Ref. Ares(2022)6676305 - 28/09/2022
Communication from the Commission - TRIS/(2017) 00520
Directive (EU) 2015/1535
Detailed opinion from the Commission (article 6, paragraph 2, second indent of Directive (EU) 2015/1535). This
detailed opinion extends the standstill period until 29-05-2017.
Comunicado detallado - Podrobné vyjádření - Udförlig udtalelse - Ausführlichen Stellungnahme - Üksikasjalik
arvamus - Εμπεριστατωμένη γνώμη - Detailed opinion - Avis circonstancié - Parere circostanziado - Detalizēts
atzinums - Detali nuomonė - Részletes vélemény - Opinjoni dettaljata - Uitvoerig gemotiveerde mening - Opinia
szczegółowa - Parecer circunstanciado - Podrobný úsudok - Podrobno mnenje - Yksityiskohtainen lausunto -
Detaljerat yttrande - Подробно становище - Aviz detaliat - Aviz detaliat.
Amplia el plazo del estatu quo hasta 29-05-2017. - Prodlužuje lhůtu pro stávající stav až do 29-05-2017. - Fristen
for status quo forlänges til 29-05-2017. - Die Laufzeit des Status quo wird verlängert bis 29-05-2017. - Praeguse
olukorra tähtaega pikendatakse kuni 29-05-2017. - Παρατείνει την προθεσμία του status quo μέχρι την
29-05-2017. - Extends the time limit of the status quo until 29-05-2017. - Prolonge le délai de statu quo jusqu'au
29-05-2017. - Proroga il termine dello status quo fino al 29-05-2017. - Pagarina “status quo” laika periodu līdz
29-05-2017. - Pratęsia status quo laiko limitą iki 29-05-2017. - Meghosszabbítja a korábbi állapot határidejét
29-05-2017-ig. - Jestendi t-terminu ta’ l-istatus quo sa 29-05-2017. - De status-quo-periode wordt verlengd tot
29-05-2017. - Przedłużenie status quo do 29-05-2017. - Prolonga o prazo do statu quo ate 29-05-2017. - Časový
limit momentálneho stavu sa predĺži až do 29-05-2017. - Podaljša rok nespremenjenega stanja do 29-05-2017. -
Jatkaa status quo määräaikaa 29-05-2017 asti - Förlänger tiden för status quo fram till: 29-05-2017 - Удължаване
на крайния срок на статуквото до 29-05-2017 - Prelungeşte termenul status quo-ului până la 29-05-2017.
Die Kommission hat diese ausführliche Stellungnahme am 24-02-2017 empfangen.
The Commission received this detailed opinion on the 24-02-2017.
La Commission a reçu cet avis circonstancié le 24-02-2017.
1. MSG 315 IND 2016 0615 B EN 27-02-2017 24-02-2017 COM 6.2(2) 27-02-2017
3. DG GROW/B/2 - N105 04/63
4. 2016/0615/B - C00A
5. article 6, paragraph 2, second indent of Directive (EU) 2015/1535
6. Within the framework of the notification procedure laid down by Directive (EU) 2015/1535 , the Belgian
authorities notified to the Commission on 25 November 2016 the draft "Royal Decree amending the Royal Decree
of 3 March 1992 concerning the placing on the market of nutrients and foodstuffs to which nutrients have been
It is explained in the notification message that the purpose of the notified draft is to establish maximum levels for
vitamins, minerals and trace minerals in food supplements and fortified foods, based on recent scientific data.
Examination of the draft has prompted the Commission to issue the following detailed opinion and comments.
Article 9 of the notified draft amends Annex 3(1) to the basic act which specifies substances the marketing of
which are prohibited.
Article 9(3) of the notified draft amends point 1.4 of Annex 3 to the basic act as follows:
"3. the provision under 1.4, replaced by the Royal Decree of 15 May 2003, shall be rectified as follows:
"1.4 Nicotinic acid and inositol hexanicotinate (inositol hexaniacinate) as a source of niacin.""
In this respect it should be recalled that Directive 2002/46/EC on food supplements and Regulation (EC) No
1925/2006 on the addition of vitamins and minerals and of certain other substances to foods harmonise the
addition of vitamins and minerals and of certain other substances to foods and food supplements as applicable.
Article 3(1) of Regulation (EC) No 1925/2006 provides:
"Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods, subject to
the rules laid down in this Regulation."
Annex I to that Regulation titled "Vitamins and minerals which may be added to foods" in point 1 "Vitamins" lists
Annex II to that Regulation titled "Vitamin formulations and mineral substances which may be added to foods"
states that for niacin the permitted formulations are nicotinic acid and nicotinamide.
The provisions of this Regulation regarding vitamins and minerals do not apply to food supplements covered by
Directive 2002/46/EC (Article 1(2)).
Directive 2002/46/EC, Article 4 stipulates:
"1. Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of
food supplements […]."
Annex I to that Directive titled "Vitamins and minerals which may be used in the manufacture of food
supplements", in point 1 "Vitamins" lists niacin.
Annex II to that Directive titled "Vitamin and mineral substances which may be used in the manufacture of food
supplements", Part A "Vitamins", point 7 provides that for niacin such permitted substances are nicotinic acid,
nicotinamide and inositol hexanicotinate (inositol hexaniacinate).
