12 January - 20 June 2016

Legislation headlines

11 Sept 13

**Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Casatella Trevigiana (PDO))
**Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Nocciola del Piemonte/Nocciola Piemonte (PGI))
**Consultation - The Food Safety, Food Hygiene and Official Controls (Sprouting Seeds) (Scotland) Regulations 2013
**Entering a name in the register of protected geographical indications Pastel de Tentúgal
**EU Commission approves health claims on cocoa flavanols, slowly digestible starch and drink which contributes to maintenance of tooth mineralisation
**Food Safety, Food Hygiene and Official Controls (Sprouting Seeds) (Wales) 2013
**Protection of geographical indications ‘Gofio Canario’
**Protection of geographic indications ‘Daujėnų naminė duona’
**Amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae
**Amendment regarding the use of Sucrose esters of fatty acids (E 473) in flavourings for water based clear flavoured drinks
**Amendment regarding the use of Neutral methacrylate copolymer and Anionic methacrylate copolymer in solid food supplements
**Protection of designations of origin ‘Paprika Žitava’/‘Žitavská paprika’
**Amendments to the application for protection of designation of origins ‘Jamón de Teruel’/‘Paleta de Teruel’
**Defra publishes summary of responses to the consultation on the Fish Labelling Regulations
**Implementing decision concerning protective measures in relation to avian influenza H7N7 in Italy
**Protection of geographical indications ‘Patata dell’Alto Viterbese’
**The conditions of approval of the active substance acetic acid
**FSA consultation - The Jam and Similar Products (Wales) Regulations 2013
**Regarding the permitted limits of yessotoxins in live bivalve molluscs
**Protected designations of origin ‘Miel de La Alcarria’
**Protection of geographical indications ‘Szentesi paprika’
**Protection of designations of origin ‘Pane Toscano’
**Protection of designations of origin ‘Châtaigne d’Ardèche’
**Protection of designations of origin ‘Miel de Tenerife’
**Maximum residue levels for diphenylamine in or on certain products
**East Kent Goldings become the first hops to gain Protected Designation of Origin status
**EFSA proposes adequate intake levels for fluoride and molybdenum
**Introducing protective measures on imports of bivalve molluscs from Turkey
**Amendment to application for PDO ‘Liquirizia di Calabria’
**Amendment to application for PDO ‘Konservolia Rovion’
**Amendment regarding the botanical name of tomato
**Protection of geographical indications ‘Antep Baklavası’/‘Gaziantep Baklavası’
**Entering a name in the register of protected geographical indications ‘Walbecker Spargeld’
**Scientific opinions

**Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin (Casatella Trevigiana (PDO))
The Commission has examined Italy’s application for the approval of amendments to the specification for the protected designation of origin ‘Casatella Trevigiana’ registered under Commission Regulation (EC) No 487/2008. Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union, as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments should be approved.

**Approving non-minor amendments to the specification for a name entered in the register of protected geographical indications (Nocciola del Piemonte/Nocciola Piemonte (PGI))
The Commission has examined Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Nocciola del Piemonte’/’Nocciola Piemonte’ registered under Commission Regulation (EC) No 1107/96 , as amended by Commission Regulation (EC) No 464/2004.  Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union, as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments to the specification should be approved.

**Approving non-minor amendments to the specification for register of protected designations of origin (Mont d’Or/Vacherin du Haut-Doubs (PDO))
The Commission has examined France’s application for the approval of amendments to the specification for the protected geographical indication ‘Mont d’Or/Vacherin du Haut-Doubs’ registered under Commission Regulation (EC) No 1107/96 ( 3 ), as amended by Regulation (EC) No 828/2003.

(3) Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union ( 5 ), as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments to the specification should be approved,

**Consultation - The Food Safety, Food Hygiene and Official Controls (Sprouting Seeds) (Scotland) Regulations 2013
The purpose of this consultation is to seek comments on the draft Scottish Statutory Instrument (SSI) on The Food Safety, Food Hygiene and Official Controls (Sprouting Seeds) (Scotland) Regulations 2013, which provides for the enforcement of a package of EU Regulations on sprouts and seeds intended for sprouting. These regulations are (EU) No 208/2013 on traceability requirements, No 209/2013 on microbiological criteria, No 210/2013 on approval of establishments and No 211/2013 on certification requirements. The SSI is attached in Annex C.  Stakeholders' are being asked to  comment on the draft SSI of the Food Safety, Food Hygiene and Official Controls (Sprouting Seeds) (Scotland) Regulations 2013, due to come into force in December 2013 and the partial BRIA, specifically on the costs and benefits of the four EU Regulations on the sprouts and seeds for sprouting sector.(FSA)

**Entering a name in the register of protected geographical indications Pastel de Tentúgal
Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Portugal’s application to register the name ‘Pastel de Tentúgal’ was published in the Official Journal of the European Union.

