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1 A-Bregenz, To Romanian authorities / to whom it may concern, Römerstrasse 2,, Austria, hereby informs. Fertilovit F 35 plus Dietary supplement with 800 µg folic acid, B-vitamins, iron, iodine and coenzyme Q10. Sustained vitamin C release. What is Fertilovit F 35 plus? Fertilovit F 35 plus is a dietary supplement specifically designed to meet the requirements of mature women who wish to conceive, but also for women younger than 35 who which to conceive. It provides complete preconceptional vitamin, antioxidant and mitochondrial health support. Folic acid is one of the B-vitamins and is abundant in fruits and vegetables. However, it is very sensitive to heat and light. Because of its importance for cell division and growth, as well as blood formation, women planning for pregnancy are recommended to supplement it. Other B-vitamins such as vitamins B6 and B12 are important for cell division and a healthy homocysteine metabolism. Pantothenic acid contributes to the healthy metabolism of steroid hormones to which the sex hormones belong, too. Other vital substances such as iron, iodine and antioxidants play an important role in supporting the body during preconception and early pregnancy as well. While iron is essential for the transport of oxygen in the blood and iodine contributes to healthy thyroid function, antioxidants like vitamin E and C protect DNA, proteins and lipids of cells from oxidative stress. For optimal effect Fertilovit F 35 plus contains vitamin C with sustained release. Oxidative stress The term oxidative stress refers to the impairment of body cells by reactive oxygen species (ROS). Normally, the ROS produced in the body are defanged by the body s protective antioxidant system. However, if there are too many ROS or too few antioxidants, this delicate balance can collapse and body cells are damaged. Oocytes are particularly susceptible to attacks by reactive oxygen species and oxidative stress is also thought to be involved in agerelated fertility decline. Living in a time in which professional demands force women to delay their desire for children, this finding is particularly important. Coenzyme Q10 Mature women planning for pregnancy benefit from mitochondrial nutrients such as coenzyme Q10. This micronutrient is involved in energy production in the mitochondria, cellular organells which are particularly abundant in oocytes. This doesn t come as a surprise, as oocytes need plenty of energy during their maturation and for early pregnancy. The preconceptional supplement Fertilovit F 35 plus has been designed taking into account these latest findings. In addition to a wide variety of important vitamins and minerals 55

2 it also contains coenzyme Q10 for mitochondrial health as well as ample antioxidants. For maximal protection around the clock, vitamin C, one of the body s major antioxidants, is released in delayed fashion. Administration form: Capsules Packaging sizes (Net quantity): 30 capsules (17.2 g) The composition of Fertilovit F 35 plus corresponds to the special requirements of mature women planning for pregnancy, but also is very well suited for women younger than 35 who which to conceive. Supplement facts: Daily dose (1 % NRV* capsule) Vitamin C 100 mg 125 Vitamin E 20 mg 166 Vitamin B1 3 mg 272 Vitamin B2 3 mg 214 Pantothenic acid 12 mg 200 Vitamin B6 4 mg 285 Vitamin B12 7 µg 280 Folic acid 800 µg 400 Vitamin D 5 µg 100 Niacin 35 mg 218 Biotin 200 µg 400 Zinc 5 mg 50 Magnesium 100 mg 26 Iron 7.5 mg 54 Iodine 150 µg 100 Coenzyme Q10 35 mg - *Percentage of Nutrition Reference Values (according to regulation 1169/2011/EU) Fertilovit F 35 plus contains neither lactose, gluten, nor gelatine. Directions: For best results, experts recommend to start taking a supplement about three months prior to conception. Take one capsule Fertilovit F 35 plus plus per day. Please read the instructions prior to use. Do not exceed the recommended dosage. Store Fertilovit F 35 plus out of the reach of little children. A dietary supplement cannot and must not replace a healthy lifestyle and a balanced diet. 55

