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(EU) No 1229/2014:拒绝批准某些食品健康声称,不涉及降低疾病风险和儿童成长健康有关的声称

嘉峪检测网        2015-09-05 15:14

【发布单位】 EUROPEAN COMMISSION
【发布文号】 (EU) No 1229/2014
【发布日期】 2014-11-18
【生效日期】
【废止日期】
【替代法规】
【效  力】
【食品伙伴网解读】

20141118,欧盟发布委员会条例(EU) No 1229/2014拒绝批准7食品健康声称,分别为(1)Tuscan卷心菜、三色唐莴苣、双色菠菜blu savoy”卷心菜组合产品有助于保护血脂避免氧化损伤2红色菠菜、绿色菠菜、红菊苣、绿菊苣绿叶甜菜、红叶甜菜红色唐莴苣,金色唐莴苣和白色唐莴苣组合产品有助于保护血脂避免氧化损伤;(3Tuscan黑卷心菜、三色唐莴苣、双色菠菜和“blu savoy”卷心菜组合产品:维持正常的血胆固醇浓度;(4红色菠菜、绿色菠菜、红菊苣、绿菊苣、绿叶甜菜、红叶甜菜、红色唐莴苣金色唐莴苣和白色唐莴苣组合产品:维持正常的血胆固醇浓度;(5香叶木苷、曲克芦丁和橘皮苷组合产品含有300mg香叶木苷、300mg曲克芦丁100mg橘皮苷类黄酮混合物维持生理静脉-毛细血管通透性的有效辅佐剂;(6香叶木苷、曲克芦丁和橘皮苷组合产品:含有300mg香叶木苷、300mg曲克芦丁和100mg橘皮苷的类黄酮混合物是维持生理静脉张力的有效辅佐剂;(7大麦茶“Orzotto”有助于保护血脂避免氧化损伤。


  COMMISSION REGULATION (EU) No 1229/2014

  of 17 November 2014

  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

  (Text with EEA relevance)

  THE EUROPEAN COMMISSION,

  Having regard to the Treaty on the Functioning of the European Union,

  Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 18(5) thereof,

  Whereas:

  (1)

  Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

  (2)

  Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’, for a scientific assessment, as well as to the Commission and the Member States for information.

  (3)

  The Authority is to deliver an opinion on the health claim concerned.

  (4)

  The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

  (5)

  Following an application from Italsur S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of Tuscan black cabbage, ‘tri-coloured’ Swiss chard, ‘bi-coloured’ spinach and ‘blu savoy’ cabbage and protection of blood lipids from oxidative damage (Question No EFSA-Q-2013-00574) (2). The claim proposed by the applicant was worded as follows: ‘contributes to the protection of blood lipids from oxidative damage’.

  (6)

  On 30 October 2013, 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 a combination of Tuscan black cabbage, ‘tri-coloured’ Swiss chard, ‘bi-coloured’ spinach and ‘blu savoy’ cabbage and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

  (7)

  Following an application from Italsur S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard and protection of blood lipids from oxidative damage (Question No EFSA-Q-2013-00575) (3). The claim proposed by the applicant was worded as follows: ‘contributes to the protection of blood lipids from oxidative damage’.

  (8)

  On 30 October 2013, 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 a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

  (9)

  Following an application from Italsur S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of Tuscan black cabbage, ‘tri-coloured’ Swiss chard, ‘bi-coloured’ spinach and ‘blu savoy’ cabbage and maintenance of normal blood LDL-cholesterol concentration (Question No EFSA-Q-2013-00576) (4). The claim proposed by the applicant was worded as follows: ‘maintains normal blood cholesterol concentration’.

  (10)

  On 30 October 2013, 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 a combination of Tuscan black cabbage, ‘tri-coloured’ Swiss chard, ‘bi-coloured’ spinach and ‘blu savoy’ cabbage and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

  (11)

  Following an application from Italsur S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard and maintenance of normal blood LDL-cholesterol concentration (Question No EFSA-Q-2013-00579) (5). The claim proposed by the applicant was worded as follows: ‘maintain normal blood cholesterol concentrations’.

  (12)

  On 30 October 2013, 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 a combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

  (13)

  Following an application from Omikron Italia S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of diosmin, troxerutin and hesperidin and maintenance of normal venous-capillary permeability (Question No EFSA-Q-2013-00353) (6). The claim proposed by the applicant was worded as follows: ‘the flavonoid mixture containing 300 mg of diosmin, 300 mg of troxerutin and 100 mg of hesperidin is a useful co adjuvant in maintaining physiological venous-capillary permeability’.

  (14)

  On 13 January 2014, 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 a combination of diosmin, troxerutin and hesperidin and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

  (15)

  Following an application from Omikron Italia S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of diosmin, troxerutin and hesperidin and maintenance of normal venous tone (Question No EFSA-Q-2013-00354) (7). The claim proposed by the applicant was worded as follows: ‘the flavonoid mixture containing 300 mg of diosmin, 300 mg of troxerutin and 100 mg of hesperidin is a useful co adjuvant in maintaining physiological venous tone’.

  (16)

  On 13 January 2014, 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 a combination of diosmin, troxerutin and hesperidin and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

  (17)

  Following an application from Italsur S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of the barley soup ‘Orzotto’ and protection of blood lipids from oxidative damage (Question No EFSA-Q-2013-00578) (8). The claim proposed by the applicant was worded as follows: ‘contributes to the protection of blood lipids from oxidative damage’.

  (18)

  On 10 January 2014, 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 the barley soup ‘Orzotto’ and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

  (19)

  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

  HAS ADOPTED THIS REGULATION:

  Article 1

  The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.

  Article 2

  This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

  This Regulation shall be binding in its entirety and directly applicable in all Member States.

  Done at Brussels, 17 November 2014.

  For the Commission

  The President

  Jean-Claude JUNCKER
 

ANNEX
Rejected health claims
Application — Relevant provisions of Regulation (EC) No 1924/2006
Nutrient, substance, food or food category
Claim
EFSA opinion reference
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
A combination of Tuscan black cabbage, ‘tri-coloured’ Swiss chard, ‘bi-coloured’ spinach and ‘blu savoy’ cabbage
Contributes to the protection of blood lipids from oxidative damage
Q-2013-00574
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
A combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard
Contributes to the protection of blood lipids from oxidative damage
Q-2013-00575
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
A combination of Tuscan black cabbage, ‘tri-coloured’ Swiss chard, ‘bi-coloured’ spinach and ‘blu savoy’ cabbage
Maintains normal blood cholesterol concentration
Q-2013-00576
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
A combination of red spinach, green spinach, red chicory, green chicory, green leaf chard, red leaf chard, red Swiss chard, golden Swiss chard and white Swiss chard
Maintain normal blood cholesterol concentrations
Q-2013-00579
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
A combination of diosmin, troxerutin and hesperidin
The flavonoid mixture containing 300 mg of diosmin, 300 mg of troxerutin and 100 mg of hesperidin is a useful co adjuvant in maintaining physiological venous-capillary permeability
Q-2013-00353
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
A combination of diosmin, troxerutin and hesperidin
The flavonoid mixture containing 300 mg of diosmin, 300 mg of troxerutin and 100 mg of hesperidin is a useful co adjuvant in maintaining physiological venous tone
Q-2013-00354
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
Barley soup ‘Orzotto’
Contributes to the protection of blood lipids from oxidative damage
Q-2013-00578

 


 


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