IT Passed! WE LOST! The Changing Interpretations of the ECJ Ruling

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The Changing Interpretations of the ECJ Ruling

 

 

 

EUROPEAN COURT RULING ON THE EU FOOD SUPPLEMENTS DIRECTIVE 12th July 2005

 

The Changing Interpretations of the ECJ Ruling

By Louise Mclean

 

29/7/05

Following the European Court of Justice ruling on food supplements,

there is one thing that campaign and industry groups do seem to agree

on – and that is that there has been a huge amount of confusion

surrounding its interpretation! As a result, the newspapers and

industry press have been full of contradictory stories – and who ends

up most confused? Consumers, retailers, practitioners…all the people

who are most dependent on a continued supply of safe and effective

food supplements.

 

 

 

Looking at the various press releases issued straight after the

Judgment (12 July 2005), I noticed that there were two distinct camps:

one which was headed by the UK industry trade associations, the Health

Food Manufacturers Association (HFMA) and the National Association of

Health Stores (NAHS), as well as Consumers for Health Choice (CHC),

and another led by the Alliance for Natural Health (ANH).

 

 

 

The HFMA/NAHS/CHC camp initially proclaimed that the case had failed –

all was lost, they said – and the last hope would be an intervention

by the British Prime Minister, Tony Blair. CHC stated:

 

 

 

" It is now certain that from 1st August, the EU regulations will be

enforced and we will start to see several thousand safe and popular

specialist vitamins and mineral supplements compulsorily removed from

the shelves of health food shops – with the full backing of the

British Government. "

 

 

 

HFMA were only mildly less gloomy, saying:

 

 

 

" Two British trade bodies have called upon the Prime Minister to

intervene in Europe following the defeat of their challenge to the

European Union's controversial Food Supplements Directive in the

courts today. Due to come into effect in August, the Directive

threatens up to 5,000 commonly consumed products on sale in the UK.

Together these contain more than 200 nutrients, used safely in

specialist supplements for many years but not on the Directive's

" positive " list of permitted substances. "

 

 

 

Quoting their legal advisor, the HFMA said:

 

 

" The ECJ exists to do justice in the EU, but today's verdict fails to

recognise the shortcomings of this Directive or protect the interests

of consumers and businesses. "

 

 

 

The ANH, in contrast, called the Judgment a " win-win " , saying:

 

 

 

" In a remarkable David and Goliath action, the Alliance for Natural

Health (ANH) has today succeeded in getting a ruling from the European

Court of Justice that requires the controversial EU Food Supplements

Directive to be very sharply circumscribed in its application… "

 

 

 

The ANH release continued:

 

" …the Court has followed the well-established principle that

legislation is, wherever possible, to be interpreted so as to avoid it

having to be annulled. The fact that the Court was able to satisfy

ANH's main concerns by that means without invalidating the Directive

(which has undoubtedly some good features) means that the judgment has

produced a win-win situation. "

 

 

 

In trying to understand these contradictory messages, I telephoned

the HFMA to ask for an interview, but they declined. I also emailed

NAHS and CHC who sent me their press releases. Only Dr Robert Verkerk

of the ANH agreed to be interviewed (see below).

 

 

 

HFMA, NAHS and CHC then sent me their combined release, which you will

find below.

 

 

 

I am therefore providing below for information (1) press releases

which were issued immediately after the Ruling from HFMA, NAHS and

CHC, (2) press releases from ANH issued on 12th and 15th July (3) a

recent statement on the situation on the ANH website, as well as (4)

the interview with Dr Verkerk of ANH. I also present (5) the most

recent joint press release of HFMA, NAHS and CHC dated 25 July 2005,

whereby the HFMA/NAHS/CHC appear to substantially change their views

compared with their statements made on 12th July, saying:

 

 

 

" Although the first stage of the FSD, implementing `positive lists'

for nutrients and nutrient sources, comes into effect on 1 August, no

vitamin & mineral supplements will be removed from shelves. This is

because, following discussions with the Health Food Manufacturers'

Association (HFMA) & National Association of Health Stores (NAHS), the

Food Standards Agency (FSA) has not only applied maximum flexibility

to giving `derogation' (temporary exemption) to some 500 non-listed

ingredients for which dossiers or other data were submitted but has

also supplied some funding to assist in the development of dossiers. "

 

 

 

 

 

Two things have become apparent to me. Firstly, it seems that HFMA,

NAHS and CHC have moved a long way from their position on 12th July,

whereas ANH appears to have not moved at all. Secondly, it seems that

HFMA, NAHS and CHC have moved a lot closer to the ANH position.

