Hello, this is Laura Orish . Currently a counsellor for European affairs working for the Authority of Romanian Research in Bucharest, Romania, and also an ex-policy officer, as a second the national expert to the Digiante services of the commission, where I worked on the One Health, International bilateral relations unit. And today we will be diving into the one healthy requirements for entry of animals and products of any origin into the union.
Just a bit of an overview of how this presentation is going to, to deal with, this topic. We will be, having one part that will be devoted to the key requirements for NGO food producing animals and products of animal origin into the union. Where we will be discussing the three main requirements, the approved residual control plan, the public health and animal health requirements, and also, I will be presenting a bit of of the new regulations on the prohibited use of antimicrobial products, that, is, enforced currently.
And it's appliable to third countries, namely non-EU countries. By the way, this presentation is mainly of interest to the veterinarians working for the national authorities, competent authorities of non-EU countries, third countries that would be willing to get access to the EU with their country's products of . human consumption.
So that would be the presentation and Set in two parts. The second part, to continue will be focusing on procedure for market access for these third countries that want to, allow to become eligible for this, this, market. With their products and we will be discussing about the process of certifying these products according to the requirements on animal health and public health.
Also, I will be talking a bit of about the composite products which are particular consignment type that usually raises problems to, to establishments. Are willing to export to the EU. And last but not the least, just where to find the certificates for animal health, and how to deal with that, in, in a good time, let's say.
The, aim of, of the, of this presentation is to, for the third countries to export animals, and, product of animal origin, designed to consumption into the EU. And therefore, the objective of, of, of, the presentation is to, provide an understanding on the legislation, and the requirements for the original or official controls, on mainly the residents of, pharmacologically active substances that come from the, veterinary medicine, products used in these animals. Pesticides and also contaminants residues.
Most importantly, all countries that are authorised currently to export, consignments of human consumption and animals, that are used for food production in that on that purpose are listed in Annex 1 to regulation 2021 per 405. Which means that these countries have in place an approved residual control plan for these residues that I've mentioned, the pharmacologically active substances, pesticides, and contaminants. This is one of the three requirements for one country to be authorised to access the EU market with their products, goods.
But this is not only one. There are other two requirements that need to be fulfilled. All three requirements have to be complied with such that to get a product or an animal species in, in, in this market.
So public health and animal health requirements are also important. But we will be starting with this requirements for an approved residual control plan in place. Of course, the EU is, is one of the biggest markets for export and exports of food and food producing animals, and therefore there is a, a wide, a lot of legislation that its governing this sector.
But the most important, I should highlight here has being the regulation 2022 per 20292. The formerly directive 9623, which is governing the use of pharmacologically active substances and residues of contaminants and pesticides. And as I highlighted the private priorly, the annex minus one to the regulation 2021 for 405.
Also related and complimenting on, that the regulation, 2024334. These are the main important ones that one country willing to be listed or get authorization for for EU market sales would want to refer to first. But there are also other pieces of legislation that that country would would want to look at the official authorities of that country.
And they are appliable also to member states, so it's not nothing more or less than than we as country member state country are are applying in our own countries. Mainly, the two regulations, 1644 and 1646, of 2022, where there are, set, set, set up where the requirements for resilience of the pharmacologically active substances. It refers to the official controls and the annual control plans that member states have to have in place and guarantee that the food.
They produce in the country, or the region within are safe for for consumption. And the other one, the 1646, where there is there are provided arrangements for performing these controls by the official authorities on the these residues of the past. Also, for the, pesticides, there is a regulation, 2021 per 1355 on multi-annual control of these residues, and, for, the, contaminants residues, there is the regulation on uniform arrangements for multiannual controls 2022.9, 132.
A third country willing to be listed in this annex. May want to refer to these two regulations that look at how to set up the official controls and the requirement that you need to to to have in place and to envision on annual control plans and reports and guarantees you have to provide after a listing and how to perform these controls on, on the reeds of . Of forbidden or or limited use substances in these animals.
