 Chromium (μg) 0,3 3,6 1,25 15 Molybdenum (μg) 0,84 4,3 3,5 18 Fluoride (mg) — 0,05 — 0,2 (1) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (see page 1 of this Official Journal). (2) Preformed vitamin A; RE = all trans retinol equivalent. (3) Preformed niacin. (4) Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0,6 μg folic acid from food for special medical purposes. (5) Based on vitamin E activity of RRR-α-tocopherol. (6) The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. (7) Total phosphorus. (8) For products intended for children of 1 to 10 years of age. ANNEX II ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(3) Chemical name of the substance Maximum residue level (mg/kg) Cadusafos 0,006 Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl) 0,006 Ethoprophos 0,008 Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) 0,004 Propineb/propylenethiourea (sum of propineb and propylenethiourea) 0,006 ANNEX III ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(4) Chemical name of the substance (residue definition) Aldrin and dieldrin, expressed as dieldrin Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton) Endrin Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion) Fentin, expressed as triphenyltin cation Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop) Heptachlor and trans-heptachlor epoxide, expressed as heptachlor Hexachlorobenzene Nitrofen Omethoate Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos) ANNEX IV NAME REFERRED TO IN ARTICLE 4 The name of food for special medical purposes shall be respectively: — in Bulgarian: ‘Храни за специални медицински цели’, — in Spanish: ‘Alimento para usos médicos especiales’, — in Czech: ‘Potravina pro zvláštní lékařské účely’, — in Danish: ‘Fødevare til særlige medicinske formål’, — in German: ‘Lebensmittel für besondere medizinische Zwecke (bilanzierte Diät)’, — in Estonian: ‘Meditsiinilisel näidustusel kasutamiseks ettenähtud toit’, — in Greek: ‘Τρόφιμα για ειδικούς ιατρικούς σκοπούς’, — in English: ‘Food for special medical purposes’, — in French: ‘Denrée alimentaire destinée à des fins médicales spéciales’, — in Croatian: ‘Hrana za posebne medicinske potrebe’, — in Italian: ‘Alimento a fini medici speciali’, — in Latvian: ‘Īpašiem medicīniskiem nolūkiem paredzēta pārtika’, — in Lithuanian: ‘Specialios medicininės paskirties maisto produktai’, — in Hungarian: ‘Speciális gyógyászati célra szánt élelmiszer’, — in Maltese: ‘Ikel għal skopijiet mediċi speċjali’, — in Dutch: ‘Voeding voor medisch gebruik’, — in Polish: ‘Żywność specjalnego przeznaczenia medycznego’, — in Portuguese: ‘Alimento para fins medicinais específicos’, — in Romanian: ‘Alimente destinate unor scopuri medicale speciale’, — in Slovak: ‘Potraviny na osobitné lekárske účely’, — in Slovenian: ‘Živila za posebne zdravstvene namene’, — in Finnish: ‘Erityisiin lääkinnällisiin tarkoituksiin tarkoitettu elintarvike (kliininen ravintovalmiste)’, — in Swedish: ‘Livsmedel för speciella medicinska ändamål’.

