The Food Supplements (Magnesium L threonate monohydrate) (Wales) Regulations 2026: integrated impact assessment

This assessment relates to an amendment, in relation to Wales, of Schedule 2 of the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 to add magnesium L-threonate monohydrate to the list of substances permitted for use in a food supplement and to set its purity criteria. This will enable its use in food supplements in Wales.

The key purpose of this regulatory proposal is to respond to an application from a business to the Food Standards Authority (“FSA”) for the use of magnesium L-threonate monohydrate as a novel food in food supplements.  As part of the consideration of this application there has been a subsequent safety assessment, a risk management recommendation and public consultation.  The substance has been authorised by the Welsh Ministers as a novel food in accordance with Regulation (EU) 2015/2283 on novel foods subject to the terms of authorisation. 

This change is small in scale and will only impact one food business (the applicant) for the first 5 years after authorisation. This is because they will retain a 5 year exclusivity period in relation to the supply and sale of the product unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or data protected as part of this authorisation. After this period, the authorisation will provide businesses with the option to produce and sell the substance in line with the terms of authorisation of the novel food. The change will not place any new burdens on businesses, and it will be optional for businesses to place the product on the market in accordance with the law. The substance has already been authorised as both a novel food and a food supplement within the EU.

Long term

No impacts identified.

Prevention

No impacts identified.

Integration

We anticipate impacts on other policy areas to be minimal, given the nature of the regulatory proposal. However, the proposal will support businesses to offer greater choice to consumers within the food supplements market in Wales, whilst ensuring the safety of all products sold. We have not identified any potential negative impacts in relation to Welsh Government’s 7 Wellbeing Goals. It is most directly supportive of ‘A Healthier Wales’.

Collaboration

This proposal falls under the four nation Nutritional Labelling and Compositional Standards (NLCS) Framework and therefore has been developed in consultation with UK Government, Food Standards Scotland and the FSA in Northern Ireland, as well as the FSA in Wales.

Involvement

Food and feed businesses, local and port health authorities, district councils, and other stakeholders with an interest in food and feed safety were invited to share their views on this proposal through the FSA’s consultation.

The consultation was open to all respondents, including members of the general public. However, this regulatory change is likely not of significant relevance or interest to the general public. No further engagement with the public was undertaken for this reason.

Impact

As part of the risk assessment process, the FSA has assessed the potential impacts that would result from the authorisation of this novel food. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests). The authorisation of this product should result in greater market competition, supporting growth and innovation in the sector.

The FSA risk management recommendation is that magnesium-L-threonate monohydrate is safe and is not liable to have an adverse effect on the target population, environmental safety and human health at the intended concentrations of use.

Costs and Savings

The change is not expected to result in any significant additional cost for Welsh Government or regulators as they are not expected to impose any additional cost on businesses operating in Wales or the wider UK.  Enabling the use of magnesium L-threonate monohydrate will provide food businesses with another form of magnesium for use in food supplements but its use will be optional.  It is anticipated producers will only use magnesium L-threonate monohydrate if they perceive there to be product or price benefit for their business.

The authorisation of magnesium L-threonate monohydrate has the potential to encourage greater market competition, supporting growth and innovation in the food supplements sector.

Mechanism

A Regulatory Impact Assessment (RIA) has been undertaken for this proposal. No significant impacts were identified through this assessment; the change will be business facilitative, optional and therefore any financial impacts should be minimal. The RIA will be published as part of the Explanatory Memorandum for the Regulations.

How have people most likely to be affected by the proposal been involved in developing it?

Food and feed businesses, local and port health authorities, district councils, and other stakeholders with an interest in food and feed safety were invited to share their views on this proposal through the FSA’s consultation.

The consultation was open to all respondents, including members of the general public. However, this regulatory change is likely not of significant relevance or interest to the general public. No further engagement with the public was undertaken for this reason.

What are the most significant impacts, positive and negative?

We have identified a no/neutral or minimal impacts in all areas, including in relation to the Welsh language, the economy and environment of Wales, people and culture. 

The most significant positive impact will be for the business who requested the authorisation of the substance for use on the food supplements market. After the expiry of the 5 year exclusivity period referred to in section 1, there will be a positive impact on other businesses who wish to use the substance in a food supplement. The regulations will place no new burdens on businesses so the only impacts identified in this area are positive. We have not identified negative impacts in any other area during our assessments.

In light of the impacts identified, how will the proposal: 

• maximise contribution to our well-being objectives and the seven well-being goals and
• avoid, reduce or mitigate any negative impacts?

The overall aims of the proposal are to support business growth and consumer choice within the food supplement market, while also ensuring the safety of the substance for use in food supplements. Whilst, given the nature of the proposal, there is limited opportunity to maximise its contribution to the wellbeing objectives and seven wellbeing goals, we consider that the proposal’s aims are supportive of Welsh Government’s commitments under these policies. For this reason, we have not deemed it necessary to put in place any measures to avoid, reduce or mitigate against any negative impacts.

How will the impact of the proposal be monitored and evaluated as it progresses and when it concludes? 

A post-implementation review of the proposed Statutory Instrument will take place in 2029, 3 years post implementation.