12 January - 20 June 2016

Legislation headlines

  • FSA - views wanted on bacterium M. aurum
  • Draft scientific opinion on dietary reference values for vitamin D – EFSA open consultation
  • Budget - new sugar levy on the soft drinks industry
  • Proposed legislation to help address declining freshwater fish stocks
  • Refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health
  • Refusing to authorise a health claim made on foods and referring to the reduction of disease risk
  • Italy launches extra virgin olive oil certification label
  • Authorising the placing on the market of 2′-O-fucosyllactose as a novel food ingredient
  • Application for entry in the register of protected designations of origin starsko ekstra djevičansko maslinovo ulje (PDO)
  • Approving non-minor amendments to protected geographical indications Karlovarský suchar (PGI)
  • Traditional speciality guaranteed (TSG) for the name ‘Tepertős pogácsa’
  • Entering a name in the register of protected geographical indications Frankfurter Grüne Soße/Frankfurter Grie Soß (PGI)
  • Entering a name in the register of protected geographical indications Polvorones de Estepa (PGI)
  • Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin Carciofo Spinoso di Sardegna (PDO)
  • Amending and correcting Annex II to Regulation (EC) No 1333/2008 as regards the use of certain food additives permitted in all categories of foods
  • Application for protected geographical indications ‘Ginja de Óbidos e Alcobaça’ (PGI)
  • Application for protected designations of origin ‘Café de Valdesia’ (PDO)
  • Entering a name in the register of protected designations of origin Pane Toscano (PDO)
  • Adjusting the geographical scope of the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810 (MON-ØØ81Ø-6)
  • Amending Annex II to Regulation (EC) No 1333/2008 as regards the title of the food category 12.3 Vinegar
  • Entering a name in the register of protected designations of origin Telemea de Ibănești (PDO)
  • Application for protected geographical indications ‘Oecher Puttes’/‘Aachener Puttes’ (PGI)
  • Application for protected designation of origin ‘Krčko maslinovo ulje’
  • Authorising the placing on the market of UV-treated bread as a novel food
  • EFSA Scientific Opinions

**FSA - views wanted on bacterium M. aurum
Solution Sciences Ltd has applied to the FSA for bacterium M. aurum to be approved for use in the European Union (EU) as a food ingredient under Regulation (EC) 258/97. M. aurum is an environmental mycobacterium that lives harmlessly in the environment and can also be found in the gut of humans and animals as part of the normal gut microflora. M. aurum is a bacterium regularly encountered if drinking untreated water. The numbers are reduced if drinking treated water or bottled water.  Views are wanted on the company’s application dossier that the FSA will present to the independent expert committee (Advisory Committee on Novel Foods and Processes) to inform its pre-market assessment of the novel food by 11 April. (FSA)

**Draft scientific opinion on dietary reference values for vitamin D – EFSA open consultation
EFSA has launched an open consultation on its draft scientific opinion on dietary reference values for vitamin D. This document proposes dietary reference values for vitamin D for adults, infants and children, pregnant and lactating women.  Vitamin D is a fat-soluble vitamin which can be obtained from food and from exposure to sunlight or artificial ultraviolet-B light. Interested parties are invited to submit written comments by 16 May 2016. (EFSA)

**Budget - new sugar levy on the soft drinks industry
In his budget presented to Parliament on 16 March 2016, The Rt Hon George Osborne MP announced a levy on soft drinks with added sugar from April 2018. He states: "So today I can announce that we will introduce a new sugar levy on the soft drinks industry. Let me explain how it will work. It will be levied on the companies. It will be introduced in two years’ time to give companies plenty of space to change their product mix. It will be assessed on the volume of the sugar-sweetened drinks they produce or import. There will be two bands – one for total sugar content above 5 grams per 100 millilitres; a second, higher band for the most sugary drinks with more than 8 grams per 100 millilitres. Pure fruit juices and milk-based drinks will be excluded, and we’ll ensure the smallest producers are kept out of scope. We will of course consult on implementation. We’re introducing the levy on the industry which means they can reduce the sugar content of their products – as many already do. It means they can promote low-sugar or no sugar brands – as many already are. They can take these perfectly reasonable steps to help with children’s health. Of course, some may choose to pass the price onto consumers and that will be their decision, and this would have an impact on consumption too. We understand that tax affects behaviour. So let’s tax the things we want to reduce, not the things we want to encourage. The OBR estimate that this levy will raise £520 million. And this is tied directly to the second thing we’re going to do today to help children’s health and wellbeing. We’re going to use the money from this new levy to double the amount of funding we dedicate to sport in every primary school." (Gov.uk)

