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You are here: BAILII >> Databases >> Scottish Court of Session Decisions >> Infant & Dietetic Food Association Ltd & Ors, Re Judicial Review [2008] ScotCS CSOH_87 (10 June 2008)
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Cite as: [2008] CSOH 87, [2008] ScotCS CSOH_87

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OUTER HOUSE, COURT OF SESSION

 

[2008] CSOH 87

 

     

 

 

 

 

 

 

 

 

 

 

 

OPINION OF LORD CLARKE

 

in the Petition of

 

(FIRST) THE INFANT AND DIETETIC FOOD ASSOCIATION LIMITED; (SECOND) JOHN WYETH & BROTHERS LIMITED; (THIRD) NUTRICIA LIMITED; AND (FOURTH) H J HEINZ LIMITED

 

Petitioners;

 

For

 

Judicial Review of a decision by the Scottish Ministers to make and lay before the Scottish Parliament the Infant Formula and Follow-On Formula (Scotland) Regulations 2007

 

 

­­­­­­­­­­­­­­­­­________________

 

 

 

Petitioners: Howie, Q.C., M V Ross; Maclay Murray & Spens LLP

Respondents: Crawford; Solicitor to the Scottish Executive

Interested parties: Mrs S Wolffe; Solicitor to the Advocate General for Scotland

 

10 June 2008

 

Introduction

[1] This petition for judicial review, which came before me for a first hearing, is concerned with the Scottish Ministers' implementation, by regulation, of a European Community Directive 2006/141/EC (hereinafter referred to as "the 2006 Directive") in relation to composition of labelling and marketing of infant formula and follow-on formula. The first named petitioners are a trade association who represent manufacturers of these products. The other petitioners are involved, in various ways, in the manufacture and sale of those products.

[2] The Regulations, which are the subject matter of the present petition, are the Infant Formula and Follow-On Formula (Scotland) Regulations 2007 (hereinafter referred to as "the 2007 Regulations"). Put briefly, the petitioners' complaint is that the Regulations, in that they provide that, as from 31 December 2007, a failure to comply with the Regulations regarding the labelling of infant formula and follow-on formula products will constitute, in Scotland, a criminal offence, were ultra vires. What is contended, on behalf of the petitioners, is that, having regard to the underlying Directive, which the Regulations purported to implement, a transitional period of some 2 years should have been provided, during which labelling of the containers of the products in question, could continue in accordance with the provisions of previous legislation regulating the matter, without any criminal offence being committed.

[3] The petition, as originally presented to the Court, set out a number of grounds of attack of the Regulations, which grounds related to the process of consultation which took place before the 2007 Regulations were enacted and alleged failures by the Scottish Ministers in respect of that process together with complaints of the defeat of certain legitimate expectations that arose thereafter. These grounds of attack were, in the event, not insisted on, and the petitioners were allowed to amend the petition to remove them from it.

[4] The issue between the petitioners and the respondents has come to be one of pure construction of what the Scottish Ministers were entitled to provide for in the 2007 Regulations in implementing the provisions of the 2006 Directive. I should add that during the discussion before me, a question arose as to whether or not the petitioners were seeking to attack, not only the labelling provisions of the 2007 Regulations, but also those provisions which deal with advertising of the relevant products. The petitioners were allowed to amend their petition to make it clear that, for present purposes at least, the attack was simply made against the provisions of the 2007 Regulations dealing with labelling.

