Järelepärimine

Rune Havgaard Sørensen

Head of Secretariat

Danish Beekeepers Association

Fulbyvej 15 - DK-4180 Sorø

www.biavl.dk

[email protected]

Cell. +45 51 30 72 06

The Danish

Beekeepers Association

FUTURE OPTIONS FOR VARROA CONTROL

Danish beekeepers have a long tradition of varroa control using organic acids in pure form following the

regulation for organic beekeeping. This practice has been developed over 30 years and introduced to all

beekeepers. The experience shows that this practice works well for beekeepers and bees. Beekeepers in

several European countries seem to prefer a practice where organic acids can be used in pure form.

With reference to dialog with DG Sante and Regulation 2019/6 new veterinary regulation (NVR), the Danish

Food Authorities has announced that all treatment of varroa in the future must only be carried out with

registered veterinary medicines (appendix 1)

The challenges of the new regulation are:

• There may be a shift towards more use of synthetic pesticides in beekeeping.

• Varroa control is complicated as multiple treatments are needed over the season and each

treatment must be adapted to the specific beekeeper management and the environmental

conditions at the time of treatment. Experience says that we need a varroa strategy, not just

individual treatments.

• Only very few products based on organic acids are registered and cannot stand alone.

• Several products have not been tested in Denmark. Furthermore, the instructions are not adapted

to Danish conditions and beehives.

Even with the ideal varroa strategy, beekeepers lose colonies every year due to Varroa problems. If

treatment options are reduced, increased colony losses must be expected. On this background we strongly

recommend that the possibilities for continued use of organic acids in pure form in beekeeping should be

investigated.

The following conditions must be noted:

• Not all transmissible animal diseases can or should be prevented and controlled through regulatory

measures, for example if the disease is too widespread, if diagnostic tools are not available, or if

the private sector can take measures to control the disease by itself (appendix 2)

• The ecology regulation states that varroa control with organic acids is only healthcare. If treated

with chemically produced allopathic products, the conversion period of 12 months applies

(appendix 3)

We kindly request to WP-honey to:

a) sharing information about the practice (implementation of the EU regulation) of availability and use of

organic varrocides in other member states

b) support for changing the interpretation or scope of the legislation in place.

Appendix 1:

Fra: [email protected] <[email protected]>

Sendt: 5. oktober 2023 16:27

Til: Anne Rath Petersen <[email protected]>

Cc: Christian Strøyer <[email protected]>; [email protected]; SANTE-VETERINARY-

[email protected]

Emne: RE: VMP - treatment of Varroa destructor in honey bees

Dear Dr Rath Petersen,

We are sorry for the delay in replying to your question.

A substance presented as having properties for treating a disease, like varroosis, would meet the definition

of ‘veterinary medicinal product’ laid down in Article 4 of Regulation (EU) 2019/6.

Regulation (EU) 2019/6 aims at ensuring a high level of public and animal health and environmental

protection. That Regulation stipulates that veterinary medicinal products within its scope can be placed on

the market only after a marketing authorisation has been granted. Once a marketing authorisation has been

granted, the veterinary medicinal products are also subject to pharmacovigilance.

In the case of food-producing species such as honeybees, the pharmacologically active substances included

in the medicinal products used need to be allowed in accordance with Regulation (EC) No 470/2009 and any

acts adopted on its basis. A withdrawal period is attached to the use of medicinal products in food-

producing animals as relevant.

There are veterinary medicinal products authorised within the EU with the indication of treatment of

Varroa destructor infestations in honeybees and containing, either alone or in combination, active

substances referred to in Annex II, Part II, point 1.9.6.3 of Regulation (EU) 2018/848 on organic production

and labelling of organic products. Those veterinary medicinal products are to be dispensed in accordance

with their classification in accordance with Article 34 and used in accordance with Article 106(1) of

Regulation (EU) 2019/6.

Only where there are no veterinary medicinal products authorised for the treatment of varroosis or those

authorised are not available in a Member State, consideration can be given to use outside the terms of the

marketing authorisation in accordance with Article 113.

We would like to draw your attention to the established principle that derogations from the Union law

governing medicinal products should be interpreted strictly.

Best regards,

SANTE VETERINARY MEDICINES

European Commission

Health and Food Safety Directorate General

Veterinary Medicines

Disclaimer:

DG SANTE’s Unit D4 is not in charge of the legal framework setting rules for organic farming.

The views expressed above are not legally binding, since only the Court of Justice of the European Union can

give an authoritative interpretation of EU law.

From: Anne Rath Petersen <[email protected]>

Sent: Wednesday, June 28, 2023 8:44 AM

To: SANTE VETERINARY MEDICINES <[email protected]>

Cc: ZAMORA ESCRIBANO Eva Maria (SANTE) <[email protected]>;

Christian Strøyer <[email protected]>

Subject: VMP - treatment of Varroa destructor in honey bees

Dear colleagues,

We hope for your assistance to clarify the following:

According to Annex II, Part II, 1.9.6.3, of Regulation 2018/848 on organic production and labelling of

organic products formic acid, lactic acid, acetic acid and oxalic acid, as well as menthol, thymol,

eucalyptol or camphor, may be used in cases of infestation with Varroa destructor in bees.

