PHC regulatory and legal affairs

INTRODUCTION

PHC regulatory and legal affairs team continue to monitor the national and international framework of laws, regulations, guidelines and principles governing food supplements and herbal medicines.  To benefit  our customers, we are proactive with our approach to regulations and research-based in developing proposals and responses to consultations. PHC continues to liaise with national, European and worldwide regulatory bodies, as well as other national and international trade associations and working parties / committees of other healthcare and related stakeholders to supply our customers with the most update and reliable legal information.

IN EUROPEAN UNION

PARLIAMENT APPROVES NEW EUROPEAN COMMISSION

The European Parliament has now approved the new European Commission by a large majority, with the three largest political groups all giving the Commission their backing.

This means that the new Commissioners, including the Health and Consumer Commissioner, John Dalli - particularly relevant for food supplement issues - will now be able to take office.   However, delays caused by the unacceptability of one candidate Commissioner, now replaced, means that the work schedule is four months behind.

Mr Dalli’s legislative priorities are given as:

• Completing the European food chain strategy
• Developing effective and efficient healthcare systems in all Member States, leading to longer and healthier lives
• Keeping the consumer at the heart of the function of the internal market, including through the increased provision of information

In relation to innovation, Dalli is quoted as saying, ‘…in this area the overarching principle remains ‘safety first’.  This, however, does not mean zero risk, or that we should not take action to enhance growth and innovation’.

REVISION TO THE UPPER LEVELS FOR VITAMINS B6 AND D?

The European Federation of Associations of Health Product Manufacturers (EHPM) has recently received a response from the European Commission (EC) to a letter requesting consideration of the revision of the upper levels (ULs) for vitamins B6 and D.

In regard to vitamin B6, the EC has responded by saying that they consider that in order to keep a coherent approach for all vitamins and minerals, they would not consider setting short term ULs as justified.

For vitamin D, however, before considering putting a request for the revision of the UL to the European Food Standards Agency, the EC is awaiting results of work carried out by EFSA on Recommended Reference Intake and also some work by the Institute of Medicine  (IOM) on the revision of the upper level  for Vitamin D.

EUROPEAN COURT RULINGS RELEVANT TO SUPPLEMENTS

The Association of Importers and Manufacturers of Natural Products in Greece, a member of the European Federation of Health Product Associations (EHPM) has been successful in overturning national legislation limiting the amount of vitamin C that could be used in food supplements to 135 mg. 

The judgment concluded that the risk to public health had not been demonstrated and thus the prohibition was neither justified nor proportionate in light of the free movement of goods (Mutual Recognition) rules, where there is now an increasing body of well-established European jurisprudence/case law.

In another ruling on national rules for food supplements in France, No C446/08, the Opinion of the Advocate General (AG) of the Court of Justice is supportive of most of the arguments given by the companies, in particular that:

• Pending harmonisation, Member States (MS) can set national levels, but in doing so must follow the principle of article 5 of the Food Supplements Directive.
• Levels that are fixed must not be based on the levels set for the most vulnerable population as their needs may not be sufficient to cover the average need of the rest of the population.
• If there is no Upper Safe Level (USL) set, MS cannot fix maximum levels.   However if USLs are set, MS can set national maximum levels at a reasonable lower level.

Although AG’s Opinion does not presume the final outcome of the case, it is a supportive reading of current legislation and important in view of the forthcoming discussion between the EC and member states on the setting of maximum levels for food supplements.

Another recent case heard by the European Court (Case 333/08 of January 28, 2010), has condemned France on the basis of its non-application of mutual recognition principles in the area of processing aids.    Although not directly related to food supplements, this case illustrates the principles established in the case law of the Court, which now repeatedly finds in favour of plaintiffs in cases concerning national restrictive rules.

Regulation for processing aids are not fully harmonised at the EU level and therefore the mutual recognition principle can apply.  The Court’s conclusion was that “By laying down, for processing aids and foodstuffs whose preparation involved the use of processing aids from other Member States where they are lawfully manufactured and/or marketed, a prior authorisation scheme not complying with the principle of proportionality, the French Republic has failed to fulfil its obligations under Article 28 EC.”

MAXIMUM LEVELS FOR VITAMINS AND MINERALS

The Institute of Life Sciences (ILSI), has recently published its latest report on intake data from food and food supplements in Europe.   This data will be used to inform the discussions of the European Commission and Member States on the setting of maximum levels for vitamins and minerals - but the timescale for progress on this issue remains unclear pending further advice from DG SANCO and its new Commissioner, John Dalli.

MAXIMUM LEVELS FOR CHILDREN

Following a consultation with its member associations on a draft response to question from the European Commission (EC) on potential maximum levels in food supplements for children, The European Federation of Health Product Associations (EHPM) has drafted a paper which offers a model and proposes levels.   The paper explains all the factors which must be taken into account to derive the levels, and particularly the conservative requirement imposed by the EC and member states to use intake data for children of 4-6 year old as a basis for calculation.

The model is in line with EHPM’s current approach to the setting of adult levels, and proposes:

• No levels to be set for Group A nutrients (for which there is no UL as no risk of excess intake is identified).
• Specific levels for Group B nutrients based on safety considerations and calculation on intake from other sources.
• Specific restrictive levels for group C nutrients taking into account potential risk of excessive intake by children.

HEALTH CLAIMS

Controversy still surrounds the assessment process for the 42,000 Article 13 health claims which were submitted for approval and which have been reduced to around 4,185 substance/health relationships for assessment by EFSA.

Of these around 1500 health claims have been accepted for assessment, with the first 500+ published in 94 opinions in October 2009.   A further 417 claims in 31 opinions were completed by the end of January and are due to be published in February 2010.   This latest tranche will include opinions on claims for probiotics, herbs and antioxidants as major categories of substances.

