(1)

Article 114 of the Treaty on the Functioning of the European Union (TFEU) provides that measures having as their object the establishment and functioning of the internal market and which concern inter alia health, safety and consumer protection must take as a base a high level of protection taking account in particular of any new development based on scientific facts.

(2)

The free movement safety of safe and wholesome food , especially when it is intended for vulnerable groups, such as infants, young children and persons with special diseases, is a aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests prerequisite for the free movement of such persons and the proper functioning of the internal market. [Am. 2]

(2a)

In this context, given that the relevant Union law has been drawn up to ensure that no food is placed on the market if it is dangerous, any substances that are liable to be harmful to the health of the groups of the population concerned should be excluded from the composition of the categories of foods covered by this Regulation. [Am. 3]

(3)

Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (3) lays down general rules on the composition and preparation of such foods that are specially designed to meet the particular nutritional requirements of the persons to whom they are intended. The majority of the provisions laid down in that Directive date back to 1977 and should therefore be reviewed fail to address the difficulty experienced by consumers in making an informed choice between dietetic foods, fortified foods, foods bearing claims and foods for normal consumption. The interaction between that legislation and Union law adopted more recently, such as Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (4), Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (5), Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to food (6) and Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (7), is a further factor making it necessary to thoroughly overhaul Directive 2009/39/EC . [Am. 4]

(4)

Directive 2009/39/EC establishes a common definition for 'foodstuffs for particular nutritional uses' and general labelling requirements, including that such foods should bear an indication of their suitability for the claimed nutritional purposes.

(5)

The general composition and labelling requirements laid down in Directive 2009/39/EC are complemented by a number of non-legislative Union acts, which are applicable to specific categories of food. In that respect, Commission Directive 2006/141/EC (8) lays down harmonised rules with respect to infant formulae and follow-on formulae, whereas Commission Directive 2006/125/EC (9) lays down certain harmonised rules with respect to processed cereal-based foods and baby foods for infants and young children. Similarly, harmonised rules are also laid down by Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (10), Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (11) and Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (12).

(6)

In addition, Council Directive 92/52/EEC (13) lays down harmonised rules with respect to infant formulae and follow-on formulae intended for export to third countries.

(6a)

According to the Council Resolution of 18 June 1992 (14), the Union should contribute to the application of appropriate practices for the marketing of breast-milk substitutes in third countries by Community-based manufacturers. [Am. 5]

(7)

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 (diabetes)'. 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 (diabetes), a Commission report (15) concludes that the scientific basis for setting specific compositional requirements is lacking. Nevertheless, the undertaking made by the Commission in Directive 2009/39/EC to recognise the nutritional requirements of sportspeople should still apply, as supported by scientific opinions of the European Food Safety Authority (the 'Authority') on claims relevant to active individuals, and the report of the Scientific Committee on Food of 28 February 2001 on composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen. Therefore, the Commission should assess, not later than 1 July 2015, the need to review general food law in this regard. [Am. 6]

(7a)

The Commission report of 26 June 2008 on food for persons suffering from carbohydrate metabolism disorders (diabetes) (16) concludes that the scientific basis for setting specific compositional requirements is lacking. This Regulation is therefore not the appropriate legal framework for that category of food. According to the Commission, it is more important, as regards persons with diabetes, to consider the quantity and model of food absorbed. This conclusion is in no way contrary to the establishment of a Union-wide strategy comprehensively targeting diabetes (Type 1 and Type 2), which affects more than 32 million Union citizens. Those figures, which are expected to increase by 16 % by 2030 as a result of the obesity epidemic and the ageing of the European population, therefore merit careful consideration at Union level, including in the area of research and development. [Am. 7]

(8)

Directive 2009/39/EC also requires a general notification procedure at national level for food presented by food business operators as falling under the definition of 'foodstuffs for particular nutritional uses' and for which no specific provisions are laid down in Union law, prior to their placing on the Union market, in order to facilitate the efficient monitoring of such food by the Member States.

