### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report concludes that the scientific basis for setting specific compositional requirements is lacking . ### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of specialised nutrition : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion has yet been reached as regards the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements , compulsory information to ensure safe use of the food and the potential impact on innovation in product development . there is a real need for harmonisation of the category of food intended to meet the expenditure of intense muscular effort , especially for sportsmen . harmonisation would remove the barriers to the free movement of these products and provide sportsmen with a high level of safety , at the same time ensuring the absence of doping substances . the commission considers the matter of doping to be a priority in its communication entitled ‘ developing the european dimension in sport’ of 18 january 2011 . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report concludes that the scientific basis for setting specific compositional requirements is lacking .


### ' food for special medical purposes ' means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . ### ‘ food for special medical purposes’ means food specially treated or formulated and intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain of their ingredients or metabolites , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . dietary foods for special medical purposes are classified in the following three categories : nutritionally complete foods 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 they are intended ; nutritionally complete foods 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 they are intended ; nutritionally incomplete foods with a standard formulation or a nutrient - adapted formulation specific for a disease , disorder or medical condition which are not suitable to be used as the sole source of nourishment . the foods referred to in points and may also be used as a partial replacement or as a supplement to the patient’s diet .


### it is appropriate to establish and update a union list of vitamins , minerals , amino acids and other substances that may be added to infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , subject to certain criteria laid down in this regulation . given the fact that the adoption of the list implies the application of criteria set out in this regulation , implementing powers should be conferred on the commission in that respect . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the commission should adopt immediately applicable implementing acts updating the union list , where , in duly justified cases relating to public health , imperative grounds of urgency so require . ### it is appropriate to establish and update a union list of vitamins , minerals and other substances that may be added to infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and food for use in energy - restricted diets , subject to certain criteria laid down in this regulation . the list should be adopted taking due account of the specific dietary habits of the population groups concerned and should take into account the lists set out in directives 2006 / 141 / ec and 2006 / 125 / ec and commission regulation no 953 / 2009 of 13 october 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses , which does not apply to liquid or solid formulae for infants and young children , and replace them . given the fact that the adoption of the list implies the application of criteria set out in this regulation , implementing powers should be conferred on the commission in that respect . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the commission should adopt immediately applicable implementing acts updating the union list , where , in duly justified cases relating to public health , imperative grounds of urgency so require .


### the dissemination of any useful information or recommendations with reference to the categories of food referred to in article 1 may be made exclusively by persons having qualifications in medicine , nutrition , pharmacy or other professionals responsible for maternal and child health care . ### the dissemination of any useful information or recommendations with reference to the categories of food referred to in points , and of article 1 may be made exclusively to persons having qualifications in medicine , nutrition , pharmacy or other professionals responsible for maternal and child health care .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec and directive 96 / 8 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods covered by article 1 , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### general labelling requirements are laid down in directive 2000 / 13 / ec of the european parliament and of the council of 20 march 2000 on the approximation of the law of the member states relating to labelling , presentation and advertising of foodstuffs . those general labelling requirements should , as a general rule , apply to the categories of food covered by this regulation . however , this regulation should also provide for additional requirements to , or derogations from , the provisions of directive 2000 / 13 / ec , where necessary , in order to meet the specific objectives of this regulation . ### general labelling requirements are laid down in regulation no 1169 / 2011 . those general labelling requirements should , as a general rule , apply to the categories of food covered by this regulation . however , this regulation should also provide for additional requirements to , or derogations from , the provisions of regulation no 1169 / 2011 , where necessary , in order to meet the specific objectives of this regulation .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and food intended to meet the expenditure of intense muscular effort should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 and 1 shall provide adequate consumer information and must not be misleading and shall not attribute properties to such products for the prevention , treatment or cure of human disease , or imply such properties .


