12 January - 20 June 2016

Legislation headlines

10 April 13

**The Contaminants in Food (England) Regulations 2013
**The Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013
**Protection of geographical indications ‘Westfälischer Knochenschinken’
**Amending MRLs in or on certain products
**Food additive re-evaluations -EFSA
**Commission recommendation on the presence of T-2 and HT-2 toxin in cereals and cereal products
**Amending Regulation (EU) No 605/2010 for the introduction into the EU of raw milk and dairy products intended for human consumption
**Amending Regulation (EEC) No 2568/91 on the characteristics of olive oil and olive-residue oil and on the relevant methods of analysis
** Sodium ascorbate (E 301) in vitamin D preparations in foods for infants and young children
**Protected geographical indications (Melon du Quercy (PGI))
**Approving non-minor amendments protected geographical indications (Mela Alto Adige/Südtiroler Apfel (PGI))
**Approving a minor amendment protected geographical indications (Cipolla Rossa di Tropea Calabria (PGI))
**Protection of designations of origin ‘Maçã Riscadinha de Palmela’
**Scientific opinions

**The Contaminants in Food (England) Regulations 2013
This consultation will provide interested parties with the opportunity to comment and express their opinion on the proposed Contaminants in Food (England) Regulations 2013. The proposed Contaminants in Food (England) Regulations 2013 will revoke the Contaminants in Food (England) Regulations 2010 and remake them with necessary amendments taking into account the provisions of Commission Regulations (EU). No 1258/2011 regarding maximum levels for nitrate in foodstuffs and Regulation (EU) No. 610/2012 on maximum levels for the presence of coccidiostats and histomonostats in food resulting from the unavoidable carry-over of these substances in non-targeted feed.  Responses are requested by close of business on 5 July 2013.

**The Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013
This consultation seeks views on the proposed legislation The Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013.  The proposed legislation revoke and re-enact all legislation within the Food Standards Agency’s remit covering food additives, flavourings, enzymes and extraction solvents into a single consolidated statutory instrument. This is part of the FSA’s intention to introduce a simplified system of food safety legislation in response to the UK Government’s Red Tape Challenge Initiative (RTC). Responses are required by close Wednesday 5 June 2013

**Protection of geographical indications ‘Westfälischer Knochenschinken’
‘Westfälischer Knochenschinken’ is fresh ham from the hind leg of the pig, on the bone, salted and dried. 

**Amending MRLs in or on certain products
Amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for emamectin benzoate, etofenprox, etoxazole, flutriafol, glyphosate, phosmet, pyraclostrobin, spinosad and spirotetramat in or on certain products.  An application has been made for using prothioconazole on rape seed, linseed, poppy seed and mustard seed.  As regards phosmet, such an application was made for table olives, potatoes and rape seeds. TheEFSA concluded in its reasoned opinions that, as regards the use of prothioconazole on rape seed, linseed, poppy seed and mustard seed, further data are necessary to address the stability of residues included in the plant risk assessment residue definition. Furthermore, the Authority highlighted that the good agricultural practice (GAP) concerns a product containing bixafen as well as prothioconazole. Consequently, the available data for raising MRLs for bixafen should also be considered. The existing MRLs should therefore remain unchanged. As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regardEN

**Food additive re-evaluations -EFSA
EFSA has prioritised the food additives for which scientific data are required to finalise their re-evaluation within deadlines established by European legislation. The Authority has launched a new call for data proactively asking Member States and other stakeholders for two types of data for 51 food additives in total: figures from industry on the amounts of these additives they report using in their products; and data derived from analyses indicating actual levels of these additives found in foods and drinks from national food authorities, research institutions, academia, food industry and other stakeholders. Submission of the data will ensure that EFSA can carry out its risk assessments of these food additives and support EU risk managers (European Commission, European Parliament, Member States) charged with regulating their use in food.

