12 January - 20 June 2016

Legislation headlines

31 July 13

**EFSA issues guiding principles for two-year whole food studies
**EFSA  approve maternal folate health claim
**Food Standards Agency review of Powers of Entry legislation
**The use of extracts of rosemary (E 392) in certain low fat meat and fish products
**The condensed milk and dried milk (Wales) regulations 2013
**Laying down rules definition, description, presentation, labelling and the protection of geographical indications of spirit drinks
**The Fruit Juices and Fruit Nectars (Wales) Regulations 2013
**ASA orders VitaburnCoffee.com to remove health claims from its website
**Entering a name in the register of protected designations of origin East Kent Goldings
**Monsanto to withdraw all pending approval requests of GM crops in the EU
**Amending Directive 98/8/EC to include 1R-trans phenothrin as an active substance
**Approving minor amendments to protected designations of origin Oignon doux des Cévennes
**Horse DNA detected in meat pie from Latvia
**Scientific opinions

**EFSA issues guiding principles for two-year whole food studies
EFSA has set out guiding principles that will help scientists carry out two-year whole food feeding studies to assess the risk of cancer and/or toxicity from the long-term consumption of such foods by humans. The report gives advice on how to design and conduct long term whole food feeding trials on rodents in line with internationally-recognised standards and identifies the limitations of these types of studies. In addition, the Authority highlights that a decision on whether these studies are needed should be taken on a case-by-case basis and only after all existing toxicological, nutritional and compositional data have been evaluated. Setting clear and specific objectives prior to launching a study is also crucial. EFSA said its guiding principles would contribute to the future establishment of protocols for two-year carcinogenicity and chronic toxicity feeding studies for both whole food and whole feed. (quoted directly)

**EFSA  approve maternal folate health claim
The EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) has approved the health  claim related to increasing  maternal folate status by supplemental folate intake and reduced risk of neural tube defects.   Following an application from Rank Nutrition Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects. The Panel considers that the food constituent, supplemental folate, which is the subject of the claim, is sufficiently characterised. Increasing maternal folate status by supplemental folate intake is a beneficial physiological effect in the context of reducing the risk of neural tube defects. In weighing the evidence, the Panel took into account that the association between low maternal folate intakes and an increased risk of neural tube defects is well established, and that a recent systematic review showed an effect of maternal folic acid intakes on the risk of neural tube defects. The Panel concludes that a cause and effect relationship has been established between increasing maternal folate status by supplemental folate intake and a reduced risk of neural tube defects.

**Food Standards Agency review of Powers of Entry legislation
This consultation seeks stakeholder views on the addition of a number of safeguards to the FSA Powers of Entry legislation relating to leaving premises as close as possible to the condition in which it was found and the seizure of materials; and the retention of current Powers of Entry and their safeguards.

**The use of extracts of rosemary (E 392) in certain low fat meat and fish products
An application for the authorisation of use of extracts of rosemary (E 392) as an antioxidant in meat preparations, low fat non-heat-treated and heat-treated processed meat and low fat processed fish and fishery products including molluscs and crustaceans was submitted on 3 February 2012 and has been made available to the Member States.  The current maximum levels of the use of extracts of rosemary (E 392) authorised in processed meat and processed fish and fishery products including molluscs and crustaceans are set according to the fat content in the respective food categories (except for dried sausages and dehydrated meat). The allowed maximum level of use of extracts of rosemary (E 392) set according to the fat content in the respective food categories does not ensure a sufficient protection of food with low fat content since there is a critical minimum dosage of this antioxidant to achieve the desired effect. Currently, extracts of rosemary (E 392) could be used at effective dosages in the products with a higher fat content. However, also the low fat products could be subject to severe oxidation due to a high proportion of unsaturated fatty acids. Therefore, it is appropriate to set the maximum level of use of extracts of rosemary (E 392) at 15 mg/kg for products with a fat content not higher than 10 % while maintaining the allowed maximum level of 150 mg/kg expressed on fat basis for the products with a fat content higher than 10 %.  In 2008 the European Food Safety Authority (‘the Authority’) evaluated the safety of extracts of rosemary (E 392) when used as a food additive and concluded that the proposed uses and use levels would not be of safety concern.

**The condensed milk and dried milk (Wales) regulations 2013
This consultation seeks comments from industry, enforcers and other interested stakeholders on the draft Condensed Milk and Dried Milk (Wales) Regulations 2013. The draft regulation provides in domestic law a proportionate, effective and risk-based enforcement in Wales of Council Directive 2001/114/EC, which applies to partly or wholly dehydrated preserved milk for human consumption, and Council Directive 2007/61/EC amending Directive 2001/114/EC. The draft regulation simplifies Regulations by consolidating two sets of regulations making referencing easier for industry and enforcers. (FSA)

**Laying down rules definition, description, presentation, labelling and the protection of geographical indications of spirit drinks
In order to clarify certain provisions of Regulation (EC) No 110/2008 and to ensure their uniform implementation in the Member States, detailed rules should be adopted, in particular as regards the use of compound terms, allusions, sales denominations and geographical indications for the presentation of spirit drinks.   Commission implementing regulation (EU) no 716/2013 of 25 July 2013 lays down the rules for protection of geographical indications of spirit drinks.