[5] At the beginning of the hearing I was advised that there had been enacted for England and Wales regulations implementing the Directive, which had the same effect as regards the date from which non-compliant labelling would amount to a criminal offence. I was, furthermore, advised that the same position obtained in Northern Ireland where regulations had been enacted to the same effect in this respect. Proceedings had been raised both in England and Wales and Northern Ireland challenging the validity of the legislation in those jurisdictions. In both of those jurisdictions, the Court had suspended, ad interim, the regulations in question, pending a hearing on the merits of the applications to the Courts which challenged their validity. Against that background, the petitioners, in the present proceedings, on 24 January 2008, sought interim suspension of the Scottish regulations. The matter came before Lord Macphail who, while holding that the petitioners had a prima facie case, nevertheless, refused to grant interim suspension. On 29 February 2008, some few days after the conclusion of the first hearing before me, Mitting J, sitting in the Administrative Court in London, issued what I understand to have been an ex tempore judgment in which he upheld the present petitioners' application before that Court to have the regulations enacted for England and Wales declared invalid in purporting to bring into effect labelling requirements with effect from 31 December 2007 when the proper date was in fact 31 December 2009. My attention was subsequently drawn to the existence of that judgment when I had the present petition at avizandum. In due course a written and approved version of the judgment was supplied to me. I had the present case put out By Order so that the parties could address me, if so advised, on the decision in that case as it was clearly relevant to the issue that I had to decide. In the event none of the parties sought to make substantive submissions in relation to it. The petitioners simply commended its reasoning to me. Counsel appearing for the respondents, at the By Order hearing, advised me that it was not the intention of the Secretary of State for Health and the Welsh Ministers to appeal the decision of Mitting J. I will return to that decision in due course.

 

The Background to the Dispute

[6] There is some significant background to the passing both of the 2006 Directive and the 2007 Regulations, European law having regulated the subject matter of the 2006 Directive since 1991. In 1991 there was passed the Commission Directive 91/321/EEC. It laid down "compositional and labelling requirements for infant formula and follow-on formula intended for use by infants of good health in the Community" (Article 1.1). Articles 1, 2(c) and (d) defined "infant formulae" and "follow-on formulae". Article 2 of the Directive provided that:

"....the products referred to in Article 1(2)(c) and (d) may be marketed within the Community only if they conform to the definitions and rules laid down in this Directive".

Articles 3 to 7 specified requirements regarding the composition of the products in question and the naming and labelling of such products. Article 10 provided that:

"Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. Those provisions should be applied in such a way as to:

- permit trade in products complying with this Directive by 1 December 1992

- prohibit trade in products which do not comply with this Directive, with effect from 1 June 1994".

In the United Kingdom, this Directive was given effect to by the Infant Formula and Follow-On Formula Regulations 1995 (S.I.1995/77). Those Regulations came into force on 1 March 1995 which meant that the United Kingdom government were at least 9 months late in implementing that Directive.

[7] The 1991 Directive was subsequently amended on a number of occasions which, in turn, required amending the United Kingdom legislation. Commission Directive 94/4/EEC amended both the previous compositional and labelling requirements. The approach to be followed as regards implementation by Member States of these new provisions, as specified in the 1994 Directive, was the same as in the 1991 Directive apart from the dates provided. Thus the 1994 Directive provided by Article 2 as follows:

"Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 March 1997. They shall forthwith inform the Commission thereof. Those laws, regulations and administrative provisions shall be applied in such a way as to:

- permit trade in products conforming to this Directive no later than 1 April 1997,

- prohibit trade in products which do not comply with this Directive, with effect from 31 March 1999".

The United Kingdom government implemented the provisions of the 1994 Directive by the Infant Formula and Follow-On Formula (Amendment) Regulations 1997 and did so on 31 March 1999 - the last date specified in Article 2. The compositional requirements were amended by a further two Directives, namely Commission Directive 1999/50/EC on 25 May 1999 and Commission Directive 2003/14/EC on 10 February 2003. Neither of those Directives was concerned with labelling. Both of those last mentioned Directives contained provisions regarding implementation by Member States in identical terms to Article 10 of the 1991 Directive, save as to dates.

[8] The 2006 Directive, with which the present proceedings are concerned, recast the 1991 Directive and introduced further amendments to it. Articles 4 to 8 and 10 replaced the compositional requirements of Articles 3 to 6 of the 1991 Directive (as amended). Article 13 made amendments regarding labelling requirements. Article 18 of the 2006 Directive is concerned with implementation and it is its provisions which are at the heart of the dispute before me. Article 18 provides:

"1. Member States shall adopt and publish, by 31 December 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with Articles 2, 3 and 5 to 17 and Annexes I to VII. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions in such a way as to:

- permit trade in products complying with this Directive by 1 January 2008 at the latest,

- without prejudice to Article 17, prohibit, with effect from 31 December 2009 trade in products which do not comply with this Directive ...."