(9)

A report from the Commission to the European Parliament and the Council on the implementation of that notification procedure (17) showed that difficulties may arise from different interpretations of the definition of foodstuffs for particular nutritional uses which appeared to be open to different interpretations by the national authorities. It therefore concluded that a revision of the scope of Directive 2009/39/EC would be required to ensure a more effective and harmonised implementation of the Union legislation.

(10)

A study report (18) concerning the revision of the legislation on foodstuffs for particular nutritional uses confirms the findings of the abovementioned Commission report on the implementation of the notification procedure and indicates that an increasing number of foodstuffs are today marketed and labelled as foodstuffs suitable for particular nutritional uses, due to the broad definition laid down in Directive 2009/39/EC. The study report also points out that the type of food regulated under that legislation differs significantly between Member States; similar food could at the same time be marketed in different Member States as food for particular nutritional uses and/or as food for normal consumption addressed to the population in general or to certain sub-groups thereof such as pregnant women, postmenopausal women, older adults, growing children, adolescents, variably active individuals and others. This state of affairs undermines the functioning of the internal market, creates legal uncertainty for competent authorities, food business operators and consumers, while the risks of marketing abuse and distortion of competition cannot be ruled out.

(11)

It appears that other Union acts recently adopted are more adapted to an evolving and innovative food market than Directive 2009/39/EC. Of particular relevance and importance in that respect are: Directive 2002/46/EC, Regulation (EC) No 1924/2006 and Regulation (EC) No 1925/2006. Furthermore, the provisions of these Union acts would adequately regulate a number of the categories of food covered by Directive 2009/39/EC with less administrative burden and more clarity as to the scope and objectives.

(11a)

There is therefore a need to remove differences in interpretation and to tackle difficulties for Member States and food business operators in combining the different pieces of food legislation, by simplifying the regulatory environment. This would ensure that similar products are treated in the same way across the Union and would create a more level playing field for all operators across the internal market, especially small and medium-sized enterprises (SMEs). [Am. 8]

(12)

Moreover, experience shows that certain rules included in or adopted under Directive 2009/39/EC are no longer effective to ensure the functioning of the internal market.

(13)

Therefore, the concept of “foodstuffs for particular nutritional uses” should be abolished and Directive 2009/39/EC should be replaced by the present act. To simplify its application and to ensure consistency throughout the Member States, the present act should take the form of a Regulation.

(14)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (19) establishes common principles and definitions for Union food law in order to ensure a high level of health protection and of human health and consumer interests, while ensuring the effective functioning of the internal market. It establishes the principles of risk analysis in relation to food , sets out that pursuant to the precautionary principle provisional risk management measures can be adopted, and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the Authority. Therefore, certain definitions laid down in that Regulation must also apply in the context of the present Regulation. Moreover, for the purpose of this Regulation, the Authority should be consulted on all matters likely to affect public health. [Am. 9]

(14a)

Where a risk to life or health exists, whether immediate or in the long term, but scientific uncertainty persists, the precautionary principle should apply to ensure a high level of health protection, taking into account cumulative toxic effects and the particular health sensitivities of the particularly vulnerable groups of the population specified in this Regulation. [Am. 10]

(15)

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, food for people intolerant to gluten and food intended for use in low and very low calorie diets . Experience has shown that the provisions laid down in Directive 2006/141/EC, Directive 2006/125/EC, as well as 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. Food intended for use in very low calorie diets is currently not covered by Directive 96/8/EC but solely by Directive 2009/39/EC. It is 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 , food for people intolerant to gluten and food intended for use in low and very low calorie diets , while taking into account Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC. [Am. 11]

(16)

To ensure legal certainty, definitions laid down in Directive 2006/141/EC, Directive 2006/125/EC and , Directive 1999/21/EC , Regulation (EC) No 41/2009 and Directive 96/8/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, food for people intolerant to gluten and food intended for use in low and very low calorie diets should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate. [Am. 12]