 

 

 

Perhaps now there will be less confusion…although perhaps you might

want to decide this for yourself? Read on!

 

 

 

 

HFMA press release issued on 12/7/05:

SURPRISE MOVE SEES CONTROVERSIAL EU DIRECTIVE UPHELD

http://www.solgar-vitamins.co.uk/newsdisplay.asp?id=3920 & back=1

 

 

 

 

 

CHC press release issued on 12/7/05:

 

British Consumers Disappointed but not Surprised by European Court

Decision

 

Vitamin & Mineral Directive Upheld

 

http://www.healthchoice.org.uk/viewpressRelease.aspx?Oid=179

 

 

 

The NAHS press release of 15th July (NAHS does not appear to have a

website):

 

European Court of Justice Judgement

 

on NAHS/HFMA Challenge to Food Supplements Directive

 

 

 

The industry was deeply shocked yesterday by the decision by the ECJ

to uphold the Food Supplements Directive. They ignored the

recommendation of Advocate General Geelhoed to declare invalid,

instead judging that the Directive did not violate principles of

proportionality, subsidiarity, sound administration, and personal

freedom. All aspects of the Directive with which health food store

owners will take issue.

 

 

 

The Court did call for some greater transparency in the dossier

process but left it to the Commission to put this into practice. They

also said that the Directive should have contained a right to legal

remedy if a dossier was not knocked back, but our legal advice is that

the Court will be reluctant to challenge a `scientific' decision.

 

 

 

Much has been made of a vague distinction that the Court makes between

natural source nutrients and chemically derived ones. Our solicitors

believe that this is largely a red-herring and does not represent a

great opportunity for the industry, confirming as it did an EU

Standing Committee decision of two years ago.

 

 

 

Unfortunately there is no right of appeal to the judgement so

retailers must now draw a line under the legal challenge, take stock

of the current situation, and plan for the future.

 

 

 

Implementation Date- 1st August

 

The full affect of the FSD was due to come into effect from the 1st of

August, less than three weeks away. Just a few months ago there were

only about 20 dossiers that had been submitted to the Food Standards

Agency for derogations until 2009. Two recent compromises by the UK

government have seen the number of derogations granted rise rapidly to

over 500, although we think about 150 are duplications.

 

 

 

Practically this means that come the 1st of August health food stores

will not feel any impact on their businesses.

 

 

 

The first government compromise was to match-fund the HFMA in

producing slimmed down dossiers, which are still very serious

technical documents, but at a fraction of the cost.

 

 

 

The second compromise, which only came a couple of weeks ago, was to

allow dossiers to contain very minimal information about length of

time on the market, any recorded adverse effects etc. The NAHS funded

the production of about 160 dossiers which made a serious contribution

to getting the number of derogations up to 500.

 

 

 

 

ANH press release issued on 12/7/05:

ANH Landmark Legal Challenge – the Verdict!

http://www.alliance-natural-health.org/index.cfm?action=news & ID=181

 

ANH press release issued on 15/7/05:

Why Most Vitamins Won't be Banned

http://www.alliance-natural-health.org/index.cfm?action=news & ID=182

 

 

 

 

 

ANH STATEMENT ON WEBSITE DATED 26 JULY 2005

 

http://www.alliance-natural-health.org/index.cfm?action=news & ID=183

 

Many of you will by now be aware that there are divided opinions on

whether the European Court of Justice (ECJ) ruling provides a `silver

lining' or not and we wish to clarify the situation for the benefit of

our Members and Supporters.

 

What really happened

 

The ANH has always been about using good science and good law to

protect natural health and our view of the ECJ judgment handed down on

12th July 2005 is, and continues to be, based on the opinion of our

legal team, led by one of the top European and Competition Law

barristers, Paul Lasok QC. Had the Food Supplements Directive been

invalidated we would now be facing a complicated system of

re-negotiation where many competing interests would have attempted to

leave their mark. This could have resulted in a long and drawn out

affair which may well have left us in a worse position. This now does

not need to happen. The Court has made clear some key provisions of

the Directive which massively reduce the difficulty of getting on to

the once-feared `positive list'.

