Recital 13 of Directive 2002/46/EC 2 –Directive of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51). (‘the Directive’) states that excessive intake of vitamins and minerals can have adverse effects on health, justifying the setting of maximum levels. Recital 14 states that: ‘When maximum levels are set, therefore, account should be taken of the upper safe levels of the vitamins and minerals, as established by scientific risk assessment based on generally acceptable scientific data, and of intakes of those nutrients from the normal diet. Due account should also be taken of reference intake amounts when setting maximum levels.’

Article 2 of the Directive defines the following terms:

‘(a)“food supplements” means foodstuffs 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, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities;

(b)“nutrients” means the following substances:

(i) vitamins,

(ii) minerals.’

Article 3 provides that: ‘Member States shall ensure that food supplements may be marketed within the Community only if they comply with the rules laid down in this Directive.’

Article 4 states that: ‘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, subject to paragraph 6. … 6. By way of derogation from paragraph 1 and until 31 December 2009, Member States may allow in their territory the use of vitamins and minerals not listed in Annex I, or in forms not listed in Annex II, provided that: (a) the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive, (b) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 12 July 2005. 7. Notwithstanding paragraph 6, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on trade in food supplements containing vitamins and minerals not included in the list in Annex I or in the forms not listed in Annex II.’

Article 5 foresees that: ‘1. Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account:

(a)upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups;

(b)intake of vitamins and minerals from other dietary sources.

2. When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population. 3. To ensure that significant amounts of vitamins and minerals are present in food supplements, minimum amounts per daily portion of consumption as recommended by the manufacturer shall be set, as appropriate. 4. The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1, 2 and 3 shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’

Article 11 provides that: ‘1. Without prejudice to Article 4(7), Member States shall not, for reasons related to their composition, manufacturing specifications, presentation or labelling, prohibit or restrict trade in products referred to in Article 1 which comply with this Directive and, where appropriate, with Community acts adopted in implementation of this Directive. 2. Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, paragraph 1 shall not affect national provisions which are applicable in the absence of Community acts adopted under this Directive.’

Décret n°2006-352 du 20 mars 2006 relatif aux compléments alimentaires (Decree No 2006-352 of 20 March 2006 on food supplements) (‘the Decree’) transposes the Directive into French law. According to its Article 5, vitamins and minerals can be used in the manufacture of food supplements under conditions to be laid down by ministerial order.

Article 6 of the Decree provides that substances with a nutritional or physiological effect can be used in food supplements essentially if they have been authorised by certain national procedures including by application of Article 16 of the Decree.

Article 7 of the Decree states that plants and preparations of plants can be used in food supplements essentially if they are traditionally recognised as foodstuffs, or have been authorised by certain national procedures including by application of Article 16 of the Decree.

Article 16 of the Decree concerns food supplements containing substances with a nutritional or physiological effect or plants or preparations of plants, which have been legally marketed in other Member States and which are being placed on the market in France for the first time.  3 – Confirmed by the French Government in its written submissions. It foresees a certain procedure for authorisation of such substances, where they have not already been authorised under Article 6 or 7 (‘Article 16 evaluation procedure’).

Under the Article 16 evaluation procedure, the importer must provide, among others, any data in its possession that is useful for the evaluation of the relevant substance.  4 – The original French text refers to ‘… toutes les données en sa possession utiles à l’appréciation de la substance …’. The competent national authority decides, within two months and on the basis of the dossier submitted, whether to authorise the product or refuse authorisation. Any refusal must be justified, either for reasons of incompleteness of the dossier, or for scientific reasons, in particular, due to risk for human health.

Articles 17 and 18 create a procedure for the revision of the maximum amounts of vitamins and minerals contained in food supplements, that have been fixed by decree adopted in application of Article 5.  5 – Pending the fixing of maxima under the Directive. Such requests are to be made to the competent national authority, which decides following consultation with the relevant national scientific body.

