The expansion of the market in the area of food supplements led to the need to amend Decree-Law No. 136/2003. The publication of Decree-Law No. 118/2015 * substantiates the necessary changes.
Notifications sent by regular mail on paper will not be considered.
Each notification corresponds to a product and, consequently, to an email
Each notification must present a dossier consisting of the following documents (see detailed information on the elements of the dossier below)
Notification Table (Excel);
Copy of the label;
Consumer information leaflet, if available;
When the operator submits a notification, he receives an automatic reply acknowledging receipt of the email. This response is not personalized, but together with the notification email, it proves that the process for that product has started. However, it does not prove compliance with the requirements of the applicable legislation.
Notifications that are not accompanied by all requested documentation will not be considered, and the operator will be informed accordingly.
2. Who can make the notification
Manufacturer – in the case of products manufactured in Portugal or in another Member State;
Importer – in the case of products manufactured in a Third Country;
Distributor established in Portugal or in any other Member State;
Legal representative, duly authorized by the manufacturer, importer or distributor.
(Attention: The diploma does not mention the distributor. This is an error that will be corrected)
3 - Documents Contained in the Notification Dossier
In the case of notifications made electronically, it is not necessary to send original documents. However, DSNA may request original documents if the situation justifies it. Copies must be enclosed with the notification email, and files must be submitted in PDF. Other extensions can cause problems both to open and to rotate the image. We do not accept documents recorded on CD or sent by regular mail.
The following Documents are part of the Dossier:
3.1Notification Table 3.2Copy of the label 3.3Consumer notification leaflet, if there is one
3.1 - Notification Table (EN) (Download, preferably with "Internet Explorer" or "Google Chrome" browsers)
The notification table in excel format must be filled in and contains the following fields:
Information on Manufacturing and Marketing (Sheet 1)
Column B - Name and address of the Notifier – indicate the person sending the notification mail, who may be the manufacturer, if the product is manufactured in Portugal or in another Member State, or the distributor or the importer, if the product is manufactured in a Third Country. The notification may also be made by the legal representative of the manufacturer, distributor or importer (e.g. law firm or consultancy firms).
Column C - Contact of the Notifier – Phone and Email.
Column D - Name and address of the Distributor – indicate the entity responsible for the distribution of the product. The distributor may be based in Portugal or in another EU country.
Column E – VAT of the Distributor – this information may be useful for a faster location in the table.
Column F - Contact of the Distributor – Phone and Email.
Column G - Name and address of the Manufacturer – indicate the company manufacturing the product, whether it is located in a Member State or in a Third Country.
Column H – VAT of the Manufacturer – only in case the company is located in Portugal.
Column I - Contact of the Manufacturer – Phone and Email.
Column J - Name and address of the Importer – indicate the company that imports the product, whether it is located in Portugal or in another Member State
Column K - VAT of the Importer – only in case the company is located in Portugal.
Column L - Contact of the Importer – Phone and Email.
Columns M-N – First Notification in the EU (YES-NO) – Mark with an “x” the applicable situation.
Column O – Notification in another MS – In case the product has already been notified in another MS, indicate this MS by choosing the correct option from the list.
Column P – MS Authority of the first Notification – If the product has already been notified in another MS, indicate to the Competent Authority of that MS whom the first notification has been submitted to; if there are documents issued by that Authority, or by Authorities of other MS, the operator shall, whenever possible, send scanned copies of such documents.
Column Q – Product Name in other MS – If the product has already been notified in another MS, indicate the specific name in that MS.
Columns R-S – Change – If it is the case of any change in a notification, mark with an "x". All changes must be notified, whether it is a change of administrative elements (e.g. address on labeling) or technical (e.g. replacing of an ingredient).
Column T – Type of change – Specify the change made to the original product (e.g. change of address, disposal / replacement of an ingredient).
Column U – Observations – refer information considered relevant.
Information relating to the Product (Sheet 2)
Name and presentation of the Product – Fill in the respective field.
Table - Requirements Verification (Sheet 2, columns B to K, lines 9 to 25).
Mark with an “x” the requirements which have been verified (see paragraph 4 of this document).
1 - In the case of products manufactured in the EU, the manufacturer, as well as the notifier or the distributor, has updated documentation proving that the manufacturing establishment is duly authorized to manufacture food supplements under the REG. (EC) No. 852/2004 (see paragraph 4.1);
2 - The product is classified as a food supplement under the Decree-Law No. 118/2015 (see paragraph 4.2);
3 – Verified compliance of the labeling requirements under the Decree-Law No. 118/2015, according to checklist (see paragraph 4.3);
4 - Verified compliance of the consumer information requirements under Regulation (EU) No 1169/2011, in accordance with the checklist (see paragraph 4.3);
6 - Verified compliance of the ingredients with the requirements of the REG. (EU) n° 2015/2283 with respect to Novel Foods, according to (see paragraph 4.5);
7 - Verified compliance of nutritional and health claims under the REG. (EC) No. 1924/2006 (see paragraph 4.6).