Would it be in accordance with the VMP Regulation to use the above mentioned substances, which

have not been authorised as VMPs, to treat varroa infestation in organic as well as conventional

beekeeping?

Kind regards,

Anne Rath Petersen

Special Veterinary Adviser, DVM | Animal Welfare and Veterinary Medicine

+45 72 27 69 00 | fvst.dk/contact

Ministry of Food, Agriculture and Fisheries The Danish Veterinary and Food Administration | Stationsparken 31-33 | DK 2600 Glostrup | Ph.

+45 72 27 69 00 | fvst.dk/contact | www.fvst.dk

Appendix 2:

REGULATION (EU) 2016/429 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the

area of animal health (‘Animal Health Law’)

(26) Not all transmissible animal diseases can or should be prevented and controlled through

regulatory measures, for example if the disease is too widespread, if diagnostic tools are not

available, or if the private sector can take measures to control the disease by itself. Regulatory

measures to prevent and control transmissible animal diseases may have important economic

consequences for the relevant sectors and may disrupt trade. It is therefore essential that such

measures are applied only when they are proportionate and necessary, such as when a disease

presents, or is suspected to present, a significant risk to animal or public health.

PART III DISEASE AWARENESS, PREPAREDNESS AND CONTROL

CHAPTER 2 The use of veterinary medicinal products for disease prevention and control

Article 46 The use of veterinary medicinal products for disease prevention and control

1. The Member States may take measures concerning the use of veterinary medicinal products for

listed diseases, to ensure the most efficient prevention or control of those diseases, provided that

such measures are appropriate or necessary. L 84/54 EN Official Journal of the European Union

31.3.2016 Those measures may cover the following:

(a) prohibitions and restrictions on the use of veterinary medicinal products;

(b) the compulsory use of veterinary medicinal products.

2. Member States shall take the following criteria into consideration when determining whether or

not to use, and how to use, veterinary medicinal products as prevention and control measures for a

specific listed disease:

(a) the disease profile;

(b) the distribution of the listed disease in:

(i) the Member State concerned;

(ii) the Union;

(iii) where relevant, neighbouring third countries and territories;

(iv) third countries and territories from which animals and products are

brought into the Union;

(c) the availability and effectiveness of the veterinary medicinal products in question,

and the risks attaching to them;

(d) the availability of diagnostic tests for detecting infections in animals treated with

the veterinary medicinal products concerned;

(e) the economic, social, animal welfare and environmental impact of the use of the

veterinary medicinal products concerned compared to other available disease prevention and control

strategies.

3. Member States shall take appropriate preventive measures concerning the use of veterinary

medicinal products for scientific studies or for the purposes of developing and testing them under

controlled conditions to protect animal and public health.

Appendix 3:

REGULATION (EU) 2018/848 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 May 2018 on organic production and labelling of organic products and repealing Council

Regulation (EC) No 834/2007

Part II: Livestock production rules

1.9.6. For bees

1.9.6.3. Health care

With regard to health care, the following rules shall apply:

(a) for the purposes of protecting frames, hives and combs, in particular from pests,

only rodenticides used in traps, and appropriate products and substances authorised pursuant to

Articles 9 and 24 for use in organic production shall be permitted;

(b) physical treatments for disinfection of apiaries such as steam or direct flame shall

be permitted;

(c) the practice of destroying the male brood shall only be permitted for the purpose of

isolating the infestation of Varroa destructor;

(d) if, despite all preventive measures, the colonies become sick or infested, they shall

be treated immediately and, if necessary, may be placed in isolation apiaries;

(e) formic acid, lactic acid, acetic acid and oxalic acid, as well as menthol, thymol,

eucalyptol or camphor, may be used in cases of infestation with Varroa destructor;

(f) if a treatment is applied with chemically synthesised allopathic products, including

antibiotics, other than products and substances authorised pursuant to Articles 9 and 24 for use in

organic production, for the duration of that treatment, the treated colonies shall be placed in

isolation apiaries and all the wax shall be replaced with wax coming from organic beekeeping.

Subsequently, the conversion period of 12 months laid down in point 1.2.2 shall apply to those

colonies

Rune Havgaard Sørensen

Head of Secretariat

Danish Beekeepers Association

Fulbyvej 15 - DK-4180 Sorø

www.biavl.dk

[email protected]

Cell. +45 51 30 72 06

The Danish

Beekeepers Association

FUTURE OPTIONS FOR VARROA CONTROL

Danish beekeepers have a long tradition of varroa control using organic acids in pure form following the

regulation for organic beekeeping. This practice has been developed over 30 years and introduced to all

beekeepers. The experience shows that this practice works well for beekeepers and bees. Beekeepers in

several European countries seem to prefer a practice where organic acids can be used in pure form.