Pursuant to Article 5 of the Decree, a ministerial order dated 9 May 2006 was adopted (‘the Order’). Annexes I and II of that order include a list of vitamins and minerals that can be used in the manufacture of food supplements and the forms in which they can be used. Annex III sets out maximum daily doses for those vitamins and minerals that cannot be exceeded.

Article 4(1) of the Directive provides that, for the manufacture of food supplements, only vitamins and minerals listed in Annex I, in the forms listed in Annex II may be used. Article 5(4) of the Directive foresees that the Commission should adopt maximum amounts of vitamins and minerals to be used in foodstuffs. However, it has not yet done so.

In the absence of Commission action in this regard, Member States remain competent to adopt such maxima, while respecting the Treaty rules, including those on the free movement of goods.  12 – Article 11(2) of the Directive; judgment of 29 April 2010, Solgar and Others (C‑446/08, EU:C:2010:233, paragraphs 19 to 24).

In its judgment in Solgar, the Court confirmed in particular that Member States must comply with Articles 34 and 36 TFEU and ‘must also be guided by the criteria laid down in Article 5(1) and (2) of [the Directive]’.  13 – Judgment of 29 April 2010, Solgar and Others (C‑446/08, EU:C:2010:233, paragraph 32). Those criteria are derived from the general requirement to base food law on risk assessment.  14 – Article 6(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1). They require that, in fixing maxima, various factors must be taken into account, namely: (i) upper safe levels of vitamins and minerals (‘upper safe level’); (ii) intakes from other dietary sources; (iii) reference intakes (together ‘the Article 5 criteria’).

It follows from the above that decisions by Member States to impose maxima on use of vitamins and minerals in food supplements must be preceded by a full risk assessment taking into account, in particular, the Article 5 criteria.

There appears to be rather broad agreement in all the written observations submitted to the Court on the points of law set out in the preceding paragraphs. In particular, it is not disputed that Member States have the possibility to adopt acts fixing maxima for use of vitamins and minerals in food supplements, on the basis of a full risk assessment.

There is, however, a disagreement about whether a full risk assessment of the relevant vitamins and minerals was carried out before adoption of the Order. Nonetheless, that point is not raised by the referring court’s first question. Whether or not a full risk assessment was carried out is for the referring court to verify. I will assume for the moment that a full risk assessment has been carried out (that is the position of the French Government), although I return to the issue in the context of the second and third questions.

More relevant here is the fact that there is a disagreement about whether there needs to be a procedure allowing for some form of additional (simplified) assessment on an individual basis. That is the focus of the first question.

In response to this, the French Government and the ESA argue in substance that, once a full risk assessment has been carried out and maxima fixed in national legislation, those maxima can be used to prevent imports. EU law does not require a specific procedure allowing for assessment of individual products which are acknowledged as exceeding the maxima.

By contrast, Noria and the Commission argue that, regardless of the existence of generally applicable maxima in national legislation, a procedure must exist whereby an importer can request authorisation to market its products in that Member State even if they exceed those maxima.

Does EU law require such a ‘simplified mutual recognition procedure’?  15 – In the Solgar case, it was argued that the Order was incompatible with EU law due to the absence of a mutual recognition procedure. However, that aspect was not addressed in the national court’s request (see Opinion of Advocate General Jääskinen in Solgar and Others (C‑446/08, EU:C:2009:795, points 28 and 29)) or the Court’s judgment.

The Directive does not refer to or define such a requirement. Nor do I see any scope for inferring such a procedural requirement from the Directive. Can such a requirement be deduced from Articles 34 and 36 TFEU and the principle of free movement of goods and mutual recognition? Crucial to the answer is the meaning of the term ‘(simplified) mutual recognition procedure’.