Summary: Foods for special medical purposes Foods for special medical purposes SUMMARY OF: Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 — the specific compositional and information requirements for food for special medical purposes WHAT IS THE AIM OF THE REGULATION? It modifies labelling requirements for foods for special medical purposes, and introduces a ban on making nutrition and health claims for such foods. It extends the rules for infant and follow-on formula on labelling, presentation, advertising and marketing to cover foods for special medical purposes intended for infants. It also extends the rules on pesticides to foods for special medical purposes intended for infants and young children. KEY POINTS The directive repeals Directive 1999/21/EC. It is a delegated act that supplements Regulation (EU) No 609/2013 on foods for specific groups. Food for special medical purposes: may only be placed on the market if it complies with this regulation; falls within 3 categories: nutritionally complete food with a standard nutrient formulation, which could constitute the sole source of nourishment, or be used as a partial replacement or supplement;nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition, which could constitute the sole source of nourishment, or be used as a partial replacement or supplement;nutritionally incomplete food which is not suitable to be used as the sole source of nourishment. Pesticides Food for special medical purposes developed for infants and young children must not contain pesticide residues exceeding 0.01 mg/kg per active substance. Food information labelling Food for special medical purposes must comply with Regulation (EU) No 1169/2011 on the labelling of foodstuffs and these statements or warnings (the first 4 points preceded by the words ‘important notice’ or equivalent) must appear on labelling: product must be used under medical supervision; whether the product is suitable for use as the sole source of nourishment; whether the product is intended for a specific age group; whether the product poses a health hazard for persons who do not have the condition for which the product is intended; the statement ‘For the dietary management of (the disease, disorder or medical condition for which the product is intended)’; precautions and contra-indications; a description of what makes the product useful in relation to the disease, disorder or medical condition, relating to the special processing and formulation, the nutrients and the product rationale; warning that the product is only to be taken by mouth; instructions for the preparation, use and storage of the product after opening. Nutritional declaration The mandatory nutrition declaration, with some specific exceptions, must include the amount (where appropriate) of minerals, vitamins, protein (including its source and nature), carbohydrate, fat and other nutrients and their components. Nutrition and health claims must not be made on food for special medical purposes. Specific requirements for food for special medical purposes developed for infants Mandatory information must be in a language easily understood by the consumers. Labelling must not include pictures of infants, or other pictures or text which may idealise the use of the product, with the exception of graphics for easy identification or illustrating preparation methods. Labelling must be designed so that consumers can make a clear distinction between such products and infant formula. Advertising must be restricted to publications specialising in baby care and scientific publications. There must be no point-of-sale advertising, free samples or any other promotional device directly to the consumer at the retail level. Manufacturers and distributors must not directly 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. Food business operators must notify the competent authority of each EU country, where the product is being placed on the market, by sending a model of the label used for the product, and any other information requested to establish compliance with this regulation. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 22 February 2019, except in respect of food for special medical purposes developed for infants, for which it applies from 22 February 2020. BACKGROUND For more information, see: Food for special medical purposes (European Commission) FAQ: foods for special medical purposes (European Food Safety Authority). MAIN DOCUMENT Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (OJ L 25, 2.2.2016, pp. 30-43) RELATED DOCUMENTS Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35-56) Successive amendments to Regulation (EU) No 609/2013 have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp. 18-63) See consolidated version. Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, pp. 71-86) See consolidated version. Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, pp. 1-33) See consolidated version. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, pp. 9-25) See consolidated version. Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (Codified version) (OJ L 339, 6.12.2006, pp. 16-35) Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, pp. 29-36) See consolidated version. last update 24.05.2019


