In an interview with ChileCarne, Dr. Arianna Bolla, an expert on European regulations who is in charge of market access for Southern Europe (Spain, Portugal, and Italy), provided valuable information about the new European Union (EU) regulation related to the prudent and responsible use of antimicrobials that will be implemented as of January 2022. The expert also shared some keys for Chilean companies producing and exporting white meat to consider when implementing drug programs for animals.

1. In your opinion, will the new EU regulation help make improvements?

It sure will. The main goal is for the European Commission, which is the body in charge of promoting the new regulations on veterinary drugs as well as medicated feed, to provide a more regulated framework for the responsible use of antimicrobials.

2. What will the criteria be for the use of antimicrobials?

The new regulation includes definitions on antimicrobials. These also include definitions of antibiotics, which act against bacteria, as well as prophylaxis and metaphylaxis, which were already part of the previous EU guidelines. In this new regulation, however, they will be more focused on providing recommendations on when to use certain antimicrobials and which ones, as well as when to use metaphylaxis to control an existing pathology on a farm, and when to use prophylaxis when there are no clinical signs in any of the animals and action must be taken to prevent the disease from spreading, for example. Prophylactic measures will be particularly restricted in terms of the number of animals that can undergo treatment and product administration as well. This must always be for small groups or even individual animals. One of the main focuses of the new regulation is to follow the regular form of prevention by following certain safety criteria.

3. What are thenew requirements for data collection on sales and antimicrobial usage in animals in the EU?

The collection requirements are going to be released soon as part of what we call delegated or implementing acts, which are separate from the regulation itself but still a part of it; and, of course, there will be a European digital system to collect data, especially related to usage. Some countries are more advanced than others on this issue. Italy, for example, has a compilation of electronic veterinary prescriptions.

The regulation stipulates that we will include uniform situations and systems to act similarly, and the information on usage will reach the end customer. There is a vision for harmonization that has not yet been put into practice because some countries are more advanced than others on this issue. Currently, more advanced European countries are sharing information with those that are behind. The current regulation sets periods, timeframes, and years for specific situations and species. Apart from the regulation, the EU is now discussing the European Green Deal: a roadmap to provide Europe with a sustainable economy. Achieving this goal will require us to transform climate and environmental challenges into opportunities in all policy areas and to achieve a just and inclusive transition for all (https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en). We are following the strategy called “farm to fork” on this issue, which also sets targets for antimicrobial usage. The regulation does not set goals, but rather the basis to act properly.

4. Based on what you have observed and analyzed, what measures should Chilean companies implement?

Other countries should take into consideration what is stated in Article 118 of the regulation, which talks about reciprocity, what third countries that export animals or animal products to Europe would be allowed to do. So far, the issue of antibiotics and their usage for growth promotion is clearly a key element. For example, European countries will not allow producers to say that they have used critical antimicrobials for growth promotion.

On the other hand, Europe is negotiating with the World Trade Organization and conducting assessments with other countries.

I think Chilean companies should have a holistic approach related to the safe use of antimicrobials. I believe that would help them fit in with many areas, from biosecurity and vaccines, to hygiene and the way feed and water are administered; but of course, this requires resources. I think every country’s government must do their part; sustainability has to be the main focus. However, real sustainability needs resources, especially at the beginning. I think producers cannot assume all the costs. The government has to remember that this is going to benefit the entire population and that people need to be fed.

5. Could you give us some tips on dealing with these new regulations?

The key issue is knowing that this regulation has been discussed for years. It is not something Europe decided overnight. Throughout these years, the EU has been monitoring the use of antimicrobials or antibiotics. And, since 2010, it has been doing data collection.

The antimicrobial classifications we use in the veterinary field are the same ones the European Medicines Agency uses to optimize cautious and responsible usage. The European Commission recommends not using certain medicines or to use them with caution. It makes recommendations on how to use them.

This regulation comes to light after years of work and discussions related to the use of antimicrobials, and it was designed following a gradual and studied process.

Regulations on veterinary drugs and medicated feed must follow the same criteria in every country. Finally, this regulation must be understood within the context of Europe itself, and that is why I think every country or region should have its own regulation tailored to its particular needs and situation.