So these are the two regulations that one of the country that's willing to be listed in this annex would want to refer it to in order to get ready for this application. But, there are also alternatives that the European Commission is accepting as, as equivalent, and one of them is the Codex Alimentarius, on the, . Food safety.
As it is seen as aligned pretty much or EU is rather aligned with this, approach that Codex Alimentario is using as its advocates for a for a risk-based approach to control and verification of these, consignments, so. It's up to the country which regulation to, to follow, but it has to be aligned with the EU requirements. There are also other regulations and, and legislations that's that are governing the RCP in order to be approved.
For a country to be approved. Very important, the regulation 37 per 2010 on prohibited substances in animals and animal products. Also the known OCR, the unofficial Controls Regulations 2017 for 625.
And, the regulations looking at the maximum, residual levels for pesticides and how to, to discern the criteria for sampling of contaminants also, the two regulations, here. This is generally the, the governing framework for the approval of of the RCP. Just a bit of an insight into the commission delegated regulation that is actually the legal basis for the country, a third country that is looking to be listed as having an approved residual control plan for food and food producing animals.
This is actually, supplementing an existing regulation, 6625 of 2017 regarding the requirements for the entry into the union of these consignments, and, and certain foods, producing animals intended for human consumption. And again, is looking at this pharmacologically active substances that derived from the veterinary medicinal products used in these animals, also, pesticides and contaminants in their their products. .
Once they comply with these requirements, they, are become authorised to enter into the EU market and we will be discussing what is the procedure and what getting authorised means actually. It's been, it's been, all over the places, this NX minus one, and I think it's very, good to take a look at this at this screenshot. It is, available in the, 2020922222 regulation that's governing, as I said, this is, .
Monitoring plan, control plan for residios. This is Annex one, and it's, looking at the implementing regulation for 105, it's one of these annexes, but it's important because, these countries that are listed here are so-called authorised to to. Sell on the EU market, all these categories of products or an animal species that are, they are having an X for in this annex.
A particular point to raise here in relation to composite products, which are those products are intended for human consumption that comprise ingredients. Of plant-based ingredients, but more importantly, products that are processed and come from animals, so, processed products of animal origin, this is how they are called. In the case of composites only.
These countries can apply for one of the four categories shown here, fish or aquaculture products, milk, eggs, or meat. So they can apply just to get authorization, to obtain authorization for, for example, for for aquaculture. And then in order to use composite ingredients in the compost sites that they want to sell on the market, for example, would would use also milk, they don't need to also produce the milk within their country.
Once they have these eggs on one of the four categories that I've mentioned, they simply request to get listed for milk, as in this case of the of Albania. And then they will be able to use milk in their composite even if they don't have the, the authorization to of their country to produce it, only because they have this other of the four type of of products are authorised for, but they have to have this product with 0 mentioned here. Coming from an EU.
Approved establishment, therefore from unauthorised country. I'll come to this situation later on when we will be discussing about the composite product, but just to highlight here that the the 5th type of of commodity, honey. Would not apply to the rule that I have just explained here.
So for honey, you, if you have an XCA, you, you wouldn't get immediately allowed to use ingredients on the other four. You'll have to have, you are allowed to sell composites only with this ingredient here, not others. But this is going to come a bit later.
So, as I said, an insight into the, legal basis of, the approval of this, plan for residual control, 202092 for 2022, is the most important regulation for the third countries that are willing to start actually applying for. Ah, for being authorised to get access in the EU market. Article 61 is actually saying that the food producing animals, products of animal origins and the composite products may enter the European Union only from a third country that has in place a control plan setting out guarantees and regarding compliance with.
The use of pharmacologically active substances within their countries, so they, they are aligned with the EU requirements and also that they give guarantee, provide guarantees and follow up on the maximum residual limits for the pharmacologically active substances they use in this producing food producing animals and products, and maximum residual levels for pesticides and contaminants. This is the most important article, for the starters, let's call this this way. There are also other articles to, to, be taken into account at the at the stage of composing the application.