### proposal for a regulation of the european parliament and of the council on food intended for infants and young children and on food for special medical purposes ### proposal for a regulation of the european parliament and of the council on food intended for infants and young children , food for special medical purposes and other food for specialised nutrition


### it is appropriate to establish and update a union list of vitamins , minerals , amino acids and other substances that may be added to infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , subject to certain criteria laid down in this regulation . given the fact that the adoption of the list implies the application of criteria set out in this regulation , implementing powers should be conferred on the commission in that respect . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the commission should adopt immediately applicable implementing acts updating the union list , where , in duly justified cases relating to public health , imperative grounds of urgency so require . ### it is appropriate to establish and update a union list of substances that may be added for specific nutritional purposes to infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and food intended for weight reduction and control , taking into account regulation 953 / 2009 , commission directive 2006 / 141 / ec and commission directive 2006 / 125 / ec , subject to certain criteria laid down in this regulation . given the fact that the adoption of the list implies the application of criteria set out in this regulation , implementing powers should be conferred on the commission in that respect . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the commission should adopt immediately applicable implementing acts updating the union list , where , in duly justified cases relating to public health , imperative grounds of urgency so require .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec should be transferred to this regulation .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , in particular the results of risk evaluations and the precautionary principle , the commission shall be empowered to adopt delegated regulations for foods covered under article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , milk based drinks intended for young children , food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission regulation 41 / 2009 , as well as commission directive 96 / 8 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food , baby food for infants and young children , milk based drinks intended for young children , food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 . in addition , the concept of ' specialised nutrition ' should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market using current union acts .


### ‘ meal replacement for weight control’ and ‘ total diet replacement for weight control’ are considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . in order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of union legislation , such statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the health claims referring to the body weight control for food presented as ‘ total diet replacement for weight control’ and as ‘ meal replacement for weight control’ and associated conditions of use as regulated under directive 96 / 8 / ec be completed prior to the entry into application of this regulation . ### ‘ meal replacement for weight control’ and ‘ total diet replacement for weight control’ are currently considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec , while foods intended for very low calorie diets are governed by directive 2009 / 39 / ec only . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . in order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of union legislation , while protecting the most vulnerable , such statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein , with the exception of foods intended for very low calorie diets , which should in future be regulated under directive 96 / 8 / ec . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the health claims referring to the body weight control for food presented as ‘ total diet replacement for weight control’ and as ‘ meal replacement for weight control’ and associated conditions of use as regulated under directive 96 / 8 / ec be completed prior to the entry into application of this regulation .


### ‘ food for special medical purposes’ means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . ### ‘ food for special medical purposes’ means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . foods for special medical purposes also include formula intended for low birth - weight and pre - term infants .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec , as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods referred to in article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### this regulation establishes compositional and information requirements for the following categories of food : ### this regulation establishes compositional and information requirements for the following categories of food for specialised nutrition :


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , and commission regulation 41 / 2009 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes , and foods for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes , food intended for weight reduction and control , and food intended to meet the expenditure of intense muscular effort . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , as well as commission directive 96 / 8 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes , food intended for weight reduction and control , and food intended to meet the expenditure of intense muscular effort , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec . in addition , the concept of ' specialised nutrition ' should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market using current union acts .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , milk based drinks intended for young children , food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , and commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food , baby food for infants and young children , milk based drinks intended for young children , food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in addition , the concept of ' specialised nutrition ' should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market using current union acts .


### ' food for special medical purposes ' means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . ### ‘ food for special medical purposes’ means food specially processed or designed and intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain of their ingredients or metabolites , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . food for special medical purposes is classified under the three following categories : nutritionally complete foods 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 they are intended ; nutritionally complete foods 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 they are intended ; nutritionally incomplete foods with a standard formulation or a nutrient - adapted formulation specific for a disease , disorder or medical condition which are not suitable to be used as the sole source of nourishment . the foods referred to in points and may also be used as a partial replacement of a person’s diet .