**EU Commission approves health claims on cocoa flavanols, slowly digestible starch and drink which contributes to maintenance of tooth mineralisation
The EU commission (regulation No 851/2013) has approved three health claims made on foods, other than those referring to the reduction of disease risk and to children development and health.  The first claim was submitted by GlaxoSmithKline Services Unlimited, which related to the effect of reformulated acidic non-alcoholic drink, containing less than 1g fermentable carbohydrate per 100 ml, calcium in a range from 0,3 to 0,9 mol per mol acidulant and displays a pH between 3,7-4,0  on the reduction of tooth demineralisation. The claim is replacing sugar-containing, acidic drinks, such as soft drinks (typically 8-12 g sugars/100 ml), with reformulated drinks contributes to the maintenance of tooth mineralisation.  In order to use the claim the reformatted drink needs to comply with the description.   The claim is restricted to the use of GlaxoSmithKline Services Unlimited and its affiliates.  The second claim was made by Mondelez International Group and is restricted to only be used by them.  The claim is that the consumption of slowly digestible starch (SDS) raises blood glucose concentration less after a meal compared to products low in SDS.  The claim may be used only on food where the digestible carbohydrates provide at least 60 % of the total energy and where at least 55 % of those carbohydrates is digestible starch, of which at least 40 % is SDS. The third claim, cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow, was made by Barry Callebaut Belgium NV.  The claim can be used for cocoa beverages (with cocoa powder) or for dark chocolate providing at least a daily intake of 200 mg of cocoa flavanols and can only be used by Barry Callebaut.

**Food Safety, Food Hygiene and Official Controls (Sprouting Seeds) (Wales) 2013
The purpose of this consultation is to seek comments from interested parties on the draft of the Food Safety, Food Hygiene and Official Controls (Sprouting Seeds) (Wales) Regulations 2013.  Following outbreaks in 2011 of food poisoning in Germany and France sprouts, and seeds intended for sprouting, were identified as the most likely source. Consequently, the European Commission has introduced a package of Regulations for the hygienic production of sprouts which are intended to safeguard public health. These Regulations will be given effect in Wales in the new SI.  An Impact Assessment (IA) has been provided, which sets out in detail its implications. Stakeholders are invited to consider the IA and comment on the FSA’s views of the impacts on costs on benefits.

**Protection of geographical indications ‘Gofio Canario’
‘Gofio Canario’ is the product made in the Canary Island archipelago by milling roasted grain, with or without the addition of sea salt. Sometimes Gofio may also contain pulses, which are processed in the same way as the cereals.

**Protection of geographic indications ‘Daujėnų naminė duona’
The PGI ‘Daujėnų naminė duona’ is a brown rye bread manufactured entirely at home in accordance with a traditional method. Rye flour dough is slowly leavened by spontaneous fermentation in a wooden trough which must be made entirely of oak, or in a trough with an oak base and side panels, and the bread is baked over live coals or in a hearth oven.

**Amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae
On request from the Commission, the European Food Safety Authority delivered, on 28 February 2012, a scientific opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow- on formulae. That opinion concluded that protein from goats’ milk can be suitable as a protein source for infant formulae and follow-on formulae provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC.  In request from the Commission, the European Food Safety Authority delivered, on 5 October 2005, a scientific opinion on the safety and suitability for particular nutritional use by infants of formula based on whey protein partial hydrolysates with a protein content of at least 1,9 g/100 kcal, which was below the minimum level provided for in the Union legislation at that time. That opinion concluded that infant formula, based on hydrolysates of whey protein derived from cows’ milk with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) and corresponding to the protein formulation assessed, is safe and suitable for use as the sole source of nutrition of infants. On the basis of that opinion, Directive 2006/141/EC, as amended by Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae, authorises the marketing of infant formulae manufactured from protein hydrolysates with such a protein content provided that the product complies with certain specific criteria set out therein.