[It is not necessary, nor should it refer the above mentioned documents to the DGAV. However, these can be requested from the operator at any time]
Columns L to W - Ingredients – Vitamins and Minerals , according to the REG. (EC) No. 1170/2009 (see paragraph 4.4)
Columns L to Q – Vitamins
Column L – Listing of all the vitamins that can be used.
Column M – Mark with an “x” the vitamins used.
Column N – Forms in which vitamins are present - choose the correct options from the list.
Column P - Daily intake of each vitamin, in the indicated units.
Column Q - According to the value in column P, the percentage of NRV is automatically indicated
Columns R to W – Minerals
Column R - Listing of all the minerals that can be used.
Column S – Mark with an “x” the minerals used.
Column T – Forms in which minerals are present - choose the correct options from the list.
Column U – Nutrient Reference Value, when it exists (according to Regulation (EU) No 1169/2011) and respective units.
Column V – Daily intake of each mineral, in the indicated units.
Column W – According to the value in column V, the percentage of NRV is automatically indicated.
Columns X to Y – Other Ingredients
Column X – list all ingredients / substances with a nutritional or physiological effect, other than vitamins and minerals. In case the parts of the plant are not discriminated, it is assumed that it will be the complete plant. Similarly, all the animals or parts of animals used, as well as any ingredients produced by animals - e.g. honey, colostrum, eggs.
Column Y - The Ingredient Status* - Choose, from the list, the document that allows the use of this ingredient to be justified under the REG. (EU) n° 2015/2283 (see paragraph 4.5). In case it is an ingredient of common use, choose the "Common Use" option.
The URL of the various documents can be found in Sheet 3 of the table
Columns Z to AA – Indicate whether the labeling contains nutrition claims.
Column AB – Indicate nutritional claims of the labeling, where appropriate.
Columns AC to AD - Indicate whether the labeling contains health claims.
Column AE - Indicate health claims on labeling, if applicable.
Column AF – Indicate ID of each claim or, in its absence, the number of the Regulation through which the claim was authorized.
Column AG – OBS – Refer the observations considered relevant.
3.2 - Copy of the Label - A copy of the carton, in PDF format, must be sent, consisting of final cardboard artwork (mock up) or copy obtained after the package has been crushed. All the particulars on the label must be legible. The operator shall verify that the size of the letters corresponds to that stipulated in Regulation (EU) No 1169/2011, on the Consumer Information
. When there is only one label affixed to a flask, without cardboard, copies of images must be sent in such a way that all the information provided on the package is clearly visible. Copies of photographs may be sent but no other type of support is accepted, even if it is digital.
. In the case of an imported product in which the operator chooses to keep the initial carton, overlapping a label with the mandatory particulars in Portuguese, it is not sufficient to only send the label and a copy of the carton must be sent with its label attached, such as the product is presented for consumption. Likewise, it is not acceptable to merely indicate the labeling particulars without being included in the final carton.
3.3 - Consumer Information Leaflet, if there is one – copy (PDF);
4. Detailed Information on the Notification Table
You do not need to submit this documentation. The DGAV shall request the documents it deems necessary in the context of the control on notifications.
4.1 – Authorization for the Manufacturing of Food Supplements – When requested, the operator must present a document proving the legality of the manufacture of food supplements, issued by the Competent Authority on this matter: in the case of establishments based in Portugal, the document is issued by the Regional Directorates of Agriculture and Fisheries of the respective zone; in establishments domiciled in another MS, the document shall be issued by the Competent Authority of that MS. This document must be issued in Portuguese, English, French or Spanish. If it is written in another language, a translation into Portuguese must be presented, validated by the respective consulate.