The striking similarity which exists between the wording of Article 18, just set out, and the wording of the implementation provisions in the previous Directives dealing with this subject matter stretching back to the original 1991 Directive may be noted. When it came to implement the 2006 Directive, devolution, of course had taken place within the United Kingdom, and the subject matter of the Directive, relating as it did to a devolved matter, it was necessary for the Scottish Ministers to produce regulations to give effect to the Directive. These are the 2007 Regulations.

 

Submissions for the Petitioners

[9] In opening his submissions for the petitioners, senior counsel advised the Court that the second and third petitioners enjoy more than 95% of the market share of the products in question in Scotland. The second to fourth named petitioners trade in the products in other parts of the European Union. The 2007 Regulations had drawn a distinction between the date whereby compliance with the compositional requirements, on the one hand, and the labelling requirements on the other hand had to be met. The petitioners' position was that the underlying Directive drew no such distinction. The transitional periods provided for in Article 18 of the Directive covered both compositional and labelling requirements. The Regulations, in making such a distinction, were, it was contended, ultra vires of the Scottish Ministers who, under section 57 of the Scotland Act 1998 were obliged to act in accordance with European Union law. There was no room for the respondents to pray in aid the provisions of section 101 of the Scotland Act to the effect that the provisions could be read as being intra vires of the Ministers. What was required by Article 18 was that Member States should adopt and publish measures which transposed the provisions of the Directive into domestic law. The measures so adopted required to be effective in the sense discussed in the case of Von Colson v Land Nordrhein-Westfahlen [1984] ECR 1891. The decision in that case was to the effect that, while Member States were free to choose the ways and means of ensuring that a Directive is implemented, that freedom did not affect the obligation, imposed on all the Member States to which the Directive is addressed, to adopt, within the framework of their national legal systems, all the measures necessary to ensure that the Directive is fully effective, in accordance with the objective which it pursued. It was submitted, however, that where the domestic legislation containing the effective measures was passed by the date provided for in the Directive in question, it was possible for that Directive to provide for a period thereafter before full implementation of the legislation in question was required. This approach to matters in European legislation was discussed in "Directives in EC law" (Second Edition) by Sacha Prechal where, at page 18, it is noted "Yet Directives do allow the Member States a certain period, varying from a few months to several years, within which the Directive must be implemented". At page 19 the writer observes "Furthermore, it must be noted that certain Directives provide for different implementation periods: a shorter period for the adoption of transposition measures and a longer one within which the factual situation must be achieved, i.e. for their application". Article 18 of the 2006 Directive, it was submitted, clearly provided, in its second part, beginning with the words "They shall apply" for the postponement of the implementation of the relevant legislation in certain respects. The question was "In what respects?". As will be seen, in the discussion before me, battle was joined between the parties as to the answer to that question, under reference to what was embraced in the words "trade in products". Regulation 31 of the 2007 Regulation, in its language, does not allow for non-compliance with labelling requirements set out in Regulations 17, 18 and 19, up until 31 December 2009. They do allow for non-compliance with the compositional rquirements by not revoking existing regulations regarding composition until 31 December 2009. The respondents do not dispute that that is the effect of the 2007 Regulations and go further and say that that was the intention of the Scottish Ministers in producing the regulations in question.

[10] Senior counsel for the petitioners drew my attention to the provisions of Article 17 of the 2006 Directive which provides for a specific and separate application date for the requirements set out in Article 7(1) and (2) in respect of "dietary foods for special medical purposes intended specifically for infants". It provides that those requirements shall not apply "mandatorily" until 1 January 2012. He noted that Regulation 30 of the 2007 Regulations, dealing with the amendment of Foods for Special Medical Purposes (Scotland) Regulations 2000, does not appear to address the provisions of Article 17 of the Directive.

