12 January - 20 June 2016

Legislation headlines

  • Defra publish policy paper – “Smarter rules for safer food”
  • Approving to the specification for a name entered in the register of protected designations of origin (Huile d'olive d'Aix-en-Provence (PDO))
  • Approving amendments for a name entered in the register of protected geographical indications (Lingot du Nord (PGI))
  • Entering a name in the register of protected geographical indications (Poljički soparnik/Poljički zeljanik/Poljički uljenjak (PGI))
  • Entering a name in the register of protected geographical indications (Ternera de los Pirineos Catalanes/Vedella dels Pirineus Catalans/Vedell des Pyrénées Catalanes (PGI))
  • Entering a name in the register of protected designations of origin (Miel de Liébana (PDO))
  • Regarding the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages
  • Amending Annex IV to Regulation (EC) No 396/2005 regarding Cydia pomonella Granulovirus (CpGV), calcium carbide, potassium iodide, sodium hydrogen carbonate, rescalure and Beauveria bassiana strain ATCC 74040 and Beauveria bassiana strain GHA
  • Amending MRL for atrazine
  • Regarding the use of Steviol glycosides (E 960) as a sweetener in mustard
  • Amending maximum residue levels for captan, propiconazole and spiroxamine
  • Scientific opinions

Defra publish policy paper – “Smarter rules for safer food”
Defra have published a policy paper entitled “Smarter rules for safer food”.  The paper notes that the smarter rules for safer food package is a set of EU proposals for protecting against animal disease and pests in the food chain. The package will simplify and strengthen health and safety standards across food, farming and horticulture supply chains from production to final use. It will affect anyone involved in the production manufacture, supply and regulation of food, feed, live animals and plants.  Collectively the package will replace over 70 existing European Directives and Regulations, simplifying legislation and making it easier to use for everyone involved.  The basic principles cover three main topics: official controls: how we will monitor and enforce the new rules, animal health: a framework for the principles of European animal health for the next 20 years and plant health: controls for protecting plants from disease and pests.  Defra are currently negotiating with the rest of the EU about the basic principles of the package and are expecting the proposals to be agreed in 2016.

Approving to the specification for a name entered in the register of protected designations of origin (Huile d'olive d'Aix-en-Provence (PDO))
The Commission has examined France's application for the approval of amendments to the specification for the protected designation of origin ‘Huile d'olive d'Aix-en-Provence’, registered under Commission Regulation (EC) No 2036/2001.  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 have been approved.

Approving amendments for a name entered in the register of protected geographical indications (Lingot du Nord (PGI))
The Commission has examined France's application for the approval of amendments to the specification for the protected geographical indication ‘Lingot du Nord’.  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 have been approved.

Entering a name in the register of protected geographical indications (Poljički soparnik/Poljički zeljanik/Poljički uljenjak (PGI))
Croatia's application to register the name ‘Poljički soparnik’/‘Poljički zeljanik’/‘Poljički uljenjak’ was published in the Official Journal of the European Union.  As no statement of opposition has been received by the Commission, the name ‘Poljički soparnik’/‘Poljički zeljanik’/‘Poljički uljenjak’ should therefore be entered in the register.

Entering a name in the register of protected geographical indications (Ternera de los Pirineos Catalanes/Vedella dels Pirineus Catalans/Vedell des Pyrénées Catalanes (PGI))
France and Spain's application to register the name ‘Ternera de los Pirineos Catalanes’/‘Vedella dels Pirineus Catalans’/‘Vedell des Pyrénées Catalanes’ was published in the Official Journal of the European Union.  As no statement of opposition has been received by the Commission, the name ‘Ternera de los Pirineos Catalanes’/‘Vedella dels Pirineus Catalans’/‘Vedell des Pyrénées Catalanes’ should therefore be entered in the register.