4.2 - Framework as Food Supplements - Decree-Law No. 118/2015- According to the definition of "food supplement", the operator must analyze the characteristics of the product which, as a whole, allow such a framework, namely:
- “(…) foodstuffs (…) – in accordance with the REG. (EC) No. 178/2002, food must be understood as anything that can be ingested or which has a strong probability of being ingested; Thus, products destined for other routes of administration are excluded, such as nasal or topical;
- “concentrated sources of nutrients (…)“ – according to Decree-Law No. 118/2015, "nutrient" means vitamins and minerals, only; this requirement excludes highly diluted products, such as homeopathic products or "Bach flowers", for example; other products marketed under "alternative therapies", where it is not possible to measure substances with a nutritional or physiological effect, are also excluded, as is the case of products constituted by water irradiated by crystals; likewise, teas, herbal teas and other infusions do not fit as food supplements;
- “(…) or substances with nutritional or physiological effect (…)” – there must be a beneficial effect, but the definition excludes pharmacological action, a function that belongs to medicines; thus, food supplements are intended to maintain the homeostasis of the body, and not to the prevention, treatment or cure of diseases. The approach of homeostasis as a tool for framing a product is well demonstrated in the document ‘Homeostasis, a practical tool to distinguish between foods (including food supplements) and medicinal products’ [link 8], drawn up by the Council of Europe in 2008;
- “(…) marketed in dose form (…)”-the definition of food supplements provides examples of dosage forms, which generally correspond to the pharmaceutical forms in which medicinal products are presented, such as tablets or ampoules, for example. Also acceptable are packages containing a product, liquid or solid, which is intended to be consumed after measuring the quantity through measuring spoons or small measuring cups – is the case of syrups, which are taken using measuring spoons or some juice, using small cups included in the package; in these cases, it is possible to determine the content of the ingredients in the measuring spoon or measuring cup;
- “(…) – are to be consumed in measured small unit quantities (…)” – within the scope of its competence in non-harmonized matters, the DGAV set a maximum of 25 g or 25 ml for "reduced quantity". Thus, when the recommended intake is a 50g sachet or a one of 30ml, the product is not framed as a food supplement.
Special attention also needs to be paid to:
Borderline products, among food supplements and other categories of foodstuffs, such as common foodstuffs or products intended for particular nutritional uses (food for sportsmen) or between food supplements and medicinal products. In order to clarify the border between food supplements and "sports food", the DGAV has produced a document containing guidelines for its framework. See document [link 9]
In the case of borderline products between food supplements and medicinal products, it should be noted that some substances which are part of the composition of medicinal products may also be incorporated as constituents into foodstuffs. The fact that a substance has pharmacological activity does not by itself mean that the product should be classified as a medicinal product – the framing of these borderline products depends on several factors, such as the content of the substances in the final product. In order to better protect public health, a working group was set up between various entities (the DGAV, the Infarmed, the ASAE, the Faculty of Pharmacy of the University of Coimbra and the Abel Salazar Institute of Biomedical Sciences) in order to define guidelines in this area, the first document [link 10] being presented now.
4.3 - Labeling / Information to the Consumer - Decree-Law No. 118/2015 and Regulation (EU) No 1169/2011 - The operator shall verify the conformity of the labeling of his products with these two regulations. In order to facilitate this task, a checklist available with the points to be checked in each of these diplomas.
. Correct indication of the ingredients:
. List of ingredients - shall contain all ingredients, in descending order of incorporation. In the case of well-known plants, only the common name (e.g. carrot, broccoli, artichoke) may be indicated. In the case of lesser known ingredients, it may indicate a common name, but this should be accompanied by the scientific name. However, in the ingredient list of the Notification Table (EN), the scientific name shall always appear; in the case of vitamins and minerals, the name of the substance which has in fact been incorporated, which corresponds to the form in which it is presented, shall be indicated in accordance with Annex II to REG. (EC) No. 1170/2009 and Directive 2002/46 – for example thiamine hydrochloride, zinc sulphate and it is not necessary to mention in the list of ingredients respectively "vitamin B1" or "zinc".
. Ingredients per daily intake - information that is intended to be easily perceived by consumers. Thus, this indication should specifically refer to the generic name (e.g. Vitamin B6, Selenium) and not the forms in which nutrients are present (e.g. Folate, Calcium, and not pteroylmonoglutamic acid or calcium succinate, respectively). Although it is not compulsory to provide these indications in the manner presented, it must be taken into account that the consumer will always be better informed and repetition of the information is not advisable.
4.4 – Indication of vitamins and minerals - REG. (EC) No. 1170/2009 and Directive 2002/46 - Information on vitamins and minerals should be in accordance with Annex II of these Regulations. The generic name of the vitamin or mineral should be indicated, as well as the form it is found (see example in the previous paragraph).
Chelates - With respect to the use of the term "chelate", sometimes used to describe compounds formed by the attachment of a metal to an amino acid, it does not clearly identify the substance in question and is not sufficient to characterize the ingredient. The chemical name of the substance should therefore always be included in the list of ingredients, whether in the form of a chelate or not (for example, "zinc bisglycinate" and not "zinc chelate"). The designation "chelate" may exist provided that the substance in question is identified in accordance with that Regulation.
