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Codex Alimentarius. The War Rages in the EU

21st March 2007 by Arrow Durfee Posted in Uncategorized

BIG PHARMA GOES ON FIGHTING.
VITAMINS IN THERAPEUTIC DOSES SHOULD BE BANNED.
A TOO-HEALTHY POPULATION IS BAD FOR BUSINESS
DCH
=============================================

The ANH mounts today the next phase of its legal activities aimed to stop a ban
on thousands of food supplement products in Europe.

Please circulate this release widely to those who might be interested.

By making 15 applications to the positive list according to the clarified and
simplified procedures set out by the European Court of Justice in 2005, we aim
to force the European Commission and other EU institutions to use proper,
transparent and proportionate procedures for adding new ingredients to the EU
Food Supplements Directive’s ‘positive lists’ while not over-stepping their
legal powers.

This entire strategy is based on the gains offered by the European Court in 2005
- which, up until now, appear to have been ignored by the EU institutions.

Read the full press release and Editor’s Notes below to find out more about this
crucial next stage of the ANH’s legal strategy on European food supplements.

ANH PRESS RELEASE: ANH puts spotlight on European Commission over food
supplement procedures

Press Release for immediate release
16 March 2007, Dorking, United Kingdom

ANH PUTS SPOTLIGHT ON EU PROCEDURES FOR FOOD SUPPLEMENTS FOLLOWING EUROPEAN COURT JUDGMENT

The Alliance for Natural Health has today informed the European Commission that
it will scrutinise its procedures and those of the European Food Safety
Authority on food supplements, in accordance with a European Court of Justice
(ECJ) judgment.

On 12 July 2005 the European Court of Justice (ECJ) in Luxembourg delivered its
judgment on a case brought by the EU-wide Alliance for Natural Health (ANH),
along with two UK health food associations. The case challenged the EU Food
Supplements Directive potential ban on thousands of food supplement products on
the EU market that contain nutrient forms not listed on the positive list of the Directive.

ANH files applications to create legal precedent:

The ANH has filed 15 applications to the Directive’s positive list as a means
of testing the European Commission and European Food Safety Authority’s
procedures, which were referred to as having the transparency of a black
box by the ECJ’s Advocate General Geelhoed in April 2005. This flaw was
regarded as being of such a profound nature that the Advocate General made a
recommendation to the ECJ that the Directive be invalidated.
When the ECJ delivered its ruling some three months later, the Directive was
upheld but on the condition that the procedures for adding vitamin and
mineral ingredients to the Directive’s limited positive lists were made fully
transparent and carried out within a reasonable time frame.
The ANH has been engaged in correspondence with the relevant authorities,
including the UK Food Standards Agency, the European Commission and the European
Food Safety Authority, on all aspects of the procedure and time lines for
applications to the positive list and has yet to receive adequate, clear
responses.

The European Commission and European Food Safety Authority appear to be
ignoring the ECJ’s ruling and continue to be operating within their black
box, says Dr Robert Verkerk, Executive & Scientific Director of the ANH.
It’s critically important now that we establish proper procedures for
permanently adding vitamins and minerals to the Directive’s positive list,
using the clarified procedures set up by the European Court, especially as
derogation dossiers, some of which were very brief, could be rejected at any
stage.

The Directive only lists 15 minerals, when scientific research has shown that
many more are needed for optimum health, at dosages greater than those found in
most contemporary diets. Among the ANH’s 15 applications, nine are
applications to have additional minerals, including sulphur, strontium,
vanadium, boron and lithium added to Annex I of the positive list.
The European Court clarifies the criteria required for positive list
applications

The ECJ also spelled out the criteria required for applications to the positive
list. The ECJ made it clear that the only criterion required to have a vitamin
or mineral added to the positive list (Annex I) was that it be normally found in
and consumed as part of the diet. In its nine test applications to Annex I of
the Directive, the ANH has demonstrated, using peer reviewed, published
scientific research or government nutrient intake statistics, that all these
substances are normally found in the diet. However, scientific research shows
that their concentration is often insufficient for optimum health, hence the
value of supplements containing these substances.