The principle of mutual recognition is derived from the prohibition of quantitative restrictions on imports between Member States and measures having an equivalent effect thereto, set out in Article 34 TFEU.  16 – See, for example, judgment of 5 February 2004, Commission v France (C‑24/00, EU:C:2004:70, paragraphs 21 and 22). According to that principle, if a product has been lawfully manufactured and/or marketed in one Member State, then other Member States must as a general rule accept importation of that product into their territory.  17 – Judgment of 20 February 1979, Rewe-Zentral (120/78, EU:C:1979:42, paragraphs 14 and 15). See also judgments of 17 June 1981, Commission v Ireland, (C‑113/80; EU:C:1981:139), and of 10 February 2009, Commission v Italy, (C‑110/05; EU:C:2009:66).

The prohibition on restrictions on the free movement of goods is not, however, absolute. Member States can still justify refusals to allow importation of products lawfully produced or marketed in other Member States. That can be done, for example, to safeguard public health, subject to the requirements of necessity and proportionality.  18 – See, for example, in relation to restrictions on inclusion of vitamins in foodstuffs, judgments of 23 September 2003, Commission v Denmark (C‑192/01, EU:C:2003:492, paragraphs 42 and 43); of 5 February 2004, Commission v France (C‑24/00, EU:C:2004:70, paragraphs 49 and 50); of 5 February 2004, Greenham and Abel (C‑95/01, EU:C:2004:71, paragraphs 37 and 38); and of 14 July 1983, Sandoz (174/82, EU:C:1983:213, paragraphs 16 and 17).

It follows that a ‘mutual recognition procedure’ in this context is not a procedure that would require Member States to recognise automatically and authorise import of any food supplement produced or marketed legally in other Member States. Member States must have the opportunity to verify the absence of genuine risks for public health and refuse imports, if such risks are indeed considered to exist.  19 – See, in this sense in relation to processing aids, judgment of 28 January 2010, Commission v France (C‑333/08, EU:C:2010:44, paragraph 109), where such a requirement is referred to as a ‘mutual recognition clause’.

A ‘mutual recognition procedure’ would then be a procedure whereby a Member State basically verifies if there is a genuine risk for public health and hence whether or not it has a valid justification for refusing importation. If no such risk and no valid justification exist, the importation cannot be legitimately prevented.  20 – The adjective ‘simplified’ (or ‘streamlined’) implies something not too time consuming or complex. I will focus here on the basic expression ‘mutual recognition procedure’.

But what happens if the risk already appears to have been fully researched and the justification fully developed? In the present case, that is the contention. The French Government effectively argues that it has justified its requirements relating to specific nutrients on the basis of a full risk assessment complying with EU law requirements in terms of thoroughness and consideration of specific factors.

Given those circumstances, what precise purpose would a mutual recognition procedure practically serve? What concrete steps would it require a Member State to take?

Would it be to repeat the same assessment of the same nutrient(s) as has already been conducted?  21 – The national court refers to the Article 16 evaluation procedure, which exists for various other substances in food supplements (see above points 10 to 12). In that procedure, the importer provides data for the evaluation of the relevant substance. The competent national authority must assess the dossier and may justify refusal on public health grounds. To the extent that the French authorities have already taken into account all such data in their original risk assessment, an application of the Article 16 evaluation procedure here would simply involve repeating that assessment. If that is indeed what is being suggested, then the answer is, in my view, a clear no.

If a Member State has complied with EU law requirements in terms of a full risk assessment of a nutrient, and has adopted generally applicable maxima on that basis, neither Article 34 TFEU nor the principles of free movement or mutual recognition require it to revise that conclusion simply because an individual importer does not like the result. On the other hand, it ought to be added that the EU law principle of effective judicial protection requires that the original act imposing generally applicable maxima must of course be open to judicial review under (primarily) national procedural rules.

In their submissions, both Noria and the Commission refer to the Court’s case-law on prior authorisations to support the argument that Member States must foresee simplified procedures for allowing commercialisation of imported products.

