12 January - 20 June 2016

Legislation headlines

  • Calcium sorbate (E 203) removed from the Union list of approved food additives
  • Amending Annex II to Regulation (EC) No 1333/2008 regarding the use of sweeteners in fine bakery wares
  • Entering a name in the register of protected designations of origin ‘Slavonski med’ (PDO)
  • Amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Ternasco de Aragón’ (PGI))
  • ‘La Clape’ enters the Register of protect designations of origin
  • Application for entering a name in the register of protected designation of origin ‘Lough Neagh Pollan’ (PDO)
  • Authorising the novel food ingredient– calanus finmarchicus
  • Authorising an extension of use of Chia seeds (Salvia hispanica) as a novel food ingredient
  • Authorising the placing on the market of UV-treated mushrooms as a novel food
  • Authorising the placing on the market of hydroxytyrosol as a novel food ingredient
  • Authorising the placing on the market of N-acetyl-D-neuraminic acid as a novel food ingredient
  • Entering a name in the register of protected geographical indications (‘Lenticchia di Altamura’ (PGI))
  • Entering a name in the register of protected geographical indications (‘Μελεκούνι’ (Melekouni) (PGI))
  • Approving non-minor amendments to the specification for a name entered in the register of protected protected geographical indications (‘Nürnberger Bratwürste’/‘Nürnberger Rostbratwürste’ (PGI))
  • Entering a name in the register of protected geographical indications (‘Carne de Salamanca’ (PGI))
  • Cancelling the registration of protected geographical indication ‘Carne de Morucha de Salamanca’ (PGI)
  • Cancelling the registration of protected geographical indication ‘Carne de Morucha de Salamanca’ (PGI)
  • Amending specification for the food additives Microcrystalline cellulose (E460(i))
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin [‘Saint-Nectaire’ (PDO)]
  • Entering a name in the register of protected geographical indications (‘Jajca izpod Kamniških planin’ (PGI))
  • Scientific opinions

Calcium sorbate (E 203) removed from the Union list of approved food additives
The commission re-evaluated calcium sorbate as a food additive and found a lack of genotoxicity data on calcium sorbate. Consequently the EFSA was not able to confirm the safety of calcium sorbate as a food additive and concluded that it should be excluded. 

Amending Annex II to Regulation (EC) No 1333/2008 regarding the use of sweeteners in fine bakery wares
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. Amendments have been made regarding the use of E 950 Acesulfame K, E 951 Aspartame, E 952 Cyclamic acid and its Na and Ca salts, E 954 Saccharin and its Na, K and Ca salts, E 955 Sucralose, E 959 Neohesperidine DC, E 961 Neotame, E 962 Salt of aspartame-acesulfame and E 969 Advantame in ‘fine bakery products for special nutritional uses’ covering ‘foods for persons suffering from carbohydrate metabolism disorders (diabetes)’.   A Commission's report concluded on foods for persons suffering from diabetes, the scientific basis for setting specific compositional requirements for those foods was lacking. Furthermore, Regulation (EU) No 609/2013 of the European Parliament and of the Council has abolished the concept of ‘foodstuffs for particular nutritional uses’, including that of ‘food for persons suffering from carbohydrate metabolism disorders (diabetes)’. Therefore, the authorisation of those sweeteners in ‘fine bakery products for special nutritional uses’ in accordance with Article 7(c) of Regulation (EC) No 1333/2008 is no longer justified and those products should not continue to be marketed.

Entering a name in the register of protected designations of origin ‘Slavonski med’ (PDO)
Croatia's application to register the name ‘Slavonski med’ was published in the Official Journal of the European Union.  As no statement of has been received by the Commission, the name ‘Slavonski med’ should therefore be entered in the register.

Amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Since the last amendment to Regulation (EU) No 10/2011, the European Food Safety Authority (‘the Authority’) has published further scientific opinions on particular substances that may be used in food contact materials (‘FCM’) as well as on the permitted use of already authorised substances.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Ternasco de Aragón’ (PGI))
The Commission examined Spain's application for the approval of amendments to the specification for the protected geographical indication ‘Ternasco de Aragón’.  The Commission published the amendment application in the Official Journal of the European Union and as no statement of opposition has been received the amendments to the specification have been approved.

‘La Clape’ enters the Register of protect designation of origin
The Commission has examined France’s application to register the name ‘La Clape’ in the Register of protect designations of origin. As no statement of objection was received the name has enter the entered the register.

Application for entering a name in the register of protected designation of origin ‘Lough Neagh Pollan’ (PDO)
The United Kingdom have applied for ‘Lough Neagh Pollan’ to enter the register of protected designation of origin.  A member of the Salmonid family, Lough Neagh Pollan is the name given to the lacustrine fish of the species Coregonus pollan which are harvested as a wild fish. Lough Neagh Pollan have been genetically ascribed as unique to Lough Neagh. As a consequence they can only be harvested from the defined geographical area of Lough Neagh.

