Plate VII.
In plain words
One capsule, for before and during pregnancy.
Oprega is a food supplement for women planning a pregnancy or already pregnant. It is built around two nutrients whose importance in pregnancy is settled science and is recognised in European law: folate and DHA.
Oprega
Capsule, 30
Eighteen nutrients in one capsule, built on 200 mg of DHA from fish oil, 400 micrograms of folate as calcium L-methylfolate, 19 mg of iron and 150 micrograms of iodine.
How many, and when
One capsule daily. A food supplement is not a substitute for a varied and balanced diet.
What these will not do
This does not replace antenatal care and it does not replace anything your doctor or midwife has prescribed. Start folate before conception if you can, because the window it matters most in closes early, often before a pregnancy is confirmed. And tell whoever is looking after your pregnancy what you are taking, so that nothing is doubled up. Iron and iodine in particular are worth them knowing about.
00 / Pregnancy and hormonal change
The one place
the law says yes.
Every other page on this site is partly a list of things we are not permitted to tell you. This one is different. Pregnancy is the single area of European food law where the highest tier of health claim exists, authorised one at a time by the Commission after a full scientific dossier. There are only a few dozen in the world. Two of them belong to this capsule.
01 / Two tiers
Not all claims are the same size.
The claims used elsewhere on this site come from a single Annex of roughly 250 sentences, published in 2012 and available to anyone whose product contains enough of the nutrient. Article 14 is a different instrument. It covers the two things an ordinary claim may never touch: the reduction of a disease risk, and the development and health of children. Each one required its own application, its own scientific opinion and its own Commission Regulation.
So this page is worth reading closely. When a company can quote an Article 14 claim it is quoting something a regulator wrote after reading the evidence. When it cannot, no amount of careful wording is a substitute for one.
02 / What the capsule may say
Two hundred milligrams, and what it buys.
One capsule provides 200 mg of DHA. That figure is not a formulation preference. It is the exact threshold written into the conditions of use for the two strongest claims European law offers this category, and Oprega meets it. We do not print those two here, for a reason set out in the next section. What we print is the general claim, which holds in every market we sell in.
DHA contributes to the maintenance of normal brain function
DHA contributes to the maintenance of normal vision
Both are conditioned on at least 40 mg of DHA per 100 g and per 100 kcal. A 200 mg capsule clears that several times over.
Oprega
Capsule · 30 · one daily
Eighteen nutrients in one capsule, built around 200 mg of DHA from fish oil, 400 mcg of calcium L-methylfolate, 19 mg of iron and 150 mcg of iodine. For women planning a pregnancy, pregnant, or breastfeeding.
Contains fish. A food supplement is not a substitute for a varied and balanced diet and a healthy lifestyle.
03 / Why the strongest claims are not here
Five countries, one set of words.
European law has a higher tier of claim, Article 14, covering the reduction of a disease risk and the development and health of children. Two of them fit this capsule exactly, and Oprega meets the 200 mg condition both of them turn on. We do not use them, and the reason is not European.
This page is read in five countries. Georgia requires prior authorisation from its Ministry of Health before an Article 14 claim may be used, and we do not hold one. India removed disease risk reduction claims for supplements outright on 1 April 2022. Uzbekistan prohibits any advertising that creates the impression of therapeutic properties, and has no positive list to shelter behind.
So a sentence that is lawful in Warsaw is unauthorised in Tbilisi and unlawful in Tashkent. We could publish five different pages. We would rather publish one, written to whichever market is strictest on each point, and leave the strongest claim we own in the file until it can be made everywhere.
There is a third, and that one we could not use even in Europe.
The best known claim in this category is an Article 14 claim about maternal folate status and a risk in early development. We are not going to reproduce it here. Quoting a claim beside the product is making it, and in two of our five markets naming that condition in supplement advertising is prohibited outright.
Its condition of use is a single line: the claim may be used only for food supplements which provide at least 400 micrograms of folic acid per daily portion. Oprega provides 400 micrograms of calcium L-methylfolate, which is a different substance and, once the arithmetic is done, a smaller amount.
European law lists folic acid and calcium L-methylfolate as two separate entries in the same Annex, so they are not interchangeable in a condition written in one of them. And 400 micrograms of the calcium salt carries roughly 369 micrograms of methylfolate, which corresponds to about 355 micrograms of folic acid on a molar basis. The threshold is 400. We are short of it, and we are short of a substance the capsule does not contain.
We could argue the point. It is untested in published European material and practice across the industry is inconsistent. We would rather change the capsule than win an argument about it, so the formulation is under review and this page makes no claim of that kind in the meantime.
