Compromise amendment

EUROPEAN PARLIAMENT

Committee on the Environment, Public Health and Food Safety

2009 - 2014

2011/0156(COD)

24.2.2012

COMPROMISE AND CONSOLIDATED

AMENDMENTS

1 - 12

Draft opinion

Frédérique Ries

(PE480.592v01-00 and PE480.605v01-00)

Food intended for infants and young children and food for special medical purposes

Proposal for a regulation

(COM(2011)0353 – C7-0169/2011 – 2011/0156(COD))

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United in diversity

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Compromise amendment 1

Frédérique Ries on behalf of the ALDE Group

Esther de Lange on behalf of the EPP Group

Daciana Octavia Sârbu on behalf of the S&D Group

Julie Girling on behalf of the ECR Group

Carl Schlyter on behalf of the Greens/ALE Group

Kartika Tamara Liotard on behalf of the GUE/NGL Group

Compromise amendment replacing Amendments 160, 161, 157, 159, 32, IMCO 17

Proposal for a regulation

Article1 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission Amendment

Foods for special medical purposes within the meaning of point (h) of the first subparagraph fall into one of the following three categories :

(i) 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;

(ii) 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;

(iii) nutritionally incomplete foods with a standard formulation or a nutrientadapted formulation specific for a disease, disorder or medical condition which are not suitable to be used as the sole source of nourishment.

Or. en

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Compromise amendment 2 (part 1)







Compromise amendment replacing Amendments 158, 169, 129, 136


Recital 16 a (new)


(16a) According to the WHO recommendations, low-birth weight infants should be fed mother's own milk.

Nonetheless, low birth-weight infants and pre-term infants often have special nutritional requirements which cannot be met by mother's own milk or standard infant formula. Food for these infants should comply with rules applicable to food for special medical purposes, when this kind of food is chosen to be the most appropriate formula taking into account the specific medical situation of the infant. Formula intended for low birth weight and/or pre-term infants should in any case comply with the requirements of

Directive 2006/141.

Or. en

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Article 1 – paragraph 1 – point c

Text proposed by the Commission

(c) food for special medical purposes .

Amendment

(c) food for special medical purposes, including formula intended for low birthweight and pre-term infants.

Or. en










Article 2 – paragraph 2 – point h


(h) '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.

Amendment h) ‘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

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pre-term infants, which also has to comply with the requirements of Directive

2006/141.

Or. en










Article 2 – paragraph 2 – point h a (new)


(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.

Or. en

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Compromise amendment replacing Amendments 6, 62, 63, 64, 65, 69, 75, 79, 80, 94, 96, 105,

137, 138, 140, 165, 166, 171, IMCO 2, ITRE 3


Recital 7


(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 1 concludes that the scientific basis for setting specific compositional requirements is lacking.

(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 regards the development of specific provisions due to widely diverging views among Member States and stakeholders concerning the scope of the specific legislation. Nevertheless, the undertaking made by the Commission in Directive

2009/39/EC to recognize the nutritional requirements of sportspeople should still apply, as supported by EFSA scientific opinions on claims relevant to active individuals, and the report of the

Scientific Committee on Food from the

28th February 2001. Therefore, the

Commission should assess, not later than

1 July 2015, the need to review general food law in this regard.

COM (2008) 392 Report from the

Commission to the European Parliament and the Council on foods for persons suffering from carbohydrate metabolism

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disorders (diabetes), Brussels, 26.6.2008.

Or. en








Compromise amendment replacing Amendments 57, 68, 74, ITRE 4 , ITRE 7, 76, 77, 88, 95,

101, 112, 130, 131, 132, 163, 164, 167, 170, 231, 268, 280, IMCO 29, ITRE 30


Article 10 – paragraph 3 a (new)


In addition to complying with the requirements of Article 9, foodstuffs intended for people intolerant to gluten, as referred to in Article 1(1)(ca), consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, shall not contain a level of gluten exceeding 100 mg/kg in the food as sold to the final consumer. Foodstuffs sold to the final consumer which contain a level of gluten not exceeding 100 mg/kg may be labelled ‘very low gluten content’.

Foodstuffs sold to the final consumer which contain a level of gluten not exceeding 20 mg/kg may be labelled

‘gluten free’.

Foodstuffs referred to in this paragraph shall also comply with the following criteria:

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

– they shall be prepared with special care,

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in compliance with good manufacturing practice (GMP), to avoid gluten contamination,

– where the terms 'very low gluten content' and 'gluten free' are used, they shall appear in proximity to the name under which the food is sold.

Or. en








Compromise amendment replacing Amendments 115, 109, 111, IMCO 9, 280, IMCO 29,

ITRE 30.