 

The legal challenge was only directed at one aspect of the Food

Supplements Directive regarding the proposed ban on up to 75% of forms

of vitamins and minerals (mainly food forms). The bottom line now, is

that this wide-scale ban will not be able to occur, on the basis that

companies are prepared to make the minimal effort required to submit

ingredients to the `positive list'.

 

Many of the arguments that the ANH was most concerned about have been

clarified by the ECJ ruling and the scope of the Directive has been

narrowed (please refer to our press release on the website for specifics).

 

It seems that the ruling may have been a compromise gesture on the

part of the Court. It has ensured that the European Institutions

(notably the European commission, the Council of Ministers and the

European Parliament) were able to avoid the embarrassment of an

overturned Directive and that the clarification of the law avoided

conflicts with EU law, which had been the key basis of contention in

the case brought by the ANH.

 

Opinions still divided

 

As you may know, this view is not shared by all and opinions seem to

be particularly polarised in the UK, where the two trade associations,

the Health Food Manufacturers Association (HFMA), the National

Association of Health Stores (NAHS) and a consumer organisation,

Consumers for Health Choice (CHC) appear to be of the opinion that the

legal challenge has failed dismally and confers no benefits to

consumers, practitioners, retailers or manufacturers.

 

In the latest issue of Health Food Business, a trade magazine that is

widely distributed to the UK health industry, which hit the health

food shops this week, it is clear that these UK trade and consumer

organisations' present campaign strategy is to create a strong

political lobby to push the Government towards national derogation

(known legally as `subsidiarity') for the UK, by using the influence

of the British Prime Minister Tony Blair while the UK holds the

6-month rotating EU Presidency. It is the opinion of our legal team

that there is no currently available mechanism for achieving this and

it was actually the ANH that ran this `subsidiarity' argument

particularly strongly in its legal challenge but the argument

unfortunately was lost for a number of reasons.

 

Derogation dossiers: just delaying the inevitable ban?

 

Mainstream industry spokespersons continue to propound the `doom and

gloom' scenario about the ECJ ruling. They say that all the work on

derogation dossiers has just bought some more time and the inevitable

bans will come into place anyway, even if it's after 2009. The ANH

argues that this need not be the case.

 

The HFMA and NAHS, as well as companies and other trade associations,

worked hard to file dossiers for the derogation provision within the

Directive which allows ingredients that have been used prior to 2003

to continue to be used at least until 31 December 2009, on the basis

that dossiers are not given an unfavourable opinion by the European

Food Safety Authority. Assuming that Member States support the

principle of mutual recognition, dossiers filed in one country will

provide derogation in another. These derogations, assuming they have

met the required criteria for safety and bioavailability, will provide

sufficient time for applications to be made to the positive list under

the now much clearer and simplified procedures. Furthermore, the ECJ

ruling makes it much more difficult for derogation or positive list

submissions to be rejected as the burden of proof for lack of safety

of a given nutrient has been firmly placed back in the regulator's court.

 

The ANH therefore urges companies to make full use of the simplified

dossier procedures pointed to by the ECJ – and so avoid the ban!

 

VERBAL OPINION OF DR ROBERT VERKERK, EXECUTIVE DIRECTOR, ALLIANCE FOR

NATURAL HEALTH – 26th JULY, 2005

 

 

 

 

 

When Dr. Robert Verkerk, executive director of the Alliance for

Natural Health was asked his verbal opinion of the ECJ ruling and how

it would affect the sale of food supplements after 1st August, 2005,

this is what he had to say:-

 

 

 

" We believe that this is quite likely to be a compromised decision on

the part of the Court whereby they are not forcing the Directive to be

amended, as the Court is required always to try to find a solution

which doesn't involve invalidation of EU Directives wherever possible

and invalidation would have anyway given us a long-drawn out,

complicated renegotiation process that could have left us considerably

worse off than we are now!

 

 

 

Even though the Judgment is ambiguous in a number of places, it is

extremely clear in other places. We believe the areas where it is

most clear will have very significant benefits for practitioners,

retailers and manufacturers across Europe, as well as for those

outside who export into Europe, particularly those involved with

innovative, leading-edge, high efficacy products which were set to be

most severely affected prior to the Judgment.

