12 January - 20 June 2016

Legislation headlines

06 Feb 13

**Amendment regarding maximum levels for melamine in canned pet food
**BASF halts EU approval of GM potatoes
**Protection of geographical indications ‘Poulet des Cévennes’/‘Chapon des Cévennes’
**Amended application to the protection of geographical indications ‘Jihočeská Niva’
**Amending the name of the holder of the authorisation of dimethylglycine sodium salt
**FoodDrinkEurope publishes guidance document on food allergen management
**Authorising the placing on the market of synthetic zeaxanthin
**Authorising an extension of use of Chia (Salvia hispanica) seed as a novel food ingredient
**MRL for 2-phenylphenol, ametoctradin, Aureobasidium pullulans strains DSM 14940 and DSM 14941, cyproconazole, difenoconazole, dithiocarbamates, folpet, propamocarb, spinosad, spirodiclofen, tebufenpyrad and tetraconazole
**MRL for dimethomorph, indoxacarb, pyraclostrobin and trifloxystrobin in or on certain products
**FSA - Views wanted on a refined oil
**Scientific opinions

**Amendment regarding maximum levels for melamine in canned pet food
Recently provided information has demonstrated that melamine can migrate in wet pet food from the can coating at a level above 2,5 mg/kg relative to a feed with a moisture content of 12 % but below the SML of 2,5 mg/kg in the wet pet food. In the light of this development in scientific and technical knowledge, it is appropriate to establish the maximum level of 2,5 mg/kg for melamine for canned wet pet food on a ‘as sold’ basis and this in line with what is foreseen for canned food.  Directive 2002/32/EC should therefore be amended accordingly.

**BASF halts EU approval of GM potatoes
BASF has decided to no longer seek European approval of its genetically modified potatoes.  BASF said in a statement it will "discontinue the pursuit of regulatory approvals for the Fortuna, Amadea, and Modena potato projects in Europe because continued investment cannot be justified due to uncertainty in the regulatory environment and threats of field destructions." (Europolitics)

**Protection of geographical indications ‘Poulet des Cévennes’/‘Chapon des Cévennes’
Are chickens with a number of characteristics from France.  The geographical area of the ‘Poulet des Cévennes’ and ‘Chapon des Cévennes’ PGI consists of 426 municipalities.

**Amended application to the protection of geographical indications ‘Jihočeská Niva’
Amendments have been made to the description of the product.  Jihoceska Niva is a cheese which is cylindrical, has a diameter of 180-200 mm and a height of approximately 10 cm (weight approximately 2,8 kg), with signs of surface treatment by washing or scraping; the bluish-green mould throughout the inside of the cheese and the smear covering part of its surface are not detrimental. The surface of the cheese may be cream to light brownish in colour.

**Amending the name of the holder of the authorisation of dimethylglycine sodium salt
Amending implementing Regulation (EU) No 371/2011 as regards the name of the holder of the authorisation of dimethylglycine sodium salt.  Taminco N.V. has submitted an application under Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation as regards Commission Implementing Regulation (EU) No 371/2011  concerning the 10 year authorisation of dimethylglycine sodium salt, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’.   The applicant claims that it transformed its legal form into a private limited liability company with effect from 1 October 2012. The applicant has submitted relevant data supporting its request. The proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned.

**FoodDrinkEurope publishes guidance document on food allergen management
FoodDrinkEurope have published guidance on Food Allergen Management for Food Manufacturers.  The document provides information on good practice in risk management of allergenic foods and certain food intolerances for food producers of foodstuffs intended for sale to the general population. FoodandDrinkEurope state that “By harmonising and disseminating good practice across the European food industry at all levels, this Guidance will ensure a consistent understanding of, and approach to, managing allergens and certain food causing intolerances to a high standard throughout the European food industry. This will help minimise the risk to allergic consumers and enable them to make informed product choices.”  The document includes general principles that can be used to manage specific foodstuffs causing allergy or certain intolerances in different situations and focuses on the production of prepacked foods.

**Authorising the placing on the market of synthetic zeaxanthin
Authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council.  On 1 June 2004, the company DSM Nutritional Products VML made a request to the competent authorities of the Netherlands to place synthetic zeaxanthin on the market as a novel food ingredient.  On 16 June 2005 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that synthetic zeaxanthin with a maximum intake for not more than 20 mg per person per day, would not present a significant risk for human health. However, it concluded that the data presented were not sufficient to complete the safety assessment. Therefore an additional assessment was required.   On 13 September 2012, EFSA adopted a ‘Statement on the safety of synthetic zeaxanthin as an ingredient in food supplements’ concluding that the use level proposed by the applicant does not raise safety concerns.