### ' food for special medical purposes ' means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . ### ‘ food for special medical purposes’ means food specially treated or formulated and intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain of their ingredients or metabolites , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . dietary foods for special medical purposes are classified in the following three categories : nutritionally complete foods 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 they are intended ; nutritionally complete foods 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 they are intended ; nutritionally incomplete foods with a standard formulation or a nutrient - adapted formulation specific for a disease , disorder or medical condition which are not suitable to be used as the sole source of nourishment . the foods referred to in points and may also be used as a partial replacement or as a supplement to the patient’s diet .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes and food intended for use in energy - restricted diets and they are presently covered by provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec respectively . experience has shown that those provisions ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focus on the general compositional and information requirements for , infant formula and follow - on formulae , processed cereal based food and baby food for infants and young children and to food for special medical purposes and food intended for use in energy - restricted diets and that the specific compositional and information requirements for these categories of food should be laid down by the commission in delegated regulations adopted pursuant to this regulation , which take into account and replace directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec and directive 96 / 8 / ec . the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of laying down the specific compositional and information requirements for the categories of food covered by this regulation , including additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and the authorisation of nutrition and health claims . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ‘ food intended to meet the expenditure of intense muscular effort , especially for sportsmen’ and ‘ food for persons suffering from carbohydrate metabolism disorders ’ . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report9 concludes that the scientific basis for setting specific compositional requirements is lacking . ### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of specialised nutrition : ‘ food intended to meet the expenditure of intense muscular effort , especially for sportsmen’ and ‘ food for persons suffering from carbohydrate metabolism disorders ’ . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached to date as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements , the mandatory information for the safe use of food intended to meet the expenditure of intense muscular effort , and the potential impact on innovation in product development . there is a genuine need for harmonisation of the category of food intended to meet the expenditure of intense muscular effort , especially for sportsmen . harmonisation will remove barriers to free movement of this category of food , while providing sportsmen a high level of safety and guaranteeing the absence of doping substances , the latter being considered as a priority by the european commission in its communication on sports of 18th january 2011 . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report9 concludes that the scientific basis for setting specific compositional requirements is lacking .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec and commission directive 96 / 8 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes and foods intended for very low calorie diets should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### vitamins , minerals , amino acids and other substances may be added to food referred to in article 1 , provided that such substances meet the following conditions : ### the nutritional substances belonging to the categories defined by implementing acts adopted pursuant to article 11 may be added to food referred to in article 1 , provided that such substances meet the following conditions :


### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report9 concludes that the scientific basis for setting specific compositional requirements is lacking . ### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , in light of the report of 22 june 2000 by the european commission’s scientific committee on food , no successful conclusion could be reached as regards the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . work on this needs to continue and the commission should draw up a report on ‘ food intended to meet the expenditure of intense muscular effort’ so that a coherent and effective strategy to protect consumers , manufacturers in the sector and the operation of the internal market may be produced . taking the conclusions of this report as its basis , the commission may submit proposals to amend the relevant union legislation or may take new initiatives , where appropriate , on a sectoral basis .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec , as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods covered by article 1 no later than 2 years after the date of the entry into force of this regulation in accordance with article 15 , with respect to the following :


### general labelling requirements are laid down in directive 2000 / 13 / ec of the european parliament and of the council of 20 march 2000 on the approximation of the law of the member states relating to labelling , presentation and advertising of foodstuffs . those general labelling requirements should , as a general rule , apply to the categories of food covered by this regulation . however , this regulation should also provide for additional requirements to , or derogations from , the provisions of directive 2000 / 13 / ec , where necessary , in order to meet the specific objectives of this regulation . ### general labelling requirements are laid down in regulation no 1169 / 2011 . those general labelling requirements should , as a general rule , apply to the categories of food covered by this regulation . however , this regulation should also provide for additional requirements to , or derogations from , the provisions of regulation no 1169 / 2011 , where necessary , in order to meet the specific objectives of this regulation .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account these three directives . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , milk - based drinks for young children and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , milk - based drinks for young children and food for special medical purposes , taking into account these three directives . furthermore , the concept of ‘ special nutritional uses’ should be maintained and strictly limited to products able to demonstrate their unique capacity to meet the specific nutritional needs of vulnerable groups of the population , as without this said products would not be able to be placed on the market under current eu law .


### ‘ meal replacement for weight control’ and ‘ total diet replacement for weight control’ are considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . in order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of union legislation , such statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the health claims referring to the body weight control for food presented as ‘ total diet replacement for weight control’ and as ‘ meal replacement for weight control’ and associated conditions of use as regulated under directive 96 / 8 / ec be completed prior to the entry into application of this regulation . ### ‘ meal replacement for weight control’ and ‘ total diet replacement for weight control’ are currently considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec , while foods intended for very low calorie diets are governed by directive 2009 / 39 / ec only . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . in order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of union legislation , while protecting the most vulnerable , such statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein , with the exception of foods intended for very low calorie diets , which should in future be regulated under directive 96 / 8 / ec . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the health claims referring to the body weight control for food presented as ‘ total diet replacement for weight control’ and as ‘ meal replacement for weight control’ and associated conditions of use as regulated under directive 96 / 8 / ec be completed prior to the entry into application of this regulation .