 

 

 

Of course, this Judgment only affects the ban on vitamins and

minerals, so has no effect on the next phase of the Directive which

will impose maximum potencies on vitamin and mineral food supplements

– this is another battle, and one that we are already deeply engaged

in. We need to see existing risk assessment methodologies being used

for nutrients thrown out, as these have been borrowed from those used

for drugs and toxic environmental chemicals. They have no place being

used for nutrients – and we need to see a new paradigm of

safety/benefit analysis being brought to bear in this area. But that's

another story.

 

 

 

The most important area to look at with the Judgment from the European

Court is the issue of accessibility to the long-feared Positive List.

We have to appreciate that the Positive List is only a major obstacle

if it is very difficult to get onto. If the Positive List is

straightforward to access, then of course it doesn't pose a major

problem.

 

 

 

Historically, the industry has had very good reason to be fearful

because the Positive List was derived from a list developed by the EU

for foods for particular nutritional uses or PARNUTS. In 1999, a large

number of food form nutrients that had been submitted to PARNUTS were

rejected on the basis of insufficient data by the then Scientific

Committee on Food, which is now incorporated into the European Food

Safety Authority.

 

 

 

Included in the list of rejected nutrients was, for example,

selenomethionine, the organically-bound food form of selenium which

occurs naturally in high concentrations in brazil nuts. As a result of

this, one of the world's largest manufacturers of selenomethionine,

has spent huge amounts of money trying to meet the data threshold

provided by the guideline document for PARNUTS, which had been revised

most recently in July 2001. This guideline document is referred to as

the NUT/21 document.

 

 

 

The problem is that this document has also been posturing as the

application form for derogation dossiers, we believe wrongly. People

have been more concerned about getting derogations than getting

nutrients on to the positive list, and the precise mechanism for

accessing the positive list, as the Advocate General pointed out in

his 5 April 2005 Opinion, is as " transparent as a black box " .

 

 

 

Now what the European Court is implying in its ruling is that the

onerous data requirements proposed by the European Commission way

exceeds the actual legal requirements for access to the Positive List.

This NUT/21 document which has been posturing as a gatekeeper to the

Positive List appears to have been a rogue document that has placed

far too great a burden on the applicant.

 

 

 

The European Court now very clearly picks up the legislative history

that we included within our case which clearly describes the different

criteria required for access to the two Annexes which make up the

Positive List.

 

 

 

In order to get onto Annex I, in which the nutrient group is

specified, all you need to demonstrate is that your product is

normally found in or consumed as part of the diet. Currently minerals

such as boron, vanadium, silicon, sulphur, cobalt, nickel, tin and

numerous others are missing from Annex 1. In other words you can go

to major reference texts such as McCance and Widdowson's Composition

of Food series, USDA, FAO or WHO data, or to the peer reviewed

scientific literature and show that these ingredients are found within

the diet. There is no specification for the dosage at all, so you

just need to show these ingredients occur in food.

 

 

 

The requirement to get onto Annex II, in which the particular forms of

the vitamin and mineral to be used are specified, which in turn should

correspond with the groups in Annex 1, are two-fold. One aspect is

safety and the other is bioavailability.

 

 

 

The criteria for safety, in terms of our reading of the Court's

Judgment and the legislative history, would not require massively

extensive data proving safety, as was originally considered to be the

case. More to the point, what it would primarily require in terms of

safety is evidence that the products are not unsafe in the proposed

usage. This might involve demonstrating that there is no evidence in

the peer-reviewed literature, government authorities and in company

records, that people have been harmed when the ingredient has been

used at the dosage and form specified.

 

 

 

The other criterion for Annex II is bioavailability. This is the

ability of the substance to be absorbed by the human body, or even a

laboratory animal. The bioavailability threshold has not be

quantified so you are not told whether you need to have 75%, 50% or

25% bioavailability. Therefore the ingredient needs to be bioavailable

at least to some extent, so theoretically evidence of 5%

bioavailability would be sufficient, although most leading-edge

companies would be interested in ingredients with much higher

bioavailability.

 

 

 

Those are the only two requirements for getting ingredients on to the

Positive List.

 

 

 

Then, quite fundamentally, the European Court has ruled that if the

European Food Safety Authority elects to reject a Positive List

application, it has to prove by a full risk assessment based on the

most up to date science and data that the substance poses a risk to

public health.