(26 a) Labelling indicating ‘lactose free’ and ‘very low lactose content’ is currently not covered by Union law: neither under

Regulation (EC) No 1924/2006 nor under specific provisions that deal with different kinds of food intolerance. These indications are, however, important for people who are intolerant to lactose. The

European Commission should therefore clarify their status under general food legislation.

Or. en

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Compromise amendment replacing Amendments 115, 109, 111, IMCO 9, 280, IMCO 29,

ITRE 30


Article 17 a (new)


Article 17 a (new)

At the latest 1 year after the entry into force of this Regulation the Commission shall present a report, and if appropriate a legislative proposal, to clarify the status of indications of 'lactose free' and 'very low lactose content' under general food legislation.

Or. en

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224, ITRE 26, 230, 232, 237, 236, IMCO 27, 239, 228, 271, 279, 107, 99, 150-156, ITRE

13, ITRE 29, 227, 229, 235, 175, 74, ITRE 4, 70, 71, 73, ITRE 7, 95, 89, 90, 93, IMCO 10




(19 a) The Commission should clarify, after consulting the European Food

Safety Authority, the status of milks intended for children between and 12 and

36 months which are currently regulated by different EU regulations

1

, 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.

Regulation (EC) No 178/2002, Regulation EC

No1925/2006, Directive 2009/39/EC, and/or

Regulation No 1924/2006.


Frédérique Ries on behalf of the ALDE Group






Compromise amendment replacing Amendments 224, ITRE 26, 230, 232, 237, 236,

Or. en

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IMCO 27, 239, 228, 271, 279, 107, 99, 150-156, ITRE 13, ITRE 29, 227, 229, 235, 175,

74, ITRE 4, 70, 71, 73, ITRE 7, 95, 89, 90, 93, IMCO 10




Milks intended for young children

By ... [ 1 year after the date of the entry into force of this Regulation] , the

Commission shall, after consulting the

European Food Safety Authority, submit a report to the European Parliament and to the Council assessing the need for special provisions regarding the composition and labelling of milks intended for young children between one and three years are required. This report shall consider the nutritional needs, the pattern of consumption, the nutritional intake and the levels of exposure to contaminants and pesticides of these young children. The report shall also consider whether Growing Up Milks have any nutritional benefits when compared to a normal diet for a child who is being weaned. In the light of the conclusions of that report, the Commission shall either:

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

(b) submit, if appropriate, in accordance with the ordinary legislative procedure and on the basis of Article 114 of the

TFEU, any appropriate legislative proposal;

Prior to the preparation of the above

Commission report the milks intended for young children between one and three years shall continue to fall within the scope of the relevant EU regulations such as Regulation (EC) No 178/2002,

Regulation EC No 1925/2006 and

Regulation (EC) No1924/2006;

Or. en

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Compromise amendment replacing Amendments IMCO 22, 41, 216, 193, ITRE 16, 194, 195,

196, 42, 240


Article 9 – paragraph 3


3. The labelling, presentation and advertising of food referred to in Article

1(1) shall provide adequate consumer information and must not be misleading.

Amendment

3. The labelling, presentation and advertising of food referred to in Article

1(1) shall be accurate, clear and easy to understand for consumers and must not be misleading.

It shall not attribute properties to such products for the prevention, treatment or cure of human disease, or imply such properties.

Or. en








Compromise amendment replacing Amendments IMCO 22, 41, 216, 193, ITRE 16, 194, 195,

196, 42, 240

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3 a. The labelling of infant formulae and follow-on formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. Graphic representations for easy identification of the product and for illustrating methods of preparation shall, however, be permitted. Directive 2006/141 will be amended accordingly.








Compromise amendment replacing Amendments 43, 197, 198, 199, 200, 201, 202, 206, 203,

ITRE 18, IMCO 23,


Article 9 – paragraph 4


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

Amendment

Or. en

4. The dissemination of any useful information or recommendations with reference to the categories of food referred to in points (a), (b) (c) and (ca) of Article

1 (1) may be made exclusively to persons having qualifications in medicine, nutrition or pharmacy . Additional information by health care professionals to the final consumer shall only be of a scientific and factual nature and shall not constitute advertising.

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Or. en








Compromise amendment replacing Amendments 17, 45, 47, 82, 81, 83, 86, 190, 191, 213,

233




(17 a) Maximum levels for pesticide residues set out in relevant Union law, in particular as taken up in Regulation (EC)

No. 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, should apply without prejudice to specific provisions set out in this Regulation and its delegated acts.