**Authorising an extension of use of Chia (Salvia hispanica) seed as a novel food ingredient
Commission Decision 2009/827/EC authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of Chia (Salvia hispanica) seed as a novel food ingredient to be used in bread products with a maximum content of 5 % Chia (Salvia hispanica) seeds.   On 14 April 2011 The Chia Company made a request to the competent authorities of the United Kingdom for an extension of use of Chia seed on the market as a novel food ingredient. In particular, they asked to use up to 10 % Chia seed in certain food categories and to sell pre- packed Chia seed with a recommended daily intake of up to 15 g.  Pursuant to Article 7(1) of Regulation (EC) No 258/97 an Implementing Decision should be adopted to authorise an extension of use of Chia seed as a novel food ingredient.

**MRL for 2-phenylphenol, ametoctradin, Aureobasidium pullulans strains DSM 14940 and DSM 14941, cyproconazole, difenoconazole, dithiocarbamates, folpet, propamocarb, spinosad, spirodiclofen, tebufenpyrad and tetraconazole
The Authority concluded in its reasoned opinions that, as regards the use of ametoctradin on spring onions, the submitted data are not sufficient to set a new MRL. For tomatoes and peppers the submitted data do not show a need to modify the existing MRLs. As regards the use of bixafen on oilseed rape, linseed, poppy seed and mustard seed, the submitted data are not sufficient to set a new MRL. As regards diquat, the Authority concluded that the intended use is not sufficiently supported by residue data and that no new uses can be currently authorised before a comprehensive review of the existing MRLs has been performed. As regards residues of epoxiconazole in animal products, the submitted data do not show a need to modify the existing MRLs. As regards the use of spirodiclofen on strawberries, the submitted data are not sufficient to set a new MRL.  As regards dithiocarbamates deriving from the use of metiram on asparagus, onions shallots and cucurbits (edible peel), no modification of the MRLs is necessary, since the MRLs set out in Annex II to Regulation (EC) No 396/2005 are identical with those requested.  As regards Aureobasidium pullulans strains DSM 14940 and DSM 14941, the Authority concluded that its inclusion in Annex IV to Regulation (EC) No 396/2005 is appropriate.

**MRL for dimethomorph, indoxacarb, pyraclostrobin and trifloxystrobin 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 dimethomorph, indoxacarb, pyraclostrobin and trifloxystrobin in or on certain products.  The Authority concluded in its reasoned opinions that, as regards the use of dimethomorph on flowering brassica, the submitted data are sufficient to set a new MRL for broccoli only. As regards indoxacarb on scarole and soya bean, the submitted data do not show a need to modify the existing MRLs. For witloof, the submitted data are not sufficient to set a new MRL. As regards the use of pyraclostrobin on sweet corn, the submitted data are not sufficient to set a new MRL.  As regards use of dimethomorph on cress and land cress no modification of the MRLs is necessary, since the MRLs set out in Part A of Annex III to Regulation (EC) No 396/2005 are identical with those requested. As regards use of pyraclostrobin on maize, millet and sorghum, no modification of the MRLs is necessary, since the MRLs set out in Annex II to Regulation (EC) No 396/2005 are identical with those requested.

**FSA - Views wanted on a refined oil
A US company has asked the Food Standards Authority’s expert advisers on novel foods to consider its application for a refined oil to be approved for use in the European Union under the simplified approval procedure. The oil is from a plant known as Buglossoides arvensis. A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union (EU) before 15 May 1997. 

**Scientific opinions

Peer review of the pesticide risk assessment of the active substance acetic acid

Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. tenebrionis strain NB-176

Methionine zinc, technically pure

Opinion on the risk to plant health posed by Puccinia horiana Hennings for the EU territory, with the identification and evaluation of risk reduction options

Scientific Opinion on the risk to plant health posed by Burkholderia caryophylli for the EU territory with the identification and evaluation of risk reduction options

Peer review of the pesticide risk assessment of the active substance Trichoderma gamsii ICC080

Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. aizawai (strains ABTS 1857, GC-91)

Peer Review of the pesticide risk assessment of the active substance sedaxane

Modification of the existing MRLs for pyraclostrobin in cucumbers and Jerusalem artichokes

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