(16a)

According to the recommendations of the World Health Organization, low-birth-weight infants should be fed their mother's own milk. Nonetheless, low-birth-weight and pre-term infants often have special nutritional requirements which cannot be met by the mother's own milk or standard infant formulae. Food for such infants should comply with rules applicable to food for special medical purposes, when this kind of food is chosen as the most appropriate formula, taking into account the specific medical situation of the infant. Formula intended for low-birth-weight or pre-term infants should in any event comply with the requirements of Directive 2006/141/EC. [Am. 13]

(17)

It is important that ingredients used in the manufacture of the categories of food covered by this Regulation are appropriate to satisfy the nutritional requirements of, and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data. Such adequacy should be demonstrated through a systematic and independent review of the available scientific data. [Am. 14]

(17a)

It is important that pesticides, maximum residue levels for which are authorised by Directive 2006/141/EC and Directive 2006/125/EC and which do not satisfy the safety conditions set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (20) be banned from the market and that they not be used in the production of food covered by this Regulation. [Am. 15]

(17b)

Maximum residue levels of pesticides set out in relevant Union law, in particular Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin (21), should apply without prejudice to specific provisions set out in this Regulation and the delegated acts adopted in accordance with this Regulation. [Am. 16]

(17c)

However, given the vulnerable nature of infants and young children, severe limitations on pesticide residues are required in infant formula and follow-on formula and processed cereal-based food and baby food for infants and young children. Specific maximum residue levels of pesticides for such products are set in Directive 2006/141/EC and Directive 2006/125/EC. Particular attention should be paid to pesticides containing substances classified as specifically hazardous to human health. [Am. 17]

(17d)

At all stages of the food production chain, food businesses and food business operators, as defined in Regulation (EC) No 178/2002, should ensure that the food covered by this Regulation comply with the requirements of food law in general and of this Regulation in particular. [Am. 18]

(18)

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 (22) Regulation (EU) 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 Directive 2000/13/EC Regulation (EU) No 1169/2011 , where necessary, in order to meet the specific objectives of this Regulation. [Am. 19]

(19)

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 , food for people intolerant to gluten and food intended for use in low and very low calorie diets , taking into account Directive 2006/141/EC, Directive 2006/125/EC and 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. [Am. 20]

(19a)

The Commission should, after consulting the Authority, clarify the status of milks intended for children between 12 and 36 months, which are currently regulated by different legal acts of the Union , such as Regulation (EC) No 178/2002, Regulation (EC) No 1924/2006, Regulation (EC) No 1925/2006 and Directive 2009/39/EC, and submit a report to the European Parliament and the Council assessing whether further legislative action is required, at the latest 1 year after the date of the entry into force of this Regulation. If appropriate the report should be accompanied by a legislative proposal. [Am. 21]

(20)

It is appropriate to establish and update a Union list annexed to this Regulation 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 and food intended for use in low and very low calorie diets , subject to certain criteria laid down in this Regulation. The annexed list should be adopted taking due account of the specific dietary habits of the groups of the population concerned and should take into account and replace the lists set out in Directives 2006/141/EC and 2006/125/EC, and Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (23), which does not apply to liquid or solid formula for infants and young children. Given the fact that the adoption and updating of the list the Annex implies the is a measure of general 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 (EU) 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 (24) to supplement or amend certain non-essential elements of this Regulation , 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 in that respect . The Commission should adopt immediately applicable implementing delegated acts updating the Union list Annex , where, in duly justified cases relating to public health, imperative grounds of urgency so require. [Am. 22]

(21)

