12 January - 20 June 2016

Legislation headlines

20 March 13

**Amendment regarding the use of Tricalcium phosphate (E 341 (iii)) in nutrient preparations intended for use in foods for infants and young children
**Views wanted on a novel food supplement – Clostridium butyricum
**Stricter trans fat standards– IMACE Code of Practice
**Protection of designations of origin Jambon sec de Corse/Jambon sec de Corse — Prisuttu
**Protection of designations of origin ‘Coppa de Corse’/‘Coppa de Corse — Coppa di Corsica
**Protection of geographical indications ‘Maccheroncini di Campofilone’
**Entering a name in the register of protected designations of origin Ficodindia di San Cono
**Entering a name in the register of protected designations of origin Kitkan viisas
**Entering a name in the register of protected geographical indications Mela Rossa Cuneo
**Entering a name in the register of protected geographical indications Spargel aus Franken/Fränkischer Spargel/Franken-Spargel
**BRC guidance document - Allergen Labelling and the Requirements in Regulation 1169/2011
**Traceability requirements for sprouts and seeds intended for the production of sprouts
**Protection of geographical indications ‘Pan de Alfacar’
**Approving the active substance ametoctradin
**Entering a name in the register of protected geographical indications Salame Felino
**Approval of the active substance ethylene
**Approving the active substance mandipropamid
**Conditions of approval of the active substance sodium hypochlorite
**Protection of geographical indications ‘Gâche vendéenne’
**Scientific opinions

**Amendment regarding the use of Tricalcium phosphate (E 341 (iii)) in nutrient preparations intended for use in foods for infants and young children
Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use.  An application for the authorisation of use of Tricalcium phosphate (E 341 (iii)) as an anti-caking agent added to nutrient preparations intended for use in infant formulae and follow-on formulae as defined by Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC was submitted on 19 June 2009 and has been made available to the Member States.  The Scientific Committee for Food advised on the safety of Tricalcium phosphate (E 341 (iii)) as a food additive in nutrient preparations intended for use in infant formulae and follow-on formulae and expressed its opinion on 7 June 1996, concluding that its use is acceptable provided that the total levels of calcium, phosphorus and the ratio between them are not exceeded. It is therefore appropriate to authorise the use of Tricalcium phosphate (E 341 (iii)) as an anti-caking agent in nutrient preparations intended for use in infant formulae and follow-on formulae.

**Views wanted on a novel food supplement – Clostridium butyricum
 A Japanese company has applied to the Food Standards Agency for approval to market a strain of the bacterium Clostridium butyricum as a novel food ingredient for use in food supplements. Views are wanted on the draft opinion prepared by the FSA's independent committee of experts.

**Stricter trans fat standards– IMACE Code of Practice
The European margarine sector, represented by IMACE, has tightened its Code of Practice on trans fatty acids (TFA) for the third time since its adoption in 1995.  The IMACE Code of Practice states that retail margarines and vegetable fat spreads should contain no more than 2% TFA on fat basis. The Code of Practice also covers business-to-business (B2B) margarines used as ingredients in food products for which IMACE Member Companies commit to actively encourage their customers to use margarine products with no more than 2% TFA on fat basis.  B2B margarines, which have to face additional technical challenges, reduced their average TFA level on fat basis by 76% from 2004 to 2012 -from 7.1% to 1.7%, below the levels of butter that can go up to 6% TFA. (quoted directly – IMACE)

RSSL's Lipids Laboratory, part of the Investigative Analysis Team can determine the fatty acid profile of all dietary fats and oils including trans fats. For more information please contact Customer Services on Freephone 0800 243482 or email  enquiries@rssl.com

**Protection of designations of origin Jambon sec de Corse/Jambon sec de Corse — Prisuttu
The designation of origin ‘Jambon sec de Corse’/‘Jambon sec de Corse — Prisuttu’ refers to Corsican dry-cured ham produced from a leg of pork of the local Nustrale breed, which is salted, dry-cured and matured.

