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OUTER HOUSE, COURT OF SESSION
[2008] CSOH 87
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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
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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.