**Commission recommendation on the presence of T-2 and HT-2 toxin in cereals and cereal products
T-2 toxin and HT-2 toxin are mycotoxins produced by various Fusarium species. T-2 toxin is rapidly metabolised to a large number of products, HT-2 toxin being a major metabolite.  The Scientific Panel on Contaminants in the Food Chain (CONTAM panel) of the European Food Safety Authority (EFSA) adopted an opinion on a request from the Commission related on the risks for animal and public health related to the presence of T-2 and HT-2 toxin in food and feed. The CONTAM Panel established a group tolerable daily intake (TDI) of 100 ng/kg b.w. for the sum of T-2 and HT-2 toxins. Estimates of chronic human dietary exposure to the sum of T-2 and HT-2 toxins based on the available occurrence data are below the TDI for populations of all age groups, and thus not an immediate health concern.  As regards the animal health risk, the CONTAM Panel concluded that for ruminants, rabbits and fish, the current estimated exposure to T-2 and HT-2 toxin is considered unlikely to be a health concern. For pigs, poultry, horses and dogs, the estimates of exposure to T-2 and HT-2 toxin indicate that the risk of adverse health effects is low. Cats are amongst the most sensitive animal species. Due to the limited data and the severe adverse health effects at low dose levels, no NOAEL or LOAEL could be established. Therefore this Recommendation is not of application for feed for cats, for which stricter measures will be established.

**Amending Regulation (EU) No 605/2010 for the introduction into the EU of raw milk and dairy products intended for human consumption
The risk arising from imports into the Union of dairy products produced from raw milk of camels of the species Camelus dromedarius (dromedary camels) from third countries or parts thereof at risk of foot-and- mouth disease listed in column C of Annex I to Regulation (EU) No 605/2010 is not greater than from imports of dairy products derived from raw milk of cows, ewes, goats or buffaloes, provided that such dairy products have undergone, or been produced from raw milk which has undergone, the heat treatments referred to in Article 4 of that Regulation. Accordingly, that Article should be amended to cover dairy products derived from raw milk of that species.  In addition, the Emirate of Dubai of the United Arab Emirates, which is a third country not listed by the World Organisation for Animal Health as being free of foot-and-mouth disease, has expressed an interest in exporting to the Union dairy products produced from raw milk derived from dromedary camels after physical or chemical treatment.  The Commission inspection service audited with satisfactory results the animal and public health controls on the production of milk derived from dromedary camels in the Emirate of Dubai. In addition, the recommendations of the Commission inspection service were adequately addressed by the Emirate of Dubai. Based on that information, it can be concluded that the Emirate of Dubai can provide the necessary guarantees to ensure that dairy products produced in the Emirate of Dubai from raw milk of dromedary camels are in conformity with the applicable animal and public health requirements for imports into the Union of dairy products from third countries or parts thereof at risk of foot-and-mouth disease listed in column C of Annex I to Regulation (EU) No 605/2010.

**Amending Regulation (EEC) No 2568/91 on the characteristics of olive oil and olive-residue oil and on the relevant methods of analysis
Pursuant to Article 113(3) of Regulation (EC) No 1234/2007, Member States are to check whether olive oils and olive-residue oils conform to the marketing and are to apply penalties as appropriate. Articles 2 and 2a of Regulation (EEC) No 2568/91 provide detailed rules for those conformity checks. Those rules should ensure that olive oil complies with that standard. The rules should be further detailed, including a risk analysis. For the purpose of those conformity checks, the term ‘marketed olive oil’ should be defined. Due to risks of fraud holders of olive oil should keep entry and withdrawal for each category of oils in a register. In order to avoid excessive administrative burdens without undermining the objectives of the olive oil register, the gathering of information should be limited until the stage of bottling of olive oil. In order to ensure the follow-up and evaluate the measures of Regulation (EEC) No 2568/91, Member States should notify the Commission not only of the national implementing measures, but also report results of the conformity checks. In order to continue the process of harmonisation with the international standards laid down by the IOC certain methods of analysis should be updated. Consequently, the method of analysis should be replaced by a more efficient method. Spectrophotometric examination in the ultraviolet can provide information on the quality of a fat, its state of preservation and changes brought about in it by technological processes.  Determination of the absolute difference between the experimental values of triacylglycerols (TAGs) with equivalent carbon number 42 (ECN42 HPLC ) obtained by determination in the oil by high performance liquid chromatography and the theoretical value of TAGs with an equivalent carbon number of 42 (ECN 42 theoretical ) calculated from the fatty acid composition. The standard is applicable to olive oils. The method is applicable to the detection of the presence of small amounts of seed oils (rich in linoleic acid) in every class of olive oils.

