12 January - 20 June 2016

Legislation headlines

  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Acciughe sotto sale del mar Ligure (PGI))
  • Publication of an application for approval of a minor amendment to the specification for name entered in the register of protected geographical indications (‘Marroni Del Monfenera’)
  • Maximum residue limit of the substance alarelin
  • Maximum residue limits for the substance bromelain
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Coco de Paimpol (PDO))
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Ternera de Extremadura (PGI))
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Chasselas de Moissac (PDO))
  • Entering a name in the register of protected designations of origin Porc noir de Bigorre (PDO)
  • Amendment to application for “Bayerisches Rindfleisch” to enter the register of protected geographical indications
  • Non-approval of the active substance beta-cypermethrin
  • Extensions of the approval periods of the active substances cyflufenamid, fluopicolide, heptamaloxyloglucan and malathion
  • Application for entering a name in the register of protected geographical indications ‘Jajca izpod Kamniških planin’ (PGI)
  • Application for entering a name in the Register of Protected geographical indications for spirit drinks ‘Карнобатска гроздова ракия’/‘Гроздова ракия от Карнобат’/‘Karnobatska grozdova rakya’/‘Grozdova rakya ot Karnobat’
  • Approving the basic substance sodium chloride as a fungicide in mushrooms
  • Extension of the approval period of the active substance quizalofop-p-tefuryl
  • Publication of an amended application for the name ‘Saint-Nectaire’ to enter the register of protected designation of origin
  • Scientific opinions

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Acciughe sotto sale del mar Ligure (PGI))
The Commission has examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Acciughe sotto sale del mar Ligure’.  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 no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved.

Publication of an application for approval of a minor amendment to the specification for name entered in the register of protected geographical indications (‘Marroni Del Monfenera’)
Italy have submitted an application for non-minor amendment to the PDO for ‘Marroni Del Monfenera’.  Amendments have been made to the product description, labelling, and packaging.

Maximum residue limit of the substance alarelin
An application for the establishment of MRLs for alarelin in rabbit has been submitted to the European Medicines Agency (‘EMA’).  EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, concluded that the likelihood that a human may be exposed to biologically relevant levels of alarelin after ingesting rabbit tissue is negligible, and has recommended that the establishment of an MRL for alarelin in rabbit is not necessary for the protection of human health.

Maximum residue limits for the substance bromelain
An application for the establishment of MRLs for bromelain in porcine species has been submitted to the European Medicines Agency (‘EMA’). EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended that the establishment of an MRL for bromelain in porcine species is not necessary for the protection of human health. 

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Coco de Paimpol (PDO))
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Coco de Paimpol’.  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 has been received by the Commission, the amendments to the specification have been approved.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Ternera de Extremadura (PGI))
The Commission has examined Spain's application for the approval of amendments to the specification for the protected geographical indication ‘Ternera de Extremadura’.  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 under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved.

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

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Chasselas de Moissac (PDO))
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Chasselas de Moissac’.  Since the amendments in question are not minor, the Commission published the amendment application.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved.

Entering a name in the register of protected designations of origin Porc noir de Bigorre (PDO)
France's application to register the name ‘Porc noir de Bigorre’ 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 ‘Porc noir de Bigorre’ should therefore be entered in the register.

Amendment to application for “Bayerisches Rindfleisch” to enter the register of protected geographical indications
Germany have made amendments to their application for “Bayerisches Rindfleisch” to enter to the register of geographical indications. Amendment have been made to the description of the product.  ‘Bayerisches Rindfleisch’ comprises carcases or cut meat originating from bovine animals (of all categories) which have been born, reared, fattened and kept in Bavaria until slaughter.

Non-approval of the active substance beta-cypermethrin
The United Kingdom received an application from Cerexagri SAS for the inclusion of the active substance beta-cypermethrin in Annex I to Directive 91/414/EEC. For that active substance, the assessment of the effects on human and animal health and the environment for the uses proposed by the applicant has been carried out.  EFSA presented to the Commission its conclusion on the pesticide risk assessment of the active substance beta-cypermethrin concluding that for the uses of beta-cypermethrin assessed there is a high risk to aquatic organisms, bees and non-target arthropods. In addition, the risk assessment for soil and aquatic organisms and the exposure assessment for groundwater could not be finalised as insufficient information was provided in relation to the fate and behaviour of the cyclopropyl ring moiety of beta-cypermethrin. Furthermore, information on metabolism in livestock, which is necessary to confirm the residue definition for animal products, and information on the toxicity profile of metabolite PBA and its relevance for consumer risk assessment, were not provided.  Despite the arguments put forward by the applicant, the concerns could not be eliminated and therefore beta-cypermethrin is not approved.