At present, pursuant to the Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the risk assessment of products of nanotechnologies, dated 19 January 2009, there is inadequate information on the risks associated with engineered nanomaterials and existing test methods may not be sufficient to address all of the issues arising in relation to engineered nanomaterials. Therefore Taking account of that scientific opinion and in view of the particular sensitivity of the vulnerable groups for whom foods covered by this Regulation are intended , engineered nanomaterials should not be included in the Union list annexed to this Regulation for the categories of food covered by this Regulation, until an evaluation as long as their safety , based on adequate and sufficient test methods, their nutritional value and their suitability for the persons for whom the food is intended have not been demonstrated by the Authority is carried out. [Am. 23]

(22)

In the interests of efficiency and legislative simplification and a clear desire to support innovation , there should be a medium-term examination of the question whether to extend the scope of the Union list annexed to this Regulation to other categories of food governed by other specific Union legislation. Such an extension should be decided by the European Parliament and the Council in accordance with the ordinary legislative procedure, on the basis of an evaluation by the Authority. [Am. 24]

(23)

It is necessary to establish procedures for the adoption of emergency measures in situations where food covered by this Regulation constitutes a serious risk to human health. In order to ensure uniform conditions for the implementation of emergency measures, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) 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 (25). The Commission should adopt immediately applicable implementing acts relating to emergency measures, where, in duly justified cases relating to public health, imperative grounds of urgency so require.

(24)

Directive 92/52/EEC states that infant formulae and follow-on formulae exported or re-exported from the European Union have to comply with Union law unless otherwise required by the importing country. This principle has already been established for food in Regulation (EC) No 178/2002. For the sake of simplification and legal certainty, Directive 92/52/EEC should therefore be repealed.

(25)

Regulation (EC) No 1924/2006 establishes the rules and conditions for the use of nutrition and health claims on food. Those rules should apply as a general rule to the categories of food covered by this Regulation, unless otherwise specified in this Regulation or non-legislative acts adopted pursuant to this Regulation.

(26)

Currently, the statements 'gluten-free' and 'very low gluten' may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in Regulation (EC) No 41/2009. Such Those statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 this Regulation and comply with requirements therein. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the nutrition claims 'gluten-free' and 'very low gluten' and their associated conditions of use as regulated under herein. Regulation (EC) No 41/2009 be completed prior to the entry into application of this Regulation should therefore be repealed . [Am. 90]

(26a)

Labelling indicating ‘lactose free’ and ‘very low lactose content’ is currently not covered by Union law. Those indications are, however, important for people who are intolerant to lactose. The Commission should therefore clarify their status under general food law. [Am. 25]

(27)

‘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 use in 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. Against the background of the growing number of food products containing generic claims and the risk of disorders in dietary habits arising from certain unsupervised diets, the Authority regularly carries out scientific assessments of health claim applications relating to meal replacement. The assessment carried out by the Authority does not cover the safety of compositional criteria put forward by the food business operator applying for the use of a claim or certain labelling methods. Specific provisions are therefore needed in this Regulation on food intended for use in low and very low calorie diets. Such provisions are an important nutrition and health safety tool for people seeking to lose weight. 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 on food intended for the general population should be regulated by Regulation (EC) No 1924/2006 and comply with requirements therein , with the exception of foods intended for use in low and very low calorie diets, which should comply with this Regulation . It is necessary that technical adaptations pursuant to Regulation (EC) 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. [Am. 26]

(27a)

In order to ensure a high level of consumer protection, adequate procedures for oversight, in respect of both hygiene and composition, both before and after foods are placed on the market, should be established at Member State level. [Am. 27]

(27b)

Pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (26), Member States should conduct inspections on the compliance of undertakings with this Regulation and the delegated acts adopted pursuant thereto, following a risk-based approach. [Am. 28]

(28)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(29)

The Commission should take adequate transitional measures are necessary to ensure legal certainty between entry into force and application of this Regulation and provide the assistance and up-to-date information necessary to the food business operators to enable food business operators them to adapt to the requirements of this Regulation. [Am. 29]

(29a)