27.7.2017 EN Official Journal of the European Union L 195/3 FRAMEWORK AGREEMENT between the European Union and Kosovo (*1) on the general principles for the participation of Kosovo in Union programmes THE EUROPEAN UNION, hereinafter referred to as ‘the Union’, of the one part, and KOSOVO (*1) of the other part, hereinafter referred to as ‘the Contracting Parties’, Whereas: (1) On 14 December 2007 the European Council underlined that the Union stands ready to play a leading role in strengthening stability in the region, stated the Union's readiness to assist Kosovo in the path towards sustainable stability and confirmed that the Union is ready to assist economic and political development through a clear European perspective, in line with the European perspective of the region. (2) On 7 December 2009 the Council welcomed the European Commission's Communication of 14 October 2009 entitled ‘Kosovo — Fulfilling its European Perspective’ and invited it to take the necessary measures to support Kosovo's progress towards the Union in line with the European perspective of the region. It attached importance to measures related to trade and visa, and encouraged the European Commission to open up for Kosovo taking part in Union programmes, integrating Kosovo into the economic and fiscal surveillance framework, activating the Instrument for Pre-accession Assistance's second component and strengthening the Stabilisation and Association Process dialogue. (3) On 14 December 2010 the Council stated that it looked forward to receiving a European Commission proposal that would allow for Kosovo's participation in Union programmes. The European Commission issued such a proposal in March 2011. (4) On 5 December 2011 the Council confirmed its commitment to find an agreement on Kosovo's participation in Union programmes, without prejudice to Member States' positions on status. (5) On 22 October 2012 the Council authorised the European Commission to open negotiations on behalf of the Union on a framework agreement with Kosovo concerning its participation in Union programmes. (6) Kosovo has expressed the wish to participate in a number of Union programmes. (7) Article 212 of the Treaty on the Functioning of the European Union refers to economic, financial and technical cooperation measures with third countries other than developing countries. (8) The specific terms and conditions, including the relevant financial contribution, for the participation of Kosovo in each particular Union programme should be determined by agreement between the European Commission, acting on behalf of the Union, and the authorities of Kosovo. (9) The signature and conclusion of this Agreement does not prejudge the position of Member States on the status of Kosovo, which will be decided in accordance with their national practice and international law. None of the terms, wording or definitions used in this Agreement, including its Annex, or in the Union programmes constitute recognition of Kosovo by the Union as an independent State, nor does it constitute recognition by individual Member States of Kosovo in that capacity where they have not taken such a step, HAVE AGREED AS FOLLOWS: Article 1 Kosovo shall be eligible to participate in the following Union programmes: (a) those current Union programmes listed in the Annex, and their successor programmes, which are open to the participation of Kosovo, once this Agreement enters into force; (b) Union programmes established or renewed after the signature of this Agreement which contain an opening clause providing for the participation of Kosovo. Kosovo shall be able to participate in Union programmes in accordance with its commitments to adopt and apply standards in the areas relevant to the programme concerned and the progress made in that respect. Article 2 Kosovo shall contribute financially to the general budget of the European Union in proportion to the specific Union programmes in which it participates. Article 3 Kosovo's representatives shall be allowed to take part, as observers and for the points which concern Kosovo, in the management committees responsible for monitoring the Union programmes to which Kosovo contributes financially. Article 4 Projects and initiatives submitted by participants from Kosovo shall, as far as possible, be subject to the same conditions, rules and procedures pertaining to the Union programmes concerned as applied to Member States. Article 5 The specific terms and conditions regarding the participation of Kosovo in each particular Union programme, in particular the