2077.pdf

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Scientific Opinion on the substantiation of health claims related to vitamins, minerals and omega-3 fatty acids (ID 1, 2, 3, 4, 5, 7, 10, 11, 12, 111, 112, 168, 173, 174, 179, 184, 201, 210, 217, 362, 372, 717, 1464, 1515, 2872, 2874, 3094, 3095, 4279, 4280, 4281, 4282, 4284, 4285, 4286, 4287, 4289, 4291, 4292, 4708) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Vitamins   health claims   minerals   omega-3-fatty acids  
ID:    4708      168      362      1515      173      174      111      112      179      372      4279      1464      184      2872      4280      4281      4282      2874      4284      4285      4286      4287      4289      1      2      4291      3      4292      4      5      7      201      10      11      12      717      210      3094      3095      217  
Produkty: Chrom, niacyna   #EN:Vitamin B12 and folate   #EN:Mix of vitamins B : B1, B2, B5, B6, B8, B9, B12, PP   Kwas foliowy, witamina B12, Witamina B6   Beta-karoten, wiamina E, witamina C   Witaminy i minerały   #EN:B vitamins (Riboflavin (B2), Niacin, Pyridoxine (B6), vitamin B12, Biotin, Pantothenic Acid, Folic Acid), vitamin C, calcium, magnesium and zinc   Witaminy   #EN:Multivitamin-mineral products   Witamina C, selen, witamina E   #EN:Vitamins, minerals, trace elements and omega-3 fatty acids (incl. DHA) (Pharmaton Matruelle)   #EN:Vitamines du groupe B : B-group vitamins (especially vitamin B5 and vitamin B8)   #EN:Vitamins, in general   #EN:Group B vitamins   #EN:Magnesium, vitamine C   #EN:Magnesium, vitamine B1, vitamine C   Cynk, witamina C, witamina E, beta-karoten, miedź   #EN:Vitamine C, vitamine E, beta-carotene   #EN:Vitamine C, vitamine E, bêta-carotène   Kwas foliowy, witamina B12   Składniki mineralne   #EN:Mix of vitamins B: B1, B6, B9, B12,PP   Witamina E, selen   #EN:Mix of vitamins B1,B6, B9, B12,PP   #EN:Mix of vitamins B : B5, B8   Wszystkie witaminy, minerały i składniki śladowe   #EN:Vitamins B1, B2, PP and magnesium   #EN:Vitamin C,E,A(Beta Carotene), and Zinc  

1. Charakterystyka żywności / składnika

The food constituents that are the subject of the health claims are vitamins and minerals, and for IDs 7, 717 and 3094 also omega-3 fatty acids, all of which are well recognised nutrients. These nutrients are measurable in foods by established methods.
Vitamins and minerals are authorised for addition to foods and for use in food supplements (Annex I of Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to vitamins and minerals naturally present in foods and those forms authorised for addition to foods and for use in food supplements (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The main dietary omega-3 fatty acids are alpha-linolenic acid (ALA) and long-chain omega-3 polyunsaturated fatty acids, mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EFSA, 2005).
The Panel considers that the food constituents, vitamins, minerals and omega-3 fatty acids, which are the subject of the health claims, are sufficiently characterised in relation to the claimed effects.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Suplementacja multiwitamin w celu podtrzymania witalności podczas starzenia się (ID 4)

2.2. Rozwój (ID 217)

For IDs 4 and 217 the claimed effects are “multivitamin supplementation to sustain vitality while aging”, and “development”. The claimed effects are not sufficiently defined, and no further details were given in the wordings or the clarifications provided by Member States which could be used to define the claimed effect. The Panel considers that the claims are general and non-specific, and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

2.3. Dostarczanie witamin i minerałów podczas ciąży i karmienia piersią (ID 5)

For ID 5 the claimed effect is “vitamins and minerals during pregnancy and lactation”. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the supply of vitamins and minerals to the body during pregnancy and lactation. The Panel considers that the claimed effect refers to the supply of a food constituent to the human body, rather than to a relationship between a food/food constituent and health as required by Regulation (EC) No 1924/2006.
For IDs 1, 2, 3, 7, 10, 11, 12, 111, 112, 168, 173, 174, 179, 184, 201, 210, 362, 372, 717, 1464, 1515, 2872, 2874, 3094, 3095, 4279, 4280, 4281, 4282, 4284, 4285, 4286, 4287, 4289, 4291, 4292 and 4708 the claimed effects refer to contribution to normal macronutrient and energy-yielding metabolism (ID 1, 184, 362, 4284, 4291, 4292), contribution to normal synthesis of nucleic acids (ID 1), contribution to normal collagen synthesis (ID 1), protection of DNA, proteins and lipids from oxidative damage (ID 1, 2872, 4285, 4286, 4287, 4289), contribution to normal conception and reproduction (ID 2, 3), normal tissue growth during pregnancy (ID 7, 717, 3094, 3095), contribution to the maintenance or achievement of a normal body weight (ID 12, 4708), contribution to normal homocysteine metabolism (ID 112), maintenance of normal vision (ID 168, 179, 201, 372, 1464), maintenance of normal bone (ID 111, 173, 210), maintenance of normal teeth (ID 173), maintenance of normal skin (ID 174), maintenance of normal hair (ID 174, 2874, 4282), maintenance of normal nails (ID 174, 2874, 4282), contribution to normal psychological functions (ID 10, 11, 1515, 4279, 4280, 4281), and reduction of tiredness and fatigue (ID 4279). The Panel considers that the target population is the general population.
Essential nutrients, including vitamins and minerals, are needed by the human body to maintain normal physiological functions. Individual vitamins, minerals and omega-3 fatty acids have various and different metabolic roles.
Claims on the role of individual vitamins and minerals (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009a, 2009b, 2009c, 2009d, 2009e, 2009f, 2009g, 2009h, 2009i, 2009j, 2009k, 2009l, 2009m, 2009n, 2009o, 2009p, 2009q, 2009r, 2009s, 2009t, 2009u, 2010s, 2010w, 2010a, 2010b, 2010c, 2010d, 2010e, 2010f, 2010g, 2010h, 2010i, 2010j, 2010k, 2010l, 2010m, 2010n, 2010o, 2010p, 2010q, 2010r, 2010v, 2010t, 2010u, 2011b, 2011c, 2011a) and of omega-3 fatty acids (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009v, 2009w, 2010x, 2010y, 2010z, 2011d, 2011e) on various body functions have already been evaluated in previous opinions.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituents, vitamins, minerals and omega-3 fatty acids, which are the subject of the health claims, are sufficiently characterised in relation to the claimed effects.
For IDs 4 and 217 the claimed effects are “multivitamin supplementation to sustain vitality while aging”, and “development”. The claims are general and non-specific, and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
For ID 5 the claimed effect is “vitamins and minerals during pregnancy and lactation”. The claimed effect refers to the supply of a food constituent to the human body, rather than to a relationship between a food/food constituent and health as required by Regulation (EC) No 1924/2006.
For IDs 1, 2, 3, 7, 10, 11, 12, 111, 112, 168, 173, 174, 179, 184, 201, 210, 362, 372, 717, 1464, 1515, 2872, 2874, 3094, 3095, 4279, 4280, 4281, 4282, 4284, 4285, 4286, 4287, 4289, 4291, 4292 and 4708 the claimed effects refer to several distinct physiological functions. The target population is assumed to be the general population. Claims on the role of individual
vitamins, minerals and omega-3 fatty acids on various body functions have already been evaluated in previous opinions.