With reference to dialog with DG Sante and Regulation 2019/6 new veterinary regulation (NVR), the Danish

Food Authorities has announced that all treatment of varroa in the future must only be carried out with

registered veterinary medicines (appendix 1)

The challenges of the new regulation are:

• There may be a shift towards more use of synthetic pesticides in beekeeping.

• Varroa control is complicated as multiple treatments are needed over the season and each

treatment must be adapted to the specific beekeeper management and the environmental

conditions at the time of treatment. Experience says that we need a varroa strategy, not just

individual treatments.

• Only very few products based on organic acids are registered and cannot stand alone.

• Several products have not been tested in Denmark. Furthermore, the instructions are not adapted

to Danish conditions and beehives.

Even with the ideal varroa strategy, beekeepers lose colonies every year due to Varroa problems. If

treatment options are reduced, increased colony losses must be expected. On this background we strongly

recommend that the possibilities for continued use of organic acids in pure form in beekeeping should be

investigated.

The following conditions must be noted:

• Not all transmissible animal diseases can or should be prevented and controlled through regulatory

measures, for example if the disease is too widespread, if diagnostic tools are not available, or if

the private sector can take measures to control the disease by itself (appendix 2)

• The ecology regulation states that varroa control with organic acids is only healthcare. If treated

with chemically produced allopathic products, the conversion period of 12 months applies

(appendix 3)

We kindly request to WP-honey to:

a) sharing information about the practice (implementation of the EU regulation) of availability and use of

organic varrocides in other member states

b) support for changing the interpretation or scope of the legislation in place.

Appendix 1:

Fra: [email protected] <[email protected]>

Sendt: 5. oktober 2023 16:27

Til: Anne Rath Petersen <[email protected]>

Cc: Christian Strøyer <[email protected]>; [email protected]; SANTE-VETERINARY-

[email protected]

Emne: RE: VMP - treatment of Varroa destructor in honey bees

Dear Dr Rath Petersen,

We are sorry for the delay in replying to your question.

A substance presented as having properties for treating a disease, like varroosis, would meet the definition

of ‘veterinary medicinal product’ laid down in Article 4 of Regulation (EU) 2019/6.

Regulation (EU) 2019/6 aims at ensuring a high level of public and animal health and environmental

protection. That Regulation stipulates that veterinary medicinal products within its scope can be placed on

the market only after a marketing authorisation has been granted. Once a marketing authorisation has been

granted, the veterinary medicinal products are also subject to pharmacovigilance.

In the case of food-producing species such as honeybees, the pharmacologically active substances included

in the medicinal products used need to be allowed in accordance with Regulation (EC) No 470/2009 and any

acts adopted on its basis. A withdrawal period is attached to the use of medicinal products in food-

producing animals as relevant.

There are veterinary medicinal products authorised within the EU with the indication of treatment of

Varroa destructor infestations in honeybees and containing, either alone or in combination, active

substances referred to in Annex II, Part II, point 1.9.6.3 of Regulation (EU) 2018/848 on organic production

and labelling of organic products. Those veterinary medicinal products are to be dispensed in accordance

with their classification in accordance with Article 34 and used in accordance with Article 106(1) of

Regulation (EU) 2019/6.

Only where there are no veterinary medicinal products authorised for the treatment of varroosis or those

authorised are not available in a Member State, consideration can be given to use outside the terms of the

marketing authorisation in accordance with Article 113.

We would like to draw your attention to the established principle that derogations from the Union law

governing medicinal products should be interpreted strictly.

Best regards,

SANTE VETERINARY MEDICINES

European Commission

Health and Food Safety Directorate General

Veterinary Medicines

Disclaimer:

DG SANTE’s Unit D4 is not in charge of the legal framework setting rules for organic farming.

The views expressed above are not legally binding, since only the Court of Justice of the European Union can

give an authoritative interpretation of EU law.

From: Anne Rath Petersen <[email protected]>

Sent: Wednesday, June 28, 2023 8:44 AM

To: SANTE VETERINARY MEDICINES <[email protected]>

Cc: ZAMORA ESCRIBANO Eva Maria (SANTE) <[email protected]>;

Christian Strøyer <[email protected]>

Subject: VMP - treatment of Varroa destructor in honey bees

Dear colleagues,

We hope for your assistance to clarify the following:

According to Annex II, Part II, 1.9.6.3, of Regulation 2018/848 on organic production and labelling of

organic products formic acid, lactic acid, acetic acid and oxalic acid, as well as menthol, thymol,

eucalyptol or camphor, may be used in cases of infestation with Varroa destructor in bees.

Would it be in accordance with the VMP Regulation to use the above mentioned substances, which

have not been authorised as VMPs, to treat varroa infestation in organic as well as conventional

beekeeping?

Kind regards,

Anne Rath Petersen

Special Veterinary Adviser, DVM | Animal Welfare and Veterinary Medicine

+45 72 27 69 00 | fvst.dk/contact

Ministry of Food, Agriculture and Fisheries The Danish Veterinary and Food Administration | Stationsparken 31-33 | DK 2600 Glostrup | Ph.