[11] Reverting to address the meaning of the expression "trade in products" in the first indent of Article 18, senior counsel for the petitioners reminded me that the first appearance of that phrase, in this context, was in Article 10 of the 1991 Directive which I have set out above. Senior counsel for the petitioners drew my attention to the use of the word "marketed" in Article 2 of the 1991 Directive. It was the position of the petitioners that the expression "trade in products" meant commerce in the whole process of making the product, putting it in its container and labelling it, or as it was also put, "what is traded on to the end user". The argument on the other side that the expression was restricted to the product content should be rejected. When the Directive sought to refer only to the compositional element, it had done so in a different way, for example in Article 7. The Directive was prohibiting trade in "materials" which, in any respect, were governed by its provisions and which did not comply with its provisions. The permission to continue to trade as before in accordance with the existing law, for a specific period, covered the whole range of activities eventually to be prohibited if not complying with the requirements of the Directive. This approach to the construction of the relevant phrase made commercial sense. It meant, it was said, that manufacturers of the products in question were given time to put not only their manufacturing arrangements into compliance with the Directive, but also the associated labelling and presentational arrangements in relation to the products. In other words, the Directive was allowing for product already in stock to be depleted, including its packaging. What was referred to as the "architecture of the Directive" was said to support this construction of the phrase. Reference was made to other terms in the Directive which, it was submitted, pointed to the broad approach to the construction of the phrase, put forward on behalf of the petitioners, being correct. For example, reference was made to the word "marketed" in Article 3, "manufactured" in Article 8 and "sold" in Article 11. The respondents' position would have been met if the word "manufacture" had been used in Article 18 instead of the expression "trade in products". Reference was made to the French version of the Directive which, it was said, supported the construction placed on the phrase by the petitioners. I was also referred to legislation implementing the Directive which used the phrase "mise dans le commerce" in transposing the effect of Article 18 into Belgian law.

[12] Senior counsel for the petitioners in support of his submissions prayed in aid the doctrine of proportionality. If he was wrong in his submissions, he said, it meant that there had been no transitional period provided for compliance with the new provisions regarding labelling. It was well recognised, in European law, that in cases like the present, undertakings required to be given some time to prepare and adapt their business to the requirements of the new legislation. Reference was made again to the textbook Prechal: "Directives in EC Law" cited supra at page 30 and the case of Societa Italiana Petroli SpA (IP) v Borsana SrL (1998) E.C.R.I-8597, particularly at 8638. What the petitioners argued for was that the Directive, properly construed, required a transitional period to be provided in respect of all the new regulations set out in the Directive (unless otherwise expressly provided for). Persons such as the petitioners had a right to continue to trade in product which in any respect did not comply with the 2006 Directive provisions for a 2 year period provided they complied with the 1995 Regulations, as amended. That right could not be taken away from them when the Scottish Ministers came to transpose the Directive into the law of Scotland. Insofar as the Scottish Ministers have purported to do so, they had acted unlawfully. Section 101 of the Scotland Act could not save them from that being the position because of the clarity with which the matter had been addressed in Article 18.

[13] Senior counsel then turned to address the Court on what remedies should be available to the petitioners if their arguments regarding the invalidity of the Regulations were to be accepted. They simply sought partial reduction of the 2007 Regulations insofar as they related to enforcement measures in respect of labelling. Reduction was required because it, unlike suspension, would have retrospective effect. I was referred to section 102 of the Scotland Act 1998. It provides as follows:

"102(1) This section applies when any Court or Tribunal decides that -

(a) an Act of the Scottish Parliament or any provision of such an Act is not within the legislative competence of the Parliament, or

(b) a Member of the Scottish Executive does not have the power to make, confirm or approve a provision of subordinate legislation that he has purported to make, confirm or approve.

(2) The Court or Tribunal may make an order -

(a) removing or limiting any retrospective effect of the decision or

(b) suspending the effect of the decision for any period and on any conditions to allow the defect to be corrected.

(3) In deciding whether to make an order under this section, the Court or Tribunal shall (among other things) have regard to the extent to which persons who are not parties to the proceedings would otherwise be adversely affected.

(4) Where a Court or Tribunal is considering whether to make an order under this section, it shall order intimation of that fact to be given to -

(a) the Lord Advocate and,

(b) the appropriate Law Officer, where the decision mentioned in subsection (1) relates to a devolution issue (within the meaning of Schedule 6),

unless the person to whom the intimation would be given is a party to the proceedings.

(5) A person to whom intimation is given under subsection (4) may take part as a party in the proceedings so far as relate to the making of an order...."

It was submitted that if the Court were to consider an order under this section was appropriate, that would not stand as an alternative to reduction. Orders under this section were, it was said, steps to be taken in the interim.