To ease access of SMEs to the market which in some sectors, for example baby food and medical food, appear to be dominated by a few large companies, the Commission should, in close cooperation with concerned stakeholders, adopt guidelines, by means of delegated acts, in order to help undertakings, in particular SMEs, to comply with the requirements laid down in this Regulation and thus facilitate competitiveness and innovation. [Am. 30]

(29b)

In order to facilitate market access for food business operators – especially SMEs – wishing to sell foods resulting from scientific and technological progress, the Commission, in close cooperation with the relevant stakeholders, should adopt guidelines on the procedure for placing such food on the market on a temporary basis. [Am. 31]

(29c)

The Commission should be empowered to authorise, by means of delegated acts, food resulting from scientific and technological progress to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the delegated act for the specific food category concerned. However, in the interests of consumer health protection, a marketing authorisation may be granted only after the Authority has been consulted. [Am. 91]

(a)

infant formula and follow-on formula;

(b)

processed cereal-based food and baby food for infants and young children;

(c)

food for special medical purposes, including formula intended for low-birth-weight and pre-term infants; [Am. 34]

(ca)

food for people intolerant to gluten; and [Am. 35]

(cb)

foods intended for use in low and very low calorie diets. [Am. 36]

(a)

the definitions of ' food ', 'retail' and 'placing on the market' set out in Article 2 and Article 3(7) and 3(8) of Regulation (EC) No 178/2002; [Am. 39]

(b)

the definitions of ‘prepacked food’ and 'labelling' and 'pre-packaged foodstuff set out in points (a) (e) and (b) (j) of Article 1(3) 2(2) of Directive 2000/13/EC Regulation (EU) No 1169/2011 ; [Am. 40]

(c)

the definitions of 'nutrition claim' and 'health claim' set out in points (4) and (5) of Article 2(2) of Regulation (EC) No 1924/2006;

(d)

the definition of 'other substance' set out in Article 2(2) of Regulation (EC) No 1925/2006; and

(da)

the definition of 'engineered nanomaterial' set out in point (t) of Article 2(2) of Regulation (EU) No 1169/2011. [Am. 41]

(a)

‘Authority’ means the European Food Safety Authority established by Regulation (EC) No 178/2002;

(b)

‘infant’ means a child under the age of 12 months;

(c)

‘young child’ means a child between one and three years;

(d)

'infant formula' means food used by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding;

(e)

'follow-on formula' means food used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants;

(f)

'processed cereal-based food' means food:

(g)

'baby food' means food intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food, excluding:

(h)

‘food for special medical purposes’ means food specially processed 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 nutrients contained therein 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 also includes formula intended for low-birth-weight and pre-term infants. Such formula also has to comply with Directive 2006/141/EC; [Am. 92]

(ha)

'formula intended for low-birth-weight and pre-term infants' means a food specifically developed to meet the medically-determined nutrient requirements of infants who are born prematurely or at a low birth weight; [Am. 43]

(hb)

'food for people intolerant to gluten' means foodstuffs for particular nutritional uses which are specially produced, prepared or processed to meet the special dietary needs of people intolerant to gluten; [Am. 44]

(hc)

‘gluten’ means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives thereof and which is insoluble in water and 0,5 M sodium chloride solution; [Am. 45]

(hd)

'food intended for use in low calorie diets' or 'LCD products', and 'food intended for use in very low calorie diets' or 'VLCD products' means specifically formulated food which, when used as instructed by the manufacturer, replaces the total daily diet.

