Romanian vitamin gummies:
how to check, in three minutes, whether they are really made in Romania
The address printed on a supplement box is not the factory's address. It is the address of the company under whose name the product is sold, and nowhere does European legislation require you to state where it was made. That is how a vitamin gummy can be sold perfectly legally in Romania, with a Romanian company on the packaging and a notification certificate from the Ministry of Health, without any of that telling you where it was produced. What follows are four checks you can do on the box, in three minutes.
Origin is not a mandatory particular:
which is why it is missing from most boxes
The first correction, and the one that changes how you read everything else: nobody is obliged to tell you where the supplement you are buying was made. European Regulation 1169/2011, which governs the provision of food information to consumers, puts origin in the category of conditional particulars, not automatic ones.
Article 26(2) states that indicating the country of origin or place of provenance is mandatory “where failure to indicate this might mislead the consumer as to the true country of origin or place of provenance of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance”. The second situation is meat from the categories listed separately in the regulation. Food supplements appear nowhere.
The same logic can be seen in the list of mandatory particulars in Article 9(1). Point (i) does not require origin in general, only “the country of origin or place of provenance where provided for in Article 26”. In other words, then and only then.
Origin is not mandatory. But the moment you write it on the packaging, it becomes a claim you are answerable for, and it brings with it a second obligation that almost nobody talks about. See chapter 4.
In practice, the absence of the statement tells you nothing. It is not a sign of bad intent and it is not a legal loophole. It is simply the silence the law allows. What does tell you something is its presence, because a manufacturer who writes “made in Romania” has chosen to stand behind a verifiable claim, in an area where it could quite comfortably have said nothing at all.
The address on the box belongs to the company that sells:
not to the factory that made it
This is where people most often go wrong. You see an address in Bucharest, Cluj or Brașov on the back of the box and draw the natural conclusion: the product is made there. That is not what the law says.
Article 8(1) of the same regulation defines who is responsible for the information on the label: “the food business operator responsible for the food information shall be the operator under whose name or business name the food is marketed”, and if that operator is not established in the Union, the importer. Article 9(1)(h) then requires the label to show “the name or business name and address of the food business operator referred to in Article 8(1)”.
Read that sentence one more time. The address the law requires is that of the responsible operator, meaning whoever places the product on the market under their own name. The factory's address appears nowhere in the list of mandatory particulars. It may be the same. Often it is not.
What it proves: that the product was manufactured in Romania. It is a voluntary statement, so the company chose to write it and is answerable for it to the consumer protection authority.
What it does not prove: that the raw materials are Romanian. Vitamins, extracts and gelling agents are bought from specialist suppliers, and there the geography is different. If the primary ingredient comes from another country, the rule in chapter 4 requires the difference to appear on the packaging.
What it proves: who is legally responsible for the information on the label and whom you contact if you have a problem with the product. It is the mandatory particular from Article 9(1)(h).
What it does not prove: absolutely nothing about the place of manufacture. A Romanian company can distribute a product made anywhere, and the wording remains perfectly correct. The variants “marketed by” and “importer” work the same way.
What it proves: that the packing operation took place in Romania.
What it does not prove: that the gummy was also made here. Packing is the last stage of the chain, and the product may arrive in bulk from a completely different country. “Packed for” is weaker still: it only tells you who ordered the packing.
The notification certificate:
what it proves and what it does not
Many supplement boxes sold in Romania carry a notification number. It is a statement that sounds like official approval and is often used as a selling point. It is worth understanding exactly.
Supplements containing vitamins and minerals are notified to the Ministry of Health under Order no. 1069 of 2007 of the Minister of Public Health. Article 10 of the order says who makes the notification: “the manufacturer, the importer or the person responsible for placing the product on the market in Romania”. The form in Annex III is filled in and the label template is submitted. Article 11 sets the issuing deadline, 15 days, with an acknowledgement of receipt within 48 hours. The service is free of charge, and Article 17 says the notification remains valid until the qualitative or quantitative composition changes.
