12 January - 20 June 2016

Legislation headlines

  • Consultation on calorie labelling for food and drink served outside of the home
  • The extension of the transition period of Article 4 concerning the flavouring ‘grill flavour concentrate (vegetable)’ FL No 21.002
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Bleu des Causses’ (PDO))
  • Entering a name in the register of protected geographical indications (‘Rucavas baltais sviests’ (PGI))
  • Entering a name in the register of protected geographical indications (‘Morcilla de Burgos’ (PGI))
  • Application for entering a name in the register of protected geographical indications ‘Bulot de la Baie de Granville’ (PGI)
  • Application for entering a name in the register of protected designation of origin (‘The Vale of Clwyd Denbigh Plum’ (PDO))
  • Application for entering a name in the register of protected designation of origin (‘Monzinger Niederberg’ (PDO))
  • Application for amendment of a specification for a name in the wine sector (‘Μαντινεία’ (Mantinia) (PDO))
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin ‘Oli de l'Empordà’/‘Aceite de l'Empordà’ (PDO)
  • Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications [‘Brioche vendéenne’ (PGI)]
  • Entering a name in the register of traditional specialities guaranteed ‘Kiełbasa krakowska sucha staropolska’ (TSG)
  • Entering a name in the register of protected designations of origin and protected geographical indications ‘Czosnek galicyjski’ (PGI)
  • Authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin
  • Authorising the placing on the market of 1-methylnicotinamide chloride as a novel food
  • Entering a name in the register of protected geographical indications ‘Marrone di Serino’/‘Castagna di Serino’ (PGI)
  • Entering a name in the register of protected geographical indications ‘Αγκινάρα Ιρίων’ (Agkinara Irion) (PGI)
  • Scientific opinions

Consultation on calorie labelling for food and drink served outside of the home
The government is seeking views on its plans to make places serving food and drink outside of the home display calorie information. This could include menus in restaurant, cafes, pubs, coffee shops and takeaways. The consultation also seeks views on: which businesses and products should have to display calorie information; what information should be displayed alongside information about calories; where this information should be displayed and; how businesses can put this into practice and whether they will face any issues or obstacles in doing so. The closing date for submissions is 7 December 2018.

The extension of the transition period of Article 4 concerning the flavouring ‘grill flavour concentrate (vegetable)’ FL No 21.002
Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.  An application for authorisation of the flavouring ‘grill flavour concentrate (vegetable)’ (FL No 21.002) belonging to the category referred to in Article 9(e), ‘other flavourings’, was submitted on 20 October 2015. On 5 October 2017, EFSA requested the applicant to submit additional scientific information and toxicological studies by 5 August 2018. The applicant informed the Commission and the Authority that the requested studies are being carried out in order. Until the evaluation by the Authority is completed, a temporarily extension of the transitional period has been added.

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (‘Bleu des Causses’ (PDO))
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Bleu des Causses’.  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.

Entering a name in the register of protected geographical indications (‘Rucavas baltais sviests’ (PGI))
Latvia's application to register the name ‘Rucavas baltais sviests’ was published in the Official Journal of the European Union . As no statement of opposition has been received by the Commission, the name ‘Rucavas baltais sviests’ has entered the register of protected geographical indications.

Entering a name in the register of protected geographical indications (‘Morcilla de Burgos’ (PGI))
Spain's application to register the name ‘Morcilla de Burgos’ was published in the Official Journal of the European Union The Commission received two notices of opposition accompanied by two reasoned statements of opposition from Mr Iñaki Libano, Cologne, Germany, and from Mr Diego Garcia representing the company Hydroplus, Chatou, France and deemed them inadmissible. Pursuant to Article 51 of that Regulation, natural or legal persons having a legitimate interest, established or resident in a Member State other than that from which the application was submitted, may not lodge a notice of opposition directly with the Commission. The name ‘Morcilla de Burgos’ therefore was entered in the register or protected geographical indications.

Application for entering a name in the register of protected geographical indications ‘Bulot de la Baie de Granville’ (PGI)
France have applied for Bulot de la Baie de Granville to enter the register of protected geographical indications. Bulot de la Baie de Granville’ is a gastropod mollusc belonging to the species Buccinum undatum. It is sold whole in its shell.  The colour of the shell, which is often light, varies from white to dark brown and from greenish white to dark green, depending on the amount of algae on the surface.

Application for entering a name in the register of protected designation of origin (‘The Vale of Clwyd Denbigh Plum’ (PDO))
The United Kingdom has sent to the Commission an application for protection of the name ‘The Vale of Clwyd Denbigh Plum’ in accordance with Article 49(4) of Regulation (EU) No 1151/2012. ‘The Vale of Clwyd Denbigh Plum’Prunus domestica Linnaeus ‘Denbigh Plum’ is the name given to the Denbigh plum grown in the designated geographical area of the Vale of Clwyd in Denbighshire in North Wales from where the plum originates. The Denbigh plum is the only plum variety native to Wales.