**Amendment regarding the use of Sucrose esters of fatty acids (E 473) in flavourings for water based clear flavoured drinks
Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food flavourings and their conditions of use. An application for authorisation of the use of Sucrose esters of fatty acids (E 473) as an emulsifier in flavourings was submitted on 20 August 2008 and has been made available to the Member States. Emulsifiers are needed to stabilise oily flavourings when these are added in water based beverages. Without the addition of an emulsifier the flavouring oil would not be soluble and would appear on the surface of the beverage as an oily ring. This prevents the even dispersal of the flavouring through the beverage and increases its exposure to oxygen, leading to reduced organoleptic acceptability. It also makes the development of clear beverages extremely difficult. These issues can be overcome to some extent with the use of washed oils however those have reduced organoleptic acceptability. The use of Sucrose esters of fatty acids enables clear beverages with improved functionality of the added flavouring.  The European Food Safety Authority issued an opinion on sucrose esters of fatty acids (E 473) and established an Acceptable Daily Intake of 40 mg/kg bw/day. The exposure to sucrose esters of fatty acids resulting from the additional proposed use in clear flavoured soft drinks represents less than 0,1% of the ADI. Taking into account that the exposure due to the additional use of this additive is negligible compared to the ADI, this additional use of Sucrose esters of fatty acids (E 473) is not liable to have an effect on human health.  It is therefore appropriate to authorise the use of Sucrose esters of fatty acids (E 473) as a food additive in flavourings for water based clear flavoured drinks.

**Amendment regarding the use of Neutral methacrylate copolymer and Anionic methacrylate copolymer in solid food supplements
Applications for authorisation of the use of Anionic methacrylate copolymer and Neutral methacrylate copolymer as glazing agents in solid food supplements were submitted on 25 and 27 April 2009 and were made available to the Member States. The European Food Safety Authority evaluated the safety of Neutral methacrylate copolymer and Anionic methacrylate copolymer when used as food additives and concluded that their use in solid food supplements at the proposed use levels is not of a safety concern.  Commission Regulation (EU) No 1129/2011 ( 6 ) authorised the use of Basic methacrylate copolymer (E 1205) in solid food supplements and Regulation (EU) No 231/2012 sets out the specifications for that food additive, including the maximum levels for arsenic, lead, mercury and copper. Those specifications have been updated to take into account the maximum levels for lead, mercury and cadmium in food.

**Protection of designations of origin ‘Paprika Žitava’/‘Žitavská paprika’
The product takes its name from Slovakia's Žitava river valley where it was first grown. Although the area in which the peppers are grown and processed has gradually spread across the Danubian Lowland, the name has been retained and is used to this day. The product used to be called just ‘Paprika Žitava’, but for linguistic and export-related reasons, it also came to be referred to as ‘Žitavská paprika’. Both names continue to be used, whether in a commercial context in accordance with customary usage in the trade, or in everyday language, such as in recipes for meat products and dishes.

**Amendments to the application for protection of designation of origins ‘Jamón de Teruel’/‘Paleta de Teruel’
Amendments have been made to the name of the products, description, geographical area, proof of origin and method of production, and labelling.  ‘Jamón de Teruel’ and ‘Paleta de Teruel’ are meat products obtained by submitting pig forelegs and hind legs to a process of salting, cleaning, post-salting, curing (drying and maturation) and ageing.

**Defra publishes summary of responses to the consultation on the Fish Labelling Regulations
Defra conducted an eight week consultation from September to November 2012 to seek views and additional information on the new requirements being introduced to provide the consumer with additional information on fishery products at the point of retail. The consultation focussed on two main proposals relating to fish labelling: a proposal to change the way the list of Commercial Designations for Fish are updated and maintained, including the addition of new Commercial Designations and options to amend the current Statutory Instrument for England to take account of new requirements introduced by the EU Fisheries Control Regulation. Although there were only five responses to the consultation, there were no major objections received against the requirements being introduced or to the approach to enforcement through the use of enforcement notices. Comments received in response to the estimates set out in the Impact Assessment, such as familiarisation costs and time saving benefits, backed the assumptions made as being reasonable assessments. The proposal to separate the Commercial Designation list from the SI and maintain this as a standalone internet based list was supported as being a clear improvement. In addition to support for the changes being proposed, a number of suggestions were received to add species to the Commercial Designation list and these will be assessed with advice from the fish experts group and included in the updated list where appropriate.