Nutrient Reference Value (NRV) - The values given in Regulation (EU) No 1169/2011 should be used, indicating the percentage of NRV corresponding to the daily intake. Although the method of indicating this parameter is not defined, it has been practical to use the designation "NRV", which more easily compares with common foodstuffs
It is also important to consider:
. The Notification Table (EN) contains all forms of vitamins and minerals, their NRV, and the percentage of NRV, calculated automatically from the intake indicated by the manufacturer.
. Maximum levels of vitamins and minerals - Are not established, but it must be taken in account the upper safety limits accepted by EFSA, the quantity of vitamins and minerals ingested through other food sources and the reference doses for the population. There is a reference document drawn up by this Authority which provides relevant indications for the establishment of maximum amounts of vitamins and minerals “TOLERABLE UPPER INTAKE LEVELS FOR VITAMINS AND MINERALS”
4.5 - Other Ingredients - All ingredients must be indicated with a nutritional or physiological effect, and for each, choose the document that allows the conclusion of the legality of their incorporation in food supplements, within the scope of REG. (EU) n° 2015/2283 When an ingredient or food does not have a consumption history in the EU before 1997, it is considered Novel Food and cannot be placed on the market until its safety is proven.
Only the vitamins and minerals to be used in food supplements are harmonized and there is some difficulty in determining if other ingredients, such as plants and other substances, can be used. There is scattered information available from other MS, such as Belgium, Italy and Germany, listing substances that can be used in food supplements. However, it must always be checked whether there has been a significant consumption assessment for the plant or substance concerned.
The Commission does not envisage the preparation of positive or negative lists of ingredients to be used in food supplements as regards "novel food" status, considering that the existing information is sufficient.
The “Traditional Food Utilization” option is reserved for well-known, well-established ingredients in the EU. Food or ingredients from other geographical areas, although used and known in those regions or cultures, cannot be included in the "Common use" option, which is reserved for the Community space.
The operator must always specify the part of the plant used, if the list consulted so indicates. Where no such indication exists, it is presumed to be the whole plant.
Extracts from plants or parts of plants are generally accepted provided that the extraction solvent is water or water with a small percentage of ethanol added. The extract thus obtained is considered to correspond to the 'profile' of the plant. The DGAV accepts extracts obtained with an extraction solvent consisting of water or water added to a maximum of 20% ethanol. For higher ethanol percentages, an assessment will be made on a case-by-case basis and, if there is any doubt, you may need to seek expert advice. Other extraction solvents or methodologies for the concentration of a particular plant constituent are not acceptable (e.g. extraction with super-critical CO2).
In case the operator does not find any reference in one of these lists or in other similar lists coming from Competent Authorities of the different MS, he must provide evidence of significant consumption of the ingredient concerned. Those supporting documents may be of a different nature (e.g. product invoices previous to 1997, consistent bibliographical references or others), and are assessed by the DGAV which is in the process of considering whether they are acceptable or not. The responsibility for collecting and presenting this documentation is always the responsibility of the economic operator.
When the situation so requires, the DGAV may consider consulting the Commission for clarification of doubts. However, it is a lengthy process that is not always conclusive.
You do not need to submit this documentation. The DGAV shall request the documents it deems necessary in the context of the control of notifications.
4.6 - Nutrition and Health Claims - REG. (EC) No. 1924/2006- The use of nutrition claims is legislated and, in general, does not raise major questions of interpretation. THE REG. (EC) No. 1924/2006 lays down the general guidelines for the use of health claims. The REG. (UE) No. 432/2012 [link 14] establishes a list of permitted health claims relating to foods which do not relate to the reduction of disease risk or to the development and health of children. The approval of health claims is a dynamic process and the Commission provides a Register of Authorized and Rejected Health and Nutrition Claims. For a better explanation, you can consult the the Commission and EFSA databases:
Where appropriate, the operator may be required to submit quality and safety studies or opinions in the context of the definition of foodstuffs. These studies should be prepared by entities with recognized technical competence in the area. A list of these entities is being prepared by the DGAV to be published and those studies may be requested to it, in order to ensure technical quality and the absence of a conflict of interests. The cost of these studies or opinions is borne by the operator.
7 - Product Response and Marketing Timeframes
A maximum period of 60 days shall elapse between receipt of the notification e-mail and a reply to the operator. This period is intended to verify that the process has been submitted correctly, with all the necessary documents, and is interrupted whenever elements are requested from the operator or safety or other assessments are requested. There is no evaluation of the product or validation of the labelling, and the control is carried out subsequently and by sampling, and may be carried out at any time.
The inexistence of a reply means that the DGAV has accepted the submission of the process, but this does not mean that the legal requirements have been verified, so that, under no circumstances, can the operator conclude that the product is authorised or in conformity.
From the moment the operator notifies the food supplement, he can put it on the market immediately, being always responsible for ensuring compliance with legal requirements.
