EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10121/2014 Rev. 1 ANNEX 
CIS (POOL/E4/2014/10121/10121R1-
EN ANNEX CIS.doc) 
[…](2014) XXX  draft 
ANNEXES 1 to 2 
  
ANNEXES 
to the 
COMMISSION REGULATION (EU) No …/.. 
 
authorising and refusing to authorise certain health claims made on foods and referring 
to the reduction of disease risk. 
  
EN 2   EN ANNEX I  
Permitted health claims  
Application – 
Relevant 
provisions of 
Regulation 
(EC) No 
1924/2006 Applicant – Address Nutrient, 
substance, 
food or food 
category Claim Conditions of use of the claim Conditions 
and/or 
restrictions of 
use of the food 
and/or 
additional 
statement or 
warning EFSA opinion 
reference 
Article 
14(1)(a) 
health claim referring to a reduction of a 
disease risk Abtei Pharma Vertriebs 
GmbH, Abtei 1, 37696, 
Marienműnster, 
Germany.  Calcium  Calcium helps to 
reduce the loss of 
bone mineral in post-menopausal women. Low bone mineral density is a risk factor 
in the development of 
osteoporotic bone 
fractures  The claim may be used only for food 
which provides at least 400 mg of 
calcium per quantified portion. 
Information shall be given to the 
consumer that the claim is specifically intended for women 50 years and older and the beneficial effect is obtained with a daily intake of at least 1200 mg of calcium from all sources. For foods with 
added calcium 
the claim may be used only for those targeting women 50 years and older  Q-2008-721 
Q- 2009-00940  
Article 
14(1)(a) 
health claim referring to a 
reduction of a 
disease risk Abtei Pharma Vertriebs 
GmbH, Abtei 1, 37696, 
Marienműnster, 
Germany. Calcium and 
vitamin D  Calcium and vitamin 
D help to reduce the 
loss of bone mineral in post-menopausal 
women. Low bone 
mineral density is a risk factor in the development of osteoporotic bone fractures  The claim may be used only for food 
supplements which provide at least 
400 mg of calcium and 15 μg of 
vitamin D per daily portion  
Information shall be given to the 
consumer that the claim is specifically 
intended for women 50 years and older 
and the beneficial effect is obtained with a daily intake of at least 1200 mg of calcium and 20 μg of vitamin D 
from all sources. For food 
supplements 
with added calcium and/or 
vitamin D the 
claim may be used only for those targeting women 50 years and older  Q-2008-721 
Q- 2009-00940   
EN 3   EN Article 
14(1)(a) 
health claim referring to a 
reduction of a 
disease risk DSM Nutritional 
Products Europe AG, 
P.O. Box 2676, 4002 
Basel, Switzerland. Vitamin D Vitamin D helps to 
reduce the risk of 
falling, which is 
positively 
associated 
with postural instability and muscle weakness
. 
Falling is a risk factor 
for bone fractures 
among men and women 60 years of 
age and older.
 The claim may be used only for food 
supplements which provide 15 μg of 
vitamin D per daily portion 
Information shall be given to the 
consumer that the beneficial effect is obtained with a daily intake of 20 μg 
of vitamin D from all sources. For food 
supplements 
with added vitamin D the 
claim may be 
used only for those targeting men and women 60 years and 
older  Q-2010-01233  
EN 4   EN ANNEX II  
Rejected health claims  
Application – Relevant provisions of 
Regulation (EC) No 1924/2006 Nutrient, substance, food or 
food category Claim EFSA opinion reference 
Article 14(1)(a) health claim referring 
to a reduction of a disease risk Glucosamine hydrocloride Slowi ng down/reduce the destruction 
process of cartilage of the musculoskeletal 
system and consequently reduce the risk of 
osteoarthritis.  Q-2009-00412 
Article 14(1)(a) health claim referring 
to a reduction of a disease risk Isolated soy protein Protein-rich soybean component has been 
shown to lower/redu ce blood cholesterol; 
blood cholesterol lowering may reduce the 
risk of (coronary) heart disease. Q-2011-00784 
Article 14(1)(a) health claim referring 
to a reduction of a disease risk Plant sterols in combination with 
Cholesternorm®mix Actively lowers cholesterol.  Q-2009-00237 
Q-2011-01114 
Article 14(1)(a) health claim referring 
to a reduction of a disease risk Eicosapentanoic acid (EPA) EPA has been shown to reduce the AA/EPA 
ratio in blood. A high AA/EPA level is a 
risk factor in the development of attention difficulties in children with ADHD-like symptoms. These children are also characterised by less hy peractivity and/or 
coexisting oppositional behaviour. Q-2012-00573 
Article 14(1)(a) health claim referring 
to a reduction of a disease risk Plant stanols (as plant stanol 
esters) Consuming 2 g/day plant stanols (as plant 
stanol esters) as part  of a diet low in 
saturated fat results in a 2-fold greater reduction in LDL-cholesterol than consuming a low saturated fat diet alone. High cholesterol is a risk factor in the 
development of coronary heart disease. Q-2012-00915