** Sodium ascorbate (E 301) in vitamin D preparations in foods for infants and young children
Amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Sodium ascorbate (E 301) in vitamin D preparations intended for use in foods for infants and young children.  An application for the authorisation of use of Sodium ascorbate (E 301) as an antioxidant in vitamin D preparations intended for use in infant formulae and follow- on formulae was submitted on 15 December 2009.  Ingredients used in the manufacture of infant formulae and follow-on formulae must meet a much stricter microbiological standard than general food, in particular for Enterobacteria and Cronobacter sakazakii. In order to achieve this, ingredients such as vitamin D preparations are subjected to a heat treatment. Such treatment in turn requires the presence of an antioxidant which is water-soluble and of neutral pH. Sodium ascorbate (E 301) was identified and proved to be the suitable antioxidant to meet that technological need.  The European Food Safety Authority evaluated the use of Sodium ascorbate (E 301) as a food additive in vitamin D preparations intended for foods for infants and young children and concluded that it is not of safety concern. 

**Amendment Protected geographical indications (Melon du Quercy (PGI))
The purpose of the France’s application is to amend the original specification by giving more detailed information on the product description, the proof of origin, the method of production, labelling, national requirements and the contact details of the control body.  Melon du Quercy is of the Charentais-type variety, a melon with a smooth or netted grey/green to yellow peel and orange flesh and a minimum weight of 450 g.

**Approving non-minor amendments protected geographical indications (Mela Alto Adige/Südtiroler Apfel (PGI))
Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Mela Alto Adige/Südtiroler Apfel’.  Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union.

**Approving a minor amendment protected geographical indications (Cipolla Rossa di Tropea Calabria (PGI))
The purpose of the application is to amend the specification in order to specify the presentation, packaging and labelling of the onions.  The protected geographical indication (PGI) ‘Cipolla Rossa di Tropea Calabria’ designates bulbs of the Allium Cepa variety which belongs to the local ecotypes. They are characterised by their shape and by their early bulbing, which is a result of the effect of the photoperiod.

**Protection of designations of origin ‘Maçã Riscadinha de Palmela’
‘Maçã Riscadinha de Palmela’ is an apple of the Riscadinha variety (family Rosaceae, genus Malus Miller, species Malus domestica Borkh.)

**Scientific Opinions

Calcium iodate anhydrous (film granulated preparation) for all species

Public health risks related to mechanically separated meat

Scientific Opinion on maize 59122 for food and feed uses, import, processing and cultivation

Modification of the existing MRLs for difenoconazole in various crops

Identification of endocrine disruptors and appropriateness of existing test methods

Maximum residue levels (MRLs) for molinate according to Article 12 of Regulation (EC) No 396/2005

The 2010 European Union Report on Pesticide Residues in Food

Sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate including exposure resulting from extension of the authorisation of sodium stearoyl-2-lactylates

Safety and efficacy of diclazuril (Clinacox® 0.5 %) as feed additive for chickens reared for laying

Safety of iodized ethyl esters of poppy seed oil as a source of iodine added for nutritional purposes to foodstuffs

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

Biosprint® for cattle for fattening

Safety and efficacy of Lactobacillus kefiri (DSM 19455)

Safety and efficacy of Bacillus subtilis PB6 (Bacillus subtilis)

Safety and efficacy of AveMix® XG 10 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase)

Safety and efficacy of Bonvital (Enterococcus faecium) for chickens

Safety and efficacy of straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes (chemical group 1) when used as flavourings for all animal species

Reasoned opinion on the modification of the existing MRLs for cyprodinil in radishes and cucurbits inedible peel

Review of the existing maximum residue levels (MRLs) for propoxycarbazone

Modification of the existing MRLs for isopyrazam in pome fruits, various stone fruits and oilseeds

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

Safety and efficacy of Iodine compounds (E2) as feed additives for all species: calcium iodate anhydrous (coated granulated preparation), based on a dossier submitted by Doxal Italia S.p.A.

Pesticide risk assessment of the active substance Bacillus thuringiensis israelensis AM65-52

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

EPA and “reduces AA/EPA ratio in blood in children with ADHD”

Substantiation of a health claim related to the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat and a two-fold greater reduction in blood LDL-cholesterol concentrations compared to the consumption of a diet low in saturated fat alone

Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis israelensis AM65-52

Bentonite-montmorillonite and sepiolite for all species

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

The European Union Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks in 2011

Scientific Opinion on VTEC-seropathotype and scientific criteria regarding pathogenicity assessment

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