According to that case-law, where a Member State requires prior authorisation, the authorisation procedure must respect minimum requirements. Thus, it must be ‘readily accessible and can be completed within a reasonable time, and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts’. A refusal can be made ‘only if such substance poses a genuine risk to public health’.  22 – See judgment of 5 February 2004, Commission v France (C‑24/00, EU:C:2004:70, paragraphs 26, 27 and 36). See also judgments of 16 July 1992, Commission v France (C‑344/90, EU:C:1992:328, paragraphs 9 and 10); of 23 September 2003, Commission v Denmark (C‑192/01, EU:C:2003:492, paragraph 46); and of 5 February 2004, Greenham and Abel (C‑95/01, EU:C:2004:71, paragraphs 35 and 36).

However, those cases are very different from the present one. They focused on situations where Member States required importers to obtain authorisation before marketing their product apparently without having first conducted a full risk assessment that would justify eventual prohibition. The Court required in such cases that importers were able to trigger a procedure that would involve proper consideration by Member States of the justifications for any restrictions. That procedure had to be effective and the decisions appealable.

The Court had taken a similar approach in earlier cases involving broad prohibitions on use of additives not based on a full risk assessment. Again in those cases, the Court has required the possibility for importers to request authorisation, and such requests can only be rejected after a full risk assessment.  23 – See, for example, judgments of 6 May 1986, Muller and Others (304/84, EU:C:1986:194, in particular paragraphs 24 and 26); and of 12 March 1987, Commission v Greece (176/84, EU:C:1987:125, paragraph 39).

However, those situations are completely different from ones where a detailed assessment of the public health justification for a particular restriction has already been carried out, and complies with the requirements of EU law in terms of scientific rigour.

In the ‘prior authorisation cases’ and ‘broad prohibition’ cases referred to above, the fundamental issue was not whether (or not) Member States foresaw specific procedural solutions national law, but rather that they ultimately had to base their restrictions on science.

Once a scientific risk assessment has been carried out, EU law does not require Member States to invent procedures providing for a repetition of that assessment, on the basis of the same evidence.

The above analysis assumes that the ‘mutual recognition procedure’ involves the Member State basically being asked to reread the same file to see if it comes to a different result. I do not consider that such an exercise is required by EU law.

The answer could, of course, be different if the Member State were indeed being asked to do something different. Whether such differences existed in the present case is a question of fact, to be ascertained by the national court. However, one specific possibility is worth highlighting here.

In my view, importers must certainly be able to present new scientific evidence that could lead to a reconsideration of the original restrictions. By ‘new scientific evidence’ I understand evidence post-dating the restrictions or otherwise not taken into account in the original assessment. Member States must give that evidence due consideration.

I would not describe that as a ‘mutual recognition procedure’. It appears to me rather more akin to a standard form of a new, fresh administrative review, commonly present in the national systems of administrative procedure: new facts came to light, which made the previously adopted administrative decision difficult to maintain for the future. Nonetheless, whatever such a procedure is called, a possibility must exist for importers to submit new evidence.  24 – This can be contrasted, for example, with a broad prohibition accompanied by a prior authorisation system where it is rather clear that a full review of existing evidence has not been conducted. See, in this sense, judgment of 16 July 1992, Commission v France (C‑344/90, EU:C:1992:328) at paragraph 7: this confirms a positive scientific assessment of the relevant substance but goes on to accept the national prohibition, subject to efficient authorisation procedures. See also paragraphs 13 to 15 of that judgment.

The existence of such a requirement is confirmed by several factors. Food law must be based on a full scientific risk analysis.  25 – Article 6(1) of Regulation No 178/2002. That requirement, in itself, clearly implies up-to-date science. I do not think that that expression could be read as meaning a full albeit outdated scientific risk assessment. That conclusion is, moreover, supported by references in the case-law to assessments on the basis of ‘the most recent results’ of scientific research.  26 – See, for example, judgment of 29 April 2010, Solgar and Others (C‑446/08, EU:C:2010:233, paragraph 69). Systemically, it is also confirmed by the existence in the Directive (as well as many other EU law acts) of mechanisms and procedures designed to ensure new scientific research is taken into consideration.  27 – Article 12 of the Directive; Article 22 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1).

