STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH SECTION ON GENERAL FOOD LAW. Summary Record of Meeting of 30 April 2012

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EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH SECTION ON GENERAL FOOD LAW Summary Record of Meeting of 30 April 2012 Chairmen: Mr Basil Mathioudakis (for Items 1, 2, 3, 3A, 5, 7 and 8) Mrs Chantal Bruetschy (for Items 4, 6, 9 and Miscellaneous) All Member States present except Bulgaria 1. Exchange of views of the Committee on a Slovenian notification of a draft Rule on the quality of meat products (2011/409/Sl) (MH) The Commission informed the delegations that this item was removed from the agenda due to the closure of the specific procedure under Article 19 of Directive 2000/13/EC initiated on the above-mentioned notification. It has been explained that, according to the further clarifications provided by the Slovenian authorities, the labelling provisions of the notified draft do not provide for new requirements but simply maintain the status quo of the current legislation. The Commission also recalled that since only new labelling requirements need to be evaluated under the specific notification procedure of Directive 2000/13/EC, the Member States should always clarify this aspect when notifying their draft measures. At this occasion, the Commission also informed the delegations that the Spanish authorities have recently withdrawn the notified draft related to the labelling of meat obtained from animals slaughtered without stunning (notification 2010/186/ES). Furthermore, the Commission explained that the preparatory work on the study announced in recital 50 of Regulation (EU) No 1169/2011 has been launched. 2. Exchange of views of the Committee on the legal situation in Member States concerning the marketing of foods containing cannabis extract (MH) Following a written question from the European Parliament on the matter, the Commission asked for an exchange on views on the legal situation in Member States concerning the marketing of foods containing cannabis extracts. 1

The vast majority of the delegations declared that, at national level, such foods are regulated by the (EU) General Food Law, health legislation and drug law. On the basis on these provisions, these Member States allow the use of cannabis extracts in foods provided that their active substances cannot be detected or their Tetrahydrocannabinol (THC) level is insignificant. Some delegations specified that specific pre-authorisation procedure is required before placing on the market of such foods in their territory. Only few delegations affirmed that, in their countries, hemp as whole is not allowed to be used in foods. In addition, all Member States agreed that the labelling of foods containing cannabis in a way that it promotes their alleged drug effects is to be considered as misleading and contrary to the EU legislation. In order to avoid the consumer being misled by such practices, few Member States have foreseen specific labelling requirements in the matter. The Commission took note of all information provided by the Member States. 3. Exchange of views of the Committee on the labelling of allergens in wine (MH) The Commission presented a draft Regulation providing for modalities of labelling the allergens in wine, to be applicable as from 1 July 2012. The Commission also informed the Member States that this legislation being of the competence of DG AGRI, will not be subject of a vote by DG SANCO Standing Committee on the Food Chain and Animal Health. The majority of delegations expressed their support on the Commission initiative. Some of them manifested however their concern as to the lack of scientific evidence justifying the rationale of the proposal and stressed their strong opposition as regards any possible prolongation of the current labelling exemption for the wine sector. The Commission explained that the proposed draft does not change the scope of Directive 2000/13/EC and obligations issuing thereof. It provides for a pragmatic approach as to how the allergens should be labelled on wine. The comments and positions expressed by the Member States will be taken into account by the Commission in finalising the draft text. 3A. Exchange of views of the Committee on a working document on the reasons for non-authorisation of health claims referred to in Article 13(1) of Regulation (EC) No 1924/2006. The Standing Committee gave a positive opinion on 5 December to a Commission Regulation establishing a list of such permitted Article 13(1) health claims. The period of scrutiny by the European Parliament and the Council ended on 27 April and the draft Regulation will be adopted by the Commission and published in the Official Journal. Once the list of these permitted health claims is established, there is an obligation to include these claims in the Union Register of nutrition and health claims, together with the claims submitted under Article 13(1) that were rejected and the reason for their rejection. This will need to be done on publication of the Commission Regulation. 2

