Now the UK has left the EU and the single market, the UK is classed as a ‘Third Country’ by the EU. This means that natural mineral waters from the UK that were previously approved via the UK and sold throughout the EU need re-authorisation to be legally sold in the EU. Not sure where to start with your natural water approval? Here’s our handy 5-step guide to the process.

Step 1: Identify an EU authority to approve the natural mineral water

To gain EU approval, the natural mineral water must first be approved by an EU country authority. Selection should be based on markets you intend to/already sell your product into. Note that it is likely that you will need to translate the label and dossier for approval in the chosen country. Also, administrative costs may be incurred by some authorities to check your data and/or carrying out a site visit.

Step 2: Gather your data

In parallel to identifying an EU authority for approval, the first step is to obtain a country of extraction certification from your primary authority, as soon as possible. In addition, other data required for your natural mineral water dossier includes compositional, microbiological and geological-hydrogeological data of the bottled water and its source. This needs to show that they meet the EU legal requirements for natural mineral water.

Step 3: Create your dossier

Now you have all the necessary data, you’ll need to present it in a clear format for review by an EU Member States’ authority. There’s no official template for the dossier but experienced regulatory professionals will be able to recommend the most suitable format.

Step 4: Submit your dossier

Submit your dossier to the EU Member State authority you wish to gain approval from. The time it takes for each country to review and make a decision will vary so it’s recommended to check this upfront.

Step 5: Addition to the EU list of recognised natural mineral waters

Now your product has been officially approved by an EU Member State authority, the authority will notify the European Commission so this Decision can be added to the official journal of the EU; this can take a few weeks.

Whilst waiting for the publication of the Decision at EU level it’s still possible to start exporting the newly-recognised natural mineral water to the EU. However, make sure that any exported products are accompanied by a copy of the Decision obtained from the EU Member states authority and your distributors in the EU are also aware of this Decision.

Need support compiling and submitting your dossier?

Leatherhead Food Research is here to support and manage the whole process of approving your natural mineral water dossier in the EU. Our team consists of former regulators and multi-lingual regulatory affairs professionals who are ready to guide you at each step. Get in touch using the form below or at [email protected] for more information. Remember, if you’re a Leatherhead Member you can use your Helpline allocation for dossier support.