+45 72 27 69 00 | fvst.dk/contact | www.fvst.dk

Appendix 2:

REGULATION (EU) 2016/429 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the

area of animal health (‘Animal Health Law’)

(26) Not all transmissible animal diseases can or should be prevented and controlled through

regulatory measures, for example if the disease is too widespread, if diagnostic tools are not

available, or if the private sector can take measures to control the disease by itself. Regulatory

measures to prevent and control transmissible animal diseases may have important economic

consequences for the relevant sectors and may disrupt trade. It is therefore essential that such

measures are applied only when they are proportionate and necessary, such as when a disease

presents, or is suspected to present, a significant risk to animal or public health.

PART III DISEASE AWARENESS, PREPAREDNESS AND CONTROL

CHAPTER 2 The use of veterinary medicinal products for disease prevention and control

Article 46 The use of veterinary medicinal products for disease prevention and control

1. The Member States may take measures concerning the use of veterinary medicinal products for

listed diseases, to ensure the most efficient prevention or control of those diseases, provided that

such measures are appropriate or necessary. L 84/54 EN Official Journal of the European Union

31.3.2016 Those measures may cover the following:

(a) prohibitions and restrictions on the use of veterinary medicinal products;

(b) the compulsory use of veterinary medicinal products.

2. Member States shall take the following criteria into consideration when determining whether or

not to use, and how to use, veterinary medicinal products as prevention and control measures for a

specific listed disease:

(a) the disease profile;

(b) the distribution of the listed disease in:

(i) the Member State concerned;

(ii) the Union;

(iii) where relevant, neighbouring third countries and territories;

(iv) third countries and territories from which animals and products are

brought into the Union;

(c) the availability and effectiveness of the veterinary medicinal products in question,

and the risks attaching to them;

(d) the availability of diagnostic tests for detecting infections in animals treated with

the veterinary medicinal products concerned;

(e) the economic, social, animal welfare and environmental impact of the use of the

veterinary medicinal products concerned compared to other available disease prevention and control

strategies.

3. Member States shall take appropriate preventive measures concerning the use of veterinary

medicinal products for scientific studies or for the purposes of developing and testing them under

controlled conditions to protect animal and public health.

Appendix 3:

REGULATION (EU) 2018/848 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 May 2018 on organic production and labelling of organic products and repealing Council

Regulation (EC) No 834/2007

Part II: Livestock production rules

1.9.6. For bees

1.9.6.3. Health care

With regard to health care, the following rules shall apply:

(a) for the purposes of protecting frames, hives and combs, in particular from pests,

only rodenticides used in traps, and appropriate products and substances authorised pursuant to

Articles 9 and 24 for use in organic production shall be permitted;

(b) physical treatments for disinfection of apiaries such as steam or direct flame shall

be permitted;

(c) the practice of destroying the male brood shall only be permitted for the purpose of

isolating the infestation of Varroa destructor;

(d) if, despite all preventive measures, the colonies become sick or infested, they shall

be treated immediately and, if necessary, may be placed in isolation apiaries;

(e) formic acid, lactic acid, acetic acid and oxalic acid, as well as menthol, thymol,

eucalyptol or camphor, may be used in cases of infestation with Varroa destructor;

(f) if a treatment is applied with chemically synthesised allopathic products, including

antibiotics, other than products and substances authorised pursuant to Articles 9 and 24 for use in

organic production, for the duration of that treatment, the treated colonies shall be placed in

isolation apiaries and all the wax shall be replaced with wax coming from organic beekeeping.

Subsequently, the conversion period of 12 months laid down in point 1.2.2 shall apply to those

colonies

Rune Havgaard Sørensen

Head of Secretariat

Danish Beekeepers Association

Fulbyvej 15 - DK-4180 Sorø

www.biavl.dk

[email protected]

