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Informācija no EVF

This month, several important steps were taken regarding animal welfare at European level :

  • The European Commission adopted a hundred test methods that do not require testing on laboratory animals in the framework of the European regulation on the registration, evaluation and authorization of chemicals (REACH)
  • EFSA’s published recommendations dedicated to calves’ welfare
  • The European Commission published a report on the protection of the welfare of laying hens.

All these documents participate in the preparatory work of the European Commission prior to the publication of a very important legislation for our profession: the update of the European Animal welfare legislation. We will keep following closely these important topics for veterinarians.

                         Piotr KWIECIŃSKI, UEVP Presiden

Update on EMA activities

Decisions of the Committee for Medicinal Products for Veterinary Use (CVMP)
The Committee for Medicinal Products for Veterinary Use (CVMP) held a meeting on the 21st and 22nd of March 2023.

The Committee adopted a positive opinion for the marketing authorisation of Newflend ND H9, a vaccine against Newcastle disease and low pathogenic avian influenza.

The Committee adopted several positive opinions for variation requiring assessment concerning quality-related changes for Bravecto, Kriptazen, Leucofeligen FeLV/RCP, Masivet, Nexgard Combo, Prevomax and Suprelorin.

The Committee adopted several positive opinions for variation requiring assessment to align the product information for Bravecto, Innovax-ILT, Nobilis Influenza H5N2, Porcilis PCV M Hyo, Poulvac E. coli, Purevax Rabies, Stronghold, Versican Plus L4, Versican Plus Pi and Versican Plus Pi/L4.

The Committee adopted four scientific advice reports to requests for initial advice concerning two biological products, one immunological product, and one pharmaceutical product.

The Committee classified a product (ATCvet classification: Alimentary tract and metabolism) for cats and dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation 2019/6 and another product (ATCvet classification: Nervous system) for dogs as not intended for a limited market and not eligible.

The Committee also adopted a recommendation for changes to the summary of product characteristics for Galliprant.

Latest news on antimicrobial resistance at EU level European Commission publishes study on the commercialization of medical countermeasures against antimicrobial resistanceOn 13th March, the European Commission published a study on “the marketing of medical countermeasures against antimicrobial resistance”. This report aims to understand the main needs and expectations of the market with regard to potential actions by the European Commission, and more specifically the European Health Emergency Preparedness and Response Authority (HERA), regarding the availability of medical countermeasures to reduce antimicrobial resistance.To this aim, the study compiled the observations of almost 115 stakeholders involved in this field. According to the results, a better management of existing financial incentives as well as the introduction of additional financial incentives were requested by the respondents. “An additional $60-100 million per year from the EU would help to stimulate innovation in the field of antimicrobial resistance in the early stages of development and increase the range of new vaccines, diagnostics and treatments against priority pathogens” they explained. Finally, non-financial support, including knowledge sharing, was also mentioned.It should be noted that this report will serve as a reference for future initiatives of the European Commission.