Information on all Health Claims being assessed by EFSA      

The central EC Register of (approved and unapproved) Health Claims has now been published on the European Commission’s (SANCO) website. It contains several disease risk reduction factor and claims for children’s products, but as yet no Article 13(1) (Generic) health claims.

Generic claims, and in particular claims for botanicals, did not fare well in the October 2009 tranche of claims, and expectations are not high for the next tranche.    Once published in the Central Register of Health Claims, unapproved claims may no longer be used in the European Union. In the face of this, European industry is carrying out an intensive lobbying campaign both nationally and in the EC aimed at ensuring that the criteria used by EFSA for the assessment of all article 13(1) claims are both proportionate and appropriate.

FOOD INFORMATION (LABELLING)

The proposed Regulation on Food Information for Consumers was published in February 2009 and since then has been the subject of intense discussion.  The two most important issues for food supplements are the mandatory labelling font size and exemption from mandatory labelling for small packages.   Industry has lobbied strongly for the deletion of mandatory font size labelling, proposing instead that the main criterion be legibility and is seeking amendment or exemption for small packages.
A final vote on the content of this Regulation is expected in the May plenary of the European Parliament.

STATUS OF DISCUSSIONS ON CONTAMINANTS

The current status of discussions between Member State experts and the European Commission (EC) on contaminants relevant to food supplements is as follows:

• Limits for non dioxin like PCBs - Consultation of stakeholders expected in April, with final adoption foreseen in spring 2010.

Review of levels for dioxin like and non dioxin like PCBs - Consultation of stakeholders expected in April, with final adoption foreseen in spring 2010.
Review of legislation on fusarium toxins - EFSA opinion awaited - Consultation of stakeholders expected in the spring, with final adoption foreseen after summer 2010.
Review of maximum levels for cadmium in foods - in progress but no defined timeline yet for consultation of stakeholders - adoption expected by end 2010.
Review of legislation on PAHs - in progress, waiting for further advice from EFSA but no defined timeline yet for consultation of stakeholders - adoption expected by end 2010.

PAN-EUROPEAN FOOD CONSUMPTION SURVEY

Article 33 of Regulation No 178/2002/EC on General Food Law requires the European Food Safety Authority (EFSA) to collect data on food consumption and the exposure of individuals to risks related to the consumption of food.  A collaborative project with European Union (EU) Member States was launched in 2008 to establish a comprehensive data base for the adult European population, and a project to generate individual food consumption data and exposure assessment studies for children, for food colours, selenium, chromium and lead.

Although the data collected so far is regarded as the best currently available in Europe, EFSA’s Scientific Committee has acknowledged that it includes crucial methodological differences, making comparisons across European countries difficult.   As a result, EFSA is now to launch and co-ordinate the first pan-European food consumption survey (EUMENU) which will run from January 2012 to December 2017 as a rolling programme covering 5 - 6 countries a year, and encompass 80,000 people.

NOVEL FOODS AND NANOTECHNOLOGY UPDATE

It appears that proposal for revision to the Novel Food Regulation are currently blocked because:

• The new Novel Food Regulation will be adopted under the Lisbon Treaty and has to indicate the new management/implementing procedures that will replace comitology and comitology with scrutiny. These are currently under discussion and will be defined between the European Commission (EC), European Parliament (EP) and Council.

• The new Health and Consumer Commissioner John Dalli, has advised the EP that the Commission expects to have a specific report and proposal on cloning in the coming year. As a result, it appears that the EP has unofficially informed the Commission that they will not deal with the novel food proposal, without having sight of this report/proposal.

One of the possibilities for progress on the Novel Food Regulations now being considered by the Commission is to have an EC reviewed proposal for novel foods that would exclude cloning (and perhaps nanotechnology).  

Additionally, although not part of the current revision of the Novel Food Regulation, it is understood that the Novel Food Expert Group is still discussing a potential guideline on the definition of “significant amount”, but will not take any decision pending the revision of the Novel Food Regulation in order not to jeopardize the chances of success of the proposed revision.

With regard to nanotechnology, the new the Commissioner for Environment, Janez Potocnik, has stated during his hearing that he would favour specific horizontal legislation on nanotechnologies. Given the scope of policies in relation to nanotechnology, this would mean that many different DGs and Units would have to work together.

IN THE UNITED KINGDOM

REVISED GUIDANCE ON NUTRITION AND HEALTH CLAIMS

The UK Food Standards Agency is currently consulting on revised guidance on the Nutrition and Health Claims on Food Regulation (EC) 1942/2006.  The key elements are:

• New guidance on health-related charity and national association endorsements.
• A revised section on health claims making reference to recommendations by doctors and health professionals to ensure that the interpretation of this provision of the Regulation is clear.
• Following discussions with stakeholders and other Member States, updates on other interpretive issues to provide additional clarity and to reflect the fact that progress has been made in implementing the regulation - for instance, some transition periods and deadlines have already passed.

WATCHDOG ACTS ON ‘HERBAL VIAGRA’ ADVERTISEMENTS

The UK Advertising Standards Authority (ASA) has advised the manufacturer of a ‘herbal viagra’ product that it is breach of UK advertising codes and that its claims are misleading.

The ASA said that the product ‘made medicinal claims to promote an unlicensed product and implied that because (the product) was made from natural ingredients, it was therefore safe and efficacious.’    In addition, because the company did not provide any evidence to substantiate the claims for the product, or proof that it offered the ‘100 per cent no-quibble money-back guarantee’ promised in the advertisement,the advertising watchdog took the view that these claims were likely to be misleading the general public.

Principle Healthcare International welcomes feedback and comments on the issues raised in this regulatory affairs newsletter.

*All images used have been taken form the web and not purchased.

Last updated: 29-04-2010