**Amendment to maximum residue levels for chlorantraniliprole, fludioxonil and prohexadione
An application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs authorising the use of a plant protection product containing the active substance chlorantraniliprole on carrots, parsnips, parsley root and celeriac.  As regards fludioxonil, an application was made for celery, celery leaves and radishes and prohexadione on peanuts. The applicant claims that the authorised use of prohexadione on peanuts in the United States leads to residues exceeding the MRLs in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of this crop.  The Authority concluded in its reasoned opinion that, as regards the use of fludioxonil on radishes, the submitted residue trials were not performed according to the supported Good Agricultural Practice.  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 regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups.

**Protection of designations of origin ‘Coppa de Corse’/‘Coppa de Corse — Coppa di Corsica
France has applied for PDO for ‘Coppa de Corse’/‘Coppa de Corse — Coppa di Corsica’  which is prepared from the chine of pigs of the local Nustrale breed and salted, cured and matured.

**Protection of geographical indications ‘Maccheroncini di Campofilone’
Italy has applied for PGI for ‘Maccheroncini di Campofilone’ which is a dried pasta produced from eggs and common wheat flour or semolina.

**Entering a name in the register of protected designations of origin (Ficodindia di San Cono (PDO))
Italy’s application to register the name ‘Ficodindia di San Cono’ was published in the Official Journal of the European Union.

**Entering a name in the register of protected designations of origin (Kitkan viisas (PDO))
Finland’s application to register the name ‘Kitkan viisas’ was published in the Official Journal of the European Union.

**Entering a name in the register of protected geographical indications (Mela Rossa Cuneo (PGI))
Italy’s application to register the name ‘Mela Rossa Cuneo’ was published in the Official Journal of the European Union . 

**Entering a name in the register of protected geographical indications (Spargel aus Franken/Fränkischer Spargel/Franken-Spargel (PGI))
Germany’s application to register the name ‘Spargel aus Franken’ or ‘Fränkischer Spargel’ or ‘Franken-Spargel’ was published in the Official Journal of the European Union. 

**BRC guidance document - Allergen Labelling and the Requirements in Regulation 1169/2011
The British Retail Consortium, in partnership with the Food and Drink Federation has published a Guidance document on Allergen Labelling and the Requirements in Regulation 1169/2011.  This document has been produced to help companies in their implementation of the provisions of the Regulation. In addition, retailers felt that the new Regulation brought an opportunity for a more consistent allergen labelling approach; the document reflects the approach that the majority of retailers have agreed to implement.  The documents states: “It is important to note that this document will help companies comply with the allergen provisions in EU FIC; however this is not the only way. The European Commission and Government Departments could publish guidance allowing a more pragmatic interpretation of the provisions of the Regulation.”  It continues by saying: “The Food Standards Agency very much welcomes the BRC’s efforts to achieve greater consistency in allergen labelling and interpretation of the new provisions. This consistent approach will make it much easier for the allergic consumer to find and understand the allergen information provided on prepacked foods and help them to make safer food choices.”

RSSL carries out allergen testing using immunological, DNA and distillation techniques, depending on the allergen to be detected. Detection limits are in the range 1- 100 mg allergen/kg of sample for almond, Brazil nut, macadamia nut, peanut, walnut, hazelnut, cashew nut, pistachio nut, pecan nut, pine nut and chestnut.  Celery, celeriac, black mustard, lupin  and kiwi allergens can be detected by DNA methods, as can crustacean, fish and mollusc allergens.  The laboratory also uses a range of UKAS accredited immunological procedures for the detection of allergens including gluten, peanut, hazelnut, almonds, soya, egg, milk, sesame and histamine.  Distillation and titration methods are used for the determination of sulphur dioxide and sulphites.  For more information please contact Customer Services on Freephone 0800 243482 or email enquiries@rssl.com.