Article 9 and Article 12, which also specify requirements for these pharmacologically active substances, and and contaminants used in animal producing products. And also composites. Also important, part in this, in this regulation is Annex one.
Which is, setting up regulations that, or, yeah, regulations that one country needs to provide on a regular basis, evidence, updated evidence and reports, guarantees also that they will maintain these status. The country and that they would abide by the EU requirements in what it concerns the level of these residents in the products that they sell. So important to, to look at is also Annex one.
It is also to not to notice here that these reports and guarantees are provided usually by countries as specified in Annex one. By the end of the 1st quarter every year. Well, in the regulation 1644.
There are a bit of more specific data about what substances are allowed, what substances are not allowed to be used, and if allowed, what levels of are allowed, what levels and limits are allowed for these substances. So these are also provided in Annex one of regulation 1644. So, two groups in this, annex, group one is providing, data on what substances, of the pharmacologically active nature are prohibited or are unauthorised to be used in food producing animals that are intended for the EU market, and there's a lot of, of, these, these substances as hormones, beta agonist for growth production.
Or promotion. Also, antimicrobials, we can see here. Dyes and plant protection products, according to, these regulations are, are forbidden to be used, .
Group B in the annex is listing those pharmacologic active substances that are authorised for use and what levels and limits are allowed for these. So this is also a very important piece of legislation that needs to be taken into account. When, it's a system is set up, just in order to, to, to, to be prepared to export to the EU, .
Regulation 1355 of 2021 is looking at the multi-annual national control programmes for pesticide residues, whereas 932 2022 is providing requirements of a uniform practical arrangement for performance of, of these controls in contaminant residues, . The important fact is that these evaluations and reports have to be and controls have to be risk-based and aimed at assessing the consumer exposure and to be compliant with the regulation of 396 of course of 2005. Well, it's, it's known that enforcement is, is one of the, the customs of, of, any legislation implementation.
In this case, the enforcement is, on one side of of the side of the member states and the other part, that could, if, if necessary, could interfere in this process is the commission services. What happens if a product, or a consignment that is, is exported to the EU from an authorised country. A mem a member state that imports that country or where these consignment arrives, is, testing and reporting to the rapid alert system, which is the specifically designed system for such actions, that alert alerts the commission on the non-compliant products.
The member states, conduct follow-up actions, to find out that there are excess of maximum, residual levels in, in these consignments. And if required, if it's kind of repetitive mistake of that producer, then at the border there are intensified controls of these consignments or at the place where they, they, they arrive, and these are laid down in the regulation 625 of 2017. When warrantied, the commission can even import bans from, from that country, or, impose free export testing or testing at the point of, of entry of that consignment.
There, there might be also the case that, a third country that's preparing for or will be willing, at least to be, to export to the EU, so to become authorised in the annex minus one to export to the EU their products or animals. Not to be able to ban the use of a forbidden or unauthorised substances. In their, in their system.
And it is possible in this case, to use, for that country to use a segregated production system, or a split system for, for this production, only for exporting to the EU. However, this is, quite, a problematic, let's say move because the requirements are adding to what it's already existing, they need to provide the certification, supplementing, the, the basic one to,, provide, record keeping evidences to, have in place an identification system and to allow for traceability of that product. So, but it's, it's, it's still possible in case, a ban of use of the most important products that are forbidden not to be used in throughout the EU cannot be applied.
Promised to give an insight on the new regulation on prohibited, antimicrobial substances. This is, this process has started, in 2023 or even earlier with the regulation, 6 of 2019. But in 2023, all countries that are, were currently at that time were listed as authorised to export the EU.
Their food producing animals and animal products, this time for human consumption were acknowledged, announced, informed that the new regulation, 2023 per 905. Is going to prohibit the use of certain antimicrobial medicinal products in animals and, products of these animals that are going to are intended for the EU market. And the reason is, mitigation of the antimicrobial resistance, in humans.