RSSL has considerable experience in re-formulating products to provide more healthy options including low salt and low sugar versions.  Using RSSL can help speed up your development cycle considerably.  For more information please contact Customer Services on +44 (0) 118 918 4076 or email enquiries@rssl.com

**Proposed legislation to help address declining freshwater fish stocks
Defra have stated that rivers across England could benefit from new Government plans to help address declining freshwater fish stocks so native species can thrive.  Migration journeys within rivers and between rivers can be impeded by structures like weirs, or water intakes, hampering fishes’ efforts to reproduce or feed.  Proposed new legislation, being set out this month, would remove obstructions or build fish passes to provide a route around or through these hurdles. This new legislation to facilitate fish passage could help recover stocks of species like salmon, which are born in our rivers and swim to the Atlantic to mature for up to three years before returning to the same river to spawn.

**Refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health
The following health claims were not authorised:

  • Following an application from InQpharm Europe Ltd, the Authority was required to deliver an opinion on a health claim related to a standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. The claim proposed by the applicant was worded as follows: ‘Helps to reduce body weight’.
  • Following an application from Natural Alternative International, Inc. (NAI), the Authority was required to deliver an opinion on a health claim related to beta-alanine and increase in physical performance during short-duration, high-intensity exercise. The claim proposed by the applicant was worded as follows: ‘Beta-alanine increases performance during short-duration high intensity exercise’. 
  • Following an application from Federación Nacional de Industrias Lácteas (FeNIL), the Authority was required to deliver an opinion on a health claim related to fat-free yogurts and fermented milks complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and reduction of body and visceral fat while maintaining lean body mass in the context of an energy-restricted diet. The claim proposed by the applicant was worded as follows: ‘Fat-free yogurts and fermented milks with live yogurt cultures, with added vitamin D, and with no added sugars, help to reduce body and visceral fat in the context of an energy-restricted diet’.
  • Following an application from Avesthagen Limited, the Authority was required to deliver an opinion on a health claim related to Teestar™, a fenugreek seed extract standardised by its content of galactomannan, and a reduction of post-prandial glycaemic responses. The claim proposed by the applicant was worded as follows: ‘Teestar™ lowers blood glucose levels’.

**Refusing to authorise a health claim made on foods and referring to the reduction of disease risk
Following an application from Lycotec Ltd, the Authority was required to deliver an opinion on a health claim related to L-tug lycopene and reduction of blood low-density lipoprotein (LDL)-cholesterol. The claim proposed by the applicant was worded as follows: ‘L-tug lycopene has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’.  The Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of L-tug lycopene and reduction of blood LDL-cholesterol concentrations. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

**Italy launches extra virgin olive oil certification label
The Italian Farmers Confederation (CIA), the National Consortium of Olive Growers (CNO) and the State Mint and Polygraphic Institute (IPZS) have launched an anti-fraud label to certify 100% Italian extra virgin olive oil.  The label has been developed in an attempt to combat Made in Italy production from fraud, which is estimated to cost the olive oil industry €1.5 billion per year. The label will consist of a numbered seal with a QR code located on the neck of the bottle.  The security mark will allow recognition and protection against counterfeiting.  The label will also enable traceability via an information system that provides data on the distribution of the sealed product and the history of the product. (Olive Oil Times)

**Authorising the placing on the market of 2′-O-fucosyllactose as a novel food ingredient
The company Glycom A/S made a request to the competent authorities of Ireland to place 2′-O-fucosyllactose on the market as a novel food ingredient.  EFSA in its ‘Scientific Opinion on the safety of 2′-O-fucosyllactose as a novel food ingredient, concluded that 2′-O-fucosyllactose is safe for the proposed uses and use levels.