financial contribution payable, will be determined by agreement between the European Commission, acting on behalf of the Union, and the authorities of Kosovo. Any such agreement shall be considered to be an integral part of this Agreement. If Kosovo applies for Union pre-accession assistance on the basis of Council Regulation (EC) No 1085/2006 (1), or pursuant to any similar regulation providing for Union external assistance to Kosovo that may be adopted in future, the conditions governing the use by Kosovo of Union assistance shall be determined in a financing agreement. Article 6 Each agreement referred to in the first paragraph of Article 5 shall stipulate, in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (2), that financial control or audits are to be carried out by, or under the authority of, the European Commission, the European Anti-fraud Office (OLAF) and the Court of Auditors. Detailed provisions shall be adopted for financial control and auditing, administrative measures, penalties and recovery that enable the European Commission, OLAF and the Court of Auditors to be granted powers equivalent to their powers with regard to beneficiaries or contractors established in the Union. Article 7 This Agreement shall apply for an indeterminate period. This Agreement may be terminated by either Contracting Party by giving six months' notice in writing. Article 8 The Contracting Parties may review this Agreement for the first time no later than three years after the date of its entry into force, and every three years thereafter, on the basis of the experience gained from Kosovo's participation in one or more Union programmes. Article 9 This Agreement shall apply, on the one hand, to the territories in which the Treaty on the Functioning of the European Union is applied and under the conditions laid down in that Treaty and, on the other hand, to the territory of Kosovo. Article 10 This Agreement shall enter into force on the first day of the first month following the date on which the Contracting Parties have notified each other of the completion of their respective procedures for its entry into force. Article 11 This Agreement shall be drawn up in duplicate in the Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish, Albanian and Serbian languages, each text being equally authentic. Съставено в Брюксел на двадесет и пети ноември през две хиляди и шестнадесета година. Hecho en Bruselas, el veinticinco de noviembre de dos mil dieciséis. V Bruselu dne dvacátého pátého listopadu dva tisíce šestnáct. Udfærdiget i Bruxelles den femogtyvende november to tusind og seksten. Geschehen zu Brüssel am fünfundzwanzigsten November zweitausendsechzehn. Kahe tuhande kuueteistkümnenda aasta novembrikuu kahekümne viiendal päeval Brüsselis. Έγινε στις Βρυξέλλες, στις είκοσι πέντε Νοεμβρίου δύο χιλιάδες δεκαέξι. Done at Brussels on the twenty fifth day of November in the year two thousand and sixteen. Fait à Bruxelles, le vingt cinq novembre deux mille seize. Sastavljeno u Bruxellesu dvadeset petog studenoga godine dvije tisuće šesnaeste. Fatto a Bruxelles, addì venticinque novembre duemilasedici. Briselē, divi tūkstoši sešpadsmitā gada divdesmit piektajā novembrī. Priimta du tūkstančiai šešioliktų metų lapkričio dvidešimt penktą dieną Briuselyje. Kelt Brüsszelben, a kétezer-tizenhatodik év november havának huszonötödik napján. Magħmul fi Brussell, fil-ħamsa u għoxrin jum ta‘ Novembru fis-sena elfejn u sittax. Gedaan te Brussel, vijfentwintig november tweeduizend zestien. Sporządzono w Brukseli dnia dwudziestego piątego listopada roku dwa tysiące szesnastego. Feito em Bruxelas, em vinte e cinco de novembro de dois mil e dezasseis. Întocmit la Bruxelles la douăzeci și cinci noiembrie două mii șaisprezece. V Bruseli dvadsiateho piateho novembra dvetisícšestnásť. V Bruslju, dne petindvajsetega novembra leta dva tisoč šestnajst. Tehty Brysselissä kahdentenakymmenentenäviidentenä päivänä marraskuuta vuonna kaksituhattakuusitoista. Som skedde i Bryssel den tjugofemte november år tjugohundrasexton. Në Bruksel, më njëzet e pesë nëntor të vitit dy mijë e gjashtëmbëdhjetë. U Briselu, dvadeset petog novembra godine dve hiljade šesnaeste. За Европейския съюз Рог la Unión Europea Za Evropskou unii For Den Europæiske Union Für die Europäische Union Euroopa Liidu nimel Για την Ευρωπαϊκή Ένωση For the European Union Pour l'Union européenne Za Europsku uniju Per l'Unione europea Eiropas Savienības vārdā – Europos Sąjungos vardu Az Európai Unió részéről Għall-Unjoni Ewropea Voor de Europese Unie W imieniu Unii Europejskiej Pela União Europeia Pentru Uniunea Europeană Za Európsku úniu Za Evropsko unijo Euroopan unionin puolesta För Europeiska unionen Për Bashkimin Evropian Za Evropsku uniju За Косово Por Kosovo Za Kosovo For Kosovo Für den Kosovo Kosovo nimel Για το Κοσσυφοπέδιο For Kosovo Pour le Kosovo Za Kosovo Per il Kosovo Kosovas vārdā – Kosovo vardu Koszovó részéről