Therefore, it follows that Article 9(3) of the notified draft, which amends point 1.4 in Annex 3 to the basic act, does
not permit the addition of nicotinic acid and inositol hexanicotinate (inositol hexaniacinate) to foodstuffs, including
For these reasons, the Commission delivers a detailed opinion provided for in Article 6(2) of Directive (EU)
2015/1535 to the effect that:
- insofar Article 9(3) of the notified draft does not permit the addition of nicotinic acid to foodstuffs covered by
Regulation (EC) No 1925/2004, it would be in breach of Article 3(1) of that Regulation and
- insofar Article 9(3) of the notified draft does not permit the addition of nicotinic acid and inositol hexanicotinate
(inositol hexaniacinate) to food supplements covered by Directive 2002/46/EC, it would be in breach of Article 4(1)
of that Directive, were this provision to be adopted without giving due consideration to the above remarks.
The Commission would remind the Belgian Government that under the terms of article 6(2) of the
above-mentioned Directive (EU) 2015/1535, the delivery of a detailed opinion obliges the Member State which has
drawn up the draft technical regulation concerned to postpone its adoption for six months from the date of its
notification. This deadline therefore comes to an end on 29 May 2017.
The Commission further draws the attention of your Government to the fact that under this provision the Member
State which is the addressee of a detailed opinion is obliged to inform the Commission of the action which it
intends to take as a result of the opinion.
The Commission furthermore invites your Government to communicate to it on adoption the definitive text of the
draft technical regulation concerned, in accordance with Article 5(3) of Directive (EU) 2015/1535.
In line with the usual procedure under EU law, please be advised that should your Government not comply with
the obligations foreseen in Directive (EU) 2015/1535 or should the text of the draft technical regulation under
consideration be adopted without account being taken of the above-mentioned objections or be otherwise in
breach of European Union law, the Commission may commence proceedings pursuant to Article 258 TFEU.
The Commission notes that the notified draft describes the general principles that apply as well as certain labelling
obligations. It also provides in Article 7 a reference to a general mutual recognition clause, which reads as follows:
"The following Article 11/1 is also inserted into the same Decree:
Article 11/1. The provisions of this Decree do not apply to products lawfully placed on the market in other Member
States of the European Union or in States party to the Agreement on the European Economic Area, unless the
principle of mutual recognition cannot be applied in accordance with Articles 34 to 36 of the Treaty on the
Functioning of the European Union."
The Commission appreciates that Belgium has introduced a mutual recognition clause in the notified draft.
However, while the draft mentions only the EU member States and the contracting States of the EEA Agreement
the mutual recognition principle should apply also to products that are lawfully manufactured and/or marketed in
The requirement to refer to all of them is based on Article 34 and 36 of the Treaty on the Functioning of the
European Union (TFEU), the EEA Agreement and the EU-Turkey Customs Union.
According to Article 34 of the TFEU any product imported from another Member State must in principle be
admitted to the territory of the importing Member State if it has been lawfully produced and/or marketed. This
principle, often referred to by the Court in its jurisprudence, implies that a Member State may not in principle
prohibit the sale in its territory of a product lawfully produced and/or marketed according to technical or quality
requirements which differ from those imposed on its domestic products if a level of equivalent protection is given
(see for example ECJ of 20 February 1979, Case 120/78, Cassis de Dijon, , page 649ff.).
The obligation to apply the principle of mutual recognition to products lawfully manufactured and/or marketed in
Turkey is based on Articles 5 to 7 of Decision 1/95 of the EC-Turkey Association Council that provide for the
elimination of measures having an effect equivalent to quantitative restrictions between the EU and Turkey.
Pursuant to Article 66 of Decision 1/95, Articles 5 to 7 must, for purposes of their implementation and application to
products covered by the Customs Union, be interpreted in conformity with the relevant judgments of the Court of
Justice of the European Communities. Therefore, principles resulting from the Court of Justice’s case-law on
issues that relate to Articles 34 and 36 of the TFEU, particularly the "Cassis de Dijon" case, apply to the EU
Member States and Turkey.
Furthermore, as far as reference to "lawfully placed on the market in States party to the Agreement on the
European Economic Area" is concerned, the Commission would note that the products covered by a standard
mutual recognition clause are products lawfully manufactured and/or marketed in another EU Member State or in
Turkey or products lawfully manufactured in an EFTA State that is a contracting party to the EEA Agreement.
Therefore, the Commission would recommend not extending the scope of the application of the mutual recognition
clause also to products that are lawfully marketed in an EFTA State that is a contracting party to the EEA
Agreement, but not manufactured there.
For further information, the Belgian authorities may refer to the Commission Communication on mutual recognition
("Commission interpretative Communication on facilitating the access of products to the markets of other Member
States: the practical application of mutual recognition", OJ C 265/02, 4 November 2003).
The partial non-conformity of the mutual recognition clause of the draft with the requirements as specified in the
Customs Union with Turkey may create obstacles to the free movement of goods within this Union. It is therefore
necessary to widen the scope of the clause to include Turkey.
necessary to widen the scope of the clause to include Turkey.
In the light of the above considerations, the Belgian authorities are invited to modify the notified draft in order to
respect the demands of the mutual recognition principle.
Member of the Commission
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043