A year before, that regulation to be, to be issued, there was a regulation, issued the 2055. That is designating antimicrobials or groups of antimicrobials that are reserved only for treatment of certain infections in humans. So this is what has been the, the, the first step when it was kind of.
Imposed a limit in using certain antimicrobials in in food producing animals, animal farms in order to prevent antimicrobial resistance in, in any, in humans. And therefore prohibited through this regulation, the use of these antimicrobials in food-producing animals. There's also a regulation that came even one year before that, regulation 1760 of 2021, supplementing the same regulation 6 of 2019 that actually sets out the criteria for the designation of antimicrobials that should be reserved followed to be reserved for this treatment of infections in, in humans.
So, based on this particular regulation, there are, certain animal products and all livestock that are intended for, the EU market, going to be affected by this new regulation, 905. With some exclusions. Therefore, these are products of animal origin that are only transiting the EU, are not, falling under this, regulation.
Nor gelatin and collagen and highly refined products or nor composite products, not also wild animals, reptiles, insects, frogs, and snails, and their products. None of these are falling under the regulations, requirements, but all livestock and the rest of animal products, thereof, are, . Referred to by this regulation.
So this regulation was initially issued in 2023, and the, third countries that were listed in Annex minus one at that time were, as I said, required, invited to submit kind of a declaration. Of, that is guaranteeing that they will be complying for, with that, with the regulation, with the requirements, regarding this antimicrobial prohibited in use. And since then, they should have.
Develop the legislation and adapt the system such that these, antimicrobial medicinal products or substances not to be reflected into the, the products of those systems that would be intended for the EU market. What is it changing besides the need for the change within the system of producing of that third country in order to get, to get compliance, compliance. It is basically a need that that country to provide, as I said, a declaration that guarantees the conformity of the country with these requirements such that the country will continue, will be able to continue the trade with that with those consignments within the EU.
And when, these trade starts with new regulations, they will, the, the official controls will accompany the certificates with the attestation of compliance for the public health. According to the new regulation, for each commodity that is undergoing exporting, this is very important. And there are also new model of health certificates for, for these trades available already.
For fishery products, live animals, and products of animal origin. So, to my knowledge, not all countries, not all third countries, were able to provide these guarantees or they provided the guarantees just for several, of the products that they are listed with in Annex -1. So the process is still ongoing, but it is known already that if they are willing to be able to continue to export to the EU these goods that they are listed with in Annex 1 after September 2026, they will have, still have to provide these guarantees, if I haven't done this already.
So this is on the new rules of prohibited antimicrobials in Apart from the residious control plan, I said that there are also two other requirements that have to be fulfilled by, to be fulfilled by a third country that is willing to, become authorised for, for the trade with the EU. For the exporting into the EU. The public health requirements and the animal health requirements.
Just quickly on the public health requirements, this is the framework, of legislation, as you can see, there's, there are, many, legislative pieces that are looking into this requirement and it's not, a full list of it. But, I would highlight here as the main important ones that, that one, should look at when they start their application is the regulation 2021 for 405, with the hygiene and residues requirements and I, with the annex minus 1. And also the regulation on official controls 625 per 2017.
Also, there, there are, regulations looking at the, several transmissible, diseases, requirements for, for food, requirements for, levels of residues in food and so, so on. The third requirements, the animal health requirements that need to be fulfilled also has its own, legislative framework. Again, I'm not I'm not saying that this is the full list, but the most important ones are, the commission implementing regulation 2021 for 105, which lists the third countries and territories within.
That are, allowed to entry into the union with animals and germinal products and products of animal origin. And there is also, again, the OCR and others, as I, I said. Well, starting the second part of, of the presentation, I, I have promised to, to provide an insight into the procedure, for a third country to be allowed or get access on the EU market and how to, to, do the certification, what is implying.
