12 January - 20 June 2016

Legislation headlines

6 Nov 13

**Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin Raschera (PDO)
**Entering a name in the register of protected geographical indications Westfälischer Knochenschinken (PGI)
**Entering a name in the register of protected geographical indications Plátano de Canarias (PGI)
**EFSA state: ’Growing-up’ formula: No additional value to a balanced diet
**EFSA publishes reference values for intake of vitamin C and manganese
**Amendment of Protection of designations of origin Neufchâtel
**Amendment regarding maximum residue limits - manganese carbonate
**Regarding maximum residue limits in foodstuffs of animal origin, regarding neomycin
**Protection of designations of origin ‘Miele Varesino’
**Protection of geographical indications ‘Almendra de Mallorca’/‘Almendra Mallorquina’/‘Ametlla de Mallorca’/‘Ametlla Mallorquina’
**Amendment of Protection of designations of origin ‘Pecorino Sardo’
**EFSA publishes feed additives guidance on renewal of authorisations
**EFSA - ’Growing-up’ formula: No additional value to a balanced diet
**Refusing to authorise certain health claims made on foods
**Amending the list of permitted health claims made on foods
**Amendment regarding histamine in fishery products
**Amending rules on organic production and labelling of organic seaweed
**Approving the active substance penflufen
**Publication of an application protection of designations of origin ‘Requeijão da Beira Baixa’
**Scientific opinions

**Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin Raschera (PDO)
The Commission has examined Italy’s application for the approval of amendments to the specification for the protected designation of origin ‘Raschera’ registered under Commission Regulation (EC) No 1263/96. Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union as required by Article 50(2) (a) of that Regulation.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendment should be approved.

**Entering a name in the register of protected geographical indications Westfälischer Knochenschinken (PGI)
Germany’s application to register the name ‘Westfälischer Knochenschinken’ was published in the Official Journal of the European Union. 

**Entering a name in the register of protected geographical indications Plátano de Canarias (PGI)
Spain’s application to register the name ‘Plátano de Canarias’ was published in the Official Journal of the European Union.  As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission the name ‘Plátano de Canarias’ should therefore be entered in the register.

**EFSA state: ’Growing-up’ formula: No additional value to a balanced diet
The use of milk-based “growing-up” formula does not bring additional value to a balanced diet in meeting the nutritional requirements of young children in the European Union, EFSA has said. EFSA’s scientific experts could identify “no unique role” for young-child formula (commonly called “growing-up formula”) in the diet of young children (those aged 1-3), concluding that it is no more effective in providing nutrients than other foods that constitute the normal diet of young children. The findings are contained in EFSA’s Scientific Opinion on nutrient requirements and dietary intakes of infants and young children in the European Union, requested by the European Commission.

**EFSA publishes reference values for intake of vitamin C and manganese
EFSA has set population reference intakes for vitamin C and adequate intakes for manganese as part of its ongoing work on Dietary Reference Values (DRVs). At the request of the European Commission, EFSA is updating advice issued previously on DRVs, taking into account new scientific evidence and recent recommendations issued at national and international level. 

**Amendment of Protection of designations of origin Neufchâtel
Neufchâtel is a cheese made exclusively from renneted cow’s milk the curds of which are taken out and pressed before moulding; it has a soft, lactic, slightly salty paste without holes that is supple, does not collapse, is firm but not excessively so, velvety and smooth, non-sticky, non-runny and non-grainy. It has a surface mould that is white in colour and the rind has no holes.

**Amendment regarding maximum residue limits manganese carbonate
According to Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.  The Committee for Medicinal Products for Veterinary Use recommended the extension of MRL for manganese carbonate in bovine species to include parenteral use, and has recommended the extrapolation of the MRLs for manganese carbonate in bovine species to all food- producing species.

**Regarding maximum residue limits in foodstuffs of animal origin, regarding neomycin
The maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry are established in accordance with Regulation (EC) No 470/2009.  Neomycin is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for all food-producing species, applicable to muscle, fat, liver, kidney, milk and eggs.  An application for the modification of the existing entry for neomycin has been submitted to the European Medicines Agency.  The Committee for Medicinal Products for Veterinary Use recommended the establishment of a revised MRL for neomycin for bovine species, applicable to kidney and liver, and the extrapolation of the revised MRLs for neomycin from cattle to all food-producing species.  Regulation (EU) No 37/2010 should therefore be amended accordingly.