Or. en









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Recital 17 b (new)


(17 b) However, given the vulnerable nature of infants and young children, severe limitations on pesticide residues are required in infant and follow-on formulae and food for infants and young children. Specific maximum residue limits for these products are set in Commission

Directive 2006/141/EC and Commission

Directive 2006/125/EC. Special attention should be paid to pesticides containing substances classified as specifically hazardous to human health.

Or. en









233




2a. The use of pesticides in agricultural products intended for the production of food referred to in Article 1(1) shall be restricted as far as possible, without prejudice to the provisions referred to in

Commission Directive 2006/125/EC and

Commission Directive 2006/141/EC.

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233


Article 10 - Paragraph 2 b (new)


2b. The annexes to the Directives relating to foods referred to in Article 1(1), which lay down limitations or bans of certain pesticides shall be updated regularly, with particular attention to be paid to pesticides containing active substances, safeners or synergists classified in accordance with Regulation (EC) No

1272/2008 as mutagen category 1A or 1B, carcinogen category 1A or 1B, toxic for reproduction category 1A or 1B, considered to have endocrine disrupting properties that may cause adverse effects in humans, or being classified as

'candidate for substitution' pursuant to article 24 of Regulation (EC) No

1107/2009.

Or. en







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Compromise amendment replacing Amendments 56, 255




Article 10 a (Access to internal market for

SMEs)

The Commission shall, in close cooperation with all stakeholders and the

Authority, adopt appropriate guidelines and provide technical guidance to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in this

Regulation and assist them in the preparation and presentation of the application for scientific assessment. The

Commission shall be empowered to adopt delegated acts in accordance with Article

15 in order to adopt those guidelines.

Or. en









116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11


Recital 16


(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the

Amendment

(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the

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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.





AM\893689EN.doc 19/31 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 use in low calorie diets (LCD) and very low calorie diets

(VLCD) . Experience has shown that the provisions laid down in 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. VLCD products are currently not covered by

Commission Directive 96/8/EC but solely by framework Directive 2009/39/EC.

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 and foods intended for use in low calorie diets (LCD) and very low calorie diets (VLCD) , while taking into account Commission Directive

2006/141/EC, Commission Directive

2006/125/EC and Commission Directive

1999/21/EC and Commission Directive

96/8/EC .

Or. en

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116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11


Recital 16


(16) To ensure legal certainty, definitions laid down in 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.

(16) To ensure legal certainty, definitions laid down in 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 use in low calorie diets (LCD) and very low calorie diets (VLCD) should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.

Or. en









116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11

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Recital 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, taking into account 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.

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Amendment

(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 and foods intended for use in low calorie diets (LCD) and very low calorie diets (VLCD) , 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.

Or. en

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116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11


Recital 27


(27) ‘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 (EC) No

1924/2006 and comply with requirements therein. 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.

Amendment

(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 very low calorie diets (VLCD) 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 this 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 European Food

Safety 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 operator applying for the use of a claim or certain labelling methods. It is therefore necessary to maintain specific provisions in this Regulation on food for use in energy-restricted diets. This is an

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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 calorie diets

(LCD) and very low calorie diets (VLCD), 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.

Or. en









116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11

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Article 1 – paragraph 1 – point c a (new)


(ca) foods intended for use in low calorie diets (LCD) and very low calorie diets

(VLCD).

Or. en









116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11


Article 2 – paragraph 2 – point h a (new)


(ha) 'foods intended for use in low calorie diets (LCD)' and 'foods intended for use in very low calorie diets (VLCD)' means specifically formulated foods which, when used as instructed by the manufacturer, replace the total daily diet. They are divided in two categories: a) products containing between 400 and

800 kcal per day (VLCD); b) products containing between 800 and

1200 kcal per day (LCD).

Or. en

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Compromise amendment replacing Amendments: 134, 168, 272, 273, 274, 275, 72, 78, 92,

116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11


Article 10.2 a (new)


Article 10.2 a (new)

1. Foods intended for use in low calorie diets (LCD) and very low calorie diets

(VLCD) are specifically formulated foods which, when used as instructed by the manufacturer, replace the total daily diet.

They are divided in two categories: a) products containing between 400 and

800 kcal per day (VLCD); b) products containing between 800 and

1200 kcal per day (LCD).

2. Products referred to in paragraph 1 shall comply with the compositional requirements of Article 10.2 b new.

3. All individual components making up the products referred to in paragraph 1, as sold, shall be contained in the same package.