Procedurally speaking, exactly how the requirement to consider new scientific evidence is fulfilled is a matter for Member States. However, in doing so, Member States must ensure that those procedures are effective. In that regard, the minimum conditions already well established by the Court in relation to prior authorisation systems for nutrients in food supplements and referred to above can, in my view, be applied mutatis mutandis. Thus, Member States must ensure that the procedure for assessing new scientific evidence is readily accessible, can be completed within a reasonable time,  28 – That does not imply any specific time frame. If there is indeed new evidence, Member States are expected to act with celerity but they must also have sufficient time to give due consideration to that evidence. and if it leads to refusal must be open to challenge before the courts.  29 – See above points 48 and 49.

It is up to the national court to determine whether, in this case, Noria was in a position to present such new evidence but was unable to do so effectively in the way outlined above.

In the light of the above, I propose to reply to the national court’s first question as follows: Article 34 TFEU and the principle of mutual recognition preclude a national rule, which prohibits importation of food supplements lawfully produced or marketed in another Member State, on the basis that those food supplements contain a nutrient in quantities exceeding a given maximum, where such maximum has been fixed without a prior scientific risk assessment guided by the criteria laid down in Article 5(1) and (2) of Directive 2002/46. Article 34 TFEU and the principle of mutual recognition require Member States to ensure that importers may seek revision of that prior risk assessment on the basis of scientific evidence not previously taken into account by the Member State. Procedures for reviewing such new scientific evidence must be readily accessible, completed within a reasonable time and the resulting decisions must be open to challenge before national courts.

Neither the national court nor any of the parties have referred to Regulation (EC) No 764/2008,  30 – Regulation of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ 2008 L 218, p. 21). also known as the ‘mutual recognition regulation’ (‘the Regulation’). For that reason, I assume it is not an issue in the main proceedings and will not consider it in detail.

Nonetheless, the Regulation does at least present some interest from a systemic point of view as the Commission has in the past stated that it applies to decisions based on national rules fixing maximum amounts of nutrients in food supplements.  31 – European Commission Enterprise and Industry Directorate-General Guidance document, ‘The application of the Mutual Recognition Regulation to food supplements’, Brussels, 1.2.2010, at point 4.2. Seen from this perspective, the Regulation confirms the general approach to the first question presented in this section.

Under the Regulation, one of the actions that must be taken by a Member State intending to adopt a decision prohibiting importation of products lawfully manufactured or sold in other Member States is to inform the operator concerned of the (public health) justifications for refusal, setting out supporting scientific evidence and allowing the operator to comment (see Article 6).

Thus, EU secondary law, in codifying what could be described as a ‘mutual recognition procedure’, aspires to impose rather limited procedural requirements on Member States. Effectively, if a decision to refuse importation is made, it must be reasoned and the operator must have had a chance to submit comments. The Regulation does not require a rerun of already executed risk assessments. It does not explicitly impose any time limit for the final decision. There is no obligation to foresee a specific provision in national law setting out the procedure.

To that extent, I consider that the Regulation provides further support that primary EU free movement law and the general principle of mutual recognition cannot in themselves impose detailed procedural requirements on Member States, in terms of adoption of specific mutual recognition provisions or procedures for ‘repeat reviews’ of scientific evidence. National law must, however, comply with the general requirements set out above in relation to the original assessment and allow for updating of that assessment on the basis of new scientific evidence (see point 56).

It is useful to distinguish at the outset between presentation and substance.

As set out above at point 29, Member States are free to set maximum amounts of vitamins and minerals in food supplements, until the Commission does so.

The real question of substance is whether a full risk assessment has been conducted on a case-by-case basis and taking into account, in particular, the Article 5 criteria.  33 – ‘Case-by-case’ should, in principle, be read as ‘nutrient-by-nutrient’ since restrictions must be based on real risk. However, it cannot be excluded that there is some justification for grouping nutrients for the purposes of scientific evaluation. See, on that point, judgment of 29 April 2004, Commission v Germany (C‑387/99, EU:C:2004:235, paragraphs 79 and 82), which envisages the grouping of substances in this way. See also my Opinion in Queisser Pharma (C‑282/15, EU:C:2016:589) at point 83. As long as that has been done, EU law does not contain specific rules on the way in which those maxima must be presented.

