12 January - 20 June 2016

Legislation headlines

  • Authorising the placing on the market of refined shrimp peptide concentrate as a novel food
  • Placing on the market of bovine milk basic whey protein isolate as a novel food
  • Entering a name in the register of protected geographical indications (‘Lička janjetina’ (PGI))
  • Entering a name in the register of protected geographical indications (‘Lucanica di Picerno’) (PGI)
  • Approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Bratislavský rožok/Pressburger Kipfel/Pozsonyi kifli (TSG)]
  • Refusal to authorise health claims based on lack of evidence
  • Entering a name in the register of protected geographical indications (‘Cioccolato di Modica’ (PGI))
  • Amending the conditions of use of the novel food lactitol
  • Proposed citizens' initiative entitled ‘Eat ORIGINal! Unmask your food
  • The use of Low-substituted hydroxypropyl cellulose (L-HPC) in food supplements
  • Amendment regarding specifications for certain sorbitan esters (E 491 Sorbitan monostearate, E 492 Sorbitan tristearate and E 495 Sorbitan monopalmitate)
  • Amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards caffeine and theobromine
  • Scientific Opinions

Authorising the placing on the market of refined shrimp peptide concentrate as a novel food
The company Marealis AS (‘the Applicant’) made a request to the competent authority of Finland to place refined shrimp peptide concentrate produced from the enzymatic hydrolysis of Northern shrimp (Pandalus borealis) shells and heads, on the Union market as a novel food ingredient.  The competent authority of Finland issued its initial assessment report. In that report, it concluded that refined shrimp peptide concentrate meets the criteria for a novel food ingredient. This was then sent to Member States and the EFSA. Member states raised concerns with regards to the safety of refined shrimp peptide concentrate for hypo-, normo-, and hyper-tensive consumers due to its putative antihypertensive effects, its potential side effects related to its postulated inhibition of the angiotensin converting enzyme (ACE) and potential cardiac effects, and its potential interactions with medicines used in the treatment of blood pressure disorders. In the EFSA Scientific Opinion on the safety of shrimp peptide concentrate as a novel food, it reports that refined shrimp peptide concentrate, in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.  The authority notes that there are number of unpublished studies regarding refined shrimp peptide concentrate.  As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years. However, this does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting the authorisation under this Regulation. As the source of the novel food comes from crustaceans, and may contain traces of fish, of other crustaceans, and of molluscs, as substances or products which cause allergies or intolerances, food supplements containing refined shrimp peptide concentrate should be appropriately labelled.

Placing on the market of bovine milk basic whey protein isolate as a novel food
Armor Protéines S.A.S. made a request to the competent authority of Ireland to place bovine milk basic whey protein isolate obtained from skimmed bovine milk through a series of purification steps, on the Union market as a novel food ingredient. The application seek to have bovine milk basic whey protein isolate used in infant and follow-on formulae, in total diet replacement foods for weight control and in foods for special medical purposes, and in food supplements. The authority of Ireland issued its initial assessment report. In that report, it concluded that bovine milk basic whey protein isolate meets the criteria for a novel food ingredient and the assessment was then sent to Member States and the EFSA was consultant.  It concluded that the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years. However, restricting the authorisation of this novel food and of the reference to the 90-day oral toxicity study in rats contained in the Applicant's file for the sole use of the Applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting the authorisation under this Regulation.  It notes that products should be labelled accordingly as bovine milk basic whey protein isolate can cause allergies. Therefore this novel food has been approved.

Entering a name in the register of protected geographical indications (‘Lička janjetina’ (PGI))
Croatia's application to register the name ‘Lička janjetina’ was published in the Official Journal of the European Union. As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Lička janjetina’ should therefore be entered in the register.

Entering a name in the register of protected geographical indications (‘Lucanica di Picerno’) (PGI)
Italy's application to register the name ‘Lucanica di Picerno’ was published in the Official Journal of the European Union.  As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Lucanica di Picerno’ should therefore be entered in the register.

Approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Bratislavský rožok/Pressburger Kipfel/Pozsonyi kifli (TSG)]
The Commission has examined Slovakia's application for the approval of amendments to the specification for the traditional speciality guaranteed ‘Bratislavský rožok’/‘Pressburger Kipfel’/‘Pozsonyi kifli’. Since the amendments in question are not minor within the meaning of the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(b) of that Regulation. As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved.