Cell. +45 51 30 72 06

The Danish Beekeepers Association

Over the past several decades the varroa mite has spread all over Europe. This means that beekeepers today operate their beekeeping in such a way that the population of varroa mites is kept low. It is not possible to eliminate the varroa mite like other diseases. It is therefore important that beekeepers have the widest range of options to choose between different operating methods to keep the population of varroa mites under control. If the beekeepers cannot regulate the varroa mite optimally, it will not only cause problems for the beekeeper, but also have secondary consequences for the pollination of agricultural products. In most European countries, beekeepers have a long tradition of varroa control using organic acids in the pure form, following the rules for organic beekeeping. This practice has been developed and adapted over 30 years and beekeepers have been educated in these methods. The experience shows that this practice works well for beekeepers and bees. With reference to article 4 all treatment of varroa must be carried out with registered veterinary medicines for the following reasons: - Honeybees are covered by the law. - The Varroa mite is a parasite and is considered a disease. Since the varroa mite is not a parasite that can be completely controlled in the bee colonies, and therefore must be regulated through operating methods, it is recommended that the control of varroa be exempted from Chapter 4, or at least that beekeepers can use methods based on organic acids in pure form. Only very few registered products on the marked are based on organic acids and these products cannot stand alone. A product can legally only be used as stated in the instruction. Several products have not been tested in more countries and they are not prepared for different conditions and beehives. Varroa control is complicated - multiple treatments are needed. Experience says that we need a varroa strategy, not just individual treatments. There may be a shift towards more use of synthetic pesticides in beekeeping. The organic acids, oxalic acid and formic acid, are found naturally in honey. The acids are pure, naturally occurring substances. Because oxalic acid and formic acid are found naturally in honey, a MRL (Maximum Limit Value) for these acids is not required. The typical treatments with organic acids are carried out after the last honey harvest. The bees that are treated are the generation of so-called winter bees that hatches in August-September. This generation lives 6-7 months and disappear in the early spring after ensuring the wintering of the bee colony. The winter bees are not honey-producing. The acids are applied in several different ways, which enable the beekeeper to use precisely the methods that work best in his or her beekeeping. The effectiveness of the various substances varies with temperature, humidity and the brood situation of the bees. Beehives are treated by evaporation or dripping of the organic acids to achieve a direct contact effect on the varroa mites. There is no need for the treatments to be absorbed into the bees. It is important to emphasize that treatments are only suppressing the mite population. There is no eradication. Organic acids are accepted within organic beekeeping (Annex II, Part II, 1.9.6.3, Letter e of Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labeling of organic products and on the repeal of Council Regulation (EC) No. 834/2007). The regulation on organic beekeeping refers to varroa control as health care.

FUTURE OPTIONS FOR VARROA CONTROL

NBBC – NBARS

21 - 22 March 2024

Regulation EU No 2019/6 article 4:

‘veterinary medicinal product’ means any substance or combination of substances which fulfils at least one of the following conditions: (a) it is presented as having properties for treating or preventing disease

in animals; (b) its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; (c) its purpose is to be used in animals with a view to making a medical diagnosis; (d) its purpose is to be used for euthanasia of animals;

Answer from the Commission:

• A substance presented as having properties for treating a disease, like varroosis, would meet the definition of ‘veterinary medicinal product’ laid down in Article 4 of Regulation (EU) 2019/6.

• Regulation (EU) 2019/6 aims at ensuring a high level of public and animal health and environmental protection. That Regulation stipulates that veterinary medicinal products within its scope can be placed on the market only after a marketing authorisation has been granted. Once a marketing authorisation has been granted, the veterinary medicinal products are also subject to pharmacovigilance.

THE BEEKEEPERS: Organic methods with organic acids in pure form. THE COMMISSION:

Marketed veterinary medicinal products

Legal use of varroa control products

NO CHANGES TO LEGISLATION SINCE 2007

THE EU COMMISSION: LIVESTOCK MAY ONLY BE

TREATED WITH APPROVED MEDICINES

VARROA IS A DISEASE, WHICH MEANS THAT VARROA

MUST BE TREATED WITH MARKETED VETERINARY

PRODUCTS

The challenges of the regulation: • Only very few products based on organic acids are

registered and cannot stand alone.

• A product can legally only be used as stated in the instruction. Several products have not been tested in more countries and they are not to different conditions and beehives.

• Varroa control is complicated - multiple treatments are needed. Experience says that we need a varroa strategy, not just individual treatments.

• There may be a shift towards more use of synthetic pesticides in beekeeping.

Questionnaire on varroa control

Riccardo Pelani

Policy Advisor

WP Honey

19/12/2023

Questionnaire

Are beekeepers allowed to use any varroa treatments (e.g. pure organic acids), or are they obliged to use only products that are

registered for varroa control?

FI, SE

Yes, they are allowed to use any varroa treatments.

DK

No, they are obliged to use only products that are registered for varroa control.

Nordic-Baltic region

Mediterranean region

IT, ES, PT

No, they are obliged to use only products that are registered for varroa control.

CZ, RO, AT, DE, SK, BE, NL

No, they are obliged to use only products that are registered for varroa control.

Western/Central Europe

Questionnaire

What is the most widespread varroa control practice in your country?

FI, SE, DK

Organic methods (e.g., organic acids, thymol).

Nordic-Baltic region

Mediterranean region

ES, PT

Synthetic varroacides (e.g., amitraz).

IT

Both organic methods (e.g., organic acids, thymol) and synthetic varroacides (e.g., amitraz).

AT, NL

Organic methods (e.g., organic acids, thymol).

CZ, RO, DE, SK, BE,

Both organic methods (e.g., organic acids, thymol) and synthetic varroacides.

Western/Central Europe

Questionnaire

Approximately, how many marketed, registered products are available in your

country?

Mediterranean region

ES 4 synthetic and 5 organic.

IT There are at least 15 products registered for Varroasis therapy. The active ingredients many fewer: Oxalic acid, Amitraz, Thymol, Fluvalinate, Flumethrin, Formic acid.

PT In Portugal there are 18 veterinary medicines approved for the treatment of varroosis in honeybees with 6 active ingredients.