Application for entering a name in the register of protected designation of origin (‘Monzinger Niederberg’ (PDO))
Germany have applied for ‘Monzinger Niederberg’ to enter the register of protected designation of origin. Monzinger Niederberg owes its fine reputation to the Riesling variety, which this exceptional terroir expresses in the best possible way. Therefore, only the Weißer Riesling vine variety is authorised under the PDO. As a minimum, the grapes are harvested with Spätlese must weight. They are exclusively white wines, free of turbidity.

Application for amendment of a specification for a name in the wine sector (‘Μαντινεία’ (Mantinia) (PDO))
Greece has sent an application for amendment of the specification for the name ‘Μαντινεία’ (Mantinia). The Commission has examined the application and concluded that the conditions laid down in Articles 93 to 96, Article 97(1), and Articles 100, 101 and 102 of Regulation (EU) No 1308/2013 have been met.  Amendments have been made to correction to the minimum natural alcoholic strength of quality sparkling white wine, Correction of the maximum yield in hectolitres of end product per hectare for dry white wine and quality sparkling white wine.

Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin ‘Oli de l'Empordà’/‘Aceite de l'Empordà’ (PDO)
The Commission has examined Spain's application for the approval of amendments to the specification for the protected designation of origin ‘Oli de l'Empordà’/‘Aceite de l'Empordà’.  The Commission published the amendment application in the Official Journal of the European Union. As no statement of opposition 2 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 [‘Boudin blanc de Rethel’ (PGI)]
The Commission has examined France's application for the approval of amendments to the specification for the protected geographical indication ‘Boudin blanc de Rethel’.  The Commission published the amendment application in the Official Journal of the European Union and as no statement of opposition was received the amendment have been approved.

Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications [‘Brioche vendéenne’ (PGI)]
The Commission has examined France's application for the approval of amendments to the specification for the protected geographical indication ‘Brioche vendéenne’.  The amended application was published in the Official Journal of the European Union, and as no statement of opposition was received the amendment has been approved.

Entering a name in the register of traditional specialities guaranteed ‘Kiełbasa krakowska sucha staropolska’ (TSG)
Poland's application to register the name ‘Kiełbasa krakowska sucha staropolska’ 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 ‘Kiełbasa krakowska sucha staropolska’ should therefore be entered in the register. 

Entering a name in the register of protected designations of origin and protected geographical indications ‘Czosnek galicyjski’ (PGI)
Poland's application to register the name ‘Czosnek galicyjski’ was published in the Official Journal of the European Union. As no statement of opposition the name ‘Czosnek galicyjski’ should be entered in the register.

Authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin
Natural zeaxanthin is a component of the normal human diet as it is found in many fruits and green vegetables as well as in egg yolk. It is also currently used in food supplements. DSM Nutritional Products Europe made a request to the Commission to authorise the amendment of the designation and of the specific labelling requirements for synthetic zeaxanthin, requesting the deletion of the term ‘synthetic’ from the designation of the novel food. DSM Nutritional Products Europe wanted the change as they consider that the labelling of food supplements containing synthetic zeaxanthin may cause due to the negative connotation of the term ‘synthetic’. Removing synthetic will alleviate any potential negative economic impact. The commission reports that there are a number of synthetic substances currently authorised and listed in the Union list of novel foods, of which the counterparts from natural origin exist, and both forms are used in food supplements. However those synthetic substances are not designated as synthetic in the Union list and are not labelled as such. The change in the designation and labelling of synthetic zeaxanthin will ensure consistency with the designation and labelling of those synthetic substances and therefore the changes have been approved.

Authorising the placing on the market of pyrroloquinoline quinone disodium salt as a novel food
Mitsubishi Gas Chemical Company, Inc. made a request to the competent authority of Ireland to place pyrroloquinoline quinone disodium salt produced from the bacterium Hyphomicrobium denitrificans on the market as a novel food. The application requests for pyrroloquinoline quinone disodium salt to be used in food supplements for the general adult population, excluding pregnant and lactating women.  The competent authority of Ireland issued its initial assessment report which came to the conclusion that an additional assessment is required for pyrroloquinoline quinone disodium salt with regards to its safety following long-term consumption at the levels proposed in the application.  This report was forward to other members states, who agreed with the initial assessment report of Ireland. The EFSA found, in their scientific opinion that pyrroloquinoline quinone disodium salt in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283. Taking into account of the intended use in food supplements for the general adult population, and the fact that the request for authorisation excludes pregnant and lactating women, food supplements containing pyrroloquinoline quinone disodium salt should be appropriately labelled.