Refusal to authorise health claims based on lack of evidence
EFSA was required to deliver an opinion on a health claim related to Condensyl® and decreases sperm DNA damage. The claim proposed by Laboratoire Nurilia was worded as follows: ‘The combination of opuntia fruit dry extract standardised in quercetin and betalain, N-acetyl cysteine, zinc, vitamin B3, E, B6, B2, B9 and B12 in Condensyl® decreases sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index). High sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index) is a risk factor for male subfertility/infertility’.

EFSA was required to deliver an opinion on a health claim related to sugar-free hard confectionery with at least 90 % erythritol and reduction of dental plaque which reduces the risk of caries. The claim proposed by Cargill R&D Centre Europe was worded as follows: ‘Sugar-free hard confectionery sweetened with at least 90 % Zerose® erythritol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries’.

EFAS was required to deliver an opinion on a health claim related to Lactobacillus fermentum CECT 5716 and decreases the Staphylococcus load in breast milk. High Staphylococcus load in breast milk is a risk factor for infectious mastitis. The claim proposed Biosearch Life the applicant was worded as follows: ‘Lactobacillus fermentum CECT 5716 decreases the Staphylococcus load in breast milk. High Staphylococcus load in breast milk is a risk factor for mammary bacterial dysbiosis/mastitis’.

EFSA was required to deliver an opinion on a health claim related to Stablor®, a drink preparation with defined macro- and micronutrient composition and specific proportion of amino acids (tryptophan to neutral amino acids ratio) and decrease in visceral fat while preserving lean mass. The claim proposed Laboratoires Nutrition et Cardiométabolisme was worded as follows: ‘In the context of a well-balanced diet and a mild caloric restriction, the addition of Stablor® contributes to decrease visceral fat while preserving lean mass in overweight or obese subjects with abdominal fat and cardiometabolic risk factors’.

EFSA was required to deliver an opinion on a health claim related to curcumin and normal functioning of joints. The claim proposed by Suomen Terveysravinto Oy was worded as follows: ‘Curcumin contributes to the normal functioning of joints’.

EFSA was required to deliver an opinion on a health claim related to a carbohydrate:protein (CHO:P) ratio ≤ 1.8 on an energy basis in the context of an energy-restricted diet and body weight. The claim proposed Marks and Spencer PLC was worded as follows: ‘Helps to achieve a reduction in body weight and body fat when consumed as part of an energy restricted diet (< 8,368 kJ/2,000 kcal/day) for a minimum of 12 weeks’.

EFSA was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and reduction of body weight in the context of an energy-restricted diet. The claim proposed by Loc Troi group was worded as follows: ‘In the context of an energy-restricted diet contributes to weight loss’.

EFSA was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration. The claim proposed by Loc Troi group was worded as follows: ‘Contributes to the maintenance of normal blood glucose levels’.

EFSA was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood pressure. The claim proposed by the applicant was worded as follows: ‘Contributes to the maintenance of normal blood pressure’.

EFSA was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood cholesterol concentration. The claim proposed by the applicant was worded as follows: ‘Contributes to the maintenance of normal blood cholesterol levels’.

Entering a name in the register of protected geographical indications (‘Cioccolato di Modica’ (PGI))
Italy's application to register the name ‘Cioccolato di Modica’ was published in the Official Journal of the European Union. As no statement of opposition has been received by the Commission, the name ‘Cioccolato di Modica’ should therefore be entered in the register.

Amending the conditions of use of the novel food lactitol
Commission Implementing Decision (EU) 2017/450 authorised, lactitol as a novel food to be used in capsule or tablet in food supplements intended for the adult population.  DuPont Nutrition Biosciences ApS have applied to change the conditions of use to include powder as an allowed form of lactitol to be used in food supplements.  The maximum level of lactitol authorised by Implementing Decision (EU) 2017/450 as a novel food to be used in capsule or tablet in food supplements is 20 g/day. The proposed use level of the novel food lactitol in powder form in the same food category corresponds to the maximum level that is currently authorized, therefore the application has been approved.

Proposed citizens' initiative entitled ‘Eat ORIGINal! Unmask your food
The objectives of the proposed citizens' initiative refer to the following: ‘1. Make the indication of the country of origin mandatory for all processed and unprocessed foods circulating in EU, with no derogation for registered trademarks and geographical indications. 2. With regard to processed foods, origin labelling is made mandatory for primary ingredients when different from the origin of the final product. 3. Improve consistency of the labels including harmonized informations about production and processing methods in order to ensure transparency throughout the food chain.’