This process. So this, the commission services, are looking, in an appliance, application to see the there are that there are proofs and guarantees that the country has in place a regulatory framework that is aligned with the EU requirements. And also that there is an official control system that ensures the intended goods that are for the country wants to export to the EU are safe, safe for human consumption and these, all these requirements, are fall into the responsibility of the competent veterinary authority of the country, which, ensures that that the system is, is aligned with the requirements and provides the certifications needed.
To ensure, and the guarantees to ensure the country is is following on the EU requirements along. In terms of public health and animal health, and of course the approved residual control plan. Well, what is actually the application about?
So, first, as I said, the, the, competent authority is sending a written official request to the commission services saying that they want to get access with such and such commodity into the EU market. This request is followed by a questionnaire that the authority is provided with by the, the, commission. It's called the initial or questioner number one.
In an initial questionnaire that is not specific to the products, it's just general data about the commodities that intend to be exported or if they are just going to be transited through the EU. And, certain data about, this, officials official controls that are are undergoing in the country. Once answered all the questions, it's very important.
All the questions in the question have to be answered accordingly. Then a second question is sent, by the commission to these, authorities. That they're actually looking at the product or the, the good that the country is willing to be authorised to export to the EU.
For example, camel milk intended for human consumption. And this is going to assess actually the capability of the authority or veterinary national authority to certify compliance with the three requirements that we discussed before, animal health, public health, and the approved residual control plan in that country. Also, this questionnaire has to be completed and very rigorously answered, and then the assessment of the services if successful, if favourable, the country might be audited by the official control, of the, the commission commission, the auditing services.
And also here there might be several steps, that could be remote audits followed by, in, in field audit. And if all these steps are fulfilled successfully by the country, then the country is proposed by the commission to be listed, in other words, to be authorised to obtain access on the EU market with those products that they were included with the questionnaire. And this, let's say this answer, this outcome is subject to agreement of the member states.
If, if there is agreement within, then the country is authorised. To access the EU market with that specific commodities. The other, which actually triggers the second step of, of this process which is looking at the establishments within the country that are going to, to, to provide these products on the EU market that also need to be approved.
And in order to obtain this EU approval, status, these establishments are going to be, listed in the EU's trade control and expert system, which is also known as Traces NT. And only once this is these establishments are are listed as EU approved establishments in traces indeed, they are allowed to export to the EU the particular goods or commodity that they are they have requested to obtain access. For in the EU market.
Well, on the composite products, I also mentioned several, several ideas, in the first part of this presentation. What are these and, what type of, composite products are, are these? Firstly, The composite products are, from my experience, one of the most problematic products that are, are sold to the EU, from the perspective of compliance with the EU requirements by certain countries.
It's, it's, because of these mixed ingredients that they, they usually, they, by definition they are made of. And the provenience, the origin of these ingredients is very important for from the beginning to be understood. I have to come from an EU approved establishment, and I'm looking at the animal origin processed products.
So, in, in, just basically, these composite products are food commodities based on mixed ingredients. That are composed by processed products of animal origin and products of animal origin, which are, in, in the final product. The regulation that is governing the composite products trade is, also, the one that we discussed at the RCP regulation 20292 of 2022.
According to that regulation, they can be, there are 3 types of composite products, according to their perishability. So those, that are, perishable products, are non-elf stable. And those that are shelf stable are of two types.
One of them type one, containing colostrum-based or processed meat, other than gelatin, collagen or a highly refined products, and shelf stable type 2. Are those composite products that are containing processed products of animal origin, according to regulation 853 of 2004, that are not containing a colostrum or meat other than gelatin collagen or HRP. For a composite products, the main, regulations that are governing the trade with this, products is, is already highlighted previously regulation 20292.
And the is that it's important to know is the rules for import of consignments of composite products of, that regulation. But also, in terms of, hygiene, hygiene rules and hygiene of foodstuffs, regulation 843 per 2004, and regulation 8152 per 2004. Also, I have been using two terms, that I think need a bit of a, of an explanation, registered versus EU approved composite product, establishment.