[14] Finally, senior counsel for the petitioners advised the Court that they did invite the Court to seek a preliminary ruling on the issue from the European Court of Justice.

 

Submissions for the Respondents

[15] Counsel for the respondents invited me to refuse the orders sought by the petitioners. In the event, however, of the Court coming to the view that the petitioners' approach to the question of construction of the relevant provisions was correct, the Court should employ the provisions of section 102(2)(b) of the Scotland Act and suspend the effect of the regulations for a period to enable the Scottish Ministers to consider their position. The alternative would be for the Court simply, in the first instance, to issue an opinion on the matter of principle raised and make no other order before being addressed by parties.

[16] Junior counsel for the respondents advised me that the 2007 Regulations had been notified to the European Commission who had said that they had noted the United Kingdom approach to implementation but did not express any view as to whether they approved with that approach or not.

[17] Turning to her substantive submissions, counsel said it was common ground between the parties that the Member States were left with a discretion as to the means to be adopted to provide effective implementation of the Directive provisions. It was not disputed by the petitioners that the Ministers required to bring the Regulations into effect by 31 December 2007 if they were comply with their obligations under the Directive. It was submitted, as it was put, that "any exception to that general requirement ought to be construed narrowly". The question raised in these proceedings really came to be this, "Did the obligation to implement the Directive with effective measures in place require the Scottish Ministers to inhibit non-compliant labelling by the end of December 2007?". The position of the Scottish Ministers was that the answer to that question had to be in the affirmative. The Directive, it was said, sought to achieve a number of results or purposes. Only when one properly identified those results or purposes could one correctly answer the question as to whether the phrase "trade in products" embraced everything from manufacture of the goods in question to their packaging and labelling, or whether the phrase had a narrower meaning. When the purpose of the Directive was properly identified, it was clear, it was said, that the phrase "trade in products" could not be treated as synonymous with "marketing of products" or as synonymous with "putting products on the market". The postponement provided for in the Directive regarding enforcement of the necessary Regulations did not apply to trading in products with non-compliant labelling. Put another way, the Directive, it was said, required that the Regulations covering "marketing" had to be complied with from 31 December 2007. That being so, it was not ultra vires of the Scottish Ministers to have made regulations providing that it was an offence to market products with labels not complying with the 2007 Regulations from 31 December 2007.

[18] Having made the foregoing submissions, junior counsel for the respondents sought to address what she claimed the purpose of the Directive was. At the broadest level she said it was a measure to protect the health of infants. That purpose was to be achieved through a number of means. The promotion of human health was given a high place in community law. Reference was made to Article 152 EC which provides:

"(1) A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities.

Community action which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health ...."

Reference was also made to the case of ABNA Ltd & Others [2004] CMLR 40. Human health considerations, it was said, took precedence over economic considerations. That was the context against which, the Directive to be considered in the present case, should be addressed. The purpose of the Directive was not to protect the petitioners' interests. It did not provide them with any rights nor did it seek to promote their administrative convenience. Recital 4 of the 2006 Directive expressly referred to the need to safeguard the health of infants during the first months of life. The underlying policy of the Directive was the promotion of breastfeeding. In this respect reference was made to Recital 27 of the 2006 Directive. It provides:

"In an effort to provide better protection for the health of infants, the rules of composition, labelling and advertising laid down in this Directive should be in conformity with the principles and aims of the International Code of Marketing of Breast-Milk Substitutes adopted by the 34th World Health Assembly, bearing in mind the particular legal and factual situations existing in the Community".

It was pointed out that in this recital, composition, labelling and advertising were referred to together with no apparent hierarchy among them. The World Health Organisation code referred to in the 27th Recital was drawn to my attention by counsel. In Article 1 of the Code it is provided:

"The aim of this Code is to contribute to the safe and adequate nutrition for infants, by the protection and promotion of breastfeeding, and by ensuring the proper use of breast-milk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution".

Article 2 of the Code provides:

"The Code applies to the marketing, and practices related thereto, of the following products: breast milk substitutes, including infant formula; or other milk products, foods and beverages, including bottle fed complementary foods, when marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breast milk; feeding bottles and teats. It also applies to their quality and availability, and to information concerning their use".

