28 Amendments of Esther DE LANGE related to 2011/0156(COD)
Amendment 59 #
Proposal for a regulation
Title
Title
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 and food for very low calorie diets
Amendment 62 #
Proposal for a regulation
Recital 7
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, 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. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report9 concludes that the scientific basis for setting specific compositional requirements is lackingWork 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.
Amendment 72 #
Proposal for a regulation
Recital 15
Recital 15
(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 and foods for very low calorie diets (VLCD). 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. 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 very low calorie diets, while taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC and amending Commission Directive 96/8/EC in order to cover VLCD.
Amendment 78 #
Proposal for a regulation
Recital 16
Recital 16
(16) 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.
Amendment 83 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) Maximum levels for pesticide residues set out in relevant Community legislation, 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.
Amendment 86 #
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17b) 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.
Amendment 92 #
Proposal for a regulation
Recital 19
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 and foods intended for very low calorie diets, 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.
Amendment 99 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) It is furthermore required to clarify the status of so-called 'growing-up milks' (GUMs), which are currently notified in 26 Member States through Directive 2009/39/EC, which is to be repealed. To this end, the Commission will present a report, and if necessary legislative proposals, at the latest one year before the repeal of Directive 2009/39/EC.
Amendment 114 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) It is important that the change in regulatory framework is carried out without changing the current definition and composition of 'gluten-free' and 'very low gluten' products, so as not to confuse the end-users of these products.
Amendment 116 #
Proposal for a regulation
Recital 27
Recital 27
(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. 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 (EC) No 1924/2006 and comply with requirements therein, with the exception of foods intended for very low calorie diets (VLCD), which should in future be regulated under Directive 96/8/EC. 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 119 #
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) A procedure should be laid down which allows foodstuffs resulting from scientific and technological innovations 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 specific directive concerned. However, on the grounds of consumer health protection, marketing authorisation may be granted only after the European Food Safety Authority has been consulted.
Amendment 120 #
Proposal for a regulation
Recital 29 b (new)
Recital 29 b (new)
Amendment 127 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) infant formula and follow-on formula for infants in good health;
Amendment 129 #
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
(c) food for special medical purposes, including formula intended for low birth- weight and pre-term infants.
Amendment 134 #
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) foods intended for use in very low calorie diets (VLCD).
Amendment 158 #
Proposal for a regulation
Article 2 – paragraph 2 – point h
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. Foods for special medical purposes also include formula intended for low birth-weight and pre-term infants.
Amendment 168 #
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) 'foods intended for very low calorie diets (VLCD)' means specifically formulated foods which, when used as instructed by the manufacturer, replace the total daily diet and contain between 400 and 800 kcal per day.
Amendment 169 #
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) 'Formula intended for low birth weight and pre-term infants' means a formula specifically developed to meet the medically-determined nutrient requirements of infants who are born prematurely or at a low birth weight (less than 2 500 g body weight).
Amendment 202 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The dissemination of any useful information or recommendations with reference to the categories of food referred to in points (a), (b) and (c) of Article 1 (1) may be made exclusively byto persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.
Amendment 206 #
Proposal for a regulation
Article 9 – paragraph 4 a (new)
Article 9 – paragraph 4 a (new)
4a. The dissemination of any useful information or recommendations with reference to the category of food referred to in point (ca) of Article 1 (1) may be made exclusively by persons having qualifications in medicine, nutrition or pharmacy.
Amendment 213 #
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
(b) the specific requirements on the use of pesticides in agricultural products intended for the production of such food and onlowest possible maximum pesticides residues in such food;
Amendment 233 #
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. The use of pesticides in agricultural products intended for the production of food referred to in Article 1(1)shall be limited as far as possible, while respecting the provisions referred to in Commission Directive 2006/125/EC and Commission Directive 2006/141/EC.
Amendment 271 #
Proposal for a regulation
Article 17 a (new)
Article 17 a (new)
Article 17 a At the latest one year before the repeal of Directive 2009/39/EC the Commission shall present a report, and if necessary legislative proposals, to clarify the status of so-called 'growing-up milks' (GUMs) under general food legislation.
Amendment 272 #
Proposal for a regulation
Article 17 b (new)
Article 17 b (new)
Commission Directive 96/8/EC
Article 1 – paragraph 2
Article 1 – paragraph 2
Article 17 b Article 1(2) of Directive 96/8/EC is replaced by: " foods intended for very low calorie diets (VLCD) are specifically formulated foods which, when used as instructed by the manufacturer, replace [...] the total daily diet and contain between 400 and 800 kcal per day."
Amendment 273 #
Proposal for a regulation
Article 17 c (new)
Article 17 c (new)
Commission Directive 96/8/EC
Article 4
Article 4
Article 17 c Article 4 of Directive 96/8/EC is replaced by: "All individual components making up the products referred to [...] Article 1(2), as sold, shall be contained in the same package."
Amendment 274 #
Proposal for a regulation
Article 17 d (new)
Article 17 d (new)
Article 17 d Article 5(1) of Directive 96/8/EC is replaced by: "1. The name under which the product is sold shall be: 'Total diet replacement for use in very low calorie diets'."
Amendment 275 #
Proposal for a regulation
Article 17 e (new)
Article 17 e (new)
Commission Directive 96/8/EC
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 282 #
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article 18a Food intended to meet the expenditure of intense muscular effort No later than 1 July 2015, the Commission shall submit a report to the European Parliament and the Council to assess the need to harmonise the rules on the composition and labelling of food intended to meet the expenditure of intense muscular effort. The Commission may accompany this report with proposals to modify the relevant Union provisions.