 

Interestingly, as soon as you are using `risk assessment' methods, you

have to consider dosage, and peculiarly the European Commission has

chose to separate provisions in the Directive which deal with

ingredients and those which deal with dosage, and as we've already

said, maximum dosage levels have yet to be enforced. Quite simply,

you cannot establish risk without considering the dosage. Everything

is toxic or unsafe at a certain dosage, even water! This is one of the

most fundamental principles of toxicology.

 

 

 

Let's look at a trace element like vanadium which is not on either

Annex I or II. It exists in the natural food supply – you eat it every

time you consume say prawns, crayfish or some other sea foods, which

for some people might not be very often! Getting on to Annex I

provides no problem, because it is easy to demonstrate the presence of

vanadiumin foods. And of course you would have to show for Annex II

that vanadium at the dosage you are using is both safe and

bioavailable. Everyone would agree that if you were to consume 50 mg

of vanadium a day, every day, it would almost certainly be harmful.

But most companies using vanadium are using it in microgram quantities

which are well demonstrated to assistblood glucose regulation. So

you've got substantial numbers of the population who are dedicated

supplement users who want to continue to consume multi-mineral

supplements containing very small doses of organically-bound vanadium,

that help them stabilise their blood sugar. Is this a crime?

 

 

 

Well now, it should be much easier to get such ingredients on to the

Positive List. Some of the companies we are working with are already

working on applications for the Positive List, based on the newly

clarified and simpler access criteria.

 

 

 

We have now presented proformas for applications to the Positive List

that are annexed in the Opinion of Paul Lasok QC, our leading EU law

barrister who has provided a very detailed interpretation of the ECJ

ruling that we are using as the basis for these views I am

expressing.. We believe that those proformas providing the legal data

requirements for the Positive List now make the Positive List so much

more accessible for manufacturers.

 

 

 

The third key area of the ruling is the fact that there appears to be

an exclusion from the ban for natural forms of vitamins and minerals

found in the diet. Exactly how those natural sources are to be

defined is still unclear because the Court has perhaps not had

sufficient information at its disposal in this regard. If you look at

the surrounding documentation at the European Food Safety Authority

and you look at cases themselves, it appears that at least some

categories of unextracted or processes natural sources would be

excluded from the ban implied by the Directive. We would argue at the

very least that would be plant-derived forms but it should also

include animal-derived forms such as cod liver oil as sources of

vitamins A and D. This situation has actually been accepted by the UK

government following a viewpoint expressed on this issue by the

European Food Safety Authority in 2002, but it hadn't yet been

accepted across all other Member States.

 

 

 

The Court in dealing with the infringement of proportionality issue

had to look very carefully at trying to balance the issue of food

forms versus chemical forms. That's where we see Paragraph 63 of the

ruling coming into play and our senior Legal Counsel, Paul Lasok, has

spent a fair bit of time deliberating the various implications that

can be drawn from the fact that Paragraph 63 was included in the way

that it was following the points raised in our case on natural sources

which were picked up in Paragraph 62.

 

 

 

You asked at the outset why opinions are so divided and what the pros

and cons are of some of the other approaches that are being put

forward by UK organizations, such as the Health Food Manufacturers

Association, the National Association of Health Stores and Consumers

for Health Choice. They have now consolidated their views which

appear to be somewhat different from those they came out with on 12

July, although their key strategy still seems to be pushing for

national derogation – which means trying to get the Directive to not

apply to internal trade in the UK. In many ways this is good, as we

have two distinct strategies. Our strategy is going for the most

generous possible interpretation that will apply across all Member

States, while theirs, because they are UK-only organizations, will

inevitably be UK-centric.

 

 

So why are opinions so divided? Different sectors of the industry

clearly have different viewpoints over the implications of the Food

Supplements Directive. They always have done. When the Directive

went through the European Parliament in 2002, the HFMA did a poll of

its members and 80% agreed the Directive was a good thing. That's why

the HFMA fully supported the Directive back then. It was only later

on that they changed their tune. ANH came into being because HFMA and

many other industry associations had a view that was regarded as very

different from those that were interested in innovative, high efficacy

food supplements. So the HFMA represents a very diverse set of

players including some of the mainstream members of the industry that

have always been strong supporters of the Directive. You could argue

therefore that having a successful legal challenge is perhaps not in

the interests of all their members.

