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The vitamin laws after Brexit

Reading time: 11 minutes

The many reactions to Brexit in both the UK and rest of the world continue to reverberate. As the UK begins with a new leadership to navigate through the complex process of leaving the European Union, it’s a good time to reflect on what the EU brought to natural health – both positive and negative.

At Alliance for Natural Health International, we’ve been closely involved with EU and national laws affecting natural products for nearly 15 years. In fact, we’ve long worked to influence these laws, especially those that contribute to excessive restrictions on individual freedoms and liberties and, thus, our ability as citizens to manage our health through natural means.

Our consultancy arm has also helped to keep many natural products on the market, and we’ve helped a large number of practitioners negotiate the complex minefield of EU and national laws.

Drawing on this background, we provide here a summary analysis of what we consider are some of the key issues facing the UK from the standpoint of its consumers and businesses, and the non-UK businesses trading in the UK, insofar as they relate to natural health.

Given the literally hundreds of EU regulations, directives, decisions and recommendations that in one way or another have impacted our ability to manage our health naturally, let alone the great slather of European case law meted out by the European Court of Justice, we’ve decided to focus on just a dozen of the key regulatory frameworks.

How EU laws are passed

Any law or directive needs to have sufficient justification to launch the proposal stage, and then it needs to survive being put through its paces in the EU’s hugely expensive and time-consuming collective decision procedures. This typically involves two readings in the European Parliament and extensive input from the EU Member States via the European Council – and, of course, this process is led from above by the undemocratically elected, unaccountable European Commission (EC).

The convoluted law-making process often means that we start with laws that are completely justifiable with ample reasons to exist, assuming they stay on the track of their originally intended purposes.

The difficulty – and this is by no means limited to the laws affecting natural health – is that the laws are pulled, pushed, squeezed and distorted by a plethora of different interests during its lengthy procession through the EU’s law-making sausage factory.

Like the ultra-processed foods we now know are significant contributors to the ill health of those who consume them, ultra-processed EU laws are undeniably bad for good laws and justice.

Things are made even worse by the fact that there are 28 EU Member States engaged in the process, along with 751 Members of the European Parliament (MEPs), all stage-managed by the European Commission, which is well known to run roughshod over the last remnants of the democratic process.

Compromise packages are the name of the game, and they typically involve backroom deals between Commissioners, EU Parliament rapporteurs and whichever Big Business sector has made the best case for why its interests need protecting over and above any public-health interests or fundamental public freedoms. Such is the tendency of the EU’s sleight of hand as EU laws are made and amended.

The good, the bad and the ugly

You’ll find that our analysis of the Dirty Dozen – the 12 biggest EU laws affecting natural health – has been divided into three main areas that we call the good, the bad and the ugly. This covers the sequential process by which the EU legal frameworks have been distorted from their original, often laudable, intended purposes. [We’ve considered the genetically modified (GM) foods framework as a single entity of law, although it is divided into many sub-laws, only the most important of which are mentioned.]

Some of this has been made possible through a deep understanding of the extensive distortion wreaked upon laws that were originally based on good, laudable reasons.

EU laws, it should be recognized, are continuously being developed, with thousands of people, mostly in Brussels, dedicating their lives solely to the task. In fact, some laws have yet to be cemented or enacted, such as the future imposition of the EU-harmonized maximum permitted levels for vitamin and mineral supplements (listed in the Foods Supplement Directive, see page 50).

For years, we’ve been centrally involved in slowing or even blocking this process, which could end up banning the amount of selenium in five Brazil nuts when taken as a food supplement, despite copious and recent evidence that Europeans are suffering elevated health risks, particularly from liver cancer, because of their low selenium status.

The final pieces of information in our Dirty Dozen list summarizes some of the key actions we believe need to be considered by the British government and its Members of Parliament as the UK starts to extricate itself from the EU in 2017. It will be a long journey, but with sufficient foresight and planning, this is a real opportunity for creating a legal infrastructure for health, wellbeing and disease prevention that could outperform any other in the world.

