12 January - 20 June 2016

Legislation headlines

  • Novel food applications: new administrative guidance for applicants published by EFSA
  • Amendment to an application for a name to enter the Register of  Protected Designation of Origination (‘Cabrales’(PDO))
  • Conferring protection of the name ‘Mergelland’ (PDO)
  • Approving an amendment to the specification for a Protected Designation of Origin (‘Pla i Llevant’ (PDO))
  • Tightening the restriction on the use of BPA in food contact materials
  • Application to enter a name in the register of protected geographical indications (‘Αγκινάρα Ιρίων’ (Agkinara Irion)’ (PGI))
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Laguiole’ (PDO))
  • Application to enter a name in the register of protected geographical indications ‘‘Choucroute d'Alsace’’ (PGI)
  • Application for the approval of an amendment to the product specification of a protected geographical indication that is not minor
  • Application for approval of an amendment to the product specification of protected geographical indications which is not minor “Radicchio Variegato di Castelfranco” (PGI)
  • Refusing health claim related to Lactobacillus plantarum 299v (Lp299v) and an increase of non-haem iron absorption
  • Approval of non-minor amendments to the product specification for a protected geographical indication Tiroler Speck (PGI)
  • Conditions of approval of the active substance penflufen
  • Extending the approval period of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride
  • Publication of an amendment application for “Lentille verte du Puy” to enter the register of protected designation of origin
  • Application to enter a name in the register of protected designations of origin (‘Cidre Cotentin’/‘Cotentin’ (PDO))
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Bayerisches Rindfleisch’/‘Rindfleisch aus Bayern’ (PGI))
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Cerezas de la Montaña de Alicante’ (PGI))
  • Addition of Sideritis scardica Giseb herba and Valeriana officinalis L. to the list of herbal substances, preparations and combinations for use in traditional herbal medicinal products
  • Entering a name in the register of protected geographical indications (‘Traditional Welsh Caerphilly’/‘Traditional Welsh Caerffili’ (PGI))
  • Scientific opinions

Novel food applications: new administrative guidance for applicants published by EFSA
EFSA have published new guidance that will help applicants to prepare novel food applications.  The administrative guidance includes a checklist of the data requirements outlined in EFSA’s “Guidance on the preparation and presentation of an application for authorisation of a novel food” and four tables where applicants should summarise the scientific studies referred to in their technical dossier.

Amendment to an application for a name to enter the Register of  Protected Designation of Origination (‘Cabrales’(PDO))
Spain have submitted an amendment to their application for Cabrales to enter the Register of Protected Designation of Origin.  Amendments have been made to labelling and other.  Cabrales is a blue-veined cheese made from raw cow's milk, sheep's milk or goat's milk or a mixture of two or all three types of milk — which must always be whole — with a balanced composition in terms of fats and proteins.

Conferring protection of the name ‘Mergelland’ (PDO)
The Commission has examined the application to register the name ‘Mergelland’ sent by the Netherlands and has published it in the Official Journal of the European Union.  As no statement of opposition has been received the name ‘Mergelland’ should be protected and entered in the register.

Approving an amendment to the specification for a Protected Designation of Origin application (‘Pla i Llevant’ (PDO))
The Commission has examined the application for the approval of an amendment to the specification for the Protected Designation of Origin ‘Pla i Llevant’, sent by Spain.  The Commission has published the application for the approval of an amendment to the specification in the Official Journal but as no statement of opposition was received the amendments have been approved.

Tightening the restriction on the use of BPA in food contact materials
The Commission has published a new Regulation that significantly tightens the restrictions on the use of BPA in food contact materials. It lowers the regulatory limit (specific migration limit or 'SML'), which is the amount allowed to migrate from the plastic material into food while keeping it safe, and extends this restriction to coating materials, which are used to line food and drink cans. The new Regulation also extends the ban from 2011 on the use of BPA in baby bottles by prohibiting the use of BPA to manufacture infant 'sippy' cups as well as the migration of BPA from coated materials containing food intended for infants and children 0–3 year olds. The new Regulation will apply from 6 September 2018.