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

Regarding the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages
An application was submitted for authorisation of the use of steviol glycosides (E 960) as a sweetener in certain energy-reduced or with no added sugars beverages falling under the food subcategory 14.1.5.2.  Steviol glycosides are non-caloric sweet-tasting constituents and may be used to replace caloric sugars in certain beverages, thus reducing the caloric content of those products. The Commission seeked the opinion of the European Food Safety Authority.  In 2010, the Authority adopted a scientific opinion on the safety of steviol glycosides for the proposed uses as a food additive (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight/day, expressed as steviol equivalents. In view of the proposed extension of uses as a food additive, the Authority revised the exposure assessment of steviol glycosides and expressed its opinions on 2 May 2014 and on 30 June 2015. As regards those extensions of uses, the Authority concluded that the exposure estimates are below the ADI for all age groups, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Exposure calculations carried out by Rijksinstituut voor Volksgezondheid en Milieu showed that the proposed extension of use did not affect the 95th percentile of exposure in young children aged 2 to 6 years in the Netherlands and that non-alcoholic beverages and flavoured fermented milk products remained the main contributors to exposure to steviol glycosides in that age group. Considering that food subcategory 14.1.5.2 covers products not intended to be consumed by toddlers (12 to 35 months old) the proposed uses and use levels of steviol glycosides (E 960) as a sweetener are not of a safety concern. Therefore, it is appropriate to authorise the use of steviol glycosides (E 960) as a sweetener added to the energy-reduced or with no added sugars beverages in food subcategory 14.1.5.2

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Amending Annex IV to Regulation (EC) No 396/2005 regarding Cydia pomonella Granulovirus (CpGV), calcium carbide, potassium iodide, sodium hydrogen carbonate, rescalure and Beauveria bassiana strain ATCC 74040 and Beauveria bassiana strain GHA
Amending Regulation (EC) No 396/on maximum residue levels of pesticides in or on food and feed of plant and animal origin.  For Cydia pomonella Granulovirus (CpGV), calcium carbide, sodium hydrogen carbonate, rescalure, Beauveria bassiana strain ATCC 74040 and Beauveria bassiana strain GHA no specific MRLs were set. As those substances were not included in Annex IV the default value of 0,01 mg/kg applies. Potassium iodide is included in Annex IV to Regulation (EC) No 396/2005. Regarding Cydia pomonella Granulovirus (CpGV), the EFSA concluded that these viruses are not pathogenic to humans and that they will not produce any toxins. These substance were then included in Annex IV to Regulation (EC) No 396/2005. As regards calcium carbide, the Authority concluded that this substance does not enter the human food chain. Therefore, it is considered appropriate to include this substance in Annex IV to Regulation (EC) No 396/2005. Potassium iodide is a mineral substance which may be used in the manufacture of food supplements. In view of this, it is considered appropriate to remove the footnote requesting evaluation.  Sodium hydrogen carbonate is approved as basic and therefore the Commission considers that the inclusion of that is appropriate. As regards rescalure, the Authority concluded that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate.  As regards Beauveria bassiana strain ATCC 74040 and Beauveria bassiana strain GHA the Authority could not conclude on the dietary risk assessment for consumers as some information was not available and further consideration by risk managers was necessary however it is concluded that the risk to humans through metabolites from these substances is negligible and Commission considers that the inclusion of those substances in Annex IV to Regulation (EC) No 396/2005 is appropriate. (Official Journal of the European Union)

Amending MRL for atrazine
For atrazine, maximum residue limits (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. The Commission requested the European Food Safety Authority, hereinafter ‘the Authority’, to provide a scientific opinion on the temporary MRLs, which were set for cereals, following an import tolerance request made by Argentina. Based on residue trials submitted by the applicant in support of the use of atrazine on maize in accordance with Argentinian Good Agricultural Practices, the Authority concluded (2) that the MRLs for atrazine in cereals should be lowered to a level of 0.05 mg/kg. Such level corresponds to the existing relevant limit of determination for atrazine in products of plant origin. The proposed MRLs do not pose a consumer health risk for the European consumers.  Regulation (EC) No 396/2005 should therefore be amended accordingly.

