What it covers
The opinion examines whether the product is lawfully marketed in the Member State of origin, identifies the Spanish national technical rules that may apply to it and that it does not meet — for food supplements, notably the positive lists of Royal Decree 1487/2009, which are more restrictive than those of many Member States — and assesses whether that divergence is covered by mutual recognition or whether, on the contrary, it is justified on grounds of legitimate public interest that would allow the Spanish authority to restrict or refuse access under Regulation (EU) 2019/515 itself.
The result is a feasibility assessment — favourable, unfavourable or conditional — and, where appropriate, an indication of what should accompany the mutual recognition declaration to minimise the risk of an administrative block.
This is the service for operators already established in the Union. Its value lies in knowing how the Spanish authorities — which in this field are largely the regional authorities of the autonomous communities — actually apply these rules, something that a reading of the Regulation alone does not reveal.
What it does not include
It does not include preparing or submitting the mutual recognition declaration to the competent regional authority, or following the procedure through to a decision, which is a subsequent engagement once feasibility is confirmed. Nor does it include assistance after a refusal or lodging a complaint with the Product Contact Point, which are handled as a separate service.
Legal framework
Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State. For food supplements, Royal Decree 1487/2009, as amended by Royal Decree 130/2018, and the procedure for proving mutual recognition published by the Spanish Agency for Food Safety and Nutrition (AESAN).
Process
Through the quote form, the company provides evidence of lawful marketing in the Member State of origin (the relevant authorisation, notification or registration), the composition of the product and, if available, the technical data sheet or label already used in that Member State. The comparative analysis is carried out against the applicable Spanish rules and the feasibility opinion is delivered within the stated timeframe.
When this is not the right service
If the product comes from a third country rather than from another Member State, mutual recognition is not available; the relevant questions are those of entry into the EU market, starting with the novel food status assessment where the ingredients are not traditional in the Union.
If the company has already decided to start the procedure and feasibility is clear, this preliminary opinion can be skipped; please use the general quote form to discuss the declaration itself.