REGULATORY NEWSLETTER 17 MARCH 2003

Contents:

• Food supplements directive
• PARNUTS
• Health Claims Regulation
• Allergen labelling
• Genetically modified ingredients
• Herbals Directive

Food supplements directive

The Food Supplement Directive is an attempt to standardise:

• the materials used in vitamin and mineral supplements and
• maximum dosages of those nutrients throughout Europe.

The implications of the Directive will differ between member states dependent upon the current regulations: member states such as the UK and Holland which have a relatively liberal approach to vitamin and mineral usage will be far more restricted in the ranges and levels of nutrients available. For the first time the UK industry will have to contend with a ‘positive list’ whereby if a nutrient or nutrient source is not included it will not be permitted in the market.

The Positive List

The challenge is to get nutrients and their sources placed on the ‘positive list’ (which is comprised of an Annex I and Annex II). A European body (the Scientific Committee for Food or SCF) has the ultimate decision as to whether a nutrient is considered appropriate for inclusion and also at what maximum level it can be used in supplementation.

Specific details as described by the FSA (Food Standards Agency):
According to article 4(6) of Directive 2002/46/EC, Member States may allow the use of vitamins and minerals not listed in Annex I or Annex II of the Directive until 31 December 2009 provided that the substance in question is:

• Used in one or more food supplements marketed in the Community on 12/07/2002 and
• The EFSA/SCF has not given an unfavourable opinion in respect of use of that substance or use in that form or
• On the basis of a dossier submitted not later than 12 July 2005.

“Our interpretation is that all three elements (i.e. marketing on 12/07/2002, dossier submission not later than 12/07/2005 and absence of an unfavourable opinion from EFSA) must be in place for us to allow continued marketing of food supplements containing substances excluded from the 'positive lists' until 31/12/09.”

Article 4(6) (b) is clear that dossiers must be submitted not later than 12 July 2005. All Member States are obliged to transpose the Directive into their own national legislation.

Summary

The new European legislation that encompasses the Food Supplement Directive also encompasses PARNUTS (foods for particular nutritional purposes such as Sports use). It is intended that one dossier should be able to meet the requirements for the positive lists for either or both directives. However it is clear that whichever directive a product is classified under it must be present on that positive list in order for it to continue on sale after 2009.

PARNUTS

If a food supplement is promoted to achieve a particular nutritional use or for a subset of the population then it falls under the PARNUTS legislation, again the form of the supplement is irrelevant as long as it appears on the positive list.

PARNUTS Dossiers - extension to Food Supplements Directive

There is discussion regarding an automatic 'read across' to other relevant Directives and again noted that the Recital to the Food Supplements Directive should allow this to happen.

Labelling: timescale

Products not correctly labelled according to the requirements of the Directive must be withdrawn from the market by August 1st 2005. There will be no transitional period alowed for products already in the retail chain although LACORS may be sympathetic to the position of such stock if manufacturers can prove that their arrangements for appropriately labelled stock are in place and in use.

Timing/transition period for labelling alterations triggered by the setting of new Maximum levels.
Unless there are safety questions, there is likely to be a transition period (of length as yet unspecified), which will include a 12-month period for implementation by Member States

Labelling/claims for minerals without RDAs

This anomaly is likely to be corrected under the forthcoming review of the Nutrition Labelling Directive.

Health Claims Regulation

An unofficial draft is in circulation although the official draft has not been released. It is not at present expected to be different from the unofficial draft.
The measures within the directive are extremely harsh:

• Basic nutrition claims (high in, low in, reduced, a source of, etc) will be allowed on a case by case basis according to pre-agreed criteria
• Any claim related to health properties of food must be assessed on the strength of an evidential dossier presented to EFSA (European Food Safety Agency)
• EFSA will evaluate all claims, in words and in images.
• Evaluation will take at least 6 months, and the final 2 months will be public.
• Final judgement on claims will also be public – whether the application is accepted or rejected
• No claims will be allowed making referent to psychological or behavioural change
• No claims will be allowed for general vague sense of wellbeing
• No claims may be made for rate or amount of weight loss, loss of appetite, sense of satiety for ANY foods.

The official draft has been expected for some time, April is now the most likely date. Industry is deeply unhappy about the provisions of the directive, on the basis that:

• It restricts claims to those who can afford the clinical work
• Clinical work might be discouraged because of lack of confidentiality
• General ‘wellbeing’ claims are important messages to consumers
• Consumers will be deprived of important information
• Many products will have to make radical changes to their packaging and promotional material

Timing is not clear, but this draft regulation is already having an impact by drawing attention of enforcement officers to its provisions, and encouraging closer scrutiny of on pack claims.

Further information on timing and action to be taken after receive of official draft and notification of Commission timetable.