In Article 3 of the Code "label" is defined as meaning "any tag, brand, marks, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to, a container...of any products within the scope of this Code". "Marketing" is defined as meaning "product promotion, distribution, selling, advertising, product public relations, and information services". I was also referred to Article 9 of the Code which deals with labelling and, in particular, what should be included in labels of infant formula. The imperative from the provisions of this Code, it was said, was clear - the protection of children - and the code addressed the requirements for producing good information in that respect. Recital 28 of the 2006 Directive took up the theme.

[19] Having regard to the matters just referred to and the overriding purpose of the 2006 Directive, seen in the light of them, junior counsel for the respondents accepted that marketing of products included labelling and all the activities involved from manufacture to sale, but, she submitted, a distinction fell to be drawn between the word "marketing" and the phrase "trade in products". In support of that submission she referred to the terms of Articles 9, 11, 12 and 13 of the 2006 Directive which deal with labelling, the wording of which, she ventured to suggest, pointed towards the phrase "trade in products" as not being intended to cover all the activities regulated by the Directive. It was, nevertheless, accepted by junior counsel that in another context the phrase "trade in products" could have a wider meaning and that that meaning would embrace the activity of labelling the products. The approach to the construction of the phrase advanced on behalf of the respondents was said to be fully supported by the provisions of Article 17 of the 2006 Directive. The fact this specific class of goods addressed in that Article had ascribed to it its own time by which the compositional regulations had to be met showed, it was suggested, that the Directive did set out different dates to be met and different timescales. Somewhat lightly, it has to be said, junior counsel for the respondents suggested that because the petitioners were not seeking to attack now the regulations insofar as they provided for the enforcement of the advertising provisions from 31 December 2007, that might involve an implicit recognition, by them, that the Directive required separate results at separate and different times. Put another way, this submission came to be that the petitioners were not putting forward a case based truly on principle, but on what was convenient for them. Counsel for the respondents then somewhat turned that proposition on its head by saying that because labelling and advertising were closely related, the present challenge could invoke an underlying challenge to the advertising regulations. Advertisement might include some non-compliant labelling. The close relationship between advertising and labelling could be seen in Regulation 2(2) of the 2007 Regulations and section 53 of the Food Safety Act 1990 which defined the word "advertisement" as including any label.

[20] The petitioners' position would result in the most unsatisfactory results if correct. It meant that products complying with the compositional requirements could be sold with non-compliant labelling until the end of 2009. That had the potential of the public being misinformed.

[21] The last substantive point made on behalf of the respondents in support of their position was this. Article 18 was a transitional provision dealing with food safety. Its language was to be contrasted with the language of transitional provisions of other Directives and regulations dealing with such matters. So for example in Directive 2006/52/EC dealing with food additives and sweeteners, Article 3 provides:

"Member States shall bring into force by 15 February 2008, the laws, regulations and administrative provisions necessary to comply with this Directive in order to:

(a) permit trade in and the use of products complying with this Directive by 15 February 2008;

(b) prohibit trade in and use of products which do not comply with this Directive by 15 August 2008.

However, products placed on the market or labelled before 15 August 2008 which do not comply with this Directive may be marketed until stocks are exhausted".

The language employed in Article 3 in that Directive from the words "however products placed on the market" would, it was submitted, be the kind of language one would have expected in Article 18 of the 2006 Directive if the petitioners' arguments were correct. Again in Regulation (EC) No.1925/2006 which deals with the addition of vitamins and certain other substances to foods, Article 18 provides:

"This Regulation shall enter into force on 20th day following that of its publication in the official journal of the European Union.

It shall apply from 1 July 2007.

Foods placed on the market or labelled prior to 1 July 2007 which do not comply with this Regulation may be marketed until their expiry date, but not later than 31 December 2009".

The use of that language in Article 18 of that Regulation, contrasted with the language in Article 18 of the 2006 Directive it was submitted reinforced the respondents' position on the matter.

