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	England and Wales High Court (Administrative Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> The Infant and Dietetics Foods Association Ltd., R (on the application of) v The Welsh Ministers [2008] EWHC 575 (Admin) (29 February 2008) URL: http://www.bailii.org/ew/cases/EWHC/Admin/2008/575.html Cite as: [2009] Eu LR 1, [2008] EWHC 575 (Admin)

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IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT

		Royal Courts of Justice Strand London WC2
		29th February 2008

1. MR JUSTICE MITTING: The Infant Formula and Follow-on Formula England Regulations SI 2007/3521 were made on 13th December 2007 and laid before Parliament on 20th December 2007. They were approved pursuant to the negative resolution procedure so as to come into effect except for the purpose of revoking predecessor regulations SI 1995/77 on 11th January 2008.
2. The claimant is a company limited by guarantee representing the interests of manufacturers of infant formula and follow-on formula. It challenges the lawfulness of part of the Regulations by judicial review proceedings commenced by the issue of a claim form on 9th January 2008. I have given permission for judicial review on the challenge advanced by Mr Beloff QC on behalf of the claimant in a rolled up hearing starting yesterday and concluding today.
3. Implementation of the Regulations and corresponding Welsh Regulations was stayed pursuant to an interim order of Forbes J on 11th January 2008. Baby Milk Action ("BMA") and National Childbirth Trust ("NCT") were given permission by Forbes J to lodge evidence or written submissions on 28th January 2008. BMA have served, and I have read, written representations: NCT have not. BMA's written representations do not address the critical legal questions which I have to answer and are accordingly of limited assistance to me in doing so.
4. I have today heard from Patty Rundell, the Policy Director of BMA and a person with senior positions in other groups similarly aligned, who has emphasised to me the importance of compliance with the labelling and informational requirements of the Directive. Again her remarks, though courteously and economically expressed, were not directed in the main to the principal legal questions which I must answer.
5. The Regulations pass into English law Commission Directive 2006/141/EC of 22nd December 2006 on infant formulae and follow-on formulae pursuant to an enabling power to be found in Section 17(1) of the Food Safety Act 1990. The Directive recast and the Regulations prospectively revoke earlier provisions dealing with the same subject matter. Commission Directive 91/321/EEC of 14th May 1991 on infant formulae and follow-on formulae was the first. It laid down "compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants of good health in the Community" (Article 1.1). It defined infant formulae and follow-on formulae in Articles 1, 2(c) and (d) respectively:

"'infant formulae' means foodstuffs intended for particular nutritional use by infants during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons.

(d)'follow-on formulae' means foodstuffs intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons."

6. Article 2 required Member States to ensure 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."

7. Compositional criteria were specified in Articles 3 to 6. Naming and labelling requirements was specified in Article 7. Restrictions on advertising and promotion and the provision of information to pregnant and nursing mothers were contained in Articles 8 and 9. Article 10 dealt with "implementation by Member States":

"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 1June 1994."

8. The United Kingdom gave belated effect to this Directive by the Infant Formula and Follow-on Formula Regulations 1995 (SI 1995/77) which came into force on 1st March 1995 at a minimum nine months after the required date; and if the argument of Mr Lasok QC for the defendant is correct (as to which more later) some of these provisions were nearly three years and nine months late.
9. The 1991 Directive was amended as to both compositional and labelling requirements by Commission Directive 94/4/EC. Article 2 dealt with implementation in identical words to Article 10 of the 1991 Directive, save as to dates:

"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."

10. The United Kingdom implemented its provisions by the last date specified in Article 2 on 31st March 1999 by the Infant Formula and Follow-on Formula (Amendment) Regulations 1997.
11. The 1991 Directive was twice further amended as to compositional requirements only, including the presence of pesticide residues by Commission Directives 1999/EC/50/EC on 25th May 1999 and 2003/14/EC on 10th February 2003. The 1999 Regulations contain provisions identical to Article 10 of the 1991 Regulation save as to date, with an end date of 1st July 2002. The 2003 Directive contain materially identical, though slightly differently ordered, provisions with an end date of 6 March 2005. I have not been shown by what date those provisions were brought into force in the United Kingdom or England and Wales or England, but as they do not concern labelling they are of no direct relevance.
12. The 2006 Directive had two purposes: to "recast" the amended 1991 Directive in the interest of clarity, and to introduce further amendments to it (Recital 2). Article 1 defined its scope in identical terms to Article 1 of the 1991 Directive. Articles 2(c) and (d) amended the definitions of infant formulae and follow-on formulae:

"(c) 'infant formulae' means foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of the appropriate complementary feed.

(d) 'follow-on formulae' means foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of this of this category of such infants."