 

The HFMA changed its tune in 2003 and at the 11th hour mounted their

legal challenge, and you will notice that HFMA spokespersons kept

referring to the goal of their challenge as being the annulment of the

Directive. We were arguing that why would you want to have an

annulment of the Directive when actually the Directive served an

important function as a safe harbour for food supplements outside a

medicines regime.

 

So what we've always been anxious to do is to tweak the Directive in

such a way that it doesn't have this untoward impact of requiring a

massive burden on industry and as a result, cause very large numbers

of nutrients to be banned. Our sole objective in the case has been to

prevent an unnecessary ban on safe and effective food supplements not

just in the UK, but across all EU Member States. There are as you

know 25 EU member states and 450 million people in Europe. The

Alliance for Natural Health is a pan-European organisation and

therefore we need to provide outcomes that benefit people not only in

the UK but in other Member States as well.

 

 

 

So another important area that causes a division of opinions in the UK

in particular, is because the strategies of the HFMA, NAHS and CHC are

inevitably primarily concerned with trying to secure gains for UK

citizens, whereas we are trying to seek gains for people right across

Europe.

 

 

 

Let's now look at the pros and cons of going down the route that HFMA,

NAHS and CHC are suggesting. They are calling for national derogation

for the UK which means getting the UK's internal trade in food

supplements to operate outside of the Directive's remit. This is

legally referred to as subsidiarity and was actually an important part

of our own legal challenge – the problem is that this aspect of the

challenge failed in the European Court!

 

 

 

The opinion we have been given by our lawyers is that you would need

to alter the instrument of EU law in relation to the principle of

subsidiarity if you wanted to achieve national derogation.

Ironically, it was the ANH who primarily ran the subsidiarity argument

in our legal challenge and as I've said that aspect of the legal

challenge was lost. It would therefore appear that there is no legal

mechanism by which to achieve subsidiarity for the UK.

 

The UK trade associations and CHC want to use the UK's influence in

Brussels while it has the EU Presidency, with the help of Tony Blair

who has declared his soft spot for this issue. They are claiming there

is a mechanism to do this, and we wish them well, and hope they can

also see the sense in ur strategy. This industry has suffered because

of its fragmentation and probably the best thing we can all do is

allow different strategies to run in parallel.

 

When there is such pressure from regulation against natural health, it

is inevitably best to utilise as many strategies as you can – if you

like, taking as many bites of the cherry as you can. Viewpoints on how

to get the best effects may be different between different groups and

interests in natural health, but what I'd hope is that ultimately we

are singing from the same song sheet. "

 

_____________________

 

(Latest joint press release from HFMA, NAHS & CHC, which indicates a

change in position over press releases issued by them on 12th July 2005)

 

THE FULL PRESS RELEASE FROM THE HFMA, NAHS AND CHC DATED 25 JULY 2005

 

HFMA

 

The Health Food Manufacturers Association

 

 

THE FOOD SUPPLEMENTS DIRECTIVE & ECJ RULING: A CLARIFICATION

25 July 2005

 

There has been some confusion following the unexpected European Court

of Justice (ECJ) verdict, announced on 12 July that upheld the Food

Supplements Directive (FSD). This bulletin aims to clarify certain points:

 

 

 

1. NO IMMEDIATE FOOD SUPPLEMENTS BAN

 

Although the first stage of the FSD, implementing `positive lists' for

nutrients and nutrient sources, comes into effect on 1 August, no

vitamin & mineral supplements will be removed from shelves. This is

because, following discussions with the Health Food Manufacturers'

Association (HFMA) & National Association of Health Stores (NAHS), the

Food Standards Agency (FSA) has not only applied maximum flexibility

to giving `derogation' (temporary exemption) to some 500 non-listed

ingredients for which dossiers or other data were submitted but has

also supplied some funding to assist in the development of dossiers.

 

However, derogation is purely short-term and will expire by 2009 at

the latest. In addition, in the near future the EU Commission will

announce proposed maximum permitted levels (MPLs) that industry fears

will be well below existing UK levels that have been based on

practical and scientific risk assessment.

 

 

 

2. CLARIFICATION OF THE ECJ VERDICT

 

Two separate challenges were mounted to the FSD – by HFMA and NAHS as

co-claimants and by the Alliance for Natural Health (ANH).