**Traceability requirements for sprouts and seeds intended for the production of sprouts
Following the outbreak of Shiga toxin-producing E. coli (STEC) in May 2011 in the Union, consumption of sprouts was identified as the most likely origin of the outbreaks.  On 20 October 2011, the European Food Safety Authority (‘EFSA’) adopted a Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds . In its Opinion, EFSA concludes that the contamination of dry seeds with bacterial pathogens is the most likely initial source of the sprout-associated outbreaks. In addition, the Opinion states that, due to the high humidity and the favourable temperature during sprouting, bacterial pathogens present on dry seeds can multiply during sprouting and result in a public health risk. Traceability is an efficient tool ensuring food safety, since it allows tracing a food through all stages of production, processing and distribution, thereby allowing rapid reaction in case of food-borne outbreaks.  Food business operators, at all stages of production processing and distribution, shall ensure they have information regarding the supplier, date of despatch amongst others, on record.

**Protection of geographical indications ‘Pan de Alfacar’
Spain have applied for the PGI of Pan de Alfacar.  The name ‘Pan de Alfacar’ refers to bread made by hand for at least one stage of the bread-making process and which has one of the following shapes: bun, roll, ring, rounded (produced from the same dough). 

**Approving the active substance ametoctradin
The effects of ametoctradin on human and animal health and the environment have been assessed.  It has appeared from the various examinations made that plant protection products containing ametoctradin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve ametoctradin.

**Entering a name in the register of protected geographical indications Salame Felino (PGI)
Italy’s application to register the name ‘Salame Felino’ was published in the Official Journal of the European Union.  The ‘Salame Felino’ PGI production area, covers the whole Province of Parma, is marked by the presence of both hilly and flat areas, as well as lakes and salt mines.  A transitional period of five years has been established in favour of the undertakings Reulen bvba and Salaisons Salamone SA referred to in Belgium’s statement of objection.

**Approval of the active substance ethylene
It is confirmed that the active substance ethylene is to be deemed to have been approved under Regulation (EC) No 1107/2009.  In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of ethylene. In particular, it is appropriate to modify the requested minimum purity level and to restrict the authorisations to indoor uses by professional users. Furthermore, when the Member States grant authorisations for plant protection products containing ethylene, they shall pay particular attention to the protection of operators, workers and bystanders and to the compliance of ethylene with the required specifications, irrespective of the form in which it is supplied to the user.

**Approving the active substance mandipropamid
The effects of the pesticide mandipropamid on human and animal health and the environment have been assessed.  The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide.   Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015.

**Conditions of approval of the active substance sodium hypochlorite
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of sodium hypochlorite. Despite comprehensive information on sodium hypochlorite as generally available commodity substance exists, if only data provided by the notifier are taken into account, the exposure assessment to operator, worker and surface water could not be finalised. Therefore, it is opportune to restrict the authorisations to indoor uses and to insert some new provisions for the Member States granting authorisations for plant protection products containing sodium hypochlorite.

**Protection of geographical indications ‘Gâche vendéenne’
‘Gâche vendéenne’ is a viennoiserie presented fresh and whole. It is always oval in shape. Its crust is fine and golden and has a lengthwise slit. The colour of the crust is lighter along the slit and darker around it.  The crumb of ‘Gâche vendéenne’ is tight and evenly coloured. It has a melting and soft texture in the mouth and a milky taste. There are particularly pronounced aromas of fresh cream and butter. They may be accompanied by vanilla and orange-blossom aromas and enhanced by optionally adding alcohol during the production process.

**Scientific opinions

Clinacox® 0.5 % for chickens reared for laying

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

Modification of the existing MRLs for acequinocyl in cucumbers, melons and pumpkins

Reasoned opinion on the modification of the existing MRL(s) for prosulfocarb in fennel

Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance flurochloridone

Scientific Opinion on the report of the FOCUS groundwater working group (FOCUS, 2009): assessment of lower tiers

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

Risk of entry of Aethina tumida and Tropilaelaps

Statement on refined dietary exposure assessment of erythritol (E 968)

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

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

Identification/Characterisation of EDs: scientific criteria and test methods

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