Allergen labelling

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs:

• It is recognised that certain ingredients contained in foodstuffs cause allergies or intolerances and some of those allergies or intolerances constitute a danger to the health of those concerned.
• The SCF has stated that the incidence of food allergies affects the lives of many people, causing conditions ranging from very mild to potentially fatal.
• The SCF has acknowledged that common food allergens include cow’s milk, fruits, legumes (especially peanuts and soybeans), eggs, crustaceans, tree nuts, fish, vegetables (celery and other foods of the Umbelliferae family), wheat and other cereals; it has also noted that adverse reactions to food additives may occur and that the avoidance of food additives is often difficult since not all are included on labelling.
• The most common food allergens are found in a wide variety of processed foods.
• Labelling should not to be regarded as the only medium of information but it is nevertheless advisable to assist consumers who have allergies or intolerances as much as possible by providing more comprehensive information about the composition of foodstuffs.
• In order to provide all consumers with better information and to protect the health of certain consumers, it should be made obligatory to include in the list of ingredients all ingredients present in the foodstuff and, in the case of ingredients known to be allergenic, to declare them by their specific name in all cases, including in alcoholic drinks, allowing no possibility of using the name of the category to which they belong, nor, in the case of additives, any exemption from inclusion in the list of ingredients.
• In order to avoid the risk that labelling may become too complex and difficult to read, procedures are needed which make it possible to avoid excessively long lists of ingredients, but without impairing the attainment of the abovementioned objectives. In order to take account of the technical constraints involved in the manufacture of foodstuffs, it is also necessary to authorise greater flexibility with regard to the listing of ingredients used in very small quantities.

Genetically modified ingredients

THE TWO EP REPORTS REGARDING THE TWO GMO PROPOSALS READY FOR DISCUSSION

Two areas of discussion have been under consideration by the Environment Committee, below are a few of the key points of each of the reports:

GMO Food and Feed

A suggested tightening of the Commission proposal on virtually every point by introducing numerous amendments:

• The extension of the scope of the Regulation to cover food derived from animals fed on GM material as well as the on-pack labelling obligations which goes beyond what the Commission has said that it could accept.
• The introduction of the precautionary principle as a key principle for the implementation of the GMO legislation.
• The lowering of the threshold for accidental contamination from 1% to 0.5%.
• Public access to the whole authorisation procedure (dossier of applicant, risk analysis documents, authorisation documents, risk management decisions, risk communication etc.), which would at an early stage reveal any company applying to use GMO’s on the European Market.
• The rendering of the authorisation procedure more detailed, with more obstacles e.g. with regard to the method of analysis, the necessity to take into account environmental risks in the risk assessment, the obligations to notify labels to the EFSA prior to marketing of a product etc.
• The setting up of rules for what can be considered to be adventitious/technically unavoidable presence of GM material (done to counter the risks of fraud and the provision of 'dummy' certificates by suppliers).
• The possibility for Member States to pull back food/feed products from the market if they have new information with regard to implications for human or animal health or the environment prior to European consultation which is proposed by the Commission. Hasty product removals from the Member State authorities based only on 'new information' could have serious negative commercial implications. She also consistently reinforces the powers of the Member States with regard to the EU institutions, which do not all share the Commission's goal to get GMO authorisations to restart.

GMO Traceablity

Below follow a few of the key principles dealt with in the amendments (17 in total):

• The main principle of the report is that food and food ingredients (same applies for feed) produced from GMOs but not containing GMO material should not be the subject to the traceability and labelling requirements. He gives Vitamin C, Citric Acid and Maize oil as examples of products produced from GMOs that should not be covered by the traceability and labelling obligations under this Regulation.
• Furthermore he introduces an amendment stating that if the presence of a GMO is adventitious or technically unavoidable and that it does not surpass a maximum threshold of 1%, provided that the GMO has been evaluated and judged not to pose a risk to human health and provided that food companies have prove that the necessary measures have been taken to avoid contamination, then the products falls outside of the scope of the Regulation.
• He also provides a row of definitions of terms used in legislation with regard to GMOs, to provide further clarity.

The next steps are that MEPs and political parties will now be invited to put forward amendments on both of the Commission Proposals, which will then be voted on together with the amendments proposed by the two rapporteurs first in the Environment Committee and then a second time in plenary in Strasbourg.

Herbals Directive

The European Parliament has now adopted a resolution for new legislation which means that traditional herbal products on sale in Europe will have to be registered. They will also have to prove their safety through traditional use over a 30 year period, 15 of which must have been in Europe. There had been some support for the view that only 10 years' use in Europe should be necessary. The new rules will be enacted through amendments to the medicines Directive 2001/83/EC.

A proposal has also been made to amend Directive 2001/83/EC to ensure the same quality and safety standards for herbal medicines in all Member States. The proposal requires:

• A special procedure for registering and marketing traditional herbal medicines to be set up.
• A rejection of requests for homeopathic products to be covered by the directive.
• An amendment allowing Member States to apply their own rules for "traditionally used non-conventional products".
• To allow herbal medicines to contain non-herbal ingredients, such as vitamins and minerals and
• Improved labelling so that consumers are notified of any possible side effects and adverse interactions with food, alcohol and other drugs.
• It would no longer be necessary for consumers to be informed if the efficacy of a product had not been clinically proven. This is on the grounds that negative information is not needed.

Herbal substances will now be listed and classified into several groups. The list will include details of each herbal substance including:

The therapeutic indication,

• The specified strength and daily dose,
• The route of administration,
• Possible adverse effects and possible interactions,
• Other information required for safe use, especially by children, pregnant women and the elderly.

At present unlicensed remedies are not permitted to state on the label what they are intended for and what conditions they can treat. Another amendment adopted will mean that a Committee on Herbal Medicinal Products will be set up to oversee lengthy and complex process of evaluating all herbal products.