Now is the time for renewed democracy and participation by the public. It’s about co-creating a bright new future with the elected representatives of the people, rather than with an unaccountable authoritarian regime. It’s also about ensuring that our health and our fundamental freedoms are considered as central to the overall plan for moving forward.

1) Food Supplements Directive

The Good

O Creates a carve-out for food supplements as a category of food rather than as medicines.

O Establishing high maximum amounts of vitamins and minerals based on good-quality risk–benefit assessments will prevent arbitrary limitations of vitamin doses by national authorities (such as those of Germany, France, Denmark, Finland and Italy).

The Bad

O Only a limited range of vitamin and mineral forms on the positive list (Annex II) can be used in food supplements.

The Ugly

O Has effectively prevented the legal sale of many hundreds of mineral forms, including all forms of silver and vanadium

O Article 5 requires that the European Commission harmonize maximum (and minimum) levels of vitamins and minerals that might, if based on poor science, restrict public access to useful/beneficial dosages.

How the UK can act in the interests of natural health

O Discard the positive list

O Don’t attempt to harmonize maximum levels with any future EU levels

O Take into account benefits of higher doses

O Exempt foods, food supplements, cosmetics and medical devices from UK medicines law.

2) Human Medicinal Products Directive

The Good

O Legal framework for pharmaceutical drugs as distinct from foods, food supplements, cosmetics and medical devices.

The Bad

O Scope and definitions are so broad that any substance or combination of substances can be classified as ‘drugs’ by national authorities unless they can be clearly characterized as foods, food supplements, cosmetics or medical devices.

The Ugly

O The ‘rule of doubt’ cemented by European Court of Justice case law gives national regulators a loaded gun to classify any product as medicinal – especially if there is evidence of clinical effectiveness.

How the UK can act in the interests of natural health

O Narrow the scope and definition of a medicin
al product

O Legally exempt foods, food supplements, cosmetics and medical devices from UK medicines law.

3) Traditional Herbal Medicinal Products Directive

The Good

O Simplified licensing scheme for herbal medicines allows their use for specific indications based on traditional practice rather than expensive clinical trials of efficacy.

The Bad

O Scope is limited to traditional herbal medicines intended for use by the public for minor ailments and with no supervision by a medical practitioner.

The Ugly

O Requires evidence of 30 years of safe use, including 15 years within the EU

O Stability requirements rule out many fully natural, multi-herb formulations and excludes combinations with non-herbal substances

O Most of the products registered under this directive are viewed as having insufficient efficacy by leading herbal medicine practitioners and experts.

How the UK can act in the interests of natural health

O Maintain the licensing system for herbal and traditional medicinal products, but make it fit for purpose and open to non-European traditions

O Facilitate a regime for good-quality herbal food supplements even if they include one or more ingredients also used in traditional medicine

O Provide an option for statutory regulation of herbal practitioners for those who want it.

4) Nutrition and Health Claims Regulation

The Good

O Prevents ‘cowboy’ health claims that are false, ambiguous or cannot be substantiated by any plausible science.

The Bad

O While foods meeting these conditions are authorized for use across the EU, there are pitifully few of them

O Wording of these claims is generally not informative enough for consumers.

The Ugly

O Over 2,000 health claims with plausible evidence are banned and a further 1,600 involving botanical preparations and related substances await a very uncertain future

O Overall, this Regulation has drastically censored the ability of businesses to communicate the benefits of health foods and supplements to the public.

How the UK can act in the interests of natural health

O Don’t integrate key problematic parts of the Regulation into any UK laws (Articles 4, 10, 13)

O Discard altogether the European Food Safety Authority (EFSA) requirements for ‘generally accepted scientific evidence’, which are too stringent

O Develop rational validation requirements for health claims based on scientific plausibility, and current and emerging evidence.

5) Novel Food Regulation

The Good

O Prevents foods new to the diets of EU citizens produced through technological or biotechnological means from being marketed without prior safety evidence or traditional safe use in ‘third’ (non-EU) countries.