Look once more at the list in Article 10. The manufacturer, the importer or the person responsible for placing it on the market. An importer bringing in gummies made in another country obtains exactly the same certificate, with the same kind of number, within the same deadline. The notification number is not proof of Romanian manufacture and was never intended to be.
What the notification actually checks. The documentation and the label. Not the contents of the box. No laboratory analysis of each batch is carried out as part of the procedure, and a notification certificate does not confirm that the marketing claims on the packaging are permitted. Whatever the certificate, the basic rules still apply: do not exceed the recommended daily dose, a supplement does not replace a varied diet, and if you are on medication or pregnant, ask your doctor's advice first.
The useful part of the story: the Ministry of Health publishes the lists of notifications on its own website, broken down by regional public health centre, including Cluj, Iași, Timișoara, Galați and Craiova. If you want to check that a product really has been notified, that is where you look, not at the logo on the box.
The primary ingredient rule:
the part almost nobody reads
This is the most interesting piece of legislation in the whole article, and also the one the market ignores most.
Regulation 1169/2011 defines, in Article 2(2)(q), the primary ingredient as “an ingredient or ingredients of a food that represent more than 50 % of that food or which are usually associated with the name of the food by the consumer”.
And Article 26(3) adds the obligation that matters: “where the country of origin or the place of provenance of a food is given and where it is not the same as that of its primary ingredient, the country of origin or place of provenance of the primary ingredient in question shall also be given, or the country of origin or place of provenance of the primary ingredient shall be indicated as being different to that of the food”.
Implementing Regulation 2018/775, applicable since 1 April 2020, also says how this looks on the packaging. The country of the ingredient can be stated, or a wording along the lines of “(name of the primary ingredient) does not originate from (the country of origin of the food)” can be used. And Article 3 requires the information to appear in the same field of vision as the product's origin statement, in letters with an x-height of at least 75% of the x-height of that statement. Not in a corner, not in type four times smaller.
| What you do | What you look for | What you find out |
|---|---|---|
| You read the ingredients list | The first two positions | What weighs the most, because ingredients are listed in descending order of weight |
| You look for an origin statement | “made in” | Whether the company has stood behind the place of manufacture or preferred to stay silent |
| You check the same field of vision | Text at 75% | Whether the primary ingredient has a different origin from the product |
| You look for the address | “distributed by” | Who is responsible for the label, not who made the product |
| You look for the notification number | The Ministry's lists | Whether the product is registered, not whether it is made here |
What this means in concrete terms for a vitamin gummy. The vitamin dose is measured in milligrams or micrograms, and a gummy weighs a few grams. The vitamin cannot possibly be the heaviest ingredient in the product, however well dosed it is. What sits in the first positions of the list is the sweet base and the gelling agent, and Article 18(1) of the regulation requires ingredients to be listed “in descending order of weight, as recorded at the time of their use in the manufacture of the food”. We took apart the arithmetic of the format at length in the article on gummies or pills.
What every supplement must state:
wherever it was made
If origin is optional, other things are not. Directive 2002/46/EC, which harmonises the rules for supplements in the Union, defines a food supplement as a foodstuff “the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form”.
Article 6(1) requires the name under which the product is sold to be “food supplement”. Paragraph (3) lists five particulars that must appear on the label, regardless of country, company or format:
- the names of the categories of nutrients or substances that characterise the product, or an indication of the nature of those nutrients or substances;
- the portion of the product recommended for daily consumption;
- a warning not to exceed the stated recommended daily dose;
- a statement to the effect that food supplements should not be used as a substitute for a varied diet;
- a statement to the effect that the products should be stored out of the reach of young children.
And paragraph (2) is the one half the market breaks: “the labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties”. It is not a recommendation of good taste. It is the text of the directive.
On top of that come the legibility rules. Article 13(2) of Regulation 1169/2011 requires mandatory particulars to be printed in characters with an x-height of at least 1.2 mm, and on packaging whose largest surface is less than 80 square centimetres, at least 0.9 mm. If you have to bring your phone up close to read the warning, something is wrong.
What is allowed to be written about effects is a separate and much stricter discussion. We took it apart using real wording from packaging in the guide on which vitamins to take in autumn.