Application to enter a name in the register of protected geographical indications (‘Αγκινάρα Ιρίων’ (Agkinara Irion)’ (PGI))
Greece have applied for the name Agkinara Irion to enter the register of protected geographical indications.  The Protected Geographical Indication ‘Agkinara Irion’ denotes heads of the local variety of artichoke known as Prasini tou Argous or Argitiki, which belongs to the species Cynara scolymus L. in the Asteraceae family.

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Laguiole’ (PDO))
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Laguiole’. Since the amendments in question are not minor within the amendment application was published 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.

Application to enter a name in the register of protected geographical indications ‘‘Choucroute d'Alsace’’ (PGI)
France have applied for the name ‘Choucroute d'Alsace’ to enter the register of protected geographical indications.  The ‘Choucroute d'Alsace’ is a processed vegetable produced by the natural anaerobic lactic acid fermentation of shredded cabbage leaves (Brassica oleracea L.) which are salted and put in fermentation vats.

Application for the approval of an amendment to the product specification of a protected geographical indication that is not minor
Italy have made some amendment to their application for  “Limone Femminello del Gargano” to enter the register of protected geographical indication.  Amendments have been made to the product description, production method, labelling and others.  The protected geographical indication ‘Limone Femminello del Gargano’ is reserved for traditionally grown cultivars belonging to the Femminello Comune variety, locally known as ‘Limone nostrale’.

Application for approval of an amendment to the product specification of protected geographical indications which is not minor “Radicchio Variegato di Castelfranco” (PGI)
Italy have made non minor amendments to the their application for Radicchio Variegato di Castelfranco to enter the register of protected geographical indications.  Amendments have been made to the description of the product, geographical area, proof of origin, method of production, and labelling.  The crops grown to produce ‘Radicchio Variegato di Castelfranco’ PGI must be plants of the Compositae family, Cichorium intybus genus, wild variety.

 

Refusing health claim related to Lactobacillus plantarum 299v (Lp299v) and an increase of non-haem iron absorption
The claim proposed by the applicant was worded as follows: ‘Lactobacillus plantarum 299v increases non-haem iron absorption’. The Commission and the Member States received the scientific opinion from the Authority, which concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Lp299v and an increase of non-haem iron absorption. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

Approval of non-minor amendments to the product specification for a protected geographical indication Tiroler Speck (PGI)
Austria have submit amendments to their application for ‘Tiroler Speck’ to enter the register of protected geographical indication.  Amendments have been made to the description of the product, proof of origin, method of production, geographical area, and labelling.  Tiroler Speck PGI is a traditionally artisanal cured pork product made from boneless leg, loin, belly, shoulder or neck. It is dry-salted, spiced, cured, cold-smoked and air-dried.

Conditions of approval of the active substance penflufen
Commission Implementing Regulation (EU) No 1031/2013 (2) approved the active substance penflufen. The approval was restricted to uses to treat seed potato tubers before or during planting limited to one sowing of seeds treated with penflufen every third year in the same field. The United Kingdom, are seeking an amendment to the conditions of approval of penflufen in order to allow its use on other seeds. Uses on barley and wheat were described in the dossier. In light of current scientific and technical knowledge, the commission has amend the conditions of approval while keeping certain conditions and restrictions and to require the applicant to provide confirmatory information provided in the first approval.

Extending the approval period of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride
Applications for the renewal of the approval of FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (3). However, the approval of those substances is likely to expire for reasons beyond the control of the applicant before a decision has been taken on the renewal of their approval. It is therefore appropriate to extend the approval period for the active substance sulfuryl fluoride by 3 years and 1 year for the active substance FEN 560.

Publication of an amendment application for “Lentille verte du Puy” to enter the register of protected designation of origin
France have submitted amended to their application for “Lentille verte du Puy” to enter the register of protected designation of origin.  Amendments have been made to the description of the product, proof of origin, method of production, labelling, and other.