AT, RO 18

NL 4

DE 15

SK There is a big number of allowed products, list is on: https://www.svps.sk/zvierata/vcely.asp .But there are just few used widely:

Avartin or Varidol (amitraz fumigation strips)

Ekopol and Ekovartin strips (with 4 types of essential oils)

Formidol pads (with formic acids)

Strips with oxalic acid and VarroMed solution.

BE 9

Western/Central Europe

FI In Finland, supply intermediaries have not registered any products as medicinal substances for varroa control. In principle, selective pesticides (such as amitraz, apistan, etc.) or acid-based products could be used if someone were to import them into the country and register them for use in Finland.

SE 3 (Apiguard, Apistan, Apivar).

DK 2

Nordic-Baltic region

Godkendte veterinære lægemidler

Product Active ingredience Marketed in Denmark

Apivar Amitraz -

Polyvar Flumethrin -

Apiguard Thymol +

MaqsPlus Myresyre -

Oxybee / Bienenwohl

Oxalsyre (+)

VarroMed Oxalsyre + Myresyre -

Questionnaire

If the beekeepers could choose freely, what would be their preferred option for varroa

treatment?

FI, SE, DK

Organic acids that they mix themselves.

Nordic-Baltic region

Mediterranean region

ES, PT

Registered products as there is growing concern among beekeepers about the effectiveness and safety of so-called homemade treatments. This concern, and the fact that there is a wide availability and variety of approved veterinary medicines on the market, means that there is no demand (and need) to resort to homemade treatments.

IT Both registered products and organic acids that they mix temselves. There is an awareness that the control of the correct use of medicines is a guarantee of the food safety of products and therefore of their quality. However, often in the commercial formulations available on the market there are co-formulants ( sugar, glycerol, water) that make their use not easy.

AT, DE, SK

Registered products with the exception in DE of oxalic acid for sublimation, since it was not registered until September.

BE, NL

Organic acids that they mix themselves.

CZ

The beekeepers can choose freely between the authorised veterinary medicine products and their suppliers. There are plenty of preferences between more than 70.000 beekeepers in the country, so it is difficult to pick up a trend.

Western/Central Europe

Questionnaire

If any, what are the main problems experience by beekeepers for using veterinary medicines

for varroa control?

FI

Availability: With Apistan, it was observed that the residues in the wax (and also in the honey) increased year by year. Varroa became resistant to the active ingredient in Apistan, and at that point, there was a shift to using natural acids.

SE

Prices.

Nordic-Baltic region

Mediterranean region

ES Lack of effectiveness.

PT, IT Prices. In Italy, to date, there is an excessive gap between free active ingredients (see oxalic acid) and their registered commercial formulations. This situation is a critical issue that limits the widespread use of registered products. The fight against varroa has a non marginal impact on the costs of maintaining the hive. The availability of health products on the market is generally not problematic, currently there is no need for veterinary prescription. A problem is also posed by the inadequacy of the formulations on the market, e.g. the only product authorised for sublimation is inadequate due to its sugar content.

AT, DE Prices. In Germany, hardly any medicament needs an prescription. They are all available. There is no shortage. The prices of the medicaments can be reduced when buying them e.g. via the beekeeping club due to subventions. But the prices might be one reason why some prefer to use unregsitered products such as technical formic acid.

BE, RO Prices and availability.

NL Prices, need for prescription.

CZ Their efficacy in controlling the varroa mite, their mode of use (more or less work and disturbance of the colony), then the price.

Western/Central Europe

The Danish Beekeepers' Association focus:

- that veterinary medicines based on organic acids and thymol are marketed in Denmark, which give beekeepers the best future options for varroa control, and preferably methods that are as close to current practice as possible

- in cooperation with other countries to continue the political process and challenge the EU's regulations, so that beekeepers have the best possible conditions for varroa control

Aiming to get the following approvals in Denmark, Sweden, Norway and Finland:

• Varroxal, for dripping, spraying and vaporizing

• Varroxal 0.71g/g beehive powder

• Thymovar

• FORMIVAR® 60 and 85 Still checking the possibility of integrating for Denmark (In Germany only 60% is approved at the moment)

How long this will take and how quickly it will happen is now an open question.

EVALUATION Deadline: 3rd of April

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14036-Animal-Health-Law-evaluation_en

Thank you

Rune Havgaard Sørensen

Head of Secretariat

Danish Beekeepers Association

Fulbyvej 15 - DK-4180 Sorø

www.biavl.dk

[email protected]