Authorising the novel food – calanus finmarchicus
The Norwegian company Calanus AS made a request to the competent authority of the United Kingdom to place oil from the crustacean (marine zooplankton) Calanus finmarchicus harvested in the Norwegian Economic Zone and the Jan Mayen zone on the Union market as a novel food ingredient within the meaning of point.  In its initial assessment the UK found that Calanus finmarchicus met novel food criteria and further assessment by member states decided that oil from Calanus finmarchicus may be placed on the Union market as a novel food ingredient to be used in food supplements at the maximum levels of 2,3 g/day.

Authorising an extension of use of Chia seeds (Salvia hispanica) as a novel food ingredient
Chia Seeds have been approved to be used as a food ingredient in bread.  The company MEGGLE Hrvatska d.o.o. made a request to the competent authority of Croatia for an extension of use of Chia seeds (Salvia hispanica) as a novel food ingredient to be used in additional food categories, namely, in yoghurt. Croatia and member states were consulted and this was approved. Chia seeds (Salvia hispanica) as specified in the Annex to this Decision may be placed on the Union market as a novel food ingredient to be used in yoghurt with the maximum content of 1,3 g of whole Chia seeds per 100 g of yoghurt or 4,3 g of whole Chia seeds per 330 g of yoghurt (portion).

Authorising the placing on the market of UV-treated mushrooms as a novel food
The company Ekoidé AB made a request to the competent authority of Sweden to place UV-treated mushrooms (Agaricus bisporus) with increased levels of vitamin D2 on the Union market as a novel food.  Both Sweden and member states approved the application, and Mushrooms (Agaricus bisporus) which have been UV-treated to increase the level of vitamin D2 as specified in the Annex to this Decision may be placed on the Union market as a novel food.

Authorising the placing on the market of hydroxytyrosol as a novel food ingredient
The company Seprox Biotech made a request to the competent authority of Spain to place synthetic hydroxytyrosol (‘hydroxytyrosol’) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97. The target population is the general population excluding children under the age of three years, pregnant women, and lactating women. The EFSA and member states were consulted and both found that that hydroxytyrosol is safe for the proposed uses and use levels.  However taking into the excluded group products need to be labelled with “This food product should not be consumed by children under the age of three years, pregnant women, and lactating women; or This food product should not be used for cooking, baking or frying.”

Authorising the placing on the market of N-acetyl-D-neuraminic acid as a novel food ingredient
The company Glycom A/S made a request to the competent authority of Ireland to place synthetic N-acetyl-D-neuraminic acid (N-acetyl-D-neuraminic acid (NANA)) on the Union market as a novel food ingredient.  The EFSA were consulted and in their opinion they stated “that N-acetyl-D-neuraminic acid is safe when added to foods other than food supplements at the proposed uses and use levels for the general population. For food supplements EFSA established that N-acetyl-D-neuraminic acid is safe at the proposed uses and use levels for individuals above 10 years of age and is also safe for infants below 10 years of age, provided that the combined exposure from different sources does not exceed 11 mg/kg bw.”  The opinion also gives sufficient grounds to establish that N-acetyl-D-neuraminic acid in the proposed uses and use levels, when used as an ingredient in food supplements, complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97 provided that adequate labelling ensures that the threshold of 11 mg/kg bw is not exceeded by combined exposure from different sources for infants below 10 years of age.  Therefore N-acetyl-D-neuraminic acid is approved.

Entering a name in the register of protected geographical indications (‘Lenticchia di Altamura’ (PGI))
Italy's application to register the name ‘Lenticchia di Altamura’ was published in the Official Journal of the European Union. As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Lenticchia di Altamura’ has entered the register.

Entering a name in the register of protected geographical indications (‘Μελεκούνι’ (Melekouni) (PGI))
Greece's application to register the name ‘Μελεκούνι’ (Melekouni) was published in the Official Journal of the European Union.  As no statement of opposition was received the name ‘Μελεκούνι’ (Melekouni) has entered the register.

Approving non-minor amendments to the specification for a name entered in the register of protected protected geographical indications (‘Nürnberger Bratwürste’/‘Nürnberger Rostbratwürste’ (PGI))
The Commission has examined Germany's application for the approval of amendments to the specification for the protected geographical indication ‘Nürnberger Bratwürste’/‘Nürnberger Rostbratwürste’.  The Commission published the amendment application in the Official Journal of the European Union and as no statement of opposition was received the amendments were approved.

Entering a name in the register of protected geographical indications (‘Carne de Salamanca’ (PGI))
Spain's application to register the name ‘Carne de Salamanca’ was published in the Official Journal of the European Union.  The German authorities have informed the Commission that the meat types defined in the Single Document needed further clarifications concerning the classification of bovine animals. At the request of the Commission, the Spanish authorities have amended point 3.2 of the single document and have clarified the product description for the types of meat. The application has now been approved and Carne de Salamanca has entered the register of protected geographical indications. 

Cancelling the registration of protected geographical indication ‘Carne de Morucha de Salamanca’ (PGI)
Spain's application to cancel the registration of the protected geographical indication (PGI) ‘Carne de Morucha de Salamanca’ was published in the Official Journal of the European Union.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Carne de Morucha de Salamanca’ (PGI) should therefore be cancelled from the register of protected designations of origin and protected geographical indications.