4. The name under which the products referred to in paragraph 1 are sold shall be: a) for products covered by point (a) of paragraph 1,

'Total diet replacement for use in very low calorie diets'; b) for products covered by point (b) of paragraph 1,

'Total diet replacement for use in low calorie diets'

5. The labelling of the products concerned shall bear, in addition to those provided

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Compromise amendment

Frédérique Ries on behalf of the ALDE Group for in Chapter IV of Regulation (EU)

1169/2011, the following mandatory particulars:

(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 Article 10.2 b new, 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, when used as instructed by the manufacturer, provides a daily intake of polyols in excess of 20 g per day, 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;

6. The labelling, advertising and presentation of the products concerned shall not make any reference to the rate or amount of weight loss which may result from their use.

Or. en

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Compromise amendment replacing Amendments: 134, 168, 272, 273, 274, 275, 72, 78, 92,

116, 32, 15, 16, 25, 29, 33, 162, IMCO 17, IMCO 11


Article 10.2 b (new)


These specifications refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer.

1. Energy

1.1. The energy provided by a product mentioned in paragraph 1 (a) of Article

10.2 a (new) shall not be less than 1680 kJ (400 kcal) and shall not exceed 3360 kJ (800 kcal) for the total daily ration.

1.2. The energy provided by a product mentioned in paragraph 1 (b) of Article

10.2 a (new) shall not be less than 3360 kJ (800 kcal) and shall not exceed 5040 kJ (1200 kcal) for the total daily ration.

2. Protein

2.1. The protein contained in products mentioned in paragraph 1 of Article 10.2 a new shall provide not less than 25 % and not more than 50 % of the total energy of the product. In any case the amount of protein of these products shall not exceed 125 g.

2.2. The abovementioned provisions on protein refer to a protein the chemical index of which is equal to that of the

FAO/WHO (1985) reference protein given in table 2. If the chemical index is lower than 100 % of the reference protein, the minimum protein levels shall be correspondingly increased. In any case the chemical index of the protein shall at

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Vitamin A

Vitamin D

Vitamin E

Vitamin C

Thiamin least be equal to 80 % of that of the reference protein.

2.3. The ‘chemical index’ shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein in and the quantity of each corresponding amino acid of the reference protein.

2.4. In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.

3. Fat

3.1. The energy derived from fat shall not exceed 30 % of the total available energy of the product.

3.2. For products mentioned in paragraph

1 of Article 10.2 a new, the linoleic acid

(in the form of glycerides) shall not be less than 4,5 g.

4. Dietary fibre

The dietary fibre content of products mentioned in paragraph 1 of Article 10.2 a new shall not be less than 10 g and shall not exceed 30 g for the daily ration.

5. Vitamins and minerals

The products mentioned in paragraph 1 of Article 10.2 a new shall provide for the whole of the daily diet at least: 100 % of the amounts of vitamins and minerals specified in Table 1.

TABLE 1

(ìg RE) 700

(ìg) 5

(mg-TE) 10

(mg)

(mg)

45

1,1

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Riboflavin

Niacin

Vitamin B

6

Folate

Vitamin B

12

Biotin

Pantothenic acid

Calcium

Phosphorus

Potassium

Iron

Zinc

Copper

Iodine

Selenium

Sodium

Magnesium (mg) 150

Manganese (mg) 1

Table 2

AMINO ACID REQUIREMENT PATTERN (1) g/100 g protein

Cystine + methionine

1,7

Histidine 1,6

Isoleucine 1,3

Leucine

Lysine

1,9

1,6

Phenylalanine 1,9

+ tyrosine

(mg)

(mg)

(mg)

(mg)

(mg)

(mg)

(ìg)

(ìg)

(mg)

(mg) 1,6

(mg-NE) 18

(mg)

(ìg)

(ìg)

(ìg)

(mg)

15

3

1,5

200

1,4

130

55

575

16

9,5

1,1

700

550

3 100

29/31 PE483.698v01-00

EN

Threonine 0,9

Tryptophan 0,5

Valine 1,3

(1) World Health Organisation.

Energy and protein requirements.

Report of a Joint FAO/WHO/UNU

Meeting. Geneva: World Health

Organisation, 1985. (WHO

Technical Report Series, 724).

EN

Or. en

Consolidated amendment 12




Compromise amendment replacing Amendments: 240, 196


Article 10 - Paragraph 3 a (new)


PE483.698v01-00 30/31

Amendment

3a. Advertising of infant formulae and follow-on formulae shall be restricted to publications specialising in baby care and scientific publications and shall contain only information of a scientific and factual nature. Member States may further restrict or prohibit such advertising.

The advertising of infant formulae and follow-on formulae shall be such that it enables consumers to make a clear distinction between infant formula and follow-on formula and avoid any risk of confusion between the above mentioned categories of products.

AM\893689EN.doc

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Justification

Or. ##

AM\893689EN.doc 31/31 PE483.698v01-00

EN

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