“The Revision of the PARNUTS Directive” Brussels, 27-28 November, 2012 CYPRUS PRESIDENCY OF THE COUNCIL OF THE EU Mrs Charitini Frenaritou Foodstuffs & Health Counselor of the CY PER REP

of the Cyprus Presidency The Priorities of the Cyprus Presidency of the Council of the EU

«TOWARDS A BETTER EUROPE» Working towards a Better Europe, the Cyprus Presidency has set the following priorities: Europe, more efficient and sustainable Europe, with a better performing and growth- based economy Europe, more relevant to its citizens Europe in the world, closer to its neighbours

The Cyprus Presidency’s priorities on FOODSTUFFS Proposal “Revision of PARNUTS” (early 2nd reading agreement) - Proposal on the “Breakfast Directives” (Council’s General Approach)

21/4/2017 “Proposal for a Regulation on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control” Proposal submitted by the Commission : 24 June 2011 Polish Presidency : Started the discussions within the Council Danish Presidency: Council’s General Approach (June 2012) European Parliament: 1st Reading (June 2012) MINISTRY OF HEALTH - EUROPEAN COORDINATION SECTOR

An agreement on the proposal was reached between Cyprus Presidency (early 2nd reading agreement): 3 Trilogues with European Parliament (Technical Meetings with the EP) - Council’s Working Groups/ COREPER 3rd Trilogue (14/11/12) An agreement on the proposal was reached between the two co-legislators, the Council of the EU and the European Parliament (endorsed by COREPER 19/11)

21/4/2017 Directive on foodstuffs intended for particular nutritional uses (PARNUTS) The majority of its provisions date back to 1977 and there was a need to be reviewed Need to remove differences in interpretation by simplifying the regulatory environment. The current framework regulating these products needed to be revised taking into account the evolution of the overall food regulatory system as well as the evolution of the market. MINISTRY OF HEALTH - EUROPEAN COORDINATION SECTOR

Main Points of the Proposal Establishes compositional and information requirements for the following categories of food: a) infant formula and follow-on formula; b) processed cereal-based food and baby food; c) food for special medical purposes; total diet replacement for weight control Establishes a Union list of substances that may be added to one or more categories of those categories of food and provides rules for the update of this list.

FURTHERMORE there are provisions for: 1). INTERPRETATION DECISIONS To ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to decide: whether or not a given food falls within the scope of this Regulation and to which category of food under the scope it belongs

2).The following Union Legislation shall be repealed: Directives 2009/39/EC, Directive 92/52/EEC and Regulation (EC) No 41/2009 (3 years after the date of the entry into force of this Regulation) Directives 96/8/EC, 2006/141/EC, 2006/125/EC, 1999/21/EC and Regulation (EC) No 953/2009 (from the date of application of delegated acts) (to avoid a legal gap in the situation when the old PARNUTS legal framework Directives are repealed as from the date of application of this new Regulation, but the Commission has not yet adopted the Delegated Acts provided in this regulation)

3). Adequate transitional measures to enable food business operators to adapt to the requirements of this Regulation (to address the stocks put on the market, taking into account the repeal of the current legislation)

Specific Requirements on: Gluten/ Lactose Milk based Drinks Food for Sportsmen Foods for special medical purposes intended for infants Novel Food/ Engineered Nanomaterials Appropriate restrictions on presentation and advertising of infant formula and on labelling on infant formula and follow on formula Support to Small Medium Enterprises (SME’s) Innovation Pesticides

Gluten/ Lactose Gluten The rules on the use of the statements 'gluten-free' and 'very low gluten‘, as contained in Regulation (EC) No 41/2009, will be regulated under Regulation (EU) No 1169/2011. The acts to be adopted should ensure at least the same level of protection for people who are intolerant to gluten as currently provided for under Regulation (EC) No 41/2009. The transfer of the rules should be completed prior to the application of this Regulation, and The Commission should consider how to ensure that people who are intolerant to gluten are adequately informed of the difference between food that is especially processed, prepared or manufactured to reduce the gluten content of one or more gluten containing ingredients and other food that is naturally free of gluten.

Lactose The establishment of rules on the use of the statements indicating the absence or reduced presence of lactose in food should be regulated under Regulation (EU) No 1169/201

Milk based Drinks The Commission shall, after consulting EFSA, present to the European Parliament and to the Council a report on the necessity, if any, of special provisions regarding the composition, labelling and other types of requirements, if appropriate, of the milk-based drinks and similar products intended for young children. This report should consider, among others: the nutritional needs of young children and the scientific base of the added value of these products in the young children’s diet The Commission may accompany this report with a legislative proposal.

Food for Sportsmen The Commission shall, after consulting EFSA, present to the European Parliament and to the Council a report on the necessity, if any, of provisions for food intended for sportsmen. The Commission may accompany this report with a legislative proposal.

Foods for special medical purposes intended for infants Developments in the market accompanied by a notable increase of food for special medical purposes intended for infants makes it necessary to review requirements such as pesticides residues, labelling, presentation, advertising, promotional and commercial practices of formulas intended for infants that should also apply, as appropriate, to these food

Novel Food/ Engineered Nanomaterials When, for a substance that has been used in accordance with this Regulation, there is a significant change in the production method or a change in particle size, for example through nanotechnology, this substance should be considered different from the one that has been used in accordance with this Regulation and should be re-evaluated under Novel Food Regulation ((EC) No 258/97).

Restrictions on presentation and advertising of infant formula and on labelling on infant formula and follow on formula The presentation and advertising of infant formula shall not include pictures of infants, or other pictures or text which may idealise the use of this category of food The labelling of infant formula and follow-on formula shall not include pictures of infants, or other pictures or text which may idealise the use of this category of food

Support to Small Medium Enterprises (SME’s) To support SME’s there is provision to ensure that appropriate guidance is made available to the SME's to assist them in the application of the Regulation. The Commission is requested to adopt guidelines providing technical guidance to facilitate compliance for all food business operators, in particular the SME’s, with specific chapters of the regulation

Innovation For the purpose of a regular update of the requirements applying to food under the scope of this regulation, the Commission will adopt and update delegated acts taking into account all relevant data, including data provided by interested parties in relation to innovative products

Pesticides The maximum residues levels in the food under the scope of this regulation should be set at the lowest achievable level to protect vulnerable groups of the population, taking into account good agricultural practices as well as other sources of exposure, such as environmental contamination. Limitations or bans of certain pesticides equivalent to those in the current provisions should be taken into account in delegated acts. Those limitations or bans should be updated regularly.

Union List The Union List will be in the Annex of the regulation and it will be include the substances that: are in the 3 lists of the current (Dir. 2006/141/EC, 2006/125/EC and Reg. 953/2009), and belongs to the following categories of substances: vitamins, minerals, amino acids, carnitine and taurine, nucleotides, choline and inositol. The update of the Union list will be done by delegated acts.

This Regulation should be binding in its entirety and directly applicable in all Member States

Cyprus Presidency of the Council of the EU