The Commission presented a document with text of the reasons for the nonauthorisation of health claims referred to in Article 13(1) of Regulation (EC) No 1924/2006. The Commission explained that it had decided to refer to nonauthorisation rather than rejection of health claims because the result of the process required in Regulation (EC) No 1924/2006 was the authorisation or non-authorisation of health claims. The word "rejected" appeared in Article 20 about the Union Register, not in the Articles about the authorisation process. Therefore the Union Register will explain the reasons for "non-authorisation" of health claims, rather than reasons for "rejection". The Commission explained in some detail what these reasons were. Member States did not have any objections to these explanations. 4. Exchange of views of the Committee on a "Guidance of significant use of novel foods or novel food ingredients" (E6-AK) Some editorial changes to the document were agreed. Member States invited the Commission to publish this guidance on the Commission website for novel food as soon as possible. 5. Exchange of views and possible opinion of the Committee on a draft Commission Implementing Regulation establishing implementing rules for the application of Article 16 of 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 foods (Art. 16 of Regulation (EC) No 1925/2006) (Opinion of the Committee via the examination procedure) (Doc. SANCO/2012/10646) (YA) The draft Commission Regulation aims at establishing implementing rules for the application of Article 16 of Regulation (EC) No 1925/2006 in particular on the provision of the relevant necessary information by the Member States to the Commission for the purpose of evaluating the effects of implementation of Regulation (EC) No 1925/2006. The Commission presented the draft measure to the Committee. During the exchange of views, many delegations expressed their disappointment at the lack of harmonised maximum amounts of vitamins and minerals in foods. They urged the Commission to undertake this exercise as envisaged by Regulation (EC) No 1925/2006. Furthermore, several delegations expressed their concerns regarding the possibility to submit the required information within the deadline specified in Regulation (EC) No 1925/2006, and requested some flexibility in this respect. The Committee agreed to a technical amendment in the Annex. Vote: Favourable opinion by qualified majority (323 in favour; 12 abstained; 10 absent) 3

6. Exchange of views and possible opinion of the Committee on a draft Commission Implementing Decision authorising the placing on the market of Gamma- Cyclodextrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (Art. 7 of Regulation (EC) No 258/97) (Opinion of the Committee via the examination procedure) (Doc. SANCO/2012/10912) (E6-AK) The draft Commission Implementing Decision aims at authorising a novel food ingredient, gamma-cyclodextrin. The Committee agreed to technical amendments in the Annex. Vote: Favourable opinion by qualified majority (323 in favour; 12 abstained; 10 absent) 7. Exchange of views of the Committee on a draft Commission Regulation refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health (Art.13(5) of Regulation (EC) No 1924/2006) (Regulatory procedure with scrutiny of the European Parliament and of the Council) (Doc. SANCO/10945/2012) (CA) The draft Commission Regulation was submitted to the Standing Committee in accordance with Article 18(5) of Regulation (EC) No 1924/2006. It would refuse to authorise the use of one health claim foreseen in Article 13(5) of that Regulation. The application related to the effects of iron on reduction of excessive hair loss in nonmenopausal women. The draft Regulation will be referred for further discussions at expert level and put to the vote of the Committee in a future meeting. 8. Exchange of views of the Committee on a draft Commission Regulation refusing to authorise certain health claims made on foods and referring to the reduction of disease risk (Art. 14(1) of Regulation (EC) No 1924/2006) (Regulatory procedure with scrutiny of the European Parliament and of the Council) (SANCO/10946/2012) (CA) The draft Commission Regulation was submitted to the Standing Committee in accordance with Article 17(1) of Regulation (EC) No 1924/2006. It would refuse to authorise the use of one health claim foreseen in Article 14(1)(a) of that Regulation. The application related to the effects of isolated soy protein on reduction of blood cholesterol, which is a risk factor in the development of coronary heart disease. The draft Regulation will be referred for further discussions at expert level and put to the vote of the Committee in a future meeting, following the consideration by EFSA of the comments of a scientific nature submitted pursuant to Article 16(6) of Regulation (EC) No 1924/2006. 4

9. Exchange of views of the Committee on a draft Commission Implementing Decision amending the labelling of novel chewing gum base. (Art. 7 of Regulation (EC) No 258/97) (Opinion of the Committee via the examination procedure) (Doc. SANCO/10969/2012) (E6-AK) Following discussion most Member States agreed that there should be a specific labelling of this novel chewing gum base. Rev-7 is not acceptable as a designation on the labelling as Rev-7 refers to a brand name. Commission Implementing Decision 2011/882/EU foresees to use as the designation of the novel chewing gum base on the labelling its full chemical name. This name appears to be too long in many cases given the size of many chewing gum packages. However, a shorter labelling as Rev-7 is not acceptable, as Rev-7 refers to a brand name. Eventually it was agree to provide for the use of the Chemical Abstract Service (CAS) Number as an alternative labelling to the full chemical name. The Commission will make a proposal to amend Commission Implementing Decision 2011/882/EU on this basis. Miscellaneous / Divers Progress with the Revision of the Novel Food Regulation and Cloning The Commission has launched the work on the impact assessment for a possible Proposal on 'Cloning of animals for food production', scheduled for adoption in 2013. A new proposal for the Revision of the Novel Food Regulation is prepared in parallel, taking into account the overall progress achieved in conciliation. Dried leaves of Stevia rebaudiana under Regulation (EC) No 258/97 According to information available to Member States and the Commission, Stevia rebaudiana was not on the market to a significant degree in the EU as a food before the entrance into force of Regulation (EC) No 258/97. However, recently new information has emerged, that dried leaves from Stevia rebaudiana may have been on the market before 1997. Therefore it was agreed to discuss the issue once more in the Working Group, based on new information to be forwarded by the Member State(s) concerned on the significant consumption on their market before 1997. 5