[22] Summarising the respondents' position on the matter, junior counsel said that for the reasons advanced any delay in the enforcement of the provisions of the Directive, permitted or required by it, related to the compositional requirements in relation to the products in question that, as she put it, being "product traded in" as opposed to "product being marketed". The respondents were required to have in place measures prohibiting, from 31 December 2007 marketing of products not in compliance with the Directive's requirements. Counsel for the respondents accepted that other countries in enacting their legislation to put into effect the Directive had not adopted the position adopted, not only by the respondents, but also the relevant Ministers in England and Wales and in Northern Ireland in this regard. The matter, however, was one for the Court ultimately to determine what the wording of the Directive required and permitted. The petitioners' interests were sufficiently satisfied by giving them a period of time to "catch up" with the compositional requirements of the Directive. The measures in the 2007 Regulations were proportionate having regard to the objective pursued in the Directive. Those measures were also necessary to achieve the objective of that Directive - reference was made to ABNA Ltd & Others [2004] 2 CMLR 40. The petition should be dismissed. Counsel for the respondents was at one with senior counsel for the petitioners in not moving the Court to seek a preliminary ruling.

[23] Counsel for the Advocate General as an interested party, adopted the submissions made on behalf of the respondents.

 

Decision

[24] As I have already indicated Mitting J, in the High Court in England, has already held, in a case brought by the present petitioners, that the Regulations passed to give effect in England and Wales to Article 18 of the 2006 Directive and which are, to all intents and purposes to the same effect as the Scottish Regulations, are invalid insofar as they prohibit labelling of the relevant products which do not comply with the new labelling requirements with effect from 31 December 2007. The arguments advanced before the Court in that case seem, from the judgment at least, to have been, perhaps, somewhat differently focused than those advanced before me. What the debate before me, as has been seen, focused on largely was the construction to be placed on the whole phrase "trade in products". The concentration in the discussion before Mitting J, seems, on the other hand, to have been on the word "products" itself. In any event, his Lordship at paragraphs 42 and 43 of his judgment had this to say:

"No material has been put before me to suggest that the Commission or its draftsmen had in mind the need for differently timed provisions for compositional and labelling requirements and I can see no sensible reason why the Commission should have had in mind any such difference.

The history of community acts in this field, including the Travaux Préparatoires, in my judgment point only one way. They support the proposition that where the draftsmen used the word 'products' in Article 18 he had in mind not just the composition of the formulae, but their packaging and labelling as well. Accordingly, and as a matter of construction, the prohibition on trade in products which did not comply as regards labelling with the provisions of the 2006 Directive only comes into effect on 31 December 2009. It follows, therefore, that the Regulations have not accurately transposed into English law, nor have the Welsh Regulations transposed into Welsh law, the requirements of the second indent of Article 18".

I have reached the same conclusion with regard to the validity of the Scottish Regulations in relation to labelling.

[25] It was common ground before me that the United Kingdom Regulations following on the 1991 Directive and the amending Directives of 1994, did not make any distinction as between the compositional and labelling requirements as to the implementation periods. That was so, even though, as pointed out by Mitting J in his judgment, the relevant provisions of the earlier Directives were in identical language, save for the dates in question, as that to be found in Article 18 of the 2006 Directive. The question certainly arises around, in my judgment, and requires to be answered, as to what changed, as a result of the 2006 Directive being enacted, which resulted, as it was contended, on behalf of the respondents for a distinction to be drawn between the compositional requirements and the labelling requirements as regards implementation measures. Junior counsel for the respondents, for all her brave efforts, did not, in my opinion, ever provide me with any satisfactory answer to that question. Counsel for the respondents placed some emphasis, in her submissions, on the requirement of Member States to bring the provisions of the Directive into law, by 31 December 2007 and, in that situation, she argued that the indents to Article 18 provided, as it were, a "derogation" from that strict requirement and that any such derogation should, in turn, be construed strictly. I disagree. As Mitting J at paragraph 32 of his judgment said:

"Directives do provide for different implementations periods; a shorter period for the transposition of measures into law and a longer one in which the factual situation presented must be achieved".

I agree with that statement and also, as his Lordship observed, that "that is precisely the technique used by the draftsmen here". I was not provided with any reference to the travaux préparatoires in relation to the 2006 Directive. Mitting J apparently was and, at paragraphs 38 and 39 of his judgment he states:

"38. In this case earlier drafts of the 2006 Directive provided for different dates for the bringing into force or adoption and publishing of laws, regulations and administrative provisions necessary to bring the Directive into force".

