We’re delighted to present to you the second instalment of our recently launched series of Regulatory Updates. Our Technical & Regulatory Executive at HTC Health, Kwame Otchere, prepares a monthly round-up covering a broad scope of news related to the European VMS industry that we think our customers might find relevant and useful. This edition includes also the update from HFMA Steering Group Meeting, which took place on the 12th September.
Ireland introduces 23% food supplement VAT
Ireland have introduced a 23% food supplement VAT which comes into place from 1st November 2019. However, this is backdated for the past 4 years. The HFMA advises their members to contact them first if a company is requested to pay any money to Irish authorities.
UK adopts EFSA’s Novel Food status for CBD
The UK have adopted EFSA’s Novel Food status for CBD, and were one of the 3 member states that pushed for the novel food status. However, the Food Standards Agency have admitted that they have not found any safety concerns about CBD. They are currently awaiting a safety report from the COT before providing any updates. Any CBD products currently on the market will not be recalled for the time being.
Changes in B2B communication of health supplements
The Health Claims Regulation will now apply to B2B communications that are marketing health supplements as finished products. For example, health claims made through articles, business brochures and even trade shows must be authorised. Previously this regulation applied to B2C communication only, but there is currently a lawsuit in Germany regarding a similar case, which prompted the UK to adopt this stance.
More efficient controls required for food supplements
The Director of Regulatory & Scientific Affairs at Food & Drink Europe (FDE) declares EU legal framework for food supplements is ‘among the strictest in the world’, but efficient controls are required to accompany this framework. This was in response to a study in The Netherlands discovering 64% of supplements contained pharmacological substances.
Many of the products contained tiny quantities of these substances, suggesting this was accidental and down to substandard production processes. But these small quantities can result in a positive doping test and have dire consequences on athletes. Some products contained doses that were far above safe, indicating these pharmacological substances were added by purpose.
It has been recommended that supplements follow similar regulations to pesticides for enforcing efficient controls.
Nicotinamide Riboside Chloride confirmed as safe
The European Food Safety Authority has confirmed the safety of Nicotinamide Riboside Chloride’s safety, vouching for this Novel Food as a reliable Niacin (vitamin B3) source.
The ruling states it is safe up to 300 mg per day for the healthy adult population. For pregnant and lactating women the ingredient is safe up to 230 mg per day.
Norway to tighten supplement ingredient laws
From January 2020 Norway plans to make a number of changes to food supplement legislation. For example, DHA and EPA will have a recommended daily dose of 1.3 and 1.8 g per day, respectively. Turmeric has been limited to 210mg per day, and caffeine has been limited to 300mg per day, divided into at least 3 doses per day.
There will also be additional requirements when registering a food supplement with the Norwegian Food Safety Authority. Some of the added requirements will include chemical name, molecular formula and CAS number of the ingredient.
Poland set maximum vitamin and mineral limits
Poland’s Ministry of Health has the country’s maximum limits for vitamins and mineral in an attempt to address the lack harmonisation in Europe. This move mirrors recent action by Germany, The Netherlands and Ireland. Folic acid, niacinamide, nicotinic acid, zinc and magnesium are amongst the vitamins and minerals affected by this change.
DFA increases iodine levels in salt
The Danish Food Agency has increased the iodine in salt, in an attempt to reduce the prevalence of iodine deficiency in pregnant and breastfeeding women. Salt will now contain 20mg per kg instead of 13mg. However, they state salt consumption should not increase and the idea is to increase iodine intake from current intakes of salt.
Iodine is an essential mineral and the EU recommends 150mcg per day. The number of sources is limited so there is a risk of deficiency. Iodine deficiency increases the risk of permanent retarded foetal development, stunted infant growth, perinatal death and low birth weight.
The majority of pregnant women intake adequate iodine from supplements but women not taking a supplement is likely to be iodine deficient. Household salt and products containing salt e.g. bakery, will all have to comply with this change.
‘Thermogenic’ supplement claims ruled as misleading
The Advertising Standards Agency (ASA) has ruled that a popular Green Tea extract breached advertising standards by claiming their Green Tea supports fat oxidation and is thermogenic. The ASA ruled these claims to be unsubstantiated and misleading.
The claims made on the supplements have not been approved but they are currently on hold. For such claims there must be adequate scientific evidence provided to the ASA before it can be used for marketing. But the ASA deemed the research provided to be insufficient because the dose used in the study was double the dose in the product.
If you have any questions relating to the news presented above, please do not hesitate to contact us for more information, as we’d be happy to advise.