**The Fruit Juices and Fruit Nectars (Wales) Regulations 2013             
This consultation seeks views on the draft Fruit Juices and Fruit Nectars (Wales) Regulations 2013.  The draft Fruit Juices and Fruit Nectars (Wales) Regulations 2013, which consolidate existing Fruit Juice legislation and to implement the provisions of Council Directive 2012/12/EU relating to fruit juices and certain similar products intended for human consumption.  Council Directive 2001/112/EC relating to fruit juices and similar products lays down rules governing the composition and labelling of these products. It has been implemented into Northern Ireland law by the Fruit Juices and Fruit Nectars Regulations (Wales) 2003. (FSA)

**ASA orders VitaburnCoffee.com to remove health claims from its website
The Advertising Standards Authority have ordered Vitaburn Coffee to not to make health claims unless they were authorised on the EU Register and not to state a rate or amount of weight loss and ensure that marketing communications were obviously identifiable as such.  These orders came after a complainant challenged the health claims made on the website, that made health claim for green coffee beans including "4 Times More Weight Loss Than Diet And Exercise", "Boosts Energy", "Rich in Antioxidants" and "Promotes Cardiovascular and Digestive Health". Further health claims included "Helps Eliminate Bad Toxins that have Built Up Over the Years", "Removes 'Sludge' from the Walls of the Colon", "Helps Get Rid of Gas and Bloating" and "Helps to Regulate the Metabolism".    The complaint challenged that the claims were misleading, because they were presented as a news article and did not make clear that it was marketing material. Vitaburncoffee.com said they no longer marketed Vitaburn and Pure Detox Plus and all ads had been removed.  However, the claims on the website also promoted and directed readers to websites for products called Nuvoryn and Puracleanse and they considered that vitaburncoffee.com needed to substantiate their marketing claims and explain the presentation of the website as a news article.

**Animal health and welfare and food safety report published
The UK Government has published the first set of reports under the European Union Balance of Competences Review. These reports aim to deepen public understanding of the UK’s relationship with the EU.  The reports draw on evidence submitted to provide a wide ranging and balanced analysis of the EU’s ability to act, the impact that EU action has on the UK national interest and future challenges.  The Food Standards Agency and the Department for Environment, Food and Rural Affairs worked on the Animal Health and Welfare and Food Safety report. This covers food safety, including feed, food labelling and food compositional standards.

**Entering a name in the register of protected designations of origin East Kent Goldings
Pursuant to Article 6(2) of Regulation (EC) No 510/2006, the United Kingdom’s application to register the name ‘East Kent Goldings’ was published in the Official Journal of the European Union . 

**Monsanto to withdraw all pending approval requests of GM crops in the EU
According to Euractiv Monsanto is to withdraw all pending approval requests to grow new types of genetically modified crops in the European Union, due to the lack of commercial prospects for cultivation there.  The article reports Jose Manuel Madero, Monsanto's President and Managing Director for Europe as saying that they will be withdrawing approval in the coming months,to allow the company to focus on growing its conventional seed business in Europe and concentrate on securing EU approval to import its genetically modified crop varieties widely grown in the United States and South America.

**Amending Directive 98/8/EC to include 1R-trans phenothrin as an active substance
D- phenothrin has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product- type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.  The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of d-phenothrin, i.e. a substance containing at least 89 % w/w of 1R-trans phenothrin.  The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of d-phenothrin in the abovementioned list of active substances in Regulation (EC) No 1451/2007. Therefore, only 1R-trans phenothrin should be included in Annex I to Directive 98/8/EC based on the existing evaluation.

**Approving minor amendments to protected designations of origin Oignon doux des Cévennes
The purpose of the application is to amend the specification by giving more detailed information on the product description, the geographical area, the proof of origin, the method of production, labelling, national requirements, packaging and the contact details of the applicant group.  The Commission has examined the amendments in question and decided that they are justified.  ‘Oignon doux des Cévennes’ is a storage onion cultivated on terraces. It is pearly white to coppery in colour, with a roundish to elongated bulb, a shiny appearance and fine and translucent tunics.

**Horse DNA detected in meat pie from Latvia
The FSA has been informed that a frozen meat pie product that was found to contain horse DNA has been withdrawn from sale. Horse meat is not identified in the ingredients list and therefore it should not have been present in the product.  The pie is a Galdin Klajies product manufactured in Latvia. The 200g packs are described on the label as 'pie with minced meat' and are distributed in the UK by Monolith UK Ltd. When Monolith tested the product, it was found to contain horse DNA at a level of more than 1%. The FSA has requested that the product now be tested for the presence of phenylbutazone, known as 'bute'. The product is supplied to small retail shops in the UK, many of which specialise in products from Eastern Europe, and one batch was affected. Monolith has informed its customers and withdrawn all supplies.

**Scientific opinions

GD on tiered RA for edge-of-field surface water

Scientific Opinion on genetically modified cotton MON 88913

L-Threonine for all animal species

Modification of the existing MRL for kresoxim-methyl in azaroles

Substantiation of a health claim related to “non fermentable” carbohydrates and maintenance of tooth mineralisation by decreasing tooth demineralisation

Substantiation of a health claim related to Preservation® and “rapid recovery of cellular activity post stress”

Substantiation of a health claim related to the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol® and reduction of blood LDL-cholesterol concentrations

Substantiation of a health claim related to iron and contribution to normal cognitive development

Reasoned opinion on the setting of new MRLs for pyriofenone in cereals, grapes and animal products

Flavouring Group Evaluation 217, Revision 1 (FGE.217Rev1). Consideration of genotoxic potential for α,β-unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: Lactones

Review of the existing maximum residue levels (MRLs) for chloropicrin according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels (MRLs) for methyl bromide according to Article 12 of Regulation (EC) No 396/2005

Evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille)

Safety evaluation of the process “INTERSEROH Step 2” used to recycle polypropylene crates for use as food contact material

Safety evaluation of the following processes based on Starlinger IV+ ® technology used to recycle post-consumer PET into food contact materials“Visy” and “SIA EkoPET

International Frameworks Dealing with Human Risk Assessment of Combined Exposure to Multiple Chemicals

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