The ECJ also stipulated that two criteria were required for applications to
Annex II of the positive list, which contains the vitamin and mineral forms
which may be used in the manufacture of food supplements. The current list
contains only 114 forms, while more than 400 forms have been used safely for
decades. A ban has yet to occur since the fate of the additional 400 or so
vitamin and mineral forms has yet to be decided following the submission of
derogation dossiers to the European Food Safety Authority prior to 12 July 2005.
In fact, only two of these submissions have been evaluated and approved since
this time. The fate of the vast majority may not be known until closer to the
end of the derogation phase in December 2009. Any dossier that is rejected will
immediately make illegal any sale of products containing the relevant
ingredient.

ANH applications prioritise natural forms of vitamins and minerals
The ANH has filed six applications to Annex II including generic and proprietary
forms of mixed carotenoids, wheatgerm oil containing natural forms of vitamin E
(mixed tocopherols and tocotrienols) and palm fruit vitamin E tocotrienols.
These sorts of natural complexes are conspicuously absent from the Directive’s
positive lists and, at the proposed dosages, are considered to be free of
harmful effects sometimes associated with isolated, synthetic vitamin forms.
Scientific studies also suggest that these natural forms of vitamins are of
greater benefit to health.

ANH intends to challenge any refused applications in the courts
Robert Collins, Legal Director of the ANH said, with so much uncertainty
about, it is essential that clear, workable and transparent procedures are
established and of course the European Court has made this abundantly clear.
The European Food Safety Authority can only reject applications if the criteria
they have given are not met or they can prove that the proposed use is unsafe.
Moreover, the Court has indicated that if the procedure results in a refusal,
the refusal must be open to challenge through the courts. Since, in our test
applications, we believe we have met the required criteria and have demonstrated
the safety of the proposed uses, we will be taking any refusals to the courts so
that proper precedents can be developed according to the procedure made law by
the European Court.

The ANH will continue to maintain very close scrutiny over the European
Commission and European Food Safety Authority procedures. It is hoped, assuming
the ECJ’s ruling is taken into account, that this will pave the way towards a
more rational and transparent approach towards regulation of all categories of
food supplements over the coming years.

ENDS.

CONTACTS
Dr Robert Verkerk, Executive & Scientific Director

Robert Collins, Legal Director

Alliance for Natural Health
The Atrium, Dorking, Surrey RH4 1XA, United Kingdom
Phone: +44 (0)1306 646 550
Fax: + 44 (0)1306 646 552
E-mail: info@…
Web: www.anhcampaign.org

EDITOR’S NOTES

About the Alliance for Natural Health (ANH) -
www.anhcampaign.org

The ANH is a UK-based, EU-focused, international, legal-scientific,
non-governmental organisation that is working on behalf of consumers, medical
doctors, complementary health practitioners and food manufacturers and
distributors, to protect and promote natural healthcare, using the principles of
good science and good law.

The ANH’s principal objective is to help develop an appropriate
legal-scientific framework and environment for the development of sustainable
approaches to healthcare. Within this setting, consumers and health
professionals should be able to make informed choices about a wide range of
health options, and in particular those that relate to diet, lifestyle and
non-drug-based or natural therapies, so that they may experience their benefits
to the full while not exposing themselves to unnecessary risks.
About the Press Release

Judgment of the ECJ on the ANH case (12 July 2005) can be downloaded from:

eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62004J0154:EN:HTML

The ANH’s key grievance
The ANH’s greatest concern over the EU Food Supplements Directive

(2002/46/EC), which affects millions in Europe who consume food supplements
containing vitamins and minerals, as well as other nutrients to support their
diets, is the absence from the positive list of many key natural forms and
complexes of vitamins and minerals. None of this would be a problem if it was
reasonably easy to have a nutrient added to the list but, unfortunately, the
data requirements set by the European Commission are so onerous that only the
largest companies have the capacity to conduct the studies required.

The Advocate General’s “black box”

Worse than this, the exact procedure, data requirements and time lines required
to gain access have not been clearly set out. This was in fact the major
stimulus for the opinion of the Advocate General, Leendert Geelhoed, handed down
on 5 April 2005, which recommended that the Directive be invalidated. He rather
famously pronounced the procedure as transparent as a black box’. Extracts
from the Advocate General’s opinion are given below:

“In short, this procedure, in so far as it may exist and in so far as it may
deserve this title, has the transparency of a black box: no provision is made
for parties to be heard, no time-limits apply in respect of decision-making;
nor, indeed, is there any certainty that a final decision will be taken. The
procedure therefore lacks essential guarantees for the protection of the
interests of private applicants….. Thus, lacking appropriate and transparent
procedures for its application, the Directive infringes the principle of
proportionality. It is, therefore, invalid.”