3 Scientifically Proven Effects of the Ingredients Vitamin C Vitamin C is a water soluble antioxidant and protects the body s cells as well as fat soluble vitamins like E from oxidative stress. Studies have revealed that oxidative stress worsens autoimmune thyroiditis and that patients benefit from taking antioxidants. Vitamin C is also important because it helps absorb iron. However, women should avoid high doses of vitamin C because it can dry up cervical fluid, preventing sperm from reaching the egg. This is why the Fertilovit F 35 plus of supplements feature a relatively low dose of vitamin C. To make the most of its vitamin C content, it is released in a sustained manner, providing its positive effect for many hours. Zinc Zinc is one of the essential trace minerals, which means that the body cannot produce it itself, but it has to be supplied via the diet. It has been found that zinc deficiencies are quite frequent even in western countries, which might be due to the fact that the body is not able to store zinc. Yet zinc plays a crucial role in the metabolism of carbohydrates, fats and proteins alike. In addition to that the immune and hormone systems as well as important antioxidative enzymes need zinc for their work. Furthermore it is crucial for the synthesis of the nucleic acids DNA and RNA, which are essential during cell division, tissue repair and embryo development. Last not least, zinc is needed for thyroid hormone metabolism. Vitamin E (D-alpha-tocopheryl acetate) Vitamins E s anti-oxidative properties promote oocyte health by effectively protecting these sensitive cells from the harmful impact of oxidative stress. Niacin Niacin belongs to the vitamins of the B-complex. It is present in every living cell and can be stored in the liver. It forms a vital building block of various coenzymes and is involved in key processes of metabolism. Additionally it has antioxidative properties. Vitamin B1 Thiamin or vitamin B1 is a water-soluble vitamin essential for the nervous system. Vitamin B2 Vitamin B2 or riboflavin has been called growth vitamin in colloquial language. It is an important precursor for coenzymes, thus playing a central role in metabolism. Vitamin B5 Vitamin B5 or pantothenic acid is necessary for the formation of coenzyme A. Coenzyme A plays a major role in the metabolism. It is involved in synthesis and breakdown of carbohydrates, fats and proteins and is crucial for the production of cholesterol. Cholesterol is needed for the synthesis of steroid hormones, many of which are essential for reproduction. Vitamin B6 Vitamin B6 has traditionally been used for easing the symptoms of premenstrual syndrome and menopause. Recent research has revealed its importance for reproductive wellness. This effect is mediated by vitamin B6 s involvement in the homocysteine pathway. 55

4 Homocysteine is a potentially harmful amino acid and vitamin B6 is needed for its breakdown into other, harmless molecules. Vitamin B6 deficiency has been associated with hyperhomocysteinemia, which impairs fertility and placenta performance. Vitamin B12 Recent research has shown that vitamin B12 supplementation may promote fertility and decrease the risk for miscarriage. Like vitamin B6 it is needed for the degradation of homocysteine. A recent study from 2006 has shown that patients with autoimmune thyroiditis have an increased risk of vitamin B12 deficiency. Vitamin D3 Among others vitamin D3 is important for the calcium and phosphate metabolism, thus being essential for bone growth. Furthermore it is needed for the development and performance of the nervous and muscle systems. Folic acid Folic acid is very delicate and easily destroyed during storage and cooking, which is why deficiencies are quite common even though fruit and vegetables are rich in folic acid. Folic acid deficiency has been associated with neurological disorders such as spina bifida (split spine). In addition to that it has antioxidative properties. Finally, folic acid is vital for the homocysteine pathway. Homocysteine is a potentially toxic amino acid, yet can be broken down into harmless molecules with the aid of folic acid, vitamin B6 and vitamin B12. A rise in homocysteine levels is known to be associated with infertility, impairment of placenta function and even increased risk of miscarriage. Biotin Biotin belongs to the vitamin B-complex. It is a constituent of enzymes and as such is involved in key pathways of the metabolism. It is known that it is also involved in the epigenetic regulation of gene function. Animal studies have found evidence that biotin deficiency is associated with a decline of fertility and an increase of malformation risk. Magnesium Magnesium deficiency is not uncommon during pregnancy. This is due to an increase in magnesium excretion on the one hand and elevated magnesium needs of the baby on the other hand. A first symptom of magnesium deficiency may be cramps in the calf, but may also involve muscular hyperexcitability of uterus muscle. Worst possible consequence of this is premature labour. Iron Iron, being a major constituent of hemoglobin, is considered essential as a blood building nutrient. It is also needed for normal hormone metabolism of the thyroid gland. Thyroid hypofunction, however, has frequently been found to be associated with reduced iron absorption, leading to an increased risk of iron deficiency. Women with iron deficiency have an elevated risk of impaired fertility. In addition to that experts recommend to check iron levels when planning for conception, because the need for iron rises considerably during pregnancy. 55