**Protection of designations of origin ‘Miele Varesino’
‘Miele Varesino’ is a single-flower acacia honey (Robinia pseudoacacia L.)  Miele Varesino’ must have the following chemical and physical characteristics: the HMF (hydroxymethylfurfural) content (when the product is put on sale) must be less than 15 mg/kg and the water content must not exceed 17,50 %.

**Protection of geographical indications ‘Almendra de Mallorca’/‘Almendra Mallorquina’/‘Ametlla de Mallorca’/‘Ametlla Mallorquina’
‘Almendra de Mallorca’/‘Almendra Mallorquina’/‘Ametlla de Mallorca’/‘Ametlla Mallorquina’ is the fruit of the almond tree (Prunus amygdalus) intended for human consumption, which may be raw or roasted, with or without the skin.

**Amendment of Protection of geographical indications ‘lomnické suchary’
Amendments have been made to the description of the product, method of production, labelling and other.  The following types of ‘Lomnické suchary’ are produced: ‘Lomnické suchary cukrované’ (sugared rusks), ‘Lomnické suchary oříškové’ (hazelnut rusks), ‘Lomnické suchary mandlové’ (almond rusks) and ‘Lomnické suchary arašídové’ (peanut rusks).

**Amendment of Protection of designations of origin ‘Pecorino Sardo’
Amendments have been made to the description of product, labelling and other.  The ‘Pecorino Sardo’ PDO is reserved for semi-cooked cheeses, made exclusively from whole ewe's milk, which may be thermised or pasteurised and of which there are two varieties.

**EFSA publishes feed additives guidance on renewal of authorisations
Under EU rules authorisations for feed additives must be renewed every ten years. EFSA has published guidance that outlines the information that applicants need to include in their dossiers, in line with relevant EU regulation. This guidance also takes into consideration comments that were submitted by stakeholders during a public consultation. The first applications will be sent to EFSA in 2015.

**EFSA - ’Growing-up’ formula: No additional value to a balanced diet
The use of milk-based “growing-up” formula does not bring additional value to a balanced diet in meeting the nutritional requirements of young children in the European Union, EFSA has said. EFSA’s scientific experts could identify “no unique role” for young-child formula (commonly called “growing-up formula”) in the diet of young children (those aged 1-3), concluding that it is no more effective in providing nutrients than other foods that constitute the normal diet of young children. The findings are contained in EFSA’s Scientific Opinion on nutrient requirements and dietary intakes of infants and young children in the European Union, requested by the European Commission.

**Refusing to authorise certain health claims made on foods
The following applications were refused. 

  • Hypo-caloric snacks (KOT products)’ - contributes to reduce the adipocytes size at the abdominal level, in the context of a low-calorie diet
  • Isoleucyl-prolyl-proline (IPP) and valyl-prolyl- proline (VPP) -  Peptides IPP and VPP help to maintain normal blood pressure
  • Appl’In® polyphenolic apple extract powder (Malus domestica) -  Appl’In® contributes to decrease glycaemic response in women
  • Coffee C21  - Regular consumption of Coffee C21 contributes to the maintenance of DNA integrity in cells of the body
  • Diacylglycerol (DAG)  oil  - Substituting your usual vegetable oil with DAG oil helps in the management of body weight through weight loss
  • Spermidine - Spermidine prolongs the growing phase (anagen) of the hair cycle
  • Bimuno® (Bimuno® GOS) - Regular daily consumption of 1,37 g galacto-oligosaccharides from Bimuno® may reduce intestinal discomfort
  • Sugar beet fibre - Sugar beet fibre decreases intestinal transit time

Other applications also refused:

  • Opti EFAX ™ - Opti EFAX ™ helps to maintain healthy blood levels of HDL cholesterol
  • KF2BL20 -  Helps to maintain hair strength
  • Hyaluronic acid - Helps to maintain good skin hydration
  • Opti EFAX ™ - Opti EFAX ™ helps to maintain healthy blood levels of triglycerides
  • Transitech® - Improves transit and durably regulates it
  • Femilub® - Helps to reduce vaginal dryness
  • A combination of lycopene, vitamin E, lutein and selenium - Helps to prepare sensitive skin from the inside to improve their tolerance to the sun
  • Prolibra® - Helps to reduce body fat while preserving lean muscle
  • Eff EXT ™ - Helps to support joint function by maintaining low levels of plasma