 

The ANH is claiming that the effect of the ECJ Judgement is to

simplify and reduce the cost of applying to add an ingredient to the

positive lists (the dossier process): to switch the burden of proof

from the applicant needing to prove that a substance is safe to the

regulator (European Food Safety Authority) needing to prove that a

substance is unsafe; and to disapply the FSD to many `natural forms of

vitamins and minerals …normally found in or consumed as part of the diet'.

 

Following discussions with the HFMA/NAHS lawyers, our comments are :

 

Adding to the Positive Lists

 

The Judgement addressed the legality of the contents of the Directive.

Whilst there were various potentially helpful comments that were

critical of the lack of transparency of the process for adding to the

Lists, and the failure to set out the process in the Directive itself,

the Judges specifically declined to prescribe changes to the process,

on the basis that their jurisdiction was limited to considering the

legality of provisions within the Directive. However the Judgement

emphasised that the dossier evaluation process should be `completed

transparently and within a reasonable time', and made clear that

responsibility for ensuring that this was the case fell squarely on

the Commission, through EFSA. This aspect of the Judgement will

strongly reinforce the progress made by the industry in gaining

recognition of the need for the positive lists to be added to in `the

least restrictive way science will allow'.

 

The Judgement also stated that any refusal to list a substance is open

to legal challenge, which may be relevant if subsequent application of

the approval process appears unfair or unreasonably slow. However, the

Judgement does not go so far as to place any explicit obligation on

the Commission/EFSA to conduct their own research to prove or disprove

safety, and therefore the focus of the industry's attention as regards

the forthcoming evaluation of dossiers by the Commission/EFSA should

be on the risk assessment methodologies used by them and the fairness

and timeliness of the process.

 

`Natural Forms of Vitamins & Minerals'

 

There is some clumsy wording in the Judgement but we do not consider

that it moves us beyond the previous clarification by the EU Standing

Committee on the Food Chain & Animal Health made in October 2002 (in

response to an HFMA-prompted question from the FSA) which stated: " The

Committee agreed that ingredients that naturally contain a nutrient

can be included in food supplements. "

 

 

 

Thus Cod Liver Oil can be included to provide Vitamins A and D,

Wheatgerm Oil to provide Vitamin E, Kelp to provide iodine, etc.

because the vitamins/minerals `naturally occur' in these ingredients.

The Standing Committee's clarification had already made clear that the

use of such ingredients in food supplements therefore would not bring

products under the FSD. However, in practice the vast majority of

vitamin and mineral source ingredients in supplements have undergone

various forms of `processing' and we note the FSA's published advice

that: " Natural " means essentially that the product is comprised of

natural ingredients, e.g. ingredients produced by nature, not the work

of man or interfered with by man " .

 

 

 

It is clear that authoritative interpretation of the Judgement is

required urgently and the NAHS has requested guidance from the FSA on

such interpretation. However, we understand that this awaits

clarification from the Commission and is unlikely to be forthcoming

until the autumn. In the meantime, we have no reason to suppose that

their interpretation will be as bullish as that of the ANH although we

will be pleased to review the full ANH opinion with our lawyers if and

when it becomes available.

 

 

 

As the ANH point out in their press release, their organisation was

founded specifically to challenge the FSD. In contrast, the HFMA and

NAHS are trade associations with a broad remit to promote the

interests of UK specialist health products.

 

 

 

3. REQUIRED ACTION

 

The Government has committed to ensuring `the providers who are

already making available a wide and growing choice of vitamin and food

supplements to the public in Britain can continue to do so' because

…'that is what the public want'.

 

 

 

We are calling for that commitment to be achieved by making a simple

amendment to the FSD whereby an individual Member State can allow the

sale of supplements outside the restrictions of the FSD in its own

territory. Such an arrangement would provide market harmonisation by

regulating the Single Market in the positive list products, while, in

accordance with the principle of subsidiarity, Member States regulate

the markets in other products, which do not need to be regulated

Community-wide.

 

Signed – 25th July 2005.

 

Health Food Manufacturers Association - Peter Aldis, Chairman

 

Health Food Manufacturers Association - David Adams, Director

 

National Association of Health Stores - John McKee, Chairman

 

Consumers for Health Choice - Michael Peet, Chairman

 

 

 

 

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Alternative Views on Health

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