Latest news on animal healthPublication of a joint EFSA-ECDCOn 13th March, the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) jointly published a report on avian influenza outbreaks.The report indicated that between December 2022 and March 2023, the number of outbreaks in European poultry has decreased compared to the peak in November 2022.However, the experts noted an increase in avian influenza cases in gulls and abnormal mortality in seagulls in several countries. As a result, the report concluded that “the risk of infection in poultry may increase in the coming months as gulls and seagulls move inland” in Europe. Member States are therefore urged to put in place prevention strategies in all “densely populated avian areas”.The report also pointed out that, despite sporadic cases of avian influenza infection resulting in serious or life-threatening illness in humans, human infections remain rare. Indeed, “Most of the recent serious human infections reported from outside the European Union have been associated with people who have been exposed to sick or dead poultry and who were not wearing personal protective equipment, particularly in backyard flocks” the experts concluded.In parallel, the European Commission has updated two implementing regulations (here and here) on 20February 2023 and 3March 2023, for the implementation of emergency measures justified by outbreaks of highly pathogenic avian influenza (HPAI) in certain EU Member States, in accordance with Regulation 2016/429 on transmissible animal diseases.Following additional outbreaks of HPAI in captive poultry and bird holdings in many European countries, in France, Czech Republic, Belgium, Germany, the Netherlands, Austria, Hungary, Poland, Romania and Slovakia, the competent national authorities have notified the European Commission of the location of the holdings and have taken the necessary measures to control the disease including the establishment of protection and surveillance zones around the outbreaks.Moreover, the competent authority of France has also decided to establish further restricted zones in addition to the protection and surveillance zones established for certain outbreaks in that Member State. It should be noted that the measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.Commission clarifies procedure for vaccination of poultry and treatment of carcases of infected animals in relation to avian influenza By answering two parliamentary questions (here and here) the European Commission has clarified the modalities of vaccination of poultry against avian influenza European legislation is designed to tackle outbreaks and limit the spread of the disease “This legislation allows Member States to use vaccines to ensure the most effective prevention or control of animal diseases, based on a risk assessment and provided that such measures are appropriate and necessary”.In addition, the European Commission adopted on 28th November 2022 a delegated act establishing, amongst others, vaccination rules for the Member States which were published in the Official Journal of the European Union on 20th February 2023. Especially for Highly pathogenic avian influenza (HPAI):The type of vaccine used: it must not contain live avian influenza virusThe animals concerned: poultry and captive birds in the establishment covered by the official vaccination planIn the context of the two questions, the European Commission explained the protective measures against HPAI to avoid contagion of other animal species or humans.According to the recommendations of the European Centre for Disease Prevention and Control (ECDC), it is recommended to wear personal protective equipment regardless of the size of the livestock operation. For dead animals, according to the Council Directive 89/391/EEC2 employers must ensure the safety of their employees, especially on a farm.Furthermore, for the disposal of carcasses of sick or suspected sick animals, the management of dead animals is subject to the Regulation 1069/2009 which specifies that Member States must ensure that they have an adequate management system “animal by-products must be collected, transported, and disposed of under conditions which prevent any risk to public and animal health”. The European Commission explained not intending any new guidelines on the subject.
Update on special control measures for African swine fever in EuropeThe European Commission has updated, by two implementing regulations published on 6th and 27th March 2023, the establishment of the special control measures for African swine fever. These measures are mentioned in the Annex to Regulation 2021/605 laying down special control measures for African swine fever. The purpose of this text is to amend the restrictive measures according to the evolution of the current epidemiological situation of the African swine fever epizootic in Europe.Outbreaks of swine fever have occurred in wild pigs in the German Land of Brandenburg. Some of these outbreaks occurred in a regulated zone II and in the vicinity of a regulated zone I. Therefore, the nearby restricted zone I becomes a regulated zone II. The others occurred in pigs kept in a regulated zone II and therefore became a regulated zone III.In Italy, several outbreaks in wild pigs have been reported in the Liguria region in a listed zone II and close to a listed zone I. Therefore, the listed zone I becomes a listed zone II in the proximity of the outbreaks. Outbreaks were observed in the Piedmont region in a listed zone II and close to a listed zone I. Therefore, the latter in the proximity of the outbreaks becomes a listed zone II.Two outbreaks were observed in the Podlaskie and Zachodniopomorskie regions in Poland in zones I, they are now listed in zone II. Several outbreaks in the Pomorskie region in Poland were observed in a regulated zone II in the proximity of a listed zone I. The latter becomes a regulated zone II in the parts close to the outbreaks.In Greece, several outbreaks in wild pigs had been observed in the region of Serres in February, but following the application of Commission implementing Regulation 2023/224. Zones I and II should now be redefined.Due to the effectiveness of previous measures against African swine fever in listed zones II in Poland, some zones in Lubuskie, Mazowieckie and Świętokrzyskie regions will now be listed in zone I. In the Świętokrzyskie region, some I listed zones will be removed from the list.As a result of the effectiveness of the previous measures in Slovakia, regulated zone III in the regions of Medzilaborce, Humenné, Sropkov, Michalovce and Sobrance will now be classified as zone II.Finally, due to the efficiency of the measures in Bulgaria in regulated zone III in the regions of Varna, Blagoevgrad, Pazardzhik and Plovdid will be classified in zone II.The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.Publication of the report for the draft regulation on organic animal feed On 7th March 2023, Martin HAUSLING (Greens / EFA, Germany) published his report on the proposed Regulation on the labelling of organic pet food. Martin HAUSLING is the rapporteur for the Parliamentary Committee on Agriculture and Rural Development (AGRI) on this text.This regulation lays down rules for the labelling of pet food and for producing animals. The aim is to adapt the labelling rules for organic foodstuffs to organic petfood, as both are retail products. In particular, the Regulation stipulates that the EU organic production logo should be mandatory for pre-packaged pet food. In addition, the text proposes to introduce specific labelling provisions for organic pet food and for the use of the logo.In his report, Martin HAUSLING welcomes the proposal. Currently it is impossible to label organic ingredients in animal feed if the whole product is not organic. For