Regarding the use of Steviol glycosides (E 960) as a sweetener in mustard
An application was submitted for authorisation of the use of steviol glycosides (E 960) as a sweetener in mustard.  Steviol glycosides are non-caloric sweet-tasting constituents which may be used to replace sucrose in the production of mustard thus allowing for an extension of its shelf life and its microbiological stability (decreasing the content of sugar prevents the process of fermentation for which sugar is a substrate) whilst retaining the demanded organoleptic properties of the product. Permitting steviol glycosides in mustard will make it possible to widen the assortment of this product by means of a product containing a sweetener different than those applied hitherto and having slightly other flavour properties.  The European Food Safety Authority (‘the Authority’) evaluated the safety of steviol glycosides, extracted from the leaves of the Stevia rebaudiana Bertoni plant, as a sweetener and noted that an Acceptable Daily Intake (ADI) for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg body weight/day. Authorising this sweetener in mustard at 120 mg/kg (as steviol equivalents) would lead to an increase in the intake of E960 within the following limits: between 0 up to 0,133 % of the ADI in the case of mean consumption and between 0 up to 1,143 % of the ADI in the case of high level consumption. This is considered to be an additional negligible exposure of the consumer and therefore is not of safety concern. Therefore, it is appropriate to authorise the use of steviol glycosides (E 960) as a sweetener added to mustard (food subcategory 12.4) at maximum level of 120 mg/kg.

Amending maximum residue levels for captan, propiconazole and spiroxamine
For captan, propiconazole and spiroxamine, maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. 

  • For captan, the EFSA submitted a reasoned opinion on the existing MRLs. It proposed to change the residue definition for plant commodities. It recommended raising or keeping the existing MRLs for certain products. It concluded that concerning the MRLs for apples, pears, quinces, medlar, loquat, apricots, cherries, peaches, plums, strawberries, blackberries, raspberries, blueberries, currants, gooseberries and tomatoes some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set at the existing level or the level identified by the Authority and reviewed in 2 years. Concerning the MRLs for almonds, table grapes, wine grapes, potatoes, cucumbers, melons, scarole, leek, maize and sorghum no information was available and that further consideration by risk managers was required. The MRLs for these products should be set at the specific limit of determination.
  • For propiconazole, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (3). It concluded that concerning the MRLs for grapefruit, lemons, limes, mandarins, apples, apricots, table and wine grapes, bananas, rape seed, barley grain, oats grain, rice grain, rye grain, wheat grain, sugar beet (root), swine muscle and fat, bovine muscle and fat, sheep muscle and fat, goat muscle and fat, poultry muscle and fat, cattle, sheep and goat milk and birds' eggs some information was not available and that further consideration by risk managers was required. The authority concluded the same for almonds, cherries, plums, strawberries, currants (red, black and white), gooseberries, peppers, cucumbers, globe artichokes, peanuts and tea.  As there is no risk for consumers, the MRLs for these products should be set at the existing level or the level identified by the Authority and reviewed in 2 years
  • For spiroxamine, the Authority, submitted a reasoned opinion on the existing MRLs . It proposed to change the residue definition and concluded that concerning the MRLs for table and wine grapes, banana, barley, oats, rye, wheat, poultry muscle, fat and liver and birds' eggs some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set at the existing level or the level identified by the Authority and reviewed in 2 years. As it is appropriate to set the residue definition for animal origin commodities as ‘spiroxamine carboxylic acid metabolite M06, expressed as spiroxamine (sum of isomers)’, sufficient information is available for setting MRLs for swine muscle, fat, liver and kidney, bovine muscle, fat, liver and kidney, sheep muscle, fat, liver and kidney, goat muscle, fat, liver and kidney, cattle, sheep and goat milk. As the MRLs for barley and oats of 0.4 mg/kg are based on a good agricultural practice that is no longer supported, the MRLs for those commodities should be reduced to 0.05 mg/kg.

Scientific opinions

Sodium selenite for all animal species

Re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives

Safety and efficacy of ethyl ester of β-apo-8’-carotenoic acid

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

Four statements questioning the EU control strategy against Xylella fastidiosa

Group HBGV for zearalenone and modified forms

Organic silicon (monomethylsilanetriol) as a source of silicon in food supplements

Acesulfame K (E 950): extension of use in FSMP in young children

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