**Implementing decision concerning protective measures in relation to avian influenza H7N7 in Italy
Italy notified the Commission of an outbreak of highly pathogenic avian influenza of subtype H7N7 in a holding on its territory where poultry or other captive birds are kept and it immediately took the measures required pursuant to Directive 2005/94/EC, including the establishment of protection and surveillance zones.  The Commission has examined those measures in collaboration with Italy, and it is satisfied that the borders of those zones established by the competent authority are at a sufficient distance to the actual holding.  The zones established in Italy need to be defined at Union level so that no consignments of live poultry, ready-to-lay poultry, day-old chicks and hatching eggs are dispatched from those zones to other Member States or to third countries. 

**Protection of geographical indications ‘Patata dell’Alto Viterbese’
The name ‘Patata dell'Alto Viterbese’ refers to the tuber of the species Solanum tuberosum, varieties Monalisa, Amber, Agate, Vivaldi, Finka, Marabel, Universa, Chopin, Arizona and Agria, grown in a defined area, showing a number of characteristics when marketed.

**The conditions of approval of the active substance acetic acid
It is confirmed that the active substance acetic acid is to be deemed to have been approved under Regulation (EC) No 1107/2009.  In the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval. It is, in particular, appropriate to require further confirmatory information.  The appendix states that only uses as herbicide may be authorised. For the implementation of the uniform principles the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators, the protection of groundwater and the protection of aquatic organisms. Conditions of use shall include, where appropriate, risk mitigation measures. The notifier shall submit confirmatory information as regards: — the acute and long-term risk to birds and mammals, — the risk to honeybees, — the risk to non-target arthropods. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2015.

**FSA consultation - The Jam and Similar Products (Wales) Regulations 2013
This consultation seeks views from those involved in the manufacture of jam and other sweet spread products on the draft Jam and Similar Products (Wales) Regulations 2013.  The Directive: sets out minimum fruit content for various fruit jams, jellies and marmalades which is also dependent of the fruit species; sets a minimum soluble solids level of 60% which all jams, jellies and marmalades must attain. It also imposes additional labelling requirements to indicate the quantity of fruit and sugar on the label to enable the consumer to compare products; and restricts the ingredients that may be added to products in addition to the characterising ingredients of fruit, sugar etc., and the treatments to which these ingredients may be subjected (e.g. heating, chilling, freezing, freeze drying etc.).  The Directive does not apply to jams used in the manufacture of biscuits, pastries and other bakery products commonly known as 'bakery jams'. (FSA)

**Regarding the permitted limits of yessotoxins in live bivalve molluscs
Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. That Regulation provides that food business operators are to ensure that live bivalve molluscs placed on the market for human consumption do not contain certain marine biotoxins in total quantities, measured in the whole body or any part edible separately, that exceed the limits set out in point 2 of Chapter V of Section VII of Annex III.  In the light of the EFSA Opinion and of the conclusions of the 32nd Session of the CODEX Committee on Fish and Fishery Products, it is appropriate to increase the current limit for yessotoxins to 3,75 milligrams yessotoxin equivalent per kilogram.

**Protected designations of origin ‘Miel de La Alcarria’
The Commission has examined Spain's application for the approval of amendments to the specification for the protected designation of origin 'Miel de La Alcarria' registered under Commission Regulation (EC) No 1107/96.  Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union ( 4 ), as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments to the specification should be approved.

**Protection of geographical indications ‘Szentesi paprika’
The protected geographical indication ‘Szentesi paprika’ denotes the fruit, grown by forcing, of the listed variety types and varieties of Capsicum annuum.                                     

**Protection of designations of origin ‘Pane Toscano’
The PDO ‘Pane Toscano’ refers to bread made by a typical method in Tuscany which requires the exclusive use of sourdough starter, water and type ‘0’ soft-wheat wholegrain flour from wheat varieties grown in a specific production area.

Protection of designations of origin ‘Châtaigne d’Ardèche’
The designation of origin ‘Châtaigne d’Ardèche’ is reserved for fruit of ancient local varieties of Castanea sativa Miller belonging to a population adapted to the local environmental conditions of the Ardèche region (ecotype) and displaying the a number of common characteristics.

