12 January - 20 June 2016

Legislation headlines

  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Lentille verte du Puy’ (PDO))
  • Authorising an extension of use of UV-treated baker's yeast (Saccharomyces cerevisiae) as a novel food
  • Authorising an extension of use levels of UV-treated mushrooms as a novel food
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Radicchio Variegato di Castelfranco’ (PGI))
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Limone Femminello del Gargano’ (PGI))
  • Concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying
  • Entering a name in the register of protected geographical indications (‘Choucroute d'Alsace’ (PGI))
  • Entering a name in the register of protected geographical indications (‘Pitina’ (PGI))
  • Suspending temporarily imports from Bangladesh of foodstuffs containing or consisting of Betel leaves (‘Piper betle’)
  • Scientific opinions

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Lentille verte du Puy’ (PDO))
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Lentille verte du Puy’.  The Commission published the amendment application in the Official Journal of the European as no statement of opposition has been received by the Commission, the amendments to the specification have been approved.

Authorising an extension of use of UV-treated baker's yeast (Saccharomyces cerevisiae) as a novel food
The company Lallemand Bio-Ingredients made a request to the competent authority of Denmark for an extension of use and use levels of UV-treated baker's yeast (Saccharomyces cerevisiae). The application requested to extend the use of UV-treated baker's yeast (Saccharomyces cerevisiae) to additional food categories, namely, pre-packed fresh and dry yeast for home baking and in food supplements without indication of maximum permitted levels. In addition, the applicant requested to amend the lower specification of the vitamin D2 content in the yeast concentrate from 1 800 000 IU (450 μg/g) to 800 000 IU (200 μg/g).  In view of the comments made by the other Member States, the applicant provided additional explanations which alleviated their concerns to the satisfaction of the Member States and the Commission. Those explanations give sufficient grounds to establish that the extension of use and use levels of UV-treated baker's yeast (Saccharomyces cerevisiae) complies with Article 12(1) of Regulation (EU) 2015/2283.

Authorising an extension of use levels of UV-treated mushrooms as a novel food
The companies Banken Champignons Group BV and J.K. Holding BV made a request to the competent authority of the Netherlands to place UV-treated mushrooms (Agaricus bisporus) with increased levels of vitamin D2 on the Union market as a novel food.  In view of the comments made by the other Member States, the applicant provided additional explanations which alleviated the concerns to the satisfaction of the Member States and the Commission the application has been approved.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Radicchio Variegato di Castelfranco’ (PGI))
The Commission has examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Radicchio Variegato di Castelfranco’. Since the amendments in question are not minor the Commission published the amendment application in the Official Journal of the European Union. As no statement of opposition was received the amendments to the specification were approved.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Limone Femminello del Gargano’ (PGI))
The Commission has examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Limone Femminello del Gargano’.  The amendment were published in the Official Journal of the European Union. As no statement of opposition were received by the Commission, the amendments to the specification have been approved.

Concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying
An application was submitted for the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying.  The EFSA under the proposed conditions of use reported that the preparation of benzoic acid, calcium formate and fumaric acid does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that it has the potential to improve the performance of chickens for fattening and this conclusion can be extended to chickens reared for laying. However, since no conclusions can be drawn on the margin of safety of the additive for major target species, the conclusions on safety cannot be extrapolated to minor avian species for fattening and to minor avian species reared for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

Entering a name in the register of protected geographical indications (‘Choucroute d'Alsace’ (PGI))
France's application to register the name ‘Choucroute d'Alsace’ 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 ‘Choucroute d'Alsace’ should therefore be entered in the register. 

Entering a name in the register of protected geographical indications (‘Pitina’ (PGI))
Italy's application to register the name ‘Pitina’ 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 ‘Pitina’ should therefore be entered in the register.