The Bad

O As the cutoff date for safe use is anything before 15 May 1997, it is becoming increasingly difficult to provide documentary evidence of prior ‘significant’ use in the EU, as sales records for that time are no longer available

O Many food ingredients incorrectly regarded as novel are banned, as the high cost of premarketing authorization poses an obstacle.

The Ugly

O While the Regulation, when initially passed in 1997, was originally intended to protect EU consumers from GM and other technologically altered foods, it has since become an EU protectionist tool that blocks public access to a diversity of plant, fungal (mushrooms) and algal (seaweeds) foods that have a wide range of proven health benefits.

How the UK can act in the interests of natural health

O Dissociate from European Commission/EU Member State ‘closed shop’ approach to determining novel food status

O Create the ability to differentiate in law between naturally occurring and ‘engineered’ nanomaterials, so the former are not unnecessarily forced through authorization

O Encourage diversification of the food supply by facilitating trade in natural foods and ingredients regarded by the EU as ‘novel’ simply because ‘significant use’ within the EU has either not happened or been adequately documented.

6) Food Information for Consumers Regulation

The Good

O Clear labelling requirements for packaged foods, including the requirement to indicate provenance.

The Bad

O Reference intakes [energy: 2,000 kcal (8,400 kJ), total fats 70 g, saturated fats 20 g, total carbohydrates 260 g, sugars 90 g, protein 50 g and salt 6 g] may be wrongly read by consumers as guidance amounts, whereas these ratios do not reflect the best macronutrient composition for the average adult.

The Ugly

O Widespread support of this Regulation by government authorities and consumer groups has encouraged increased rates of consumption of packaged and highly processed foods because of labelling information, leading away from the consumption of unpackaged, unprocessed or lightly processed, whole foods.

How the UK can act in the interests of natural health

O Implement newly developed non-mandatory guideline daily amount (GDA) labelling for packaged foods

O Develop policies and education to increase awareness of the health benefits of consuming home-prepared, whole, largely unprocessed foods as part of a varied and diverse diet.

7) General Food Law

The Good

O General rules relate to responsibilities of food-business operators, including placing the onus of food safety on these operators.

The Bad

O Established the EFSA, exposed as having conflicts of interest while green-lighting GM foods and issuing negative opinions on scientifically valid health-claim applications.

The Ugly

O Misapplication of the ‘precautionary principle’ – which proposes resisting the introduction of new products or processes with unknown ultimate effects – which the Regulation seeks to harmonize (Article 7) across the EU, denying EU consumers freedom of choice and presenting barriers to trade.

How the UK can act in the interests of natural health

O Move away from any enforced reliance on laws based on EFSA opinions

O Apply the precautionary principle fairly and judiciously to protect consumers from genuine food-related risks

OEncourage trade of ingredients and foods both within and outside the EU.

8) GMO regulatory framework

The Good

O Mandatory labelling of GM foods and animal feeds has resulted in high levels of rejection of GM foods for human consumption in the marketplace and, thus, the decision of most food manufacturers to avoid using GM ingredients or foods

O The ‘safeguard clause’ allows individual EU Member States to avoid cultivating GM crops even if authorized by the European Commission following a positive safety assessment by the EFSA.

The Bad

O Inadequate framework for evaluating
long-term environmental and human health safety has led to authorization of more than 50 GM crops

O Inadequate regulation to guard against GM transgenetic flow into non-target plants and organisms.

The Ugly

O Insufficient requirements for scientific verification of GM food and feed crop safety for humans and animals

O Insufficient consideration given to overall impact of GM crop technologies on human health and the environment, especially when combined with the use of glyphosate-based herbicides (see Pesticides
Residues Regulation page 55).

