ANH launches next phase of legal strategy on EU food
supplements
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The ANH mounts today the next phase of its legal activities aimed
to stop a ban on thousands of food supplement products in Europe. ANH PRESS RELEASE: ANH puts spotlight on
European Commission over food supplement procedures
Press Release – for immediate release ANH PUTS SPOTLIGHT ON EU PROCEDURES FOR FOOD SUPPLEMENTS FOLLOWING
EUROPEAN COURT JUDGMENT The On 12 July 2005 the European Court of Justice (ECJ) in 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 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 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.
Dr Robert Verkerk, Executive & Scientific Director
Phone: +44 (0)1306 646 550 EDITOR’S NOTES About the 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: The ANH’s key grievance The ANH’s greatest concern over the EU Food Supplements Directive
(2002/46/EC), which affects millions in 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 Commission’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 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 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. ____________________________________ forwarded by Zeus
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