04 / What the capsule does carry
Eighteen nutrients, and the ones that earn a sentence.
A claim may be made for a nutrient only where the product supplies at least fifteen per cent of the European reference value for it. Every nutrient in this formulation clears that. These are the entries that matter most for this reader, quoted as authorised.
Folate contributes to maternal tissue growth during pregnancy
Folate has a role in the process of cell division
Iron contributes to the reduction of tiredness and fatigue
Vitamin C increases iron absorption
Iodine contributes to the normal production of thyroid hormones and normal thyroid function
Zinc contributes to normal fertility and reproduction
Seven separate nutrients in this capsule independently support the same authorised claim about tiredness and fatigue: iron, folate, vitamin C, niacin, riboflavin, vitamin B6 and vitamin B12. We quote it once rather than seven times, because saying it seven times would be a sales technique rather than a fact.
06 / What is in it
Eighteen nutrients, and the two the law is about.
Two of these figures are not formulation preferences. Four hundred micrograms of folate and two hundred milligrams of DHA are the exact thresholds written into the conditions of use for the claims this page is permitted to make. The other sixteen are there because a pregnancy needs them, and they are given below at the amounts a label has to carry.
Oprega, one capsule
Nutrient and form
In ours
Of reference value
Legal minimum
DHA, from fish oil
200 mg
no NRV
no minimum
Vitamin C, ascorbic acid
70 mg
88%
12 mg
Nicotinamide
20 mg
125%
2.4 mg
Vitamin E, as acetate
20 mg
167%
1.8 mg
Iron, as ferrous fumarate
19 mg
136%
2.1 mg
Zinc, as zinc sulphate monohydrate
15 mg
150%
1.5 mg
Vitamin B6, from pyridoxine hydrochloride
8.2 mg
586%
0.21 mg
Pantothenic acid, from calcium D-pantothenate
89%
0.9 mg
Vitamin D3, cholecalciferol
5 mcg
100%
0.75 mcg
Thiamin, from thiamine mononitrate
2.43 mg
221%
0.17 mg
Riboflavin
2 mg
143%
0.21 mg
Copper, from copper sulphate pentahydrate
1 mg
100%
0.15 mg
Vitamin A, as beta-carotene
333 mcg RE
42%
120 mcg
Iodine, as potassium iodide
150 mcg
100%
22.5 mcg
Folate, as calcium L-methylfolate
400 mcg
200%
30 mcg
Biotin
30 mcg
60%
7.5 mcg
Selenium, as sodium selenite
30 mcg
55%
8.25 mcg
Vitamin B12
6 mcg
240%
0.38 mcg
On the vitamin B6
The specification gives 10 milligrams of pyridoxine hydrochloride, which is 8.2 milligrams of vitamin B6. In 2023 EFSA reset the tolerable upper intake level for vitamin B6 to 12 milligrams a day and that limit expressly includes pregnant and breastfeeding women. Eight point two leaves real headroom under it. We show the converted figure because that is what a label carries, and we show the salt figure because that is what the manufacturer weighs.
Two figures we have converted
The beta-carotene is specified as a thirty per cent grade at 2 milligrams. We have read the 2 milligrams as beta-carotene, which gives 333 micrograms of retinol equivalents and is consistent with every other line on this specification. Read the other way it would fall below the fifteen per cent threshold and could not be declared at all. The pantothenate is converted on the same basis. Both are with the manufacturer.
On the forms in this capsule
The zinc here is zinc sulphate, the selenium sodium selenite, the copper copper sulphate. Alpha Biselen, Intense and Acnexa use bisglycinate, selenomethionine and gluconate, and the hair and skin barrier pages set out why. This capsule does not.
05 / The line
What is still not ours to say?
An Article 14 claim is the furthest European law will go, and it stops a long way short of where marketing would like to be. It says that a low maternal folate status is a risk factor. It does not say that a supplement prevents anything. It says that maternal DHA contributes to normal development. It does not say that more DHA makes a better brain, and the law is right about that.
One thing on this page is a change to the product rather than a change to the copy.
The vitamin B6 in this capsule is 10 mg. In 2023 EFSA reset the tolerable upper intake level for vitamin B6 to 12 mg a day, and that limit expressly includes pregnant and breastfeeding women. One capsule therefore uses about eighty-three per cent of the daily ceiling before anything is eaten. It is under the limit. It is closer to it than we want for a product designed to be taken every day for a year or more, so it is on the reformulation list, and it is written here rather than left in a file.
If you are pregnant or planning to be, the person to speak to is your doctor or midwife, before this or any other supplement. A food supplement is not a substitute for a varied and balanced diet and a healthy lifestyle. One capsule daily, and do not exceed it.