Those establishments that are registered are, under the authority of, National Competent veterinary Authority. They are not EU approved, so they are not listed to export to the EU. There are also those establishments that are EU approved.
That means that the establishments are listed by the EU and are allowed to export their consignments to the EU. Therefore, there are 2 establishments. However, two types of establishments.
However, in certain cases, even Registered establishments can. Enter. EU market In what it concerns the composite product.
Providing they fulfil certain regulations and it very much depends on the number of processing stages of the processed product of animal origin. As we can see here, if the, product of animal origin is unprocessed, Then it will be processed in an establishment that is EU approved in order to be used in a composite product that would be intended for the EU market. Also those establishments that are, using the processed products of animal origin.
Coming from an EU approved establishment, but that would require further stages of processing until they obtain the final composite product. O, in other words, they undergo many more processing in order to to get to the final product. These, establishment that is producing these products have to be, has to be EU approved.
For example, if using, milk, that would be processed into milk powder to obtain the composite product which is, pod pudding or, pudding or ice cream, for example, where you would be having to process that ingredient, of animal origin that has been processed several times before in order to get the final product. This establishment needs to be EU proved. In the case of those Products that have been previously processed and the in order to obtain the product, the composite product, there's no need to further process it.
These establishment don't need to be EU proofd they only have to be registered, but this again have to come. This product has, has to come to have been processed in an EU approved establishment. If this product, there's also this situation, if the composite products, in order to be obtained requires further processing of the, processed, product of animal origin ingredients.
Also, This doesn't need to be, this establishment doesn't need to be EU approved only to be registered. For example, if you want to obtain biscuits using an egg ingredient, and then you'll have the biscuits. The establishment it doesn't need to be EU approved, but it has to have the ingredient of animal origin from an EU approved establishment.
What is important to to understand is that each ingredient that is contained in an in a composite product and it's the animal origin that we are looking at, it has the original from an EU approved establishment, each ingredient in a composite product. Of course, the requirements that apply to a composite product in order for them to be, exported to an EU country. Are the same as for for any other product or or goods of human consumption.
They have to come to from a country that has an approved residual control plan in place and it's listed in Annex 1 of regulation 405. Has to come to fulfil the requirements on public health and animal health, according to the legislation that we discussed in the first part of this presentation. In case of requirements, your requirements, an additional, mentioning is that, there are specific exemptions from, the border control, at the control posts.
For certain products. So, composite products that are of low risk for public health, and those would be type 2 shel shelf stable products that are not, do not have ingredients of of processed meat or colostrum. They don't, they are not controlled at the border, according to the annex to regulation 631.
Also, another exception to the the requirements regarding the official certificate, that is required for all products according to regulation 20235 of 2020. This regulation is not applicable to type two shelf stable composite products, but these ingredients, gelatin or collagen coming from ruminant bones require an additional authorization because of the, ESB risk. Also, the private attestation, that it's not according to regulation 2235, is not appliable to non-shelf stable and type two shelf stable composites, but again, they require certification to guarantee their safety for consumption by humans.
Where to find health, animal health certificates, they would be usually in the annexes of, of regulations. Important is, to know what regulation governs, what type or group of, of, consignments or animals intended for, for export. So, for animals and animal products, the animal health certificates are found in the annex of, of, the regulation 20 to 35 of 2020.
The certificates for geminal products and certain terrestrial animals are found in regulation 403 of 2021, and the certificates for certain animal byproducts are found in regulation 142 of 2011. For further references, and additional resources for learning. On how to, to apply for, for, being listed or where to refer to for, for regulations or guidance.
I provided here a list of, with the web links of, several m resources that could be hopefully useful in, in this process. And with this, I hope it is, it, it helps this presentation, understanding a bit, a little bit more the EU regulations and help potential applicants on having a a successful trade with the with the EU. Thank you all and wish you all a good, good luck.