How the UK can act in the interests of natural health

O Prevent the UK government, with its long-standing pro-GM crop stance, from relaxing the already inadequate EU GM regulatory framework and so gravely endangering human health and the environment

O Based on the huge uncertainties concerning GM crop cultivation and without their need to meet food needs of humans and animals, a moratorium on outdoor GM cultivation should be applied until sufficient case-specific safety data are available.

9) Contaminants in Foodstuffs Regulation

The Good

O Sets maximum levels of contaminants in foodstuffs, thereby protecting consumers and improving quality standards for food and supplement industries.

The Bad

O Inadequate range of contaminants considered

O Ignores any consideration of long-term effects of consumption of specific mixtures of contaminants.

The Ugly

O Maximum levels are determined more on the basis of what industry can live with rather than safety considerations

O Tolerances for recognized human carcinogens like benzopyrenes and dioxins are too high.

How the UK can act in the interests of natural health

O Develop thresholds for contaminants based on human health and environmental safety, taking into account the effects of combined and common exposures.

10) Food Additives Regulation

The Good

O Authorization system for individual additives and food groups helps limit the use of food additives for technological purposes.

The Bad

O Safety assessments required by EFSA and other international bodies are of variable quality, and seemingly dependent on the applicant and based on additives assessed in isolation

O Inadequate consideration given to additive, antagonistic and synergistic effects of multiple food additives in specific foodstuffs.

The Ugly

O Additives that trigger severe adverse reactions in some people or may be carcinogenic, such as aspartame, benzoate preservatives and artificial colourants, are not only allowed, but mandated.

How the UK can act in the interests of natural health

O Reassess evaluations by authorities like the EFSA, United Nation’s Food and Agriculture Organization (FAO) and World Health Organization/FAO Joint Expert Committee on Food Additives (JECFA) on the basis of the latest evidence of safety and benefits

O Consider the effects of interactions between additives and other foods and nutrients (for example, benzoate preservatives and vitamin C, which can produce the carcinogen benzene).

11) Pesticide Residues Regulation

The Good

O Provides a framework that prevents indiscriminate use of most common pesticides to provide some degree of protection of human health and the environment.

The Bad

O Levels are based on thresholds achievable with average patterns of use in the field, not on human safety criteria or impact on non-target organisms.

The Ugly

O Many pesticides, including some probable human carcinogens like glyphosate, are mandated

O Combined effects of pesticide mixtures on foods are entirely ignored.

How the UK can act in the interests of natural health

O Base pesticide maximum levels on safety, not on levels achieved by use

O Base pesticide tolerances on individual crop/agroecosystems so that pesticides overall are minimized and the development of sustainable agricultural practices encouraged.

12) Mutual Recognition Regulation

The Good

O A key tenet of the EU single market is ensuring free movement of goods where there are no public-health concerns.

The Bad

O Impact on public health of a given product is open to wide interpretation, depending on whether a given Member State does or doesn’t want the product sold in its territory.

The Ugly

O Member States like the UK have often not taken much notice of mutual recognition, considering it a Continental European concept, as it has only recently been formally written into EU-wide law.

How the UK can act in the interests of natural health

O Aim to not impose unnecessary and unjustifiable barriers to trade when the UK negotiates new trade deals with EU and non-EU countries and blocs.

Heads down, not in the sand

The real work of reframing the many laws on food and supplements is just beginning in earnest for Prime Minister Theresa May and her new cabinet. Uncertainty is guaranteed unless the UK people and its various trade sectors work together. This will require many of those who are currently still reeling from the decision of the British people to take stock and contribute, pro-actively, to the creation of a new UK freed from the shackles of the EU.

At the Alliance for Natural Health, we will be taking a much more active part in the political process in the UK, while continuing to support citizens and natural health interests in the remaining 27 EU member states.

You can contribute to this process of rewriting by sending this article to your local MP and urging him or her to consider our suggestions for creating new vitamin and food laws that allow the nation’s health – and the natural health industry – to flourish.

Dr Rob Verkerk, WDDTY columnist and panel member, is the founder and executive and scientific director of the Alliance for Natural Health (ANH).

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