Authorising the placing on the market of 1-methylnicotinamide chloride as a novel food
Pharmena SA (‘the Applicant’) made a request to the competent authority of the United Kingdom to place synthetic 1-methylnicotinamide chloride on the Union market as a novel food ingredient.  The application requests for 1-methylnicotinamide chloride to be used in food supplements for the general adult population, excluding pregnant and lactating women. The United Kingdom issued its initial assessment report. In that report, it came to the conclusion that 1-methylnicotinamide chloride meets the criteria for novel food ingredient. The report was forwarded to other member states and also the EFSA.  EFSA in its scientific opinion gives sufficient grounds to establish that 1-methylnicotinamide chloride in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.  Taking into account of the intended use in food supplements for the general adult population, and the fact that the request for authorisation excludes pregnant and lactating women, food supplements containing 1-methylnicotinamide chloride should be appropriately labelled.

Application to enter a name in the register of protected designation of origin (Uhlen Blaufüsser Lay/Uhlen Blaufüßer Lay (PDO))
Germany has sent an application for protection of the name ‘Uhlen Blaufüsser Lay’/‘Uhlen Blaufüßer Lay’.  White Riesling wines are matured on the Uhlen Blaufüsser Lay estate. There are three types of grapevine product, each with slightly different properties: quality wine (Qualitätswein), wine with special attributes (Prädikatswein) and quality sparkling wine from defined regions (Sekt b.A.).  Young Uhlen Blaufüsser Lay wines have a pale yellow, occasionally greenish colour which becomes more intense as the product ages before turning a rich, luscious golden colour once the wine has fully matured.

Application to enter a name in the register of protected designation of origin (Uhlen Roth Lay (PDO))
Germany has sent an application for protection of the name ‘Uhlen Roth Lay’.  The Commission has examined that application and concluded that the conditions laid down in Articles 93 to 96, Article 97(1), and Articles 100, 101 and 102 of that Regulation are met. The application was published in the Official Journal of the European Union.

Application to enter a name in the register of protected designation of origin (Uhlen Laubach (PDO))
Germany has sent an application for protection of the name ‘Uhlen Laubach’. The Commission has examined that application and concluded that the conditions laid down in Articles 93 to 96, Article 97(1), and Articles 100, 101 and 102 of that Regulation are met. The application was published in the Official Journal of the European Union.

Amending Implementing Regulation (EU) No 29/2012 as regards the requirements for certain indications on the labelling of olive oil
Operators have the possibility to indicate different optional indications in the labelling of olive oils and olive-pomace oils. In particular, the acidity may appear on the label provided that certain physicochemical parameters (peroxide value, waxes content and ultraviolet absorption) are also indicated. The indication of the harvesting year in the label of extra virgin and virgin olive oils is optional for the operators when 100 % of the contents of the container come from one single harvesting year. In order to provide additional information on the age of an olive oil to consumers, Member States should be allowed to make the indication of the harvesting year compulsory. However, with a view not to disturb the functioning of the single market, such compulsory indication should be limited to their domestic production, obtained from olives harvested in their territory and intended for their national markets only. Implementing Regulation (EU) No 29/2012 should therefore be amended accordingly.

Entering a name in the register of protected geographical indications ‘Marrone di Serino’/‘Castagna di Serino’ (PGI)
Italy's application to register the name ‘Marrone di Serino’/‘Castagna di Serino’ 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 ‘Marrone di Serino’/‘Castagna di Serino’ has entered the register.

Entering a name in the register of protected geographical indications ‘Αγκινάρα Ιρίων’ (Agkinara Irion) (PGI)
Greece's application to register the name ‘Αγκινάρα Ιρίων’ (Agkinara Irion) 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 ‘Αγκινάρα Ιρίων’ (Agkinara Irion) should therefore be entered in the register.

Scientific opinions

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for flonicamid in various root crops

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

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

Pest risk assessment of Spodoptera frugiperda for the European Union

Modification of the existing maximum residue level for cycloxydim in strawberries

Peer review of the pesticide risk assessment of the active substance cypermethrin

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

 Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Pest risk assessment of Spodoptera frugiperda for the European Union

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

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

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

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

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

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

National summary reports on pesticide residue analysis performed in 2016

Update of the tolerable upper intake level for vitamin D for infants

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Update of the tolerable upper intake level for vitamin D for infants

Peer review of the pesticide risk assessment of the active substance florpyrauxifen (variant assessed florpyrauxifen‐benzyl)

Scientific opinion on the safety of monacolins in red yeast rice

Safety of Allanblackia seed oil for extended uses in vegetable oils and milk and in yellow fat and cream‐based spreads up to 30% (w/w)

Refined exposure assessment of extracts of rosemary (E 392) from its use as food additive

Re‐evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) as food additives

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

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