5 Coenzyme Q10 Of all the body s cells the oocytes have by far the most mitochondria. This does not come as a surprise, because the mitochondria are the cells power plants responsible for energy production. Coenzyme Q10 (CoQ10) is a micronutrient involved in energy production in the mitochondria and has been shown to promote mitochondrial health. For quite some time there seemed to be no evidence suggesting a need for coenzyme Q10 supplementation. However, recent research has revealed that coenzyme Q10 levels can drop considerably with increasing age. Iodine Iodine is very important for healthy thyroid function. The thyroid gland produces hormones that are key regulators of growth processes and metabolism. Therefore it is essential that mothers-to-be have a sufficient supply of iodine to support not only themselves but also the baby. Even though in areas of iodine deficiency like Austria, Switzerland and Germany certain foods are enriched in iodine, iodine supply is still not sufficient for the needs of a mother-to-be. Contrary to that, women with autoimmune thyroiditis (e.g. Hashimoto's thyroiditis) are supposed to avoid iodine exposure, because excess iodine has been shown to worsen the symptoms of the disease. Hence, fertility vitamins for these patients have to be free of iodine. Contra-indications Women who suffer from autoimmune thyroiditis, have issues with your iron metabolism or have a known intolerance to any of the ingredients should not consume Fertilovit F 35 plus. Representative bibliography Vitamin C - Contributes to normal energy metabolism: EFSA 2009; 7(9):1226 ; 2010;8(10): Contributes to normal function of the immune system: EFSA 2009; 7(9):1226 ; 2010;8(10): Contributes to protecting cells from oxidative stress: EFSA 2009; 7(9):1226 ; 2010;8(10): Contributes to collagen formation - Vital for iron metabolism (transferrin -> ferritin) - Henmi et al showed 2003 in a controlled randomized study that women taking 750 mg ascorbic acid per day had higher progesterone levels and higher pregnancy rates - Antioxidants like vitamin C are particularly important for active and passive smokers (Alberg et al, 2002, Dietrich et al, 2003). - Women with total vitamin C intakes of <10th percentile preconceptionally have twice the risk of preterm delivery because of premature rupture of the membranes (Siega- Riz et al, 2003) - In patients with a luteal phase defect supplementation of vitamin C leads to higher pregnancy rates (Henmi et al, 2003) Vitamin E - Contributes to protecting cells from oxidative stress: EFSA 2010;8(10):

6 - particularly folic acid, vitamin B6, vitamin C, vitamin D, vitamin E, iodine, selenium, iron,... might have a positive impact on infertility treatment (Buhling and Graejecki, 2013) Vitamin D - vitamin D deficiency has been linked to infertility and pregnancy loss (Lerchbaum et al, 2012) - Contributes to normal function of the immune system: EFSA 2010; 8(2): Has a role in cell division: EFSA 2009; 7(9):1227 Vitamin B1 (Thiamine) - Contributes to normal energy metabolism: EFSA 2009; 7(9): Contributes to normal heart action: EFSA 2009; 7(9):1222 Vitamin B2 (Riboflavin) - Contributes to normal energy metabolism: EFSA 2010;8(10): Contributes to maintenance of normal red blood cells: EFSA 2010;8(10): Contributes to protecting cells from oxidative stress: EFSA 2010;8(10):1814 Vitamin B3 (Niacin) - Contributes to normal energy metabolism: EFSA 2009; 7(9):1224; 2010;8(10):1757 Vitamin B5 (Pantothenic acid) - Contributes to normal energy metabolism: EFSA 2009; 7(9): Contributes to normal synthesis and metabolism of steroid hormones, vitamin D and some neurotransmitters: EFSA 2009; 7(9):1218 Vitamin B6 (Pyridoxine) - Contributes to normal energy metabolism: EFSA 2010;8(10): Contributes to normal homocysteine metabolism: EFSA 2010;8(10): Contributes to normal red blood cell formation: EFSA 2009; 7(9): Contributes to normal function of the immune system: EFSA 2009; 7(9): Contributes to regulation of hormone action: EFSA 2009; 7(9): Used in traditional medicine for relief of premenstrual syndrome, menopausal symptomes and for fertility improvement. - Deficiency of vitamin B6 has been linked to decreased conception rates and an increased risk of early miscarriage (Ronnenberg et al, 2007) Biotin - Contributes to normal energy metabolism: EFSA 2009; 7(9):1209 Folic acid - Contributes to growth of maternal tissue during pregnancy: EFSA 2009; 7(9): Contributes to normal blood formation: EFSA 2009; 7(9): Contributes to normal homocysteine metabolism: EFSA 2009; 7(9): Contributes to normal function of the immune system: EFSA 2009; 7(9): Has a role in cell division: EFSA : 2009; 7(9):1213 ; 2010;8(10):