Five things people say:
and which do not stand up
The company on the box is the operator responsible for the information on the label, under Article 8(1). It can be Romanian and sell a product made anywhere. The link between the company's nationality and the place of manufacture does not exist, either in the text or in practice.
Notification under Order 1069/2007 is a procedure for registering the documentation and the label template, with a 15-day deadline and no fee. It does not include an analysis of the contents of the box as part of the procedure for issuing the certificate.
Legally, there is nothing to hide: origin is mandatory only when leaving it out would mislead. Editorially, though, a manufacturer who chooses to state the place of manufacture gives you something to check, and one who stays silent does not. The difference is real, but it is a difference in transparency, not in compliance.
Doses cannot be deduced from the country. You read them from the table on the box, expressed as percentages of the nutrient reference values, which are the same throughout the Union. Two products made in different countries can have exactly the same dose, and two made in the same country can differ fivefold.
Packing is a separate stage from manufacturing. A product can arrive in bulk and be portioned here, and the statement remains correct. If you are interested in the place of manufacture, look for exactly the word that describes manufacturing, not packing.
What you can check
on our boxes
The same eight things we asked you to look for on anyone else's boxes, on ours.
ROOTFUL makes gummies and capsules manufactured in Romania, and we say so on the packaging. The raw materials, as with any supplement sold in Europe, come from specialist suppliers: vitamins and standardised extracts are not produced in the same facility as the gummy.
What you can check on our boxes, without taking our word for it: the name “food supplement”, the ingredients list in order of weight, the recommended daily portion, the warning not to exceed the dose, the statement that it does not replace a varied diet, the warning about children, the address of the responsible operator and the statement of manufacture. The same eight things we asked you to look for on anyone else's.
As for what the ingredients do: vitamin D contributes to the normal function of the immune system and to the maintenance of normal muscle function, vitamin C contributes to the reduction of tiredness and fatigue, and zinc contributes to normal cognitive function. Those are the authorised wordings. Anything else, however good it sounds, is not allowed to appear on the box or here.
Frequently asked questions:
what people most often ask about a gummy's label
Look on the packaging for wording that explicitly states the place of manufacture, such as “made in Romania” or “produced in”. If there is none, the information is not mandatory and you cannot deduce anything from the company's address, which is the address of the operator under whose name the product is sold. The last option is to ask the manufacturer directly, in writing, and to ask for an answer you can keep.
It means that company is responsible for the information on the label and for placing the product on the market. Regulation 1169/2011, in Article 9(1)(h), requires the name and address of this operator, not of the factory. “Distributed by” says nothing about where the food was produced and does not oblige the company to declare it.
No. Notification under Order 1069/2007 means the company has submitted a form and a label template, and the authority has registered the product. The certificate is issued within 15 days and remains valid until the composition changes. It is not a laboratory analysis of the contents of the box and it is not an approval of the marketing claims.
Not in itself. Stating origin is mandatory in only two situations: when leaving it out would mislead the buyer, and for meat on the regulation's special list. A supplement that is silent about its origin complies with the law. The difference is that a manufacturer who states the place of manufacture stands behind a verifiable claim, while one who stays silent gives you nothing to check.
Regulation 1169/2011 defines it as the ingredient that represents more than 50% of the food or that the buyer usually associates with the name of the product. If the label states the origin of the food and the primary ingredient comes from somewhere else, the difference must be written on the packaging, in the same field of vision. The rule has applied since 1 April 2020.
Directive 2002/46/EC requires five things: the categories of nutrients or their nature, the portion recommended for daily consumption, the warning not to exceed the recommended daily dose, the statement that supplements do not replace a varied diet and the warning that they should be kept out of the reach of young children. The name under which the product is sold must be “food supplement”.
Note: the information in this article is for educational purposes. It does not replace personalised medical advice. The article describes labelling and notification rules and does not attribute any health effect to any ingredient. Food supplements are not medicines and are not intended to diagnose, treat or prevent disease. Do not exceed the recommended daily dose. Keep out of the reach of children.
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