Directive upheld by the ECJ, but…

Three months later, when the ECJ delivered its judgment, many were surprised to
find that the 13 judges in the case did not follow the Advocate General’s
recommendation to invalidate the Directive. Rather, the judges decided to uphold
the Directive, yet at the same time, through the 25-pages of their ruling, they
provided key clarification that went a very long way to remove the black veil
from Advocate General Geelhoed’s box.

The unveiling of the Advocate General’s “black box” by the ECJ
The ECJ makes very clear in paragraph 82 of its ruling that transparency must be
maintained, as well as clarifying the European Commissionr’s responsibilities
to interested parties, viz:

“The absence of any such provisions cannot, however, be regarded as such as to
jeopardise the proper functioning of the procedure for modifying the positive
lists within a reasonable time. It is none the less the responsibility of the
Commission, by virtue of the implementing powers conferred on it by Directive
2002/46 concerning, inter alia, the way the procedure is operated, to adopt and
make accessible to interested parties, in accordance with the principle of sound
administration, the measures necessary to ensure generally that the consultation
stage with the European Food Safety Authority is carried out transparently and
within a reasonable time.”

The European Court clarifies the criteria required for applications to the positive list
Many companies have understandably feared that they cannot afford to make
applications to the positive lists because of onerous data requirements
stipulated by the European Commission. Others have been given the impression
that they cannot make an application for a specific vitamin or mineral form
(Annex II) because the group to which the form belongs is not listed in Annex I
of the positive list. However, the ECJ made clear in its judgment the criteria
required to gain access to both Annexes of the Directive’s positive list, as
well as indicating that the procedure needs to be fully transparent and must be
carried out “within a reasonable time”.
Criterion required for applications to Annex I of the positive list
The Court specifies only one criterion required for applications to Annex 1,
which presently contains 13 vitamins, and only 15 minerals. The criterion is as
follows, as demonstrated in paragraph 85 of the judgment: the criterion that the vitamin or mineral be normally found in, and consumed as part of, the diet is the only relevant criterion for the purposes of the list in Annex I to the directive.
Criteria required for applications to Annex II of the positive list. Also in paragraph 85, the Court clarifies the two criteria required for applications to Annex II:
“As regards the list in Annex II to the directive, it is apparent that
the only relevant criteria are those relating to the safety and bioavailability
of the chemical substance in question.”

ECJ clarifies basis for refusals

Paragraph 73 of the ruling re-states that the procedure for applications to the
positive list must be completed in a reasonable time and applies the
burden of proof for lack of safety on the competent authorities in cases where
applications are refused: “Such a procedure must be accessible in the sense that it must be expressly mentioned in a measure of general application which is binding on the
authorities concerned. It must be capable of being completed within a reasonable
time. An application to have a substance included on a list of authorised
substances may be refused by the competent authorities only on the basis of a
full assessment of the risk posed to public health by the substance, established
on the basis of the most reliable scientific data available and the most recent
results of international research. If the procedure results in a refusal, the
refusal must be open to challenge before the courts (see, by analogy, Case
C’24/00 Commission v France [2004] ECR I’1277, paragraphs 26, 27 and 36, and
Case C‘95/01 Greenham and Abel [2004] ECR I‑1333, paragraphs 35, 36 and
50).”

Conclusion

The European Court, in its ruling of July 2005, appeared to go a very long way
towards addressing the claimants’ main concerns, while at the same time
avoiding the severe option of invalidating the Directive. This approach may have
been developed to provide as much of a win-win situation to all parties as could
be mustered, while at the same time saving the European institutions the
embarrassment of an over-turned Directive.

The difficulty for many leading-edge, innovative manufacturers has been that
since the ruling, almost two years ago, the European Commission appears to be
ignoring the ECJ’s ruling. Geelhoed, who has now retired, may be surprised to
find that his “black box” has yet to be made transparent.

The ANH’s strategy to test the ECJ ruling will, it is hoped, apply the
pressure needed to ensure transparent, clear and proportionate procedures for
applications to the Directive’s positive list. It will likely set a precedent
which will then be applied to other groups of nutrients such as botanicals,
essential fatty acids, amino acids and probiotics.

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