Extensions of the approval periods of the active substances cyflufenamid, fluopicolide, heptamaloxyloglucan and malathion
For active substances which do not fall in the prioritised categories in Implementing Decision C(2016)6104, the approval period should be extended by either two or three years, taking into account the current date of expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance is to be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making. It is therefore appropriate to extend the approval period for active substance malathion by two years, and to extend the approval periods of active substances cyflufenamid and fluopicolide by three years.

Application for entering a name in the register of protected geographical indications ‘Jajca izpod Kamniških planin’ (PGI)
Slovenia have applied for the name ‘Kamniških planin’ to enter the register of protected geographical indication.  ‘Jajca izpod Kamniških planin’ eggs have a smooth shell of uniform thickness and a matt lustre that gives the impression of lasting freshness. The eggshells are hard.

Application for entering a name in the Register of Protected geographical indications for spirit drinks ‘Карнобатска гроздова ракия’/‘Гроздова ракия от Карнобат’/‘Karnobatska grozdova rakya’/‘Grozdova rakya ot Karnobat’
‘Карнобатска гроздова ракия’/‘Гроздова ракия от Карнобат’/‘Karnobatska grozdova rakya’/‘Grozdova rakya ot Karnobat’ is a wine spirit with a minimum alcoholic strength of 40 % vol., which: is obtained by single or double distillation at less than 65 % vol. of wine produced from grapes, where a maximum of 75 litres of wine can be obtained from 100 kg of grapes, and in terms of composition and organoleptic characteristics meets the requirements for the production of a wine spirit.

Approving the basic substance sodium chloride as a fungicide in mushrooms
An application from the Agriculture and Horticulture Development Board (UK) and the Institut Technique de l'Agriculture Biologique (ITAB) has been submitted for the approval of salt as a basic substance for use as a fungicide in mushrooms.  EFSA reviewed the application and concluded that sodium chloride fulfils the criteria of a foodstuff.  However it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.

Extension of the approval period of the active substance quizalofop-p-tefuryl
Active substances propaquizafop, quizalofop-p-ethyl and quizalofop-p-tefuryl have approvals which were originally expiring between 2019 and 2021. Considering that the three substances are ester variants of quizalofop, they share similar properties. Taking into account Implementing Decision C/2016/6104, the hazard properties of quizalofop-p-tefuryl (4) and the fact that the three substances have important similarities, it is appropriate to group them together in order to align the timing of their assessment and the peer-review process carried out by the European Food Safety Authority. Consequently, the dossiers for the three substances should be submitted to their respective rapporteur Member States within the same time frame.  The approvals of propaquizafop and quizalofop-p-ethyl expire on 30 November 2021. In order to align the timing of the assessment of the substance quizalofop-p-tefuryl with the assessment of the other two substances the approval period of the substance quizalofop-p-tefuryl should be extended.

Publication of an amended application for the name ‘Saint-Nectaire’ to enter the register of protected designation of origin
France have made amendments to the application for the name Saint-Nectaire to enter the PDO.  Amendments have been made to product description, proof of origin, method of production, labelling and other. ‘Saint Nectaire’ is a cheese made exclusively from renneted cow's milk, with a semi-hard, pressed, uncooked, fermented and salted paste.

Scientific opinions

Risks to human and animal health related to the presence of deoxynivalenol and its acetylated and modified forms in food and feed

Scientific opinion of Flavouring Group Evaluation 502 (FGE.502): grill flavour ‘Grillin’ 5078’

Scientific opinion of Flavouring Group Evaluation 503 (FGE.503): grill flavour ‘Grillin’ CB-200SF’

Pest risk assessment of Diaporthe vaccinii for the EU territory

Risks to human and animal health related to the presence of deoxynivalenol and its acetylated and modified forms in food and feed

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