(a)

the use of the expression ‘specialised nutrition’, either alone or in conjunction with other words, to designate such food;

(b)

all other markings or any presentation likely to give the impression that the food belongs to one of the categories referred to in Article 1(1). [Am. 56]

(a)

the specific compositional requirements of food referred to in Article 1(1);

(b)

the specific requirements on the use of pesticides in agricultural products intended for the production of such food and on pesticides residues in such food;

(c)

the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1) including the authorisation of nutrition and health claims thereof; those requirements shall include the specific related rules already in force for food referred to in Article 1(1); [Am. 66]

(ca)

the requirements for information to be provided on recommendations for appropriate use of food referred to in Article 1(1); [Am. 67]

(d)

the notification procedure for the placing on the market of a food referred to in Article 1(1) in order to facilitate the efficient official monitoring of such food on the basis of which food business operators shall notify the competent authority of the Member State(s) where the product is being marketed;

(e)

the requirements on promotional and commercial practices relating to infant formulae;

(f)

the requirements on information to be provided on infant and young child feeding in order to ensure adequate information on appropriate feeding practices; and

(fa)

a requirement for post-market monitoring of food referred to in Article 1(1), in order to verify whether the specific requirements are being complied with. [Am. 68]

—

not exceeding 100 mg/kg may be labelled ‘very low gluten content’;

—

not exceeding 20 mg/kg may be labelled ‘gluten free’.

—

it shall provide roughly the same amount of vitamins and mineral salts as the foodstuffs they are replacing,

—

it shall be prepared with special care, in compliance with good manufacturing practice (GMP), to avoid gluten contamination,

—

where the terms ‘very low gluten content’ or ‘gluten free’ are used, they shall appear in proximity to the name under which the food is marketed. [Am. 70]

(a)

for VLCD products,

(b)

for LCD products,

(a)

the available energy value expressed in kJ and kcal, and the content of proteins, carbohydrates and fat, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption;

(b)

the average quantity of each mineral and each vitamin for which mandatory requirements are stipulated in paragraph 5 of AnnexII, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption;

(c)

instructions for appropriate preparation, when necessary and a statement as to the importance of following those instructions;

(d)

if a product provides a daily intake of polyols in excess of 20 g per day, when used as instructed by the manufacturer, there shall be a statement to the effect that the food may have a laxative effect;

(e)

a statement on the importance of maintaining an adequate daily fluid intake;

(f)

a statement that the product provides adequate amounts of all essential nutrients for the day;

(g)

a statement that the product should not be used for more than three weeks without medical advice.

(a)

they do not, on the basis of the generally accepted and peer-reviewed scientific evidence available, pose a safety concern to the health of the consumer; and,

(b)

they are available for use by the human body;

(ba)

they are suitable for the nutritional use for which they are intended; and

(bb)

they have, on the basis of generally accepted scientific evidence, a nutritional or physiological effect.

(a)

the condition in point (a) of paragraph 2 has been demonstrated on the basis of adequate test methods; and

(b)

their nutritional value and the suitability for the persons for whom they are intended has been shown. [Am. 87]

(a)

the name and the address of the applicant;

(b)

the name and a clear description of the substance

(c)

the composition of the substance;

(d)

the proposed use of the substance and conditions thereof;

(e)

a systematic review of the scientific data and appropriate peer-reviewed studies performed following generally accepted expert guidance on the design and conduct of such studies;

(f)

scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it isintended and its suitability for the intended uses;

(g)

scientific evidence demonstrating that the substance is available for use by the human body and has a nutritional or physiological effect ;

(h)

a summary of the content of the application.

—

a specification of the substance;

—

where appropriate, a specification of the conditions of use; and

—

where appropriate, a specification of the applicable purity criteria.

(i)

the name and address of the applicant;

(ii)

the name and description of the substance;

(iii)

the justification for the use of the substance in or on specific food;

(iv)

information that is relevant to the assessment of the safety of the substance;

(v)

where applicable, the analysis method(s) used by the applicant;

(va)

any scientific data gathered from animal testing for the assessment of the safety of the substance. [Am. 75]

(a)

decide that there is no need for special provisions regarding the composition and labelling of milks intended for young children; or

(b)

if appropriate, submit, in accordance with the ordinary legislative procedure and on the basis of Article 114 of the TFEU, a legislative proposal.

1.1.

1.2.

2.1.

2.2.

2.3.

2.4.

3.1.

3.2.