Suspending temporarily imports from Bangladesh of foodstuffs containing or consisting of Betel leaves (‘Piper betle’)
Commission Implementing Decision 2014/88/EU prohibited the importation into the Union of foodstuffs containing or consisting of betel leaves from Bangladesh, originally for a limited period of application until 31 July 2014. It was adopted following a high number of notifications issued to the Rapid Alert System for Food and Feed (RASFF) due to the presence of a wide range of Salmonella strains, including Salmonella Typhimurium, found in foodstuffs containing or consisting of betel leaves (‘Piper betle’, commonly known as ‘Paan leaf’ or ‘Betel quid’) from Bangladesh.  Since Bangladesh was not able to provide guarantees securing the imports of betel leaves into the Union, Commission Implementing Decisions 2014/510/EU (3), (EU) 2015/1028 (4), and (EU) 2016/884 (5) extended the period of application of the temporary suspension of imports of these products until 30 June 2015, 30 June 2016 and 30 June 2018 respectively. The proposed action plan submitted by Bangladesh in January 2018 is still incomplete and there are no guarantees on its effective application and enforcement. Therefore the period of temporary suspension of imports has been extended.

Scientific opinions

Safety assessment of the process ‘Gneuss 1’, based on Gneuss technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘Gneuss 2’, based on Gneuss technology, used to recycle post‐consumer PET into food contact materials

Safety and efficacy of betaine anhydrous for food‐producing animal species based on a dossier submitted by AB Vista

Safety and efficacy of vitamin B2 (riboflavin) produced by Ashbya gossypii ■■■■■ for all animal species based on a dossier submitted by BASF SE

Safety evaluation of the food enzyme α‐amylase from a genetically modified Bacillus licheniformis (strain NZYM‐AV)

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)

Safety and efficacy of COXAM® (amprolium hydrochloride) for chickens for fattening and chickens reared for laying

Assessment of the application for renewal of authorisation of Actisaf® Sc47 (Saccharomyces cerevisiae CNCM I‐4407) for lambs for fattening, minor dairy ruminants, horses and pigs for fattening

Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants

African swine fever in wild boar

Pest categorisation of Melampsora medusae

Pest categorisation of Xiphinema americanum sensu lato

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus licheniformis (strain NZYM‐AN)

Safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM‐KP)

Pest categorisation of Pantoea stewartii subsp. stewartii

Pest categorisation of Chrysomyxa arctostaphyli

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

EFSA cross‐cutting guidance lifecycle

Safety and efficacy of muramidase from Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species

Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171)

Scientific opinion on pesticides in foods for infants and young children

Modification of the terms of authorisation of lecithins as a feed additive for all animal species

Safety and efficacy of vitamin B12 (in the form of cyanocobalamin) produced by Ensifer spp. as a feed additive for all animal species based on a dossier submitted by VITAC EEIG

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 8: suitability of taxonomic units notified to EFSA until March 2018

Updated quantitative risk assessment (QRA) of the BSE risk posed by processed animal protein (PAP)

Safety assessment of the process ‘Gneuss 1’, based on Gneuss technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘Gneuss 2’, based on Gneuss technology, used to recycle post‐consumer PET into food contact materials

Safety and efficacy of betaine anhydrous for food‐producing animal species based on a dossier submitted by AB Vista

Safety and efficacy of vitamin B2 (riboflavin) produced by Ashbya gossypii ■■■■■ for all animal species based on a dossier submitted by BASF SE

Pest categorisation of Arceuthobium spp. (non‐EU)

Assessment of the application for renewal of authorisation of Levucell®SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for dairy ewes and dairy goats

Safety of natural mixture of illite, montmorillonite and kaolinite (Argile Verte du Velay) for all animal species

Updated pest categorisation of Xylella fastidiosa

Pest categorisation of Synchytrium endobioticum

Safety of egg membrane hydrolysate as a novel food pursuant to Regulation (EU) 2015/2283

Scientific Opinion on the safety and efficacy of Aviax 5% (semduramicin sodium) for chickens for fattening

Flavouring Group Evaluation 203 Revision 2

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Assessment of the application for renewal of authorisation of Calsporin® (Bacillus subtilis DSM 15544) for chickens for fattening

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