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Babytol D3 + DHA Omega for you!

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DHA (docosahexaenoic acid) is an omega-3 fatty acid that plays a key role in the normal visual development of infants, especially during the first year of life, when intensive development of ocular structures and the nervous system occurs. DHA is an important structural component of nervous tissue and the eye and is essential for the proper formation of the visual system in early childhood.

According to regulatory and scientific guidelines of the European Union, the beneficial effect of DHA on normal visual development is achieved with a daily intake of at least 100 mg of DHA. This health claim is based on the assessment of the European Food Safety Authority (EFSA) and has been officially approved through European Commission legislation for nutritional products intended for infants.

DHA is the main structural component of the retina, the photosensitive layer responsible for receiving and processing light signals. The retina consists of multiple layers, including photoreceptors (rods and cones), and DHA accounts for approximately 35–50% of the total fatty acids in photoreceptor membranes. This high proportion of DHA is essential for proper retinal function and efficient transmission of visual signals.

Thanks to its role in the structure of photoreceptors and nerve cells of the eye, DHA contributes to the normal development of vision in infants. Therefore, an adequate daily intake of DHA, in the amount of at least 100 mg, is considered an important nutritional factor during the first year of life.

Source (regulatory health claim):
Commission Regulation (EU) No 440/2011 – Docosahexaenoic acid (DHA) intake contributes to the normal visual development of infants up to 12 months of age; the beneficial effect is obtained with a daily intake of 100 mg of DHA.
https://www.legislation.gov.uk/eur/2011/440/annexes/data.xht?view=snippet&wrap=true 


Vitamin D3 (cholecalciferol) is an essential fat-soluble micronutrient that plays a key role in the normal growth and development of bones in children. Its primary biological function is to contribute to the normal absorption and utilization of calcium and phosphorus from the digestive tract, minerals that are essential for proper mineralization of bone tissue and the formation of a strong skeleton.

Vitamin D3 also affects calcium and phosphorus metabolism through the regulation of parathyroid hormone activity and transport mechanisms in the intestines and kidneys, supporting the maintenance of optimal concentrations of these minerals in the blood and bones. This is particularly important during growth in infants and children, when the skeleton undergoes intensive development and mineralization.

According to available clinical evidence, vitamin D plays a significant role in bone growth and remodeling, as well as in maintaining their strength and structural integrity during childhood. Adequate vitamin D status is associated with better indicators of bone mineralization and a reduced risk of conditions related to vitamin D deficiency.

Source: Vitamin D in pediatric age: Current evidence – PMC free article, Journal of Clinical Medicine.
https://pmc.ncbi.nlm.nih.gov/articles/PMC10060648/ 

Vitamin D3 (cholecalciferol) plays an important role in the normal function of the immune system in children. This vitamin is involved in the regulation of innate and adaptive immune responses and contributes to the proper activity of immune cells, including monocytes, macrophages, and lymphocytes, which are essential for the body’s defense.

According to regulatory approved health claims of the European Union, vitamin D contributes to the normal function of the immune system in children, making this claim officially authorized and based on the scientific evaluation of the European Food Safety Authority (EFSA). This role of vitamin D is particularly important in early childhood, when the immune system is undergoing intensive development.

Scientific evidence shows that an adequate vitamin D status contributes to a normal immune response and that its deficiency is associated with impairments in immune system function in children.

Scientific source (review study):
Martens PJ, Gysemans C, Verstuyf A, Mathieu C. Vitamin D’s Effect on Immune Function. Nutrients, 2020.
https://pmc.ncbi.nlm.nih.gov/articles/PMC7281985/ 

Babytol D3 + DHA Omega is formulated so that one twist-off capsule provides the recommended daily dose of vitamin D3 and DHA omega-3 fatty acid, intended for infants. This form of packaging enables precise dosing without the need to measure drops or adjust the amount.