**Protection of designations of origin ‘Miel de Tenerife’
‘Miel de Tenerife’ is the honey produced by melliferous bees on the island of Tenerife, from the nectar of flowers or secretions from other parts of plants that grow in the island's different ecosystems.

**Maximum residue levels for diphenylamine in or on certain products
As regards diphenylamine in apples and pears, Member States, third countries and food business operators informed the Commission of an unavoidable cross- contamination that affects untreated apples and pears and which is due to the presence of residues of diphenylamine in storage facilities, in particular machinery, surfaces and containers with particular regard to bins, and that is technically not feasible to completely remove at this stage.  Based on the monitoring data received on the cross- contamination, it is appropriate to set a temporary MRL as low as possible, given the consumer concerns raised by diphenylamine, and that would still allow the normal marketing and trade of untreated apples and pears.

**East Kent Goldings become the first hops to gain Protected Designation of Origin status
East Kent Goldings will be the toast of the county after becoming the first variety of hops to have their name legally protected against imitation.  The oldest known variety of hop grown in the UK has been awarded Protected Designation of Origin status by the European Commission in recognition of their quality, history, and links to the local area. (Defra)

**Nutrition: EFSA consults on dietary reference values for manganese
EFSA has launched a public consultation on its Scientific Opinion proposing adequate levels of manganese intake for adults and children. Comments on the opinion, which is part of the Authority’s ongoing work on dietary reference values, can be submitted until 13 September.

**EFSA proposes adequate intake levels for fluoride and molybdenum
EFSA’s nutrition experts have continued their work on Dietary Reference Values (DRVs) by publishing their first pieces of advice on micronutrients (vitamins and minerals). The two scientific opinions on the minerals fluoride and molybdenum follow previous advice on DRVs for energy, macronutrients – protein, fats and carbohydrates –dietary fibre, and water. EFSA will publish a series of further opinions on DRVs for micronutrients, including vitamin C, folate, iron, zinc, calcium, and iodine. (quoted directly)

**Introducing protective measures on imports of bivalve molluscs from Turkey
The Commission’s audit service, the Food and Veterinary Office has carried out a follow-up audit in Turkey to evaluate the official controls of the production of fishery products and bivalve molluscs intended for export to the Union. The audit identified several deficiencies in the implementation of official controls and in particular significant shortcomings of analyses in the official laboratories visited. Therefore it is appropriate to suspend imports into the Union of live and chilled bivalve molluscs originating in Turkey until the Turkish authorities will be in position to provide the necessary guarantees.

**Amendment to application for PDO ‘Liquirizia di Calabria’
Amendments have been made to the geographical area.  ‘Liquirizia di Calabria’ protected designation of origin is reserved exclusively for fresh or dried liquorice and its extract.

**Amendment to application for PDO ‘Konservolia Rovion’
Amendments have been made to the description of product, proof of origin, method of production, and packaging.  ‘Konservolia Rovion’ are olives.

**Amendment regarding the botanical name of tomato
In the light of the development of scientific knowledge, the International Code of Botanical Nomenclature (ICBN) has been revised, in particular with respect to the botanical name of the species tomato.

**Protection of geographical indications ‘Antep Baklavası’/‘Gaziantep Baklavası’
‘Antep Baklavası’/‘Gaziantep Baklavası’ is a sweet pastry made of layers of filo pastry filled with semolina cream and Antep pistachio and sweetened with syrup.

**Entering a name in the register of protected geographical indications ‘Walbecker Spargel’
Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Germany’s application to register the name ‘Walbecker Spargel’ was published in the Official Journal of the European Union.

**Scientific opinions

Dietary Reference Values for fluoride

Dietary Reference Values for molybdenum

Modification of the existing MRLs for trifloxystrobin in horseradish, parsley root and purslane

Modification of the existing MRLs for pymetrozine in azaroles, celery and fennel

Anticipation of future notifications to EFSA of microbial taxonomic units intentionally introduced into the food chain

Safety of polyvinyl alcohol-polyethylene glycol-graft-co-polymer as a food additive

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

Peer review of the pesticide risk assessment of the active substance Bacillus pumilus QST 2808

Peer review of the pesticide risk assessment of the active substance S-abscisic acid

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

Peer Review of the pesticide risk assessment of confirmatory data submitted for the active substance oryzalin

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for propargite according to Article 12 of Regulation (EC) No 396/2005

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

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