him, since the food is for animals, there is no justification for stricter labelling rules than for human food. He considers it appropriate to align the regulation with the regulation of organic food for humans. The rapporteur suggests technical amendments and the specification of food products mainly composed of ingredients coming from hunting or fishing.The European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) gave its opinion on the proposed regulation in a letter signed by committee chairman Pascal CANFIN (RE, France). According to the ENVI committee, to be labelled organic, 95% of the ingredients must be organic. Otherwise, the reference can only be in the list of ingredients specifying the percentage of organic ingredients. The ENVI Committee welcomed the regulatory proposal and its possible role in reaching the 25% of organic agriculture by 2023. However, the ENVI Committee recalls the importance of considering animal welfare standards and animal health.Publication of a Delegated Act of the European Commission to amend the regulation on germinal products and their transportOn 21st March 2023, a Delegated Act of the European Commission from 13th January 2023 has been published in the Official Journal of the European Union concerning the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals. This regulation completes and modifies the delegated act 2020/686. It clarifies several points:The extension of traceability requirements to all processed products and not just sex-sorted semenThe clarification of Article 19 of Delegated Regulation 2020/686 which sets out requirements for bovine, porcine, ovine, caprine and equine donors moving between semen collection centresIn the case of porcine donor animals, the regulation should be modified to put different possibilities of follow-up when using different types of diagnostic methodsFor classical swine fever of porcine animals kept at semen collection centres, testing should be discontinued in countries without reports of disease or vaccination in the last 12 monthsReferences to the epizootic haemorrhagic disease virus should be modified for better monitoring of the disease according to international WOAH standards and better alignment with other European regulationsThe requirements regarding the addition of antibiotics to semen should be made optional and rationalisedErrors should be corrected.
Latest news on animal welfareThe European Commission regulates towards less animal testing under the Regulation for the registration, evaluation, authorization and restriction of chemicals (REACH)On 3rd March 2023, the European Commission adopted, within the framework of the European regulation on the registration, evaluation and authorization of chemicals (REACH) a hundred test methods that do not require testing on laboratory animals. In fact, most of these methods are new approach methods (NAM), which do not require animal testing.Under REACH, animal testing must be avoided as much as possible and replaced by other methods. Companies must share their data and thus avoid unnecessary animal testing. REACH requires industry to have sufficient information on hazardous chemicals. There may still be the need for animal testing in some cases. Companies wishing to conduct tests must report them to the European Chemicals Agency and must then obtain authorization.Two NGOs advocate for a positive list to protect the welfare of animals traded as pets On March 23rd, Eurogroup for animals and AAP published a white paper EU POSITIVE LIST A proposal to regulate the trade in animals destined for life as a pet which aims to demonstrate the legal feasibility of a positive list to end the suffering of animals traded as pets.The publication highlights what these NGOs see as the problems of the current pet trade, explains the current legal framework and proposes a positive list for the EU. One of the problems is the consideration of exotic pets and the lack of uniformity in their regulation which result in difficult controls on trade flows and enforcement of regulations.It is within this context that the NGOs propose a European positive list based on scientific evaluation while taking into account the requirements of animal welfare of animals considered as pets.The NGOs organized an event at the European Parliament to present this white paper. The event was chaired by Manuela RIPA (Greens/EFA, Germany) and Pascal DURAND (S&D, France).
EFSA’s recommandations for the welfare of calves On 29th March 2023, the European Food Safety Authority (EFSA) published its scientific opinion and recommendations regarding the welfare of calves.The experts have identified fifteen consequences according to different types of livestock breeding: respiratory problems, restriction of movement, stress due to isolation…Therefore, the authority provides several recommendations:Leave calves with their mothers for at least one day after birthCalves should be kept in groups of no more than seven animals. They should not be kept alone and not in small paddocks.The animals should have at least 20 m² of space each.For feeding, the animals must have an adequate supply of colostrum, milk and fodder.In addition, the EFSA study concludes that animal welfare indicators for calves can be collected at the slaughterhouse, provided that they are complemented by farm animal behaviour.In a statement issued on 29th March 2023, Eurogroup for animals welcomes the report but explained that science is pushing for longer contact with the mother. The NGO recommends 8 weeks together via a system of contact at least half of the day.NGOs join forces to ask the European Commission to ban the killing of male day-old chicks and female ducklings On 17th March 2023, several NGOs sent a letter to the European Commissioner for Health and Food Satety Stella KYRIAKIDES asking to ban the killing of male day-old chicks and female ducklings in the framework of the future legislation on animal welfare expected for the end of 2023. The coalition insists that no exemptions should be allowed to this ban.“On average, EU eggs producers kill 330 million day-old male chicks annually, and millions day-old female ducks are estimated to be killed in foie gras production, mainly in the EU”The letter mentions the prohibition already present in 4 countries of the EU (Germany, France, Austria, and Italy) however derogations persist in these cases notably in France and in Austria.The European Union considers the controls of the respect of the welfare of laying hens satisfactory On 27th March 2023 in a report of the European Commission untitled Overview report on the protection of the welfare of laying hens at all stages of productionthe welfare controls of the laying hens have been judged satisfactory. The study was carried out by the Directorate-General for Health and Food Safety (DG SANTE).The report focuses on the quality of official controls to ensure the welfare of laying hens. The animals must have a nest, perching space, litter and unrestricted access to feed. The results are based on a survey in 2021 via questionnaires in 16 Member states and audits in 9 other Member states.The results of the study are quite positive on the implementation of the control requirements, additional requirements are to be reported in several Member states, which however create unequal conditions of competition between European producers. The results are to be analysed in the context of the future animal welfare legislation of the European Commission.However, it should be noted that the study reports a lack of requirements for chicks and pullets and consequently little monitoring of the welfare of these animals.The report also mentions the gradual evolution towards a cage-free system and identifies areas for improvement.

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