Twist-off capsules are designed for simple, practical, and hygienic use. The capsule is opened by gently twisting and removing the top part, after which the content can be squeezed directly into the baby’s mouth or onto a spoon. In this way, it is ensured that the baby receives a precisely defined amount of active ingredients every day.

Individually dosed capsules reduce the risk of incorrect dosing and make daily use easier for parents, while preserving the stability and quality of the ingredients until the moment of use.

DHA (docosahexaenoic acid) in the product Babytol D3 + DHA Omega is derived from marine microalgae oil, a natural source of DHA omega-3 fatty acid. Microalgae represent the primary source of DHA in the marine ecosystem, as they are the original producers of this fatty acid, which is then transferred through the food chain.

Microalgae oil is obtained from microalgae cultivated under strictly controlled conditions, enabling a high level of purity and consistent raw material quality. This method of production significantly reduces the risk of contamination with heavy metals, dioxins, and other pollutants that may be present in uncontrolled marine sources.

The safety of DHA derived from microalgae oil for use in infants has been evaluated and confirmed by the European Food Safety Authority (EFSA) as part of the novel food approval process. Based on available scientific evidence, EFSA concluded that DHA from microalgae is a safe source for use in products intended for infants and young children, including products for special nutritional purposes.

Thanks to its controlled origin, high purity, and regulator-confirmed safety, microalgae oil represents a high-quality and reliable source of DHA for supporting the normal development of vision and the nervous system at the earliest stages of life.

Regulatory source (EFSA – Novel Food):
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
Safety of DHA-rich oil from microalgae as a novel food ingredient.
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3843 

DHA omega-3 fatty acid

DHA omega-3 fatty acid

DHA omega-3 contributes to the maintenance of normal visual development in infants and children. Continuous use is recommended up to the age of three.

Vitamin D3 – normal growth and development of bones in children

Vitamin D3 – normal growth and development of bones in children

Vitamin D3 (cholecalciferol) plays a key role in the normal growth and development of bones in children. Its primary function is to contribute to the normal absorption and utilization of calcium and phosphorus, minerals that are essential for proper mineralization of bone tissue during the growth period.

Adequate intake of vitamin D3 enables the maintenance of normal calcium levels in the blood, which is a prerequisite for normal mineralization and development of bones and teeth, as well as for the formation of a healthy skeleton during childhood. Due to intensive growth in early life, vitamin D3 represents an important nutritional factor for supporting proper development of the skeletal system in infants and children.

According to regulatory approved health claims of the European Union, vitamin D contributes to the normal growth and development of bones in children, making this claim officially authorized and based on the scientific evaluation of the European Food Safety Authority (EFSA).

Regulatory source (authorized health claim):
European Commission – EU Register of Nutrition and Health Claims (EFSA evaluation):
Vitamin D contributes to the normal growth and development of bone in children.
https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=search 

The simplest method of administration – twist-off capsule

The simplest method of administration – twist-off capsule

Babytol D3 + DHA Omega uses twist-off capsules that enable simple, precise, and hygienic administration in infants.

The capsule is opened by gently twisting and removing the top part, after which the content is squeezed directly into the baby’s mouth or onto a spoon. This method of administration eliminates the need for measuring drops and reduces the risk of incorrect dosing.

Individually dosed capsules ensure that the baby receives a precisely defined amount of vitamin D3 and DHA every day, in accordance with the recommended daily dose.

Infants on natural and mixed feeding

Infants on natural and mixed feeding

In infants who are breastfed (naturally fed), the intake of certain nutrients may be limited. Breast milk naturally contains low amounts of vitamin D, which is why leading pediatric institutions recommend additional vitamin D intake for breastfed infants.
(According to CDC and the American Academy of Pediatrics)

Vitamin D supplementation in infants is based on recommendations from leading health and pediatric institutions. According to guidelines from the Centers for Disease Control and Prevention (CDC), infants under 12 months of age require 400 IU of vitamin D per day.
These recommendations exist because infant nutrition, including breastfeeding and formula feeding, often does not provide sufficient vitamin D intake without additional supplementation.