Għall-Kosovo Voor Kosovo W imieniu Kosowa Pelo Kosovo Pentru Kosovo Za Kosovo Za Kosovo Kosovon puolesta För Kosovo Për Kosovën Za Kosovo (*1) This designation is without prejudice to positions on status, and is in line with UNSCR 1244(1999) and the ICJ Opinion on the Kosovo declaration of independence. (1) Council Regulation (EC) No 1085/2006 of 17 July 2006 establishing an Instrument for Pre-Accession Assistance (IPA) (OJ EU L 210, 31.7.2006, p. 82). (2) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ EU L 298, 26.10.2012, p. 1). ANNEX LIST OF CURRENT UNION PROGRAMMES REFERRED TO IN ARTICLE 1 — Fiscalis 2020 (1) — Customs 2020 (2) — Hercule III (3) — Justice (4) — Rights, Equality and Citizenship Programme (5) — Europe for Citizens (6) — Civil Protection Mechanism (7) — Interoperability solutions for European public administrations, businesses and citizens (ISA2) (8) — COSME (9) — Programme for Employment and Social Innovation (EaSI) (10) — Erasmus+ (11) — Creative Europe (12) — Horizon 2020 (13) — Health for Growth Programme (14) — Consumer Programme (15) — LIFE (16) — Copernicus (17) (1) Regulation (EU) No 1286/2013 of the European Parliament and of the Council of 11 December 2013 establishing an action programme to improve the operation of taxation systems in the European Union for the period 2014-2020 (Fiscalis 2020) and repealing Decision No 1482/2007/EC (OJ EU L 347, 20.12.2013, p. 25). (2) Regulation (EU) No 1294/2013 of the European Parliament and of the Council of 11 December 2013 establishing an action programme for customs in the European Union for the period 2014-2020 (Customs 2020) and repealing Decision No 624/2007/EC (OJ EU L 347, 20.12.2013, p. 209). (3) Regulation (EU) No 250/2014 of the European Parliament and of the Council of 26 February 2014 establishing a programme to promote activities in the field of the protection of the financial interests of the European Union (Hercule III programme) and repealing Decision No 804/2004/EC (OJ EU L 84, 20.3.2014, p. 6). (4) Regulation (EU) No 1382/2013 of the European Parliament and of the Council of 17 December 2013 establishing a Justice Programme for the period 2014 to 2020 (OJ EU L 354, 28.12.2013, p. 73). (5) Regulation (EU) No 1381/2013 of the European Parliament and of the Council of 17 December 2013 establishing a Rights, Equality and Citizenship Programme for the period 2014 to 2020 (OJ EU L 354, 28.12.2013, p. 62). (6) Council Regulation (EU) No 390/2014 of 14 April 2014 establishing the ‘Europe for Citizens’ programme for the period 2014-2020 (OJ EU L 115, 17.4.2014, p. 3). (7) Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ EU L 347, 20.12.2013, p. 924). (8) Decision (EU) 2015/2240 of the European Parliament and of the Council of 25 November 2015 establishing a programme on interoperability solutions and common frameworks for European public administrations, businesses and citizens (ISA2 programme) as a means for modernising the public sector (OJ EU L 318, 4.12.2015, p. 1). (9) Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014 — 2020) and repealing Decision No 1639/2006/EC (OJ EU L 347, 20.12.2013, p. 33). (10) Regulation (EU) No 1296/2013 of the European Parliament and of the Council of 11 December 2013 on a European Union Programme for Employment and Social Innovation (‘EaSI’) and amending Decision No 283/2010/EU establishing a European Progress Microfinance Facility for employment and social inclusion (OJ EU L 347, 20.12.2013, p. 238). (11) Regulation (EU) No 1288/2013 of the European Parliament and of the Council of 11 December 2013 establishing ‘Erasmus+’: the Union programme for education, training, youth and sport and repealing Decisions No 1719/2006/EC, No 1720/2006/EC and No 1298/2008/EC (OJ EU L 347, 20.12.2013, p. 50). (12) Regulation (EU) No 1295/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Creative Europe Programme (2014 to 2020) and repealing Decisions No 1718/2006/EC, No 1855/2006/EC and No 1041/2009/EC (OJ EU L 347, 20.12.2013, p. 221). (13) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ EU L 347, 20.12.2013, p. 104). (14) Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union's action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC (OJ EU L 86, 21.3.2014, p. 1). (15) Regulation (EU) No 254/2014 of the European Parliament and of the Council of 26 February 2014 on a multiannual consumer programme for the years 2014-20 and repealing Decision No 1926/2006/EC (OJ EU L 84, 20.3.2014, p. 42). (16) Regulation (EU) No 1293/2013 of the European Parliament and of the Council of 11 December 2013 on the establishment of a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EC) No 614/2007 (OJ EU L 347, 20.12.2013, p. 185). (17) Regulation (EU) No 377/2014 of the European Parliament and of the Council of 3 April 2014 establishing the Copernicus Programme and repealing Regulation (EU) No 911/2010 (OJ EU L 122, 24.4.2014, p. 44).

