UK government and trade associations support dossiers

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.