Application to enter a name in the register of protected designations of origin (‘Cidre Cotentin’/‘Cotentin’ (PDO))
France have applied for ‘Cidre Cotentin’/‘Cotentin’ to enter the register of protected designations of origin.  ‘Cidre Cotentin’/‘Cotentin’ is an unpasteurised, ungasified sparkling cider made from the pure juice of cider apples of specific traditional varieties. ‘Cidre Cotentin’/‘Cotentin’ is distinguished by its colour, which falls between straw yellow and orange yellow, and its fine sparkle. To the nose, it has subtle aromas where you can often find notes of butter and dried grass. It has a good balance in the mouth, with dominant bitter tastes. Its discreet acidity adds freshness to this bitterness.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Bayerisches Rindfleisch’/‘Rindfleisch aus Bayern’ (PGI))
The Commission has examined Germany's application for the approval of amendments to the specification for the protected geographical indication ‘Bayerisches Rindfleisch’/‘Rindfleisch aus Bayern’.  The amendments were published in the Official Journal but as no opposition has been received the amendments have been approved.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Cerezas de la Montaña de Alicante’ (PGI))
The Commission has examined Spain's application for the approval of amendments to the specification for the protected geographical indication ‘Cerezas de la Montaña de Alicante’. The amendments were published in the Official Journal but as no opposition has been received the amendments have been approved.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (‘Pane di Matera’ (PGI))
The Commission has examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Pane di Matera’. The amendments were published in the Official Journal but as no opposition has been received the amendments have been approved.

Addition of Sideritis scardica Giseb herba and Valeriana officinalis L. to the list of herbal substances, preparations and combinations for use in traditional herbal medicinal products
Sideritis scardica Griseb., herba and Valeriana officinalis L. can be both be considered as a herbal substances, herbal preparations or a combination thereof within the meaning of Directive 2001/83/EC and comply with the requirements set out in that Directive and should be added to the list of herbal substances, preparations and combinations for use in traditional herbal medicinal products. 

Entering a name in the register of protected geographical indications (‘Traditional Welsh Caerphilly’/‘Traditional Welsh Caerffili’ (PGI))
The United Kingdom's application to register the name ‘Traditional Welsh Caerphilly’/‘Traditional Welsh Caerffili’ 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 ‘Traditional Welsh Caerphilly’/‘Traditional Welsh Caerffili’ should therefore be entered in the register.

Scientific opinions

Listeria monocytogenes contamination of ready-to-eat foods and the risk for human health in the EU
The principles and methods behind EFSA’s Guidance on Uncertainty Analysis in Scientific Assessment

Human acute exposure assessment to tropane alkaloids

Safety assessment of the active substances carboxymethylcellulose, acetylated distarch phosphate, bentonite, boric acid and aluminium sulfate, for use in active food contact materials

Human acute exposure assessment to tropane alkaloids

Safety assessment of the active substances carboxymethylcellulose, acetylated distarch phosphate, bentonite, boric acid and aluminium sulfate, for use in active food contact materials

Listeria monocytogenes contamination of ready-to-eat foods and the risk for human health in the EU
The principles and methods behind EFSA’s Guidance on Uncertainty Analysis in Scientific Assessment

Human acute exposure assessment to tropane alkaloids

Safety assessment of the active substances carboxymethylcellulose, acetylated distarch phosphate, bentonite, boric acid and aluminium sulfate, for use in active food contact materials

Human acute exposure assessment to tropane alkaloids

Safety assessment of the active substances carboxymethylcellulose, acetylated distarch phosphate, bentonite, boric acid and aluminium sulfate, for use in active food contact materials

Safety assessment of the process ‘Concept Plastic Packaging’, based on Starlinger Decon technology, used to recycle post-consumer PET into food contact materials

Safety assessment of the process ‘EstPak Plastik’, based on Starlinger Decon technology, used to recycle post-consumer PET into food contact materials

Assessment of a decontamination process for dioxins and PCBs from fish meal by hexane extraction and replacement of fish oil

Assessment of a decontamination process for dioxins and PCBs from fish meal by replacement of fish oil

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