There is no requirement that maxima be presented nutrient by nutrient. There is no requirement that maxima be presented as absolute amounts (for example, in mg) as opposed to multiples of recommended daily allowances.

In replying to this question, Noria and the ESA basically argue that a full scientific assessment has not been carried out, and the way the maxima are presented proves (or at least confirms) that point.

Whether or not such a full scientific assessment has been carried out and how that is proven are questions of fact and evidentiary rules for the national court to resolve. However, I do not consider that the choice of a particular method of presentation can in itself constitute irrefutable proof that a full assessment was or was not carried out.

This conclusion is, moreover, clearly supported by the Court’s judgment in Commission v Germany.  34 – Judgment of 29 April 2004, C‑387/99, EU:C:2004:235. In that judgment the Commission contested a German rule which automatically classified products that contained three times the recommended daily dose of vitamins (the rule applied to a range of vitamins) as medicinal products. The Court condemned what it referred to as the ‘triple amount rule’, because it was not preceded by a pharmacological evaluation of each vitamin or group of vitamins. In doing so, the Court acknowledged that the evaluation ‘may correctly lead to the same result’. However, the reality was that such a case-by-case analysis had not been conducted.  35 – Judgment of 29 April 2004, Commission v Germany (C‑387/99, EU:C:2004:235, paragraphs 81 and 82).

I would add the following observations concerning the adequacy of the risk assessment.

First, as mentioned above, the risk assessment must, in principle, be carried out on a nutrient-by-nutrient basis. Some form of common assessment cannot be completely excluded, but would have to be duly justified.  36 – See above, footnote 32. In their observations, the French Government confirmed that the maxima were fixed on the basis of scientific opinions of the relevant French body, and annexed copies of those. I note that those opinions appear to cover some but not all nutrients for which maxima have been fixed and which appear in the Noria products (on the basis of the product descriptions contained in Noria’s observations).

Second, the risk assessment must be based on data of a certain quality. For example, Article 5 of the Directive refers to ‘generally accepted scientific data’. What this implies, in particular whether there is a need to refer to international scientific research, is further discussed under question 3.

Third, Noria, the Commission and the ESA’s observations on these questions refer to one of the Article 5 criteria in particular, namely the upper safe level. It is unclear whether upper safe levels were ever fixed for all the nutrients concerned.

Whether those levels have actually been fixed is a question of fact for the national court. It is the case that those levels constitute one of the Article 5 criteria and as such must, in principle, be taken into account in the fixing of maxima.  37 – Judgment of 29 April 2010, Solgar and Others (C‑446/08, EU:C:2010:233, paragraph 66).

That said, even where upper safe levels have not been established, it may still be possible for Member States to invoke the precautionary principle to justify protective measures. Thus, as confirmed by the Court in Solgar, if ‘scientific uncertainty persists as regards the existence or extent of real risks to human health … Member State may, in accordance with the precautionary principle, take protective measures without having to wait until the reality and seriousness of those risks are fully demonstrated. However, the risk assessment cannot be based on purely hypothetical considerations’.  38 – Judgment of 29 April 2010, Solgar and Others (C‑446/08, EU:C:2010:233, paragraph 67).

In the light of the above, I propose to reply to the national court’s second question as follows: Article 34 TFEU and the principle of mutual recognition preclude a national rule, which prohibits importation of food supplements lawfully produced or marketed in another Member State, on the basis that those food supplements contain a nutrient in quantities exceeding a given maximum, where such maximum has been fixed without a prior scientific risk assessment guided by the criteria laid down in Article 5(1) and (2) of Directive 2002/46. Where such a prior risk assessment has been conducted, the aforementioned principles and provisions of EU law do not prevent presentation of resulting maxima either (a) by group of two or more nutrients or (b) as multiples of reference intakes.