Amending specification for the food additives Microcrystalline cellulose (E460(i))
An application was submitted for the amendment of specifications concerning the food additive microcrystalline cellulose (E 460(i)). The current specification as regards the solubility of the food additive microcrystalline cellulose (E 460(i)) states ‘Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution’. The applicant requests that the solubility of this food additive is amended to ‘Insoluble in water, ethanol, ether and dilute mineral acids. Practically insoluble or insoluble in sodium hydroxide solution’. The EFSA concluded that the amendment proposed by the applicant is not of a safety concern. However, they recommended that the concentration of sodium hydroxide solution to be used in the solubility test should be indicated in the EU specifications. Consequently, the description of the solubility of the food additive microcrystalline cellulose (E 460(i)) in sodium hydroxide solution (concentration: 50 g NaOH/L) was amended to ‘practically insoluble or insoluble’.

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin [‘Saint-Nectaire’ (PDO)]
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Saint-Nectaire’.  Since the amendments in question are not minor the Commission published the amendment application in the Official Journal of the European Union.  However as no statement of opposition has been received the amendments to the specification have been approved.

Entering a name in the register of protected geographical indications (‘Jajca izpod Kamniških planin’ (PGI))
Slovenia's application to register the name ‘Jajca izpod Kamniških planin’ was published in the Official Journal of the European Union. As no statement of opposition has been received by the Commission, the name ‘Jajca izpod Kamniških planin’ should therefore be entered in the register,

Scientific opinions

Modification of the existing maximum residue level for metazachlor in Chinese cabbage

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for turkeys for fattening

Avian influenza overview September – November 2017

Safety evaluation of the food enzyme peroxidase obtained from soybean (Glycine max) hulls

Low atmospheric pressure system for stunning broiler chickens

Safety and efficacy of ENZY CARBOPLUS® (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as a feed additive for avian species, weaned piglets and minor weaned porcine species

Re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive

Pest categorisation of small-spored Alternaria carrying the genes for the AM- or AK-toxin biosynthesis

Pest categorisation of Elsinoë fawcettii and E. australis

Assessment of decontamination processes for dioxins and dioxin-like PCBs in fish oil by physical filtration with activated carbon

Pest categorisation of Cephalcia lariciphila

Pest categorisation of Stegophora ulmea

Pest categorisation of Davidsoniella virescens

Safety and efficacy of an essential oil from Origanum vulgare subsp. hirtum (Link) letsw. var. Vulkan when used as a sensory additive in feed for all animal species

Clarification of some aspects related to genotoxicity assessment

Pest categorisation of Xiphinema californicum

Modification of the existing maximum residue level for fluopicolide in chards

L-carnitine and contribution to normal lipid metabolism: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Black tea and maintenance of normal endothelium-dependent vasodilation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Re-evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives

Administrative guidance for the processing of applications for regulated products

Safety assessment of the process ‘Morssinkhof Plastics’, used to recycle high-density polyethylene and polypropylene crates for use as food contact materials

Safety assessment of the active substance selenium nanoparticles, for use in active food contact materials

Safety assessment of the substance isobutane, for use in food contact materials

Pest categorisation of Toxoptera citricida

Update of the risk assessment on 3-monochloropropane diol and its fatty acid esters

Pest categorisation of Listronotus bonariensis

Safety of orthosilicic acid-vanillin complex (OSA-VC) as a novel food ingredient to be used in food supplements as a source of silicon and bioavailability of silicon from the source

Safety of hydroxyanthracene derivatives for use in food

Evaluation of a paper by Guarnaccia et al. (2017) on the first report of Phyllosticta citricarpa in Europe

Review of the existing maximum residue levels for fenoxycarb according to Article 12 of Regulation (EC) No 396/2005

Modification of the existing maximum residue levels for trifloxystrobin in various crops

Review of the existing maximum residue levels for bispyribac according to Article 12 of Regulation (EC) No 396/2005

Evaluation of data concerning the necessity of pymetrozine as an insecticide to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods

Pest categorisation of the Gonipterus scutellatus species complex

Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)

Setting of a maximum residue level for cyantraniliprole in leeks

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for acequinocyl in light of confirmatory data

Safety of low-substituted hydroxypropyl cellulose (L-HPC) to be used as a food additive in food supplements in tablet form

Modification of the existing maximum residue levels for fenhexamid in various crops

Modification of the existing maximum residue levels for difenoconazole in various crops

Review of the existing maximum residue levels for flurochloridone according to Article 12 of Regulation (EC) No 396/2005

GP/EFSA/NUTRI/2014/01 Scientific substantiation of health claims made on food: collection, collation and critical analysis of information in relation to claimed effects, outcome variables and methods of measurement

Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

Outcome of a public consultation on the draft guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

Modification of the existing maximum residue level for deltamethrin in kale

NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Pest categorisation of Xanthomonas oryzae pathovars oryzae and oryzicola

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