Cell. +45 51 30 72 06

The Danish Beekeepers Association

Over the past several decades the varroa mite has spread all over Europe. This means that beekeepers today operate their beekeeping in such a way that the population of varroa mites is kept low. It is not possible to eliminate the varroa mite like other diseases. It is therefore important that beekeepers have the widest range of options to choose between different operating methods to keep the population of varroa mites under control. If the beekeepers cannot regulate the varroa mite optimally, it will not only cause problems for the beekeeper, but also have secondary consequences for the pollination of agricultural products. In most European countries, beekeepers have a long tradition of varroa control using organic acids in the pure form, following the rules for organic beekeeping. This practice has been developed and adapted over 30 years and beekeepers have been educated in these methods. The experience shows that this practice works well for beekeepers and bees. With reference to article 4 all treatment of varroa must be carried out with registered veterinary medicines for the following reasons: - Honeybees are covered by the law. - The Varroa mite is a parasite and is considered a disease. Since the varroa mite is not a parasite that can be completely controlled in the bee colonies, and therefore must be regulated through operating methods, it is recommended that the control of varroa be exempted from Chapter 4, or at least that beekeepers can use methods based on organic acids in pure form. Only very few registered products on the marked are based on organic acids and these products cannot stand alone. A product can legally only be used as stated in the instruction. Several products have not been tested in more countries and they are not prepared for different conditions and beehives. Varroa control is complicated - multiple treatments are needed. Experience says that we need a varroa strategy, not just individual treatments. There may be a shift towards more use of synthetic pesticides in beekeeping. The organic acids, oxalic acid and formic acid, are found naturally in honey. The acids are pure, naturally occurring substances. Because oxalic acid and formic acid are found naturally in honey, a MRL (Maximum Limit Value) for these acids is not required. The typical treatments with organic acids are carried out after the last honey harvest. The bees that are treated are the generation of so-called winter bees that hatches in August-September. This generation lives 6-7 months and disappear in the early spring after ensuring the wintering of the bee colony. The winter bees are not honey-producing. The acids are applied in several different ways, which enable the beekeeper to use precisely the methods that work best in his or her beekeeping. The effectiveness of the various substances varies with temperature, humidity and the brood situation of the bees. Beehives are treated by evaporation or dripping of the organic acids to achieve a direct contact effect on the varroa mites. There is no need for the treatments to be absorbed into the bees. It is important to emphasize that treatments are only suppressing the mite population. There is no eradication. Organic acids are accepted within organic beekeeping (Annex II, Part II, 1.9.6.3, Letter e of Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labeling of organic products and on the repeal of Council Regulation (EC) No. 834/2007). The regulation on organic beekeeping refers to varroa control as health care.

FUTURE OPTIONS FOR VARROA CONTROL

NBBC – NBARS

21 - 22 March 2024

Regulation EU No 2019/6 article 4:

‘veterinary medicinal product’ means any substance or combination of substances which fulfils at least one of the following conditions: (a) it is presented as having properties for treating or preventing disease

in animals; (b) its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; (c) its purpose is to be used in animals with a view to making a medical diagnosis; (d) its purpose is to be used for euthanasia of animals;

Answer from the Commission:

• A substance presented as having properties for treating a disease, like varroosis, would meet the definition of ‘veterinary medicinal product’ laid down in Article 4 of Regulation (EU) 2019/6.

• Regulation (EU) 2019/6 aims at ensuring a high level of public and animal health and environmental protection. That Regulation stipulates that veterinary medicinal products within its scope can be placed on the market only after a marketing authorisation has been granted. Once a marketing authorisation has been granted, the veterinary medicinal products are also subject to pharmacovigilance.

THE BEEKEEPERS: Organic methods with organic acids in pure form. THE COMMISSION:

Marketed veterinary medicinal products

Legal use of varroa control products

NO CHANGES TO LEGISLATION SINCE 2007

THE EU COMMISSION: LIVESTOCK MAY ONLY BE

TREATED WITH APPROVED MEDICINES

VARROA IS A DISEASE, WHICH MEANS THAT VARROA

MUST BE TREATED WITH MARKETED VETERINARY

PRODUCTS

The challenges of the regulation: • Only very few products based on organic acids are

registered and cannot stand alone.

• A product can legally only be used as stated in the instruction. Several products have not been tested in more countries and they are not to different conditions and beehives.

• Varroa control is complicated - multiple treatments are needed. Experience says that we need a varroa strategy, not just individual treatments.

• There may be a shift towards more use of synthetic pesticides in beekeeping.

Questionnaire on varroa control

Riccardo Pelani

Policy Advisor

WP Honey

19/12/2023

Questionnaire

Are beekeepers allowed to use any varroa treatments (e.g. pure organic acids), or are they obliged to use only products that are

registered for varroa control?

FI, SE

Yes, they are allowed to use any varroa treatments.

DK

No, they are obliged to use only products that are registered for varroa control.

Nordic-Baltic region

Mediterranean region

IT, ES, PT

No, they are obliged to use only products that are registered for varroa control.

CZ, RO, AT, DE, SK, BE, NL

No, they are obliged to use only products that are registered for varroa control.

Western/Central Europe

Questionnaire

What is the most widespread varroa control practice in your country?

FI, SE, DK

Organic methods (e.g., organic acids, thymol).

Nordic-Baltic region

Mediterranean region

ES, PT

Synthetic varroacides (e.g., amitraz).