The second indent stated:

"They shall prohibit, with effect from (X + 2 years) trade in products which are not in conformity with Articles ...."

The Articles included Article 8 which in the then existing draft dealt with labelling. Clearly the draftsmen of the earlier drafts had in mind the meaning of "products" which included the labelling of the products.

"39. By March 2006 the drafting changed. The second indent now read:

They shall prohibit, with effect from (12 months after the last day of the month of publication plus 2 years) trade in products which are not in conformity with this Directive.

This was nearly the same formula which had been used in the 1991 and 1996 LSC 7 Directives and which found its way into Article 18 of the 2006 Directive".

With respect to his Lordship the reference to the 1996 Directive should be a reference to the 1994 Directive. His Lordship then at paragraph 41 stated:

"41. In my judgment it is clear what occurred in the drafting of this Directive. The draftsmen had in mind that products in the context of what became Article 18 included the labelling of products, but chose to achieve transposing requirements that covered both the formula, its packaging and its labelling, in a simpler phrase which had been used to like effect in the two earlier Directives".

That conclusion, in my respectful judgement, appears to be entirely justified. Counsel for the respondents in the present case accepted that the phrase "trade in products" was capable of embracing the activity of labelling the products. She was right to do so. In my judgement, the phrase as a matter of ordinary English language means engaging in the sale, purchase or exchange of the goods in question for profit. Where the goods are customarily sold in containers with labels what is sold is goods and their labelled containers. Nothing in the French version of the Directive would, to my eyes, suggest that the ordinary use of that phrase in the English language, as I have just defined it, would require to be modified. Even if the concentration requires to be more focused, as it was in the English proceedings, on the word "products" itself, the same result, in my judgement, is reached. It had been argued before the Court, in the English case, on behalf of the English and Welsh Ministers that the word "products" should be equiparated with the word "formulae". The Court accepted that certain of the 2006 Directives provisions provided formidable support for that proposition. Certain parts of Article 13 clearly use the word "formulae" and the word "products" interchangeably. It was noted, however, that in Article 13(8)(a) it is provided:

"The requirements, prohibitions and restrictions referred to in paragraphs 3 to 7 shall apply to:

(a) ...their shape, appearance or packaging, the packaging material used, the way in which they are arranged and the setting in which they are displayed;"

Mitting J then observed, at paragraph 28 of his judgment:

"Infant and follow-on formulae do not have a shape, as the Directive makes clear they are a powder which is put into useable form by the addition of water. When using the word 'products' in Article 13.8(a) the draftsman clearly had something else in mind".

His Lordship then went on to refer to provisions of Article 14.3 which is to the following effect:

"Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the healthcare system or health workers".

It was the view of the Court that "the products there referred to plainly include at least packaging. Otherwise how could they be equated to samples?". I gratefully adopt the reasoning of Mitting J in relation to these matters. In the argument before me counsel for the respondents simply failed to provide me with any persuasive reason as to why the phrase "trade in products" should be construed in the narrower way she suggested. It has not been so construed by the United Kingdom authorities in previous legislation designed to address the very same matters as arise now under Article 18 of the 2006 Directive. No other Member State has apparently shared the view, adopted on behalf of the respondents in this case, that the labelling requirement, by virtue of the provisions of the Directive, must be made enforceable in domestic law from 31 December 2007, having regard to the wording of Article 18 of the 2006 Directive. In my view the wording of Article 18, applying a purposive approach to its construction, simply does not require the construction to be placed upon it advanced on behalf of the respondents. The construction placed upon it by the respondents is in my judgement wholly eccentric and wrong. The fact that in the other Directive and Regulation referred to by counsel for the respondents dealing with food additives and vitamins other language was used which would not allow for the construction in relation to labelling which the respondents contend for the present case is, in my judgement, nothing to the point. The task is for the Court to place the proper construction on the actual words used in Article 18 of the 2006 Directive.

[27] For the reasons given, the 2007 Regulations, in relation to the enforcement of the labelling requirements are invalid.

[28] As was ultimately urged upon me, by counsel for all parties, I shall have the case put out By Order for discussion as to what orders should be pronounced in the light of this Opinion.

 

 

 

 


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