UK government and trade associations support dossiers/ UK FSA

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UK government and trade associations support dossiers/ UK FSA

Mon, 27 Jun 2005 04:12:26 +0100

 

 

 

 

UK government and trade associations support dossiers

 

The UK's Health Food Manufacturers Association (HFMA) have pushed the

UK government hard to promote dossiers - ANH wonders why?

 

The ANH is concerned about the fact that the HFMA are promoting

dossiers in their current form when they themselves are challenging,

in parallel with the ANH, the legality of the EU Food Supplements

Directive.

 

This provides a very mixed message for the Regulators.

 

Advocate General Geelhoed, in his Opinion released on 5 April

considered the dossier system to be non-transparent and this

contributed significantly to his view that the Directive was invalid

under EU law, in its present state.

 

Therefore by promoting dossiers (see Nutraingredients.com release

below), the HFMA and the UK government are promoting a system that is

potentially defective and invalid under EU law.

 

The existing dossier system will contribute, in the view of the ANH,

to even greater problems when the Directive is expanded to include

nutrient groups other than vitamins and minerals, including plant

extracts, phytonutrients, amino acids, essential fatty acids, fibre, etc.

 

Furthermore, submission of a dossier on vitamins and minerals is no

guarantee of approval by the European Food Safety Authority. The

dossier system is strictly only a derogation, for approved substances,

up until 31 December 2009. It is not a system that guarantees

substances are added to the 'positive list'.

 

The ANH argues that the framework for assessing safety of food

supplements needs to be completely re-developed from the ground up.

The existing system is seriously defective and dispropotionate. There

is also no proper scientific rationale behind the separation of

nutrient forms (Article 4) and dosages (Article 5) as in the present

Directive, if the key criteria on selection of nutrients for trade in

the European Union is to be safety. Safety, from a toxicological

viewpoint, is a function of both the intrinsic properties of a given

substance and its exposure i.e. dosage. These two aspects therefore

need to be considered together.

 

In the view of the ANH, the best way forward is to commission research

by independent risk assessment scientists, with the purpose of

developing a new regulatory framework that is both scientifically

valid as well as being compatible with European law. ANH is close to

being able to commission such work.

 

UK releases funding to support more supplement dossiers

 

(Source:

http://www.nutraingredients.com/news/ng.asp?n=60728 & m=1NIE617 & c=siizoxouzpdntny)

 

17/06/2005 - The UK's food authority said this week that it will

provide up to £20,000 (€30,000) to pay for external scientists to

produce more dossiers for supplement ingredients not currently on the

European directive's positive list, reports Dominique Patton.

 

The Food Standards Agency (FSA) said it wanted to encourage further

dossier submission, by giving derogation to all dossiers submitted in

the UK or another member state, and supporting the scientific work, in

order to protect consumer choice in the UK.

The deal, largely negotiated by the Health Food Manufacturer's

Association (HFMA), is expected to lead to between 50 and 80 new

dossiers, in addition to the 29 already completed.

 

Extensive dossiers of scientific and technical information are

required to keep any ingredients not listed in the new European

supplements directive on the market after the law enters into force on

1 August.

 

UK trade groups estimate that more than 200 ingredients, currently

used in popular vitamin and mineral supplements in the UK, have been

omitted from the 2002 directive's 'positive' list of permitted

ingredients.

 

Only 29 dossiers have so far been submitted to FSA. A major barrier to

their submission is cost, which can go up to €350,000 for the more

complex materials, which have little readily available data.

 

Under the new agreement, FSA will match funding by the HFMA to pay a

team of scientists led by HFMA technical adviser Michael Evans. The

group has already started work on the dossiers and submitted a further

33 last week. They are aiming to add a similar amount before the 12

July deadline.

 

Coincidentally, this date will also decide the future of the directive

itself. UK trade groups, anticipating serious damage by the law to

their business, took the Commission to the European Court of Justice

in January, alleging that it infringed basic principles of free trade.

 

An initial opinion from the advocate general in April was in favour of

rewriting the directive. The final judgement on 12 July is more likely

to support the advocate general than go against his view but industry

has continued working on dossiers to limit the risks of the directive

going ahead.

