What about post-Brexit food supplements that have been notified in the UK?
Although the United Kingdom has not been part of the European Union (EU) due to the Brexit, since February 1, 2020 and has become a third country, until December 31, 2020, the EU legislation regarding free movement will continue to apply of food supplements and food products for specific population groups.
In this post, we will tell you what requirements, from the end of this transitional period, both community and British companies that market food supplements in Spain after Brexit must take into account.
These measures will affect some 90 Spanish companies that market 3,013 food supplements and food products for specific population groups in the United Kingdom. Likewise, it will also concern 41 other British companies that market 268 products from this sector in Spain.
The measures will be different depending on whether they are companies domiciled in Spain that market food supplements in Spain, notifying previously in the United Kingdom by the principle of mutual recognition, and companies based in the United Kingdom that market food supplements in Spain, notifying through AESAN.
a) Companies with domicile in Spain that market food supplements in Spain having previously notified in the United Kingdom.
The EU and the UK continue to negotiate what kind of notification procedure the competent authorities will carry out.
As for the products marketed in Spain under the principle of mutual recognition, which prove their legal marketing in the United Kingdom and have substances not authorized in our legislation, they may continue to be marketed as of January 1, 2021 as long as they do not have to present modification in labeling.
If after January 1, 2021 there is a change in the labeling, which implies notifying this change in labeling in Spain, it is necessary to prove the legal marketing in another EU country (such as Portugal, France or Italy) or that of the United Kingdom itself would be valid, depending on the conditions established in the association agreement that is reached:
- If an equivalence agreement is reached between the European Union and the United Kingdom, the accreditation of its previous commercialization in the United Kingdom will be valid.
- If no equivalence agreement is reached between the European Union and the United Kingdom, it will be necessary to prove prior and legal marketing in another member state other than the United Kingdom.
Therefore, all those companies that are marketing food supplements in Spain having previously notified in the United Kingdom, after January 1, 2021, if they modify the labelling of those food supplements, they will have to notify again in Spain the modification of the label after having notified again in the United Kingdom (if the company wants and if there is an agreement with the United Kingdom) or in another country of the European Union (if there is no agreement with the United Kingdom).
Given the complexity that the situation of food supplements may imply after Brexit, however, from LegaleGo we are already notifying in other countries of the European Union with the same notification effects as the United Kingdom such as Ireland or Portugal. Countries where there are no fees and where notification is at the moment.
b) Companies domiciled in the United Kingdom that market food supplements in Spain.
Although the commercial agreement that is adopted between both parties to know whether the United Kingdom standards for food supplements will be recognized or not in the EU is yet to be defined, until then it should be considered:
- That batches of British products that are physically on the Community market may continue to be present in the Spanish market until stocks last, having to prove through any supporting document (invoice, delivery note, contract, etc.) that the merchandise is has been marketed in the EU before December 31, 2020.
- Until December 31, 2020, companies based in the United Kingdom, faced with the new situation of food supplements after Brexit, will be able to make changes to the labels and put a registered office in a country of the European Union or a change of responsible company to another domiciled in the EU. In this way, continuity in the commercialization of new batches in Spain will be ensured, provided that the supporting documentation for said changes is provided and the changes made are reflected on the new label.
At LegaleGo we carry out all the necessary procedures for companies based in the United Kingdom to have domicile in Spain.
- If the transitional period has ended and the stocks of products entered into the Spanish market until December 31, 2020 , a change has not been notified as provided in the previous point:
- Post-Brexit food supplements will not appear in the public product search engine
- Food supplements after Brexit will have to be notified again as a “new product” by an importing company with registered office in the EU before being marketed in Spain. Said company name and European address is the one that must appear on the product label, being responsible for the food information to the consumer and its marketing.