**Application for entry in the register of protected designations of origin starsko ekstra djevičansko maslinovo ulje (PDO)
Croatia has applied to enter ‘Istarsko ekstra djevičansko maslinovo ulje’ in the register of protected designations of origin.  ‘Istarsko ekstra djevičansko maslinovo ulje’ is an extra virgin olive oil obtained directly from the fruit of the olive tree (Olea europaea, L.) solely by mechanical means.  It has a number of physico-chemical and organoleptic characteristics. 

**Approving non-minor amendments to protected geographical indications Karlovarský suchar (PGI)
The Commission has examined the Czech Republic's application for the approval of amendments to the specification for the protected geographical indication ‘Karlovarský suchar’.  The amendments have been approved and will be published in the Official Journal of the European Union.

**Traditional speciality guaranteed (TSG) for the name ‘Tepertős pogácsa’
The commission has published the name ‘Tepertős pogácsa’ in the register.  When the product is placed on the market, the label may contain the following information: ‘magyar hagyományok szerint előállított’ (produced in accordance with Hungarian traditions).

**Entering a name in the register of protected geographical indications Frankfurter Grüne Soße/Frankfurter Grie Soß (PGI)
Germany's application to register the name ‘Frankfurter Grüne Soße’/‘Frankfurter Grie Soß’ was published in the Official Journal of the European Union. 

**Entering a name in the register of protected geographical indications Polvorones de Estepa (PGI)
Spain's application to register the name ‘Polvorones de Estepa’ was published in the Official Journal of the European Union  and as no statement of opposition has been received the name ‘Polvorones de Estepa’ should therefore be entered in the register.

**Approving non-minor amendments to the specification for a name entered in the register of protected designations of origin Carciofo Spinoso di Sardegna (PDO)
The Commission has examined Italy's application for the approval of amendments to the specification for the protected designation of origin ‘Carciofo Spinoso di Sardegna.’  As no statement of opposition has been received the amendments to the specification have been approved,

**Amending and correcting Annex II to Regulation (EC) No 1333/2008 as regards the use of certain food additives permitted in all categories of foods
Due to the difficulties encountered during the transfer of food additives to the new categorisation system provided in Annex II to Regulation (EC) No 1333/2008, foods for infants and young children were not transferred from Article 2(3)(b) of Directive 95/2/EC to Table 1 of Part A of Annex II to Regulation (EC) No 1333/2008. It should be ensured that the carry-over principle does not apply to those foods. Therefore, that table should be corrected to include foods for infants and young children provided in Directive 2009/39/EC of the European Parliament and of the Council, as replaced by Regulation (EU) No 609/2013 of the European Parliament and the Council.

**Application for protected geographical indications ‘Ginja de Óbidos e Alcobaça’ (PGI)
Portugal have applied for PGI for ‘Ginja de Óbidos e Alcobaça’.  ‘Ginja de Óbidos e Alcobaça’ is the name given to the fruit of the ‘Galega’ cultivar, a member of the Rosaceae family, sub-family of stone fruit, genus Prunus, species Prunus cerasus L., obtained in the geographical area, essentially characterised by its red colour, small size, slightly flattened form, with a number of chemical and organoleptic characteristics.

**Application for protected designations of origin ‘Café de Valdesia’ (PDO)
Dominican Republic have applied for PDO for ‘Café de Valdesia’.  ‘Café de Valdesia’ is the fruit of the coffee tree (Coffea arabica L.), of the typica and caturra varieties, which is shade grown in the defined geographical area — comprising the main coffee-growing areas in the Provinces of Ocoa, Peravia and San Cristóbal — and meets a number of specific requirements.