The use of Low-substituted hydroxypropyl cellulose (L-HPC) in food supplements
Only food additives included in the Union list in Annex II to Regulation (EC) No 1333/2008 may be placed on the market as such and used in foods under the conditions of use specified therein. An application has been submitted for the authorisation of the use of low-substituted hydroxypropyl cellulose (L-HPC) as a food additive in food supplements in tablet form falling under the food category 17.1 ‘Food supplements supplied in a solid form’ in Part E of Annex II to Regulation (EC) No 1333/2008.  EFSA reported no safety concern, at a maximum use level of 20 000 mg/kg and a typical use level of 10 000 mg/kg.  Low-substituted hydroxypropyl cellulose (L-HPC) is water insoluble cellulose that facilitates the manufacturing of solid food supplements in tablet form due to its good compressibility and binding properties. Being insoluble in water, it absorbs water while increasing in volume. The increased volume makes the tablet disintegrating rapidly providing a fast release of the nutrients in the stomach. It is therefore appropriate to include low-substituted hydroxypropyl cellulose (L-HPC) in the Union list of food additives and to assign E 463a as E-number to that additive to enable its authorisation as a glazing agent in food supplements in solid form (tablet) at a maximum use level of 20 000 mg/kg.  The specifications for low-substituted hydroxypropyl cellulose (L-HPC) (E 463a) should be included in Regulation (EU) No 231/2012 when it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

Amendment regarding specifications for certain sorbitan esters (E 491 Sorbitan monostearate, E 492 Sorbitan tristearate and E 495 Sorbitan monopalmitate)
An application was submitted for the amendment of specifications concerning the food additives sorbitan monostearate (E 491), sorbitan tristearate (E 492) and sorbitan monopalmitate (E 495). The applicant requests that the reference to the congealing range as an identification method of sorbitan monostearate (E 491), sorbitan tristearate (E 492) and sorbitan monopalmitate (E 495) in the Union specifications be removed as it is not an optimal method for identification due to a lack of a clear and common methodology. EFSA report that this is not a safety concern. It concluded that the removal of the congealing range from the Union specifications would result in less characterisation of the various sorbitan esters of saturated fatty acids, and that this identification parameter could be replaced by another one. The Authority noted that out of all analytical methods available, gas chromatography analysis appears to deliver the most accurate and reliable results and is fit for purposes of food controls.

Amendment regarding Cochineal, Carminic acid, Carmines (E 120)
Cochineal, Carminic acid, Carmines (E 120) is a substance authorised as a colour in a variety of foods in accordance with Annex II to Regulation (EC) No 1333/2008. Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the Union before 20 January 2009 are subject to a new risk assessment by the European Food Safety Authority (‘the Authority’). For that purpose, a program for the re-evaluation of food additives is laid down in Commission Regulation (EU) No 257/2010 (3), according to which the re-evaluation of colours had to be completed by 31 December 2015. On 18 November 2015 the Authority delivered a Scientific Opinion on the re-evaluation of cochineal, carminic acid, carmines (E 120) as a food additive. The Authority concluded that the present dataset did not give reasons to revise the Acceptable Daily Intake (ADI) value for E 120 and that the refined exposure estimates were below the ADI for all population groups. However, the Authority recommended to revise the current title ‘Cochineal, Carminic acid, Carmines’, so that it would more accurately reflect the material used as a food additive and to update the specifications as regards the percentage of material not accounted for, the maximum limits for toxic elements and the presence of proteinaceous compounds. The Union list of approved food additives shall be amended in accordance.

Amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards caffeine and theobromine
The substances caffeine (FL No 16.016) and theobromine (FL No 16.032) were listed with footnote 1 according to which the evaluation for those substances had to be completed by the European Food Safety Authority. EFSA completed the evaluation of the safety of caffeine (FL No 16.016) and theobromine (FL No 16.032) when used as flavouring substances and concluded that their use as flavouring substances does not give rise to safety concerns based on their estimated levels of intake in certain food categories. The conditions of use already laid down in the Union list may therefore be maintained.  Therefore, caffeine (FL No 16.016) and theobromine (FL No 16.032) should be listed as evaluated substances in the Union list of flavouring substances without the footnote reference contained in their current entries of the Union list.

Scientific Opinions

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

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

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Avian influenza overview May – August 2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

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

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety of zinc chelate of methionine sulfate for the target species

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Thecaphora solani

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Melampsora farlowii

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

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