### the definitions of ' labelling ' and ' pre - packaged foodstuff ' in points and of article 1 of directive 2000 / 13 / ec ; ### the definitions of ‘ prepacked food’ and ' labelling ' in points and of article 2 of regulation no 1169 / 2011 ;


### no later than [ 2 years after the date of the entry into force of this regulation ] , the commission shall establish and subsequently update a union list of permitted substances that meet the conditions of paragraph 1 , by means of implementing regulations . the entry of a substance in the union list shall include a specification of the substance , and , where appropriate , specify the conditions of use and the applicable purity criteria . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified grounds of extreme urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14 . ### no later than [ 2 years after the date of the entry into force of this regulation ] , the commission shall establish and subsequently update a union list of permitted substances that meet the conditions of paragraph 1 , by means of implementing acts . the entry of a substance in the union list shall include a specification of the substance , and , where appropriate , specify the conditions of use and the applicable purity criteria . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified grounds of extreme urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14 .


### the dissemination of any useful information or recommendations with reference to the categories of food referred to in article 1 may be made exclusively by persons having qualifications in medicine , nutrition , pharmacy or other professionals responsible for maternal and child health care . ### paragraph 3 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine , nutrition and pharmacy or other professionals responsible for maternal and child health care .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , food for special medical purposes , and foods for people intolerant to gluten . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , and commission regulation 41 / 2009 ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , food for special medical purposes , and foods for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec commission directive 1999 / 21 / ec , and commission regulation no 41 / 2009 .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes , food intended for weight reduction and control , and food intended to meet expenditure of intense muscular effort , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes , food intended for weight reduction and control , and food intended to meet the expenditure of intense muscular effort laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of regulation no 1169 / 2011 and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### proposal for a regulation of the european parliament and of the council on food intended for infants and young children and on food for special medical purposes ### proposal for a regulation of the european parliament and of the council on food intended for infants and young children , on food for special medical purposes and on foodstuffs for people intolerant to gluten


### ' food for special medical purposes ' means food intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain nutrients contained therein , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . ### ‘ food for special medical purposes’ means food specially processed or designed and intended for the dietary management of patients to be used under medical supervision . it is intended for the exclusive or partial feeding of patients with a limited , impaired or disturbed capacity to take , digest , absorb , metabolise or excrete ordinary food or certain of their ingredients or metabolites , or with other medically - determined nutrient requirements , whose dietary management cannot be achieved only by modification of the normal diet . food for special medical purposes is classified under the three following categories : nutritionally complete foods 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 they are intended ; nutritionally complete foods 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 they are intended ; nutritionally incomplete foods with a standard formulation or a nutrient - adapted formulation specific for a disease , disorder or medical condition which are not suitable to be used as the sole source of nourishment . the foods referred to in points and may also be used as a partial replacement of a person’s diet .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account these three directives . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes , as well as food intended to meet the expenditure of intense muscular effort . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , as well as food intended to meet the expenditure of intense muscular effort , taking into account these three directives . the concept of ‘ food for specific uses’ should therefore be maintained but strictly limited to products able to demonstrate their unique capacity to meet the specific nutritional needs of vulnerable groups of the population which would otherwise not be able to be placed on the market in a harmonised way under current eu law whilst fully complying with the rules on free movement .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 and 1 shall provide adequate consumer information and must not be misleading and shall not attribute properties to such products for the prevention , treatment or cure of human disease , or imply such properties .


### no direct payments shall be granted to natural or legal persons , or to groups of natural or legal persons , where one of the following applies : ### no direct payments shall be granted to natural or legal persons , or to groups of natural or legal persons which are placed onto a ' negative list ' partly decided at eu level , identifying non - active farmers . in addition , member states may define additional non - discriminative criteria at their discretion to exclude applicants who are economically marginally engaged in agricultural activities .