The DHA content in breast milk can vary significantly depending on the mother’s diet, as confirmed in European nutritional guidelines. Therefore, DHA is considered an important nutritional factor in early development, especially up to the age of three, when intensive brain and vision maturation occurs. For this reason, EFSA clearly recommends 100 mg of DHA daily for all infants up to three years of age (throughout the full 24 months).
(According to EFSA)

The same dosage is also recommended for infants on mixed feeding according to the Serbian Pediatric Association.
(According to the Serbian Pediatric Association)

Babytol D3 + DHA Omega provides vitamin D3 and DHA omega-3 fatty acid, which are important for the normal development of bones and the visual system in infants and young children. The product is intended for breastfed infants and can be used from the third month of life, in accordance with pediatric advice.

Sources:

Vitamin D | Infant and Toddler Nutrition — CDC
https://www.cdc.gov/infant-toddler-nutrition/vitamins-minerals/vitamin-d.html  

EFSA – DHA and infant nutrition
https://www.efsa.europa.eu/en/efsajournal/pub/3761  

Serbian Pediatric Association
https://www.udruzenjepedijatara.rs/wp-content/uploads/2023/07/AZUR_Definitivno_DHA.pdf 

Milena M.

Unique and high quality, you deserve all the praise for Babytol D3 + DHA and Babytol DHA.

The right thing for all our babies. Thank you 4U pharma.

Milena M.
Babytol D3 + DHA Omega for you! - Klinicke studije

Vitamin D supplementation in infants is based on recommendations from leading health and pediatric institutions. According to guidelines from the Centers for Disease Control and Prevention (CDC), infants under 12 months of age require 400 IU of vitamin D per day.

These recommendations exist because infant nutrition, including breastfeeding and formula feeding, often does not provide sufficient vitamin D intake without additional supplementation.

CDC recommendations are consistent with the positions of the American Academy of Pediatrics (AAP), which states that all infants and children, including adolescents, should have a minimum daily intake of 400 IU of vitamin D, starting soon after birth, to prevent vitamin D deficiency and rickets.

In addition to the CDC, vitamin D supplementation in infants is consistently supported by other leading authorities, including the NIH (Office of Dietary Supplements) and the American Academy of Pediatrics (AAP) in the United States, as well as ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology and Nutrition) in Europe, while EFSA (European Food Safety Authority) provides the scientific framework in the EU for dietary reference values and safe upper intake levels of vitamin D, which form the basis of supplementation recommendations.

Sources:
– Centers for Disease Control and Prevention – Vitamin D for Infants and Toddlers - https://www.cdc.gov/infant-toddler-nutrition/vitamins-minerals/vitamin-d.html 

– Wagner CL, Greer FR. Prevention of rickets and vitamin D deficiency. Pediatrics, 2008. https://pubmed.ncbi.nlm.nih.gov/18977996/ 

– NIH (Office of Dietary Supplements) – Vitamin D Fact Sheet (Health Professional):
https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/ 

ESPGHAN (JPGN, 2013) – “Vitamin D in the Healthy European Paediatric Population”:
https://onlinelibrary.wiley.com/doi/10.1097/MPG.0b013e31828f3c05 

EFSA (EFSA Journal, 2016) – Dietary Reference Values for vitamin D:
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4547 

DHA (docosahexaenoic acid) is an omega-3 fatty acid that is naturally present in the brain and the retina of the eye, which is why it is often highlighted in early life as an important nutrient for the normal development of vision and the brain in infants and young children.

For this reason, relevant authorities such as the European Food Safety Authority (EFSA – European Food Safety Authority) state that the goal is for infants and young children to have an intake of 100 mg of DHA per day up to the age of three (more precisely, up to the end of the 24th month of life).