**Entering a name in the register of protected designations of origin Pane Toscano (PDO)
Italy's application to register the name ‘Pane Toscano’ was published in the Official Journal of the European Union.  The United Kingdom and Belgium opposed the registration, as they considered that the name ‘Pane Toscano’ is generic and noted that the product specification should have included rules on the origin of the seeds, and that the influence of the temperature on the characteristics of the flours.  The countries were invited to engage in appropriate consultations, however as no agreement was reached by the parties the Commission adopted a decision.  Despite the allegations submitted by the opponents, the Commission deemed it is appropriate to register the name ‘Pane Toscano’ as a protected designation of origin.  They list a number of reasons including that the name to be registered refers to the product ‘bread’ and not to flour or wheat.

**Adjusting the geographical scope of the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810 (MON-ØØ81Ø-6)
The Official Journal of the European Union notes that the cultivation of genetically modified maize (Zea mays L.) MON 810 shall be prohibited in the territories listed in the Annex to this Decision. The 21 countries listed include Northern Ireland (United Kingdom), Scotland (United Kingdom) and Wales (United Kingdom).

**Amending Annex II to Regulation (EC) No 1333/2008 as regards the title of the food category 12.3 Vinegars
The Union list of food additives currently includes the food additives on the basis of the categories of food to which they may be added to. In Part D of the Union list, food category 12 covers salts, spices, soups, sauces, salads and protein products and includes subcategory 12.3 — vinegars. Part E of the Union list sets out the following authorised additives for food category 12.3: Group I additives, caramels (E 150a-d) and sulphur dioxide — sulphites (E 220-228) only in fermentation vinegar. Acetic acid (also used as a food additive E 260) when diluted with water (4-30 % by volume) could be used as a food or food ingredient in the same manner as vinegars from agricultural origin. In some Member States only vinegars obtained from the fermentation of agricultural products are allowed to be named ‘vinegars’. In other Member States, however, both products obtained from the dilution with water of acetic acid and vinegars obtained from the fermentation of agricultural products are marketed under the name ‘vinegar’. Following discussions with Member States it is appropriate to revise the title of food category 12.3 ‘Vinegars’ to specify that it includes diluted acetic acid (diluted with water to 4-30 % by volume) fit for human consumption in order to ensure that there is transparency and legal certainty regarding the use of food additives in that food.

**Entering a name in the register of protected designations of origin Telemea de Ibănești (PDO)
The application from Romania to register the name ‘Telemea de Ibănești’ was published in the Official Journal of the European Union.  The Commission received one notice of opposition from Greece.  However Greece and Romania reached an agreement that the protection of the designation ‘Telemea de Ibănești’ should not cover the stand alone name ‘Telemea’ but only the compound name ‘Telemea de Ibănești’ as a whole.  Therefore, the designation of origin ‘Telemea de Ibănești’ (PDO) should be protected as a whole, whereas the term ‘Telemea’ may continue to be used in labelling or presentations within the territory of the Union provided the principles and rules applicable in its legal order respected.

**Application for protected geographical indications ‘Oecher Puttes’/‘Aachener Puttes’ (PGI)
Germany have applied for PGI for ‘Oecher Puttes’/‘Aachener Puttes’.  Oecher Puttes is a blood sausage speciality with a solid, down-to-earth character and a spicy taste which is sold fresh, tinned or smoked. Some variations of Oecher Puttes are smoked.

**Application for protected designation of origin ‘Krčko maslinovo ulje’
Croatia have applied for PDO for ‘Krčko maslinovo ulje’.  ‘Krčko maslinovo ulje’ is an extra virgin olive oil obtained directly from the fruit of the olive tree solely by mechanical means. When placed on the market, ‘Krčko maslinovo ulje’ must have a number of characteristics.

**Authorising the placing on the market of UV-treated bread as a novel food
Viasolde AB which makes the equipment for UV-treatment made a request to the competent authorities of Finland to place ultraviolet (UV) treated bread on the market as a novel food.  The aim of the UV treatment is to enhance the vitamin D content of the bread, which means that the nutritional value of the bread would significantly differ from the nutritional value of traditionally baked bread. The Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for UV-treated bread as novel food.  EFSA concluded in its ‘Scientific Opinion on the safety of UV-treated bread as a novel food’, that bread enriched with vitamin D2 through UV treatment is safe under the proposed conditions of use.

**EFSA Scientific Opinions

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