**Amending the list of permitted health claims made on foods
The Authority gave a favourable assessment to the health claim referring to the effect of carbohydrates on the maintenance of brain function and proposed as appropriate conditions of use for that claim that ‘a daily intake of 130 g of glycaemic carbohydrates has been estimated to cover the glucose requirement of the brain’. However, a number of Member States raised concerns that such authorisation with its conditions of use would promote and encourage consumption of foods containing sugars other than those naturally contained. Furthermore, it would convey a conflicting and confusing message to consumers, particularly in light of national dietary advice to reduce sugars consumption. It is considered that, for this specific health claim, conflicting objectives can be addressed, by authorising the claim only under specific conditions of use limiting its use to foods which are either low in sugars or to foods to which sugars have not been added although they may contain sugars naturally.  In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 130 g of carbohydrates from all sources. The claim may be used for food which contains at least 20 g carbohydrates which are metabolised by humans, excluding polyols, per quantified portion and complies with the nutrition claim LOW SUGARS or WITH NO ADDED SUGARS as listed in the Annex to Regulation (EC) No 1924/2006.

**Amendment regarding histamine in fishery products
Fish sauce produced by fermentation is a liquid fishery product. The Codex Alimentarius Commission has fixed new recommended maximum levels of histamine in such fish sauce which are different from the ones set out in Annex I to Regulation (EC) No 2073/2005. That recommendation is in line with the information on consumer exposure data presented by the European Food Safety Authority (‘EFSA’) in its Scientific Opinion on risk based control of biogenic amine formation in fermented foods.

**Amending rules on organic production and labelling of organic seaweed
Regulation (EC) No 834/2007 establishes basic requirements for the organic production of seaweed and aquaculture animals.  Seven Member States recently submitted requests for a revision of the rules on products, substances and techniques which can be used in organic aquaculture production. 

**Approving the active substance penflufen
The United Kingdom received on 9 December 2009 an application from Bayer CropScience AG for the inclusion of the active substance penflufen in Annex I to Directive 91/414/EEC.  For that active substance, the effects on human and animal health and the environment have been assessed.   It has appeared from the various examinations made that plant protection products containing penflufen may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve penflufen. In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is in particular appropriate to require further confirmatory information.

**Publication of an application protection of designations of origin ‘Requeijão da Beira Baixa’
‘Requeijão da Beira Baixa’ is produced through the precipitation or coagulation, by heating, of the lactoalbumin and lactoglobulin in the whey obtained as a by-product of the manufacturing of ‘Queijos da Beira Baixa’ (‘Queijo de Castelo Branco’ PDO, ‘Queijo Amarelo da Beira Baixa’ PDO, ‘Queijo Picante da Beira Baixa’ PDO) and is obtained in the specified geographical area. It is presented as a fresh, unfermented product.

**Scientific opinions

Safety of “Methyl Vinyl Ether-Maleic Anhydride Copolymer” (chewing gum base ingredient) as a Novel Food ingredient

Annual Post-Market Environmental Monitoring (PMEM) report from BASF Plant Science Company GmbH on genetically modified potato EH92-527-1 in 2012

Refined exposure assessment for amaranth (E 123)

Safety and efficacy of manganese compounds (E5) as feed additives for all species: manganous oxide and manganous sulphate monohydrate, based on a dossier submitted by Eramet & Comilog Chemicals S.A

Efficacy of Ronozyme® Rumistar (alpha-amylase) as a feed additive for dairy cows

Substantiation of a health claim related to a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard and protection of blood lipids from oxidative damage pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Safety and efficacy of Econase® GT (endo-1,3(4)-beta-glucanase) as a feed additive for chickens for fattening and weaned piglets

Safety and efficacy of L-cysteine hydrochloride monohydrate as a flavouring additive for pets

Efficacy of L. plantarum and P. acidilactici as silage additives

Dietary Reference Values for manganese

Dietary Reference Values for vitamin C

Modification of the existing MRL for cyfluthrin in artichokes

Nutrient requirements and dietary intakes of infants and young children in the EU

Safety of rapeseed protein isolate

Substantiation of a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise

Substantiation of a health claim related to pantothenic acid and contribution to normal energy-yielding metabolism

Review of the existing maximum residue levels (MRLs) for oxadiargyl

Modification of the MRL for dicamba in genetically modified soybean

Re-evaluation of boric acid (E 284) and sodium tetraborate (borax) (E 285) as food additives

Safety of “citicoline” as a Novel Food ingredient

Safety of “coriander seed oil” as a Novel Food ingredient

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