IT

Both organic methods (e.g., organic acids, thymol) and synthetic varroacides (e.g., amitraz).

AT, NL

Organic methods (e.g., organic acids, thymol).

CZ, RO, DE, SK, BE,

Both organic methods (e.g., organic acids, thymol) and synthetic varroacides.

Western/Central Europe

Questionnaire

Approximately, how many marketed, registered products are available in your

country?

Mediterranean region

ES 4 synthetic and 5 organic.

IT There are at least 15 products registered for Varroasis therapy. The active ingredients many fewer: Oxalic acid, Amitraz, Thymol, Fluvalinate, Flumethrin, Formic acid.

PT In Portugal there are 18 veterinary medicines approved for the treatment of varroosis in honeybees with 6 active ingredients.

AT, RO 18

NL 4

DE 15

SK There is a big number of allowed products, list is on: https://www.svps.sk/zvierata/vcely.asp .But there are just few used widely:

Avartin or Varidol (amitraz fumigation strips)

Ekopol and Ekovartin strips (with 4 types of essential oils)

Formidol pads (with formic acids)

Strips with oxalic acid and VarroMed solution.

BE 9

Western/Central Europe

FI In Finland, supply intermediaries have not registered any products as medicinal substances for varroa control. In principle, selective pesticides (such as amitraz, apistan, etc.) or acid-based products could be used if someone were to import them into the country and register them for use in Finland.

SE 3 (Apiguard, Apistan, Apivar).

DK 2

Nordic-Baltic region

Godkendte veterinære lægemidler

Product Active ingredience Marketed in Denmark

Apivar Amitraz -

Polyvar Flumethrin -

Apiguard Thymol +

MaqsPlus Myresyre -

Oxybee / Bienenwohl

Oxalsyre (+)

VarroMed Oxalsyre + Myresyre -

Questionnaire

If the beekeepers could choose freely, what would be their preferred option for varroa

treatment?

FI, SE, DK

Organic acids that they mix themselves.

Nordic-Baltic region

Mediterranean region

ES, PT

Registered products as there is growing concern among beekeepers about the effectiveness and safety of so-called homemade treatments. This concern, and the fact that there is a wide availability and variety of approved veterinary medicines on the market, means that there is no demand (and need) to resort to homemade treatments.

IT Both registered products and organic acids that they mix temselves. There is an awareness that the control of the correct use of medicines is a guarantee of the food safety of products and therefore of their quality. However, often in the commercial formulations available on the market there are co-formulants ( sugar, glycerol, water) that make their use not easy.

AT, DE, SK

Registered products with the exception in DE of oxalic acid for sublimation, since it was not registered until September.

BE, NL

Organic acids that they mix themselves.

CZ

The beekeepers can choose freely between the authorised veterinary medicine products and their suppliers. There are plenty of preferences between more than 70.000 beekeepers in the country, so it is difficult to pick up a trend.

Western/Central Europe

Questionnaire

If any, what are the main problems experience by beekeepers for using veterinary medicines

for varroa control?

FI

Availability: With Apistan, it was observed that the residues in the wax (and also in the honey) increased year by year. Varroa became resistant to the active ingredient in Apistan, and at that point, there was a shift to using natural acids.

SE

Prices.

Nordic-Baltic region

Mediterranean region

ES Lack of effectiveness.

PT, IT Prices. In Italy, to date, there is an excessive gap between free active ingredients (see oxalic acid) and their registered commercial formulations. This situation is a critical issue that limits the widespread use of registered products. The fight against varroa has a non marginal impact on the costs of maintaining the hive. The availability of health products on the market is generally not problematic, currently there is no need for veterinary prescription. A problem is also posed by the inadequacy of the formulations on the market, e.g. the only product authorised for sublimation is inadequate due to its sugar content.

AT, DE Prices. In Germany, hardly any medicament needs an prescription. They are all available. There is no shortage. The prices of the medicaments can be reduced when buying them e.g. via the beekeeping club due to subventions. But the prices might be one reason why some prefer to use unregsitered products such as technical formic acid.

BE, RO Prices and availability.

NL Prices, need for prescription.

CZ Their efficacy in controlling the varroa mite, their mode of use (more or less work and disturbance of the colony), then the price.

Western/Central Europe

The Danish Beekeepers' Association focus:

- that veterinary medicines based on organic acids and thymol are marketed in Denmark, which give beekeepers the best future options for varroa control, and preferably methods that are as close to current practice as possible

- in cooperation with other countries to continue the political process and challenge the EU's regulations, so that beekeepers have the best possible conditions for varroa control

Aiming to get the following approvals in Denmark, Sweden, Norway and Finland:

• Varroxal, for dripping, spraying and vaporizing

• Varroxal 0.71g/g beehive powder

• Thymovar

• FORMIVAR® 60 and 85 Still checking the possibility of integrating for Denmark (In Germany only 60% is approved at the moment)

How long this will take and how quickly it will happen is now an open question.

EVALUATION Deadline: 3rd of April

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14036-Animal-Health-Law-evaluation_en

Thank you