Can you walk us, step by step, through the enlargement process?  

In a nutshell. it starts when a country submits an application to the Council, which is then followed by an opinion by the Commission. EU Member States decide unanimously to grant the country candidate status, subject to conditions. Once these conditions are met accession negotiations can begin. The Commission proposes a draft negotiating framework as a basis for the talks and these start once Member States agree on the framework. During negotiations, which are structured according to clusters and chapters, the country prepares to implement EU laws and standards. Once negotiations on all areas are finalised, the Commission gives its opinion on the readiness of the country to become an EU Member State. Based on this opinion, EU Member States decide unanimously to close the accession negotiations. The European Parliament must also give its consent. Finally, all EU Member States and the candidate country sign and ratify an Accession Treaty, and this enables the country to become an EU Member State. 

Can you elaborate on DG SANTE’s role in this process? 

Our DG plays a crucial role in the European Union's enlargement process. Our primary responsibility lies in ensuring that candidate countries align their health and food safety standards with EU regulations. We provide technical assistance, guidance, and support to facilitate their transition toward meeting the EU's rigorous criteria in these domains. We are in the lead on two Chapters of the EU acquis: Chapter 12 on Sanitary and phytosanitary (SPS) measures and Chapter 28 on Public Health. SPS on its own is a vast area of EU law comprising of 55% of the acquis. It covers all the quarantine and biosecurity measures which are applied to protect humans, animals and plants from risks arising from pests and diseases, as well as from additives, toxins and contaminants in food and feed. Going through all that acquis with each prospective EU candidate is an enormous task.   

What do we do to assist candidate countries in aligning with EU standards? 

Our approach involves comprehensive collaboration and capacity-building. We engage in an intense dialogue with each candidate country, offering them expertise, training, and guidance on how to implement EU health and food safety legislation. This includes sharing best practices, conducting workshops, and providing financial assistance through various programmes to strengthen their institutions and regulatory frameworks. Through the work of the Health and Food Audits and Analysis Directorate in Grange we audit, evaluate and verify the situation on the ground, identifying opportunities for improvement and suggesting training/development that may be required. The work of the candidate countries to align their health and food safety standards with the EU is pivotal for their successful integration into the EU. It not only ensures the protection of public health but also enhances consumer confidence and facilitates the smooth functioning of the Single Market. By adhering to these standards, candidate countries demonstrate their commitment to shared values and principles, which are fundamental to the EU.   

Could you highlight some of the challenges faced in harmonizing health and food safety standards during the enlargement process? 

Harmonizing standards is a complex task. One challenge is the diverse starting points of candidate countries, who vary widely in their infrastructure, resources, and expertise. Additionally, ensuring compliance with a wide array of EU regulations requires a significant effort. We also must carefully balance the need for speed of adaptation with maintaining the quality and effectiveness of these measures. In the screening process, DG SANTE will explain the EU acquis on SPS and Public Health in separate meetings for each country. To give an example, the screening exercise to present the SPS acquis takes one whole week with intervention of around 50 SANTE colleagues responsible for the different policy areas. I am very grateful for the huge support given by the colleagues across SANTE during these exercises. A second meeting is then organised for each country to explain their plans to transpose and implement the EU acquis. The preparation that goes into each of the screening meetings alone is enormous. Once negotiation positions are established, all the candidates submit theirs to the Commission and that is where the fun starts! The Commission initiates the negotiations based on the position adopted by Council. The length of this process varies from country to country, depending on the preparation of each country. It requires deep technical evaluation of all the documents and may take several years.