Sources:

- EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific Opinion on Dietary Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans fatty acids, and cholesterol. EFSA J [Internet]. 2010 [cited 2026 Feb 6]. Available from: https://www.efsa.europa.eu/en/efsajournal/pub/1461 

- Food and Agriculture Organization of the United Nations; World Health Organization. Fats and fatty acids in human nutrition: Report of an expert consultation [Internet]. 2010 [cited 2026 Feb 6]. Available from: https://www.fao.org/fileadmin/user_upload/nutrition/docs/requirements/fatsandfattacidsreport.pdf 

Early and regular provision of DHA in the first two to three years is important because this is the period when the structures of the brain and vision develop most intensively, and the quality of fatty acid intake at that time can have a “long-term impact” on development. In addition, omega-3 fatty acids (such as DHA) are involved in processes that help regulate and resolve inflammatory responses, which is why they are often considered in the context of a more balanced immune response.

Sources:

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific Opinion on the substantiation of a health claim related to docosahexaenoic acid (DHA) and contribution to normal brain development pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA J [Internet]. 2014;12(10):3840 [cited 2026 Feb 6]. Available from: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3840.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). DHA and ARA and visual development – Scientific substantiation of a health claim related to docosahexaenoic acid (DHA) and arachidonic acid (ARA) and visual development pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA J [Internet]. 2009 [cited 2026 Feb 6]. Available from: https://www.efsa.europa.eu/en/efsajournal/pub/941.htm.

Serhan CN, Back M, Chiurchiù V, Hersberger M, Mittendorfer B, Calder PC, et al. Expert consensus report on lipid mediators: role in resolution of inflammation. FASEB J [Internet]. 2024 [cited 2026 Feb 6]. Available from: https://faseb.onlinelibrary.wiley.com/doi/10.1096/fj.202400619R.

Please note that the referenced clinical studies and scientific sources relate to individual product ingredients and their effects, not to the product as a whole.

Babytol D3 + DHA Omega for you! - Klinicke studije

After your baby is 3 months old, Babytol D3 + DHA Omega is recommended, as it contains DHA and vitamin D3, essential for your baby until the age of 3. 

For children up to the age of three, we recommend replacing omega-3 fatty acids with our products for the youngest - Babytol D3 + DHA during the autumn and winter months, and during the spring and summer, Babytol DHA.  

For children up to the age of three, we recommend replacing omega-3 fatty acids with our products for the youngest - Babytol D3 + DHA during the autumn and winter months (October-March), and during the spring and summer (April-September) Babytol DHA.  

DHA omega-3 fatty acid is an important structural component of the nerve cells of the brain and retina of the eye. DHA accounts for 97% of all omega-3 fatty acids in the brain and 93% of all omega-3 fatty acids in the retina of the eye. Brain growth and development in a child is most intense in the last trimester of pregnancy (brain grows 260%) and the first year of life (brain grows 175%). 

DHA omega-3 fatty acid at a dose of 100mg per day is of great importance for normal vision development in infants up to 12 months. 

The recommended dose of vitamin D3 for all newborns is 400 IU and is mandatory from the second week until the age of one year. 

This recommended dose is contained in one twist – off capsule of Babytol D3 + DHA Omega. 

Children in the second year until adolescence are advised to use vitamin D3 in the winter months (from October to March). 

In order to provide the required amount of DHA omega-3 through breastfeeding, nursing mothers should consume 250-300 g of ‘blue’ sea fish (mackerel, sardines, sprat, herring, tuna) per week. Statistics have shown that mothers in Europe consume several times less than the recommended intake. One of the reasons is the eating habit (less than two servings of oily fish per week), and the other reason is dietary restrictions due to contamination with heavy metals (lead, mercury) in oily fish. 

If the diet is not balanced, the breastfeeding woman can provide the required amount of DHA omega-3 through milk if she takes 200mg of DHA per day.