 

If the verdict is negative, maximising the number of UK derogations

greatly reduces the number of products banned by the directive in the

short-term.

 

" We're very pleased with this. It's a sign of commitment by the FSA. I

haven't heard of anything like this being done before by FSA, " HFMA

director David Adams told NutraIngredients.com.

 

The dossier process does not however guarantee an ingredient's

permanent acceptance on the marketplace. The derogation lasts until

2009, when the European Food Safety Authority (EFSA) must decide on

the ingredient's status.

 

" It still leaves the longer-term issue of how and whether to fund the

very extensive extra work that is likely to be required for dossiers

to obtain final approval from EFSA, " explained Adams.

 

FSA is not evaluating any of the dossiers it receives, but merely

acting as a postbox to the Commission.

 

" We are relying on available data and not creating any new data for

these dossiers. As some are not particularly full, it is quite

possible that EFSA will ask detailed questions that require further

scientific work, " Adams explained.

 

This process could be altered by the outcome of the courtcase. If the

decision follows that of the judge's initial opinion, HFMA is hoping

for both harmonisation and national exceptions to the law.

 

" We and our lawyers have developed a straightforward change to the

directive that would create the opportunity for national exceptions

but still allow pan-EU harmonisation and we would hope to see such a

change implemented by the EU, " said Adams.

 

An assessment of the directive's impact by the FSA in 2002 suggested

that reformulation would cost manufacturers up to £3,000 (€4,372) per

product. Companies also face relabelling costs of between £300-£500

for all products to comply with new labelling requirements under the law.

 

17-Jun-05

 

__

UK Food Standards Agency recognises ANH's legal challenge in the

European Courts of Justice

 

Please find below a letter from the Food Standards Agency

acknowledging the significance of the ANH Legal Challenge to the EU

Food Supplements Directive

 

Please find below a letter received today from the Food Standards

Agency in the UK which demonstrates that legislators and the European

Food Safety Authority (EFSA) have acknowledged the significance of

ANH's legal challenge.

 

However, it is essential that pressure is maintained given that very

extensive dossiers to show the safety of plant extracts,

phytonutrients, probiotics, amino acids, essential fatty acids, fibre

and enzymes etc would be likely to create an even greater hurdle for

leading-edge food supplements than the dossier system for vitamins and

minerals. In addition ANH's work to ensure appropriate settings of

maximum dosage levels, and proper scientific risk assessment is critical.

 

 

 

 

Letter to the Alliance for Natural Health

 

 

 

23 June 2005

 

 

Reference:

 

 

 

 

 

 

PROVISIONS FOR PROVIDING DEROGATION FOR VITAMINS AND MINERALS

 

As you know, the resource recently provided by the Food Standards

Agency has ensured that a number of dossiers have been given

derogation and can remain on the market after 1 August. We

nevertheless recognise that a large number of substances will still

not be covered by dossiers and therefore will not be available for use

in products after this date. In view of the short time between the

ruling from the European Court of Justice and the date the Directive

comes into effect, the Agency has agreed to give derogation in

response to the provision of basic information. This information will

then be forwarded to the European Commission and the European Food

Safety Authority (EFSA). This will maintain consumer choice and

ensure that as many substances as possible are submitted for

evaluation by EFSA and allow products to remain on the market for the

foreseeable future although companies may need to provide more

information to EFSA in order for products to be marketed indefinitely.

 

Information addressing the following points should be submitted to the

Agency with a covering letter by 10 July to allow transmission to the

Commission by its 12 July deadline.

 

Contact name and address for company

 

Name of substance

 

Length of time available on the market

 

Are you aware of any reports of adverse effects associated with these

substances – if so please provide details

 

I would be grateful if you could forward this information to your

members. I have also written to the National Association of Health

Food Stores, the Health Foods Manufacturers Association, the Council

for Responsible Nutrition and the Proprietary Association of Great

Britain.

 

 

 

Yours sincerely

 

 

Clair Baynton

 

24-Jun-05

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