Thus, the earlier requirement for infant formulae to relate to the first four to six months of life was replaced by one which referred to the first months of life; and for "aged over four months" there was substituted "when appropriate complementary feeding is introduced" in the case of follow-on formulae. Article 3, replicating Article 2 of the 1991 Directive, provides:

"Infant formulae and follow-on formulae may be marketed within the Community only if they comply with this Directive."

13. Articles 4 to 8 and 10 replicate the compositional requirements of Articles 3 to 6 of the 1991 Directive (as amended). If there are any amendments they are not material to this claim. Articles 11 and 12 deal with the naming in Community languages of infant formulae and follow-on formulae. Article 13 deals with labelling:

"1. The labelling shall bear, in addition to those provided for in Article 3(1) of Directive 2000/13/EC, the following mandatory particulars:

(a) in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast fed;

(b) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of six months, that it should form only part of a diversified diet, that it is not to be used as a substitute for breast milk during the first six months of life and that the decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, based on the individual infant's specific growth and development needs;

(c) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use;

(d) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol and carnitine, expressed in numerical form, per 100 ml of the product ready for use;

(e) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage.

2. The labelling may bear the following particulars:

(a) for infant formulae and follow-on formulae the average quantity of nutrients mentioned in Annex III when such declaration is not covered by paragraph 1(d) of this Article, expressed in numerical form, per 100 ml of the product ready for use;

(b) for follow-on formulae in addition to numerical information, information on vitamins and minerals included in Annex VII, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use.

3. The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast feeding.

The use of the terms "humanised", "maternalised", "adapted", or similar terms shall be prohibited.

4. The labelling of infant formulae shall, in addition, bear the following mandatory particulars, preceded by the words "Important Notice" or their equivalent:

(a) a statement concerning the superiority of breast feeding;

(b) a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care.

5. The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation.

6. The labelling of infant formulae may bear nutrition and health claims only in the cases listed in Annex IV and in accordance with the conditions set out therein.

7. Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between such products so as to avoid any risk of confusion between infant formulae and follow-on formulae.

8. The requirements, prohibitions and restrictions referred to in paragraphs 3 to 7 shall also apply to:

(a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed;

(b) advertising."

14. The following changes are introduced by comparison with Article 7.2 to 7.7 of the amended 1991 Regulations. They are helpfully summarised in the second witness statement of Claire Boville, a senior official in the Food Standards Authority. Article 13.1(b) of the Directive requires that the label on follow-on formulae shall bear a statement to the effect that,

"it is not to be used as a substitute for breast milk during the first six months of life",

The equivalent wording in the 1991 Directive was "four months."

15. The same provision also requires that the label on follow-on formulae shall bear a statement that,

"the decision to begin complementary feeding should be made only on the advice of independent persons."

There was no equivalent provision in the 1991 Directive.

16. Article 13(1)(e) of the Directive requires that the label on infant formulae and follow-on formulae must bear instructions as to the appropriate preparation, storage and disposal of the product. The equivalent wording in the 1991 Directive addresses preparation only.
17. Article 13.6 of the Directive provides that only certain nutrition and health claims may be made in respect of infant formulae and if they are made they must comply with conditions set out in Annexe 4. The equivalent wording in the 1991 Directive is identical, but the Annexe is altered.
18. Article 13.7 of the Directive provides, for the first time, that:

"Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between such products so as to avoid any risk of confusion between infant formulae and follow-on formulae."

(Which is of particular concern to Ms Randall).

19. Articles 14 and 15 replicated Articles 8 and 9 of the 1991 Directive. Article 18 deals with implementation and is the subject of this claim:

"(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 1January 2008 at the latest.

- ... Prohibit, with effect from 31 December 2009 trade in products which do not comply with this Directive.

..."

20. The 2007 Regulations implemented in slightly different order but in almost identical words the provisions of the 2006 Directive. The requirements of Article 13 were broken down into those relating to infant formulae which are contained in Regulation 17, and follow-on formulae which are contained in Regulation 18. Article 13.7 is replicated in Regulation 19. It is not necessary to set out the text of the Regulations.
21. The legislative technique to secure compliance with the labelling requirements is to prohibit the marketing of "infant formula" and "follow-on formula" which "contravenes or fails to comply with" Regulations 17, 18 and 19 amongst others (Regulation 3(1) and (2)). Failure to comply with Regulation 3 is an offence liable on summary conviction to a fine not exceeding level 5 on the standard scale.(Regulation 28(1)).
22. Mr Lasok QC seeks to uphold the lawfulness of the Regulations as regards the implementation of their labelling provisions, by reference to six propositions. First, the word "products" is used in one sense only in the recitals and in the operative articles of the Directive; secondly, "products" means "formulae"; thirdly, when the word "products" is used in Article 18 it has the same meaning - "formulae"; fourthly, "adopt" and "publish" means to bring into effect so as to be immediately enforceable in Member States, save to the extent that is expressly stated elsewhere in Article 18; fifthly,the second indent in Article 18 only applies to Formulae; sixthly and finally, the second indent does not apply to other provisions of the Directive, for example labelling and marketing.
23. The first two of those submissions finds powerful support in the text of the Directive. Without setting them out in full, reference to Recitals 4, 6, 13 and 23 and to Articles 3, 9, 10.1, 10.4, 13.1(b) to (e), 13.2(a) and (b), 13.3, 13.4(b), 13.5 and 13.7 make his point. It is shown at its strongest in those articles which deal together with formulae and labelling: Article 13.3:

"The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast feeding."

24. Article 13.5:

"The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation."

25. Article 13.7:

"Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between such products so as to avoid any risk of confusion between infant formulae and infant follow-on formulae."

26. Those Articles demonstrate that in that context the draftsman undoubtedly equated the word "products" with "formulae". If the word had been identically used in every provision in this Directive Mr Lasok's argument would have had not merely logical force but would have compelled an interpretation of Article 18 in the sense for which he contends.
27. There is, however, one Article in the Directive which unquestionably has a different meaning. Article 13.8(a) provides:

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

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

28. Infant and follow-on formulae do not have a shape, as the Directive makes clear they are a powder which is put into usable form by the addition of water. When using the word "products" in Article13.8(a) the draftsman clearly had something else in mind.
29. It is also difficult to construe Article 14.3 in a sense which equates products with formulae.

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

The products there referred to plainly include at least packaging. Otherwise how could they be equated to samples?

30. Mr Lasok accepts that the word "products" in an appropriate context can include packaging and labelling. His submission is that in the context of this Directive it does not have and is not capable of having that wider meaning.
31. For reasons which I will explain in due course I do not accept Mr Lasok's basic proposition that when the draftsman used the word "products" in Article 18 he meant exclusively formulae. Nor do I accept Mr Lasok's fourth proposition. The obligation to "adopt" and "publish" laws, regulations and administrative provisions necessary to comply with the Directive means, and means no more than, to pass into published law.
32. The legislative technique adopted by the draftsman of the Directive is one that is commonly used in Community acts as is made clear by the Second Edition of Sacha Prechal's work on Directives in EC Law. In chapter 2.3, pages and 18 and 19, she states, wholly uncontroversially, that in the absense of the specification of date on which a Community act is to be brought in force the act enters into force on the twentieth day following the date of publication; but Directives do provide for different implementation periods: a shorter period for the transposition of measures into law and a longer one in which the factual situation presented must be achieved.
33. That is precisely the technique used by the draftsman here. The obligation on Member States is to pass the provisions of the Directive into law by 31st December 2007, but to do so as to secure the effects specified in the two indents by the dates specified in them. Even in relation to the permissive provision, the date is not identical to the date by which the Community act must be passed into domestic law. In this context I have derived no assistance from Case C-131/97 Carbonari [1999] ECR I-1103 which deals with a different category of Community act and different subject matter. Unlike the Community act in that case, this Directive does not have direct effect in domestic law save as to the result to be achieved.
34. It is to be noted that the two indents refer to "trade in products". The first indent could in English text be read as requiring compliance in relation to "trade in products". But the second indent could not bear that meaning: it uses the plural "do", not "does". If the prohibition applies to "trade in products" it would have referred to "trade in products which does not comply with this Directive", not "do". Mr Beloff accepts that the transpositional requirements apply to products. The French text makes that clear beyond argument using as it does the plural in both indents.
35. Accordingly, the critical question of construction which I have to determine is what is meant by "products". I have already rejected the narrow construction for which Mr Lasok contends. To ascertain its meaning, in my judgment, it is necessary to look at the previous history of Community acts in this area and to the travaux préparatoires of this Directive. As I have already recited, the words of Article 18 replicate, save as to dates, the words in the 1991 and 1996 Directives, both of which dealt with labelling. The United Kingdom complied in the case of the first Directive belatedly with its obligations to transpose into law and give effect to the Directives by reference to the end date specified in the transposing article. There is no evidence as to what occurred in other Member States but I believe I can say without fear of contradiction that it would be very surprising if any Member State had immediately transposed the requirements of the 1991 and 1996 Directives into law rather than adopting the same approach as that of the United Kingdom.
36. Further, Mr Lasok's construction of Article 10 of that Directive would have required Member States to bring into force, ie to give effect to and enforce, laws relating to labelling 20 days after 14th May 1991 - hence my observation at the start of this judgment that he appears to contend the United Kingdom Government was nearly three years and nine months late in complying with Article 10.
37. Such a construction would, I have no doubt, come as a considerable and unwelcome surprise to Member States. What can be drawn properly from these considerations is that the draftsman of the 2006 Regulations would have had in mind the wording and consequences of previous regulations, in particular the 1991 Regulations.
38. The travaux préparatoires provide a further clue. Mr Lasok submits that it is only cases in which a clear intent can be derived from travaux préparatoires that it is useful to use them as an aid to construction. He relies on France v The Commission Joined Cases C-68/94 and C-30/95, the judgment of the court of 31st March 1998 at paragraph 167:

"Third, with respect to the travaux préparatoires, it appears from the documents in the case that they cannot be regarded as expressing clearly the intention of the authors of the Regulation as to the scope of the term 'dominant position'. In those circumstances, travaux préparatoires provide no assistance for the interpretation of the disputed concept ..."

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 draftsman 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 + 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 Directives and which found its way into Article 18 of the 2006 Directive.

40. Ms Boville attended all but two of the preparatory meetings and does not recall anyone paying attention to the drafting change of the transposition requirements. Mr Lasok therefore submits that it is not clear what the draftsman had in mind, and therefore it is neither permissible or useful to look at the drafts to which I referred.
41. In my judgment it is clear what occurred in the drafting of this Directive. The draftsman 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.
42. 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.
43. 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 draftsman 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 do not comply as regards labelling with the provisions of the 2006 Directive only comes into effect on 31st 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.
44. I did at one stage contemplate that the Directive may have given a margin of appreciation to Member States as to the date upon which they would introduce the prohibition. Both Mr Lasok and Mr Beloff submit, and I accept, that the second indent contains no such latitude. The requirement is to prohibit "with effect from" a particular date, not "by" that date. Accordingly, it follows from my analysis that provisions of the Regulations require to be recast.
45. MR BELOFF: My Lord, in the light of Mr Lasok's helpful indication that that suffices for present purposes but is it necessary to have (inaudible) no agreement as to recasting, I know not, rather than to have further proceedings (inaudible) disagreement and (inaudible).
46. MR LASOK: I would have thought we can simply make an order, or at least draft an order, that encapsulates the final part of your Lordship's judgment which basically says that the labelling requirements -- I can't remember how your Lordship puts it, but we can take those two lines; it will form the declaration. My submission would be that apart from costs -- and obviously my learned friend is entitled to his costs -- that would be all that was required. It will then be for the respondent to make the appropriate alterations to the Regulations or do whatever is necessary and I think that what they would do is to take account of the entirety of the judgment.
47. MR JUSTICE MITTING: I am a little concerned about the breadth of the current stay which has the effect of prohibiting manufacturers who comply with the Directive from putting their goods on the market.
48. MR LASOK: Well our submission would be that the stay can be lifted with immediate effect. Your Lordship has made a declaration that there is noncompliance with the Directive in relation to the labelling requirements. It necessarily -- because the second indent is to be construed as applying the prohibition as from the end of 2009 it actually necessarily follows from that declaration that that part of the 2007 Regulations could not be applied against a trader and accordingly the current stay is superfluous. Our submission would simply be that that order can now be discharged because the proceedings are effectively at an end and that your Lordship has made the relevant declaration and that is clearly binding on the respondent.
49. MR BELOFF: My Lord we are entirely content with that. My learned friend has raised the (inaudible) of our costs, can I ask your Lord ship so to order?
50. MR JUSTICE MITTING: Indeed, to be the subject of a detailed assessment if not agreed.
51. MR BELOFF: Exactly. My Lord, we are very grateful to your Lordship for sitting --
52. MR JUSTICE MITTING: Not at all.
53. MR LASOK: The only problem though is permission to appeal. In that respect I have managed to forget entirely what now are the normal rules, and I assume --
54. MR JUSTICE MITTING: You ask me I say yes or no. In this instance I say yes.
55. MR LASOK: I am much obliged.
56. MR JUSTICE MITTING: Anything else? There will be liberty to apply in the event it becomes necessary to work out the order. Can I leave the drafting of the order to one or both of you jointly.
57. MR BELOFF: My Lord, yes.
58. MR JUSTICE MITTING: Mr Beloff, Mr Lasok, the associate has the structure of the order already prepared. What he wants is the wording of the declaration. If you will agree that before you leave the court then he will incorporate it into the order, or I suspect it will be better for a little time of reflection to get it quite right.
59. MR BELOFF: My Lord, yes.
60. MR JUSTICE MITTING: And if there is would -- Mr Beloff sometime early next week?
61. MR BELOFF: Yes.
62. MR JUSTICE MITTING: Very well. Mr Beloff, what is required is the wording of the declaration, everything else I think you will find in the associate's draft.