Summary: Participation of Kosovo *This designation is without prejudice to positions on status, and is in line with UNSCR 1244 (1999) and the ICJ Opinion on the Kosovo declaration of independence. in EU programmes Participation of Kosovo* in EU programmes SUMMARY OF: Framework agreement on Kosovo’s involvement in EU programmes WHAT IS THE AIM OF THIS AGREEMENT? It makes Kosovo eligible for participation in selected EU programmes and sets out the conditions for this involvement, such as integration into the economic and fiscal surveillance framework, and the requirement to meet standards and make appropriate financial contributions. KEY POINTS In 2007 the European Council underlined that the EU stood ready to play a leading role in strengthening stability in the Western Balkans region, and stated that it was willing to assist Kosovo in the path towards sustainable stability. The EU has reaffirmed that it is ready to assist economic and political development through a clear European perspective, while Kosovo has expressed the wish to participate in a number of EU programmes. This framework makes Kosovo eligible for participation in certain EU projects, as part of activating the second phase of the Instrument for Pre-accession Assistance (IPA II), and strengthening the process set in motion by the Stabilisation and Association Agreement with Kosovo, which came into force on 1 April 2016. The main points of the framework agreement are as follows. Kosovo is now eligible to participate in a number of EU programmes, listed below, as well as any new programme specifically providing for the participation of Kosovo. Participation depends on Kosovo's commitment and progress in applying standards in the relevant areas. Kosovo will contribute financially to the general budget of the EU in proportion to the specific programmes in which it participates. Kosovo representatives can take part as observers, where Kosovo is involved, in the management committees monitoring the programmes to which Kosovo contributes financially. Projects and initiatives submitted by participants from Kosovo are subject to the same conditions as those applied in EU countries; The terms of Kosovo's participation in each EU programme, in particular the financial contribution, will be decided between the European Commission and the authorities of Kosovo. Each agreement will stipulate, in accordance with Regulation (EU, Euratom) No 966/2012, that financial control or audits will be under the authority of the Commission, the European Anti-fraud Office (OLAF) and the European Court of Auditors, who will have equivalent powers in relation to financial control and auditing, administrative measures, penalties and recovery as they have in the EU; If Kosovo applies for EU pre-accession assistance under IPA II, the conditions will be determined in a financing agreement. The agreement applies to the territories to which the Treaty on the Functioning of the European Union applies, under the conditions set out therein, and the territory of Kosovo. It applies for an indeterminate period, but can be ended by either party with 6 months’ notice. It must be reviewed every 3 years based on the experience of Kosovo’s participation in EU programmes. EU programmes which allow Kosovo’s participation, at the time of signing the agreement Fiscalis 2020 Customs 2020 Hercule III Justice Rights, Equality and Citizenship Programme Europe for Citizens Civil Protection Mechanism Interoperability solutions for European public administrations, businesses and citizens (ISA2) COSME Programme for Employment and Social Innovation (EaSI) Erasmus+ Creative Europe Horizon 2020 Health for Growth Programme Consumer Programme LIFE Copernicus FROM WHEN DOES THE AGREEMENT APPLY? It has applied since 1 August 2017. BACKGROUND For more information, see: Kosovo (European Commission) Kosovo and the EU (European External Action Service). MAIN DOCUMENT Framework Agreement between the European Union and Kosovo* on the general principles for the participation of Kosovo in Union programmes (OJ L 195, 27.7.2017, pp. 3-8) RELATED DOCUMENTS Stabilisation and Association Agreement between the European Union and the European Atomic Energy Community, of the one part, and Kosovo*, of the other part (OJ L 71, 16.3.2016, pp. 3-321) Regulation (EU) No 231/2014 of the European Parliament and of the Council of 11 March 2014 establishing an Instrument for Pre-accession Assistance (IPA II) (OJ L 77, 15.3.2014, pp. 11-26) *This designation is without prejudice to positions on status, and is in line with UNSCR 1244 (1999) and the ICJ Opinion on the Kosovo declaration of independence. last update 07.12.2017