### the authority shall act within the scope of directive 2006 / 48 / ec , directive 2006 / 49 / ec , directive 2002 / 87 / ec , directive 2005 / 60 / ec , directive 2002 / 65 / ec and directive 94 / 19 / ec , including all directives , regulations , and decisions based on these acts , and of any further community act which confers tasks on the authority . ### the authority shall act within the scope of directive 2006 / 48 / ec , directive 2006 / 49 / ec , directive 2002 / 87 / ec , directive 2005 / 60 / ec , directive 2002 / 65 / ec and directive 94 / 19 / ec , including all directives , regulations , and decisions based on these acts , and of any further eu act which confers tasks on the authority . the authority shall also act in the field of activities of credit institutions , financial conglomerates , investment firms , payment institutions and e - money institutions , including matters of corporate governance , auditing and financial reporting , provided that such actions by the authority are necessary to ensure the effective and consistent application of the legislation referred to in this paragraph .


### any action by the competent authorities in relation to facts which are subject to a decision pursuant to paragraph 4 or 6 shall be compatible with those decisions . ### when taking action in relation to issues which are subject to a decision pursuant to paragraph 4 or 6 competent authorities shall comply with such decision .


### where the national authority does not comply with the recommendation , the commission should be empowered to address a decision to the national supervisory authority concerned in order to ensure compliance with community law , creating direct legal effects which can be invoked before national courts and authorities and enforced under article 226 of the treaty . ### where the national authority does not comply with the recommendation within a deadline fixed by the authority , the authority should address a decision without delay to the national supervisory authority concerned in order to ensure compliance with union law , creating direct legal effects which can be invoked before national courts and authorities and enforced under article 258 of the treaty .


### where a member state considers that a decision taken under article 10 impinges on its fiscal responsibilities , it may notify the authority , the commission and the council within three working days after notification of the authority ' s decision to the competent authority that the decision will not be implemented by the competent authority . ### where a member state considers that a decision taken under article 10 impinges directly on its fiscal responsibilities , it may notify the authority , the commission and the council within three working days after notification of the authority ' s decision to the competent authority that the decision will not be implemented by the competent authority .


### where the competent authority has not complied with community law within one month from receipt of the authority ' s recommendation , the commission may , after having been informed by the authority or on its own initiative , take a decision requiring the competent authority to take the action necessary to comply with community law . ### where the competent authority has not complied with union law within ten working days as provided for in the second subparagraph of paragraph 3 , the authority shall take a decision requiring the competent authority to take the action necessary to comply with union law .


### where the commission has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation . ### where the existence of an emergency situation is declared pursuant to paragraph 1 , the authority shall adopt individual decisions necessary to ensure that competent authorities take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation .


### all other decisions of the board of supervisors shall be taken by simple majority of members . ### the board of supervisors shall act on the basis of qualified majority of its members , as defined in article 16 of the treaty on the european union , for acts specified in articles 7 , 8 and all measures and decisions adopted under chapter vi .


### member states have a core responsibility in preserving financial stability in crisis management , in particular with regard to stabilising and resolving individual ailing financial institutions . measures by the authority in emergency or settlement situations affecting the stability of a financial institution should not impinge on the fiscal responsibilities of member states . a mechanism should be established whereby member states may invoke this safeguard and ultimately bring the matter before the council for a decision . it is appropriate to confer on the council a role in this matter given the particular responsibilities of the member states in this respect . ### member states have a core responsibility in preserving financial stability in crisis situations , in particular with regard to stabilising and resolving individual ailing financial institutions . measures by the authority in emergency or settlement situations affecting the stability of a financial institution should not impinge on the fiscal responsibilities of member states . a mechanism should be established whereby member states may request that the decision of the authority be reconsidered .


### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority may take a decision requiring them to take specific action or to refrain from action in order to settle the matter , in compliance with community law . ### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority shall in accordance with the procedure set out in the second subparagraph of article 29 take a decision to settle the disagreement and to require them to take specific action , in compliance with union law with binding effects on the competent authorities concerned .


### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of depositors , investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by community law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should endorse those draft technical standards in accordance with community law in order to give them binding legal effect . the draft technical standards have to be adopted by the commission . they would be subject to amendment if , for example , the draft technical standards were incompatible with community law , would not respect the principle of proportionality or would run counter to the fundamental principles of the internal market for financial services as reflected in the acquis of community financial services legislation . to ensure a smooth and expedited adoption process for those standards , the commission should be subject to a time limit for its decision on the endorsement . ### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of depositors , investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by union law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should endorse those draft technical standards in accordance with union law in order to give them binding legal effect . the commission should be empowered , in accordance with article 290 of the treaty on the functioning of the european union to adopt the technical standards by means of delegated acts . the delegation should be made in the basic legislative act and should be able to be revoked by the european parliament or the council . the period for delegation should be extended on the request of the commission , unless the european parliament or the council object . the standards should be adopted by the commission by means of regulations or decisions as delegated acts in accordance with article 290 of the treaty on the functioning of the european union . the word ' delegated ' should be inserted in the title of those acts . the standards adopted pursuant to the procedure of article 7 of this regulation should enter into force only if no objection has been expressed by the european parliament or the council within a period of three months .


### where the commission has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation . ### where the esrb has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with this regulation and the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial market participants and competent authorities satisfy the requirements laid down in that legislation .


### the board of supervisors shall act on the basis of qualified majority of its members , as defined in article 205 of the treaty , for acts specified in articles 7 , 8 and all measures and decisions adopted under chapter vi . ### the board of supervisors shall act on the basis of qualified majority of its members , as defined in article 16 of the eu treaty and in article 3 of the protocol on transitional provisions annexed to the treaty on european union and to the treaty on the functioning of the european union .


### contribute to a consistent application of community legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , promoting a coherent functioning of colleges of supervisors and taking actions in emergency situations ; ### contribute to a consistent application of community legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , ensuring effective and consistent supervision of financial institutions with eu dimension and a coherent functioning of colleges of supervisors and taking actions , inter alia , in emergency situations ;


### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of depositors , investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by community law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should endorse those draft technical standards in accordance with community law in order to give them binding legal effect . the draft technical standards have to be adopted by the commission . they would be subject to amendment if , for example , the draft technical standards were incompatible with community law , would not respect the principle of proportionality or would run counter to the fundamental principles of the internal market for financial services as reflected in the acquis of community financial services legislation . to ensure a smooth and expedited adoption process for those standards , the commission should be subject to a time limit for its decision on the endorsement . ### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of depositors , investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by eu law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should be empowered to adopt delegated acts in accordance with the procedure referred to in article 290 of the treaty on the functioning of the european union concerning technical standards in financial services .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . before adopting draft technical standards , guidelines and recommendations the authority should carry out an impact study . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions union credit and investment institutions , their employees , academia and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or by eu legislation .


### the board of supervisors shall act on the basis of qualified majority of its members , as defined in article 205 of the treaty , for acts specified in articles 7 , 8 and all measures and decisions adopted under chapter vi . ### the board of supervisors shall act on the basis of simple majority of its members .


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### 1 in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the council , following appropriate consultations with the commission , the esrb , and where appropriate , the european supervisory authorities , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation .


### in order to ensure efficient and effective supervision and a balanced consideration of the positions of the competent authorities in different member states , the authority should be able to settle disagreements between those competent authorities with binding effect , including within colleges of supervisors . a conciliation phase should be provided for , during which the competent authorities may reach an agreement . the authority ' s competence should cover disagreements on procedural obligations in the cooperation process as well as on the interpretation and application of community law in supervisory decisions . existing conciliation mechanisms provided for in sectoral legislation have to be respected . in the event of inaction by the national supervisory authorities concerned , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial institutions in areas of community law directly applicable to them . ### in order to ensure efficient and effective supervision and a balanced consideration of the positions of the competent authorities in different member states , the authority should be able to settle disagreements between those competent authorities with binding effect , including within colleges of supervisors . a conciliation phase should be provided for , during which the competent authorities may reach an agreement . the authority ' s competence should cover disagreements on procedural obligations in the cooperation process as well as on the interpretation and application of union law in supervisory decisions . existing conciliation mechanisms provided for in sectoral legislation have to be respected . in the event of inaction by the national supervisory authorities concerned , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial institutions in areas of union law directly applicable to them . this also applies to disagreements within a college of supervisors .