7 - A diet high in synthetic folate may be associated with increased progesterone levels and lower risk of sporadic anovulation (Gaskins et al, 2012) - Important for healthy neural tube development - Supplementation during fertility treatment improves oocyte quality (Szymanski et al, 2003) Vitamin B12 (Cobalamin) - Contributes to normal energy metabolism: EFSA 2009; 7(9): Contributes to normal homocysteine metabolism: EFSA 2010;8(10): Contributes to normal formation of red blood cells: EFSA 2009; 7(9): Contributes to normal function of the immune system: EFSA 2009; 7(9): Has a role in cell division: EFSA 2009; 7(9):1223; 2010;8(10): Deficiencies are frequently found in vegetarians - In 2001, Bennet et al found that patients (n=14) with vitamin B12 deficiency often suffer from from subfertility and miscarriage. Supplementing the vitamin resulted in a rise in pregnancy rate and a fall in miscarriage rate - Molloy et al (2008) showed that low B12 levels in early pregnancy are linked to an increased risk of spina bifida (split spine) Zinc - Contributes to normal DNA-synthesis: EFSA 2010;8(10): Contributes to normal fertility and reproduction: EFSA 2009; 7(9): Contributes to normal function of the immune system: EFSA 2009; 7(9): Contributes to protecting cells from oxidative stress: EFSA 2009; 7(9): Has a role in cell division: EFSA 2009; 7(9):1229 Magnesium - Contributes to normal energy metabolism: EFSA 2009; 7(9): Has a role in cell division: EFSA 2009; 7(9): Pregnancy is associated with an increased risk for deficiency due to an increased demand and an increase of up to 25 % in excretion - Deficiency symptoms include muscular hyperexcitability, which in pregnancy might lead to premature labor - Therefore supplementation of magnesium is recommended from 16 gestational week - Dose is important: Studies show (e.g.fine et al, 1991) that only 35 % from 120 mg are resorbed by the body and when taking a higher dose of 360 mg this is even reduced to 18 % Iron - Contributes to normal energy metabolism: EFSA 2009; 7(9):1215; 2010;8(10): Contributes to normal to normal hemoglobin and red blood cell formation: EFSA 2009; 7(9):1215; 2010;8(10): Contributes to normal transport of oxygen in the human body: EFSA 2009; 7(9):1215; 2010;8(10): Contributes to normal function of the immune system: EFSA 2009; 7(9): Contributes to reduction of tiredness: EFSA 2010;8(10): Has a role in cell division: EFSA 2009; 7(9): Consumption of iron supplements and nonheme iron from other sources may decrease the risk of ovulatory infertility (Chavarro et al 2006) 55

8 - During pregnancy demand doubles from 15 mg to 30 mg - Women with iron deficiency have decreased fertility (Rushton et al, 1991) Coenzyme Q10 - Antioxidant - Tissue concentration is 5 10 x higher than vitamin E (Bentinger et al, 2007) - Important for ATP-synthesis in the mitochondria (Mitchell, 1975, Santos-Ocana, 2002) - Effective ATP production is required for oocyte maturation and early stages of embryonic development (Jansen etal, 1998) - Tissue concentration of coenzyme Q10 declines with age (Pignatti et al, 1980) - When supplementing coenzyme Q10, the majority is detected in adrenal gland and ovary ( Bentiger et al, 2008) Iodine - Contributes to normal energy metabolism: EFSA 2009; 7(9):1214; 2010;8(10): Contributes to normal thyroid function and normal thyroid hormone synthesis: EFSA 2009; 7(9):1214; 2010;8(10): Mothers to be are recommended to have full stores, as the child will cause an increased demand Dr. Daniel Matthes, Regulatory Affairs 55