### members of the board of supervisors and the management board , the executive director , and members of the staff of the authority including officials seconded by member states on a temporary basis shall be subject to the requirements of professional secrecy pursuant to article&#160 ; 287 of the treaty and the relevant provisions in the relevant community legislation , even after their duties have ceased . ### members of the board of supervisors and the management board , the executive director , and members of the staff of the authority including officials seconded by member states on a temporary basis shall be subject to the requirements of professional secrecy pursuant to article&#160 ; 339 of the treaty and the relevant provisions in the relevant community legislation , even after their duties have ceased .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in due proportions community credit and investment institutions of different member states , sizes and banking sectors , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation .


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the esrb , upon its own initiative or following a request by the authority , the council , the european parliament or the commission , may issue a warning declaring the existence of an emergency situation in order to enable the authority without further requirements to adopt the individual decisions referred to in paragraph 3 .


### each member other than the chairperson shall have an alternate , who may replace the member of the management board if that person is prevented from attending . ### each member shall have an alternate , who may replace the member of the management board if that person is prevented from attending . the chairperson ' s alternate shall be elected in accordance with article 33 .


### at the request of the authority , competent authorities and other public authorities of the member states shall provide the authority with all the necessary information to carry out the duties assigned to it by this regulation . ### at the request of the authority , competent authorities of the member states shall provide the authority with all the necessary information to carry out the duties assigned to it by this regulation .


### without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in areas where the legislation referred to in article 1 requires cooperation , coordination or joint decision making by competent authorities from more than one member state , the authority , at the request of one or more of the competent authorities concerned , may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraph 2 . ### 1 without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in cases specified in the legislation referred to in article 1 , the authority , at the request of one or more of the competent authorities concerned , may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraph 2 .


### the european parliament may invite the chairperson or his alternate , while fully respecting his or her independence , to make a statement regularly before its competent committee and answer questions put by members of that committee . ### the chairperson shall at least quarterly , make a statement before the european parliament and answer any questions put by its members .


### the commission shall take such a decision no later than three months from the adoption of the recommendation . the commission may extend this period by one month . ### the authority shall take such a decision no later than one month from the adoption of the recommendation .


### before taking the decisions provided for in article 9 , article 10 and and article 11 and , the authority shall inform the addressee of its intention to adopt the decision , setting a time limit within which the addressee may express its views on the matter , taking full account of the urgency of the matter . ### before taking the decisions provided for in this regulation , the authority shall inform the addressee of its intention to adopt the decision , setting a time limit within which the addressee may express its views on the matter , taking full account of the urgency of the matter .


### the board of appeal shall be composed of six members and six alternates , who shall be individuals with relevant knowledge and experience , excluding current staff of the competent authorities or other national or community institutions involved in the activities of the authority . ### the board of appeal shall be composed of six members and six alternates . it shall comprise individuals , excluding current staff of the competent authorities or other national or eu institutions or financial institutions involved in the activities of the authority , of high repute with a proven record of relevant knowledge and professional expertise , including supervisory experience at a sufficiently high level in the fields of banking , insurance and occupational pensions , securities markets or other financial services , and at least two members with sufficient legal expertise to provide expert legal advice on the authority ' s exercise of its powers .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority may adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law , including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority shall adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law , including the cessation of any practice .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority may adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law , including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty on the functioning of the european union , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial institution complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority may adopt an individual decision , in accordance with the procedure laid down in article 9 , addressed to a financial market participant requiring the necessary action to comply with its obligations under union law , including the cessation of any practice .


### the authority may develop technical standards in the areas specifically set out in the legislation referred to in article 1 . the authority shall submit its draft standards to the commission for endorsement . ### the authority may develop technical standards to complete , update and modify elements that are not essential to the legislative acts referred to in article 1 . the technical standards shall not imply strategic decisions and its content shall be delimited by the legislative acts on which they are based .


### without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in areas where the legislation referred to in article 1 requires cooperation , coordination or joint decision making by competent authorities from more than one member state , the authority , at the request of one or more of the competent authorities concerned , may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraph 2 . ### without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in areas where the legislation referred to in article 1 requires cooperation , coordination or joint decision making by competent authorities from more than one member state , the authority , on its own initiative or at the request of one or more of the competent authorities concerned , shall take the lead in assisting the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4 .